Background: Drugs are double edged weapons, they are used in treatment of the patients but in return can harm as well. The safety of drug prescribing has become a need of the hour topic in medicine. Safety monitoring of patients via Pharmacovigilance tool has become an integral part of pharmacotherapy. This study has been undertaken to analyze the various individual case safety reports including the Special situation cases of medicational error and over dose and to promote the reporting of adverse drug reactions (ADRs) among the healthcare professionals (HCPs).Methods: A retrospective non-interventional observational study was done for indexed period of six months at AMC-PvPI under Osmania Medical College and General Hospital. The reported individual case safety reports (ICSRs) are evaluated on basis of demographics of age and gender, seriousness criteria, outcome parameters and causality assessment of suspected drug (s) and suspected ADR/AE (s) as per the ICH guidelines and WHO causality assessment scale.Results: A total of 177 ICSRs are reported out of that 137 were ADRs, 36-medication error cases and 4-cases of over dose. The incidence of ADRs in females are high compared with males was identical. The occurrence of ADRs in adult patients (61%) was significantly higher than other age groups. Of total ADRs, most of them were with analgesics (26%) and highly reported system organ classification was CNS. Overall, 79% patients were recovered from ADRs.Conclusions: The results depicted an insight to the HCPs on the importance of monitoring and reporting of ICSRs. Our study results emphasized need to roll out a pharmacovigilance practice tool to ensure the safe use of drugs for better Pharmacotherapy and development of pharmacogenomic studies.

Background: Drug utilization studies play crucial role in the health sector and ultimately it provides insight into the efficiency of drug use and results of such research can be used to help to set priorities for the rational use of medicines and allocation of health care budgets. Respiratory tract infections (RTIs) contributing to significant mortality and morbidity of populations especially in developing countries like India. Polypharmacy and irrational prescription are significant negative fallouts in treatment of RTIs. Keeping in view of this, our study was undertaken to analyze the drug utilization pattern of RTIs.Methods: The study was conducted at Gandhi Hospital, after obtaining permission from the Institutional Ethics Committee. We have collected data of 600 case records of the patients diagnosed with respiratory tract infection and evaluated for prescribing patterns in consonance with WHO indicators.Results: Out of the total case records 348 (58%) were of male patients and 252 (42%) of female patients. Age wise distribution was done; 79 (13.16%) 0-15 years, 46 (7.67%) 16-30 years, 123 (20.50%) 31-45 years, 194 (32.33%) 46-60 years and 158 (26.33%) patients belongs to >60 years of age group respectively. A total of 4682 drugs were prescribed, 2468 (52.71%) antibiotics, 768 (16.4%) bronchodilators, 581 (12.4%) corticosteroids, 323 (6.89%) antacids, 542 (11.57%) in miscellaneous category respectively. With regard to formulations 2463 (52.60%) oral, 1463 (31.24%) injectable and 756 (16.14%) inhalational drugs were prescribed. Numbers of Fixed dose combinations were 712 (15.20%). 7.8 drugs were prescribed per prescription. 2493 (53.24%) drugs were prescribed from National Essential Medicine List. 4168 (89.02%) drugs were prescribed by their brand names.Conclusions: Prescription of drugs with branded names, Irrational prescribing, poly pharmacy were observed in our study. So there is an urgent need for creating awareness among the health care professionals regarding rational prescription by using data from from drug utilization studies.