ABSTRACT
BACKGROUND: The lack of specific medicines and labeling recommendations for the pediatric population is a long-standing problem. Using data from an observational study of adverse drug reactions (ADRs) among pediatric inpatients, we aimed to test the hypothesis that off-label status is a risk factor for ADRs. METHODS: A prospective intensive surveillance was conducted at a pediatric ward of a public teaching hospital. Adverse events to labeled and off-label use were assessed for incidence, severity and predictors. A multivariate Cox proportional hazards regression model used to assess off-label use is a risk factor for ADR occurring. RESULTS: Off-label and labeled use were responsible for 34 (67%) and 17 (33%) ADRs respectively. Medicines which lacked complete pediatric labeling had the greatest odds for ADRs (9.21% of medicines in this category were implicated, OR 2.84 (95% CI 1.37-7.09). Number of off-label medicines given to patient significantly increased the hazard of an ADR (hazard ratio (HR) 1.28, 95% CI 0.43-3.78, P = 0.002). Number of medicines given also significantly increased the hazard (HR 1.2, 95% CI 0.80-1.71, P < 0.001). CONCLUSIONS: Use of off-label medicines were more likely to be implicated in an ADR than labeled medicines. This off-label use would be acceptable if evidence of potential benefits outweighs ADRs risk.
Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Off-Label Use/statistics & numerical data , Tertiary Care Centers/statistics & numerical data , Child , Child, Preschool , Female , Humans , Incidence , India/epidemiology , Infant , Male , Patient Safety , Prospective Studies , Risk FactorsABSTRACT
BACKGROUND: Drug-related problems (DRPs) frequently occur in modern medical practice, increasing the morbidity and mortality as well as increasing cost of care. OBJECTIVE: The study is to evaluate the incidence of DRPs in patients admitted to a psychiatric department. MATERIALS AND METHODS: A prospective observational study was conducted for a period of 4 months at Baliga psychiatric hospital. All prescriptions of the study population were screened for DRPs such as adverse drug reactions (ADRs) and potential drug-drug interactions (pDDIs) by using computerized database system. RESULTS: Out of 120 patients, 19 patients had observed 26 DRPs. Out of 33 patients, 19 patients had observed 26 ADRs and 14 patients had observed 24 pDDIs. The overall incidence of DRPs was 15.83%. Female patients outnumbered the male patients, in which 12 women constitute 10% followed by men 7 (5.83%). The common ADRs observed were hyponatremia and headache. Considering the outcomes, 20 (76.9%) cases recovered from ADRs and 20 (76.9%) of the ADRs were definitely preventable. Majority of ADRs were probable and were found to be mild to moderately severe. CONCLUSIONS: Age, female gender and polypharmacy were the risk factors for the developing DRPs.
ABSTRACT
Background. In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian drug formulary. Methods. The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital. Off-label use was assessed using the National Formulary of India (NFI). Predictors of off-label use were determined by logistic regression. Results. Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories. Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI. Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use. Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI; P < 0.001) and hospital stay of six to 10 days (OR 1.91, 95% CI; P < 0.001). Conclusion. Off-label prescribing is common among pediatric patients. There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy.
