Good Pharmaceutical Medical Practice (2.0)
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.
i. Section 801, Food and Drug Administration Amendments Act (FDAAA 801), Food and Drug Administration, 2007
ii. Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, 2013
iii. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, Official Journal of the European Communities, 1 May 2001
iv. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, Official Journal of European Union, 27 May 2014
v. International Clinical Trials Registry Platform, World Health Organisation. http://www.who.int/ictrp/en/
vi. International Committee of Medical Journal Editors (ICMJE) Policy on Clinical Trial Registration, ICMJE. http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
vii. Section 113, Food and Drug Administration Modernization Act, Food and Drug Administration, 1997
viii. Good Medical Practice, London, General Medical Council, 2013
ix. Good Pharmaceutical Medical Practice, London, Faculty of Pharmaceutical Medicine, 2008
x. Good Pharmaceutical Medical Practice, London, Faculty of Pharmaceutical Medicine, 12 November 2014
xi. Consent, General Medical Council https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/consent
xii. Confidentiality, General Medical Council https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/confidentiality/managing-and-protecting-personal-information
xiii. Guideline for Good Clinical Practice, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. 10 June 1996
xiv. Good Pharmacovigilance Practices, European Medicines Agency. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp
xv. Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of Good Laboratory Practice (GLP), Official Journal of the European Union, 2004
xvi. Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version), Official Journal of the European Union, 2004
xvii. Good Manufacturing Practice Guidelines. Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC, European Commission
xviii. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines http://www.ich.org/products/guidelines.html
xix. Openness and honesty when things go wrong: The professional duty of candour https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/candour—openness-and-honesty-when-things-go-wrong
xx. Leadership and management for all doctors https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/leadership-and-management-for-all-doctors
xxi. EMA/121340/2011: Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU Regulatory Authorities
xxii. The ABPI Code of Practice for the Pharmaceutical Industry https://abpi.org.uk/what-we-do/working-with-industry-and-academia/the-abpi-code-of-practice/
xxiii. The Data Protection Act, 2018 http://www.legislation.gov.uk/ukpga/2018/12/contents/enacted
xxiv. Financial and commercial arrangements and conflicts of interest https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/financial-and-commercial-arrangements-and-conflicts-of-interest