Preventability

The aim of the study was to analyze the incidence of adverse drug reactions (ADRs) at a tertiary care hospital and assess the functioning of the reporting system. The outcome of the study would provide information regarding associated factors and pharmacoeconomic impact of the ADRs. The causality assessment was determined by WHO UMC probability scale and Naranjo’s algorithm. Outcomes of ADR, management and the pharmacoeconomic impact was assessed. Overall incidence of ADRs among the patients was 4.5%. A total of 61 ADRs were detected from 54 patients. As per the WHO UMC scale 44.3% of the ADRs were possible and as per the Naranjo’s scale 53.1% of the ADRs were possible. Majority of the reactions were moderate in severity (47.6%). Most of the ADRs (73.8%) were predictable reactions and 39.3% were probably preventable. Multiple drug therapy (27.77%) was the most common associated factor. Withdrawal of the offending drug was the main line of management.  Symptomatic treatment was required in majority of cases. The total direct cost involved in treatment of ADRs was INR 1, 10,284 (US$ 1730.22) at a rate of INR 2042.29 US$ 32.08 per patient. The direct cost per patient involved in ADR related hospital admissions (INR 2689 i.e US$ 42.30) was higher than ADR during hospitalization (INR 1769.60 i.e US $ 27.83).The ADRs were not recognized and recorded in majority of the cases. Patients on multiple drug therapy are more vulnerable to ADRs. The incidence and alarming pharmacoeconomic impact of the ADRs suggest that there is a need for a continuous monitoring system at tertiary care hospitals.

The field of patient’s drug safety has been receiving great deal of attention, since adverse drug reaction has been recognized as hazards of drug therapy. Adverse drug reactions are a great cause of concern to the healthcare professionals, patients and the pharmaceutical industry. However, may times it goes undetected and ignored by the patients and healthcare professionals. Hence we took a prospective observational study to analyse the Adverse Drug reactions among all patients admitted in general medicine department in Justice KS Hegde Charitable Hospital, Mangalore. The study was carried out for a period of eight months from September 2012 to April2013. The suspected adverse drug reactions were later analysed for their causality, severity and preventability by using the different adverse drug reaction assessment scales. A total of 640 cases has been followed and 47 Adverse Drug Reactions has been reported from the 40 patients during the study period. Male predominance was noted over females in case of total number of patients. Majority Adverse Drug Reactions were in the age group 70-79(31.91%). The most common class of drugs involved in adverse drug reactions is Antibiotics (17.39%) followed by Antihypertensive 7(15.21%). The most common system involved in adverse drug reaction is Digestive system (19.36%) followed by dermatological system (13.04%). Out of the 47 adverse drug reactions reported, 53% were probable, 45% were possible and 2% were unlikely. The severity assessment done by using the Hartwig and Seigel scale indicate that majority of the ADRs were ‘Mild’ followed by moderate and severe respectively. The preventability assess shows that most of ADRs are Probably Preventable 28(59.57%) followed by Not preventable 16(34.04%) and definitely preventable 3(6.38%). Monitoring and reporting of adverse drug reactions in the hospital is one of the best method to identify the causality between exposure to the drug and the occurrence of adverse drug reaction. Proper education and training to the healthcare professional’s towards ADR reporting will have a positive attitude towards continuous reporting and improving patient safety.