Analgesic switching in chronic users of dextropropoxyphene in France.
addictovigilance
analgesics
dextropropoxyphene
drug utilization
safety-based drug withdrawals
Journal
Fundamental & clinical pharmacology
ISSN: 1472-8206
Titre abrégé: Fundam Clin Pharmacol
Pays: England
ID NLM: 8710411
Informations de publication
Date de publication:
21 Oct 2023
21 Oct 2023
Historique:
revised:
01
10
2023
received:
07
08
2023
accepted:
09
10
2023
medline:
21
10
2023
pubmed:
21
10
2023
entrez:
21
10
2023
Statut:
aheadofprint
Résumé
The combination dextropropoxyphene/paracetamol (DXP/P) was the most prescribed opioid analgesic until its withdrawal in 2011. This study investigated dispensations of analgesics in chronic users of DXP/P during the 18 months following its withdrawal. A cross-sectional study repeated yearly was conducted by using the French reimbursement database from 2006 to 2015. Chronic DXP/P users were defined as patients who received at least 40 boxes of DXP/P in the year prior to withdrawal. Data on analgesic dispensing were analyzed at DXP/P withdrawal (T0) and then every 6 months for 18 months. A total of 63 671 subjects had a DXP/P reimbursement in the year prior to its discontinuation, of whom 7.1% were identified as chronic users (mean age: 71.5 years, women: 68.7%). Among the patients taking DXP/P alone at T0 (74.6%), one fourth switched to a peripheral analgesic, one fourth to a combination of peripheral analgesic/opioid, one fourth to another opioid, and the others mainly discontinued their treatment (14.1%) or died. During the following 12 months, most of the subjects taking only peripheral analgesics continued this treatment, while half of the subjects with a combination of opioid/peripheral analgesic or taking only an analgesic remained on this type of treatment. Eighteen months after DXP/P withdrawal, more than 10% of patients stopped taking an analgesic. Vigilance is required regarding any change in analgesics by regularly reassessing patients' pain and, in the case of opioid treatments, by monitoring the risk of use disorders.
Sections du résumé
BACKGROUND
BACKGROUND
The combination dextropropoxyphene/paracetamol (DXP/P) was the most prescribed opioid analgesic until its withdrawal in 2011.
OBJECTIVES
OBJECTIVE
This study investigated dispensations of analgesics in chronic users of DXP/P during the 18 months following its withdrawal.
METHODS
METHODS
A cross-sectional study repeated yearly was conducted by using the French reimbursement database from 2006 to 2015. Chronic DXP/P users were defined as patients who received at least 40 boxes of DXP/P in the year prior to withdrawal. Data on analgesic dispensing were analyzed at DXP/P withdrawal (T0) and then every 6 months for 18 months.
RESULTS
RESULTS
A total of 63 671 subjects had a DXP/P reimbursement in the year prior to its discontinuation, of whom 7.1% were identified as chronic users (mean age: 71.5 years, women: 68.7%). Among the patients taking DXP/P alone at T0 (74.6%), one fourth switched to a peripheral analgesic, one fourth to a combination of peripheral analgesic/opioid, one fourth to another opioid, and the others mainly discontinued their treatment (14.1%) or died. During the following 12 months, most of the subjects taking only peripheral analgesics continued this treatment, while half of the subjects with a combination of opioid/peripheral analgesic or taking only an analgesic remained on this type of treatment.
CONCLUSION
CONCLUSIONS
Eighteen months after DXP/P withdrawal, more than 10% of patients stopped taking an analgesic. Vigilance is required regarding any change in analgesics by regularly reassessing patients' pain and, in the case of opioid treatments, by monitoring the risk of use disorders.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Agence Nationale de Sécurité du Médicament et des Produits de Santé
ID : 2015-5038
Informations de copyright
© 2023 The Authors. Fundamental & Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of Société Française de Pharmacologie et de Thérapeutique.
Références
ANSM. Médicaments Contenant L'association Dextropropoxyphène/Paracétamol: Recommandation de l'EMEA de Retrait de ces Médicaments à la Suite de L'évaluation Européenne et Avis Divergent de l'Afssaps. 2009. [accessed https://archiveansm.integra.fr/content/download/20487/248676/version/1/file/Document-communication+DXP.pdf]
Collins SL, Edwards JE, Moore RA, McQuay H. Single dose dextropropoxyphene, alone and with paracetamol (acetaminophen), for postoperative pain. Cochrane Database Syst Rev. 2000;1999(2):CD001440.
Daveluy A, Micallef J, Sanchez-Pena P, et al. Ten-year trend of opioid and non-opioid analgesic use in the French adult population. Br J Clin Pharmacol. 2021;87(2):555-564. doi:10.1111/bcp.14415
Hider-Mlynarz K, Cavalié P, Maison P. Trends in analgesic consumption in France over the last 10 years and comparison of patterns across Europe. Br J Clin Pharmacol. 2018;84(6):1324-1334. doi:10.1111/bcp.13564
Reset A, Skurtveit S, Furu K, Skovlund E. Effect of the market withdrawal of dextropropoxyphene on use of other prescribed analgesics. Scand J Pain. 2018;18(4):667-674. doi:10.1515/sjpain-2018-0103
Van Ganse E, Belhassen M, Ginoux M, et al. Use of analgesics in France, following dextropropoxyphene withdrawal. BMC Health Serv Res. 2018;18(1):231. doi:10.1186/s12913-018-3058-1
European Medicines Agency. Dextropropoxyphene. 2011. [accessed https://www.ema.europa.eu/en/medicines/human/referrals/dextropropoxyphene]
Food and Drug Administration. fda-drug-safety-communication-fda-recommends-against-continued-use-propoxyphene. 2010. [accessed https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-recommends-against-continued-use-propoxyphene]
Pageot C, Bezin J, Smith A, et al. Impact of medicine withdrawal on reporting of adverse events involving therapeutic alternatives: a study from the French spontaneous reporting database. Drug Saf. 2017;40(11):1099-1107. doi:10.1007/s40264-017-0561-y
Tuppin P, de Roquefeuil L, Weill A, Ricordeau P, Merlière Y. French national health insurance information system and the permanent beneficiaries sample. Rev Epidemiol Sante Publique. 2010;58(4):286-290. doi:10.1016/j.respe.2010.04.005
Tuppin P, Rudant J, Constantinou P, et al. Value of a national administrative database to guide public decisions: from the systeme national d'information interregimes de l'Assurance Maladie (SNIIRAM) to the systeme national des donnees de sante (SNDS) in France. Rev Epidemiol Sante Publique. 2017;65(Suppl 4):S149-S167. doi:10.1016/j.respe.2017.05.004
Bezin J, Duong M, Lassalle R, et al. The national healthcare system claims databases in France, SNIIRAM and EGB: powerful tools for pharmacoepidemiology. Pharmacoepidemiol Drug Saf. 2017;26(8):954-962. doi:10.1002/pds.4233
Duong M, Gulmez SE, Salvo F, et al. Usage patterns of paracetamol in France. Br J Clin Pharmacol. 2016;82(2):498-503. doi:10.1111/bcp.12957
Bosco-Levy P, de Boissieu P, Gouverneur A, et al. National trends in use and costs of oral anticancer drugs in France: an 8-year population-based study. Pharmacoepidemiol Drug Saf. 2017;26(10):1233-1241. doi:10.1002/pds.4282
Moulis G, Lapeyre-Mestre M, Palmaro A, Pugnet G, Montastruc JL, Sailler L. French health insurance databases: what interest for medical research? Rev Med Interne. 2015;36(6):411-417. doi:10.1016/j.revmed.2014.11.009
Ministère des solidarités et de la santé. Base de Données Publique des Médicaments. [accessed http://base-donnees-publique.medicaments.gouv.fr/].
WHO Collaborating Centre for Drug Statistics Methodology. Comparison of the WHO ATC Classification & EphMRA/PBIRG Anatomical Classification. 2016. [accessed https://www.ephmra.org/media/1082/who-atc-2016-comparison.pdf]
Nordmann S, Pradel V, Lapeyre-Mestre M, et al. Doctor shopping reveals geographical variations in opioid abuse. Pain Physician. 2013;16(1):89-100.
Dupouy J, Palmaro A, Fatseas M, et al. Mortality associated with time in and out of buprenorphine treatment in French office-based general practice: a 7-year cohort study. Ann Fam Med. 2017;15(4):355-358. doi:10.1370/afm.2098
Labianca R, Sarzi-Puttini P, Zuccaro SM, Cherubino P, Vellucci R, Fornasari D. Adverse effects associated with non-opioid and opioid treatment in patients with chronic pain. Clin Drug Investig. 2012;32(Suppl 1):53-63. doi:10.2165/11630080-000000000-00000
Becquemont L, Delespierre T, Bauduceau B, et al. Consequences of dextropropoxyphene market withdrawal in elderly patients with chronic pain. Eur J Clin Pharmacol. 2014;70(10):1237-1242. doi:10.1007/s00228-014-1722-x
Bismuth S, Leng EL, Oustric S, Montastruc JL, Lapeyre-Mestre M. Which analgesic after dextropropoxyphene withdrawal? A survey in a sample of general practitioners in southwest of France. Therapie. 2011;66(1):25-28. doi:10.2515/therapie/2011004
Jeffery MM, Morden NE, Larochelle M, Shah ND, Hooten WM, Meara E. Response to propoxyphene market withdrawal: analgesic substitutes, doses, and adverse events. Med Care. 2020;58(1):4-12. doi:10.1097/MLR.0000000000001221
Ottewell L, Walker DJ. Co-proxamol: where have all the patients gone? Rheumatology (Oxford). 2008;47(3):375. doi:10.1093/rheumatology/kem281
Combier A, Bon L, Van Ganse E, et al. Perceptions of French general practitioners and patients regarding dextropropoxyphene withdrawal: a qualitative study. BMJ Open. 2018;8(9):e021582. doi:10.1136/bmjopen-2018-021582
Gentile G, Jego M, Spadari M, Griffiths K, Jouanjus E, Micallef J. Identification and tracking of Addictovigilance signals in general practice: which interactions between the general practitioners and the French Addictovigilance network? Fundam Clin Pharmacol. 2018;32(6):643-651. doi:10.1111/fcp.12401
Perino P, Singier A, Noize P, et al. Interest of reimbursement open access data for surveillance of drug use in France: the case of oxycodone. Fundam Clin Pharmacol. 2023;37:176.
Tavassoli N, Lapeyre-Mestre M, Sommet A, Montastruc JL, the French Association of Regional Pharmacovigilance Centres. Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol). Br J Clin Pharmacol. 2009;68(3):422-426. doi:10.1111/j.1365-2125.2009.03472.x
Pereira-Maia K, Leguelinel-Blache G, Eiden C, et al. Management of a tramadol use disorder in patients hospitalized for withdrawal. Fundam Clin Pharmacol. 2023;37:92.
Montastruc F, Benevent J, Touafchia A, et al. Atropinic (anticholinergic) burden in antipsychotic-treated patients. Fundam Clin Pharmacol. 2018;32(1):114-119. doi:10.1111/fcp.12321