A pharmaceutical physician can start Pharmaceutical Medicine Specialty Training (PMST) after gaining a post in pharmaceutical medicine and after completion of the Foundation Programme (F1 and F2) and two years of post-Foundation approved UK clinical training in any medical specialty or its equivalent in other medical specialties.
The nature of the clinical training prior to specialty training in pharmaceutical medicine must include experience of acute and continuing clinical management and care, and wide experience of prescribing and monitoring the effects of medicines.
The specialties in which this experience is gained are not critical and pharmaceutical physicians come from a wide variety of medical and surgical disciplines.
The programme of PMST consists of the specialty knowledge-based assessment – the Diploma in Pharmaceutical Medicine examination – which must be passed prior to the award of a CCT, and practical competency-based training in an individualised programme centred on an approved workplace training environment.
Practical PMST comprises a modular programme in six fields of practice in pharmaceutical medicine that accompanies and / or follows the award of the Diploma in Pharmaceutical Medicine. The six operational modules are Medicines Regulation, Clinical Pharmacology, Statistics and Data Management, Clinical Development, Healthcare Marketplace and Drug Safety Surveillance.
A seventh, common, module in pharmaceutical medicine continues from the generic module for the medical specialties delivered during clinical training with its emphasis on individual patient care within the NHS. The common module in pharmaceutical medicine encompasses the principles of Good Pharmaceutical Medical Practice and Interpersonal, Management and Leadership Skills relevant to the ethical and professional work of a pharmaceutical physician practising outside the NHS.
Successful completion of the training programme leads to a Certificate of Completion of Training (CCT), the holder of which is eligible to apply for entry to the Specialist Register of the General Medical Council (GMC) in the UK.
To acquire and demonstrate a knowledge of and competency in medicines’ regulation to the level necessary to fulfil the role of a pharmaceutical physician;
To demonstrate the competency to execute tasks relating to the conduct of clinical trials, Marketing Authorisation procedures, and post-authorisation monitoring of safety, efficacy and quality of medicines in fulfilment of national, European and / or other international regulatory requirements.
To acquire knowledge of and competency in clinical pharmacology and supporting disciplines to the level necessary to fulfil proficiently the role of a Pharmaceutical Physician; To contribute to investigations, judgements and decisions on the clinical pharmacology of a medicine in all phases of its research and development; To apply such knowledge in the continuing support and extension of the clinical indications, formulations and dosage schedules, in the investigation and assessment of suspected adverse drug reactions, in submissions to regulatory and pricing authorities, and in product information for doctors and patients; To recognise the need to obtain external or internal expert advice on unusual or unfamiliar findings or on particular aspects outside one’s own knowledge or experience.
Statistics and Data Management
To contribute clinical input to enable effective collaborative work with professional statistical and data management staff; thereby ensuring optimal study design, and effective management, analysis and reporting of clinical trial data to meet scientific and regulatory standards.
To acquire competency to prepare a constructive overview of the disease area and demonstrate the relevance of developing a product in this area; To prepare or critique a clinical development plan to explore the safety and efficacy of a new pharmaceutical agent that will lead to its safe adoption into clinical practice after approval by national and international regulatory agencies; To oversee a programme of clinical trials that will demonstrate ethically and adequately the safety and efficacy of a new pharmaceutical agent in compliance with national and international laws, regulations and guidelines; To appraise constructively and report on the evidence of safety and efficacy of a new pharmaceutical agent and assess its benefits, risks and place in the pharmaceutical armamentarium.
To be able to keep the welfare of patients and clinical trial participants at the forefront of decision-making in the promotion of medicines and design of clinical trials; To acquire knowledge of the healthcare environment in which pharmaceutical marketing takes place; To be able to apply this knowledge & Good Medical Practice to the role of the pharmaceutical physician; To ensure that marketing activities in the healthcare environment are and remain appropriate, ethical and legal.
Drug Safety Surveillance
To acquire and demonstrate knowledge of and competency in the surveillance of the safety of medicines during all stages of development and clinical use, with particular emphasis on the choice, application and analysis of appropriate surveillance methods, on the principles of international regulatory reporting requirements, on the timely revisions of product information and practical methods for managing risk to patients and clinical trial subjects.
Interpersonal, Management and Leadership Skills
To demonstrate a knowledge of, and competency to apply that knowledge appropriately to a number of interpersonal and management skills appropriate to the work of a pharmaceutical physician operating in a managed environment.
Trainees must use the workplace-based assessment (WPBA) tools, which are available on the trainee e-portfolio. The WBPAs for pharmaceutical medicine are the:
- Pharmaceutical Medicine Assessment Tool (PMAT)
- Teaching Observation (TO)
- Project-based Discussion (PbD)
- Multi-source feedback (MSF)
We encourage trainees and assessors to refer to our PMAT dictionary when using this WPBA.
FPM’s Diploma in Pharmaceutical Medicine (DPM) examination is the knowledge-based assessment for PMST. There are no alternative examinations that a trainee can sit to complete this assessment. Please visit our DPM page for more information about the examination.