Newly licensed drugsBMJ 1996; 313 doi: https://doi.org/10.1136/bmj.313.7066.1157 (Published 09 November 1996) Cite this as: BMJ 1996;313:1157
- R E Ferner
- Consultant physician West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham B18 7QH
Should be on probation until their value is demonstrated
The Medicines Act 1968 set up a licensing authority that grants a marketing authorisation (product licence) for a medicinal product only if it is effective and safe and of good quality. Once licensed, a drug can usually be prescribed by any doctor under the NHS. But general use of a newly licensed drug may be undesirable.
Firstly, the licensing process cannot define uncommon adverse effects. It is easier to measure common therapeutic benefits than rare, but important, reactions. The numerical problem is daunting. If n patients have been treated, and none has suffered a particular adverse effect, then we can be 95% sure that the true incidence of that adverse effect is between 0/n and 3/n.1 Licensing decisions are based on trials involving on average around 1500 patients,2 so at the time of licensing, a serious reaction that affects as many as 1 in 500 patients could be undetected, and undetectable. Britain's Committee on Safety of Medicines asks for “yellow card” reports of any reactions to newly licensed medicines, marked with an inverted black triangle. A post marketing surveillance scheme, which monitors prescriptions and adverse events, exists only in general practice. Both schemes rely on the good will of prescribers rather …