Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?
DOI:
https://doi.org/10.60103/phc.v24i3.680Keywords:
Off-label use; opioid; pharmacoepidemiology; primary health care; tramadol/dexketoprofen; drug combinationsAbstract
Introduction: The use of the fixed-dose combination of tramadol/dexketoprofen in Spain and in other countries has increased considerably. The authorized therapeutic indication for this medicinal product is the short-term symptomatic treatment of moderate to severe acute pain in adult patients. The objective of this study was to describe the pattern of use of tramadol/dexketoprofen in the field of primary health care.
Method: A cross-sectional, descriptive and multicenter study was carried out. The study population included all patients from a Primary Care Department (53 Primary Care teams) with an active prescription of tramadol/dexketoprofen on March 28, 2018. The target population was those patients who were prescribed tramadol/dexketoprofen. dexketoprofen for >20 days.
Results: A total of 176 patients had an active prescription for tramadol/dexketoprofen. All patients (100%) had a duration of treatment greater than 5 days and 72.7% (N=128) greater than 20 days. The mean duration of treatment was 14±160.9 days in patients who had less than 20 days of treatment and 224±160.8 days in patients who had more than 20 days of treatment. 35.1% of the patients were treated with >2 pain medications and concomitantly with tramadol/dexketoprofen. The general practitioner initiated 65.6% of the prescriptions.
Conclusions: The fixed-dose combination of tramadol/dexketoprofen was frequently used off-label, according to the product characteristics and the available scientific evidence. This study warns about the potential risks associated with the use of this drug in clinical practice, such as lack of effectiveness and/or the appearance of adverse effects.
Downloads
References
Nahin RL. Estimates of pain prevalence and severity in adults: United States, 2012. J Pain. 2015;16:769-80. doi: 10.1016/j.jpain.2015.05.002
Breivik H, Collett B, Ventafridda V, et al. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10:287-333. doi: 10.1016/j.ejpain.2005.06.009
Guy GP, Zhang K, Bohm MK, et al. Vital signs: Changes in opioid prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017;66:697-704. doi: 10.15585/mmwr.mm6626a4
Schubert I, Ihle P, Sabatowski R. Increase in opiate prescription in Germany between 2000 and 2010: a study based on insurance data. Dtsch Arztebl Int. 2013;110:45-51. doi: 0.3238/arztebl.2013.0045
Alenezi, A, Yahyouche, A, Paudyal V. Current status of opioid epidemic in the United Kingdom and strategies for treatment optimisation in chronic pain. Int J Clin Pharm. 2021;43(2):318-322. doi: 10.1007/s11096-020-01205-y
Downes JM, Klepser DG, Foster J, et al. Development of a standardized approach for managing opioids in adults with chronic noncancer pain. Am J Health Syst Pharm. 2018;75:321-6. doi: 10.2146/ajhp161012
Caldeira D, Broeiro P, Cimadeira F, et al. Opioids prescribing trend between 2013 and 2017 in the Lisbon and Tagus Valley region, Portugal. Int J Clin Pharm. 2021;43(2):323-7. doi: 10.1007/s11096-020-01199-7
Agencia Española de Medicamentos y Productos Sanitarios. Observatorio de uso de medicamentos. Utilización de medicamentos opioides en España durante el periodo 2010-2021. v.200619. Disponible en: https://www.aemps.gob.es/medicamentos-de-uso-humano/observatorio-de-uso-de-medicamentos/utilizacion-de-medicamentos-opioides-en-espana/. [Acceso 20 de abril de 2022]
Varrassi G, Hanna M, Macheras G, et al. Multimodal analgesia in moderate-to-severe pain: a role for a new fixed combination of dexketoprofen and tramadol. Curr Med Res Opin. 2017;33:1165-73. doi: 10.1080/03007995.2017.1310092
Agencia Española de Medicamentos y Productos Sanitarios. Enanplus® 75 mg/25 mg comprimidos recubiertos con película. Ficha técnica. Disponible en: https://cima.aemps.es/cima/dochtml/ft/80925/FT_80925.html. [Acceso 5 de mayo de 2017]
O'Brien T, Christrup LL, Drewes AM, et al. European Pain Federation position paper on appropriate opioid use in chronic pain management. Eur J Pain. 2017;21:3-19. doi: 10.1002/ejp.970
Gobierno de Cataluña. Departamento de Salud. [Organigrama: Unidad de coordinación y estrategia del medicamento]. Disponible en: http://www14.gencat.cat/sacgencat/AppJava/organigrama.jsp?codi=10137&jq=200001. [Acceso 18 de marzo de 2019]
Erskine D, Wanklyn S. Opioid safety: striking the right balance. Drug Ther Bull. 2021;59:34. doi: 10.1136/dtb.2020.000068
Manchikanti L, Kaye AM, Knezevic NN, et al. Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American Society of Interventional Pain Physicians (ASIPP) guidelines. Pain Physician. 2017;20:S3-S92.
Chou R, Hartung D, Turner J, et al. Opioid treatments for chronic pain. Comparative effectiveness review No. 229. 2020; [Internet]. AHRQ Publication No. 20-EHC011. Rockville (MD): Agency for Healthcare Research and Quality (US), April 2020.
Anónimo. What place is there for tramadol/dexketoprofen?. Drug Ther Bull. 2018;56(6):66-8. doi: 10.1136/dtb.2018.6.0635
McQuay HJ, Moore RA, Berta A, et al. Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. Br J Anaesth. 2016;116(2):269-76. doi: 10.1093/bja/aev457
Moore RA, McQuay HJ, Tomaszewski J, et al. Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy. BMC Anesthesiol. 2016;16:9. Erratum in: BMC Anesthesiology. 2017;17(1):159. doi: 10.1186/s12871-017-0452-x
Catalán A, Borrell F, Pons A, et al. Seguridad del paciente en atención primaria: proyecto PREFASEG (PREscripción FArmacológica SEGura). Med Clin (Barc). 2014;143(Suppl 1):32-5. doi: 10.1016/j.medcli.2014.07.008
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2022 Montserrat Viñas-Bastart, Míriam Oms-Arias, Àfrica Pedraza-Gutiérrez, Irene Lizano-Díez, Eduardo L. Mariño, Pilar Modamio Charles
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
La revista Pharmaceutical Care España se publica bajo una licencia «Creative Commons, Reconocimiento, No Comercial y Compartir Igual 4.0 Internacional» (CC BY-NC-SA 4.0)», que permite a otros compartir el trabajo con un reconocimiento de la autoría del trabajo y la publicación inicial en esta revista (con excepción de los usos comerciales).
Los autores que publican en esta revista están de acuerdo con los siguientes términos:a) Los autores conservan los derechos de autor (derechos morales) y garantizan a la revista el derecho de ser el primer soporte documental publicado del trabajo.
b) Se permite y anima a los autores a difundir la versión del trabajo revisado por pares y aceptada para su publicación (por ejemplo, en repositorios institucionales o temáticos), recomendando hacerlo con la versión final del editor “pdf”, “html” o “xml”).