According to researchers from Brazil’s São Paulo State University, a lack of pharmacovigilance training is a key factor behind underreporting of adverse drug reactions in the country.
The researchers reviewed 29 studies that had been published over 20 years to try and identify the main causes of ADR underreporting. Over 80% of the studies had taken place in hospitals. 22 of the studies involved physicians and 10, pharmacists.
The investigators compiled a list of the “seven deadly sins” that they concluded were behind the underreporting they found –
1. Ignorance – over pharmacovigilance procedures, especially the misconception that only serious ADRs must be reported,
2. Lack of confidence – reluctance to report suspicious ADRs unless any damage was undoubtedly caused by the use of a specific drug,
3. Complacency – assuming that serious ADRs have already been well documented,
4. Fear – of litigation,
5. Guilt – caused by feeling responsible for damage observed in the patient,
6. Greed – from the ambition to publish research results for financial benefit,
7. Indifference – or lack of time, or other excuses related to postponing ADR notification.
Ignorance and insecurity were the main causes they found and were strongly linked with poor knowledge of pharmacovigilance practices amongst pharmacists and physicians. Based on their overall findings, the researchers added an eighth deadly sin regarding ADR underreporting: the lack of training on drug safety for pharmacists and physicians.
For more information on this research, see the article published in the Pharmacy Times on Thursday.
Whitehall Training has a 4 module course that covers all aspects of pharmacovigilance. The individual modules deal with, 1 - Drug Safety, 2 - Global Regulation, 3 - Audit, and 4 - Signalling and Risk Assessment. The course was written by Steve Jolley, who has 25 years’ experience in drug safety & pharmacovigilance, and is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America.
|
|
 |
|
|
Share on LinkedIn |
Share via Email |
