The paper outlines the role of the Swedish Medical Products Agency (Läkemedelsverket) in managing medicine shortages. The agency receives reports from pharmaceutical companies, investigates causes, and disseminates information to pharmacies, healthcare providers, and the public. While focusing on mitigating shortages, the agency clarifies its non-involvement in manufacturing or sales decisions.
View Article and Find Full Text PDFBackground: Chloroquine and hydroxychloroquine (C/HC) received considerable international media attention due to anticipated treatment effect in COVID-19. This led to increased prescriptions threatening to generate product shortages for patients prescribed within approved indications.We evaluated effects of a temporary regulation mandating pharmacies to only dispense C/HC prescribed by physicians with defined specialties.
View Article and Find Full Text PDFPost-marketing reports of suspected adverse drug reactions are important for establishing the safety profile of a medicinal product. However, a high influx of reports poses a challenge for regulatory authorities as a delay in identification of previously unknown adverse drug reactions can potentially be harmful to patients. In this study, we use natural language processing (NLP) to predict whether a report is of serious nature based solely on the free-text fields and adverse event terms in the report, potentially allowing reports mislabelled at time of reporting to be detected and prioritized for assessment.
View Article and Find Full Text PDFReporting of suspected adverse drug reactions (ADRs), from healthcare professionals and from consumers, contributes to early detection of new safety risks with medicines. The reporting of adverse reactions has been working well during the pandemic but indicates at the same time a significant under-reporting (hidden statistics). The propensity to report clearly increases with enhanced communication.
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