From Mr A. R. Cox, MRPharmS
SIR,—Dr Tooley in his letter regarding pharmacovigilance (PJ, October 23, p671) states a need to involve pharmaceutical companies in the reporting of adverse drug reactions, and says that they should receive reports at the same time as the authorities. He goes on to say that the Medicines Control Agency only supplies anonymised information to the pharmaceutical industry, which means that follow up is not possible.
The policy of supplying anonymous data was implemented because of the concern that the reporter would be harassed by pharmaceutical companies. Indeed, such instances have occurred.1 The present yellow card system depends on mutual trust built up over many years by the Committee on Safety of Medicines and its understanding of the complex confidentiality and legal issues that are present in adverse drug reaction reporting. Also, the CSM does follow up every ADR report that merits further attention, contrary to the impression given by Dr Tooley.
The reporting rate for adverse drug reactions has been calculated to be 6.3 per cent in one general medical unit.2 The time taken to complete an adverse drug reaction report is often cited as a factor for under-reporting,3,4 so, suggesting there is a need for the pharmaceutical company to be informed at the same time as the CSM is likely to discourage spontaneous reporting. People should not be put off sending in a yellow card because of a perceived need to contact the company and the extra work this will involve.
Dr Tooley goes on to say that incorrect reporting may lead to system overload. The guidelines for submitting a yellow card are clearly laid out in the British National Formulary, and a 24-hour Freefone service is available if the reporter requires advice (0800 731 6789). I encourage people to use the forms provided in the BNF and make their contribution to pharmacovigilance.
Anthony Cox
Senior Pharmacist, City Hospital NHS Trust, Birmingham
| 1. Jones G, Mann RD. Better reporting of adverse drug reactions. BMJ 1987;294: 901-2. |
| 2. Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJM, Aronson JK et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Pharmacol 1996;42:423-9. |
| 3. Bateman DN, Sanders GLS, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern region. Ibid 1992;34:421-6. |
| 4. Belton KJ, Lewis SC, Payne S, Rawlins MD. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Ibid 1995;39: 223-6. |