Communicating information about drug safetyBMJ 2006; 333 doi: https://doi.org/10.1136/bmj.333.7559.143 (Published 13 July 2006) Cite this as: BMJ 2006;333:143
- R E Ferner, director (email@example.com)1,
- J K Aronson, reader in clinical pharmacology2
- 1 West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham B18 7QH,
- 2 University Department of Clinical Pharmacology, Radcliffe Infirmary, Oxford OX2 6HE
- Correspondence to: R E Ferner
- Accepted 19 May 2006
Prescribers and patients need information about the established harms of a drug as well as its benefits. This information helps prescribers to calculate the likely balance of benefit to harm before prescribing a drug. It also enables them to avoid using a drug in circumstances of particular risk (for example, renal insufficiency), to choose preventive strategies (for example, using a bisphosphonate to prevent glucocorticoid induced osteoporosis), to know when to monitor for harm when the risk is defined (for example, regular blood counts in patients taking clozapine), and to recognise an adverse reaction when it occurs. Patients need to know about harms for similar reasons. They need to be able to decide whether the likely benefit outweighs the potential harm. They may be more aware than the prescriber of circumstances that prevent their taking the drug. And it is in their interest to be alert to the possibility that an unwanted event that occurs while they are taking the drug is an adverse drug reaction. What is the best way to provide information about drug harms?
Ideally, prescribing information should list the potential harmful effects of every drug together with the following information about each effect: its relation to the dose, its time course, the factors that alter an individual's susceptibility to it, its seriousness, and the probability of it occurring, at least in the population and preferably in the individual.
In practice, however, this information is rarely available, for several reasons. Firstly, most drug studies focus on benefits and are relatively poor at detecting harms, for which larger studies are required. Harms can be hard to detect for reasons that relate to the …