Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice
| Autor: | Elena Wolff-Holz, Niels S. Vermeer, Sofia Zastavnik, Ana Hidalgo-Simon, Thijs J. Giezen |
|---|---|
| Přispěvatelé: | Pharmacy |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions 030226 pharmacology & pharmacy Article Pharmacovigilance 03 medical and health sciences 0302 clinical medicine medicine Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) Drug reaction Intensive care medicine Biosimilar Pharmaceuticals Pharmacology Biological Products business.industry Research Treatment options Biosimilar Articles medicine.disease Europe Clinical Practice 030220 oncology & carcinogenesis Identifiability business Adverse drug reaction |
| Zdroj: | Clinical Pharmacology and Therapeutics Clinical Pharmacology & Therapeutics, 105(4), 962-969. Wiley-Blackwell |
| ISSN: | 1532-6535 0009-9236 |
| DOI: | 10.1002/cpt.1310 |
| Popis: | Biologicals are established treatment options that require pharmacovigilance adapted to their specific nature, including the need for products to be identifiable up to the specific manufacturer in reports of adverse drug reactions (ADRs). This study explored the identifiability of 10 classes of similar and related biologicals up to the level of the manufacturer in ADR reports received from European clinical practice between 2011 and June 2016. Adequate identifiers were reported for 96.7% of the suspected biologicals, ranging from 89.5% for filgrastim to 99.8% for interferon beta-1a. The product identifiability remained consistently high over time for classes of biologicals for which biosimilars were introduced during follow-up. The overall batch traceability was, however, only ensured for 20.5% of the suspected biologicals and needs further improvement. This study shows that the European system for identification of ADRs to the level of the manufacturer is robust, allowing for the timely detection of potential product-specific safety signals for biologicals. |
| Databáze: | OpenAIRE |
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