Drug interchangeability: Clinical efficacy and safety

Abstract

The paper deals with the problem of the interchangeability of brand-name and generic drugs. Touching upon official terminology and the normative documents that govern the registration of generics in Russia and foreign countries, the authors state that there is no concerted approach to estimating drug interchangeability, indicate that there are some disadvantages of using a method for proving the bioequivalence of the compared drugs as evidence for their therapeutic equivalence, and point out that Russia’s legal regulation of drug circulation lacks attention to the proper use of generics. The problem of interchangeability is particularly acute when prescribing narrow therapeutic range drugs, including anticonvulsant drugs. The results of the investigations discussed in the article demonstrate the need for a very cautious approach to using generic drugs in the therapy of epilepsy due to the fact that the disease may worsen. The authors come to the conclusion that treatment with less expensive generic drugs is far from always more economical. The change from a brand-name for a generic drug should be carefully approached, basing on the data of properly designed and conducted studies of therapeutic equivalence.

Keywords

• brand-name drug
• generic drug
• bioequivalence
• therapeutic equivalence
• narrow therapeutic range
• anticonvulsant drugs
• epilepsy