Level 2 Certificate in Pharmaceutical Science ( )

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1 Level 2 Certificate in Pharmaceutical Science ( ) Qualification handbook for centres 500/9575/4 September 2010 Version 1.0

2 About City & Guilds City & Guilds is the UK s leading provider of vocational qualifications, offering over 500 awards across a wide range of industries, and progressing from entry level to the highest levels of professional achievement. With over 8500 centres in 100 countries, City & Guilds is recognised by employers worldwide for providing qualifications that offer proof of the skills they need to get the job done. City & Guilds Group The City & Guilds Group includes City & Guilds, ILM (the Institute of Leadership & Management, which provides management qualifications, learning materials and membership services), City & Guilds NPTC (which offers land-based qualifications and membership services), City & Guilds HAB (the Hospitality Awarding Body), and City & Guilds Centre for Skills Development. City & Guilds also manages the Engineering Council Examinations on behalf of the Engineering Council. Equal opportunities City & Guilds fully supports the principle of equal opportunities and we are committed to satisfying this principle in all our activities and published material. A copy of our equal opportunities policy statement is available on our website. Copyright The content of this document is, unless otherwise indicated, The City and Guilds of London Institute and may not be copied, reproduced or distributed without prior written consent. However, approved City & Guilds centres and candidates studying for City & Guilds qualifications may photocopy this document free of charge and/or include a PDF version of it on centre intranets on the following conditions: centre staff may copy the material only for the purpose of teaching candidates working towards a City & Guilds qualification, or for internal administration purposes candidates may copy the material only for their own use when working towards a City & Guilds qualification The Standard Copying Conditions (which can be found on our website) also apply. Please note: National Occupational Standards are not The City and Guilds of London Institute. Please check the conditions upon which they may be copied with the relevant Sector Skills Council. Publications City & Guilds publications are available from our website or from our Publications Sales department, using the contact details shown below. Every effort has been made to ensure that the information contained in this publication is true and correct at the time of going to press. However, City & Guilds products and services are subject to continuous development and improvement and the right is reserved to change products and services from time to time. City & Guilds cannot accept liability for loss or damage arising from the use of information in this publication. City & Guilds 1 Giltspur Street London EC1A 9DD T +44 (0) F +44 (0)

3 Level 2 Certificate in Pharmaceutical Science ( ) Qualification handbook for centres September 2010 Version 1.0 Level 2 Certificate in Pharmaceutical Science ( ) 1

4 City & Guilds Skills for a brighter future 2 Level 2 Certificate in Pharmaceutical Science ( )

5 Contents 1 Introduction to the qualification Qualification structure Opportunities for progression Qualification support materials 6 2 Centre requirements Resource requirements Candidate entry requirements 9 3 Course design and delivery Initial assessment and induction Recommended delivery strategies 10 4 Assessment Summary of assessment methods Recording forms 11 5 Units 12 Unit 201 Communicating with pharmacy customers 14 Unit 202 Law, regulation, health and safety in pharmacy 19 Unit 203 Working in the pharmacy team 24 Unit 204 Ordering and issuing stock in the pharmacy 28 Unit 205 Receiving, storing and maintaining stock in the pharmacy 33 Unit 206 Preparing for and manufacture of aseptic products 37 Unit 207 Assisting in the preparation, manufacture and assembly of medicinal products 42 Unit 208 Selling over the counter medicines in the pharmacy 47 Unit 209 Processing a Prescription 52 Unit 210 Assemble prescriptions safely 56 Appendix 1 Sources of general information 61 Level 2 Certificate in Pharmaceutical Science ( ) 3

6 City & Guilds Skills for a brighter future 4 Level 2 Certificate in Pharmaceutical Science ( )

7 1 Introduction to the qualification This document contains the information that centres need to offer the following qualification: Qualification title and level Level 2 Certificate in Pharmaceutical Science City & Guilds qualification number ( ) Qualification accreditation number 500/9575/4 Last registration date 31/12/2013 Last certification date 31/12/2015 This knowledge qualification has been designed for those wishing to work in a pharmacy setting, either in the community or in a hospital. The qualification can be used as a stand alone knowledge qualification or, taken in conjunction with the City & Guilds Level 2 NVQ Certificate in Pharmacy Service Skills, will contribute to the Level 2 Apprenticeship in Pharmacy as specified by Skills for Health Qualification structure To achieve the Level 2 Certificate in Pharmaceutical Science, learners must achieve 15 credits from the mandatory units and a minimum of 15 credits from the optional units available. Unit accreditation number City & Guilds unit number Unit title Mandatory/ optional for full qualification H/601/ Communicating with Pharmacy Customers Mandatory 5 Credit value M/601/ Law, regulation, Health and Safety in Pharmacy Mandatory 5 T/601/ Working in the Pharmacy Team Mandatory 5 A/601/ Preparing for and manufacture of aseptic products Optional 5 M/601/ Ordering and issuing stock in the pharmacy Optional 5 T/601/ Receiving, storing and maintaining stock in the pharmacy Optional 5 Level 2 Certificate in Pharmaceutical Science ( ) 5

8 Unit accreditation number City & Guilds unit number Unit title R/601/ Assisting in the preparation, manufacture and assembly of medicinal products Mandatory/ optional for full qualification Optional 5 Credit value H/601/ Selling Over The Counter Medicines in the Pharmacy Optional 5 F/601/ Processing a Prescription Optional 5 Y/601/ Assemble Prescriptions Safely Optional Opportunities for progression This knowledge qualification has been designed to prepare candidates wishing to work in a pharmacy setting. It can be taken as a stand alone qualification or, with the City & Guilds Level 2 NVQ Certificate in Pharmacy Service Skills, as part of the Apprenticeship for Pharmacy at Level 2. Candidates can progress to the City & Guilds Level 3 Diploma in Pharmaceutical Science Qualification support materials City & Guilds also provides the following publications and resources specifically for this qualification: Description How to access Assignment guide for centres Assignment guide for candidates Marking guide Standard recording forms Level 2 Certificate in Pharmaceutical Science ( )

9 2 Centre requirements 2.1 Resource requirements Human resources Staff delivering this qualification must be able to demonstrate that they meet the following occupational expertise requirements. They should: be technically competent in the area for which they are delivering training and/or have experience of providing training. This knowledge must be at least to the same level as the training being delivered have recent relevant experience in the specific area they will be assessing have credible experience which is clearly demonstrable through continuing learning and development Centre staff may undertake more than one role, eg tutor and assessor or internal verifier, but must never internally verify their own assessments. Assessors and internal verifiers Assessors must: hold or be working towards the appropriate Assessor qualification as identified by the qualifications regulators. Assessors holding older qualifications must be able to demonstrate that they are assessing to current standards have credible experience which is clearly demonstrable through continuing learning and development. Internal Verifiers must: be a registered and practising Pharmacist or a practising Pharmacy Technician other than in Northern Ireland, pharmacy technicians must be registered or eligible to register with the Pharmacy regulator. Within Great Britain, unregistered Pharmacy Technicians who are eligible to register can only act as verifiers during the transitional registration period It is crucial that internal verifiers understand the nature and context of the assessors work and that of their candidates due to the critical nature of the work and the legal and other implications of the assessment process have a working knowledge of pharmacy and/or GP dispensing settings, the regulation, legislation and codes of practice for the service (where applicable), and the requirements of national standards at the time any assessment is taking place occupy a position that gives them authority and resources to co-ordinate the work of assessors, provide authoritative advice, call meetings as appropriate, visit and observe assessments and carry out all the other internal verification roles as defined by the relevant national occupational standard hold or be working towards the appropriate Internal Verifier qualifications as identified by the qualifications regulators. Internal verifiers holding older qualifications must be able to demonstrate that they are assessing to current standards. have undertaken the appropriate assessor qualification identified by the regulator and practised as an assessor prior to undertaking the IV role. Level 2 Certificate in Pharmaceutical Science ( ) 7

10 It is recognised that internal verifiers are expected to verify the assessment process and not reassess the evidence provided. Co-ordinating Assessors and Lead Assessors In order that the requirements for occupational competence of assessors can be met while allowing flexibility of delivery, candidates may have more than one assessor involved in the assessment process. Where more than one assessor is involved in the qualification there must be a named assessor who is responsible for the overall co-ordination of the assessment for each candidate. This person will be responsible for integrating, planning and directing assessment for the whole qualification. Where more than one assessor is involved in a unit, there must be named assessor who is responsible for the overall coordination of the assessment for that unit. The lead assessor must ensure that the best use is made of all available evidence and will make the final judgment of competence in each unit where other assessors have been involved. It is expected that all assessors will work closely with internal verifiers to ensure standardised practice and judgments within the assessment process External verifiers External verifiers must: be a registered and practising Pharmacist or a practising Pharmacy Technician other than in Northern Ireland, be registered or eligible to register with the Pharmacy regulator. Within Great Britain, unregistered Pharmacy Technicians who are eligible to register with the Pharmacy regulator can only act as external verifiers during the transitional registration period. have working knowledge of pharmacy and/or GP dispensing settings, the regulation, legislation and codes of practice for the service (where applicable), and the requirements of national standards at the time any assessment is taking place hold, or be working towards, the appropriate external verifier qualification as identified by the qualifications regulators. External verifiers holding older qualifications must be able to demonstrate that they are assessing to current standards External verifiers who are not yet qualified against the appropriate competences but have the necessary occupational competence and experience, can be supported by a qualified external verifier who does not necessarily have the occupational expertise or experience. have credible experience which is clearly demonstrable through continuing learning and development. Assessment Centres Assessment centres will be responsible for maintaining up-to-date information on assessors, internal verifiers and expert witnesses and for ensuring the currency of the competence of internal verifiers and all those involved in the assessment process. Continuing professional development (CPD) Centres are expected to support their staff in ensuring that their knowledge remains current of the occupational area and of best practice in delivery, mentoring, training, assessment and verification, and that it takes account of any national or legislative developments. 8 Level 2 Certificate in Pharmaceutical Science ( )

11 2.2 Candidate entry requirements Candidates should not be entered for a qualification of the same type, content and level as that of a qualification they already hold. There are no formal entry requirements for candidates undertaking this qualification. However, centres must ensure that candidates have the potential and opportunity to gain the qualification successfully. Level 2 Certificate in Pharmaceutical Science ( ) 9

12 3 Course design and delivery 3.1 Initial assessment and induction Centres will need to make an initial assessment of each candidate prior to the start of their programme to ensure they are entered for an appropriate type and level of qualification. The initial assessment should identify: any specific training needs the candidate has, and the support and guidance they may require when working towards their qualification. This is sometimes referred to as diagnostic testing. any units the candidate has already completed, or credit they have accumulated which is relevant to the qualification they are about to begin. City & Guilds recommends that centres provide an induction programme to ensure the candidate fully understands the requirements of the qualification[s] they will work towards, their responsibilities as a candidate, and the responsibilities of the centre. It may be helpful to record the information on a learning contract. 3.2 Recommended delivery strategies Centre staff should familiarise themselves with the structure, content and assessment requirements of the qualification before designing a course programme. Centres may design course programmes of study in any way which: best meets the needs and capabilities of their candidates satisfies the requirements of the qualification[s]. When designing and delivering the course programme, centres might wish to incorporate other teaching and learning that is not assessed as part of the qualification[s]. This might include the following: literacy, language and/or numeracy personal learning and thinking personal and social development employability Where applicable, this could involve enabling the candidate to access relevant qualifications covering these skills. 10 Level 2 Certificate in Pharmaceutical Science ( )

13 4 Assessment 4.1 Summary of assessment methods For this qualification candidates will be required to complete the following assessments: one assignment for each unit City & Guilds provides the following assessments: Assignments versions A, Time constraints The following time constraints must be applied to the assessment of this qualification: It is anticipated that an assignment should take no longer than eight hours, in total, to complete. Centre staff should guide candidates to ensure excessive evidence gathering is avoided. Centres finding that assignments are taking longer, should contact the external verifier for guidance All assignments must be completed and assessed within the candidate s period of registration. Centres should advise candidates of any internal timescales for the completion and marking of individual assignments. 4.2 Recording forms Candidates and centres may decide to use a paper-based or electronic method of recording evidence. Amendable (MS Word) versions of the forms are available on the City & Guilds website Although it is expected that new centres will use these forms, centres may devise or customise alternative forms, which must be approved for use by the external verifier, before they are used by candidates and assessors at the centre. City & Guilds endorses several eportfolio systems. Further details are available at: Level 2 Certificate in Pharmaceutical Science ( ) 11

14 5 Units Availability of units The units for this qualification follow. They may also be obtained from the centre resources section of the City & Guilds website. The learning outcomes and assessment criteria are also viewable on the National Database of Accredited Qualifications (NDAQ) Structure of units The units in this qualification are written in a standard format and comprise the following: City & Guilds reference number unit accreditation number title level credit value unit aim relationship to NOS, other qualifications and frameworks endorsement by a sector or other appropriate body information on assessment learning outcomes which are comprised of a number of assessment criteria notes for guidance. Summary of units City & Guilds unit number Unit title Unit accreditation number Credit value 201 Communicating with Pharmacy Customers H/601/ Law, regulation, Health and Safety in Pharmacy M/601/ Working in the Pharmacy Team T/601/ Preparing for and manufacture of aseptic products A/601/ Level 2 Certificate in Pharmaceutical Science ( )

15 City & Guilds unit number Unit title Unit accreditation number Credit value 205 Ordering and issuing stock in the pharmacy M/601/ Receiving, storing and maintaining stock in the pharmacy T/601/ Assisting in the preparation, manufacture and assembly of medicinal products R/601/ Selling Over The Counter Medicines in the Pharmacy H/601/ Processing a Prescription F/601/ Assemble Prescriptions Safely Y/601/ Level 2 Certificate in Pharmaceutical Science ( ) 13

16 Unit 201 Communicating with pharmacy customers Level: 2 Credit value: 5 NDAQ number: H/601/7774 Unit aim This unit will ensure that the learner will have the necessary knowledge and understanding to be able to communicate effectively with Pharmacy customers. Learning outcomes There are four learning outcomes to this unit. The learner will be able to: 1. Understand the importance of effective communications with pharmacy customers 2. Understand the importance of identifying pharmacy customers needs 3. Know how to meet pharmacy customers needs 4. Know how to work within the limitations of their role Guided learning hours It is recommended that 30 hours should be allocated for this unit, although patterns of delivery are likely to vary. Support of the unit by a sector or other appropriate body This unit is endorsed by Skills for Health. Assessment This unit will be assessed by: an assignment covering practical skills and underpinning knowledge. 14 Level 2 Certificate in Pharmaceutical Science ( )

17 Unit 201 Outcome 1 Communicating with pharmacy customers Understand the importance of effective communications with pharmacy customers 1. describe the key features of effective communication with pharmacy customers 2. describe how to use verbal communication within a pharmacy setting 3. describe how to use non verbal communication within a pharmacy setting 4. describe the possible consequences of poor communication with pharmacy customers 5. describe techniques for managing potential conflict within a pharmacy setting 6. describe what actions to take when dealing with complaints Pharmacy customers: internal and external Verbal and non-verbal communication skills: o Different methods: face to face, telephone, written, electronic, paper o Body language: positive and negative, attitude, eye contact, gestures, tone and volume of voice o Barriers to communication: physical barriers, environmental barriers i.e. noise, impairments i.e. sight, hearing, emotional barriers i.e. individual perceptions i.e. anger, fear, anxious, upset, confused, abusive. Complaints: o Service or product complaints o Conflict management: recognising and minimising potential conflict, customer loyalty, dealing with angry or upset customers o Organisational policies for handling complaints: standard operating procedures Level 2 Certificate in Pharmaceutical Science ( ) 15

18 Unit 201 Outcome 2 Communicating with pharmacy customers Understand the importance of identifying pharmacy customers needs 1. describe how to identify pharmacy customers needs 2. describe different types of pharmacy customers needs 3. explain the importance of correctly recognising pharmacy customers needs. Identify pharmacy customers needs: o Individuals: those with special requirements i.e. hearing impairment, sight impairment,, language difficulties, those with some idea of their needs, those with no idea of their needs, patient s representatives o Individuals needs: requests for information, advice, assistance, specific product information, service information, healthcare advice o Questioning technique: use of questions,(2wham), open and closed questions, techniques used to check individuals understanding of communication i.e. listening, explaining, interpreting, paraphrasing, summarising. 16 Level 2 Certificate in Pharmaceutical Science ( )

19 Unit 201 Outcome 3 Communicating with pharmacy customers Know how to meet pharmacy customers needs 1. list information sources or advice available to meet pharmacy customers needs 2. describe how to check that pharmacy customers needs have been met. Information sources: o Resources i.e. standard operating procedures, reference books, electronic resources, written resources, workplace policies and procedures: customer complaint procedures, local polices and procedures o Questioning technique: use of questions,(2wham), open and closed questions, techniques used to check individuals understanding of communication i.e. listening, explaining, interpreting, paraphrasing, summarising o Patient information: waiting times, keeping customers informed of any delays, stock availability. Level 2 Certificate in Pharmaceutical Science ( ) 17

20 Unit 201 Outcome 4 Communicating with pharmacy customers Know how to work within the limitations of their role 1. explain the roles and responsibility of staff when dealing with pharmacy customers 2. describe which requests should be referred to the pharmacist or other senior persons 3. describe when complaints should be referred to a relevant authority in line with organisational policy. Roles and Responsibilities of staff: o Pharmacist, pharmacy technicians, pharmacy support staff, other healthcare professionals o Legal and ethical responsibilities, pharmacy protocols, organisational policies and procedures, confidentiality, staff training requirements, complaints procedure. Referred to a relevant authority: pharmacist, manager, supervisor, other healthcare professional 18 Level 2 Certificate in Pharmaceutical Science ( )

21 Unit 202 Law, regulation, health and safety in pharmacy Level: 2 Credit value: 5 NDAQ number: M/601/7776 Unit aim This unit will ensure that the learner will have the necessary knowledge and understanding to be able to carry out their pharmacy job role lawfully and safely. Learning outcomes There are four learning outcomes to this unit. The learner will be able to: 1. Understand the main laws relating to the delivery of a pharmacy service 2. Know the requirements of a pharmacy workplace health and safety 3. Understand the hazards and risks within the pharmacy workplace 4. Know how to respond to pharmacy workplace hazards and risks Guided learning hours It is recommended that 30 hours should be allocated for this unit, although patterns of delivery are likely to vary. Support of the unit by a sector or other appropriate body This unit is endorsed by Skills for Health. Assessment This unit will be assessed by: an assignment covering practical skills and underpinning knowledge. Level 2 Certificate in Pharmaceutical Science ( ) 19

22 Unit 202 Outcome 1 Law, regulation, health and safety in pharmacy Understand the main laws relating to the delivery of a pharmacy service 1. outline the main pharmacy services legislations 2. describe the key differences in the legal requirements for the different classes of medicines 3. describe role, responsibilities and legal duties of the staff responsible for the pharmacy workplace 4. describe the impact of legislation on the pharmacy workplace Basics of current pharmacy services legislation and regulations that apply to pharmacies for the sale of medicines: o Medicines Act 1968 Classification of medicines: GSL, P, POM o Misuse of Drugs Act 1971 Misuse of drugs regulations 2001 ( & amendments): schedules 1-5, treatment of addicts o Poisons Act 1972: sale of poisons o Veterinary Regulations o Denatured Alcohol Current Pharmacy professional regulation: o General Pharmaceutical Council (GPhC) Standards of practice Retail Pharmacy Business: registration of premises Registration of Pharmacists and Pharmacy Technicians Responsible Pharmacist Pharmacists: Pharmacy Technicians, Pharmacy Assistants, Other Healthcare Professionals Basics of legislation relevant to pharmacy services: Data Protection Act, Consumer Protection Act, Trades Description Act, Waste Disposal regulations. 20 Level 2 Certificate in Pharmaceutical Science ( )

23 Unit 202 Outcome 2 Law, regulation, health and safety in pharmacy Know the requirements of a pharmacy workplace health and safety 1. identify the responsibilities and legal duties for health and safety by law for: the pharmacy workplace their job role 2. describe the safe working practices that should be followed in the pharmacy workplace 3. explain why personal presentation is important in maintaining health and safety in the pharmacy workplace 4. describe how personal behaviour contributes to health and safety of staff and customers in the pharmacy workplace. Current Legislation: o The Health and Safety at Work Act 1974 o Manual Handling Operations 1992 (& amendments) o Health and Safety (Display Screen Equipment) Regulations 1992) o Organisational Statutory and Mandatory Training including infection control, fire safety, hand hygiene Working practices: o Organisational Codes of Conduct and behaviour o All activities, procedures, identifying hazards, use of materials, substances or equipment and working techniques used in carrying out a work or job related task including procedures for reporting hazards and unsafe working practices Workplace instructions: An organisation s instructions, method statements, safe systems of work, guidelines and processes on how to behave and perform tasks in the workplace. Instructions covering, for example: o the use of safe working methods and equipment the safe use of hazardous substances o smoking, eating, drinking and drugs o what to do in the event of an emergency o personal presentation Level 2 Certificate in Pharmaceutical Science ( ) 21

24 Unit 202 Outcome 3 Law, regulation, health and safety in pharmacy Understand the hazards and risks within the pharmacy workplace 1. define the terms hazards and risks 2. identify the hazards which exist in the pharmacy workplace 3. name the risks to the environment which may be present in the workplace and/or job role 4. describe how to minimise risks 5. explain the importance of remaining alert to the presence of hazards in the pharmacy workplace. Hazards: i.e. spills, trips, breakages, obstructions, faulty equipment or machinery, environmental factors, incorrect storage of medicines or raw materials, disposal of waste and unwanted medicines Current Legislation: Control of Substances Hazardous to Health (COSHH) Chemical (Hazard Information and Packaging for Supply) regulations 2009 (CHIP4), Chemical Labelling Packaging (CLP), Safety Data Sheets Working practices: risk assessment, workplace standard operating procedures Workplace instructions: organisational fire alarms and drills, major incident procedures, responding to emergencies. 22 Level 2 Certificate in Pharmaceutical Science ( )

25 Unit 202 Outcome 4 Law, regulation, health and safety in pharmacy Know how to respond to pharmacy workplace hazards and risks 1. outline the extent and responsibility of your role in controlling risks in the pharmacy workplace 2. identify which risks and hazards must be referred 3. outline the workplace instructions for managing risks that you are not able to deal with 4. name the responsible people to whom health and safety matters should be reported 5. describe where and when to get additional health and safety assistance 6. describe how to safely use common equipment and materials in the pharmacy workplace according to manufacturers and suppliers instructions. Current Legislation: The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR), Heath and Safety Executive (HSE) Workplace instructions: organisational procedures for reporting incidences and accidents Responsible person/ people: the person or people at work to whom any health, safety and welfare issues or hazards should be reported. Level 2 Certificate in Pharmaceutical Science ( ) 23

26 Unit 203 Working in the pharmacy team Level: 2 Credit value: 5 NDAQ number: T/601/7777 Unit aim This unit will ensure that the learner will have the necessary knowledge and understanding to be able to function as a productive member of the pharmacy team. Learning outcomes There are three learning outcomes to this unit. The learner will be able to: 1. Know the legal and ethical requirements relevant to work within the pharmacy team 2. Understand the principles that underpin effective teamwork 3. Know own strengths and weaknesses as part of a pharmacy team Guided learning hours It is recommended that 30 hours should be allocated for this unit, although patterns of delivery are likely to vary. Support of the unit by a sector or other appropriate body This unit is endorsed by Skills for Health. Assessment This unit will be assessed by: an assignment covering practical skills and underpinning knowledge. 24 Level 2 Certificate in Pharmaceutical Science ( )

27 Unit 203 Outcome 1 Working in the pharmacy team Know the legal and ethical requirements relevant to work within the pharmacy team 1. identify the codes of practice and conduct that provide standards and guidance to pharmacy team members. 2. describe current legislation and organisational procedures relating to: Accessing records Storage and retrieval of information including data protection Team working 3. describe how to apply organisational policies and procedures to individual services and to relationships within the pharmacy team 4. state why it is important to adhere to organisational procedures at all times. 5. outline legislation and organisational procedures on equality, diversity, discrimination and rights when working in a team Codes of practice and conduct: o Code of Ethics for Pharmacists and Pharmacy Technicians o Code of Conduct for Pre-registration Trainee Pharmacy Technicians o Code of Conduct for Pre-registration Trainee Pharmacists Basics of current legislation: o Data Protection Act 2003 o Freedom of Information Act 2000 o Disability Discrimination Act 2003 o Equal Opportunities Act 1996 o Human Rights Act 2000 Organisational procedures: o Standard Operating Procedures (SOPs) o Organisational policies and procedures relating to: Disciplinary procedures Grievance procedures Complaints procedures Raising concerns Appraisal and performance review procedures Level 2 Certificate in Pharmaceutical Science ( ) 25

28 Unit 203 Outcome 2 Working in the pharmacy team Understand the principles that underpin effective teamwork 1. state the key feature of effective team work for a pharmacy team 2. explain how individual styles of interaction impact on team work 3. describe the potential impact of poor teamwork in a pharmacy team: a. on staff b. on the customers c. on the organisation 4. describe techniques for overcoming problems when interacting with the pharmacy team 5. explain the organisation s policy and procedure for handling complaints Individual styles of interaction: team models such as Belbin, Myer-Briggs Organisation s policy and procedures: o Complaints procedure o Customer services policies and procedures o Standard Operating Procedures (SOPs). 26 Level 2 Certificate in Pharmaceutical Science ( )

29 Unit 203 Outcome 3 Working in the pharmacy team Know own strengths and weaknesses as part of a pharmacy team as part of a pharmacy team 1. work within the limits of own competence and authority 2. identify own strengths and weaknesses as an individual pharmacy worker 3. identify own strengths and weaknesses as a pharmacy team member 4. outline team related development and learning opportunities available. Strengths and weaknesses o personal: self awareness, strengths, weaknesses, opportunities and threats, SWOT analysis, personal development plans Team: SWOT analysis, team dynamics, team building, barriers to effective working, handling problems within the team Level 2 Certificate in Pharmaceutical Science ( ) 27

30 Unit 204 Ordering and issuing stock in the pharmacy Level: 2 Credit value: 5 NDAQ number: M/601/7552 Unit aim This unit provides learners with knowledge of the importance of efficient, safe stock management when ordering and issuing stock. Learning outcomes There are four learning outcomes to this unit. The learner will be able to: 1. Understand pharmacy stock and its control 2. Know how to order pharmacy stock 3. Know how to issue pharmacy stock 4. Understand pharmacy stock records Guided learning hours It is recommended that 30 hours should be allocated for this unit, although patterns of delivery are likely to vary. Support of the unit by a sector or other appropriate body This unit is endorsed by Skills for Health. Assessment This unit will be assessed by: an assignment covering practical skills and underpinning knowledge. 28 Level 2 Certificate in Pharmaceutical Science ( )

31 Unit 204 Outcome 1 Ordering and issuing stock in the pharmacy Understand pharmacy stock and its control 1. explain current procedures for dealing with stock 2. explain the roles and responsibilities of staff for stock control 3. list different drug formulations within pharmacy stock 4. discuss the products recall process 5. describe the difference between branded and generic medicines. Limitations: o roles and responsibilities o referral process o appropriate person Policies: o purpose o standard operating procedures o basics of national and local guidelines, Good Distribution Practice o basics of ethical and legal requirements o Health and Safety, Control of Substances Hazardous to Health (COSHH) o waste policy Drug alerts: o company recall o medicines and healthcare products regulatory agency (MHRA) recall o purpose o shared information o role and responsibilities Formulations: types of formulations e.g. hard capsules, tablets, lozenges, injections, i.e. intravenous, intramuscular, sub-cutaneous, internal liquids i.e. mixtures, suspensions, ointments, creams, lotions, suppositories, pessaries, eye drops, ear drops, nose drops, mouthwashes, patches Level 2 Certificate in Pharmaceutical Science ( ) 29

32 Unit 204 Outcome 2 Ordering and issuing stock in the pharmacy Know how to order pharmacy stock 1. describe the pharmacy order process 2. name sources of stock 3. describe how to respond to an urgent need for stock. Sources of Stock: o suppliers o wholesalers o contract o emergency supply and urgent orders o hospitals o delivery services. Good stock management: o brand and generic names o stock rotation o stock levels, quantity of stock, stock adjustments o shelf life o storage conditions o seasonal variations. 30 Level 2 Certificate in Pharmaceutical Science ( )

33 Unit 204 Outcome 3 Ordering and issuing stock in the pharmacy Know how to issue pharmacy stock 1. describe the pharmacy stock issuing process 2. describe how to respond to an urgent stock request 3. name packaging required for specific products 4. state the action taken where stock is not fit for purpose Issuing process: o accurate product selection o types of order requisitions: i.e. picking lists, bar codes, ward orders, assembly list, issue lists Special packaging o purpose o containers o labelling o types of transport used o refrigeration o cool chain o security Not fit for purpose: o unavailable o expired o contaminated o damaged o drug recall/alert Level 2 Certificate in Pharmaceutical Science ( ) 31

34 Unit 204 Outcome 4 Ordering and issuing stock in the pharmacy Understand pharmacy stock records 1. describe the systems used to maintain stock records 2. explain how the computer is used for stock control purposes Records: o purpose o type of records o function of records o parameters set for ordering stock o input and retrieval of stock data o use of computer systems o back up systems o paper and electronic records 32 Level 2 Certificate in Pharmaceutical Science ( )

35 Unit 205 Receiving, storing and maintaining stock in the pharmacy Level: 2 Credit value: 5 NDAQ number: T/601/7553 Unit aim This unit provides learners with knowledge of the importance of efficient, safe stock management when receiving, storing and maintaining stock. Learning outcomes There are three learning outcomes to this unit. The learner will be able to: 1. Understand pharmacy stock 2. Know how to receive and store pharmacy stock 3. Know how to maintain pharmacy stock Guided learning hours It is recommended that 30 hours should be allocated for this unit, although patterns of delivery are likely to vary. Support of the unit by a sector or other appropriate body This unit is endorsed by Skills for Health. Assessment This unit will be assessed by: an assignment covering practical skills and underpinning knowledge. Level 2 Certificate in Pharmaceutical Science ( ) 33

36 Unit 205 Outcome 1 Receiving, storing and maintaining stock in the pharmacy Understand pharmacy stock 1. explain current procedures for dealing with stock 2. explain the roles and responsibilities of staff for stock control 3. list different products formulations 4. discuss the products recall process 5. describe the difference between branded and generic medicines. Limitations: o roles and responsibilities o referral process o appropriate person Policies: o purpose o standard operating procedures o basics of national and local guidelines, Good Distribution Practice o basics of ethical and legal requirements o Health and Safety, Control of Substances Hazardous to Health (COSHH) o waste policy Drug alert: o company recall o medicines and healthcare products regulatory agency (MHRA) recall o purpose o shared information o role and responsibilities Formulations: o types of formulations e.g. hard capsules, tablets, lozenges, injections, i.e. intravenous, intramuscular, sub-cutaneous, internal liquids i.e. mixtures, suspensions, ointments, creams, lotions, suppositories, pessaries, eye drops, ear drops, nose drops, mouthwashes, patches. 34 Level 2 Certificate in Pharmaceutical Science ( )

37 Unit 205 Outcome 2 Receiving, storing and maintaining stock in the pharmacy Know how to receive and store pharmacy stock 1. describe the pharmacy stock receipt process 2. name sources of stock 3. describe how to deal with discrepancies 4. list different stock locations. Sources of Stock: o suppliers o wholesalers o contract o emergency supply and urgent orders o hospitals o delivery services Discrepancies: o incorrect drug strength, formulation, quantity, order, o expired o damaged o batch numbers o unavailable stock o missing stock o drug alert o contaminated. Level 2 Certificate in Pharmaceutical Science ( ) 35

38 Unit 205 Outcome 3 Receiving, storing and maintaining stock in the pharmacy Know how to maintain pharmacy stock 1. describe the systems used to maintain stock 2. state the importance of maintaining correct storage conditions. Records: o purpose o stock checks o type of records o function of records o input and retrieval of stock data o use of computer systems o back up systems o paper and electronic records. Safe storage requirements: o location o general areas, room temperature o refrigeration o isolated o ventilated o secure o tidy Good stock management: o brand and generic names o stock rotation o shelf life o checking expiry dates of stock, quantity of stock, seasonal variations. 36 Level 2 Certificate in Pharmaceutical Science ( )

39 Unit 206 Preparing for and manufacture of aseptic products Level: 2 Credit value: 5 NDAQ number: A/601/7781 Unit aim The unit will help the learner develop the necessary knowledge and understanding to be able to work safely in an Aseptic unit. Learning outcomes There are four learning outcomes to this unit. The learner will be able to: 1. Know the legislation, policies and good practice relevant to aseptics 2. Know the requirements for environmental and personal hygiene in the aseptic unit 3. Know the processes used for manufacture and preparation of Aseptic products 4. Know about the requirements for packaging, documentation and storage Guided learning hours It is recommended that 30 hours should be allocated for this unit, although patterns of delivery are likely to vary. Support of the unit by a sector or other appropriate body This unit is endorsed by Skills for Health. Assessment This unit will be assessed by: an assignment covering practical skills and underpinning knowledge. Level 2 Certificate in Pharmaceutical Science ( ) 37

40 Unit 206 Outcome 1 Preparing for and manufacture of aseptic products Know the legislation, policies and good practice relevant to aseptics 1. list the current legislation related to aseptic processes 2. state how Good Manufacturing Practice applies to aseptic processes 3. state the importance of Standard Operating Procedures in aseptic processes 4. describe the difference between batch manufacture and dispensing for an individual patient 5. explain the importance of knowing the limits of own role 6. describe the importance of knowing who to report to Basics of current legislation: o Rules and Guidance for pharmaceutical manufactures and distributors o Medicines Act 1968, Section 10 o Aseptic Dispensing for NHS patients o Quality Assurance of Aseptic Services- edition 4 o Health and Safety, Control of Substances Hazardous to Health (COSHH) o The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) Organisational procedures: o local Standard Operating Procedures (SOPs). Limitations: o referral or report to Pharmacist, pharmacy technician, supervisor, colleague o checks: in-process checks, equipment checks, volume checks, visual product checks, quality control sampling, reconciliation of labels, end of process checks o accidents, injuries, errors. 38 Level 2 Certificate in Pharmaceutical Science ( )

41 Unit 206 Outcome 2 Preparing for and manufacture of aseptic products Know the requirements for environmental and personal hygiene in the aseptic unit 1. list the different types of environmental areas used for the manufacture of aseptic products 2. name sources of contamination 3. describe the personal hygiene requirements in aseptic processes 4. explain the need for maintaining the aseptic environment. Basics of current legislation: o Rules and Guidance for pharmaceutical manufacture s and distributors o Aseptic Dispensing for NHS patients o Quality Assurance of Aseptic Services- edition 4 o Aseptic Dispensing for NHS patients. Organisational Legislation: o local Standard Operating Procedures (SOPs). Environmental areas: o changing room o clean room o preparation room o laminar flow cabinet o isolator. Environmental monitoring: o air sampling o settle plates o sessional and weekly cleaning o surface sampling, i.e. contact plates, finger dabs Environmental Parameters: o air pressure differentials o temperature o air flow o microbiological monitoring Sources of contamination: o microbial, chemical, particulate. Level 2 Certificate in Pharmaceutical Science ( ) 39

42 Unit 206 Outcome 3 Preparing for and manufacture of aseptic products Know the processes used for manufacture and preparation of Aseptic products 1. describe the common materials used in aseptic processes 2. describe common aseptic processes 3. state the processes for the safe handling and disposal of hazardous waste. Basics of current legislation: o Rules and Guidance for pharmaceutical manufacture s and distributors o Aseptic Dispensing for NHS patients o Quality Assurance of Aseptic Services- edition 4 o Health and Safety, Control of Substances Hazardous to Health (COSHH) o Waste disposal regulations. Organisational Legislation: o local Standard Operating Procedures (SOPs). Common materials: o consumables: measures, mixers, pumps, filters, syringes, needles, transfer devices, venting devices, giving sets, alcohol wipes. Aseptic processes: o mixing, filtration, reconstitution, filling, transfer, dilution. 40 Level 2 Certificate in Pharmaceutical Science ( )

43 Unit 206 Outcome 4 Preparing for and manufacture of aseptic products Know about the requirements for packaging, documentation and storage 1. outline the packaging and labelling requirements for aseptic products 2. identify documents used in the aseptic processes 3. outline the importance of maintaining correct storage conditions. Basics of current legislation: o Rules and Guidance for Pharmaceutical Manufacturers and Distributors o Medicines Act, Section 10 o Aseptic Dispensing for NHS patients o Quality Assurance of Aseptic Services o Health and Safety, Control of Substances Hazardous to Health (COSHH). Organisational procedures: o local Standard Operating Procedures (SOP s). Documentation: o environmental monitoring records (e.g. air pressure differential log) o cleaning records o work sheets o equipment logs o quality exception reports o batch worksheets o batch number allocation records o accident or incident reporting forms. Level 2 Certificate in Pharmaceutical Science ( ) 41

44 Unit 207 Assisting in the preparation, manufacture and assembly of medicinal products Level: 2 Credit value: 5 NDAQ number: R/601/9164 Unit aim The aim of this unit is to provide the learner with the knowledge to understand the processes and procedures required for assisting in pharmacy manufacturing. Learning outcomes There are four learning outcomes to this unit. The learner will be able to: 1. Know the legislation, policies and good practice relevant to medicines manufacture 2. Know the requirements for environmental and personal hygiene 3. Know about the materials and processes used in medicines manufacture 4. know about the requirements for packaging, labelling and documentation Guided learning hours It is recommended that 30 hours should be allocated for this unit, although patterns of delivery are likely to vary. Support of the unit by a sector or other appropriate body This unit is endorsed by Skills for Health. Assessment This unit will be assessed by: an assignment covering practical skills and underpinning knowledge. 42 Level 2 Certificate in Pharmaceutical Science ( )

45 Unit 207 Outcome 1 Assisting in the preparation, manufacture and assembly of medicinal products Know the legislation, policies and good practice relevant to medicines manufacture 1. list the current legislation related to pharmacy manufacturing 2. state how Good Manufacturing Practice applies to pharmacy manufacturing 3. state the importance of Standard Operating Procedures in pharmacy manufacturing 4. describe the difference between batch manufacture and dispensing for an individual patient 5. state the importance of knowing the limits of your role and knowing to whom matters are reported. Basics of legislation: o Rules and Guidance for Pharmaceutical Manufacturers and Distributors o basic principles of quality assurance o application of legislation to working procedures and practice o Good Manufacturing Practice o Standard Operating Procedures (SOPs) o Health and Safety, Control of Substances Hazardous to Health (COSHH) o documentation. Manufacture for stock: o requirements for licensed manufacturing. Manufacture for individual patients: o requirements for manufacture for individual patient o requirements for dispensing for individual patient. Limitations: o referral or report to Pharmacist, Pharmacy Technician, supervisor, colleague o checks: in-process checks, equipment checks, volume checks, visual product checks, quality control sampling, reconciliation of labels, end of process checks o accidents, injuries, errors. Level 2 Certificate in Pharmaceutical Science ( ) 43

46 Unit 207 Outcome 2 Assisting in the preparation, manufacture and assembly of medicinal products Know the requirements for environmental and personal hygiene 1. list the different types of environmental areas used for the manufacturing of medicines 2. name sources of contamination 3. describe personal hygiene requirements in pharmacy manufacture 4. describe the need for maintaining the medicines manufacturing environmental. Environmental areas: o non- sterile and sterile preparation areas o changing rooms o clean room o laminar flow cabinets o isolators. Sources of contamination: o microbial, chemical, particulate. Environmental hygiene: o hygiene requirements for the maintenance of a controlled environment used in medicines manufacture, i.e. air pressure monitoring, use and maintenance of equipment, calibration of balances, sessional cleaning, equipment log, contact and settle plates Personal hygiene: o hygiene requirements in accordance with SOP s for personnel assisting in medicines manufacture, i.e. hand washing, hand hygiene, personal presentation, changing procedures, personal protective equipment Environmental Parameters: o air pressure differentials o temperature o microbiological monitoring 44 Level 2 Certificate in Pharmaceutical Science ( )

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