Modern drugs have changed epilepsy, which affects people of all ages. However, for young people with epilepsy, the framework of drug development has stalled. In the wake of the thalidomide catastrophe, the misconception emerged that for people < 18 years of age drugs, including antiseizure medications (ASMs), need separate proof of efficacy and safety, overall called \"pediatric drug development\". For ASMs, this has changed to some degree. Authorities now accept that ASMs are effective in < 18 years as well, but they still require \"extrapolation of efficacy,\" as if minors were another species. As a result, some of the pediatric clinical epilepsy research over the past decades was unnecessary. Even more importantly, this has hampered research on meaningful research goals. We do not need to confirm that ASMs work before as they do after the 18th birthday. Instead, we need to learn how to prevent brain damage in young patients by preventing seizures and optimize ASMs\' uses. Herein we discuss how to proceed in this endeavor.

OBJECTIVE: We aimed to evaluate the risk of colorectal adenocarcinoma (CRA) associated with long-term use of proton pump inhibitors (PPIs) in a large nationwide cohort.
METHODS: Retrospective cohort study.
METHODS: This research was conducted at the national level, encompassing the entire population of Sweden.
METHODS: This study utilised Swedish national registries to identify all adults who had ≥180 days of cumulative PPI use between July 2005 and December 2012, excluding participants who were followed up for less than 1 year. A total of 754 118 maintenance PPI users were included, with a maximum follow-up of 7.5 years.
METHODS: Maintenance PPI use (cumulative≥180 days), with a comparator of maintenance histamine-2 receptor antagonist (H2RA) use.
METHODS: The primary outcome measure was the risk of CRA, presented as standardised incidence ratios (SIRs) with 95% confidence intervals (CIs). Subgroup analyses were performed to explore the impact of indications, tumour locations, tumour stages and the duration of follow-up. A multivariable Poisson regression model was fitted to estimate the incidence rate ratios (IRRs) and 95% CIs of PPI versus H2RA use.
RESULTS: Maintenance PPI users exhibited a slightly elevated risk of CRA compared to the general population (SIR 1.10, 95% CI=1.06 to 1.13) for both men and women. Individuals aged 18-39 (SIR 2.79, 95% CI=1.62 to 4.47) and 40-49 (SIR 2.02, 95% CI=1.65 to 2.45) had significantly higher risks than the general population. Right-sided CRA showed a higher risk compared to the general population (SIR 1.26, 95% CI=1.20 to 1.32). There was no significant difference in the risk of CRA between maintenance PPI users and maintenance H2RA users (IRR 1.05, 95% CI=0.87 to 1.27, p<0.05).
CONCLUSIONS: Maintenance PPI use may be associated with an increased risk of CRA, but a prolonged observation time is needed.

OBJECTIVE: To provide an initial understanding of problems and potential solution strategies for part-time clinical pharmacist work in China, and provide references for the training of part-time clinical pharmacists.
METHODS: The study was conducted in a tertiary teaching hospital in China, and the project lasted 6 months. Phenomenological methods were used to guide the research design. Research data were obtained by conducting one-to-one semistructured interviews with part-time clinical pharmacists, and interview data were coded and analysed through thematic analysis.
RESULTS: A total of 21 pharmacists were interviewed in a semistructured manner, and the results showed that following problems exist in the work of part-time clinical pharmacists: the existing professional knowledge is not adequate to meet the demands of clinical service; the career orientation of part-time clinical pharmacists is not clear; lack of professional self-confidence in clinical pharmacy practice; there is no suitable entry point to carry out pharmacy service work; it is difficult to communicate effectively, and for in addition, 17 potential solution strategies are proposed for the current problems, which can provide reference for the development of part-time clinical pharmacists\' work.
CONCLUSIONS: The work performed by part-time clinical pharmacists is currently immature and the strategies derived from this study may serve as potential solutions to resolve the part-time clinical pharmacy practice challenges.

BACKGROUND: Diabetes and depression are among the 10 biggest health burdens globally. They often coexist and exhibit a strong bidirectional relationship. Depression leads to decreased adherence to self-care activities. This impacts glycaemic control and worsens type 2 diabetes mellitus (T2D). Both conditions have a synergistic effect and lead to greater complications, hospitalisations, healthcare expenditure and a worse quality of life. There is no consensus on managing people with comorbid T2D and depression. Bupropion is an efficacious antidepressant with many properties suitable for T2D with depression, including a favourable metabolic profile, persistent weight loss and improvement in sexual dysfunction. We will assess the efficacy and safety of add-on bupropion compared with standard care in people with T2D and mild depression. This study can give valuable insights into managing the multimorbidity of T2D and depression. This can help mitigate the health, social and economic burden of both these diseases.
METHODS: This cross-over randomised controlled trial will recruit people with T2D (for 5 years or more) with mild depression. They will be randomised to add-on bupropion and standard care. After 3 months of treatment, there will be a washout period of 1 month (without add-on bupropion while standard treatment will continue). Following this, the two arms will be swapped. Participants will be assessed for glycosylated haemoglobin, adherence to diabetes self-care activities, lipid profile, urine albumin-to-creatinine ratio, autonomic function, sexual function, quality of life and adverse events.
BACKGROUND: The Institutional Ethics Committee at All India Institute of Medical Sciences, Jodhpur has approved this study (AIIMS/IEC/2022/4172, 19 September 2022). We plan to disseminate the research findings via closed group discussions at the site of study, scientific conferences, peer-reviewed published manuscripts and social media.
BACKGROUND: CTRI/2022/10/046411.

OBJECTIVE: To assess antibiotic prescribing practice and its determinants among outpatient prescriptions dispensed to the elderly population.
METHODS: A prescription-based, cross-sectional study.
METHODS: Six community chain pharmacies in Asmara, Eritrea.
METHODS: All outpatient prescriptions dispensed to the elderly population (aged 65 and above) in the six community chain pharmacies in Asmara, Eritrea.
METHODS: Data were collected retrospectively, between 16 June 2023 and 16 July 2023. Antibiotic prescribing practice was assessed using the 2023 World Health Organization (WHO) Access, Watch and Reserve (AWaRe) classification system. Descriptive statistics and logistic regression were performed using IBM SPSS (V.26.0). P values less than 0.05 were considered as significant.
RESULTS: Of the 2680 outpatient prescriptions dispensed to elderly population, 35.8% (95% CI: 34.0, 37.6) contained at least one antibiotic. Moreover, a total of 1061 antibiotics were prescribed to the elderly population. The most commonly prescribed antibiotics were ciprofloxacin (n=322, 30.3%) and amoxicillin/clavulanic acid (n=145, 13.7%). The Access category accounted for the majority of antibiotics (53.7%) with 32.1% from the Watch category. Prescriber qualification (Adjusted Odds Ratio (AOR)= 0.60, 95% CI: 0.44, 0.81) and polypharmacy (AOR= 2.32, 95% CI: 1.26, 4.27) were significant determinants of antibiotic prescribing in the elderly population. Besides, sex (AOR=0.74, 95% CI: 0.56, 0.98), prescriber qualification (AOR=0.49, 95% CI: 0.30 to0.81) and level of health facility (AOR 0.52, 95% CI 0.34 to 0.81) were significant determinants of a Watch antibiotic prescription.
CONCLUSIONS: Antibiotics were prescribed to a considerable number of the elderly population, with more than half of them falling into the Access category. Further efforts by policy-makers are needed to promote the use of Access antibiotics while reducing the use of Watch antibiotics to mitigate risks associated with antimicrobial resistance.

BACKGROUND: Polypharmacy is common among individuals with multimorbidity, often leading to inappropriate medication use and is associated with an increased risk of frailty, hospitalisation and mortality. Structured medication reviews (SMRs) have emerged as a promising method for optimising medication use. However, research examining their efficacy is limited. This review aims to evaluate the impact of SMRs on improving outcomes for adults with multimorbidity and polypharmacy in primary care settings. Additionally, this review seeks to identify prevailing patterns and trends in the mode of delivery of SMRs.
METHODS: A systematic review will be conducted using Ovid MEDLINE, Ovid EMBASE, Web of Science and CINAHL (1997-present). Primary outcomes will include medication-related measures such as dose, frequency and dosage form. Secondary outcomes under investigation will include physical, mental, functional and health service outcomes, as reported. Two independent reviewers will conduct the screening and data extraction, resolving disagreements through discussion. Once eligible studies are identified, the extracted data will be summarised in tabular format. The risk of bias in the articles will be assessed using either the Cochrane Risk of Bias 2 tool or the Newcastle-Ottawa scale, depending on the design of the studies retrieved. Subgroup analysis will be performed using demographic variables and modes of delivery where the data supports. If appropriate, a meta-analysis of the data extracted will be conducted to determine the impact of the SMRs on reported outcomes. If a meta-analysis is not possible due to heterogeneity, a narrative synthesis approach will be adopted.
BACKGROUND: This proposed review is exempt from ethical approval as it aims to collate and summarise peer-reviewed, published evidence. This protocol and the subsequent review will be disseminated in peer-reviewed journals, conferences and patient-led lay summaries.
UNASSIGNED: CRD42023454965.

OBJECTIVE: To examine the current prevalence and cost of paediatric off-label drug prescriptions in Gansu, China, and the potential influencing factors.
METHODS: The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis.
METHODS: A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020.
RESULTS: We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians.
CONCLUSIONS: Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.

In 2017, a severe shortage of infusion bags resulted in a paradigm change in medication administration practice from intermittent infusion to intravenous push. The Institute for Safe Medication Practices proposed safe practice guidelines for adult intravenous push medications. A different study showed that ready-to-administer medication prepared in the sterile area of a pharmacy reduces the risk of harm, nurses\' time for medication administration and the cost of medications. Based on the recommendation of the Institute for Safe Medication Practices, we decided to conduct a pilot study on the implementation of sterile compounding and administration of intravenous push medication in adult patients admitted to the hospital. In the study, the stability of five intravenous push antibiotic syringes was also determined in the syringes.

BACKGROUND: Opioid overdoses in the USA have increased to unprecedented levels. Administration of the opioid antagonist naloxone can prevent overdoses.
OBJECTIVE: This study was conducted to reveal the pharmacoepidemiologic patterns in naloxone prescribing to Medicaid patients from 2018 to 2021 as well as Medicare in 2019.
METHODS: Observational pharmacoepidemiologic study SETTING: US Medicare and Medicaid naloxone claims INTERVENTION: The Medicaid State Drug Utilisation Data File was utilised to extract information on the number of prescriptions and the amount prescribed of naloxone at a national and state level. The Medicare Provider Utilisation and Payment was also utilised to analyse prescription data from 2019.
METHODS: States with naloxone prescription rates that were outliers of quartile analysis were noted.
RESULTS: The number of generic naloxone prescriptions per 100 000 Medicaid enrollees decreased by 5.3%, whereas brand naloxone prescriptions increased by 245.1% from 2018 to 2021. There was a 33.1-fold difference in prescriptions between the highest (New Mexico=1809.5) and lowest (South Dakota=54.6) states in 2019. Medicare saw a 30.4-fold difference in prescriptions between the highest (New Mexico) and lowest states (also South Dakota) after correcting per 100 000 enrollees.
CONCLUSIONS: This pronounced increase in the number of naloxone prescriptions to Medicaid patients from 2018 to 2021 indicates a national response to this widespread public health emergency. Further research into the origins of the pronounced state-level disparities is warranted.

OBJECTIVE: To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home.
METHODS: Randomised, parallel design.
METHODS: Medical wards at six hospital sites in southern Ontario, Canada.
METHODS: Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks.
METHODS: Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care.
METHODS: Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation.
RESULTS: Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)).
CONCLUSIONS: This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial.
BACKGROUND: NCT02777047.