ABSTRACT
Aim: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. Methods: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. Results: A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; 14 required further data generation; and the remaining 96 FDCs could not be categorized into any of the above. Vitamins and minerals/supplements, antibacterial for systemic use, and drugs for gastroesophageal reflux disease (GERD) and peptic ulcer were the most used FDCs. Conclusion: Based on the finding that some prescriptions contained irrational FDCs, it is recommended that a rigorous, regular, and uniform method of evaluation be implemented to approve/ban FDCs and that prescribers be periodically notified about the status of the bans.
ABSTRACT
Background: To sensitize nurses about Trigger Tool Method (TTM) and to evaluate the impact of TTM on adverse drug event (ADE) reporting by nurses at a tertiary care teaching hospital in India.Methods: This was prospective, interventional, single center study conducted among nursing health professionals of Civil Hospital Ahmedabad (CHA) posted in Medicine Department. They were sensitized about ADE reporting, pharmacovigilance, methods of ADRs reporting and details about TTM. Also, a list of 17 triggers was prepared by the investigator and given to nurses. They were educated to report ADEs using TTM. At the initiation and end of study, questionnaires were given to evaluate knowledge, attitude and practice of ADR reporting among participant nurses. All triggers and ADEs reported were analyzed in terms of association between them, effectiveness of trigger in detecting an ADR and in terms of Positive Predictive Value (PPV). Reported ADRs were also assessed for causality, severity and preventability.Results: A total 758 patients were admitted during the study period in the respective medicine department. List of 17 triggers consists of 9 drug triggers (DT), 1 laboratory trigger (LT) and 7 patient triggers (PT). Of these 17 triggers, 14 triggers were identified by nurses. These 14 triggers were noticed 130 times. These included DT (100 times), LT (0 times) and PT (30 times). Of the various triggers observed, 7 DT and 4 PT were related to ADRs. Hence, 11 triggers (64.70%) were positive (related to ADRs), out of 17 total triggers under evaluation. 21 ADRs were observed using TTM by nurses.Conclusions: The TTM helps to detect and report ADRs by nurses. Educational interventions about TTM help in better detection and reporting of ADRs.
ABSTRACT
Drug interactions are an important cause of medication errors. The present study was conducted to evaluate the nature and clinical significance of potential drug-drug interactions (DDIs) in inpatients of Medicine Department at a tertiary care hospital in India. The second day prescription of every alternate indoor patient from five randomly selected medical units of a tertiary care hospital were collected. Prescriptions were analyzed for potential DDIs using the web based interaction checkers of Medscape and Current Index of Medical Specialties. The average numbers of drugs per prescription and potential DDIs per prescription and the types, age wise distribution and clinical significance of the potential DDIs were evaluated. A total of 3405 potential DDIs were detected in 257 prescriptions. An average 8.28 drugs were prescribed per prescription. The most common drug groups involved in potential DDIs were diuretics (n=255), NSAIDs (n=225), β blockers (n=143), cardiac glycosides (n=129) and statins (n=122). Potential DDIs were most frequent in patients between 61-75 years of age. The clinical significance was graded as serious (n=123), significant (n=949), minor (n=2328) and contraindicated (n=5). An increased risk of rhabdomyolysis (n=41) and an increase in QTc interval (n=38) were the most common potentially serious DDIs detected. Of the 1077 DDIs (excluding minor DDIs), 615 were pharmacodynamic and 462 were pharmacokinetic interactions. Potential DDIs increased with an increase in the number of prescribed drugs. Improved awareness among prescribers is required to reduce the risks associated with DDIs. Use of drug groups, commonly involved in potential DDIs, should be minimized and optimized while prescribing.