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The Pharmaceutical Society of Zambia
Pre-Registration Training Manual for
Pharmacy Tutors and
Internee Pharmacists
2004 - 2010
Developed by:
Pharmaceutical Society of Zambia
Continuing Pharmaceutical Education & Development Committee
(CPEDC)
February 2004
Prepared & Compiled by CPEDC Chair:
Lungwani T.M. Muungo: DipPharm, BScPharm, MPhil, PhD, MPharmSZ
2
Table of Contents
Acronyms.........................................................................................................................................5
Acknowledgments............................................................................................................................6
Preface .............................................................................................................................................7
I. GENERAL AND PROCEDURAL REQUIREMENTS FOR INTERNSHIP AND
EXAMINATIONS ...........................................................................................................................8
1. General Information..................................................................................................................8
2. Conditions of Admission to internship training and examination................................................8
3. Dates and Venue of Examinations.............................................................................................9
4. Entry and re-entry to examinations.......................................................................................... 10
5. Conduct of the Examinations................................................................................................... 10
6. Notification of Results ............................................................................................................ 10
7. Appeals Procedure.................................................................................................................. 10
Chapter 1........................................................................................................................................ 11
1.0 INTERNSHIP TRAINING PROGRAMME .............................................................................. 11
1.1 Introduction .......................................................................................................................... 11
1.2 CORE COMPONENT: ......................................................................................................... 13
1.3 SECTORAL COMPONENT:................................................................................................ 13
1.4 THE SOCIETY – RECOGNISED INTERNSHIP TRAINING TEAM................................... 14
1.4.1 TUTORS........................................................................................................................ 14
1.4.2 THE TRAINERS............................................................................................................ 15
1.4.3 MENTORS........................................................................................................................ 15
1.4.4 OTHERS (TEACHERS/INSTRUCTORS)...................................................................... 15
1.4.5 THE INTERNSHIP TRAINEE....................................................................................... 15
1.5 THE TASKS OF EACH TUTOR AND/OR TRAINER(S):.................................................... 17
1.5.1. PLANNING.................................................................................................................. 17
1.5.2 INITIAL ASSESSMENT ............................................................................................... 18
1.5.3 TRAINING.................................................................................................................... 19
1.5.3.7 Providing Feedback......................................................................................................... 21
So - what is Competence?............................................................................................................... 23
1.5.3.10.3 Training for Assessment.......................................................................................... 24
1.5.3.10.4 Proposed Format of the Internship Competence-Based Programme.......................... 25
1.5.4 ASSESSMENT OF COMPETENCE........................................................................ 29
1.5.5 RECORDING ACHIEVEMENT.................................................................................... 33
1.5.6 REVIEW AND FEEDBACK.......................................................................................... 36
Chapter 2........................................................................................................................................ 48
INTERNSHIP TRAINING FOR PHARMACY GRADUATES FROM RECOGNIZED
UNIVERSITY DEGREE PROGRAM ........................................................................................ 48
1.0 THE PSZ AND OTHER RELEVANT PHARMACEUTICAL BODIES IN ZAMBIA: THEIR
LEGAL, ETHICAL AND PROFESSIONAL ASPECTS TOWARDS THE NATIONAL HEALTH
SYSTEM.................................................................................................................................... 50
1.1 Pharmaceutical Society of Zambia (PSZ)........................................................................... 50
1.2 Pharmaceutical Regulatory Authority and the Board in Zambia.......................................... 50
1.3 Medical Council of Zambia ............................................................................................... 50
1.4 The National Health System in Zambia.............................................................................. 50
1.5 Sale and Supply of Medicines and Poisons......................................................................... 51
1.6 Professional Ethics........................................................................................................... 51
2.0 THE BASIS OF RESPONDING TO SYMPTOMS INCLUDING THE MAJOR
CATEGORIES OF SYMPTOMS AND THE APPROPRIATE RESPONSES FOR A
PHARMACIST .......................................................................................................................... 52
2.1 The styles of questioning................................................................................................... 52
2.2 Differentiation of symptoms, advice and referral when possible ......................................... 52
2.2.9 The Eye ............................................................................................................................. 58
3.0 PHARMACOLOGICAL AND THERAPEUTIC ASPECTS OF THE PROVISION OF A
PHARMACEUTICAL SERVICE INCLUDING THE SALE AND SUPPLY OF MEDICINES
3
AND DISPENSING, WITH PARTICULAR REFERENCE TO MAJOR ADVERSE
REACTIONS, INTERACTIONS AND CONTRA-INDICATIONS............................................. 60
3.1 Reading and Interpreting Prescriptions............................................................................... 60
3.2 Therapeutic Knowledge Base ............................................................................................ 60
3.3 Drug Action, Absorption, Distribution, Metabolism and Elimination *** ........................... 61
3.4 Drug Interactions............................................................................................................... 62
3.5 Adverse Drug Reactions and Side Effects .......................................................................... 62
3.6 Contra-indications............................................................................................................. 63
5.0 THE ADVISORY ASPECTS OF A PHARMACEUTICAL SERVICE.................................. 66
5.1 Advice to Patients and Careers: ......................................................................................... 66
5.2 Advice to Medical and Other Health Care Professionals..................................................... 67
5.3 Advice to members of the public ....................................................................................... 67
6.0 PHYSICAL PHARMACEUTICAL ASPECTS OF COMPOUNDING AND ................... 69
6.1 Extemporaneous Dispensing Methods................................................................................ 69
6.2 Bulk Manufacturing .......................................................................................................... 70
6.3. Raw Materials, Active Ingredients and Finished Products.................................................. 70
6.4 Excipients ......................................................................................................................... 71
6.5 Stability and Storage ......................................................................................................... 71
6.6 Packaging ......................................................................................................................... 71
6.7 Labeling............................................................................................................................ 72
6.8 Good Dispensing Practice.................................................................................................. 72
6.9 Good Manufacturing Practice ............................................................................................ 72
7.0 THE PRINCIPLES OF PROCUREMENT, STORAGE, AND STOCK CONTROL OF
MEDICINES.............................................................................................................................. 73
7.1 Procurement...................................................................................................................... 73
7.2 Wholesaling...................................................................................................................... 73
7.3 Storage.............................................................................................................................. 73
7.4 Stock Control.................................................................................................................... 73
Chapter 3........................................................................................................................................ 75
3.0 THE SECTORAL WORK EXPERIENCE PROGRAMME ................................................... 75
3.1 Internship Work Experience for Trainees in Community Practice....................................... 75
3.2. Internship Work Experience for Trainees in Hospital Practice .......................................... 85
3.3. Pre-registration Work Experience for Trainees in Industrial Establishments....................... 94
2. Responsibilities of the “Qualified Person” ............................................................................... 94
3. Development of sterile and non-sterile preparations, including:............................................ 95
4. The principles and practice of Good Manufacturing and Good Laboratory Practice .............. 95
5. Manufacture of sterile and non-sterile preparations, including:-............................................ 95
6. Quality Control of sterile and non-sterile preparations, including:- ....................................... 95
7. Regulatory requirements pertaining to the conduct of clinical trials and the licensing of
products.................................................................................................................................. 96
8. Clinical Trial Supplies, including:........................................................................................ 96
9. Provision if information....................................................................................................... 96
Chapter 4........................................................................................................................................ 97
4.0 The End of internship and Registration Examination.............................................................. 97
4.1 The Registration Examination ............................................................................................ 97
Appendix 1................................................................................................................................... 131
Internship Training in Zambia for Pharmacy Degree Certificate Graduates ................................ 131
Appendix 2................................................................................................................................... 133
TUTORS’ LIST FOR PRE-REGISTRATION TRAINING ....................................................... 133
Appendix 3................................................................................................................................... 135
CONTINUOS ASSESSMENT PERFORMANCE CRITERIA FORM....................................... 135
(CAP FORM)........................................................................................................................... 135
Appendix 4................................................................................................................................... 141
CHECKLIST FOR REGISTRATION AS A PHARMACIST .................................................... 141
Appendix 5................................................................................................................................... 146
RESULTS STATEMENT FORM / RSF FORM........................................................................ 146
4
Appendix 6................................................................................................................................... 147
REGISTRATION RECOMMENDING FORM / RRF FORM ................................................... 147
5
Acronyms
ADR Adverse Drug Reation
AIDS Acquired Immuno-disease syndrome
BNF British National Formulary
CBTP Competence Based Training Programme
DEC Drug Enforcement Commission
CBoH Central Board of Health
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
GNC General Nursing Council
HIV Human Immune Virus
MSH Management Sciences for Health
MCZ Medical Council of Zambia
NGO Non-Governmental Organization
NSRC National Scientific Research Council
OTC Over the counter
PMR Patient Medical Record
PRA Pharmaceutical Regulatory Authority
PSZ Pharmaceutical Society of Zambia
QC Quality Control
QA Quality Assurance
TB Tuberculosis
TNP Total Parenteral Nutrition
UTH University Teaching Hospital
ZNF Zambia National Formulary
6
Acknowledgments
The Pharmaceutical Society of Zambia thanks the Medical Council of Zambia for its
partnership and confidence in the Society’s professional development. The Council
through its statutory powers delegated the Society to develop a structural experiential
learning of internee pharmacist. Special thanks to Ministry of Health and Central
Board of health for their guidance and leadership. The Society also thanks United
States Agency for International Development for their financial support through the
Management Sciences for Health’s Rational Pharmaceutical Management Project.
We are thankful for the RPM Plus technical support and effort to develop and
implementation of the Pre-registration program. The University of Zambia Pharmacy
Department will always have a special place and thank you for academic leadership.
Lastly but not the least we thank the individual contributors to the manual Dr
Lungwani T. M. Muungo, National Co-ordinator for Continuing Education Section
for the Pharmaceutical Society of Zambia and Head of Pharmacy Department at
UNZA; Oliver Hazemba, The President of Pharmaceutical Society of Zambia,
Caroline Lweendo Yeta, Pharmacy Specialist, Velepi Mtonga, Acting Director
General from Central Board of Health for their support. All the tutors for internee
pharmacist contributed to significant development and changes to this document. We
thank you for your continued support, undeservedly contribution to pharmacy
education.
We also acknowledge the early involvement of the Robert Gordon University
academic staff (Dereck Chapman, Brian Arris, Barry Melia and Catherine
Stevenson) that participated in the collaboration relationship with the new
Department of Pharmacy, at the University of Zambia. The visiting staff contributed
in both information and technical transfer process. They advised on the gradual and
professional process to introduce the new graduates from the department of
pharmacy training programme into the professional practice of pharmacy in the
country. Hence the establishment of the structured pre-registration training process
for the country.
7
Foreword
Post academic apprenticeship pharmacy education is meant to prepare graduates into
professional practice. The process was designed to expose the newly qualified
pharmaceutical professionals to both industrial and clinical areas of pharmacy
practice, hence involvement of retail, industrial and hospital pharmacy. The whole
process will be organized through the following organs:
1. Medical Council of Zambia will provide the means to provisionally recognize the
graduates while undertaking the apprentice training
2. The Ministry of Health as a government department to monitor the provision of
pharmaceutical care by the internee pharmacists
3. The pharmaceutical Society as the initiators and implementers of the structured
training programme through the indentified and trained tutor pharmacists.
The ministry will also engage the internee pharmacists on temporary employment for
their participation to provide the pharmaceutical care services during the course of
training.
The training offers mutual benefits both to the trainees and the ministry of health.
The trainees benefit through acquiring necessary professional skills as required for
the full registered personnel while the ministry has easy and quick access to the
trained pharmaceutical personnel in comparatively large number to cater for a wider
area of operations in the country’s health sector
8
I. GENERAL AND PROCEDURAL REQUIREMENTS FOR INTERNSHIP
AND EXAMINATIONS
1. General Information
1.1 The internship examination is one of the requirements jointly agreed by Medical
Council of Zambia and Pharmaceutical Society of Zambia as a way of
recognizing the full registration of anyone intending to practice as pharmacist in
Zambia
1.2 No person that applies for full registration and commenced internship training on
or after 17th
June, 2004 should be allowed to register and work as a pharmacist
unless that applicant has passed the internship examination.
1.3 The training will be structured as required by the registering bodies
1.4 The training will be reviewed and approved on regular basis through The
Pharmaceutical Society of Zambia, educational section
1.5 The applicant will be expected to register provisionally with MCZ for at least
ONE year prior commencing practical internship training and subsequently
passing the internship examination before full registration as a pharmacist.
2. Conditions of Admission to internship training and examination
2.1 Personal details:
- Approved undergraduate degree training program in pharmacy
- Certificate of Oath taking by the approved process. The time of taking the Oath
will depend on place of training for the primary degree certificate. Those locally
trained will take their Oath immediately after induction ceremony by the School
of Medicine while those from abroad will take theirs individually as the case may
entail.
- A letter of offer of internship training from the recommended institutions (
Hospitals, Retail Chemists, Pharmaceutical industries) to the Medical Council of
Zambia.
- Legal mandate from Medical Council of Zambia to undertake internship training
by providing the applicant with either provisional or temporary registration for
the local or abroad training respectively.
- Secured a trained and approved supervising Tutor Pharmacist (Appendix 2)
- Satisfactory completion of at least 44 weeks of internship training for the first
entry (Appendix 3)
- The Tutor will be guided by the training checklist to ensure that the trainee
would successfully and exhaustively complete the training (Appendix 4)
- Minimum of 24 weeks waiting time for re-sitting examination.
2.2. Eligibility to sit for first entry registration examination (that lapses after ONE
year of first attempt Examination)
- Successfully completed a four years degree program from the School of
Medicine, University of Zambia or an equivalent degree (photocopy of the
degree certificate)
9
- Has legal mandate from Medical Council of Zambia to have undertaken
internship training by being either provisionary or temporary registered as the
circumstance may be appropriate for at least ONE year (Assigned a registration
number – see the registration certificate)
- Has successfully undertaken a comprehensive and supervised practical training
by the trained and approved tutors (See the Tutors list).
- The tutor(s) has affirmed that the applicant has undergone such training and that
can proceed to write an end of internship training examination (Appendix 3).
- The intention to write an examination has been notified to Pharmaceutical
Society of Zambia education section at least ONE month prior to the designated
examination date by the internee pharmacists in agreement with supervising
tutors ( either using the continuos assessment performance criteria form - CAP
form or letter writing by the supervising tutors to education section of PSZ)
- Has undertaken such a comprehensive and supervised practical training at
recommended and approved sites (Appendix 1)
- The only allowed examination number to be quoted on examination documents
will be either Temporary or Provisional number assigned by Medical Council of
Zambia (reference to provisional/temporary registration certificates).
- The internship pharmacist has made a nominal examination fee payments and
non-refundable that will be ploughed back into examination logistical
arrangements.
- The applicants that fail first time attempt will be eligible to re-enter the
examination within 6 months without undergoing practical training but will be
required to make prescribed examination fee payments each time of attempting
an examination.
- The applicants that fail second time attempt will be eligible to re-enter the
examination only on satisfactory completion of a further 6 months period of
supervised at any of the recommended practical training sites.
- The applicants that fail third time attempt will be eligible to re-enter the
examination only on satisfactory completion of a further 12 months period of
supervised at any of the recommended practical training sites.
- Any subsequent failure will attract extensive interviews on the parts of the
applicant and the previous supervisors to establish the actual problem and decide
on the next course of action. That may be either discontinued process of
registration as a pharmacist in Zambia or recommend a new process of training
that may start from academic training through to the internship stages.
3. Dates and Venue of Examinations
3.1 Two examinations each year:
- Main Examination will be held between 1st
April and 15th
June, inclusive, in
each year
- Supplementary Examination will be held between 1st
and 16th
December
inclusive, in each year.
- Exact dates for both examinations will be communicated to the applicants
through their approved tutors by the Pharmaceutical Society of Zambia at the
earliest possible time.
10
3.2 For now, there will be TWO venues for the examinations in Zambia:
- Lusaka province venue
- Copperbelt province venue
- The supplementary examination could be held either at one or both of the two
provinces depending on the circumstances.
4. Entry and re-entry to examinations
3.3 Time of notice for the intention to write in each case will be 4 weeks.
3.4 Special arrangements required may be available to those applicants that may
genuinely require such.
5. Conduct of the Examinations
- Normal standards of examinations will apply – Starting time, during the
examinations and Ending time (See the examination sample papers).
- The candidates will provide themselves with the materials and documents that
will be needed for the examinations – reference books for open book
examinations, pencils, pens, erasers, and any other items that may be specified by
the PSZ for the examinations.
- Examination scripts are the property of PSZ and not the examination centers
- No electronic or any other devices that may assist in communication among the
examination candidates will be allowed on the candidates or writing desks during
the examinations.
6. Notification of Results
- Officially will be notified to the individual applicant by the committee of
examiners under PSZ (Appendix 5).
- PSZ will advise the Registrar of MCZ of the applicant’s performance and
recommendations for transfer to full Register of Pharmacists (Appendix 6).
7. Appeals Procedure
- Candidates participating in the examinations will be allowed to appeal against
their unexpected outcome of the results to the National co-ordinator for
continuing education section of PSZ
- The appeals will be attended to when made within 21 working days after the
results have been officially released to the applicants.
- The examinations committee will be expected to dispose of the appeal cases
within the period of 60 working days from the receipt or date of each appeal.
11
Chapter 1
1.0 INTERNSHIP TRAINING PROGRAMME
1.1 Introduction
The Pharmaceutical Act of 2004, of the Zambian laws provides that the
pharmaceuticals to the public should only be supplied from a recognised
pharmaceutical outlet directly under the management / supervision / control of a
registered pharmacist. By definition, ‘Registered Pharmacist’ means a person
registered as a pharmacist under the Medical and Allied Professional Act. The
regulations of this Act provides that such a registered health professional
(practitioner) must be in possession of a primary degree in pharmacy and will have
made a formal application to either ‘Provisional’ or ‘Temporary’ registration for
maximum period of TWO (2) years dependent on the primary degree training.
The localised undergraduate degree program in pharmacy started in 2001.
Effectively, this became a standard measure for pharmacy degree training for those
that intend to work as pharmacists in Zambia. The training is housed in the
department of pharmacy, located in Clinic 2 of University Teaching Hospital (UTH)
under the School of Medicine.
The outcomes of this training are the graduates with a degree certificate, which is
one the required document for admission into the internship training for full
registration. The period of degree training has been designed to take as the following
forms dependent on the pre-requisite qualifications:
1. Four (4) years at the School of Medicine for those students from the Main stream
Campus (School of Natural Sciences).
2. Four (4) years at the School of Medicine for those students with varied relevant
qualifying documents (degree certificates from health related fields, preferably in
biological and chemistry studies, ‘A’ level certificates).
3. Three (3) years at the School of Medicine for those students coming from the
health service facilities with diploma certificates in pharmacy technology. These
students may take an assessment examination prior to the start of the first
semester of the third year of the program at the Ridgeway campus.
4. The trained applicant will have followed a full-time training program as for that
of UNZA.
5. The degree certificates have been designed and issued by the training institution
as BPharm degree certificate like for UNZA.
6. Those with foreign degree certificates will be expected to have a minimum of
Bachelors Degree in Pharmacy ONLY – BScPharm; BPharm; MPharm;
PharmD (Doctor of Pharmacy) and will have satisfied an adjudicating process
12
undertaken by the School of Medicine through the Department of Pharmacy for
Registering body of Zambia.
7. The above qualifications may be allowed or assessed (Future Development) to be
registered onto the Specialists Register provided they are accompanied by
corresponding and recognized postgraduate training at the minimum of Masters
degree certification (with a dissertation) in the following fields of pharmacy
practice: Clinical Pharmacy; Industrial Pharmacy and in academia in any of the
Core Subject Fields (Sources and Chemistry of Drugs, Scientific Basis of
Therapeutics; Drug Dosage Form & Formulation and Pharmacy Practice) for
pharmacy education
8. The following degree programmes will not be assessed as primary entry
qualifications for pharmacists’ professional registration: Bachelors Degree in
Chemistry, Biology, Pharmacology, Pharmaceutical Sciences, Pharmaceutical
Technology, Human Medicine, Veterinary Medicine, Herbal Medicine and
Diploma in Pharmacy or any pharmaceutical sound-related training disciplines.
9. However, for the future developments, the following may be allowed to register
as Industrial Pharmacists ONLY if the registering body establishes such registers
for the Bachelor of Science in Pharmaceutical Sciences, Pharmacoeconomics
and Pharmaceutical Technology or as assessed and qualified by the
pharmaceutical expert committee of the PSZ
The undergraduate degree program in pharmacy was introduced in Zambia for the
first time, through the School of Medicine, in 2001. Effectively, the enrolled students
for the program started attending lectures on the 1st
of May in the same year. Also
effectively, from May 2001, the new department of pharmacy was born and located
in Clinic 2 of University Teaching Hospital (UTH) that included both academic and
service units for hospital pharmaceutical services.
The internship trainees must undertake and complete satisfactorily the whole length
of internship before becoming eligible to register as pharmacists. Below is a
summary of the material covered at seminars for internship tutors.
The internship programme is intended to take the newly graduated students through a
process of development to a point at which they are able to function as an
independent and individual professional practitioner. This developmental process
should allow the trainee objectively to:
 Develop the skills required in the professional practice
 Develop the ability to transfer skills and concepts to new situations
 Apply knowledge gained during academic studies
 Gain new knowledge relating to practice
These objectives can only be achieved if the trainee is actively involved in real-life
tasks and situations in addition to receiving information and being given the
13
opportunity to observe others. Adequate self-evaluation and feedback must
accompany such experience on performance, which the trainee should then use to
improve future performance.
The Pharmaceutical Society's requirements for internship training and experience
will comprise the following components
1.2 CORE COMPONENT:
This will be expressed as Competence Based Training Programme (CBTP) that
will require the tutors/teachers/instructors to ASSESS the trainee pharmacists of
their competence in the areas deemed vital for the profession of pharmacy
(GENERIC ASPECTS). The end of internship training and professional
examination (Internship examination) will complement CBTP. It will be upon
successful completion of the internship training year, full written recommendation
from the tutor and passing of the examination for the trainee to be put on full register
of qualified pharmacists.
1.3 SECTORAL COMPONENT:
List of pharmaceutical sectors that the trainees will be exposed to during their pre-
registration training, though not exhaustive, has been attached (Appendix 1).
All those involved in internship training can make a major contribution to the
profession but can only do so effectively with adequate commitment to the process
(Appendix for tutors).
14
1.4 THE SOCIETY – RECOGNISED INTERNSHIP TRAINING TEAM
1.4.1 TUTORS
For purposes of internship training, the Pharmaceutical Society of Zambia will
require every set of premises approved for training to have at least one recognised
Tutor that will have responsibility for:
 Ensuring that pre-registration training is carried out according to the Society’s
prescribed procedures.
 Co-ordination training at the premises
 Acting as a liaison person with the Society’s training section
 Undertaking evaluation of training provision at the premises to ensure that it is
improved when possible
 Make the required final recommendation for the trainee’s fitness to be a
registered pharmacist
Because of these responsibilities, the registering authority will be required to demand
that each tutor should be:
 Engaged in a full-time job or employment
 A full registered and paid up pharmacist for at least not less than one year
 Have been working in that employment he/she is applying from for the tutoring
position
 Has been an active participant of continuing education programs
By setting these criteria, the Society seeks to ensure that the Trainer Pharmacist has
sufficient availability, experience and professional commitment to act as a pre-
registration tutor.
In addition, the tutor has the considerable responsibility of ensuring that trainees gain
the most out of their pre-registration year and thus, indirectly, that the profession
gains the most from its newly-registered members.
The tutor fulfilling the following functions will achieve this:
 Acting as good role model for the trainee(s)
 Serving as a learning resource for the trainee by being available all the time to
answer and solve the difficulty situations the trainee might encounter
 Have sufficient awareness and understanding of the pre-registration programme
 Provide continuity for the trainees
 Act as a mentor when working with the trainee
15
1.4.2 THE TRAINERS
A Trainer will be any person other than the tutor who supervises the trainee during a
particular part of the programme and is usually, but not always, a pharmacist
operating normally on training site away from usual place that may have added
advantage towards the training of the internship pharmacist.
Examples of trainers are supervising, shop managers that are non pharmaceutical
professionals, section heads in community pharmacy and section heads in hospital or
industrial premises e.g. technologists, nurses, medical doctors etc.
Like the tutor, the trainer should:
Be a good role model for the trainee
Serve as a learning resource and
Act as mentor to the trainee during their time of working together (unless a mentor is
allocated to trainees separately – see below)
1.4.3 MENTORS
A mentoring system can be instigated for internship trainees to good effect. A
Mentor should be somebody assigned to the internee pharmacist for the duration of
the training period at the establishment, who is available to meet regularly with the
trainee and talk through anything the trainee wishes to raise. A mentor is not
necessarily the same person as a tutor/trainer, since a trainee may come across
several trainers in different departments throughout his or her training year. A
mentor might usefully be a pharmacist who has quite recently registered to provide
the trainee with someone who has been through the process of internship training not
so long ago. The system can help trainees feel less isolated and alone, particularly
during the early stages of their training. Many graduates move to a part of the
country that may be familiar to them for their training so not only do they not know
anybody at work, they may have no friends in the area. Often, the sense of isolation
leads to a depressed state that has knock-on effects on performance at work. It can
therefore be to the employer's benefit as well as to the trainee’s, if the trainee is taken
officially under somebody's wing.
1.4.4 OTHERS (TEACHERS/INSTRUCTORS)
Any other group of workers at any selected training site and can offer a specialised
skill that is required by a pharmacist in the normal working environment.
1.4.5 THE INTERNSHIP TRAINEE
Without whom, the profession of pharmacy would not continue!
The trainee has the greatest responsibility of anyone during the Internship year, in
the sense that it is s/he who must ultimately demonstrate to the tutor that s/he is able
to function as an independent professional practitioner, and is a fit and proper person
16
to be registered.
To this end, trainees should:
 Adopt a positive and committed approach to the pre-registration year
 Seek to learn at every opportunity, whether through experience, by questioning
and observation of others or by consulting information sources
 Seek to apply existing knowledge in the full range of activities undertaken
17
1.5. THE TASKS OF EACH TUTOR AND/OR TRAINER(S):
The experiential learning for trainees an educational strategy and requires adherence
to the following tasks for each tutor and trainee; planning, initial assessment,
training, assessment of competence, recording achievement, and review and
feedback
1.5.1. PLANNING
To plan how training will be provided and competence assessment carried out in line
with Society’s prescribed general framework. The Internship year needs to be
planned if it is to be effective and meet its stated objectives. A plan of training needs
to cover the following:
a) What sort of training will be needed, i.e. by what learning method will each
performance criterion be achieved?
On its own, observation by the trainee of another person at work does not constitute
'training’ in a competence-based programme since it cannot by itself lead to the
gaining of competence. The trainee must have involvement in an activity.
Tutors should bear in mind the following
 The need to think ahead and book or obtain courses and any additional training
sites that may be needed, whether face to face or distance learning or on-site
training.
 Any learning difficulties the trainee may have, e.g. physical, organizational
(perhaps no time during the working day).
b) Who will be responsible for the training?
c) Who else will be available to provide support to the trainee?
The tutor/trainer should discuss with the trainee - and the relevant staff – which
members of the pharmacy staff will be available and suitable to help the trainee on a
day-to-day basis. e.g.
 Will there be a particular pharmacist that will be working closely with him/her at
certain times in a hospital setting?
 How might various members of the support staff assist in the trainee’s training
Programmes
d) What sources of evidence of competence will be acceptable?
e) When and how will assessment take place?
 Will certain times be set aside for observation of particular activities and, if so,
when will this be? The trainee must be given adequate notice.
18
f) How often will a tutor or trainer meet with the trainee to discuss progress?
It may be helpful to meet more frequently during the early part of the pre-registration
year than later on, but in any case, regular meetings should occur and the trainee
should know at the outset when and where such meetings would occur. Tutors and
trainers should endeavour to stick to agreed meetings. It may be beneficial to have a
short, e.g. half-hour, meeting once a week and a longer session once a month. The
Society's Council stipulates that:
 The tutor should meet with the trainee at least once a month (if s/he is not
working alongside the trainee)
 A trainer or the tutor should talk with the trainee in a set-aside session for at least
15 minutes each week
1.5.2 INITIAL ASSESSMENT
To determine the trainee’s competence and previous experience at the start of his/her
internship training, i.e. has previous experience already given the trainee some
competence in certain areas? Internship trainees begin their training with a great
diversity of practice-related ability depending upon the following
 How much previous experience of pharmacy work they have actually had, e.g.
vacation employment, and whether it has been relevant to their pre registration
post.
 How much they have gained from any previous experience. This can vary
greatly from one person to the another, even though on paper they may seem to
have identical experience. Where the trainee has worked, hi/her level of
confidence and the work s/he was given to do will all have an effect.
 How much practice-related curriculum content they had in their degree course,
and how much they learned from it.
It should be remembered that all trainees will have had no previous workplace
experience at all and cannot be expected to show competence in any area of
pharmacy practice. If a tutor/trainer has worked with internship trainees before with
some prior experience, s/he may be surprised by a trainee who is a complete novice,
and perhaps expect too much of him/her initially. For these reasons, it is helpful to
carry out an initial assessment of the trainee. The best way to start this is by the
trainee undertaking self-assessment for all the units of competence. The trainee can
either do this him/herself or use it in discussion with the tutor/trainer, or the tutor and
trainee can go through the units together and jointly record the trainee's competence.
A suggested method of self-assessment for the trainee is as follows. For each
performance criterion, the trainee could use the following categories:
A) I have done this before/do it now and don’t need further training
B) I have done this before/do it now but I need further practice or guidance
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C) I have not done this before and need training, guidance and practice.
Within Grade B, s/he could further subdivide it into a "high" or "low" category; high
indicating little work to move to A and low indicating only just beyond C.
An initial plan of training is thus identified by those performance criteria which are
felt to fall into categories Band C. Obviously the tutor/trainer will still require
evidence of competence in those performance criteria/elements which have been
marked 'A', but these are likely to be few.
The trainee should then feel encouraged if s/he carries out later self-assessments and
has moved categories from C to Band B to A.
Tutors should also endeavour to find out at the start of the trainee's year, if they have
not done so already, what are the trainee's aspirations and areas of special interest.
1.5.3 TRAINING
Plan is meant to give to the trainee training guidance and relevant experience for all
the CORE PERFORMANCE criteria and SECTORAL aspects. There are various
ways in which the trainee can receive training
 One to one training from the tutor
 One to one training from a trainer as directed by the tutor
 Attendance at appropriate study days/training course
 Use of distance learning package that will be generated by the Society
1.5.3.1 Principles of Coaching in the Workplace
For each period of training, the tutor/trainer will be required to adopt the following
style for accountability and review of what will have been covered during practical
sessions
1. Assess training NEEDS
2. Plan to meet those NEEDS
3. Implement the PLAN
4. Evaluate the OUTCOMES and give feedback to 2
1.5.3.2 Assessing Needs for Training
What should be covered: look at current capabilities and past experiences to identify
training needs.
How should it be done: consider the trainee's learning style. Do not inflict your own
style on him/her, i.e. how does s/he prefer to learn, to ensure that you do not train in
an inappropriate manner e.g. allow enough time for thought before doing if the
trainee is a strong theorist, but allow him/her to get involved if s/he is a strong
activist. Do not inflict your own style on him/her.
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Copy of a self-assessment questionnaire to determine their own and their trainee's
preferred learning style may be prepared by the Pharmaceutical Society of Zambia.
1.5.3.3. Planning Training to Meet Needs
Involve the trainee in plans for training so s/he can feel ownership of the experience:
 Decide what your learning objectives are
 Decide how you are going to achieve them
Set targets together: these must be realistic and achievable (refer to current
capabilities and other factors that might affect progress)
1.5.3.4 Implementing the Plan (One to One Training)
Remember that other types of training may be required also to meet needs e.g.
organize courses in relevant areas.
Vary your approach between the following two roles when appropriate:
 Instructor for new tasks and situations and for inexperienced or unconfident
learner
 Facilitator for familiar tasks and situations and for experienced and confident
learners
Instruction = "hands on" Demonstrate, direct, discuss
Facilitation = "hands off" Be available to help and answer questions but be less
involved.
1.5.3.5 Conducting a Session of Training
Follow these important rules:
 Agree the intended outcome (and in relation to other wider targets)
 Plan and prepare to ensure outcome is achievable with time and resources
available
 Keep instruction short and simple (use stepwise approach)
 Allow learner to practice and take responsibility for own learning
 Listen and observe attentively
 Allow learner to make mistakes (when appropriate)
 Allow discussion.
The following steps - evaluation and feedback - are crucial parts of coaching if it is
to be effective. Too often training is given without evaluation and feedback so there
is no measure of how effective the training has been or of how to proceed in the
future.
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1.5.3.6 Evaluating the Outcome
 Review learner’s performance against targets
 Review progress in relation to learning plan
 Provide feedback
1.5.3.7 Providing Feedback
Some differences between good and bad feedback are:
Constructive V destructive
Positive V negative
Unhurried V rushed
Empathetic V judgmental
Helpful V uninformative
Calm V emotional
Supportive V derogatory
Sensitive V uncaring
Encouraging V demotivating
Honest V overly optimistic
Fair V biased
You could probably think of many more. The list not exhausted.
The golden rules of feedback and review are:
 Adopt a positive, non-threatening approach
 Encourage the trainee to participate allow self-evaluation first
 Be honest, but fair
 Relate comments to targets and performance
 Give credit where it is due: go from the positive to the negative and end on a
positive note
 Be constructive in criticism – suggest solutions
 Ensure the trainee has clearly understood: be specific, not vague
 Amend plans if necessary: be flexible
1.5.3.8 Conclusion
Remember to be an effective coach and above all, think how you would feel if you
were on the receiving end of your own brand of coaching. This can be achieved by:
 Having a plan
 Being clear
 Being open
 Being helpful
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Once the trainee has received training, s/he will of course need opportunities for
putting learning into practice and so must not be prevented from getting involved
whenever possible. Involvement in-patient counselling activities, for example, are
crucial if the trainee is to develop competence but tutors/trainers will need to decide
when the trainee is ready for this. It is usual practice for the trainee to be closely
monitored in the early stages of experience and then allowed a more free rein later.
1.5.3.9 Off-the-Job Training
Whilst the Society will try specify the areas of training in the syllabus, it might not
prescribe how exactly this will be done according to different training sites because:
 Within internship training establishments there is a wide variety of in-house
experience and training provision.
 The prior experience, learning and qualification of trainees’ ranges widely from a
very limited amount to a great deal.
This gives rise to variable need for off-the-job training courses and/or secondment
elsewhere so that it will be impossible for the Society to know what individual
trainees will require in the way of training to supplement that provided in the
workplace. (For example, even with first aid, there will be some trainees who have a
current or valid first aid certificate or who have undertaken a suitable course during
their degree programme).
It is therefore necessary for the Society to delegate to the internship training provider
the responsibility of looking at how the in-house training provision and the
individual trainee's prior achievements match the Society's requirements and of
filling any gaps that exist by the use of off-the-job courses, distance learning
packages or any other means appropriate and available. If it will be a MUST for the
trainee to spend some times at another pharmacy or pharmacy sector to gain extra
training or experience.
A variety of means is available for tutors to cover topics that it might be difficult to
provide at the pharmacy, for example:
 The trainee attending courses or using distance-learning packages provided by
the PSZ, e.g. covering the ZNF, EDL, etc.
 Contacting the local pharmaceutical service providers to find out what off-the-
job opportunities that can be provided for their trainees.
 Arranging for trainees to visit other establishments or events, e.g. other
pharmacies, doctors and dental surgeries, NGOs that provide pharmaceutical
services, etc.
 Obtaining material from the PSZ offices
 Obtaining relevant learning packages that may be available form PSZ and
passing them to the trainee(s) for their use.
 Arranging for the trainee to attend any necessary courses not specific to
pharmacy, e.g. first aid, communication skill assertiveness training.
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Tutors should remember that it is their responsibility to ensure that all the required
components are covered, and should therefore provide training at no cost to the
trainee.
1.5.3.10 The Competence-Based Training Programme
The aim of this guide is to help the tutor, the trainers and the trainee to use the
competence-based training programme as effectively as possible. Additionally, tutors
are required to attend a Society organised workshops about internship training and
trainees receive information from the Education Section during regularly.
The main aim of the competence-based approach is to be certain that the trainee is
competent by assessing his/her performance and knowledge.
So - what is Competence?
Competence can be defined as "the ability to perform consistently to the required
standard",
From this definition, it can be seen that:
 The concern is with the outcome, not the process, i.e. the person’s ability to
perform is at issue, not the learning process involved.
 Performance must be consistent, not acceptable only some of the time. In reality
it is impossible to be certain of a person’s competence at all times but before a
trainee is considered competent, the assessor must satisfied that performance to
date indicates consistent competence.
 Performance is not graded. Either it reaches the required standard or it does not
(yet)
1.5.3.10.1 Why should this approach be used for pharmacy internship trainees?
In the past, some internship training programs have operated by a simple checklist
system in which the competence of the trainee was largely assumed once the trainee
had been given information, gained some experience and observed others at work.
The competence-based approach, however, assesses the trainee's ability to translate
this learning into competent performance. Internship tutors have - without perhaps
realizing it - always assessed the competence of their trainees with respect to the
dispensing process (i.e. by thorough checking) and, to a variable extent, some other
professional activities and skills. The competence-based approach simply formalizes
this so that every internship trainee is assessed across the same defined range of
activities and skills, i.e. those constituting the CORE of pharmacy practice. A very
useful analogy is that of learning to drive i.e. it would be dangerous to allow a person
to drive alone after he has simply watched another driver on a few occasions and
been told what to do. The learner needs to receive instruction, practice thoroughly
himself and then undertake a practical test to determine whether he has developed
competence. A benefit to tutors and trainees of this approach is that the detail enables
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all concerned to know exactly what is expected of the trainee before registration and
helps to pinpoint areas, which the trainee needs to develop. A competence-based
programme, by being broken down into individual performance criteria, gives the
assessor and the trainee targets for which to aim. In this way, training and assessment
can be carried out by reference to these stated criteria, rather than by telling the
trainee a vague statement such as "You must work in a professional manner" or "You
must be able to counsel patients". The performance criteria given in this manual are
those required by the Society for the purposes of registration as a pharmaceutical
chemist but some employers might wish to go further in their expectation of trainees.
There is no problem with this provided that the trainee is clear at the outset what is
expected of him/her. Moving goal posts are not helpful to anyone.
With the identification of targets for which to aim comes an effective mechanism for
feedback on performance. The tutor/trainer should relate his feedback to the targets
by concentrating firstly on the criteria that have been met and then turning to those
that require further training or development.
1.5.3.10.2 Who assesses the trainee? (I.e. who is the "assessor")?
In many establishments, the training and assessment will (of necessity) be carried out
by the internship tutor. But in larger establishments, such as hospitals and large
community pharmacies, it can be effective to have the assessment conducted by a
person different from those responsible for the training. In this way, that one person
can be trained in the particular techniques of competence assessment and both
trainee and assessor may feel more comfortable if they have not worked closely
together beforehand.
1.5.3.10.3 Training for Assessment
For managers to conduct assessment of their trainee's competence within PSZ
requirements, work-based assessor courses will be prepared and available. Although
the internship programme is not an accredited MCZ (and there will be no future
plans to merge the two), the principles of competence assessment within it are
similar to those for MCZ, so tutors might like to consider undertaking one of these
work-based assessor courses. Alternatively, tutors in large establishments might wish
to send one of their trainer pharmacists on such a course and this person could then
effectively conduct the assessment of all trainees at the establishment. Although
there would be no immediate need to obtain the work-based assessor qualification at
the end of it.
NOTE: There might be bodies to award for work-based assessor qualifications.
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1.5.3.10.4 Proposed Format of the Internship Competence-Based Programme
The programme has the following components:
i. Units of Competence
Each unit relates to a discrete work area but should not be viewed in isolation. It is
the achievement of an agreed range of units, which constitutes competence in the
workplace
ii. Elements of Competence
Within units, the elements describe what a person should be able to do and are an
outcome of learning
iii. Performance Criteria
These specify the standards of performance against which achievement will be
measured.
iv. Definitions
These clarify and enlarge upon the performance criteria to assist tutors and trainees
in their understanding
a) Underpinning Knowledge
In any profession, it is important that members have a sufficient body of knowledge
to underpin practice in a variety of situations.
The possession of some knowledge can be inferred from the demonstration of
competent performance whilst other related knowledge may not be inferred from
observation but must be checked.
The knowledge underpinning each element or unit is specified as being either in the
registration examination syllabus or additional to it.
b) Interpretation of the Performance Criteria
Even with definitions, some of the performance criteria, particularly those in the
professional unit, are open to interpretation because it is not possible for the Society
to stipulate exactly what the standard should be; e.g. what would constitute
"reliability". The definition could be expanded it a little but, again, "acceptable time-
keeping" cannot be defined in any way that would have real worth and meaning to
all concerned. In such cases, the tutor and trainee(s) (with the trainers where
applicable) must agree at the outset their own definitions, so that, in addition to the
assessor knowing the exact standard required, the trainee can assess him/herself
against this standard. This is preferable to him/her having little idea of whether
his/her own particular standard is acceptable or not.
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The units making up the programme are as follows:
A. The professional unit, elements
B. Demonstrate a professional approach
C. Communicate effectively
D. Work effectively as part of the team
E. undertake personal and professional development
c) The Practical Units
1. Provide an effective service for the supply of treatments to patients
2. Provide an advisory and guidance service
3. Provide care an/or advice in response to the need for emergency aid or first
aid.
The differences between the Practical and Professional Units are:
Practical Professional
Task-based Behaviuor-based
Apply to particular functions Underpin the whole of practice
Assessed at a particular time and place Assessed as a continuum of
development throughout the year and
recorded via the 3-monthly appraisal
system
1.5.3.11 Evidence of Competence
Within competence-based training, the onus is on the trainee to provide evidence of
competence, which the assessor (the tutor or a trainer) then evaluates to decide
whether or not it meets the performance criteria.
i) What is evidence?
Since the purpose of the competence-based approach is to check the trainee's ability
at work, the only primary evidence is direct observation of the trainee's work
performance by the assessor.
However, it is not always possible to observe trainees for all performance criteria
and therefore secondary types of evidence must also be used. These can be:
 Projects, assignments, case studies. Must be signed by a supervisor for
authentication
 Questioning or discussions with the trainee to check knowledge or discuss the
evidence record
 Records or reports of everyday work and situations encountered
 Simulations/role plays. Either set up by the tutor/trainer or carried out at training
course/study day
 Prior achievement (in a previous job role). Needs verification by assessor
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 Certificates and existing qualifications, e.g. First Aid, Communication skills
Some suggestions for sources of secondary evidence are given alongside the
performance criteria later in the manual.
If anyone has used an assessment tool that has worked particularly well, please let
the Education section of the Society know for passing on to others in the pre-
registration bulletin.
An important source of evidence for internship trainees, particularly for the
professional unit, will be other people with whom the trainee has worked who can be
questioned by the assessor and asked for information. Often they will be used to
corroborate what the trainee has recorded about his/her handling of a particular
situation. When assessing against the performance criteria by seeking the opinions of
other staff, it can be useful to have a standard form on which the third party can write
a short report about the trainee's performance, known as a '1estimonial".
Testimonials should not be used to the exclusion of other types of evidence, but can
be very helpful particularly for the professional performance criteria.
Patients can also be asked for their opinions of the trainee's performance: in some
work settings, it may be possible to assign regular patients to the trainee so that s/he
can always be responsible for dealing with their needs or inquiries, provided of
course that the patients agree to this.
ii) The trainee's record of evidence
An evidence record should be created by the trainee to present to the assessor.
The principle is that the trainee should record events as they occur, even those that
occur in the tutor or trainer's absence, to provide evidence and a basis for discussion
and questioning of the trainee. This may best be done by the trainee carrying a
notebook in which to record events quickly and then transferring the notes to the
manual at a later stage (rather like the old "record of events" that some tutors may
remember).
While the trainee may not be able to make an evidence record for every single
performance criterion, s/he should be encouraged to think about how her/his working
activities can be related to the performance criteria. This will help the assessor to
build up a composite picture of the trainee's competence from not only observation
of the trainee at works, but also other types of evidence presented.
The evidence record so created can then be used in three ways:
 In discussions with the assessor to indicate competence
 To show where gaps exist and opportunities for evidence need creating, e.g. by
assignment work, specially set tasks or role plays
 By the trainee in the future to help resolve problems
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iii) The nature of evidence
For evidence to be acceptable, it must be:
 Valid and relevant to the performance criteria in question
 Sufficient to ensure confidence about competence
 Authentic, not someone else’s work
 Up-to-date, e.g. a first aid qualification
iv) How much evidence will be needed?
There is no easy answer to this since tutors' opinions are likely to vary in the way
they will be required to assess the trainees before allowing them to counsel patients
unsupervised. Professional judgement will be important here, together with the
particular characteristics of individual trainees. But the overriding principles could
be:
 The assessor must be confident about the trainee’s competence
 A one-off piece of evidence is rarely sufficient
It is of course accepted that, even with the competence-based approach, there are no
guarantees of competence all the time after registration. All the tutor can reasonably
be expected to do is to satisfy him/her that at the period of pre-registration stage the
trainee has produced enough evidence of competence to be signed onto the register.
The intended final outcome is that the internship trainee demonstrates
competence in all training elements by the end of the training period.
NB Although as an employer, the assessor may wish the trainee to demonstrate a
high level of competence, for the professional body's entrance requirement the need
is simply for the new registrant to be competent as per the standard definition of
profession of pharmacy.
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1.5.4 ASSESSMENT OF COMPETENCE
Assessment of Competence helps to decide whether the trainee is competent in a
particular area or needs further training/practice. The main difference of a
competence-based programme from a traditional experience-only programme is that
competence is required to be assessed rather than being assumed. The assessment
should have the following features:
 It should not normally confer achievement on a one-off basis alone, as the trainee
should demonstrate ability in a range of circumstances, e.g. the trainee must
dispense competently during busy times and when quiet; when the pharmacy is
short-staffed; and when the labeling personnel or machine is out of action
 It should not be based on a grading system, but on whether the trainee is or not
yet competent
Assessment should ideally be seen as separate from training because:
 During training help can be given to the trainee whereas assessment should
mimic the real life situation of needing to “go it alone”
 The trainee must not be assessed until ready i.e. until s/he has received adequate
training
1.5.4.1 So how will assessment be carried out?
In order to demonstrate competence, the trainee will have to provide evidence of
competence to the assessor (tutor or trainer). Here the onus is largely on the trainee
to provide the evidence but suitable types of evidence will be agreed with the
tutor/trainer during the planning process.
The steps in the assessment process are:
 Look at the evidence presented in relation to the performance criteria
 Decide whether the evidence points to:
a. competence
b. the need for further training, guidance or practice
1.5.4.2 Assessing by observation
Within a competence-based training programme, it is not sufficient simply to
observe the trainee informally for a judgement about his/her competence. Whilst
there is still a need for this day-to-day observation in the pre-registration programme
(especially for the professional unit), it will not be enough on its own as the basis for
assessment because it might not comprehensive and therefore not targeted to specific
performance criteria.
The following examples of questions that may be asked by tutors, and possible
answers to them, may help to clarify some of the issues concerning assessment by
observation
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Q. At what stage should I carry out an observation assessment of my trainee(s)?
A. Always trains your trainee adequately before conducting an assessment by
observation. That is, do not assess by observation until she has had sufficient training
and practice. Discuss with your trainee whether she feels ready to be assessed: most
will be happy to start the assessment process after sufficient training if they are not
made to feel intimidated. A few might have confidence problems and will need
gentle persuasion before they admit to being ready. After all, most people would not
be ready to take their driving test after only two lessons but people do vary in how
much instruction they need to become competent and feel confident.
Q. Do I have to assess at a particular pre-arranged time?
Some tutors will feel more comfortable with the approach of "during this
week/fortnight I will be assessing you against last part of training etc.
Whichever approach you choose, remember that the main thing is to structure the
assessment to ensure that all performance criteria are addressed. What must be
avoided is a vague observation over a long period of time, because usually this
means that clear targets are not identified and the trainee may be unsure of his
progress, in terms of both his good performance and his performance requiring
improvement. There is a vast difference between broad observation and vague
observation.
Q. How many performance criteria should be assessed at one time?
A. It is up to the assessor how many performance criteria are assessed at one time: it
may be appropriate to assess only a couple or a whole element. How many are
assessed at one time is not the crucial issue - what is more important is that the
assessments are structured by relating them to a set of performance criteria, i.e. the
assessor and the trainee must be clear about what is being assessed.
Q. Which performance criteria should I assess first?
A. Good approach, used by many trained assessors, is to complete a set of basic
("easy") performance criteria before tackling the more complex ones, rather than
trying to mix them in together. By checking off the simple criteria before tackling the
more difficult ones, the trainee (and assessors) will feel that something has been
achieved. Otherwise, the trainee may be demotivated by falling short of requirements
early on. There will undoubtedly be some overlap between elements when you
observe your trainee, particularly in terms of combinations of practical and
professional criteria. This may lead to a situation in which you are able to check off
some of the practical but identify areas for further development in the professional.
This is to be expected, since the professional unit constitutes more of a continuum,
punctuated by the appraisals.
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Q. Does it matter when feedback is given to my trainee(s)?
A. It is important to provide feedback to the trainee as soon as possible after the
assessment. It is best to adopt the approach of getting the trainee to assess his/her
own performance before the assessor delivers his verdict. Remember also to go from
the positive to the negative and provide constructive suggestions with any criticism.
Q. How should the assessment by observation be conducted?
A. Before assessment:
 Plan in advance with the trainee when and where the assessment will take place
 If a patient will be involved in the task being assessed, seek his/her permission
 Explain clearly to the trainee what the process will involve and which
performance criteria will be assessed. Remember to help the trainee feel less
threatened about the assessment by adopting an encouraging attitude, particularly
before the early assessments.
A. During the assessment:
 Be as discreet as possible, whilst ensuring that you can see clearly what the
trainee is doing and hear what s/he is saying. (only intervene if the trainee is
about to put him/herself or another person in jeopardy, for example by giving the
wrong advice)
 Take notes if you find this useful to aid your memory but remember that this can
be very intimidating to the trainee so if you do, explain carefully why this is to
the trainee beforehand.
A. After the assessment:
 Immediately afterwards (or as soon as possible), feedback your observations to
the trainee. It is often helpful to invite the trainee to appraise his/her own
performance as a starting point for discussion.
 Be positive in your feedback by congratulating the trainee on his/her good
performance first and then moving on to the areas needing development
 Ask questions of the trainee to fill in any gaps in performance or to check
underpinning knowledge e.g. “What would you have said to the patient if…?”Or
“How would you have handled a situation in which…?”. Make sure your
questions are under stood by the trainee and rephrase them if necessary
 Suggest ways of improving performance i.e. do not tell the trainee that a
particular aspect was not handled well without discussing strategies that could be
tried in the future
 Summarize the trainee’s achievement in terms of the performance criteria met
and those requiring further training and/or assessment
 Plan with the trainee how further training or practice will be provided and when
the next assessment will be carried out (but bear in mind that plans may need
changing later)
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 Make a record of these points on the assessment record sheet (or your own
equivalent).
1.5.4.3 Assessing the Practical Units
This is relatively easy, since they are task-based with clearly expected outcomes and
should be assessed when the trainee undertakes the relevant tasks.
1.5.4.4 Assessing the Professional Unit
This is more difficult, since professional behaviour is hard to define, even harder to
measure and to a certain extent dependent on the observer's personal opinion.
However, there are strategies that can be employed to reduce this subjectivity a little:
 The assessor should never rely on the opinion of one (usually him/her). S/he
should obtain the views of as many other people as possible who have also
worked with the trainee. This might be difficult in the in the one-to-one scenario
of a community pharmacy but even then cover pharmacists, relief managers and
others can be asked for their judgment s (such people should always be informed
beforehand of the performance criteria being assessed, rather than being asked to
give information afterwards when they may not have observed in context. See
earlier information about testimonial)
 If there is disagreement about competence between the assessor and trainee, third
party evidence should help to settle the dispute. If none is available, an
alternative strategy might be needed such as moving the trainee to a new location
for a period (the Education Division can be contacted for advice in such
circumstances)
 The assessor should be his/her experience of the behaviour and skills of other
pharmacists to decide on an acceptable standard against which to measure the
trainee’s performance
 Agree the standards expected at the start of the year and get the trainee to self-
asses throughout the year as a basis for discussions.
Whenever possible, trainees should demonstrate their competence by positive
evidence of actual activity and therefore tutors should endeavour to provide
opportunities for the necessary involvement whenever it is feasible. However, some
of the performance criteria are, by definition, demonstrated by absence of evidence
to the contrary, e.g. "A manner is demonstrated which instills confidence"
As the definition explains, this will mostly be shown by absence of contradictory
evidence since it is not possible actually to know whether the person with whom the
trainee is dealing feels confident. In such cases, the performance criterion might
serve more to highlight a problem area than to provide positive evidence of
competence.
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1.5.5 RECORDING ACHIEVEMENT
This is meant to document when the trainee has achieved competence or gained
sufficient experience in given areas. After an assessment time or period, the assessor
should make a record of whether the evidence presented demonstrated competence
or a need for further development (how this recording is done is up to the assessor,
but a specimen assessment record sheet is provided below as an example and how
such a record sheet might be completed, see the checklist :
TO KNOW THE ORGANIZATION OF THE PSZ AND OTHER RELEVANT
PHARMACEUTICAL BODIES IN ZAMBIA: THEIR LEGAL, ETHICAL
AND PROFESSIONAL ASPECTS TOWARDS THE NATIONAL HEALTH
SYSTEM:
1.1 Pharmaceutical Society of Zambia (PSZ)
1.2 Pharmaceutical Regulation Authority of Zambia (PRA)
1.3 Medical Council of Zambia (MCZ)
1.4 Drug and Enforcement Commission (DEC)
1.5 General Nursing Council (GNC)
1.6 The National Health System in Zambia
1.7 Sale and Supply of Medicines and Poisons
1.8 Professional Ethics
Once the assessor is satisfied that sufficient evidence has been presented by the
trainee to demonstrate competence against a performance criterion, or a group of
performance criteria; s/he should enter this in the column provided on the pages
facing the performance criteria as given in the example above.
Performance criteria should normally be recorded individually, but it will be
acceptable to group them together where appropriate, provided of course that the
assessor is satisfied that each criterion will be or has been addressed.
34
Date: 12/10/2005 Assessment Record Sheet Trainee Name: Mr. Y.T. Phiri
No.of Performance
criteria (p.c.) being
assessed)
How assessed D D+ C B A Not yet
achieved
Future
development.
1.1 Questioning of
trainee
A
1.2 Questioning of
trainee
Trainee needs
to present more
information to
the patient……
Trainee will
spend time
observing and
discussing with
the tutor….
1.3 Questioning of
trainee
B
1.4 Questioning of
trainee
B
1.5 Questioning of
trainee
A
1.6 Observation
and questioning
of trainee
B
1.7 Observation
and questioning
of trainee
C
1.8 Observation
and questioning
of trainee
C
% Mark Grade Number of Criteria
% Pass
85 and Above A
75 – 84 B
60 – 74 C
50 – 59 D+
49 and below D
Recording Progress
Progress with the practical elements is reported on the summary record, which
should be sent to the Education section of the PSZ with the half-year appraisal, and
with the final appraisal/declaration (Appendix 3 for CAP Form).
Progress with the professional unit will be reported on the 3-monthly appraisal
forms that will be given from PSZ education section. It is important that all trainers
and assessors are provided with copies of the appraisal form so that:
a. They are aware of what is expected of the trainee
b. They are able to make notes throughout the trainee's working time with them.
35
If there is then not the opportunity for liaison between the appraiser and other
trainers before the appraisal is done, copies of the trainers' notes and testimonials can
be used as evidence.
36
1.5.6 REVIEW AND FEEDBACK
This unit descries the discussions with the trainee on how s/he is progressing.
Sessions in which feedback is given to the trainee and progress reviewed is needed
because:
 Trainees must be given feedback to know how they are doing
 Plans may need to be changed due to altered circumstances or simply because the
trainee is unable to meet target dates
Progress with the professional unit will be reviewed and documented at each 3
monthly appraisal stage, as a minimum, and regular sessions must also be set-aside
for the review and recording of progress with the practical units. It should be
remembered PSZ intends to make it a requirement that the trainee should be to be
given time for review and discussion at least once a week, with the tutor or a trainer.
NOTES FOR THE TRAINER/TUTOR ABOUT THE CONDUCT OF THESE
SESSIONS:
i) Tutor and your trainee should:
 Look back at what has (and has not yet) been achieved
 Sum up the present position
 Agree a plan for the future, involving specific targets
ii) Remember the following golden rules:
 Plan beforehand what you want to discuss during the session, allowing time also
for your trainee to bring up points or ask questions
 Ensure that you have a time and place set aside which is:-
- Non-threatening – easy chairs are best, do not sit across a desk
- Private – there should be no interruptions
 The tutor should put the trainee at ease e.g.
- Offer a cup of tea or coffee
- Start by talking briefly about a matter not related to work
- Adopt a welcoming attitude
The tutor should enable the trainee to feel safe enough to open up, thus allowing a
more fruitful and useful discussion.
 Encourage your trainee to talk freely
 Ask open questions as much as possible, but remember to keep control by
bringing the conversation back to the point if necessary
 When giving feedback, remember to:-
37
- Discuss in relation to targets. Use the performance criteria as a guide to explain
where targets have or have not been met.
- Feedback positively in the first instance, i.e. give credit where it’s due before
talking about those areas which require improvement
- Stick to facts. Do not make assumptions
- Be constrictive when giving negative feedback, e.g. suggest alternative ways of
achieving something
- Avoid shocks or surprises. If there has been a problem, the trainee should have
been made aware of it when it occurs
- Take responsibility for any feedback you give I.e. does not hide behind
somebody else’s opinion
 Check your understanding of your trainee’s comments by summarizing and
asking if your summary is correct
 Record the main points of the review and any action plan that has been agreed.
You and your trainee should initial or sign this. The purpose is to:--
- Avoid or minimize later disagreements
- Provide a document for each party to use as a reference for future action and
review
- Provide information to pass to any new tutor or trainer about the trainee’s
progress
iii) Finally
There may be some questions in the minds of tutors, trainers and trainees as yet
unanswered. Here are a few of those raised by existing tutors:
Q. How can "real life" situations be created? The trainee may perform better
when observed than s/he would if not observed.
A. This is recognised to be a possibility, except that if the trainee is able to perform
competently, even if only "for show", then that ability must be possessed by the
trainee. The possibility of the trainee choosing not to use that ability on another
occasion may not be identified and in any case is unlikely if s/he consistently
demonstrates competence throughout the training period. Of greater concern is the
possibility of nervousness reducing performance but in most cases this improves as
the trainee gains confidence and can be helped by giving as much encouragement as
possible.
Q. Why is there so much detail in the performance criteria? Surely some of the
basics do not need to be covered since all trainees are - or will be graduates?
A. Firstly, it is important to be sure of a trainee's ability in the basics before
progressing to higher level tasks and skills, and remember that trainees vary
considerably in their previous experience.
38
Secondly, such detail may seem out-of-place for the more able trainees, but it will
help to pinpoint where trainees with problems are going wrong.
Q. What about industrial joint schemes: how will the CBTP be covered?
A. Many of the performance criteria have been written in a generic way to enable
their assessment in a variety of situations. As much as possible should be covered in
the industrial setting; the professional elements apply equally to all practice settings
and be addressed continuously. The remainder of the units should then be addressed
in the other six-month placement. Effective liaison between tutors in the two
placements will be needed and thorough completion of documentation
by the first tutor should facilitate the transfer of information to the second tutor.
It is up to the Trainers to decide for themselves whether the assessment by the tutor
is sufficient or whether s/he wishes to conduct a second assessment of competence
before signing the trainee onto the register. This may especially be the case for
rotational sessions during their training.
1.5.6.1 The Professional Unit
A. Demonstrate a Professional Approach
B. Communicate Effectively
C. Work Effectively as Part of a Team
D. Undertake Personal and Professional Development
A. Demonstrate a Professional Approach
This element will be concerned with the trainee demonstrating the application of
professional standards across all aspects of practice.
 Actions and attitudes should be demonstrated which indicate a commitment to
quality of pharmaceutical care of the patient.
 A polite and helpful manner will be demonstrated.
 A manner is demonstrated which instills confidence.
 Standards of personal behaviour meet the requirements of the organisation.
 Reliability is demonstrated.
 Initiative is demonstrated when it is warranted.
 Recognition of personal limitations is demonstrated.
 Work is carried out in an organised manner and with attention to detail so that the
desired result is achieved.
 Work is prioritized effectively.
 Tasks are pursued to completion and within agreed time limits (unless overriding
circumstances make this impossible).
 Problems or potential problems should be identified and appropriate corrective
action taken or solution found
 New situations are responded to with flexibility and willingness
 Stressful situations are handled without undue agitation
39
 Decisions are made which demonstrate the ability to think clearly and logically
and to use discretion
 Tasks and situations are approached with due regard to legal implications and
health organizational policy
 Appropriate equipment at hand is used effectively
 The safety of the working area is maintained at all times so that the health and
safety of the health colleagues and the public at large is not compromised
 The security of the premises is also upheld at all times
When performance criteria are hard to define or measure a useful tool is to agree the
standards expected at the start of the year with the trainee? The trainee can then carry
out self-assessment through the year as a basis for discussion before assessment by
the tutor/trainer. For the whole professional unit, testimonials (spoken or written)
from other staff and patients are vital to provide evidence and reduce subjectivity.
B. Communicate Effectively
This element will be concerned with the trainee's ability to communicate effectively
across the full range of interpersonal transactions.
 A sufficient command of the English Language is demonstrated.
 The speaker is listened to with attention and without being interrupted
unnecessarily.
 Conversations (in person or over the telephone) are conducted in a manner,
which demonstrates due regard to confidentiality and the feelings of the other
person.
 Questioning is used effectively to elicit necessary information and increase
understanding.
 Responses in conversation are helpful and clear.
 Responses and statements are spoken with an appropriate degree of confidence.
 Body language is appropriate to the situation.
 Clear, concise and well-structured written material is provided when required.
 All responses (whether spoken or written) are. Tailored to the needs of the
recipient.
 A clear polite and helpful telephone manner is demonstrated
 Complaints or demands are responded in a polite manner
 An appropriately assertive manner is used when unreasonable demands or
complaints are made
40
C. Work Effectively as Part of a Team
This element will be concerned with the trainee's ability to work effectively with
colleagues.
 A manner is demonstrated which indicates that due respect is given to the ideas
and opinions of colleagues.
 Promises and undertakings to colleagues are honoured unless circumstances
make this impossible.
 If promises and undertakings are not honoured, the reasons are explained clearly.
 Advice and criticisms are offered to colleagues in a manner unlikely to cause
offence.
 The involvement of colleagues is enlisted tactfully whenever the need to ensure
efficiency of service dictates.
 Constructive criticism is received in a positive manner.
 Suitable actions are taken to prevent or resolve conflicts with colleagues,
managers or other work contacts.
 Staffs that will require training in specific tasks are shown what to do in a
helpful, clear and positive manner.
 Feedback and further guidance to staff so trained is given in a constructive
manner.
D. Undertake Personal and Professional Development
This element will be concerned with the trainee's ability to use self-evaluation and
feedback from others to develop both personally and professionally. The meeting of
these performance criteria will indicate that the trainee is able to conduct self-audit.
 The ability to self-evaluate and reflect on experiences is demonstrated.
 Feedback on performance is used effectively to improve competence.
 The ability to accept responsibility for meeting own development needs and
achieving targets is demonstrated.
 A commitment to continuing education is demonstrated.
Knowledge Base for the Professional Unit
The underpinning knowledge required for this unit is contained in the Registration
Examination Syllabus plus the following:
 The role of:
- The registered pharmacist in the main areas of practice
- Pharmaceutical facilitators and advisers/Health Boards advisers
- Community services pharmacists
- Supervising pharmacists
- Pre-registration tutor or trainers supervisors
41
- Pharmacy Postgraduate Education and professional development
- Branch Secretaries and Chairmen
 Use of English, spoken and written
 Theories of communication, including the use of body language
 Local organizational policies and policies and procedures (i.e. the
policies/procedures applying in the premises in which the trainee undertakes pre-
registration training)
1.5.6.2 Practical Units
Unit 1: Provide an Effective Service for the Supply of Treatments to Patients
Unit 2: Provide an Advisory and Guidance Service
Unit 3: provide care and/or advice in response to the need for emergency or first aid
Unit 1:Provide an Effective Service for the Supply of Treatments to Patients
This unit is concerned with the trainee's ability to supply accurately and efficiently
against prescriptions; all treatments required by patients i.e. medicines, dressings and
appliances, together with associated information/support. This process encompasses
all functions from receipt of the prescription through to the supply of the item(s) and
any necessary post-supply procedures. All aspects of the process require professional
judgement and responsibility to be exercised.
Throughout this unit, the term "prescription" should be taken to encompass also
signed orders and other legitimate requests for supplies of medicines and relevant
pharmaceutical products. The terms "local procedures" and "local policies" are used
throughout to mean the set procedures and policies at the premises in which the
trainee is receiving training.
Note:
All work performance requires a sound foundation of competence in basic tasks and
therefore achievement of the basic performance criteria should not be assumed but
checked before progressing to the more complex performance aspects.
Element 1.1 Receive the Prescription
This element will be concerned with ensuring that the trainee effectively uses the
stage of receiving the prescription to benefit both the patient and the person who will
be dispensing it.
 The patient's particulars are confirmed to ensure they are correctly entered on the
prescription.
 Procedures relating to charges, exemptions and issue of receipts are followed
correctly.
 Correct and helpful information relating to prescription collection is given to
patient or patient's representative.
42
 Problems relating to the prescription at this stage are resolved as soon, as is
reasonably possible.
Element 1.2 Assess Dispense the Prescription
This element will be concerned with the trainee's ability to adequately and
effectively interpret, assess, dispense and check prescriptions for the full range of
treatments supplied: medicines, dressings and appliances.
 Initial screening and interpretation of the prescription is carried out thoroughly.
 The prescription is assessed adequately and problems correctly identified.
 Patient medication histories are used effectively, when available, in the
assessment of prescriptions.
 Problems are resolved by appropriate action as quickly as possible.
 Any necessary calculations are performed accurately.
 The correct product is extracted from the stocks for each item being dispensed.
 All items are packed and labeled correctly.
 An effective self-checking mechanism is employed to identify own dispensing
errors.
 Errors so identified are adequately rectified as soon as possible
 All required quality assurance procedures are followed during the dispensing
process
 The process is carried out without unnecessary delay
 Effective checking of others is carried out when appropriate
Element 1.3 Prepare Pharmaceutical Products
This element will be concerned with the trainee's ability to prepare accurately any
medicine prepared by the combination of ingredients, whether extemporaneously in
the pharmacy or in hospital and industrial manufacturing units.
 An initial formulation for the product is established and modified suitably if
necessary, according to accepted practice.
 Calculations are carried out accurately.
 Suitable equipment for the preparation process is selected and used correctly.
 Ingredients are selected, weighed and measured accurately.
 Ingredients are mixed in the correct order and with the correct technique.
 The product is packed and labeled correctly.
 The correct expiry date and storage conditions are assigned to the finished
product.
 The correct batch number and product licence numbers are assigned to the
finished product, when necessary.
 All necessary quality assurance procedures are followed throughout the process.
 Any required documentation is completed correctly, thoroughly and at the right
time.
43
Element 1.4 Present Dispensed Items to Patient or Patient’s Representative
This element will be concerned only with the presentation of dispensed items to
patients or their representatives. For competence in communication and the giving of
advice generally, refer to Professional Element Band Practical Unit 2.
 The identity of the person collecting the dispensed item(s) is adequately
confirmed before any item is issued.
 Correct and clear advice on use of the item(s) is given.
 Factors likely to affect patient compliance are adequately recognised and suitably
addressed.
 Questions are accurately and clearly answered or referred if necessary.
 Oral advice is adequately supplemented by written information and/or
demonstration when necessary.
 Helpful and accurate information is given about appropriate courses of future
action for the patient.
Element 1.5 Maintain Stock at the Premises
In those premises where stock ordering will be initiated by the dispensers and/or
clerical staff, the trainee will be expected to demonstrate acquired competence in
these performance criteria to demonstrate a good understanding of the underlying
principles for possible future practice needs.
 Depleted stock is replenished from store where possible or re-ordered according
to local procedures and policies to maintain optimum levels.
 Any need for items to be obtained specially or urgently is recognised and is acted
upon to obtain supplies without delay and according to local procedures.
 Due regard for adequate stock rotation is demonstrated
 Incoming stock is checked thoroughly against documentation.
 Discrepancies or damages in incoming stock are identified and local procedures
for dealing with these are correctly followed.
 Stock is put away tidily and with due regard to storage requirements.
 Delivery notes, invoices and credit notes are processed correctly, according to
local procedures.
 Stock checks are carried out thoroughly and unwanted stock dealt with correctly.
 Items returned are dealt with correctly according to local and legal requirements.
Element 1.6 Complete and Process Documentation
This element will be concerned with ensuring that the trainee pays due attention to
the whole supply process by properly completing any administrative procedures.
 Prescriptions or orders are endorsed clearly and correctly according to local
hospital requirements.
 All required records are completed as soon, as is reasonably possible.
44
 Completed prescriptions are processed and assembled according to requirement
of the local health facility procedures.
Unit 2:Provide an Advisory and Guidance Service
This unit will be concerned with the trainee's ability to provide advice to any person
requiring it, be they patients in the community or in hospital, members of the public,
other health care workers or colleagues. The unit should be assessed with cross-
reference to professional element B.
Element 2.1 Provide advice and Guidance to People Requiring Assistance
 A person’s need for assistance – whether overt or covert – is recognised
 The exact nature of the need is carefully established
 Suitable advice and factually correct information is given in relation to drug
treatment
 Accurate and up-to-date advice for the non-drug management of health is given
when the need or opportunity arises.
 Advice is delivered clearly and concisely
 Advice is given in an acceptable manner and only when it is appropriate to do so.
 The recipient is encouraged to ask questions if need be to improve understanding
 Referral is made to the correct person/body when it arises
Element 2.2 Use Information Source to Answer Queries
This element will be concerned with the use of information sources to answer queries
or give advice in the course of carrying out normal day-to-day duties. Specialised
information services are likely to be dealt with separately in the hospital and
industrial experience sections.
 The most appropriate source is used to obtain information.
 Correct information, which adequately answers the query, is extracted from the
source and delivered to the Enquirer.
 After use, text-based reference sources are replaced, and reorganised if
necessary, to ensure ease of access in the future.
NOTE: Knowledge Base for Units 1 and 2 are contained within Registration
Examination Syllabus
Unit 3:provide care and/or advice in response to the need for emergency or first
aid
This unit is not a competence unit as such, since it is not possible to be sure that a
person will be competent in these activities. However, it is a required training unit
for the Society's pre-registration programme and a declaration of completion must be
provided at - or before - the time of applying for registration.
This unit will be concerned with the trainee's ability to provide first-line treatment or
45
advice when an accident or condition causes a person to require emergency help or
first aid. It is included in the core competence in recognition of the public's
expectation that pharmacists can be able to provide advice and/or care in such
situations, irrespective of the pharmacist's type of day-to-day practice i.e. whilst it is
community pharmacists who are most commonly approached for such advice or
help, any "off-duty" pharmacist might be called upon by friends, relatives or
neighbours to provide first-line assistance. It is in the interests of the public and the
profession for entrants to the pharmaceutical register to be equipped with the skills
and knowledge needed to meet this expectation.
The "range" with each element describes the range of conditions to be covered: it is
not a comprehensive list of all situations, which might arise but a list of those most
commonly occurring.
The majority of this unit will best be covered by the trainee attending a course
provided by a first aid organisation or other appropriate person or body e.g. a clinics
although some of its content could be covered in-house if desired and possible. The
task of finding a suitable course could be given to the trainee to do as a small
assignment and this might provide evidence for other performance. Fill any training
gaps "in-house" i.e. any parts of the range not covered on the training course. For
example, the course may not inform the trainee about how to deal with bites and
stings, so the tutor (or a trainer) will need to do this. Current first aid qualifications
held by trainees should be investigated for content and any gaps covered.
Element 3.1 Respond to medical emergencies
In this element, the trainee will be expected to demonstrate sufficient awareness of
life-saving techniques and underpinning knowledge to respond effectively when a
person's life is put at risk by an accident or medical condition (as specified in the
range below). The trainee should demonstrate the ability to determine, and
differentiate between, appropriate courses of action according to the situation i.e.
whether to:
A. Call for help from an appropriate person or organisation and/or
B. Administer first-line treatment or provide help to the casualty.
i) Performance Criteria:
 The situation is assessed correctly and the safety of all those in the immediate
vicinity of the accident ensured before proceeding.
 The nature of the casualty's problem is identified correctly.
 Appropriate emergency treatment is given without delay, without risk to the
person giving treatment and with regard to legal limitations.
 The casualty is referred or taken to the appropriate person/agency for follow-up
treatment.
 Accidents at work are reported and recorded in accordance with set procedures,
when applicable.
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2004 internship training manual 2004 - 2010 for psz

  • 1. The Pharmaceutical Society of Zambia Pre-Registration Training Manual for Pharmacy Tutors and Internee Pharmacists 2004 - 2010 Developed by: Pharmaceutical Society of Zambia Continuing Pharmaceutical Education & Development Committee (CPEDC) February 2004 Prepared & Compiled by CPEDC Chair: Lungwani T.M. Muungo: DipPharm, BScPharm, MPhil, PhD, MPharmSZ
  • 2. 2 Table of Contents Acronyms.........................................................................................................................................5 Acknowledgments............................................................................................................................6 Preface .............................................................................................................................................7 I. GENERAL AND PROCEDURAL REQUIREMENTS FOR INTERNSHIP AND EXAMINATIONS ...........................................................................................................................8 1. General Information..................................................................................................................8 2. Conditions of Admission to internship training and examination................................................8 3. Dates and Venue of Examinations.............................................................................................9 4. Entry and re-entry to examinations.......................................................................................... 10 5. Conduct of the Examinations................................................................................................... 10 6. Notification of Results ............................................................................................................ 10 7. Appeals Procedure.................................................................................................................. 10 Chapter 1........................................................................................................................................ 11 1.0 INTERNSHIP TRAINING PROGRAMME .............................................................................. 11 1.1 Introduction .......................................................................................................................... 11 1.2 CORE COMPONENT: ......................................................................................................... 13 1.3 SECTORAL COMPONENT:................................................................................................ 13 1.4 THE SOCIETY – RECOGNISED INTERNSHIP TRAINING TEAM................................... 14 1.4.1 TUTORS........................................................................................................................ 14 1.4.2 THE TRAINERS............................................................................................................ 15 1.4.3 MENTORS........................................................................................................................ 15 1.4.4 OTHERS (TEACHERS/INSTRUCTORS)...................................................................... 15 1.4.5 THE INTERNSHIP TRAINEE....................................................................................... 15 1.5 THE TASKS OF EACH TUTOR AND/OR TRAINER(S):.................................................... 17 1.5.1. PLANNING.................................................................................................................. 17 1.5.2 INITIAL ASSESSMENT ............................................................................................... 18 1.5.3 TRAINING.................................................................................................................... 19 1.5.3.7 Providing Feedback......................................................................................................... 21 So - what is Competence?............................................................................................................... 23 1.5.3.10.3 Training for Assessment.......................................................................................... 24 1.5.3.10.4 Proposed Format of the Internship Competence-Based Programme.......................... 25 1.5.4 ASSESSMENT OF COMPETENCE........................................................................ 29 1.5.5 RECORDING ACHIEVEMENT.................................................................................... 33 1.5.6 REVIEW AND FEEDBACK.......................................................................................... 36 Chapter 2........................................................................................................................................ 48 INTERNSHIP TRAINING FOR PHARMACY GRADUATES FROM RECOGNIZED UNIVERSITY DEGREE PROGRAM ........................................................................................ 48 1.0 THE PSZ AND OTHER RELEVANT PHARMACEUTICAL BODIES IN ZAMBIA: THEIR LEGAL, ETHICAL AND PROFESSIONAL ASPECTS TOWARDS THE NATIONAL HEALTH SYSTEM.................................................................................................................................... 50 1.1 Pharmaceutical Society of Zambia (PSZ)........................................................................... 50 1.2 Pharmaceutical Regulatory Authority and the Board in Zambia.......................................... 50 1.3 Medical Council of Zambia ............................................................................................... 50 1.4 The National Health System in Zambia.............................................................................. 50 1.5 Sale and Supply of Medicines and Poisons......................................................................... 51 1.6 Professional Ethics........................................................................................................... 51 2.0 THE BASIS OF RESPONDING TO SYMPTOMS INCLUDING THE MAJOR CATEGORIES OF SYMPTOMS AND THE APPROPRIATE RESPONSES FOR A PHARMACIST .......................................................................................................................... 52 2.1 The styles of questioning................................................................................................... 52 2.2 Differentiation of symptoms, advice and referral when possible ......................................... 52 2.2.9 The Eye ............................................................................................................................. 58 3.0 PHARMACOLOGICAL AND THERAPEUTIC ASPECTS OF THE PROVISION OF A PHARMACEUTICAL SERVICE INCLUDING THE SALE AND SUPPLY OF MEDICINES
  • 3. 3 AND DISPENSING, WITH PARTICULAR REFERENCE TO MAJOR ADVERSE REACTIONS, INTERACTIONS AND CONTRA-INDICATIONS............................................. 60 3.1 Reading and Interpreting Prescriptions............................................................................... 60 3.2 Therapeutic Knowledge Base ............................................................................................ 60 3.3 Drug Action, Absorption, Distribution, Metabolism and Elimination *** ........................... 61 3.4 Drug Interactions............................................................................................................... 62 3.5 Adverse Drug Reactions and Side Effects .......................................................................... 62 3.6 Contra-indications............................................................................................................. 63 5.0 THE ADVISORY ASPECTS OF A PHARMACEUTICAL SERVICE.................................. 66 5.1 Advice to Patients and Careers: ......................................................................................... 66 5.2 Advice to Medical and Other Health Care Professionals..................................................... 67 5.3 Advice to members of the public ....................................................................................... 67 6.0 PHYSICAL PHARMACEUTICAL ASPECTS OF COMPOUNDING AND ................... 69 6.1 Extemporaneous Dispensing Methods................................................................................ 69 6.2 Bulk Manufacturing .......................................................................................................... 70 6.3. Raw Materials, Active Ingredients and Finished Products.................................................. 70 6.4 Excipients ......................................................................................................................... 71 6.5 Stability and Storage ......................................................................................................... 71 6.6 Packaging ......................................................................................................................... 71 6.7 Labeling............................................................................................................................ 72 6.8 Good Dispensing Practice.................................................................................................. 72 6.9 Good Manufacturing Practice ............................................................................................ 72 7.0 THE PRINCIPLES OF PROCUREMENT, STORAGE, AND STOCK CONTROL OF MEDICINES.............................................................................................................................. 73 7.1 Procurement...................................................................................................................... 73 7.2 Wholesaling...................................................................................................................... 73 7.3 Storage.............................................................................................................................. 73 7.4 Stock Control.................................................................................................................... 73 Chapter 3........................................................................................................................................ 75 3.0 THE SECTORAL WORK EXPERIENCE PROGRAMME ................................................... 75 3.1 Internship Work Experience for Trainees in Community Practice....................................... 75 3.2. Internship Work Experience for Trainees in Hospital Practice .......................................... 85 3.3. Pre-registration Work Experience for Trainees in Industrial Establishments....................... 94 2. Responsibilities of the “Qualified Person” ............................................................................... 94 3. Development of sterile and non-sterile preparations, including:............................................ 95 4. The principles and practice of Good Manufacturing and Good Laboratory Practice .............. 95 5. Manufacture of sterile and non-sterile preparations, including:-............................................ 95 6. Quality Control of sterile and non-sterile preparations, including:- ....................................... 95 7. Regulatory requirements pertaining to the conduct of clinical trials and the licensing of products.................................................................................................................................. 96 8. Clinical Trial Supplies, including:........................................................................................ 96 9. Provision if information....................................................................................................... 96 Chapter 4........................................................................................................................................ 97 4.0 The End of internship and Registration Examination.............................................................. 97 4.1 The Registration Examination ............................................................................................ 97 Appendix 1................................................................................................................................... 131 Internship Training in Zambia for Pharmacy Degree Certificate Graduates ................................ 131 Appendix 2................................................................................................................................... 133 TUTORS’ LIST FOR PRE-REGISTRATION TRAINING ....................................................... 133 Appendix 3................................................................................................................................... 135 CONTINUOS ASSESSMENT PERFORMANCE CRITERIA FORM....................................... 135 (CAP FORM)........................................................................................................................... 135 Appendix 4................................................................................................................................... 141 CHECKLIST FOR REGISTRATION AS A PHARMACIST .................................................... 141 Appendix 5................................................................................................................................... 146 RESULTS STATEMENT FORM / RSF FORM........................................................................ 146
  • 5. 5 Acronyms ADR Adverse Drug Reation AIDS Acquired Immuno-disease syndrome BNF British National Formulary CBTP Competence Based Training Programme DEC Drug Enforcement Commission CBoH Central Board of Health GLP Good Laboratory Practice GMP Good Manufacturing Practice GNC General Nursing Council HIV Human Immune Virus MSH Management Sciences for Health MCZ Medical Council of Zambia NGO Non-Governmental Organization NSRC National Scientific Research Council OTC Over the counter PMR Patient Medical Record PRA Pharmaceutical Regulatory Authority PSZ Pharmaceutical Society of Zambia QC Quality Control QA Quality Assurance TB Tuberculosis TNP Total Parenteral Nutrition UTH University Teaching Hospital ZNF Zambia National Formulary
  • 6. 6 Acknowledgments The Pharmaceutical Society of Zambia thanks the Medical Council of Zambia for its partnership and confidence in the Society’s professional development. The Council through its statutory powers delegated the Society to develop a structural experiential learning of internee pharmacist. Special thanks to Ministry of Health and Central Board of health for their guidance and leadership. The Society also thanks United States Agency for International Development for their financial support through the Management Sciences for Health’s Rational Pharmaceutical Management Project. We are thankful for the RPM Plus technical support and effort to develop and implementation of the Pre-registration program. The University of Zambia Pharmacy Department will always have a special place and thank you for academic leadership. Lastly but not the least we thank the individual contributors to the manual Dr Lungwani T. M. Muungo, National Co-ordinator for Continuing Education Section for the Pharmaceutical Society of Zambia and Head of Pharmacy Department at UNZA; Oliver Hazemba, The President of Pharmaceutical Society of Zambia, Caroline Lweendo Yeta, Pharmacy Specialist, Velepi Mtonga, Acting Director General from Central Board of Health for their support. All the tutors for internee pharmacist contributed to significant development and changes to this document. We thank you for your continued support, undeservedly contribution to pharmacy education. We also acknowledge the early involvement of the Robert Gordon University academic staff (Dereck Chapman, Brian Arris, Barry Melia and Catherine Stevenson) that participated in the collaboration relationship with the new Department of Pharmacy, at the University of Zambia. The visiting staff contributed in both information and technical transfer process. They advised on the gradual and professional process to introduce the new graduates from the department of pharmacy training programme into the professional practice of pharmacy in the country. Hence the establishment of the structured pre-registration training process for the country.
  • 7. 7 Foreword Post academic apprenticeship pharmacy education is meant to prepare graduates into professional practice. The process was designed to expose the newly qualified pharmaceutical professionals to both industrial and clinical areas of pharmacy practice, hence involvement of retail, industrial and hospital pharmacy. The whole process will be organized through the following organs: 1. Medical Council of Zambia will provide the means to provisionally recognize the graduates while undertaking the apprentice training 2. The Ministry of Health as a government department to monitor the provision of pharmaceutical care by the internee pharmacists 3. The pharmaceutical Society as the initiators and implementers of the structured training programme through the indentified and trained tutor pharmacists. The ministry will also engage the internee pharmacists on temporary employment for their participation to provide the pharmaceutical care services during the course of training. The training offers mutual benefits both to the trainees and the ministry of health. The trainees benefit through acquiring necessary professional skills as required for the full registered personnel while the ministry has easy and quick access to the trained pharmaceutical personnel in comparatively large number to cater for a wider area of operations in the country’s health sector
  • 8. 8 I. GENERAL AND PROCEDURAL REQUIREMENTS FOR INTERNSHIP AND EXAMINATIONS 1. General Information 1.1 The internship examination is one of the requirements jointly agreed by Medical Council of Zambia and Pharmaceutical Society of Zambia as a way of recognizing the full registration of anyone intending to practice as pharmacist in Zambia 1.2 No person that applies for full registration and commenced internship training on or after 17th June, 2004 should be allowed to register and work as a pharmacist unless that applicant has passed the internship examination. 1.3 The training will be structured as required by the registering bodies 1.4 The training will be reviewed and approved on regular basis through The Pharmaceutical Society of Zambia, educational section 1.5 The applicant will be expected to register provisionally with MCZ for at least ONE year prior commencing practical internship training and subsequently passing the internship examination before full registration as a pharmacist. 2. Conditions of Admission to internship training and examination 2.1 Personal details: - Approved undergraduate degree training program in pharmacy - Certificate of Oath taking by the approved process. The time of taking the Oath will depend on place of training for the primary degree certificate. Those locally trained will take their Oath immediately after induction ceremony by the School of Medicine while those from abroad will take theirs individually as the case may entail. - A letter of offer of internship training from the recommended institutions ( Hospitals, Retail Chemists, Pharmaceutical industries) to the Medical Council of Zambia. - Legal mandate from Medical Council of Zambia to undertake internship training by providing the applicant with either provisional or temporary registration for the local or abroad training respectively. - Secured a trained and approved supervising Tutor Pharmacist (Appendix 2) - Satisfactory completion of at least 44 weeks of internship training for the first entry (Appendix 3) - The Tutor will be guided by the training checklist to ensure that the trainee would successfully and exhaustively complete the training (Appendix 4) - Minimum of 24 weeks waiting time for re-sitting examination. 2.2. Eligibility to sit for first entry registration examination (that lapses after ONE year of first attempt Examination) - Successfully completed a four years degree program from the School of Medicine, University of Zambia or an equivalent degree (photocopy of the degree certificate)
  • 9. 9 - Has legal mandate from Medical Council of Zambia to have undertaken internship training by being either provisionary or temporary registered as the circumstance may be appropriate for at least ONE year (Assigned a registration number – see the registration certificate) - Has successfully undertaken a comprehensive and supervised practical training by the trained and approved tutors (See the Tutors list). - The tutor(s) has affirmed that the applicant has undergone such training and that can proceed to write an end of internship training examination (Appendix 3). - The intention to write an examination has been notified to Pharmaceutical Society of Zambia education section at least ONE month prior to the designated examination date by the internee pharmacists in agreement with supervising tutors ( either using the continuos assessment performance criteria form - CAP form or letter writing by the supervising tutors to education section of PSZ) - Has undertaken such a comprehensive and supervised practical training at recommended and approved sites (Appendix 1) - The only allowed examination number to be quoted on examination documents will be either Temporary or Provisional number assigned by Medical Council of Zambia (reference to provisional/temporary registration certificates). - The internship pharmacist has made a nominal examination fee payments and non-refundable that will be ploughed back into examination logistical arrangements. - The applicants that fail first time attempt will be eligible to re-enter the examination within 6 months without undergoing practical training but will be required to make prescribed examination fee payments each time of attempting an examination. - The applicants that fail second time attempt will be eligible to re-enter the examination only on satisfactory completion of a further 6 months period of supervised at any of the recommended practical training sites. - The applicants that fail third time attempt will be eligible to re-enter the examination only on satisfactory completion of a further 12 months period of supervised at any of the recommended practical training sites. - Any subsequent failure will attract extensive interviews on the parts of the applicant and the previous supervisors to establish the actual problem and decide on the next course of action. That may be either discontinued process of registration as a pharmacist in Zambia or recommend a new process of training that may start from academic training through to the internship stages. 3. Dates and Venue of Examinations 3.1 Two examinations each year: - Main Examination will be held between 1st April and 15th June, inclusive, in each year - Supplementary Examination will be held between 1st and 16th December inclusive, in each year. - Exact dates for both examinations will be communicated to the applicants through their approved tutors by the Pharmaceutical Society of Zambia at the earliest possible time.
  • 10. 10 3.2 For now, there will be TWO venues for the examinations in Zambia: - Lusaka province venue - Copperbelt province venue - The supplementary examination could be held either at one or both of the two provinces depending on the circumstances. 4. Entry and re-entry to examinations 3.3 Time of notice for the intention to write in each case will be 4 weeks. 3.4 Special arrangements required may be available to those applicants that may genuinely require such. 5. Conduct of the Examinations - Normal standards of examinations will apply – Starting time, during the examinations and Ending time (See the examination sample papers). - The candidates will provide themselves with the materials and documents that will be needed for the examinations – reference books for open book examinations, pencils, pens, erasers, and any other items that may be specified by the PSZ for the examinations. - Examination scripts are the property of PSZ and not the examination centers - No electronic or any other devices that may assist in communication among the examination candidates will be allowed on the candidates or writing desks during the examinations. 6. Notification of Results - Officially will be notified to the individual applicant by the committee of examiners under PSZ (Appendix 5). - PSZ will advise the Registrar of MCZ of the applicant’s performance and recommendations for transfer to full Register of Pharmacists (Appendix 6). 7. Appeals Procedure - Candidates participating in the examinations will be allowed to appeal against their unexpected outcome of the results to the National co-ordinator for continuing education section of PSZ - The appeals will be attended to when made within 21 working days after the results have been officially released to the applicants. - The examinations committee will be expected to dispose of the appeal cases within the period of 60 working days from the receipt or date of each appeal.
  • 11. 11 Chapter 1 1.0 INTERNSHIP TRAINING PROGRAMME 1.1 Introduction The Pharmaceutical Act of 2004, of the Zambian laws provides that the pharmaceuticals to the public should only be supplied from a recognised pharmaceutical outlet directly under the management / supervision / control of a registered pharmacist. By definition, ‘Registered Pharmacist’ means a person registered as a pharmacist under the Medical and Allied Professional Act. The regulations of this Act provides that such a registered health professional (practitioner) must be in possession of a primary degree in pharmacy and will have made a formal application to either ‘Provisional’ or ‘Temporary’ registration for maximum period of TWO (2) years dependent on the primary degree training. The localised undergraduate degree program in pharmacy started in 2001. Effectively, this became a standard measure for pharmacy degree training for those that intend to work as pharmacists in Zambia. The training is housed in the department of pharmacy, located in Clinic 2 of University Teaching Hospital (UTH) under the School of Medicine. The outcomes of this training are the graduates with a degree certificate, which is one the required document for admission into the internship training for full registration. The period of degree training has been designed to take as the following forms dependent on the pre-requisite qualifications: 1. Four (4) years at the School of Medicine for those students from the Main stream Campus (School of Natural Sciences). 2. Four (4) years at the School of Medicine for those students with varied relevant qualifying documents (degree certificates from health related fields, preferably in biological and chemistry studies, ‘A’ level certificates). 3. Three (3) years at the School of Medicine for those students coming from the health service facilities with diploma certificates in pharmacy technology. These students may take an assessment examination prior to the start of the first semester of the third year of the program at the Ridgeway campus. 4. The trained applicant will have followed a full-time training program as for that of UNZA. 5. The degree certificates have been designed and issued by the training institution as BPharm degree certificate like for UNZA. 6. Those with foreign degree certificates will be expected to have a minimum of Bachelors Degree in Pharmacy ONLY – BScPharm; BPharm; MPharm; PharmD (Doctor of Pharmacy) and will have satisfied an adjudicating process
  • 12. 12 undertaken by the School of Medicine through the Department of Pharmacy for Registering body of Zambia. 7. The above qualifications may be allowed or assessed (Future Development) to be registered onto the Specialists Register provided they are accompanied by corresponding and recognized postgraduate training at the minimum of Masters degree certification (with a dissertation) in the following fields of pharmacy practice: Clinical Pharmacy; Industrial Pharmacy and in academia in any of the Core Subject Fields (Sources and Chemistry of Drugs, Scientific Basis of Therapeutics; Drug Dosage Form & Formulation and Pharmacy Practice) for pharmacy education 8. The following degree programmes will not be assessed as primary entry qualifications for pharmacists’ professional registration: Bachelors Degree in Chemistry, Biology, Pharmacology, Pharmaceutical Sciences, Pharmaceutical Technology, Human Medicine, Veterinary Medicine, Herbal Medicine and Diploma in Pharmacy or any pharmaceutical sound-related training disciplines. 9. However, for the future developments, the following may be allowed to register as Industrial Pharmacists ONLY if the registering body establishes such registers for the Bachelor of Science in Pharmaceutical Sciences, Pharmacoeconomics and Pharmaceutical Technology or as assessed and qualified by the pharmaceutical expert committee of the PSZ The undergraduate degree program in pharmacy was introduced in Zambia for the first time, through the School of Medicine, in 2001. Effectively, the enrolled students for the program started attending lectures on the 1st of May in the same year. Also effectively, from May 2001, the new department of pharmacy was born and located in Clinic 2 of University Teaching Hospital (UTH) that included both academic and service units for hospital pharmaceutical services. The internship trainees must undertake and complete satisfactorily the whole length of internship before becoming eligible to register as pharmacists. Below is a summary of the material covered at seminars for internship tutors. The internship programme is intended to take the newly graduated students through a process of development to a point at which they are able to function as an independent and individual professional practitioner. This developmental process should allow the trainee objectively to:  Develop the skills required in the professional practice  Develop the ability to transfer skills and concepts to new situations  Apply knowledge gained during academic studies  Gain new knowledge relating to practice These objectives can only be achieved if the trainee is actively involved in real-life tasks and situations in addition to receiving information and being given the
  • 13. 13 opportunity to observe others. Adequate self-evaluation and feedback must accompany such experience on performance, which the trainee should then use to improve future performance. The Pharmaceutical Society's requirements for internship training and experience will comprise the following components 1.2 CORE COMPONENT: This will be expressed as Competence Based Training Programme (CBTP) that will require the tutors/teachers/instructors to ASSESS the trainee pharmacists of their competence in the areas deemed vital for the profession of pharmacy (GENERIC ASPECTS). The end of internship training and professional examination (Internship examination) will complement CBTP. It will be upon successful completion of the internship training year, full written recommendation from the tutor and passing of the examination for the trainee to be put on full register of qualified pharmacists. 1.3 SECTORAL COMPONENT: List of pharmaceutical sectors that the trainees will be exposed to during their pre- registration training, though not exhaustive, has been attached (Appendix 1). All those involved in internship training can make a major contribution to the profession but can only do so effectively with adequate commitment to the process (Appendix for tutors).
  • 14. 14 1.4 THE SOCIETY – RECOGNISED INTERNSHIP TRAINING TEAM 1.4.1 TUTORS For purposes of internship training, the Pharmaceutical Society of Zambia will require every set of premises approved for training to have at least one recognised Tutor that will have responsibility for:  Ensuring that pre-registration training is carried out according to the Society’s prescribed procedures.  Co-ordination training at the premises  Acting as a liaison person with the Society’s training section  Undertaking evaluation of training provision at the premises to ensure that it is improved when possible  Make the required final recommendation for the trainee’s fitness to be a registered pharmacist Because of these responsibilities, the registering authority will be required to demand that each tutor should be:  Engaged in a full-time job or employment  A full registered and paid up pharmacist for at least not less than one year  Have been working in that employment he/she is applying from for the tutoring position  Has been an active participant of continuing education programs By setting these criteria, the Society seeks to ensure that the Trainer Pharmacist has sufficient availability, experience and professional commitment to act as a pre- registration tutor. In addition, the tutor has the considerable responsibility of ensuring that trainees gain the most out of their pre-registration year and thus, indirectly, that the profession gains the most from its newly-registered members. The tutor fulfilling the following functions will achieve this:  Acting as good role model for the trainee(s)  Serving as a learning resource for the trainee by being available all the time to answer and solve the difficulty situations the trainee might encounter  Have sufficient awareness and understanding of the pre-registration programme  Provide continuity for the trainees  Act as a mentor when working with the trainee
  • 15. 15 1.4.2 THE TRAINERS A Trainer will be any person other than the tutor who supervises the trainee during a particular part of the programme and is usually, but not always, a pharmacist operating normally on training site away from usual place that may have added advantage towards the training of the internship pharmacist. Examples of trainers are supervising, shop managers that are non pharmaceutical professionals, section heads in community pharmacy and section heads in hospital or industrial premises e.g. technologists, nurses, medical doctors etc. Like the tutor, the trainer should: Be a good role model for the trainee Serve as a learning resource and Act as mentor to the trainee during their time of working together (unless a mentor is allocated to trainees separately – see below) 1.4.3 MENTORS A mentoring system can be instigated for internship trainees to good effect. A Mentor should be somebody assigned to the internee pharmacist for the duration of the training period at the establishment, who is available to meet regularly with the trainee and talk through anything the trainee wishes to raise. A mentor is not necessarily the same person as a tutor/trainer, since a trainee may come across several trainers in different departments throughout his or her training year. A mentor might usefully be a pharmacist who has quite recently registered to provide the trainee with someone who has been through the process of internship training not so long ago. The system can help trainees feel less isolated and alone, particularly during the early stages of their training. Many graduates move to a part of the country that may be familiar to them for their training so not only do they not know anybody at work, they may have no friends in the area. Often, the sense of isolation leads to a depressed state that has knock-on effects on performance at work. It can therefore be to the employer's benefit as well as to the trainee’s, if the trainee is taken officially under somebody's wing. 1.4.4 OTHERS (TEACHERS/INSTRUCTORS) Any other group of workers at any selected training site and can offer a specialised skill that is required by a pharmacist in the normal working environment. 1.4.5 THE INTERNSHIP TRAINEE Without whom, the profession of pharmacy would not continue! The trainee has the greatest responsibility of anyone during the Internship year, in the sense that it is s/he who must ultimately demonstrate to the tutor that s/he is able to function as an independent professional practitioner, and is a fit and proper person
  • 16. 16 to be registered. To this end, trainees should:  Adopt a positive and committed approach to the pre-registration year  Seek to learn at every opportunity, whether through experience, by questioning and observation of others or by consulting information sources  Seek to apply existing knowledge in the full range of activities undertaken
  • 17. 17 1.5. THE TASKS OF EACH TUTOR AND/OR TRAINER(S): The experiential learning for trainees an educational strategy and requires adherence to the following tasks for each tutor and trainee; planning, initial assessment, training, assessment of competence, recording achievement, and review and feedback 1.5.1. PLANNING To plan how training will be provided and competence assessment carried out in line with Society’s prescribed general framework. The Internship year needs to be planned if it is to be effective and meet its stated objectives. A plan of training needs to cover the following: a) What sort of training will be needed, i.e. by what learning method will each performance criterion be achieved? On its own, observation by the trainee of another person at work does not constitute 'training’ in a competence-based programme since it cannot by itself lead to the gaining of competence. The trainee must have involvement in an activity. Tutors should bear in mind the following  The need to think ahead and book or obtain courses and any additional training sites that may be needed, whether face to face or distance learning or on-site training.  Any learning difficulties the trainee may have, e.g. physical, organizational (perhaps no time during the working day). b) Who will be responsible for the training? c) Who else will be available to provide support to the trainee? The tutor/trainer should discuss with the trainee - and the relevant staff – which members of the pharmacy staff will be available and suitable to help the trainee on a day-to-day basis. e.g.  Will there be a particular pharmacist that will be working closely with him/her at certain times in a hospital setting?  How might various members of the support staff assist in the trainee’s training Programmes d) What sources of evidence of competence will be acceptable? e) When and how will assessment take place?  Will certain times be set aside for observation of particular activities and, if so, when will this be? The trainee must be given adequate notice.
  • 18. 18 f) How often will a tutor or trainer meet with the trainee to discuss progress? It may be helpful to meet more frequently during the early part of the pre-registration year than later on, but in any case, regular meetings should occur and the trainee should know at the outset when and where such meetings would occur. Tutors and trainers should endeavour to stick to agreed meetings. It may be beneficial to have a short, e.g. half-hour, meeting once a week and a longer session once a month. The Society's Council stipulates that:  The tutor should meet with the trainee at least once a month (if s/he is not working alongside the trainee)  A trainer or the tutor should talk with the trainee in a set-aside session for at least 15 minutes each week 1.5.2 INITIAL ASSESSMENT To determine the trainee’s competence and previous experience at the start of his/her internship training, i.e. has previous experience already given the trainee some competence in certain areas? Internship trainees begin their training with a great diversity of practice-related ability depending upon the following  How much previous experience of pharmacy work they have actually had, e.g. vacation employment, and whether it has been relevant to their pre registration post.  How much they have gained from any previous experience. This can vary greatly from one person to the another, even though on paper they may seem to have identical experience. Where the trainee has worked, hi/her level of confidence and the work s/he was given to do will all have an effect.  How much practice-related curriculum content they had in their degree course, and how much they learned from it. It should be remembered that all trainees will have had no previous workplace experience at all and cannot be expected to show competence in any area of pharmacy practice. If a tutor/trainer has worked with internship trainees before with some prior experience, s/he may be surprised by a trainee who is a complete novice, and perhaps expect too much of him/her initially. For these reasons, it is helpful to carry out an initial assessment of the trainee. The best way to start this is by the trainee undertaking self-assessment for all the units of competence. The trainee can either do this him/herself or use it in discussion with the tutor/trainer, or the tutor and trainee can go through the units together and jointly record the trainee's competence. A suggested method of self-assessment for the trainee is as follows. For each performance criterion, the trainee could use the following categories: A) I have done this before/do it now and don’t need further training B) I have done this before/do it now but I need further practice or guidance
  • 19. 19 C) I have not done this before and need training, guidance and practice. Within Grade B, s/he could further subdivide it into a "high" or "low" category; high indicating little work to move to A and low indicating only just beyond C. An initial plan of training is thus identified by those performance criteria which are felt to fall into categories Band C. Obviously the tutor/trainer will still require evidence of competence in those performance criteria/elements which have been marked 'A', but these are likely to be few. The trainee should then feel encouraged if s/he carries out later self-assessments and has moved categories from C to Band B to A. Tutors should also endeavour to find out at the start of the trainee's year, if they have not done so already, what are the trainee's aspirations and areas of special interest. 1.5.3 TRAINING Plan is meant to give to the trainee training guidance and relevant experience for all the CORE PERFORMANCE criteria and SECTORAL aspects. There are various ways in which the trainee can receive training  One to one training from the tutor  One to one training from a trainer as directed by the tutor  Attendance at appropriate study days/training course  Use of distance learning package that will be generated by the Society 1.5.3.1 Principles of Coaching in the Workplace For each period of training, the tutor/trainer will be required to adopt the following style for accountability and review of what will have been covered during practical sessions 1. Assess training NEEDS 2. Plan to meet those NEEDS 3. Implement the PLAN 4. Evaluate the OUTCOMES and give feedback to 2 1.5.3.2 Assessing Needs for Training What should be covered: look at current capabilities and past experiences to identify training needs. How should it be done: consider the trainee's learning style. Do not inflict your own style on him/her, i.e. how does s/he prefer to learn, to ensure that you do not train in an inappropriate manner e.g. allow enough time for thought before doing if the trainee is a strong theorist, but allow him/her to get involved if s/he is a strong activist. Do not inflict your own style on him/her.
  • 20. 20 Copy of a self-assessment questionnaire to determine their own and their trainee's preferred learning style may be prepared by the Pharmaceutical Society of Zambia. 1.5.3.3. Planning Training to Meet Needs Involve the trainee in plans for training so s/he can feel ownership of the experience:  Decide what your learning objectives are  Decide how you are going to achieve them Set targets together: these must be realistic and achievable (refer to current capabilities and other factors that might affect progress) 1.5.3.4 Implementing the Plan (One to One Training) Remember that other types of training may be required also to meet needs e.g. organize courses in relevant areas. Vary your approach between the following two roles when appropriate:  Instructor for new tasks and situations and for inexperienced or unconfident learner  Facilitator for familiar tasks and situations and for experienced and confident learners Instruction = "hands on" Demonstrate, direct, discuss Facilitation = "hands off" Be available to help and answer questions but be less involved. 1.5.3.5 Conducting a Session of Training Follow these important rules:  Agree the intended outcome (and in relation to other wider targets)  Plan and prepare to ensure outcome is achievable with time and resources available  Keep instruction short and simple (use stepwise approach)  Allow learner to practice and take responsibility for own learning  Listen and observe attentively  Allow learner to make mistakes (when appropriate)  Allow discussion. The following steps - evaluation and feedback - are crucial parts of coaching if it is to be effective. Too often training is given without evaluation and feedback so there is no measure of how effective the training has been or of how to proceed in the future.
  • 21. 21 1.5.3.6 Evaluating the Outcome  Review learner’s performance against targets  Review progress in relation to learning plan  Provide feedback 1.5.3.7 Providing Feedback Some differences between good and bad feedback are: Constructive V destructive Positive V negative Unhurried V rushed Empathetic V judgmental Helpful V uninformative Calm V emotional Supportive V derogatory Sensitive V uncaring Encouraging V demotivating Honest V overly optimistic Fair V biased You could probably think of many more. The list not exhausted. The golden rules of feedback and review are:  Adopt a positive, non-threatening approach  Encourage the trainee to participate allow self-evaluation first  Be honest, but fair  Relate comments to targets and performance  Give credit where it is due: go from the positive to the negative and end on a positive note  Be constructive in criticism – suggest solutions  Ensure the trainee has clearly understood: be specific, not vague  Amend plans if necessary: be flexible 1.5.3.8 Conclusion Remember to be an effective coach and above all, think how you would feel if you were on the receiving end of your own brand of coaching. This can be achieved by:  Having a plan  Being clear  Being open  Being helpful
  • 22. 22 Once the trainee has received training, s/he will of course need opportunities for putting learning into practice and so must not be prevented from getting involved whenever possible. Involvement in-patient counselling activities, for example, are crucial if the trainee is to develop competence but tutors/trainers will need to decide when the trainee is ready for this. It is usual practice for the trainee to be closely monitored in the early stages of experience and then allowed a more free rein later. 1.5.3.9 Off-the-Job Training Whilst the Society will try specify the areas of training in the syllabus, it might not prescribe how exactly this will be done according to different training sites because:  Within internship training establishments there is a wide variety of in-house experience and training provision.  The prior experience, learning and qualification of trainees’ ranges widely from a very limited amount to a great deal. This gives rise to variable need for off-the-job training courses and/or secondment elsewhere so that it will be impossible for the Society to know what individual trainees will require in the way of training to supplement that provided in the workplace. (For example, even with first aid, there will be some trainees who have a current or valid first aid certificate or who have undertaken a suitable course during their degree programme). It is therefore necessary for the Society to delegate to the internship training provider the responsibility of looking at how the in-house training provision and the individual trainee's prior achievements match the Society's requirements and of filling any gaps that exist by the use of off-the-job courses, distance learning packages or any other means appropriate and available. If it will be a MUST for the trainee to spend some times at another pharmacy or pharmacy sector to gain extra training or experience. A variety of means is available for tutors to cover topics that it might be difficult to provide at the pharmacy, for example:  The trainee attending courses or using distance-learning packages provided by the PSZ, e.g. covering the ZNF, EDL, etc.  Contacting the local pharmaceutical service providers to find out what off-the- job opportunities that can be provided for their trainees.  Arranging for trainees to visit other establishments or events, e.g. other pharmacies, doctors and dental surgeries, NGOs that provide pharmaceutical services, etc.  Obtaining material from the PSZ offices  Obtaining relevant learning packages that may be available form PSZ and passing them to the trainee(s) for their use.  Arranging for the trainee to attend any necessary courses not specific to pharmacy, e.g. first aid, communication skill assertiveness training.
  • 23. 23 Tutors should remember that it is their responsibility to ensure that all the required components are covered, and should therefore provide training at no cost to the trainee. 1.5.3.10 The Competence-Based Training Programme The aim of this guide is to help the tutor, the trainers and the trainee to use the competence-based training programme as effectively as possible. Additionally, tutors are required to attend a Society organised workshops about internship training and trainees receive information from the Education Section during regularly. The main aim of the competence-based approach is to be certain that the trainee is competent by assessing his/her performance and knowledge. So - what is Competence? Competence can be defined as "the ability to perform consistently to the required standard", From this definition, it can be seen that:  The concern is with the outcome, not the process, i.e. the person’s ability to perform is at issue, not the learning process involved.  Performance must be consistent, not acceptable only some of the time. In reality it is impossible to be certain of a person’s competence at all times but before a trainee is considered competent, the assessor must satisfied that performance to date indicates consistent competence.  Performance is not graded. Either it reaches the required standard or it does not (yet) 1.5.3.10.1 Why should this approach be used for pharmacy internship trainees? In the past, some internship training programs have operated by a simple checklist system in which the competence of the trainee was largely assumed once the trainee had been given information, gained some experience and observed others at work. The competence-based approach, however, assesses the trainee's ability to translate this learning into competent performance. Internship tutors have - without perhaps realizing it - always assessed the competence of their trainees with respect to the dispensing process (i.e. by thorough checking) and, to a variable extent, some other professional activities and skills. The competence-based approach simply formalizes this so that every internship trainee is assessed across the same defined range of activities and skills, i.e. those constituting the CORE of pharmacy practice. A very useful analogy is that of learning to drive i.e. it would be dangerous to allow a person to drive alone after he has simply watched another driver on a few occasions and been told what to do. The learner needs to receive instruction, practice thoroughly himself and then undertake a practical test to determine whether he has developed competence. A benefit to tutors and trainees of this approach is that the detail enables
  • 24. 24 all concerned to know exactly what is expected of the trainee before registration and helps to pinpoint areas, which the trainee needs to develop. A competence-based programme, by being broken down into individual performance criteria, gives the assessor and the trainee targets for which to aim. In this way, training and assessment can be carried out by reference to these stated criteria, rather than by telling the trainee a vague statement such as "You must work in a professional manner" or "You must be able to counsel patients". The performance criteria given in this manual are those required by the Society for the purposes of registration as a pharmaceutical chemist but some employers might wish to go further in their expectation of trainees. There is no problem with this provided that the trainee is clear at the outset what is expected of him/her. Moving goal posts are not helpful to anyone. With the identification of targets for which to aim comes an effective mechanism for feedback on performance. The tutor/trainer should relate his feedback to the targets by concentrating firstly on the criteria that have been met and then turning to those that require further training or development. 1.5.3.10.2 Who assesses the trainee? (I.e. who is the "assessor")? In many establishments, the training and assessment will (of necessity) be carried out by the internship tutor. But in larger establishments, such as hospitals and large community pharmacies, it can be effective to have the assessment conducted by a person different from those responsible for the training. In this way, that one person can be trained in the particular techniques of competence assessment and both trainee and assessor may feel more comfortable if they have not worked closely together beforehand. 1.5.3.10.3 Training for Assessment For managers to conduct assessment of their trainee's competence within PSZ requirements, work-based assessor courses will be prepared and available. Although the internship programme is not an accredited MCZ (and there will be no future plans to merge the two), the principles of competence assessment within it are similar to those for MCZ, so tutors might like to consider undertaking one of these work-based assessor courses. Alternatively, tutors in large establishments might wish to send one of their trainer pharmacists on such a course and this person could then effectively conduct the assessment of all trainees at the establishment. Although there would be no immediate need to obtain the work-based assessor qualification at the end of it. NOTE: There might be bodies to award for work-based assessor qualifications.
  • 25. 25 1.5.3.10.4 Proposed Format of the Internship Competence-Based Programme The programme has the following components: i. Units of Competence Each unit relates to a discrete work area but should not be viewed in isolation. It is the achievement of an agreed range of units, which constitutes competence in the workplace ii. Elements of Competence Within units, the elements describe what a person should be able to do and are an outcome of learning iii. Performance Criteria These specify the standards of performance against which achievement will be measured. iv. Definitions These clarify and enlarge upon the performance criteria to assist tutors and trainees in their understanding a) Underpinning Knowledge In any profession, it is important that members have a sufficient body of knowledge to underpin practice in a variety of situations. The possession of some knowledge can be inferred from the demonstration of competent performance whilst other related knowledge may not be inferred from observation but must be checked. The knowledge underpinning each element or unit is specified as being either in the registration examination syllabus or additional to it. b) Interpretation of the Performance Criteria Even with definitions, some of the performance criteria, particularly those in the professional unit, are open to interpretation because it is not possible for the Society to stipulate exactly what the standard should be; e.g. what would constitute "reliability". The definition could be expanded it a little but, again, "acceptable time- keeping" cannot be defined in any way that would have real worth and meaning to all concerned. In such cases, the tutor and trainee(s) (with the trainers where applicable) must agree at the outset their own definitions, so that, in addition to the assessor knowing the exact standard required, the trainee can assess him/herself against this standard. This is preferable to him/her having little idea of whether his/her own particular standard is acceptable or not.
  • 26. 26 The units making up the programme are as follows: A. The professional unit, elements B. Demonstrate a professional approach C. Communicate effectively D. Work effectively as part of the team E. undertake personal and professional development c) The Practical Units 1. Provide an effective service for the supply of treatments to patients 2. Provide an advisory and guidance service 3. Provide care an/or advice in response to the need for emergency aid or first aid. The differences between the Practical and Professional Units are: Practical Professional Task-based Behaviuor-based Apply to particular functions Underpin the whole of practice Assessed at a particular time and place Assessed as a continuum of development throughout the year and recorded via the 3-monthly appraisal system 1.5.3.11 Evidence of Competence Within competence-based training, the onus is on the trainee to provide evidence of competence, which the assessor (the tutor or a trainer) then evaluates to decide whether or not it meets the performance criteria. i) What is evidence? Since the purpose of the competence-based approach is to check the trainee's ability at work, the only primary evidence is direct observation of the trainee's work performance by the assessor. However, it is not always possible to observe trainees for all performance criteria and therefore secondary types of evidence must also be used. These can be:  Projects, assignments, case studies. Must be signed by a supervisor for authentication  Questioning or discussions with the trainee to check knowledge or discuss the evidence record  Records or reports of everyday work and situations encountered  Simulations/role plays. Either set up by the tutor/trainer or carried out at training course/study day  Prior achievement (in a previous job role). Needs verification by assessor
  • 27. 27  Certificates and existing qualifications, e.g. First Aid, Communication skills Some suggestions for sources of secondary evidence are given alongside the performance criteria later in the manual. If anyone has used an assessment tool that has worked particularly well, please let the Education section of the Society know for passing on to others in the pre- registration bulletin. An important source of evidence for internship trainees, particularly for the professional unit, will be other people with whom the trainee has worked who can be questioned by the assessor and asked for information. Often they will be used to corroborate what the trainee has recorded about his/her handling of a particular situation. When assessing against the performance criteria by seeking the opinions of other staff, it can be useful to have a standard form on which the third party can write a short report about the trainee's performance, known as a '1estimonial". Testimonials should not be used to the exclusion of other types of evidence, but can be very helpful particularly for the professional performance criteria. Patients can also be asked for their opinions of the trainee's performance: in some work settings, it may be possible to assign regular patients to the trainee so that s/he can always be responsible for dealing with their needs or inquiries, provided of course that the patients agree to this. ii) The trainee's record of evidence An evidence record should be created by the trainee to present to the assessor. The principle is that the trainee should record events as they occur, even those that occur in the tutor or trainer's absence, to provide evidence and a basis for discussion and questioning of the trainee. This may best be done by the trainee carrying a notebook in which to record events quickly and then transferring the notes to the manual at a later stage (rather like the old "record of events" that some tutors may remember). While the trainee may not be able to make an evidence record for every single performance criterion, s/he should be encouraged to think about how her/his working activities can be related to the performance criteria. This will help the assessor to build up a composite picture of the trainee's competence from not only observation of the trainee at works, but also other types of evidence presented. The evidence record so created can then be used in three ways:  In discussions with the assessor to indicate competence  To show where gaps exist and opportunities for evidence need creating, e.g. by assignment work, specially set tasks or role plays  By the trainee in the future to help resolve problems
  • 28. 28 iii) The nature of evidence For evidence to be acceptable, it must be:  Valid and relevant to the performance criteria in question  Sufficient to ensure confidence about competence  Authentic, not someone else’s work  Up-to-date, e.g. a first aid qualification iv) How much evidence will be needed? There is no easy answer to this since tutors' opinions are likely to vary in the way they will be required to assess the trainees before allowing them to counsel patients unsupervised. Professional judgement will be important here, together with the particular characteristics of individual trainees. But the overriding principles could be:  The assessor must be confident about the trainee’s competence  A one-off piece of evidence is rarely sufficient It is of course accepted that, even with the competence-based approach, there are no guarantees of competence all the time after registration. All the tutor can reasonably be expected to do is to satisfy him/her that at the period of pre-registration stage the trainee has produced enough evidence of competence to be signed onto the register. The intended final outcome is that the internship trainee demonstrates competence in all training elements by the end of the training period. NB Although as an employer, the assessor may wish the trainee to demonstrate a high level of competence, for the professional body's entrance requirement the need is simply for the new registrant to be competent as per the standard definition of profession of pharmacy.
  • 29. 29 1.5.4 ASSESSMENT OF COMPETENCE Assessment of Competence helps to decide whether the trainee is competent in a particular area or needs further training/practice. The main difference of a competence-based programme from a traditional experience-only programme is that competence is required to be assessed rather than being assumed. The assessment should have the following features:  It should not normally confer achievement on a one-off basis alone, as the trainee should demonstrate ability in a range of circumstances, e.g. the trainee must dispense competently during busy times and when quiet; when the pharmacy is short-staffed; and when the labeling personnel or machine is out of action  It should not be based on a grading system, but on whether the trainee is or not yet competent Assessment should ideally be seen as separate from training because:  During training help can be given to the trainee whereas assessment should mimic the real life situation of needing to “go it alone”  The trainee must not be assessed until ready i.e. until s/he has received adequate training 1.5.4.1 So how will assessment be carried out? In order to demonstrate competence, the trainee will have to provide evidence of competence to the assessor (tutor or trainer). Here the onus is largely on the trainee to provide the evidence but suitable types of evidence will be agreed with the tutor/trainer during the planning process. The steps in the assessment process are:  Look at the evidence presented in relation to the performance criteria  Decide whether the evidence points to: a. competence b. the need for further training, guidance or practice 1.5.4.2 Assessing by observation Within a competence-based training programme, it is not sufficient simply to observe the trainee informally for a judgement about his/her competence. Whilst there is still a need for this day-to-day observation in the pre-registration programme (especially for the professional unit), it will not be enough on its own as the basis for assessment because it might not comprehensive and therefore not targeted to specific performance criteria. The following examples of questions that may be asked by tutors, and possible answers to them, may help to clarify some of the issues concerning assessment by observation
  • 30. 30 Q. At what stage should I carry out an observation assessment of my trainee(s)? A. Always trains your trainee adequately before conducting an assessment by observation. That is, do not assess by observation until she has had sufficient training and practice. Discuss with your trainee whether she feels ready to be assessed: most will be happy to start the assessment process after sufficient training if they are not made to feel intimidated. A few might have confidence problems and will need gentle persuasion before they admit to being ready. After all, most people would not be ready to take their driving test after only two lessons but people do vary in how much instruction they need to become competent and feel confident. Q. Do I have to assess at a particular pre-arranged time? Some tutors will feel more comfortable with the approach of "during this week/fortnight I will be assessing you against last part of training etc. Whichever approach you choose, remember that the main thing is to structure the assessment to ensure that all performance criteria are addressed. What must be avoided is a vague observation over a long period of time, because usually this means that clear targets are not identified and the trainee may be unsure of his progress, in terms of both his good performance and his performance requiring improvement. There is a vast difference between broad observation and vague observation. Q. How many performance criteria should be assessed at one time? A. It is up to the assessor how many performance criteria are assessed at one time: it may be appropriate to assess only a couple or a whole element. How many are assessed at one time is not the crucial issue - what is more important is that the assessments are structured by relating them to a set of performance criteria, i.e. the assessor and the trainee must be clear about what is being assessed. Q. Which performance criteria should I assess first? A. Good approach, used by many trained assessors, is to complete a set of basic ("easy") performance criteria before tackling the more complex ones, rather than trying to mix them in together. By checking off the simple criteria before tackling the more difficult ones, the trainee (and assessors) will feel that something has been achieved. Otherwise, the trainee may be demotivated by falling short of requirements early on. There will undoubtedly be some overlap between elements when you observe your trainee, particularly in terms of combinations of practical and professional criteria. This may lead to a situation in which you are able to check off some of the practical but identify areas for further development in the professional. This is to be expected, since the professional unit constitutes more of a continuum, punctuated by the appraisals.
  • 31. 31 Q. Does it matter when feedback is given to my trainee(s)? A. It is important to provide feedback to the trainee as soon as possible after the assessment. It is best to adopt the approach of getting the trainee to assess his/her own performance before the assessor delivers his verdict. Remember also to go from the positive to the negative and provide constructive suggestions with any criticism. Q. How should the assessment by observation be conducted? A. Before assessment:  Plan in advance with the trainee when and where the assessment will take place  If a patient will be involved in the task being assessed, seek his/her permission  Explain clearly to the trainee what the process will involve and which performance criteria will be assessed. Remember to help the trainee feel less threatened about the assessment by adopting an encouraging attitude, particularly before the early assessments. A. During the assessment:  Be as discreet as possible, whilst ensuring that you can see clearly what the trainee is doing and hear what s/he is saying. (only intervene if the trainee is about to put him/herself or another person in jeopardy, for example by giving the wrong advice)  Take notes if you find this useful to aid your memory but remember that this can be very intimidating to the trainee so if you do, explain carefully why this is to the trainee beforehand. A. After the assessment:  Immediately afterwards (or as soon as possible), feedback your observations to the trainee. It is often helpful to invite the trainee to appraise his/her own performance as a starting point for discussion.  Be positive in your feedback by congratulating the trainee on his/her good performance first and then moving on to the areas needing development  Ask questions of the trainee to fill in any gaps in performance or to check underpinning knowledge e.g. “What would you have said to the patient if…?”Or “How would you have handled a situation in which…?”. Make sure your questions are under stood by the trainee and rephrase them if necessary  Suggest ways of improving performance i.e. do not tell the trainee that a particular aspect was not handled well without discussing strategies that could be tried in the future  Summarize the trainee’s achievement in terms of the performance criteria met and those requiring further training and/or assessment  Plan with the trainee how further training or practice will be provided and when the next assessment will be carried out (but bear in mind that plans may need changing later)
  • 32. 32  Make a record of these points on the assessment record sheet (or your own equivalent). 1.5.4.3 Assessing the Practical Units This is relatively easy, since they are task-based with clearly expected outcomes and should be assessed when the trainee undertakes the relevant tasks. 1.5.4.4 Assessing the Professional Unit This is more difficult, since professional behaviour is hard to define, even harder to measure and to a certain extent dependent on the observer's personal opinion. However, there are strategies that can be employed to reduce this subjectivity a little:  The assessor should never rely on the opinion of one (usually him/her). S/he should obtain the views of as many other people as possible who have also worked with the trainee. This might be difficult in the in the one-to-one scenario of a community pharmacy but even then cover pharmacists, relief managers and others can be asked for their judgment s (such people should always be informed beforehand of the performance criteria being assessed, rather than being asked to give information afterwards when they may not have observed in context. See earlier information about testimonial)  If there is disagreement about competence between the assessor and trainee, third party evidence should help to settle the dispute. If none is available, an alternative strategy might be needed such as moving the trainee to a new location for a period (the Education Division can be contacted for advice in such circumstances)  The assessor should be his/her experience of the behaviour and skills of other pharmacists to decide on an acceptable standard against which to measure the trainee’s performance  Agree the standards expected at the start of the year and get the trainee to self- asses throughout the year as a basis for discussions. Whenever possible, trainees should demonstrate their competence by positive evidence of actual activity and therefore tutors should endeavour to provide opportunities for the necessary involvement whenever it is feasible. However, some of the performance criteria are, by definition, demonstrated by absence of evidence to the contrary, e.g. "A manner is demonstrated which instills confidence" As the definition explains, this will mostly be shown by absence of contradictory evidence since it is not possible actually to know whether the person with whom the trainee is dealing feels confident. In such cases, the performance criterion might serve more to highlight a problem area than to provide positive evidence of competence.
  • 33. 33 1.5.5 RECORDING ACHIEVEMENT This is meant to document when the trainee has achieved competence or gained sufficient experience in given areas. After an assessment time or period, the assessor should make a record of whether the evidence presented demonstrated competence or a need for further development (how this recording is done is up to the assessor, but a specimen assessment record sheet is provided below as an example and how such a record sheet might be completed, see the checklist : TO KNOW THE ORGANIZATION OF THE PSZ AND OTHER RELEVANT PHARMACEUTICAL BODIES IN ZAMBIA: THEIR LEGAL, ETHICAL AND PROFESSIONAL ASPECTS TOWARDS THE NATIONAL HEALTH SYSTEM: 1.1 Pharmaceutical Society of Zambia (PSZ) 1.2 Pharmaceutical Regulation Authority of Zambia (PRA) 1.3 Medical Council of Zambia (MCZ) 1.4 Drug and Enforcement Commission (DEC) 1.5 General Nursing Council (GNC) 1.6 The National Health System in Zambia 1.7 Sale and Supply of Medicines and Poisons 1.8 Professional Ethics Once the assessor is satisfied that sufficient evidence has been presented by the trainee to demonstrate competence against a performance criterion, or a group of performance criteria; s/he should enter this in the column provided on the pages facing the performance criteria as given in the example above. Performance criteria should normally be recorded individually, but it will be acceptable to group them together where appropriate, provided of course that the assessor is satisfied that each criterion will be or has been addressed.
  • 34. 34 Date: 12/10/2005 Assessment Record Sheet Trainee Name: Mr. Y.T. Phiri No.of Performance criteria (p.c.) being assessed) How assessed D D+ C B A Not yet achieved Future development. 1.1 Questioning of trainee A 1.2 Questioning of trainee Trainee needs to present more information to the patient…… Trainee will spend time observing and discussing with the tutor…. 1.3 Questioning of trainee B 1.4 Questioning of trainee B 1.5 Questioning of trainee A 1.6 Observation and questioning of trainee B 1.7 Observation and questioning of trainee C 1.8 Observation and questioning of trainee C % Mark Grade Number of Criteria % Pass 85 and Above A 75 – 84 B 60 – 74 C 50 – 59 D+ 49 and below D Recording Progress Progress with the practical elements is reported on the summary record, which should be sent to the Education section of the PSZ with the half-year appraisal, and with the final appraisal/declaration (Appendix 3 for CAP Form). Progress with the professional unit will be reported on the 3-monthly appraisal forms that will be given from PSZ education section. It is important that all trainers and assessors are provided with copies of the appraisal form so that: a. They are aware of what is expected of the trainee b. They are able to make notes throughout the trainee's working time with them.
  • 35. 35 If there is then not the opportunity for liaison between the appraiser and other trainers before the appraisal is done, copies of the trainers' notes and testimonials can be used as evidence.
  • 36. 36 1.5.6 REVIEW AND FEEDBACK This unit descries the discussions with the trainee on how s/he is progressing. Sessions in which feedback is given to the trainee and progress reviewed is needed because:  Trainees must be given feedback to know how they are doing  Plans may need to be changed due to altered circumstances or simply because the trainee is unable to meet target dates Progress with the professional unit will be reviewed and documented at each 3 monthly appraisal stage, as a minimum, and regular sessions must also be set-aside for the review and recording of progress with the practical units. It should be remembered PSZ intends to make it a requirement that the trainee should be to be given time for review and discussion at least once a week, with the tutor or a trainer. NOTES FOR THE TRAINER/TUTOR ABOUT THE CONDUCT OF THESE SESSIONS: i) Tutor and your trainee should:  Look back at what has (and has not yet) been achieved  Sum up the present position  Agree a plan for the future, involving specific targets ii) Remember the following golden rules:  Plan beforehand what you want to discuss during the session, allowing time also for your trainee to bring up points or ask questions  Ensure that you have a time and place set aside which is:- - Non-threatening – easy chairs are best, do not sit across a desk - Private – there should be no interruptions  The tutor should put the trainee at ease e.g. - Offer a cup of tea or coffee - Start by talking briefly about a matter not related to work - Adopt a welcoming attitude The tutor should enable the trainee to feel safe enough to open up, thus allowing a more fruitful and useful discussion.  Encourage your trainee to talk freely  Ask open questions as much as possible, but remember to keep control by bringing the conversation back to the point if necessary  When giving feedback, remember to:-
  • 37. 37 - Discuss in relation to targets. Use the performance criteria as a guide to explain where targets have or have not been met. - Feedback positively in the first instance, i.e. give credit where it’s due before talking about those areas which require improvement - Stick to facts. Do not make assumptions - Be constrictive when giving negative feedback, e.g. suggest alternative ways of achieving something - Avoid shocks or surprises. If there has been a problem, the trainee should have been made aware of it when it occurs - Take responsibility for any feedback you give I.e. does not hide behind somebody else’s opinion  Check your understanding of your trainee’s comments by summarizing and asking if your summary is correct  Record the main points of the review and any action plan that has been agreed. You and your trainee should initial or sign this. The purpose is to:-- - Avoid or minimize later disagreements - Provide a document for each party to use as a reference for future action and review - Provide information to pass to any new tutor or trainer about the trainee’s progress iii) Finally There may be some questions in the minds of tutors, trainers and trainees as yet unanswered. Here are a few of those raised by existing tutors: Q. How can "real life" situations be created? The trainee may perform better when observed than s/he would if not observed. A. This is recognised to be a possibility, except that if the trainee is able to perform competently, even if only "for show", then that ability must be possessed by the trainee. The possibility of the trainee choosing not to use that ability on another occasion may not be identified and in any case is unlikely if s/he consistently demonstrates competence throughout the training period. Of greater concern is the possibility of nervousness reducing performance but in most cases this improves as the trainee gains confidence and can be helped by giving as much encouragement as possible. Q. Why is there so much detail in the performance criteria? Surely some of the basics do not need to be covered since all trainees are - or will be graduates? A. Firstly, it is important to be sure of a trainee's ability in the basics before progressing to higher level tasks and skills, and remember that trainees vary considerably in their previous experience.
  • 38. 38 Secondly, such detail may seem out-of-place for the more able trainees, but it will help to pinpoint where trainees with problems are going wrong. Q. What about industrial joint schemes: how will the CBTP be covered? A. Many of the performance criteria have been written in a generic way to enable their assessment in a variety of situations. As much as possible should be covered in the industrial setting; the professional elements apply equally to all practice settings and be addressed continuously. The remainder of the units should then be addressed in the other six-month placement. Effective liaison between tutors in the two placements will be needed and thorough completion of documentation by the first tutor should facilitate the transfer of information to the second tutor. It is up to the Trainers to decide for themselves whether the assessment by the tutor is sufficient or whether s/he wishes to conduct a second assessment of competence before signing the trainee onto the register. This may especially be the case for rotational sessions during their training. 1.5.6.1 The Professional Unit A. Demonstrate a Professional Approach B. Communicate Effectively C. Work Effectively as Part of a Team D. Undertake Personal and Professional Development A. Demonstrate a Professional Approach This element will be concerned with the trainee demonstrating the application of professional standards across all aspects of practice.  Actions and attitudes should be demonstrated which indicate a commitment to quality of pharmaceutical care of the patient.  A polite and helpful manner will be demonstrated.  A manner is demonstrated which instills confidence.  Standards of personal behaviour meet the requirements of the organisation.  Reliability is demonstrated.  Initiative is demonstrated when it is warranted.  Recognition of personal limitations is demonstrated.  Work is carried out in an organised manner and with attention to detail so that the desired result is achieved.  Work is prioritized effectively.  Tasks are pursued to completion and within agreed time limits (unless overriding circumstances make this impossible).  Problems or potential problems should be identified and appropriate corrective action taken or solution found  New situations are responded to with flexibility and willingness  Stressful situations are handled without undue agitation
  • 39. 39  Decisions are made which demonstrate the ability to think clearly and logically and to use discretion  Tasks and situations are approached with due regard to legal implications and health organizational policy  Appropriate equipment at hand is used effectively  The safety of the working area is maintained at all times so that the health and safety of the health colleagues and the public at large is not compromised  The security of the premises is also upheld at all times When performance criteria are hard to define or measure a useful tool is to agree the standards expected at the start of the year with the trainee? The trainee can then carry out self-assessment through the year as a basis for discussion before assessment by the tutor/trainer. For the whole professional unit, testimonials (spoken or written) from other staff and patients are vital to provide evidence and reduce subjectivity. B. Communicate Effectively This element will be concerned with the trainee's ability to communicate effectively across the full range of interpersonal transactions.  A sufficient command of the English Language is demonstrated.  The speaker is listened to with attention and without being interrupted unnecessarily.  Conversations (in person or over the telephone) are conducted in a manner, which demonstrates due regard to confidentiality and the feelings of the other person.  Questioning is used effectively to elicit necessary information and increase understanding.  Responses in conversation are helpful and clear.  Responses and statements are spoken with an appropriate degree of confidence.  Body language is appropriate to the situation.  Clear, concise and well-structured written material is provided when required.  All responses (whether spoken or written) are. Tailored to the needs of the recipient.  A clear polite and helpful telephone manner is demonstrated  Complaints or demands are responded in a polite manner  An appropriately assertive manner is used when unreasonable demands or complaints are made
  • 40. 40 C. Work Effectively as Part of a Team This element will be concerned with the trainee's ability to work effectively with colleagues.  A manner is demonstrated which indicates that due respect is given to the ideas and opinions of colleagues.  Promises and undertakings to colleagues are honoured unless circumstances make this impossible.  If promises and undertakings are not honoured, the reasons are explained clearly.  Advice and criticisms are offered to colleagues in a manner unlikely to cause offence.  The involvement of colleagues is enlisted tactfully whenever the need to ensure efficiency of service dictates.  Constructive criticism is received in a positive manner.  Suitable actions are taken to prevent or resolve conflicts with colleagues, managers or other work contacts.  Staffs that will require training in specific tasks are shown what to do in a helpful, clear and positive manner.  Feedback and further guidance to staff so trained is given in a constructive manner. D. Undertake Personal and Professional Development This element will be concerned with the trainee's ability to use self-evaluation and feedback from others to develop both personally and professionally. The meeting of these performance criteria will indicate that the trainee is able to conduct self-audit.  The ability to self-evaluate and reflect on experiences is demonstrated.  Feedback on performance is used effectively to improve competence.  The ability to accept responsibility for meeting own development needs and achieving targets is demonstrated.  A commitment to continuing education is demonstrated. Knowledge Base for the Professional Unit The underpinning knowledge required for this unit is contained in the Registration Examination Syllabus plus the following:  The role of: - The registered pharmacist in the main areas of practice - Pharmaceutical facilitators and advisers/Health Boards advisers - Community services pharmacists - Supervising pharmacists - Pre-registration tutor or trainers supervisors
  • 41. 41 - Pharmacy Postgraduate Education and professional development - Branch Secretaries and Chairmen  Use of English, spoken and written  Theories of communication, including the use of body language  Local organizational policies and policies and procedures (i.e. the policies/procedures applying in the premises in which the trainee undertakes pre- registration training) 1.5.6.2 Practical Units Unit 1: Provide an Effective Service for the Supply of Treatments to Patients Unit 2: Provide an Advisory and Guidance Service Unit 3: provide care and/or advice in response to the need for emergency or first aid Unit 1:Provide an Effective Service for the Supply of Treatments to Patients This unit is concerned with the trainee's ability to supply accurately and efficiently against prescriptions; all treatments required by patients i.e. medicines, dressings and appliances, together with associated information/support. This process encompasses all functions from receipt of the prescription through to the supply of the item(s) and any necessary post-supply procedures. All aspects of the process require professional judgement and responsibility to be exercised. Throughout this unit, the term "prescription" should be taken to encompass also signed orders and other legitimate requests for supplies of medicines and relevant pharmaceutical products. The terms "local procedures" and "local policies" are used throughout to mean the set procedures and policies at the premises in which the trainee is receiving training. Note: All work performance requires a sound foundation of competence in basic tasks and therefore achievement of the basic performance criteria should not be assumed but checked before progressing to the more complex performance aspects. Element 1.1 Receive the Prescription This element will be concerned with ensuring that the trainee effectively uses the stage of receiving the prescription to benefit both the patient and the person who will be dispensing it.  The patient's particulars are confirmed to ensure they are correctly entered on the prescription.  Procedures relating to charges, exemptions and issue of receipts are followed correctly.  Correct and helpful information relating to prescription collection is given to patient or patient's representative.
  • 42. 42  Problems relating to the prescription at this stage are resolved as soon, as is reasonably possible. Element 1.2 Assess Dispense the Prescription This element will be concerned with the trainee's ability to adequately and effectively interpret, assess, dispense and check prescriptions for the full range of treatments supplied: medicines, dressings and appliances.  Initial screening and interpretation of the prescription is carried out thoroughly.  The prescription is assessed adequately and problems correctly identified.  Patient medication histories are used effectively, when available, in the assessment of prescriptions.  Problems are resolved by appropriate action as quickly as possible.  Any necessary calculations are performed accurately.  The correct product is extracted from the stocks for each item being dispensed.  All items are packed and labeled correctly.  An effective self-checking mechanism is employed to identify own dispensing errors.  Errors so identified are adequately rectified as soon as possible  All required quality assurance procedures are followed during the dispensing process  The process is carried out without unnecessary delay  Effective checking of others is carried out when appropriate Element 1.3 Prepare Pharmaceutical Products This element will be concerned with the trainee's ability to prepare accurately any medicine prepared by the combination of ingredients, whether extemporaneously in the pharmacy or in hospital and industrial manufacturing units.  An initial formulation for the product is established and modified suitably if necessary, according to accepted practice.  Calculations are carried out accurately.  Suitable equipment for the preparation process is selected and used correctly.  Ingredients are selected, weighed and measured accurately.  Ingredients are mixed in the correct order and with the correct technique.  The product is packed and labeled correctly.  The correct expiry date and storage conditions are assigned to the finished product.  The correct batch number and product licence numbers are assigned to the finished product, when necessary.  All necessary quality assurance procedures are followed throughout the process.  Any required documentation is completed correctly, thoroughly and at the right time.
  • 43. 43 Element 1.4 Present Dispensed Items to Patient or Patient’s Representative This element will be concerned only with the presentation of dispensed items to patients or their representatives. For competence in communication and the giving of advice generally, refer to Professional Element Band Practical Unit 2.  The identity of the person collecting the dispensed item(s) is adequately confirmed before any item is issued.  Correct and clear advice on use of the item(s) is given.  Factors likely to affect patient compliance are adequately recognised and suitably addressed.  Questions are accurately and clearly answered or referred if necessary.  Oral advice is adequately supplemented by written information and/or demonstration when necessary.  Helpful and accurate information is given about appropriate courses of future action for the patient. Element 1.5 Maintain Stock at the Premises In those premises where stock ordering will be initiated by the dispensers and/or clerical staff, the trainee will be expected to demonstrate acquired competence in these performance criteria to demonstrate a good understanding of the underlying principles for possible future practice needs.  Depleted stock is replenished from store where possible or re-ordered according to local procedures and policies to maintain optimum levels.  Any need for items to be obtained specially or urgently is recognised and is acted upon to obtain supplies without delay and according to local procedures.  Due regard for adequate stock rotation is demonstrated  Incoming stock is checked thoroughly against documentation.  Discrepancies or damages in incoming stock are identified and local procedures for dealing with these are correctly followed.  Stock is put away tidily and with due regard to storage requirements.  Delivery notes, invoices and credit notes are processed correctly, according to local procedures.  Stock checks are carried out thoroughly and unwanted stock dealt with correctly.  Items returned are dealt with correctly according to local and legal requirements. Element 1.6 Complete and Process Documentation This element will be concerned with ensuring that the trainee pays due attention to the whole supply process by properly completing any administrative procedures.  Prescriptions or orders are endorsed clearly and correctly according to local hospital requirements.  All required records are completed as soon, as is reasonably possible.
  • 44. 44  Completed prescriptions are processed and assembled according to requirement of the local health facility procedures. Unit 2:Provide an Advisory and Guidance Service This unit will be concerned with the trainee's ability to provide advice to any person requiring it, be they patients in the community or in hospital, members of the public, other health care workers or colleagues. The unit should be assessed with cross- reference to professional element B. Element 2.1 Provide advice and Guidance to People Requiring Assistance  A person’s need for assistance – whether overt or covert – is recognised  The exact nature of the need is carefully established  Suitable advice and factually correct information is given in relation to drug treatment  Accurate and up-to-date advice for the non-drug management of health is given when the need or opportunity arises.  Advice is delivered clearly and concisely  Advice is given in an acceptable manner and only when it is appropriate to do so.  The recipient is encouraged to ask questions if need be to improve understanding  Referral is made to the correct person/body when it arises Element 2.2 Use Information Source to Answer Queries This element will be concerned with the use of information sources to answer queries or give advice in the course of carrying out normal day-to-day duties. Specialised information services are likely to be dealt with separately in the hospital and industrial experience sections.  The most appropriate source is used to obtain information.  Correct information, which adequately answers the query, is extracted from the source and delivered to the Enquirer.  After use, text-based reference sources are replaced, and reorganised if necessary, to ensure ease of access in the future. NOTE: Knowledge Base for Units 1 and 2 are contained within Registration Examination Syllabus Unit 3:provide care and/or advice in response to the need for emergency or first aid This unit is not a competence unit as such, since it is not possible to be sure that a person will be competent in these activities. However, it is a required training unit for the Society's pre-registration programme and a declaration of completion must be provided at - or before - the time of applying for registration. This unit will be concerned with the trainee's ability to provide first-line treatment or
  • 45. 45 advice when an accident or condition causes a person to require emergency help or first aid. It is included in the core competence in recognition of the public's expectation that pharmacists can be able to provide advice and/or care in such situations, irrespective of the pharmacist's type of day-to-day practice i.e. whilst it is community pharmacists who are most commonly approached for such advice or help, any "off-duty" pharmacist might be called upon by friends, relatives or neighbours to provide first-line assistance. It is in the interests of the public and the profession for entrants to the pharmaceutical register to be equipped with the skills and knowledge needed to meet this expectation. The "range" with each element describes the range of conditions to be covered: it is not a comprehensive list of all situations, which might arise but a list of those most commonly occurring. The majority of this unit will best be covered by the trainee attending a course provided by a first aid organisation or other appropriate person or body e.g. a clinics although some of its content could be covered in-house if desired and possible. The task of finding a suitable course could be given to the trainee to do as a small assignment and this might provide evidence for other performance. Fill any training gaps "in-house" i.e. any parts of the range not covered on the training course. For example, the course may not inform the trainee about how to deal with bites and stings, so the tutor (or a trainer) will need to do this. Current first aid qualifications held by trainees should be investigated for content and any gaps covered. Element 3.1 Respond to medical emergencies In this element, the trainee will be expected to demonstrate sufficient awareness of life-saving techniques and underpinning knowledge to respond effectively when a person's life is put at risk by an accident or medical condition (as specified in the range below). The trainee should demonstrate the ability to determine, and differentiate between, appropriate courses of action according to the situation i.e. whether to: A. Call for help from an appropriate person or organisation and/or B. Administer first-line treatment or provide help to the casualty. i) Performance Criteria:  The situation is assessed correctly and the safety of all those in the immediate vicinity of the accident ensured before proceeding.  The nature of the casualty's problem is identified correctly.  Appropriate emergency treatment is given without delay, without risk to the person giving treatment and with regard to legal limitations.  The casualty is referred or taken to the appropriate person/agency for follow-up treatment.  Accidents at work are reported and recorded in accordance with set procedures, when applicable.