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- Title
Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance.
- Authors
Kaplan, Sigal; Bergamasco, Aurore; Sergerie, Martin; Castilloux, Anne-Marie; Moride, Yola
- Abstract
<bold>Background: </bold>Fentanyl buccal tablet (FBT), a potent opioid, was approved in Canada in 2013 for breakthrough pain in opioid-tolerant adult cancer patients. Additional risk minimization measures (aRMMs), consisting of communications to patients and healthcare providers (HCPs), were implemented from November 2014 through September 2015.<bold>Objectives: </bold>The aim of this study was to assess the effectiveness of FBT aRMMs as measured by prescriber knowledge, understanding, and behavior regarding key safety concerns (off-label use, use in non-opioid-tolerant patients, misuse/abuse/diversion, and drug-drug interaction) and to evaluate illicit FBT use.<bold>Methods: </bold>The study included three components: (1) a knowledge and understanding (KAU) survey of FBT prescribers conducted in two waves: November 2016-February 2017 and April-September 2018; (2) a retrospective prescription study of medical records of patients treated with FBT by a subgroup of prescribers from the KAU survey; and (3) Web surveillance of illicit FBT use in Canada using the search term FENTORA (May 2014-September 2018). The aRMMs were considered effective if the lower bound of the 95% confidence interval indicated that at least 65% of respondents met or partly met the knowledge objective for each key safety concern.<bold>Results: </bold>KAU survey: Of 46 eligible HCPs, 97.8% met or partly met the knowledge objective on use in breakthrough pain cancer patients, 97.8% on use in opioid-tolerant patients, 89.1% on dose and titration, 100% on abuse/addiction, and 58.7% on drug-drug interaction. Retrospective prescription study: Of 22 FBT-treated patients identified from 14 HCPs, 45.5% had cancer, 50.0% recorded a breakthrough pain indication, and 36.4% reported opioid tolerance; however, only 13.6% of patients were prescribed FBT according to the approved indication. Web surveillance: Of 932 FBT posts in Canada, only 40 (4.3%) mentioned illicit use.<bold>Conclusions: </bold>The aRMMs as measured by the prescriber KAU were effective for most key safety messages; however, not all key messages of the aRMMs were stringently followed in routine practice.
- Subjects
CANADA; BREAKTHROUGH pain; CANCER patients; MEDICAL records; CANCER treatment; OPIOIDS; NARCOTICS; DRUG tablets; RESEARCH; ANALGESICS; RESEARCH methodology; FENTANYL; RETROSPECTIVE studies; BEHAVIOR; EVALUATION research; MEDICAL cooperation; COMPARATIVE studies; BUCCAL administration
- Publication
Drug Safety, 2020, Vol 43, Issue 2, p163
- ISSN
0114-5916
- Publication type
journal article
- DOI
10.1007/s40264-019-00882-7