Self-Reporting of Adverse Drug Reactions in Iraqi Hospitals: Patient’s Perspectives
Author(s)
Kadhim Ali Kadhim
Affiliation(s)
Department of Clinical Pharmacy, College of Pharmacy, Al-Mustansriya University, Baghdad, Iraq.
Department of Clinical Pharmacy, College of Pharmacy, Al-Mustansriya University, Baghdad, Iraq.
ABSTRACT
Background: Adverse drug reactions (ADRs) represent the important cause of morbidity and mortality that affect patients using drugs. Previous studies have clarified the knowledge and attitude toward ADRs reporting among healthcare providers, while studies toward awareness of patients are limited. Aim and Objective: To evaluate knowledge and attitude toward ADRs reporting among patients visiting general hospitals in Baghdad City. Methods: This observational study was conducted on randomly selected 300 patients at the out-patient setting of general hospitals in Baghdad. Demographic characteristics of participants were documented and questionnaire regarding knowledge and perceptions was given to fill up, and the data were analyzed using descriptive statistics. Results: Demographic analysis showed that 55% of patients were males, 62% of them were from rural areas, and only 34% were college graduates. Regarding knowledge about ADRs, 73.3% patients were aware about ADRs and 37% had experienced ADRs in past. None of the respondents were aware of ADR reporting center. Regarding perceptions toward ADR, 84.2% agreed to report ADR in future and 90% respondents believed that ADR reporting may strengthen the patient safety. According to 61% of patients, patient education program is the best way to educate them regarding ADR. Conclusion: Educational interventions are highly recommended to improve awareness among patients regarding the validity of ADRs reporting.
Background: Adverse drug reactions (ADRs) represent the important cause of morbidity and mortality that affect patients using drugs. Previous studies have clarified the knowledge and attitude toward ADRs reporting among healthcare providers, while studies toward awareness of patients are limited. Aim and Objective: To evaluate knowledge and attitude toward ADRs reporting among patients visiting general hospitals in Baghdad City. Methods: This observational study was conducted on randomly selected 300 patients at the out-patient setting of general hospitals in Baghdad. Demographic characteristics of participants were documented and questionnaire regarding knowledge and perceptions was given to fill up, and the data were analyzed using descriptive statistics. Results: Demographic analysis showed that 55% of patients were males, 62% of them were from rural areas, and only 34% were college graduates. Regarding knowledge about ADRs, 73.3% patients were aware about ADRs and 37% had experienced ADRs in past. None of the respondents were aware of ADR reporting center. Regarding perceptions toward ADR, 84.2% agreed to report ADR in future and 90% respondents believed that ADR reporting may strengthen the patient safety. According to 61% of patients, patient education program is the best way to educate them regarding ADR. Conclusion: Educational interventions are highly recommended to improve awareness among patients regarding the validity of ADRs reporting.
Cite this paper
Kadhim, K. (2015) Self-Reporting of Adverse Drug Reactions in Iraqi Hospitals: Patient’s Perspectives. Pharmacology & Pharmacy, 6, 566-572. doi: 10.4236/pp.2015.612058.
Kadhim, K. (2015) Self-Reporting of Adverse Drug Reactions in Iraqi Hospitals: Patient’s Perspectives. Pharmacology & Pharmacy, 6, 566-572. doi: 10.4236/pp.2015.612058.
References
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http://dx.doi.org/10.1136/bmj.e4690 [5] Pirmohamed, M., James, S., Meakin, S., Green, C., Scott, A.K., Walley, T.J., Farrar, K., Park, B.K. and Breckenridge, A.M. (2004) Adverse Drug Reactions as Cause of Admission to Hospital: Prospective Analysis of 18,820 Patients. BMJ, 329, 15-19.
http://dx.doi.org/10.1136/bmj.329.7456.15 [6] Sarker, A., Ginn, R., Nikfarjam, A., O’Connor, K., Smith, K., Jayaraman, S., et al. (2015) Utilizing Social Media Data for Pharmacovigilance: A Review. Journal of Biomedical Informatics, 54, 202-212.
http://dx.doi.org/10.1016/j.jbi.2015.02.004 [7] Harmark, L., van Hunsel, F. and Grundmark, B. (2015) ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems. Drug Safety, 38, 337-347.
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http://dx.doi.org/10.5694/mja13.10069 [9] Passier, A., ten Napel, M., van Grootheest, K. and van Puijenbroek, E. (2009) Reporting of Adverse Drug Reactions by General Practitioners. A Questionnaire-Based Study in the Netherlands. Drug Safety, 32, 851-858.
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http://dx.doi.org/10.1046/j.1365-2710.2002.00416.x [13] Jha, N., Ratthore, D.S., Shankar, P.R. and Gyawali, S. (2014) Pharmacovigilance Knowledge among Patients at a Teaching Hospital in Lalitpur District, Nepal. Journal of Clinical and Diagnostic Research, 8, 32-34.
http://dx.doi.org/10.7860/jcdr/2014/7378.4097 [14] Elkalmi, R., Hassali, M.A., Al-Lela, O.Q., Jawad Awadh, A.I., Al-Shami, A.K. and Jamshed, S.Q. (2013) Adverse Drug Reactions Reporting: Knowledge and Opinion of General Public in Penang, Malaysia. Journal of Pharmacy and Bioallied Sciences, 5, 224-228.
http://dx.doi.org/10.4103/0975-7406.116824 [15] Blenkinsopp, A., Wilkie, P., Wang, M. and Routledge, P.A. (2006) Patient Reporting of Suspected Adverse Drug Reactions: A Review of Published Literature and International Experience. British Journal of Clinical Pharmacology, 63, 148-156.
http://dx.doi.org/10.1111/j.1365-2125.2006.02746.x [16] Hartigan-Go, K. (2002) Developing a Pharmacovigilance System in the Philippines, a Country of Diverse Culture and Strong Traditional Medicine Background. Toxicology, 181-182, 103-107.
http://dx.doi.org/10.1016/S0300-483X(02)00263-9 [17] Vessal, G., Mardani, Z. and Mollai, M. (2009) Knowledge, Attitudes, and Perceptions of Pharmacists to Adverse Drug Reaction Reporting in Iran. Pharmacy World & Science, 31, 183-187.
http://dx.doi.org/10.1007/s11096-008-9276-6 [18] Ahmed, A.M., Izham, I.M. and Subish, P. (2010) Importance of Consumer Pharmacovigilance System in Developing Countries: A Case of Malaysia. Journal of Clinical and Diagnostic Research, 4, 2929-2935. [19] Palaian, S., Alshakka, M. and Izham, M. (2010) Developing a Consumer Reporting Program in Malaysia: A Novel Initiative to Improve Pharmacovigilance. Pharmacy World & Science, 32, 2-6.
http://dx.doi.org/10.1007/s11096-009-9342-8 [20] World Health Organization (2012) Safety Monitoring of Medicinal Products: Reporting System for the General Public.
http://www.who.int/medicines/areas/quality_safety/safety_efficacy/qas_
safetymonitoringmp/en/ [21] Avery, A.J., Anderson, C., Bond, C.M., Fortnum, H., Gifford, A., Hannaford, P.C., et al. (2011) Evaluation of Patient Reporting of Adverse Drug Reactions to the UK “Yellow Card Scheme”: Literature Review, Descriptive and Qualitative Analyses, and Questionnaire Surveys. Health Technology Assessment, 15, 1-4.
http://dx.doi.org/10.3310/hta15200 [22] Harmark, L., van Hunsel, F. and Grundmark, B. (2015) ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems. Drug Safety, 38, 337-347.
http://dx.doi.org/10.1007/s40264-015-0264-1 [23] Margraff, F. and Bertram, D. (2014) Adverse Drug Reaction Reporting by Patients: An Overview of Fifty Countries. Drug Safety, 37, 409-419.
http://dx.doi.org/10.1007/s40264-014-0162-y [24] World Health Organization (2006) The Safety of Medicines in Public Health Programs: Pharmacovigilance an Essential Tool. WHO, Geneva.
[1] World Health Organization (1972) International Drug Monitoring: The Role of National Centers. Technical Report Series No. 498, World Health Organization, Geneva. [2] Kalaiselvan, V., Mishra, P. and Singh, G.N. (2014) Helpline Facility to Assist Reporting of Adverse Drug Reactions in India. WHO South East Asia Journal of Public Health, 3, 194. [3] Ishiguro, C., Hall, M., Neyarapally, G.A. and Dal Pan, G. (2012) Post-Market Drug Safety Evidence Sources: An Analysis of FDA Drug Safety Communications. Pharmacoepidemiology and Drug Safety, 21, 1134-1136.
http://dx.doi.org/10.1002/pds.3317 [4] Watson, R. (2012) New EU Drug Safety Committee Ends National Reporting of Drug Reactions. BMJ, 345, e4690.
http://dx.doi.org/10.1136/bmj.e4690 [5] Pirmohamed, M., James, S., Meakin, S., Green, C., Scott, A.K., Walley, T.J., Farrar, K., Park, B.K. and Breckenridge, A.M. (2004) Adverse Drug Reactions as Cause of Admission to Hospital: Prospective Analysis of 18,820 Patients. BMJ, 329, 15-19.
http://dx.doi.org/10.1136/bmj.329.7456.15 [6] Sarker, A., Ginn, R., Nikfarjam, A., O’Connor, K., Smith, K., Jayaraman, S., et al. (2015) Utilizing Social Media Data for Pharmacovigilance: A Review. Journal of Biomedical Informatics, 54, 202-212.
http://dx.doi.org/10.1016/j.jbi.2015.02.004 [7] Harmark, L., van Hunsel, F. and Grundmark, B. (2015) ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems. Drug Safety, 38, 337-347.
http://dx.doi.org/10.1007/s40264-015-0264-1 [8] Robertson, J. and Newby, D.A. (2013) Low Awareness of Adverse Drug Reaction Reporting Systems: A Consumer Survey. MJA, 199, 684-686.
http://dx.doi.org/10.5694/mja13.10069 [9] Passier, A., ten Napel, M., van Grootheest, K. and van Puijenbroek, E. (2009) Reporting of Adverse Drug Reactions by General Practitioners. A Questionnaire-Based Study in the Netherlands. Drug Safety, 32, 851-858.
http://dx.doi.org/10.2165/11314490-000000000-00000 [10] World Health Organization (2002) The Importance of Pharmacovigilance: An Essential Tool. WHO, Geneva. [11] World Health Organization (2002) Safety of Medicines—A Guide to Detecting and Reporting of Adverse Drug Reactions. Why Health Professionals Need to Take Action. WHO, Geneva. [12] Hughes, L., Whittlesea, C. and Luscombe, D. (2002) Patients’ Knowledge and Perceptions of the Side-Effects of OTC Medication. Journal of Clinical Pharmacy and Therapeutics, 27, 243-248.
http://dx.doi.org/10.1046/j.1365-2710.2002.00416.x [13] Jha, N., Ratthore, D.S., Shankar, P.R. and Gyawali, S. (2014) Pharmacovigilance Knowledge among Patients at a Teaching Hospital in Lalitpur District, Nepal. Journal of Clinical and Diagnostic Research, 8, 32-34.
http://dx.doi.org/10.7860/jcdr/2014/7378.4097 [14] Elkalmi, R., Hassali, M.A., Al-Lela, O.Q., Jawad Awadh, A.I., Al-Shami, A.K. and Jamshed, S.Q. (2013) Adverse Drug Reactions Reporting: Knowledge and Opinion of General Public in Penang, Malaysia. Journal of Pharmacy and Bioallied Sciences, 5, 224-228.
http://dx.doi.org/10.4103/0975-7406.116824 [15] Blenkinsopp, A., Wilkie, P., Wang, M. and Routledge, P.A. (2006) Patient Reporting of Suspected Adverse Drug Reactions: A Review of Published Literature and International Experience. British Journal of Clinical Pharmacology, 63, 148-156.
http://dx.doi.org/10.1111/j.1365-2125.2006.02746.x [16] Hartigan-Go, K. (2002) Developing a Pharmacovigilance System in the Philippines, a Country of Diverse Culture and Strong Traditional Medicine Background. Toxicology, 181-182, 103-107.
http://dx.doi.org/10.1016/S0300-483X(02)00263-9 [17] Vessal, G., Mardani, Z. and Mollai, M. (2009) Knowledge, Attitudes, and Perceptions of Pharmacists to Adverse Drug Reaction Reporting in Iran. Pharmacy World & Science, 31, 183-187.
http://dx.doi.org/10.1007/s11096-008-9276-6 [18] Ahmed, A.M., Izham, I.M. and Subish, P. (2010) Importance of Consumer Pharmacovigilance System in Developing Countries: A Case of Malaysia. Journal of Clinical and Diagnostic Research, 4, 2929-2935. [19] Palaian, S., Alshakka, M. and Izham, M. (2010) Developing a Consumer Reporting Program in Malaysia: A Novel Initiative to Improve Pharmacovigilance. Pharmacy World & Science, 32, 2-6.
http://dx.doi.org/10.1007/s11096-009-9342-8 [20] World Health Organization (2012) Safety Monitoring of Medicinal Products: Reporting System for the General Public.
http://www.who.int/medicines/areas/quality_safety/safety_efficacy/qas_
safetymonitoringmp/en/ [21] Avery, A.J., Anderson, C., Bond, C.M., Fortnum, H., Gifford, A., Hannaford, P.C., et al. (2011) Evaluation of Patient Reporting of Adverse Drug Reactions to the UK “Yellow Card Scheme”: Literature Review, Descriptive and Qualitative Analyses, and Questionnaire Surveys. Health Technology Assessment, 15, 1-4.
http://dx.doi.org/10.3310/hta15200 [22] Harmark, L., van Hunsel, F. and Grundmark, B. (2015) ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems. Drug Safety, 38, 337-347.
http://dx.doi.org/10.1007/s40264-015-0264-1 [23] Margraff, F. and Bertram, D. (2014) Adverse Drug Reaction Reporting by Patients: An Overview of Fifty Countries. Drug Safety, 37, 409-419.
http://dx.doi.org/10.1007/s40264-014-0162-y [24] World Health Organization (2006) The Safety of Medicines in Public Health Programs: Pharmacovigilance an Essential Tool. WHO, Geneva.