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Step 2 Accreditation 2010/11 - General Pharmaceutical Council

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<strong>Step</strong> 2 <strong>Accreditation</strong> of an Overseas Pharmacists’<br />

Assessment Programme (OSPAP), Kingston University<br />

Report of an accreditation event, 4 May 20<strong>11</strong><br />

Introduction and background<br />

The <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong> (GPhC) is the statutory regulator for pharmacists and pharmacy technicians and is the accrediting body for pharmacy education in<br />

Great Britain. The GPhC assumed responsibility for pharmacy regulation from the Royal <strong>Pharmaceutical</strong> Society of Great Britain (RPSGB) on 27 September <strong>2010</strong>.<br />

An Overseas Pharmacists' Assessment Programme (OSPAP) is a postgraduate diploma which is undertaken as the first part of the route to registration required by those<br />

who have qualified as a pharmacist from outside of the EEA. An OSPAP is a one‐year course designed to ensure that those who have qualified overseas receive the<br />

appropriate education and training to prepare them for UK Practice and entry to pre‐registration training.<br />

Kingston University signalled to the Royal <strong>Pharmaceutical</strong> Society of Great Britain (RPSGB) its intention to apply to provide such a programme with a view to recruiting<br />

overseas pharmacists to commence the programme in September <strong>2010</strong>. As a result, an accreditation team from the Society visited the University on Tuesday 9 February<br />

<strong>2010</strong>. The then accreditation team recommended to the regulator that Kingston University was not ready to proceed from <strong>Step</strong> 1 to <strong>Step</strong> 2 of the process for accrediting<br />

new OSPAPs and must make a reapplication for accreditation to be considered. The then accreditation team’s reasons were that 1) the course team was unable to<br />

answer with any certainty a substantial number of questions about the logic and structure of the course. In particular, the then accreditation team was not given<br />

adequate reasons for the inclusion or exclusion of areas of science in the course and the particular suitability of existing MPharm modules for the OSPAP. This related to<br />

criterion 25, 2) the then accreditation team questioned the course team about accreditation criteria and received insufficient evidence to agree that some had been fully<br />

met. The relevant criteria were: 5, 9, <strong>11</strong>, 15, 25 and 27. The record of this event gives full reasons for the team’s position on these criteria., 3) linked to the previous two<br />

reasons was the inaccuracy and brevity of responses to some indicative syllabus items. The then accreditation team’s principal reason was that a substantial number of<br />

the responses in the documentation were single sentences giving the team no sense of the rationale behind coverage in particular areas. Members of the course team<br />

agreed that there was a mismatch between some syllabus items and their commentaries on them. As this was the case, the documentation as submitted represented an<br />

inadequate evidence base for accreditation purposes.<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

1


The University resubmitted documentation in May <strong>2010</strong> and a re‐visit by a Society accreditation team took place on 16 June <strong>2010</strong>. At this visit, the accreditation team<br />

agreed to recommend to the Society’s Education Committee that the Kingston University OSPAP be recognised in the first instance for a period of one year, subject to<br />

two conditions. Thus, the University was allowed to enrol students in September <strong>2010</strong>. The conditions were 1) that module descriptors be rewritten to accurately reflect<br />

the curriculum content. Whilst the individual elements of the indicative syllabus had been satisfied as evidenced by the School’s oral submission, neither the written<br />

submission nor the current module descriptors supported this. This related to criterion 25. The rewritten module descriptors must be submitted to the Society’s<br />

<strong>Accreditation</strong> Department for approval by 16 July <strong>2010</strong>, and 2) that the advertising booklet for students be rewritten and submitted to the Society’s accreditation team<br />

for review prior to dissemination. During the visit the accreditation team was reassured to hear from the Associate Dean of the University’s commitment to supporting<br />

the Kingston OSPAP.<br />

The <strong>Step</strong> 2 visit detailed within this accreditation record followed the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>’s September <strong>2010</strong> accredited processes and reaccreditation was to<br />

the GPhC’s interim standards for accreditation ofOverseas Pharmacy Assessment Programme.<br />

Documentation<br />

Following receipt of the provider’s submission documentation, a pre‐visit meeting was held on 28 March 20<strong>11</strong>, at which the meetings’ schedule and any additional<br />

documentation requirements were agreed. The pre‐visit meeting was attended by the accreditation team leader, the GPhC <strong>Accreditation</strong> and Recognition Manager and<br />

the provider’s representatives.<br />

The following documents were submitted by the provider in advance of the step 2 accreditation visit:<br />

1. Document for <strong>Accreditation</strong> of the Postgraduate diploma in Pharmacy practice (OSPAP) <strong>Step</strong> 2<br />

The following documents were submitted by the provider during the step 2 accreditation visit:<br />

2. Compendium of module guides<br />

3. Variances in module guides from module descriptors document<br />

4. Placements and feedback document<br />

5. SSCC minutes 27/10/10<br />

6. SSCC minutes 10/03/<strong>11</strong><br />

7. PYM010‐PYM080 module boxes<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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The visit<br />

The step 2 accreditation visit took place on the 4 th May 20<strong>11</strong> at the Department of Pharmacy, Kingston University. A private meeting of the accreditation team was held<br />

on the 3rd May 20<strong>11</strong>.<br />

The visit comprised a series of meetings at the University. The meetings were with senior School staff to discuss strategic issues, course staff to discuss the syllabus,<br />

student representatives, and senior University officers. The accreditation team also had the opportunity to meet with 10 students representing the entirety of the<br />

current cohort.<br />

The <strong>Accreditation</strong> Team:<br />

The GPhC accreditation team (‘the team’) comprised:<br />

Name Designation at the time of accreditation event<br />

Mrs Linda Stone *<br />

<strong>Accreditation</strong> team leader, pharmacy consultant, past President of RPSGB, community<br />

pharmacy background<br />

Professor Larry Gifford <strong>Accreditation</strong> team member (academic), Professor of Pharmacy Education and Deputy Head of<br />

School, Keele University School of Pharmacy<br />

Dr Brian Curwain <strong>Accreditation</strong> team member (International Panel), Freelance pharmacist consultant to NHS and<br />

industry, Past Chair, English Pharmacy Board, member of International Panel of GPhC, former<br />

PCT head of medicines management<br />

Mr Surinder Bassan <strong>Accreditation</strong> team member (pharmacist, hospital), Chief Pharmacist, Southampton Universities<br />

Hospital and member of International Panel of GPhC<br />

along with:<br />

Name Designation at the time of visit<br />

Ms Joanne Martin* <strong>Accreditation</strong> and Recognition Manager, <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong><br />

Ms Martha Pawluczyk** Registration Manager, <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong><br />

Ian Marshall Rapporteur<br />

*attended pre‐visit meeting<br />

**attended the Day 1 private meeting of the accreditation team only<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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There were no conflicts of interest expressed by members of the accreditation team. The Vice Chancellor declared that he is a member of the GMC accreditation team at<br />

Keele University School of Medicine. This was not regarded as a conflict of interest.<br />

The accreditation criteria<br />

Criteria (See Appendix 1)<br />

Outcomes: the graduate…<br />

(criteria 1‐17)<br />

Processes: the student…<br />

(criteria 18‐‐24)<br />

Processes: the OSPAP…<br />

(criteria 25‐32)<br />

<strong>Accreditation</strong> team’s commentary<br />

The accreditation team agreed that all 17 criteria in this section had been met. The team noted that the OSPAP students were<br />

enthusiastic adult learners who were enjoying a worthwhile course. Students were comfortable with the UK requirements in<br />

law and professional matters and were conversant with the area of ethical dilemmas and decision‐making. The team found the<br />

students somewhat vague on the subjects of medicines management and pharmaceutical care. The team noted that the<br />

Department conducted diagnostic testing of prior knowledge during the induction week and provided remedial support where<br />

required. Students expressed themselves as wishing to become pharmacists and queried the inclusion of so much science and<br />

critical analysis in the OSPAP; the Department indicated that it wished to dispel this view of modern pharmacy provision.<br />

The accreditation team agreed that all 7 criteria in this section had been met. The team noted that students were comfortable<br />

with the concept of continued professional development and with the UK standards of conduct, ethics and performance.<br />

Students arrange their own placement in community pharmacy in Semester 1, often in the pharmacy where they regularly<br />

work. Staff opined that this system had both positive (familiarity with the environment) and negative (possibility of bias)<br />

aspects. It was stressed that some students lived long distances from the University and hence a placement close to their<br />

home was advantageous. It was also stressed that students were required to complete workbooks relating to the placement to<br />

differentiate it from a normal working day. The accreditation team was of the view that the students selecting their own<br />

placement represented poor academic practice and would have preferred to have seen students working on neutral territory.<br />

The accreditation team agreed that all 8 criteria in this section had been met. The course director and module leaders indicated<br />

that the course had gone well and that there had been no problems with the delivery. It was reported that the attitude of the<br />

students had been very professional and that they had been a pleasure to teach. The accreditation team was told that the<br />

practice of co‐teaching parts of the OSPAP with the MPharm had both advantages and disadvantages. In this respect, students<br />

interviewed expressed the view that they were often confused as to whether they were being treated as undergraduate or<br />

postgraduate students. The team was told that the Department planned to introduce more separate teaching for the two<br />

cohorts in the next teaching year. Students commented that they found very confusing the departmental practice of referring<br />

to modules by code rather than by title, a view with which the accreditation team concurred.<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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The teaching fellows are pharmacists working in practice and hence are aware of the latest developments in the practice area.<br />

Teachers in pharmacy practice keep up‐to‐date with developments in the profession and on the science side, students<br />

undertake critical evaluations of research papers. The team was surprised to learn that the Department did not have as part of<br />

its quality approach an agreed method of providing lecture information to students, rather it being left to individual teachers to<br />

decide on their own method. The team did not regard this as good practice. The accreditation team also noted some<br />

indications of student dissatisfaction with the feedback on assignments. The teaching team indicated that because of the small<br />

cohort size it was possible to give individual feedback, but it was also stated that group feedback is given at the end of some<br />

modules. The accreditation team was told that the Department had made little progress in developing interprofessional<br />

learning since the <strong>Step</strong> 1 visit. The team was told that no other healthcare professions were on the site and that the timetable<br />

issues with St George’s Hospital Medical School continued to be insoluble. The accreditation team accepted this explanation<br />

and, noting that this criterion is currently not mandatory, agreed that the criterion was met. However, it was pointed out to the<br />

Department that the new GPhC standards for both MPharm and OSPAP degrees demand an element of interprofessional<br />

learning. Accordingly, it will be a recommendation of this record that that the University should use its best endeavours to<br />

explore teaching and learning opportunities with students of other healthcare professions.<br />

Structures<br />

(criteria 33‐42)<br />

The accreditation team agreed that all 10 criteria in this section had been met. The accreditation team noted comments in the<br />

minutes of the Staff Student Consultative Committee concerning the shortage of books in the library. Students interviewed<br />

described the library as always being crowded. The documentation stated that the library purchases recommended textbooks<br />

in the ratio of one book per ten students. The team was satisfied by a statement from the Information Specialist (Science) that<br />

he maintained a watching brief on usage of books and both he and the Acting Dean indicated that the library was prepared to<br />

purchase extra copies if the need arose. The accreditation team was cognisant of the fact that since the <strong>Step</strong> 1 visit the<br />

University, through an error that was no fault of the Department of Pharmacy, had admitted 50 additional students to Year 1 of<br />

the MPharm programme in September <strong>2010</strong>. The team was told that the University had acknowledged that the Department of<br />

Pharmacy required extra resource to cope with this temporary increased student load and that extra fixed‐term appointments<br />

had been made for the next 2 years. The team leader indicated that the GPhC would expect this extra support to be maintained<br />

throughout the period that the extra students would be on course in order that neither the MPharm nor OSPAP provisions<br />

would be compromised. The Acting Dean indicated that there was uncertainty about the figures quoted in the original business<br />

plan in the current financial climate for universities but he was comfortable that the funding level to the OSPAP programme<br />

would be preserved. Likewise, the Vice Chancellor, although unable to promise the precise sums that would be available,<br />

indicated that the University would continue to support pharmacy at appropriate levels to maintain the student:staff ratio.<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

5


Summary and conclusions<br />

This conclusion concerns the first part of the two‐part step 2 accreditation event. The second part of the event is a return visit to the University by the team leader and<br />

the Head of Education and Quality Assurance to confirm the appropriate conduct of the assessment process for the <strong>2010</strong>/20<strong>11</strong> academic year in July 20<strong>11</strong>.<br />

In reaching its conclusion based on this <strong>Step</strong> 2 visit, the accreditation team made two separate judgements:<br />

1. whether or not the University met the criteria for a new provider delivering a new OSPAP; and<br />

2. whether or not the University met the criteria for an established provider delivering an existing OSPAP<br />

The accreditation team agreed that both sets of criteria had been met, subject to conditions and recommendations.<br />

Consequently, the accreditation team agreed to recommend to the Registrar of the GPhC that Kingston University be permitted to progress from the process for the<br />

accreditation of a new OSPAP to the process for the accreditation of an existing OSPAP. The result of this is that Kingston University now delivers a fully accredited<br />

OSPAP, subject to the confirmatory visit later in July.<br />

The accreditation team also agreed to recommend to the Registrar that Kingston University be accredited as an OSPAP provider for a period of three years .<br />

There are no conditions.<br />

There is one recommendation:<br />

1) that the University should use its best endeavours to explore teaching and learning opportunities with students of other healthcare professions. This is to meet<br />

criterion 31.<br />

The accreditation team was pleased to hear the Vice Chancellor’s assurance of the University’s continued support for the pharmacy provision and his view on the<br />

standard of the student experience at Kingston University.<br />

The team leader and the Head of education and Quality Assurance will return to the University on 5 July 20<strong>11</strong> for the second part of the <strong>Step</strong> 2 accreditation to check<br />

that the assessment process has been conducted appropriately. At this meeting, the views of external examiners will be sought. They will be asked the following:<br />

- whether all graduating students have met all the learning outcomes of the course;<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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- whether the course is securely at Master’s level;<br />

- whether the assessment process has been conducted fully in accordance with relevant academic regulations;<br />

- whether there are any issues which would or could have the potential to affect academic standards in the future.<br />

Satisfactory answers to all of these questions must be obtained. Accordingly, the Head of education and Quality Assurance will inform the Registrar of this outcome, so<br />

that he can confirm full accreditation on behalf of the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>.<br />

The Head of Education and Quality Assurance will also inform the Preregistration Department of the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong> that the OSPAP is now fully<br />

accredited so that any signed pass list submitted by Kingston University to the Preregistration Department of the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong> can be used to confirm<br />

that the students on the list can be permitted to begin preregistration training. The visiting team will direct the School to inform the OSPAP students of this process.<br />

The team leader reminded the University of the following:<br />

- The <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong> has assumed responsibility for the regulation of pharmacy education. The Pharmacy Order, the legislation establishing the<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong> as regulator, states that the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong> accept previous decisions of the Society. In this context, that means<br />

previous accreditation decisions of the Society will stand.<br />

- The recommendations of the accreditation team are not binding on the Registrar and the Registrar may add, remove or modify points on reflection and in light of the<br />

accreditation panel views.<br />

- The <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>’s record and report will be sent to the University shortly to comment on factual accuracy. The providers must respond to the<br />

definitive version of the record and report within three months of receipt.<br />

- Thereafter the summary report, along with the University’s response, will be published on the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>’s website and remain for the duration<br />

of the accreditation period. The record remains confidential to the institution and the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>.<br />

- All accredited providers are required to inform the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong> annually of changes to the curriculum and/or resources.<br />

The accreditation team’s feedback is confidential until it has been ratified by the Registrar of the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>.<br />

Following the above event, a <strong>Step</strong> 2 part 2 confirmatory visit was conducted on 5 July 20<strong>11</strong>. Following positive responses from the External Examiners<br />

at this visit the accreditation team’s recommendation for accreditation remained.<br />

The Registrar of the <strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong> subsequently agreed with the accreditation team’s recommendations and approved the Kingston<br />

University OSPAP for accreditation for a period of three years.<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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Appendix 1<br />

Prerequisite with regard to entry to the OSPAP<br />

All OSPAP entrants must have satisfied all relevant requirements of the GPhC’s International Panel<br />

at the successful conclusion of the OSPAP, the graduate…<br />

1. takes personal responsibility for his/her learning, developing a foundation for subsequent continuing professional development,<br />

2. can communicate effectively, orally and in writing, with his/her teachers and peers, as a sound basis for future interaction with patients, carers and other healthcare<br />

professionals,<br />

3. can undertake structured problem‐solving,<br />

4. is able to recognise ethical dilemmas in healthcare and science, and understands ways in which these might be managed by healthcare professionals, whilst taking<br />

account of relevant law,<br />

5. appreciates and has an understanding of main sources of drugs; ways in which drugs are purified, characterised and analysed; their physico‐chemical properties; and<br />

properties drugs display as biologically active molecules in living systems,<br />

6. has an understanding of the design, manufacture and performance of drug dosage forms and is able critically to appreciate the inter‐relationship between<br />

formulation, drug delivery and therapeutic effectiveness,<br />

7. understands how medicines are developed, manufactured and brought to the market place,<br />

8. has proved him/herself capable of performing pharmaceutical calculations accurately,<br />

9. has the capability to prepare extemporaneously any medicine for which this would be regarded as the normal means of provision, including by aseptic technique,<br />

10. is able to interpret and evaluate, for safety, quality, efficacy and economy, prescriptions and other orders for medicines, and to advise patients and other healthcare<br />

professionals about medicines and their usage,<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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<strong>11</strong>. is aware of and understands systems for the quality assurance of products and pharmaceutical services. This includes the management of risk,<br />

12. is able to design, improve, and operate within standard operating procedures, including Patient Group Directions,<br />

13. is able to supply medicines in accordance with legal and professional requirements,<br />

14. can undertake critical appraisal of information or conjecture in all forms of presentation,<br />

15. can apply appropriate approaches and methods to manage scientific and practice problems,<br />

16. has a foundation of knowledge, understanding and skills for promoting good health; diagnosing disease; and prescribing medicines,<br />

17. understands and can explain concepts of medicines management and pharmaceutical care.<br />

Processes<br />

the student…<br />

18. is inculcated with a concern for the patient, normally above other considerations,<br />

19. gains first‐hand structured experience of practice, including contact with patients and practitioners of other healthcare professions,<br />

20. is required to communicate with individuals and audiences,<br />

21. is required to apply, library and other information resources,<br />

22. is required to apply routinely, word‐processing, spreadsheet, database, e‐mail and information retrieval computer applications,<br />

23. has brought to his/her attention the continuing professional development opportunities open to practising pharmacists,<br />

24. Is encouraged to seek networking opportunities in professional pharmacy organisations<br />

the OSPAP…<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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25. is planned with reference to the indicative syllabus appended and students’ prior learning.<br />

26. seeks to develop students' skills of self‐management, teamworking and peer assessment,<br />

27. has the features of positioning knowledge, understanding and skills in a pharmaceutical context and with reference to pharmacy practice,<br />

28. in the processes of curriculum review and development, benefits from the academic staff properly taking account of major advances and developments potentially<br />

impacting on pharmacy,<br />

29. features a variety of approaches to achieving and assessing learning appropriate to its stated objectives, including lectures, practical classes, seminars, workshops,<br />

tutorials, computer‐based/aided learning, clinical visits, problem‐solving exercises, essays and other assignments, and examinations,<br />

30. includes significant staff‐led or supervised time devoted to the topics of British pharmacy law and professional requirements, and their applications in practice, this<br />

being in addition to the assimilation of legal and professional requirements into a substantial proportion of a dispensing practical course,<br />

31. where appropriate and possible, has the student taught and learning alongside and together with students of other healthcare professions,<br />

32. has pharmacy teaching taking place alongside and with reference to research and other postgraduate activities.<br />

Structures<br />

33. For its proper ethos, quality assurance, and scientific and professional leadership, the OSPAP is within the control of, and predominantly delivered by, an<br />

autonomous school or department of pharmacy,<br />

34. accommodation, human, equipment, and other resources available to the school or department of pharmacy are sufficient for the effective delivery of the OSPAP to<br />

planned numbers of students, properly taking account of the full teaching, research and other commitments of the unit,<br />

35. the school or department of pharmacy applies an appropriately expert academic staff, including such in the practice of pharmacy, to the delivery of the OSPAP<br />

36. teacher‐practitioners and visiting lecturers from community and hospital pharmacy practice, and appropriate persons from other healthcare professions are involved<br />

in teaching/support for learning and assessment,<br />

37. the student has access to a personal tutor or tutors for academic guidance and pastoral care,<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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38. there is an active staff‐student consultative committee,<br />

39. pharmacy law, professional requirements and practice are taught ‐ predominantly by pharmacists ‐ from within the identifiable organisational unit which provides<br />

the bulk of teaching and other support for learning for the OSPAP,<br />

40. there is assessment of competence in dispensing by either one examination at the end of the dispensing course, taken under full examination conditions with an<br />

external examiner present; or a series of tests taken under examination conditions, with an external examiner having the right to attend any of the practical tests<br />

and attending some part of the assessment every year. The external examiner is associated with the overall assessment,<br />

41. there is a requirement for achievement of a satisfactorily high standard in assessments of both dispensing practice, and pharmacy law and professional<br />

requirements, irrespective of the student's performance in other subjects. Compensation of marks for these subjects is not allowed and success in these subjects is a<br />

condition for successful completion of the OSPAP,<br />

42. regulations governing the OSPAP are based on those applying to the MPharm degree course of the school or department.<br />

Indicative syllabus<br />

The patient<br />

The patient is the main or ultimate focus of everything in the OSPAP course. The items grouped under this heading address the biological, environmental, psychological<br />

and some of the social foundations of treatment with medicines.<br />

1. The unique role of the pharmacist in ensuring that the patient benefits from pharmaceutical intervention.<br />

2. Principles and methodologies of the social and behavioural sciences relevant to pharmacy.<br />

3. Health and illness: definitions and perceptions.<br />

4. Theory and practice of personal and inter‐personal skills, including written and verbal communication skills, and study skills.<br />

5. The ideas and approaches of compliance or concordance in health care provision, particularly as they apply to medicines‐taking.<br />

6. The pharmacist’s contribution to the promotion of good health and disease prevention.<br />

7. Normal and abnormal bodily function: biochemistry, genetics, microbiology, nutrition, immunology, physiology, pathology, pathophysiology and infective processes.<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

<strong>11</strong>


8. Aetiology and epidemiology of major diseases and the principles of their drug treatment.<br />

9. Symptoms recognition and management, the principles of differential diagnosis, important diagnostic methods and tests, and medical terminology.<br />

10. Disease management and care planning, including application of clinical guidelines, prescribing and medication review.<br />

<strong>11</strong>. Complementary therapies.<br />

12. Drug and substance misuse, and physiological and psychological dependence. Clinical toxicology associated with drug over‐dosage, drug or substance misuse or<br />

accidental exposure.<br />

Medicines : drug action<br />

The focus here is on drugs in use, particularly in the patient. The first three items in this short list are large in scale and high in importance.<br />

13. Molecular basis of drug action and the actions of drugs within living systems; molecular, cellular, biological, and physical aspects.<br />

14. Clinical therapeutic uses of drugs and medicines in man, including contraindications for, adverse reactions to, and interactions of drugs, and their relevance to<br />

treatment.<br />

15. Drug absorption, distribution, metabolism and excretion and influences thereon, including formulation, route of administration, dosage regimen, ageing and disease.<br />

16. Clinical evaluation of new and existing drugs and medicines, and post‐marketing surveillance. Good Clinical Practice.<br />

17. Prospects for new approaches in therapeutics.<br />

Medicines : the drug substance<br />

For patient safety and often for the quality and efficacy of treatment, it is important that the pharmacist, uniquely among the team of health professionals, has an<br />

appreciation and understanding of the sources and properties of the drugs which form the biologically‐active and therapeutic components of medicines.<br />

18. Sources and purification of substances used in medicine of biotechnological, chemical synthetic, immunological, mineral and plant origin.<br />

19. Physico‐chemical aspects of drugs and biological systems, including thermodynamics and chemical kinetics.<br />

20. Specifications of substances used in medicine, including physical and chemical tests.<br />

21. Analytical methods: principles, design, development, validation and application.<br />

22. Prediction of drug properties, including chemical compatibilities, from molecular structure.<br />

23. Drug design and discovery: principles, approaches and future prospects.<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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24. Cell and molecular biology, including genomics, proteomics and gene therapy, relevant to pharmacy.<br />

25. Biological methods of measuring drug activity and biological standards.<br />

26. Biotechnology and biotechnological processes.<br />

Medicines : the medicinal product<br />

The formulation and compounding of medicines, taking the pure drug substance and producing a dosage form for administration to the patient, are at the heart of<br />

pharmaceutical science. This is established as the main area of contribution of pharmacy to the pharmaceutical sciences. More importantly, for the safety, quality,<br />

efficacy and economy of treatment with medicines, all pharmacists need knowledge, understanding and capability in this area.<br />

27. Sale and supply of medicines, including evaluation and management of risk and provision of advice.<br />

28. Medicines: licensing of medicines; consumer protection, including product liability and unlicensed medicines; legal classifications of medicines, including controlled<br />

drugs and their sub‐classes.<br />

29. Materials used in formulations and devices for the delivery of drugs, their biological, chemical and physical properties, and the development and application of<br />

standards.<br />

30. Biopharmaceutics, developmental pharmaceutics, pre‐formulation and formulation studies; design and standardisation of medicines for administration to the body<br />

by different routes and for delivery to specific target sites.<br />

31. The influence of manufacture and distribution on product quality with respect to biological safety, bioavailability (including bio‐equivalence), dosage uniformity and<br />

stability.<br />

32. Packaging and labelling; purpose, design and evaluation.<br />

33. Quality assurance of pharmaceutical products and processes, including Good Laboratory Practice, Good <strong>Pharmaceutical</strong> Manufacturing Practice and the role of the<br />

Qualified Person.<br />

34. Microbiological contamination: sources, determination, consequences and control.<br />

35. Sterilisation processes and aseptic procedures in the preparation of pharmaceutical products and medical devices; monitoring of sterilisation processes.<br />

36. Environmental control in manufacturing facilities and in the supply chain.<br />

37. Degradation of medicines; evaluation and control of biological, chemical and physical degradation.<br />

38. Immunological, biotechnological and radiopharmaceutical products.<br />

39. Dressings and other wound management products.<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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40. Medical devices: their types, regulation and, particularly, their usage for the measurement and maintenance of physiological function or medicine delivery.<br />

41. Statutes and main regulations related to medicines and poisons.<br />

Healthcare systems and the roles of professionals<br />

For pharmacists to be able to practise effectively, efficiently and confidently they need to know about, understand and have some of the skills to operate within<br />

healthcare systems, alongside and together with other health professionals and other scientists.<br />

42. Health care systems: NHS community, primary, secondary and tertiary care; private health care; the pharmaceutical industry; scientific and medical publishing; all<br />

including the roles of pharmacists, and other healthcare professionals and other scientists. (To include coverage of concepts of medicines management and<br />

pharmaceutical care.)<br />

43. Public health and the role of the pharmacist.<br />

44. The duty of care to the patient and the wider public: concept, scope and application of the Standards of conduct, ethics and performance.<br />

45. Codes, standards and systems of governance and practice; risk management; and personal accountability, to include the need for, and means of, continuing<br />

professional development.<br />

46. Professional and multi‐professional audit. Managing and learning from errors.<br />

47. Present and potential use of information technology in pharmacy and more widely in healthcare.<br />

The wider context<br />

The pharmacist needs a realistic and well‐informed view of how healthcare, and pharmacy within it, fits and operates within the wider world.<br />

48. The political and legal framework, requirements and processes relevant to pharmacy.<br />

49. Health policy and economics, including particularly pharmacoeconomics.<br />

50. Scientific, clinical, health services and social services research; methods and results relevant to pharmacy.<br />

51. Laboratory, other workplace and environmental safety and protection, including health and safety at work, the Control of Substances Hazardous to Health, Chemicals<br />

Hazard Information and Packaging for Supply, and waste disposal.<br />

<strong>General</strong> <strong>Pharmaceutical</strong> <strong>Council</strong>, OSPAP <strong>Step</strong> 2 accreditation report<br />

Kingston University, 4 May 20<strong>11</strong><br />

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