Jeffrey K. Aronson

A thorough analysis of a case that involves a medication that may have caused or contributed to an adverse outcome, or a comparison of two compounds in a patent dispute, requires consideration of many processes that affect the clinical effects of a medication. These include its chemical structure, its pharmacological actions (pharmacodynamics), the pharmaceutical formulation, and its absorption, distribution, metabolism, and excretion (pharmacokinetics). They also include analysis of clinical details, including the diagnosis, the quality of the prescribing decisions, the accuracy of the prescription, dispensing, and administration of medications, and how appropriately the case was managed, including monitoring. A causality assessment should be attempted for both the general case and the particular case. Knowledge of the systems that describe a medication's mechanisms of action (EIDOS) and the dose-relationships and time-courses of adverse outcomes and individual susceptibilities to them (DoTS) can inform several aspects of the analysis. Reports should be written in clear English and should not contain statements that rely on expertise that the expert does not possess.

Since the discipline expanded during 1970–1990, the number of UK consultant clinical pharmacologists has fallen. This paper describes the results of a questionnaire survey of the work patterns of 53 UK consultant clinical pharmacologists, including 35 (66%) employed by universities and 13 (25%) employed by the National Health Service (NHS). The range of activities undertaken includes: teaching medical students and others the principles of clinical pharmacology and practical therapeutics; research in a wide range of pharmacological and therapeutic areas; patient care, mostly in acute and general hospital medicine and in out‐patient clinics; service both locally and nationally on a wide range of committees related to drug therapy; editorial work on learned journals and preparation of written teaching materials, including journal articles, didactic textbooks, reference books, and e‐learning materials. The median amount of time that a UK consultant clinical pharmacologist spends on these activities is 50 hours per week; several work more than that. The time is spent as follows: teaching 10%; research 40%; clinical work 30%; policy and administration 12%; editorial work and writing 8%. The numbers of physicians who have been newly registered with the General Medical Council as clinical pharmacologists each year has so far been undiminished, but the number of consultant posts has fallen in 1990–2010. Many trainees therefore leave the discipline when they become consultants.

1 This is a manifesto for UK clinical pharmacology.2 A clinical pharmacologist is a medically qualified practitioner who teaches, does research, frames policy, and gives information and advice about the actions and proper uses of medicines in humans and implements that knowledge in clinical practice. Those without medical qualifications who practise some aspect of clinical pharmacology could be described as, say, ‘applied pharmacologists’.3 Clinical pharmacology is operationally defined as a translational discipline in terms of the basic tools of human pharmacology (e.g. receptor pharmacology) and applied pharmacology (e.g. pharmacokinetics) and how they are used in drug discovery and development and in solving practical therapeutic problems in individuals and populations.4 Clinical pharmacologists are employed by universities, health‐care services, private organizations (such as drug companies), and regulatory agencies. They are• mentors and teachers, teaching laboratory science, clinical science, and all aspects of practical drug therapy as underpinned by the science of pharmacology; they write and edit didactic and reference texts;• researchers, covering research described by the operational definition;• clinicians, practising general medicine, clinical toxicology, other medical specialties, and general practice;• policy makers, framing local, national, and international medicines policy, including formularies, licensing of medicines and prescribing policies.5 The future of clinical pharmacology depends on the expansion and maintenance of a central core of practitioners (employed by universities or health‐care services), training clinical pharmacologists to practise in universities, health‐care services, private organizations, and regulatory agencies, and training other clinicians in the principles and practice of clinical pharmacology.