E-DRUG: The seven-year rule for safer prescribing (4)
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Dear E-druggers,
Wolfe raises important points regarding the paucity of safety information at the time a new drug is approved for marketing because of the relatively short duration of clinical trials and the strictly controlled non-representative subjects population. In the UK, every new drug carries a black triangle and healthcare professionals as well as patients are encouraged to report every suspected adverse reaction including minor ones.
This intensive monitoring is meant to ensure that any new safety hazards are identified promptly but I would be interested to know if there is any difference between the UK/EU and the US in the time it takes for a regulatory decision to be made to either restrict use or withdraw from the market.
It appears to me though that what is needed is a more nuanced approach than a blanket seven year rule. Surely, we can accept a high risk to benefit ratio if the new drug is for the treatment of terminally ill patients where, even if it is not a break through, the quality of life might be enhanced.
If, on the other hand, the new drug is for the treatment of self-limiting conditions or for prophylaxis then it makes sense to expect a low risk to benefit ratio. Were it to be widely adopted, the seven year rule could hypothetically delay the accumulation of adequate safety information even further.
It is a difficult balance but we simply won't know how safe the new drug is until enough people have been exposed to it.
regards,
Cephas Dzuda MPH, MSc
Prescribing Support Pharmacist
cephasdzuda@msn.com