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Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing.

ABSTRACT: Unlicensed and off label drug use is an issue recognized worldwide in pediatric pharmacotherapy. The study was designed to assess the prevalence and predictors of unlicensed and off label drug use in neonatal population of Pakistan.A prospective, observation study was conducted in nursery units at pediatric department of four tertiary care hospitals during the 1 year. Micromedex DRUGDEX was used to evaluate the case notes of 1300 patients. Logistic regression was employed to calculate the odds ratio for the predictors of unlicensed and off label drug use.A total of 1300 patients were included in this study who were treated with 52 different drugs. The prevalence of off label drug use was higher (52.14%) as compared to unlicensed drug use (33.35%). Dose (61.29%) and indication (13.68%) were the most frequent reasons for off label prescribing. In comparison to the corresponding reference categories, females and preterm infants were less likely to receive unlicensed prescriptions. While patients staying at hospital more than 5 days and infants receiving 3 or more medications were significantly more likely to receive unlicensed prescriptions. Moreover, in comparison to the corresponding reference categories, females were less likely to receive off label prescriptions while infants receiving 3 or more medications were 7 times more likely to receive off label prescriptions.The significant prevalence of unlicensed and off label drug prescriptions was found in neonatal population of Pakistan. The findings imply that more data on prevalence of unlicensed and off label prescriptions are required to provide a better picture of pediatric therapy in developing countries. Furthermore, advance formulations with new dosing in pediatrics is also necessary to minimize the risk of adverse drug events.

SUBMITTER: Aamir M

PROVIDER: S-EPMC6060516 | biostudies-other | 2018 Jul

REPOSITORIES: biostudies-other

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Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing.

Aamir Muhammad M Khan Jamshaid Ali JA Shakeel Faisal F Shareef Rabeea R Shah Nazia N

BMC pediatrics 20180725 1

<h4>Background</h4>Unlicensed and off label drug use is an issue recognized worldwide in pediatric pharmacotherapy. The study was designed to assess the prevalence and predictors of unlicensed and off label drug use in neonatal population of Pakistan.<h4>Method</h4>A prospective, observation study was conducted in nursery units at pediatric department of four tertiary care hospitals during the 1 year. Micromedex DRUGDEX was used to evaluate the case notes of 1300 patients. Logistic regression wa ...[more]

PMID: 30045715

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Project description:Reports from drug utilization reviews are important tools employed in the assessment of healthcare practices. The objective of this study was to evaluate drug utilization patterns among elderly hospitalized patients on poly-pharmacy regimens in Pakistan.A descriptive, non-experimental, cross-sectional study was carried out from December 2015 to March 2016 in six tertiary-care hospitals in the Punjab province of Pakistan. The population under study were patients aged ≥60 years, taking ≥5 medicines per day (i.e., patients on poly-pharmacy) and who were hospitalized in the selected tertiary-care hospitals. In this study, data was collected from 600 hospitalized elderly patients (100 patients per hospital). All medicines prescribed on each in-patient chart were noted on a pre-designed pro-forma sheet and were classified under the Anatomical Therapeutic Chemical (ATC) classification system. Multiple linear regression analysis was used to determine the independent factors associated with poly-pharmacy in this cohort. Statistical Package for Social Sciences (SPSS) was used to analyze the data. P-value < .05 indicated statistical significance.In 600 hospitalized in-patient (male 52.7% and female 47.3%) medication charts, 3179 medicines were prescribed. The most commonly prescribed drug classes were: A: alimentary tract and metabolism 80% (A02: drugs for acid related disorders 64.5%, A03: drugs for functional gastrointestinal disorders 21.5%), N: nervous system 66.3% (N02: analgesics 67.2%, N03: antiepileptic's 11.2%), J: anti-infectives for systemic use 62.2% (J01: antibacterial for systemic use 82.5%, J04: antimycobacterials 15.3%) and C: cardiovascular system 48.3% (C07: beta blocking agents 19.8%, C10: lipid modifying agents 16.5%), respectively. The most commonly prescribed active substances were: A02BC01 (omeprazole 51.3%), N02BE01 (paracetamol 50.8%) and J01DD04 (ceftriaxone 40.2%), respectively. In multiple linear regression analysis, male gender (95% CI -.205, -.006, p = .039, B = -.091), being divorced (95% CI -.604, -.136, p = .002, B = -.130) and presence of comorbidity (95% CI .068, .267, p = .001, B = .144) were the independent factors associated with increased drug use among elderly hospitalized patients on poly-pharmacy.The rational use of medicines is of utmost importance, most particularly in the elderly population. More consideration should be given to rationalizing pharmacotherapy in elderly hospitalized patients who are on poly-pharmacy regimens in Pakistan.

Project description:BACKGROUND:Off- label drug use refers to the use of medicines outside of their marketing authorization with respect to dose, dosage form, route of administration, indication or age. Off-label/unlicensed drug use significantly associated with adverse drug reactions and medication errors in neonates and critically ill neonates are more vulnerable to these problems. OBJECTIVE:To assess the prevalence and associated factors with off-label and unlicensed drug use in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital. METHODS:A cross-sectional study was conducted from March 01,2019 to April 30, 2019 in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital. Neonates admitted for 24?h and took at least one medicine were included in the study. Data was collected from prescription and medical charts. The off-label and license status of the medicine was verified based on European medicine Agency electronic medicine compendium. Data was analyzed by SPSS version 21.0. Binary and multivariate logistic regression was done to assess the predictors of off-label/unlicensed medicine use at p-value ?0.05 significance level. RESULT:A total of 364 medicines prescribed for 122 neonates were analyzed. The prevalence of off-label and unlicensed drug use was 246 (67.58%), and 86 (23.63%) respectively. Of the total 122 neonates, 114(93.44%), and 57(46.72%) of them were exposed to at least one off-label and unlicensed drug respectively. Antibiotics were the most commonly prescribed off-label and unlicensed drugs. No statistically significant association was found between demographic as well as health related variables with off-label/unlicensed medicine use at p-value of ?0.05 significance level. CONCLUSION:Off-label and unlicensed medicine use was high among neonates admitted to intensive care unit of the hospital. Selecting the safest medicines for such vulnerable patients is crucial to promote rational prescribing and better therapeutic benefit.

Dataset Information

Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing.

Publications

Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing.

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