DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20194149

A pharmacovigilance study of adverse drug reactions in a tertiary care hospital in Haryana

Manmeet Kaur, Tirthankar Deb, Jayant Kairi, Ankit Arora

Abstract


Background: Adverse drug reaction (ADR) is an inevitable risk associated with all the prescribed medicines. They vary in severity & duration in any population. Thus, ADRs are monitored and assessed on a large scale in our country by the Pharmacovigilance programme of India through adverse drug reaction monitoring centres. This study was taken to assess the pattern of ADR reported in a tertiary care hospital in Haryana.

Methods: This study was conducted in the Kalpana Chawla Government Medical College, Karnal, Haryana from January 2018 to June 2019. ADRs were collected from different departments and were analysed according to gender, age, department wise distribution, drugs class involved and ADR that was reported.

Results: A total of 233 ADRs were reported in the above mentioned period. Females were affected more than males, maximum number reported in the age group of 21-60 years. The maximum number of ADRs reported was from Dermatology department. Antimicrobials were the class of drugs that were responsible for the maximum number of ADRs reported. Skin manifestations of various types were the most reported ADRs.

Conclusions: By keeping a careful and timely watch majority of the ADRS can be prevented by early intervention. There is also a need to ensure timely check on the drugs supplied by the various pharmaceutical companies who get the contract for government supply. This will be a step towards improving patient safety.


Keywords


Keywords: Adverse drug reactions, Pharmacovigilance programme of India, Adverse drug reaction monitoring centres, Causality assessment

Full Text:

PDF

References


Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255-9.

Katusiime B, Semakula D, Lubinga SJ. Adverse drug reaction reporting among health care workers at Mulago National Referral and Teaching hospital in Uganda. Afr Health Sci. 2015;15(4):1308-17.

Annu, Priyanka;ADR Monitoring:An essential need for better Health Care and Safety. PharmaTutor. 2016;4(8):13-6.

Moore TJ, Psaty BM, Furberg CD. Time to act on drug safety. Journal of the American Medical Association, 1998;279:1571-3.

Routledge P. 150 years of pharmacovigilance. Lancet. 1998;351:1200-1.

AmASale PN, Deshpande SA, Nakhate YD, Arsod NA. Pharmacovigilance Process in India:An overview. J Pharmacovigi. 2018;6:259.

Rajadhyaksha V. Safety reporting - making it safely effective or effectively safe? Perspect Clin Res. 2012;3:85-6.

Sah AO, Pal SN, Olsson S, Dodoo A, Bencheikh RS. Specific features of medicines safety and pharmacovigilance in Africa. Ther Adv Drug Saf. 2012;3(1):25-34.

Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over Pharmacovigilance. Int J Clin Pharm. 2018;40(4):744-7.

Suke SG, Kosta P, Negi H. Role of Pharmacovigilance in India: An overview. Online J Public Health Inform. 2015;7(2):e223.

Gupta YK. Pharmacovigilance Programme for India. Available at: http://www.pharmabiz.com. Accessed on 3 June 2019.

Singh KM, Kanase HR. Pharmacovigilance Programme of India. The Beginning, Current Status and Recent Progress. Adv Pharmacoepidemiol Drug Saf. 2017;6:219.

Kavya HB Recent Development of Pharmacovigilance System in India. J Pharma Care Health Sys. 2018;5:193.

Mahajan MM, Thatte UM, Gogtay NJ, Deshpande S. An analysis of completeness and quality of adverse drug reaction reports at an adverse drug reaction monitoring centre in Western India. Perspect Clin Res. 2018;9(3):123-6.

Ozcan G, Aykac E, Kasap Y, Nemutlu NT, Sen E, Aydinkarahaliloglu ND. Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation. Drugs Real World Outcomes. 2016;3(1):33-43.

Sahu RK, Yadav R, Prasad P, Roy A, Chandrakar S. Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance. Springerplus. 2014;3:695.

Zancan A, Locatelli C, Ramella F, Tatoni P, Bacis G, Vecchio S, Manzo L. A new model of pharmacovigilance? A pilot study. Biomed Pharmacother. 2009;63:451-5.

Venkatasubbaiah PM, Reddy P, Satyanarayana SV. Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital. Alexandria J Med. 2018;54:597-603.

Sharma PK, Misra AK, Gupta A, Singh S, Dhamija P, Pareek P. A retrospective analysis of reporting of adverse drug reactions to oncology drugs:An experience from a national center of clinical excellence. Indian J Pharmacol. 2018;50(5):273-8.

Behera SK, Rath B, Biswal SB and Mohapatra S. Pattern of adverse drug reactions in a tertiary care hospital in Western Odisha. Int J Pharm Sci Res. 2018;9(6):2471-7.

Bhattacharjee P, Das L, Ghosh R, Lalromawii, Das UK. Pattern of adverse drug reactions reported at a tertiary health care teaching hospital of Tripura:a retrospective study. Int J Basic Clin Pharmacol. 2016;5:1293-9.

Lihite RJ, Mangala Lahkar M, Das S, Hazarika D, Kotni M, Maqbool M, Swapna Phukan S. A study on adverse drug reactions in a tertiary care hospital of Northeast India Alexandria J Med. 2017;53:151-6.

Singh P, Agrawal M, Hishikar R, Joshi U, Maheshwari B, Halwai A. Adverse drug reactions at adverse drug reaction monitoring center in Raipur:Analysis of spontaneous reports during 1 year. Indian J Pharmacol. 2017;49:432-7.

Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res. 2006;54(3):226-33.

Lobo MGA, Pinheiro SMB, Castro JGD, Momenté VG, Pranchevicius MCS. Adverse drug reaction monitoring: Support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol. 2013;14;5.

Jhaj R, Malhotra S. Adverse drug reactions among inpatients in a north Indian referral hospital. Natl Med J India. 2000;13(1):16-8.

Adhikari A, Bhattacharjee N, Bhattacharya S, Indu R, Ray M. Evaluation of Adverse Drug Reports from a Tertiary Care Hospital of Kolkata, West Bengal, India. J Young Pharm. 2017;9(3):311-4.

Rehan HS, Chopra D, Sah RK, Mishra R. Adverse Drug Reactions: Trends in a Tertiary Care Hospital. Current Drug Safety. 2012;7:384-8.

Akhideno PE, Fasipe OJ, Isah AO, Owhin OS, Adejumo OA. Pattern of medications causing adverse drug reactions and the predisposing risk factors among medical in-patients in clinical practice:A prospective study. J Med Sci. 2019;39:18.

Potharaju HR, Kabra SG. Prescription audit of outpatient attendees of secondary level government hospitals in Maharashtra. Indian J Pharmacol. 2011;43(2):150-6.

Goel RK, Bhati Y, Dutt HK and Chopra VS., Prescribing pattern of drugs in the outpatient department of a tertiary care teaching hospital in Ghaziabad, Uttar Pradesh. J App Pharm Sci. 2013;3(4):48-51.

Khan LM, Al-Harthi SE, Saadah OI. Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University Hospital and impact of pharmacovigilance in reporting ADR. Saudi Pharm J. 2013;21(3):261-6.

Bhabhor PH, Patel TK, Vahora R, Patel PB, Desai N. Adverse drug reactions in a tertiary care teaching hospital in India:analysis of spontaneously reported cases. Int J Basic Clin Pharmacol. 2014;3:1078-85.

Sutradhar SD, Ray D. A cross-sectional study of patterns of adverse drug reactions reported in the department of pharmacology of a tertiary care teaching hospital in North East India. Int J Comprehensive Adv Pharmacol. 2017;2(1):33-5.

The use of the WHO-UMC system for standardized case causality assessment. Available at: https://www.who-umc.org/media/2768/standardised-case- causality-assessment.pdf. Accessed on 22 August 2019.

Badyal DK, Kanish B, Gulrez G. Causality assessment and pattern of adverse drug reactions in a tertiary care hospital. Int J Basic Clin Pharmacol. 2018;7:210-4.

Rajeshreddy SGSV, Patil LV. Causality assessment and the severity of the adverse drug reactions in tertiary care hospital:a pharmacovigilance study. Int J Basic Clin Pharmacol. 2017;6:2800-3.

Kumar A, Majhee L, Gari M. Causality, severity and preventability assessment of adverse drug reactions in patients received anti-retroviral therapy in a tertiary care hospital: A retrospective study. Natl J Physiol Pharm Pharmacol. 2017;7(2):178-82.

Hartwig SC, Siegel J and Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. AM J Hosp Pharm. 1992;49:2229-32.