Drug Safety

pp 1–15 | Cite as

Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance

  • Sigal KaplanEmail author
  • Aurore Bergamasco
  • Martin Sergerie
  • Anne-Marie Castilloux
  • Yola Moride
Original Research Article



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.


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.


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.


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.


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.



The authors would like to acknowledge Rukki Mirotznik for providing editorial support.

Compliance with Ethical Standards


This study was funded by Teva Canada Innovation.

Conflict of interest

Sigal Kaplan and Martin Sergerie are employees of Teva Pharmaceutical Industries Ltd and/or its affiliates. Aurore Bergamasco, Anne-Marie Castilloux and Yola Moride are employees of YOLARX Consultants, which received financial support from Teva Canada Innovation to conduct this research.


The views expressed in this manuscript are those of the authors and do not necessarily reflect those of Teva.

Supplementary material

40264_2019_882_MOESM1_ESM.pdf (1.2 mb)
Supplementary material 1 (PDF 1262 kb)


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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Teva Pharmaceutical Industries LtdNetanyaIsrael
  2. 2.YOLARX ConsultantsParisFrance
  3. 3.Teva Canada InnovationMontrealCanada
  4. 4.YOLARX ConsultantsMontrealCanada
  5. 5.Faculty of PharmacyUniversité de MontréalMontrealCanada
  6. 6.Rutgers, The State University of New JerseyNew BrunswickUSA

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