PERFORMANCE APPRAISAL FOR by peisty474

VIEWS: 682 PAGES: 24

									               PERFORMANCE APPRAISAL FOR

               PHARMACEUTICAL PHYSICIANS

              PARTICIPATING IN REVALIDATION




                    Guidance Documentation

                      and Appraisal Forms




Version 1.0                    1
                      Performance Appraisal for Pharmaceutical Physicians

Introduction

This set of documents reflects the agreement reached with the GMC on standard appraisal for pharmaceutical
physicians.

"Appraisal must follow a standardised format if it is to be applied consistently and satisfy the GMC’s
requirements for revalidation. This documentation will support appraisal and can be the vehicle for the delivery
of the GMC’s revalidation requirements. The use of standardised documentation will ensure that information
from a variety of sources will be recorded and expressed consistently."

Pharmaceutical Physicians must be aware that if an existing/alternative format is retained it must be adapted to
comply with the requirements of this agreement in full.

It will be necessary for the purposes of revalidation that the doctor’s work be considered under the headings of
the GMC’s “Good Medical Practice” as modified by the Faculty of Pharmaceutical Medicine (“Good
Pharmaceutical Medical Practice”) and agreed by the GMC.

This documentation is designed to provide a formal, supportive, consistent structure to the appraisal process. It
covers the process in sequence and suggests the information and evidence which the parties to appraisal will
wish to bring to the process.

Appraisal documentation
Completing the documents as fully as possible is an important facet of appraisal, not least as it provides a
written agreement and encourages consistency, but in addition the dialogue between individuals and the
exchange of views is equally important.

Every pharmaceutical physician being appraised should prepare an appraisal folder. This is a systematically
recorded set of all the documents: information, evidence and data which will help inform the appraisal process.
It should be considered confidential to yourself and your appraiser unless required as the result of an audit.
Once the folder has been set up it can be updated as necessary. The complete documentation will allow access
to the original documents (or summaries), record what the appraisal process concluded and, finally, what action
was agreed as the outcome following discussion.

The appraisal process will not of itself result in the generation of significant amounts of new evidence or
information, rather it will capture the information that already exists. What goes into the folder will, for the
most part, be available from medical governance activity, the job itself and other existing sources. One result of
the appraisal process will be to identify areas where there are gaps to be filled or where perhaps data need to be
better collated or presented. This is likely to be more apparent in the early years after appraisal is launched.




Version 1.0                                             2
Preparing for appraisal

Successful appraisal depends on both the parties giving their contribution some thought beforehand. Both
parties should give themselves enough time to produce, exchange and consider any documents necessary for the
appraisal – a few weeks rather than a few days in advance is best. Where, for whatever reason, a third party
needs to contribute to an appraisal this should also be discussed and agreed well in advance.

We suggest that it would greatly help the process if both the appraiser and the appraisee thought through the
following questions before the interview:

   how good a pharmaceutical physician am I?
   how well do I perform?
   how up to date am I?
   how well do I work in a team?
   what resources and support do I need?
   how well am I meeting my objectives?
   what are my development needs?

It is very important that the discussion, a vital component of appraisal, is planned in diaries well-ahead and
protected. Ad hoc arrangements will fail the appraisee and the appraiser. Essentially, the timing, location and
people involved in the appraisal need to be discussed and confirmed about a month beforehand. It is essential
that adequate time is allocated for preparation, both for the appraiser and the appraisee. Employers must
recognise that preparation time and time for carrying out the appraisal are instead of, rather than additional to
the pharmaceutical physician's existing duties and workload, and therefore should take place during usual
working hours. In the first year of the scheme it must be recognised that appraisees will require further time for
work involved in setting up their appraisal folders.

Should concerns arise during appraisal
Both the appraiser (who will usually be a registered medical practitioner) and the appraisee need to recognise
that they must protect the interests of patients where they believe that issues of health, conduct or performance
are a threat to patients (GMC Good Medical Practice paragraph 23). If, as a result of the appraisal process the
appraiser believes that the activities of the appraisee are such as to put patients' interests at risk, the appraisal
process should be stopped and action taken. If the situation is then remedied the appraisal process can continue.
Nothing in the operation of the appraisal process can over-ride the basic professional obligation to protect the
interests of patients.

Pharmaceutical physicians

The nature of pharmaceutical medicine means that the information and evidence brought to the appraisal
process will in some respects differ from colleagues in other clinical specialties. Some sections of the appraisal
forms may appear less relevant for pharmaceutical physicians but must nevertheless be completed as fully as
possible. Adequate explanation of any gaps is considered imperative. References to Good Medical Practice
and to Maintaining Good Medical Practice clearly refer in the case of pharmaceutical physicians to the practice
of pharmaceutical medicine.

Version 1.0                                              3
GMC Revalidation

This documentation has been prepared in the light of proposals by the GMC to introduce revalidation for all
doctors.

Briefly, the GMC's proposals call for a five-yearly demonstration of all doctors' fitness to practice. Under the
proposed scheme, this will be based on information and evidence to be seen by GMC panels. As far as is
possible, the documentation has been designed to allow the information and evidence gathering processes of
appraisal and the summaries of outcomes to fulfil the requirements of revalidation as soon as it is introduced.
This means that doctors will be able to produce the evidence they need for revalidation as part of a seamless
process which avoids complexity and duplication. However, whilst there is a clear connection between
revalidation and appraisal there are also differences. Revalidation concerns itself with a standard measured
against the framework of the GMC's guidance on Good Medical Practice and Appraisal in addition will take a
broader look at a doctor's work and service delivery.


Instructions for using this document

This document can either be printed and completed manually or completed and stored electronically. If you
choose to complete this document electronically, you should be aware of the following conventions:
1. To complete this form you will need to download and save it on your computer.
2. This is a protected document. This means that you will be unable to type in any field that isn't designed to
    allow electronic data entry (in most cases, these are the light grey fields).
3. In most cases, you will be able to enter an unlimited amount of text. As you enter text and/or add carriage
    returns, the document will autosize to show all of your text.
4. Please enter all dates in the format DD-MM-YYYY (two-digit day, two-digit month, and four-digit year).
5. Try to be as complete as possible in your descriptions and information provided.
6. Start by clicking on the left-hand edge of the grey area beside "Appraisee Name". After you have finished
    typing the appraisee name, either hit the [Tab] key or click on the left-hand edge of the next grey cell and
    complete the next item.
7. If you wish to directly edit a field without using the [Tab] key remember to position your pointer towards
    the left-hand edge of the table cell until the pointer changes to ( ), then single-click to highlight the desired
    field.
8. In order to delete text that you have entered, please click in the position of the desired change and use the
    [Delete] or [Backspace] key to remove the incorrect text.
9. Where appropriate, completion guidelines have been added and these will appear at the bottom of your
    screen.
10. You will notice that the signature pages have no place to enter any text electronically. Please print, sign,
    and archive these pages for future reference.




Version 1.0                                              4
                                          CONFIDENTIAL


         APPRAISAL FORM FOR PHARMACEUTICAL PHYSICIANS
      For help with completing the Appraisal Forms please refer back to the Guidance Documentation

Appraisee Name:

Appraisal Period:
From (DD-MM-YYYY):                               To (DD-MM-YYYY):

Appraiser Name:
Appraiser Job Title:

Qualifications:




Employer (if appropriate):

Appraiser's Contact
Address:

Relationship to Appraisee:




Version 1.0                                        5
                                            CONFIDENTIAL


         APPRAISAL FORM FOR PHARMACEUTICAL PHYSICIANS


                                                   Form 1

                                           Background Details




              The aim of this form is to provide (1) basic background information to identify
              you individually, (2) brief details of your professional status and career, and (3)
              the opportunity for you to supplement this with other information you think is
              helpful.

              You should provide at the end of the form, any other personal details which help
              to describe your current role. For example, membership of medical and specialist
              societies, honorary appointments and civic appointments.




Version 1.0                                           6
                                               CONFIDENTIAL


                                              Personal Details
Registered Address:                                    Contact Address (if different):




Date of primary medical qualification in the UK
(DD-MM-YYYY):

or
Date of primary medical qualification which has
been recognised in the UK (DD-MM-YYYY):

Job Title:

Are you an independent pharmaceutical physician? Yes:                              No:

Whether you are a permanent employee or an independent working predominantly with one or more
companies/clients you should provide here the following information:

1. The name and address of your current main employer/client:



2. The date you started your current post with your
main employer/client (DD-MM-YYYY):

3. Have you worked for anyone else since your          Yes:                        No:
last revalidation appraisal?

If yes, list your other employer(s)/client(s). Include job title, employer/client, address and start and end dates
(state "ongoing" if end date does not apply). If you work independently for many clients then just include a
representative list covering the major pieces of work you have undertaken.




Version 1.0                                              7
                                            CONFIDENTIAL


                                    Personal Details Continued
Type of GMC Registration currently held:
GMC Registration number:
Date of first GMC Registration (DD-MM-YYYY):
Starting date of first appointment/work in
pharmaceutical medicine, including for a
regulatory agency (DD-MM-YYYY):
Is this your first revalidation?                    Yes:                      No:
Has your registration been called into question     Yes:                      No:
since your last appraisal? (If this is your first
appraisal, is your registration currently in
question?)
Date of last revalidation, if applicable (DD-MM-
YYYY):
Other relevant details, memberships, appointments not mentioned previously (including honorary and civic
posts) etc. Where relevant you may wish to use examples from this section in support of later sections on
relationships with colleagues, probity etc.




Version 1.0                                           8
                                            CONFIDENTIAL


         APPRAISAL FORM FOR PHARMACEUTICAL PHYSICIANS

                                                   Form 2

                              Details of Your Current Medical Activities




              The aim of this form is to provide you with an opportunity to describe your
              current role. You should explain what you do and where you work in as much
              detail as possible.

              You may replace parts of this section with your job specification/description if
              this covers all the required elements.

              Your description should cover your work at all locations since your last appraisal.
              Please provide information in all sections or provide an explanation if you leave
              any part blank.




Version 1.0                                           9
                                             CONFIDENTIAL


                          Details of Your Current Medical Activities
Day-to-Day Work You Do in Your Specialty
Provide a short description of the different types of activity you undertake (with approximate percentage).
Examples may include, but are not limited to:

   Medical/Project related activities
       – Developing protocols, prescribing information, writing reports and expert opinions
       – Reviewing ADRs and producing PSURs.
       – Committee work (e.g. Project teams, Protocol review committees, Safety committees etc)
       – Literature reviews
       – Reviewing promotional material
   Management activities
       – Management of resources/budgets
       – Managing/advising staff
       – Staff assessment
   Training and development activities
       – Teaching
       – Coaching/mentoring




Version 1.0                                            10
                                               CONFIDENTIAL


                   Details of Your Current Medical Activities Continued
Additional Specialty Work
Provide details of any other work related to your area of specialty, e.g., external lecturing, work for specialist
societies, journal editing/refereeing.




Out-Patient/Other Clinical Work
Provide details of e.g., out-patient work/clinical attachments/work as a clinical pharmacology investigator not
mentioned previously.




Work for Regional, National or International Organisations
Provide details of any additional work for regional, national or international organisations not mentioned
previously.




Other Professional Activities
Provide details of any other professional activities, including non specialist general medical work, not
mentioned previously. Include, e.g., research, general teaching/academic work, other management activities
etc.




Version 1.0                                              11
                                            CONFIDENTIAL


         APPRAISAL FORM FOR PHARMACEUTICAL PHYSICIANS

                                                  Form 3A

                  Record of Reference Documentation Supporting the Appraisal




              This form corresponds to the 7 domains of “Good Medical Practice” as revised
              by the Faculty of Pharmaceutical Medicine and retitled “Good Pharmaceutical
              Medical Practice”. It is designed to capture relevant information for all
              pharmaceutical physicians.

              You should list relevant information and evidence from your work, your company
              (if appropriate) and elsewhere which relates to your job. A representative sample
              may be appropriate if the volume arising from a particular activity is excessive
              e.g. the review of promotional material.

              If under the terms of existing confidentiality agreements you are unable to include
              actual documents in your appraisal folder, then a note confirming that the work
              has been done is acceptable; for example an e-mail from a client.




Version 1.0                                           12
                                               CONFIDENTIAL


                               Record of Reference Documentation
1. Good Medical Practice
Pharmaceutical physicians play a key role in patient care. They should have a thorough understanding of their
therapeutic areas, follow ICH Guidelines, regulatory requirements and the declaration of Helsinki.
Pharmaceutical physicians must fulfil their obligations in clarifying, evaluating and reporting adverse events.
They should ensure that documents accurately reflect the data and provide relevant and accurate data for
publication. Pharmaceutical physicians should ensure that the information provided in the Summary of Product
Characteristics (SPC) is consistent with the terms of the Marketing Authorisation, ensure that patient
information leaflets are clear and understandable and ensure that all promotional material and representative
product training is consistent with the SPC.
Examples of appropriate documentation (either written, reviewed or signed off) may include but are not limited
to:
 Project plans                                            PSURs
 CTX clinical section                                     Communication activities, including publication
 Protocols                                                   planning/congresses etc
 Study reports                                            Internal/external meetings organised/chaired
 MAA clinical expert opinion                              Management activities, e.g., appointing staff etc.
 Promotional material approved
List each document below, in the order they appear in your appraisal folder.




2. Maintaining Good Medical Practice
The purpose of this section is to record Continuing Professional Development (CPD) activities undertaken since
your last appraisal. It is suggested that CPD is divided into: medical/scientific orientated activities and personal
development activities.
Pharmaceutical physicians are required by the nature of their job to keep themselves abreast of advances that
will have a major impact on the development of the new medicines of the future. Activities may include
professional meetings, presentations, consultations with key opinion leaders, authorship and journals read, in-
house training and self learning. For further advice, please see the Faculty of Pharmaceutical Medicine guidance
note on what may be counted for CPD purposes.
List each document below, in the order they appear in your appraisal folder. You may replace parts of this
section with copies of the information from your CPD diary where appropriate.




Version 1.0                                             13
                                              CONFIDENTIAL


                       Record of Reference Documentation Continued
3. Teaching and Training, Appraising and Assessing
Pharmaceutical physicians must ensure that they provide accurate and verifiable information and that they
respect the professional integrity of those they are training.
Pharmaceutical physicians with managerial responsibility for colleagues must ensure that they are adequately
trained for their job function and that appraisals are carried out objectively.
Record in this section your teaching and training, appraising and assessing activities since your last appraisal.
Examples may include, but are not limited to:
 A summary of supervision/mentoring duties.
 Examinations, refereeing, editorships.
 Teaching/lecturing activities.
List each document below, in the order they appear in your appraisal folder.




4. Relations with Subjects
It is unusual for pharmaceutical physicians to have direct contact with patients but there are many examples
where they make an important contribution to ensuring a good standard of practice and care.
Examples may include, but are not limited to:
 Involvement in human volunteer studies as the investigator or supervisor
 Subject feedback forms
 Consent forms/patient information leaflets developed.
 Responses to requests for drug safety and medical information.
 Participation in patient organisations and patient contact during committee work.
List each document below, in the order they appear in your appraisal folder.




Version 1.0                                            14
                                             CONFIDENTIAL


                      Record of Reference Documentation Continued
5. Working Relationships with Colleagues
Whether working alone or in teams pharmaceutical physicians must always treat colleagues fairly and must not
undermine trust in the care or treatment that patients receive. They must show personal accountability for
professional conduct and care and participate in regular reviews and audit of standards and performance.
Pharmaceutical physicians must be willing to deal openly and supportively with problems in the performance,
conduct or health of team members.
Examples may include, but are not limited to:
 A list of the business teams in which you work.
 Feedback received as part of training activities or other appraisal processes
 Peer review forms for yourself or the teams in which you work.
 Evidence of repeat business if you work independently.
List each document below, in the order they appear in your appraisal folder.




6. Probity
Pharmaceutical physicians often work with or for a commercially driven organisation. They must be extra
vigilant that personal financial gain does not result in inappropriate decisions and practices whether in writing
reports and signing documents, or research, or in financial and commercial dealings.
Consider here any financial interests in your employing organisation e.g. executive main board director, share
holder, stock options awarded (if more than 5% of issued stock) and describe any concerns raised or problems
encountered that may have led to a potential conflict of interest during the year. This may also include indirect
financial interests and any form of disciplinary, regulatory or criminal proceedings since your last appraisal.
For revalidation purposes it is sufficient to provide a self-declaration about how effectively you are meeting
good medical practice standards of probity in matters which might affect your fitness to practice pharmaceutical
medicine.




Version 1.0                                            15
                                             CONFIDENTIAL


                      Record of Reference Documentation Continued
7. Health
Whilst the risk of transmitting communicable diseases is only an issue for pharmaceutical physicians working in
direct contact with patients or volunteers, your judgement and performance and the work of others may be
affected by such things as stress and depression. Pharmaceutical physicians should be vigilant to these
problems, both in themselves and colleagues.
You should record here any concerns raised or problems you have experienced during the year and provide a
self-declaration about your effectiveness in ensuring that your personal health does not affect your fitness to
practice medicine.




Version 1.0                                           16
                                              CONFIDENTIAL


                   Form 3A Reference Documentation Signature Sheet
The appraisee has provided documentation covering the period since their last revalidation appraisal,
encompassing the seven domains required by the GMC of good medical practice, maintaining good medical
practice, teaching and training, appraising and assessing, relations with subjects, working relationships with
colleagues, probity and health.

I confirm that I am suitably qualified and have carefully examined all entries for this appraisee. All information
entered is to the best of my knowledge, correct as of the date below.

Appraiser:                                                                                   Date:


                                   name and signature                                          DD-MM-YYYY




Version 1.0                                             17
                                           CONFIDENTIAL


         APPRAISAL FORM FOR PHARMACEUTICAL PHYSICIANS

                                                 Form 3B

              Personal and Professional Development Plan From Your Last Appraisal




              You should include here your personal and professional development plan agreed
              at your last appraisal. This will facilitate discussion on progress towards your
              development goals. You should record where goals have been achieved or where
              further action is required. It is assumed that where a development need has not
              been met in full it will remain a need and will either be reflected in the coming
              year's plan or have resulted in another action.




Version 1.0                                          18
                                                              CONFIDENTIAL


                                         Personal and Professional Development Plan
You should copy here specific objective/development actions agreed at your last appraisal (and at any interim meeting). This will facilitate
discussion at this appraisal. Alternatively, you may insert a duplicate copy of your personal and professional development plan from your last
appraisal together with any updates.

You should agree with your appraiser the status of each objective/development action and enter this information in the last column.

     What personal           How will I address them      Date by which I plan to          Desired outcome                   Status
 objectives/development                                      achieve the goal
   actions have been
        identified
(Explain the need)          (Explain how you will        (The date agreed with        (How will your practice      (Include agreement of
                            take action, and any         your appraiser)              change as a result)          completion with your
                            resources you need)                                                                    appraiser)
1.
2.
3.
4.
5.
6.
7. etc




Version 1.0                                                            19
                                              CONFIDENTIAL


      Form 3B Personal and Professional Development Plan Signature Sheet
We confirm that the above information is an accurate record of the appraisee's position with regard to their
personal and professional development plan since their last revalidation appraisal.
Appraisee:                                                                                 Date:


                                  name and signature                                          DD-MM-YYYY

Appraiser:                                                                                  Date:


                                  name and signature                                          DD-MM-YYYY




Version 1.0                                            20
                                           CONFIDENTIAL


         APPRAISAL FORM FOR PHARMACEUTICAL PHYSICIANS

                                                 Form 4

                    Summary of Appraisal Discussion with Agreed Actions and
                       New Personal and Professional Development Plan




              The aim of this section is to provide an agreed summary of the appraisal
              discussion based on the documents listed in Form 3 A/B and a description of the
              actions agreed, including the elements of the personal and professional
              development plan.

              This form should be completed by the appraiser and agreed by the appraisee.
              Under each heading the appraiser should explain which of the documents listed in
              Form 3 A/B informed this part of the discussion and the conclusions reached.




Version 1.0                                         21
                                           CONFIDENTIAL


                             Summary of Appraisal Discussion

                                Commentary and Agreed Actions

1. Good Medical Practice




2. Maintaining Good Medical Practice




3. Teaching and Training, Appraising and Assessing




4. Relations with Subjects




5. Working Relationships with Colleagues




6. Probity




7. Health




8. Any Other Comments




Version 1.0                                     22
                                                               CONFIDENTIAL


                                         Personal and Professional Development Plan
You should summarise here specific objectives/development actions agreed at your appraisal. This will facilitate future discussion on your
development goals. You may replace this page with your own company's form if this covers all of the required elements.

The important areas to cover are: action to maintain skills, action to develop or acquire new skills, or action to change or improve existing
practices.
       What personal         How will I address them Date by which I plan to                 Desired outcome                     Status
 objectives/development                                          achieve the goal
     actions have been
         identified
(Explain the need)          (Explain how you will          (The date agreed with         (How will your practice       (Include subsequent
                            take action, and any           your appraiser)               change as a result)           agreement of completion
                            resources you need)                                                                        with your appraiser)
1.
2.
3.
4.
5.
6.
7. etc




Version 1.0                                                             23
                                             CONFIDENTIAL


                                Appraisal Form Signature Sheet
We agree that the above information in Form 4 is an accurate summary of the appraisal discussion, agreed
actions and the personal and professional development plan.
Appraisee:                                                                               Date:


                                  name and signature                                        DD-MM-YYYY

Appraiser:                                                                                Date:


                                  name and signature                                        DD-MM-YYYY

Record below the names of any third parties who made a significant contribution to the appraisal process (over
and above providing routine feedback) and indicate the capacity in which they did so.




Version 1.0                                            24

								
To top