Prevalence and factors associated with medication administration errors in the neonatal intensive care unit: A multicentre, nationwide direct observational study.

AIM(S): To determine the prevalence of medication administration errors and identify factors associated with medication administration errors among neonates in the neonatal intensive care units. DESIGN: Prospective direct observational study. METHODS: The study was conducted in the neonatal intensive care units of five public hospitals in Malaysia from April 2022 to March 2023. The preparation and administration of medications were observed using a standardized data collection form followed by chart review. After data collection, error identification was independently performed by two clinical pharmacists. Multivariable logistic regression was used to identify factors associated with medication administration errors. RESULTS: A total of 743 out of 1093 observed doses had at least one error, affecting 92.4% (157/170) neonates. The rate of medication administration errors was 68.0%. The top three most frequently occurring types of medication administration errors were wrong rate of administration (21.2%), wrong drug preparation (17.9%) and wrong dose (17.0%). Factors significantly associated with medication administration errors were medications administered intravenously, unavailability of a protocol, the number of prescribed medications, nursing experience, non-ventilated neonates and gestational age in weeks. CONCLUSION: Medication administration errors among neonates in the neonatal intensive care units are still common. The intravenous route of administration, absence of a protocol, younger gestational age, non-ventilated neonates, higher number of medications prescribed and increased years of nursing experience were significantly associated with medication administration errors. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The findings of this study will enable the implementation of effective and sustainable interventions to target the factors identified in reducing medication administration errors among neonates in the neonatal intensive care unit. REPORTING METHOD: We adhered to the STROBE checklist. PATIENT OR PUBLIC CONTRIBUTION: An expert panel consisting of healthcare professionals was involved in the identification of independent variables.

Prevalence, Risk Factors, and Management of Metabolic Acidosis in Chronic Kidney Disease Patients: A Multicenter Retrospective Study in Malaysia.

Background Metabolic acidosis in chronic kidney disease (CKD) patients has lately gained attention due to the growing evidence of its treatment benefits. This study aims to provide baseline data on the prevalence, risk factors, and current management of metabolic acidosis among the pre-dialysis adult Malaysian CKD population. Methodology This multicenter cross-sectional retrospective study involved pre-dialysis CKD patients above 18 years old on regular nephrology clinic follow-up at three Malaysian government hospitals with nephrology subspecialty. Demographic data, clinical information, laboratory data, and a list of concomitant medications were collected. Factors associated with the occurrence of metabolic acidosis were identified via multiple logistic regression. Results Six hundred and fifty-seven CKD patients were screened for this study, in which only 39.4% (n=259) had available bicarbonate levels. From this, a total of 86.1% (n=223) had metabolic acidosis. Higher estimated glomerular filtration rate (odds ratio (OR) 0.96, 95% confidence interval (CI) 0.93-1.00, p=0.043) and those with cardiovascular disease (OR 0.33, 95% CI 0.15-0.73; p=0.007) were significantly associated with lower odds of metabolic acidosis. There were 43.0% (n=96) on alkali therapy with sodium bicarbonate solution being the most common (n=91, 94.8%). Among those receiving alkali therapy, only 19.8% (n=19) achieved bicarbonate levels of ≥ 22 mEq/L. Conclusion Our study showed that metabolic acidosis was highly prevalent, although few achieved target levels despite supplementation, supporting the need for focused management of metabolic acidosis in the CKD population.

Polypharmacy and medication regimen complexity in transfusion-dependent thalassaemia patients: a cross- sectional study.

BACKGROUND: Medication burden and complexity have been longstanding problems in chronically ill patients. However, more data are needed on the extent and impact of medication burden and complexity in the transfusion-dependent thalassaemia population. AIM: The aim of this study was to determine the characteristics of medication complexity and polypharmacy and determine their relationship with drug-related problems (DRP) and control of iron overload in transfusion-dependent thalassaemia patients. METHOD: Data were derived from a cross-sectional observational study on characteristics of DRPs conducted at a Malaysian tertiary hospital. The medication regimen complexity index (MRCI) was determined using a validated tool, and polypharmacy was defined as the chronic use of five or more medications. The receiver operating characteristic curve analysis was used to determine the optimal cut-off value for MRCI, and logistic regression analysis was conducted. RESULTS: The study enrolled 200 adult patients. The MRCI cut-off point was proposed to be 17.5 (Area Under Curve = 0.722; sensitivity of 73.3% and specificity of 62.0%). Approximately 73% and 64.5% of the patients had polypharmacy and high MRCI, respectively. Findings indicated that DRP was a full mediator in the association between MRCI and iron overload. CONCLUSION: Transfusion-dependent thalassaemia patients have high MRCI and suboptimal control of iron overload conditions in the presence of DRPs. Thus, future interventions should consider MRCI and DRP as factors in serum iron control.

The impact of chelation compliance in health outcome and health related quality of life in thalassaemia patients: a systematic review.

Understanding consequences of poor chelation compliance is crucial given the enormous burden of post-transfusional iron overload complications. We systematically reviewed iron-chelation therapy (ICT) compliance, and the relationship between compliance with health outcome and health-related quality of life (HRQoL) in thalassaemia patients. Several reviewers performed systematic search strategy of literature through PubMed, Scopus, and EBSCOhost. The preferred reporting items of systematic reviews and meta-analyses (PRISMA) guidelines were followed. Of 4917 studies, 20 publications were included. The ICT compliance rate ranges from 20.93 to 75.3%. It also varied per agent, ranging from 48.84 to 85.1% for desferioxamine, 87.2-92.2% for deferiprone and 90-100% for deferasirox. Majority of studies (N = 10/11, 90.91%) demonstrated significantly negative correlation between compliance and serum ferritin, while numerous studies revealed poor ICT compliance linked with increased risk of liver disease (N = 4/7, 57.14%) and cardiac disease (N = 6/8, 75%), endocrinologic morbidity (N = 4/5, 90%), and lower HRQoL (N = 4/6, 66.67%). Inadequate compliance to ICT therapy is common. Higher compliance is correlated with lower serum ferritin, lower risk of complications, and higher HRQoL. These findings should be interpreted with caution given the few numbers of evidence.

Health-related quality of life in osteoporosis: a systematic review of measurement properties of the QUALEFFO-41.

The 41-item Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) is a widely used and freely available patient-reported outcome measure (PROM). However, data on its reliability, validity, and responsiveness remain unclear. Therefore, this study aimed to systematically review the measurement properties of the QUALEFFO-41. A systematic search of MEDLINE, EBSCOhost, and Cochrane Library from their inception up to December 2022 was performed. Data were extracted, and the methodological quality of each measurement property was evaluated according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. The evidence of the measurement properties was rated against the updated criteria for good measurement properties, and the quality of evidence was graded using the modified GRADE approach. A total of 99 articles were identified, of which eight studies were included in the review. The QUALEFFO-41 is categorized as B as it demonstrated moderate quality evidence for sufficient content validity, moderate-to-high quality evidence for sufficient hypothesis testing for construct validity (except for the social function domain for convergent validity), and very low-quality evidence for sufficient responsiveness. For structural validity and internal consistency, only the domains of pain and general health perception were sufficient with low-quality evidence. For reliability, only the domain of physical function was sufficient with low-quality evidence. None of the studies reported measurement error, cross-cultural validity, and criterion validity. The QUALEFFO-41 may be a promising, valid, and reliable PROM to assess HRQoL in osteoporosis patients with vertebral fractures. However, future studies must focus on good methodological quality to strengthen the evidence of measurement properties, especially on structural validity, reliability, responsiveness, and cross-cultural validity. The systematic review evaluated the measurement properties of the QUALEFFO-41 questionnaire for assessing Health-Related Quality of Life (HRQoL) in osteoporosis patients. The review found moderate-to-high-quality evidence for construct validity but limited evidence for responsiveness and other properties. Future studies should focus on strengthening the evidence, particularly for structural validity, reliability, responsiveness, and cross-cultural validity. The QUALEFFO-41 shows promise as a valid and reliable PROM for HRQoL assessment in osteoporosis patients.

Corrigendum: Drug-related problems among transfusion-dependent thalassemia patients: a real-world evidence study.

[This corrects the article DOI: 10.3389/fphar.2023.1128887.].

Nurses' perception of medication administration errors and factors associated with their reporting in the neonatal intensive care unit.

Medication administration is a complex process, and nurses play a central role in this process. Errors during administration are associated with severe patient harm and significant economic burden. However, the prevalence of under-reporting makes it challenging when analysing the current landscape of medication administration error (MAE) and hinders the implementation of improvements to the existing system. The aim of this study is to describe the reasons for the occurrence of MAEs and the reasons behind the under-reporting of MAEs, to determine the estimated percentage of MAE reporting and to identify factors associated with them from the nurses' perspective. This cross-sectional study was conducted using a validated self-administered questionnaire. The questionnaire contained 65 questions which were divided into three sections: (i) reasons for the occurrence of MAEs, which consisted of 29 items; (ii) reasons for not reporting MAEs, which consisted of 16 items; and (iii) percentage of MAEs actually reported, which consisted of 20 items. It was distributed to 143 nurses in the neonatal intensive care units of five public hospitals in Malaysia. Multivariable logistic regression was used to identify the factors associated with MAE reporting. The estimated percentage of MAE reporting was 30.6%. The most common reasons for MAEs were inadequate nursing staff (5.14 [SD 1.25]), followed by drugs which look alike (4.65 [SD 1.06]) and similar drug packaging (4.41 [SD 1.18]). The most common reasons for not reporting MAEs were that nursing administration focuses on the individual rather than looking at the systems as a potential cause of the error (4.56 [SD 1.32]) and that too much emphasis is placed on MAEs as a measure of the quality of nursing care (4.31 [SD 1.23]). Factors statistically significant with MAE reporting were administration response (adjusted odds ratio [AOR] = 6.90; 95% confidence interval (CI) = 2.01-23.67; P = 0.002), reporting effort (AOR = 3.67; 95% CI = 1.68-8.01; P = 0.001), and nurses with advanced diploma (AOR = 0.29; 95% CI = 0.13-0.65; P = 0.003). Our findings show that under-reporting of MAEs is still common and less than a third of the respondents reported MAEs. Therefore, to encourage error reporting, emphasis should be placed on the benefits of reporting, adopting a non-punitive approach, and creating a blame-free culture.

Budget impact of increasing uptake of denosumab for the treatment of postmenopausal osteoporosis in Malaysia.

This study evaluated the financial impact of increasing denosumab usage for managing postmenopausal osteoporosis over a 5-year period from the Malaysian healthcare provider's perspective. A gradual moderate increase in denosumab uptake would have a minimal budget impact, with potential savings in fracture treatment expenses. Optimizing denosumab usage could be a cost-effective and potentially affordable strategy to alleviate the economic burden of osteoporosis in Malaysia. PURPOSE: The study aimed to evaluate the budget impact of increasing the uptake of denosumab for the management of postmenopausal osteoporosis in Malaysia. METHODS: A Markov budget impact model was developed to estimate the financial impact of osteoporosis treatment. We modelled a scenario in which the uptake of denosumab would increase each year compared with a static scenario. A 5-year time horizon from the perspective of a Malaysian MOH healthcare provider was used. Model inputs were based on Malaysian sources where available. Sensitivity analyses were performed to examine the robustness of the modelled results. RESULTS: An increase in denosumab uptake of 8% per year over a 5-year time horizon would result in an additional budget impact, from MYR 0.26 million (USD 0.06 million) in the first year to MYR 3.25 million (USD 0.78 million) in the fifth year. When expressed as cost per-member-per-month (PMPM), these were less than MYR 0.01 across all five years of treatment. In sensitivity analyses, the acquisition cost of denosumab and medication persistence had the largest impact on the budget. CONCLUSION: From the perspective of a Malaysian MOH healthcare provider, moderately increasing uptake of denosumab would have a minimal additional budget impact, partially offset by savings in fracture treatment costs. Increasing the use of denosumab appears affordable to reduce the economic burden of osteoporosis in Malaysia.

Drug-related problems among transfusion-dependent thalassemia patients: A real-world evidence study.

Introduction: Thalassemia is among the most common genetic disorders globally and many patients suffer from iron overload (IOL) complications that mainly affect the heart, liver and endocrine system. These events may be further complicated by drug-related problems (DRP), an inherent issue among patients with chronic diseases. Objective: The study aimed to evaluate the burden, associated factors and impacts of DRP in transfusion-dependent thalassemia (TDT) patients. Method: Eligible TDT patients under follow-up in a tertiary hospital between 01 March 2020 to 30 April 2021 were interviewed and their medical records were reviewed retrospectively to identify any DRP. DRPs were classified using the Pharmaceutical Care Network Europe (PCNE) classification version 9.1. The incidence and preventability of DRP were assessed and the associated risk factors were estimated by univariate and multivariate logistic regression. Results: A total of 200 patients were enrolled with a median (interquartile range: IQR) age of 28 years at enrolment. Approximately 1 in 2 patients were observed to suffer from thalassemia-related complications. Throughout the study period, 308 DRPs were identified among 150 (75%) participants, with a median DRP per participant of 2.0 (IQR 1.0-3.0). Of the three DRP dimensions, treatment effectiveness was the most common DRP (55.8%) followed by treatment safety (39.6%) and other DRP (4.6%). The median serum ferritin level was statistically higher in patients with DRP compared with patients without DRP (3833.02 vs. 1104.98 µg/L, p < 0.001). Three risk factors were found to be significantly associated with the presence of DRP. Patients with frequent blood transfusion, moderate to high Medication Complexity Index (MRCI) and of Malay ethnicity were associated with higher odds of having a DRP (AOR 4.09, 95% CI: 1.83, 9.15; AOR 4.50, 95% CI: 1.89, 10.75; and AOR 3.26, 95% CI: 1.43, 7.43, respectively). Conclusion: The prevalence of DRP was relatively high amongst TDT patients. Increased medication complexity, more severe form of the disease and Malay patients were more likely to experience DRP. Hence, more viable interventions targeted to these groups of patients should be undertaken to mitigate the risk of DRP and achieve better treatment outcomes.

Development and validation of a risk prediction model for medication administration errors among neonates in the neonatal intensive care unit: a study protocol.

INTRODUCTION: Medication administration errors (MAEs) are the most common type of medication error. Furthermore, they are more common among neonates as compared with adults. MAEs can result in severe patient harm, subsequently causing a significant economic burden to the healthcare system. Targeting and prioritising neonates at high risk of MAEs is crucial in reducing MAEs. To the best of our knowledge, there is no predictive risk score available for the identification of neonates at risk of MAEs. Therefore, this study aims to develop and validate a risk prediction model to identify neonates at risk of MAEs. METHODS AND ANALYSIS: This is a prospective direct observational study that will be conducted in five neonatal intensive care units. A minimum sample size of 820 drug preparations and administrations will be observed. Data including patient characteristics, drug preparation-related and administration-related information and other procedures will be recorded. After each round of observation, the observers will compare his/her observations with the prescriber's medication order, hospital policies and manufacturer's recommendations to determine whether MAE has occurred. To ensure reliability, the error identification will be independently performed by two clinical pharmacists after the completion of data collection for all study sites. Any disagreements will be discussed with the research team for consensus. To reduce overfitting and improve the quality of risk predictions, we have prespecified a priori the analytical plan, that is, prespecifying the candidate predictor variables, handling missing data and validation of the developed model. The model's performance will also be assessed. Finally, various modes of presentation formats such as a simplified scoring tool or web-based electronic risk calculators will be considered.

Prevalence, Causes and Severity of Medication Administration Errors in the Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis.

INTRODUCTION: Neonates are at greater risk of preventable adverse drug events as compared to children and adults. OBJECTIVE: This study aimed to estimate and critically appraise the evidence on the prevalence, causes and severity of medication administration errors (MAEs) amongst neonates in Neonatal Intensive Care Units (NICUs). METHODS: A systematic review and meta-analysis was conducted by searching nine electronic databases and the grey literature for studies, without language and publication date restrictions. The pooled prevalence of MAEs was estimated using a random-effects model. Data on error causation were synthesised using Reason's model of accident causation. RESULTS: Twenty unique studies were included. Amongst direct observation studies reporting total opportunity for errors as the denominator for MAEs, the pooled prevalence was 59.3% (95% confidence interval [CI] 35.4-81.3, I2 = 99.5%). Whereas, the non-direct observation studies reporting medication error reports as the denominator yielded a pooled prevalence of 64.8% (95% CI 46.6-81.1, I2 = 98.2%). The common reported causes were error-provoking environments (five studies), while active failures were reported by three studies. Only three studies examined the severity of MAEs, and each utilised a different method of assessment. CONCLUSIONS: This is the first comprehensive systematic review and meta-analysis estimating the prevalence, causes and severity of MAEs amongst neonates. There is a need to improve the quality and reporting of studies to produce a better estimate of the prevalence of MAEs amongst neonates. Important targets such as wrong administration-technique, wrong drug-preparation and wrong time errors have been identified to guide the implementation of remedial measures.

The cost-effectiveness of different types of educational interventions in type II diabetes mellitus: A systematic review.

Aims: Educational interventions are effective to improve peoples' self-efficacy in managing diabetes complications and lifestyle changes. This systematic review aims to assess and compare various aspects of educational interventions and to provide updated pharmacoeconomics data. Methods: Literature searches were conducted using databases such as EBSCOhost, Ovid, PubMed, Scopus, and Web of Science. Outcomes such as study characteristics, costs, medication adherence, effectiveness and were narratively summarized, and the quality of each article was assessed. Results: A total of 27 studies were retrieved. The types of educational interventions were classified as face-to-face strategy, structured programs, telemedicine health education, a combination approach, and others. All types of educational interventions (N = 24, 89%) were reported to be cost-effective. The cost-effectiveness of the other two studies was considered to be not cost-effective while the outcome of one study could not be determined. The majority of the studies (N = 24, 89%) had moderate-quality evidence whereas thirteen (48%) studies were regarded to provide high-quality economic evaluations. Conclusion: All types of educational interventions are highly likely to be cost-effective. The quality of economic evaluations is moderate but the most cost-effective types of educational interventions could not be determined due to variations in the reporting and methodological conduct of the study. A high-quality approach, preferably utilizing the societal perspective over a long period, should be standardized to conduct economic evaluations for educational interventions in T2DM. Systematic Review Registration: website, identifier registration number.

A retrospective study on chemotherapy-induced nausea and vomiting in highly/moderately emetogenic chemotherapy: incidence and prescribing practice.

BACKGROUND: Chemotherapy-induced nausea vomiting (CINV) is a common and significant problem in oncology patients and rated as one of cancer chemotherapy's most distressing side effects. The objectives of this study are to describe the incidence of CINV in highly and moderately emetogenic chemotherapy-treated patients and the prescribing pattern of CINV prophylaxis. METHODS: This retrospective, cross-sectional single-center study randomly collected data on demographics, CINV episodes, and prescribing patterns for adult oncology patients receiving intravenous highly or moderately emetogenic chemotherapy (HEC/MEC) between January and December 2019. RESULTS: A total of 419 randomly selected records of HEC/MEC recipients with 2388 total chemotherapy cycles were included. The mean age was 53.6 ± 12.6 years old. The majority was female (66%), Malay (54.4%), diagnosed with cancer stage IV (47.7%), and with no comorbidities (47%). All patients were prescribed with IV granisetron and dexamethasone before chemotherapy for acute prevention, whereas dexamethasone and metoclopramide were prescribed for delayed prevention. Aprepitant was not routinely prescribed for the prevention of CINV. CINV incidence was 57% in the studied population and 20% in the total cycle. This study found a significant association between CINV incidence with performance status and cisplatin-based chemotherapy (OR = 3.071, CI = 1.515-6.223, p = 0.002; OR = 4.587, CI = 1.739-12.099, p = 0.02, respectively). CONCLUSION: CINV incidence was rather high per patient but relatively low per cycle. Most patients were prescribed with dual regimen antiemetic prophylaxis. IMPACT: This study provides evidence that there was suboptimal use of recommended agents for CINV, and there is a clear need for further improvements in CINV management.

A systematic review of the cost-effectiveness of medicationadherence-enhancing intervention for asthma.

Objective: This systematic review aimed to evaluate the cost-effectiveness of medication adherence-improving interventions in patients with asthma.Data source: Search engines including PubMed, Scopus and EBSCOhost were used to locate relevant studies from the inception of the databases to 19 October 2018. Drummond's checklist was used to appraise the quality of the economic evaluation.Study selection: Economic studies evaluating the cost-effectiveness of medication adherence enhancing interventions for asthmatic patients were selected. Relevant information including study characteristics, quality assessment, health outcomes and costs of intervention were narratively summarized. The primary outcome of interest was cost-effectiveness (CE) values and the secondary outcomes were costs, medication adherence and clinical consequences.Results: Twenty studies including 11 randomized controlled trials, 6 comparative studies and 3 modeled studies using Markov models were included in the review. Among these, 15 studies evaluated an educational intervention with 13 showing cost-effectiveness in improving health outcomes. The CE of an internet-based intervention showed similar results between groups, while 3 studies of simplified drug regimens and adding a technology-based training program achieved the desirable cost-effectiveness outcome.Conclusion: Overall, our results would support that all of the identified medication adherence-enhancing interventions were cost-effective considering the increased adherence rate, improved clinical effectiveness and the reduced costs of asthma care. However, it was not possible to identify the most cost-effective intervention. More economic studies with sound methodological conduct will be needed to provide stronger evidence in deciding the best approach to improve medication adherence.

Effects of CYP3A5 Polymorphism on Rapid Progression of Chronic Kidney Disease: A Prospective, Multicentre Study.

Personalised medicine is potentially useful to delay the progression of chronic kidney disease (CKD). The aim of this study was to determine the effects of CYP3A5 polymorphism in rapid CKD progression. This multicentre, observational, prospective cohort study was performed among adult CKD patients (≥18 years) with estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2, who had ≥4 outpatient, non-emergency eGFR values during the three-year study period. The blood samples collected were analysed for CYP3A5*3 polymorphism. Rapid CKD progression was defined as eGFR decline of >5 mL/min/1.73 m2/year. Multiple logistic regression was then performed to identify the factors associated with rapid CKD progression. A total of 124 subjects consented to participate. The distribution of the genotypes adhered to the Hardy-Weinberg equilibrium (X2 = 0.237, p = 0.626). After adjusting for potential confounding factors via multiple logistic regression, the factors associated with rapid CKD progression were CYP3A5*3/*3 polymorphism (adjusted Odds Ratio [aOR] 4.190, 95% confidence interval [CI]: 1.268, 13.852), adjustments to antihypertensives, young age, dyslipidaemia, smoking and use of traditional/complementary medicine. CKD patients should be monitored closely for possible factors associated with rapid CKD progression to optimise clinical outcomes. The CYP3A5*3/*3 genotype could potentially be screened among CKD patients to offer more individualised management among these patients.

Parenteral nutrition-associated hyperglycemia: Prevalence, predictors and management.

BACKGROUND & AIMS: Hyperglycemia is among the common complications of parenteral nutrition (PN) and is often associated with increased mortality despite being treatable. Studies of parenteral nutrition causing hyperglycemia are limited and even available studies lack methodological conduct. This study aimed to evaluate the prevalence, predictors and management of PN-associated hyperglycemia (PN-AH). METHODS: A retrospective study was conducted at a tertiary hospital. Patients ≥ 18 years old who received parenteral nutrition from 2015 to 2018 were conveniently selected. The demographic data, diagnosis, clinically relevant data, blood glucose readings and management of hyperglycemia were gathered from electronic medical records. RESULTS: Among 300 patients included in the study, 140 (46.7%) reported the PN-AH events. Multivariate logistic regression analysis showed female sex, Malay ethnicity, underlying type 2 diabetes mellitus, liver impairment, elevated pre-PN glucose level > 180 mg/dL and ICU admission were independently associated with hyperglycemia (p < 0.05 for all variables). Furthermore, factors such as ICU admission, underlying diabetes mellitus and hyperglycemia before starting PN, cause earlier development of PN-AH. More frequent monitoring of PN was observed in the ICU, guided by a protocol, as compared to the non-ICU setting. CONCLUSION: The prevalence of PN-AH is a significant complication to require medical attention. The predictors such as female gender, Malay ethnicity, underlying Diabetes Mellitus, liver impairment, hyperglycemia before starting PN, and ICU admission should be applied in clinical settings to improve the detection of PN-AH. A guideline outlining the risk factors, monitoring strategies and treatment plans should be developed to improve the detection and management of PN-AH.

Community Pharmacists' Knowledge, Attitude, and Practice in Providing Self-Care Recommendations for the Management of Premenstrual Syndrome.

Background and objectives: Premenstrual syndrome (PMS) comprises a variety of physical and emotional symptoms that affect women of reproductive age. The distress caused by PMS often leads to self-medication, and many over-the-counter or non-prescription products are available for relieving PMS symptoms. The choice of a suitable product should be based on advice from a health professional, such as a community pharmacist. Hence, we assessed the knowledge, attitude, and practice of Malaysian community pharmacists in providing self-care recommendations for the management of PMS. Materials and Methods: A cross-sectional survey was carried out in Kuala Lumpur, Malaysia from September to November 2018 using a self-administered questionnaire. The respondents were community pharmacists working in Kuala Lumpur and were chosen from a list of Type A license holders in the city. Results: We achieved a response rate of 79% and included 181 questionnaires in the final analysis. Of the 181 respondents, most of them (76.8%; n = 139) had medium to good levels of knowledge of PMS. Likewise, most of the respondents (78.5%; n = 142) had positive attitudes toward their role in PMS management. Having taken courses on managing minor illnesses in women substantially enhanced their levels of knowledge of (p = 0.002), but not their attitude towards, PMS management. Among the PMS-relieving products, the most commonly recommended products were ibuprofen (79%; n = 143), mefenamic acid (74.5%; n = 135), and naproxen (66.9%; n = 121), which are well known for their anti-inflammatory effect. This suggests that the respondents based their product choice on sound evidence. Conclusions: Community pharmacists can play an important role in the management of PMS. In future work, a larger sample can be assembled to obtain more insight into the readiness of community pharmacists to help women in self-managing PMS and establish a specialized service to this end.

A Prospective Cohort Study of Factors Associated with Empiric Antibiotic De-escalation in Neonates Suspected with Early Onset Sepsis (EOS).

BACKGROUND: Prolonged empiric antibiotic use, resulting from diagnostic uncertainties, in suspected early onset sepsis (EOS) cases constitutes a significant problem. Unnecessary antibiotic use increases the risk of antibiotic resistance. Furthermore, prolonged antibiotic use increases the risk of mortality and morbidity in neonates. Proactive measures including empiric antibiotic de-escalation are crucial to overcome these problems. METHODS: This was a prospective cohort study conducted in the neonatal intensive care units of two public hospitals in Malaysia. Neonates with a gestational age greater than 34 weeks who were started on empiric antibiotics within 72 h of life were screened. The data were then stratified according to de-escalation and non-de-escalation practices, where de-escalation practice was defined as narrowing down or discontinuation of empiric antibiotic within 72 h of treatment. RESULTS: A total of 1045 neonates were screened, and 429 were included. The neonates were then divided based on de-escalation (n = 207) and non-de-escalation (n = 222) practices. Neonates under non-de-escalation practices showed significantly longer durations of antibiotic use compared to those under de-escalation practices (p < 0.05), with no difference in treatment outcomes. Five factors were found to be associated with de-escalation of antibiotics. They are cesarean section delivery, exposure to antenatal steroids, nil history of maternal pyrexia, absence of meconium-stained amniotic fluid, and normal C-reactive protein ≤ 0.5 mg/dL (p < 0.05). CONCLUSIONS: Empiric antibiotic de-escalation appears feasible as a routine form of treatment for EOS in late preterm and term neonates.

Budget impact analysis of increasing prescription of renin-angiotensin system inhibitors drugs to standard anti-hypertensive treatments in patients with diabetes and hypertension in a hypothetical cohort of Malaysian population.

INTRODUCTION: Renin-angiotensin system inhibitors (RAS) drugs have a proteinuria-reducing effect that could prevent the progression of kidney disease in diabetic patients. Our study aimed to assess the budget impact based on healthcare payer perspective of increasing uptake of RAS drugs into the current treatment mix of standard anti-hypertensive treatments to prevent progression of kidney disease in patient's comorbid with hypertension and diabetes. METHODS: A Markov model of a Malaysian hypothetical cohort aged ≥30 years (N = 14,589,900) was used to estimate the total and per-member-per-month (PMPM) costs of RAS uptake. This involved an incidence and prevalence rate of 9.0% and 10.53% of patients with diabetes and hypertension respectively. Transition probabilities of health stages and costs were adapted from published data. RESULTS: An increasing uptake of RAS drugs would incur a projected total treatment cost ranged from MYR 4.89 billion (PMPM of MYR 27.95) at Year 1 to MYR 16.26 billion (PMPM of MYR 92.89) at Year 5. This would represent a range of incremental costs between PMPM of MYR 0.20 at Year 1 and PMPM of MYR 1.62 at Year 5. Over the same period, the care costs showed a downward trend but drug acquisition costs were increasing. Sensitivity analyses showed the model was minimally affected by the changes in the input parameters. CONCLUSION: Mild impact to the overall healthcare budget has been reported with an increased utilization of RAS. The long-term positive health consequences of RAS treatment would reduce the cost of care in preventing deterioration of kidney function, thus offsetting the rising costs of purchasing RAS drugs. Optimizing and increasing use of RAS drugs would be considered an affordable and rational strategy to reduce the overall healthcare costs in Malaysia.

Meta-analyses of newer antiepileptic drugs as adjunct for treatment of focal epilepsy in children.

AIM: This study conducted a systematic review evaluating the effectiveness of newer antiepileptic drugs (AEDs) (namely, lamotrigine, levetiracetam, topiramate, vigabatrin, zonisamide, oxcarbazepine, perampanel, gabapentin, and stiripentol) as add-on for treatment of focal epilepsy in children. METHODS: Articles were retrieved from EMBASE, Medline and Cochrane Library from inception to January 2016. Treatment outcomes were analysed based on responder, seizure-free, withdrawal and adverse event rates. Quality of each study was also assessed. RESULTS: Twelve articles fulfilled the inclusion criteria. Heterogeneity and quality of the included studies were considered acceptable. Overall, newer AEDs as adjunct therapy in children with inadequate control of focal seizure showed a trend of better seizure outcomes. The pooled ORs for responder, seizure-free and withdrawal rates were 2.15 (95%CI:1.72, 2.69), 1.99 (95%CI:0.72, 5.48) and 0.69 (95%CI:1.13, 2.39) respectively. Adverse events of newer AEDs were comparatively higher than placebo (OR:1.64, 95%CI:1.13, 2.39). CONCLUSION: In our updated review, newer AEDs as adjunct therapy for focal epilepsy in children have trends of better effectiveness compared to placebo. Newer AEDs are associated with statistically more children with >50% seizure reduction, and a trend of better seizure freedom. Their tolerability would also be considered acceptable with the observed low withdrawal rate. However, the relative lack of well-conducted RCTs evaluating their effectiveness against other active AED treatment in children would not facilitate evidence-based practice. This highlights the knowledge gap and the need for more well-conducted RCTs against active treatments to ascertain the long term effectiveness and the role of newer AEDs in managing epilepsy in children.