Developing an Ethics and Policy Framework for Psychedelic Clinical Care: A Consensus Statement.

Importance: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice. Objective: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice. Evidence Review: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 broad topics: research ethics issues; managing expectations and informed consent; therapeutic ethics; training, education, and licensure of practitioners; equity and access; and appropriate role of gatekeeping. Attendees with relevant expertise presented on each topic, followed by group discussion. Meeting organizers (A.L.M., I.G.C., D.S.) drafted a summary of the discussion and recommendations, noting points of consensus and disagreement, which were discussed and revised as a group. Findings: This consensus statement reports 20 points of consensus across 5 ethical issues (reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping), with corresponding relevant actors who will be responsible for implementation. Areas for further research and deliberation are also identified. Conclusions and Relevance: This consensus statement focuses on the future of government-approved medical use of psychedelic medicines in the US and abroad. This is an incredibly exciting and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.

Systematic Review of Outcomes for Assessment of Medication Adherence Enhancing Interventions: An ISPOR Special Interest Group Report.

OBJECTIVES: The lack of universal guidance on outcome measures for evaluating medication adherence enhancing interventions (MAEIs) poses a challenge for assessing their effectiveness. This literature review aimed to provide a systematic overview of outcome measures currently used for the value assessment of MAEIs. METHODS: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and searched MEDLINE, PsycINFO, Scopus, CINAHL, and Academic Search Complete for randomized and nonrandomized clinical trials, prospective cohort studies, model-based economic evaluations, and value frameworks published in English between January 2010 and September 2020. Two independent reviewers screened all titles and abstracts, followed by a full-text review. Due to the large number of relevant studies, data extraction was limited to articles published between January 2018 and September 2020. We collected data on the general characteristics of the study, the type of intervention, and the outcomes measured. RESULTS: We screened 14 685 records and identified 308 articles for data extraction. Behavioral interventions were the most common (n = 143), followed by educational interventions (n = 110) and mixed-method interventions (n = 73). Outcomes were clustered into 7 categories with medication adherence (n = 286) being the most frequently measured, followed by clinical outcomes (n = 155), health-related quality of life (n = 57), resource use (n = 43), patient satisfaction (n = 31), economic outcomes (n = 18), and other outcomes (n = 76). CONCLUSIONS: Various outcomes measures have been used to evaluate MAEIs, with only a small number of studies exploring economic and patient-reported outcomes. Future research is warranted to develop a consensus-based set of criteria for assessing MAEIs to facilitate the comparison of interventions and enable informed decision making.

Attitudes, Beliefs, and Perceptions on Cannabis Among Older Adults Aged 65 and Older: A cross-sectional Survey.

OBJECTIVE: With the rise of medical and recreational cannabis use among older adults, concerns about the potential risks and benefits of cannabis use are increasing. This pilot study aimed to determine the attitudes, beliefs, and perceptions of older adults toward cannabis as a medicinal product, to establish a foundation for future research on how healthcare providers communicate with this population regarding cannabis. METHODS: A cross-sectional survey was conducted on adults aged 65 and older living in Philadelphia. The survey included questions related to participants' demographics, knowledge, attitudes, beliefs, and perceptions of cannabis. Participants were recruited via flyer distributions, publications in newsletters, and a local newspaper. Surveys were conducted from December 2019 through May 2020. Quantitative data were presented using counts, mean, median, and percentages, and qualitative data were analyzed by categorizing common responses. RESULTS: The study aimed to recruit 50 participants, of whom 47 met the requirements, and had their data analyzed, resulting in an average age of 71 years. The majority of participants were male (53%) and Black (64%). Seventy-six percent of participants considered cannabis a highly important treatment for older adults, and 42% considered themselves highly knowledgeable about cannabis. Over half of the participants reported being asked about tobacco (55%) or alcohol (57%) use by their PCP compared to 23% being asked about cannabis. Participants indicated that they most commonly turned to the internet and social media for information about cannabis, while only a small number mentioned relying on their primary care physician (PCP) for such information. DISCUSSION: The results of this pilot study highlight the need for accurate and reliable information about cannabis for older adults and their healthcare providers. As the use of cannabis as a therapy continues to rise, it is crucial for healthcare providers to address misconceptions and encourage older adults to seek out evidence-based research. Further research is needed to explore healthcare providers' perceptions of cannabis therapy and how they can better educate older adults.

Baseline characteristics and secondary medication adherence among Medicare patients diagnosed with transthyretin amyloid cardiomyopathy and/or receiving tafamidis prescriptions: A retrospective analysis of a Medicare cohort.

BACKGROUND: Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed, life-threatening condition that mostly affects older persons. In May 2019, regulatory approval of tafamidis provided the first pharmacologic treatment of ATTR-CM. In the pivotal phase 3 Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT), 97.2% of patients were classified as adherent (defined as taking ≥ 80% of scheduled doses). Given its recent approval, there is limited real-world evidence examining patient adherence to tafamidis. OBJECTIVE: To evaluate adherence patterns, demographics, and clinical characteristics of patients in the United States receiving tafamidis prescriptions through Medicare. Secondarily, we aimed to evaluate concomitant medications filled by this patient population. METHODS: We conducted a retrospective cohort study of US Medicare claims data, limited by the Health Insurance Portability and Accountability Act of 1996, in adult patients with an adjudicated pharmacy claim for tafamidis (tafamidis free acid 61-mg capsule once daily or tafamidis meglumine four 20-mg capsules once daily) between May 1, 2019, and June 30, 2021. Gaps in therapy were measured using day gaps between prescription refills and continuous measure of medication gaps. Implementation adherence was assessed through modified medication possession ratio (MPRm), medication refill adherence (MRA), and proportion of days covered (PDC). Patients were grouped based on Medicare coverage. Patients were analyzed by subgroups based on age and at the zip code level, via distressed communities index quartiles and rural-urban tiers. RESULTS: A total of 3,558 patients who received a prescription fill of a tafamidis formulation were identified using Medicare Fee-for-Service (FFS) and Medicare Advantage (MA) claims data from May 1, 2019, to June 30, 2021. The characteristics of this patient population were consistent with published literature, as 98.6% were older than 65 years, 53.4% were between 75 years and 84 years, and 81.5% were male. In the patient population receiving tafamidis refills, adherence was high across all 3 measures, with mean MPRm greater than 90% and mean MRA greater than 80%, across all age groups. Mean PDC adherence rates were 79% or more across all age groups. Concomitant medications were generally indicated for heart failure and thrombosis. Among monotherapy groups with similar demographic makeup, adherence was significantly higher among users of tafamidis free acid vs tafamidis meglumine (P < 0.0001 across all mean adherence measures). CONCLUSIONS: Our results demonstrate that real-world adherence to tafamidis in the Medicare population is high, regardless of age, zip code-level socioeconomic quartile, or geography. Adherence was higher among patients receiving tafamidis free acid, suggesting that the enhanced convenience of a single capsule once daily may positively contribute to adherence among patients with ATTR-CM. DISCLOSURES: Darrin Benjumea is an employee of Genesis Research who has been contracted by Pfizer, Inc., for involvement in this study. Andrew Peterson is an employee of University of the Sciences who has been contracted by Pfizer, Inc., for involvement in this study. Zach Bredl is an employee of Care Journey who has been contracted by Pfizer, Inc., for involvement in this study. Anuja Roy, Nick Marchant, Jose Alvir, Rahul Bhambri, Jason Kemner, and Bhash Parasuraman are employees of Pfizer, Inc., and own stock and/or stock options. This study was supported by Pfizer, Inc.

What Justifies the Allocation of Health Care Resources to Patients with Disorders of Consciousness?

This paper critically engages ethical issues in the allocation of novel, and potentially costly, health care resources to patients with disorders of consciousness. First, we review potential benefits of novel health care resources for patients and their families and outline preliminary considerations to address concerns about cost. We then address two problems regarding the allocation of health care resources to patients with disorders of consciousness: (1) the problem of uncertain moral status; and (2) the problem of accurately measuring the welfare burdens these resources would relieve. We conclude by suggesting that opportunity-based frameworks might complement standard approaches for justifying resources allocation to patients with disorders of consciousness.

Public attitudes toward allocating scarce resources in the COVID-19 pandemic.

The general public is subject to triage policies that allocate scarce lifesaving resources during the COVID-19 pandemic, one of the worst public health emergencies in the past 100 years. However, public attitudes toward ethical principles underlying triage policies used during this pandemic are not well understood. Three experiments (preregistered; online samples; N = 1,868; U.S. residents) assessed attitudes toward ethical principles underlying triage policies. The experiments evaluated assessments of utilitarian, egalitarian, prioritizing the worst-off, and social usefulness principles in conditions arising during the COVID-19 pandemic, involving resource scarcity, resource reallocation, and bias in resource allocation toward at-risk groups, such as the elderly or people of color. We found that participants agreed with allocation motivated by utilitarian principles and prioritizing the worst-off during initial distribution of resources and disagreed with allocation motivated by egalitarian and social usefulness principles. At reallocation, participants agreed with giving priority to those patients who received the resources first. Lastly, support for utilitarian allocation varied when saving the greatest number of lives resulted in disadvantage for at-risk or historically marginalized groups. Specifically, participants expressed higher levels of agreement with policies that shifted away from maximizing benefits to one that assigned the same priority to members of different groups if this mitigated disadvantage for people of color. Understanding these attitudes can contribute to developing triage policies, increase trust in health systems, and assist physicians in achieving their goals of patient care during the COVID-19 pandemic.

Association of Medication Adherence with Hospital Utilization and Costs Among Elderly with Diabetes Enrolled in a State Pharmaceutical Assistance Program.

BACKGROUND: Medication adherence is crucial for the successful treatment among elderly patients with diabetes taking oral antidiabetic medications (OAMs). Cost of medications, lack of insurance coverage, and low income are major contributing factors towards medication nonadherence. State pharmaceutical assistance programs (SPAPs) provide medications at little or no cost to income-eligible patients and have potential to improve medication adherence among elderly patients. Despite this, limited research has focused on the association of medication adherence with health care utilization among elderly patients enrolled in SPAPs, and inclusion of health care costs as an outcome is even rarer. OBJECTIVE: To evaluate the relationship between adherence to OAMs and hospital utilization and costs among elderly patients with diabetes who were enrolled in a SPAP. METHODS: This retrospective observational study included elderly patients with diabetes enrolled in Pennsylvania's Pharmaceutical Assistance Contract for the Elderly (PACE) program in 2015. Medication adherence was estimated as the proportion of days covered (PDC; adherent: PDC≥80%, nonadherent: PDC < 80%). Hospital utilization and costs were estimated using hospital discharge records from the Pennsylvania Health Care Cost Containment Council. Multiple adjusted regression analyses were used to examine the association of medication adherence with hospital utilization (all-cause and diabetes-related number of inpatient hospital visits and length of stay [LOS]) and costs. RESULTS: Among 9,497 elderly PACE enrollees with diabetes, 81% were adherent, and 21% were hospitalized. Compared with adherent patients, patients who were nonadherent to OAMs had twice the odds of all-cause and diabetes-related hospitalization. Controlling for covariates, nonadherent patients had 27% more all-cause (95% CI = 9%-36%) and 21% more diabetes-related (95% CI = 5%-40%) hospital visits than adherent patients. Covariate-adjusted LOS for nonadherent patients was 24% longer than that of adherent patients for all-cause hospitalization (95% CI = 1.171-1.311) and 12.7% longer for diabetes-related hospitalization (95% CI = 1.036-1.227). Medication nonadherence was associated with significantly greater all-cause ($22,670 vs. $16,383; P < 0.0001) and diabetes-related ($13,518 vs. $12,634; P = 0.0003) hospitalization costs. CONCLUSIONS: Among SPAP-enrolled elderly patients, nonadherence to OAMs was significantly associated with increased risk of hospitalization, longer hospital stays, and greater hospitalization costs. Attention is needed to improve medication adherence among elderly receiving financial assistance to pay their prescriptions to reduce economic burden on the health care system. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose.

The pharmacist and pharmacy have evolved to become more than the corner drugstore: a win for vaccinations and public health.

Perhaps under acknowledged in the adult immunization delivery system are pharmacists. Depending on the state, pharmacists can assess and administer vaccines to patients under vaccination protocols, standing orders or with a physician's prescription for vaccination. As most individuals live within miles of a community pharmacy that offer accessibility, broad operating hours, and lack of visit fees or few requirements for appointments, the role of the local community pharmacy and pharmacists has evolved. Many pharmacies have embraced immunizations as a service offering seasonal influenza and often a range of Advisory Committee on Immunization Practices-recommended vaccines across the lifespan. Pharmacists are moving away from strictly product distribution to supporting public health and prevention, experiencing tremendous growth and expansion of services across the public health and primary care spectrum. Pharmacies are using vaccination services as a strategy to transform and advance community pharmacy, shaping a model that provides greater convenience and access to vaccines and other preventive services benefiting population and public health while seeking to optimize health outcomes and control health-care costs.

Towards the assessment of quality of life in patients with disorders of consciousness.

PURPOSE: To generate foundational knowledge in the creation of a quality-of-life instrument for patients who are clinically diagnosed as being in a vegetative or minimally conscious state but are able to communicate by modulating their brain activity (i.e., behaviourally nonresponsive and covertly aware). The study aimed to identify a short list of key domains that could be used to formulate questions for an instrument that determines their self-reported quality of life. METHODS: A novel two-pronged strategy was employed: (i) a scoping review of quality-of-life instruments created for patient populations sharing some characteristics with patients who are behaviourally nonresponsive and covertly aware was done to compile a set of potentially relevant domains of quality of life; and (ii) a three-round Delphi consensus process with a multidisciplinary panel of experts was done to determine which of the identified domains of quality of life are most important to those who are behaviourally nonresponsive and covertly aware. Five expert groups were recruited for this study including healthcare workers, neuroscientists, bioethicists, quality-of-life methodologists, and patient advocates. RESULTS: Thirty-five individuals participated in the study with an average response rate of 95% per round. Over the three rounds, experts reached consensus on 34 of 44 domains (42 domains were identified in the scoping review and two new domains were added based on suggestions by experts). 22 domains were rated as being important for inclusion in a quality-of-life instrument and 12 domains were deemed to be of less importance. Participants agreed that domains related to physical pain, communication, and personal relationships were of primary importance. Based on subgroup analyses, there was a high degree of consistency among expert groups. CONCLUSIONS: Quality of life should be a central patient-reported outcome in all patient populations regardless of patients' ability to communicate. It remains to be determined how covertly aware patients perceive their circumstances and quality of life after suffering a life-altering injury. Nonetheless, it is important that any further dialogue on what constitutes a life worth living should not occur without direct patient input.

Alive inside.

This article provides an ethical analysis of the U.S. practice guideline update on disorders of consciousness. Our analysis focuses on the guideline's recommendations regarding the use of investigational neuroimaging methods to assess brain-injured patients. Complex and multifaceted ethical issues have emerged because these methods alter the clinical understanding of consciousness. We address issues of false hope, patient suffering, and cost. We argue that, in spite of these concerns, there is significant benefit to using neuroimaging to assess brain-injured patients in most cases.

Mapping pharmacy deserts and determining accessibility to community pharmacy services for elderly enrolled in a State Pharmaceutical Assistance Program.

OBJECTIVES: Limited studies have investigated geographic accessibility to a nearby community pharmacy for elderly which is an essential determinant of the access to medications and pharmacy services. This research identified pharmacy deserts and investigated availability of different types of community pharmacies and their services for elderly enrolled in a State Pharmaceutical Assistance Program (SPAP). METHODS: The state of Pennsylvania in the US was used as a case to demonstrate the geographic accessibility to community pharmacy and services for elderly enrolled in SPAP. The locations of community pharmacies and households of elderly enrolled in SPAP were derived from Pharmaceutical Assistance Contract for the Elderly programs' database. The street addresses were geocoded and the distance to a nearby community pharmacy was calculated for study sample using the haversine formula. The demographic and geographic data were aggregated to Census Tracts and pharmacy deserts were identified using the predefined criteria. Descriptive statistical analysis was used to determine whether there are statistical differences in the socio-demographic profiles and distribution of different types of community pharmacies and their services in pharmacy deserts and non-deserts. This research used hot spot analyses at county level to identify clusters of pharmacy deserts, areas with high concentration of different racial/ethnic groups and clusters of high densities of chain and independent pharmacies. RESULTS: The Spatial analysis revealed that 39% and 61% Census Tracts in Pennsylvania were pharmacy deserts and non-deserts respectively (p < 0.001). Pharmacy deserts were found to have significantly more females, married and white elderly and fewer blacks and Hispanics compared to pharmacy non-deserts. Pharmacy deserts had significantly fewer chain and independent pharmacies and less delivery and 24-hour services in pharmacies than pharmacy non-deserts. Hot spot analyses showed that clusters of pharmacy deserts were more concentrated in southcentral, northwest and northeast regions of the state which represent rural areas and overlapped with clusters of high concentration of white individuals. CONCLUSIONS: The findings suggest that urban-rural inequality, racial/ethnic disparity and differences in availability of pharmacies and their services exist between pharmacy deserts and non-deserts. The methodological approach and analyses used in this study can also be applied to other public health programs to evaluate the coverage and breadth of public health services.

A Nationwide Assessment of the Emergency Department Management of Acute Urinary Retention Due to Urethral Stricture.

OBJECTIVE: To evaluate the nationwide practice patterns of the management of acute urinary retention (AUR) secondary to urethral stricture (US) in an emergency department (ED) setting. MATERIALS AND METHODS: We used the 2006-2010 Nationwide Emergency Department Sample to identify men with US who received treatment for AUR. We excluded patients with benign prostatic hyperplasia, vesicourethral anastomotic stenosis, neurogenic bladder, and bladder cancer. Primary outcome was urethral dilation or suprapubic tube (SPT) placement as initial AUR management. Patient demographics and hospital factors were also examined. Multivariate logistic regression was performed to examine factors associated with initial AUR management. RESULTS: We identified 4794 weighted ED encounters of men with US who underwent urethral dilation or SPT placement for AUR. Mean age was 58.6 ± 0.8 years. A total of 4084 (85%) men received urethral dilation, whereas 710 had SPT (15%) placement. In bivariate analysis, patients who received SPT were likely to be younger (P <.001), treated in recent years (P = .002), and in hospitals in the West region (P = .003). In multivariate analysis, SPT placement was significantly associated with younger age (P = .004), public insurance (P = .03), recent treatment years (P = .02), and hospitals in the West region (P = .02). Income and hospital teaching status did not have significant association with initial treatment choice. CONCLUSION: Urethral dilation remains the most common urologic intervention in the ED for AUR due to US; however, there is an increasing trend toward SPT placement. Patients who are younger, publicly insured, or who receive care in the West region are more likely to receive a SPT for initial treatment of AUR due to US.

Initial Medication Adherence in the Elderly Using PACE Claim Reversals: A Pilot Study.

BACKGROUND: The Medicare Modernization Act, with its requirements for Medicare Part D to comply with electronic prescribing (e-prescribing), bolstered the adoption of e-prescribing, which increased to 73% in 2013. Therefore, understanding whether electronic prescriptions are less likely to be picked up is important as e-prescribing continues to be emphasized. OBJECTIVE: To assess whether prescription origin is among the factors associated with initial medication adherence, using claim reversals as a proxy measure. METHODS: A cross-sectional study was completed using a sample of reversed claims from the Pharmaceutical Assistance Contract for the Elderly (PACE) program for September 2014. The total number of reversed claims for new prescriptions (15,966) was categorized by prescription origin (written, telephone, electronic, fax, and pharmacy). Using a chi-square analysis, the reversed claims were compared among prescription origin to determine if there is a difference in the proportion of electronic prescriptions reversed compared with those from other origins. RESULTS: When compared with all other prescription origins, electronic prescriptions (E) were more likely to be reversed at day 0 (E = 50%, any other [AO] = 49%, P < 0.05) and after day 0 (E = 58%, AO = 42%, P < 0.05). CONCLUSIONS: Electronic prescriptions are associated with a higher rate of claim reversals and may reflect poorer initial adherence. Electronic prescriptions may more likely be forgotten or not picked up because they were not presented to the pharmacy by the patient. The growing adoption of electronic prescriptions merits particular attention, since it may be a factor in initial medication adherence in the elderly. DISCLOSURES: This study was not supported by any funding. Peterson reports advisory board and consultancy fees from IMS Health and Pfizer and employment by Genentech. Klaiman is currently employed by AccessMatters. No other financial or other conflicts of interests were reported. Study concept and design were primarily contributed by Forestal, along with Klaiman and Peterson. Heller took the lead in data collection, along with Forestal, and data interpretation was performed by Forestal, Klaiman, and Peterson. Forestal, Klaiman, and Heller were responsible for manuscript preparation.

Initial Medication Adherence in the Elderly Using PACE Claim Reversals: A Pilot Study.

BACKGROUND: The Medicare Modernization Act, with its requirements for Medicare Part D to comply with electronic prescribing (e-prescribing), bolstered the adoption of e-prescribing, which increased to 73% in 2013. Therefore, understanding whether electronic prescriptions are less likely to be picked up is important as e-prescribing continues to be emphasized. OBJECTIVE: To assess whether prescription origin is among the factors associated with initial medication adherence, using claim reversals as a proxy measure. METHODS: A cross-sectional study was completed using a sample of reversed claims from the Pharmaceutical Assistance Contract for the Elderly (PACE) program for September 2014. The total number of reversed claims for new prescriptions (15,966) was categorized by prescription origin (written, telephone, electronic, fax, and pharmacy). Using a chi-square analysis, the reversed claims were compared among prescription origin to determine if there is a difference in the proportion of electronic prescriptions reversed compared with those from other origins. RESULTS: When compared with all other prescription origins, electronic prescriptions (E) were more likely to be reversed at day 0 (E = 50%, any other [AO] = 49%, P < 0.05) and after day 0 (E = 58%, AO = 42%, P < 0.05). CONCLUSIONS: Electronic prescriptions are associated with a higher rate of claim reversals and may reflect poorer initial adherence. Electronic prescriptions may more likely be forgotten or not picked up because they were not presented to the pharmacy by the patient. The growing adoption of electronic prescriptions merits particular attention, since it may be a factor in initial medication adherence in the elderly. DISCLOSURES: This study was not supported by any funding. Peterson reports advisory board and consultancy fees from IMS Health and Pfizer and employment by Genentech. Klaiman is currently employed by AccessMatters. No other financial or other conflicts of interests were reported. Study concept and design were primarily contributed by Forestal, along with Klaiman and Peterson. Heller took the lead in data collection, along with Forestal, and data interpretation was performed by Forestal, Klaiman, and Peterson. Forestal, Klaiman, and Heller were responsible for manuscript preparation.

Weight Management Counseling for Wrestling Athletes.

Helping a wrestler manage body weight can be a daunting process for a pediatric health care provider. Each high school wrestling program has been mandated by the National Federation of State High School Associations to determine an appropriate weight classification for each individual wrestler. This article discusses how an appropriate weight class is determined, the methods for ascertaining a person's hydration status and body density, and the importance of a fully hydrated and normally nourished state that will allow for optimal athletic performance for a wrestler.

The Impact of HbA1c Testing on Total Annual Healthcare Expenditures Among Newly Diagnosed Patients with Diabetes.

BACKGROUND: In 2010, diabetes was the seventh leading cause of death in the United States. Diabetes also imposes a huge financial burden on the US economy. In 2009, the American Diabetes Association International Expert Committee recommended the use of the glycated hemoglobin (HbA1c) test as a uniform diagnostic measure to identify patients with diabetes. Although HbA1c is a convenient diagnostic test, it is also more expensive than older tests and could, therefore, have an impact on patients' healthcare expenditures. OBJECTIVES: To determine if HbA1c testing has an impact on total annual healthcare expenditures among newly diagnosed patients with diabetes and to analyze the factors that are associated with the total healthcare expenditures among diabetic patients before and after HbA1c was implemented as a standard diagnostic factor. METHODS: This was an observational, retrospective, cross-sectional study. The Medical Expenditure Panel Survey-Household Component 2009 and 2011 databases were used to form the study cohort of patients with diabetes. The total mean healthcare expenditures among patients with diabetes formed the dependent variable. A proxy variable representing a diagnosis of diabetes with and without the use of HbA1c testing in 2009 and in 2011, respectively, formed the main independent variable along with demographic factors, comorbidities, and healthcare services utilization in both years. A generalized linear regression was conducted to determine the association of HbA1c testing with total diabetes-related healthcare expenditures. RESULTS: The mean total healthcare expenditure decreased in 2011 compared with 2009. The HbA1c test did not show an association with the total healthcare expenditures versus earlier diabetes-related diagnostic factors. The total expenditures were associated with private insurance, the incidence of a previous heart attack, prescription drug refills, inpatient hospital stays, home care, hospital discharges, and visits to outpatient providers and physicians in both years. CONCLUSIONS: The HbA1c diagnostic factor did not yield any association with diabetes healthcare expenditures. Although the total healthcare expenditures were reduced in 2011 compared with 2009, it cannot be established that the reduction in costs is solely attributed to the implementation of the HbA1c diagnostic criteria. Further research on healthcare expenditures for diabetic patients diagnosed with and without the use of HbA1c testing is warranted to establish any possible association.

Symptomatic Overlap and Therapeutic Opportunities in Primary Headache.

Headache, a nearly universal experience, remains costly, disabling, and often suboptimally managed. The most common presentations in the United States are migraine, tension-type headache (TTH) and "sinus" headache, but their extensive symptomatic overlap suggests that these conditions can be approached as variations in the same underlying pathology and managed accordingly. We use case studies of patients with varying prior diagnoses (none, migraine, TTH, and sinus headache), as well as a 4-question diagnostic screening tool, to illustrate how pharmacists can use this conceptual framework to simplify identification, management, and referral of patients with primary headache conditions of uncertain etiology.

A systematic literature review of psychosocial and behavioral factors associated with initial medication adherence: a report of the ISPOR medication adherence & persistence special interest group.

OBJECTIVES: Numerous factors influencing medication adherence in chronically ill patients are well documented, but the paucity of studies concerning initial treatment course experiences represents a significant knowledge gap. As interventions targeting this crucial first phase can affect long-term adherence and outcomes, an international panel conducted a systematic literature review targeting behavioral or psychosocial risk factors. METHODS: Eligible published articles presenting primary data from 1966 to 2011 were abstracted by independent reviewers through a validated quality instrument, documenting terminology, methodological approaches, and factors associated with initial adherence problems. RESULTS: We identified 865 potentially relevant publications; on full review, 24 met eligibility criteria. The mean Nichol quality score was 47.2 (range 19-74), with excellent reviewer concordance (0.966, P < 0.01). The most prevalent pharmacotherapy terminology was initial, primary, or first-fill adherence. Articles described the following factors commonly associated with initial nonadherence: patient characteristics (n = 16), medication class (n = 12), physical comorbidities (n = 12), pharmacy co-payments or medication costs (n = 12), health beliefs and provider communication (n = 5), and other issues. Few studies reported health system factors, such as pharmacy information, prescribing provider licensure, or nonpatient dynamics. CONCLUSIONS: Several methodological challenges synthesizing the findings were observed. Despite implications for continued medication adherence and clinical outcomes, relatively few articles directly examined issues associated with initial adherence. Notwithstanding this lack of information, many observed factors associated with nonadherence are amenable to potential interventions, establishing a solid foundation for appropriate ongoing behaviors. Besides clarifying definitions and methodology, future research should continue investigating initial prescriptions, treatment barriers, and organizational efforts to promote better long-term adherence.