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- Title
Preventability of adverse effects of analgesics: analysis of spontaneous reports.
- Authors
Cazacu, Irina; Miremont-Salamé, Ghada; Mogosan, Cristina; Fourrier-Réglat, Annie; Loghin, Felicia; Haramburu, Françoise
- Abstract
Objectives: The aims of this study were to determine the patterns of analgesic adverse drug reactions (ADRs) and to assess their preventability and contributing factors. Methods: This is a retrospective, descriptive study conducted on ADRs of analgesics and other drugs indicated as analgesics, spontaneously reported to the Bordeaux pharmacovigilance center from January 2011 to June 2012. Results: The 141 cases selected for the analysis included 16 cases of medication errors (11.3 %) and 15 addiction cases (10.6 %). In total, 214 ADRs were registered, for which 173 analgesic medicines were suspected. The most frequent ADRs reported were nervous system disorders (26.6 %), psychiatric disorders (15.0 %), and skin and subcutaneous tissue disorders (12.1 %). Tramadol alone or in combination (17.3 %), followed by morphine (15 %), fentanyl (9.8 %), and paracetamol (8.7 %) were the most frequently involved analgesics. More than half of the cases (54.6 %) were serious and led to hospitalization or prolonged hospitalization. Preventability was determined for 134 cases (95 %): 51.5 % were considered as preventable, 26.1 % not preventable, and 22.4 % not assessable. The main contributing factors for the preventable cases included negligence of recommendations for analgesic use and failure to consider patients' risk factors when prescribing. Conclusions: A significant number of analgesic ADRs could be prevented, and being aware of their contributing factors promotes efficient analgesia with minimum risks to the patients.
- Subjects
PREVENTION of drug side effects; ANALGESICS; RESEARCH methodology; PHARMACOLOGY; RESEARCH funding; RETROSPECTIVE studies
- Publication
European Journal of Clinical Pharmacology, 2015, Vol 71, Issue 5, p625
- ISSN
0031-6970
- Publication type
Article
- DOI
10.1007/s00228-015-1829-8