Mandatory nonmedical switching from originator to biosimilar infliximab in patients with inflammatory arthritis and psoriasis in British Columbia: a cohort study.

BACKGROUND: In 2019, British Columbia's public drug plan, PharmaCare, was the first in Canada to implement a nonmedical switching policy from originator infliximab to its biosimilar, for patients with inflammatory arthritis or psoriasis. We aimed to detect signals of impact on health services utilization during the first year of policy implementation and to provide early data to policy-makers. METHODS: We constructed cohorts of users of originator infliximab: 3 historical cohorts (2016-2018) and 1 policy cohort (2019). We extracted data from BC Ministry of Health databases from 2015 to 2020, as we followed each cohort for 365 days from May 27 of each cohort's respective year. We excluded patients with gastrointestinal conditions and those not covered by PharmaCare. We examined the cumulative incidence of infliximab prescription refills, switching to other biologic drugs and use of additional health services. A log-likelihood ratio of 1.96 compared with the null hypothesis was used as the threshold for differences between the policy cohort and the historical cohorts. RESULTS: The study included a total of 572 unique patients: 520 in the 2016 historical cohort, 461 in the 2017 historical cohort, 423 in the 2018 historical cohort and 377 in the policy cohort (with some patients included in multiple cohorts; 335 [58.6%] were included in all 4 cohorts). During months 8 and 9 of follow-up, a transient signal was observed in infliximab refills (7.2% decrease in refilling infliximab for the fourth time for the policy cohort, log-likelihood ratio > 1.96). An anticipated increase in visits to specialists was observed from month 4 forward (15.0%, log-likelihood ratio > 1.96). No signal was observed for increased use of other health services (log-likelihood ratio < 1.96). INTERPRETATION: Early monitoring did not detect signals of negative impacts on health services use during the first year of the policy. Detailed, longer-term cohort studies and hypothesis-testing methods could provide additional assurance about the safety of the policy.

Change in Antimicrobial Use During COVID-19 Pandemic in South Carolina Hospitals: A Multicenter Observational Cohort Study.

OBJECTIVES: This retrospective cohort study examined the impact of the pandemic on antimicrobial use (AU) in South Carolina hospitals. METHODS: Antimicrobial use in days of therapy (DOT) per 1000 days-present was evaluated in 17 hospitals in South Carolina. Matched-pairs mean difference was used to compare AU during the pandemic (March-June 2020) with that during the same months in 2019 in hospitals that did and did not admit patients with COVID-19. RESULTS: There was a 6.6% increase in overall AU in the seven hospitals that admitted patients with COVID-19 (from 530.9 to 565.8; mean difference (MD) 34.9 DOT/1000 days-present; 95% CI 4.3, 65.6; P = 0.03). There was no significant change in overall AU in the remaining 10 hospitals that did not admit patients with COVID-19 (MD 6.0 DOT/1000 days-present; 95% CI -55.5, 67.6; P = 0.83). Most of the increase in AU in the seven hospitals that admitted patients with COVID-19 was observed in broad-spectrum antimicrobial agents. A 16.4% increase was observed in agents predominantly used for hospital-onset infections (from 122.3 to 142.5; MD 20.1 DOT/1000 days-present; 95% CI 11.1, 29.1; P = 0.002). There was also a 9.9% increase in the use of anti-methicillin-resistant Staphylococcus aureus (MRSA) agents (from 66.7 to 73.3; MD 6.6 DOT/1000 days-present; 95% CI 2.3, 10.8; P = 0.01). CONCLUSION: The COVID-19 pandemic appears to drive overall and broad-spectrum antimicrobial use in South Carolina hospitals admitting patients with COVID-19. Additional antimicrobial stewardship resources are needed to curtail excessive antimicrobial use in hospitals to prevent subsequent increases in antimicrobial resistance and Clostridioides difficile infection rates, given the continuing nature of the pandemic.

[Drug use during the covid-19 pandemic in Italy.] / L'uso dei farmaci durante la pandemia di covid-19 in Italia.

The Italian Medicines Agency has started, since the first months of 2020, a monitoring of drug use during the covid-19 pandemic. This made it possible to identify specific trends in hospital and local purchases, such as the extensive use of off-label drugs with little evidence of efficacy during the first weeks of the epidemic, and to progressively assess the degree of implementation of regulatory and ministerial recommendations.Fin dalle prime fasi dell'emergenza covid-19 è emersa per l'Agenzia Italiana del Farmaco (AIFA) la necessità di monitorare in modo specifico l'uso dei farmaci utilizzati nel corso dell'epidemia. È infatti fondamentale, in un contesto caratterizzato da grande incertezza e da continui aggiornamenti delle linee guida, disporre di informazioni utili a una corretta lettura e interpretazione dei dati. È stato quindi realizzato un primo rapporto dell'Osservatorio Nazionale sull'Impiego dei Medicinali (OsMed) sull'uso dei farmaci utilizzati, a livello ospedaliero e territoriale, nella fase iniziale dell'epidemia1. Questo metteva a confronto i consumi relativi al periodo compreso tra marzo a maggio del 2020 con quelli del trimestre immediatamente precedente, da dicembre 2019 a febbraio 2020. In seguito, il 4 marzo 2021, è stato pubblicato un aggiornamento dei dati in riferimento alle fasi successive dell'epidemia2. Il monitoraggio ha preso in considerazione diverse categorie di farmaci, andando a valutare le oscillazioni negli acquisti in riferimento al progressivo aggiornamento degli indirizzi regolatori. I volumi osservati per ciascun farmaco sono stati standardizzati per 10.000 abitanti/die, andando a valutare le differenze pre- e post-covid-19 in termini di differenza assoluta, differenza percentuale e di p-value (p).

Gaps in Evidence-Based Therapy Use in Insured Patients in the United States With Type 2 Diabetes Mellitus and Atherosclerotic Cardiovascular Disease.

Background Evidence-based therapies are generally underused for cardiovascular risk reduction; however, less is known about contemporary patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease. Methods and Results Pharmacy and medical claims data from within Anthem were queried for patients with established atherosclerotic cardiovascular disease and type 2 diabetes mellitus. Using an index date of April 18, 2018, we evaluated the proportion of patients with a prescription claim for any of the 3 evidence-based therapies on, or covering, the index date ±30 days: high-intensity statin, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, and sodium glucose cotransporter-2 inhibitor or glucagon-like peptide-1 receptor agonist. The potential benefit of achieving 100% adoption of all 3 evidence-based therapies was simulated using pooled treatment estimates from clinical trials. Of the 155 958 patients in the sample, 24.7% were using a high-intensity statin, 53.1% were using an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, and 9.9% were using either an sodium glucose cotransporter-2 inhibitor or glucagon-like peptide-1 receptor agonists. Overall, only 2.7% of the population were covered by prescriptions for all 3 evidence-based therapies, and 37.4% were on none of them. Over a 12-month period, 70.6% of patients saw a cardiologist, while only 18% saw an endocrinologist. Increasing the use of evidence-based therapies to 100% over 3 years of treatment could be expected to reduce 4546 major atherosclerotic cardiovascular events (myocardial infarction, stroke, or cardiovascular death) in eligible but untreated patients. Conclusions Alarming gaps exist in the contemporary use of evidence-based therapies in this large population of insured patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease. These data provide a call to action for patients, providers, industry, regulators, professional societies, and payers to close these gaps in care.

A real-world data approach to determine the optimal dosing strategy for pembrolizumab.

INTRODUCTION: Cancer drug therapy costs continue to rise and threaten the sustainability of Canada's public healthcare system. Previous studies have calculated potential savings utilizing different dosing regimens of cancer treatments. Our objectives were to determine the financial impact of drug wastage and to explore cost-effective dosing regimens for pembrolizumab. METHODS: This was a retrospective study reviewing data for non-small cell lung cancer and melanoma patients at all six BC Cancer Regional Centres during fiscal years 2017 and 2018. Pembrolizumab waste amounts recorded in pharmacy wastage logs were totalled. Estimates of the number of vials used were compared between vial sharing and non-vial sharing practices to determine the cost differences. Costs for dosing regimens used during fiscal years 2017 and 2018 were compared to 2 mg/kg weight-based dosing (to a maximum of 200 mg), 2 mg/kg dosing rounding down within 5% and 10%, and flat dosing of 200 mg. RESULTS: There were a total of 202 non-small cell lung cancer and 182 melanoma patients with 2948 doses dispensed. Documented wastage was valued at $1,829,047.44 (8.65%) and across all six centres, vial sharing could reduce costs by $3,207,600.00 using the 100 mg vials. Compared to fiscal years 2017 and 2018, 2 mg/kg dosing (to a maximum of 200 mg) was the most cost-effective, decreasing costs by $222,719.20; flat dosing of 200 mg was the most expensive, increasing costs by $6,625,260.40. CONCLUSIONS: Having smaller vial sizes, practicing vial sharing, and using weight-based dosing all improve cost savings. Further investigations on the allocation of resources to optimize drug use and minimize wastage are needed.

Antibiotic Use Among Residents Receiving Skilled Nursing Care in 29 U.S. Nursing Homes.

BACKGROUND: Data describing antibiotic use in U.S. nursing homes remain limited. We report antibiotic use among skilled nursing facility residents from 29 U.S. nursing homes and assessed correlations between antibiotics prescribed to residents in skilled care and nursing home characteristics. DESIGN: Retrospective cohort study. SETTING: Twenty-nine U.S. nursing homes in the same healthcare corporation. PARTICIPANTS: Residents receiving skilled care in 2016. MEASUREMENTS: We used pharmacy invoice and nursing home census data to calculate the days of antibiotic therapy per 1,000 days of skilled care (1,000 DOSC), the rate of antibiotic starts per 1,000 DOSC, the length of antibiotic therapy, and the average antibiotic spectrum index. We also assessed correlations between antibiotic use and nursing home characteristics. RESULTS: Antibiotics accounted for an average of 9.6% (±0.6%) of systemic medications prescribed among residents receiving skilled care. On average, 26.8% (±2.9%) of antibiotics were intravenous. Fluoroquinolones were prescribed at the highest rates (19% across all facilities), followed by beta-lactam/beta-lactamase inhibitors (11%), first- and second-generation cephalosporins, sulfonamides, and oral tetracyclines (each at 9%). Both the proportion of residents using enrolled in Medicare and number of unique prescribers responsible for systemic prescriptions positively correlated with the rate of antibiotic starts. CONCLUSIONS: Our study demonstrates that pharmacy invoices represent a useful and preexisting source of data for assessing antibiotic prescriptions among individuals receiving skilled nursing care. The correlation between the number of unique prescribers and antibiotic starts suggests that prescribers are central to efforts to improve antibiotic use in nursing homes.

High hepatitis C treatment uptake among people with recent drug dependence in New South Wales, Australia.

BACKGROUND & AIMS: High HCV treatment uptake among people at most risk of transmission is essential to achieve elimination. We aimed to characterise subpopulations of people with HCV based on drug dependence, to estimate direct-acting antiviral (DAA) uptake in an unrestricted treatment era, and to evaluate factors associated with treatment uptake among people with recent drug dependence. METHODS: HCV notifications in New South Wales, Australia (1995-2017) were linked to opioid agonist therapy (OAT), hospitalisations, incarcerations, HIV notifications, deaths, and prescription databases. Drug dependence was defined as hospitalisation due to injectable drugs or receipt of OAT, with indicators in 2016-2018 considered recent. Records were weighted to account for spontaneous clearance. Logistic regression was used to analyse factors associated with treatment uptake among those with recent drug dependence. RESULTS: 57,467 people were estimated to have chronic HCV throughout the DAA era. Treatment uptake was highest among those with recent (47%), compared to those with distant (38%), and no (33%) drug dependence. Among those with recent drug dependence, treatment was more likely among those with HIV (adjusted odds ratio [aOR] 1.71; 95% CI 1.24-2.36), recent incarceration (aOR 1.10; 95% CI 1.01-1.19), and history of alcohol use disorder (aOR 1.22; 95% CI 1.13-1.31). Treatment was less likely among women (aOR 0.78; 95% CI 0.72-0.84), patients of Indigenous ethnicity (aOR 0.75; 95% CI 0.69-0.81), foreign-born individuals (aOR 0.86; 95% CI 0.78-0.96), those with outer-metropolitan notifications (aOR 0.90; 95% CI 0.82-0.98), HBV coinfection (aOR 0.69; 95% CI 0.59-0.80), and >1 recent hospitalisation (aOR: 0.91; 95% CI 0.84-0.98). CONCLUSIONS: These data provide evidence of high DAA uptake among people with recent drug dependence, including those who are incarcerated. Enhancing this encouraging initial uptake among high-risk populations will be essential to achieve HCV elimination. LAY SUMMARY: To facilitate HCV elimination, those at highest risk of infection and transmission are a treatment priority. This study shows the successes of Australia's universal provision of DAA therapy in reducing the barriers to treatment which have historically persisted among people who inject drugs. Despite higher DAA therapy uptake among those with recent drug dependence, gaps remain. Strategies which aim to reduce marginalisation and increase treatment uptake to ensure equitable HCV elimination must be advanced.

Sex Differences in Antipsychotic and Benzodiazepine Prescribing Patterns: A Cohort Study of Newly Admitted Nursing Home Residents with Dementia in Ontario, Canada.

BACKGROUND: In nursing homes, residents with dementia frequently receive potentially inappropriate medications that are associated with an increased risk of adverse events. Despite known sex differences in clinical presentation and sociodemographic characteristics among persons with dementia, few studies have examined sex differences in patterns and predictors of potentially inappropriate medication use. OBJECTIVES: The objectives of this study were to examine sex differences in the patterns of antipsychotic and benzodiazepine use in the 180 days following admission to a nursing home, estimate clinical and sociodemographic predictors of antipsychotic and benzodiazepine use in male and female residents, and explore the effects of modification by sex on the predictors of using these drug therapies. METHODS: We conducted a retrospective cohort study of 35,169 adults aged 66 years and older with dementia who were newly admitted to nursing homes in Ontario, Canada between 2011 and 2014. Health administrative databases were linked to detailed clinical assessment data collected using the Resident Assessment Instrument (RAI-MDS 2.0). Cox proportional hazards models were adjusted for clinical and sociodemographic covariates to estimate the rate of antipsychotic and benzodiazepine initiation and discontinuation in the 180 days following nursing home admission in the total sample and stratified by sex. Sex-covariate interaction terms were used to assess whether sex modified the association between covariates and the rate of drug therapy initiation or discontinuation following nursing home entry. RESULTS: Across 638 nursing homes, our analytical sample included 22,847 females and 12,322 males. At admission, male residents were more likely to be prevalent antipsychotic users than female residents (33.8% vs 28.3%; p < 0.001), and female residents were more likely to be prevalent benzodiazepine users than male residents (17.2% vs 15.3%, p < 0.001). In adjusted models, female residents were less likely to initiate an antipsychotic after admission (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.73-0.86); however, no sex difference was observed in the rate of benzodiazepine initiation (HR 1.04, 95% CI 0.96-1.12). Female residents were less likely than males to discontinue antipsychotics (HR 0.89, 95% CI 0.81-0.98) and benzodiazepines (HR 0.82, 95% CI 0.75-0.89). Sex modified the association between some covariates and the rate of changes in drug use (e.g., widowed males exhibited an increased rate of antipsychotic discontinuation (p-interaction = 0.03) compared with married males), but these associations were not statistically significant among females. Sex did not modify the effect of frailty on the rates of initiation and discontinuation. CONCLUSIONS: Males and females with dementia differed in their exposure to antipsychotics and benzodiazepines at nursing home admission and their patterns of use following admission. A greater understanding of factors driving sex differences in potentially inappropriate medication use may help tailor interventions to reduce exposure in this vulnerable population.

Survey on clinical use and non-use of recombinant human erythropoietin in European neonatal units.

Objectives Recombinant human erythropoietin (rhEPO) has been shown to effectively and safely prevent the anemia of prematurity and to reduce the transfusion need in very low birth weight (VLBW) infants and has been licensed for this indication in Europe in 1997. The objective of the study was to obtain information on the use or non-use of rhEPO in neonatal units in Germany and other European countries. Methods Anonymized 14-questions web-based questionnaire. Results Seventy-nine questionnaires from Germany and 63 questionnaires from other 15 European countries were completed. Of the responders, 39% indicated to use rhEPO routinely or occasionally in VLBW infants, whereas 61% responded to never use rhEPO in this population. The major reasons given for non-use were lack of recommendation in national guidelines (69%) and/or doubt about efficacy of rhEPO to reduce transfusion need (53%). Twenty-seven percent of the responders indicated to use rhEPO for neonates with birth weights above 1,500 g. Neuroprotection in VLBW infants (26%) and hypoxic ischemic encephalopathy in term neonates (27%) were given as indications for off label use of rhEPO. Conclusions This survey indicates that rhEPO is used for the anemia of prematurity as licensed in less than half of neonatal units in Germany and other European countries. On the other hand it seems to be used off label in neonates for neuroprotection in a considerable number of units although there is no final evidence on its neuroprotective effects.

The outcome of domiciliary medication reviews and their impact: a systematic review.

OBJECTIVES: Medication reviews in the domiciliary setting are becoming more prevalent internationally. Understanding the benefits of these reviews is essential to ensuring quality healthcare services. To date there has not been a systematic evaluation of the outcomes of these services and their impact on patients. A systematic review of the literature was undertaken with a view to understanding the impact of medication reviews in this setting. Controlled and uncontrolled studies were included. Outcomes were categorised according to the ECHO model. A narrative synthesis was developed. KEY FINDINGS: Nineteen out of 31 papers included demonstrated an improvement in outcome. Clinical outcomes were the most commonly measured and humanistic outcomes the least commonly measured. Domiciliary medication reviews (DMRs) services are presented as providing benefit. However, it is difficult to quantify the impact of services from the published outcomes. SUMMARY: Future work should focus on demonstrating the meaningful changes to patients that DMRs have enabled.

Web search popularity, publicity, and utilization of direct oral anticoagulants in the United States, 2008-2018: A STROBE-compliant study.

We aimed to study the changing popularity of oral anticoagulants and the potential association between media coverage and real-world utilization practice, using time series analysis.In this STROBE-compliant study, we used Google Trends data to study public interest for direct oral anticoagulants (DOACs) (dabigatran, rivaroxaban, apixaban, and edoxaban) and warfarin in the United States (10-year coverage, beginning July 1st, 2008 ending June 30th, 2018). We validated our findings on a sample of 50 consecutive datasets (accumulated between July 6th, 2018 and October 19th, 2018), using the same search criteria. We used the LexisNexis Academic database to quantify monthly media coverage for DOACs and explored its association with interest by the public, using the cross-correlation coefficient function. Finally, we studied the association between public interest and real-world utilization data, including published US-wide data on ambulatory anticoagulation visits.The approval of dabigatran in 2010 marked an increasing public interest for DOACs. Dabigatran exhibited a steep rise early after Food and Drug Administration approval that peaks in 2011, to be surpassed sequentially by rivaroxaban (2012) and apixaban (2014). Apixaban has outperformed its competitors in popularity since mid-2017, and, by the end of the observation period, was close to warfarin that is on first place. Media coverage was low before approval of the first oral DOAC (dabigatran), increased thereafter (median 13 news articles per month vs 64, P < .001), with peaks on the approval dates (81 vs 48, P = .003). Media coverage had a weak immediate impact on DOACs public interest and public interest patterns preceded changes in ambulatory anticoagulation visits by up to 5 months.For a long-run observation period, a single Google Trends search will suffice to produce robust estimations of the relative popularity between treatment options, such as oral anticoagulants. Media coverage has limited immediate impact and relative public interest is a potential lead indicator of changes in actual utilization.

Pain during medical abortion in early pregnancy in teenage and adult women.

INTRODUCTION: Women experience pain during medical abortion, yet optimal pain management remains unclear. We studied the pain experience and need of analgesics during early medical abortion (≤63 days of gestation) among teenage and adult women. We also assessed predictive factors of severe pain. MATERIAL AND METHODS: We recruited 140 primigravid women: 60 teenagers and 80 adult women aged between 25 and 35 years old. The group of teenagers included 19 women under the age of 18 years old (minors). The abortion was performed with mifepristone (200 mg) followed by vaginal misoprostol (800 µg), mainly self-administered at home for adults. Minors were hospitalized during misoprostol administration. Pain medication consisted of ibuprofen 600 mg and paracetamol 1000 mg, first doses taken simultaneously with misoprostol and repeated, if needed, up to three times daily. Additional opiates (mainly tramadol or oxycodone) were administered at hospital if needed. Pain was measured using the visual analogue scale (VAS, 0-100 mm). RESULTS: The maximal pain VAS (median, interquartile range) was 75 (54-91). Of all the women, 57.7% experienced severe pain (VAS ≥70) during abortion care and 93.5% of women needed additional analgesics in addition to prophylactic pain medication. Teenagers needed additional analgesics more often than adults (5 [3-8] vs 3 [2-6] times, P = .021); 38.0% of all teenagers (64.7% of the minors) received additional opiates compared with 7.9% in adult women. Severe pain (VAS ≥70) was associated with history of dysmenorrhea (adjusted odds ratio [OR] 2.60 [95% confidence interval [CI] 1.21-5.59, P = .014]), anxiety at baseline (2.64 [1.03-6.77], P = .044) and emesis during abortion (5.24 [2.38-11.57], P < .001). Hospital administration of misoprostol did not lower the risk for severe pain experience (OR 0.84 [95% CI 0.34-2.05], P = .694). Satisfaction with care was high in study population (median VAS 91 [interquartile range 79-97]) and was not associated with the use of narcotic analgesic or place of misoprostol administration. CONCLUSIONS: Pain intensity was high both in teenage and adult women undergoing medical abortion, yet satisfaction on care was high. More effective analgesics than ibuprofen and paracetamol should be offered to all women undergoing early medical abortion, especially to those with history of dysmenorrhea. Also, routine use of antiemetics might be advisable.

Prescribing practices using WHO prescribing indicators and factors associated with antibiotic prescribing in six community pharmacies in Asmara, Eritrea: a cross-sectional study.

Background: Antibiotics require more prudent prescribing, dispensing and administration than other medicines because these medicines are at a greater risk of antimicrobial resistance (AMR). Studying the current medicine use practices and factors affecting the prescribing of an antibiotic would help decision makers to draft policies that would enable a more rational use of medicines. Methods: A prospective, descriptive, and cross-sectional study was conducted to assess the current prescribing practices including antibiotics use in six community pharmacies in Asmara. A total of 600 encounters were reviewed using the WHO core prescribing indicators between May 5 and May 12, 2019 using stratified random sampling technique. Descriptive statistics and logistic regression were employed using IBM SPSS® (version 22). Results: The average number of medicines per prescription was 1.76 and 83.14% of the medicines were prescribed using generic names while 98.39% of the medicines were from the National Essential Medicines List (NEML). The percentage of prescriptions containing antibiotics was 53%. The number of encounters containing injections was 7.8%. Patient age, gender and number of medicines prescribed were significantly associated with antibiotic prescribing at bivariate and multivariable models. Subjects under the age of 15 were approximately three times more likely to be prescribed antibiotic compared to subjects whose age is 65 and above (Adjusted Odds Ratio (AOR): 2.93, 95%CI: 1.71-5). Similarly, males were more likely to be prescribed antibiotic than females (AOR: 1.57, 95%CI: 1.10-2.24). Subjects to whom three to four medicines prescribed were two times more likely to be prescribed an antibiotic compared to those who were to be prescribed one to two medicines per encounter (AOR: 2.17, 95%CI: 1.35-3.5). A one-unit increase in the number of medicines increased the odds of antibiotic prescribing increased by 2.02 units (COR: 2.02; 95%CI: 1.62-2.52). Conclusions: This study found that the percentage of antibiotics being prescribed at the community pharmacies in Asmara was 53% which deviated significantly from the WHO recommended values (20-26.8%). Furthermore, the percentage of encounters with an injection was 7.8% lower than the WHO value of 13.4-24.0%. Patients' age, gender and number of medicines were significantly associated with antibiotic prescribing.

Antibiotic prescriptions in Italian hospitalised children after serial point prevalence surveys (or pointless prevalence surveys): has anything actually changed over the years?

BACKGROUND: Point prevalence surveys have been used in several studies to provide immediate and easily comparable information about antibiotic use and showed that about one third of hospitalised children had on ongoing antimicrobial prescription during their hospital admission. The aim of this study, as part of the Global Antimicrobial Resistance, Prescribing and Efficacy in Neonates and Children project, is to describe antimicrobial prescriptions among hospitalised children in four tertiary care hospitals in Italy to show if something has changed over the years. METHODS: Four tertiary care Italian's hospitals joined three Point Prevalence Surveys (PPSs) in three different period of the year. All children under 18 years of age with an ongoing antimicrobial prescription, admitted on the participating wards at 8 o'clock in the morning of the selecting day were enrolled. RESULTS: A total of 1412 patients (475 neonates and 937 children) were admitted in the days of three PPSs. Overall, among the total admitted patients, 565 patients (40%) had an ongoing antimicrobial prescription in the days of the survey A total of 718 antibiotics were administered in the 485 admitted children and 133 in neonates. The most common indications for antibiotic therapy in children was Lower respiratory tract infections (244/718, 34%), while in neonates were prophylaxis for medical problems (35/133, 26.3%), newborn prophylaxis for newborn risk factors (29/133, 21.8%) and prophylaxis for surgical disease (15/133, 11.3%). CONCLUSIONS: Based on our results, it appears that nothing has changed since the last PPS and that the quality improved targets, underlyined in previous studies, are always the same. Serial PPSs can be part of AMS strategies but they are not sufficient alone to produce changes in clinical practice.

Review of purchases of unapproved medications by the Veterans Health Administration.

PURPOSE: Many medications that were marketed prior to 1962 but lack Food and Drug Administration (FDA) approval are prescribed in the United States. Usage patterns of these "unapproved medications" are poorly elucidated, which is concerning due to potential lack of data on safety and efficacy. The purpose of this project was to characterize purchases of unapproved medications within the Veterans Health Administration (VHA) by type, frequency, and cost. METHODS: VHA purchasing databases were used to create a list of all products with National Drug Codes (NDCs) purchased nationwide in fiscal year 2016 (FY16). This list was compared to FDA databases to identify unapproved prescription medications. For each identified combination of active pharmaceutical ingredient (API) and route of administration ("API/route combination"), numbers of packages purchased and associated costs were added. RESULTS: VHA pharmacy purchasing records contained 3,299 unapproved products with NDCs in FY16. After excluding equipment, nutrition products, compounding ingredients, nonmedication products, and duplicate NDCs, there were 600 unique NDCs associated with 130 distinct API/route combinations. The most commonly acquired product was prescription sodium fluoride dental paste (350,775 packages). The greatest pharmaceutical expenditure was for sodium hyaluronate injection ($24.5 million). Unapproved products accounted for less than 1% of overall VHA pharmacy purchasing in FY16. CONCLUSION: VHA purchased many unapproved prescription products in FY16 but is taking action to address use of such products in consideration of safety and efficacy data and available alternatives.

The technical and economic impact of veterinary interventions aimed at reducing antimicrobial use on broiler farms.

Antimicrobial resistance is a global threat for both human and animal health. One of the main drivers of antimicrobial resistance is inappropriate antimicrobial use in livestock production. The aim of this study was to examine the technical and economic impact of tailor-made interventions, aimed at reducing antimicrobial use in broiler production. Historical (i.e., before intervention) and observational (i.e., after intervention) data were collected at 20 broiler farms. Results indicate that average daily gain and mortality generally increased after intervention, whereas feed conversion and antimicrobial use decreased. Economic performance after interventions was generally higher than before the interventions. Sensitivity analyses on price changes confirm the robustness of the findings.

Discontinuation, persistence and adherence to subcutaneous biologics delivered via a homecare route to Scottish adults with rheumatic diseases: a retrospective study.

OBJECTIVES: To understand patterns of subcutaneous (SC) biologics use over time in adults with inflammatory rheumatic musculoskeletal diseases receiving a homecare delivery service. DESIGN: Retrospective cohort. SETTING: Patients in secondary care receiving SC biologics in the largest Scottish Health Board. PARTICIPANTS: A new bespoke cohort was created from routine data gathered as part of a health board Homecare Service Database. Patients over 18 years who received a supply of SC biologic from January 2012 to May 2015 with a diagnosis for rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) were included. OUTCOMES MEASURED: A standardised framework was applied by measuring discontinuation rates, persistence using Kaplan-Meier analysis and Cox regression and adherence using medication refill adherence (MRA) and compliance rate (CR). RESULTS: 751 patients were identified (AS: 105, PsA: 227, RA: 419) of whom 89.3% had more than one biologic delivery (median days' follow-up: AS: 494; PsA: 544; RA: 529) and 83.2% did not switch biologic. For all conditions, approximately half were persistent on their index biologic (52% AS, 54% PsA, 48%RA). Of patients who discontinued treatment, the majority reinitiated with the same biologic (19% AS, 18% PsA and 21% RA). Overall adherence during the period of treatment was over 80% when calculated using MRA (median %MRA: AS: 84.0%, PsA: 85.0%, RA: 82.4%) or CR (median %CR: AS: 96.6%, PsA: 97%, RA: 96.6%). CONCLUSION: Use of linked routine data is a sustainable pathway to enable ongoing evaluation of biologics use. A more consistent approach to studying use (discontinuation, persistence and adherence metrics) should be adopted to enable comparability of studies.

Practices in the Usage and Reconstitution of Poly-L-Lactic Acid

BACKGROUND: Poly-L-lactic acid (PLLA) is increasingly used for a range of indications, from HIV lipodystrophy to gluteal augmentation; however, there is no clear consensus on appropriate product preparation and use. OBJECTIVE: To establish current practices for PLLA reconstitution and usage in the USA. METHODS AND MATERIALS: A 19-question survey pertaining to the reconstitution and use of PLLA was distributed to members of the American Board of Cosmetic Surgery and American Board of Facial Cosmetic Surgery and at several cosmetic conferences. 410 questionnaires were returned anonymously over a 3-month period. The results were collated and analyzed. RESULTS: The commonest indication for PLLA was HIV lipodystrophy (46.8%), followed by gluteal augmentation (42.4%). For the face, the majority used a dilution of 9-10 mL (60.4%). For the gluteal region, the majority used a dilution greater than 21 mL (51.3%). Most respondents reconstituted PLLA in sterile water (59.8%) more than 21 hours before use (51.0%) and added lidocaine to the solution (94.7%). Most physicians used topical anesthetic cream (83.2%), manual agitation (85.8%) and recommended self-massage post-treatment (99.6%). CONCLUSION: There is considerable variation in PLLA reconstitution and use. Further well-designed studies are needed to establish the safest, most effective ways to use this product. J Drugs Dermatol. 2019;18(9):880-886.

Exploring the Impact of the Rational Antibiotic Use System on Hospital Performance: The Direct Effect and the Spillover Effect.

Irrational antibiotic usage not only causes an increase in antibiotic-borne diseases, but also inflicts pain on patients, as a result of inappropriate treatment. In order to resolve the hazards caused by irrational antibiotic usage, a kind of e-health service, the Rational Antibiotic Use System (RAUS), has been incorporated into the hospital information system. The RAUS provides doctors and patients with the functions of antibiotic usage monitoring, antibiotic information consultation and antibiotic prescription support. Though existing literature has already proved the usefulness of the RAUS on monitoring doctors' behavior, the effects on hospital performance from an organizational perspective has rarely been measured by empirical data. Therefore, our study has explored the effects of the RAUS on the performance of a large Chinese hospital, which has implemented the RAUS since March 2014. Through empirical research, we quantified the effects of the implementation of the RAUS on a hospital's performance from both the direct effects on the "drug income" and the spillover effect on the "treatment income". The results indicate a significant positive spillover effect on the treatment incomes of a hospital in its inpatient activities (seen as significant in the long term) and in its outpatient activities (seen as significant in both the short and long terms). In addition, this research provides certain theoretical and practical implications for the dilemma of e-health services application in irrational antibiotic usage.

[Surveillance of antibiotic agents according to § 23 of the German Infection Protection Act-data and results from hospitals in Frankfurt am Main, Germany, 2012-2017]. / Antibiotika-Verbrauchs-Surveillance nach § 23 Infektionsschutzgesetz ­ Daten und Erfahrungen aus den Krankenhäusern in Frankfurt am Main, 2012­2017.

BACKGROUND: Since 2011, German hospitals have been requested to record and evaluate antibiotic use in their institution. In this publication, the use of antibiotics in hospitals belonging to the administrative district Frankfurt/Main between 2012 and 2017 is presented and discussed with regards to the targets set in 2014. These targets are to improve the perioperative prophylaxis, reduce the use of cefuroxime, and increase the penicillin/cephalosporin ratio. METHODS: Since 2012, hospitals in Frankfurt/Main have been transmitting the defined daily doses (DDD) of all antibiotics used, the absolute number of patients, and their days of treatment. Since 2013, the data have also distinguished between intensive care and other units. The Frankfurt health authority calculated the total number of antibiotics and the DDD/100 patient days for all hospitals combined as well as for every hospital compared to each other. RESULTS: From 2012 to 2017, the number of absolute annual patient days increased from 1,592,161 to 1,615,180. Antibiotic use decreased from 1,073,975 DDD to 953,349 DDD, leading to a decrease from 67.5 DDD per 100 patient days to 59.0 DDD per 100 patient days. Cefuroxime was the most frequently used antibiotic in all hospitals. The use of cefuroxime showed a significant decrease between 2012 and 2017 (from 250,398 in 2012 to 165,160 DDD in 2017, a decrease of 34%). The use of ceftriaxone was reduced by 27%, ciprofloxacin by 9%, and levofloxacin by 16%. DISCUSSION: The targets set in 2014 were reached in the entirety of Frankfurt hospitals. However, there were significant differences between the hospitals taking part. The results were given as feedback to the hospitals in order to support their efforts in further improving antibiotic stewardship.