Evaluation of the impact of Responsible Pharmacist Regulations

Transcription

1 Evaluation of the impact of Responsible Pharmacist Regulations 2011 TNS UK Limited JN September TNS UK Ltd 1 Page

2 Contents Contents Executive Summary Introduction The working environment Awareness and understanding of the Regulations Implementation of the Regulations Impact of the Regulations Barriers and facilitators Stakeholder workshop findings Conclusions and Recommendations Appendix 1. Research method Appendix 2. Questionnaire development Appendix 3. Weighting of the quantitative data Appendix 4. Sample profile Appendix 5. Additional data and findings Appendix 6. Questionnaires Appendix 7. Topic guide and materials TNS UK Ltd 1 Page

3 Executive Summary Executive Summary Impact evaluation of the Responsible Pharmacist Regulations Background The Responsible Pharmacist Regulations 1 came into force in October 2009, creating a legal duty for the pharmacist to ensure the safe and effective running of the pharmacy at all times. The Regulations built on the 1968 Medicines Act, which governs the sale and supply of medicine, and sought to bring clarity to the role and responsibilities of the pharmacist as well as to support pharmacists in developing their clinical role 2. A second phase of amendments to the Act, involving changes to the supervision requirements, will follow a public consultation this autumn. In this context, the Royal Pharmaceutical Society and Professional Forum of the Pharmaceutical Society of Northern Ireland commissioned TNS BMRB to carry out an independent evaluation of the impact of the Responsible Pharmacist Regulations, headlines of which are provided below. Research objectives The overarching aim of the research was to understand from practitioners whether the Responsible Pharmacist Regulations have delivered on their policy intent of supporting an increased clinical role alongside safe and effective running of the pharmacy. Specific research objectives are as follows: To assess comprehension amongst pharmacy staff of the Responsible Pharmacist Regulations and the extent of compliance To understand how the Regulations are being enacted in practice To capture views to determine the perceived advantages and disadvantages of the Regulations (operational and strategic) 1 The Medicines (Pharmacies) (Responsible Pharmacist) Regulations (2008). Available at: The Responsible Pharmacist: Consultation on the Content of the Responsible Pharmacist Regulation. Department of Health (2007:16), Sections 1.4, p.13. Also covered in Section 5.6, p TNS UK Ltd 2 Page

4 Executive Summary To measure impact on patient safety and on clinical leadership, extension of services and personalised care To highlight solutions to any issues arising in terms of barriers to implementation or impact and build ownership of them in the process. Research method The study used a mixed method quantitative and qualitative methodology, engaging 2,028 pharmacists and 509 support staff via online and paper based surveys, with an additional 45 in depth telephone interviews and five in situ case studies. The sample included all pharmacy settings affected by the Regulations. The main data capture was informed by a development phase involving a review of grey literature, interviews with stakeholders and pilot and scoping interviews with pharmacists and support staff. It was followed by a stakeholder event designed to take findings forward and agree on any areas for change. Summary of findings The Regulations were being introduced into a context of overall job satisfaction, but with distinct frustrations around breaks, training and, in the community sector in particular, a degree of stress relating to taking on more roles and services with the same or less staff. Throughout the findings, key variables affecting response to the Regulations were: the pharmacy setting (and specifically the type of community pharmacy); the amount of time spent as RP; and, whether worked as a locum these are highlighted in the main body of the report. The research found high awareness of the Regulations and around nine in ten of both pharmacists and support staff understood the basic requirements for record keeping, overall legal accountability for the safe and effective running of the pharmacy and having a single responsible pharmacist (RP) in charge at all times. There was less clarity around how the Regulations work in practice, in relation to: Absence, with one in four (26) pharmacists and four in ten (39) members of support staff incorrectly believing that the RP could be absent for more than two hours if another pharmacist was present; The RP s role in establishing roles and responsibilities of other members of staff and in establishing, maintaining and reviewing pharmacy procedures; Lines of responsibility between the RP and the superintendent, with only half of pharmacists (53) and support staff (46) being clear on this; The legal requirement to keep the record: almost a third did not know it was a criminal offence not to do this TNS UK Ltd 3 Page

5 Executive Summary Qualitatively, there was found to be much lower awareness of the policy intent of the Regulations; with some interpretation of a link to patient safety but very little to supporting more personalised care and enhancing the pharmacist's clinical role 3. Nine in ten RPs think they have implemented the Regulations well and, qualitatively, the processes did seem to be in place, particularly with regard to SOPs and the record. Processes were not necessarily translating into practice, with: Only around one in three RPs believing they have the authority to make changes to SOPs and staff roles and responsibilities and fewer (18 and 25 respectively) having done so; Only four in ten (43) locums reading the SOPs at all or most of the premises that they work in as an RP, a quarter (24) never doing this and one in five (20) doing so at very few premises where they work. Distinct barriers to using the absence provision: Qualitatively, in terms of perceptions of pressure from employers and patients and lack of perceived need; and Both qualitatively and quantitatively, in terms of a strong professional culture of being present with 44 strongly disagreeing, irrespective of the Regulations, that a pharmacy should be able to continue to operate while the pharmacist is absent. Seven in ten pharmacists agreed that the Regulations put the RP in a difficult position by making them legally responsible for people and processes outside their control; qualitatively, this was driving behaviours which were felt to undermine patient safety, as well as adding professional stress and workplace tension. Just over half of pharmacists (54) felt that the Regulations had had no impact; reasons given qualitatively were that SOPs had already been in place, very few pharmacists were making use of absence, and some felt that the level of responsibility and accountability had not changed. Perceived changes were largely operational with some negatives for pharmacists around administrative/paperwork (26) and breaks (14) and benefits around patient safety (12) Support staff were generally more positive than pharmacists overall, and particularly about patient safety (20) and the quality of patient care (15) However, there was also evidence that the Regulations were driving RPs towards more defensive practice: Half of pharmacists (46) felt they should be more empowered to exercise professional judgement but in reality need to follow SOPs more closely. 3 As was the intention of the Regulations as stated in the Responsible Pharmacist: Consultation on the Content of the Responsible Pharmacist Regulation. Department of Health (2007:16), Sections 1.4, p.13. Also covered in Section 5.6, p TNS UK Ltd 4 Page

6 Executive Summary Similarly, half (45) thought the Regulations made the use of SOPs more important to protect them from accusations of unprofessional behaviour. Few changes were perceived in terms of professional empowerment and little impact on autonomy; less than one in five pharmacists felt the Regulations had empowered them to exercise their personal professional judgement (17) or had allowed them greater personal control (16). However, in a few cases where SOPs were written as a team, positive effects on team work, efficiency and likelihood for the SOPs to be practicable were reported. The qualitative research revealed a fundamental tension within the Regulations between a perception of a broadened definition of legal accountability on the one hand driving RPs to be more present, and the absence provisions on the other. Contextual factors were compounding the pressure to remain physically present and preventing a greater clinical role: commercial and customer demands for continual access to medicines; a perceived lack of authority to make changes to the working environment; a lack of clarity about what legal responsibilities meant for practice and the professional identity of the pharmacist (rooted firmly in physical presence in the pharmacy). Around half of pharmacists felt having the right mix of staff (58) and better training (46) would aid the implementation of the Regulations; qualitatively, it was felt that better team working and effective relationships with senior management enabled an increased sense of ownership of the Regulations and authority to make changes. Summary of conclusions and recommendations Eight recommendations have emerged from the research 1. Distinguish the responsibilities between the RP and the superintendent/ owner There is a need to distinguish the responsibilities between the RP and the superintendent/ owner. Overall, superintendents or owners should have responsibilities for matters relating to the business and premises. The RP should be responsible for the local implementation of the SOPs and matters relating to the care of the patients. There was consensus around the need for professional bodies, working with regulators, to provide guidance around the interpretation of the Regulations and demonstrating how the regulations should be enacted in practice. There was little agreement around the need for regulatory changes to enable this TNS UK Ltd 5 Page

7 Executive Summary 2. Empower the RP to make decisions around how absence is used as well as to make changes to safety procedures There is a need to empower RPs to operate with sufficient levels of control to make decisions around absences and changes to the SOPs. Clear guidance is needed on how absence should be used and contractual frameworks may need to be reviewed in this context. The circumstances under which superintendents are able to overrule the authority of an RP also need to be clarified. 3. Provide clarity on the role of the technician and liability in relation to dispensing errors There is an opportunity to provide greater clarity on the role of the technician through the current registration process and the consultation on supervision. Again, through the use of scenarios, the professional bodies and regulators 4 need to make these issues real for pharmacy teams, describing how liability plays out in practice. Some stakeholders suggested that there is a need to remove the criminality from a single dispensing error. In the context of this review, this issue is not directly related to RP regulations, but rather would require changes to primary legislation. This would be difficult to achieve in the short term. 4. Clarify the policy intent around absence; define what can be done; enable the clinical role of the pharmacist. There is a need to clearly communicate the policy intent around the absence provision in the Regulations, to enable the clinical role of pharmacists. 3. Absence should be positioned as allowing RPs greater flexibility in decisions around their clinical role. Greater clarity on what activities can be undertaken in the absence of the RP is also required and should be looked at in the context of supervision. 5. Reduce the complexity of SOPs to a minimal standardised framework Despite local variation, there is a need to move away from detailed and prescriptive sets of SOPs, and produce a minimal standardised framework in which professional judgement is valued. One option could be for employers to work with professional bodies, regulators and pharmacy organisations to agree where there are commonalities across the profession and develop a core set of procedures. 4 In Northern Ireland, where the PSNI does not currently have statutory powers to register technicians, further consideration needs to be given to relative responsibilities in the current situation TNS UK Ltd 6 Page

8 Executive Summary 6. Address the poor strategic fit with hospitals There is a poor operational and strategic fit between the regulations and the needs and/or structures of hospitals. Either the regulations should be disapplied in hospital settings (an option noted in the stakeholder meeting) or there needs to be fundamental changes to enable provision for that sector. 7. Address the impact on locums A locum test concerning how the regulations will be enacted in practice should be developed to minimise the negative impact of the regulations on locums. 8. Ensure the Regulations are future facing, accommodating changing models of professional practice Any changes to professional leadership, regulatory practice or the legal framework needs to be set in the context of where the profession is going. Specifically, as well as policy drivers around local empowerment, patient focus and personalised care, the industry is moving from a volume based contract to one focused on service provision. Scenarios developed by professional bodies and regulators should consider what safe and effective care will look like in the coming years, accounting for political, economic, social and technical drivers. Specifically, they should consider whether any professional or regulatory response has the flexibility to meet the future demands of the profession. There is now an opportunity to work across the profession to aspire and help co create this shared vision of the future TNS UK Ltd 7 Page

9 Introduction 1. Introduction The policy background to the RP Regulations, objectives of the research and how the research was designed and delivered 1.1 Background Policy background The Responsible Pharmacist Regulations 5 came into force in October 2009, creating a legal duty for the responsible pharmacist (RP) to ensure the safe and effective running of the pharmacy at all times. The Regulations built on the 1968 Medicines Act, which governs the sale and supply of medicine, and sought to bring clarity to the role and responsibilities of the pharmacist as well as to support pharmacists in developing their clinical role 6. Specifically, the Regulations were intended, together with the introduction of changes to the NHS community pharmacy contractual arrangements in England, to support: patient safety patient access to medicines the pharmacist s clinical role more personalised care for patients Government s intention is that these aims are delivered via a two part legislative change process, of which the Responsible Pharmacist Regulations were the first part, and changes to supervision, due to be consulted on this autumn, form the second. The Regulations (discussed in more depth below) focus on a range of administrative requirements and specifically define the legal and other duties of the RP. This includes the need to maintain a written record and display a notice naming the RP in charge of the pharmacy at all times; together with responsibility to establish standard operating procedures to guide the ordering, preparation, dispensing and sale of medicines. In addition to these administrative duties, the Regulations also provide rules on the RP s absence from the pharmacy limited to two hours during business hours. 5 The Medicines (Pharmacies) (Responsible Pharmacist) Regulations (2008). Available at: The Responsible Pharmacist: Consultation on the Content of the Responsible Pharmacist Regulation. Department of Health (2007:16) = Sections 1.4, p.13. Also covered in Section 5.6, p TNS UK Ltd 8 Page

10 Introduction These three strands effective procedures, clear accountability and absence provide the policy intent of the Regulations: promoting safe and effective pharmacy practice; and enabling pharmacists to work more flexibly and play a greater clinical role beyond the pharmacy (for instance by attending meetings with GPs; or arranging domiciliary appointments with patients). In order to enable this wider clinical role in the community, the Government decided to make phased changes to the Medicines Act To date, the Regulations make changes to the personal control requirements of the Act to enable absence of the responsible pharmacist. Changes to the supervision requirements (which control the sale or supply of medicines in pharmacies) will follow a public consultation this autumn. In this context, the Royal Pharmaceutical Society and Professional Forum of the Pharmaceutical Society of Northern Ireland commissioned TNS BMRB to carry out an independent evaluation of the impact of the Responsible Pharmacist Regulations, objectives of which are provided in Section Content of Regulations The Regulations are relatively succinct and cover four key areas of practice: 1. Display of a notice 2. Pharmacy records 3. Pharmacy procedures 4. Absence from the pharmacy Display of a notice Regulations state that the RP must display a notice conspicuously stating: Their name Their registration number The fact that they are in charge of the pharmacy at that time If the RP is absent from the pharmacy, they should not remove the notice even if there is a second pharmacist in the pharmacy. Only if the RP changes throughout the day, should the name and registration number on the notice change. Pharmacy record The pharmacy record is a written log of who the RP is at all times. The RP is responsible for ensuring the following information is recorded: Responsible pharmacist s name Registration number 2011 TNS UK Ltd 9 Page

11 Introduction Date and time they signed on and signed off being the responsible pharmacist In relation to any absences while signed on, the RP must also record: date, time of departure and time of return. The record has to be kept in written or electronic form and be available at the premises for inspection. The pharmacy owner or superintendent pharmacist must keep the pharmacy record for a period of no less than five years. Failure to complete the record, or keep it, is a criminal offence. Pharmacy procedures The pharmacy procedures are a written record of the standard operating procedures (SOPs) that govern the safe and effective running of a pharmacy. They cover the following. 1. Arrangements to secure that medicinal products are: ordered stored prepared sold by retail supplied in circumstances corresponding to retail sale delivered outside the pharmacy and disposed of in a safe and effective manner 2. The circumstances in which a member of pharmacy staff who is not a pharmacist may give advice about medicinal products 3. The identification of members of pharmacy staff who are, in the view of the RP, competent to perform specified tasks relating to the pharmacy business 4. The keeping of records about the matters mentioned above (in 1) 5. Arrangements which apply during the absence of the RP from the premises 6. Steps to be taken when there is a change of RP at the premises 7. The procedure which is to be followed if a complaint is made about the pharmacy business 8. The procedure which is to be followed if an incident occurs which may indicate that the pharmacy business is not running in a safe and effective manner 9. The manner in which changes to the pharmacy procedures are to be notified to the staff Procedures must be recorded in written or electronic form, be available at the premises for inspection, and be regularly reviewed TNS UK Ltd 10 Page

12 Introduction Absence of the responsible pharmacist The absence element of the Regulations provides rules around the RP s absence from the pharmacy. Specifically, the RP can be absent from the pharmacy for a maximum of two hours, during the operational hours of the pharmacy, between midnight and midnight. The total period of absence allowed for all the responsible pharmacists during one 24 hour period must not exceed two hours. An RP who is absent must: Only be absent if the pharmacy can continue to run safely and effectively Remain contactable Be able to return with reasonable promptness, and do so where they feel it is necessary Where being able to be contacted or return is not practicable, arrangements to ensure another pharmacist is available to staff is required. Only General Sales List (GSL) medicines can be sold in the absence of the RP, unless there is a second pharmacist on premises Scoping the study Prior to the research, a review was undertaken of published and grey literature (including online forums) to scope anecdotal evidence of the impact of the Regulations and help frame potential questions for respondents in the study. To complement this, 10 stakeholder interviews and 5 initial interviews with pharmacists and support staff were also conducted. Key issues which were raised by this process as meriting exploration in the evaluation are summarised below. Understanding the regulations: levels of awareness or comprehension of the regulations. Clarity on absence: understanding of details of the absence rule, particularly whether rest breaks were covered through absence and whether legislation would conflict with the EU working time directive. Professional standards and liability: extent of concern that the RP may be held legally accountable for dispensary errors made by pharmacy support staff. SOPs: Level of control in shaping SOPs in multiple chains (hereafter called multiples ); the extent to which SOPs are rigidly stuck to TNS UK Ltd 11 Page

13 Introduction Locums: extent of concern that locums could be held legally accountable for pharmacy procedures they are not familiar with. Professional autonomy: the balance of power and responsibility between RPs, superintendents and owners (particularly in multiples or supermarkets). Pharmacy record: extent to which RP s are being signed on in their absence by employers or other staff (for instance if late into work). Impact in hospitals: understanding the extent to which the regulations impact on hospital dispensing, in the context of predominantly ward based dispensing settings. 1.2 Research Objectives The overarching aim of the research is to understand from practitioners whether the Responsible Pharmacist Regulations have delivered on their policy intent of supporting an increased clinical role alongside safe and effective running of the pharmacy. Specific research objectives are as follows: To assess comprehension amongst pharmacy staff of the Responsible Pharmacist Regulations and the extent of compliance To understand how the Regulations are being enacted in practice To capture views to determine the perceived advantages and disadvantages of the Regulations (operational and strategic) To measure impact on patient safety and on the clinical role, extension of services and personalised care To highlight solutions to any issues arising in terms of barriers to implementation or impact and build ownership of them in the process. 1.3 Research methodology The research comprised of three stages: A scoping and development stage comprising desk research, 10 stakeholder and 5 pharmacist interviews, questionnaire development and testing; The main data capture stage: online and postal surveys sent to pharmacists and support staff, five qualitative area based case studies, and 45 qualitative telephone depth interviews; Analysis, testing and solutions: presentation of interim findings, an open space stakeholder workshop to reflect on findings and generate solutions; reporting TNS UK Ltd 12 Page

14 Introduction The research approach is summarised in Figure 1.1. More detail is available in Appendix 1. Figure 1.1 Research approach The quantitative research provides statistically representative findings among pharmacists which can be generalised to the wider pharmacist population, giving a robust measure of how widespread an attitude and behaviour is, and the extent of its impact. Findings among support staff should be treated as indicative only (see Section ). The qualitative research provides interpretative information behind these figures, to provide a deeper understanding of the issues underlying the quantitative findings. Further information on all elements of the method is provided in Appendix Profile of the sample Quantitative sample The quantitative survey was sent out by post to 8,000 pharmacists, across Great Britain and Northern Ireland, with the number in Scotland, Wales and Northern Ireland overrepresented to allow for more robust analysis in these smaller nations, but then reweighted back to correct proportions (see Appendix 3). In total, 2,028 pharmacists and 509 members of support staff responded to the survey TNS UK Ltd 13 Page

15 Introduction Pharmacists Of the 2,028 pharmacists who responded to the survey, 1,845 worked in sectors affected by the Responsible Pharmacist Regulations (community, hospital, primary care, prison or internet). The remaining 183 worked solely in industry, academia, or other environments, so were not eligible for the main survey. A breakdown by sector, across all survey respondents is included in Appendix 4. This section provides a profile of the 1,845 pharmacists who responded to the survey and worked in sectors affected by the Regulations, and are therefore the focus of this report. The data are weighted to reflect the overall profile of pharmacists working in Great Britain and Northern Ireland. One in five pharmacists held more than one job, with some of these working across multiple sectors. Of those who worked in any sector affected by the Regulations, 76 worked for at least some of the time in community pharmacies, 22 in hospital pharmacies, 10 in primary care and <1 in prisons and internet pharmacies. Analysis throughout this report is carried out based on main sector of employment 7, which is summarised in Table 1.2. Overall there was little difference by nation, although those in Wales and Northern Ireland were less likely to work in primary care as their main employment. Table 1.2 Pharmacists main sector of employment Sector Total England Scotland Wales Northern Ireland Base: All in sectors affected by Regs (1,845) (1,261) (146) (229) (209) Community Hospital Primary care * 2* Prison <1 <1 Internet <1 <1 Other 1 1 <1 2 2 * Indicates a significant difference from the total All those who worked in community pharmacies were asked in which type of community pharmacy they held their position most often, even if their main job was outside of community pharmacy. Half (51) worked in large multiples, with independents accounting for the next largest group (21), as illustrated in Table 1.3. Key differences by nation were: 7 Where the main sector of employment was in a sector not affected by the Regulations (1 of all who worked in sectors affected by the Regulations), main sector is considered to be the job done most often from those within the five sectors affected by the Regulations TNS UK Ltd 14 Page

16 Introduction Pharmacists working in community pharmacies in Scotland were more likely to work in small chains and less likely to work in supermarkets Pharmacists working in community pharmacies in Northern Ireland were more likely to work in independents and less likely to work in supermarkets Table 1.3 Community pharmacists main place of work Community pharmacy type Total England Scotland Wales Northern Ireland Base: All community pharmacists (1,445) (996) (104) (187) (158) Independent pharmacy * Small chain (2 4 stores) * Medium sized multiple (5 25 stores) Large multiple (over 25 stores) Supermarket chain * 7 1* * Indicates a significant difference from the total Both pharmacy setting and type of community pharmacy were found to be key variables affecting response to the Responsible Pharmacist Regulations. Where applicable, this is highlighted in the main body of the report. Further employment related factors, such as number of other staff worked with and weekly numbers of prescriptions were typically linked to these broader measures and are covered in Appendix 4. Whether and for what proportion of the time pharmacists worked as an RP (Chart 1.4) and whether or not they worked as a locum (Chart 1.5) were also key factors affecting response to the Responsible Pharmacist Regulations. Six in ten (63) of those who worked in a pharmacy held the position of responsible pharmacist all the time that they were working in the pharmacy (Chart 1.4). As would be expected, this was higher among those who worked in a community pharmacy as their main job (78 compared with just 11 of those who worked in a hospital pharmacy as their main job). This was, however, lower in supermarket pharmacies (59) than other community pharmacies. Almost half (48) of those who worked in a hospital as their main job held the position of responsible pharmacist less than a quarter of the time they were working in the pharmacy, with this role typically being shared between a large number of staff. Those working with fewer other staff, those in less busy pharmacies (defined by the estimated number of weekly prescriptions issued) and those in rural areas were also more likely to always take the role of responsible pharmacist. These variables are clearly linked, 2011 TNS UK Ltd 15 Page

17 Introduction being driven by the size of pharmacy, which in many cases is driven by its type. Always taking the role of RP was also more likely among those who worked as locums. Chart 1.4 Proportion of time working as a responsible pharmacist * Indicates a significant difference from the total Pharmacists in Northern Ireland were less likely than those in the UK as a whole to hold the role of responsible pharmacist all the time (52 compared with 63) and more likely to hold this role less than three quarters of the time (26 compared with 18). This is perhaps a little surprising as Northern Ireland pharmacists were more likely to work in independent pharmacies (29 compared with 21 Table 1.3). There is no clear evidence of why this might be, but it is possible that it reflects different modes of working compared with the other nations Locums Three in ten (31) worked as a locum at the time of the survey. As described above, this group were more likely than the average to work as a responsible pharmacist all the time they were working in a pharmacy. They were also more likely to hold more than one job 8 (37 held two or more jobs, compared with 21 of all pharmacists in sectors affected by the Regulations). 8 See questionnaire in Appendix 6 for definition of jobs 2011 TNS UK Ltd 16 Page

18 Introduction Chart 1.5 Whether work as a locum * Indicates a significant difference from the total Those in Northern Ireland were less likely to be currently employed as a locum, but more likely to have previously held this role, suggesting a change in employment structures in Northern Ireland. This was however no more likely to be linked to the Responsible Pharmacist Regulations than any other nation. Two percent said that they no longer worked as a locum and this was due to the Responsible Pharmacist Regulations. This is discussed in more detail in Chapter 4. Men were more likely than women to be a locum (37 compared with 27), as were older pharmacists (57 of those aged 60 and over). Three in ten (31) pharmacists worked hours a week, which fell to just 19 among locums. Locums were divided between those who worked part time (21 worked 21 hours a week or less compared with 13 of all pharmacists) and those who worked very long hours (33 worked at least 41 hours a week, compared with 28 of all pharmacists) Support Staff The true profile of support staff is currently unknown as this information is not currently collected (See Table 1.7 for definition of support staff). As this group were sampled via the pharmacists, a pragmatic decision was taken to weight the support staff data by nation, according to the profile of pharmacists, to correct for the oversampling of the smaller 2011 TNS UK Ltd 17 Page

19 Introduction nations (see Appendix 3). This will have brought it closer to its natural profile, although the accuracy of this cannot be verified. No further corrective weighting was possible, so all results based on support staff should be used with caution and treated as indicative only. Tables 1.6 and 1.7 show the profile of support staff according to pharmacy type and job role, as achieved in this survey. The majority (83) worked in community pharmacies, with no significant difference by nation, although the small base sizes in Scotland and Northern Ireland should be noted and these results used with caution. Table 1.6 Support staff main sector of employment Sector Total England Scotland Wales Northern Ireland Base: All respondents (509) (360) (39)^ (71) (39)^ Community Hospital ^ Caution: Low base size There was a good spread of responses across dispensing/pharmacy assistants, pharmacy technicians and accuracy checking technicians, with fewer counter assistants (although more in Northern Ireland) and accuracy checkers responding to the survey. Table 1.7 Support staff main job role 9 Job role Total England Scotland Wales Northern Ireland Base: All respondents (509) (360) (39)^ (71) (39)^ Dispensing/Pharmacy assistant Pharmacy technician Accuracy checking technician Counter assistant * Accuracy checker ^ Caution: Low base size, * Indicates a significant difference from the total Further employment related factors, such as number of other staff worked with and weekly numbers of prescriptions were typically linked to these broader measures of sector and type of community pharmacy and are covered in the appendix. Further breakdowns by employment status and demographics are included in Appendix 4. 9 At the time of the research, the job titles of support staff were as shown in the table TNS UK Ltd 18 Page

20 Introduction Qualitative sample Individual depth interviews 45 tele depth interviews were conducted with pharmacists and support staff across a range of pharmacy outlets, covering the geographic, professional and sector wide variables of interest to the study. All pharmacists recruited took the responsible pharmacist role from between a quarter of the time to all the time that they were working. Support staff included pharmacy technicians, accuracy checking technicians, dispensing assistants and counter assistants. Table 1.8 Qualitative sample structure: tele depth interviews Total England Scotland Wales Northern Ireland Sector Community Multiple Independent Supermarket Hospital Prison Internet 2 Location Urban Rural Job role Pharmacist Support staff Locum Case studies Five area based case studies were conducted, comprising in depth interviews and observations with pharmacists in three premises in each area. Where possible, both a pharmacist and a member of support staff were spoken to in each premises and in community pharmacies, customers were also spoken to TNS UK Ltd 19 Page

21 Introduction Table 1.9 Qualitative sample structure: case studies Total England Scotland Wales Northern Ireland Sector Community Multiple Independent Supermarket Hospital Prison Location Urban community Rural community Urban other Job role Pharmacist Technician* Support Staff* Customers* * Not included in total 1.5 Conduct of the study Quantitative The quantitative survey was developed by TNS BMRB, with the help of early qualitative work and the rapid literature review. It was reviewed at key stages by the project group from RPS/Professional Forum of the PSNI and piloted on a small number of pharmacists to test comprehension and relevance of questions. The findings from the pilot were reviewed and the questionnaire finalised in discussion with the project group from RPS/Professional Forum of the PSNI. Findings from the pilot are described in Appendix 2. The main quantitative survey was sent out by post on 22 July 2011 to 8,000 pharmacists, across Great Britain and Northern Ireland. The number sent out in Scotland, Wales and Northern Ireland was over represented to allow for more robust analysis in these smaller nations, but then reweighted back to correct proportions (see Appendix 3). The pack that was sent out included a questionnaire for pharmacists to complete themselves and a questionnaire to pass on to a member of support staff who they worked with. Unique log in details were also available to give the option to complete the survey online and reminders were sent where an address was available. Further details of the survey 2011 TNS UK Ltd 20 Page

22 Introduction method and the questionnaires are included as appendices. In total, 2,028 pharmacists and 509 members of support staff responded to the survey by the closing date of 15 August All quantitative analysis has been carried out on cross tabulated aggregated data, with both pharmacists and support staff analysed separately. All data contained in this report are weighted, and details of the weighting can be found in Appendix Qualitative A topic guide was developed which was informed by the areas identified in the development phase of the research. All interviews were conducted across the fieldwork period of 1 st 19 th August, by experienced qualitative researchers. The data gathered was analysed using our in house framework approach of Matrix Mapping 10. Our analytical approach is highly rigorous and able to withstand close public scrutiny (see Appendix 1 for further details). The findings have been illustrated with the use of verbatim quotations and examples. 1.6 Interpretation of the data Quantitative data interpretation All quantitative analysis in the main body of this report is based on respondents in sectors affected by the Regulations (1,845 pharmacists and 509 support staff). Key subgroups of this, such as the four nations, locums, RPs and those working in particular sectors are referenced where they differ significantly from the total. Where a question is only asked of a subset of respondents, this is indicated. Throughout this report, significant differences between subgroups and the total sample (for example each nation compared with the total sample) and between key subgroups (for example those who work as an RP compared with those who do not) are indicated by *. Each chart and table that this applies to is clearly labelled to indicate the comparative groups. Figures in tables and charts may not always add up to 100 for the following reasons: Refusals to respond or responses of Don t know are usually omitted unless Don t know accounts for a significant number of responses and is therefore a finding of interest 10 Matrix Mapping is a TNS BMRB analysis system which works from verbatim transcripts and involves a systematic process of sifting, summarising and sorting the material according to key issues and themes. Further information on this process is included in Appendix TNS UK Ltd 21 Page

23 Introduction Rounding (for example, if there are three response options to a question and 33.3 of the total sample gives each answer, then each would be rounded to 33, making the total appear as 99) Where more than one answer may be given to a question (this is stated where it applies) Tables and charts which show breakdown by main sector of employment only include subgroups of community, hospital and primary care. Those working mainly in prison or internet pharmacies have been excluded from sub analysis due to them being present in very small numbers (n=2 and n=3 respectively). In addition, there were 15 pharmacists who did not answer the question on employment sector but answered the remainder of the survey. As they were able to do this, it has been assumed that they were in a sector affected by the Regulations Qualitative data interpretation Throughout the report, verbatim quotes are used to illustrate key findings. In most cases, these are referenced using the job title and sector, whether rural or urban, nation and gender. For example: (Permanent pharmacist, community independent, rural, Wales, female) (Technician, hospital, urban, Northern Ireland, male) In the case of internet based pharmacists these are simply labelled for example: (Internet pharmacist, male) Guide to terms Throughout the report, reference is made to the professional bodies, regulators and other pharmacy organisations. Professional bodies are intended to include: The RPS, the Professional Forum of the PSNI and the Association of Pharmacy Technicians UK (APTUK); Regulators include: the GPHC and PSNI Other pharmacy organisations and unions include, for example: Company Chemists Association (CCA); the Guild of Healthcare Pharmacists (GHP); National Pharmacy Association (NPA); Pharmacists Defence Association (PDA); 2011 TNS UK Ltd 22 Page

24 Introduction 2. The working environment Establishing the context to the Regulations which could be affecting how they are viewed, understood and implemented This chapter describes the context, from the point of view of pharmacists and support staff, in which the Responsible Pharmacist Regulations were being enacted. This is with a view to understanding how the external environment may be affecting both impact of the Regulations and perceptions of them (described in subsequent chapters). It covers job satisfaction (both overall and with specific elements of the job) and highlights differences in the working context between setting, job role and, where apparent, between countries. Key findings There is professional job satisfaction on the surface Deeper probing reveals frustrations, especially around breaks and training There is particular concern where pharmacists are taking on more roles, and being asked to provide more services with the same or fewer staff as a result of cutbacks in relation to financial pressures Overall, the research demonstrated levels of satisfaction at a surface level, particularly amongst support staff and those working in hospitals, with two thirds (66) of pharmacists and over eight in ten (84) support staff satisfied with their job overall. As well as being more satisfied overall, support staff were also more satisfied than pharmacists with all aspects of the job (Chart 2.1). Areas of least satisfaction for pharmacists were pay, frequency and length of breaks, amount of training and to an extent, the amount of support they received TNS UK Ltd 23 Page

25 Introduction Chart 2.1 Satisfaction with aspects of job * Indicates a significant difference between the groups The extent to which a pharmacist held the position of an RP had a large impact on their job satisfaction. This is illustrated by Chart 2.2, with those who were an RP at all being significantly less likely to be satisfied with each of the aspects of their job than those who never held this position. In the qualitative work (which only included pharmacists who worked as an RP) many pharmacists and support staff described a sense of satisfaction in a demanding and varied job but with increasing pressures in some areas TNS UK Ltd 24 Page

26 Introduction Chart 2.2 Satisfaction with aspects of job by responsible pharmacist status * Indicates a significant difference between the groups Pharmacists who worked in a community pharmacy were less likely to be satisfied both overall and with each of the different job aspects, than those working in a hospital or primary care (Table 2.3). It should be noted that those working in community pharmacies were also more likely to be an RP which, given the results shown in Chart 2.2 above, may be a contributing factor. Those in hospitals and primary care were more likely than the average to be satisfied across most of the elements, although there was no difference by sector for satisfaction with working environment (Table 2.3) TNS UK Ltd 25 Page

27 Introduction Table 2.3 Satisfaction with aspects of job by sector Very or fairly satisfied Total Community Hospital Primary care Base: All in sectors affected by Regs (1,845) (1,371) (337) (117) Job overall 66 62* 74* 81* Number of hours worked * Level of responsibility 71 67* 80* 80* Working environment Amount of support * 65* Pay * 62* Frequency/Length of breaks 46 39* 64* 64* Amount of training * 59* * Indicates a significant difference from the total Those in smaller types of community pharmacies, and in independents in particular, were typically less satisfied with the number of hours they worked than those in larger multiples and supermarkets. However, for most of the other elements, those in independents, small chains and medium sized multiples were more likely to be satisfied than those in large multiples and supermarkets. Other differences of note from the quantitative research were: Locums were generally a little less satisfied across most of the elements. The greatest difference was in satisfaction with the amount of training they received (33 satisfied, compared with 45 of all pharmacists) Pharmacists in Scotland were less likely to be satisfied with the number of hours they worked (64), despite there being no difference in the average number of hours they worked (See Appendix 4, Table 11.6) Pharmacists in Wales were more likely to be satisfied with their pay (58) Pharmacists in Northern Ireland were more likely to be satisfied with the amount of training they received (55) The qualitative work found several sources of stress unique to community pharmacy practice. These were: Staff shortages occurring simultaneously with pressure to provide new services, such as Medicines Use Reviews (MURs) and managing delivery services. Northern Ireland and Scotland were said to be experiencing unique pressures with remuneration being a particular problem currently as new financial arrangements came into force. In multiples and supermarkets, a commercialisation of the pharmacist role, with new responsibilities for managing shop sales and stock. Some of these pharmacists were 2011 TNS UK Ltd 26 Page

28 Introduction feeling the impacts of recent introductions in multiples and supermarkets of nonpharmacy managers who placed more emphasis on sales targets. A culture of very few breaks, with pharmacists and support staff working in the community often not stopping for lunch. Whilst some multiples and supermarkets had a structured and formalised approach to breaks supported by adequate cover, this was not universally the case. In independents, the smaller numbers of staff available drove a more informal approach in which pharmacists took breaks or grabbed food where they could in quiet periods TNS UK Ltd 27 Page

29 Awareness and understanding of the Regulations 3. Awareness and understanding of the Regulations Assessing comprehension of the Regulations both in terms of their requirements and purpose This chapter assesses comprehension of the Regulations; both in terms of their requirements and their purpose. It looks firstly at overall awareness and then examines knowledge and understanding of the requirements in detail. It finally highlights areas of confusion which can be seen to influence implementation and impact as shown in subsequent chapters. Key findings High awareness of the basic requirements of the Regulations, but lower awareness of policy intent Understanding and knowledge of detail not always present Ambiguity and grey areas, particularly around precise responsibilities and legal implications 3.1 Awareness and claimed knowledge All pharmacists and support staff had heard of the Responsible Pharmacist Regulations and the vast majority said they knew at least something about them (Chart 3.1). Two thirds (66) of pharmacists and almost six in ten (57) support staff claimed to have a thorough or good understanding of the Regulations TNS UK Ltd 28 Page

30 Awareness and understanding of the Regulations Chart 3.1 Awareness and claimed knowledge of the Regulations * Indicates a significant difference between the groups Only a quarter (25) of those who were never an RP felt they had a thorough or good understanding of the Regulations, compared with 73 who worked as an RP at all and 78 who carried out this role all the time. The proportion who felt they had a thorough or good understanding of the Regulations was also higher among the following: Those who worked in community pharmacies (78) and within this, medium sized multiples in particular (84) Locums (74) Those in Northern Ireland (74), but lower among those in Scotland (57) All RPs interviewed in the qualitative work were familiar with the Regulations and the time they had come into effect, as were some but not all support staff. Some support staff were content to have a low awareness and expected to be given information on a need to know basis by their pharmacist. Support staff awareness was also influenced by relationships with managers and training objectives, for example, where appraisals and aspects of training required they review certain SOPs. Regulations were foremost associated with a few simple procedures which had been made a daily requirement to complete the record and to display the notice. Some pharmacists 2011 TNS UK Ltd 29 Page

31 Awareness and understanding of the Regulations were conscious of an increased legal responsibility and most felt an increased sense of being responsible for everything. From that point forward until you sign out, you are responsible for the day to day running of the pharmacy and for everything that goes on in the pharmacy while you're responsible (Internet pharmacist, male) During the lead up to the introduction of the Regulations, information had been readily available through pharmacy organisations, and many had attended training. Whilst toolkits and training provided by the professional bodies and pharmacy organisations were mentioned across the nations, the value of online training was particularly mentioned in Northern Ireland. Many of those in hospitals learnt about the Regulations through membership organisations or staff meetings, with those in multiples and supermarkets receiving most of their information through their employer. In the qualitative work, a strong awareness of procedural requirements contrasted with a very low awareness of the strategic aims of the Regulations. There were three principal interpretations of the intent of the Regulations: Pharmacists believed their focus to principally be around increasing patient safety via monitoring and processes, creating an audit trail to improve consistency and accountability; and making people s job roles explicit to ensure the smooth day to day running of the pharmacy. So they can see who is responsible, if something does go wrong they can see who was in charge (Locum, community independent, N. Ireland, female) A small number were aware of the link between Regulations and future work on remote supervision, particularly those reading pharmacy journals regularly. I see the Regulations as the first step in freeing up the pharmacist to take on more clinical roles. But the next step is supervision, which is extremely controversial. (Community multiple pharmacist, urban North England, female) Very few pharmacists made the connection between the Regulations and their interest in advancing the clinical role of the pharmacist. Awareness where it existed was based on an understanding at the launch of the Regulations that they would 2011 TNS UK Ltd 30 Page

32 Awareness and understanding of the Regulations increase flexibility for the pharmacist primarily through an ability to be absent from the pharmacy Understanding of the Regulations Beyond an understanding of the basic procedural requirements of the Regulations, more detailed knowledge and understanding of how the requirements should be enacted was less apparent. There was evidence of real confusion relating to ambiguity in some areas of how the Regulations should work in practice. Knowledge was assessed quantitatively by asking both pharmacists and support staff which of a number of different items they thought were covered by the Regulations. Chart 3.2 shows all areas asked about, with those shown as purple bars being elements covered by the Regulations, while those shown as green bars were dummy options, agreed on in the development phase and included to make sure that respondents were not simply selecting all the options. Overall, 21 of pharmacists and 10 of support staff gave the correct response for all nine items covered. This was higher among: Pharmacists in Northern Ireland (30) Pharmacists working in community (25) and large multiples in particular (28) Support staff working in large multiples (17) One in four (24) pharmacists and one in three (34) support staff were able to give the correct response for six items or fewer. This lower level of knowledge was more prevalent among: Support staff working mainly in hospitals (70) Pharmacists working mainly in hospitals (43) or primary care (49) Pharmacists who never worked as an RP (49) 11 As stated in the Responsible Pharmacist: Consultation on the Content of the Responsible Pharmacist Regulation. Department of Health (2007:16), Section 5.6, p TNS UK Ltd 31 Page

33 Awareness and understanding of the Regulations Chart 3.2 Knowledge of specific aspects of the Regulations * Indicates a significant difference between the groups Both pharmacists and support staff were clear, with around nine in ten or more correctly recognising that the Regulations covered record keeping, overall legal accountability for the safe and effective running of the pharmacy and having a single RP in charge at all times. On the surface, it may also appear that pharmacists were clear on rules around absence (87 correctly identified that the RP can be absent for no more than two hours in a 24 hour period). However, one in four (26) incorrectly believed that the RP could be absent for more than two hours if another pharmacist was present. This therefore appears to be an area of some confusion, and even more so among support staff where four in ten (39) incorrectly believed that the RP could be absent for more than two hours if another pharmacist was present. There was little clarity around the RP establishing roles and responsibilities of other members of staff and the RP being responsible for establishing, maintaining and reviewing pharmacy procedures. While pharmacists were generally clear on the process of record keeping, almost a third did not know it was a criminal offence not to do this. These findings were supported by the qualitative research, which found pharmacists had a firm grasp of the immediate daily duties and were confident to enact these, but were less knowledgeable about their own responsibility in relation to others and where exactly lines 2011 TNS UK Ltd 32 Page

34 Awareness and understanding of the Regulations of legal accountability were drawn. The aspects of responsibility emerging as grey areas were: The role of the RP in relation to the SOPs The requirement in relation to SOPs was viewed in terms of a responsibility to implement, adhere to and to ensure that other staff members adhered to them. There was little understanding about the RP s role in relation to ensuring staff competency to fulfil these requirements. There was also evident ambiguity around legal accountability for their content; for example, if RPs had followed the SOPs correctly, where an incident occurred, could the Head Office be culpable because centrally prescribed SOPs had been at fault? The roles of superintendent and owner, according to the Regulations The Regulations were perceived to have shifted responsibility from superintendent to pharmacist, but the extent and precise effects of this were unknown. It was assumed that the superintendent created the environment in which SOPs could be implemented. This was taken to include equipment and the physical environment, but responsibility for professional standards on a given day, and in the longer term, was felt to be ambiguous with many assuming this to be the role of employers. There were questions over the liability of the owner and superintendent with pharmacists unsure in what circumstances liability could still fall to an owner or superintendent if an incident occurred. In the quantitative surveys, both pharmacists and support staff were asked whether they understood how responsibilities differed between RP and superintendent. Only around half (53 of pharmacists and 46 of support staff) said that that they did understand, although this was a little higher among those who worked as an RP at least half the time (60) and also those in community pharmacies (62), particularly medium multiples (70). It is also revealing that one in four (26) pharmacists and four in ten (38) support staff admitted that they were not sure. The role of the RP in managing team workforce standards Many pharmacists, predominantly in multiples, felt that responsibility for professional standards, staffing issues and all workforce decisions were outside their own remit and fell to the pharmacy owner, local manager or Head Office. Being unable to bring on another member of staff, for example, meant they were unsure whether they could be accountable for this area of management (whilst in the Regulations they are responsible for identifying staff according to competency 12 ). These uncertainties were fuelled by concerns that 12 The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 Section 4. (1) (c) the identification of members of pharmacy staff who are, in the view of the responsible pharmacist, competent to perform certain tasks relating to the pharmacy business 2011 TNS UK Ltd 33 Page

35 Awareness and understanding of the Regulations pharmacies sometimes operated in a context of understaffing, which was seen as a risk factor increasing the chances of error. Responsibility for the actions of a second pharmacist Managing peer pharmacists was considered a difficult issue in relation to the Regulations, as the RP lacked a line manager s authority to monitor and instruct them. Many pharmacists across settings were unsure whether they would take responsibility for the activities of a second pharmacist, who was expected to be professionally accountable for their actions. It was uncertain how this argument would play out in the event of a serious dispensing error. Responsibility for maintaining the record As stated, few pharmacists were clear about criminal accountability for maintaining an accurate record. Occasionally, further ambiguities were introduced where the Head Office in multiples monitored completion of the online pharmacy record, leading pharmacists to believe Head Office were also responsible in the event of failure to sign on. We actually log in online which means it is not just us that are responsible but the company the regional office checks [on] who has actually logged in or hasn t (Permanent pharmacist, community multiple, South England, female) What absence could be used for and when Absence was associated by some pharmacists with taking a break, with some stating that they did not need to use the absence provision because cover was provided for breaks. There also appeared to be some preconceptions about when absence was allowed, either within the prescriptions of the Regulations or by employers. "Basically, you are allowed to go for two hours if it s of importance to the health board...it s only if you're meeting with the health board apparently". (Wales, community independent, Locum, female) 2011 TNS UK Ltd 34 Page

36 Implementation of the Regulations 4. Implementation of the Regulations Understanding how the different elements of the Regulations are being enacted in practice as well as factors influencing this This chapter provides an understanding of how the Regulations were translating into practice. It first examines how well RPs feel they have implemented the Regulations and as an overarching point the level of authority they believe they have across key areas of staff roles and responsibilities, changing SOPs and going outside normal pharmacy procedures. It then explores implementation of the Regulations in relation to SOPs (writing, amending and adhering to them), the pharmacy record and absence. The chapter closes by exploring reactions to the legal implications of the Regulations. Key findings Nine in ten RPs think they have implemented the Regulations well and the processes did seem to be in place, particularly with regard to SOPs and the record Processes were not necessarily translating into practice, with many RPs not believing they have the authority to make changes to SOPs and staff roles and responsibilities Seven in ten pharmacists (70) agreed that the Regulations put them in a difficult legal position 4.1 How well RPs feel they have implemented the Regulations Pharmacists who took on the role of the RP were asked how well they felt they had implemented the Responsible Pharmacist Regulations (Chart 4.1). This was a subjective measure, based on respondents own understanding of the Regulations TNS UK Ltd 35 Page

37 Implementation of the Regulations Chart 4.1 How well felt to have implemented Regulations Nine in ten RPs (87) felt they had implemented the Regulations well, with a quarter (25) claiming to have implemented them very well. RPs who felt they had implemented the Regulations very well were more likely to be those who mainly worked in supermarkets (35) and less likely to be those who: Worked mainly in hospitals (11) Worked as an RP for less than half the time (16) There was a strong positive correlation between knowledge of the Regulations and how well RPs felt they had implemented the Regulations: 94 of those who got all nine items about the Regulations correct felt they had implemented the Regulations well, and a third (33) felt they had done so very well. In comparison, three quarters (77) of those who got 0 6 items correct felt they had implemented the Regulations well, with 13 feeling they had implemented them very well. However, qualitatively, it was clear that interpretation of implementation of the requirements of the Regulations was very narrow and was influenced by the areas of ambiguity, confusion and lack of awareness described in Section 3. For many, implementing the Regulations was primarily about putting processes in place, so adherence meant putting up the sign, having SOPs in place, and signing and in and out 2011 TNS UK Ltd 36 Page

38 Implementation of the Regulations which were considered simple to do. For hospitals, prisons and those prescribing online, these processes were perceived to be less relevant than to community practice, as there was always more than one pharmacist in the dispensary, medicines were clinically checked by others and there was no patient contact. In hospitals particularly, there was also a high degree of confidence in the systems to assure patient safety, and little perceived need for further specifications around this. "I'm aware of the existence of the rules on paper. In real life terms, it's a bit confusing how they could be implemented in a useful way in an online pharmacy, or any other pharmacy in which I've worked. You wouldn't be able to use it." (Internet pharmacist, male) 4.2 Standard Operating Procedures Chart 4.2 shows the proportion of RPs who believed they had the authority to change an SOP or change the role of staff members; and the proportion who had actually done each of these in the last 18 months. Chart 4.2 Authority and actions to change SOPs or staff roles Only three in ten (31) RPs said they had the authority to change SOPs and fewer (18) had taken this action in the last 18 months. RPs in the community sector were more likely than those working in hospitals to believe they had the authority to change SOPs (33 compared with 22), but were no more likely to have actually done so (18 compared with 16) TNS UK Ltd 37 Page

39 Implementation of the Regulations However, they were more likely to have changed SOPs if based in an independent pharmacy (42) or small chain (34). In contrast, community pharmacists based in large multiples (8) or supermarkets (4) were significantly less likely than those in hospitals to have changed an SOP. RPs in Northern Ireland were more likely than average to say they had the authority to change an SOP (45) and to have actually done this (28). This may be linked to there being disproportionately more pharmacists in Northern Ireland working in independent pharmacies, where RPs said they had the greatest authority to change SOPs. RPs currently working as locums were less likely than those who had never worked as a locum both to feel they have the authority to change Standard Operating Procedures (22 compared with 34) and to have actually done so (10 compared with 19). The qualitative research found various practices occurring in relation to SOPs: Basic processes in place: with all having SOPs in place at the time of research. Independents had frequently written these for the first time in response to Regulations, often downloaded as templates from sites such as the National Pharmacy Association. For others, such as some multiples, supermarkets and hospitals, SOPs had existed before the introduction of the Regulations and had been added to. Limited ownership of SOPs in some sectors: it was rare amongst those we spoke to qualitatively that they had written the SOPs themselves, with the exception of owners, superintendent pharmacists and hospital dispensary managers. In multiples and supermarkets in particular, whilst making limited amendments to SOPs was considered possible in theory this was not taking place in practice. It was felt not to be encouraged and certain administrative barriers such as requirements to apply to change an SOP acted as disincentives. While many pharmacists were content to accept a standard set of SOPs and felt this was appropriate to their job, some wished to change them but did not feel able to deviate from the norm. It was felt by this latter group to be easier to tow the line than to challenge SOPs as this could increase vulnerability in case of an error. Some were using the written SOPs but working around them verbally. It s fine that they are prepared from a higher source (Permanent pharmacist, prison, N. Ireland, male) 2011 TNS UK Ltd 38 Page

40 Implementation of the Regulations I personally don't think I'd be prepared to take on Head Office if I wasn't happy with the SOPs; actually I'm not particularly happy with the format of the SOPs if I'm honest, but to take on Head Office to get them changed to a format I would like is not going to happen so I just have to face the fact that they're legal, and just go with it. (Permanent pharmacist, community multiple, N. England, female) Some pharmacists, particularly in independents and hospitals, stated that they had the opportunity to contribute to or be consulted on SOP content, which could be part of buy in to support adherence particularly where the RP role rotated around a wider team. A few reported writing SOPs as a team, with positive effects on team working, overall efficiency and likelihood for the SOPs to be practicable and therefore read and applied. I think you can adapt to it and go ahead with it, but always you can kind of make mini SOPs of these depending on your own staff and their learning needs (Permanent pharmacist, community multiple, S. England, female) Evident differences in the extent to which SOPs were being read, applied and reviewed: Some multiples instructed that SOPs be read on a periodic basis, or any time significant changes came in, but this was less expected among independents and there appeared to be little policing in either case. In practice, once established, few RPs were consulting or rereading SOPs because of their large size, and pharmacists own knowledge of what they believed safe working to be. In many cases new SOPs were added with each introduction of a new control drug, meaning that these SOPs became extremely long and unwieldy. To be honest since we have completed the SOPs they have not been referred to once and I don t think I would be alone in saying that. I d say if you go into a lot of pharmacies they would be exactly like small pharmacies, they would say exactly the same thing. (Permanent pharmacist, community independent, N. Ireland, male) Authority issues for RPs in hospitals: The RP was not necessarily deferred to by technicians and other pharmacists seeking guidance and advice, for several reasons: Availability: Technicians reported asking any pharmacist available, or the most senior or experienced person they could find. This tended to occur because the RP was either the Dispensary Manager who was not immediately accessible, or a pharmacist who was less experienced than other colleagues present. Established hierarchies: Dispensary managers who were RP reported exercising authority through the position of line manager rather than RP, but could also struggle 2011 TNS UK Ltd 39 Page

41 Implementation of the Regulations with clinical pharmacists who were highly confident in exercising their own professional judgement who may not respond well to all assertions of authority Changing staff roles In the quantitative research one in four (38) RPs felt they had the authority to change staff roles with a quarter (25) of RPs having changed the roles of staff members. Community pharmacists generally (41) and independent community pharmacists specifically (54) were more likely than hospital pharmacists (25) to feel they had the authority to change staff roles, and were also more likely to have changed them (36 for independents, 26 for community in general, 18 for hospitals) RPs in Northern Ireland (49) were more likely than average to believe they had the authority to change staff roles Locums were less likely to both believe they had the authority (23) and to actually carry this out (15) Qualitatively, a distinction was made between the authority to switch staff to other tasks in the short term if they lacked the appropriate competency, and the authority to address a staff shortage. General understaffing was cited as the more pressing issue here, as changing people s roles was considered useless if they could not source other staff to fill gaps. Changing the roles of staff members was primarily felt to be a workforce decision which fell within the remit of senior managers, with the exception of independent owners who were the RP. A small number of RPs, engaged qualitatively, felt able to request changes to staff, and expected their manager to respond; these individuals reported strong relationships with the pharmacy owner/manager, and tended to work in independents. So the problem is it's not been clear cut who has the final say in terms of staffing, but in my experience, it's been store managers, not the responsible pharmacist (Permanent pharmacist, community independent, N. England, female) In most cases, RPs were monitoring and managing staff competencies more informally: on the job; and based on experience of working with them. While many trusted their staff to seek their help rather than monitor them, stresses increased where pharmacists were not confident in staff skills and responded by closer management which increased their own workload. This was clearly more difficult for locums, who described a pressure to cope with the staff present on a given day. The layout and size of the pharmacy as well as the practicalities of workload also constrained how present the RP could be to all their staff, and it was considered impossible to oversee all activities. Few had enacted formal training in order to ensure staff could meet the requirements of the Regulations but there were 2011 TNS UK Ltd 40 Page

42 Implementation of the Regulations those who were informally feeding back to support staff where their monitoring identified repetitive errors. I've worked in places where you can't hear what's going on at the counter. Unless you had microphones on the desk, there's no way you can know exactly what's going on. I think you have to trust your staff. (Permanent pharmacist, community independent, N. England, male) "I prefer it [instruction] in a nicer way rather than stressing them out because there are more chances of mistakes, more chances of problems and everything so yes, just a bit more relaxed. I think that s not right to have set rules for them." (Permanent pharmacist, community multiple, S. England, female) Locums and SOPs The qualitative research indicated particular practical barriers to implementation of the Regulations regarding SOPs for locums. Many pharmacists recognised that locums were in a difficult position when it came to SOPs, as they lacked the time to read them before starting a shift and were not familiar enough with the support staff to make decisions about their competency. If [XXX] said to me, they ve allowed two folders, here you are, I d be like, so you re going to pay me to sit here and read that page, run the Pharmacy? I'm not reading in my own time, so you have conflict there. (Permanent pharmacist, community independent, S. England, female) Chart 4.3 displays the proportion of premises where locums were able to read through and professionally assess the pharmacy SOPs before commencing as an RP TNS UK Ltd 41 Page

43 Implementation of the Regulations Chart 4.3 Reading and assessing SOPs (locums) The quantitative research showed that whilst four in ten (43) locum RPs read the SOPs at all or most of the premises that they worked in, a quarter (24) never did so before commencing as an RP, and a further one in five (20) did so at very few premises where they work. The likelihood of reading SOPs at all or most premises was higher among older and more experienced locum pharmacists. There was significant variation at the other end of the scale: The proportion of locum RPs who never read and assessed the SOPs before commencing work ranged from a quarter (27) in England to only around one in ten in the other nations (12 in Scotland, 14 in Wales, 9 in Northern Ireland) There was no clear pattern by type of pharmacy, although those who mainly worked in large pharmacy chains were slightly more likely than average to never read and assess the SOPs before commencing work (29) Half (54) of those who felt they had not implemented the Regulations well said they never read and assessed the SOPs, compared with 16 of those who felt they implemented the Regulations very well Qualitatively, it was found that locums did not tend to read the SOPs in advance of starting at a new pharmacy, except for those occasions where the pharmacy required the locum to 2011 TNS UK Ltd 42 Page

44 Implementation of the Regulations sign the SOPs before beginning work, when they were sent by a day in advance. In some cases locums worked in a limited number of pharmacies, in which case they had, over the course of time, read the SOPs in those places. Wide ranging attitudes in the qualitative research towards this aspect of compliance reflected different locums approaches to decisions about where to work and what they saw their responsibilities to be. I wouldn't work in places I'm not familiar with now... if they phone me up to work there I turn it down because nowadays you are very much more aware of the legal implications... (Locum, community independent, S. England, female) It's hard enough to get locum work these days as it is, you're not going to go telling some pharmacy manager how to work you just get on with it, you don't tell people to change things, you may as well just retire (Locum, community independent, N. Ireland, male) Strategies for coping with the risks of managing an unfamiliar team and working without sight of the SOPs included locums: Giving verbal briefings and instructions to staff before starting work or simply carrying out the work themselves Deliberately limiting the number of pharmacies they locum ed for In the quantitative research one in ten locum pharmacists (9) had refused to work as an RP in the last 18 months because of how a pharmacy was operated, and another quarter (26) had thought about doing so but then gone ahead and worked anyway (Chart 4.4). Almost two thirds (65) had not refused or thought about refusing to work because of how a pharmacy was operated TNS UK Ltd 43 Page

45 Implementation of the Regulations Chart 4.4 Refusals to work as a locum RP The issue was more in evidence for locums working in supermarkets, where half of locums had either refused work (16) or thought about doing so but worked anyway (34). By nation, it was lowest in Northern Ireland, where only 3 had actually refused and 17 had considered doing so. In Scotland, 40 had considered refusing but had then gone on to work as a locum RP. In the qualitative research, there was a similarly mixed reaction: There were few who said they had refused to work in a pharmacy because of how it operated. Where this had occurred it was mostly in independents, within the first 12 months post enforcement of Regulations. In these cases, owners had not been aware of the SOP requirements or were flippant about the quality and level of detail required, causing locums to feel particularly vulnerable. There was no clear evidence of refusals to work at the point of arriving at a pharmacy, though anecdotes of relying on downloaded SOPs in these instances were mentioned. In some cases locums had considered the possibility of refusal and sometimes had concerns, but had chosen to go ahead and work. In these cases, to challenge the employer by a refusal on a day that had been contracted was felt to be too damaging to their employability. Instead, the decision to refuse work for the pharmacy again in the future was a more popular approach to managing risk TNS UK Ltd 44 Page

46 Implementation of the Regulations Prior to the Regulations coming into force, stakeholders had predicted numbers of locum pharmacists stopping being locums as a result of the Responsible Pharmacist Regulations. The quantitative findings showed 2 said they had given up locum work as a direct result of the Regulations. This translates to 3 of all pharmacists who had ever done locum work. In the qualitative research, one locum had chosen to move into a permanent job to avoid the uncertainties created by the Regulations: That's the reason I became [a permanent pharmacist]...from a risk point of view I'm far better off knowing the SOPs, and being confident about them, and able to sign on than feeling extremely vulnerable as a locum. (Permanent pharmacist, community multiple, North England, female) 4.3 The pharmacy record The qualitative research (the only data available on implementation of the pharmacy record) indicated that the use of a pharmacy record was widespread, with very few issues affecting adherence. Most multiples and hospitals had used a similar system prior to the Regulations and for those independents and hospitals that didn t already have a record, pharmacists reported that it had been a relatively simple process to put into place. The main issues preventing or undermining compliance were: First and foremost, human error in forgetting to sign in or out. Many felt that once they had adapted to doing this daily, it became a norm and forgetfulness was less of a problem. One multiple also monitored employee compliance, which acted as an extra driver, and in some cases support staff were encouraged to remind RPs. In hospitals and multiples where existing processes were creating duplication and a perception of irrelevance in completing the RP record. Where the RP was the only individual working in a particular pharmacy in a given week and there was less buy in to the need to complete the record accurately each day. This tended to occur most in independents and was reflective of their view that the record was less important to their working environment. In a small number of cases there was evidence of some owners filling out the record either in advance or retrospectively. "If taken to the letter, I would be doing it every time I went to the toilet" (Permanent pharmacist, community independent, Wales, male) Some confusion around the appropriate procedure in the event of an RP being late meant that in a few cases support staff were opening the pharmacy under absence 2011 TNS UK Ltd 45 Page

47 Implementation of the Regulations conditions without an RP being signed on, or with pharmacists phoning in to request that support staff sign in on their behalf. The possibility for misinterpretation of the record when there is a difference between the date on which a prescription label was printed and when it was actually dispensed; with some RPs taking the action of introducing a double signature procedure to prevent doubt. However, even here illegible signatures were felt to cause problems. 4.4 Absence Pharmacists and support staff taking part in the quantitative survey were asked whether the Regulations had made them any clearer in relation to the rules around RP absence (Chart 4.5). Chart 4.5 Clarity on absence * Indicates a significant difference between the groups Half of pharmacists (52) said they were clearer about absences, with only a small minority (10) now less clear about absence rules as a result of the Regulations. Results were similar for support staff, although slightly more (58) claimed to be clearer. Within the pharmacist population, those who felt they were clearer in relation to rules about pharmacist absence were: 2011 TNS UK Ltd 46 Page

48 Implementation of the Regulations Those working in the community sector (57), and in supermarkets in particular (63), compared with just 34 of those working in a hospital Locums (57 compared with 51 of those who did not work as a locum) Those in Northern Ireland (67), compared with half of those in England (52) and Wales (51) and just four in ten of those in Scotland (42) Those who never worked as an RP were less likely to feel clearer on absence (31, compared with 54 of those who worked as an RP). Amongst pharmacists claiming to be much clearer on absence as a result of the Regulations, 97 correctly thought that the RP can be absent from the pharmacy (while open) for no more than two hours in a 24 hour period. However, there was still some confusion around whether the RP can be absent for more than two hours if another pharmacist is present, with 28 of those stating they were much clearer, incorrectly believing this to be true (compared with 26 of all pharmacists Chart 3.2) Qualitatively it was clear that very few pharmacists were using the absence provision, though it was known the Regulations allowed for it. The factors driving this low usage were: Profit margins discouraging RPs from leaving the premises during working hours. This was prominent among multiples and supermarkets, where pharmacists felt that they were strongly discouraged from leaving and in some cases, were instructed against doing so. Professional identity: pharmacists saw their presence in the pharmacy as a core part of their role, enabling them to interact directly with customers, be available to provide advice to both patients and support staff, and oversee dispensing of medicines. This was the prevailing view in independents and multiples among pharmacists across experience levels and geographical location. Delivering best access to medicines: pharmacists did not feel that absence could be justified to customers or staff, as customers expected a walk in service and would therefore get impatient very quickly, placing pressure on support staff who may struggle to cope, especially in areas of high prevalence of addiction to prescriptions. Absence was seen to be in tension with delivering best access to medicines, as this meant being available to dispense and advise all customers seeking them. The imperative behind pharmacists presence was not maximising sales, but customer satisfaction, patient safety and human resources TNS UK Ltd 47 Page

49 Implementation of the Regulations The nature of the business means I can't feasibly be away. People can't collect their prescriptions, pharmacy medicines can't be sold the whole thing just grinds to a halt unless the pharmacist is there. (Permanent pharmacist, community multiple, North England, male) No need: some pharmacists did not see a use for absence in the context of their work. While recognising that there were a few extra services it could support such as medical visits, in home oxygen supply and services for nursing homes, these were only expected to apply to a few pharmacies. Using absence to provide in pharmacy services away from the counter such as MURs or chronic care was considered, but dispensing and regular customer sales were prioritised and so those delivering these services preferred to employ a second pharmacist. There were occasions where RPs working in the community had used the absence rule in emergencies, for example to correct an error or visit a customer with limited mobility; in these cases the extra flexibility was appreciated as previously the pharmacy would have had to close, with consequences for continuity of pharmacy services. The use of absence to support adherence to a PCT contract was also mentioned, on rare occasions when the RP was late to allow them to have the pharmacy open for a certain number of hours. Customers in one Welsh case study mentioned noticing that it had become quicker to get prescriptions as the pharmacist was always there, or absent for periods of minutes instead of 3 hours. However, it could not be determined whether this change was due to the Regulations or to a change in ownership, roughly 18 months previously. In the quantitative survey, respondents were asked to give their opinion about how the pharmacy should continue to operate in the absence of the RP, irrespective of what is currently required by the Regulations. The question asked was as follows, with the results for pharmacists shown in Chart 4.6. Finally, irrespective of what the Responsible Pharmacist Regulations actually say, to what extent do you agree or disagree with each of the following statements? A Pharmacy should be able to continue to operate while the Pharmacist is absent, as long as this is for less than 2 hours GSL (General Sales List) medicines must not be sold in a Pharmacy unless a Pharmacist is present Pharmacy medicines must not be sold in a Pharmacy unless a Pharmacist is present Prescriptions must not be handed out in a Pharmacy unless a Pharmacist is present 2011 TNS UK Ltd 48 Page

50 Implementation of the Regulations Chart 4.6 Views on absence Two thirds (67) of pharmacists disagreed that GSL medicines must not be sold in a pharmacy unless a pharmacist is present, and half (47) disagreed strongly. This means most pharmacists were in favour of General Sales List medicines being sold without a pharmacist present. However, a majority of pharmacists were against pharmacies operating without a pharmacist, and prescriptions or pharmacy medicines being handed out without a pharmacist present. Only a third (33) agreed that a pharmacy should be able to operate during a pharmacist absence of less than two hours, whereas just under half (44) disagreed strongly with this statement. Half of pharmacists (52) strongly agreed that prescriptions must not be handed out unless a pharmacist is present, and three quarters (73) strongly agreed that pharmacy medicines must not be sold unless a pharmacist is present. Those least likely to agree that a pharmacy should be able to continue to operate for up to two hours without a pharmacist were: Those who worked mainly in supermarkets (26, compared with 39 of those in independents) Those who worked mainly in hospitals (25) Locums (27) 2011 TNS UK Ltd 49 Page

51 Implementation of the Regulations Strong agreement that prescriptions must not be handed out unless a pharmacist is present was higher among: Those based in the community sector (55 compared with 45 of those in hospitals), and particularly those in supermarkets (68) Locums (59) Those who always worked as an RP (56, compared with 45 of those who never did this) Conversely, those in Scotland were less likely to hold this view (40) Those more likely to strongly agree that pharmacy medicines must not be sold unless a pharmacist is present were more likely to be: Those based in the community sector (77 compared with 62 of those in hospitals) and particularly those in supermarkets (81) Locums (79) Those who always worked as an RP (77, compared with 58 of those who never did this) Conversely, those in Scotland were less likely to hold this view (62) Results for support staff showed a similar picture, albeit with slightly weaker strength of opinion. Six in ten (58) disagreed that General Sales List medicines must not be sold in a pharmacy unless a pharmacist is present. Half (50) strongly agreed that prescriptions must not be handed out unless a pharmacist is present, and seven in ten (71) strongly agreed that pharmacy medicines must not be sold unless a pharmacist is present. Support staff were more divided as to whether a pharmacy should be able to operate during a pharmacist absence of less than two hours, with 42 agreeing but 41 disagreeing. More details can be found in Appendix Legal responsibility Pharmacists were also asked about the legal changes to their role, specifically whether they felt the Regulations put them in a difficult position by making them legally responsible for people and processes not within their control (Chart 4.7) TNS UK Ltd 50 Page

52 Implementation of the Regulations Chart 4.7 Difficulty of legal responsibility Seven in ten pharmacists (70) agreed that the Regulations put them in a difficult legal position, with four in ten (40) agreeing strongly. Only a small proportion (8) disagreed. Agreement was higher among the following: Pharmacists working in the community sector (74, compared with 64 of those working in a hospital and 50 of those in primary care) Those based in England (72, compared with 64 in Scotland, 68 in Wales and 63 in Northern Ireland) Locums (81) Those working as an RP (76, compared with just 43 of those who never held this role) In the qualitative research, legal aspects of the Regulations were interpreted quite broadly, encompassing completion of the record and displaying a notice, as well as the implications of being found not to have adhered to SOPs in the event of a serious incident. In practice, this covered responsibility for every sale and for prescriptions that were taken and dispensed and that all SOPs were followed. The introduction of the record increased the perception of an audit culture and a need for strict compliance TNS UK Ltd 51 Page

53 Implementation of the Regulations Qualitatively it was felt that the pharmacist s professional responsibility had not changed but there was some consciousness that the Regulations had hardened their practice from a professional to a legal obligation. People s level of awareness of this position, their comfort with it and the responses they had to it, varied a great deal; these are described in the following qualitative typologies (also shown below in Figure 4.8) 13 : SLEEPWALKERS: were simply unaware of the legal implications of the decisions they were taking or failing to take due to low understanding of the detail of the regulations and their legal requirements. IMPROVERS: were aware of their increased responsibility and felt that this raised consciousness had made them more effective in managing their staff and working environment to the benefit of patient care and safety. CLAMS: had a sense of increased responsibility but felt that it had made them more present, clamp down on staff and suspend their professional judgement in order to protect themselves from accusations of blame. This practice was acknowledged to have lessened the sense of trust and cooperation among the teams with whom they worked. CAPTAINS: frequently owners or senior practitioners, were aware of their legal accountability and had not changed their practice but stated that this was because they had always had this responsibility or felt they had the autonomy they needed. OSTRICHES: were worried about an increased sense of responsibility but powerless to do anything about it in terms of managing staff or their environment apart from cross fingers, try not to think about it or simply hope. In some cases this could be seen to result in increased personal stress and job dissatisfaction. 13 It should be noted that these typologies are drawn from qualitative interpretation and without further quantitative research may be indicative but are not generalisable to the wider population TNS UK Ltd 52 Page

54 Implementation of the Regulations Figure 4.8 A qualitative typology of reactions to the legal aspects of the Regulations Difficulties stemmed from: Ambiguity: a sense of legal binding to follow SOPs, which had created some grey areas as they stretched across most areas of practice and involved other members of staff. I think the only thing that this has maybe thrown up is it s a legal document, isn't it, and the legalities of who is responsible is a bit ambiguous (Hospital pharmacist, Scotland, male) Level of confidence in staff and ability to understand and influence competencies: many felt that in practice, responsibility for dispensing was shared among staff such as accuracy checking technicians and other pharmacists, but opinions were divided as to whether regulators or criminal courts would take this view. A sense of vulnerability and lack of senior support: the greatest change was for those who feared that this left them extremely vulnerable to blame or being exploited by seniors and other staff. Particularly in multiples and supermarkets, pharmacists felt they had lost some protection from seniors or that the lines had blurred, and the implications of this were subject to wide interpretation, even within the same business. As discussed in Section 3.2, the responsibility and liability of the owner and superintendent were grey areas in the Regulations, which created new discomfort. There were instances reported of Head Office being less willing to advise than prior to 2011 TNS UK Ltd 53 Page

55 Implementation of the Regulations the Regulations, which was seen as a conscious distancing from the RP, such as in making decisions about whether the pharmacy was safe to open. Sometimes I feel you just lose the right of speech because you are told you know it s legal so why didn t you do it? (Permanent pharmacist, community multiple, Scotland, female) 2011 TNS UK Ltd 54 Page

56 Implementation of the Regulations 5. Impact of the Regulations Capturing the perceived advantages and disadvantages of the Regulations and measuring their impact on strategic objectives Key findings Just over half (54) of pharmacists felt there had been no impact Changes that were recognised were largely operational, with some benefits perceived around better patient care and safety Few changes in terms of professional empowerment and little impact on autonomy 5.1 Perceptions of change Half of pharmacists (54) agreed with the statement that the Responsible Pharmacist Regulations have made no difference to my practice (Chart 5.1). Chart 5.1 Whether Regulations have made a difference 2011 TNS UK Ltd 55 Page

57 Implementation of the Regulations Hospital pharmacists were more likely than community pharmacists to agree that the Regulations had made no difference to their practice (61 compared with 53), reflecting the more limited application of the Regulations to many hospitals. There were no other significant differences between the key groups of interest, and it should be noted that this question was not asked of support staff. As part of the quantitative survey, both pharmacists and support staff were shown a list of items, which might have changed as a result of the Regulations 14, and asked to indicate whether each one had done so. Across all the surveyed items, only a minority of respondents thought they had changed (typically Chart 5.2). A third (34) of pharmacists and 41 of support staff thought nothing had changed as a result of the Regulations. This was higher (41) amongst pharmacists who never took on the role of RP. Chart 5.2 Observed changes * Indicates a significant difference between the groups The most observed change for both pharmacists (33) and support staff (28) was the amount of administration and paperwork. The second biggest change for pharmacists was 14 The list was constructed from emerging issues from the initial development work 2011 TNS UK Ltd 56 Page

58 Implementation of the Regulations the frequency and length of breaks (22), whereas this was not one of the main changes observed by support staff (11). The other biggest changes observed by both pharmacists and support staff related to patient safety, the quality of the dispensing service and how efficiently the pharmacy is run, with support staff also likely to mention the quality of patient care. Qualitatively pharmacists and support staff repeated a similar story of very little difference with many stating the only impact has been record keeping. Reasons given for the lack of difference were that SOPs had already been in place, very few pharmacists were making use of absence, and some felt that the level of responsibility and accountability had not changed. Customers could identify no changes to service that could be directly attributed to the Regulations, but those who noted any change described improvements and all were positive about the level of service in general. 5.2 Positive and negative impacts For items that respondents in the quantitative survey felt had changed as a result of the Regulations, they were asked to indicate how they had changed, namely whether they were better now, initially worse but now improved, or worse now and an ongoing problem. Chart 5.3 shows the top five issues for pharmacists and support staff (a full break down of results can be found in Appendix 5). The perceived positives and negative impacts of the Regulations were also explored qualitatively TNS UK Ltd 57 Page

59 Implementation of the Regulations Chart 5.3 Whether changes felt to be for better or worse Perceived positive impacts Clarity and improved patient safety Just over one in ten (12) pharmacists felt there had been a positive impact on patient safety, compared with half this number (6) who felt this was worse as a result of the Regulations. Among support staff, this bias towards the positive was even more apparent (15 thought this was better now and only 2 considered it to be worse and an ongoing problem). Pharmacists who were more likely to have recognised a positive change in the area of patient safety were: Those in the community sector (14, compared with 6 of those in hospitals and 7 of those in primary care) Those working as an RP (13, compared with 6 of those who never held this role) Those working in Northern Ireland (20) Qualitatively, pharmacists felt that Regulations were driving safer practice in the following ways: The greater clarity that the Regulations had brought both in broad terms by clarifying responsibility and on a day to day level by triggering tighter procedures via the introduction of SOPs; 2011 TNS UK Ltd 58 Page

60 Implementation of the Regulations In some cases, the writing of SOPs had helped crystallise best working practices, focusing staff on their specific skills and team working. This was seen among smaller independent pharmacies, in which the owner and the RP worked well together. Some locums also welcomed the impact of SOPs in ensuring teams worked to the same clearly defined system; In turn, some permanent pharmacists and support staff, felt that the physical act of signing onto the register was improving the sense of responsibility and practice of locums Greater efficiency Quantitatively, 6 of pharmacists and 13 of support staff felt that the Regulations had improved the efficiency of how the pharmacy was run. For pharmacists, this was balanced by those who felt efficiency was worse as a result of the Regulations (7), whereas only 3 of support staff held the negative view. Qualitatively, independents who were introducing SOPs for the first time as a result of the Regulations identified particularly positive benefits in terms of improved practice. For locums working in these independent pharmacies, it had made working practices smoother and more manageable, providing a clear framework for staff to work together Creation of an audit trail Qualitatively, the audit trail created by the record was considered to bring distinct benefits, particularly for pharmacies with frequent changes of the RP or who used locums to trace who was responsible on a given day where problems had arisen. Support staff most commonly mentioned this to be positive due to the protection that they felt this provided to them. Quantitatively, with the exception of the amount of administration and paperwork, support staff generally saw changes as being for the better. Where there had been a change, the vast majority of support staff thought patient safety, the quality of patient care, how efficiently the pharmacy is run and the quality of the dispensing service were now better (Chart 5.3) Perceived negative impacts Admin and paperwork The primary negative impact perceived by both pharmacists and support staff was increased paperwork. Quantitatively (Chart 5.3), just over a quarter (26) felt that the amount of admin/paperwork was worse as a result of the Regulations and that this was an ongoing problem. The view that administration had worsened was particularly evident for: 2011 TNS UK Ltd 59 Page

61 Implementation of the Regulations Pharmacists working in the community sector (29 compared with 17 of those in hospitals and 11 of those in primary care), and specifically those working for a small chain (37) Those who always worked as the RP (31, compared with 20 of those who took on the role under half the time, and just 12 of those who were never the RP) Reasons given for the negative views on admin and paperwork during qualitative interviews were the record and SOPs; simply the act of signing in and out and the number of SOPs which needed to be written and added to as new drugs or changes required new procedures. This was particularly the case for small independents who did not feel the record had practical value, given they were the sole signatory. Because we are a small independent pharmacy and we just don t need them, you know it is easier for me to explain to you how to do something than have a book on the shelf that.. and most of the things are copied from the NPA sheets that are published anyway so they actually mean nothing effectively. (Permanent pharmacist, community independent, N. Ireland, male) Emotional stress The qualitative research revealed a number of pharmacists who felt a degree of demonstrable emotional stress as a result of the Regulations, primarily in relation to the stipulation of 100 responsibility. This was particularly the case where pharmacists did not feel they had the authority to support this level of responsibility; namely those working in multiples and supermarkets. Some locums or pharmacists working as RP with a second pharmacist also expressed discomfort with being responsible for someone else s practice Frequency and length of breaks In the quantitative survey, pharmacists indicated that the frequency and length of breaks had got worse and that this was an ongoing problem (14, compared with 6 who felt this was now better). Issues around breaks also emerged from their attitudes towards their job (see Chapter 2). For locum pharmacists and those working in supermarkets, frequency and length of breaks had been particularly badly affected by the Regulations: 22 of locums and 24 of those mainly working for a supermarket chain said frequency and length of breaks had changed for the worse. There was little mention of an impact on breaks in the qualitative research, although it was apparent that some were confusing the absence provision with breaks TNS UK Ltd 60 Page

62 Implementation of the Regulations Rigid interpretation of SOPs and defensive practice Half of all pharmacists (46) felt they should be more empowered to exercise professional judgement but in reality need to follow SOPs more closely (Chart 5.4). A further third (34) neither agreed nor disagreed, meaning that only a small minority disagreed (Chart 5.4). Agreement was highest among: Pharmacists working in the community sector (55 compared with 24 of those in hospitals and 19 of those in primary care) Those working in supermarkets (66) and large chains (60) in particular (compared with 47 of those working in small chains and 45 of those in independents) Locums (58) Those who worked as an RP all the time (57 compared with 19 of those who never did this) Chart 5.4 Adherence to SOPs Similarly, just under half of pharmacists (45) agreed that the RP Regulations made the use of SOPs more important to protect them from accusations of unprofessional behaviour (Chart 5.4). This was higher among: Pharmacists working in supermarkets (54) and large multiples (55) Those working in Northern Ireland (59) Those who worked as an RP (49 compared with 22 of those who never did this) 2011 TNS UK Ltd 61 Page

63 Implementation of the Regulations Loss of professional judgement Four in ten (43) RPs felt they had the authority to go outside normal company procedures, for instance to meet patient needs, and a third (34) had done this in the last 18 months (Chart 5.5). Chart 5.5 Authority to go outside normal company procedures There was no difference between those working in the community sector and those working in hospitals. However, there were differences within the community sector: Those in independents and small chains were most likely to believe they had the authority to go outside normal company procedures (59 and 66 respectively) Those in large multiples and supermarkets were least likely to believe this (31 and 33 respectively) Those in large multiples (29) and supermarkets (28) were also least likely to have actually gone outside normal company procedures Qualitatively, going outside normal company procedures to prioritise patient needs was justified as part of a pharmacist s duty, through acts such as provision of medicines out of hours. A quarter (26) of RPs had called the superintendent in the last 18 months to discuss either changing SOPs, changing the roles of staff members or going outside normal company procedures TNS UK Ltd 62 Page

64 Implementation of the Regulations Qualitatively, suspension of professional judgement was linked most frequently to an awareness of increased legal responsibility in the absence of the authority to support it (as shown in Section 4.5, and described by the Ostrich typology in Figure 4.8). 5.3 Strategic impact Less than one in five pharmacists felt the Regulations had empowered them to exercise their personal professional judgement (17) or had allowed them greater personal control (16) Chart 5.6. Qualitatively, a few pharmacists felt empowered to make decisions and manage other staff. These were exceptional cases in which the creation of new SOPs had clarified staff roles, and encouraged them to be more proactive in the running of the pharmacy. In most cases it had been the reverse effect, with pharmacists feeling they should be more cautious for the reasons mentioned above. As RP, I probably have more authority or ability to make those crucial decisions whereas before I would have thought it's not my responsibility, I just work here, it's a hard decision to make, you don't want to...it's nice to have the ability, it's not nice to have to make the decision. (Community pharmacist, supermarket, Northern Ireland, male) 2011 TNS UK Ltd 63 Page

65 Implementation of the Regulations Chart 5.6 Impact on empowerment and personal control Community pharmacists were more likely than those in other sectors to feel empowered by the Regulations to exercise their judgement: one in five (21) agreed with this, compared with 6 of those in a hospital and 8 of those working in primary care. This closely follows the difference in attitude between those who ever work as the RP (19 agreed) and those who never do (8 agreed). Similarly, one in five community pharmacists (19) agreed that the Regulations allow them greater personal control, falling to 10 amongst primary care pharmacists and 6 amongst hospital pharmacists. One in ten (11) of those who never take on the role of RP agreed that the Regulations allow greater personal control. When asked specifically whether the Regulations had given them more or less professional autonomy, around two thirds of pharmacists (64) said the Regulations had made no difference. The remainder were split evenly between those saying the Regulations had given them more professional autonomy (12) and those saying they had given them less (13), with a further 7 unsure (Chart 5.7) TNS UK Ltd 64 Page

66 Implementation of the Regulations Chart 5.7 Impact on professional autonomy Those more likely to agree that the Regulations gave them greater personal control were: Community pharmacists (15 compared with 4 of hospital pharmacists) Those who worked as the RP (13 compared with 5 of those who never did this) Pharmacists working in Northern Ireland (19) 2011 TNS UK Ltd 65 Page

67 Barriers and facilitators 6. Barriers and facilitators Summarising the factors influencing implementation and the ability of the Regulations to achieve their strategic purpose Key findings A tension in the Regulations between legal responsibility and absence, compounded by contextual factors, was making RPs more not less present This presented a barrier to meeting the strategic aims of more personalised care and an increased clinical leadership role The right mix of staff, better training and strong working relationships were felt to support delivery of the Regulations 6.1 Tensions within the Regulations There was a fundamental tension apparent within the Regulations between a perception of increased legal accountability and the Absence provisions (shown in Figure 6.1 below). These two aspects of the Regulations were felt to be pulling the RP in different directions the former anchoring them in the pharmacy; the latter leading them away from it. Figure 6.1 Impact on professional autonomy 2011 TNS UK Ltd 66 Page

68 Barriers and facilitators The perceived hardening of legislation was felt to increase liability to criminal charges, which inclined pharmacists towards more defensive practice. People were not prepared to take absence from the pharmacy, particularly when the consequences of an error were considered more likely to be punitive. A lack of clarity about what precisely was required by law was encouraging in turn a more rigid approach to management. By contrast, the provision for use of absence required autonomy and flexibility in working practice. The Regulations aimed to foster these attributes, in order to achieve the strategic aims of supporting an enhanced clinical role and more personalised care 15. Yet activities undertaken during absence from the pharmacy were not considered a core part of the pharmacist s clinical role, either by the majority of participants nor, in their perceptions, by employers. Related tensions also arose within the strategic aims of the Regulations, with the purposes of supporting patient access to medicines and patient safety on the one hand, and a more empowered role for pharmacists and more personalised care for patients on the other. Patient safety and access to medicines was seen to be delivered through pharmacist availability at the pharmacy. Further contextual factors were compounding the pressure to remain physically present and preventing an extended clinical role: commercial and customer demands for continual access to medicines, a perceived lack of authority to make changes to the working environment, the professional identity of the pharmacist (rooted firmly in physical presence in the pharmacy) and a lack of clarity about what legal responsibilities meant for practice. All of these factors culminated in a view from pharmacists that a greater clinical role and more personalised care delivered through absence from the pharmacy was not feasible. 6.2 What has helped deliver the Regulations Qualitatively, several factors were identified by participants as currently supporting implementation. Firstly, where teams worked together to agree SOPs, staff found they enabled them to work much more effectively as teams and the SOPs were consulted in practice; overall this was seen to support better and safer patient care. Secondly, good relationships between the RP and their managers supported pharmacists in achieving staff levels they felt were appropriate, and clearly allowing 15 As stated in the Responsible Pharmacist: Consultation on the Content of the Responsible Pharmacist Regulation. Department of Health (2007:16), Section 5.6, p TNS UK Ltd 67 Page

69 Barriers and facilitators them the authority to take the decisions necessary to implement the regulations both supporting their professional leadership role. The biggest help is having the staff, the right people, at the right place, at the right time. I do a lot of work with the store manager to make sure that that happens. (Permanent pharmacist, community multiple, N. England, male) Lastly, evidence throughout the findings of the greater adoption of the Regulations in Northern Ireland may suggest learnings which can be applied to support implementation elsewhere (discussed more fully in the Conclusions). Looking to the future, pharmacists and support staff were asked in the quantitative survey what, if anything, they thought needed to occur to aid the implementation of the Regulations. They were prompted with a list of ten items (Chart 6.2), but also had the option to give their own response. Chart 6.2 Requirements to aid the implementation of the Regulations (prompted) * Indicates a significant difference between the groups Very few pharmacists (8) thought nothing needed to change, although this was higher in independents (13) and small chains (14) and rose to 21 amongst support staff TNS UK Ltd 68 Page

70 Barriers and facilitators Among both pharmacists and support staff, 15 were unsure what would need to change. Amongst pharmacists, this was higher among: Primary care pharmacists (32) and hospital pharmacists (29), compared with 9 of community pharmacists Those who never worked as an RP (39 compared with 11 who did work as an RP) A majority of both pharmacists (58) and support staff (51) said that they needed to have the right mix of staff available at any time in order to aid the implementation of the Regulations. After this, the changes most commonly identified by both pharmacists and support staff were: having better quality staff training; having more staff training; and having more staff available. Thus staff availability and training were seen as the main priorities to aid the implementation of the Regulations. The top spontaneous responses by pharmacists were that the Responsible Pharmacist Regulations should be scrapped altogether (3), that they should be given adequate or proper breaks (2) and that the RP should be given more authority (2). Since all of these responses were unprompted, the proportions are not comparable with the prompted items. Rather, they indicate the changes apart from those on the list that pharmacists view as most necessary. Qualitatively pharmacists additionally suggested: Greater clarity around the grey areas of the Regulations (outlined in Section 4.2), particularly to: elucidate the roles and responsibilities of the Superintendent and technicians; clarify the pharmacist s authority in certain decisions regarding the safe sale and supply; and raise awareness of the strategic aims of the regulations, including the pharmacist s entitlement to authority on certain issues. Removing tensions in the regulations either by stopping the RP being legally responsible for things they were certain they could not control. In particular: other staff s mistakes; the SOPs; professional standards; and the environment; 2011 TNS UK Ltd 69 Page

71 Barriers and facilitators Or, by relaxing rules around supervision in terms of allowing clinically checked prescriptions to be given out and pharmacy medicines to be sold whilst an RP was absent. Providing support to give the RP the best chance of managing implementation of the Regulations effectively. Suggestions included: An independent advice line to raise sensitive issues, such as those concerning the superintendent/employer; Pharmacies to provide an up to date matrix of staff skills for locums, or those providing cover; and Universal SOPs for core areas, or an executive summary that locums or those providing cover could confidently use across settings. Influencing the working context to set a minimum number of staff to prescription ratio. This was considered particularly important in multiples. Leadership from the professional bodies: giving guidance on what the professional identity of the pharmacist could look like, with specific reference to the Regulations and their aims. This would help the pharmacy community to fully appreciate what they should expect of employers and of themselves, as well as conveying how the profession is changing and what it can encompass TNS UK Ltd 70 Page

72 Stakeholder workshop findings 7. Stakeholder workshop findings 7.1 Open space event summary of key points At the culmination of this research, stakeholders from the pharmacy community were brought together in an open space workshop 16, to discuss the research findings and consider their implications for the Regulations and wider pharmacy practice going forward. Participants came from professional bodies (including the RPS and the Professional Forum of the PSNI) employer representatives, unions, advice and support forums, regulators and government. Discussions were focused on generating thoughts on what if anything needs to change in two areas: in the Regulations themselves; and within the wider environment. A concluding plenary was used to synthesise the day s discussions and end with key points raised. Full details of the methodology are provided in Appendix 9.7 and a summary of discussion provided below, in terms of: Areas of interest within the findings; Priority areas for focus; and Solutions suggested for each area Areas of interest within the findings Participants were provided with the full presentation of high level findings in advance and a summary on the day. At key junctures throughout the presentation, participants were invited to raise areas of interest; a synopsis of points arising is provided below. Awareness and understanding How to bring clarity to the role of superintendent: the grey area of uncertainty around superintendents responsibilities in relation to the Regulations was considered a key issue to address. 16 An open space is an event where participants define the agenda, with relatively little shaping from event organisers. The day was loosely structured, with findings presented and discussed in a morning plenary which generated areas to focus on in the afternoon, when participants broke into smaller facilitated groups TNS UK Ltd 71 Page

73 Whose responsibility it should be for ensuring staff (including RP) understanding of the Regulations RP or superintendent. How to ensure RPs understand the strategic intentions of the Regulations overall. Professional standards and legal aspects: how to clarify the balance of liability between the pharmacist and technician. Determining what the right mix of staff should look like, and what the roles of support staff should be in implementing the regulations. Within this, RPs were considered disadvantaged if there was little information to determine staff competencies. Implementation of the Regulations Challenges specific to locums: To pinpoint how and where practical working constraints led to very different experiences. How locums could meet their responsibilities for professional standards, given the constraints of the short time period for contact with any team. Issues stemming from the difference in models between hospital and community sectors: For example, the seniority to implement Regulations within the hierarchies of hospital, where seniors may resist deferring to a junior RP. Whether any priorities within hospital settings conflict with Regulations, which could lead to unintentional non adherence. Level of professional experience: suggested to impact on ability to implement the Regulations, with potential implications for patient safety. How a pharmacist could and should decide whether SOPs are reasonable or not: how to exercise professional judgement. Expectations of SOPs and their role: how to reconcile conflicting ideals to be both localised and tailored, while also supporting standardisation. In considering this, the impact of over long SOPs was also raised. Absence: pharmacists interpretations of physical presence in relation to service quality, and the impact of this on absence. Potential for absence to conflict with contractual arrangements and terms of service, and to consider the conditions under which absence would be used for patient benefit TNS UK Ltd 72 Page

74 Impact of the Regulations Perceptions of control: different views as to whether the Regulations created more responsibility but less control, leading to stress; or whether this was just a perception, which could be addressed. The empowering/disempowering potential within the Regulations: to what extent there had been an over focus on SOPs in the Regulations, detracting from more empowering aims. Defining the strategic aims: Whether the RPR was solely about the safe supply and sale of medications or was also to empower the pharmacist s professional leadership role and support more personalised care. Whether the levers within the Regulations were achieving the wider strategic aims. What professional autonomy should mean: in practical terms, and in different settings. Beyond this, what the respective barriers are; how far these are perceived or actual barriers; and if so, what would be required to change these perceptions. The wider context: how Primary Legislation and future changes to Supervision should influence the discussion of ways ahead for the Regulations. Differences in the sample: higher satisfaction amongst support staff and apparently greater engagement in Northern Ireland needed discussions to explore possible causes Priority areas of focus From the discussions above, three overarching themes emerged that participants wished to focus on for the afternoon sessions 17. These were: Power and Responsibility; The practicality of SOPs; and Absence. A summary of discussions around each area and any perceived change needed, in terms of the Regulations and the wider environment, is provided below. Power and responsibility: Discussions around: Lack of awareness of roles, including legal accountability of technicians for a mistake, and superintendent responsibility for aspects of work outside the RP s control. 17 Researchers facilitated group sessions of 4 8 people, focused on one theme. The afternoon was split into two repeat sessions, so each participant could select two of the three themes. The afternoon ran in two 40 minute sessions, each followed by 10 minutes of feedback to the plenary TNS UK Ltd 73 Page

75 The wording of SOPs: RP to establish, maintain and review SOPs a need for clarity on what establishment means. The potential for low confidence to make professional decisions to lead RPs to fall back on SOPs as a safety net. Northern Ireland: considered to have achieved more success in education about the Regulations by having imparted their enabling and flexible intent, resulting in greater confidence within the pharmacist community. Solutions suggested by stakeholders: Overall working to ensure Regulations could be interpreted in ways which made them enabling, not prescriptive. More guidance and standards, to support understanding of the RP role in practice. Learning from good practice: for example, Northern Ireland s use of scenarios and training to show what a safe and effective pharmacy looks like. Clarification on the roles of superintendent and technician, as enablers of a greater professional leadership role for the RP. Clarification on accountability and liability, to help allay fears and defensive practice. Developing a culture in pharmacy in which people feel able to challenge and change the SOPs. SOPs: Discussions around: Confusion in distinguishing between what was held in primary legislation, and what was held in the Regulations around SOPs. A lack of detail to guide implementation was felt to have resulted in differences of interpretation of what an SOP should be and, accordingly, adherence. Lengthening and increasing complexity of SOPs, as an unintended consequence of incremental amends over time, could make them prescriptive. External agency requests for additions relating to insurance requirements felt to be contributing to this expansion. The sheer variety in the content of SOPs; seen to be unhelpful, particularly for emergency locums and in supporting patient safety. This was felt to go against the principle of Standard Operating Procedures. Low uptake of ability to change the SOPs; debate around whether this was part of a culture of fear, potentially compounded by a focus in GPhC inspections on SOP adherence. Solutions suggested by stakeholders: 2011 TNS UK Ltd 74 Page

76 Clarifying the Superintendent s and RP s role in writing and implementing SOPs. Creating guidance so that RPs understand which SOPs they are legally responsible for. Re definition of what a SOP is and should do using guidance, as well as education and training, to build confidence. Managing the influence of external organisations, e.g. PCT, NPSA. Exploring the idea of standardisation of SOPs in the interests of patient safety, including reduction to a core set. Absence: Discussions around: Re communicating absence as the enabler of greater flexibility was agreed to be a goal, but whether a pharmacist (not necessarily RP) always needed to be present in the pharmacy was subject to debate. Currently the contractual framework was thought to influence, or impinge upon, implementation, particularly due to its variation across the UK. Considered useful to distinguish between RP duties to oversee safe and effective running of the pharmacy, and issues around the development of their clinical role. How to build the trust necessary within teams to enable absence to be used. Solutions suggested by stakeholders: Clarify the intentions of absence, in relation to patient safety. Clarify the roles of RP and superintendent, in relation to decisions over absence. Create enforcement measures to prevent superintendents restricting use of absence by overruling the authority of RP. Clarify rules regarding absence, to prevent misuse. Revisit the skills requirements of the RP, and create a means of assessment, e.g. prevent day 1 pharmacists being assigned RP position, by creating, for example, a requirement for a minimum of 1 year s experience. RPs to have arbitration power: the autonomy to have an overview about what it is essential to review (i.e. clinical checking and controlled drugs), and what other things can be flexed a bit. Build more trust among staff, to free the RP to leave the premises with confidence. Increase pharmacists professional confidence and autonomy through a stronger narrative about the empowering aims of the Regulations, and the requirement that the responsible pharmacist exercises their own professional judgement TNS UK Ltd 75 Page

77 8. Conclusions and Recommendations 8.1 Conclusions The impact of the Responsible Pharmacist Regulations has been mixed. At one level, there is a relatively widespread perception that the impact has been minimal with over two thirds of pharmacists agreeing or neutral to the statement that they have made no difference to their practice. However, scratch beneath the surface and there is evidence both of improvements and unintended consequences around safety, empowerment, professional judgement and working practices. These impacts have strategic significance: both for the safe and effective running of the pharmacy and the future direction of the profession. In the sections below, conclusions are considered in terms of the implications of the Regulations around pharmacy administration, practice, patient safety, as well as the RP s clinical role. Recommendations 18 are then developed that highlight potential ways to maximise impact of the regulations, whilst building stakeholder ownership. Differences in impact Overall, the Regulations have brought different levels of impact (see figure 8.1). They have been greatest in terms of operational and administrative processes and practices, and lesser in terms of the wider strategic intent of the Regulations. Each of these areas is now considered. 18 Recommendations have particularly been drawn from findings from the Open Space stakeholder event (see above section) TNS UK Ltd 76 Page

78 Figure 8.1: Impact of the Responsible Pharmacist Regulations Impact on administrative procedures The impact of the Regulations has been greater in relation to changes to administrative procedures, such as the establishing of a pharmacy record and developing the SOPs. This has helped to secure, in administrative terms, a minimal level of safe and accountable practice. It has had most impact on smaller independent pharmacies, where operating procedures did not exist or were piecemeal. Its impact was also noted by support staff in relation to improving systems for locums. In terms of the Regulations, basic awareness and administrative compliance around the need to keep a notice, the pharmacy record and pharmacy procedures have been largely achieved. There would now be limited value in further communications by professional bodies to raise awareness around the fundamentals of the Regulations. This administrative impact is important as it helps lay the foundation for the effective running of the pharmacy. However, while basic awareness is high, this has not yet been matched by strong understanding of the detail of the Regulations. This was particularly in relation to misunderstandings around absence but also in relation to the grey areas in roles and responsibilities between pharmacists and superintendents. The impact on practice is explored next TNS UK Ltd 77 Page

79 Impact on pharmacy practice Overall, awareness of the Regulation has not improved safety and effectiveness in certain cases. Specifically, the Regulations do not appear to have empowered a significant proportion of RPs to exercise their professional judgement. As a consequence, certain pharmacists have lost the confidence to make professional decisions, as they do not have faith that the system will back them up. Instead, they are falling back onto the letter of the SOPs as a safety net. These issues do not relate to a knowledge gap about the content of the Regulations which on the whole are simple and relatively well understood. Rather it concerns the implications of the Regulations: where responsibilities lie across pharmacy practice; and the RP s legal liability in relation to other pharmacy staff. There are three elements to this: Responsibilities between RP and superintendents/owners One of the most significant issues for pharmacists particularly working in supermarkets or multiples relates to the balance of authority and responsibility between the RP, the superintendent and the owner. Specifically, pharmacists were concerned that they had liability for operational pharmacy practices that were outside their control: mainly around premises standards (fixtures and fittings), drug ordering, training and staffing levels/ working patterns. A key issue is clarity on the responsibility of the superintendent/owner for environmental and employment factors, leaving the RP to focus on how the SOPs are being implemented locally, and on day to day safety. Responsibilities between the RP, support staff and other pharmacists In addition to pharmacy management, the Regulations have also impacted on relationships in the local pharmacy team. The two most significant areas were: 1. Uncertainty around the role of the technician. The litmus test in this context is where liability around dispensing errors lies between the RP and the technician. 2. Confusion between the role of the RP and second pharmacist. This was complicated due to professional autonomy and the RP lacking any formal means to monitor or instruct a second pharmacist (such as line management responsibility). Fear around regulation enforcement Finally, and related to the above, there was fear around how the Regulations would be applied in practice. This concern did not seem to relate to specific regulatory decisions for 2011 TNS UK Ltd 78 Page

80 instance, neither the Elizabeth Lee case 19 nor the locum charged for the unsecure storage of a Controlled Drugs cabinet 20 appeared to be significant drivers of opinion during the qualitative research (though they were cited as important by certain stakeholders). Rather, it related to a general anxiety around a lack of control in the pharmacy, with pharmacists feeling vulnerable that senior staff would not back them in the case of an incident. Defensive practice Overall, rather than acting to enable the pharmacists, these three elements have led to greater defensive practice specifically with RP s following the letter of the SOPs for legal protection. SOPs are viewed as needing to be adhered to, rather than acting as a framework to guide professional judgement. This is a significant cultural barrier to change. It should be noted that these unintended impacts have not been universal. At their most successful, the Regulations have helped to improve collaborative working and the co design of the SOPs amongst local teams helping to empower and enable safe and effective practice. While such stories were few, it indicates that implementation is affected by leadership and cultural factors, and is possible within the context of the current Regulations. Differences in impact between Northern Ireland and the rest of the UK can also be explained in this context. With this in mind, how to address this imbalance between power and responsibility is one of the biggest challenges emerging from the research and is discussed in more depth in the recommendations section. Impact on patient safety Evidence for the impact on patient safety is less clear. The study did not collect statistics on patient safety incidents and even with this data, econometric analysis would be needed to distinguish the impact of the regulations from other factors influencing safety reporting. Impact on safety can only be inferred through the perceptions and behaviours of pharmacists and support staff. From the survey, safety was spontaneously mentioned as the area most improved as a consequence of the Regulations (noted by 18 pharmacists and 22 support staff). From the qualitative research, it is also clear that the Regulations have led to the implementation of tighter procedures that support patient safety. They have also 19 BBC (2009). Pharmacists attack 'unfair law'. Available at: 20 Koziol, M. (2011). Decision time on RP and supervision. Insight Magazine, Summer 11. PDA. Available at: pda.org/pdf/insight/2011 summer insight community.pdf 2011 TNS UK Ltd 79 Page

81 acted to make safety top of mind for staff: through acts such as signing the register. From this, it is likely that the Regulations have driven safe and effective practices in certain pharmacies, particularly where systems were previously lacking. However, it is also clear that the Regulations may also be driving behaviours that may detract from patient safety. The most significant of these is that pharmacists do not feel enabled to exercise their professional judgement through the regulations relying on the SOPs, rather than always acting in what they believe is the best interests of patients. This in itself is likely to impact on patient safety. In addition, evidence from other research has highlighted that a lack of professional empowerment, combined with fear of disciplinary action, increases workplace pressure which can lead to dispensing errors and reduced health outcomes through the ineffective use of pharmacists time. 21 Overall, the public will expect a legal framework to ensure their safety around drug dispensing and the Regulations seem to have helped to develop minimal safety standards within the sector. The critical issue is how to address unintended consequences within the legal framework. Professionalism The area of least impact of the Regulations relates to advancing the clinical role of pharmacists particularly there was little use of the absence rule to enable a wider clinical role in the community. 22 There are a number of reasons for this: cultural and structural barriers to the use of absence not least a fundamental tension in the regulations creating pull factors to remain onsite (see 6.1) low levels of awareness and understanding of the wider policy intent of the regulations professional identity of the RP strongly linked to physical presence in the pharmacy It should be noted there was not evidence through the interviews of widespread misuse of the absence provision by employers to extend operation of pharmacies or that pharmacies were routinely operating prior to opening without a pharmacist being present. Overall, RPs cited the opposite concern that there were pressures from multiples and supermarkets not to leave the premises, particularly during busy working hours. 21 Royal Pharmaceutical Society (2009) Professional workload report. RPS: London; Royal Pharmaceutical Society (2011). Reducing workplace pressure through professional empowerment. RPS: London. 22 An intention stated in the Responsible Pharmacist: Consultation on the Content of the Responsible Pharmacist Regulation. Department of Health (2007:16), Section 5.6, p TNS UK Ltd 80 Page

82 The extent to which absence plays a role in future pharmacy practice will be addressed through the review of supervision. However, if absence is to enable a wider clinical role, there will need to be: Trust between employers, superintendents and RPs so that decisions around absence are taken locally and not overruled Clarity around the purpose of absence and the dispensing activities that can go on without an RP A stronger narrative about the empowering aims of the Regulations, and the requirement that the Responsible Pharmacist exercises their own professional judgement. A more flexible approach to roles of pharmacy staff to enable either the RP or a second pharmacist to carry out wider clinical duties Specific areas where the Regulations do not meet needs effectively It is worthwhile highlighting two groups for whom the Regulations appear to be working less effectively: locums and hospitals. Locums Whilst there was evidence that the Regulations have helped improve practice amongst locums, negative impacts have been particularly significant for this group. Specifically: A significant number of locums are not reading the SOPs before signing on as an RP, particularly when working for a new employer, with the size and complexity of procedures making this impractical. As well as safety concerns, this also opens up the potential for legal liability. There is an urgent need to simplify SOPs, as well as adopting practices such as sending SOPs to locums to sign off prior to starting at a pharmacy. Locums are held accountable for pharmacy practice areas outside their control mirroring the issues noted above around RPs responsibilities for fixtures and fittings as well as staffing levels. This again points to a need to distinguish responsibilities between environmental and workplace standards from the day to day running of the pharmacy. Cultural and professional factors create barriers to locums having the confidence to speak up when they have concerns around pharmacy safety. Professional empowerment is important here together with the development of more trusting relationships between employers and locum staff. All of these combined have exacerbated the existing challenges of locum practice TNS UK Ltd 81 Page

83 Hospitals The Regulations have also had distinct impacts in hospitals. Specifically, the Regulations have conflicted with traditional patient safety practices and hierarchies. For instance the RP may struggle to assert their control over other pharmacists. In addition, a large amount of dispensing of medicines goes on in the ward, which is both outside the scope of the Regulation and is undertaken by other clinical staff. Overall, these are not safety issues per se, but point to a lack of operational and strategic fit of the regulations within the hospital setting. Enabling factors around implementation Before recommendations are discussed, it is worthwhile highlighting a series of enabling factors that have helped the implementation of the Regulations. As well as qualitative evidence from case studies in the UK, this particularly draws on learning from the experience in Northern Ireland. There are 3 issues: 1. Sector structure and size: it might appear that size and diversity of the sector have affected the implementation of the regulations. In Northern Ireland in particular, the sector is much smaller around 2,000 community pharmacists overall, together with an absence of large multiples. This may have increased the ability for effective communications, and could indicate that regional or local focus for communications may be better placed than a national roll out for future activities. 2. Effective communications: Training and support to make the regulations real for people was important. Training needs to embed the intent of the Regulations in the language and the culture of the pharmacy to help move the perception that rather than putting people into a box, the Regulations aim to empower them. The use of scenarios to enable people to discuss how Regulations may work out in practice was particularly important. Within the Northern Ireland context, a coordinated programme of communications between the PSNI and the Centre for Pharmacy Learning and Development was also important. 3. Relationships between management and pharmacy staff: local organisational culture was a major enabler. Pharmacies with a strong team culture generally were able to develop the SOPs and implement the Regulations more effectively than those where there was a lack of trust between support staff and/or senior management. Moreover, instances where the RP has been empowered by the superintendent or employer to make decisions positively reinforced behaviours and enabled implementation of the Regulations TNS UK Ltd 82 Page

84 8.2 Recommendations Overall, there are three broad levers that can be utilised to help effect change and improve the implementation of the Regulations. These are summarised in Figure 8.2. Figure 8.2: Levers to facilitate the implementation of the Regulations They comprise the following: the legal framework and amendments to Regulations changes to regulatory practices and the extent to which Regulations are restrictive or permissive changes to leadership through the professional bodies and employers Enabling the recommendations will require changes to one or more of these elements. Ultimately, any decision moving forwards needs to be outcome based and focused on developing behaviours that promote the empowerment of RPs and patient safety. In discussing the recommendations, we highlight pros and cons in using these levers to achieve change. 1. Distinguish the responsibilities between the RP and the superintendent/ owner The key recommendation of the research is to clarify the responsibilities between the RP and the superintendent and/or owner. Overall, superintendents or owners should have responsibilities for matters relating to the business and premises for instance around 2011 TNS UK Ltd 83 Page

85 appropriate staffing levels, training, premises standards and drug ordering. The RP should be responsible for the local implementation of the SOPs and matters relating to the care of the patients. There was broad consensus on this point from stakeholders. How to enable this: There was a high consensus around the need for professional bodies, working with regulators, to provide guidance around the interpretation of the Regulations and demonstrating how the regulations should be enacted in practice. Specifically, a communications and training programme needs to be developed to explore what safe and effective looks like under different scenarios. The emphasis here is on coaching, winning hearts and minds and developing an enabling environment for implementation. However, despite consensus around the role of professional bodies, there was little agreement around the need for regulatory changes. Arguments for change to the Regulations include: Arguments for amending Regulations were normative and centred on the fact that RPs have legal accountability for areas they do not have power to change. The Regulations therefore need to be altered to clearly define responsibilities of superintendents and owners otherwise poor regulatory decisions will inevitably follow (as regulators can only enforce the law). It was noted there are already provisions in the regulations for owners/superintendents in terms of the requirement to keep the pharmacy record for 5 years. Simple wording could be used to describe broad areas of responsibility, without detailing specifics. Arguments against change to the Regulations include: Arguments to maintain the current regulations were practical and centred on three reasons: it would take a significant amount of time and energy to enact changes to the Regulations, with no guarantee of success. This time would be better spent enabling pharmacists to deal with implementation; regulatory instruments can be a crude lever to engender behaviour change, which is more about persuasion and communication; and once changes are made to the Regulations they become increasingly prescriptive, making it harder to adapt to the needs of future practice. Overall, given the focus of this review, it is not possible to recommend which of these options should be taken forward with regard to future practice TNS UK Ltd 84 Page

86 One option is a dual strategy whereby professional bodies work with the GPhC and the PSNI to help enable the pharmacy community, as well as discuss with the Department of Health the scope and limitations for regulatory changes in more depth. If, ultimately, no regulatory changes are made, it is vital that regulation is permissive and any enforcement decisions taken are viewed as fair and proportionate. 2. Empower the RP to make decisions around how absence is used as well as to make changes to safety procedures There is a need to empower RPs to operate with sufficient levels of control and make decisions locally around absences and changes to the SOPs. How to enable this: Key here is for professional bodies to work with superintendents and employers to build trust around empowerment of staff and the commercial value of local decision making. Clear guidance is needed on how absence could, if desired, be used and contractual frameworks may need to be reviewed in this context. With regard to SOPs, RPs should have the ability to go outside procedures without fear of repercussions. The circumstances under which superintendents are able to overrule the authority of an RP also need to be clarified. These provisions should be explored in relation to recommendations 1 and 3 above. 3. Provide clarity on the role of the technician and liability in relation to dispensing errors Related to the above is the need to develop greater clarity around the role of the technician and liability of the RP, particularly in relation to dispensing errors. How to enable this: There is an opportunity to provide greater clarity on the role of the technician through the current registration process and the consultation on supervision. Again, through the use of scenarios, the professional bodies and regulators need to make these issues real for pharmacy teams, describing how liability plays out in practice. In terms of the stakeholder event, it should be noted that there was not a call for the RP regulations to specify the role of the technician. However, it was suggested by some that there is a need to remove the criminality from a single dispensing error. To address this would require changes to primary legislation rather than the RP regulations which would be difficult to achieve in the short term TNS UK Ltd 85 Page

87 Pragmatically, a focus on clarifying roles and responsibilities through professional and regulatory leadership, whilst using evidence gathered through this research to inform MHRA s review of the Medicines Act may be fruitful. 4. Clarify the policy intent around absence; define what can be done; enable the clinical role of the pharmacist. There is a need to clearly communicate the original policy intent of absence. Through the forthcoming supervision consultation the extent to which absence is seen as an enabler for the clinical role of pharmacists in the community can be explored. Absence should be positioned as allowing RPs greater flexibility in decisions around their clinical role. Greater clarity on what activities can be undertaken in the absence of the RP is also needed this will additionally be shaped by the forthcoming debate on supervision. How to enable this: When considering supervision, there needs to be a concerted effort between policy makers, professional bodies and regulators to get the proposition, messaging and channels of communication co ordinated so that pharmacists are clear on the reasons for absence. In particular, the value of absence, relative to spending time in the pharmacy, needs to be examined. 5. Reduce the complexity of SOPs to a minimal standardised framework SOPs have become unwieldy and are not effectively read or reviewed in practice. Despite local variation, there is a need to move away from detailed and prescriptive sets of SOPs, and produce a minimal standardised framework in which professional judgement is valued. How to enable this: There have been previous efforts to develop generic SOPs for pharmacists for instance by the National Pharmacy Association. One option could be for employers to work with professional bodies and regulators to agree where there are commonalities in procedures and develop a core set of practices at the heart of patient safety in any pharmacy outlet. 6. Address the poor operational and strategic fit with hospitals The regulations do not appear to be improving practices in hospital settings, where different safety cultures and processes exist. Overall, there appears to be a poor operational and strategic fit between the regulation and the needs/structures of hospitals. Either the regulations should be disapplied in hospital settings (an option noted in the stakeholder meeting) or there needs to be fundamental changes to enable provision for that sector TNS UK Ltd 86 Page

88 How to enable this: This is a complex issue and will require discussion between policy makers, regulators, professional bodies and senior hospital leadership. 7. Address the impact on locums Many of the concerns noted by pharmacists around the impact of the regulations were amplified by locums. There are specific issues around the authority of locums relative to their responsibility, as well as practical difficulties in terms of reading SOPs. How to enable this: This can be addressed through recommendations 1 and 4 above, particularly by developing a locum test around how the regulations will be enacted in practice. From the survey evidence, it would appear that Northern Ireland have developed a different model of locum working in recent years and it may be worth exploring benefits of this approach in this context. 8. Ensure the Regulations are future facing, accommodating changing models of professional practice Underpinning all of the above, any changes to professional leadership, regulatory practice or the legal framework needs to be set in the context of where the profession is going. Specifically, as well as policy drivers around local empowerment, patient focus and personalised care, the industry is moving from a volume based contract to one focused on service provision. How to enable this: Scenarios developed by professional bodies and regulators should be consider what safe and effective care will look like in the coming years. Specifically, they should account for drivers shaping the sector (through tools like PESTLE analysis) 23 and consider whether any professional or regulatory response has the flexibility to meet the future demands of the profession. 23 Understanding the Political, Economic, Social, Technical, Legal and Environmental drivers for the profession TNS UK Ltd 87 Page

89 A summary of recommendations is provided below. Recommendation Level of stakeholder agreement around potential actions Key stakeholders Distinguish the Low Professional bodies; responsibilities between pharmacy organisations; the RP and the pharmacists; superintendent/ owner employers; regulators; policy makers. Empower the RP to make Low Employers; Professional decisions bodies; pharmacy organisations; pharmacists. Provide clarity on the role Moderate Professional bodies; of the technician and pharmacists; technicians; liability in relation to regulators; policy makers; dispensing errors employers. Clarify rules and purpose Low Policy makers, around absence Professional bodies; Pharmacy organisations; pharmacists; employers; regulators. Reduce the complexity of Moderate Professional bodies; the SOPs pharmacy organisations; pharmacists; employers. Address the poor Moderate Employers; Regulators; operational and strategic fit Policy makers; with hospitals Professional bodies. Address the impact on Professional bodies; locums pharmacy organisations; locums; employers. Make the regulations High Policy makers; future facing Professional bodies; employers; regulators. Priority High Medium High Medium Medium Medium High Medium 2011 TNS UK Ltd 88 Page

90 Overall, this review presents an opportunity for the profession to take stock of the impact of the Regulations in the context of the coming review on supervision. Any interventions to help enable implementation need to have patient safety, the empowerment of the RP and the flexibility to respond to future challenges of the profession at their core. The extent to which regulatory changes are needed to enable this is contested. However, much can be progressed while these policy debates play out. The RPS, Professional Forum of the PSNI, GPhC and the PSNI, together with employers, unions and other professional bodies and pharmacy organisations will have a key role to play in this process developing standards, education, pharmacy culture and employment practice to enable safety and support the future direction of the profession TNS UK Ltd 89 Page

91 Appendix 1. Research method 9. Appendix 1. Research method The research included a number of phases, which are described in detail below. 9.1 Rapid literature review The development phase of the research began with a rapid literature review of the content of and background to the Responsible Pharmacist Regulations, any literature relating to their introduction and reception and existing evidence on impacts of the Regulations. The primary aim of the review was to inform the design and delivery of the research, by ensuring it took account of all knowledge to date, and to ensure the researchers were clear on the detail of the Regulations. As there was a relatively slim amount of literature available, the desk research drew on a range of pharmacy resources and publications to ground current and historical developments. These included journal articles; pharmacist bodies publications and forums; guidance and practitioner resources; consultations; and, research. 9.2 Stakeholders interviews Ten stakeholder interviews were carried out in order to inform design of materials and sample, and the conduct of the study. Given the large range of stakeholders in this area, RPS/Professional Forum of the PSNI was consulted in selecting the sample. The final breakdown was Pharmacists Defence Association Guild of Healthcare Pharmacists Association of Pharmacy Technicians UK General Pharmaceutical Council Superintendent for a Multiple Pharmacy Independent Pharmacy Federation Pharmacy Law and Ethics Association Company Chemists Association/Pharmacy Voice Association of Teaching Hospital Pharmacists Pharmacy Defence Association, Locum Committee 2011 TNS UK Ltd 90 Page

92 Appendix 1. Research method A topic guide was used for these interviews (see Appendix 7). Findings from this stage were subject to rapid analysis alongside the scoping interviews with pharmacy practitioners, described below. 9.3 Qualitative scoping research with pharmacy practitioners Five qualitative scoping interviews with pharmacists and technicians were undertaken with the primary aim of informing the development and particularly the wording of the quantitative survey. Pharmacists were recruited free find and reflected a range of settings, sectors and geography. A monetary incentive for participation was offered. A topic guide was used, which sought to explore language and develop a contextual understanding around the four main areas of the Regulations, in order to frame the tools for data capture most accurately; and to provide a sense check of the overall data capture methods to be used in the study. 9.4 Questionnaire development The questionnaire used to quantitatively assess the impact of the Responsible Pharmacist Regulations among both pharmacists and support staff working in pharmacies was developed by TNS BMRB, with the help of early qualitative work and the rapid literature review. It was reviewed at key stages by the project group from RPS/Professional Forum of the PSNI. In order to test comprehension and relevance of the questions, a small number of pharmacists (6) were asked to pilot the self completion paper questionnaire and give their feedback. The findings from the pilot were reviewed and questionnaire finalised in discussion with the project group from RPS/Professional Forum of the PSNI. A copy of the findings from the pilot are provided in Appendix Qualitative telephone depth interviews and case studies The sample frame for the qualitative research aimed to ensure a broad range of RPs and support staff across the UK were interviewed, and to explore the impact of the Regulations in more depth through the use of case studies. 45 tele depths were carried out to a pre agreed sample frame (see Table 1.8 in Section 1.4) and engaged permanent pharmacists, locums and technicians across the UK The case studies were carried out in five geographic areas in Northern Ireland, Scotland, Wales, South and North England. Overall 15 premises were visited (3 pharmacies per area). The premises represented the range of business type: hospital, supermarket, community multiples and independents; with a greater proportion in 2011 TNS UK Ltd 91 Page

93 Appendix 1. Research method the community. The total number recruited included 15 pharmacists, 10 technicians and 3 other support staff. Informal customer interviews and ethnographic observation of practice was also carried out in premises which gave permission. All pharmacists engaged in the qualitative research were responsible pharmacists for at least a quarter of the time they work. To determine whether this study required ethical approval, the National Research Ethics Service (NRES) guidance was considered and advice was sought from the local ethics committee at Guys Hospital and from NRES. Following the NRES guidance document Defining Research, the primary aim of research is to derive generalisable new knowledge, whereas the aim of audit and service evaluation projects is to measure standards of care. Research is to find out what you should be doing; audit is to find out if you are doing planned activity and assesses whether it is working. (Defining Research: NRES Guidance 2009) As the primary aim of this study was to evaluate how the Regulations were working in practice rather than to test a hypothesis, it was advised the work could be considered a service evaluation and it was agreed that approval was not required for this project. Furthermore, interactions with the public entailed seeking customers views about their experience of the pharmacy service, as opposed to personal information regarding their health. Participants were recruited via a mix of free find (own network) and using 300 randomly selected pharmacy premises from the same GPhC and PSNI databases used in generating the quantitative sample. Participants were offered the choice of how they contributed either face to face in the case studies or by telephone, with all participants offered monetary incentives according to the extent of their involvement. At the point of recruitment, a letter from the RPS was offered as a source of further information and quality assurance. Where possible, a member of the support staff was recruited for the case study interviews via a piggyback method. Both the case studies and tele depths took place from 1 19th August across England, Scotland, Wales and Northern Ireland. Each case study took place over 1 day, allowing 2 3 hours in each premises. The 3 premises in each area were therefore located as closely together as possible. In the rural areas, the case studies took place over 1.5 days. All interviews with pharmacists lasted 45 minutes each and with support staff 30 minutes each TNS UK Ltd 92 Page

94 Appendix 1. Research method Researchers were briefed by the core team and given the literature review as part of their preparation. During interviews, topic guides were used as an aide memoire, to help the researcher prompt and probe where appropriate, to explore views in more detail. Researchers assured all participants of the confidentiality and anonymity of the research. All interviews were digitally recorded, and all case study material was transcribed. The data gathered was analysed using our in house framework approach of Matrix Mapping, a description of which is provided below. Material collected through qualitative methods is invariably unstructured and unwieldy. Much of it is text based, consisting of verbatim transcripts of interviews and discussions. The primary aim of any analytical method is to provide a means of exploring coherence and structure within a cumbersome data set whilst retaining a hold on the original accounts and observations from which it is derived. Matrix Mapping works from verbatim transcripts and involves a systematic process of sifting, summarising and sorting the material according to key issues and themes. The process begins with a familiarisation stage and would include a researcher s review of the audio tapes and/or transcripts. Based on the coverage of the topic guide, the researchers experiences of conducting the fieldwork and their preliminary review of the data, a thematic framework is constructed. The analysis then proceeds by summarising and synthesising the data according to this thematic framework using a range of techniques such as cognitive mapping and data matrices. When all the data have been sifted according to the core themes, the analyst begins to map the data and identify features within the data: defining concepts, mapping the range and nature of phenomena, creating typologies, finding associations, and providing explanations. Matrix mapping is then supported with full team brainstorming sessions to develop themes and patterns iteratively. 9.6 Quantitative surveys The quantitative survey was sent out by post on 22 July to 8,000 pharmacists, selected at random from databases held by the General Pharmaceutical Council (GPhC) and the Pharmaceutical Society of Northern Ireland (PSNI) according to the following specifications: Order the database by nation (i.e. sort by England, Scotland and Wales within the GPhC database). Within nation, order the database by postcode TNS UK Ltd 93 Page

95 Appendix 1. Research method For each nation, select the required number of records by generating a random starting point and then selecting 1 in n, where n = number of records available/number of records required. Oversampling in Scotland, Wales and Northern Ireland was carried out in order to achieve a target of 200 respondents in these nations, allowing for more robust analysis by nation. Corrective weighting was applied to return these to their natural proportions (see Appendix 3). Table 9.1 Target numbers of pharmacist interviews and sample selection by nation Nation Target number of interviews Number of records required England 1,400 5,600 Scotland Wales Northern Ireland TOTAL 2,000 8,000 Pharmacists received a pack containing the following items: A covering letter on RPS and Professional Forum of the PSNI headed paper which included background to the survey, reassurance of confidentiality, a request to pass on the support staff questionnaire, unique online login details for those who wanted to complete the survey online instead of on paper and details of contacts at RPS and TNS BMRB in case of queries An 8 page paper questionnaire for them to complete themselves An 8 page paper questionnaire to pass on to a member of support staff (printed on green paper to differentiate it, and with unique online login details on the front page) Two return envelopes one for each questionnaire In order to boost response rates, reminders were sent out to all those selected who had an address recorded on the database (6,618 of the 8,000 records) and had not completed the survey by the reminder dates of 29 July 2011 and 8 August 2011, with a final reminder going out on 12 August The reminders included a hyperlink to the online survey. A postal reminder was sent on 2 August 2011 to 1,253 pharmacists who did not have an address on the database and had not responded by this date. In total, 2,028 pharmacists (1,511 by post and 517 online) and 509 members of support staff (479 by post and 30 online) responded to the survey by the closing date of 15 August TNS UK Ltd 94 Page

96 Appendix 1. Research method The online survey could not be accessed after this date and any responses received in the post after this date were not processed. 9.7 Stakeholder workshop Following the main stages of research, a full day open space workshop was undertaken on 14 th September 2011 involving 24 key stakeholders. An open space event is a meeting where participants define the agenda, with relatively little shaping from event organisers. In advance and on the day, participants were provided with a presentation on the findings from the Evaluation of the Responsible Pharmacist Regulations. In relation to these findings, participants were invited to collectively decide on the issues they wanted to take forward into group discussions to generate suggestions for change. The aims of the workshop were therefore for participants to decide, in relation to the findings of the evaluation of the Responsible Pharmacist Regulations: 1. The issues of most importance for discussion; and 2. What if anything needs to change: Within the Regulations Within the wider environment Stakeholders were selected in consultation with RPS/Professional Forum of the PSNI, including those who had participated in interviews during the development stage, and invitations were sent by . The event was held at TNS BMRB offices, chaired and facilitated by TNS BMRB staff. One week before the event, participants were provided with a slide deck presentation of findings and an agenda for the day to read. On the day a short overview of the findings was presented, interspersed with opportunities for participants to raise issues they felt arose from these results. These were noted down by the research team, then clustered and prioritised by the group. Three key thematic areas were identified, which were discussed in mini groups over the course of two afternoon sessions. The event ended with a plenary session to prioritise actions TNS UK Ltd 95 Page

97 Appendix 2. Questionnaire development 10. Appendix 2. Questionnaire development 10.1 Sample selection for the questionnaire pilot and recruitment The membership team at RPS were asked to draw a sample of 300 pharmacists whose membership details included both telephone number and address. From this, TNS BMRB randomly selected 30 Pharmacists to contact for the pilot. These included pharmacists working in community (15), hospital (6), primary care (3) academia (3) and industry (3), although it was subsequently decided that only those working in community, hospital and primary care should be included as the Responsible Pharmacist Regulations are not relevant to academic and industry sectors. Therefore s were sent out to 24 Pharmacists on 28 June 2011 by RPS, informing them of the survey and asking for their assistance. Later in the same week, TNS BMRB called the pharmacists who had been ed to see if they were happy to participate in the pilot, and if so to arrange an appointment for a telephone call to feed back on their experiences of completing the questionnaire. They were informed that the questionnaire would be sent to them by on 5 July 2011 and appointments for feedback by telephone were arranged for 6 7 July It was explained to the pharmacists that completing the questionnaire would take no more than 10 minutes and the feedback telephone call would take around 20 minutes. In total nine appointments were made The pilot questionnaire The 8 page pilot questionnaire was sent as an attachment to those pharmacists who had agreed to take part. They were asked to print it out and complete it, based on their own experiences as a pharmacist, before their telephone appointment time. They were told that they would be asked about how they found completing the questionnaire, what they thought of the topics covered, and the relevance of the questions to themselves and others working in pharmacies. It was also suggested that they might find it helpful to make some notes on these issues immediately after completing the questionnaire TNS UK Ltd 96 Page

98 Appendix 2. Questionnaire development 10.3 Completed pilot interviews In total, TNS BMRB spoke to six pharmacists about their experiences of completing the questionnaire. Three of the original nine were unable to complete the questionnaire before their telephone appointments and revised appointment times were not possible within the time available (due to deadlines for signing off the final version of the questionnaire). Interviews took place with three pharmacists who worked in community pharmacies, two who worked in hospital pharmacies and one who worked in primary care Findings from the pilot All pharmacists who completed the questionnaire were able to do so in around minutes. Some thought it looked quite long when they first saw it but none had a problem with the length once they had completed it. The apparent length was felt to put some off from completing it, so it was decided that a time estimate should be included in the covering letter based on experiences from the pilot, and anything that could be done to reduce the length would also help with response rates. Pharmacists appreciated the opportunity to give their views and were happy to talk about their experience of filling in the questionnaire. They felt that it gave comprehensive coverage of the issues and were generally able to answer all the questions, even if they were not fully aware of the points of the Regulations themselves. The only area felt to be missing was in stopping working as a Locum pharmacist due to the Regulations this is discussed further below. Although Pharmacists were generally able to answer the questions, they did make a number of points which were taken into account to improve the questionnaire. These are described below Number of prescription items ANSWER Q3 IF YOU WORK IN A COMMUNITY PHARMACY AT ALL Q3. Approximately how many prescription items a week are issued at the Community Pharmacy where you work? If you work in more than one, please think about the main one you work at. 1,500 or less 1,501 8,000 More than 8,000 Don t know 2011 TNS UK Ltd 97 Page

99 Appendix 2. Questionnaire development Not all pharmacists felt that they accurately knew the number of prescription items, especially if they only worked in the pharmacy for a few hours a week. However, the bands were broad enough that they were reasonably confident as to which one of the three was correct for them. The middle band was felt to be quite large; this was not seen as a problem, it was just pointed out. Given the purpose is to categorise Pharmacies as busy, average or quiet, and these bands have been selected to reflect that, it should still serve this purpose. Recommendation No changes needed for this question Types of staff Q6. What types of staff are employed within the pharmacy at your main place of work? Tick more than one if relevant. I don t work in a pharmacy Other pharmacist(s) Pharmacy technician(s) Counter assistant(s) Dispensing assistant(s) Dispenser(s) / pharmacy assistant(s) Accuracy checker(s) Accuracy checking technician(s) Dispensary Manager Pharmacists did not always know the difference between all these job titles. In particular, this was the case for Dispensing assistants and Dispensers / pharmacy assistants and also Accuracy checkers and Accuracy checking technicians. One pharmacist also thought that Accuracy checking technicians overlapped with Pharmacy technicians. In addition, one pharmacist stated that they worked with someone who was qualified as a technician but was employed as a counter assistant. According to the definitions provided by RPS (which were not included in the questionnaire): Dispensing assistants trained to NVQ level 2 or equivalent (different course from counter assistants) 2011 TNS UK Ltd 98 Page

100 Appendix 2. Questionnaire development Dispensers / pharmacy assistants trained to NVQ level 2. Some organisations describe their pharmacy technicians as dispensers but dispensers are level 2 assistants. Anyone who is trained to level 3 should be identified as a pharmacy technician and register with the GPhC. Accuracy checkers trained to NVQ level 2. These are not accuracy checking technicians. On a legal level they are assistants / dispensers and locums will take full responsibility for their work as they are not regulated. Accuracy checking technicians qualified technician with additional training. They should have a certificate to demonstrate their competence and they are regulated by the GPhC when it comes to accountability. Pharmacy technicians trained to level 3 in both knowledge and competency such as NVQ 3 and registered as a pharmacy technician with GPhC Recommendation It would benefit Pharmacists if some basic definitions were included at this question as it would clarify the difference between Accuracy checkers, Accuracy checking technicians and Pharmacy technicians. In addition, there does not appear to be much difference between the definitions of Dispensing assistants and Dispensers / pharmacy assistants so these could be reduced to a single category Number of staff Q7. Approximately how many members of staff are employed within the pharmacy at your main place of work? Write in number of staff: This was interpreted to only include the job roles at Q6, which was the intention. It was also agreed that it was easier to answer the question at a total level (i.e. the way it is positioned here) than it would have been to count up the number of each type of staff (which had been an alternative suggestion). Pharmacists did however query whether the question was asking about at any one time or in total. The Pharmacist who worked in primary care pointed out that this was not relevant to Pharmacists who did not work in a pharmacy at all TNS UK Ltd 99 Page

101 Appendix 2. Questionnaire development Recommendation The purpose of this question is to see if there is a difference in views between those working in larger and smaller pharmacies, which should be reflected by the number of staff working at any given time. It is not possible to fully capture all the different working patterns (e.g. part time workers) so this question needs to be straightforward (i.e. it is not possible to ask about the working patterns of all member of staff), but must also be consistently interpreted. The following wording is therefore suggested. At any given time, approximately how many members of staff would be working in the Pharmacy at your main place of work? To address the point made by the primary care pharmacist, there should be a box added for pharmacists to tick that they do not work in a pharmacy as their main place of work Authority to make changes Q10. Do you have the authority to do any of the following? Change a Standard Operating Procedure Change the roles of staff members Go outside normal company procedures, e.g. to meet patient needs Yes No Not sure Some pharmacists felt they had an input into some of these, even if they did not have overall authority to make changes. One pharmacist commented that she did not think anyone had the authority to do any of these, not even the Chief Pharmacist. Recommendation Information on input to change should be captured and can be done so by adding in an additional option so that responses are: Yes No, but I would be involved in the process No, not at all Not sure A similar approach should be taken for Q11, which asks which have actually been done TNS UK Ltd 100 Page

102 Appendix 2. Questionnaire development Knowledge of the Responsible Pharmacist Regulations Q13. To the best of your knowledge, which of the following are covered by the Regulations? Please tick as many as you think apply There has to be a sole individual in the role of the Responsible Pharmacist at all times The Responsible Pharmacist is legally accountable for the safe and effective running of the Pharmacy The Responsible Pharmacist has the responsibility to establish and clarify roles and responsibilities of other members of staff In the absence of the Responsible Pharmacist, support staff can hand out prescriptions that have already been checked The Responsible Pharmacist is responsible for establishing, maintaining and reviewing Pharmacy procedures Records must be kept to show when an individual becomes and ceases to become the Responsible Pharmacist It is a criminal offence to fail to keep records of who is holding the Responsible Pharmacist position The Responsible Pharmacist can be absent from the Pharmacy (while it is open) for no more than 2 hours in a 24 hour period The Responsible Pharmacist can be absent from the Pharmacy (while it is open) for more than 2 hours if another Pharmacist is present None of these are covered by the Regulations I don t know what is covered by the Regulations This was felt to be a long and difficult question. In particular it was noted that there was a lot to read and this made it off putting. There was also a suggestion that people may go and look up the answer to make sure they got it right. Primary care and hospital pharmacists did not feel that they knew the answers and it was felt to be most applicable to community pharmacists. Recommendation There is a possibility that this question will not provide meaningful data and therefore results may have to be used with caution. While we might recommend its removal for this reason, we do recognise that it is important to be able to measure knowledge levels and therefore that it would be difficult to remove it in the absence of a suitable alternative TNS UK Ltd 101 Page

103 Appendix 2. Questionnaire development Disciplinary action Q19. Have you done either of the following in the last 18 months as a result of the Responsible Pharmacist Regulations? Taken disciplinary action against another member of staff Been the subject of disciplinary action yourself Yes No Not sure Pharmacists were happy to answer No to these questions, but felt that if this actually applied to someone then they might feel uncomfortable in giving a Yes answer in case there were any consequences. Recommendation Although confidentiality will be stressed in the covering letter, it would probably be beneficial to re iterate it here Understanding and implementing the Regulations Q20. Which of the following have helped you to understand and implement the Regulations? And which have prevented this? Tick Yes or No for each item under each heading, or Not applicable if this does not apply to you Changes in working hours Staff working part time Use of locums Changes in the number or type of staff Training Amendments to systems or processes Length of opening hours Helped? Prevented? Not applicable Yes No Yes No Pharmacists felt this very difficult to answer and did not feel it was clear what was being asked and about who for example changes in whose working hours? They also did not feel that the things they were being asked about necessarily related to changes in the Regulations many of these were already in place before the Regulations came in so most answered Not applicable. Q24 was felt to better cover the impact of the Regulations. Recommendation Remove this question as it is not working at all. Changes and whether these are for the better or worse should be adequately covered by Q TNS UK Ltd 102 Page

104 Appendix 2. Questionnaire development Changes as a result of the Regulations Q24. The following are things which some people think have changed as a result of the Responsible Pharmacist Regulations. (a) For each one, please tick the box in column (a) if you think it has changed as a result of the Regulations. (b) For any item that you have ticked in column (a), how do you think it has changed? The quality of patient care The quality of the dispensing service Patient safety The number of services available within the pharmacy The amount of healthcare advice staff can give Opening hours (for patients) Working hours (for staff) Use of locums Frequency/Length of breaks Staff having the right amount of training Staff having the right amount of support The amount of time you spend working outside the dispensary premises The amount of admin/paperwork The skill mix within pharmacy staff The organisational structure within the pharmacy The relationship between Superintendent and employee The amount of time available for patient care How efficiently the pharmacy is run The level of customer service (a) Changed as a result of Regulations? Better now (b) How changed? Initially worse but now improved Worse now and an ongoing problem In general this question was felt to be easily understood and did not pose any problems. However, some pharmacists felt that nothing had changed so left the question blank, but would have preferred to have a box to tick to state this. Recommendation Add an option to tick for Nothing has changed Additional areas to cover It was felt that the Regulations made it more difficult to take on locum work because of being put in a difficult situation when they do not agree with the practices in the pharmacy or fully know/understand the set up. Some pharmacists who had previously worked as a 2011 TNS UK Ltd 103 Page

105 Appendix 2. Questionnaire development locum no longer wanted to do this. This was a different point to refusing to take on a particular Locum RP position (Q18) and should be addressed through a new question. One Pharmacist wanted an opportunity to get across negative thoughts about the Regulations as there was nowhere obvious on the questionnaire to express this. In particular this was in relation to being responsible over other colleagues, implying that they are suddenly irresponsible. It was mainly the wording that she objected to, but acknowledged that it was probably too late to change it now. It was queried whether an additional statement at Q14 could be added to cover this. As the questionnaire was felt to be comprehensive, the open question at Q25 was not required and it was therefore recommend that it be removed as it was unlikely to provide any additional information Issues for specific pharmacists The pharmacist who worked in primary care felt that there were a number of questions not relevant to those not working in a pharmacy, because of not needing to implement the Regulations. Questions should therefore be carefully checked to assess relevance to those not working in a pharmacy. She did however point out that many of those who work in primary care also do locum work in community pharmacies so would have more direct experience than she did herself. Another felt that locums knew less about the Regulations than other pharmacists, so this will be an interesting issue to explore further once the full data is available. It was felt that some questions were difficult to answer for someone who was not an RP. However, as all pharmacists do still need to be aware of the Regulations this is still important to cover and data can be analysed according to whether a respondent is ever an RP or not Support staff The pharmacists who took part in the pilot were asked how they thought other members of pharmacy staff would get on with answering the questions. It was generally felt that little would be relevant to support staff as they do not always see the difference the Regulations have made, and it is not specifically part of their job. Some thought that technicians may know more, but that was likely to be down to the individual. It will be interesting to explore how much support staff actually do know and what they perceive to be applicable to them TNS UK Ltd 104 Page

106 Appendix 3. Weighting of the quantitative data 11. Appendix 3. Weighting of the quantitative data 11.1 Pharmacists Corrective weighting was applied to the pharmacists data to account for the oversampling in the smaller nations (see Appendix 1) and for non response bias. The weighting profile was taken from the most up to date sources available. For Great Britain, this was the 2010 Register for demographics (nation, gender and age) and the 2008 census for main pharmacy sector worked in. For Northern Ireland, the source of all profile data was the membership database supplied by PSNI. As the profile data sources comprised all pharmacists, including those who were ineligible for this survey (for example those working solely in industry), the decision was made to include all respondents in the weighting process, rather than filter them out before this took place. A filter was then applied post weighting to exclude those not eligible for the main questionnaire. This ensured that the profile of eligible pharmacists in this survey was the closest possible match to the true profile of this group. Not all pharmacists answered some of the questions required for weighting (namely gender, age and main pharmacy sector). Where this was the case, for the purposes of weighting, these respondents were randomly assigned a category in proportion to the proportion each category was weighted to. This ensured the profile structure was maintained. As the profile of pharmacists was quite different in Northern Ireland compared with Great Britain, the two groups were weighted separately and then a second weight applied to return the nations to their correct proportions (95.6 in Great Britain and 4.4 in Northern Ireland). These proportions were supplied by the Royal Pharmaceutical Society. Table 10.1 shows the weighting profiles for pharmacists in Great Britain and Northern Ireland TNS UK Ltd 105 Page

107 Appendix 3. Weighting of the quantitative data Table 10.1 Weighting profile pharmacists Weighting dimension Great Britain Northern Ireland Nation England 85.0 Scotland 9.8 Wales 5.2 Gender Male Female Age 29 years or under years years years years or over Main pharmacy sector Community Hospital Primary Care 6.5 Industry 3.7 Academia 2.5 Other For main pharmacy sector, in GB Other = Prison, Internet, Other Pharmacy or Non Pharmacy and in NI Other = Primary care, Industry, Academia, Prison, Internet, Other Pharmacy or Non Pharmacy 11.2 Support staff As the profile of support staff was unknown, it was agreed that weighting should not be applied and results should always be used with caution. However, the effect of the oversampling of pharmacists in Scotland, Wales and Northern Ireland, would also have led to disproportionately high numbers of support staff in each of these nations. It was therefore agreed that the support staff data should be weighted to the proportions of pharmacists in each of the four nations. While there is no guarantee that the profile of support staff matches that of pharmacists, this was taken to be a pragmatic solution and the resultant profile should at least be closer to true than the sampling strategy allowed for. The weighting profile of support staff is summarised in Table TNS UK Ltd 106 Page

108 Appendix 3. Weighting of the quantitative data Table 10.2 Weighting profile support staff All support staff Weighting dimension Nation England 81.2 Scotland 9.4 Wales 5.0 Northern Ireland TNS UK Ltd 107 Page

109 Appendix 4. Sample profile 12. Appendix 4. Sample profile Further detail on the respondent profile, both by employment structure and demographics, is included below Quantitative sample Pharmacists Employment structure Tables 11.1 and 11.2 show the breakdown by sector among all pharmacists who responded to the survey, focussing first of all on main job (Table 11.1) and then on all jobs held (Table 11.2). It should be noted that pharmacists who worked outside of the affected sectors as their main job, but did still work in one of these sectors at all, were still considered to be eligible for the main survey. Table 11.1 Pharmacists main sector of employment Sector Total England Scotland Wales Northern Ireland Base: All respondents (2,028) (1,393) (163) (242) (230) Community Hospital Primary care * Prison <1 <1 <1 Internet <1 <1 Industry * 1* Academia 3 3 <1 4 4 Other pharmacy Non pharmacy <1 1 Refused 1 1 <1 1 * Indicates a significant difference from the total 2011 TNS UK Ltd 108 Page

110 Appendix 4. Sample profile Table 11.2 All sectors worked in by pharmacists (all respondents) Sector Total England Scotland Wales Northern Ireland Base: All respondents (2,028) (1,393) (163) (242) (230) Community * 73 Hospital Primary care * Prison <1 <1 <1 Internet <1 <1 Industry * 1* Academia 4 4 1* 5 5 Other pharmacy * 2 Non pharmacy * Indicates a significant difference from the total While the majority of pharmacists held just one job, around one in five held two or more jobs. Those in Scotland were the most likely to hold just one job (Tables 11.3 and 11.4). Table 11.3 Number of jobs held by pharmacists (all respondents) Number of jobs Total England Scotland Wales Northern Ireland Base: All respondents (2,028) (1,393) (163) (242) (230) * * 19 13* <1 <1 * Indicates a significant difference from the total Table 11.4 Number of jobs held by pharmacists (all in sectors affected by Regulations) Northern Number of jobs Total England Scotland Wales Ireland Base: All in sectors affected by Regs (1,845) (1,261) (146) (229) (209) * * <1 <1 * Indicates a significant difference from the total 2011 TNS UK Ltd 109 Page

111 Appendix 4. Sample profile Pharmacists worked an average of 37.1 hours a week, with no significant differences between nations and no difference between those in sectors affected by the Regulations and across all sectors (Tables 11.5 and 11.6). Table 11.5 Average weekly hours worked by pharmacists (all respondents) Weekly hours worked Total England Scotland Wales Northern Ireland Base: All respondents (2,028) (1,393) (163) (242) (230) * Mean Refused * Indicates a significant difference from the total Table 11.6 Average weekly hours worked by pharmacists (all in sectors affected by Regs) Northern Weekly hours worked Total England Scotland Wales Ireland Base: All in sectors affected by Regs (1,845) (1,261) (146) (229) (209) * Mean Refused * Indicates a significant difference from the total A simple categorisation was used to divide community pharmacies into quiet, average and busy, according to the number of prescription items they dealt with each week. Six in ten (61) fell into the middle category, with little difference by nation TNS UK Ltd 110 Page

112 Appendix 4. Sample profile Table 11.7 Average number of prescription items per week (all community pharmacists) Northern Average prescription items per week Total England Scotland Wales Ireland Base: All community pharmacists (1,445) (996) (104) (187) (158) 1,500 or less * 31 1,501 8, More than 8, * * Indicates a significant difference from the total Three quarters of those who worked in hospital pharmacies worked in those registered with the GPhC or PSNI at least some of the time (Table 11.8). Table 11.8 GPhC/PSNI registered status of hospital pharmacy (all hospital pharmacists) Northern Hospital registration status Total England Scotland Wales Ireland Base: All hospital pharmacists (345) (223) (33)^ (47)^ (42)^ Every Hospital Pharmacy I work in is registered I work in some Hospital Pharmacies that are registered and some that are * 10 not No Hospital Pharmacy I work in is registered * 9 I m not sure whether they are registered or not ^ Caution: Low base size, * Indicates a significant difference from the total Six in ten of those who worked in a pharmacy said there were up to five members of professional or technical staff at their main place of work (Table 11.9). The mean was 13 members of staff, with this skewed by the largest hospital pharmacies: hospital pharmacies had an average of 37 members of professional or technical staff, compared with six in community pharmacies TNS UK Ltd 111 Page

113 Appendix 4. Sample profile Table 11.9 Number of professional or technical staff at main place of work Number of staff Total England Scotland Wales Northern Ireland Base: All who work in a pharmacy (1,710) (1,164) (133) (216) (197) * * * Mean * Indicates a significant difference from the total Pharmacists worked with a variety of other staff (Table 11.10), with four in five working with dispensing or pharmacy assistants and half working with other pharmacists. Those in Northern Ireland were least likely to work with the support staff member types listed (with the exception of counter assistants) but were no more or less likely than those in other nations to work with other pharmacists. Table Types of staff at main place of work Other staff at main place of work Total England Scotland Wales Northern Ireland Base: All who work in a pharmacy (1,727) (1,172) (136) (219) (200) Dispensing/Pharmacy assistant(s) * Counter assistant(s) Pharmacy technician(s) * Other pharmacists Accuracy checking technician(s) * Accuracy checker(s) * 7* * Indicates a significant difference from the total Pharmacists responding to and eligible for the survey had been working as a pharmacist for an average of 18 years. This was slightly longer in Wales and slightly less time in Scotland and Northern Ireland (Table 11.11). Fewer than one in ten (8) had only been a pharmacist since the Regulations came into operation TNS UK Ltd 112 Page

114 Appendix 4. Sample profile Table Number of years working as a pharmacist Number of years as a pharmacist Total England Scotland Wales Northern Ireland Base: All in sectors affected by Regs (1,845) (1,261) (146) (229) (209) * 1* 13* * 7* * * * * Mean * 20.6* 13.2* * Indicates a significant difference from the total Over half had been working in their current main job for five years or less. The average was seven years (Table 11.12). Table Number of years working in current main job Sector Total England Scotland Wales Northern Ireland Base: All in sectors affected by Regs (1,845) (1,261) (146) (229) (209) * * * < Mean * 6.6 * Indicates a significant difference from the total Demographics Although the sample was weighted by key demographics (gender and age), there was a different natural fallout across the nations, as illustrated by Table and Scotland had a higher proportion of female pharmacists, while Wales had a higher proportion of older pharmacists TNS UK Ltd 113 Page

115 Appendix 4. Sample profile Table Gender Gender Total England Scotland Wales Northern Ireland Base: All in sectors affected by Regs (1,845) (1,261) (146) (229) (209) Male * Female * * Indicates a significant difference from the total Table Age Age Total England Scotland Wales Northern Ireland Base: All in sectors affected by Regs (1,845) (1,261) (146) (229) (209) 29 years or under * 31* years years years * 9* 60 years or over * 11 4* * Indicates a significant difference from the total 12.2 Quantitative sample Support staff Employment structure All support staff who responded to the survey were eligible as pharmacists were asked to only pass the questionnaire on to those in specific roles in community and hospital pharmacies. The profile of support staff according to their employment structure is shown in Tables Table Support staff main sector of employment Main sector of employment Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ Community Hospital ^ Caution: Low base size, * Indicates a significant difference from the total 2011 TNS UK Ltd 114 Page

116 Appendix 4. Sample profile Table All sectors worked in by support staff All sectors of employment Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ Community * 90 Hospital ^ Caution: Low base size, * Indicates a significant difference from the total Table Number of jobs held by support staff Number of jobs held Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ * <1 <1 3 ^ Caution: Low base size, * Indicates a significant difference from the total Table Average weekly hours worked by support staff Average weekly hours Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ Mean * Refused * 21 ^ Caution: Low base size, * Indicates a significant difference from the total 2011 TNS UK Ltd 115 Page

117 Appendix 4. Sample profile Table Average number of prescription items per week Average prescription items per week Total England Scotland Wales Northern Ireland Base: All community support staff (428) (298) (32)^ (63) (35)^ 1,500 or less ,501 8, More than 8, ^ Caution: Low base size, * Indicates a significant difference from the total Table GPhC/PSNI registered status of hospital pharmacy Hospital registration status Total England Scotland Wales Northern Ireland Base: All hospital support staff (62) (48)^ (3)^ (7)^ (4)^ Every Hospital Pharmacy I work in is registered * I work in some Hospital Pharmacies that are registered and some that are 4 4 not No Hospital Pharmacy I work in is registered I m not sure whether they are registered or not ^ Caution: Low base size, * Indicates a significant difference from the total Table Number of professional or technical staff at main place of work Number of staff Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ Mean * ^ Caution: Low base size, * Indicates a significant difference from the total 2011 TNS UK Ltd 116 Page

118 Appendix 4. Sample profile Table Types of staff at main place of work (all respondents) Staff at main place of work Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ Pharmacists Dispensing/Pharmacy assistant(s) * 62 Counter assistant(s) Pharmacy technician(s) Accuracy checking technician(s) * Accuracy checker(s) 5 6 1* 8 Not Stated * 10 ^ Caution: Low base size, * Indicates a significant difference from the total Table Number of years working in a pharmacy Number of years in a pharmacy Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ * Mean * ^ Caution: Low base size, * Indicates a significant difference from the total 2011 TNS UK Ltd 117 Page

119 Appendix 4. Sample profile Table Number of years working in current main job Number of years in current main job Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ Mean * ^ Caution: Low base size, * Indicates a significant difference from the total Registration status of support staff was not collected due to this being an ongoing process at the time of the survey and also due to it not being a requirement in Northern Ireland Demographics The profile of support staff by age and gender is shown in Table and Table Gender Sector Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ Male * 3 Female * ^ Caution: Low base size, * Indicates a significant difference from the total 2011 TNS UK Ltd 118 Page

120 Appendix 4. Sample profile Table Age Sector Total England Scotland Wales Northern Ireland Base: All support staff (509) (360) (39)^ (71) (39)^ 29 years or under years years years years or over ^ Caution: Low base size, * Indicates a significant difference from the total 12.3 Qualitative profile Table Qualitative sample structure: tele depth interviews Total England Scotland Wales Northern Ireland Sector Community Multiple Independent Supermarket Hospital Prison Internet 2 Location Urban Rural Job role Pharmacist Support staff Locum TNS UK Ltd 119 Page

121 Appendix 4. Sample profile Table Qualitative sample structure: case studies Total England Scotland Wales Northern Ireland Sector Community Multiple Independent Supermarket Hospital Prison Location Urban community Rural community Urban other Job role Pharmacist Technician* Support Staff* * Not included in total 2011 TNS UK Ltd 120 Page

122 Appendix 5. Additional data and findings 13. Appendix 5. Additional data and findings Further details on findings covered in the main body of the report are included below Pharmacist absence At the end of the quantitative survey, respondents were asked to give their opinion, irrespective of the Regulations, on four different statements expressing a view about pharmacist absence. These statements related to: sale of General Sales List medicines without a pharmacist present; operating the pharmacy when the pharmacist is absent for less than two hours; handing out prescriptions without a pharmacist present; and sale of pharmacy medicines without a pharmacist present. The results for pharmacists are discussed in Chapter 4 and illustrated in Chart 4.6 and the results for support staff are shown in Chart 12.1 below. Chart 12.1 Views on Absence Support Staff 2011 TNS UK Ltd 121 Page

123 Appendix 5. Additional data and findings Results for support staff showed a similar picture to results for pharmacists, albeit with slightly weaker strength of opinion. Six in ten (58) disagreed that General Sales List medicines must not be sold in a pharmacy unless a pharmacist is present. Half (50) strongly agreed that prescriptions must not be handed out unless a pharmacist is present, and seven in ten (71) strongly agreed that pharmacy medicines must not be sold unless a pharmacist is present. Support staff were more divided as to whether a pharmacy should be able to operate during a pharmacist absence of less than two hours, with 42 agreeing but 41 disagreeing Changes as a result of the Regulations For items that respondents felt had changed as a result of the Regulations, they were asked to indicate how they had changed, namely whether they were better now, initially worse but now improved, or worse now and an ongoing problem. Chart 5.3 shows the top five issues for pharmacists and support staff, but a full break down of results is shown below (Tables ), looking in turn at changes for the better, changes that were initially for the worse but now improved, and changes that were for the worse and are an ongoing problem. Support staff were more likely than pharmacists to believe there had been changes for the better as a result of the Regulations (55 of support staff said there had been no changes for the better, compared with 62 of pharmacists), and less likely to believe there had been sustained changes for the worse (69 of support staff said there had been no sustained changes for the worse, compared with 52 of pharmacists). For almost every change, support staff were more likely than pharmacists to think it had been for the better, whereas pharmacists were more likely to think it had been for the worse TNS UK Ltd 122 Page

124 Appendix 5. Additional data and findings Table 12.2 Whether better now as a result of the Regulations Better as a result of the Regulations Pharmacists Support Staff Base: All pharmacists working in a sector affected by the Regulations/ All support staff (1,845) (509) Patient safety 12 20* The number of services available within the pharmacy 7 12* The quality of the dispensing service 6 14* How efficiently the pharmacy is run 6 13* Frequency/Length of breaks 6 5 The level of customer service 5 12* The quality of patient care 5 15* The organisational structure within the pharmacy 4 8* The staff skill mix within the pharmacy 4 5 The amount of healthcare advice staff can give 4 9* Staff having the right amount of training 4 7* The amount of time you spend working outside the dispensary premises 4 3 Opening hours (for patients) 3 5* The relationship between Superintendent and employee 3 5* The amount of time available for patient care 3 6* Staff having the right amount of support 3 6* Use of locums 2 4* Working hours (for staff) 2 4* The amount of admin/paperwork 1 3* None 62* 55 * Indicates a significant difference between the groups 2011 TNS UK Ltd 123 Page

125 Appendix 5. Additional data and findings Table 12.3 Whether initially worse but now improved as a result of the Regulations Initially worse but now improved as a result of the Regulations Pharmacists Support Staff Base: All pharmacists working in a sector affected by the regulations/ All support staff (1,845) (509) The amount of admin/paperwork 6 7 The organisational structure within the pharmacy 2 2 How efficiently the pharmacy is run 2 3 Staff having the right amount of training 2 2 The quality of the dispensing service 2 2 The staff skill mix within the pharmacy 2 2 The amount of healthcare advice staff can give 2 2 The amount of time available for patient care 2 1 Use of locums 2 2 Frequency/Length of breaks 2 1 Staff having the right amount of support 1 2 The relationship between Superintendent and employee 1 1 Working hours (for staff) 1 1 The quality of patient care 1 2 The level of customer service 1 2 The amount of time you spend working outside the dispensary premises 1 1 The number of services available within the pharmacy 1 3* Patient safety 1 2 Opening hours (for patients) 1 2 None * Indicates a significant difference between the groups 2011 TNS UK Ltd 124 Page

126 Appendix 5. Additional data and findings Table 12.4 Whether worse now and an ongoing problem as a result of the Regulations Worse now and an ongoing problem as a result of the Regulations Pharmacists Support Staff Base: All pharmacists working in a sector affected by the regulations/ All support staff (1,845) (509) The amount of admin/paperwork 26* 16 Frequency/Length of breaks 14* 4 The relationship between Superintendent and employee 9* 2 The amount of time available for patient care 9* 5 Working hours (for staff) 8* 3 How efficiently the pharmacy is run 7* 3 Patient safety 6* 2 The quality of the dispensing service 6* 2 The level of customer service 6* 2 The quality of patient care 6* 2 The organisational structure within the pharmacy 5* 1 The amount of time you spend working outside the dispensary premises 5* 2 Staff having the right amount of support 5 3 Use of locums 4 3 The amount of healthcare advice staff can give 4* 2 The staff skill mix within the pharmacy 4* 2 The number of services available within the pharmacy 3 2 Staff having the right amount of training 3 3 Opening hours (for patients) 2 2 None 52 69* * Indicates a significant difference between the groups 2011 TNS UK Ltd 125 Page

127 Appendix 6. Questionnaires 14. Appendix 6. Questionnaires 14.1 Responsible Pharmacist Regulations Survey: Pharmacists CURRENT WORK SITUATION Q1. Please circle the number that most closely corresponds to your current main job and any others you have. Please also write in the number of hours per week that you usually work. MAIN JOB JOB 2 JOB 3 JOB 4 Circle a number Average weekly hours Circle a number Average weekly hours Circle a number Average weekly hours Circle a number Community Pharmacy Owner Manager Locum Relief Second Non-store based Other Hospital Pharmacy Locum Band Band Band 8a Band 8b Band 8c Band 8d Band Primary care Prison Internet Industry Academia Other pharmacy Non-pharmacy TNS UK Ltd 126 Page Average weekly hours IF YOU ONLY WORK IN SECTORS SHADED GREY ABOVE THEN THE REST OF THIS SURVEY WILL NOT APPLY TO YOU. YOU DO NOT NEED TO ANSWER ANY FURTHER QUESTIONS, JUST ANSWER Q1 AND RETURN THE QUESTIONNAIRE IN THE SUPPLIED ENVELOPE. IF YOUR MAIN JOB IS IN ONE OF THE SECTORS SHADED GREY ABOVE, BUT YOU ALSO WORK IN OTHER SECTORS (NOT SHADED GREY) THEN PLEASE ANSWER THE QUESTIONS ABOUT THE MAIN JOB THAT YOU HOLD OUTSIDE OF THOSE SECTORS SHADED GREY ABOVE.

128 Appendix 6. Questionnaires PLEASE ANSWER ALL QUESTIONS UNLESS THE TEXT INDICATES THAT A QUESTION OR SERIES OF QUESTIONS DOES NOT APPLY TO YOU. ANSWER Q2 AND Q3 IF YOU WORK IN A COMMUNITY PHARMACY AT ALL Q2. Please indicate in which of the following organisations you hold your position(s). Tick one box only in column (a), and as many boxes in column (b) as relevant. Independent pharmacy Small chain (2-4 stores) Medium sized multiple (5-25 stores) Large multiple (Over 25 stores) Supermarket chain (a) Most often (b) Any other Q3. Approximately how many prescription items a week are issued at the Community Pharmacy where you work? If you work in more than one, please think about the one you indicated in column (a) at Q2. 1,500 or less 1,501-8,000 More than 8,000 Don t know ANSWER Q4 IF YOU WORK IN A HOSPITAL PHARMACY AT ALL Q4. Is/Are the Hospital Pharmacy(ies) that you work in registered with the General Pharmaceutical Council / Pharmaceutical Society of Northern Ireland? Every Hospital Pharmacy I work in is registered I work in some Hospital Pharmacies that are registered and some that are not No Hospital Pharmacy I work in is registered I m not sure whether they are registered or not Q5. What is the postcode of your main place of work? Write in postcode: / _ Q6. What types of staff are employed within the pharmacy at your main place of work? Tick more than one if relevant. I don t work in a pharmacy Other pharmacist(s) Accuracy checking technician(s) [qualified technician with addition training] Pharmacy technician(s) [trained to NVQ/SVQ level 3] Dispensing/Pharmacy assistant(s) [trained to NVQ/SVQ level 2] Accuracy checker(s) [trained to NVQ/SVQ level 2] Counter assistant(s) Q7. At any given time, approximately how many members of professional or technical staff would be working in the pharmacy at your main place of work? Write in number of staff: I don t work in a pharmacy 2011 TNS UK Ltd 127 Page

129 Appendix 6. Questionnaires ATTITUDES TOWARDS YOUR JOB Q8. Please indicate how satisfied or dissatisfied you are with the following aspects of your job. Tick one box for each statement. The number of hours you work The frequency / length of breaks The level of responsibility you have The amount of support you have The amount of training you receive Your pay Your working environment Your job overall Very satisfied Fairly satisfied Neither satisfied nor dissatisfied Fairly dissatisfied Very dissatisfied Does not apply THE RESPONSIBLE PHARMACIST REGULATIONS The Responsible Pharmacist Regulations came into effect in October 2009, creating a legal duty for the pharmacist to ensure that the pharmacy is running safely and efficiently at all times. Q9. Do you ever take the role of Responsible Pharmacist in your main job, and if so for roughly what proportion of the time? I never work in a pharmacy Yes all the time that I am working in the pharmacy Yes at least three quarters of the time I am working in the pharmacy Yes at least half but less than three quarters of the time I am working in the pharmacy Yes at least a quarter but less than half the time I am working in the pharmacy Yes but less than a quarter of the time I am working in the pharmacy Never when I am working in the pharmacy ANSWER Q10 AND Q11 ONLY IF YOU EVER WORK AS A RESPONSIBLE PHARMACIST Q10. When working as a Responsible Pharmacist, do you have the authority to do any of the following? Change a Standard Operating Procedure Change the roles of staff members Go outside normal company procedures, e.g. to meet patient needs Yes No, but I would be involved in the process No, not at all Not sure 2011 TNS UK Ltd 128 Page

130 Appendix 6. Questionnaires Q11. In your role as a Responsible Pharmacist, have you done any of the following in the last 18 months? Changed a Standard Operating Procedure Changed the roles of staff members Gone outside normal company procedures, e.g. to meet patient needs Called the Superintendent to discuss any of the above Yes No, but I was involved in the process No, not at all Not sure Q12. How much do you think you know about the Responsible Pharmacist Regulations? I have a thorough understanding of all the Regulations I have a good understanding of the Regulations that affect me and my work I have some basic understanding of the Regulations, but not in detail I know very little about the Regulations I have heard about the Regulations but nothing more I have not heard of the Regulations before today Q13. To the best of your knowledge, which of the following are covered by the Regulations? Please tick Yes, No or Don t know for each option below. There has to be a sole individual in the role of the Responsible Pharmacist at all times The Responsible Pharmacist is legally accountable for the safe and effective running of the Pharmacy The Responsible Pharmacist has the responsibility to establish and clarify roles and responsibilities of other members of staff In the absence of the Responsible Pharmacist, support staff can hand out prescriptions that have already been checked The Responsible Pharmacist is responsible for establishing, maintaining and reviewing Pharmacy procedures Records must be kept to show when an individual becomes and ceases to become the Responsible Pharmacist It is a criminal offence to fail to keep records of who is holding the Responsible Pharmacist position The Responsible Pharmacist can be absent from the Pharmacy (while it is open) for no more than 2 hours in a 24 hour period The Responsible Pharmacist can be absent from the Pharmacy (while it is open) for more than 2 hours if another Pharmacist is present Yes No Don t know 2011 TNS UK Ltd 129 Page

131 Appendix 6. Questionnaires Q14. To what extent do you agree or disagree with the following statements about the Responsible Pharmacist Regulations? Tick one box for each statement. I feel more empowered to exercise my personal professional judgement The Responsible Pharmacist Regulations have made no difference to my practice I feel that I should be more empowered to exercise my professional judgement but in reality I need to follow the SOPs more closely I think that the Responsible Pharmacist Regulations make the use of SOPs more important to protect me from accusations of unprofessional behaviour The Regulations put the Responsible Pharmacist in a difficult position by making them legally responsible for people and processes that are not within their control. I think the Responsible Pharmacist Regulations allow greater personal control Agree strongly Agree slightly Neither agree nor disagree Disagree slightly Disagree strongly Does not apply ANSWER Q15 ONLY IF YOU EVER WORK AS A RESPONSIBLE PHARMACIST Q15. As best you understand them, how well do you feel you have implemented the Responsible Pharmacist Regulations? Very well Fairly well Not very well Not sure Q16. Would you say that you understand how the responsibilities differ between the Responsible Pharmacist and the Superintendent? Yes No Not sure Q17. Which of the following statements best applies to you? I have never worked as a Locum I used to work as a Locum, but no longer do this as a direct result of the Responsible Pharmacist Regulations I used to work as a Locum, but no longer do this for some other reason I currently work as a Locum 2011 TNS UK Ltd 130 Page

132 Appendix 6. Questionnaires ANSWER Q18 AND Q19 ONLY IF YOU HAVE WORKED AS A LOCUM IN THE LAST 18 MONTHS Q18. Are you able to read through and professionally assess all of the Standard Operating Procedures for the Pharmacy before commencing as a Responsible Pharmacist? At all of the premises where I work At most of the premises where I work At some of the premises where I work At very few of the premises where I work At none of the premises where I work I have not worked as a Locum Responsible Pharmacist Not sure Q19. In the last 18 months, have you refused, or thought about refusing to work as a Responsible Pharmacist in a Pharmacy because of how it is operated? I have actually refused I thought about it, but went ahead and worked anyway I have not refused or thought about refusing to work I have not had the opportunity to work as a Responsible Pharmacist Q20. Have you done either of the following in the last 18 months as a result of the Responsible Pharmacist Regulations? Please note that all responses will be kept confidential and individual responses will never be identified. Taken disciplinary action against another member of staff Been the subject of disciplinary action yourself Yes No Not sure Q21. What, if anything, do you think needs to occur to aid the implementation of the Responsible Pharmacist Regulations? Tick as many as you think apply I don t think anything needs to change Make more staff available Make more use of locums Make less use of locums Have the right mix of staff available at any time Have more staff training Have better quality staff training Make amendments to systems or processes Increase length of opening hours Decrease length of opening hours Have more spot checks/audits Something else: WRITE IN I don t know what would need to change 2011 TNS UK Ltd 131 Page

133 Appendix 6. Questionnaires ANSWER Q22 AND Q23 ONLY IF YOU WORK IN A PHARMACY AT ALL Q22. Would you say the Responsible Pharmacist Regulations have given you more or less professional autonomy? A lot more professional autonomy A little more professional autonomy Has not really changed the amount of professional autonomy I have A little less professional autonomy A lot less professional autonomy Not sure Q23. As a result of the Responsible Pharmacist Regulations, would you say that you are more or less clear in relation to rules about Pharmacist absences from the Pharmacy? Much clearer A little clearer No real change A little less clear Much less clear Not sure Q24. The following are things which some people think have changed as a result of the Responsible Pharmacist Regulations. (a) For each one, please tick the box in column (a) if you think it has changed as a result of the Regulations. (b) For any item that you have ticked in column (a), how do you think it has changed? If you think none of the items listed below have changed, please tick here The quality of patient care The quality of the dispensing service Patient safety The number of services available within the pharmacy The amount of healthcare advice staff can give Opening hours (for patients) Working hours (for staff) Use of locums Frequency/Length of breaks Staff having the right amount of training Staff having the right amount of support The amount of time you spend working outside the dispensary premises The amount of admin/paperwork The staff skill mix within the pharmacy The organisational structure within the pharmacy The relationship between Superintendent and employee The amount of time available for patient care How efficiently the pharmacy is run The level of customer service (a) Changed as a result of Regulations? (b) How changed? Initially worse but Better now now improved Worse now and an ongoing problem 2011 TNS UK Ltd 132 Page

134 Appendix 6. Questionnaires Q25. Finally, irrespective of what the Responsible Pharmacist Regulations actually say, to what extent do you agree or disagree with each of the following statements? Tick one box for each statement. A Pharmacy should be able to continue to operate while the Pharmacist is absent, as long as this is for less than 2 hours GSL (General Sales List) medicines must not be sold in a Pharmacy unless a Pharmacist is present Pharmacy medicines must not be sold in a Pharmacy unless a Pharmacist is present Prescriptions must not be handed out in a Pharmacy unless a Pharmacist is present Agree strongly Agree slightly Neither agree nor disagree Disagree strongly Disagree slightly Does not apply ABOUT YOU Q26. How long have you been working as a Pharmacist? Write in to the nearest year - 0 if less than 6 months Write in number of years: Q27. How long have you been working in your current main job? Write in to the nearest year - 0 if less than 6 months Write in number of years: Q28. Are you? Male Female Q29. How old are you? 29 years or under years years years 60 years or over Thank you for completing this survey. Please send the questionnaire to Kantar Operations in the envelope provided (no stamp required) by 15 August TNS UK Ltd 133 Page

135 Appendix 6. Questionnaires 14.2 Responsible Pharmacist Regulations Survey: Support staff PHARMACIST: Please pass this questionnaire and a pre-paid return envelope to a member of pharmacy support staff that you work with for them to complete independently. This can be someone working in any of the following roles in a Community or Hospital Pharmacy: - Accuracy checking technician - Pharmacy technician - Dispensing/Pharmacy assistant - Accuracy checker - Counter assistant If you do not work with anyone in any of these roles in a Community or Hospital Pharmacy, please tick the box and return this questionnaire with your own completed questionnaire PHARMACY SUPPORT STAFF: Thank you for agreeing to take part in this survey, which aims to find out how the Responsible Pharmacist Regulations are affecting pharmacy staff. The research has been commissioned by the Royal Pharmaceutical Society and the Pharmaceutical Society for Northern Ireland and is being undertaken by TNS-BMRB, an independent social research company. It will be used to identify whether further change is needed in order to help optimise safe and effective pharmaceutical care. Please answer all questions, unless indicated by the text above the question, and then return the questionnaire in the envelope provided (no stamp required) by 15 August. All responses will be treated in the strictest confidence by TNS-BMRB, and only passed back to the Royal Pharmaceutical Society anonymously and aggregated with other responses. If you would prefer to complete the survey online, you can do so by going to and entering your unique access code, which is <ACCESS CODE>. If you would like more information about this study, please contact David Elston at TNS- BMRB on or [email protected]. Alternatively, you can get in touch with Beth Allen, Head of Research at the Royal Pharmaceutical Society, on or [email protected] TNS UK Ltd 134 Page

136 Appendix 6. Questionnaires CURRENT WORK SITUATION S1. Please tick the box that most closely corresponds to your current main job and any others you have. Please also write in the number of hours per week that you usually work. Community Pharmacy Accuracy checking technician Pharmacy technician Dispensing/ Pharmacy assistant Accuracy checker Counter assistant Hospital Pharmacy Accuracy checking technician Pharmacy technician Dispensing/ Pharmacy assistant Accuracy checker Counter assistant MAIN JOB JOB 2 JOB 3 JOB 4 Tick a box Average weekly hours Tick a box Average weekly hours Tick a box Average weekly hours Tick a box Average weekly hours ANSWER S2 AND S3 IF YOU WORK IN A COMMUNITY PHARMACY S2. If you work in a Community Pharmacy at all, please indicate in which of the following organisations you hold your position(s). Tick one box only in column (a), and as many boxes in column (b) as relevant. Independent pharmacy Small chain (2-4 stores) Medium sized multiple (5-25 stores) Large multiple (Over 25 stores) Supermarket chain (a) Most often (b) Any other 2011 TNS UK Ltd 135 Page

137 Appendix 6. Questionnaires S3. Approximately how many prescription items a week are issued at the Community Pharmacy where you work? If you work in more than one, please think about the one you indicated in column (a) at S2. 1,500 or less 1,501-8,000 More than 8,000 Don t know ANSWER S4 IF YOU WORK IN A HOSPITAL PHARMACY S4. Is/Are the Hospital Pharmacy(ies) that you work in registered with the General Pharmaceutical Council / Pharmaceutical Society of Northern Ireland? Every Hospital Pharmacy I work in is registered I work in some Hospital Pharmacies that are registered and some that are not No Hospital Pharmacy I work in is registered I m not sure whether they are registered or not S5. What is the postcode of your main place of work? Write in postcode: / _ S6. To the best of your knowledge, what types of staff are employed within the pharmacy at your main place of work? Tick more than one if relevant. Pharmacist(s) Accuracy checking technician(s) [qualified technician with addition training] Pharmacy technician(s) [trained to NVQ/SVQ level 3 Dispensing/Pharmacy assistant(s) [trained to NVQ/SVQ level 2] Accuracy checker(s) [trained to NVQ level 2] Counter assistant(s) S7. At any given time, approximately how many members of professional or technical staff would be working in the pharmacy at your main place of work? Write in number of staff: 2011 TNS UK Ltd 136 Page

138 Appendix 6. Questionnaires ATTITUDES TOWARDS YOUR JOB S8. Please indicate how satisfied or dissatisfied you are with the following aspects of your job. Tick one box for each statement. The number of hours you work The frequency / length of breaks The level of responsibility you have The amount of support you have The amount of training you receive Your pay Your working environment Your job overall Very satisfied Fairly satisfied Neither satisfied nor dissatisfied Fairly dissatisfied Very dissatisfied Does not apply THE RESPONSIBLE PHARMACIST REGULATIONS The Responsible Pharmacist Regulations came into effect in October 2009, creating a legal duty for the pharmacist to ensure that the pharmacy is running safely and efficiently at all times. S9. How much do you think you know about the Responsible Pharmacist Regulations? I have a thorough understanding of all the Regulations I have a good understanding of the Regulations that affect me and my work I have some basic understanding of the Regulations, but not in detail I know very little about the Regulations I have heard about the Regulations but nothing more I have not heard of the Regulations before today 2011 TNS UK Ltd 137 Page

139 Appendix 6. Questionnaires S10. To the best of your knowledge, which of the following are covered by the Regulations? Please tick Yes, No or Don t know for each option below. There has to be a sole individual in the role of the Responsible Pharmacist at all times The Responsible Pharmacist is legally accountable for the safe and effective running of the Pharmacy The Responsible Pharmacist has the responsibility to establish and clarify roles and responsibilities of other members of staff In the absence of the Responsible Pharmacist, support staff can hand out prescriptions that have already been checked The Responsible Pharmacist is responsible for establishing, maintaining and reviewing Pharmacy procedures Records must be kept to show when an individual becomes and ceases to become the Responsible Pharmacist It is a criminal offence to fail to keep records of who is holding the Responsible Pharmacist position The Responsible Pharmacist can be absent from the Pharmacy (while it is open) for no more than 2 hours in a 24 hour period The Responsible Pharmacist can be absent from the Pharmacy (while it is open) for more than 2 hours if another Pharmacist is present Yes No Don t know S11. Would you say that you understand how the responsibilities differ between the Responsible Pharmacist and the Superintendent? Yes No Not sure S12. Have you done either of the following in the last 18 months as a result of the Responsible Pharmacist Regulations? Please note that all responses will be kept confidential and individual responses will never be identified. Taken disciplinary action against another member of staff Been the subject of disciplinary action yourself Yes No Not sure 2011 TNS UK Ltd 138 Page

140 Appendix 6. Questionnaires S13. What, if anything, do you think needs to occur to aid the implementation of the Responsible Pharmacist Regulations? Tick as many as you think apply I don t think anything needs to change Make more staff available Make more use of locums Make less use of locums Have the right mix of staff available at any time Have more staff training Have better quality staff training Make amendments to systems or processes Increase length of opening hours Decrease length of opening hours Have more spot checks/audits Something else: WRITE IN I don t know what would need to change S14. As a result of the Responsible Pharmacist Regulations, would you say that you are more or less clear in relation to rules about Pharmacist absences from the Pharmacy? Much clearer A little clearer No real change A little less clear Much less clear Not sure 2011 TNS UK Ltd 139 Page

141 Appendix 6. Questionnaires S15. The following are things which some people think have changed as a result of the Responsible Pharmacist Regulations. (a) For each one, please tick the box in column (a) if you think it has changed as a result of the Regulations. (b) For any item that you have ticked in column (a), how do you think it has changed? If you think none of the items listed below have changed, please tick here The quality of patient care The quality of the dispensing service Patient safety The number of services available within the pharmacy The amount of healthcare advice staff can give Opening hours (for patients) Working hours (for staff) Use of locums Frequency/Length of breaks Staff having the right amount of training Staff having the right amount of support The amount of time you spend working outside the dispensary premises The amount of admin/paperwork The staff skill mix within the pharmacy The organisational structure within the pharmacy The relationship between Superintendent and employee The amount of time available for patient care How efficiently the pharmacy is run The level of customer service (a) Changed as a result of Regulations? (b) How changed? Initially worse but Better now now improved Worse now and an ongoing problem 2011 TNS UK Ltd 140 Page

142 Appendix 6. Questionnaires S16. Finally, irrespective of what the Responsible Pharmacist Regulations actually say, to what extent do you agree or disagree with each of the following statements? Tick one box for each statement. A Pharmacy should be able to continue to operate while the Pharmacist is absent, as long as this is for less than 2 hours GSL (General Sales List) medicines must not be sold in a Pharmacy unless a Pharmacist is present Pharmacy medicines must not be sold in a Pharmacy unless a Pharmacist is present Prescriptions must not be handed out in a Pharmacy unless a Pharmacist is present Agree strongly Agree slightly Neither agree nor disagree Disagree strongly Disagree slightly Does not apply ABOUT YOU S17. How long have you been working in a Pharmacy? Write in to the nearest year - 0 if less than 6 months Write in number of years: S18. How long have you been working in your current main job? Write in to the nearest year - 0 if less than 6 months Write in number of years: S19. Are you? Male Female S20. How old are you? 29 years or under years years years 60 years or over Thank you for completing this survey. Please send the questionnaire to Kantar Operations in the envelope provided (no stamp required) by 15 August TNS UK Ltd 141 Page

143 Appendix 7. Topic guide and materials 15. Appendix 7. Topic guide and materials 15.1 Topic guide: Pharmacists (permanent and locums) 1. Introduction (2 mins) Aim: The aim of the research is to establish an evidence base to understand the nature of the impacts of the Responsible Pharmacist Regulations, and to measure their extent. This will then feed into the direction of the RPS and the Professional Forum of the PSNI s professional leadership in this area. Researcher explain: Surveys of 2000 pharmacists and 500 support staff are also being carried out. This interview is being conducted to provide an in-depth understanding of the impacts of regulations, and what factors affect how they are implemented on the ground in different settings. TNS-BMRB independent research agency; working on behalf of Royal Pharmaceutical Society & the Pharmaceutical Society of Northern Ireland. Purpose of the interview (see box above) Recording interviews; explain recordings are only available to the research team Emphasise confidentiality and reassure that whilst their views will be used, none of the findings will be attributed to them. The RPS / Professional Forum of the PSNI will not know who has taken part. And none of their views will be discussed with or revealed to employers or other members of staff in their pharmacy. Reassure - not a test or audit, it is for RPS/Professional Forum of the PSNI to understand the perspective of pharmacists and pharmacy support staff and their experience of the Regulations important to get honest and open views. Duration of interview 45 minutes 2. Interviewee background and context (5 mins) Briefly explore interviewee background o Job role o Time in post o Day-to-day tasks and responsibilities o What it s like being a pharmacist these days o Who do they manage and who are they managed by 2011 TNS UK Ltd 142 Page

144 Appendix 7. Topic guide and materials Working context: (briefly) explore how job has changed over past 18 months o Positive changes o Negative changes For both of the above: probe briefly on what caused these changes Clarify whether any of these are directly related to Responsible Pharmacist Regulations 3. Awareness and communication of the RPRs (5 mins) Assessing comprehension NOTE TO RESEARCHER: for all of the below assess how confident the participant is in their knowledge and how broad their knowledge is or any areas of specific focus according to role o o o What they understand the RPR requirements to be (list everything they think it covers) What they understand the broader aims (policy intent) of the RPRs to be If they are not aware, what would they guess them to be? Whether they are aware of upcoming changes to supervision If so, expectation of how this will fit with the RPRs Sources of information o How do they know about the above / where did they find out 4. Initial views on the RPR and their impact (3 mins) Initial views o What they think of them positive / negative any change in their views over time and what prompted these changes o Broad view on extent of impact in their experience 5. Exploring and mapping implementation (15 mins) Using the PROCESS MAP (A3 Stimulus): build a map of practices before the RPR and after to identify the key changes in practice across each of the 5 main areas of the regulation. Please rotate the order in which you tackle each of the areas to ensure all are covered For each area probe. a) extent of implementation b) influences (barriers to / facilitators of implementation) Where specific probes are indicated in CAPS for particular audiences these should be asked in addition to the main probes TNS UK Ltd 143 Page

145 Appendix 7. Topic guide and materials Participants may fit into more than one category and in these cases several different specific probes will be relevant. For example a LOCUM could also be working in their main job in A MULTIPLE, where there are 2 OR MORE PHARMACISTS so in Legal status below they would be asked all of these specific probes. Legal status a) extent of implementation - How would they explain their responsibility in the pharmacy now and what does this mean in terms of day-to-day practice - To what extent were they responsible in the pharmacy before the RPRs and what did this mean in practice / in terms of working with others - Explore extent of change i.e. in practice, how much has changed in their responsibility level between now and before the RPRs - Where 2 OR MORE PHARMACISTS only, how do they decide who the RP will be - How do they interpret their legal responsibility in relation to the responsibility of the owner / employer / superintendent / support staff e.g. in securing the environment, in professional practice o What are they responsible for and what are others responsible for o I.e. what would happen if e.g. a shelf fell down on a customer s head in the pharmacy? A fridge storing medicines failed and wasn t noticed? Who would be responsible? What action would be taken? - Explore how they feel about it b) influences (barriers / facilitators of implementation) - To what extent do they feel able to be legally responsible for the safe running of the pharmacy - What influences this (spontaneous to all) o To what extent do they have sufficient autonomy to control areas of pharmacy provision such as the physical environment, staffing arrangements (MULTIPLES in particular) o Understanding of staff s capability (LOCUMS in particular) Professional standards (including training) a) extent of implementation - How do they interpret RP s requirement in terms of ensuring professional standards - How this is different from before - What actions they have taken to ensure professional standards are sufficient e.g. any specific training programmes put in place as a result of the RPRs? - How they decide what is sufficient and whether staff meet this level i.e. how do they monitor professional standards - What they do to maintain / address professional standards i.e. have they issued any guidance / enacted training as a result of RPR b) influences (barriers / facilitators of implementation) 2011 TNS UK Ltd 144 Page

146 Appendix 7. Topic guide and materials - What influences their ability to ensure professional standards i.e. what helps them / what hinders them in ensuring staff have the skills - Is there money / time / a culture of wider training to fill any gaps in knowledge (particularly COMMUNITY) Standard Operating Procedures (SOPs) a) extent of implementation - What SOPs did they have in place before the RPRs - Have they written new SOPs since the introduction of the RPRs - COMMUNITY did they buy them - How are these different from the previous ones - MULTIPLES / LOCUMS working in MULTIPLES: to what extent SOPs are tailored for each premises or are they being rolled out across the same ones - LOCUMS working in several different COMMUNITY premises: how do they accommodate working with many different SOPs - LOCUMS: check if they have ever disagreed with SOPS and if so what do they do, have they ever refused to sign on - Who reads them: How many of and which types of staff are familiar with these new SOPs and how do / did they ensure this - How often do they as RP review/amend the SOPs - How often are staff required to review them - What are the processes in place to ensure new staff / locums are familiar with their SOPs b) influences (barriers / facilitators of implementation) - What influences their ability to ensure SOPs which are RPR compliant e.g. - do they have the autonomy to make changes - do they have training availability - LOCUMS: clarity / how the SOPs are written Pharmacy Record a) extent of implementation - What sort of things are recorded in the record and how frequently - Can you explain to me how the process of signing in works in practice - What record did they keep before the introduction of the RPRs - What has changed in their documentation since the RPRs, if anything, and when did this happen - Is there a sign displayed in the pharmacy they work in - What happens if someone is late who is due to sign in - How confident are they that their record is always accurate b) influences (barriers / facilitators of implementation) - What has influenced their ability to maintain the pharmacy record i.e. what ever gets in the way or what makes it easier 2011 TNS UK Ltd 145 Page

147 Appendix 7. Topic guide and materials Absence a) extent of implementation - How do they interpret the new rules in relation to absence (note any mention of restbreaks this is not part of RPRs) - What were the arrangements in terms of absence from the pharmacy before the RPRs - How have the Regulations changed anything in their day-to-day role - How do they use the 2 hours and for what sort of activities, in what instances, how regularly; - INTERNET: How does the absence rule effect them in practice b) influences (barriers / facilitators of implementation) - What has influenced their use of the 2 hours absence i.e. what stops them using it / what makes them able to be absent o MULTIPLES in particular: explore any pressure not to be absent; any evidence of multiples enacting the 2 hours either at the beginning / end of day o HOSPITAL: is this relevant to them (with many pharmacists covering each other) o Capability of support staff (esp in COMMUNITY) RESEARCHERS: Then use this map as the basis for the remaining discussion (even if only for your own reference if on telephone). Note to interviewers: this area is lower priority so skip if you are short of time External influences Sense check influence on these changing processes of any external factors such as: o Other areas of regulation such as the Working Time Directive o the NHS contract o The recession / budget cuts o The evolving role of pharmacists o For COMMUNITY: commercial / business pressures o Any other influences? 6. Understanding impacts (5-10 mins) RESEARCHERS: Use the mapped changes to process as recorded from above to unpick perceived impacts of the RPRs. If useful, use the A3 IMPACTS Stimulus to record these Which is the most important area of change for them resulting from the RPRs and why Explore any positive impacts of the RPRs, across the different areas o For the RP o For locum RPs o For support staff 2011 TNS UK Ltd 146 Page

148 Appendix 7. Topic guide and materials o o For owners / employers commercial viability For patients safety, quality of service, access to medicines Explore any negative impacts of the RPRs, across the different areas o For the RP o For locum RPs o For support staff o For owners - commercial viability o For patients safety, quality of service, access to medicines, greater range of services For any where there is no impact, probe why If not mentioned, how have the changes required by the RPRs in each of the main areas had an impact on: o Skill mix and workload e.g. number of locums, their own workload, administrative burden, range and number of support staff o Organisational/ management structures e.g. extent of delegation, rubberstamping o Working relationships. Spontaneous then if not mentioned probe: Between pharmacists Between pharmacists and employer Between pharmacist and support staff Between pharmacist and superintendent (frequency of contact in relation to RPRs) Between the superintendent and employer 7. Meeting the aims of the RPRs (5 mins) Refer back to aims briefly (discussed at section 3) and explore extent to which changes are supporting or hindering the RPR s policy aims: o Patient safety o Patient access to medicines o Empowerment of pharmacists clinical leadership role o Personalised care for patients Using A3 AIMS stimulus where helpful to map in what ways the changes have: Supported the aim Had no impact Hindered the aim Overall, to what extent do they think the RPRs have met their aims RESEARCHER REF some potential ways the RPRs may have hindered aims are as follows: o Patient safety o Patient access to medicines Having to wait for RP to come back from absence for prescriptions o Empowerment of pharmacists clinical leadership role 2011 TNS UK Ltd 147 Page

149 Appendix 7. Topic guide and materials o Check-boxing / added bureaucracy Criminal liability leading to increased cautiousness Junior RPs esp in large multiples having insufficient authority Personalised care for patients Absence from pharmacy less patient contact on premises (but more off-premises??) Potential for even more remote working with supervision What are the main barriers to the RPR meeting its objectives o Spontaneous o Then prompt with SCENARIOS from anecdotal evidence Are any of these of concern, either now or for the future? What are the main facilitators: o What encourages/facilitates implementation o Any requirement for training e.g. from support organisations Finally, looking future o Any changes in the regulatory framework that would help the RPRs better meet their aims o Anything that should be taken into account when considering changes to supervision, in light of learning from the impact of the RPRs Any other thoughts/ suggestions THANK AND CLOSE 2011 TNS UK Ltd 148 Page

150 Appendix 7. Topic guide and materials 15.2 Topic guide: Support staff 1. Introduction (2 mins) Aim: The aim of the research is to establish an evidence base to understand the nature of the impacts of the Responsible Pharmacist Regulations, and to measure their extent. This will then feed into the direction of the RPS and Professional Forum of PSNI s professional leadership in this area. Researcher explain: Surveys of 2000 pharmacists and 500 support staff are also being carried out. This interview is being conducted to provide an in-depth understanding of the impacts of Regulations, and what factors affect how they are implemented on the ground in different settings. TNS-BMRB independent research agency; working on behalf of Royal Pharmaceutical Society & the Pharmaceutical Society of Northern Ireland. Purpose of the interview (see box above) Recording interviews; explain recordings are only available to the research team Emphasise confidentiality and reassure that whilst their views will be used, none of the findings will be attributed to them. The RPS / Professional Forum of the PSNI will not know who has taken part. And none of their views will be discussed with or revealed to employers or other members of staff in their pharmacy. Reassure - not a test or audit, it is for RPS/Professional Forum of the PSNI to understand the perspective of pharmacists and pharmacy support staff and their experience of the Regulations important to get honest and open views. Duration of interview 30 minutes 2. Interviewee background and context (3 mins) Briefly explore interviewee background o Job role [technician / accuracy checking technician (ACT), dispensing assistant] o Time in post and time since qualifying o Day-to-day tasks and responsibilities o What it s like being a [INSERT ROLE] these days o Who do they manage and who are they managed by 3. Awareness and communication of the RPRs (5 mins) Assessing comprehension NOTE TO RESEARCHER: for all of the below assess how confident the participant is in their knowledge and how broad their knowledge is or any areas of specific focus according to role o What they understand the RPR requirements to be (list everything they think it covers) 2011 TNS UK Ltd 149 Page

151 Appendix 7. Topic guide and materials o o What they understand the broader aims (policy intent) of the RPRs to be If they are not aware, what would they guess them to be? Whether they are aware of upcoming changes to supervision If so, expectation of how this will fit with the RPRs Sources of information o How do they know about the above / where did they find out 4. Initial views on the RPR and their impact (3 mins) Initial views o What they think of them positive / negative any change in their views over time and what prompted these changes o Broad view on extent of impact in their experience 5. Exploring and mapping implementation (10 mins) Using the PROCESS MAP (A3 Stimulus): build a map of practices before the RPR and after to identify the key changes in practice across each of the 5 main areas of the regulation. Please rotate the order in which you tackle each of the areas to ensure all are covered For each area probe. a) extent of implementation b) influences (barriers to / facilitators of implementation) Where specific probes are indicated in CAPS for particular audiences these should be asked in addition to the main probes. Legal status a) extent of implementation - How would they explain the RP s responsibility in the pharmacy now and what does this mean in terms of day-to-day practice - What was the RP s legal status before the RPRs - Explore extent of change i.e. in practice, how much has changed in the RP s responsibility level between now and before the RPRs - How do they interpret their own legal responsibility in terms of their professional practice and in relation to the responsibility of the RP / owner / employer other support staff e.g. o I.e. what would happen if e.g. they make a dispensing error on a prescription that the RP checked? - Explore how they feel about it 2011 TNS UK Ltd 150 Page

152 Appendix 7. Topic guide and materials Professional standards (including training) a) extent of implementation - How do they interpret RP s requirement in terms of ensuring professional standards - How this is different from before - Have they experienced any specific training programmes being put in place as a result of the RPRs - What is done to monitor their training needs and do they feel this is sufficient why / why not Standard Operating Procedures (SOPs) a) extent of implementation - Have they seen any new SOPs since the introduction of the RPRs - What SOPs were in place before the RPRs - If there are new ones, how are they different from the previous ones - Have they read them how was this enforced - How often are the SOPs reviewed/amended by the RP - How often are they required to re-read them b) influences (barriers / facilitators of implementation) - What influences their ability to understand and uphold the new RPR SOPs Pharmacy Record a) extent of implementation - What sort of things are recorded in the record and how frequently - What record was kept before the introduction of the RPRs - What has changed in their documentation since the RPRs, if anything, and when did this happen - Is there a sign displayed in the pharmacy they work in - Can you explain to me how the process of signing in works in practice - Who is responsible for filling it in - What happens if someone is late who is due to sign in - How confident are they that the record is always accurate Absence a) extent of implementation - How do they interpret the new rules in relation to absence (note any mention of restbreaks this is not part of RPRs) - What were the arrangements in terms of the pharmacist s absence from the pharmacy before the RPRs - How have the new absence rules changed anything in their day-to-day role - How do they feel about it RESEARCHERS: Then use this map as the basis for the remaining discussion (even if only for your own reference if on telephone) TNS UK Ltd 151 Page

153 6. Understanding impacts (5 mins) RESEARCHERS: Use the mapped changes to process as recorded from above to unpick perceived impacts of the RPRs. If useful, use the A3 IMPACTS Stimulus to record these Explore any positive impacts of the RPRs, across the different areas o For support staff o For patients safety, quality of service, access to medicines Explore any negative impacts of the RPRs, across the different areas o For support staff o For patients safety, quality of service, access to medicines For any where there is no impact, probe why If not mentioned, how have the changes required by the RPRs in each of the main areas had an impact on: o Skill mix and workload e.g. number of locums, their own workload, administrative burden o Organisational/ management structures e.g. extent of delegation, rubberstamping o Working relationships. Spontaneous then if not mentioned probe: Between pharmacists Between pharmacist and support staff 7. Finally (2 mins) Finally, looking to the future o Is there anything that they would like to be changed in the regulations or in the way that they are supported For any mentioned probe what this would achieve Any other thoughts/ suggestions THANK AND CLOSE 2011 TNS UK Ltd 152 Page

154 15.3 Stimulus material 2011 TNS UK Ltd 153 Page