DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20164107

A cross-sectional study evaluating the awareness of pharmacovigilance among MBBS interns of a teaching hospital in south India

Mohammed Naseeruddin Nadeem, Ayesha Vaseem, Maliha Maqdoom

Abstract


Background: Spontaneous reporting is the backbone of any pharmacovigilance programme. The pharmacovigilance programme of India, started in 2010 has not seen considerable success, owing to underreporting of adverse drug reactions (ADRs). This can be attributed to a lack of awareness of pharmacovigilance among the healthcare professionals. This study was conducted with the aim to evaluate the level of knowledge, awareness, attitude and practice of pharmacovigilance among interns of a teaching hospital.

Methods: An observational, cross-sectional study was done among interns of a teaching hospital. A predesigned Questionnaire was distributed among 150 interns, from which 138 completed questionnaires were considered. The questionnaire consisted of 16 questions dealing with knowledge, awareness, attitude and practice of pharmacovigilance. Data was analysed and presented as percentage of respondents.

Results: 71% interns correctly identified the definition of pharmacovigilance. However, their awareness was deficient, in particular about the existence of an ADR monitoring centre in their own institution (33%). The rate of ADR reporting was immensely inadequate (12 %), which is a matter of utmost concern and requires immediate attention. The factors discouraging them from reporting ADRs were insufficient knowledge about the reporting procedure and a lack of time to report.

Conclusions: Interns lacked the required level of awareness, attitude and practice of pharmacovigilance, which needs to be resolved instantly by organizing frequent training sessions. Continued medical education programmes and workshops may be helpful in increasing their awareness and consequently to improve the rate of spontaneous ADR reporting.


Keywords


Adverse drug reactions, Interns, Pharmacovigilance, Spontaneous reporting

Full Text:

PDF

References


Pharmacovigilance. World Health Organization. 2016 Available from: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/.

Adverse Drug Reactions Database [Internet]. Adr-database.com. 2016. Available from: http://www.adr-database.com/What%20are%20ADRs.html#Definition.

Lazarou J, Pomeranz B, Corey P. Incidence of Adverse Drug Reactions in Hospitalized Patients: a meta - analysis of prospective studies. JAMA. 1998;279(15):1200.

Pirmohamed M. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ. 2004;329(7456):15-9.

Ayani I, Aguirre C, Gutiérrez G, Madariaga A, Rodríguez-Sasiaín J, Martínez-Bengoechea M. A cost-analysis of suspected adverse drug reactions in a hospital emergency ward. Pharmacoepidemiology and Drug Safety. 1999;8(7):529-34.

Lopez-Gonzalez E, Herdeiro M, Figueiras A. Determinants of Under-Reporting of Adverse Drug Reactions. Drug Safety. 2009;32(1):19-31.

Feely J, Moriarty S, O'Connor P. Stimulating reporting of adverse drug reactions by using a fee. BMJ. 1990;300(6716):22-3.

Prakash S. Pharmacovigilance in India. Indian J Pharmacol. 2007;39:123-3.

Gupta YK. Ensuring Patient Safety - Launching the New Pharmacovigilance Programme of India. Pharma Times. 2010;42:21-6.

ISPOR India. Pharmacovigilance Programme of India (PvPI). ISPOR India; 2013. Available from: http://www.isporindia.com/wp-content/ uploads/2013/04/Dr.-V.-Kalaiselvan.pdf

Inman WH. The attitudes to the adverse drug reaction reporting. Br J Clin Pharmacol. 1996;41:433-5.

Edwards I, Olsson S. WHO: global monitoring. In: Pharmacovigilance, Mann RD, Andrew E, editors. Chichester: John Wiley and Sons; 2002:169-182.

Indian Pharmacopoeia Comission. 2016. Available from: http://www.ipc.gov.in/PvPI/WHO% 20news.pdf.

Williams D, Feely J. Underreporting of adverse drug reactions: attitudes of Irish doctors. Irish Journal of Medical Science. 1999;168:257-61.

Perlik F, Slanar O, Smid M, Petracek J. Attitude of Czech physicians to adverse drug reaction reporting. European Journal of Clinical Pharmacology. 2002;58(5):367-9.

Figueiras A, Tato F, Fontainas J, Gestal-Otero J. Influence of Physicians' Attitudes on Reporting Adverse Drug Events. Medical Care. 1999;37(8):809-14.

Gupta P, Udupa A. Adverse drug reaction reporting and Pharmacovigilance: Knowledge, attitudes and perceptions amongst resident doctors. J Pharma Sci Res. 2011;3:1064-9.

Kamtane R, Jayawardhani V. Knowledge, attitude and perception of physicians towards adverse drug reaction (ADR) reporting: A pharmacoepidemiological study. Asian J Pharm Clin Res. 2012;5(3):210-4.

Radhakrishnan R, Sudha V, Danturulu MV. An educational intervention to assess knowledge attitude practice of Pharmacovigilance among health care professionals in an Indian tertiary care teaching hospital. International Journal of PharmTech Research. 2011;3(2):678-92.

Deepak P, Jayashree V Nagaral. Awareness of Pharmacovigilance among medical students. International Journal of Recent Trends in Science and Technology. 2014; 13(2): 262-65.

Ramesh M, Parthasarathi G. Adverse drug reaction reporting: the attitudes and the perceptions of the medical practitioners. Asian Journal of Pharmaceutical and Clinical Research. 2009;2(2):10-4.

Kharkar M, Bowalekar S. Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting. Perspect Clin Res. 2012;3(3):90.

Qing L, Su-min Z, Hua-ting C, Shi-ping F, Xin Y, Dong L, et al. Awareness and attitudes of healthcare professional in Wuhan, China to the reporting of adverse drug reactions. Chinese Medical Journal. 2004;117(6):856-61.

Belton K, Lewis S, Payne S, Rawlins M, Wood S. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. British Journal of Clinical Pharmacology. 1995;39(3):223-6.

Bateman DN, Sanders GL, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. British Journal of Clinical Pharmacology. 1992;34(5):421-6.

Tabali M, Jeschke E, Bockelbrink A, Witt CM, Willich SN, Ostermann T. Educational intervention to improve the physician reporting of the adverse drug reactions (ADRs) in a primary care setting in the complementary and alternative medicine programs. BMC Public Health. 2009;9(1):274.