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Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit.

ABSTRACT: 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.

SUBMITTER: Gidey MT

PROVIDER: S-EPMC7118957 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit.

Gidey Meles Tekie MT Gebretsadkan Yohannes Gebrehaweria YG Tsadik Afewerki Gebremeskel AG Welie Abraham Gebrezgabiher AG Assefa Brhane Teklebrhan BT

Italian journal of pediatrics 20200403 1

<h4>Background</h4>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.<h4>Objective</h4>To assess the prevalence and associated factors with off-label and unlicensed drug use in neonatal intensive ...[more]

PMID: 32245504

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Project description:Background Cancer-related pain (CRP) is a major problem with a potential negative impact on quality of life of the patients and their caregivers. Purpose To assess the adequacy of cancer-related pain management in Ayder Comprehensive Specialized Hospital (ACSH). Methodology. A facility-based cross-sectional study design was conducted in ACSH from January to March 2019. A well-structured professional-assisted questionnaire using Brief Pain Inventory-Short Form (BPI-SF) was used to collect data concerning the severity of pain, functioning interference, and adequacy of pain management in cancer patients. Data were analyzed using SPSS v.21. Result Out of 91 participants, 47 (51.6%) were male and 52 (57.1%) were between the age group of 18–45, with the mean age of 44.8?±?13.6 years. According to the pain assessment tool (BPI), 85 (93.4%) patients experienced pain and 90 (98.9%) patients had activity interference; negative pain management index (PMI) was observed in 40 (43.95%) patients, showing that 43.95% were receiving inadequate pain management. Out of 38 patients who received no analgesics, 35.2% were found to have inadequate pain management, whereas those who took strong opioids had 100% effective pain management and the majority of the patients were in stage III. Among 38 (41.76%) only 20 (52.63%) received adequate pain management, based on patients' self-report in which 18.7% of the participants stated that they got 30% pain relief and only 1.1% got 90% relief. The predictors of undertreatment were presence of severe pain, metastasis, comorbidity, and stage of the cancer and could also be due to the educational level and monthly income, as evidenced by significant association. Conclusion This study suggests that cancer pain management in ACSH was sufficient for only 56%. However, large numbers of individuals are suffering from a manageable pain. Hence, remedial action should be taken, including increasing awareness of symptom management in medical staff and incorporating existing knowledge into routine clinical practice.

Project description:BackgroundAs the healthcare industry shifts toward patient-centered models, providers will need to fully understand patient satisfaction and how they affect their practices. This study aimed to assess patient satisfaction towards the emergency medical care and factors associated with at Ayder specialized comprehensive hospital, Emergency room, Mekelle, Ethiopia.MethodsAn institution-based cross-sectional study was conducted from March 1-30, 2019. A systematic random sampling method was used to enroll 299 study participants. Data were collected using a standard Brief Emergency Department Patient Satisfaction Scale questionnaire by trained data collectors. Data was entered into EpiData 3.1 then exported and analyzed by SPSS version 22. Binary and multiple logistic regression were used to assess the factors associated with patient satisfaction. Where the p-value of <0.05 was considered significant.ResultsA total of 299 participants were enrolled in the study with a response rate of 99.3%. On overall patient satisfaction score majority (81.9%) of them were satisfied with the emergency medical care provided. The satisfaction rate towards emergency staff courtesy, emergency room environment, physician care satisfaction, general patient satisfaction, and patient family satisfaction was 80.3%, 37.5%, 75.9%, 70.9%, and 49.8% respectively. Those who arrived during the morning time of the day tend to be satisfied more with the emergency services (AOR = 4.8, 95% CI: 2.08, 11.4), while having low educational status (able to read and write) (AOR = 0.12, 95% CI: 0.03, 0.50) and waiting time till seen by a doctor (AOR = 1.3, 95% CI: 1.003, 1.4) was found to affect patient satisfaction negatively.ConclusionsThe total patient satisfaction score towards emergency medical care was found to be good. The hospital management and emergency room staff should act on the identified factors especially on minimizing the patients waiting time to improve the quality of care in the emergency department.

Project description:BackgroundOne of the major factors contributing to newborn morbidity and mortality across the globe is respiratory distress. In resource-constrained developing nations like Ethiopia, it is a significant issue. Depending on the quality of the care provided, the incidence and time to recovery may differ amongst medical facilities. However, Ethiopia still lacks appropriate data on the incidence and time to recovery from respiratory distress.ObjectiveThe aim of the study was to assess the incidence, time to recovery, and predictors among neonates admitted with respiratory distress in the neonatal intensive care unit at the University of Gondar Comprehensive Specialized Hospital.MethodsAn institution-based retrospective follow-up study design was conducted among 452 neonates with respiratory distress. Data were collected using a data extraction checklist from the medical registry. The extracted data were entered into EPI INFO version 7.2.1.0 and then exported to STATA version 14 for analysis. The median time to recovery, the Kaplan Meier curve, and the log-rank test was computed. Both bi-variable and multivariable Cox regression models were applied to analyze the data. p-value ≤ 0.05 was considered statistically significant.ResultsOf all respiratory distressed neonate,311 were recovered. The overall incidence rate of neonates admitted with from respiratory distress was 11.5 per 100-neonate day (95% CI: 10.30-12. 87) with 2,703-person day observation and the median time to recovery from respiratory distress was 7 days with (IQR = 3-13 days). Predictors of time to recovery from respiratory distress were very low birth weight (AHR = 0.17, 95% CI: 0.08-0.41), low birth weight (AHR = 0.50, 95% CI: 0.31-0.81), very preterm (AHR = 0.42,95% CI:0.20-0.89), sepsis (AHR = 0.50 95% CI: 0.38-0.65), hypothermia (AHR = 0.61, 95% CI: 0.39-0.81), and Apgar scores less than seven at first (AHR = 0.35, 95% CI: 0.15-0.79) and fifth minute (AHR = 0.45, 95% CI: 0.20-0.97).ConclusionThe incidence and time to recovery in this study were discreetly acceptable as compared to previous study. The aforementioned predictors could be used to identify neonates with respiratory distress who are at risk of developing a long-term illness and guide prompt referral to hospitals. This will also provide clinicians with prognostic information, as longer recovery times have economic and social implications in resource limited countries like Ethiopia.

Project description:IntroductionLipodystrophy can cause poor glycemic control in addition to cosmetic problems in children and adolescents with type 1 diabetes mellitus. However, data on its prevalence and associated factors is scarce among children and adolescents who live in developing countries like Ethiopia.ObjectiveTo determine the prevalence and identify associated factors of lipodystrophy in children and adolescents with type 1 diabetes mellitus who visited the endocrinology clinic of Ayder Comprehensive Specialized Hospital between May 1 and July 31, 2020.MethodThis was an institution-based cross-sectional study conducted on 57 children and 65 adolescents with type 1 diabetes mellitus who had been taking insulin injections for a year or more. The dependent variable was lipodystrophy. A pretested, structured questionnaire was used to collect data related to lipodystrophy and other characteristics. The principal investigator oversaw the data collection, which was done by pediatric and child health specialty residents with training. Data was subjected to descriptive statistics, and predictors of lipodystrophy were identified by fitting a multivariable logistic regression model. Statistical significance was declared at p < 0.05.ResultsMore than half (53.3%) of patients were in the age range of 13 to 17. The male-to-female ratio was almost 1:1. Educational status for 63.1% of patients was primary school. Four-fifths of patients were residing in urban areas. Of the 122 participants, 60 (49.2%) had lipodystrophy (48.3% lipohypertrophy and 0.8% lipoatrophy), with grade II lipohypertrophy being the most common type at 81.7%. The thigh was the most common site of lipodystrophy. In multivariable regression analysis, the long duration of insulin injection (AOR = 3.6, 95% CI, 1.5 to 9.0, p = 0.005) and inappropriate rotation of the injection site (AOR = 9.0, 95% CI, 2.2 to 37.0, p = 0.002) were significantly associated with lipodystrophy. HbA1c testing was conducted for 70 patients, and poor glycemic control (HbA1c ≥ 7%) was found in 43 (61.4%) of them. Patients with lipodystrophy were more likely to have poor glycemic control (75%) than those without lipodystrophy (47.1%) (p = 0.016).ConclusionThe prevalence of lipodystrophy was comparable with other studies. Long duration of insulin injection and improper rotation of the injection site are associated with an increased risk of lipodystrophy. Patients with lipodystrophy were more likely to have poor glycemic control, defined by higher HgA1c, than those without lipodystrophy. Proper education of patients and their parents must include correct injection techniques, rotating injection sites, and changing injection sites intermittently to lessen the risk of developing lipodystrophy.

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Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit.

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Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit.

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