Aim: Adverse drug reactions are the recognized hazards of any treatment at any point of time.  The aim of this study is to analyze the ADRs during one year period in various department of Government Rajaji Hospital, Madurai, Tamilnadu, the relationship between each reaction and the drug and preventability of the ADR.

Materials and Methods: The study involved total sum of 500 Individual case safety reports (ICSRs) collected from the period of January 2016 to December 2016.  The WHO causality assessment scale was used to assess the relationship between the adverse drug reaction and the suspected drug. ADR preventability was assessed using Modified Shumock and Thornton scale.

Results: Out of total of 500 ICSR’s 62% were reported in the age group above 40 years, 31% were between 16 to 40 years; 6% between 3 to 16 years and just 1% reported below the age of 3 years.  Anti cancer drugs tops the list with 55 % of ADR , 14 % for Anti-retroviral drugs, 13 %  for Antibacterial agents, 8 % for Anti tuberculosis drugs, 3 % reported for Anti epileptic drugs; 2% for NSAID’S and 7% miscellaneous drugs. According to the WHO causality assessment scale 22 % of ICSRs were possible cases, 65 % were probable and 13% were certain. Among 500 ADRs 15% was preventable 30% probably preventable 55% were not preventable.

Conclusion: The study reveals how monitoring helps to quantify the burden of ADR and focus  the preventable ADR, find out unknown reactions  and to reduce the physical, psychological and economic burden to the patient.

Keywords: Individual case safety reports, adverse drug reactions, WHO causality assessment scale, preventability.

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Dr M.Shanthi

Professor, Institute of Pharmacology, Madurai Medical College Madurai

Email: shanthi This email address is being protected from spambots. You need JavaScript enabled to view it.