DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20184320

Comparison of impact of undergraduate teaching program to assess the knowledge and attitude towards pharmacovigilance and adverse drug reporting among undergraduate medical students at a teaching medical institute in South India

K. H. Hemanth Kumar, J. K. Akshay

Abstract


Background: Pharmacovigilance has become an important tool to ensure the safety of patient in recent years. To ensure right practice of pharmacovigilance, proper understanding is very essential and the medical colleges with the undergraduate teaching program become a vital platform to educate and train the medical students towards pharmacovigilance. This study compares the impact of teaching program of the undergraduate curriculum in assessing the knowledge and attitude of the undergraduate medical students towards pharmacovigilance.

Methods: The study includes 158 undergraduate medical students of second year being trained in pharmacology at Mysore Medical College. A validated and standardized questionnaire was distributed to all the students twice, once during their 3rd term (pre-sensitization) and the second time during their 5th term (post sensitization). Willingness to answer and complete the questionnaire was considered as consent.

Results: The pre and post sensitization questionnaires were analyzed individually. A decrease from 114 to 90 students (15.19 % decrease) willing to complete the questionnaire was seen. The mean total knowledge score was 6.37±1.90 during the pre-test as compared to 6.35±1.78 in the post test analysis. An overall increase was seen with the knowledge of ADRs and pharmacovigilance. Only 18.4% knew of the presence of an ADR monitoring center in the institute pre-test which increased to 64.4% post sensitization. 81.6% answered rightly the type of ADRs that needs to be reported as compared to the 67.3% pre-sensitization. The overall attitude towards ADR reporting was seen to be in the right direction, with 71% saying that pharmacovigilance covered adequately in the curriculum. Voluntary reporting attitude increased from 74.6% to 88%. 70% of the students feel ADR reporting as a professional obligation, while only 54% felt so pre-sensitization.

Conclusions: Pharmacovigilance should be included in the curriculum with more hours dedicated to teaching. Various interesting methods should be implemented to train and made aware of its importance to ensure patient safety on a global scale.


Keywords


Adverse drug reactions, Pharmacovigilance, PvPI, Sensitization, Undergraduate curriculum

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References


WHO policy perspectives on medicines. Pharmacovigilance: ensuring the safe use of medicines. Geneva: World Health Organization; 2004. Available at: http://www.who.int/medicines/.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. J Am Med Assoc. 1998;279(15):1200-5.

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 18 820 patients. BMJ. 2004;329(7456):15-9.

Oshikoya KA. Adverse drug reactions in children: Types, incidence and risk factors. Nigerian J Paediatr. 2006;33(2):29-35.

Martínez‐Mir I, García‐López M, Palop V, Ferrer JM, Rubio E, Morales‐Olivas FJ. A prospective study of adverse drug reactions in hospitalized children. British J Clin Pharmacol. 1999;47(6):681-8.

World Health Organization: Essential medicines and health products. Pharmacovigilance. Available at: www.WHO.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/.

Rajesh R, Vidyasagar S, Nandakumar K. Highly active antiretroviral therapy induced adverse drug reactions in Indian human immunodeficiency virus positive patients. Pharmac Pract. 2011;9(1):48-55.

Figueiras A, Tato F, Fontaiñas J, Gestal-Otero JJ. Influence of physicians' attitudes on reporting adverse drug events: a case-control study. Med Care. 1999;37(8):809-14.

Williams D, Feely J. Underreporting of adverse drug reactions: attitudes of Irish doctors. Irish J Med Sci. 1999;168(4):257-61.

Perlik F, Slanař O, Šmíd M, Petráček J. Attitude of Czech physicians to adverse drug reaction reporting. Europ J Clinic Pharmacol. 2002;58(5):367-9.

Belton KJ, Lewis SC, Payne S, Rawlins MD, Wood SM. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Brit J Clinic Pharmacol. 1995;39(3):223-6.

Hasford J, Goettler M, Munter KH, Müller-Oerlinghausen B. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clinic Epidemiol. 2002;55(9):945-50.

Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Physicians’ attitudes and adverse drug reaction reporting. Drug Safety. 2005;28(9):825-33.

Akshay JK, Kumar HKH. Knowledge and perception towards pharmacovigilance and adverse drug reactions reporting among medical students at a teaching hospital in South India. Int J Basic Clin Pharmacol. 2018;7:866-72.

Reddy VL, Pasha SJ, Rathinavelu M, Reddy YP. Assessment of knowledge, attitude and perception of pharmacovigilance and adverse drug reaction (ADR) reporting among the pharmacy students in south India. IOSR J Pharm Biol Sci. 2014;9(2):34-43.

Desai CK, Iyer PG, Panchal J, Shah S, Dikshit RK. An evaluation of knowledge, attitude, and practice of adverse drug reaction among prescriber at a tertiary care hospital. Perspect Clin Res. 2011;2(4):129-36.

Gupta P, Udupa A. Adverse drug reporting and pharmacovigilance: knowledge, attitude and perception among resident doctors. J Pharm Sci Res. 2011;3(2):1064-6.

Palaian S, Ibrahim MI, Mishra P. Health professionals’ knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharm Pract. 2011;9(4):228-35.

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(1):191-6.

Datta S, Sengupta S. An evaluation of knowledge, attitude and practice of adverse drug reaction reporting in a tertiary care teaching hospital of Sikkim. Perspect Clin Res. 2015;6(4):200-6.

Ganesan S, Vikneswaran G, Reddy KC, Subrahmanyam DK, Adithan C. A Survey on knowledge, attitude and practice of pharmacovigilance towards adverse drug reactions reporting among doctors and nurses in a tertiary care hospital in South India. J Young Pharm. 2016;8(4):471-6.

Figueiras A, Herdeiro MT, Polonia J, Gestal -Otero JJ: An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. J Am Med Assoc. 2006;296(9):1086-93.