A PROSPECTIVE ANALYSIS OF ADVERSE DRUG REACTIONS IN TERTIARY CARE REFERRAL HOSPITAL, PERINTHALMANNA

A PROSPECTIVE ANALYSIS OF ADVERSE DRUG REACTIONS IN TERTIARY CARE REFERRAL HOSPITAL, PERINTHALMANNA

              The study was conducted with an objective to find out the incidence and severity of adverse drug reactions, causality assessment of ADRs, to study the underlying reasons and overall trends of ADRs among patients by motivating the healthcare professionals in this hospital to report ADRs and to improve pharmacovigilance awareness among physicians in order to improve the pharmacovigilance system in India by preparing a guideline.

              This was a prospective, spontaneous reporting study conducted over a period of 9 months. All the suspected ADRs due to medication both prescribed and over the counter, taken by patients were noted and reported. Patients of all age groups who developed adverse drug reactions were included for the study. The data for the study was taken from Case sheets,  Treatment charts, Investigation reports of patients who had experienced an ADR, Personal interviews with patient/patient’s attendant, reporting persons / clinicians, and Prescriptions from the past.

             The overall rate of ADR occurrence in the study seems to be lower compared to that cited in studies carried out elsewhere. This may be mainly attributed to the new ADR reporting and monitoring system being established.  . Geriatrics and adult patients were most commonly affected by ADRs with a predominance of male gender. Maximum number of ADRs came from General medicine department and more number of ADRs was reported in June. Antibiotics and Diuretics were the drugs commonly caused ADRs compared to other drugs. In this study, skin was most affected organ by the adverse drug reactions. Multiple drug therapy and age were the most prominent predisposing factors of ADRs seen in our hospital. Well-trained pharmacists, who are involved in patient care activities, are a definite asset in early detection and prevention of ADRs, ensuring quality drug use and in providing better patient care.

          Causality assessment of suspected drugs was assessed using Naranjo scale. According to Naranjo scale most of the reported ADRs belong to probable followed by possible and definite. The severities of the reactions were done using Hart Wig Scale. Majority of the reactions were moderate. The present study shows that most of the ADRs were predictable and were definitely preventable.

     

          Adverse drug reactions are an inevitable risk factors associated with the use of modern medicines. However, careful attention to dosage, age and renal function can minimize the risk of developing ADRs in many patients. Our study shows most of the developed ADRs were managed by withdrawing the offending drug and symptomatic treatment. In this pharmacist, physician, nurses, patients and patient’s volunteers must help in reporting ADRs. If this culture is adopted and practiced well, we can minimize ADRs and also provide a good quality of life to patients. Developing and maintaining electronic documentation of patients’ medical records may serve as a valuable tool to detect early signals of potential ADRs. Also, the implementation of a computerized reporting system in hospital setup may hasten reporting of ADRs and is suggested.      

Shinu

Sr Lecturer