IDEAS home Printed from https://ideas.repec.org/a/spr/drugsa/v43y2020i2d10.1007_s40264-019-00882-7.html
   My bibliography  Save this article

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

Author

Listed:
  • Sigal Kaplan

    (Teva Pharmaceutical Industries Ltd)

  • Aurore Bergamasco

    (YOLARX Consultants)

  • Martin Sergerie

    (Teva Canada Innovation)

  • Anne-Marie Castilloux

    (YOLARX Consultants)

  • Yola Moride

    (YOLARX Consultants
    Université de Montréal
    Rutgers, The State University of New Jersey)

Abstract

Background 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. Objectives 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. Methods 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. Results 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. Conclusions 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.

Suggested Citation

  • Sigal Kaplan & Aurore Bergamasco & Martin Sergerie & Anne-Marie Castilloux & Yola Moride, 2020. "Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance," Drug Safety, Springer, vol. 43(2), pages 163-177, February.
    • Handle: RePEc:spr:drugsa:v:43:y:2020:i:2:d:10.1007_s40264-019-00882-7
    DOI: 10.1007/s40264-019-00882-7
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40264-019-00882-7
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.
    File URL: https://libkey.io/10.1007/s40264-019-00882-7?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Wally Landsberg & Imad Al-Dakkak & Antonia Coppin-Renz & Uli Geis & Timothy Peters-Strickland & Emiel Heumen & Mirza Rahman, 2018. "Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study," Drug Safety, Springer, vol. 41(8), pages 797-806, August.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Rania Mouchantaf & Doris Auth & Yola Moride & June Raine & Soon Young Han & Meredith Y. Smith, 2021. "Risk Management for the 21st Century: Current Status and Future Needs," Drug Safety, Springer, vol. 44(4), pages 409-419, April.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Andrea M. Russell & Elaine H. Morrato & Rebecca M. Lovett & Meredith Y. Smith, 2020. "Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review," Drug Safety, Springer, vol. 43(5), pages 427-446, May.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:drugsa:v:43:y:2020:i:2:d:10.1007_s40264-019-00882-7. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com/economics/journal/40264 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.