Assessment of a Geriatric Evaluation and Management in the Home (GEMITH) Service at a Quaternary Hospital: A Retrospective Observational Study.

Background: The increasing aging population in Australia has created a higher demand for specialist geriatric services within hospitals. A Geriatric Evaluation and Management in the Home (GEMITH) service was implemented at a quaternary Queensland hospital. The GEMITH service was unique as it incorporated a specialist pharmacist into the multidisciplinary team. Objective: To determine the medication safety and quality impact of the GEMITH service by evaluating the type and clinical significance of specialist pharmacist interventions. Methods: This was retrospective observational study of clinical interventions made by the GEMITH pharmacist for patients admitted to the service between October 2020 to April 2021. All pharmacist interventions were rated for their clinical significance using the Society of Hospital Pharmacists of Australia (SHPA) risk classification system. The ratings were undertaken by a panel of three pharmacists that independently assessed the interventions, coming together for final discussion. A narrative analysis of the interventions were derived through group consensus. Results: There was a total of 119 admissions to the GEMITH service, with 132 clinical interventions made by the specialist geriatric pharmacist. The majority (47%) of interventions were considered as low risk interventions, although high- (21%) and extreme-risk (2%) interventions still occurred. The most common type of intervention (32%) involved medication reconciliation. Other intervention types included monitoring recommendations, dosing interventions, and deprescribing suggestions. Conclusion: Multiple clinical interventions were made by the GEMITH pharmacist, which prevented possible and significant medication-related harm. This demonstrated the quality impact of the specialist pharmacist in improving medication safety for geriatric patients.

Calculating the cost of medication errors: A systematic review of approaches and cost variables.

INTRODUCTION: Medication errors are an unnecessary cost to a healthcare system and patients of a country. This review aimed to systematically identify published cost variables used to calculate the cost of medication errors and to explore any updates on findings already known on calculating the cost of medication errors during the past 10 years. METHODS: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Electronic databases, PubMed, Scopus, Emerald and JSTOR were searched, using keywords "medication error" AND "cost" and predetermined inclusion criteria. Duplicate articles were removed. Quality check was done using 10 criteria. Cost variables used in calculating the cost of medication errors were extracted from each article. RESULTS: Among 3088 articles, 33 articles were selected for review. Most studies were conducted in Western countries. Cost variables used (types and number) by different studies varied widely. Most studies (N=29) had used direct costs only. A few studies (N=4) had used both direct and indirect costs for the purpose. Perspectives considered when calculating cost of medication errors also varied widely. A total of 35 variables used to calculate medication error costs were extracted from selected articles. CONCLUSION: Variables used to calculate the cost of medication errors were not uniform across studies. Almost a decade after systematic reviews previously reporting on this area, a validated methodology to calculate the cost of medication errors has still not been reported to date and highlights the still pending necessity of a standard method to be established.

A smart medicine reminder kit with mobile phone calls and some health monitoring features for senior citizens.

The demand for an effective system that combines cutting-edge technologies with medical research to improve healthcare systems has increased with the development of medical technology. The most fundamental form of disease prevention is taking the right medication when needed. With the right care, many fatal diseases can be cured or prevented. Therefore, it is crucial to follow the doctor's recommended drug plan. Healthcare experts now have serious concerns about patients not being able to take their prescribed medications on time, particularly elderly patients. Due to age-related memory loss, people who have been given multiple prescriptions at once over an extended period of time are more likely to forget to take their medication on time or to take the wrong medication. Sometimes, a patient's inability to take the right medication at the right time might have a major impact on their health. Aside from being forgetful, patients, especially the elderly and illiterate, may not be able to read the name stated on medical containers, leading to the consumption of the wrong medication. These errors contribute to non-adherence to pharmaceuticals, which is detrimental to the patient's health. As a result, there is a significant problem that hinders the success of the treatment. The medication reminder system is intended for people who frequently take medications or vitamin supplements in order to handle this. In order to help an elderly person properly take their medication and help the patient have a healthy life, we have created a ground-breaking portable multifunctional medicine reminder kit with phone calls. Other intelligent characteristics of the smart medicine reminder include the capacity to show the time, date, and day in real time, the detection of smoke, the measurement of air humidity and temperature in the room, the measurement of heartbeats per second, the patient's body temperature, and the oxygen saturation level.

Developing a Model for Quantifying QTc-Prolongation Risk to Enhance Medication Safety Assessment: A Retrospective Analysis.

There are currently no established methods to predict quantitatively whether the start of a drug with the potential to prolong the QTc interval poses patients at risk for relevant QTc prolongation. Therefore, this retrospective study aimed to pave the way for the development of models for estimating QTc prolongation in patients newly exposed to medications with QTc-prolonging potential. Data of patients with a documented QTc prolongation after initiation of a QTc-prolonging drug were extracted from hospital charts. Using a standard model-building approach, general linear mixed models were identified as the best models for predicting both the extent of QTc prolongation and its absolute value after the start of a QTc-time-prolonging drug. The cohort consisted of 107 adults with a mean age of 64.2 years. Patients were taking an average of 2.4 drugs associated with QTc prolongation, with amiodarone, propofol, pipamperone, ondansetron, and mirtazapine being the most frequently involved. There was a significant but weak correlation between measured and predicted absolute QTc values under medication (r2 = 0.262, p < 0.05), as well as for QTc prolongation (r2 = 0.238, p < 0.05). As the developed models are based on a relatively small number of subjects, further research is necessary to ensure their applicability and reliability in real-world scenarios. Overall, this research contributes to the understanding of QTc prolongation and its association with medications, providing insight into the development of predictive models. With improvements, these models could potentially aid healthcare professionals in assessing the risk of QTc prolongation before adding a new drug and in making informed decisions in clinical settings.

[Ward-based clinical pharmacists in intensive care medicine: an economic evaluation]. / Stationsapotheker:innen in der Intensivmedizin: ökonomische Nutzenanalyse.

BACKGROUND: The positive impact of pharmaceutical care in improving medication safety is considered proven. Little is known about the economic benefit of clinical pharmaceutical services in Germany. OBJECTIVE: In 2020, a pilot project was started at the Ernst von Bergmann Hospital to introduce ward-based clinical pharmacists in intensive care medicine, also in order to determine the economic benefit of the medication management offered. METHODS: By a team of experienced intensive care physicians and clinical pharmacists on the basis of a consensus principle, each pharmaceutical intervention (PI) was assigned a probability score (Nesbit probability score) with which an adverse drug event (ADE) would have occurred. Assuming that each ADE results in an increased length of stay, the costs of intensive care treatment/day were used as potential savings. The model thereby combines the findings of two international publications to enable an economic analysis of pharmaceutical services. RESULTS: During the study period, 177 pharmaceutical interventions were evaluated and corresponding probability scores for the occurrence of ADE were determined. From this, annual savings of €â€¯80,000 through avoided costs were calculated. CONCLUSION: In this project, the economic benefit of pharmaceutical services in intensive care medicine was proven. Ward-based clinical pharmacists are now an integral part of the intensive care treatment team at the Ernst von Bergmann Hospital.

UK Prescribing Safety Assessment (PSA): The development, implementation and outcomes of a national online prescribing assessment.

AIMS: The United Kingdom (UK) Prescribing Safety Assessment (PSA) is a 2-h online assessment of basic competence to prescribe and supervise the use of medicines. It has been undertaken by students and doctors in UK medical and foundation schools for the past decade. This study describes the academic characteristics and performance of the assessment; longitudinal performance of candidates and schools; stakeholder feedback; and surrogate markers of prescribing safety in UK healthcare practice. METHODS: We reviewed the performance data generated by over 70 000 medical students and 3700 foundation doctors who have participated in the PSA since its inception in 2013. These data were supplemented by Likert scale and free text feedback from candidates and a variety of stakeholder groups. Further data on medication incidents, collected by national reporting systems and the regulatory body, are reported, with permission. RESULTS: We demonstrate the feasibility, high quality and reliability of an online prescribing assessment, uniquely providing a measure of prescribing competence against a national standard. Over 90% of candidates pass the PSA on their first attempt, while a minority are identified for further training and assessment. The pass rate shows some variation between different institutions and between undergraduate and foundation cohorts. Most responders to a national survey agreed that the PSA is a useful instrument for assessing prescribing competence, and an independent review has recommended adding the PSA to the Medical Licensing Assessment. Surrogate markers suggest there has been improvement in prescribing safety in practice, temporally associated with the introduction of the PSA but other factors could be influential too. CONCLUSIONS: The PSA is a practical and cost-effective way of delivering a reliable national assessment of prescribing competence that has educational impact and is supported by the majority of stakeholders. There is a need to develop national systems to identify and report prescribing errors and the harm they cause, enabling the impact of educational interventions to be measured.

Inappropriate quetiapine use at a large academic medical center: frequency of misuse and associated costs of adverse effects.

Background: Quetiapine is an antipsychotic with dose-related receptor affinity, which is commonly prescribed by specialties outside of psychiatry. Quetiapine can have adverse effects including weight gain, hyperglycemia, and falls. Therefore, quetiapine is a good focus medication to assess the need for an antipsychotic stewardship protocol. Objective: To assess the need for an antipsychotic stewardship protocol at a large, urban academic medical center by evaluating quetiapine usage. Design: A retrospective review of quetiapine dispensing history for all strengths (immediate release: 25, 50, 100, 200, 300 mg; extended release: 50, 150, 200, 300 mg) over 1 year (1 December 2021 to 30 November 2022) in patients aged 18 and older was conducted at a large, urban academic medical center. Methods: An antipsychotic protocol for safe and effective quetiapine use was developed utilizing its package insert, clinical guidelines, and primary peer-reviewed literature. Once identified by prescription fill, a retrospective chart review was completed for quetiapine indication, dose, and frequency. Each prescription was reviewed for appropriateness using the antipsychotic stewardship protocol. Results: Out of 521 quetiapine prescriptions for 181 unique patients, 67% of scripts were inappropriate. The costs associated with this inappropriate use were extrapolated to be over $350,000 per year when accounting for long-term harms associated with the development of type 2 diabetes mellitus and falls in older adults. Conclusion: Promoting the safe and effective use of antipsychotics through developing and implementing an antipsychotic stewardship protocol may reduce patient harm and associated costs from inappropriate use.

Inappropriate quetiapine use at a large academic medical center Psychotropic stewardship aims to improve patient outcomes and minimize side effects associated with psychotropic use ­ including antipsychotics. Studies have investigated psychotropic stewardship in elderly patients but have not reviewed its utility in the general adult population. Quetiapine is an antipsychotic with dose-related receptor affinity, meaning that at different doses of the medication, it acts on different receptors and exerts different clinical effects as a sedative, antidepressant, or antipsychotic. Quetiapine is commonly prescribed across medical specialties and can have significant adverse effects, including weight gain, hyperglycemia, and falls. Therefore, quetiapine is a suitable focus medication to assess the need for an antipsychotic stewardship protocol. We developed a protocol for safe and effective quetiapine use utilizing its package insert, clinical guidelines, and primary peer-reviewed literature. We reviewed the dispensing history of quetiapine over one year at two pharmacies at a large, urban academic medical center. Once identified by prescription fill, we completed a retrospective chart review for quetiapine indication, dose, and frequency. We reviewed each prescription for appropriateness using our antipsychotic stewardship protocol. Of 521 quetiapine prescriptions for 181 unique patients filled over one year, 67% of scripts were inappropriate. We extrapolated the costs associated with this inappropriate use to be over $350,000 per year when accounting for long-term harms associated with quetiapine use, including the development of type 2 diabetes mellitus and falls in older adults. Our findings illustrate that promoting the safe and effective use of antipsychotics through developing and implementing an antipsychotic stewardship protocol may reduce patient harm and associated costs from inappropriate use. Psychiatric pharmacists are well-positioned to manage these stewardship program's development, implementation, and dissemination.

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.

Comprehension of prescription orders with and without pictograms: tool validation and comparative assessment among a sample of participants from a developing country.

BACKGROUND: Medication errors can often occur due to the patient's inability to comprehend written or verbal medication orders. This study aimed to develop pictograms of selected medication orders and to validate the comprehension of prescription orders index and compare the comprehension scores with and without pictograms. In addition to determine the predictors that could be associated with a better or worse comprehension of prescription orders with pictograms versus that of their written counterparts. METHODS: A cross-sectional study was conducted using a snowball sampling technique. Six pictograms were developed to depict specific medication orders. The comprehension of prescription orders index was constructed and validated. The study then compared the comprehension scores of prescription orders with and without pictograms, and identified the predicting factors score difference. RESULTS: A total of 1848 participants were included in the study. The structure of the comprehension of prescription orders index was validated over a solution of four factors, with an adequate Kaiser-Meyer-Olkin (KMO) measure of sampling adequacy of 0.711 and a significant Bartlett's test of sphericity (P < 0.001). The construct validity of the index was further confirmed by highly significant correlations between each item and the full index (P < 0.001). The study also found a significant association between the difference in comprehension scores for prescription orders with and without pictograms and several factors, including age, level of education, area of residence, number of children, and smoking status with the difference of comprehension scores (P < 0.001). CONCLUSION: Pictogram-based instructions of medication orders were better understood by the Lebanese population than written instructions, making the incorporation of pictograms in pharmacy practice paramount to optimize medication use by the patient and thus yielding better health outcomes.

Closed-Loop Medication Management with an Electronic Health Record System in U.S. and Finnish Hospitals.

Many medication errors in the hospital setting are due to manual, error-prone processes in the medication management system. Closed-loop Electronic Medication Management Systems (EMMSs) use technology to prevent medication errors by replacing manual steps with automated, electronic ones. As Finnish Helsinki University Hospital (HUS) establishes its first closed-loop EMMS with the new Epic-based Electronic Health Record system (APOTTI), it is helpful to consider the history of a more mature system: that of the United States. The U.S. approach evolved over time under unique policy, economic, and legal circumstances. Closed-loop EMMSs have arrived in many U.S. hospital locations, with myriad market-by-market manifestations typical of the U.S. healthcare system. This review describes and compares U.S. and Finnish hospitals' EMMS approaches and their impact on medication workflows and safety. Specifically, commonalities and nuanced differences in closed-loop EMMSs are explored from the perspectives of the care/nursing unit and hospital pharmacy operations perspectives. As the technologies are now fully implemented and destined for evolution in both countries, perhaps closed-loop EMMSs can be a topic of continued collaboration between the two countries. This review can also be used for benchmarking in other countries developing closed-loop EMMSs.

Operationalizing a Medication Safety Gap Assessment for a Large Health System.

Background: Medication errors continue to be a leading cause of medical errors. In the United States alone, 7000 to 9000 people die annually due to a medication error, and many more are harmed. Since 2014, the Institute for Safe Medication Practices (ISMP) has advocated for several best practices in acute care facilities derived from reports of patient harm. Methods: The medication safety best practices chosen for this assessment were based on the 2020 ISMP Targeted Medication Safety Best Practices (TMSBP) and health system-identified opportunities. Each month, for 9 months, select best practices were covered with associated tools to assess the current state, document the gap, and close identified gaps. Results: Overall, 121 acute care facilities participated in most safety best practice assessments. Of the best practices assessed, there were 8 practices that more than 20 hospitals documented as not implemented and 9 practices where more than 80 hospitals had fully implemented them. Conclusion: Full implementation of medication safety best practices is a resource-intensive process that requires strong change management leadership at a local level. As noted by the redundancy in published ISMP TMSBP, there is an opportunity to continue improving safety in acute care facilities across the United States.

Cannabis dispensary staff approaches to counseling on potential contraindications to cannabis use: insights from a national self-report survey.

BACKGROUND: Legal cannabis is available in more than half of the United States. Health care professionals (HCPs) rarely give recommendations on dosing or safety of cannabis due to limits imposed by policy and lack of knowledge. Customer-facing cannabis dispensary staff, including clinicians (pharmacists, nurses, physician's assistants), communicate these recommendations in the absence of HCP recommendations. Little is known about how dispensary staff approach individuals with complex medical and psychiatric comorbidities. Using responses from a national survey, we describe how cannabis dispensary staff counsel customers with medical and psychiatric comorbidities on cannabis use and examine whether state-specific cannabis policy is associated with advice given to customers. METHODS: National, cross-sectional online survey study from February 13, 2020 to October 2, 2020 of dispensary staff at dispensaries that sell delta-9-tetrahydrocannabinol containing products. Measures include responses to survey questions about how they approach customers with medical and psychiatric comorbidities; state medicalization score (scale 0-100; higher score indicates more similarity to regulation of traditional pharmacies); legalized adult-use cannabis (yes/no). We conducted multiple mixed effects multivariable logistic regression analyses to understand relationships between state medicalization and dispensary employees' perspectives. RESULTS: Of 434 eligible respondents, most were budtenders (40%) or managers (32%), and a minority were clinicians (18%). State medicalization score was not associated with responses to most survey questions. It was associated with increased odds of encouraging customers with medical comorbidities to inform their traditional HCP of cannabis use (Odds ratio [OR]=1.2, 95% confidence interval [CI] 1.0-1.4, p=0.03) and reduced odds of recommending cannabis for individuals with cannabis use disorder (CUD) (OR=0.8, 95% CI 0.7-1.0, p=0.04). Working in a state with legalized adult-use cannabis was associated with recommending traditional health care instead of cannabis in those with serious mental illness (OR 2.2, 95% CI 1.1-4.7, p=0.04). Less than half of respondents believed they had encountered CUD (49%), and over a quarter did not believe cannabis is addictive (26%). CONCLUSIONS: When managing cannabis dosing and safety in customers with medical and psychiatric comorbidity, dispensary staff preferred involving individuals' traditional HCPs. Dispensary staff were skeptical of cannabis being addictive. While state regulations of dispensaries may impact the products individuals have access to, they were not associated with recommendations that dispensary staff gave to customers. Alternative explanations for dispensary recommendations may include regional or store-level variation not captured in this analysis.

Evaluation of the Prescribing Skills Assessment implementation, performance and medical student experience in Australia and New Zealand.

AIMS: The UK Prescribing Safety Assessment was modified for use in Australia and New Zealand (ANZ) as the Prescribing Skills Assessment (PSA). We investigated the implementation, student performance and acceptability of the ANZ PSA for final-year medical students. METHODS: This study used a mixed-method approach involving student data (n = 6440) for 2017-2019 (PSA overall score and 8 domain subscores). Data were also aggregated by medical school and included student evaluation survey results. Quantitative data were analysed using descriptive and multivariate analyses. The pass rate was established by a modified Angoff method. Thematic analyses of open-ended survey comments were conducted. RESULTS: The average pass rate was slightly higher in 2017 (89%) which used a different examination to 2018 (85%) and 2019 (86%). Little difference was identified between schools for the PSA overall performance or domain subscores. There was low intercorrelation between subscores. Most students provided positive feedback about the PSA regarding the interface and clarity of questions, but an average of 35% reported insufficient time for completion. Further, 70% on average felt unprepared by their school curricula for the PSA, which is in part explained by the low prescribing experience; 69% reported completing ≤10 prescriptions during training. CONCLUSION: The ANZ PSA was associated with high pass rates and acceptability, although student preparedness was highlighted as a concern for further investigation. We demonstrate how a collaboration of medical schools can adapt a medical education assessment resource (UK PSA) as a means for fulfilling an unmet need.

Assessment of knowledge, cultural beliefs, and behavior regarding medication safety among residents in Harbin, China.

BACKGROUND: Medication misuse or overuse is significantly associated with poor health outcomes. Information regarding the knowledge, cultural beliefs, and behavior about medication safety in the general population is important. AIM: To conduct a survey on medication habits and explored the potential factors impacting medication safety. METHODS: The current survey included adults from 18 districts and counties in Harbin, China. A questionnaire on medication safety was designed based on knowledge, cultural beliefs, and behavior. Both univariate and multivariate analyses were used to explore the factors that impacted medication safety. RESULTS: A total of 394 respondents completed the questionnaires on medication safety. The mean scores for knowledge, cultural beliefs, and behavior about medication safety were 59.41 ± 19.33, 40.66 ± 9.24, and 60.97 ± 13.69, respectively. The medication knowledge score was affected by age (P = 0.044), education (P < 0.001), and working status (P = 0.015). Moreover, the cultural beliefs score was significantly affected by education (P < 0.001). Finally, education (P = 0.003) and working status (P = 0.011) significantly affected the behavior score. CONCLUSION: The knowledge, cultural beliefs, and behavior about medication safety among the general population was moderate. Health education should be provisioned for the elderly, individuals with a low education level, and the unemployed to improve medication safety in Harbin, China.

Assessment of knowledge, attitude, and practices of acute kidney injury incidence with co-administration of piperacillin/tazobactam and vancomycin among healthcare workers: A cross-sectional study.

Background: No studies have identified a link between acute kidney injury (AKI) incidence due to the co-administration of vancomycin and piperacillin/tazobactam (VPT) and healthcare providers' knowledge, attitudes, and practices. We aimed to (1) assess the knowledge, attitudes, and practices towards AKI due to VPT co-administration among healthcare providers in Saudi Arabia, and (2) examine the relationship between healthcare providers' knowledge and attitudes about AKI due to VPT co-administration and their practices. Methods: This cross-sectional study was conducted between February 2022 and April 2022. Healthcare providers, including physicians, pharmacists, and nurses, were included in the study population. The correlation coefficient assessed the relationship between knowledge, attitude, and practice. Spearman's rho was used as a test statistic. Results: Of the invited healthcare providers, 192 responded to the survey. A significant difference in knowledge was found among healthcare providers for two variables: the definition of AKI (p < 0.001) and appropriate management of AKI due to VPT (p = 0.002). Physicians were found to rely less on the most common causative organisms of infection to guide empirical antibiotic therapy (p < 0.001). In addition, physicians were less likely to switch piperacillin/tazobactam to cefepime or meropenem in combination with vancomycin with AKI incidence (p = 0.001). A positive attitude towards the perceived AKI risk with VPT was positively correlated with avoiding using VPT unless no alternatives were available (Rho = 0.336) and taking protective measures when using VPT (Rho = 0.461). Conclusion: Deviation has been observed in the knowledge, attitudes, and practices of AKI incidence with the co-administration of piperacillin/tazobactam and vancomycin among healthcare workers. Interventions at the organizational level are recommended to guide best practices.

Development and psychometric assessment of self-reported patient medication safety scale (SR-PMSS).

Objectives: Patient medication safety can affect their clinical outcomes and plays an important role in patient safety management. However, few tools have been developed to assess patient medication safety. This study aimed to develop and validate the self-reported patient medication safety scale (SR-PMSS). Methods: We developed SR-PMSS guided by the Donabedian Structure-Process-Outcome framework and used psychometric methods to test its validity and reliability. Results: A total of 501 patients with an average age of 56.81 ± 14.47 were enrolled in this study. The SR-PMSS consisted of 21 items and 5 factors. The content validity was good with item-level content validity index (CVI) > 0.78, average scale-level CVI (S-CVI) > 0.9, and universal agreement S-CVI > 0.8. Exploratory factor analysis extracted a five-factor solution with eigenvalues > 0.1, explaining 67.766% of the variance. Confirmatory factor analysis showed good model fit, acceptable convergent validity, and discriminant validity. The Cronbach's α coefficient for SR-PMSS was 0.929, the split-half reliability coefficient was 0.855, and the test-retest reliability coefficient was 0.978. Conclusions: The SR-PMSS was a valid and reliable instrument with good reliability and validity to evaluate the level of patient medication safety. The target users of the SR-PMSS are all people who are taking or have used prescription medications. The SR-PMSS can be used by healthcare providers in clinical practice and research to identify patients at risk for medication use and intervene with them to reduce adverse medication events and provide support for patient safety management. Plain Language Summary: SR-PMSS - a self-reported tool to assess patient medication safetyMedication therapy was the most common and frequent treatment method to prevent and cure diseases. Medication safety issues may occur in the process of medication use. Patient medication safety can affect their clinical outcomes and plays an important role in patient safety management. However, there are few tools to assess patient medication safety currently, and most of them focused on medication safety related to hospitals or healthcare workers. We developed the self-reported patient medication safety scale (SR-PMSS) guided by the Donabedian Structure-Process-Outcome framework. Then, we conducted a two-round expert consultation, clarity verification, and item simplification to determine the final version of the scale. The SR-PMSS consisted of 21 items and 5 factors and it had good validity and reliability. The target users of the SR-PMSS are all people who are taking or have used prescription medications. Healthcare providers can use the SR-PMSS in clinical practice and research to identify patients at risk for medication use and intervene with them to reduce adverse medication events and provide support for patient safety management.

Sulfonylureas as second line therapy for type 2 diabetes among veterans: Results from a National Longitudinal Cohort Study.

AIMS: To assess if switching to or adding sulfonylureas increases major adverse cardiovascular events (MACE) or severe hypoglycemia versus remaining on metformin alone. MATERIALS AND METHODS: This was a retrospective, longitudinal cohort utilizing United States Veterans Health Administration and Medicare data. Veterans with type 2 diabetes on metformin monotherapy between 2004 and 2006 were identified. Follow-up occurred through 2016. Those treated with either metformin plus a second-generation sulfonylurea (N = 45,305) or converted from metformin to a second-generation sulfonylurea (N = 2813) were compared to those receiving metformin monotherapy (N = 65,550). Hazard ratios (HR) and 95%CI from longitudinal competing risk Cox models were used to measure the association between sulfonylureas and outcomes. RESULTS: Switching to or adding a sulfonylurea to metformin was associated with 3 times the risk of severe hypoglycemia versus metformin monotherapy (HR:3.44, 95% CI: 3.06,3.85 and HR: 3.08, 95% CI: 2.77,3.42, respectively). Switching to or adding a sulfonylurea to metformin was associated with a 7-19% higher risk of MACE versus metformin monotherapy (HR: 1.07, 95% CI: 1.00,1.14 and HR: 1.19, 95% CI: 1.13,1.25, respectively). CONCLUSIONS: Switching to and adding second-generation sulfonylureas was associated an increase in severe hypoglycemia and MACE versus remaining on metformin alone. In an era where guidelines recommend diabetes therapies based on compelling indications, safety outcomes should be a key consideration when selecting therapy.

A coordinated approach for managing polypharmacy among children with medical complexity: rationale and design of the Pediatric Medication Therapy Management (pMTM) randomized controlled trial.

BACKGROUND: Children with medical complexity (CMC) often rely upon the use of multiple medications to sustain quality of life and control substantial symptom burden. Pediatric polypharmacy (≥ 5 concurrent medications) is prevalent and increases the risk of medication-related problems (MRPs). Although MRPs are associated with pediatric morbidity and healthcare utilization, polypharmacy is infrequently assessed during routine clinical care for CMC. The aim of this randomized controlled trial is to determine if a structured pharmacist-led Pediatric Medication Therapy Management (pMTM) intervention reduces MRP counts, as well as the secondary outcomes of symptom burden and acute healthcare utilization. METHODS: This is a hybrid type 2 randomized controlled trial assessing the effectiveness of pMTM compared to usual care in a large, patient-centered medical home for CMC. Eligible patients include all children ages 2-18 years old, with ≥ 1 complex chronic condition, and with ≥ 5 active medications, as well as their English-speaking primary caregivers. Child participants and their primary parental caregivers will be randomized to pMTM or usual care before a non-acute primary care visit and followed for 90 days. Using generalized linear models, the overall effectiveness of the intervention will be evaluated using total MRP counts at 90 days following pMTM intervention or usual care visit. Following attrition, a total of 296 CMC will contribute measurements at 90 days, which provides > 90% power to detect a clinically significant 1.0 reduction in total MRPs with an alpha level of 0.05. Secondary outcomes include Parent-Reported Outcomes of Symptoms (PRO-Sx) symptom burden scores and acute healthcare visit counts. Program replication costs will be assessed using time-driven activity-based scoring. DISCUSSION: This pMTM trial aims to test hypotheses that a patient-centered medication optimization intervention delivered by pediatric pharmacists will result in lower MRP counts, stable or improved symptom burdens, and fewer cumulative acute healthcare encounters at 90 days following pMTM compared to usual care. The results of this trial will be used to quantify medication-related outcomes, safety, and value for a high-utilization group of CMC, and outcomes may elucidate the role of integrated pharmacist services as a key component of outpatient complex care programs for this priority pediatric population. TRIAL REGISTRATION: This trial was prospectively registered at clinicaltrials.gov (NCT05761847) on Feb 25, 2023.