DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20184861

An analysis of seriousness, predictability and preventability of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective observational record based study

Jihana Shajahan, Abdul Aslam Parathoduvil, Sangeetha Purushothaman

Abstract


Background: Adverse drug reactions (ADR) are the leading cause of mortality and morbidity in all health care systems. Hospital based ADR monitoring and reporting programmes can throw some light upon the profile of ADRs and ways to prevent them, facilitating rational drug use. An attempt has been made in this study to analyse the seriousness, predictability, preventability, severity and outcome of ADRs occurring in a tertiary care hospital.

Methods: This was a retrospective observational study based on the data collected from ADRs reported to an approved ADR monitoring centre (AMC). Data collected was evaluated for seriousness, predictability, preventability, severity and outcome using appropriate scales. Simple descriptive statistics was used for analysis.

Results: The total number of ADRs reported was 300. Among this 39% reactions were serious. The commonest reason for considering as serious reaction was prolongation of hospitalization. The overall predictability was 40.4%. Total preventability was found to be 18.3%. Assessment of severity showed 55.3 %, 41.7%, 3% reactions in mild, moderate and severe grades respectively. 64.3% patients had recovered from the reaction and 30% were recovering at the time of reporting ADR. Only 0.3% ADRs caused death.

Conclusions: Authors hope this study will foster the culture of reporting and analysing ADRs among health care professionals and students. The findings from the study can create awareness among health care professionals regarding the impact of ADRs on the treatment course.


Keywords


Adverse drug reactions, Pharmacovigilance, Predictability, Preventability, Seriousness

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References


Manjunath SM, Raju GN, Someswara GM. A cross-sectional study on the extent of Pharmacovigilance awareness among fifth term medical students. Indian J Pharmacy Pharmacol. 2015;2(3):146-9.

Raut A, Patel P, Patel C, Pawar A. Preventability, predictability and seriousness of adverse drug reactions amongst medicine inpatients in a teaching hospital: a prospective observational study. Int J Pharmaceut Chem Sci. 2012;1(3):1293-99.

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 Natural Sci Biol Med. 2013 Jan;4(1):191-6.

Feely J, Moriarty S, O'Connor P. Stimulating reporting of adverse drug reactions by using a fee. Br Med J. 1990 Jan 6;300(6716):22.

Deepak P, Jayashree V Nagaral. Awareness of pharmacovigilance among medical students: Int J Recent Trends Sci Technol. 2014;13(2):262-5.

Elizabeth ST, Kia RA, Yagnik RM, Nagaraju K. Knowledge, attitude and skills of nurses of Delhi towards adverse drug reaction reporting. Indian J Pharmacy Pract. 2012;5:45-51.

Geer MI, Koul PA, Tanki SA, Shah MY. Frequency, types, severity, preventability and costs of Adverse Drug Reactions at a tertiary care hospital. J Pharmacol Toxicol Methods. 2016 Sep 1;81:323-34.

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

Vora MB, Trivedi HR, Shah BK, Tripathi CB. Adverse drug reactions in inpatients of internal medicine wards at a tertiary care hospital: a prospective cohort study. J Pharmacol Pharmacotherapeutics. 2011 Jan;2(1):21-5.

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 Jan 23;7(2):210-4.

Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Internal Med. 2005 Jun 27;165(12):1363-9.

Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9.

Aronson JK, Ferner RE. Joining the DoTS: new approach to classifying adverse drug reactions. BMJ. 2003 Nov 20;327(7425):1222-5.

Davies EC, Green CF, Mottram DR, Pirmohamed M. Adverse drug reactions in hospitals: a narrative review. Current Drug Safety. 2007 Jan 1;2(1):79-87.