Keywords
Pharmacovigilance
drug-related side effects and adverse reactions
drug utilization
ambulatory care
patient participation
drug-related side effects and adverse reactions
drug utilization
ambulatory care
patient participation
How to Cite
Pino Marín, D., Madrigal Cadavid, J., Ceballos, M., Cano, A., & Amariles, P. (2018). Results of the implementation of the report of suspicion of adverse drug reactions by patients: structured review. Salud UIS, 50(2), 136–142. https://doi.org/10.18273/revsal.v50n2-2018005
Abstract
Objective: To identify the contribution of the report of suspected adverse drug reactions by patients, as well as the barriers and facilitators associated with this strategy. Methodology: Structured review based on PubMed / MedLine articles in English and Spanish, until 05/30/2017, using the keywords: Pharmacovigilance reporting AND patient report. Results: 16 articles were identified with information related to the object of study and three more were included taking into account their relevance. Main barriers and facilitators of patients for reporting suspected adverse drug reactions, the effects of the report and its characteristics, were identified. Besides, similarities and disparities between reports from health professionals and patients were described. Conclusions: The implementation of the report by patients decreases sub-reporting in pharmacovigilance. In addition, it allows the active participation and integration of patients’ experiences about adverse drug reactions.
References
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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.
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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.
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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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