DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20163260

Knowledge, attitude, and practice of pharmacovigilance among health care professionals in a tertiary care hospital: a cross sectional study

Vinoth Kalaichelvan, Meenakshi Balasubramanian, Ezhil J. Ramya

Abstract


Background: Spontaneous reporting of Adverse drug reactions (ADRs) has played an important role in the detection of serious, unsuspected, and unusual ADRs previously not detected during the clinical trials. However, underreporting remains a major obstacle in the implementation of pharmacovigilance program. The present cross-sectional study was conducted to assess the knowledge, attitude, and practice (KAP) related to pharmacovigilance among the health-care professionals (HCPs) in Tirunelveli Medical College Hospital, Tamilnadu.

Methods: To assess KAPs of Health care professionals toward pharmacovigilance and ADR reporting; a predesigned, structured, 12 item questionnaire was used.

Results: A total of 200 questionnaires were distributed among the HCPs including Postgraduate, Interns and Staff nurses. 72.7% postgraduates, 54.29% interns and 52.63% of staff nurses were aware regarding the existence of a National Pharmacovigilance Program of India. 72.7% postgraduates, 65.71% interns and 52.63% staff nurses felt that ADR reporting is a professional obligation for them .Only 37.14% interns, 15.79% staff nurses and 11.4% postgraduates have been trained for reporting adverse reactions. Although all staff nurses (100%) followed by 79.50% postgraduates and 48.57% interns experienced ADR in their practice, only 31.58% staff nurses, 20.50% postgraduates and 11.43% interns have ever reported ADR to pharmacovigilance centre.

Conclusions: The deficiencies in knowledge and attitude require urgent attention not only to improve the rate of spontaneous reporting, but also for enhanced safety of the patients. Pharmacovigilance should be included in the nursing curriculum and workshops should be conducted for the undergraduate and postgraduate medical students regularly.


Keywords


ADR reporting, Health-care professionals, Pharmacovigilance

Full Text:

PDF

References


World Health Organization Collaborating Centre for International Drug Monitoring. The importance of pharmacovigilance. Safety monitoring of medicinal products. Geneva: World Health Organization; 2002. Available at http://apps.who.int/medicinedocs/en/d/Js4893e/. Accessed on 8 October 2015.

Pharmacovigilance programme of India 2010. CDSCO, Ministry of Health and Family Welfare, Government of India. 2010. Available at http://cdsco.nic.in/ pharmacovigilance.htm. Accessed on 8 October 2015.

Lopez Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32:19-31.

Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJ, Aronson JK, et al. Adverse drug reaction in a hospital general medical unit meriting notification to the committee on safety of medicines. Br J Clin Pharmacol. 1996;42:423-42.

Feely J, Moriarty S, O’Connor P. Stimulating reporting of adverse drug reaction by using a fee. Br Med J. 1990;300:22-3.

Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: An observational study. J Nat Sci Biol Med. 2013;4:191-6.

Muraraiah S, Rajarathna K, Sreedhar D, Basavalingu D, Jayanthi CR. A questionnaire study to assess the knowledge, attitude and practice of pharmacovigilance in a paediatric tertiary care centre. J Chem Pharm Res. 2011;3:416-22.

Remesh A. Identifying the reasons for under reporting of ADR: across sectional survey. Res J Pharm Biol Chem Sci. 2012;3:1379-86.

Li Q, Zhang SM, Chen HT, Fang SP, Yu X, Liu D, et al. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chin Med J. 2004;117:856‑61.

McGettigan P, Feely J. ADR reporting: opinion and attitudes of medical practitioners in Ireland. Pharmacoepidemiol Drug Saf. 1995;4:355‑8.

Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. Br Med J. 2004;329:15‑9.

Torwane NA, Hongal S, Gouraha A, Saxena E, Chavan K. Awareness related to reporting of adverse drug reactions among health caregivers: a cross-sectional questionnaire survey. J Nat Accred Board Hosp Healthcare Providers. 2015;2:23-9.

Drug safety information. PvPI. 2015;5:9-10.

Tabali M, Jeschke E, Bockelbrink A, Witt CM, Willich SN, OstermannT, et al. Educational intervention to improve physician reporting of adverse drug reactions (ADRs) in a primary care setting in complementary and alternative medicine. BMC Public Health. 2009;9:274.