Prevalence and nature of manufacturer-sponsored patient support programs for prescription drugs in Canada: a cross-sectional study.

BACKGROUND: Globally, pharmaceutical companies offer patient support programs in tandem with their products, which aim to enhance medication adherence and patient experience through education, training, support and financial assistance. We sought to identify the proportion and characteristics of such patient support programs in Canada and to describe the nature of supports provided. METHODS: We conducted a crosssectional study to identify and characterize all marketed prescription drugs available in Canada as of Aug. 23, 2022, using the Health Canada Drug Product and CompuScript databases. To describe the nature of supports provided, we conducted a content analysis of publicly available patient support program websites and Web-based documents. Using logistic regression, we identified characteristics of drugs associated with having a patient support program including brand-name or branded generic (generic medications with a proprietary name), orphan (medications for rare diseases) or biologic drug status; estimated total cost of prescriptions dispensed at retail pharmacies; and price per unit. RESULTS: Of the 2556 prescription drugs marketed by 89 companies in the study period, 256 (10.0%) had a patient support program in Canada. Many of the 89 drug manufacturers (n = 55, 61.8%) offered at least 1 patient support program, frequently relying on third-party administrators for delivery. Brandname and branded generic medications, biologic agents and drugs with orphan status were more likely to have a patient support program than generic drugs. Compared with drugs priced $1.01-$10.00 per unit, drugs priced $10.01-$100.00 per unit were nearly 8 times more likely to have a patient support program (adjusted odds ratio 7.54, 95% confidence interval 4.07- 14.64). Most sampled patient support programs included reimbursement navigation (n = 231, 90.2%) and clinical case management (n = 223, 87.1%). INTERPRETATION: About 1 in 10 drugs marketed in Canada has a manufacturersponsored patient support program, but these are concentrated around brand-name, branded generic, biologic and high-cost drugs, often for rare diseases. To understand the impact of patient support programs on health outcomes and sustainable access to cost-effective medicines, greater transparency and independent evaluation of patient support programs is necessary.

Impact of the COVID-19 Controlled Drugs and Substances Act exemption on pharmacist prescribing of opioids, benzodiazepines and stimulants in Ontario: A cross-sectional time-series analysis.

Background: Due to the coronavirus disease 2019 (COVID-19) pandemic, Health Canada issued an exemption to the Controlled Drugs and Substances Act (CDSA) on March 19, 2020, enabling pharmacists to act as prescribers of controlled substances to support continuity of care. Our study investigates utilization of the CDSA exemption by Ontario pharmacists with the intent to inform policy on pharmacist scope of practice and to improve future patient outcomes. Methods: We conducted a time-series analysis of pharmacist-prescribed opioid, benzodiazepine and stimulant claims data using Ontario Narcotics Monitoring System (NMS) data between January 2019 and December 2021. We used ARIMA modelling to measure the change to these classes of claims and to opioid claims containing quantities greater than a 30-day supply. Results: Postexemption, the average weekly number of pharmacist-prescribed opioid, benzodiazepine and stimulant claims rose by 146% (160 to 393 claims/week), 960% (49 to 515 claims/week) and 2150% (8 to 177 claims/week), respectively. There was a 2-week lag period between the time of announcement and the statistically significant increase in claims on April 5, 2020(p < 0.0001). The total number of claims for opioid quantities exceeding a 30-day supply decreased by 60%. Cumulative pharmacist-prescribed claims accounted for under 2% of the total NMS claims. Interpretation: Ontario pharmacists used the CDSA exemption but were prescribing at low rates. These findings suggest an effective change to pharmacy practice as the low rates show pharmacists used the exemption as a last line of defense. This may lead to further studies exploring treatment breaks during the COVID-19 pandemic and future changes to pharmacist scope to benefit patients.