Good Pharmaceutical Medical Practice (2.0)
Updated Sept 2020
Good Pharmaceutical Medical Practice (GPMP 2.0) provides all doctors practising pharmaceutical medicine guidance and direction on expected standards, conduct and behaviour.
The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom (FPM) advocates that the principles outlined in this document are appropriate for all those involved in the practice of pharmaceutical medicine anywhere in the world.
Introduction and definitions
GPMP 2.0 complements existing international and national legislationi-vii, with the UK General Medical Council (GMC) Good Medical Practice 2013viii as its foundation. GPMP 2.0 extends upon the principles first outlined in FPM forerunner Good Pharmaceutical Medical Practice 2008ix (updated 2014x).
GPMP 2.0 reflects advances in practice and broadens the scope to encompass the increasingly complex, diverse roles of pharmaceutical physicians. This version is intended to be read alongside Good Medical Practiceviii.
DOMAIN 1: Knowledge, skills and performance
- You must keep your professional knowledge and skills up to date.
- You must take steps to monitor and improve the quality of your work.
- You should demonstrate your involvement in learning and how this will positively affect your future practice of pharmaceutical medicine.
- You should maintain membership of, or be associated with, one or more professional bodies relevant to your practice of pharmaceutical medicine.
DOMAIN 2: Safety and quality
- Medical input should be provided to ensure the safety of patients and optimise the benefit-risk balance of a drug.
- You should take account of feedback from other individuals and groups, including healthcare professionals, regulatory bodies and organisations representing patients, and, when needed, undertake quality improvement programmes.
- You must include appropriate safety monitoring in the design of a clinical trial, according to the level of knowledge and risk associated with the intervention.
- You must take additional care when investigating interventions with a novel mechanism of action, particularly those that target the immune system or with a potential for biological amplification.
- You should ensure that populations recruited to clinical trials are not exposed to undue risk due to underlying comorbidities, or cognitive or communication difficulties.
- You should consider the needs of vulnerable or marginalised populations and, where appropriate, ensure that they are not excluded from clinical research in areas relevant to them, either pre- or post- regulatory approval, recognising the special care that must be taken.
- You should share clinical trial results, both positive and negative, in a timely manner to reduce unnecessary studies and enhance patient safety.
DOMAIN 3: Communication, partnership and teamwork
- You must listen to patients, take account of their views, and respond honestly to their questions.xi
- You must presume that every adult patient has the capacity to make decisions and make reasonable adjustments to support patients to understand information. When it is determined that a patient lacks capacity, is vulnerable and/or unconscious, you should listen to the views of anyone who has been appointed to represent the patient. You should take account of the carers’ views and respond honestly to the carers’ concerns.
- You should involve children and young people as much as possible in decision making processes and assess their capacity to consent. You must ensure that parents or legal representatives understand all the information when they are asked to consent on behalf of the child or young person. (http://www.hra-decisiontools.org.uk/consent/principles-children-EngWalesNI.html; https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/0-18-years/making-decisions)
- You should ensure that patients’ perspectives are included during the clinical development of medicines.
- You should anticipate the information needs of patients in the preparation of communications such as informed consent forms, patient information leaflets, patient support materials and social media. These should be accurate, complete and expressed in terms that are easily understood and not misleading. In relation to informed consent for clinical trials, there should be additional checks to ensure that the information provided has been fully understood, prior to consent being obtainedxvii
- The promotion of medicines must be based on ongoing assessment of all the available information and be in accordance with the labelling. Information provided to healthcare workers should permit objective clinical decision-making based on the merits of available products.
- You must be readily accessible for safety issues and medical monitoring activities, to take responsibility or provide information, advice and support as appropriate.
DOMAIN 4: Maintaining trust
- An apology is an expression of regret that an event has occurred and is not necessarily an admission of liability or guilt. If a patient has suffered harm, then you should express regret and empathy.xix
- When conducting clinical research, it is often not possible to predict an adverse event or side effect of treatment or to be able to fully explain the likely long-term effects. It is important to express this uncertainty before treatment and not give unfounded reassurance.
Good Pharmaceutical Medical Practice
The Good Pharmaceutical Medical Practice Support Network has been established to provide guidance and direction to pharmaceutical physicians who face ethical or medical dilemmas in their practice.
The network will run in conjunction with the Good Pharmaceutical Medical Practiceguidance document, which will be used as the global touchstone for best practice. Responses will be given that are in line with the FPM’s charitable objectives i.e. promote the science of pharmaceutical medicine and to develop and maintain competence, ethical integrity and high professional standards in the practice of pharmaceutical medicine.
The network is free to use and is available to all members of the Faculty and all registered doctors involved in the practice of pharmaceutical medicine, anywhere in the World. A panel of experienced FPM Fellows have volunteered to give guidance to all those who need it, whether they are a seasoned professional or a trainee. Guidance will be given anonymously, generally in writing.
Find out more here.