Drug Safety
-
Problematic prescription drug use is reflected by or associated with drug-seeking aberrant behaviours. Research gaps include lack of post-marketing evidence and instruments. As part of the pharmacovigilance requirements, a risk management plan was developed for fentanyl buccal tablets (FEBT) by the manufacturer, with an additional pharmacovigilance activity requested by the regulatory authority, to investigate the risks of misuse, abuse, criminal use, off-label use and accidental exposure to FEBT after the product became commercially available. A Modified Prescription-Event Monitoring (M-PEM), observational, post-authorisation safety surveillance (PASS) study was conducted, with an overall aim to examine the use of FEBT in relation to their safety as prescribed in primary care in England. One of the exploratory objectives included estimating the prevalence of aberrant behaviours during FEBT treatment. ⋯ In this PASS study, the prevalence of at least one pre-existing risk factor for dependence was 26%, whilst the frequency of aberrant behaviours observed during treatment was 8%. Patients with aberrant behaviours had several different characteristics to patients without. This study demonstrates the feasibility of the systematic collection of physician reports of risk factors for dependence and aberrant behaviours to facilitate the development of risk scores, using these reports to support the post-marketing risk management of products with misuse potential.