Innovation, affordability, access: Alzheimer disease drugs and the Inflation Reduction Act.

OBJECTIVES: This analysis examines the implications of new Alzheimer disease drugs in the era of the Inflation Reduction Act (IRA). It focuses on balancing innovation in Alzheimer disease treatment with affordability and access, assessing the impact on Medicare's budget, patient cost, and health care system readiness. STUDY DESIGN: A comprehensive review was conducted, synthesizing information from recent FDA drug approvals, drug pricing models, Medicare coverage policies, and the updated regulations under the IRA. This analysis reflects on the broader clinical and economic consequences of introducing new Alzheimer disease treatments. METHODS: The study employs a qualitative review of existing literature, policy documents, and economic data. It explores the implications of Alzheimer disease drugs on health care policy, analyzing the economic and clinical impacts within the current health care landscape in the US. RESULTS: The study highlights the economic challenges posed by the high costs of new Alzheimer disease drugs, contrasting with their moderate clinical benefits and potential risks. It discusses the limitations of the IRA in regulating drug prices and the resulting implications for Medicare's budget. Additionally, it examines disparities in health care access and system preparedness for these new treatments. CONCLUSIONS: The study findings underscore the need for a comprehensive approach to ensure fair pricing and equitable access to Alzheimer disease treatments. It suggests the application of frameworks such as the ISPOR Value Flower, focusing on diversity, equity, and comprehensive economic evaluations, to navigate the evolving landscape of Alzheimer disease treatment in the context of the IRA.

Addressing buprenorphine supply barriers: A guidance commentary.

The current supply-side constraints limiting buprenorphine availability at pharmacies may reduce the potential impact of recent initiatives to improve medications for opioid use disorder (MOUD) access. The recent opioid litigation combined with existing federal regulation and enforcement has resulted in significant restrictions to the distribution and dispensing practices of pharmaceutical wholesalers and pharmacies countrywide. Previously discussed solutions to these problems do not seem to have produced actionable improvements to the current landscape. However, a novel solution to this problem may exist in the form of a Drug Enforcement Administration (DEA) guidance letter. These guidance letters allow the DEA to communicate directly to registrants, providing detailed interpretation and clarity regarding the DEA's expectations and enforcement realities. Recently, the DEA guidance letter portal was used to remind registrants that the DEA does not create quantitative thresholds or volume limits on controlled substance distribution. An additional guidance letter could be issued to ease the concerns about liability connected to the distribution and dispensing of buprenorphine. In particular, this guidance could acknowledge certain terms of the distributor settlement agreement as legal precedent and clarify that buprenorphine is not subject to the same restriction as other defined "highly diverted" controlled substances. Such guidance may also serve to provide both pharmaceutical wholesalers and pharmacies with assurance that an increase in buprenorphine distribution would not directly result in increased DEA scrutiny. This strategy represents an actionable step toward the goal of providing better access to MOUD by reducing existing supply-side limitations.

The availability of fentanyl test strips in Georgia community pharmacies.

BACKGROUND: Fentanyl test strips (FTS) are increasingly being used to test counterfeit pharmaceuticals and illicit drugs for fentanyl before consumption. On July 1, 2022, Georgia legalized the distribution of FTS. One strategy for expanding FTS distribution in the community involves leveraging community pharmacies. However, less is known about FTS distribution through community pharmacies. OBJECTIVES: This preliminary study aimed to assess the availability of FTS in Georgia community pharmacies and examine pharmacists' knowledge and attitudes regarding FTS provision. METHODS: This study used a cross-sectional design. A randomized telephone survey of 700 pharmacies, stratified by pharmacy type, was carried out from September 2022 to January 2023. Survey questions assessed FTS stock status, pharmacists' awareness of Georgia's FTS legalization, willingness to receive FTS information, and comfort in providing FTS education. Descriptive statistics and multivariate logistic regression analyses were used to analyze the data. RESULTS: Of the 376 survey respondents, the vast majority were not aware of the Georgia FTS legalization (82.71% [n = 311]) and did not have FTS stocked in their pharmacies (94.91% [n = 354]). While most participants were willing to receive FTS information (70.21% [n = 264]), only slightly over half reported feeling comfortable providing FTS education (54.70% [n = 205]). Multivariate analyses showed that female participants were less likely to feel comfortable providing FTS education to patients/clients at the pharmacy (adjusted odds ratio: 0.58; confidence interval: 0.36 to 0.92). CONCLUSION: Findings suggest that Georgia community pharmacies may not stock FTS and that pharmacists may be unaware of the state's FTS legalization, but they are willing to receive information about FTS. Future studies should use a representative sample to design and implement strategies to support pharmacists' provision of FTS, including a destigmatization approach for those not comfortable discussing FTS.

Community pharmacists' naloxone counseling: A theory-informed qualitative study.

BACKGROUND: Opioid-related overdose (ORO) deaths have reached a record high in the United States. Naloxone is an opioid antagonist that can rapidly reverse an opioid overdose. Pharmacists are in an ideal position to provide naloxone and related counseling, given their accessibility and expertise. However, minimal research is available on community pharmacists' naloxone counseling. OBJECTIVES: The aim of this study was to investigate Georgia community pharmacists' naloxone counseling as well as explore their attitudes, subjective norms, and perceived behavioral control toward counseling. METHODS: Semi-structured telephone interviews were conducted to elicit pharmacists' beliefs and practices regarding naloxone counseling. The interviews were guided by open-ended questions based on the theory of planned behavior (TPB). Thematic analysis was performed to identify the modal salient beliefs expressed by the pharmacists. The Consolidated Criteria for Reporting Qualitative Research was used to report the study findings. RESULTS: A total of 12 community pharmacists participated. Pharmacists held mixed attitudes toward naloxone counseling. While they recognized it as a vital part of their profession to prevent ORO deaths, they also expressed concerns about offending patients. Regarding normative beliefs, pharmacists identified several groups, including regulatory agencies (e.g., Board of Pharmacy, CDC), managers, news/media, patients, and doctors, influencing their provision of naloxone counseling. Facilitators to counseling included receiving naloxone training and having access to counseling guidelines and resources. Reimbursement issues, high costs of naloxone, and lack of patient awareness were the most commonly cited barriers. Pharmacists reported participating in counseling and providing information on identifying signs of opioid overdose and administering naloxone. CONCLUSIONS: The TPB is a useful framework for understanding community pharmacists' beliefs and practices regarding naloxone counseling. Capitalizing on facilitators and targeting barriers related to pharmacists' reimbursement issues, high costs of naloxone, and increasing patients' awareness of naloxone use and benefits may enhance pharmacists' naloxone counseling.

Association of Life's Simple 7 and ideal cardiovascular health in American Indians/Alaska Natives.

OBJECTIVE: American Indians and Alaska Natives (AI/ANs) are an understudied population at high risk for cardiovascular diseases (CVDs); little is known about contextual factors contributing to CVDs in AI/ANs. This study examined the association of Life's Simple 7 (LS7) factors and social determinants of health (SDH) with CVD outcomes in a nationally representative sample of AI/ANs. METHODS: We conducted a cross-sectional study of 8497 AI/ANs using 2017 Behavioural Risk Factor Surveillance Survey data. Individual LS7 factors were summarised as ideal and poor levels. Coronary heart disease, myocardial infarction and stroke were defined as CVD outcomes. Healthcare access measures represented SDH. Logistic regression analyses examined associations of LS7 factors and SDH with CVD outcomes. Population attributable fractions (PAFs) quantified individual contributions of LS7 factors to CVD outcomes. RESULTS: N=1,297 (15%) participants with CVD outcomes were identified. Smoking, physical inactivity, diabetes, hypertension and hyperlipidaemia were LS7 factors associated with CVD outcomes. Hypertension was the largest contributor to CVD (aPAF 42%; 95% CI 37% to 51%), followed by hyperlipidaemia (aPAF 27%; 95% CI 17% to 36%) and diabetes (aPAF 18%; 95% CI 7% to 23%). Compared with individuals with poor LS7 levels, participants with ideal levels showed 80% lower odds of CVD outcomes (aOR 0.20; 95% CI 0.16 to 0.25). Access to health insurance (aOR 1.43, 95% CI 1.08 to 1.89) and a regular care provider (aOR 1.47, 95% CI 1.24 to 1.76) were associated with CVD outcomes. CONCLUSIONS: Effective interventions are needed to address SDH and attain ideal LS7 factors to improve cardiovascular health among AI/ANs.

Pharmacists' naloxone services beyond community pharmacy settings: A systematic review.

BACKGROUND: Pharmacists' provision of naloxone services in community pharmacy settings is well-recognized. Recently, studies describing pharmacists' naloxone services in settings other than community pharmacies have emerged in the literature. There is a need to synthesize evidence from these studies to evaluate the scope and impact of pharmacists' naloxone services beyond community pharmacy settings. OBJECTIVES: The objectives of this systematic review were to a) identify pharmacists' naloxone services and their outcomes, and b) examine knowledge, attitudes, and barriers (KAB) related to naloxone service provision in non-community pharmacy settings. METHODS: Eligible studies were identified using PubMed, Web of Science, and CINAHL. Inclusion criteria were as follows: peer-reviewed empirical research conducted in the U.S. from January 2010 through February 2022; published in English; and addressed a) pharmacists' naloxone services and/or b) KAB related to the implementation of naloxone services. PRISMA guidelines were used to report this study. RESULTS: Seventy-six studies were identified. The majority were non-randomized and observational; only two used a randomized controlled (RCT) design. Most studies were conducted in veterans affairs (30%) and academic medical centers (21%). Sample sizes ranged from n = 10 to 217,469, and the majority reported sample sizes <100. Pharmacists' naloxone services involved clinical staff education, utilization of screening tools to identify at-risk patients, naloxone prescribing and overdose education and naloxone dispensing (OEND). Outcomes of implementing naloxone services included improved naloxone knowledge, positive attitudes, increased OEND, and overdose reversals. Pharmacists cited inadequate training, time constraints, reimbursement issues, and stigma as barriers that hindered naloxone service implementation. CONCLUSION: This systematic review found robust evidence regarding pharmacist-based naloxone services beyond community pharmacy settings. Future programs should use targeted approaches to help pharmacists overcome barriers and enhance naloxone services. Additional research is needed to evaluate pharmacist naloxone services by using rigorous methodologies (e.g., larger sample sizes, RCT designs).

COVID-19 vaccination among pregnant people in the United States: a systematic review.

OBJECTIVE: Pregnant people are at increased risk of COVID-19-related morbidity and mortality, and vaccination presents an important strategy for preventing negative outcomes. However, pregnant people were not included in vaccine trials, and there are limited data on COVID-19 vaccines during pregnancy. The objectives of this systematic review were to identify the safety, immunogenicity, effectiveness, and acceptance of COVID-19 vaccination among pregnant people in the United States. DATA SOURCES: Four databases (PubMed, Web of Science, CINAHL, and Google Scholar) were used to identify eligible studies published from January 1, 2020 through February 6, 2022. STUDY ELIGIBILITY CRITERIA: Inclusion criteria were peer-reviewed empirical research conducted in the United States, publications in English, and research addressing 1 of the following topics: safety, immunogenicity, effectiveness, and acceptance of COVID-19 vaccination among pregnant people. METHODS: A narrative synthesis approach was used to synthesize findings. Critical appraisal was done using the JBI (formerly Joanna Briggs Institute) tool. RESULTS: Thirty-two studies were identified. Most studies (n=24) reported the use of Pfizer and Moderna COVID-19 vaccines among pregnant people; only 6 reported the Janssen vaccine. Of the 32 studies, 11 examined COVID-19 vaccine safety, 10 investigated immunogenicity and effectiveness, and 11 assessed vaccine acceptance among pregnant people. Injection-site pain and fatigue were the most common adverse events. One case study reported immune thrombocytopenia. COVID-19 vaccination did not increase the risk of adverse pregnancy or neonatal outcomes compared with unvaccinated pregnant people. After COVID-19 vaccination, pregnant people had a robust immune response, and vaccinations conferred protective immunity to newborns through breast milk and placental transfer. COVID-19 vaccine acceptance was low among pregnant people in the United States. African American race, Hispanic ethnicity, younger age, low education, previous refusal of the influenza vaccine, and lack of provider counseling were associated with low vaccine acceptance. CONCLUSION: Peer-reviewed studies support COVID-19 vaccine safety and protective effects on pregnant people and their newborns. Future studies that use rigorous methodologies and include diverse populations are needed to confirm current findings. In addition, targeted and tailored strategies are needed to improve vaccine acceptance, especially among minorities.

Comparative and combined effectiveness of innovative therapies in cancer: a literature review.

To achieve therapeutic innovation in oncology, already expensive novel medicines are often concomitantly combined to potentially enhance effectiveness. While this aggravates the pricing problem, comparing effectiveness of novel yet expensive (concomitant) treatments is much needed for healthcare decision-making to deliver effective but affordable treatments. This study reviewed published clinical trials and real-world studies of targeted and immune therapies. In total, 48 studies compared and/or combined multiple novel products on breast, colorectal, lung and melanoma cancers. To a great extent, products evaluated in each study were owned by one manufacturer. However, cross-manufacturer assessments are also needed. Next to costs and intensive market competition, the absence of a regulatory framework enforcing real-world multiproduct studies prevents these from being conducted. Trusted third parties could facilitate such real-world studies, for which appropriate and efficient data access is needed.