[Translated article] Current situation and evolution of the availability of drugs in the pediatric population in Spain.

OBJECTIVE: To analyze the characteristics of the new medicines approved in the pediatric population in the last 3 years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. METHODS: Descriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorized or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. RESULTS: During the study period, 129 drugs included their indication in the pediatric population. 13.9% of them are not marketed, 46.5% are in a situation of non-financing, under study or without a request for financing, and 4.6% are financed for a specific pediatric subpopulation. 52.7% are original drugs, 4.7% are generic, 38.8% are biological, 3.8% are biosimilar, and 17.8% are orphan drugs. 57.36% of these medicines obtain the pediatric indication due to extension of the indication and 42.64% obtain it because they are new medicines that already include their studies in the pediatric population. CONCLUSIONS: Drugs with authorized indications are increasingly available in the pediatric population and the trend is to extend the indication of authorized drugs to the adult population. However, barriers in terms of financing and marketing need to be expedite and overcome to facilitate access to them.

Association of Antipsychotic Polypharmacy and Two-Year All-Cause Mortality: A Population-Based Cohort Study of 33,221 Italian Continuous Users.

Background: Differences in survival between patients treated with antipsychotic monotherapy vs. polytherapy are debated. This study aimed to examine the association of antipsychotic polytherapy with 2-year all-cause mortality in a population-based cohort. Methods: Data were retrieved from healthcare databases of four local health units of Lombardy, Italy. Subjects aged 18-79 years who received continuous antipsychotic prescriptions in 2018 were identified. Overall survival among patients with antipsychotic monotherapy vs. polytherapy was compared. A multivariate Cox PH model was used to estimate the association between antipsychotic therapy, or antipsychotic use (continuous vs. non-continuous), and all-cause mortality. Adjustments were made for the presence of metabolic disturbances, total antipsychotic dosage amount (olanzapine equivalent doses), age, and sex. Results: A total of 49,875 subjects receiving at least one prescription of antipsychotics during 2018 were identified. Among the 33,221 patients receiving continuative antipsychotic prescriptions, 1958 (5.9%) experienced death from any cause at two years. Patients with continuous antipsychotic use had a 1.13-point increased mortality risk compared with non-continuous users. Patients treated with antipsychotic polytherapy showed an adjusted mortality risk increased by 17% (95% CI: 2%, 33%) compared to monotherapy. Conclusions: The study highlights the potential risks associated with antipsychotic polypharmacy, emphasizing the importance of optimizing drug prescriptions to improve patient safety and reduce mortality rates in individuals receiving antipsychotic therapy.

Patterns of initial and first-intensifying antidiabetic drug utilization among patients with type 2 diabetes mellitus in Scotland, 2010-2020: A retrospective population-based cohort study.

AIM: To evaluate the utilization and prescribing patterns of antidiabetic drugs (ADDs) for patients with type 2 diabetes mellitus (T2DM) at treatment initiation and first intensification. METHODS: A retrospective cohort study was performed using linked routinely collected data of patients with T2DM who received ADDs between January 2010 and December 2020 in Scotland. The prescribing patterns were quantified using frequency/percentages, absolute/relative change, and trend tests. RESULTS: Overall, 145 909 new ADD users were identified, with approximately 91% (N = 132 382) of patients receiving a single ADD at first treatment initiation. Metformin was the most often prescribed monotherapy (N = 118 737, 89.69%). A total of 50 731 patients (39.40%) who were started on metformin (N = 46 730/118 737, 39.36%) or sulphonylurea (SU; N = 4001/10 029, 39.89%) monotherapy had their treatment intensified with one or more additional ADD. Most initial-metformin (45 963/46 730; 98.36%) and initial-SU users (3894/4001; 97.33%) who added further drugs were intensified with single ADDs. SUs (22 197/45 963; 48.29%) were the most common first-intensifying monotherapy after initial metformin use, but these were replaced by sodium-glucose cotransporter-2 (SGLT2) inhibitors in 2019 (SGLT2 inhibitors: 2039/6065, 33.62% vs. SUs: 1924/6065, 31.72%). Metformin was the most frequently added monotherapy to initial SU use (2924/3894, 75.09%). Although the majority of patients received a single ADD, the use of combination therapy significantly increased over time. Nevertheless, there was a significant increasing trend towards prescribing the newer ADD classes (SGLT2 inhibitors, dipeptidyl peptidase-4 inhibitors) as monotherapy or in combination compared with the older ones (SUs, insulin, thiazolidinediones) at both drug initiation and first intensification. CONCLUSIONS: An overall increasing trend in prescribing the newer ADD classes compared to older ADDs was observed. However, metformin remained the most commonly prescribed first-line ADD, while SGLT2 inhibitors replaced SUs as the most common add-on therapy to initial metformin use in 2019.

Comparison of polypharmacy and potentially inappropriate medication use in older adults with and without dementia receiving residential medication management reviews.

OBJECTIVES: Among residents who had a residential medication management review (RMMR), there is a lack of studies assessing exposure to polypharmacy and potentially inappropriate medications (PIMs) in people with dementia. This study compared the exposure to polypharmacy and PIMs in residents with dementia and without dementia receiving RMMR. METHODS: A retrospective analysis was performed using data of 16,261 residents living in 343 Australian residential aged care facilities who had an RMMR in 2019. Medication use was assessed as polypharmacy (defined as ≥9 medications) and use of ≥1 PIMs using the 2019 updated Beers criteria. Dementia diagnosis was determined with ICD-10 coding from medical records. Descriptive analyses reported resident demographics and patterns of medication use. Pearson's χ2 tests and logistic regression analysis were conducted to compare medication exposure between residents with and without dementia. RESULTS: Among 16,261 residents, 6781 (42%) had dementia. Residents with dementia were significantly more likely to be exposed to polypharmacy and PIMs, compared to those without dementia (74% vs. 70% and 83% vs. 73%, p < .001 respectively). Residents with dementia had 1.31 times the odds of exposure to polypharmacy (adjusted OR: 1.31, 95% CI: 1.22-1.41, p < .001) and 1.88 times the odds of being prescribed ≥1 PIMs than people without dementia (adjusted OR: 1.88, 95% CI: 1.73-2.04, p < .001). CONCLUSIONS: In a study of residents receiving RMMR, polypharmacy and PIMs were highly common, and those with dementia were more likely to be exposed to inappropriate polypharmacy. There is a need for targeted deprescribing strategies to immediately address inappropriate prescribing in residents, particularly those living with dementia.

Use of medication in pregnancy on the rise: Study on 1.4 million Danish pregnancies from 1998 to 2018.

INTRODUCTION: Maternal demographics have evolved, and more women than ever enter pregnancy with preexisting comorbidity and with potentially complex medication exposure, including polypharmacy (concomitant intake of multiple medications). This study aims to describe the evolution of medication use in pregnancy in Denmark from 1998 to 2018 with special focus on polypharmacy, patterns of use, and underlying demographics. MATERIAL AND METHODS: A Danish nationwide historical registry study based on all clinically recognized pregnancies with a gestation ≥10 weeks between 1998 and 2018. Medication use was estimated by redemption of prescriptions during pregnancy. RESULTS: Among a total of 1 402 327 clinically recognized pregnancies, redemption of at least one prescription medication during pregnancy increased from 56.9% in 1998 to 63.3% in 2018, coinciding with an increased use of polypharmacy (from 24.8% in 1998 to 35.2% in 2018). The prevalence of pregnant women who used medications for chronic conditions increased more than the prevalence of women treated for occasional or short-time conditions. Redemption of one or multiple prescription medications during pregnancy was mostly seen among pregnant women ≥35 years of age. However, pregnant women <25 years old exhibited the largest increase in medication use during the study period. CONCLUSIONS: Medication use in general, and polypharmacy in particular, increased from 1998 to 2008, possibly as the result of an increased prevalence of pregnant women with chronic conditions requiring pharmacological treatment. Notably, a marked maternal age-based discrepancy in usage pattern was observed, highlighting the need for further research in this area. The rise in the prevalence of polypharmacy during pregnancy underscores the need for pharmacovigilance to monitor adverse effects. Future studies should investigate the patterns of polypharmacy and the accompanying maternal and fetal risks.

Retrospective review of medicine utilization for noncommunicable diseases in three public sector pharmacies in Jamaica.

Objective: The rational use of medicines offers a cost-saving strategy to maximize therapeutic outcomes for developing and developed countries. The aim of this study was to evaluate the rational use of medicines for selected noncommunicable diseases (NCDs) at three pharmacies at public hospitals in Jamaica using the World Health Organization's (WHO's) prescribing indicators. Methods: In this retrospective cross-sectional study, prescriptions for adult outpatients containing at least one medicine for cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease or asthma that were filled between January and July 2019 were reviewed using WHO's prescribing indicators for the rational use of medicines. Data were analyzed and expressed as descriptive and inferential statistics. For all analyses conducted, significance was determined at P < 0.05. Results: A total of 1 500 prescriptions covering 5 979 medicines were reviewed; prescriptions were mostly written for female patients aged 42-60 years. Polypharmacy was observed in 35.6% (534) of prescriptions, and there was an average of 4 medicines per prescription, with a maximum of 17. Most of the prescriptions at each site were filled, with the main reason for not dispensing a medicine being that it was out of stock. Generic prescribing was high for all sites, accounting for more than 95% (5 722) of prescribed medicines. There was full compliance with prescribing according to the WHO Model List of Essential Medicines at two of the sites, but it was just off the target at Site 1, by 1.4%. Conclusions: The WHO guidelines for the rational use of medicines were followed with respect to the proportion of medicines prescribed from the WHO Model List and the proportion of antibiotics prescribed. The number of medicines per prescription and the proportion of medicines prescribed by generic name did not meet the WHO criteria. However, prescribing was aligned with treatment guidelines for the selected NCDs.

Patterns of immunotherapy utilization for non-small cell lung cancer in Texas pre- and post-regulatory approval.

PURPOSE: Immunotherapy has shown remarkable benefits for non-small cell lung cancer (NSCLC) since approved by the US Food and Drug Administration (FDA). Texas, however, ranks below the national average in access to treatment for NSCLC. This retrospective cohort study assessed first-line immunotherapy treatment patterns and associated factors pre- and post-FDA approval in Texas. METHODS: Patients ≥18 years diagnosed with NSCLC from the Texas Cancer Registry database (2011-2018) and were stratified into pre- and post-FDA approval era. The rates of immunotherapy utilization were examined, and the average annual percent change (AAPC) in immunotherapy utilization across patient subgroups was compared. Multivariable logistic regression was used to identify associations of patient characteristics with immunotherapy utilization for patients with metastatic- and all-stage NSCLC. RESULTS: A total of 13,501 and 9509 patients with NSCLC were identified in pre-post-approval periods, respectively. Post-approval, immunotherapy utilization increased from 1.7 to 13.0%, and AAPC from 54.8 to 82.7%. Pre-approval, patients living in a county with ≥20% of households below the poverty level were less likely to receive immunotherapy (OR = 0.73, 95% CI = 0.61-0.94) while patients with private insurance were more likely to receive immunotherapy (OR = 1.56, 95% CI = 1.10-2.23). Post-approval, socioeconomic disparities were more prominent (10-19.9 and ≥20% of households below the poverty level: OR = 0.77, 95% CI = 0.66-0.90 and OR = 0.71, 95% CI = 0.60-0.86, respectively). Patients with metastatic NSCLC showed similar patterns of socioeconomic disparities pre- and post-approval. CONCLUSIONS: Our findings suggest that patients' socioeconomic status hinders immunotherapy utilization for NSCLC in Texas. This emphasizes the need for state health policy reforms such as Medicaid expansion and tailored cancer care strategies.

Use of leflunomide among girls and women of childbearing age and occurrence of leflunomide-exposed pregnancies in Germany.

Leflunomide is contraindicated during pregnancy and treatment cessation is recommended two years before pregnancy. We aimed to describe leflunomide use in women of childbearing age in Germany, the occurrence of pregnancies in women using leflunomide and malformations among children possibly exposed in utero. Using the GePaRD database (claims data, ∼20% of the German population), we determined annual age-standardized prevalences of leflunomide use between 2004 and 2019 among females aged 13-49 years. Further, we estimated the number of exposed pregnancies by assessing whether the exposure window assigned to the last dispensation before pregnancy (days covered by the dispensation plus two years) overlapped the onset of pregnancy or whether there was a dispensation in the first eight weeks of pregnancy. For exposed live births, a mother-baby linkage was performed and the presence of congenital malformation was assessed. The age-standardized prevalence of leflunomide use ranged between 0.34 and 0.46 per 1000 females during the study period. About one third of the users were ≤40 years. We identified 205 leflunomide-exposed pregnancies ending during the study period. 71% of these pregnancies ended in a live birth (26% preterm) and 10% in an induced abortion. In 86% of the live births (n=125) the mother-baby linkage was successful. Among these 125 children, 13 children (10%) had congenital malformations. In conclusion, we observed a considerable number of pregnancies in women using leflunomide in the two years before or during early pregnancy. This highlights the importance of monitoring the implementation of existing risk minimization measures for leflunomide in Germany.

Use of antimicrobials in pediatric wards of five Brazilian hospitals.

The use of antimicrobials (AMs) in pediatric infections is common practice and use may be inappropriate leading to antimicrobial resistance. Off-label AM use is also common in this group and can result in drug-related problems. There is lack of DUR data in Brazil and in Latin America, specially for AM pediatric use. The aim of this study was to describe the utilization of AMs in hospitalized children in five hospitals in Brazil. We conducted an observational study of the utilization of AMs in pediatric wards in hospitals in the states of Ceará (CE), Sergipe (SE), Rio de Janeiro (RJ), Rio Grande do Sul (RS) and the Federal District (DF). Data derived from patient medical records and prescriptions were collected over a six-month period in each hospital. The number of AMs used by each patient was recorded, and AM use was assessed using Days of therapy (DOT) and Length of therapy (LOT) per 1000 patient days according to different patient characteristics. Off-label (OL) use was described according to age. The study analyzed data from 1020 patients. The sex and age distributions were similar across the five hospitals. However, differences were found for comorbidities, history of ICU admission and length of hospital stay. The most common diseases were respiratory tract infections. There were wide variations in DOT/1000PD (278-517) and LOT/1000PD (265-390). AM utilization was highest in the hospital in SE. The consumption of second-generation penicillins and cephalosporins was high. The prevalence of OL use of AMs was higher for patients in the RJ hospital, in infants, in patients who underwent prolonged hospital stays, and in patients who used multiple AMs. The AM that showed the highest prevalence of OL use was azithromycin, in both oral and parenteral formulations. Overall AM use was high and showed differences in each setting, possibly influenced by local characteristics and by prescribing standards adopted by pediatricians.

Screening of dermatology drugs for aberrant use-patterns: An application of epidemiologic estimates and measures of inequality in drug use.

AIMS: Dermatology treatments require adherence for safe and effective use. Real-world healthcare databases can reveal drug utilization patterns and uncover inappropriate or unexpected use. This study aimed to analyse dermatology drug utilization patterns using epidemiological and inequality measures, leveraging Danish nationwide registries. It also assessed the feasibility of this method for detecting aberrant drug use. METHODS: We formed a 2019 cohort of all patients treated for skin conditions through Danish healthcare registries. We calculated prevalence, incidence rates and treatment duration for dermatological drugs. Inequality in drug utilization was assessed using Lorenz curves, Gini coefficients and other measures. RESULTS: The study encompassed 1 021 255 patients using 94 dermatology drugs. Most usage aligned with 'expected clinical use', but we detected inequality, with some drugs having high Gini coefficients and disproportionate consumption by the top percentile of users. Notable findings included potential inappropriate antibiotic use, excessive topical corticosteroid use and unexpected drug use duration. CONCLUSIONS: In Denmark, dermatology drugs are used primarily as anticipated, with minimal unexpected patterns. Specific follow-up is required to draw conclusions about inappropriate use. This approach demonstrates broad applicability for screening aberrant drug utilization.

Trends in Systemic Glucocorticoid Utilization in the United Kingdom from 1990 to 2019: A Population-Based, Serial Cross-Sectional Analysis.

Purpose: Associations between systemic glucocorticoid (SGC) exposure and risk for adverse outcomes have spurred a move toward steroid-sparing treatment strategies. Real-world changes in SGC exposure over time, after the introduction of steroid-sparing treatment strategies, reveal areas of successful risk mitigation as well as unmet needs. Patients and Methods: A population-based ecological study was performed from the Optimum Patient Care Research Database to describe SGC prescribing trends of steroid-sparing treatment strategies in primary care practices before and after licensure of biologics in the United Kingdom from 1990 to 2019. Each analysis year included patients aged ≥5 years who were registered for ≥1 year with a participating primary care practice. The primary analysis was SGC exposure, defined as total cumulative SGC dose per patient per year, for asthma, severe asthma, chronic obstructive pulmonary disease (COPD), nasal polyps, Crohn's disease, rheumatoid arthritis, ulcerative colitis, and systemic lupus erythematosus. Secondary outcomes were percentages of patients prescribed SGCs and number of SGC prescriptions per patient per year. Results: The number of patients who met study inclusion criteria ranged from 219,862 (1990) to 1,261,550 (2019). At the population level, patients with asthma or COPD accounted for 67.7% to 73.2% of patients per year with an SGC prescription. Over three decades, decreases in SGC total yearly dose ≥1000 mg have been achieved in multiple conditions. Patients with COPD prescribed SGCs increased from 5.8% (1990) to 34.8% (2017). SGC prescribing trends for severe asthma, Crohn's disease, and ulcerative colitis show decreased prescribing trends after the introduction of biologics. Conclusion: Decreases in total yearly SGC doses have been shown in multiple conditions; however, for conditions such as severe asthma and COPD, an unmet need remains for increased awareness of SGC burden and the adoption or development of SGC-sparing alternatives to reduce overuse.

Physician characteristics associated with antiviral prescriptions for older adults with COVID-19 in Japan: an observational study.

OBJECTIVES: Although guidelines recommend antiviral therapy for outpatients with COVID-19 who are at high risk of progressing to severe conditions, such as older adults, many patients do not receive appropriate treatment. Little is known, however, about the physician factors associated with the prescription of guideline-recommended antiviral therapy for patients with COVID-19. DESIGN: A cross-sectional study. SETTING: Data including outpatient visits in primary care clinics in Japan from April to August 2023. PARTICIPANTS: We analysed 30 953 outpatients aged ≥65 years treated with COVID-19 (mean (SD) age, 75.0 (7.6) years; 17 652 women (57.0%)) in 1394 primary care clinics. OUTCOME MEASURES: The primary outcome was the prescription of guideline-recommended antivirals (ie, nirmatrelvir-ritonavir or molnupiravir), adjusted for patient characteristics, months of visits and regions. RESULTS: Antiviral prescriptions were concentrated among a small proportion of physicians; for example, the top 10% of physicians that had the largest number of nirmatrelvir-ritonavir prescriptions accounted for 92.4% of all nirmatrelvir-ritonavir prescriptions. After adjusting for potential confounders, physicians with higher patient volumes were more likely to prescribe guideline-recommended antivirals to their patients (adjusted OR (aOR) for high vs low volume, 1.76; 95% CI 1.31 to 2.38; adjusted p<0.001). We found no evidence that the likelihood of guideline-recommended antiviral prescription differed based on physicians' gender (aOR for women vs men, 1.24; 95% CI 0.88 to 1.74; adjusted p=0.48) or age (aOR for 45-59 vs <45 years, 1.16; 95% CI 0.87 to 1.54; adjusted p=0.48; aOR for ≥60 vs <45 years, 0.88; 95% CI 0.66 to 1.16; adjusted p=0.48). These patterns were similar when examining nirmatrelvir-ritonavir and molnupiravir separately. CONCLUSIONS: Our findings suggest that provider-level factors, such as the clinical experience of treating the patients with COVID-19, play an important role in the appropriate prescription of antiviral medications for COVID-19 in the primary care setting.

National Trends in Antidepressant Use in Australian Residential Aged Care Facilities (2006-2019).

OBJECTIVES: Antipsychotics have been the focus of reforms for improving the appropriateness of psychotropic medicine use in residential aged care facilities (RACFs). Comprehensive evaluation of antidepressant use in RACFs is required to inform policy and practice initiatives targeting psychotropic medicines. This study examined national trends in antidepressant use among older people living in RACFs from 2006 to 2019. DESIGN: National repeated cross-sectional study. SETTING AND PARTICIPANTS: Individuals aged 65 to 105 years who were permanent, long-term (≥100 days) residents of Australian RACFs between January 2006 and December 2019 were included. METHODS: Annual age- and sex-adjusted antidepressant prevalence rates and defined daily doses (DDDs) supplied per 1000 resident-days from 2006 to 2019 were determined. Age- and sex-adjusted prevalence rate ratios (aRRs) and 95% confidence intervals (CIs) were estimated using Poisson and negative binomial regression models. RESULTS: A total of 779,659 residents of 3371 RACFs were included (786,227,380 resident-days). Overall, antidepressant use increased from 46.1% (95% CI, 45.9-46.4) in 2006 to 58.5% (95% CI, 58.3-58.8) of residents in 2019 (aRR, 1.02; 95% CI, 1.02-1.02). Mirtazapine use increased from 8.4% (95% CI, 8.2-8.5) to 20.9% (95% CI, 20.7-21.1) from 2006 to 2019 (aRR, 1.07; 95% CI, 1.07-1.07). Antidepressant use increased from 350.3 (95% CI, 347.6-353.1) to 506.0 (95% CI, 502.8-509.3) DDDs/1000 resident-days (aRR, 1.03; 95% CI, 1.03-1.03), with mirtazapine utilization increasing by 6% annually (aRR, 1.06; 95% CI, 1.06-1.06). CONCLUSIONS AND IMPLICATIONS: This nationwide study identified a substantial increase in antidepressant use among residents of Australian RACFs, largely driven by mirtazapine. With nearly 3 in every 5 residents treated with an antidepressant in 2019, findings highlight potential off-label use and suggest that interventions to optimize care are urgently needed.

Factors Related to the Evaluation of Essential Medicines Use in Health Facilities in Indonesia

Background: Indonesia has recently implemented a national policy to ensure equitable access to medicines, promote their rational use, and maintain a reliable and quality supply, specifically for essential medicines. Several organizations have conducted evaluations on essential medicines use but have yielded varying results and cannot reflect the actual situation. Objectives: This study aims to discover the current situation regarding essential medicines and identify the most important factors to be considered during future indicator-based evaluations in health facilities in Indonesia. Methods: This qualitative study was carried out using FGDs and interview from January to February 2022. The sample population consisted of ten experts selected based on predetermined criteria. The discussions were recorded and transcribed verbatim in the original language, thematically coded with Nvivo, and analyzed for common themes. Results: This study found 32 factors related to the use of essential medicines in Indonesia, divided into three categories of components, namely access, medicine handling quality, and rational use. Furthermore, a total of 10, 8, and 14 main factors were related to access, handling quality, and rational use, respectively. The discussion provided various perspectives on measuring drug use, specifically essential medicines. Based on expert opinions, evaluating the utilization of essential medicines by relying on existing guidelines was insufficient due to superficiality and irrelevance within the Indonesian health system. Conclusion: Based on the results, one of the crucial factors to consider during evaluation was the accessibility of medicines, which encompassed their availability in health facilities and affordability to patients... (AU)

Pharmacological treatments and medication-related problems in nursing homes in Catalonia: a multidisciplinary approach.

Background: Aging correlates with increased frailty, multi-morbidity, and chronic diseases. Furthermore, treating the aged often entails polypharmacy to achieve optimal disease management, augmenting medication-related problems (MRPs). Few guidelines and tools address the problem of polypharmacy and MRPs, mainly within the institutionalized elderly population. Routine pharmacological review is needed among institutionalized patients. This pharmacological review may improve with a multidisciplinary approach of a collaboration of multiple health professionals. This study aimed to describe institutionalized patients, systematically review their medication plans, and then give recommendations and identify MRPs. Methods: A cross-sectional study was performed using data obtained from patients living in five nursing homes in the northern area of Barcelona, Spain. The inclusion criteria comprised institutionalized patients with public health coverage provided by the Health Department of Catalonia. A detailed description of the clinical characteristics, chronic diseases, pharmacological treatments, recommendations, incomplete data, and MRPs, such as potential drug-drug interactions, therapeutic duplications, contraindications, and drugs deemed inappropriate or of doubtful efficacy, was made. The clinical pharmacologist was the medical doctor specialist who acted as the coordinator of the multidisciplinary team and actively reviewed all the prescribed medications to make recommendations and detect MRPs. Results: A total of 483 patients were included. Patients had a mean age of 86.3 (SD 8.8) years, and 72.0% were female individuals. All patients had at least three health-related problems, with a mean of 17.4 (SD 5.6). All patients, except one, had a minimum of one prescription, with a mean of 8.22 drugs prescribed (SD 3.5) per patient. Recommendations were made for 82.4% of the patients. Of these recommendations, verification of adequate use was made for 69.3% and withdrawal of a drug for 49.5%. Conclusion: This study demonstrates a high prevalence of health-related problems and several prescribed drugs in nursing homes in Catalonia. Many recommendations were made, confirming the increased proportion of polypharmacy, MRPs, and the need for standardized interventions. A multidisciplinary team approach, including general practitioners, geriatric assessments, a clinical pharmacist, and a clinical pharmacologist, should address this problem.

Real-world differences in dosing and clinical utilization of OnabotulinumtoxinA and AbobotulinumtoxinA in the treatment of upper limb spasticity.

According to prescribing information, potency units are not interchangeable between botulinum toxin A products. This exploratory study compared real-world dosing and utilization of onabotulinumtoxinA and abobotulinumtoxinA in adults with upper limb spasticity. In this retrospective study, 101 clinicians provided chart data via online surveys for 215 US post-stroke patients treated for upper limb spasticity with ≥3 onabotulinumtoxinA or abobotulinumtoxinA doses (phase 1: 9/18/2020-12/10/2020; phase 2: 9/30/2021-12/7/2021). Most participating clinicians were physicians (70.3%) specializing in neurology (71.3%) or physiatry (20.8%). In the onabotulinumtoxinA (n = 107) and abobotulinumtoxinA (n = 108) groups, ∼75% of patients had moderate-to-severe spasticity. A range of onabotulinumtoxinA:abobotulinumtoxinA dose ratios (1:2.2 [95% CI: 1.8, 2.6] to 1:4.1 [95% CI: 3.0, 6.0]) was observed across muscles. For the most recent dose, mean number of muscles injected was greater for onabotulinumtoxinA (4.3) versus abobotulinumtoxinA (3.1; P = 0.0003). For onabotulinumtoxinA versus abobotulinumtoxinA, the proportion of injections was 81.3% versus 63.9% (P = 0.0067) in forearm muscles and 23.4% versus 3.7% (P = 0.0001) in hand muscles. Mean injection intervals were similar (onabotulinumtoxinA: 102.0 days; abobotulinumtoxinA: 99.1 days). Differences in real-world dosing and utilization of onabotulinumtoxinA and abobotulinumtoxinA for upper limb spasticity were observed. There was no standard dose-conversion ratio, consistent with each product's prescribing information.

Design and statistical analysis reporting among interrupted time series studies in drug utilization research: a cross-sectional survey.

INTRODUCTION: Interrupted time series (ITS) design is a commonly used method for evaluating large-scale interventions in clinical practice or public health. However, improperly using this method can lead to biased results. OBJECTIVE: To investigate design and statistical analysis characteristics of drug utilization studies using ITS design, and give recommendations for improvements. METHODS: A literature search was conducted based on PubMed from January 2021 to December 2021. We included original articles that used ITS design to investigate drug utilization without restriction on study population or outcome types. A structured, pilot-tested questionnaire was developed to extract information regarding study characteristics and details about design and statistical analysis. RESULTS: We included 153 eligible studies. Among those, 28.1% (43/153) clearly explained the rationale for using the ITS design and 13.7% (21/153) clarified the rationale of using the specified ITS model structure. One hundred and forty-nine studies used aggregated data to do ITS analysis, and 20.8% (31/149) clarified the rationale for the number of time points. The consideration of autocorrelation, non-stationary and seasonality was often lacking among those studies, and only 14 studies mentioned all of three methodological issues. Missing data was mentioned in 31 studies. Only 39.22% (60/153) reported the regression models, while 15 studies gave the incorrect interpretation of level change due to time parameterization. Time-varying participant characteristics were considered in 24 studies. In 97 studies containing hierarchical data, 23 studies clarified the heterogeneity among clusters and used statistical methods to address this issue. CONCLUSION: The quality of design and statistical analyses in ITS studies for drug utilization remains unsatisfactory. Three emerging methodological issues warranted particular attention, including incorrect interpretation of level change due to time parameterization, time-varying participant characteristics and hierarchical data analysis. We offered specific recommendations about the design, analysis and reporting of the ITS study.

COVID-19 and pregnancy: A European study on pre- and post-infection medication use.

PURPOSE: The COVID-19 pandemic has impacted medication needs and prescribing practices, including those affecting pregnant women. Our goal was to investigate patterns of medication use among pregnant women with COVID-19, focusing on variations by trimester of infection and location. METHODS: We conducted an observational study using six electronic healthcare databases from six European regions (Aragon/Spain; France; Norway; Tuscany, Italy; Valencia/Spain; and Wales/UK). The prevalence of primary care prescribing or dispensing was compared in the 30-day periods before and after a positive COVID-19 test or diagnosis. RESULTS: The study included 294,126 pregnant women, of whom 8943 (3.0%) tested positive for, or were diagnosed with, COVID-19 during their pregnancy. A significantly higher use of antithrombotic medications was observed particularly after COVID-19 infection in the second and third trimesters. The highest increase was observed in the Valencia region where use of antithrombotic medications in the third trimester increased from 3.8% before COVID-19 to 61.9% after the infection. Increases in other countries were lower; for example, in Norway, the prevalence of antithrombotic medication use changed from around 1-2% before to around 6% after COVID-19 in the third trimester. Smaller and less consistent increases were observed in the use of other drug classes, such as antimicrobials and systemic corticosteroids. CONCLUSION: Our findings highlight the substantial impact of COVID-19 on primary care medication use among pregnant women, with a marked increase in the use of antithrombotic medications post-COVID-19. These results underscore the need for further research to understand the broader implications of these patterns on maternal and neonatal/fetal health outcomes.

Drug Utilization Evaluation Study of Ciprofloxacin Use and Adverse Events Occurrence: Role of Community Pharmacists.

Background: Antimicrobial resistance is a global health crisis threatening optimal management of infectious diseases. Ciprofloxacin is a widely used fluoroquinolone in various disease conditions. Resistance against ciprofloxacin is increasing, leading to nonoptimal management of patients. Thus, the aim of this study was to assess ciprofloxacin use in the community setting in terms of appropriate prescribing, dosing, frequency, and duration of use. Methods: A cross-sectional, retrospective study was conducted by community pharmacists in 5 community pharmacies in Egypt from September 2021 to February 2022. Patients prescribed oral ciprofloxacin during the period of the study were included. Data on demographics, indications for ciprofloxacin, dosing regimen, adverse events, and drug interactions were collected. Results: A total of 151 patients' record indicated for ciprofloxacin were included in the study, of whom 44.4% were men and 55.6% were women who were neither pregnant nor lactating. Based on international guidelines, 96.69% ciprofloxacin prescriptions were appropriate; 96.03% contained correct ciprofloxacin dosing whereas 3.97% were overdose. A total of 90. 73% had correct frequency of administration and 96.03% records had correct durations. Only 1.99% of patients were ≤18 years of age, which is an absolute contraindication. Interacting drugs with ciprofloxacin were 28.5% with acetaminophen, 31.1% with ibuprofen, 16.6% with antacids, 21.2% with chlorpheniramine, and 7.9% with prednisolone. Adverse events included 1.32% hypoglycemia, 0.66% hyperglycemia, 3.97% tendinitis, and 2.65% QTc (heart rate-corrected QT interval) prolongation. Conclusion and relevance: Ciprofloxacin use in community pharmacies is appropriate according to international guidelines. Ongoing drug utilization evaluation is necessary to ensure rational drug use, which in turn can decrease resistance rates.

Assessing medication use patterns by clinical outcomes severity among inpatients with COVID-19: A retrospective drug utilization study.

PURPOSE: This study assessed medication patterns for inpatients at a central hospital in Portugal and explored their relationships with clinical outcomes in COVID-19 cases. METHODS: A retrospective study analyzed inpatient medication data, coded using the Anatomical Therapeutic Chemical classification system, from electronic patient records. It investigated the association between medications and clinical severity outcomes such as ICU admissions, respiratory/circulatory support needs, and hospital discharge status, including mortality (identified by ICD-10-CM/PCS codes). Multivariate analyses incorporating demographic data and comorbidities were used to adjust for potential confounders and understand the impact of medication patterns on disease progression and outcomes. RESULTS: The analysis of 2688 hospitalized COVID-19 patients (55.3% male, average age 62.8 years) revealed a significant correlation between medication types and intensity and disease severity. Cases requiring ICU admission or ECMO support often involved blood and blood-forming organ drugs. Increased use of nervous system and genitourinary hormones was observed in nonsurvivors. Corticosteroids, like dexamethasone, were common in critically ill patients, while tocilizumab was used in ECMO cases. Medications for the alimentary tract, metabolism, and cardiovascular system, although widely prescribed, were linked to more severe cases. Invasive mechanical ventilation correlated with higher usage of systemic anti-infectives and musculoskeletal medications. Trends in co-prescribing blood-forming drugs with those for acid-related disorders, analgesics, and antibacterials were associated with intensive interventions and worse outcomes. CONCLUSIONS: The study highlights complex medication regimens in managing severe COVID-19, underscoring specific drug patterns associated with critical health outcomes. Further research is needed to explore these patterns.