Clinical pharmacology and the Faculty of Pharmaceutical Medicine

The Faculty of Pharmaceutical Medicine was founded in 1989 as one of two faculties of the three Royal Colleges of Physicians in the UK. From its inception, the Faculty has had a strong association with clinical pharmacology. Indeed, many would be surprised if it were otherwise, as clinical pharmacology and therapeutics are fundamental to the pharmaceutical business of the discovery, development and registration of drugs. The founder President of the Faculty was Sir Abe Goldberg, an academic clinical pharmacologist and a previous chairman of the Committee on Safety of Medicines, and other clinical pharmacologists were well represented on the founding committees.

The present Board of the Faculty has a standing representation from the three Colleges, with two clinical pharmacologists among the nominees. The Clinical Pharmacology Specialty Committee of the Royal College of Physicians of London also has representation on the Faculty Board.

The overarching responsibility of the Faculty is to set, maintain and raise standards of practice in pharmaceutical medicine. Members come from the pharmaceutical industry including contract research organizations and biotechnology companies, and the regulatory authorities. These organizations include physicians working as clinical pharmacologists. However, just as the discipline of clinical pharmacology has broadened to embrace newer specialties such as molecular biology and pharmaco-economics, and is responsible for standards of training in clinical pharmacology and therapeutics at undergraduate and postgraduate level, so the Faculty encompasses all the aspects one would expect to be represented in a maturing and international specialty representing 1300 members working in over 40 countries.

Where are the areas of synergy between clinical pharmacology and the Faculty and how will these evolve?

First, there is the movement of clinical pharmacologists and physicians from specialisms with allied skills into industry and regulatory authorities to take up technical and managerial positions. Movement in the other direction does occur but is unfortunately rarer.

Second, the joint industrial, National Health Service (NHS) and academic clinical pharmacology training programmes have been in place for 3 years. We can expect these to yield a continuous cadre of trained clinical pharmacologists who will have the opportunity to enter academia, the NHS or the pharmaceutical industry [1].

Third, there is the area of postgraduate training and development for pharmaceutical physicians leading to specialist certification. For academic and NHS based clinical pharmacologists, this has been in place for 3 years, and now pharmaceutical medicine is on the brink of achieving recognition in the UK as a registerable specialty. A considerable body of work has been undertaken by the Faculty Board and various subcommittees to bring this about [2], and final approval of the specialty is expected in the near future.

Pharmaceutical medicine is a very broad specialty. It encompasses physicians working in basic research, through experimental medicine to identify potentially useful surrogate markers, to running and managing phase I, II and III trials, and to pharmaco-economics and healthcare in the market-place.

Following 2 years of postregistration general professional training, a physician entering the pharmaceutical industry is entitled to register with the Faculty as an Affiliate and enter a 4 year period of higher medical training (HMT). The trainee undertakes a centralized, 2 year, modular, knowledge-based training programme followed by a written and oral examination to attain the Diploma in Pharmaceutical Medicine. At this stage the physician may become an Associate of the Faculty. There then follows a 2 year period of advanced training which is based on six practical modules, of which a minimum of two will involve the workplace. These modules are in the design stage at present and will be aimed at the acquisition and development of skills and competencies to undertake specific roles. This modular programme will be tailored to the needs of individual trainees. Completion of HMT is marked by attaining Membership of the Faculty and, it is envisaged, specialist registration.

Physicians enter the pharmaceutical industry at different points in their medical careers and, by and large, are appointed to specific posts, not primarily as trainees. To take account of this, the scheduling of the basic and advanced programmes of HMT is flexible and may overlap so that previously acquired skills can be taken into account. In recognition of physicians with significant previous experience who have passed the Diploma in Pharmaceutical Medicine and who do not wish or need to undertake HMT, there is the opportunity to submit a dissertation on work in pharmaceutical medicine which, if approved, would lead to Membership of the Faculty but not to specialty certification.

What is the importance of clinical pharmacology in this postgraduate training programme? Acquisition of knowledge about how drugs work, their limitations, the variability of response and how they can be used optimally in practice, underpins the whole of pharmaceutical medicine. The application of the skills honed through the acquisition of this knowledge varies depending on the kind of appointment. These fundamental principles are recognized in the HMT programme. The Diploma in Pharmaceutical Medicine has a significant clinical pharmacology component including a basic understanding of pharmacokinetics, drug action (pharmacodynamics), and the mechanisms underlying drug toxicity. One of the six practical modules of HMT is dedicated to clinical pharmacology and is designed to give the career pharmaceutical physician a higher level of competency in clinical pharmacology skills, thus permitting more independent and responsible levels of activity. Career industrial clinical pharmacologists aiming to be principal investigators, managing clinical pharmacology units or heading departments of clinical pharmacology will have to develop full competency in all elements of this module. It may well be that clinical pharmacology within industry will become a subspecialty in its own right, with its own specialist certification status.

Industrial and academic clinical pharmacologists are involved in lecturing on postgraduate courses in pharmaceutical medicine, and in setting and conducting the Diploma examination of the Faculty. The construction of the clinical pharmacology module for HMT is also directed by a small number of clinical pharmacologists. The next stage – the implementation – of the training programme will involve wider participation. As mentioned above, it will need to be tailored to the individual and to be supervised within the workplace. The modular programme is likely to be a mix of distance learning and formal working groups and tutorials, with appropriate assessment and appraisal steps. It is expected that different organizations – academia, industry and regulatory authorities – will ‘tender’ for different portions of these modules and be responsible for cross-employee training. These are arrangments that challenge some of the boundaries that exist between organizations, but build on a concept of the individual having responsibility for an evolving portfolio of personal development.

Clinical pharmacology, as a discipline, has well-defined and widely recognized basic principles that need to be acquired during HMT, but has a diffusion of skilled and knowledgeable personnel across academia, health groups, industry and regulatory authorities who can set standards and guide the educational programme. To deliver the information and impart the skills and competencies to pharmaceutical physicians, this clinical pharmacology diaspora will require innovative partnerships with common aims. These are goals well worth fostering for clinical pharmacology as a fundamental pillar of the Faculty and the emerging specialty of pharmaceutical medicine.