Our French sister publication La Revue Prescrire annually publishes an overview of ‘drugs to be avoided’. Although these drugs have market authorisation, their efficacy is often unproven, and they may have serious or frequent side-effects, and all in all they do more harm than good. The purpose of the list is to inform general practitioners, specialists and pharmacists about these drugs and to prevent them being prescribed to patients. The article presented in this issue of Gebu is the first in a series based on the overview of drugs to be avoided, and has been adapted to the Dutch situation. Each instalment will discuss drugs from one pharmaceutical category. The present article first presents a general explanation of the systematic procedure followed in drawing up the list, after which the first category, those for cardiovascular diseases, is discussed. (Gebu 2017; 51: 79-84)
The overview lists drugs with an unfavourable balance between efficacy and side-effects for the applications for which they have been authorised.
Drugs with no proven efficacy but with serious side-effects, or drugs whose efficacy is comparable to that of other drugs for the same application but which have more side-effects, should not be prescribed by specialists or automatically continued by GPs. Registration authorities and health agencies should undertake concrete steps to protect patients and promote the use of treatments with an acceptable balance between efficacy and side-effects. They could also apply stricter requirements when it comes to proving the efficacy of a drug on hard endpoints, in case a drug is authorised on the basis of favourable findings on surrogate endpoints. Drugs are currently being put on the market without proof that their efficacy is greater than that of comparable drugs that are already on the market. It is sufficient that their efficacy is equivalent, and the margins for equivalence are often very wide. In addition, the studies used to apply for market authorisation yield insufficient data to fully map the side-effects of a drug. If in practice the drug proves to have more, or more serious, side-effects after all, it is not easy to have the authorisation withdrawn.
A positive development is that these ‘drugs to be avoided’ are not commonly included in Dutch guidelines. Nevertheless, although their use in actual practice appears to be limited, in absolute numbers it still involves tens of thousands of patients. Professional associations could be even more reticent about including new drugs in their guidelines. It is only after their efficacy has been proven in multiple randomised studies on hard endpoints that new drugs should be definitively included in guidelines. If medical practitioners fully adhered to such guidelines, drugs with unproven efficacy and possibly unknown serious side-effects would hardly ever be used.
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*The literature refers to the Dutch text