Search

The article presents a review of modern regulatory and legal framework and draft regulatory documents on circulation of interchangeable drugs with regard to standard instructions for medical use. The analysis included more than 70 documents. There are two slightly different notions in this field: a generic drug and an interchangeable drug. A generic drug is not necessarily an interchangeable drug. The interchangeability of a drug is determined during pre-marketing evaluation. Some differences concerning normative requirements to the content of standard instructions for interchangeable drugs have been observed when comparing the regulatory framework of Russia, CIS countries and the EU. It is necessary to look not only at bioequivalence as an equivalent of interchangeability, but also take into account characteristics of excipients, and therapeutic equivalence based on preclinical and clinical trial results. The analysis of differences in regulatory documents can form the basis for further harmonization of requirements to instructions for medical use of interchangeable drugs.

The article discusses the results of an opinion poll among healthcare professionals and pharmacists devoted to finding out their attitude to the main problems associated with instructions for medicinal products. It was discovered that there was a lack of consensus on what could be regarded as official and unofficial sources of information about medicinal products. The poll elicited the attitude towards instructions for medicinal products among specialists and, indirectly, the general public, and helped establish a need for introducing changes into the instruction form.

The article summarises the results of a 2015 survey of healthcare professionals and pharmacists that was aimed to reveal their educational needs on the subject of interchangeable medicines. It was discovered that the respondents were not sufficiently informed about interchangeability of medicines, because independent exploration of regulatory framework does not help to get to know this topic well enough. The survey helped to identify a group of specialists who needed training in «interchangeability of medicines» more than others.