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Accreditation of Dispensing and Pharmacy Assistant programmes This template should be used to demonstrate how the training provider meets the GPhC’s accreditation criteria for education and training programmes for dispensing assistants and pharmacy assistants The accreditation submission should include: This template, completed in full, to include: - A narrative explaining how each criterion is met. The narrative must be written in prose, clearly explaining how the criteria will be met. Reference to links, file names, or module titles on their own are not acceptable. - Full reference to the documents you are providing as evidence. Any other pertinent information. You should provide documentary evidence to support the information that you have provided within the template. Following review of your submission document and associated evidence you may be required to submit additional items of evidence, if this is necessary you will be notified in advance of your accreditation event. The process for reaccreditation of dispensing assistant programmes will follow the same format as described for accreditation. The submission documentation must include, additionally, an introduction section which includes the following: Accreditation submission template – Pharmacy and Dispensing Assistant courses, 2014-15 1

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Page 1: DA submission template, updated March 2012 · Web viewWord and a .PDF version of your completed submission template A . PDF version of each supporting document education@pharmacyregulation.org

Accreditation of Dispensing and Pharmacy Assistant programmes

This template should be used to demonstrate how the training provider meets the GPhC’s accreditation criteria for education and training programmes for dispensing assistants and pharmacy assistants

The accreditation submission should include: This template, completed in full, to include:

- A narrative explaining how each criterion is met. The narrative must be written in prose, clearly explaining how the criteria will be met. Reference to links, file names, or module titles on their own are not acceptable.

- Full reference to the documents you are providing as evidence. Any other pertinent information.

You should provide documentary evidence to support the information that you have provided within the template. Following review of your submission document and associated evidence you may be required to submit additional items of evidence, if this is necessary you will be notified in advance of your accreditation event.

The process for reaccreditation of dispensing assistant programmes will follow the same format as described for accreditation. The submission documentation must include, additionally, an introduction section which includes the following:

An overview of how the programme has developed since the last accreditation event, including a summary of any major changes Information on the number of trainees who have undertaken/are undertaking the programme. A summary of the response to any conditions and recommendations that were made by the accreditation team at the previous event. Where a

provider opted not to action a recommendation, an explanation of the rationale for this decision should be provided.

Please ensure that you refer to the guidance within this template as failure to provide your submission in the correct format, with the required level of detail and clarity, could lead to your accreditation event being cancelled or postponed. Information on how to submit your documentation can be found on the last page of this document.

If you have any questions regarding your accreditation submission please contact the GPhC’s Quality Assurance (Education) team on 0203 713 7973 or 7978

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Name of training provider:

Name of course to be accredited:

Contact name:

Job title:

Address:

Telephone:

Mobile:

Email:

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General notes regarding completion of the template

Except where single pieces of information or lists are asked for, your commentary must be written in prose. Directions to other documents only will not be accepted.

Hyperlinks may be used within your commentary to signpost to evidence but please check that the links are not broken and that external access is permitted. Please ensure that all documentary evidence provided is referred to within your commentary.

Referencing additional materials

For ease of reference, all supporting material should be numbered and named appropriately (for example, Appendix One – Trainee Handbook, Appendix Two – Staff CVs)

Please ensure the same document name is used throughout the submission and in the appendices. When referencing supporting material within the submission, please indicate the document clearly (for example, in bold) and use the full name and appendix

number throughout.

For reaccreditation only

Provider’s commentary

General note: Except where single pieces of information or lists are asked for, the provider’s commentary should be written in prose. Directions to other documents only will not be accepted. Supporting documents should be included as an appendix to the application template.

(Please delete the guidance notes when completing commentaries.)

Introduction for reaccreditation Include:• An overview of how the programme has developed since the last accreditation event, including a summary of any major

changes• Information on the number of trainees who have undertaken/are undertaking the programme.• A summary of the response to any conditions and recommendations that were made by the accreditation team at the

previous event. Where a provider opted not to action a recommendation, an explanation of the rationale for this decision should be provided.

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1. The Training Programme

Provide information on how your training programme meets the General Pharmaceutical Council’s (GPhC) requirements and is at the required academic level.

Criteria Provider’s commentary

General note: Except where single pieces of information or lists are asked for, the provider’s commentary should be written in prose. Directions to other documents only will not be accepted. Supporting documents should be included as an appendix to the application template.

(Please delete the guidance notes when completing commentaries.)

a. The programme is equivalent to one or more units of the S/NVQ level 2 (QCF)

Course summary to include module or unit titles and the phasing or sequence of the modules or units in the programme.

b. The unit(s) the course is designed to cover are specified.

Specify units covered.

c. The course content covers the relevant units of the ‘GPhC underpinning knowledge template’ (see mapping of the course to the programme requirements).

Refer to Appendix 1

d. For each unit, the transfer of underpinning knowledge into the workplace is demonstrated through the use of a variety of methods

Summary of activities and assessments including assessment methods

e. The programme is taught at Qualifications Credit framework level 2.

Evidence that the training programme is at the required academic level.

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f. The programme is planned with reference to the S/NVQ (QCF) level 2 underpinning knowledge template.

g. Assessments have been developed by subject experts from the Pharmacy sector and directly relate to and the relevant units of the S/NVQ (QCF) level 2 underpinning knowledge template.

Provide details of individuals, course panel or equivalent group responsible for the development of the programme. CVs should be provided (see supporting documentation).

Additional information on the training programme.Provide additional information on your course. This must include:

How the course is delivered, for instance distance learning, day release, Total expected total student workload (guided learning hours), number of curriculum hours for each part of the course, contact time with training

provider. Anticipated duration of the training programme and maximum and minimum permitted durations. How the training programmes is funded.

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2. Academic and management structures

Provide evidence that you have adequate academic and management structures in place.

Criteria Provider’s commentarya. Assessment process and

strategies assure appropriate standards in assessment and that students are able to demonstrate fitness for purpose.

Information on the management of quality assurance procedures. Details of marking criteria, how marking is done and by whom, measures to ensure consistency, how borderline issues and dealt with.

Course regulations covering re-sits, resubmissions and extenuating circumstances including rationale.

b. In the processes of programme review and development, the training provider has taken account of advances in pharmacy practice , for instance recent POM to P reclassifications, and developments potentially impacting on pharmacy

Details of how the course will be reviewed and details of individuals, course panel or equivalent group responsible for the review and how any changes will be disseminated to students. CVs should be provided (see supporting documentation).

c. Course regulations include procedures for appeals against assessment decisions

Course regulations and procedures for appeals against assessment decisions.

d. Course regulations include procedures for dealing with suspected plagiarism and/or malpractice

Course regulations and procedures for dealing with suspected malpractice/plagiarism.

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Additional information on your academic and management structures.Provide additional information on your academic and management structures not covered in criteria 2a to 2d above.

3. Resources

Provide evidence that you have adequate resources to support the delivery of your training programme.

Criteria Provider’s commentary

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a. Buildings, human, equipment, and other resources available to the training provider are sufficient for the effective delivery of the course to the numbers of students on the course, and overall.

Information on human resources including numbers with names of staff associated with the training programme(s) with descriptions of their roles, qualifications/credentials backgrounds and contractual status in relation to the training provider. CVs should be provided (see supporting documentation).

Information on equipment and support services.

Current and planned annual intakes.Admissions policy and marketing strategyCommentary on completion and success rates of students on this course, or a similar programme if this is a new course

b. Record keeping systems are able to generate data on candidates completing, completion rates, student sector of practice and disability.

Information on record keeping systems.

c. Systems are in place for issuing certificates of completion to successful students in the GPhC’s approved format.

Please provide a sample certificate. Confirmation that systems are in place for the issuing of certificates to successful trainees.

The certificate must refer to the fact that the course is accredited by the General Pharmaceutical Council. The units of the NVQ 2 Pharmacy Services that the course is designed to be equivalent to must be listed on the certificate using the full unit titles.

d. There is an appropriate mix of tutors, mentors and assessors.

Information on who is responsible for tutoring, mentoring and assessing the student. Clarify roles and responsibilities of the training provider and others, for instance the workplace supervising pharmacist and what support is provided by the training provider for those supporting the student

e. The student has access to a personal tutor or tutors for academic guidance and pastoral care.

Description of student access to tutors and mentors including who is the tutor and how tutors are accessed by the student for instance face to face, online, by telephone.

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f. The student is instructed in the use of information resources.

Information provided to students on available resources.

g. There are adequate student feedback mechanisms in place.

Evidence of two-way communication between course provider and students. Details of student feedback mechanisms, for instance questionnaires, and how the information gathered informs course development. Description of mechanisms for feeding back to students on performance.

h. The training provider seeks to provide the student with a positive learning experience.

Information about how the is student supported and support given to tutors and mentors

Additional information on your resources.Provide additional information on your organisation. This must include:

How the training programme is funded Information about the range of education and training provided, including modes of delivery. Brief details of all training packages marketed to pharmacy support staff.

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Supporting documentation

List below the supporting document that you are providing

The following list is indicative of the documents you will need to provide:• Training materials (reference criterion 1a)• Assessments (for instance MCQs, workbooks) and assessment criteria (reference criteria 1d and 2a)• Staff CVs, including names, descriptions of roles, credentials/qualifications and background (reference criteria 1d, 2b and 3a)• Course regulations covering assessment (reference criterion 2a)• Course regulations covering appeals (reference criterion 2c)• Course regulations covering plagiarism (reference criterion 2d)• Sample certificate (reference criterion 3c) • Learning contact outlining the responsibilities of training provider, tutor and student. (reference criteria 3d)• Student handbook (reference criteria 3d to 3h. Also criteria 2a, 2c and 2d with regard to course regulations)• Supervisor handbook (reference criteria 3d to 3h. Also criteria 2a, 2c and 2d with regard to course regulations)

Expand table as necessary

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Appendix 1 - Mapping to programme requirements

Please demonstrate how the training programme has been designed to meet one or more units of the NVQ level 2 (QCF) Pharmacy Services by providing a mapping using the tables below.

Any units which are not covered by your training programme should be shaded grey.

1. Assist with the provision of a pharmacy service to meet individual needs

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply:

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice1.1 A working knowledge of SOPs and the importance of

adhering to them at all times1.2 A working knowledge of the importance of

maintaining individual satisfaction, loyalty andconfidence to the organisation and how you contribute towards it

1.3 A working knowledge of the organisation’s policy on individual service and individual relationships and how this applies to your role

1.4 A working knowledge of the organisations procedure for handling complaints

1.5 A working knowledge of the importance of working within the limits of your competence and authority

1.6 A working knowledge of the importance of establishing the requirements of individualsclearly and accurately

1.7 A working knowledge of the importance of verbal and non verbal communication when communicating with individuals

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Provide information1.8 A working knowledge of how to give clear and

accurate information and check the individual’s understanding

1.9 A working knowledge of relevant products and services or advice for which informationand/or advice is required

1.10 A working knowledge of where to get assistance if you can’t provide information and advice yourself

1.11 A working knowledge of what source of information to use, what information can be given to the individual

1.12 A working knowledge of the source(s) of information that can be accessed and the information that can be given to individuals by the pharmacist

Resolve queries and complaints1.13 A working knowledge of how to manage conflict

and/or individuals who are angry1.14 A working knowledge of how to assess complaints

and what action to take1.15 A working knowledge of when you should refer

complaints to a higher authority

2. Make sure your own actions reduce risks to health and safety

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply knowledge of:

Name of document and unit/module number

Page Accreditation team use only

2.1 What ‘hazards’ and ‘risks’ are2.2 Their responsibilities and legal duties for health and

safety in the workplace2.3 Their responsibilities for health and safety as

required by the law covering their job role

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2.4 The hazards which exist in their workplace and the safe working practices which they must follow

2.5 The particular health and safety hazards which may be present in their own job and the precautions they must take

2.6 The importance of remaining alert to the presence of hazards in the whole workplace

2.7 The importance of dealing with, or promptly reporting risks

2.8 The responsibilities of health and safety in their job description

2.9 The safe working practices for their own job role2.10 The responsible people they should report health

and safety matters to2.11 Where and when to get additional health and safety

assistance2.12 Their scope and responsibility for controlling risks2.13 Workplace instructions for managing risks which

they are unable to deal with2.14 Suppliers’ and manufacturers’ instructions for the

safe use of equipment, materials and products which they must follow

2.15 The importance of personal presentation in maintaining health and safety in their workplace

2.16 The importance of personal behaviour in maintaining the health and safety of themselves and others

2.17 The risks to the environment which may be present in their workplace and/or in their own job

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3. Contribute to the effectiveness of teams

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply:

Name of document and unit/module number Page Accreditation team use only

Values3.1. A working knowledge of legal and organisational

requirements on equality, diversity, discrimination and rights when working in teams

Legislation and organisational policy and procedures3.2. A working knowledge of codes of practice and

conduct, and standards and guidance relevant to their own roles, responsibilities, accountability and duties of others when working in teams to support individuals

3.3. A working knowledge of current local, UK and European legislation, and organisational requirements, procedures and practices for:

a) Accessing recordsb) Recording, reporting, confidentiality and sharing

information, including data protectionc) Team working

3.4. A working knowledge of how to access up-to-date copies of the organisation’s workplace policies, procedures and systems, and practice and service standards related to team working

Theory and practice3.5. A working knowledge of the principles that

underpin effective team working3.6. A working knowledge of individuals’ styles of

interaction and how these can affect team working3.7. A working knowledge of barriers to developing

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relationships within the team and how these can be overcome

3.8. A working knowledge of problems which may be encountered when relating to and interacting with other team members and how these can be best handled

3.9. A working knowledge of their own strengths and weaknesses as an individual worker and as a team member

3.10. A working knowledge of development and learning opportunities available to support them in team working and activities

4. Assist in the sale of medicines and products

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply:

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice4.1. A working knowledge of the pharmacy protocol on

the sale of medicines and SOPs including:a) What is listed in themb) How to use themc) Why it is important that SOPs should be followed

at all times4.2. A factual knowledge of the legal responsibility and

authority of the pharmacist and others in the organisation

4.3. A working knowledge of legal and ethical requirements for confidentiality

Specific health related knowledge and skills4.4. A working knowledge of the main actions and side

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effects of the active ingredients within commonly used non-prescription medicines

4.5. A working knowledge of the differences between:a) General Sales List (GSL) medicinesb) Pharmacy (P)c) Prescription Only Medicines (POM) items

Procedures and techniques4.6. A working knowledge of the use of questioning

techniques such as 2WHAM4.7. A working knowledge of the needs of different

types of individuals4.8. A working knowledge of the sources of information

to access4.9. A working knowledge of the information that is

suitable to give individuals4.10. A working knowledge of the type of

information/advice that needs to be referred to a pharmacist or a pharmacy technician

5. Receive prescriptions from individuals

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply:

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice5.1 A working knowledge of the importance of working

within the limits of their own role and recognising when to refer to an appropriate person

5.2 A working knowledge of Standard Operating Procedures regarding the receiving of prescriptions and the importance of adhering to them at all times

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5.3 A working knowledge of current legislation relating to prescription charges and exemptions and differences in practice across the UK

5.4 A working knowledge of regulations and procedures relating to prescriptions for clinical trials

5.5 A working knowledge of the relevant national and local guidelines, policies and procedures that are available and how and when they should be accessed

5.6 A working knowledge of the different types of prescribers

Specific health related knowledge and skills5.7 A working knowledge of the different types of

prescriptions and when they are used5.8 A working knowledge of the details required on a

prescription and why they are necessary5.9 A working knowledge of exemptions and how

individuals can claim refunds, including the use of official forms and prepayment certificates

Procedures and techniques5.10 A working knowledge of how to deal with

individuals with special needs5.11 A working knowledge of the transactional and

administration procedures as required by governmental regulations and those that apply to the workplace

Records and documentation5.12 A working knowledge of the importance of

maintaining dispensary records

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6. Assemble prescribed items

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply:

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice6.1. A working knowledge of the importance of working

within the limits of their own role and recognising when to refer to an appropriate person

6.2. A working knowledge of current ethical and legal requirements that govern the dispensing and issuing of a prescription

6.3. A working knowledge of SOPs and the importance of adhering to them at all times

6.4. A working knowledge of relevant national and local guidelines, policies and procedures that are available including when they should be used and how to use them

6.5. A working knowledge of the importance of personal hygiene and correct use of protective clothing

6.6. A working knowledge of basic hygiene and the importance of maintaining a clean working environment and equipment

Specific health related knowledge and skills6.7. A factual knowledge of the principles underlying

the dispensing of sterile products6.8. A factual knowledge of factors which cause

deterioration of stock including: Environmental conditions Storage conditions Microbial contamination

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6.9. A factual knowledge of sources of contamination and appropriate corrective action including:

Microbial Cross-chemical Physical, environmental and storage conditions

6.10. A factual knowledge of prescribing conventions and abbreviations

6.11. A factual knowledge of the common proprietary and generic names

6.12. A working knowledge of dosage forms and their properties and use

6.13. A working knowledge of different strengths, doses and quantities of medicines, and why they are used and how to calculate them

7. Order pharmaceutical stock

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice7.1 A working knowledge of working within the limits

of their own authority and when to refer to an appropriate person

7.2 A factual awareness of current legislation that applies to the ordering of pharmaceutical stock

7.3 A working knowledge of their responsibilities under current legislation when ordering pharmaceutical stock

7.4 A working knowledge of the importance of following ordering SOPs

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7.5 A working knowledge of the health and safety requirements related to ordering of pharmaceutical stock

7.6 A working knowledge of local or regional pharmaceutical contracts

Specific health related knowledge and skills7.7 A working knowledge of the different formulation

of drugs and why it is important to order sufficient quantities of the correct formulation and strength

7.8 A working knowledge of the difference between branded and generic drugs

7.9 A working knowledge of the importance of referring to current drug alerts and company recalls when ordering pharmaceutical stock

Ordering stock7.10 A working knowledge of the sources and suppliers

of stock

7.11 A working knowledge of the procedures for responding to urgent requests.

7.12 A working knowledge of the importance of taking account of seasonal variations when ordering pharmaceutical stock

7.13 A working knowledge of the action to be taken if stock is unavailable

Records and documentation7.14 A working knowledge of the input and retrieval

of stock data

7.15 A working knowledge of the parameters set for

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the computer ordering system

7.16 A working knowledge of the importance of maintaining correct, accurate documentation, including backup systems to IT failure where appropriate.

8. Receive pharmaceutical stock

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice8.1 A working knowledge of working within the limits

of their own authority and when to refer to an appropriate person

8.2 A factual knowledge of current legislation and their responsibilities that apply to the receipt of pharmaceutical stock

8.3 A working knowledge of the importance of following SOPs related to receiving pharmaceutical stock

8.4 A working knowledge of the COSHH and health and safety requirements related to receipt of pharmaceutical stock

8.5 A working knowledge of local or regional pharmaceutical contracts

Specific health related knowledge and skills8.6 A working knowledge of the different formulation

of drugs and why it is important to stock sufficient

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quantities of the correct formulation and strength

8.7 A working knowledge of the difference between branded and generic drugs

8.8 A working knowledge of the importance of referring to current drug alerts and company recalls when receiving pharmaceutical stock

Receiving stock8.9 A working knowledge of the sources and suppliers

of stock

8.10 A working knowledge of the procedures that apply to receiving pharmaceutical stock, including:

a) only receiving stock identified on the original orderb) expiry dates and batch numbersc) identifying damaged, contaminated or deteriorated

stock8.11 A working knowledge of the action to be taken if

stock is unavailable

8.12 A working knowledge of the action to be taken if received stock:

a) not on original orderb) is not the complete orderc) beyond expiry dated) has inconsistent batch number or batch number

for which drug alerts/recalls have been issuede) damaged or contaminated

8.13 A working knowledge of promptly informing the appropriate person of the availability of the stock where the goods received are for a special or outstanding order

Incorporating received stock into storage

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8.14 A working knowledge of the storage requirements of different types of products and why they are important

8.15 A working knowledge of the importance placing received stock in a manner that allows stock rotation

8.16 A working knowledge of the importance placing received stock in a safe storage environment

Resolve queries and complaints8.17 A working knowledge of the input and retrieval of

stock data

8.18 A working knowledge of the parameters set for the computer ordering system where appropriate

8.19 A working knowledge of the importance of maintaining correct, accurate documentation, including back up systems to IT failure where appropriate

9. Maintain pharmaceutical stock

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module Page Accreditation team use only

Legislation, policy and good practice9.1 A working knowledge of working within the limits

of their own authority and when to refer to an appropriate person

9.2 A working knowledge of your responsibilities and current legislation that applies to maintaining

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pharmaceutical stock

9.3 A working knowledge of the importance of following SOPs related to maintaining pharmaceutical stock

9.4 A working knowledge of the health and safety requirements related to:

a) maintaining pharmaceutical stockb) disposing of outdated, damaged or

decontaminated stockSpecific health related knowledge and skills

9.5 A working knowledge of the different formulation of drugs and why it is important to stock sufficient quantities of the correct formulation and strength

9.6 A working knowledge of the difference between branded and generic drugs

9.7 A working knowledge of the of the action to take immediately when drug alerts and company recalls are received

Maintaining stock9.8 A working knowledge of the importance of

maintaining a safe storage environment

9.9 A working knowledge of the storage requirements of different types of products and why they are important

9.10 A working knowledge of the importance of storing stock into the correct:

a) storage areab) location

9.11 A working knowledge of the importance of taking any special storage requirements into

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consideration

9.12 A working knowledge of the importance of good stock management, including:

a) the rotation of stockb) checking expiry dates of stockc) the quantity of stock - taking account of seasonal

variationsd) identifying damaged, contaminated or deteriorated

stock9.13 A working knowledge of the action to be taken if

stock is unavailable

9.14 A working knowledge of the action to be taken if stock:

a) is beyond expiry dateb) is damaged or contaminatedc) has inconsistent batch number or batch number

for which drug alerts/recalls have been issuedRecords and documentation

9.15 A working knowledge of the input and retrieval of stock data

9.16 A working knowledge of the parameters set for the computer ordering system

9.17 A working knowledge of the importance of maintaining correct, accurate documentation, including back up systems to IT failure where appropriate.

10. Issue pharmaceutical Stock

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To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice10.1 A working knowledge of working within the limits

of your their authority and when to refer to an appropriate person

10.2 A factual knowledge of current legislation that applies to issuing pharmaceutical stock

10.3 A working knowledge of your responsibilities under current legislation when issuing pharmaceutical stock

10.4 A working knowledge of the importance of following SOPs related to issuing pharmaceutical stock

10.5 A working knowledge of the health and safety requirements related to issuing pharmaceutical stock

Specific health related knowledge and skills10.6 A working knowledge of the different formulation

of drugs and why it is important to issue sufficient quantities of the correct formulation and strength

10.7 A working knowledge of the difference between branded and generic drugs

Issuing stock10.8 A working knowledge of the action to be taken if

stock is not fit for purpose

10.9 A working knowledge of the importance of checking stock for issue against current drug alerts/recalls

10.10 A working knowledge of the procedures for

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responding to urgent requests

10.11 A working knowledge of which products need special packaging and transportation and why it is important to adhere to these special requirements.

10.12 A working knowledge of the importance of labelling containers correctly

10.13 A working knowledge of issuing stock to the correct destination using the correct delivery method

Records and documentation10.14 A working knowledge of the input and retrieval of

stock data

10.15 A working knowledge of the importance of maintaining correct, accurate documentation, including back up systems to IT failure where appropriate

11. Assist in the manufacturer and assembly of medicinal products

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice11.1 A working knowledge of the basic principles of

quality assurance relating to manufacture of medicinal products

11.2 A working knowledge of the principles of current good manufacturing practice (cGMP)

11.3 A working knowledge of the difference between preparation for individuals and preparation for stock

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and how this is generally implemented in the workplace

11.4 A factual knowledge of current health and safety legislation and how it applies to the working environment, including COSHH

11.5 A working knowledge of the principles of SOPs and why it is important to work within these procedures

11.6 A working knowledge of the limits of their own role and the referral procedures

Specific health related knowledge and skills11.7 A working knowledge of basic hygiene and the

importance of maintaining a clean working environment

11.8 A working knowledge of personal hygiene and the use of protective / clean room clothing

11.9 A working knowledge of the possible sources of contamination

11.10 A working knowledge of environmental parameters, their importance and how to carry out their monitoring

11.11 A working knowledge of the principles of weights and measures

Materials and Equipment11.12 A working knowledge of the preparation, assembly

and maintenance of equipment

Procedures and techniques11.13 A working knowledge of principles and procedure

of different processes in manufacturing medicinal products and when to use them

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11.14 A working knowledge of labelling and packaging requirements

11.15 A working knowledge of the reasons for and importance of carrying out in-process checks, end product quality checks and quarantine requirements

11.16 A working knowledge of the disposal of waste materials and cleaning material

11.17 A working knowledge of dismantling, cleaning, decontaminating and storing equipment

11.18 A working knowledge of cleaning and decontamination of preparation area

Records and documentation11.19 A working knowledge of the importance of

recording information clearly, accurately and in a systematic, timely manner and of the storing of this information

12. Assist in the preparation of documentation, material and other items for manufacture and assembly of medicinal products

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice12.1 A working knowledge of the basic principles of

quality assurance including current good manufacturing practice (cGMP)

12.2 An understanding of the difference between preparation for individual patients and preparation

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for stock and how this is generally implemented in the workplace

12.3 A factual knowledge of their responsibilities under COSHH and current health and safety legislation and how it applies to the working environment

12.4 A working knowledge of the importance of SOPs and why they must always work within these procedures

12.5 A working knowledge of the importance of working within the limits of their role

Specific health related knowledge and skills12.6 A working knowledge of basic hygiene and the

importance of maintaining a clean working environment including conducting a weekly and monthly clean

12.7 A working knowledge of the importance of personal hygiene and the correct use of protective / clean room clothing

12.8 A working knowledge of the different types of environmental areas and when they should be used

12.9 A working knowledge of the possible sources of contamination

Materials health related knowledge and skills12.10 A working knowledge of the materials,

consumables and equipment necessary for the preparation of medicinal products

12.11 A working knowledge of the principles of formulae calculations, weights and measures

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Procedures and techniques12.12 A working knowledge of the procedures for

cleaning, decontamination, and preparing the environment and equipment

12.13 A working knowledge of labelling and packaging requirements and conventions

Records and documentation12.14 A working knowledge of the importance of

recording information clearly, accurately and in a systematic, timely manner and of the storing of this information

13. Prepare aseptic products

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice13.1 A working knowledge of the basic principles of

quality assurance including (cGMP) current good manufacturing practice

13.2 An working knowledge of the difference between preparation for individual patients and preparation for stock and how this is generally implemented in the workplace

13.3 A working knowledge and understanding of the recognised guidelines relating to aseptic preparation

13.4 A factual knowledge of current health and safety

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legislation and how it applies to the working environment, including COSHH

13.5 A working knowledge of the importance of SOPs and why they must always work within these procedures

13.6 A working knowledge of the limits of their own role and the referral procedures to an appropriate person

Specific health related knowledge and skills13.7 A working knowledge of basic hygiene and the

importance of maintaining a clean working environment

13.8 A working knowledge of the importance of personal hygiene and the correct use of protective / clean room clothing

13.9 A working knowledge of the different types of environmental areas and when they should be used

13.10 A working knowledge of the possible sources of contamination and the appropriate methods of prevention

13.11 A working knowledge of the importance of storing products correctly (including any quarantine requirements) especially in relation to maintaining the cold chain from both chemical and microbiological aspects

13.12 A working knowledge (including action and uses) of the various types of products

Materials and equipment13.13 A working knowledge of the different types of

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equipment and consumables and which products they must be used for

13.14 A working knowledge of the procedures for preparing, cleaning and decontaminating equipment and environmental areas

13.15 A working knowledge of the importance of storing equipment safely and in a condition ready for use

13.16 A working knowledge of the principles of formulae calculations, weights and measures

Procedures and techniques13.17 A working knowledge of the environmental

parameters that govern the working area, their importance, and how to carry out their monitoring

13.18 A working knowledge of the correct handling of cytotoxic drugs and how to minimise the risks

13.19 A working knowledge of the importance of carrying out accuracy and quality checks

13.20 A working knowledge of the importance of label and product reconciliation

13.21 A working knowledge of the methods and materials used for packaging

13.22 A working knowledge of the procedures for the safe handling and disposal of waste materials

Records and documentation13.23A working knowledge of the importance of

recording information clearly, accurately and in a systematic, timely manner and of the storing information that includes:

a) paper basedb) electronic

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13.24 A working knowledge and understanding of the importance of using validated documentation

13.25 A working knowledge of local error reporting procedures and communication channels

13.26 A working knowledge of national error reduction policies/strategies

14. Prepare documentation, material and other items for the preparation of aseptic products

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice14.1 A working knowledge of the basic principles of

quality assurance including current good manufacturing practice (cGMP)

14.2 A working knowledge of the difference between preparation for individual patients and preparation for stock and how this is generally implemented in the workplace

14.3 A working knowledge and understanding of the recognised guidelines relating to aseptic preparation

14.4 A factual knowledge of their responsibilities under COSHH and current health and safety legislation and how it applies to the working environment

14.5 A working knowledge of the importance of SOPs and why they must always work within these procedures

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14.6 A working knowledge of the importance of working within the limits of their own role

Specific health related knowledge and skills14.7 A working knowledge of basic hygiene and the

importance of maintaining a clean working environment

14.8 A working knowledge of the importance of personal hygiene and the correct use of protective / clean room clothing

14.9 A working knowledge of the different types of environmental areas and when they should be used

14.10 A working knowledge of the possible sources of contamination

14.11 A working knowledge of the various types of products

Materials and equipment14.12 A working knowledge of the materials and

equipment necessary for the preparation of aseptic products

14.13 A working knowledge of the principles of formulae calculations, weights and measures

14.14 A working knowledge for the safe handling of cytotoxic drugs

Procedures and techniques14.15 A working knowledge of the procedures for

cleaning, decontamination, and preparing the environment and components

Records and documentation

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14.16 A working knowledge of the importance of recording information clearly, accurately and in a systematic, timely manner and of the storing of this information

15. Assist in the issuing of prescribed items

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice15.1 A working knowledge of the limits of their own role

and when to refer to an appropriate person

15.2 A working knowledge of principles for issuing dispensed medicines and products and the local Standard Operating Procedures that relate to this

15.3 A working knowledge of the current ethical and legal requirements that govern the issuing of a prescription

Procedures and techniques15.4 A working knowledge of how to deal with

individuals with special needs

15.5 A working knowledge of the importance of confirming the individual’s identity before issuing dispensed items

15.6 A working knowledge of the importance of providing information on:

a) the storage and maintenance of prescribed itemsb) possible side effects

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Records and documentation15.7 A factual knowledge of the importance of

maintaining dispensary records including the use of the dispensary computer

15.8 A factual knowledge of how medicines are administered

Materials and equipment15.9 A working knowledge of the importance of

selecting the correct equipment for use

15.10 A working knowledge of the properties of different types of container types and when to use each

16. Undertake an in-process accuracy check of assembled prescribed items prior to the final accuracy check

To demonstrate knowledge and understanding in this NOS , assistants should be able to apply :

Name of document and unit/module number

Page Accreditation team use only

Legislation, policy and good practice16.1An in-depth understanding of the limits of their own

role and recognising when to refer to an appropriate person

16.2An in-depth understanding of Standard Operating Procedures and the importance of adhering to them at all times

16.3A working knowledge of current ethical and legal and professional requirements that govern the dispensing of a prescription

16.4A working knowledge of the different types of check on a prescription

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16.5A working knowledge of different types of prescribers

16.6 A working knowledge of the types of medicines supply

16.7 A working knowledge of how to identify near misses and dispensing errors

16.8 A basic awareness of the causes and consequences of near misses and dispensing errors

16.9 A basic awareness of error recording

Specific health related knowledge and skills16.10 A working knowledge of the details required on a

prescription and why these are necessary

16.11 A working knowledge of the prescribing conventions and abbreviations

16.12 A working knowledge of the common proprietary and generic names

16.13 A factual knowledge of how medicines are administered

16.14 A working knowledge of different strengths, doses and quantities of medicines

16.15 A working knowledge of different relevant national and local guidelines, policies, procedures that are available including:

a) when they should be used

b) how to use them

Records and documentation16.16 A working knowledge of when and why Patient

Medication Records (PMRs) are used

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16.17 A working knowledge of the importance of maintaining dispensary records.

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Submitting your accreditation documentation to the GPhC

You must send the following by post:

4 hard copies of your submission document (completed submission template and supporting documents). Each copy should be bound or stapled (No box files, ring binders or lever arch files).

Quality Assurance (Education) Team General Pharmaceutical Council 25 Canada Square London E14 5LQ and the following by email:

A Word and a .PDF version of your completed submission template A .PDF version of each supporting document

[email protected]

Please ensure that the hard copies and electronic copies arrive with the GPhC’s Quality Assurance (Education) Team on, or before, the submission deadline. The deadline for submission documentation is normally six weeks in advance of the accreditation event; however, you will be notified of your exact deadline date once the date of your accreditation event is agreed.

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