Evaluation of Pharmacovigilance System in Iran
BackgroundEvaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the st...
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| Format: | Article |
| Language: | English |
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Kerman University of Medical Sciences
2022-07-01
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| Series: | International Journal of Health Policy and Management |
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| Online Access: | https://www.ijhpm.com/article_3984_996488f1aaa4fcb334e6ea40204420e0.pdf |
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| author | Malahat Khalili Hamid Sharifi Bita Mesgarpour Mehrnaz Kheirandish Sten Olsson Naghmeh Javidnikou Ali Akbar Haghdoost |
| author_facet | Malahat Khalili Hamid Sharifi Bita Mesgarpour Mehrnaz Kheirandish Sten Olsson Naghmeh Javidnikou Ali Akbar Haghdoost |
| author_sort | Malahat Khalili |
| collection | DOAJ |
| description | BackgroundEvaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement. MethodsThis study was conducted in 2 parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran. ResultsIran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed. ConclusionA robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators’ status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives. |
| first_indexed | 2024-04-10T05:28:42Z |
| format | Article |
| id | doaj.art-1469047fb5cd4ac88348d366c452c728 |
| institution | Directory Open Access Journal |
| issn | 2322-5939 |
| language | English |
| last_indexed | 2024-04-10T05:28:42Z |
| publishDate | 2022-07-01 |
| publisher | Kerman University of Medical Sciences |
| record_format | Article |
| series | International Journal of Health Policy and Management |
| spelling | doaj.art-1469047fb5cd4ac88348d366c452c7282023-03-07T09:11:16ZengKerman University of Medical SciencesInternational Journal of Health Policy and Management2322-59392022-07-01117990100010.34172/ijhpm.2020.2433984Evaluation of Pharmacovigilance System in IranMalahat Khalili0Hamid Sharifi1Bita Mesgarpour2Mehrnaz Kheirandish3Sten Olsson4Naghmeh Javidnikou5Ali Akbar Haghdoost6HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, IranHIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, IranNational Institute for Medical Research Development, Tehran, IranDepartment for Assessment and Control of Prescribing and Use of Medicines and Health Products, Food and Drug Administration, Tehran, IranInternational Society of Pharmacovigilance, London, UKDeceased August 14, 2020HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, IranBackgroundEvaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement. MethodsThis study was conducted in 2 parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran. ResultsIran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed. ConclusionA robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators’ status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives.https://www.ijhpm.com/article_3984_996488f1aaa4fcb334e6ea40204420e0.pdfpharmacovigilanceadverse drug reactionpharmacoepidemiologyiran |
| spellingShingle | Malahat Khalili Hamid Sharifi Bita Mesgarpour Mehrnaz Kheirandish Sten Olsson Naghmeh Javidnikou Ali Akbar Haghdoost Evaluation of Pharmacovigilance System in Iran International Journal of Health Policy and Management pharmacovigilance adverse drug reaction pharmacoepidemiology iran |
| title | Evaluation of Pharmacovigilance System in Iran |
| title_full | Evaluation of Pharmacovigilance System in Iran |
| title_fullStr | Evaluation of Pharmacovigilance System in Iran |
| title_full_unstemmed | Evaluation of Pharmacovigilance System in Iran |
| title_short | Evaluation of Pharmacovigilance System in Iran |
| title_sort | evaluation of pharmacovigilance system in iran |
| topic | pharmacovigilance adverse drug reaction pharmacoepidemiology iran |
| url | https://www.ijhpm.com/article_3984_996488f1aaa4fcb334e6ea40204420e0.pdf |
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