Pharmacovigilance study in medicine department in a tertiary care hospital

Authors

  • Rajat Mishra Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Patna, Bihar, India
  • Santosh Kumar Jeevangi Department of Pharmacology, Mahadeveppa Rampure Medical College (MRMC) Gulbarga Karnataka, India
  • Shrenik Vardhamane Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Patna, Bihar, India
  • Sunil Kumar Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Patna, Bihar, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20164133

Keywords:

Adverse drug reactions, Causality, Health care professionals, Pharmacovigilance Preventability, Under reporting

Abstract

Background: Adverse drug reactions (ADRs) are major worldwide public health problem. Proper reporting of an ADR is very important as it reduces number of deaths due to ADR and extra financial burden on patients. The aim of the study was to assess the pattern of ADR reporting in outpatients and inpatients of medicine department and to assess their causality, severity and preventability.

Methods: This was a prospective observational study done from April 2013 to June 2014 or in 100 consecutive study subjects (which ever happen first) with ADRs in department of medicine. The clinical pattern, spectrum of ADRs reported and assessment of ADRs in terms of causality, severity and preventability .The causality, severity and preventability assessment was done on the basis of applying various scales for each of them.

Results: A total of 153 suspected ADRs were reported and evaluated from 100 patients. Dermatological system (28%) was most commonly involved. Drug class most commonly associated was Antimicrobials (51%). 68% ADRs were classified as “Probable” in view of causality, while 68% were found to be “Moderate” in case of severity. In 65% of the cases the ADRs was “Probably Preventable”. In majority of the cases the suspected drug was withdrawn and alternate therapy was instituted. Most patients recovered from the ADR.70% of these ADR was Type A.

Conclusions: Awareness about ADR reporting is still poor amongst healthcare professionals in India. Conducting regular training programmes can improve the number of ADR reporting.

References

Jacoline C, Marie L, Mare A. Epidemiology of ADRs in Europe. A review of recent observational studies. Springer. 2015;38(5).

Vishal R. Tandon, Vijay K, Annil M, Zahid Gi, Vivek M, and Vijant C Fatal adverse drug reactions Experience of adverse drug reactions in a tertiary care teaching hospital of North India- A case series. Indian J Crit Care Med. 2014;18(5):315-9.

Rao PGM, Archana B, Jose J. Implementation and results of an ADR reporting programme at an Indian teaching hospital. Indian Journal of Pharmacology. 2006;38(4):293-4.

Rabbur RSM, Emmerton L. An introduction to adverse drug reporting system in different countries. Intl J Pharm Prac. 2005;13(1):91-100.

Sriram S, Ghasemi A, Ramasamy R, Devi M, Balasubramanian R, Ravia TK. Prevalence of ADRs at a private tertiary care hospital in south India. Journal of Research in Medical Sciences. 2011;16(1):16-25.

Vora MB, Trivedi HR, Shah BK, Tripathi CB. ADRs in inpatients of internal medicine ward at a tertiary care hospital: A prospective cohort study. Journal of Pharmacology and Pharmacotherapeutics. 2011;2(1):21-5.

Rahmawati F, Pramantara DP. ADRs (ADRs) in geriatric hospitalized patients. Majalah Farmasi Indonesia. 2008;19(4):185-90.

Hazell L, Shakir SAW. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29:385-96.

McGettigan P, Golden J, Conroy RM, Arthur N, Feely J. Reporting of adverse drug reactions by hospital doctors and the response to intervention. Br J Clin Pharmacol. 1997;44:98-100.

Padmaja U, Adhikari P, Pereira P. A Prospective Analysis of ADRs in a South Indian Hospital. Online Journal of Health Allied Sciences. 2009;8(3):12.

Singh H, Dulhani N, Kumar BN, Singh P, Tewari P, Nayak K. A Pharmacovigilance Study in Medicine Department of Tertiary Care Hospital in Chhattisgarh (Jagdalpur), India. General Pharmacy. 2010;2(1):95-100.

Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K. ADRs as cause of admission to hospital: Prospective analysis of 18 820 patients. BMJ. 2004;329:15-9.

Palanisamy S, Kumaran AK, Rajasekaran A. A study on assessment, monitoring, documentation and reporting of adverse drug reaction at a multi-specialty tertiary care hospital in South India. Int J Pharmatech Res. 2009;1(4):1519-1522.

Munir P, Sally J and Shaun M. Adverse drug reaction as cause of admissions to hospital: Prospective analysis of 18820 patients. British Medical Journal. 2004:329-15.

Kongaew C.A prospective observational study on the prevalence of adverse drug reaction. British Medical journal. 2010:23-25.

Gonzalez EL, Herderio MT, Figueiras A. Determinants of under-reporting of adverse drug reaction a systematic review. Drug Saf. 2009;32(1):19-31

Mukeshkumar B, Vora, Hiren R. Adverse drug reactions in inpatients of internal medicine wards at a tertiary care hospital. A prospective cohort study. J pharmacol pharmacother. 2011;2(1):21-5.

Arulmani R, Rajendran SD, and Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clinpharmacol. 2008;:65(2):210-6.

Cornelis S, Jeanne PD, Claire S. Adverse drug reaction related hospitalizations: A population based cohort study. Pharmacoepidemiology and Drug safety. 2008:365-371.

Li XY. To investigate the occurrences and features of adverse drug reaction. Journal of Harbin Medical Unit; 2010:01-026.

Jha N, Bajracharya O, Namgyal T. Prevalence of adverse drug reactions (ADRs) with the commonly prescribed drugs in different hospitals of Kathmandu valley. Kathmandu University Medica Journal. 2007;5(4):504-10.

Edward IR, Aronson JK. Adverse drug reaction: definition, diagnosis and management. Lancet. 2000;356(9237):1255-9.

Fracas A, Bojita M. Adverse drug reaction in clinical practice: a causality assessment of a case of drug-induced pancreatitis. J Gastrointestin Liver Dis. 2009;18(3):353-8.

Karyn M, Sullivan, Linda MS. Adverse drug reaction reporting by pharmacy students in a teaching hospital. American Journal of Health-System Pharmacy. 2008;65:1177-9.

Khotaei GT. Adverse reactions to antibiotics in hospitalized Iranian children, J Microbiolo Immunol Infect. 2008;41:160-4.

Gor AP, Desai SV. Adverse drug reaction in the inpatients of Medicine Department of a rural tertiary care teaching hospital and influence of pharmacovigilance in reporting ADR. Indian J Pharmacol. 2008;40(1):37-40.

Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clinpharmacol. 2008;65(2):210-6.

Ramesh M. Adverse drug reactions in a South Indian hospital-their severity and cost involved. Pharmaco epidemiology and Drug safety. 2003;5(4):669-75.

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Published

2016-12-21

How to Cite

Mishra, R., Jeevangi, S. K., Vardhamane, S., & Kumar, S. (2016). Pharmacovigilance study in medicine department in a tertiary care hospital. International Journal of Basic & Clinical Pharmacology, 5(6), 2608–2615. https://doi.org/10.18203/2319-2003.ijbcp20164133

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Original Research Articles