Education And Debate

Towards the safer use of medicines

BMJ 1995; 311 doi: (Published 14 October 1995) Cite this as: BMJ 1995;311:1003
  1. A W Asscher, chairmana,
  2. G D Parr, honorary secretarya,
  3. V B Whitmarsh, chairman of pharmacoepidemiology groupa
  1. aMedical Benefit/Risk Foundation, London W1M 8AE
  1. Correspondence to: Professor Sir William Asscher, Principal's Office, St George's Hospital Medical School, London SW17 0RE.
  • Accepted 26 June 1995

In Britain the tools are now available to provide better information on safety of medicines in both hospital and community settings, and this could be done at relatively modest cost. The needs of patients, doctors, and pharmacists are changing; although more research is needed, such information as is presently available must be both better and more widely publicised and understood. Universities, government, the pharmaceutical industry, and educated journalism all have an important part to play in this process.

Some 2500 drugs are listed in the British National Formulary, and biotechnology will soon provide even more. An aging population with multiple illnesses will increasingly challenge therapeutic skills (figure).1 2 Patients are asking for more information, which comes from various sources. Both doctors and patients are likely to be confused, and this will have a detrimental effect on the use of medicines. No human activity is risk free--cycling, driving, or even crossing the road carry surprisingly high risks.3 Taking modern medicines is a relatively safe activity,4 but because risks can never be wholly eliminated, vigilance and continuous re-evaluation are required.

Survival curve. Adapted from Coni et al48; reproduced with permission of Blackwell Science

Definitions and size of the problem

Adverse drug reactions are unwanted or unintended effects of a medicine which occur during its proper use. Adverse events are untoward occurrences following exposure to a medicine but not necessarily caused by the medicine. Most doctors understand risk to be the probability of a particular adverse outcome following exposure to a given amount of hazard. Other disciplines--and indeed patients--often use different definitions, and this may be a source of confusion in discussions between doctors and their patients.

When a product licence is granted, little is known about the safety of the new drug; on average only about 1500 patients have been exposed to it.5 Therefore …

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