IDEAS home Printed from https://ideas.repec.org/a/spr/drugsa/v40y2017i3d10.1007_s40264-016-0489-7.html
   My bibliography  Save this article

Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France

Author

Listed:
  • Marine Auffret

    (Centre Régional de Pharmacovigilance, CHU Lille)

  • Julien Labreuche

    (Univ. Lille, CHU Lille, EA 2694 - Santé Publique: épidémiologie et qualité des soins)

  • Alain Duhamel

    (Univ. Lille, CHU Lille, EA 2694 - Santé Publique: épidémiologie et qualité des soins)

  • Sylvie Deheul

    (Service d’Addictovigilance, CHU Lille)

  • Olivier Cottencin

    (CHU Lille
    Univ Lille)

  • Régis Bordet

    (Centre Régional de Pharmacovigilance, CHU Lille
    Service d’Addictovigilance, CHU Lille
    INSERM U1171 Univ Lille)

  • Sophie Gautier

    (Centre Régional de Pharmacovigilance, CHU Lille
    INSERM U1171 Univ Lille)

  • Benjamin Rolland

    (CHU Lille
    INSERM U1171 Univ Lille)

Abstract

Introduction Off-label prescribing (OLP) may raise serious safety concerns that traditional spontaneous reporting of adverse drug reactions (ADRs) may not identify in a timely manner. In France, the ‘Multidisciplinary Consultation Service for Off-Label Prescribing in Addiction Medicine’ (CAMTEA) is a proactive regional system established to identify ADRs associated with the OLP of baclofen for alcohol dependence. Objective The aim was to demonstrate, using the French pharmacovigilance database (FPVD), that CAMTEA allowed for the reporting of a substantial amount of ADRs, comparable in nature to those provided via spontaneous reporting. Method The 2012–2013 FPVD notifications associated with baclofen OLP were extracted. The ten most frequent types of ADRs among ‘serious’ and ‘non-serious’ reports were listed. The frequency of each type of ADR was compared between CAMTEA and spontaneous reporting, and the magnitudes of the differences were assessed using standardized differences. Results A total of 428 baclofen reports (1043 ADRs) were identified, among which 221 (51.64%) originated from CAMTEA. The ten most frequent ADRs in ‘serious’ reports were (1) confusion (17.3%), (2) seizures (11.5%), (3) drowsiness/sedation (11.5%), (4) agitation (10.9%), (5) coma (9.6%), (6) hallucinations (7.7%), (7) falls (7.1%), (8) behavioral disorders (5.8%), (9) withdrawal syndrome (5.1%), and (10) space–time disorientation (5.1%). A standardized difference of

Suggested Citation

  • Marine Auffret & Julien Labreuche & Alain Duhamel & Sylvie Deheul & Olivier Cottencin & Régis Bordet & Sophie Gautier & Benjamin Rolland, 2017. "Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Depende," Drug Safety, Springer, vol. 40(3), pages 257-262, March.
    • Handle: RePEc:spr:drugsa:v:40:y:2017:i:3:d:10.1007_s40264-016-0489-7
    DOI: 10.1007/s40264-016-0489-7
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40264-016-0489-7
    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/s40264-016-0489-7?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.

    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:40:y:2017:i:3:d:10.1007_s40264-016-0489-7. 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.

    We have no bibliographic references for this item. You can help adding them by using 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.