Widespread hyoscine hydrobromide toxicity due to contract manufacturer malpractice : the travacalm episode
| Autor: | Larry F Kelly, John McEwen, Patrick M Purcell, Adrian S Krauss, Barry R Thompson |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Adult
Male medicine.medical_specialty Contract manufacturer Drug Industry Motion Sickness Scopolamine Contracts Toxicology Malpractice Pharmacovigilance medicine Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) Intensive care medicine Child Pharmaceutical industry Pharmacology Highly skilled Hydrobromide business.industry Australia Middle Aged medicine.disease Surgery Toxicity Drug and Narcotic Control Female business Adverse drug reaction Tablets |
| Zdroj: | Drug safety. 30(5) |
| ISSN: | 0114-5916 |
| Popis: | An outbreak of hyoscine hydrobromide toxicity was detected through the Australian pharmacovigilance system. The unexpectedly wide variation in hyoscine hydrobromide content between individual tablets within single packets created difficulties in initially explaining the clinical experiences. Strict time requirements for review of incoming adverse drug reaction reports and close involvement of the highly skilled national drug regulatory laboratory resulted in early identification of the cause of the outbreak and led in turn to the identification of malpractice by the contract manufacturer. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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