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OBJECTIVES: Adherence to medications is important for the management of chronic diseases. Although the proportion of days covered (PDC) is a common metric for measuring adherence, it may be insufficient to distinguish relevant differences in medication-taking behavior. Group-based trajectory models (GBTMs) have been used to better represent adherence over time. This study aims to examine adherence patterns 1 year after initiation among users of sodium-glucose cotransporter 2 (SGLT2) inhibitors using GBTMs and evaluate the ability of baseline characteristics to predict adherence trajectory. STUDY DESIGN: SGLT2 inhibitor new-user cohort study from 2014 to 2018. METHODS: We calculated 12-month PDC and categorized patients with PDC of 80% or greater as adherent. We performed multivariable logistic regression on adherence status controlling for baseline covariates. GBTMs were fit to identify adherence patterns 12 months following SGLT2 inhibitor initiation. Five multinomial logistic regression models including different subsets of predictors were used to predict adherence trajectory group assignment. RESULTS: In a cohort of 228,363 SGLT2 inhibitor users, the mean PDC was 57%, with 36% of the cohort being adherent. Overall, women and patients with anxiety or depression were less likely to be adherent. Six patterns of SGLT2 inhibitor adherence were identified with GBTMs: 1 fill (PDC = 0.08), early discontinuation (PDC = 0.22), consistently low adherence (PDC = 0.35), moderate adherence (PDC = 0.48), high adherence (PDC = 0.79), and near-perfect adherence (PDC = 0.95). All prediction models showed poor predictive accuracy (0.35). CONCLUSIONS: We found wide variation in adherence patterns among SGLT2 inhibitor users in a national cohort. Predictors from a health care claims database were unable to accurately predict adherence trajectory.
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Diabetes Mellitus Tipo 2 , Cumplimiento de la Medicación , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Femenino , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Estudios de Cohortes , Anciano , Adulto , Estados Unidos , Modelos LogísticosRESUMEN
The COVID-19 pandemic was associated with increases in the prevalence of depression and anxiety among children and young adults. We studied whether the pandemic was associated with changes in prescription benzodiazepine use. We conducted a population-based study of benzodiazepine dispensing to children and young adults ≤ 24 years old between January 1, 2013, and June 30, 2022. We used structural break analyses to identify the pandemic month(s) when changes in prescription benzodiazepine dispensing occurred, and interrupted time series models to quantify changes in dispensing following the structural break and compare observed and expected benzodiazepine use. A structural break occurs where there is a sudden change in the trend of a time series. We observed an immediate decline in benzodiazepine dispensing of 23.6 per 100,000 (95% confidence interval [CI]: -33.6 to -21.2) associated with a structural break in April 2020, followed by a monthly decrease in the trend of 0.3 per 100,000 (95% CI: -0.74 to 0.14). Lower than expected benzodiazepine dispensing rates were observed each month of the pandemic from April 2020 onward, with relative percent differences ranging from - 7.4% (95% CI: -10.1% to - 4.7%) to -20.9% (95% CI: -23.2% to -18.6%). Results were generally similar in analyses stratified by sex, age, neighbourhood income quintile, and urban versus rural residence. Further research is required to understand the clinical implications of these findings and whether these trends were sustained with further follow-up.
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Several new classes of medications for diabetes have recently become available newer medication classes have been increasing in use. It is unclear how their utilization varied across provinces and how the COVID-19 pandemic may have affected these trends. Our objective was to investigate Canada-wide and province-specific trends in diabetes medication dispensed by drug class over time, while also examining the impact of the COVID-19 pandemic and related restrictions on diabetes medication dispensing. We conducted a repeated cross-sectional analysis study. Data were obtained from IQVIA's CompuScript database for Canada-wide prescription dispensing patterns in primary care from January 2018 to December 2021. Drug classes of interest were biguanides dipeptidyl peptidase 4 inhibitors, sulfonylurea's, insulins, sodium-glucose co-transporter 2 inhibitors, and glucagon-like peptide-1 receptor agonists. We examined trends before and after the onset of the pandemic with special attention to changes during periods of high COVID-19 activity. Most drug classes displayed a stable number of prescriptions each month throughout, except for glucagon-like peptide-1 receptor agonists and sodium-glucose co-transporter 2 inhibitors, which demonstrated a consistent pattern of increased dispensing. Sodium-glucose co-transporter inhibitors and glucagon-like peptide-1 receptor agonists exhibited the greatest growth over the examined period, of 7.9% and 5.0% increases, respectively. For sodium-glucose co-transporter 2 inhibitors, Prince Edward Island (4.0%) displayed the greatest growth while Ontario showed the least (2.5%). For glucagon-like peptide-1 receptor analogs, Saskatchewan (11.3%) displayed the greatest growth and Newfoundland the least (4.5%). The pandemic did not impact overall dispensing trends. However, spikes in COVID-19 cases corresponded to changes in dispensing for most drug classes. Important variations across Canada in guideline-recommended medication classes seems to be increasing over time. This is likely due to differing formulary listing and access to drug coverages. If so, future research could explore national formulary harmonization across Canada and health outcomes for patients with diabetes.
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COVID-19 , Hipoglucemiantes , Humanos , Estudios Transversales , COVID-19/epidemiología , Hipoglucemiantes/uso terapéutico , Canadá/epidemiología , Prescripciones de Medicamentos/estadística & datos numéricos , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/epidemiología , Pautas de la Práctica en Medicina/tendencias , Pautas de la Práctica en Medicina/estadística & datos numéricos , Inhibidores de la Dipeptidil-Peptidasa IV/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , SARS-CoV-2 , Pandemias , Compuestos de Sulfonilurea/uso terapéutico , Insulina/uso terapéuticoRESUMEN
Janus Kinase (JAK) inhibitors have emerged as a novel category of medications to treat a variety of immune-mediated conditions. However, limited insight exists regarding the impact of safety concerns on their usage and prescribing practices. Therefore, the objective of this study was to describe the utilization of JAK-inhibitors in Canada, both nationally and within individual provinces. We used data from IQVIA's Compuscript database. We conducted a repeated cross-sectional study of all JAK-inhibitor units dispensed in retail pharmacies (tofacitinib, ruxolitinib, baricitinib, and upadacitinib) within the ten Canadian provinces from July 1, 2016, to June 30, 2022. Throughout Canada, outpatient pharmacies dispensed an estimated total of 26,126,409 JAK-inhibitor units between 2016 and 2022, averaging 9,431 units dispensed per 100,000 population. All provinces had increasing rates of JAK-inhibitor units dispensed over time, whereby between July 2021 to June 2022, New Brunswick exhibited the highest rates (27,696 units per 100,000), and Prince Edward Island demonstrated the lowest rates (10,065 units per 100,000). In this study, utilization of JAK-inhibitors increased in Canada over the study period, evident at both provincial and national levels. Variability in JAK-inhibitor utilization between provinces underscores the necessity for further investigations to ascertain appropriate usage practices. Key Points ⢠From 2016 to 2022, an estimated total of 26,126,409 JAK-inhibitor units were dispensed in retail pharmacies across Canada, with an average rate of 9,431 units dispensed for every 100,000 people in the population. ⢠Tofacitinib was the most dispensed JAK-inhibitor during the entire study period, making up 76% of all units dispensed. Ruxolitinib, upadacitinib, and baricitinib made up 16%, 7.9%, and 1.1% of the JAK-inhibitor units dispensed, respectively. ⢠The variance in provincial adoption of JAK-inhibitors across Canada might be influenced by several factors, including drug coverage availability, disease prevalence, and physician prescribing patterns.
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OBJECTIVE: Digital substance use treatment programs present an opportunity to provide nonresidential care for people with problematic substance use. In June 2021, the provincial government in Ontario provided free access to Breaking Free Online (BFO), a digital behavioral change program for people with substance use disorders. METHODS: An observational study was conducted with retrospective data to characterize clients' use and engagement patterns in BFO and examine changes in self-reported outcomes. RESULTS: In total, 6,370 individuals registered for BFO between June 2021 and October 2022, of whom 3,650 completed the intake assessment. Most of these clients were self-referred (64%), with 37% having been referred by health service providers. More than one-half of the clients (52%) resided in Ontario West or East regions. Support for addressing problematic alcohol use was the most requested program (40%). By October 2022, about 44% of the clients had completed between one and four of 12 program strategies. Analysis revealed significant changes in pre-post scores across four validated scales (p<0.001), indicating a decrease in anxiety and depression, an increase in quality of life, an improvement in recovery progression, and a decrease in severity of symptoms associated with substance use disorders. CONCLUSIONS: BFO clients with higher completion rates had the most improvement across the scales used; however, clients with lower and medium completion rates also had improvements. Because of the shame and stigma associated with substance use, digital supports with low barriers to entry can help support the autonomy, privacy, and preferences of individuals seeking help for problematic substance use.
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Background: There is limited knowledge on international trends in topical calcineurin inhibitor (TCI) utilization. Objective: To describe international TCI utilization trends from 2012 to 2019 and evaluate the relationship of country-level economic status, geographic location, and atopic dermatitis (AD) disease burden with drug utilization. Methods: We used IQVIA MIDAS® pharmaceutical quarterly sales data to attain country-level purchasing of TCIs in grams from 2012 to 2019. A multivariable linear regression estimated the association between countries' sociodemographic index (SDI), AD disability-adjusted life year (DALY) rates, and geographic location with TCI utilization. Results: A total of 68 countries were included in our analysis. From 2012 to 2019, overall TCI utilization increased by 66% but remained 11.2 times higher in high-sociodemographic compared with low-middle/low-sociodemographic countries. SDI and geographic location were associated with greater TCI utilization in multivariable analyses, whereas AD DALY rates were not. High-SDI countries used 21,476 grams (95% confidence interval [CI]: 11,915 to 31,036) and high-middle SDI countries used 9,403 grams (95% CI: -393 to 19,200) more TCIs per 100,000 people compared with low-middle/low-SDI countries, respectively. Northern hemisphere countries used 8,588 grams more TCIs per 100,000 people (95% CI: 612 to 16,564). Conclusions: We demonstrated greater TCI utilization among high-SDI compared with lower SDI countries.
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OBJECTIVES: To evaluate whether providing family physicians with feedback on their antibiotic prescribing compared with that of their peers reduces antibiotic prescriptions. To also identify effects on antibiotic prescribing from case-mix adjusted feedback reports and messages emphasising antibiotic associated harms. DESIGN: Pragmatic, factorial randomised controlled trial. SETTING: Primary care physicians in Ontario, Canada PARTICIPANTS: All primary care physicians were randomly assigned a group if they were eligible and actively prescribing antibiotics to patients 65 years or older. Physicians were excluded if had already volunteered to receive antibiotic prescribing feedback from another agency, or had opted out of the trial. INTERVENTION: A letter was mailed in January 2022 to physicians with peer comparison antibiotic prescribing feedback compared with the control group who did not receive a letter (4:1 allocation). The intervention group was further randomised in a 2x2 factorial trial to evaluate case-mix adjusted versus unadjusted comparators, and emphasis, or not, on harms of antibiotics. MAIN OUTCOME MEASURES: Antibiotic prescribing rate per 1000 patient visits for patients 65 years or older six months after intervention. Analysis was in the modified intention-to-treat population using Poisson regression. RESULTS: 5046 physicians were included and analysed: 1005 in control group and 4041 in intervention group (1016 case-mix adjusted data and harms messaging, 1006 with case-mix adjusted data and no harms messaging, 1006 unadjusted data and harms messaging, and 1013 unadjusted data and no harms messaging). At six months, mean antibiotic prescribing rate was 59.4 (standard deviation 42.0) in the control group and 56.0 (39.2) in the intervention group (relative rate 0.95 (95% confidence interval 0.94 to 0.96). Unnecessary antibiotic prescribing (0.89 (0.86 to 0.92)), prolonged duration prescriptions defined as more than seven days (0.85 (0.83 to 0.87)), and broad spectrum prescribing (0.94 (0.92 to 0.95)) were also significantly lower in the intervention group compared with the control group. Results were consistent at 12 months post intervention. No significant effect was seen for including emphasis on harms messaging. A small increase in antibiotic prescribing with case-mix adjusted reports was noted (1.01 (1.00 to 1.03)). CONCLUSIONS: Peer comparison audit and feedback letters significantly reduced overall antibiotic prescribing with no benefit of case-mix adjustment or harms messaging. Antibiotic prescribing audit and feedback is a scalable and effective intervention and should be a routine quality improvement initiative in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04594200.
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Antibacterianos , Retroalimentación , Médicos de Atención Primaria , Pautas de la Práctica en Medicina , Anciano , Femenino , Humanos , Masculino , Antibacterianos/uso terapéutico , Prescripciones de Medicamentos/estadística & datos numéricos , Prescripciones de Medicamentos/normas , Ontario , Servicios Postales , Pautas de la Práctica en Medicina/estadística & datos numéricosRESUMEN
Niraparib was recently funded in Canada for the maintenance treatment of ovarian cancer following platinum-based chemotherapy. However, the drug's safety profile in the real world remains uncertain. We conducted a cohort study to describe the patient population using niraparib and the proportion that experienced adverse events between June 2019 and December 2022 in four Canadian provinces (Ontario, Alberta, British Columbia [BC], and Quebec). We used administrative data and electronic medical records from Ontario Health, Alberta Health Services, and BC Cancer, and registry data from Exactis Innovation. We summarized baseline characteristics using descriptive statistics and reported safety outcomes using cumulative incidence. We identified 514 patients receiving niraparib. Mean age was 67 years and most were initiated on a daily dose of 100 or 200 mg/day. Grade 3/4 anemia, neutropenia, and thrombocytopenia occurred in 11-16% of the cohort. In Ontario, the three-month cumulative incidence of grade 3/4 thrombocytopenia was 11.6% (95% CI, 8.3-15.4%), neutropenia was 7.1% (95% CI, 4.6-10.4%), and anemia was 11.3% (95% CI, 8.0-15.2%). Cumulative incidences in the remaining provinces were similar. Initial daily dose and proportions of hematological adverse events were low in the real world and may be related to cautious prescribing and close monitoring by clinicians.
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Indazoles , Neoplasias Ováricas , Piperidinas , Humanos , Femenino , Neoplasias Ováricas/tratamiento farmacológico , Indazoles/uso terapéutico , Indazoles/efectos adversos , Anciano , Piperidinas/uso terapéutico , Piperidinas/efectos adversos , Persona de Mediana Edad , Canadá , Estudios de Cohortes , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Anciano de 80 o más Años , Piperazinas/uso terapéuticoRESUMEN
BACKGROUND: Evidence for worsening mental health among individuals with intellectual and developmental disabilities (IDD) during COVID-19 sparked concerns for increased use of psychoactive medications. OBJECTIVE: To examine the impact of COVID-19 on psychoactive medication use and clinical monitoring among individuals with IDD in Ontario, Canada. METHODS: We conducted a repeated cross-sectional study among individuals with IDD and examined weekly trends for psychoactive medication dispensing and outpatient physician visits among those prescribed psychoactive medications between April 7, 2019, and March 25, 2023. We used interventional autoregressive integrated moving average models to determine the impact of the declaration of emergency for COVID-19 (March 17, 2020) on the aforementioned trends. RESULTS: The declaration of emergency for COVID-19 did not significantly impact psychoactive medication use among individuals with IDD. Provision of clinical monitoring remained relatively stable, apart from a short-term decline in the weekly rate of outpatient physician visits following the declaration of emergency for COVID-19 (step estimate: 21.26 per 1000 individuals [p < 0.01]; ramp estimate: 0.88 per 1000 individuals [p = 0.01]). When stratified by mode of delivery, there was a significant shift towards virtual care (step estimate: 78.80 per 1000 individuals; p < 0.01). The weekly rate of in-person physician visits gradually increased, returning to rates observed prior to the COVID-19 pandemic in January 2023. CONCLUSION: Although access to clinical care remained relatively stable, the shift towards virtual care may have negatively impacted those who encounter challenges communicating via virtual mediums. Future research is required to identify the support systems necessary for individuals with IDD during virtual health care interactions.
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BACKGROUND: High-quality primary care is associated with better health outcomes and more efficient and equitable health system performance. However, the rate of primary care attachment is falling, and timely access to primary care is worsening, driving many patients to use walk-in clinics for their comprehensive primary care needs. This study sought to explore the experiences and perceived roles and responsibilities of walk-in physicians in this current climate. Methods: Qualitative interviews were conducted with nineteen physicians currently providing walk-in care in Ontario, Canada between May and December 2022. RESULTS: Limited capacity for continuity and comprehensiveness of care were identified as major sources of professional tension for walk-in physicians. Divergent perspectives on their roles were anchored in how physicians viewed their professional identity. Some saw providing continuous and comprehensive care as an infringement on their professional role; others saw their professional role as more flexible and responsive to population needs. Regardless of their professional identity, participants reported feeling ill-equipped to manage the swell of unattached patients, citing a lack of time, resources, connectivity to the system, and remuneration flexibility. Conclusions: As practice demands of walk-in clinics change, an evolution in the professional roles and responsibilities of walk-in physicians follows. However, the resources, structure, and incentives of walk-in care have not evolved to reflect this, leaving physicians to set their own professional boundaries with patients. This results in increasing variations in care and confusion across the primary care sector around who is responsible for what, when, and how.
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Accesibilidad a los Servicios de Salud , Atención Primaria de Salud , Humanos , Ontario , Masculino , Femenino , Persona de Mediana Edad , Rol del Médico , Adulto , Instituciones de Atención Ambulatoria , Actitud del Personal de Salud , Médicos/psicologíaRESUMEN
STUDY DESIGN: Descriptive repeated-cross sectional retrospective longitudinal cohort study. OBJECTIVE: To investigate the impact of the COVID-19 pandemic on homecare services in individuals with traumatic or non-traumatic Spinal Cord Injury (SCI). SETTING: Health administrative database in Ontario, Canada. METHODS: A repeated cross-sectional study using linked health administrative databases from March 2015 to June 2022. Monthly homecare utilization was assessed in 3381 adults with SCI using Autoregressive Integrated Moving Average (ARIMA) models. RESULTS: Compared to pre-pandemic levels, between March 2020 to June 2022, the traumatic group experienced a decrease in personal and/or homemaking services, as well as an increase in nursing visits from April 2020-March 2022 and June 2022. Case management increased at various times for the traumatic group, however therapies decreased in May 2020 only. The non-traumatic group experienced a decrease in personal and/or homemaking services in July 2020, as well as an increase in nursing visits from March 2020 to February 2021 and sporadically throughout 2020. Case management also increased at certain points for the non-traumatic group, but therapies decreased in April 2020, July 2020, and September 2021. CONCLUSION: The traumatic group had decreases in personal and/or homemaking services. Both groups had increases in nursing services, increases in case management, and minimal decreases in therapies at varying times during the pandemic. Investigation is warranted to understand the root cause of these changes, and if they resulted in adverse outcomes.
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COVID-19 , Servicios de Atención de Salud a Domicilio , Traumatismos de la Médula Espinal , Humanos , Traumatismos de la Médula Espinal/epidemiología , Traumatismos de la Médula Espinal/terapia , COVID-19/epidemiología , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Adulto , Estudios Transversales , Ontario/epidemiología , Estudios Longitudinales , Anciano , Manejo de CasoRESUMEN
Background: Actinic Keratoses (AK) are precancerous lesions that can lead to Squamous Cell Carcinoma. International differences in the utilization of topical medications to treat AK are not well described. Objectives: To describe international differences in topical AK medication utilization, including associations of countries' economic status with AK medication utilization. Methods: We used IQVIA MIDAS pharmaceutical sales data for 65 countries (42 high-income, 24 middle-income) from April 2011 to December 2021. We calculated each country's quarterly utilization of medications in grams per 1000 population. We used univariable linear regression to assess the association between country economic status and AK medication utilization. Results: High-income countries used 15.37 more grams per 1000 population of 5-fluorouracil (95% CI: 9.68, 21.05), 4.64 more grams per 1000 population of imiquimod (95% CI: 3.45, 5.83), and 0.32 more grams per 1000 population of ingenol mebutate (95% CI: 0.05, 0.60). Limitations: Missing medication utilization data for some countries. Conclusion: High-income countries use more topical AK therapies than middle-income countries.
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BACKGROUND: The drug toxicity crisis continues to accelerate across Canada, with rapid increases in opioid-related harms following the onset of the COVID-19 pandemic. We sought to describe trends in the burden of opioid-related deaths across Canada throughout the pandemic, comparing these trends by province or territory, age, and sex. METHODS: We conducted a repeated cross-sectional analysis of accidental opioid-related deaths between Jan. 1, 2019, and Dec. 31, 2021, across 9 Canadian provinces and territories using aggregated national data. Our primary measure was the burden of premature opioid-related death, measured by potential years of life lost. Our secondary measure was the proportion of all deaths attributable to opioids; we used the Cochrane-Armitage test for trend to compare proportions. RESULTS: Between 2019 and 2021, the annual number of opioid-related deaths increased from 3007 to 6222 and years of life lost increased from 126 115 to 256 336 (from 3.5 to 7.0 yr of life lost per 1000 population). In 2021, the highest number of years of life lost was among males (181 525 yr) and people aged 30-39 years (87 045 yr). In 2019, we found that 1.7% of all deaths among those younger than 85 years were related to opioids, rising to 3.2% in 2021. Significant increases in the proportion of deaths related to opioids were observed across all age groups (p < 0.001), representing 29.3% and 29.0% of deaths among people aged 20-29 and 30-39 years in 2021, respectively. INTERPRETATION: Across Canada, the burden of premature opioid-related deaths doubled between 2019 and 2021, representing more than one-quarter of deaths among younger adults. The disproportionate loss of life in this demographic group highlights the critical need for targeted prevention efforts.
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Analgésicos Opioides , Pandemias , Adulto , Masculino , Humanos , Analgésicos Opioides/efectos adversos , Canadá/epidemiología , Estudios Transversales , Mortalidad PrematuraRESUMEN
BACKGROUND: Variations in primary care practices may explain some differences in health outcomes during the COVID-19 pandemic. We sought to evaluate the characteristics of primary care practices by the proportion of patients unvaccinated against SARS-CoV-2. METHODS: We conducted a population-based, cross-sectional cohort study using linked administrative data sets in Ontario, Canada. We calculated the percentage of patients unvaccinated against SARS-CoV-2 enrolled with each comprehensive-care family physician, ranked physicians according to the proportion of patients unvaccinated, and identified physicians in the top 10% (v. the other 90%). We compared characteristics of family physicians and their patients in these 2 groups using standardized differences. RESULTS: We analyzed 9060 family physicians with 10 837 909 enrolled patients. Family physicians with the largest proportion (top 10%) of unvaccinated patients (n = 906) were more likely to be male, to have trained outside of Canada, to be older, and to work in an enhanced fee-for-service model than those in the remaining 90%. Vaccine coverage (≥ 2 doses of SARS-CoV-2 vaccine) was 74% among patients of physicians with the largest proportion of unvaccinated patients, compared with 87% in the remaining patient population. Patients in the top 10% group tended to be younger and live in areas with higher levels of ethnic diversity and immigration and lower incomes. INTERPRETATION: Primary care practices with the largest proportion of patients unvaccinated against SARS-CoV-2 served marginalized communities and were less likely to use team-based care models. These findings can guide resource planning and help tailor interventions to integrate public health priorities within primary care practices.
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COVID-19 , SARS-CoV-2 , Humanos , Masculino , Femenino , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19 , Estudios Transversales , Pandemias , Médicos de Familia , Ontario/epidemiología , Estudios de Cohortes , Atención Primaria de SaludRESUMEN
BACKGROUND: Alpha-1 receptor antagonists may interfere with IL-6 signaling and could therefore be a potential treatment for COVID-19. However, the effectiveness of these drugs in mitigating the risk of clinical deterioration among non-hospitalized patients with COVID-19 is unknown. OBJECTIVES: The aim of this study is to examine the association between alpha-1 antagonist exposure and the 30-day risk of a hospital encounter or death in nonhospitalized patients with COVID-19. METHODS: We conducted a population-based cohort study of Ontario residents aged 35 years and older who were eligible for public drug coverage and who had a positive test for SARS-CoV-2 between January 1, 2020, and March 1, 2021. We matched each individual receiving an alpha-1 antagonist at the time of their positive test with two non-exposed individuals using propensity scores. Our outcome was a composite of a hospital admission, emergency department visit, or death, 1 to 30 days following the positive test. RESULTS: We matched 3289 alpha-1 antagonist exposed patients to 6189 unexposed patients. Overall, there was no difference in the 30-day risk of the primary outcome among patients exposed to alpha-1 antagonists at the time of their diagnosis relative to unexposed individuals (28.8% vs. 28.0%; OR 1.00, 95% CI 0.91 to 1.11). In a secondary analysis, individuals exposed to alpha-1 antagonists had a lower risk of death in the 30 days following a COVID diagnosis (OR 0.79; 95% CI 0.66 to 0.93). CONCLUSION: Alpha-1 antagonists did not mitigate the 30-day risk of clinical deterioration in non-hospitalized patients with COVID-19. Our findings do not support the general repurposing of alpha-1 antagonists as a treatment for such patients, although there may be subgroups of patients in whom further research is warranted.
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Importance: Drug shortages are a chronic and worsening issue that compromises patient safety. Despite the destabilizing impact of the COVID-19 pandemic on pharmaceutical production, it remains unclear whether issues affecting the drug supply chain were more likely to result in meaningful shortages during the pandemic. Objective: To estimate the proportion of supply chain issue reports associated with drug shortages overall and with the COVID-19 pandemic. Design, Setting, and Participants: This longitudinal cross-sectional study used data from the IQVIA Multinational Integrated Data Analysis database, comprising more than 85% of drug purchases by US pharmacies from wholesalers and manufacturers, from 2017 to 2021. Data were analyzed from January to May 2023. Exposure: Presence of a supply chain issue report to the US Food and Drug Administration or the American Society of Health-Systems Pharmacists (ASHP). Main Outcomes and Measures: The main outcome was drug shortage, defined as at least 33% decrease in units purchased within 6 months of a supply chain issue report. Random-effects logistic regression models compared the marginal odds of shortages for drugs with vs without reports. Interaction terms assessed heterogeneity prior to vs during the COVID-19 pandemic and by drug characteristics (formulation, age, essential medicine status, clinician- vs self-administered, sales volume, and number of manufacturers). Results: A total of 571 drugs exposed to 731 supply chain issue reports were matched to 7296 comparison medications with no reports. After adjusting for drug characteristics, 13.7% (95% CI, 10.4%-17.8%) of supply chain issue reports were associated with subsequent drug shortages vs 4.1% (95% CI, 3.6%-4.8%) of comparators (marginal odds ratio [mOR], 3.7 [95% CI, 2.6-5.1]). Shortages increased among both drugs with and without reports in February to April 2020 (34.2% of drugs with supply chain issue reports and 9.5% of comparison drugs; mOR, 4.9 [95% CI, 2.1-11.6]), and then decreased after May 2020 (9.8% of drugs with reports and 3.6% of comparison drugs; mOR, 2.9 [95% CI, 1.6-5.3]). Significant associations were identified by formulation (parenteral mOR, 1.9 [95% CI, 1.1-3.2] vs oral mOR, 5.4 [95% CI, 3.3-8.8]; P for interaction = .008), WHO essential medicine status (essential mOR, 2.2 [95% CI, 1.3-5.2] vs nonessential mOR, 4.6 [95% CI, 3.2-6.7]; P = .02), and for brand-name vs generic status (brand-name mOR, 8.1 [95% CI, 4.0-16.0] vs generic mOR, 2.4 [95% CI, 1.7-3.6]; P = .002). Conclusions and Relevance: In this national cross-sectional study, supply chain issues associated with drug shortages increased at the beginning of the COVID-19 pandemic. Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk.
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COVID-19 , Humanos , Estados Unidos/epidemiología , COVID-19/epidemiología , Pandemias , Estudios Transversales , Preparaciones Farmacéuticas , Medicamentos GenéricosRESUMEN
PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2024 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2024 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, endocrine drugs, generics, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2024 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2023, overall pharmaceutical expenditures in the US grew 13.6% compared to 2022, for a total of $722.5 billion. Utilization (a 6.5% increase), new drugs (a 4.2% increase) and price (a 2.9% increase) drove this increase. Semaglutide was the top drug in 2023, followed by adalimumab and apixaban. Drug expenditures were $37.1 billion (a 1.1% decrease) and $135.7 billion (a 15.0% increase) in nonfederal hospitals and clinics, respectively. In clinics, increased utilization drove growth, with a small impact from price and new products. In nonfederal hospitals, a drop in utilization led the decrease in expenditures, with price and new drugs modestly contributing to growth in spending. Several new drugs that will influence spending are expected to be approved in 2024. Specialty, endocrine, and cancer drugs will continue to drive expenditures. CONCLUSION: For 2024, we expect overall prescription drug spending to rise by 10.0% to 12.0%, whereas in clinics and hospitals we anticipate an 11.0% to 13.0% increase and a 0% to 2.0% increase, respectively, compared to 2023. These national estimates of future pharmaceutical expenditure growth may not be representative of any health system because of the myriad of local factors that influence actual spending.
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Costos de los Medicamentos , Gastos en Salud , Medicamentos bajo Prescripción , Estados Unidos , Humanos , Medicamentos bajo Prescripción/economía , Costos de los Medicamentos/tendencias , Gastos en Salud/tendencias , Gastos en Salud/estadística & datos numéricos , Aprobación de Drogas , Predicción , Bases de Datos FactualesRESUMEN
Multi-criteria decision analysis (MCDA) is a value assessment tool designed to help support complex decision-making by incorporating multiple factors and perspectives in a transparent, structured approach. We developed an MCDA rating tool, consisting of seven criteria evaluating the importance and feasibility of conducting potential real-world evidence (RWE) studies aimed at addressing uncertainties stemming from initial cancer drug funding recommendations. In collaboration with the Canadian Agency for Drugs and Technologies in Health's Provincial Advisory Group, a validation exercise was conducted to further evaluate the application of the rating tool using RWE proposals varying in complexity. Through this exercise, we aimed to gain insight into consensus building and deliberation processes and to identify efficiencies in the application of the rating tool. An experienced facilitator led a multidisciplinary committee, consisting of 11 Canadian experts, through consensus building, deliberation, and prioritization. A total of nine RWE proposals were evaluated and prioritized as low (n = 4), medium (n = 3), or high (n = 2) priority. Through an iterative process, efficiencies and recommendations to improve the rating tool and associated procedures were identified. The refined MCDA rating tool can help decision-makers prioritize important and feasible RWE studies for research and can enable the use of RWE for the life-cycle evaluation of cancer drugs.
Asunto(s)
Antineoplásicos , Técnicas de Apoyo para la Decisión , Humanos , Canadá , Antineoplásicos/uso terapéutico , Neoplasias/tratamiento farmacológico , Evaluación de la Tecnología Biomédica/métodos , ConsensoRESUMEN
OBJECTIVES: To assess the distribution and spending by cost-effectiveness category among those drugs with the highest public spending levels in Canada. DESIGN: Repeated cross-sectional study. SETTING: The Canadian provinces of Manitoba, Ontario, New Brunswick, Nova Scotia, Prince Edward Island and Newfoundland. MAIN OUTCOMES AND MEASURES: Cost-effectiveness assessments by the Canadian Agency for Drugs and Technologies in Health (CADTH) for top-100 brand-name outpatient drugs by gross public plan spending in any year between 2015 and 2021 in Canada Institute for Health Information's National Prescription Drug Utilization Information System data. Gross public plan spending by cost-effectiveness category. RESULTS: From 2015 to 2021, 152 brand-name drugs occupied a top-100 rank and were included in the analysis. Of those, 117 had been assessed by CADTH. During the 7-year period, there was an increase in both top-100 drugs with cost-effective (from 18 to 24) and cost-ineffective (from 29 to 41) assessments, while drugs not assessed or with an unclear assessment declined (from 31 to 19 and from 22 to 16, respectively). As a share of spending on top-100 drugs with an assessment, spending on cost-effective drugs was mostly stable at 40%-46% from 2015 to 2021, while spending on cost-ineffective drugs increased from 30% to 45%. CONCLUSION: A large and growing share of public drug spending has been allocated to cost-ineffective drugs in Canada. Dedicating large budgets to such treatments prevents spending with greater health impact elsewhere in the healthcare system and could restrain the capacity to pay for groundbreaking pharmaceutical innovation in the future.
Asunto(s)
Presupuestos , Costos de los Medicamentos , Humanos , Canadá , Estudios Transversales , Análisis Costo-Beneficio , OntarioRESUMEN
BACKGROUND: Across Canada, the COVID-19 pandemic occurred amidst an ongoing drug toxicity crisis. Although elevated rates of substance-related harms have been observed nationally, it remains unknown if the pandemic state of emergency led to disproportionate increases in opioid toxicities among people with opioid use disorder (OUD) compared to those without. METHODS: We conducted a population-based repeated cross-sectional time series analysis of fatal and non-fatal opioid toxicities between January 1, 2014, and December 31, 2021, in Ontario, Canada. We used interventional autoregressive integrated moving average models to examine the impact of the pandemic on monthly rates of opioid toxicities per 100,000 Ontario residents stratified by people with and without OUD. RESULTS: We identified 80,296 opioid toxicities of which 53.5 % occurred among people with OUD. Among 52,052 unique individuals, 60.5 % were male and 46.2 % were 25-44 years old. Between January 2014 and December 2021, the rate of opioid toxicities increased from 2.6 to 10.5 per 100,000 (rate ratio [RR]=4.07). The magnitude of this increase differed among people with OUD (0.8 to 7.4 per 100,000; RR=9.35) and without OUD (1.8 to 3.1 per 100,000; RR=1.74). We observed a significant ramp increase in the overall rate of opioid toxicities following the declaration of the pandemic emergency in March 2020 (+0.19 per 100,000 monthly, 95 % CI: 0.029, 0.36, p = 0.021). In a stratified analysis, we found a similar ramp increase among people with OUD (+0.19 per 100,000 monthly, 95 % CI: 0.10, 0.28, p < 0.001); however, this was not observed among people without OUD (p = 0.95). CONCLUSIONS: The rate of opioid toxicities accelerated across Ontario following the pandemic-related state of emergency, with the majority of this increase among people with OUD. The important differences observed among people with OUD compared with those without, highlights the critical need for improved access to harm reduction and treatment interventions among this population.