ABSTRACT
Hybrid medicines are defined as medicines that do not fill generic medicines' definition, forming a medicines group that stands half-way between reference medicinal products and generic medicines. The term "hybrid" was introduced in France in 2018, but the concept has existed for some fifteen years in Community legislation. The aim of this work is to expose hybrid medicines' legal framework, in Europe and in France. Hybrid medicines' European legal framework specifies in a guide of the European Medicines Agency, marketing authorization procedures that can be used for hybrid medicines, and what is required for marketing authorization applications. In France, a register of hybrid medicines' groups has been created, and registration procedures were specified in a decree at the end of 2019. Legal texts also underlined that substitution within hybrid medicines' group would be possible for some specific medical cases. Decrees specifying hybrid medicines' groups list and specific medical cases allowing substitution, are not appeared yet at the end of February 2021. Moreover, some elements have never been raised, particularly medical and economic assessment modalities.
Subject(s)
Drugs, Generic , Marketing , Europe , FranceABSTRACT
OBJECTIVES: The aim of this study is to give an overview of hybrid medicines, term introduced in France by the Social Security Financing Act for 2019, with special attention to those available in Paris Public Hospitals (AP-HP), and to analyze their therapeutic values and economic issues. METHODS: Research by keywords on European and French health authorities' websites was done to provide a list of hybrid medicines. Then, an analysis of their profile and of their differences from reference medicinal products was done. A reflection on hybrid medicines likeness to "new medicines" or to "generic medicines" was carried out. Lastly, their therapeutic interests, their risks and their costs were assessed. RESULTS: In France 85 hybrid medicines were identified, including 41 commercialized, and 21 available in AP-HP. Six different types of differences from the reference medicinal product were found out. Over 90% of hybrid medicines show at least one interest compared to the reference medicines, even if it is not a major innovation. However, more than a third of hybrid medicines are associated to a risk in case of drug substitution with the reference medicinal product. Hybrid medicines costs appear to be lower than reference medicines, but with smaller discounts than what is usually observed with generic medicines. CONCLUSION: Hybrid medicines constitute a very heterogeneous population, whether in terms of differences from reference medicines, of interests or risks. Common rules development for all hybrid medicines may be complex and would require taking every couple hybrid/reference medicines specificities into account.
Subject(s)
Drugs, Generic , Hospitals, Public , France , ParisABSTRACT
OBJECTIVE: We aimed to document amoxicillin-clavulanic acid prescription to improve the proper use of antibiotics in hospital settings. We used three criteria: quality of medical charts, adequacy of indications, and adequacy of treatment duration. METHOD: This study was designed as a one-day point prevalence survey carried out by antibiotic lead specialists. RESULTS: We included 387 prescriptions from 32 hospitals. Immunodeficiency was recorded as a risk factor in 30% of patients. Computerized prescriptions were observed in 79% of cases. The indication was mentioned in 73% of cases and a 48/78-hour re-assessment of the antibiotic therapy was performed in 54% of cases. The antibiotic indication was primarily for pneumonia and was deemed appropriate in 75% of patients. Adult mean treatment duration was 11.1 days. Use of dual combination therapy and/or treatment duration exceeding two weeks accounted for the main reasons for an inappropriate use of antibiotics. Prescriptions recorded as having been made by senior physicians were of the shortest treatment duration (P=0.0163). CONCLUSION: Medical charts should be better filled in. Reinforcing the role of senior physicians in supervising antibiotic prescriptions is likely to result in a better control of treatment duration and ultimately in a reduced antibiotic consumption. By reinforcing the collaboration between pharmacists and antibiotic lead specialists, the improvement of computerized prescriptions at hospital level should help better detect the "at risk" prescriptions, namely those exceeding seven days or those combining antibiotics.
