Original Article

The role of Clinical Pharmacists in the improvement of a pharmacovigilance system: A review of the reported adverse drug reactions during 2004-2010 in Mazandaran Province of Iran

Abstract

Background: Following establishment of Iranian Adverse Drug Reaction (ADR) Monitoring  Center  in  1997, ADR  committees  were  established  in  all  hospitals  of Mazandaran Province of Iran. Clinical pharmacists from Mazandaran University of Medical Sciences have been involved with these committees since 2007. The aim of this study was to compare the results of the pharmacovigilance system before and after active involvement of clinical pharmacists.
Methods:  This  study  included Yellow  Cards  filled out  by  healthcare  providers  inMazandaran Province during 2004-2010. Frequency of Adverse Drug Reactions (ADRs), route of administration, reporters, number of reports in each years and damaged organs were focuses. Statistical analysis was performed by SPSS 16 software. P< 0.05 was considered as significant difference.
Results: A total of 793 yellow cards were completed during 2004 – 2010. Only 38 ADRs(4.8%) were related to 2004-2007. Most of the reports generated by Nurses (49.3%) followed by Pharmacists and Physicians (P< 0.001). Forty-one reactions (5.2%) were serious, most related to Ceftriaxone, Desfonac and Vancomycin.
Conclusion: Clinical pharmacists’ intervention regarding establishing ADR committees in the hospitals improved the output of the pharmacovigilance system, although under- reporting is still a major drawback of spontaneous reporting.

Wasser Fallen JB, Livio F, Buclin T, Tillet L and Yersin B. Rate, type and cost of adverse drug reactions in emergency department admissions. Eur J Intern Med. 2001; 12:442-7.

Lezarou J, Pomeranz BM, Corey PN. Incideence of adverse drug reaction In hospitalized patient: A Meta-analysis of prospective studies. JAMA. 1998; 279(15):1200-5.

Pirmohamed M, James S, Meakin S, Green C, Scott A, Walley T, et al. Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18820 patients. BMJ. 2004; 329:15-19.

Millar JS. Consultation owing to adverse drug reaction in a single practice. Br J pract. 2001;51:130-31.

WHO. The importance of Pharmacovigilance, safety monitoring of medical products. Geneva: WHO, 2002.

World Health Organization Scientific Group On Monitoring Adverse Reactions and the WHO Collaborating Center for International Drug Monitoring, Uppsala Monitoring Center, Sweden.

Official reports of Iranian adverse drug reaction Monitoring Center (IADRMC), 2010.

Sohrevardi, SM. Adverse Drug Reaction in Guide to rational drug Prescribing. First edition. Esfahan: Kankash Publishing. 2006; 87-92.

Ghasemian R, Mahmoodi M, Khalilian A. Review of physician knowledge, attitudes and behavior related to reporting adverse drug events in Sari; Journal of Mazandaran University of Medical Sciences. 2005; 15(50):97- 104.

Salehifar E, Ala Sh, Gholami K. Review of nurses and pharmacists knowledge, attitudes and behavior related to reporting adverse drug events in Mazandaran Province. Journal of Mazandaran University of Medical Sciences. 2005;16 (56):115-125.

Tajik F, Javid N, Seied Ali Allahi H, Yoosefian SH. Official reports of Iranian adverse drug reaction Monitoring Center (IADRMC). Razi. 2010; 251: 62-72.

Official reports of the Food and Drug Deputy of Mazandaran University of Medical Science, 2010.

Morrison-Griffiths S, Walley TJ, Park BK, Breckenridge AM, Pirmohamed M. Reporting of adverse drug reactions by nurses. Lancet. 2003; 361: 1347-8.

Hall M, Mccormack P, Arthus N, Feely J. The Spontaneous reporting of adverse drug reactions by nurses. Br J Clin Pharmacol. 1995; 40: 173-5.

Soleimani F, et al. Official reports of National Rational Drug Prescribing Committee , 2008.

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IssueVol 1, No 1 (Winter 2013) QRcode
SectionOriginal Article(s)
Keywords
Pharmacovigilance Adverse Drug Reaction Mazandaran Adverse Drug Reaction Reporting Systems

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How to Cite
1.
Salehifar E, Ala S, Amini M, Azhdari E, Mir-Shafa F. The role of Clinical Pharmacists in the improvement of a pharmacovigilance system: A review of the reported adverse drug reactions during 2004-2010 in Mazandaran Province of Iran. J Pharm Care. 2015;1(1):8-12.