Palavras-chave
Farmacovigilancia
efectos colaterales y reacciones adversas relacionados con medicamentos
utilización de medicamentos
atención ambulatoria
participación del paciente
efectos colaterales y reacciones adversas relacionados con medicamentos
utilización de medicamentos
atención ambulatoria
participación del paciente
Como Citar
Pino Marín, D., Madrigal Cadavid, J., Ceballos, M., Cano, A., & Amariles, P. (2018). Resultados de la implementación del reporte de sospecha de reacciones adversas a medicamentos por pacientes: revisión estructurada. Salud UIS, 50(2), 136–142. https://doi.org/10.18273/revsal.v50n2-2018005
Resumo
Objetivo: Identificar la contribución del reporte de reacciones adversas a medicamentos por pacientes, así como las barreras y facilitadores asociados con esta estrategia. Metodología: Revisión estructurada en PubMed/MedLine de artículos en inglés y/o español, hasta el 30/05/2017, con los términos: Pharmacovigilance reporting AND patient report. Resultados: Se obtuvieron 16 artículos con información relacionada con el objeto de estudio y se incluyeron tres artículos más considerados como relevantes. Se identificaron las principales barreras y facilitadores del paciente para reportar la sospecha de reacciones adversas a medicamentos, los efectos del reporte y las características del mismo. De igual forma, se describieron las diferencias y similitudes entre el reporte por profesionales de la salud y pacientes. Conclusiones: La implementación del informe por pacientes disminuye el sub-reporte en farmacovigilancia. Además, permite la participación activa y la integración de las experiencias del paciente con las reacciones adversas a los medicamentos.
Referências
1. Ivy SP, Siu LL, Garrett-Mayer E, Rubinstein L. Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task of national cancer institute investigational drug steering committee. Clin Cancer Res. 2010;16(6): 1726-1736. doi: 10.1158/1078-0432.CCR-09-1961.
2. Vlahakes GJ. The value of phase IV clinical testing. N Engl J Med. 2006; 354(4): 413-415.
3. World Health Organization, the Uppsala Monitoring Centre. The importance of pharmacovigilance. Uppsala: World Health Organization, the Uppsala Monitoring Centre, 2002.
4. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006; 29(5): 385-396.
5. Molokhia M, Tanna S, Bell D. Improving reporting of adverse drug reactions: systematic review. Clin Epidemiol. 2009; 1: 75-92.
6. van Hunsel F, Härmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012; 35(1): 45-60.
7. Unión Europea. Offic J European Union. Directive 2010/84/EU of the European Parliament and of the Council. 31 Dic 2010.
8. Pino-Marín D, León-Torres A, Amariles P. Propuesta de un formato para el reporte de sospecha de reacciones adversas a medicamentos por pacientes en Colombia. Rev Univ Ind Santander Salud. 2016; 48(3): 365-373. doi: http://dx.doi.org/10.18273/revsal.v48n3-2016010.
9. Al Dweik R, Stacey D, Kohen D, Yaya S. Factors affecting patient reporting of adverse drug reactions: a systematic review. Br J Clin Pharmacol. 2017; 83(4): 875-883. doi: 10.1111/bcp.13159.
10. Yamamoto M, Kubota K, Okazaki M, Dobashi A, Hashiguchi M, Doi H, et al. Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan. Patient Prefer Adherence. 2015; 9: 173-184. doi: 10.2147/PPA.S75761.
11. de Langen J, van Hunsel F, Passier A, de Jongvan den Berg L, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf. 2008; 31(6): 515-524.
12. Banovac M, Candore G, Slattery J, Houÿez F, Haerry D, Genov G, et al. Patient Reporting in the EU: Analysis of EudraVigilance Data. Drug Saf. 2017; 40(7): 629-645. doi: 10.1007/s40264-017-0534-1.
13. Matos C, Härmark L, van Hunsel F. Patient reporting of adverse drug reactions: an international survey of national competent authorities’ views and needs. Drug Saf. 2016; 39(11): 1105-1116.
14. Rolfes L, van Hunsel F, van der Linden L, Taxis K, van Puijenbroek E. The quality of clinical information in adverse drug reaction reports by patients and healthcare professionals: a
retrospective comparative analysis. Drug Saf. 2017; 40(7): 607-614.
15. van Hunsel F, de Waal S, Härmark L. The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015. Pharmacoepidemiol Drug Saf. 2017; 26(8): 977-983. doi: 10.1002/pds.4236.
16. Leone R, Moretti U, D’Incau P, Conforti A, Magro L, Lora R, et al. Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study. Drug Saf. 2013; 36(4): 267-276. doi: 10.1007/s40264-013-0028-8.
17. Durrieu G, Palmaro A, Pourcel L, Caillet C, Faucher A, Jacquet A, et al. First French experience of ADR reporting by patients after a mass immunization campaign with Influenza A(H1N1) pandemic vaccines: a comparison of reports submitted by patients and healthcare professionals. Drug Saf. 2012; 35(10): 845-854. doi: 10.2165/11631800-000000000-00000.
18. Cumber SL, Heffer SJ, Gandhi S, et al. The Yellow Card Scheme: experience of patient reporting of adverse drug reactions 5 years since launch [abstract]. Pharmacoepidemiol Drug Saf. 2010;19: S321.
19. Parretta E, Rafaniello C, Magro L, Coggiola Pittoni A, Sportiello L, Ferrajolo C, et al. Improvement of patient adverse drug reaction reporting through a community pharmacist-based intervention in the Campania region of Italy. Expert Opin Drug Saf. 2014;13 Suppl 1:S21-9.
20. Staniszewska A, Dąbrowska-Bender M, Olejniczak D, Duda-Zalewska A, Bujalska-Zadrożny M. Patient knowledge on reporting adverse drug reactions in Poland. Patient Prefer Adherence. 2016; 11: 47-53. doi: 10.2147/PPA.S117572.
21. van Hunsel F, Passier A, van Grootheest K. Comparing patients´ and healthcare professionals´ ADR reports after media attention: the broadcast of a Dutch television programme about the benefits and risks of statins as an example. Br J Clin Pharmacol. 2009; 67(5): 558-564. doi: 10.1111/j.1365-2125.2009.03400.x.
22. Rolfes L, Wilkes S, van Hunsel F, van Puijenbroek E, van Grootheest K. Important information regarding reporting of adverse drug reactions: a qualitative study. Int J Pharm Pract. 2014; 22(3): 231-233. doi: 10.1111/ijpp.12056.
23. van Geffen ECG, van der Wal SW, van Hulten R, de Groot MCH, Egberts ACG, Heerdink ER. Evaluation of patients´ experiences with antidepressants reported by means of a medicine reporting system. Eur J Clin Pharmacol. 2007; 63(12): 1193-1199. doi: 10.1007/s00228-007-0375-4.
24. Dweik RA, Yaya S, Stacey D, Kohen D. Spontaneous adverse drug reaction reporting by patients in Canada: a multi-method study-study protocol. Springerplus. 2016; 5: 213. doi: 10.1186/s40064-016-1838-9.
25. van Hunsel F, van der Welle C, Passier A, van Puijenbroek E, van Grootheest K. Motives for reporting adverse drug reactions by patientreporters in the Netherlands. Eur J Clin Pharmacol. 2010; 66(11): 1143-1150. doi: 10.1007/s00228-010-0865-7.
26. Mukherjee S, Sen S, Kalaiselvan V, Tripathi SK. Consumer reporting of adverse drug reactions: a current perspective. IJGP. 2016; 10(3): 136-144.
27. Invima. Boletín de Farmaseguridad Vol 5 N°5, 2016.
28. Calderón-Ospina C, Urbina-Bonilla A. La Farmacovigilancia en los últimos 10 años: actualización de conceptos y clasificaciones. Logros y retos para el futuro en Colombia. Rev Médica UIS. 2012; 24(1): 53-66.
2. Vlahakes GJ. The value of phase IV clinical testing. N Engl J Med. 2006; 354(4): 413-415.
3. World Health Organization, the Uppsala Monitoring Centre. The importance of pharmacovigilance. Uppsala: World Health Organization, the Uppsala Monitoring Centre, 2002.
4. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006; 29(5): 385-396.
5. Molokhia M, Tanna S, Bell D. Improving reporting of adverse drug reactions: systematic review. Clin Epidemiol. 2009; 1: 75-92.
6. van Hunsel F, Härmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012; 35(1): 45-60.
7. Unión Europea. Offic J European Union. Directive 2010/84/EU of the European Parliament and of the Council. 31 Dic 2010.
8. Pino-Marín D, León-Torres A, Amariles P. Propuesta de un formato para el reporte de sospecha de reacciones adversas a medicamentos por pacientes en Colombia. Rev Univ Ind Santander Salud. 2016; 48(3): 365-373. doi: http://dx.doi.org/10.18273/revsal.v48n3-2016010.
9. Al Dweik R, Stacey D, Kohen D, Yaya S. Factors affecting patient reporting of adverse drug reactions: a systematic review. Br J Clin Pharmacol. 2017; 83(4): 875-883. doi: 10.1111/bcp.13159.
10. Yamamoto M, Kubota K, Okazaki M, Dobashi A, Hashiguchi M, Doi H, et al. Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan. Patient Prefer Adherence. 2015; 9: 173-184. doi: 10.2147/PPA.S75761.
11. de Langen J, van Hunsel F, Passier A, de Jongvan den Berg L, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf. 2008; 31(6): 515-524.
12. Banovac M, Candore G, Slattery J, Houÿez F, Haerry D, Genov G, et al. Patient Reporting in the EU: Analysis of EudraVigilance Data. Drug Saf. 2017; 40(7): 629-645. doi: 10.1007/s40264-017-0534-1.
13. Matos C, Härmark L, van Hunsel F. Patient reporting of adverse drug reactions: an international survey of national competent authorities’ views and needs. Drug Saf. 2016; 39(11): 1105-1116.
14. Rolfes L, van Hunsel F, van der Linden L, Taxis K, van Puijenbroek E. The quality of clinical information in adverse drug reaction reports by patients and healthcare professionals: a
retrospective comparative analysis. Drug Saf. 2017; 40(7): 607-614.
15. van Hunsel F, de Waal S, Härmark L. The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015. Pharmacoepidemiol Drug Saf. 2017; 26(8): 977-983. doi: 10.1002/pds.4236.
16. Leone R, Moretti U, D’Incau P, Conforti A, Magro L, Lora R, et al. Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study. Drug Saf. 2013; 36(4): 267-276. doi: 10.1007/s40264-013-0028-8.
17. Durrieu G, Palmaro A, Pourcel L, Caillet C, Faucher A, Jacquet A, et al. First French experience of ADR reporting by patients after a mass immunization campaign with Influenza A(H1N1) pandemic vaccines: a comparison of reports submitted by patients and healthcare professionals. Drug Saf. 2012; 35(10): 845-854. doi: 10.2165/11631800-000000000-00000.
18. Cumber SL, Heffer SJ, Gandhi S, et al. The Yellow Card Scheme: experience of patient reporting of adverse drug reactions 5 years since launch [abstract]. Pharmacoepidemiol Drug Saf. 2010;19: S321.
19. Parretta E, Rafaniello C, Magro L, Coggiola Pittoni A, Sportiello L, Ferrajolo C, et al. Improvement of patient adverse drug reaction reporting through a community pharmacist-based intervention in the Campania region of Italy. Expert Opin Drug Saf. 2014;13 Suppl 1:S21-9.
20. Staniszewska A, Dąbrowska-Bender M, Olejniczak D, Duda-Zalewska A, Bujalska-Zadrożny M. Patient knowledge on reporting adverse drug reactions in Poland. Patient Prefer Adherence. 2016; 11: 47-53. doi: 10.2147/PPA.S117572.
21. van Hunsel F, Passier A, van Grootheest K. Comparing patients´ and healthcare professionals´ ADR reports after media attention: the broadcast of a Dutch television programme about the benefits and risks of statins as an example. Br J Clin Pharmacol. 2009; 67(5): 558-564. doi: 10.1111/j.1365-2125.2009.03400.x.
22. Rolfes L, Wilkes S, van Hunsel F, van Puijenbroek E, van Grootheest K. Important information regarding reporting of adverse drug reactions: a qualitative study. Int J Pharm Pract. 2014; 22(3): 231-233. doi: 10.1111/ijpp.12056.
23. van Geffen ECG, van der Wal SW, van Hulten R, de Groot MCH, Egberts ACG, Heerdink ER. Evaluation of patients´ experiences with antidepressants reported by means of a medicine reporting system. Eur J Clin Pharmacol. 2007; 63(12): 1193-1199. doi: 10.1007/s00228-007-0375-4.
24. Dweik RA, Yaya S, Stacey D, Kohen D. Spontaneous adverse drug reaction reporting by patients in Canada: a multi-method study-study protocol. Springerplus. 2016; 5: 213. doi: 10.1186/s40064-016-1838-9.
25. van Hunsel F, van der Welle C, Passier A, van Puijenbroek E, van Grootheest K. Motives for reporting adverse drug reactions by patientreporters in the Netherlands. Eur J Clin Pharmacol. 2010; 66(11): 1143-1150. doi: 10.1007/s00228-010-0865-7.
26. Mukherjee S, Sen S, Kalaiselvan V, Tripathi SK. Consumer reporting of adverse drug reactions: a current perspective. IJGP. 2016; 10(3): 136-144.
27. Invima. Boletín de Farmaseguridad Vol 5 N°5, 2016.
28. Calderón-Ospina C, Urbina-Bonilla A. La Farmacovigilancia en los últimos 10 años: actualización de conceptos y clasificaciones. Logros y retos para el futuro en Colombia. Rev Médica UIS. 2012; 24(1): 53-66.
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