A consistent and uninterrupted supply of pharmaceuticals is essential for optimal pharmacotherapy. However, some cases of supply disruptions and recalls have been reported. In particular, the withdrawal of some drugs from the market was occurred in recent year. Nevertheless, the characteristics of these drugs were unknown. The aim of this study was to analyze the ratio of generic drugs and the profile of generic drugs that have been withdrawn from the market. Data were collected from a drug information database for the period between April 2017 and March 2022 and analyzed for characteristics, such as price, number of suppliers, and reasons for withdrawal. The results showed a 1.4-fold increase in the number of drugs discontinued in 2021 compared with that in 2017, with 78.6% of the drugs discontinued being generic drugs. The proportion of discontinued generic drugs costing less than 10 yen (29.2%) was higher than those remaining on the market (15.0%). Additionally, the proportion of withdrawn generic drugs sold by four or more suppliers (67.6%) was higher than those that remained in the market (38.4%). In most cases (78.8%), the reasons for the discontinuation of these generic drugs were not disclosed. This study showed that most drugs withdrawn in Japan during the study period were generic drugs, characterized by low prices or many suppliers. Our study contributes to the understanding of the instability in the pharmaceutical supply chain in Japan.
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http://dx.doi.org/10.1248/yakushi.23-00098 | DOI Listing |
Arch Dermatol Res
January 2025
Department of Pharmacy, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia.
Background: Topical steroids are widely used in dermatology for their anti-inflammatory and immunosuppressive effects, but misuse can cause skin thinning and systemic issues. In Ethiopia, where skin conditions are common, understanding how topical steroids are prescribed and used is essential for ensuring their safe and effective use.
Objective: The study aimed to assess topical steroids' prescription and utilization pattern in Dessie Comprehensive Specialized Hospital (DCSH) from February 1 to May 30, 2024.
Bull World Health Organ
January 2025
Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
Objective: To investigate access to essential anticancer medicines for children throughout China.
Methods: We obtained cross-sectional drug use data for 2021 from 55 tertiary children's hospitals in seven geographical regions (one third of public children's hospitals in mainland China). Affordability was assessed by comparing the single-day copayment for each medicine with the same generic name and route of administration (i.
AAPS PharmSciTech
January 2025
Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, Texas, USA.
Poly(lactide-co-glycolide) (PLGA) is widely used in a variety of long-acting injectables. However, its biodegradable nature creates potential chemical stability challenges during melt extrusion, where PLGA is exposed to elevated temperature (100-140 °C) for several minutes. This study evaluated the thermal stability of three PLGA grades (Resomer® 502, 502H, and 505) with varying molecular weights and chain-ends using a differential scanning calorimeter and twin-screw extruder.
View Article and Find Full Text PDFJ Pharm Biomed Anal
December 2024
Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, St. Louis, MO 63110, USA.
With recent advances in quantitative high-resolution mass spectrometry (HRMS), there is growing interest in developing liquid chromatography (LC)-HRMS methods that can simultaneously quantify numerous critical impurities in a peptide or protein drug. This approach is attractive as it could reduce the total number of methods and instruments required during product development and quality control testing, while taking advantage of the technique's high specificity and sensitivity. To investigate the feasibility of this approach for peptide drugs, an LC-HRMS method was validated for the quantification of six peptide-related impurities in teriparatide, the 34-amino acid active ingredient in Forteo.
View Article and Find Full Text PDFBackground And Objectives: Generic formulations of glatiramer acetate have been available since 2015 yet remain underprescribed relative to the branded product. We sought to characterize the association between branded glatiramer prescribing in the Medicare program and financial payments from the manufacturer (Teva Pharmaceuticals).
Methods: Using publicly available Medicare Part D and Open Payments data from the Centers for Medicare and Medicaid Services, we evaluated overall utilization from 2012 to 2021 and compared the prevalence, frequency, and magnitude of financial payments made in 2019 to neurologists who prescribed branded and generic versions of glatiramer in 2020.
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