Monitoring Adverse Drug Reactions under National Pharmacovigilance Programme at Select Hospital in Bangalore

Kiran Kumar Chemudugunta¹*, Dr. Habib Habibuddin M^2
1Research Scholar, Rayalaseema University, Kurnool, Andhra Pradesh, India
²Chairman, Adept Pharma and Bio Science, Excellence Pvt. Ltd, Hyderabad, Telangana, India

A B S T R A C T
Drugs are the most widely used medical intervention in the world today, as they are capable of modifying fundamental biological processes. The beneficial effects of the drugs are coupled with the in escapable risk of untoward effects. The mortality and the morbidity associated with these adverse effects post diagnostic problem because they can involve every organ and system of the body and are often mistaken for signs of underlying disease. Hence,  the  present  study was carried out  to  identify  incidences  of ADRs  and  assess  the  strategies  involved  in management of  each  ADR. A 9 month prospective observational, non-interventional study was carried out at Bgs global hospital Bangalore after  obtaining  institutional  ethical committee clearance of Bgs global hospital  bangalore. The ADRs were monitored by Spontaneous reporting by using yellow forms and by conducting chart reviews. A total of 100 ADRs were encountered during the study period, 65(65%) were  detected  by  chart  reviews  and  35(35%)  by  spontaneous  reporting.  Patients demographics revealed that, higher percentage 33(33%) of patients were in the age group of 41-50 years. ADR induced hospital admissions were 12(12%) and ADRs during the hospital stay of the inpatients were 88(88%).  89(89%)  ADRs were probable and 82(82%) ADRs were found to be moderate in Severity. 49(49%) ADRs were observed to be probably preventable. Analysis of ADR profile showed that, 46(46%) ADRs were Type A and 54(54%) ADRs were Type B. 37(37%) ADRs affected the skin, and 24(24%) affected GItract. Antibiotics were implicated in the 43(43%) ADRs followed by NSAIDS 17(17%) ADRs, 7(7%) of the total ADRs were due to anti epileptic drugs. Withdrawal of the causative drug-Alternate therapy and symptomatic treatment was observed to be the most preferred choice in 29(35.5%) ADRs in whom the causative drug could be assessed. Where more than 1 drug was implicated in an ADR encountered, drug withdrawal & symptomatic treatment was observed to be the preferred choice for the management in 6(11.3%) ADRs. A total number of 90 ADRs led to additional healthcare costs to the patients. The total cost of management of both Type A and Type B ADRs were Rs. 2, 32,439.00. Hospital-based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of drugs. This information may be useful in identifying and minimizing preventable ADRs while generally enhancing the knowledge of the prescribers to deal with ADRs more efficiently.
Keywords: Adverse   Drug   Reactions   (ADRs),   Spontaneous   Reporting,   Chart Review