Generic drug prescribing in primary care: A nationwide analysis

Bayram, Dilara; Aydın, Volkan; Gelal, Ayşe; Aksoy, Mesil; Akıcı, Ahmet

doi:10.1111/ijcp.14284

Cited by 3 publications

(1 citation statement)

References 36 publications

(76 reference statements)

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“…Correspondingly, generic drugs refer to the equivalent substitute manufactured based on the original drug formula, which is the same as brands in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use ( Rana and Roy, 2015 ). Since generic drugs usually have a lower cost of running and market prices than brands, they have accounted for a significant share of the global pharmaceutical market, accounting for 86% in the United States, 68.6% in Canada, and 17%–83% in Europe ( Bayram et al, 2021 ). Generic drugs have indeed become the cornerstone for providing affordable medicines to patients.…”

Section: Introductionmentioning

confidence: 99%

Contrastive analysis on the safety of brand and generic nebivolol: a real-world pharmacovigilance study based on the FDA adverse event reporting system

Wang,

Zhong,

et al. 2024

Front. Pharmacol.

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Background: The equivalence of generic drugs to their brand-name counterparts is a controversial issue. Current literature indicates disparities between the generic nebivolol (GN) and the brand nebivolol (BN).Aim: The study is designed to investigate the safety difference between GN and BN and provide reference information for clinical practice.Methods: We reviewed adverse event (AE) reports that recorded nebivolol as the primary suspect drug in the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2022, conducted a disproportional analysis to detect signals for the GN and BN respectively, and compared the AE heterogeneity between them using the Breslow-Day test.Results: A total of 2613 AE reports of nebivolol were recorded in the FAERS database from 2004 to 2022, of which 2,200 were classified as BN, 346 as GN, and 67 unclassifiable AE reports were excluded. The signals of 37 AEs distributed in cardiac, gastrointestinal, psychiatric, and nervous systems were detected in disproportional analysis. 33 out of 37 AEs were positive signals, with 21 not previously listed on the drug label, indicating an unrecognized risk with nebivolol. In the heterogeneity analysis of AE signals between GN and BN, the GN generally showed a higher AE signal value than BN, especially 15 AEs distributed in the cardiac, neurological, and psychiatric systems that showed statistically significantly higher risk by taking GN.Conclusion: Our study shows some previously overlooked adverse effects of nebivolol. It suggests that the risk of GN’s adverse effects may be higher than those in BN, which deserves further attention and investigation by healthcare professionals, regulators, and others.

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Section: Introductionmentioning

confidence: 99%

Contrastive analysis on the safety of brand and generic nebivolol: a real-world pharmacovigilance study based on the FDA adverse event reporting system

Wang,

Zhong,

et al. 2024

Front. Pharmacol.

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Pharmacy practice and policy research in Türkiye: a systematic review of literature

Gülpınar,

Pehlivanlı,

Babar

2024

Journal of Pharmaceutical Policy and Practice

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Background In recent decades, there has been an interest in clinical pharmacy practice in Türkiye with emerging studies in this area. Despite the recent emergence of diverse pharmacy practice studies in Türkiye, a comprehensive assessment of overall typology of studies and impact has not been conducted thus far. Objectives This systematic review aims to document and assess pharmaceutical policy and practice literature published within the last 5 years in Türkiye. The other aim is to summarise the expected impact of published studies on policy and practice research. Methods The systematic review was conducted according to the guidelines described in the PRISMA Statement. A comprehensive search approach, incorporating Medical Subject Headings (MeSH) queries and free-text terms was employed to locate pertinent literature related to pharmacy practice and policy in Türkiye. The search covered the period from January 1, 2019, to January 1, 2024, and involved electronic databases including PubMed, Medline Ovid, Scopus, ScienceDirect, Springer Link, PlosOne, and BMC. Results In the final grouping, 73 articles met the inclusion criteria and were selected for this review. Among the quantitative studies, majority studies were cross-sectional survey studies. Through the rigorous thematic content analysis seven research domains were developed from the selected literature: drug utilisation and rational drug use, the emerging role of pharmacist, access to medicines and generic medicines, community pharmacy practice, pharmacovigilance/adverse drug reactions, and pharmacoeconomic studies. Conclusions The pharmacist role is evolving; however, several challenges remain in fully realising the potential of pharmacists. These include regulatory barriers, limited public awareness of pharmacists’ expanded roles, workforce capacity issues, and the need for ongoing professional development and training. Research studies are needed in the areas of generic prescribing, medicine adherence, intervention studies in community and hospital pharmacy practice, and on pharmacoeconomics and pharmacovigilance.

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Improving access to medicines by popularising generics: a study of ‘India’s People’s Medicine’ scheme in two districts of Maharashtra

Lavtepatil

Ghosh

2022

BMC Health Serv Res

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Background In spite of being the ‘pharmacy of the world’, access to essential medicines for a large majority of Indians is constrained by both physical and financial reasons. According to an estimate, medicines account for 69% of household out-of-pocket spending on health care. To make quality generic medicine affordable, India’s People’s Medicine Scheme (Jan Aushadhi) was launched in 2008 and then revamped and rebranded as Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP) in 2015. The current study focuses on the availability, affordability and acceptability aspects of PMBJP essential medicines. Methods We have used a mixed-methods approach, with the survey-based quantitative component supplemented by a qualitative component consisting of in-depth interviews (IDIs). The survey was conducted in 11 PMBJP pharmacies in Mumbai and Palghar. Data were gathered on the availability, stock-outs, price and affordability of 35 essential medicines and 2 consumables. Results Apart from the limited coverage of essential medicines and the significant presence of Fixed dose combinations (FDCs) in the PMBJP medicine list, the availability of surveyed essential drugs was also found to be low (47%) in PMBJP outlets. Across Mumbai and Palghar districts, around 50% and 42% of medicines were found to be out of stock for the period of 3–6 months respectively. The cost of generic medicines of PMBJP outlets for treating various conditions range from 0.01 days’ wages to 0.47 days’ wages for the lowest paid unskilled worker in Maharashtra. Conclusions The study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings. But, in order to fully realise the potential of this scheme, some policy actions are urgently required. First, the PMBJP drug list must include all essential drugs that feature in NLEM. Second, BPPI should procure only those drugs that pass the bioequivalence test. Third, compulsory de-branding of generics should be done in a phased manner. Fourth, PMBJP’s medicine procurement and distribution policies must be reviewed to address the supply chain issues. Moreover, there is a need for major pharmaceutical policy reforms to promote generic medicines in a big way. Regulations to support mandatory generic prescribing and generic substitution by pharmacists are needed.

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Generic drug prescribing in primary care: A nationwide analysis

Cited by 3 publications

References 36 publications

Contrastive analysis on the safety of brand and generic nebivolol: a real-world pharmacovigilance study based on the FDA adverse event reporting system

Contrastive analysis on the safety of brand and generic nebivolol: a real-world pharmacovigilance study based on the FDA adverse event reporting system

Pharmacy practice and policy research in Türkiye: a systematic review of literature

Improving access to medicines by popularising generics: a study of ‘India’s People’s Medicine’ scheme in two districts of Maharashtra

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