Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?
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...
| المؤلفون الرئيسيون: | , , , , , |
|---|---|
| التنسيق: | مقال |
| اللغة: | English |
| منشور في: |
Fundación Pharmaceutical Care España
2022-06-01
|
| سلاسل: | Pharmaceutical Care España |
| الموضوعات: | |
| الوصول للمادة أونلاين: | https://www.pharmcareesp.com/index.php/PharmaCARE/article/view/680 |
| _version_ | 1827924773634572288 |
|---|---|
| author | Montserrat Viñas-Bastart Míriam Oms-Arias Àfrica Pedraza-Gutiérrez Irene Lizano-Díez Eduardo L. Mariño Pilar Modamio Charles |
| author_facet | Montserrat Viñas-Bastart Míriam Oms-Arias Àfrica Pedraza-Gutiérrez Irene Lizano-Díez Eduardo L. Mariño Pilar Modamio Charles |
| author_sort | Montserrat Viñas-Bastart |
| collection | DOAJ |
| description |
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.
|
| first_indexed | 2024-03-13T05:16:34Z |
| format | Article |
| id | doaj.art-d0c43f21bbb946f9b85192fe1c638a1c |
| institution | Directory Open Access Journal |
| issn | 1139-6202 2794-1140 |
| language | English |
| last_indexed | 2024-03-13T05:16:34Z |
| publishDate | 2022-06-01 |
| publisher | Fundación Pharmaceutical Care España |
| record_format | Article |
| series | Pharmaceutical Care España |
| spelling | doaj.art-d0c43f21bbb946f9b85192fe1c638a1c2023-06-16T00:22:19ZengFundación Pharmaceutical Care EspañaPharmaceutical Care España1139-62022794-11402022-06-01243Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?Montserrat Viñas-Bastart0Míriam Oms-Arias1Àfrica Pedraza-Gutiérrez2Irene Lizano-Díez3Eduardo L. Mariño4Pilar Modamio Charles5Unidad de Farmacia Clínica y Atención Farmacéutica, Departamento de Farmacia y Tecnología Farmacéutica y Fisicoquímica, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, BarcelonaDirección de Atención Primaria Costa de Ponent, Institut Català de la Salut, L’Hospitalet de Llobregat, BarcelonaDirección de Atención Primaria Costa de Ponent, Institut Català de la Salut, L’Hospitalet de Llobregat, BarcelonaUnidad de Farmacia Clínica y Atención Farmacéutica, Departamento de Farmacia y Tecnología Farmacéutica y Fisicoquímica, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, BarcelonaUnidad de Farmacia Clínica y Atención Farmacéutica, Departamento de Farmacia y Tecnología Farmacéutica y Fisicoquímica, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, BarcelonaUnidad de Farmacia Clínica y Atención Farmacéutica, Departamento de Farmacia y Tecnología Farmacéutica y Fisicoquímica, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, Barcelona 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. https://www.pharmcareesp.com/index.php/PharmaCARE/article/view/680Off-label use; opioid; pharmacoepidemiology; primary health care; tramadol/dexketoprofen; drug combinations |
| spellingShingle | Montserrat Viñas-Bastart Míriam Oms-Arias Àfrica Pedraza-Gutiérrez Irene Lizano-Díez Eduardo L. Mariño Pilar Modamio Charles Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern? Pharmaceutical Care España Off-label use; opioid; pharmacoepidemiology; primary health care; tramadol/dexketoprofen; drug combinations |
| title | Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern? |
| title_full | Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern? |
| title_fullStr | Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern? |
| title_full_unstemmed | Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern? |
| title_short | Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern? |
| title_sort | off label use of fixed dose combination of tramadol and dexketoprofen in primary health care evidence based or cause for concern |
| topic | Off-label use; opioid; pharmacoepidemiology; primary health care; tramadol/dexketoprofen; drug combinations |
| url | https://www.pharmcareesp.com/index.php/PharmaCARE/article/view/680 |
| work_keys_str_mv | AT montserratvinasbastart offlabeluseoffixeddosecombinationoftramadolanddexketoprofeninprimaryhealthcareevidencebasedorcauseforconcern AT miriamomsarias offlabeluseoffixeddosecombinationoftramadolanddexketoprofeninprimaryhealthcareevidencebasedorcauseforconcern AT africapedrazagutierrez offlabeluseoffixeddosecombinationoftramadolanddexketoprofeninprimaryhealthcareevidencebasedorcauseforconcern AT irenelizanodiez offlabeluseoffixeddosecombinationoftramadolanddexketoprofeninprimaryhealthcareevidencebasedorcauseforconcern AT eduardolmarino offlabeluseoffixeddosecombinationoftramadolanddexketoprofeninprimaryhealthcareevidencebasedorcauseforconcern AT pilarmodamiocharles offlabeluseoffixeddosecombinationoftramadolanddexketoprofeninprimaryhealthcareevidencebasedorcauseforconcern |