Developing A Community Based Pharmacovigilance Program In Western Nepal: A Significant Initiative To Ensure Drug SafetyCorrespondence Address :
P. Subish M.Pharm, Assistant Professor ,Department of Hospital and Clinical Pharmacy/ Pharmacology, Manipal Teaching Hospital/ Manipal College of Medical Sciences, Pokhara, Nepal. Phone: +977 61 526416 Extn:130/221, E-mail:firstname.lastname@example.org
In the year 2004, Pharmacovigilance activities were initiated in Nepal. The Department of Drug Administration (DDA), the national drug regulatory authority of Nepal acts as the national center for adverse drug reaction (ADR) monitoring and regional centers operate in liaison with the DDA. During that period only one center in Nepal is actively involved in ADR monitoring. This center is located at the Manipal Teaching Hospital (MTH), Pokhara, a 700 bed tertiary care teaching hospital. This center has taken the initiative in establishing the Pharmacovigilance activities in Nepal. Since inception (September 2004), the center has received nearly 300 ADR reports from the various departments of the hospital. The center has analyzed the various drugs causing the ADRs, their causality, severity, economic impact etc. In the year 2005, Nepal received membership in the WHO ADR monitoring program.
The current system of ADR monitoring in Western region of Nepal is beneficial only in reporting the ADRs that occur in hospital setup. This system does not encompass ADRs that occur with over the counter (OTC) medications and in the ambulatory patient settings. Hence, it has been decided by the Western regional Pharmacovigilance center to extend the ADR reporting to the community sector. The main objective of this program is to report and monitor ADRs occurring at the community level through community pharmacists. In a country like Nepal, in many cases the community pharmacists are the first point of contact for the patients with minor illness and drugs are dispensed without the patient having a valid prescription. Therefore, it has been decided to involve the community pharmacists as the key professionals in reporting the ADRs.
To begin with, the center has designed, field-tested and validated a Knowledge, Attitude and Practice (KAP) questionnaire. The baseline KAP of the community pharmacists in the Western region of Nepal (approximately 200) will be taken and the pharmacists with a good KAP scores will be identified and trained. The training will be provided by the pharmacists and the specialists who are involved in ADR monitoring in the country. After obtaining adequate training, the community pharmacists will be asked to report the suspected ADRs. Upon reporting the ADRs, the pharmacist at the Pharmacovigilance center will analyze the ADRs for their causality, severity, and preventability. The ADRs reports will be reported to the Uppsala Monitoring center, the WHO center for drug monitoring, Uppsala, Sweden through the â€˜Vigiflow onlineâ€™ program. It is hope that through this initiative we will be able to study the pattern of ADRs occurring in the community setting in Western Nepal.
The authors acknowledge Dr. Beverley Snell, Centre for International Health, and Macfarlane Burnet Institute for Medical Research and Public Health, Australia for reviewing the initial version of the manuscript and adding comments. Authors also acknowledge the Health Action International Asia Pacific (HAIAP) for extending the support for funding this project.
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