Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary.

The approval and adoption of biosimilar products are essential to contain increasing healthcare costs and provide more affordable choices for patients. Despite steady progress in the number of the US Food and Drug Administration (FDA) biosimilar approvals over the years, biosimilar adoption in the United States has been slow and gradual, largely driven by payers rather than clinicians. In order to better understand the barriers to biosimilar adoption in the clinic, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA jointly hosted a virtual workshop on April 13, 2022, titled "Biosimilars: A Decade of Experience and Future Directions - Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology." This summary documents the experiences of four leading academic clinicians with specialties in oncology, rheumatology, gastroenterology, and endocrinology and their perspectives on how to increase biosimilar adoption, including the role of clinical pharmacology. Besides systemic changes in pricing and reimbursement, there is a need for additional education of a broad range of providers, including advanced care practitioners, and patients themselves. Educational efforts highlighting the rigor of the studies that support the approval of biosimilars-including the clinical pharmacology studies-and the benefits of biosimilars, can play a major role in improving biosimilar acceptance.

Categorization and comparisons of drug recalls for manufacturers and compounders.

BACKGROUND: Ensuring the quality and safety of the pharmaceutical supply chain is a key policy focus vital to protecting the public from harmful or potentially harmful medications. Although the Food and Drug Administration (FDA) reports the number of recalled products per fiscal year and categorizes recalls based on product type and recall classification, these reports do not distinguish between manufactured and compounded products. OBJECTIVES: This research aims to categorize drug recalls based on the reason for recall and then to compare this reason between manufacturers and compounders. METHODS: All publicly available drug recall data were downloaded from the FDA Data Dashboard website on January 24, 2021. Two reviewers independently categorized the recalling firm, distribution pattern, and reason for recall, and a third reviewer resolved all conflicts. Descriptive statistics were reported for recall event classification, distribution, and recall reason for the full sample. Chi-square test of independence was used to assess categorical variables by facility type (manufacturer or compounder) as well as by event classification (class I, II, or III). A subgroup analysis was performed focusing on class I level recalls only, representing the most serious recall, and similar statistical procedures were performed. RESULTS: From June 8, 2012, to January 24, 2021, there were 12,343 drug products recalled; 6771 were from a manufacturer, and 5572 were from a compounder. Most recalls from both compounders and manufacturers were class II recalls with products being distributed to multiple states. Sterility assurance was the predominant reason for recall among compounders, whereas product quality was the most frequent recall reason for manufacturers. There were statistically significant differences in class I recalls between compounders and manufacturers and recall reason compared across recall classification. CONCLUSION: There was a statistically significant difference in the reason for a drug to be recalled, the distribution level, and the product class for manufactured and compounded products.

Cardiology electronic consultations: Efficient and safe, but consultant satisfaction is equivocal.

BACKGROUND: Cardiovascular electronic consultation is a new service line in consultative medicine and enables care without in-person office visits. We aimed to evaluate accessibility and time saved as measures of efficiency, determine the safety of cardiology electronic consultations, and assess satisfaction by responding cardiologists. METHODS: Using a mixed-methods approach and a modified time-driven, activity-based, costing framework, we retrospectively analysed cardiology electronic consultations. A random subset of 500 electronic consultations referred between 2013-2017 were reviewed. Accessibility was determined based upon increased number of patients served without the need for an in-person clinic visit. To assess safety, medical records were reviewed for emergency room visits or hospital admission at six months from the initial electronic consultation date. Responding cardiologist satisfaction was assessed by voluntary completion of an online survey. RESULTS: The majority of electronic consultations were related to medication advice, clearance for surgery, evaluation of images, or guidance after abnormal testing. Recommendations included echo (10.8%), stress testing (5.0%), other imaging (4.0%) and other subspecialist referrals (3.8%). Electronic consultations were completed within 0.7±0.5 days of the request, with a time to completion of 5-30 min. Over a six-month follow-up, 13.9% of patients had an in-person visit and 2.2% of patients were hospitalised, but none were directly related to the electronic consultation question. Satisfaction by responding cardiologists was modest. CONCLUSION: In conclusion, within a single-payer system, cardiology electronic consultations represent a convenient and safe alternative for providing consultative cardiovascular care, but further optimization is necessary to minimise electronic consultation fatigue experienced by cardiologists.