Pharmaceutical Physician Education and Training
Executive Summary
Pharmaceutical Medicine Specialty Training (PMST) is a workplace-centred competency-based training programme, which is designed to provide education and training for doctors joining pharmaceutical medicine (PM). The programme incorporates the Diploma in Pharmaceutical Medicine (DPM) with a practical modular curriculum and physicians are accredited with a Certificate of Completion of Training (CCT) and placed on the GMC's specialist register on satisfactory completion of the scheme.
Education and training in PM is essential for pharmaceutical physicians (PPs) to perform their roles to professional and industry standards, which will also be expected for revalidation of doctors in the future. The benefits to employers of appropriately trained and accredited professional staff lie in their increased knowledge and capability and the resulting increased efficiency, flexibility and productivity that such competence provides.
Appropriate training lowers risk, for example of regulatory failure or pharmacovigilance crisis. The direct cost of providing PMST to the standard of a CCT for PPs is in the range £5,000-15,000 over a 4-year period, the costs above the minimum £5,000 being dependent on the average number of external courses attended.
Pharmaceutical Physicians and Pharmaceutical Medicine
Pharmaceutical physicians come from a wide range of clinical backgrounds and specialties with or without additional scientific training and research experience. They work in medical departments of pharmaceutical companies, in contract clinical research organisations (CROs) and in medicines regulatory agencies.
A UK PP will be a fully registered doctor with a minimum of four years postgraduate clinical training. PPs undertake a wide range of activities and roles in early- and late-phase clinical development of new medicines, drug safety monitoring and benefit-risk assessment, in medical affairs and the commercialisation & life-cycle management of medicines.
These activities make up the substance of their medical discipline - pharmaceutical medicine, a broad medical specialty that requires PPs to have a wide range of experience, which includes training and expertise in basic research, drug development & evaluation, clinical trials and registration as well as an understanding of pharmacoeconomics, medical marketing, business administration and the social impact of healthcare.
On joining pharmaceutical medicine, physicians require education and training in PM, in order to meld their clinical, and in some cases scientific skills with the requirements for practising PM in the development and maintenance of medicines.
The Training Programme
Education & training for PPs over the last 30 years has focussed on the acquisition of knowledge for the Diploma in Pharmaceutical Medicine of the RCP of the UK.
With the recognition of PM as a medical specialty this training has now developed to a full workplace-centred competency-based programme, PMST. PMST incorporates the DPM with a practical modular curriculum in medicines regulation, early and late phase clinical development of medicines, healthcare marketplace, drug safety surveillance and a generic module of interpersonal and management skills and meeting the requirements of good pharmaceutical medical practice (GPMP).
The aim of PMST is for PPs to acquire the necessary knowledge, skills and attitudes to practise PM to the highest technical, ethical and professional standards for the benefit of the employing organisation, its medicinal products and the well being & safety of patients. On satisfactory completion of training the physician is accredited - through the issue of a CCT from the Postgraduate Medical Education and Training Board (PMETB).
Benefits and Costs of Pharmaceutical Physician Training
The training programme provides structured and quality assured learning, professional benchmarking and broadening of the contextual perspective of the medical role in industry, ensuring physicians are aware of developments across the breadth of pharmaceutical medicine and outside their immediate job function.
For the individual, the training programme prevents pigeon-holing, widens career options and is empowering, whilst being part of life-long learning, forming continuing professional development. Education and training in PM is essential for PPs to perform the role to the standard, which will be expected for revalidation of doctors in the future.
The benefits to employers of appropriately trained and accredited professional staff lie in their increased knowledge and capability and the resulting increased efficiency, flexibility and productivity that these provide. Appropriate training lowers risk, for example of regulatory failure or pharmacovigilance crisis, and it helps career development, providing a framework for physicians' development and appraisal within the organisation.
Offering training through PMST increases employee loyalty, whilst possibly aiding recruitment of doctors and their retention within the organisation, with consequent cost-savings for the employer. The employer demonstrates a responsibility for staff development, showing that the organisation prioritises the training and development of its physicians (and other professional staff), which in turn enhances the profile, credibility and reputation of the organisation within the pharmaceutical and wider healthcare industry.
The commitment, resources and costs of any workplace training are viewed by employers also in terms of necessity, need and added value to the organisation. The costs of training PPs, over an indicative 4-year period, derive from completing the DPM, undertaking any taught courses where knowledge and experience cannot be provided in-house to meet the curricular requirements of PMST, and programme administration.
The costs of training pharmaceutical physicians, over an indicative 4-year period, derive from completing the Diploma in Pharmaceutical Medicine, undertaking any necessary taught courses where knowledge and experience cannot be provided in-house to meet the curricular requirements of the modular PMST programme, and programme enrolment, certification and administration. The direct cost of providing training (PMST) to the standard of a CCT for pharmaceutical physicians is in the range £5,000-15,000 over a 4-year period, the costs above the minimum £5,000 being dependent on the average number of external courses attended.
Common Questions and Answers
PMST is now established in the UK as the approved programme for PP training in PM and is overseen by the regulatory body for postgraduate medical education, the PMETB. PMST will not deter candidates from moving within the company to accept a position outside the UK. Regulations were changed recently so that PMST participants can continue their training outside the UK when certain conditions are met, for example the identification of a new educational supervisor.
Whilst PMST is not mandatory at present, there is a view that in future PPs wishing to work in certain roles in the industry, for example principal investigators, qualified persons, medical directors, will be required to be accredited. Thus, for organisations to fill these positions, likely to be critical to their normal functioning, PMST will have to be provided.
Concluding Comment
PM can provide dynamic and challenging careers for PPs who feel that their medical skills extend beyond individual patient encounters. Commercial acumen, management & leadership skills and an ability to communicate effectively are all hallmarks of successful doctors in the industry.
The work of PPs influences many aspects of the medical profession and of the well being and safety of patients consuming the industry's medicinal products.
Arguably, this work also represents one of society's best hopes for the development of innovations and new medicines for future healthcare. To have appropriately trained, accredited and publicly accountable physicians in these roles and undertaking this work seems a logical request and indeed an essential requirement.