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.

Spontaneous adverse event notifications by patients subsequent to the marketing of a new formulation of Levothyrox® amidst a drug media crisis: atypical profile as compared with other drugs

“…Levothyrox ® and its generics have recently been under scrutiny by the French regulatory agency. This led the ANSM to authorize a nonsubstitution of the brand‐name version by its generics despite government financial constraints and the necessity to improve the pharmaceutical form of the princeps. As a result, the MAH replaced lactose, one inert reagent of the pellet, by mannitol and citric acid to increase the stability, and improved the bioequivalence.…”

Drug prescription pattern of outpatients in a tertiary care teaching hospital in Tamil Nadu

“…Moreover, a variety of strategies have been recommended by experts to overcome the barriers to genetic prescribing and the most vital of these include enforcing statutory obligations, setting clear guidelines for generic prescribing, and legally de-incentivizing prescribing by propriety name. [ 21 ]…”

Spontaneous reporting of adverse drug reactions as an outlet for patient dismay? The case of Levothyrox® change of excipients

“…The mean number of SOCs per report was significantly greater for LNF (6 AE 2, median 5 [4][5][6][7]) than for C (2 AE 1, median 1 [1-3], P < 0.001) (Figure 3a,b). The SOC distribution was similar for LNF and C except for "Gastrointestinal disorders," predominant in C, and "Investigations," predominant in LNF (Figure 4 and Table 2).…”

“…This drug is widely prescribed worldwide, with up to 2.6 million patients in France alone, and has been available for over 30 years, with no overt problem [4]. Some years ago, despite financial constraints, the Agence Nationale de Sécurité des Médicaments (ANSM) dropped the discretion given to pharmacists to substitute generics for Levothyrox ® , because of generic-associated reports of ADRs [5,6], leaving Levothyrox ® as the leading brand of its kind on the market. However, in 2017, the ANSM raised quality concerns about that brand and required its Marketing Application Holder (MAH) to meet new regulatory specifications.…”