The FDA established a cross-sector stakeholder group to engage on issues that affect outsourcing facilities, health care providers that purchase and use their products, and other stakeholders in the ecosystem. The purpose of these meetings is to convene industry experts to share individual perspectives on compounded drug quality, production, demand, and clinical use.
Drug and Staff Shortages Presentation
- A group member presented data on the impact of drug and staff shortages. The discussion focused on both recent data and historical trends.
- Recent ASHP data suggests that 66% of new shortages in 2021 and 2022 are injectable drug products, and there are approximately 240 active drug shortages in Q4 2021 and Q1 2022. ASHP historical data indicates that the earliest currently active drug shortage tracked by ASHP dates to 2008. It was noted there was a significant and consistent increase in the number of ASHP-tracked shortages that remain active for shortages beginning in 2016 to present with a peak in 2019-2020.
- It was reported that hospitals are perceiving increased workforce shortages for both entry-level and experienced pharmacy technicians. As of 2021 the shortage of pharmacy technicians is at the highest level since data collection began in 2007.
Discussion of Duke Margolis Center for Health Policy Drug Shortages Meeting
- Another group member attended the Duke Margolis Center for Health Policy meeting on drug shortages in Washington D.C. in November 2018 titled Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. They shared the meeting’s presentation slides and notes on the meeting with the group.
- The meeting was part of a federal inter-agency task force effort led by FDA and contributed to the publishing of the FDA report Drug Shortages: Root Causes and Potential Solutions in 2019 and updated in 2020.
- While the meeting was more than three years ago, CSS group participants noted the intensity and duration of drug shortages as described by the presentation and discussed continued relevance of some issues and themes.
- Participants discussed how the prevalent shortages of low-cost sterile injectable generic drugs could be related to their diminishing profitability and manufacturer exits from these markets as manufacturers increasingly shift production to newer, more profitable drug products.
- Participants discussed considerations which affect purchaser decision-making, such as reimbursement and budget, and those which impact 503B decision-making, such as the time required for process development and stability testing.
Facilitated Discussion on Drug Shortages
- Participants from hospital systems described the impact of acute drug shortages on their operations, including their need for daily internal meetings to discuss strategies to preserve patient care with limited supply of certain drugs.
- When facing a drug shortage, the hospital and health system stakeholders also described their supply chain decision-making process, including their need to consider the impact and duration of the shortage, and then determine whether they have the capacity to compound in-house or if a 503A or 503B has the capacity to meet their needs.
- Participants from 503B firms described the factors which influence whether a drug in shortage is a good fit for 503B production. Products that were identified as potentially viable included small molecule, injectable, or older generic drug products. Low-margin products like IV fluids and saline flushes that can be produced in greater volumes by contract manufacturers or generic drug companies were identified to be less ideal for 503B production.
- 503B participants mentioned the financial and time commitment required to conduct stability studies and the risk of having to cease production after a short tail period when a drug in shortage becomes available from the manufacturer as key factors in their decision-making.
- There was also discussion that being able to predict shortages in a proactive manner would be helpful regarding both purchasing and production-related decision making.
- Participants also discussed examples where non-profit foundations have collaborated with 503Bs to enable their production of certain drugs predicted to be in shortage by funding stability studies. Hospital and health system participants mentioned they are less able to fund stability studies or commit to purchasing a certain volume of 503B drug shortage products due to financial constraints.
- Both 503B and hospital and health system participants discussed potential collaboration opportunities to identify specific drugs in shortage that have high clinical need, are good fits for 503B production.
Participants discussed the following:
- Feedback on the goals and focus areas of the group
- One goal is to foster an improved understanding of the outsourcing facility sector now and in the coming years, including how the industry serves providers and patients.
- Outsourcing facility representatives mentioned their hopes to share best practices with each other, such as strategies to better understand and meet demand and lessons learned from deploying automation or other manufacturing practices at outsourcing facilities.
- Drug and workforce shortages, lack of public awareness of the industry, and lack of transparency were mentioned as ongoing problems affecting the industry.
- The hospital and clinical representatives mentioned their hopes to raise awareness about the impact of drug shortages, to learn more about the manufacturing side of the industry, and to have a more streamlined process for finding, evaluating, and purchasing 503B drug products.
- Future discussion topics
- Demand and Patient Need
- Drug shortages
- Current and future role of 503B Outsourcing Facilities
- Education and messaging about the 503B industry
- Initial discussion on demand and patient need
- Participants discussed what key questions are useful to address when examining demand/patient need, such as, “Which products would providers like to buy from 503B outsourcing facilities but cannot?” “What challenges do you face in forecasting demand?” and “What tools could help providers better understand 503B product availability?”
- Hospital and clinical stakeholders mentioned they purchase products from multiple 503B outsourcing facilities, but some products may only be available from one 503B outsourcing facility, which can lead to gaps in meeting patient need if the outsourcing facility has downtime due to shortage or shutdowns.
- Also discussed was the impact of clinical use guidelines in production and purchase decision-making; these guidelines are followed by prescribers and may vary across clinical specialties. Participants noted knowledge gaps may exist, such as a lack of real-time awareness of product availability and lack of purchaser knowledge of 503B outsourcing facility capacity for certain products.
- Participants discussed gaps that exist within demand transparency, such as a lack of real-time awareness of product availability and lack of purchaser knowledge of 503B outsourcing facility capacity for certain products.
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