Evaluation of the impact of Responsible Pharmacist Regulations

Evaluation of the impact of Responsible Pharmacist Regulations 2011 TNS UK Limited JN226985 September 2011 2011 TNS UK Ltd 1 Page

Contents Contents Executive Summary... 2 1. Introduction... 8 2. The working environment... 23 3. Awareness and understanding of the Regulations... 28 4. Implementation of the Regulations... 35 5. Impact of the Regulations... 55 6. Barriers and facilitators... 66 7. Stakeholder workshop findings... 71 8. Conclusions and Recommendations... 76 9. Appendix 1. Research method... 90 10. Appendix 2. Questionnaire development... 96 11. Appendix 3. Weighting of the quantitative data... 105 12. Appendix 4. Sample profile... 108 13. Appendix 5. Additional data and findings... 121 14. Appendix 6. Questionnaires... 126 15. Appendix 7. Topic guide and materials... 142 2011 TNS UK Ltd 1 Page

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: http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_0955 70 2 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 45. 2011 TNS UK Ltd 2 Page

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. 2011 TNS UK Ltd 3 Page

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 45 2011 TNS UK Ltd 4 Page

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. 2011 TNS UK Ltd 5 Page

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. 2011 TNS UK Ltd 6 Page

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. 2011 TNS UK Ltd 7 Page

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 1.1.1 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: http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_0955 70 6 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 45 2011 TNS UK Ltd 8 Page

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 1968. 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 1.2. 1.1.2 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

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. 2011 TNS UK Ltd 10 Page

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. 1.1.3 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. 2011 TNS UK Ltd 11 Page

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. 2011 TNS UK Ltd 12 Page

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 1.4.1.3). 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 1. 1.4 Profile of the sample 1.4.1 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. 2011 TNS UK Ltd 13 Page

Introduction 1.4.1.1 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 70 70 67 72 73 Hospital 21 21 25 21 21 Primary care 7 7 8 4* 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. 2011 TNS UK Ltd 14 Page

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 21 21 17 21 29* Small chain (2 4 stores) 9 8 17* 11 12 Medium sized multiple (5 25 stores) 8 8 10 6 9 Large multiple (over 25 stores) 51 51 50 55 47 Supermarket chain 9 11 4* 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

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. 1.4.1.2 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

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 33 40 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). 1.4.1.3 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

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 83 83 82 89 90 Hospital 13 13 8 10 10 ^ 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 34 36 21 35 33 Pharmacy technician 29 29 36 28 28 Accuracy checking technician 22 22 26 30 13 Counter assistant 9 8 8 4 23* Accuracy checker 1 1 1 3 ^ 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. 2011 TNS UK Ltd 18 Page

Introduction 1.4.2 Qualitative sample 1.4.2.1 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 45 13 10 10 10 Community 32 10 7 8 7 Multiple 18 5 4 5 4 Independent 10 3 2 2 3 Supermarket 4 2 1 1 Hospital 8 2 2 2 2 Prison 3 1 1 1 Internet 2 Location 43 13 10 10 10 Urban 27 9 6 6 6 Rural 16 4 4 4 4 Job role 43 13 10 10 10 Pharmacist 22 8 5 4 5 Support staff 8 2 2 2 2 Locum 13 3 3 4 3 1.4.3 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. 2011 TNS UK Ltd 19 Page

Introduction Table 1.9 Qualitative sample structure: case studies Total England Scotland Wales Northern Ireland Sector 15 6 3 3 3 Community 11 4 2 3 2 Multiple 5 2 1 1 1 Independent 4 1 1 1 1 Supermarket 2 1 0 1 0 Hospital 3 1 1 0 1 Prison 1 1 0 0 0 Location 14 5 3 3 3 Urban community 6 2 2 1 1 Rural community 5 2 0 2 1 Urban other 3 1 1 0 1 Job role 14 5 3 3 3 Pharmacist 14 5 3 3 3 Technician* 3 1 2 1 Support Staff* 4 2 1 1 1 Customers* 20 6 8 5 1 * Not included in total 1.5 Conduct of the study 1.5.1 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 email reminders were sent where an email address was available. Further details of the survey 2011 TNS UK Ltd 20 Page

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 2011. 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 3. 1.5.2 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 1.6.1 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 1. 2011 TNS UK Ltd 21 Page

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. 1.6.2 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) 1.6.3 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

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. 2011 TNS UK Ltd 23 Page

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. 2011 TNS UK Ltd 24 Page

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). 2011 TNS UK Ltd 25 Page

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 73 72 74 82* Level of responsibility 71 67* 80* 80* Working environment 61 60 62 69 Amount of support 55 52 61* 65* Pay 51 48 59* 62* Frequency/Length of breaks 46 39* 64* 64* Amount of training 45 43 51* 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

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. 2011 TNS UK Ltd 27 Page

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. 2011 TNS UK Ltd 28 Page

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