Today on ASHPOfficial, Tom Kraus interviews Erin Fox, who is the Senior Director of Drug Information and Support Services at the University of Utah Health. She is the 2019 Zellmer Lecture Award winner and a national expert on drug shortages. Erin advises a member of congress and has worked with ASHP to inform policies on drug shortages. Tom and Erin discuss how drug shortages affect patient care, as well as how the FDA and congress can minimize the resulting impact.
(1:04) In m...
Today on ASHPOfficial, Tom Kraus interviews Erin Fox, who is the Senior Director of Drug Information and Support Services at the University of Utah Health. She is the 2019 Zellmer Lecture Award winner and a national expert on drug shortages. Erin advises a member of congress and has worked with ASHP to inform policies on drug shortages. Tom and Erin discuss how drug shortages affect patient care, as well as how the FDA and congress can minimize the resulting impact.
(1:04) In mid-2017 there was a large increase in the number of drug shortages, specifically to do with quite common products. Erin explains how frustrating the problem is, because it isn’t going away, and her team is currently monitoring 280 drug shortages. Manufacturing issues to do with quality or reduced output are triggering the shortages. Many of the issues seen by the FDA, including birds flying around in sterile environments, mold on walls, and metal shavings in vials take years to rectify. The manufacturers themselves devise their own processes to comply with guidelines, but the FDA only inspects when companies intentionally do not follow their own processes or falsify data. Economics also plays a role, as common drugs that hospitals use are treated as commodities. Hospitals are incentivized to use the lowest-cost products, because they are reimbursed on a DRG basis. The competition for these contracts with hospitals leads to some companies being underwater on the commodity-based drugs, meaning they will focus more of their efforts on other drugs with higher margins.
(6:07) To incentivize quality, it’s important to include transparency. Currently, there is no requirement that a manufacturer release where its products are being produced, so that when there is a health concern, purchasers can avoid the quality issues. By adding transparency, purchasers can decide to buy higher quality items with fewer shortages and recalls, which are also costly. The FDASIA (Food and Drug Administration Safety and Innovation Act) Law was also introduced in 2012 to improve disclosure from companies to the FDA about drug shortages. The FDA can use the data to try to stop shortages in the future, but once a shortage is reported, it’s difficult to solve, because other countries or companies do not have enough product to share with a market as large as the US.
(9:30) When drug companies contract outside manufacturers, there is no requirement to disclose which manufacturer produced a company’s product. Added transparency here would also allow for quality to be rewarded in the future. When a contract manufacturer is responsible for multiple companies’ supplies of the same drug, any service interruption can cause a massive drug shortage. To add to this weak link in the supply chain, there is no requirement from the FDA for contract manufacturers to have a continuity plan in the event of a shutdown. Commenting is open on the docket now and asking a manufacturer about contingency planning would be an excellent way to use FDA quality metrics to rate a manufacturer higher.
(12:47) 503B compounding pharmacies can help with drug shortages but can’t begin work until the drug appears on the FDA shortage list. The FDA takes time before a drug appears on its list and the compounder will then need an additional three-four weeks to make a good batch. The compounders don’t have much insight into what drugs may be put on the shortage list and how long they will be on the list, such that they may be stuck with a large batch that they can no longer sell. Other tools the FDA can deploy include asking other manufacturers to ramp up production of drugs and assisting in moving a manufacturers application to the front of the line if necessary.
(17:10) There are a few ways to think about national security as it relates to drug shortages. The first is to ask: do we have enough drugs if we need to send our soldiers to war, and do we have enough to take care of our own patents and to keep the hospitals running? The second aspect to consider is where the foreign sources for drug manufacturing come from and what the fallout would be if those sources cut off supply. Most antibiotics source raw materials from China, for example.
Outbound Links & Resources Mentioned
Learn more about ASHP’s policy solutions to reduce drug shortages at: https://www.ashp.org/Advocacy-and-Issues/Key-Issues/Drug-Shortages
Takeaways in Today’s Episode
- The frequency of drug shortages being reported is increasing, and Erin’s team is currently monitoring 280 active drug shortages.
- Drug shortages are a result of quality issues at manufacturing facilities and glitches in the manufacturing process when one company holds a large market share of a product.
- The FDA will inspect drug manufacturers when processes are not being followed or data are being falsified, which is an increasing problem.
- Hospitals are in a race to the bottom in terms of drug costs, due to the DRG structure.
- To incentivize quality, transparency in the drug manufacturing process is required.
- In 2012, ASHP supported the FDASIA Law to pass, which required manufacturers to disclose if there was going to be a shortage or stop on production.
- On low-cost products, it’s easier for contract manufacturers to have a shortage than to invest time in a what-if/backup plan.
- The FDA was hopeful that 503B compounding pharmacies could help with drug shortages, but the time required to produce the drugs is at least a few weeks, by which time the drug may have come off the list and the compounders can no longer sell it.
- There have been increasing conversations lately to do with national security as it relates to drug shortages.
- More than 80% of raw materials for drug manufacturing come from foreign sources.
- Consolidation of manufacturers leads to more fragility in the supply chain, particularly for injectables.
- The FDA is closest to being able to predict shortages but requires more data points and transparency from suppliers and manufacturers to obtain a predictive model.
We also want to make listeners aware that legislation was recently introduced that incorporates several of these priorities.
The introduction of this legislation is a first step to advancing these policy priorities. To become law, the legislation will need to be approved by the full Senate and the House of Representatives.
Listeners can see ASHP’s policy solutions and let congress know they support this legislation by following the link in the show notes to this podcast, or in the advocacy section of ASHP.org.
