Analyzing Potential Interactions Between Complementary and Alternative Therapies, Over-the-Counter, and Prescription Medications in the Older Population.

BACKGROUND: The escalating use of complementary and alternative medicine (CAM) raises concerns, particularly among geriatric patients taking multiple medications. Notably, the doubled chance of major drug interactions between prescription and over-the-counter (OTC) drugs in older adults underscores the need for further research. This study aimed to evaluate clinically significant CAM and prescription medication interactions in a geriatric clinic, emphasizing the growing importance of understanding CAM implications in health care. METHODS: A 2-year cross-sectional study, approved by the Institutional Review Board, enrolled 420 participants aged 65 and older from a geriatric primary care clinic. Participants completed a survey, and pharmacy students conducted chart reviews to evaluate potential CAM products and prescription medication interactions. RESULTS: Among the 420 participants-who were predominantly White females and who were taking supplements, OTC medications, or both-15.6% experienced potential drug interactions. Ginkgo biloba, garlic, and calcium were common contributors to major, moderate, and minor interactions, respectively, among supplements. Meanwhile, ibuprofen was among the contributors to major and moderate interactions among OTC medications. Most supplements and OTC medications were disclosed to health care professionals. However, there was a lack of investigation by health care professionals regarding CAM use, emphasizing a discrepancy between patient-reported and physician-inquired CAM usage. CONCLUSION: This study highlighted the significant use of CAM and/or OTC medications, particularly among vulnerable older adults, revealing a concerning 15.6% rate of potential drug interactions. The findings emphasized the need for awareness among health care practitioners and standardized CAM surveys to enhance accuracy and patient safety.

Prescription medication use in the 10 years prior to diagnosis of young onset Alzheimer's disease: a nationwide nested case-control study.

BACKGROUND: Patients with young onset Alzheimer's disease (YOAD) face long diagnostic delays. Prescription medication use may provide insights into early signs and symptoms, which may help facilitate timely diagnosis. METHODS: In a register-based nested case-control study, we examined medication use for everyone diagnosed with YOAD in a Danish memory clinic during 2016-2020 compared to cognitively healthy controls. Prescription medication use were grouped into 13 overall categories (alimentary tract and metabolism, blood and blood forming organs, cardiovascular system, dermatologicals, genitourinary system and sex hormones, systemic hormonal preparations, antiinfectives for systemic use, antineoplastic and immunomodulating agents, musculo-skeletal system, nervous system, antiparasitic products, respiratory system, and sensory organs). Further stratifications were done for predetermined subcategories with a use-prevalence of at least 5% in the study population. Conditional logistic regression produced odds ratios, which given the use of incidence-density matching is interpretable as incidence rate ratios (IRRs). The association between prescription medication use and subsequent YOAD diagnosis was examined in the entire 10-year study period and in three time-intervals. RESULTS: The study included 1745 YOAD cases and 5235 controls. In the main analysis, several overall categories showed significant associations with YOAD in one or more time-intervals, namely blood and blood forming organs and nervous system. Prescription medication use in the nervous system category was increased for YOAD cases compared to controls already 10->5 years prior to diagnosis (IRR 1.17, 95% CI 1.05-1.31), increasing to 1.57 (95% CI 1.39-1.78) in the year preceding diagnosis. This was largely driven by antidepressant and antipsychotic use, and especially prominent for first-time users. CONCLUSIONS: In this study, medication use in several categories was associated with YOAD. Onset of treatment-requiring psychiatric symptoms such as depression or psychosis in mid-life may serve as potential early indicators of YOAD.

Affordability and adherence gains for Medicare Part D low-income subsidy recipients when low-income subsidy benefits expanded in 2024.

BACKGROUND: The lowest-income beneficiaries enrolled in the Medicare Part D prescription drug program receive "full subsidies" that waive the premium and deductible and impose minimal copayments. Those with slightly higher incomes and assets may be eligible for "partial subsidies." Prior to 2024, individuals receiving partial subsidies faced reduced Part D premiums and deductibles and paid 15% coinsurance. Under provisions of the Inflation Reduction Act, recipients of partial subsidies were upgraded to full subsidies beginning in 2024. The objective of this pilot study was to assess whether the new policy is likely to reduce cost-related nonadherence to prescribed medications- a common problem faced by older adults even among those receiving subsidies. OBJECTIVE: To compare cost-related nonadherence among partial- vs full-subsidy recipients with similar characteristics. METHODS: We used 2019 Medicare Current Beneficiary Survey data for the study. The Medicare Current Beneficiary Survey is uniquely suited for this work because it contains administrative data on low-income subsidy enrollment plus extensive survey-based information on financial resources necessary to establish program eligibility and rates of cost-related nonadherence. Explanatory variables included sociodemographic characteristics, economic resources, work status, and health variables. RESULTS: We found that the partial-subsidy group reported significantly more cost-related nonadherence (39% vs 22%; P = 0.01) arising both from a lower propensity to fill some prescriptions (23% vs 12%; P = 0.03) and to more delays in filling others (29% vs 8%; P = 0.03). The differences were more pronounced for women and racial and ethnic minority groups in contrast to men and majority populations, respectively. Because the study samples were small, we could not conduct a detailed regression analysis. CONCLUSIONS: The magnitude of cost-related nonadherence effects associated with partial-subsidy cost sharing suggests that the Inflation Reduction Act policy to expand low-income subsidies may boost medication adherence, most notably among women and racial and ethnic minority groups.

Prescribed Drug Use and Aneurysmal Subarachnoid Hemorrhage Incidence: A Drug-Wide Association Study.

BACKGROUND AND OBJECTIVES: Current benefits of invasive intracranial aneurysm treatment to prevent aneurysmal subarachnoid hemorrhage (aSAH) rarely outweigh treatment risks. Most intracranial aneurysms thus remain untreated. Commonly prescribed drugs reducing aSAH incidence may provide leads for drug repurposing. We performed a drug-wide association study (DWAS) to systematically investigate the association between commonly prescribed drugs and aSAH incidence. METHODS: We defined all aSAH cases between 2000 and 2020 using International Classification of Diseases codes from the Secure Anonymised Information Linkage databank. Each case was matched with 9 controls based on age, sex, and year of database entry. We investigated commonly prescribed drugs (>2% in study population) and defined 3 exposure windows relative to the most recent prescription before index date (i.e., occurrence of aSAH): current (within 3 months), recent (3-12 months), and past (>12 months). A logistic regression model was fitted to compare drug use across these exposure windows vs never use, controlling for age, sex, known aSAH risk factors, and health care utilization. The family-wise error rate was kept at p < 0.05 through Bonferroni correction. RESULTS: We investigated exposure to 205 commonly prescribed drugs between 4,879 aSAH cases (mean age 61.4, 61.2% women) and 43,911 matched controls. We found similar trends for lisinopril and amlodipine, with a decreased aSAH risk for current use (lisinopril odds ratio [OR] 0.63, 95% CI 0.44-0.90, amlodipine OR 0.82, 95% CI 0.65-1.04) and an increased aSAH risk for recent use (lisinopril OR 1.30, 95% CI 0.61-2.78, amlodipine OR 1.61, 95% CI 1.04-2.48). A decreased aSAH risk in current use was also found for simvastatin (OR 0.78, 95% CI 0.64-0.96), metformin (OR 0.58, 95% CI 0.43-0.78), and tamsulosin (OR 0.55, 95% CI 0.32-0.93). By contrast, an increased aSAH risk was found for current use of warfarin (OR 1.35, 95% CI 1.02-1.79), venlafaxine (OR 1.67, 95% CI 1.01-2.75), prochlorperazine (OR 2.15, 95% CI 1.45-3.18), and co-codamol (OR 1.31, 95% CI 1.10-1.56). DISCUSSION: We identified several drugs associated with aSAH, of which 5 drugs (lisinopril and possibly amlodipine, simvastatin, metformin, and tamsulosin) showed a decreased aSAH risk. Future research should build on these signals to further assess the effectiveness of these drugs in reducing aSAH incidence. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that some commonly prescribed drugs are associated with subsequent development of aSAH.

Changes in Health Care and Prescription Medication Affordability in the US During the COVID-19 Pandemic.

Importance: In the US, the COVID-19 pandemic led to a significant rise in unemployment and economic loss that disproportionately impacted low-income individuals. It is unknown how health care and prescription medication affordability changed among low-income adults during the COVID-19 pandemic overall and compared with their higher-income counterparts. Objective: To evaluate changes in health care affordability and prescription medication affordability during the COVID-19 pandemic (2021 and 2022) compared with pre-COVID-19 pandemic levels (2019) and whether income-based inequities changed. Design, Setting, and Participants: This retrospective cross-sectional study included adults 18 years and older participating in the National Health Interview Survey (NHIS) in 2019, 2021, and 2022. Low-income adults were defined as having a household income of 200% or less of the federal poverty level (FPL); middle-income adults, 201% to 400% of the FPL; and high-income adults, more than 400% of the FPL. Data were analyzed from June to November 2023. Main Outcomes and Measures: Measures of health care affordability and prescription medication affordability. Results: The study population included 89 130 US adults. Among the weighted population, 51.6% (95% CI, 51.2-52.0) were female, and the mean (SD) age was 48.0 (0.12) years. Compared with prepandemic levels, during the COVID-19 pandemic, low-income adults were less likely to delay medical care (2022: 11.2%; 95% CI, 10.3-12.1; 2019: 15.4%; 95% CI, 14.3-16.4; adjusted relative risk [aRR], 0.73; 95% CI, 0.66-0.81) or avoid care (2022: 10.7%; 95% CI, 9.7-11.6; 2019: 14.9%; 95% CI, 13.8-15.9; aRR, 0.72; 95% CI, 0.64-0.80) due to cost, while high-income adults experienced no change, resulting in a significant improvement in income-based disparities. Low-income and high-income adults were less likely to experience problems paying medical bills but experienced no change in worrying about medical bills during the COVID-19 pandemic compared with prepandemic levels. Across measures of prescription medication affordability, low-income adults were less likely to delay medications (2022: 9.4%; 95% CI, 8.4-10.4; 2019: 12.7%; 95% CI, 11.6-13.9; aRR, 0.74; 95% CI, 0.65-0.84), not fill medications (2022: 8.9%; 95% CI, 8.1-9.8; 2019: 12.0%; 95% CI, 11.1-12.9; aRR, 0.75; 95% CI, 0.66-0.83), skip medications (2022: 6.7%; 95% CI, 5.9-7.6; 2019: 10.1%; 95% CI, 9.1-11.1; aRR, 0.67; 95% CI, 0.57-0.77), or take less medications (2022: 7.3%; 95% CI, 6.4-8.1; 2019: 11.2%; 95% CI, 10.%-12.2; aRR, 0.65; 95% CI, 0.56-0.74) due to costs, and these patterns were largely similar among high-income adults. Improvements in measures of health care and prescription medication affordability persisted even after accounting for changes in health insurance coverage and health care use. These patterns were similar when comparing measures of affordability in 2021 with 2019. Conclusions and Relevance: Health care affordability improved for low-income adults during the COVID-19 pandemic, resulting in a narrowing of income-based disparities, while prescription medication affordability improved for all income groups. These findings suggest that the recent unwinding of COVID-19 pandemic-related safety-net policies may worsen health care affordability and widen existing income-based inequities.

School closures and prescription medication use among children and adolescents before and during the COVID-19 pandemic in the USA, 2019-2022.

The impact of schools closing for in-person instruction in the USA during the COVID-19 pandemic on the use of prescription medications is not known. In this study, we examined changes in the total prescriptions filled, specifically for attention deficit hyperactivity disorder (ADHD) medications, among school-aged children and adolescents aged 10-19 years during periods before and after complete school closures between October 2019 and September 2022. Our findings indicate that complete school closures were associated with declines in the use of ADHD medications among younger populations in the USA. These findings suggest that the underuse of ADHD medications may be an overlooked contributor to declines in academic performance observed during periods of school closures during the COVID-19 pandemic.

Factors associated with the use of benzodiazepine and opioid prescription drug in the student population: a cross-sectional study.

The misuse of benzodiazepines and opioid medications is frequent in students. To improve our understanding of this behavior, we aimed to identify factors associated with separate and concomitant use of these substances. Anonymous self-reported questionnaires were e-mailed to students enrolled at a French university between March and July 2021, covering: sociodemographic characteristics, academics, psychoactive substance use, ADHD symptomatology (adulthood and childhood), and psychiatric/psychological or addiction follow-up. Factors associated with the use of benzodiazepines and opioid medications included female sex (OR = 1.41 [1.08; 1.86]) and OR = 1.38 [1.06; 1.79], respectively), older age (OR = 1.65 [1.04; 2.6] and OR = 2.17 [1.4; 3.36], respectively), current psychiatric/psychological follow-up (OR = 6.53 [5.18; 8.24] and OR= 1.5 [1.12; 2.0], respectively), ADHD symptomatology (OR= 2.33 [1.71;3.16] and OR= 1.61 [1.15; 2.24], respectively), polyconsumption (tobacco use for benzodiazepine users, OR = 1.38 [1.04; 1.82]; alcohol use OR = 1.67 [1.17; 2.39] and tobacco use OR = 1.62 [1.23; 2.14] for opioid users). These factors were even more strongly associated with the concomitant use of benzodiazepines and opioid medications: older age (OR = 3.64 [2.22; 5.99]), female sex (OR = 1.54 [1.1; 2.14]), grade repetition (OR = 1.7 [1.14; 2.54]), psychiatric/psychological follow-up (OR = 4.51 [3.35;6.06]), ADHD symptomatology (OR = 5.3 [3.69; 7.63]), polyconsumption (tobacco use OR = 2.05 [1.39; 3] and cannabis use, OR = 2.07 [1.97; 4.16]. The factors associated with the use of benzodiazepines and prescription opioids identified in this study could lead to the development of targeted prevention methods.

Patent Portfolios Protecting 10 Top-Selling Prescription Drugs.

Importance: Brand-name drugs are sold at high prices in the US during market exclusivity periods protected by patents. Multiple overlapping patents protecting a drug are known as patent thickets and can effectively delay the emergence of price-lowering generic competition for many years. Objective: To evaluate the composition of patent thickets of 10 top-selling prescription drugs in the US and compare the characteristics of drug patents filed during development with those filed on these products after US Food and Drug Administration (FDA) approval. Design and Setting: This cross-sectional study examined US patent thickets of the 10 prescription drugs with the highest US net sales revenue in 2021 using information on issued patents and patent applications as of June 30, 2022, obtained from a public database by the Initiative for Medicines, Access, and Knowledge. Data were analyzed from September 2022 to June 2023. Main Outcomes and Measures: Prevalence of patents filed before and after FDA approval; types of claims present in issued patents (ie, chemical composition, method of use, process or synthesis, formulation, and delivery device); and patent thicket density (number of active patents at a given time). Results: The 10 top-selling prescription drugs in the US for 2021 included 4 small-molecule drugs and 6 biologics. These 10 drugs were linked to 1429 patents and patent applications: 742 (52%) issued patents, 218 (15%) pending applications, and 469 (33%) abandoned applications. Almost three-quarters of patent applications (1028 [72%]) were filed after FDA approval. The postapproval proportion was higher for biologics (80%) than for small-molecule drugs (58%). Postapproval filing of patent applications peaked in the first 5 years after FDA approval for small-molecule drugs and 12 years after FDA approval for biologics. Of 465 patents issued for applications filed after FDA approval, 189 (41%) had method of use claims, 127 (27%) had formulation claims, and 103 (22%) had process or synthesis claims, while 86 (19%) had chemical composition claims and 46 (10%) had device claims. Patent thicket density peaked 13 years after FDA approval, at which time these 10 drugs were protected by a median (IQR) of 42 (18-83) active patents, 66% of which were filed after FDA approval. Conclusions and Relevance: This study found that among the 10 top-selling prescription drugs in the US in 2021, patents filed after FDA approval and containing claims covering aspects other than the active ingredient of the drug contributed to patent thickets. Scrutiny of patent applications and of patents filed after FDA approval is needed to facilitate timely generic or biosimilar competition.

Sustainability challenges concerning the effects of high-priced drugs on the day-to-day operations of community pharmacies in Finland.

BACKGROUND: High-priced drugs pose a challenge for health budgets, policies, and patient safety. One of the key roles of community pharmacies is to ensure availability to prescription drugs regardless of their price. This has been identified as challenging in certain situations concerning high-priced drugs. OBJECTIVES: The aim is to investigate the views of proprietary pharmacists regarding the effects of high-priced drugs on the day-to-day operations of pharmacies. METHODS: The data collection of the study was performed as a national cross-sectional online survey. The inclusion criteria were being a proprietary pharmacist and a member of the Association of Finnish Pharmacies. The survey contained questions yielding both quantitative and qualitative answers. The study focused on the qualitative data which was analysed by deductive thematic analysis. RESULTS: In total 604 proprietary pharmacists were sent the survey, and 174 eligible answers were included in the study, giving a response rate of 29%. The result describes the relationships between the economic, social, and environmental dimensions of sustainable development based on a framework by Wanamaker, with respect to high-priced drugs and community pharmacy operations as viewed by proprietary pharmacists. The main findings of the study show that proprietary pharmacists find the implementation of real-time reimbursement payments, a further reform of the pharmacy tax, and the abolishment of return bans to the wholesaler as risk mitigations and means to attain sustainability with respect to high-priced drugs and pharmacy practice. They experience that these changes would diminish high-priced drugs unnecessarily ending up as medical waste and improve the working conditions of the pharmacy staff by alleviating stress. CONCLUSIONS: According to the respondents, high-priced drugs pose challenges for community pharmacies and the legislation and reimbursement system need to adapt to these challenges. If not, community pharmacies in Finland continue to face severe financial declines based on the study results.

Federal Trade Commission Actions on Prescription Drugs, 2000-2022.

Importance: The Federal Trade Commission's (FTC) oversight role in the pharmaceutical market is critical to the health of patients and the health care system. This study characterized the FTC's policy on the pharmaceutical market in recent decades, identifying the types of actions it has favored, barriers it has faced, and authorities that remain untested. Objective: To review FTC legal actions in the pharmaceutical market from 2000-2022. Evidence Review: Legal actions were determined through manual review of search results from the FTC's online Legal Library as well as a 2023 FTC report on pharmaceutical actions. The alleged misconduct, type of legal action taken, timing, and outcome were collected from press releases, complaints, orders, and other legal documents. Findings: From 2000-2022, the FTC challenged 62 mergers, brought 22 enforcement actions against allegedly unlawful business practices, and made 1 rule related to pharmaceuticals. Alleged misconduct in enforcement actions involved anticompetitive settlements in patent litigation (n = 11), unilateral actions by brand manufacturers to delay generic competition (n = 6), noncompete agreements (n = 4), and monopolization (n = 3), with 10 outcomes involving monetary payment, totaling $1.6 billion. Of the 62 mergers the FTC challenged, 61 were allowed to continue, 58 after divesting certain drugs to third-party competitors. The FTC's reliance on drug divestitures decreased from 18 drugs per year from 2000-2017 to 4.3 per year from 2017-2023. Conclusions and Relevance: The FTC brought about 1 enforcement action and 3 merger actions per year against pharmaceutical manufacturers from 2000-2022, pursuing a small fraction of the estimated misconduct and consolidation in the pharmaceutical marketplace. Although the FTC faces substantial legal and practical limitations, important tools remain untested, including a rule defining "unfair methods of competition," that may allow it to more effectively prevent repetitive patterns of anticompetitive behavior.

Prescription medication use among patients with type 2 diabetes in the United States: 1999-2020.

AIMS: We aimed to examine trends in overall prescription medication use among patients with type 2 diabetes in the United States to provide insights for patient care. MATERIALS AND METHODS: We used nationally representative data from the National Health and Nutrition Examination Survey from 1999 to 2020 and included adult patients with type 2 diabetes. We examined the use of prescription drugs, overall and by drug class, polypharmacy (use of ≥5 medications), and number of medications attributed to specific classes. RESULTS: In the period 2015-2020, the mean patient age was 59.6 (51.0-70.0) years, with 46.8% (43.6-49.9) being female and 57.8% (52.8-62.8) being non-Hispanic White. Among 9489 adults with type 2 diabetes, the prevalence of polypharmacy was high and increased from 35.1% (31.6-38.6) in 1999-2002 to 47.2% (43.7-50.7) in 2003-2006, and further to 51.1% (48.3-53.9) in 2015-2020 (p for trend <0.001). Increasing trends of polypharmacy were found across all population subgroups and across the majority of therapeutic classes. Use of non-cardiometabolic medications was common. Among them, the most common were antidepressants (19.8%), proton pump inhibitors (19.0%) and analgesics (16.2%). Among patients with polypharmacy, approximately 40% of medication use was attributed to non-cardiometabolic medications. CONCLUSIONS: Prescription medication burden and complexity increased substantially among patients with type 2 diabetes, with more than 50% of patients with polypharmacy. Attention should be paid to this escalating medication use and regimen complexity, which requires multidisciplinary and coordinated care.

Rx -to- OTC switch increased access and lowered cost of topical adapalene.

Topical adapalene gel is an effective and well tolerated acne treatment that transitioned from prescription to over-the-counter (OTC) availability in 2016. Historically, prescription to OTC transitions have lowered costs to patients and payers and increased access to medications. This study used sales and prescriber data to assess access to topical retinoid therapies and their costs in the pre- and post- Rx-to-OTC transition. We demonstrate that the prescription to OTC transition of adapalene gel increased access to this medication, while lowering costs to patients and payers, including Medicare patients. These results provide a necessary call to action for future OTC shifts with other high safety profile, well-tolerated medications in ultimate efforts and hopes of cost savings for patients, insurers, and Medicare within our healthcare industry.

Substances in Counterfeit Prescription Pills Seized by Law Enforcement, 2017-2022.

This study examines substances identified during testing of counterfeit prescription pills seized by law enforcement in Rhode Island from 2017 to 2022.

The Cost of Medications at a Student-Run Free Clinic in New Haven, Connecticut, 2021-2023.

Introduction: Haven is a student-run free clinic in New Haven, Connecticut, that serves more than 500 patients annually. Haven's pharmacy department helps patients obtain medications by providing discount coupons or medications from the clinic's in-house pharmacy, directly paying for medications at local pharmacies, and delivering medications to patients' homes. This study aimed to identify prescriptions that have the highest cost among Haven patients. Methods: Our sample consisted of all Haven patients who attended the clinic from March 2021 through March 2023. Patients were eligible to be seen at Haven if they were aged 18 to 65 years, lacked health insurance, and lived in New Haven. We determined the lowest cost of each medication prescribed to Haven patients by comparing prices among local pharmacies after applying a GoodRx discount. We defined expensive medication as more than $20 per prescription. We excluded medical supplies. Results: Of the 594 Haven patients in our sample, 64% (n = 378) required financial assistance and 22% (n = 129) were prescribed at least 1 expensive medication. Among 129 patients prescribed an expensive medication, the mean (SD) age was 45.0 (12.3) years; 65% were women, and 87% were Hispanic or Latino. Median (IQR) household annual income was $14,400 [$0-$24,000]. We identified 246 expensive medications; the median (IQR) price per prescription was $31.43 ($24.00-$52.02). The most frequently prescribed expensive medications were fluticasone propionate/salmeterol (accounting for 6% of all expensive medications), medroxyprogesterone acetate (6%), albuterol sulfate (5%), and rosuvastatin (5%). Conclusion: The average Haven patient has an income well below the federal poverty level, and many have chronic cardiovascular and respiratory conditions that require expensive medications. Future research should work toward making medications universally affordable.

New trends of drug abuse in custodial settings: A systematic review on the misuse of over-the-counter drugs, prescription-only-medications, and new psychoactive substances.

The article presents a systematic literature review on the use and the psychiatric implications of over-the-counter drugs (OTC), prescription-only-medications (POM), and new psychoactive substances (NPS) within custodial settings. The searches wer carried out on 2 November 2022 on PubMed, Scopus, and Web of Science in line with PRISMA guidelines. A total of 538 records were identified, of which 37 met the inclusion criteria. Findings showed the most prevalent NPS and OTC and POM classes reported in prisons were synthetic cannabinoids receptor agonists (SCRAs) and opioids, respectively. NPS markets were shown to be in constant evolution following the pace of legislations aimed to reduce their spread. The use of such substances heavily impacts the conditions and rehabilitation of persons in custody, with consequent physical and mental health risks. It is important to raise awareness of the use and misuse of such substances in prisons (i) from an early warning perspective for law enforcement and policy makers (ii) to prompt doctors to cautiously prescribe substances that may be misused (iii) to improve and increase access to treatment provided (iv) to add such substances to routine toxicological screening procedures (v) to improve harm reduction programmes.

Consequences of cost barriers to prescriptions: cohort study in Aotearoa New Zealand.

AIMS: A NZ$5 co-payment prescription charge was removed in July 2023 but may be reinstated. Here we quantify the health impact and cost of not being able to afford this charge. METHODS: We linked New Zealand Health Surveys (2013/2014-2018/2019) to hospitalisation data using data available in Integrated Data Infrastructure (IDI). Cox proportional-hazards models compared time to hospitalisation between those who had faced a cost barrier to collecting a prescription and those who had not. RESULTS: Of the 81,626 total survey respondents, 72,243 were available for analysis in IDI. A further 516 were excluded to give an analysis dataset of 71,502. Of these, 5,889 (8.2%) reported not collecting a prescription due to cost in the previous year. Among people who faced a cost barrier, 60.0% (95% confidence interval [CI] 58.7-61.2%) were admitted to hospital during the study period, compared to 43.9% (95% CI 43.6-44.3%) of those who did not. Having adjusted for socio-demographic variables, people who faced a cost barrier were 34% (hazard ratio 1.34; 95% CI 1.29-1.39) more likely to be admitted to hospital than those who did not. Annual avoidable hospitalisation costs-were prescription co-payments to remain free-are estimated at $32.4 million per year based on the assumption of a causal relationship between unmet need for prescription medicines and subsequent hospitalisation. CONCLUSIONS: The revenue to the health system from co-payments may be offset by the costs associated with avoidable hospitalisations.

Role of Specialty Drugs in Rising Drug Prices for Medicare Part D.

Importance: Prices for brand-name drugs affect both federal spending and out-of-pocket liability for Medicare Part D enrollees. Objective: To examine how prices for brand-name drugs, net of rebates and discounts, have changed from 2010 to 2019 and to examine the role of specialty drugs in those changes. Design, Setting, and Participants: This study involved a descriptive analysis of prescription drug spending and prices between 2010 and 2019. The universe of prescription drug event data from those years were combined with confidential data from the Centers for Medicare & Medicaid Services on rebates and discounts that manufacturers and pharmacies pay to Medicare Part D plans to calculate rebate percentages, net spending, and net prices at the drug level. Specialty drugs were identified using information from IQVIA, allowing for a stratified analysis by specialty status. Data were analyzed from March 2019 to March 2024. Main Outcomes and Measures: Average prices (net of rebates and discounts in 2019 US dollars) and average annual price growth for brand-name prescription drugs, overall and separately for specialty and nonspecialty drugs. Results: Average net prices for brand-name drugs doubled from 2010 to 2019 (from $167 to $370). Growth in specialty drug prices was an underlying factor in those increases: average annual price growth was 13.2% for specialty drugs compared with 2.6% for nonspecialty drugs. Price growth for specialty drugs over the decade was smaller than what the Congressional Budget Office reported for the 2010 to 2015 period (increase of 22.3% per year vs 4.5% per year for nonspecialty drug prices), suggesting that price growth slowed after 2015. Drugs that treat hepatitis C contributed to that difference because prices for those drugs were initially high and then subsequently fell. Absent those drugs, price growth for specialty drugs averaged 18.1% in the first half of the decade and 6.9% in the second half. Conclusions and Relevance: Results of this study show that prices for specialty drugs have continued to increase over time in the Medicare Part D program, which contributes to high out-of-pocket liability for users of those drugs in addition to US federal budgetary expenditures.

Auditing the prescription drug consumer price index in a changing marketplace.

Changes in the dynamics of prescription drug markets have raised issues regarding whether the United States Bureau of Labor Statistics' (BLS') Prescription Drug Consumer Price Index (CPI-Rx) has adequately kept up with the evolving marketplace. The CPI-Rx limits its sampling frame to retail outpatient outlets and excludes prescription pharmaceuticals dispensed in non-retail settings such as hospitals, physician/clinic outpatient facilities, and nursing homes. Thus, the CPI-Rx overlooks the increasingly important specialty pharmaceuticals dispensed in non-retail settings, whose transactions are instead captured in the overall hospital and professional services component of the medical care CPI. Specialty drugs now account for about 55% of all U.S. drug spending, double the share of a decade earlier. To the extent specialty drug price growth differs from that of traditional pharmaceuticals, the CPI-Rx could provide an inaccurate measure of overall drug price inflation. We calculate a chained Laspeyres CPI using data from the Merative™ MarketScan® Databases for the years 2010-2019 and IQVIA-designated specialty drugs and offer evidence showing that by not sampling specialty drugs in non-retail settings, the CPI-Rx has understated overall U.S. prescription drug inflation by just under 75 basis points annually. We discuss implications for health care policy and suggest the BLS examine the feasibility of publishing an overall pharmaceutical price index incorporating both traditional and specialty pharmaceuticals dispensed in retail and non-retail settings.