title: Solution-driven approaches to generic substitution challenges - a survey among international experts.
abstract: The main objective of this study was to explore the perception and understanding of economic, legal, and social barriers that may restrain generic uptake among recognized international experts in health care, and to identify and verify recommendations on how to streamline generic substitution (GS) at no expense of therapeutic safety. A questionnaire survey was devised, and experts with world-renowned expertise in the field of generic medicinal products were selected. Almost 3/4 of respondents claimed that all drugs that satisfy bioequivalence criteria represent similar efficacy and adverse effects, and 1/4 of respondents believed that some differences could be reported. The majority of experts supported (i) the right of patients to refuse GS, (ii) the right of physicians to veto GS, and (iii) the introduction of a statutory obligation to provide patients with access to the cheapest generics available on the market. The main obstacles to more general uptake of generics were as follows: (i) perception of generics as lower quality products, (ii) absence of a transparent policy governing GS, and (iii) disincentives to pharmacists and physicians. Among the most popular recommendations were as follows: (i) introduction of various measures to aid physicians in generic prescribing, (ii) setting clear guidelines specifying when GS is not advisable, (iii) supporting competition on the generic market. The views of experts and the resulting recommendations were strongly affected by their opinion on the bioequivalence of generics. From this analysis, we have selected several principal recommendations which could help shape successful healthcare policies regarding GS.
authors.affiliation: Department of Pharmacoeconomics, Medical University of Warsaw, Żwirki i Wigury 81/59 str., 02-091, Warsaw, Poland.
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Drozdowska
authors.affiliation: Department of Pharmacoeconomics, Medical University of Warsaw, Żwirki i Wigury 81/59 str., 02-091, Warsaw, Poland.|Polish Society of Health Economic, Żwirki i Wigury 81/59 str., 02-091, Warsaw, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Hermanowski
mesh_terms: D000328:Adult; D011307:Drug Prescriptions; D057915:Drug Substitution / Q000009:adverse effects / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology; D016568:Drugs, Generic / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D010595:Pharmacists; D055553:Prescription Drugs / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic; D055553:Prescription Drugs
keywords: bioequivalence; experts opinions; generic substitution; patent protection; patient co-payment; patients’ rights