ROCKY ROAD AHEAD FOR NEW FDA CHIEF CALIFF

Final Senate approval by a historically narrow 50-46 vote came only after the White House and Califf's supporters lobbied hard to gain sufficient support, a success that is very different from Califf's 89-4 approval back in 2016. Pressure to help control the high cost of prescription drugs will continue to drive FDA support for developing complex generic drugs and biosimilars. There is pressure to clarify rules governing e-cigarettes;a need to address serious health problems arising from contaminated food and seafood, including significant volumes of imported products;and the safety of cosmetic products, dietary supplements, sunscreens, and other non-prescription products raise additional complex issues.

Analysis: FDA's COVID-19 Accelerated Pathways

Current FDA programs to accelerate access In order to accelerate the product approval process, four regulatory programs currently exist to reduce development and review times for products that address unmet medical needs for the treatment of serious or life-threatening conditions. In May 2014, FDA issued a Final Guidance for Industry entitled, "Expedited Programs for Serious Conditions-Drugs and Biologics" which addresses fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.3 In addition to this guidance document, under section 564 of the FD&C Act, 21 U.S.C. 360bbb3, in a situation where the Secretary of Health and Human Services (HHS) issues a declaration of emergency or threat justifying authorization of emergency use for a product caused by chemical, biological, radiological or nuclear (CBRN) agents, as well as an infectious disease, the Commissioner of the FDA may authorize an EUA of an unapproved product or an unapproved use of an approved product. In January 2017, the "Emergency Use Authorization of Medical Products and Related Authorities" guidance was finalized.4 Fast Track designation Section 112 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), entitled "Expediting Study and Approval of Fast Track Drugs," mandates the facilitation of the development and processes to expedite review of therapeutics intended to treat serious or life-threatening conditions presenting with unmet medical needs. [...]a two-tiered system of review times, Standard Review and Priority Review was created.

Surveying over the counter and prescription only medication misuse in treatment services during COVID-19

Background: A greater understanding of Over the Counter (OTC) and Prescription Only Medication (POM) misuse amongst adults accessing substance misuse services (SMS) during COVID-19 is required to identify how SMS can better meet the needs of the people who require treatment. Aim: To use a questionnaire to explore OTC/POM misuse during COVID-19 in adults accessing community SMS in England. Methods: In 2020 to 2021 anonymous self-administered online/paper questionnaires which collated quantitative and qualitative data were completed. They were piloted for suitability and ethical approval was obtained. Thematic analysis was conducted for qualitative data and chi-square tests used to assess the relationship between quantitative variables. Results: Participants were Caucasian (94.6% British), majority male (58.9%), aged 18 to 61 years. Most were prescribed medication for problematic substance use, with a 92.5% self-reported adherence rate. The misuse of benzodiazepines (22.2%) codeine products (30.8%) and pregabalin (14.5%) predominated and 37.5% misused 2 or more medicines. Administration was usually oral and concomitant use of other substances was common: alcohol 44.6% (52% daily), tobacco/vaping 73.2% and illicit substances 58.9%. There were statistically significant associations identified, including between changes during COVID-19 to OTC/POM misuse and illicit use. Only 56 questionnaires were included in the analysis: we believe this low number was because of infection control measures, limited footfall in services, pressures on staff limiting their capacity to distribute the paper questionnaires and reliance upon telephone consultations limiting online distribution. Increasing OTC/POM misuse and obtaining illicit supplies were reported when access to usual supplies were restricted;however, changes to doses/dispensing arrangement liberalisation in response to COVID-19 were positively viewed. Conclusion: OTC/POM misuse, including polypharmacy and concomitant use of other substances occurred during COVID-19: SMS need to be vigilant for these issues and mitigate the associated risks for example with harm reduction interventions. Further qualitative research is required to explore the issues identified. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Countering Counterfeiters and Diverters

[...]the anticounterfeiting packaging market is projected to grow at a 7.8% compound annual growth rate to USS189.9 billion (€158 billion) in 2026 (1). [...]in anticipation of a spike in counterfeiting, the US Immigration and Customs Enforcement Homeland Security Investigations (HSI) has launched Operation Stolen Promise 2, to halt the production, distribution, and sale of illicit COVID-19 treatments and vaccines. The fact that the COVID-19 vaccines need to be shipped in stringent cold storage containers with radio frequency identification (RFID) temperature sensors along with specialized transportation methods will make it more difficult for counterfeiters to enter the supply chain, but not impossible." [...]Pitts predicts an increased focus on consumer engagement.

Seven days in medicine: 6-12 May 2020

In a report summarising the feedback it had received,2 the charity noted a litany of "horrendous” safety concerns, as workers were concerned about a lack of personal protective equipment and about their mental health. NICE: assess covid patients for kidney injury Patients with suspected or confirmed covid-19 should be assessed for acute kidney injury (AKI) on hospital admission or transfer, said the National Institute for Health and Care Excellence (NICE). In a new guideline aimed at healthcare professionals who are not kidney specialists, the institute said that patients with suspected or confirmed covid-19 should be monitored for AKI throughout their stay in hospital and managed appropriately if it develops.

Factors Associated With Adherence to First-line Antiviral Therapy Among Commercially Insured Patients With Chronic Hepatitis B.

Background: Nonadherence to antiviral therapy can lead to poor clinical outcomes among patients with chronic hepatitis B (CHB). We used a claims database to evaluate risk factors for nonadherence to antiviral therapy among commercially insured patients with CHB in the United States. Methods: We obtained data for commercially insured adult patients with CHB prescribed entecavir or tenofovir disoproxil fumarate (TDF) in 2019. Primary outcomes were adherence to entecavir and adherence to TDF. Enrollees with a proportion of days covered (PDC) ≥80% were considered adherent. We presented adjusted odds ratios (AORs) from multivariate logistic regressions. Results: Eighty-three percent (n = 640) of entecavir patients were adherent, and 81% (n = 687) of TDF patients were adherent. Ninety-day supply (vs 30-day supply; AOR, 2.21; P < .01), mixed supply (vs 30-day supply; AOR, 2.19; P = .04), and ever using a mail order pharmacy (AOR, 1.92, P = .03) were associated with adherence to entecavir. Ninety-day supply (vs 30-day supply; AOR, 2.51; P < .01), mixed supply (vs 30-day supply; AOR, 1.82; P = .04), and use of a high-deductible health plan (vs no high-deductible health plan; AOR, 2.29; P = .01) were associated with adherence to TDF. Out-of-pocket spending of >$25 per 30-day supply of TDF was associated with reduced odds of adherence to TDF (vs <$5 per 30-day supply of TDF; AOR, 0.34; P < .01). Conclusions: Ninety-day and mixed-duration supplies of entecavir and TDF were associated with higher fill rates as compared with 30-day supplies among commercially insured patients with CHB.

Prolonged Cessation of Chronic Opioid Analgesic Therapy: A Multidisciplinary Intervention

Am J Manag Care. 2022;28(2):60-65. https://doi.org/10.37765/ajmc.2022.88785 _____ Takeaway Points Building on articles previously published in this journal, this research suggests a potential path toward an effective and sustained clinical approach to decrease chronic opioid analgesic therapy use in the population of patients with chronic, noncancer pain. * We retrospectively examine the initial and sustained success rates of full mu agonist chronic opioid analgesic therapy (COAT) cessation in the setting of chronic, noncancer pain (CNCP) through voluntary participation in a pilot program—implemented via 2 sites and care teams—that provided a standardized, multidisciplinary curriculum containing robust complementary care. * This study provides unusually lengthy follow-up for postintervention COAT cessation monitoring of up to 24 months. * Initial COAT cessation success rates were high, and sustained success at 6 months and beyond was even higher (90%, 95%, and 97%, respectively), indicating that the program curriculum may be an effective strategy for broader application for sustainable COAT cessation in the setting of CNCP. _____ A recent CDC report suggests that years of nationwide medical and managed care regulations to limit prescription opioid access, dose, and time exposure have had minimal positive impact on life expectancy in the United States.1 Despite the wide abandonment of opioid prescriptions by the medical community, opioid-related mortality and morbidity have continued to rise, a trajectory that has accelerated due to the COVID-19 pandemic.1-3 Aside from being a contributor to overdose-related death, full mu agonist chronic opioid analgesic therapy (COAT) has been shown to impede vocational and social return to function and to increase length of disability.1,3,4 Managed care charges for patients with opioid dependency are more than 550% higher than the average annual per-patient charge.5 Also, the population of "opioid refugees" is gaining numbers—patients who were made dependent upon opioids by recent, but now out-of-favor, prescribing practices for the management of chronic pain and are now abruptly unable to find a medical source for the same medications.6 This has moved many patients with chronic pain dependent upon opioids to drastic measures such as seeking new or multiple prescribers, emergency medical care, or even illicit opioid sources.7 The medical community has been trialing and comparing several approaches to combat the ineffective use of COAT for chronic, noncancer pain (CNCP). Some managed care institutions have attempted a model of coverage cessation for these medications, resulting in paradoxically increased costs as patients struggle to cope.3 Clinicians have reported varying levels of success to promote COAT cessation through outpatient weaning8-12 and single-modality approaches of cognitive behavioral therapy (CBT),13,14 acupuncture,10 interdisciplinary programing,15-24 and buprenorphine substitution.20,25-27 None of the data present a definitive, best-practice approach to the challenge of the opioid epidemic in the setting of chronic pain. Every activity was designed for home exercise and was led by a licensed or credentialed expert in that field, such as a physician, nurse practitioner, psychologist, licensed acupuncturist, physical therapist, or licensed physical therapy assistant. Because the PDMP is ubiquitous as a record of presence and volume of prescribed controlled substances in California, with few exceptions (see Discussion), lack of an entry in the PDMP was interpreted as that subject not using opioids.

Variation in Spending Associated With Primary Care Practices

Am J Manag Care. 2021;27(7):297-300. https://doi.org/10.37765/ajmc.2021.88557 _____ Takeaway Points Physician practices account for a significant amount of variation in spending. * There is widespread variation in spending associated with physician practices. * This likely reflects variation in utilization and in the prices of care delivered by the practice and the sites they refer to. * Significant savings can be obtained if patients shift from practices associated with high spending to those with low spending. _____ Although the country is making preliminary steps toward recovery, the COVID-19 pandemic has sent the United States into its most significant economic downturn since the Great Depression, which will significantly exacerbate pressure for employers to control health care spending. A large body of literature documents the significant variation in prices within markets, from which it can be inferred that considerable cost-saving opportunities are associated with price shopping.1 Importantly, physician practice prices have not been found to be associated with quality or efficiency metrics.2 The literature on practice style variation suggests that there may also be savings opportunities from identifying physicians with less intensive practice styles.3 For example, physician beliefs about treatment regimens contribute to significant regional differences in physician practice spending.4 Similarly, physician experience is associated with spending, as less experienced primary care physicians (PCPs) and specialists have higher overall costs.5 Much of the practice variation literature focuses on market-level analysis, which masks widespread variation within geography.6,7 For this reason, the National Academy of Medicine has called for greater understanding of variation attributable to physician practice styles.8 We extend the nascent research on this topic using unique data on commercial prices and spending. [...]patient preferences regarding specialist visits are associated with higher specialist utilization, suggesting that other factors besides PCP referrals can play significant roles in care usage.9 Moreover, research has shown that patients are often unwilling to sacrifice time or money to maintain continuity of care with PCPs;such continuity is associated with better outcomes and more cost-effective care.10 However, given that PCPs serve as a first contact and main provider for most individuals, identifying variation in practice spending and prices still provides valuable insight into how best to utilize primary care efficiently. Because we controlled for 3-digit zip code, the quartiles should be interpreted as relative to other practices in their 3-digit zip code.

A PRESCRIPTION FOR CALAMITY: WHY THE DEPARTMENT OF LABOR'S PHARMACY BENEFIT MANAGEMENT PROGRAM FALLS SHORT AS A SINGULAR SOLUTION TO THE U.S. OPIOID CRISIS

The purpose of this Note is to create a holistic solution for the U.S. Department of Labor to apply amidst the United States ongoing opioid crisis, which will serve to both prevent addiction before it can develop and treat existing cases of addiction. To this aim, this Note examines and analyzes the connections between the opioid crisis and another co-existing public health crisis, the COVID-19 pandemic, and the procurement procedures taken to resolve them. The argument is developed throughout three sections. First, this Note provides background information demonstrating the detrimental impact of opioid misuse and addiction, as well as the impact that COVID-19 in particular has had on rates of misuse and addiction in the United States. ally, this section introduces efforts taken to resolve the crisis, including the Department of Labors Pharmacy Benefit Management program, which is the subject of this Note. Second, this Note examines the Department of Labors Pharmacy Benefit Program, addressing the singularly preventative nature of the program, which fails to support a holistic solution. Additionally, this Note addresses concerns relating to the use of pharmacy benefit management services in general, particularly the cost-increasing nature of such mechanisms. In the final section, following an examination of the procurement procedure used to acquire COVID-19 vaccines, this Note proposes the application of a similar pharmaceutical procurement approach to combatting the opioid crisis. To conclude, this Note argues that by contracting with pharmaceutical companies to develop a safer and less addictive treatment plan, the Department of Labor would be able to prevent, as well as treat, opioid addiction.

Pharmacy Student Perceptions and Knowledge of Online Pharmacy Use

Objective. Currently, there is no set of accreditation standards for integrating the dangers of illegal online pharmacies into Doctor of Pharmacy (PharmD) curricula. As a result, many pharmacists are unable to recognize the differences between a legal and illegal online pharmacy or educate patients on the dangers of online pharmacies. The objectives of this study were to assess gaps in student pharmacists' knowledge and to assess the impact of adding education regarding online pharmacies into PharmD programs. Methods. A pre- and postsurvey design was developed. Data were collected through an electronic questionnaire distributed to second-year pharmacy (P2) students to evaluate student knowledge gaps at baseline and after education on illegal online pharmacies. Results. A total of 102 students responded to the presurvey, with 93 (91%) consenting to participate. Out of 100 respondents to the postsurvey, 84 (84%) students consented. Approximately 87% (81/93) of respondents indicated some awareness of prescription medications being purchased online. Most students (89%, 77/86) stated that they do not believe the university has provided adequate curriculum on illegal online pharmacies and counterfeit medications. After receiving education on the relevant topics, 64% (55/85) stated they now felt their education was adequate. Conclusion. Although pharmacy students were aware of the existence of illegal online pharmacies, they were not aware of the significance of this patient safety issue or how to accurately identify suspicious websites. It is imperative that PharmD programs incorporate formal education on the risks that illegal online pharmacies pose to patient and medication safety.

Essays on labor markets and health: Employment conditions and drug, suicide, and alcohol-related mortality among working-age adults in the United States

Americans in the twenty-first century are dying earlier in life and at higher rates from preventable causes than in nearly any other developed economy. Understanding of the root determinants of the recent reversal in life expectancy and identifying policy approaches to combat the rise in midlife mortality is a national public health and economic imperative. This dissertation focuses on the well-documented increase in fatal drug overdose, suicide, and alcohol-related mortality-a collection of causes of death often referred to as the "deaths of despair"-and examines the potential economic determinants of the acceleration in these causes of death over the past several decades. Building upon extensive literature examining macroeconomic and labor market conditions as upstream factors shaping population health, the following chapters consist of two empirical analyses intended to estimate the causal effect of short- to medium-term changes in local employment rates on these causes of death among working-age adults during the 2003-2017 period. These studies are of increasing importance as the United States continues to experience widespread employment uncertainty and prolonged economic distress in the wake of the COVID-19 pandemic.The first study presented in this dissertation focuses on the effects of county-level employment conditions on "deaths of despair" using a Bartik-style shift-share instrument to isolate demand-driven variation in county-level employment rates. In line with most existing studies that document countercyclical variation in suicide, I estimate that a one percentage point increase in the current-year employment-to-population ratio decreases non-drug suicide rates by one to two percent. On the other hand, my causal models suggest that rates of fatal drug overdose increase by a similar magnitude as the economy improves, and I find no evidence of changes in alcohol-related mortality in response to short-term employment shocks. I conduct a simulation exercise based on these point estimates to show that in general, and especially for accidental drug overdose, these estimated effects are small relative to the increases in cause-specific mortality over the 2003-2017 period.Motivated by the procyclical variation in accidental drug overdose uncovered in the first study, the second analysis examines the extent to which county employment rates affect the demand for prescription opioid medication among a population of commercially insured adults. This study draws on de-identified, individual-level pharmacy and medical claims from 2003-2017 aggregated to the county level to test the hypothesis that county-level employment fluctuations differentially affect the demand for prescription opioids that place individuals at higher (versus lower) risk for abuse and dependence. Unlike existing studies, I find no evidence of an effect of employment conditions on the demand for prescription opioids overall or differential effects between high- and low-risk prescriptions.The relatively small magnitude of the estimated effects, suggestive evidence of heterogeneity across demographic groups, and mixed findings on the cyclicality of these causes of death over various time horizons all point to a more complex set of factors underlying the rising rates of "deaths of despair" that is not explained by local employment rates alone. Developing a more nuanced understanding of these trends-particularly along key dimensions such as race/ethnicity and socioeconomic status-will be critically important in designing equitable policies to help the country recover from the COVID-19 pandemic and to reverse the disconcerting trends of increasing midlife mortality in the years to come. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Sociocultural factors associated with persistent prescription opioid use among Puerto Rican adults in Massachusetts

Background: Understanding ecological-level factors associated with persistent prescription opioid use (PPOU) may inform research and efforts to reduce prescription opioid-related complications. Puerto Rican Adults (PRAs) have disparities in health outcomes and depression and may be at greater risk of PPOU. Determinants of allostatic loads, including acculturation, migration history, social support, perceived discrimination, have not been explored as correlates of PPOU among PRAs. Further, no study has explored whether depressive symptoms affect PRA's PPOU. Opioid overdose fatality rates among Hispanics have further increased amidst the ongoing COVID-19 pandemic, amplifying the need for exploration of socio-ecological level factors associated with PPOU. Aim: The primary aim of this study was to estimate the incidence and prevalence of prescription opioid use (POU) among PRAs and to evaluate whether sociocultural factors of acculturation and migration history (intrapersonal), social support and network size (interpersonal), and perceived discrimination (community level) predicted PPOU. Furthermore, this study examined the relationship between depression and PPOU and whether depression mediated the effects of perceived discrimination on PPOU. Method: The Socio-Ecological Model (SEM) was adapted to guide this longitudinal secondary analysis study of the Boston Puerto Rican Health Study (BPRHS) cohort. The BPRHS is an ongoing cohort study of PRAs in the Greater Boston area. Baseline (0-year), 2-year, and 5-year datasets were used to estimate incidence and prevalence of POU among the PRA's cohort. The measures were acculturation and migration history, social support and network size, perceived discrimination, depression symptoms, and PPOU. Association between incidence and prevalence of POU by demographic factors were examined. The relationship between SEM-level factors and depression were examined with binary logistic regression. Using Baron and Kenny's method (1986), multivariable binary logistic and linear regression models examined whether depression mediated the effects of perceived discrimination on PPOU. Results: Participants were 45-75 years old (N = 798) of Puerto Rican descent (72.9% women) with 6.5% persistent opioid users compared to non-users (93.5%). Increasing incidence and prevalence of POU were observed at each follow-up. Lower income households were more likely to have higher incidence and prevalence of POU. Multivariate logistic regression models revealed an association between perceived discrimination and PPOU (OR = 2.85, 95% CI 1.46-5.58). No significant association was observed between acculturation, migratory history, social support and PPOU. Depressive symptoms were associated with PPOU (OR = 1.03, 95% CI: 1.00-1.05, p <= 0.03) and partially mediated the effects of perceived discrimination on PPOU by 10.3%, after adjustment of covariates. Conclusion: Reports of associations between perceived discrimination, depression and PPOU broadens current knowledge on factors linked to PPOU in the PRAs subpopulation. This research has important implications for policy, nursing research and clinical practice. Nurses and healthcare professionals may design tailored interventions to reduce PPOU by targeting these risk factors. Addressing perceived discrimination and depressive symptoms may impact PRA's exposure to PPOU and reduce their risk of prescription opioid-related complications. Future research should explore other multi-level factors that may influence PPOU and other potential mechanisms that may explain the effects of perceived discrimination on PPOU. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Patient centred care: filling in the gaps

Research by Courtney Davis and colleagues on new cancer drugs approved by the European Medicines Agency is concerning on this front (doi:10.1136/bmj-2022-073711).1 The study found that important information about the benefits of cancer drugs was not included in patient leaflets and that concerns about the reliability of evidence for these benefits were omitted in communication to clinicians and patients. Isabelle Munyangaju and colleagues discuss falling global vaccination rates in light of the covid-19 pandemic (doi:10.1136/bmj.p627).6 Vaccination campaigns stalled because of disruption to primary healthcare services, "a failure to deliver services to the hardest to reach, ‘last mile' populations,” and rising vaccine hesitancy caused by the spread of misinformation. The ongoing success of vaccination campaigns will rely on healthcare communities working with local populations to develop a mutual understanding and to fill knowledge gaps where good sources of information are missing, and poor evidence is shared.

Localized Syndemic Assemblages: COVID-19, Substance Use Disorder, and Overdose Risk in Small-Town America

Pandemics do not exist in isolation and COVID-19 is no exception. We argue that existing health crises, notably substance use disorder (SUD), developed syndemic relationships with COVID-19 that produced compounding deleterious effects. Combining Merrill Singer's theory of syndemics and assemblage theory, we analyze the combinatory impact of overdose and COVID-19 within a localized context. We focus on Sandusky, Ohio, where we combine police reports, in-depth interviews with area residents, and ethnographic data to compare conditions before and after the emergence of COVID-19. We find dramatic shifts in relevant local contexts due to COVID-19, inhibiting existing systems of law and public policy aimed at overdose prevention and SUD treatment. Further, our findings provide evidence of complications in the COVID-19 response originating from the overdose epidemic.

Inequalities in children's mental health care: Analysis of routinely collected data on prescribing and referrals to secondary care

Background: One in eight children in the United Kingdom are estimated to have a mental health condition, and many do not receive support or treatment. The COVID-19 pandemic has negatively impacted mental health and disrupted the delivery of care. Prevalence of poor mental health is not evenly distributed across age groups, by sex or socioeconomic groups. Equity in access to mental health care is a policy priority but detailed socio-demographic trends are relatively under-researched. Methods: We analysed records for all mental health prescriptions and referrals to specialist mental health outpatient care between the years of 2015 and 2021 for children aged 2 to 17 years in a single NHS Scotland health board region. We analysed trends in prescribing, referrals, and acceptance to out-patient treatment over time, and measured differences in treatment and service use rates by age, sex, and area deprivation. Results: We identified 18,732 children with 178,657 mental health prescriptions and 21,874 referrals to specialist outpatient care. Prescriptions increased by 59% over the study period. Boys received double the prescriptions of girls and the rate of prescribing in the most deprived areas was double that in the least deprived. Mean age at first mental health prescription was almost 1 year younger in the most deprived areas than in the least. Referrals increased 9% overall. Initially, boys and girls both had an annual referral rate of 2.7 per 1000, but this fell 6% for boys and rose 25% for girls. Referral rate for the youngest decreased 67% but increased 21% for the oldest. The proportion of rejected referrals increased steeply since 2020 from 17 to 30%. The proportion of accepted referrals that were for girls rose to 62% and the mean age increased 1.5 years. Conclusions: The large increase in mental health prescribing and changes in referrals to specialist outpatient care aligns with emerging evidence of increasing poor mental health, particularly since the start of the COVID-19 pandemic. The static size of the population accepted for specialist treatment amid greater demand, and the changing demographics of those accepted, indicate clinical prioritisation and unmet need. Persistent inequities in mental health prescribing and referrals require urgent action. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Medication adherence among adult kidney transplant recipients: A mixed methods examination

Kidney transplantation remains the best and most cost-effective treatment for patients with end stage kidney disease, and the number of kidney transplants performed in the U.S. annually has increased steadily since 2015. To ensure transplant success, kidney transplant recipients (KTRs) are often prescribed lifelong, complex medication regimens that include immunosuppressants, anti-infectives, and medications to control comorbid chronic conditions. Taking these medications as prescribed is essential, as nonadherence can lead to significant complications. Overall, KTRs face significant health burdens, and must be confident, and competent, in their ability to manage a range of conditions and self-care behaviors, including medication-taking.Using data and accessing participants from a large clinical trial, we applied mixed methods to address gaps in the transplant literature related to medication regimen adherence and self-management of health among adult KTRs. In doing so, we sought to (1) characterize medication nonadherence among KTRs;(2) understand KTR experiences of medication-taking;and (3) evaluate the impact of the COVID-19 pandemic on KTRs' ability to self-manage their health. We found evidence of both immediate and downstream barriers to regimen adherence, patient- and health system-level barriers to adherence, and barriers to which minority KTRs might be particularly vulnerable. Importantly, our findings indicated that adherence to medications taken for comorbid conditions might prove more difficult for KTRs than adherence to immunosuppressants. We also found that the pandemic might have challenged KTRs' ability to manage their health by compromising access to necessary care, including vaccination in the early stages of eligibility, and by exacerbating rates of anxiety. Based on our findings, we provide recommendations - both within and outside the context of the ongoing pandemic - to support KTRs in engaging in critical health behaviors like appropriate medication-taking. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Quality Improvement Project for Antibiotic Stewardship in Urgent Care

Overprescribing antibiotics is currently a major issue in the outpatient setting. Inappropriate antibiotic prescriptions are leading to costly adverse effects, including antibiotic resistance. Antibiotic stewardship interventions are adaptable tools that are readily available to prescribers to reduce the overuse of antibiotic prescriptions. The purpose of this project was to implement an Antibiotic Stewardship Bundle in an urgent care clinic. The overall aims of this project were to decrease the amount of unnecessary antibiotics prescribed and increase best prescribing practice. The results of the quality improvement project showed inappropriate antibiotic prescription rates decreased from 54.7% to 35.4% (P = 0.0006).

Impact of COVID-19 treatment options on hospital pharmacy's workload: lessons learned

Background and ImportanceTreatment guidelines for COVID-19 have rapidly been evolving. Different drugs against COVID-19 have urgently emerged to control the pandemic, challenging hospital pharmacies to make these antiviral and immunomodulatory therapies timely available for admitted patients.Aim and ObjectivesTo analyse the prescribing patterns of COVID-19 drugs in our hospital and its impact on the pharmacy's workload.Material and MethodsWe retrospectively analysed drug registration data from 1 January 2020 to 16 March 2022 of COVID-19 drugs (dexamethasone, remdesivir, baricitinib, casirivimab/imdevimab and sotrovimab) for hospitalised patients. Consumption data were expressed as number of patients and number of preparations. To determine pharmacy's workload, we measured the average time for drug ordering, preparation and dispensing. Hydroxychloroquine and baricitinib were excluded as these are commercially available oral drugs which are distributed according to standard procedures.ResultsThe volume of dispensed COVID-19 drugs fluctuated along with the hospitalisation waves of the COVID-19 epidemic. Oral dexamethasone was the most frequently prescribed drug throughout the whole period, which is consistent with the strong recommendation in the national guideline. Remdesivir, introduced in our practice since October 2020, was the second most prescribed drug despite low evidence. From October 2021 until December 2021, 41 infusions of remdesivir were administered, compared to 381 infusions from January 2022 until March 2022. Compared to dexamethasone and remdesivir, monoclonal antibodies (casirivimab/imdevimab and sotrovimab) were less commonly used: 48 prepared infusions between September 2021 and March 2022. Most drugs were given in combination. Remdesivir and monoclonal antibodies were manually ordered to fulfil urgent needs as the supply is managed nationwide by the government. Infusions were prepared at once due to limited stability. Ordering, preparing and dispensing required an average of 35 minutes per patient to complete.Conclusion and RelevanceThe COVID-19 pandemic impacted pharmacy's workload. We could have made more timesaving decisions such as the use of commercially available methylprednisolone instead of dexamethasone and batching remdesivir preparations. Hospital pharmacists should be involved in developing national guidelines and take into account the impact on daily practice.References and/or Acknowledgements1. Sciensano, Interim clinical guidance for adults with confirmed COVID-19, July 2022, Version 29Conflict of InterestNo conflict of interest