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Background Medication safety is an important health issue for nursing home residents (NHR). They usually experience polypharmacy and often take potentially inappropriate medications (PIM) and antipsychotics. This, coupled with a frail health state, makes NHR particularly vulnerable to adverse drug events (ADE). The value of systematic medication reviews and interprofessional co-operation for improving medication quality in NHR has been recognized. Yet the evidence of a positive effect on NHR’ health and wellbeing is inconclusive at this stage. This study investigates the effects of pharmacists’ medication reviews linked with measures to strengthen interprofessional co-operation on NHR’ medication quality, health status and health care use. Methods Pragmatic cluster randomised controlled trial in nursing homes in four regions of Germany. A total of 760 NHR will be recruited. Inclusion: NHR aged 65 years and over with an estimated life expectancy of at least six months. Intervention with four elements: i) introduction of a pharmacist’s medication review combined with a communication pathway to the prescribing general practitioners (GPs) and nursing home staff, ii) facilitation of change in the interprofessional cooperation, iii) educational training and iv) a “toolbox” to facilitate implementation in daily practice. Analysis: primary outcome - proportion of residents receiving PIM and ≥ 2 antipsychotics at six months follow-up. Secondary outcomes - cognitive function, falls, quality of life, medical emergency contacts, hospital admissions, and health care costs. Discussion The trial assesses the effects of a structured interprofessional medication management for NHR in Germany. It follows the participatory action research approach and closely involves the three professional groups (nursing staff, GPs, pharmacists) engaged in the medication management. A handbook based on the experiences of the trial in nursing homes will be produced for a rollout into routine practice in Germany. Trial registration Registered in the German register of clinical studies (DRKS, study ID DRKS00013588 , primary register) and in the WHO International Clinical Trials Registry Platform (secondary register), both on 25th January 2018.

Background The aim of this trial is to evaluate the effect of SENATOR software on incident, adverse drug reactions (ADRs) in older, multimorbid, hospitalized patients. The SENATOR software produces a report designed to optimize older patients’ current prescriptions by applying the published STOPP and START criteria, highlighting drug-drug and drug-disease interactions and providing non-pharmacological recommendations aimed at reducing the risk of incident delirium. Methods We will conduct a multinational, pragmatic, parallel arm Prospective Randomized Open-label, Blinded Endpoint (PROBE) controlled trial. Patients with acute illnesses are screened for recruitment within 48 h of arrival to hospital and enrolled if they meet the relevant entry criteria. Participants’ medical history, current prescriptions, select laboratory tests, electrocardiogram, cognitive status and functional status are collected and entered into a dedicated trial database. Patients are individually randomized with equal allocation ratio. Randomization is stratified by site and medical versus surgical admission, and uses random block sizes. Patients randomized to either arm receive standard routine pharmaceutical clinical care as it exists in each site. Additionally, in the intervention arm an individualized SENATOR-generated medication advice report based on the participant’s clinical and medication data is placed in their medical record and a senior medical staff member is requested to review it and adopt any of its recommendations that they judge appropriate. The trial’s primary outcome is the proportion of patients experiencing at least one adjudicated probable or certain, non-trivial ADR, during the index hospitalization, assessed at 14 days post-randomization or at index hospital discharge if it occurs earlier. Potential ADRs are identified retrospectively by the site researchers who complete a Potential Endpoint Form (one per type of event) that is adjudicated by a blinded, expert committee. All occurrences of 12 pre-specified events, which represent the majority of ADRs, are reported to the committee along with other suspected ADRs. Participants are followed up 12 (+/− 4) weeks post-index hospital discharge to assess medication quality and healthcare utilization. This is the first clinical trial to examine the effectiveness of a software intervention on incident ADRs and associated healthcare costs during hospitalization in older people with multi-morbidity and polypharmacy. Trial registration number Clinicaltrials.gov NCT02097654 , 27 March 2014.

IntroductionMultimorbidity and polypharmacy are important risk factors for drug-related hospital admissions (DRAs). DRAs are often linked to prescribing problems (overprescribing and underprescribing), as well as non-adherence with drug regimens for different reasons. In this trial, we aim to assess whether a structured medication review compared with standard care can reduce DRAs in multimorbid older patients with polypharmacy.Methods and analysisOPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people is a European multicentre, cluster randomised, controlled trial. Hospitalised patients ≥70 years with ≥3 chronic medical conditions and concurrent use of ≥5 chronic medications are included in the four participating study centres of Bern (Switzerland), Utrecht (The Netherlands), Brussels (Belgium) and Cork (Ireland). Patients treated by the same prescribing physician constitute a cluster, and clusters are randomised 1:1 to either standard care or Systematic Tool to Reduce Inappropriate Prescribing (STRIP) intervention with the help of a clinical decision support system, the STRIP Assistant. STRIP is a structured method performing customised medication reviews, based on Screening Tool of Older People’s Prescriptions/Screening  Tool to Alert to Right Treatment criteria to detect potentially inappropriate prescribing. The primary endpoint is any DRA where the main reason or a contributory reason for the patient’s admission is caused by overtreatment or undertreatment, and/or inappropriate treatment. Secondary endpoints include number of any hospitalisations, all-cause mortality, number of falls, quality of life, degree of polypharmacy, activities of daily living, patient’s drug compliance, the number of significant drug–drug interactions, drug overuse and underuse and potentially inappropriate medication.Ethics and disseminationThe local Ethics Committees in Switzerland, Ireland, The Netherlands and Belgium approved this trial protocol. We will publish the results of this trial in a peer-reviewed journal.Main fundingEuropean Union’s Horizon 2020 programme.Trial registration number NCT02986425 , SNCTP000002183 , NTR6012, U1111-1181-9400.

Background Potentially inappropriate medications (PIMs) are frequent in older adults, contributing to hospitalizations, adverse events, and healthcare burden. We aimed to estimate direct PIM cost trends from 2012 to 2021 among older women and men in Quebec, Canada. Methods Using medico-administrative data, we assessed direct costs paid by the public insurer (medication cost and professional fee, excluding out-of-pocket payments by individuals) of PIMs claimed by adults ≥65 years covered by the public drug plan. Costs for 16 PIM classes, identified using 2015 and 2019 Beers criteria, were calculated and stratified by sex and age group (65-74, 75-84, ≥85) for each fiscal year. We assessed the proportion of PIMs among all medication expenditures. We computed average costs/enrollee and usage prevalence for the costliest PIM classes. Trends were estimated using univariate linear regression with 95% confidence intervals. Results We found a non-statistically significant decrease in total PIM claim costs, from $206 million in 2012 to $186 million in 2021 (trend: -2.9[-17.4; 11.6]), representing 5.4% of medication expenditures for adults ≥65 in 2021. The reduction in total costs was more accentuated in women, whose annual costs were higher than those of men in all age groups. Average cost/enrollee decreased from $179 to $119 (trend: -7[-19; 5]), with a drop from $216 to $142 for women and $132 to $92 for men. Costs/enrollee were higher in 75-84 and ≥85 age groups. Costliest PIM classes included proton-pump inhibitors, benzodiazepines, antipsychotics, antidepressants, estrogens (women), and hypoglycemic agents (men). Cost trends did not always follow prevalence trends for these PIM classes. Conclusion PIM costs among older adults slightly decreased from 2012 to 2021. Appropriate prescribing and deprescribing appear crucial for reducing these costs. Further research should focus on estimating the societal impact and the cost-effectiveness analysis of deprescribing initiatives and other regulatory measures.

Although potentially inappropriate medications (PIMs) have been linked to poor health outcomes, country-specific PIM criteria have not been compared. Thus, we compared the identification of PIMs between the Screening Tool for Older Person's Appropriate Prescriptions for Japanese (STOPP-J) and the 2015 American Geriatrics Society Beers Criteria in elderly patients receiving home-based medical services. A 5-year prospective cohort study was conducted with 196 patients receiving home-based medical services. Data were collected using questionnaires and chart reviews and included detailed information on prescription medication. STOPP-J and the Beers Criteria were used to categorize PIM and non-PIM recipients. All-cause mortality and first hospitalization were compared using a multivariate Cox regression model. PIMs were detected in 132 patients (67.3%) by STOPP-J and in 141 patients (71.9%) by the Beers Criteria, and the mean numbers of PIMs were 1.3 ± 1.3 and 1.2 ± 1.1, respectively. The three most frequently prescribed STOPP-J PIMs were hypnotics (26.8%), diuretics (25.6%), and NSAIDs (12.6%), compared with proton pump inhibitors (PPIs) (29.8%), hypnotics (26%), and NSAIDs (8.1%) according to the Beers Criteria. STOPP-J PIMs were associated with all-cause mortality (HR 3.01, 95% CI 1.37-6.64) and hospitalization (HR 1.91, 95% CI 1.17-3.09); neither was associated with Beers Criteria PIMs. Using a modified Beers Criteria (excluding PPIs), PIMs were correlated with first hospitalization (HR 1.91, 95% CI 1.17-3.09). PIMs categorized by STOPP-J are associated with hospitalization and mortality in Japanese patients receiving home-based medical services. PPIs, commonly used for acid-related diseases, do not seem to have deleterious effects on health outcomes. Country-oriented, medication-specific criteria would be of considerable clinical utility.

PurposeThe aim of this study was to explore patterns and long-term development in prescribing potentially inappropriate medication (PIM) according to the EU(7)-PIM list to elderly patients in Germany.MethodsWe analysed anonymized German claims data. The study population comprised 6.0 million insured individuals at least 65 years old, including all their prescriptions reimbursed in 2019. For the analysis of long-term development, we used data for the years 2009–2019. Factors associated with PIM prescribing were considered from two perspectives: patient-oriented analysis was performed with logistic regression and prescriber-oriented analysis was performed with multiple linear regression.ResultsEU(7)-PIM prevalence was reduced from 56.9% in 2009 to 45.1% in 2019. Average annual volume (DDDs/insured) decreased from 145 in 2009 to 121 in 2019. These figures are substantially greater than those for the older PRISCUS list. The majority of investigated ATC level 2 groups with the highest EU(7)-PIM DDD volume exhibited substantial decreases; moderate increases were found for antihypertensive and urological drugs. Antithrombotics increased strongly with the introduction of direct oral anticoagulants. The most prevalent EU(7)-PIM medication was diclofenac; however, in the age group 85+ years, apixaban was twice as prevalent as diclofenac. Polypharmacy, female sex, age < 90 years, need for nursing care and living in Eastern regions were identified as risk factors. Prescriber specialty was the most marked factor in the prescriber-oriented analysis.ConclusionAlthough the use of EU(7)-PIMs has been declining, regional differences indicate considerable room for improvement. The comparison with PRISCUS highlights the necessity of regular updates of PIM lists.

This study aimed to compare the prevalence of potentially inappropriate medications (PIMs) among Chinese aged patients using the Beers criteria of 2015, the Screening Tool of Older Persons' Prescriptions (STOPP) of 2014 and the criteria of PIMs for older adults in China (Chinese criteria), and to identify the correlates of the PIMs' use. A retrospective, cross-sectional study was conducted among geriatric patients at Beijing Chao-Yang Hospital between January 2018 and March 2018. Three criteria (the Beers criteria of 2015, the STOPP criteria of 2014 and the Chinese criteria) were used to detect PIMs. A multivariate logistic regression analysis was carried out to determine factors associated with the use of PIMs. Leading PIMs for each set of criteria were also listed. The concordance among the three PIM criteria was calculated using kappa tests. Totally, 863 inpatients aged ≥65 years were included. The prevalence of patients receiving at least one PIM was 80.2%, 58.1% and 44.0% according to the Chinese criteria, 2015 Beers criteria and 2014 STOPP criteria, respectively. The Beers and the STOPP criteria indicated a moderate coherence, whereas the Chinese criteria showed poor concordance with the other two criteria. Proton-pump inhibitors in the Beers and STOPP criteria and clopidogrel in the PIM-Chinese accounted for most leading PIMs. The most important factor associated with PIM use by all three sets of criteria was the number of prescribed medications. Data showed a high PIM prevalence among older adults in China, which was associated with the number of prescribed medications. The Chinese criteria had the highest detection rate but a poor concordance with the Beers and STOPP criteria ( <0.001).

Background Older adults requiring care often have multiple morbidities that lead to polypharmacy, including the use of potentially inappropriate medications (PIMs), leading to increased medical costs and adverse drug effects. We conducted a cross-sectional study to clarify the actual state of drug prescriptions and the background of polypharmacy and PIMs. Methods Using long-term care (LTC) and medical insurance claims data in the Ibaraki Prefecture from April 2018 to March 2019, we included individuals aged ≥ 65 who used LTC services. The number of drugs prescribed for ≥ 14 days and the number of PIMs were counted. A generalized linear model was used to analyze the association between the backgrounds of individuals and the number of drugs; logistic regression analysis was used for the presence of PIMs. PIMs were defined by STOPP-J and Beers Criteria. Results Herein, 67,531 older adults who received LTC services were included. The median number of total prescribed medications and PIMs was 7(IQR 5–9) and 1(IQR 0–1), respectively. The main PIMs were loop diuretics/aldosterone antagonists (STOPP-J), long-term use of proton pump inhibitors (Beers Criteria), benzodiazepines/similar hypnotics (STOPP-J and Beers Criteria), and nonsteroidal anti-inflammatory drugs (STOPP-J and Beers Criteria). Multivariate analysis revealed that the number of medications and presence of PIMs were significantly higher in patients with comorbidities and in those visiting multiple medical institutions. However, patients requiring care level ≥1, nursing home residents, users of short-stay service, and senior daycare were negatively associated with polypharmacy and PIMs. Conclusions Polypharmacy and PIMs are frequently observed in older adults who require LTC. This was prominent among individuals with comorbidities and at multiple consulting institutions. Utilization of nursing care facilities may contribute to reducing polypharmacy and PIMs. Graphical Abstract

PurposeBy discussing the corresponding situation of PIM criteria and labels, it provides a reference for the formulation and update of the criteria and the content of the section of “medications for the elderly” in the labels, so as to realize rational drug use for the elderly.MethodsExtract the four indicators of Beers criteria, STOPP criteria, and the EU(7)-PIM list that involve dosage, duration, age, and mortality, and compare them with the latest labels for drugs marketed in the USA and the EU.ResultsThere are 148 drugs involving four indicators in the criteria, and 85.14% of the drugs are found in at least one region. In terms of dose, there are 28 drugs with inconsistent descriptions in the labels of the two regions, accounting for 47.46% of the 59 drugs found in both regions. A total of 42.37% of the drugs are consistent in both regions with the criteria (25/59), 28.81% of the drugs are inconsistent in both regions with the criteria (17/59), and 28.81% of the drugs are inconsistent in only one region with the criteria (17/59). The doses of 50 drugs found in F/D labels are consistent with the criteria, accounting for 54.35% of the 92 drugs found in F/D labels, and of 41 drugs found in E/H SmPC are consistent with the criteria, accounting for 60.29% of the 68 drugs found in E/H SmPC. Only the duration of omeprazole in the labels in both regions is consistent with the criteria, and only the age of prasugrel in both regions is consistent with the criteria. Five drugs whose labels mentioned increased mortality, accounting for 38.46% of the 13 drugs found in both regions.ConclusionThere are certain differences between PIM criteria and PIM criteria, labels and labels, and PIM criteria and labels, which will affect the use of drugs in the elderly. Therefore, the unity between the criteria and labels should be strengthened to provide more instructive guidance for the elderly, so as to jointly realize rational drug use in the elderly.

To investigate the frequency of Beers Criteria (BC) medication and opioid use in patients age 65 years and older arriving in the Emergency Department. We performed a retrospective observational study of a convenience sample of 400 patients, age 65 years and older, arriving to and discharged solely from the Emergency Department. We examined 400 sequential patient charts with visit dates April–July 2017, for the presence of a Beers Criteria medication or opioid prescription. We also examined each chart for nine specific chief complaints, including return visits and subsequent admissions. Of the 400 patients included in this study, 304 patients (76%; 95% confidence interval [CI] 72% to 80%) had at least 1 prescription at the index ED visit for an “avoid” or “use with caution” Beers Criteria medication. Of these patients, 194 (64%; 95% CI 58% to 69%) had ≥2 Beers medication prescriptions and 122 patients (40%; 95% CI 35% to 46%) had ≥3 Beers medication prescriptions. We found no difference in the number of patients with a chief complaint of interest between the BC medication list (28%) and lacking a BC medication (29%) (p-value = 1). No patients returned in the next 7 days for a medication-related complaint. The results of this study call into question the routine application of lists without high-quality evidence to critique the prescribing of certain medications. Further patient-oriented study of the relevance of the Beers Criteria list, especially in light of the changed face of medication profiles and populations, is called for.