Addressing Supply Chain Challenges & Improving Patient Access

Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding discuss the challenges faced by patients and healthcare providers due to drug shortages, particularly for semaglutide and other medications. It highlighted the role of compounding pharmacies in addressing these shortages and the importance of distinguishing legitimate compounding pharmacies from illicit actors. The conversation also emphasized the need for collaboration between pharmaceutical manufacturers, healthcare providers, and regulatory agencies to improve the drug supply chain and ensure patient access to essential medications.

How can we foster greater collaboration between pharmaceutical manufacturers, healthcare providers, and regulatory agencies to address supply chain challenges and improve patient access to medications?

Scott Brunner: We are in this interesting time where compounding is saving the day for so many patients on compounded GLP-1s. I know the drug makers don't want or like that, and we readily acknowledge that those FDA approved GLP-1s should be the standard if that drug is available, that's what ought to be prescribed. But you know where the drug maker interest and the com. Counter interest. And I would say the prescriber and patient interest overlap, and there is an overlap. It's on patient safety. And I would love to see us all join hands on that issue where we know we agree, and let's work to wipe out some of this counterfeiting and the illicit actors, and let's make sure patients know that the drugs they are being dispensed are legitimate and quality drugs.

Tenille Davis: The FDA only legally has to consider data submitted to it by drug makers when determining if a medication is in shortage. So even though there's a place on the FDA website for consumers, patients, pharmacists, prescribers, to submit information on shortages, the FDA doesn't have to use that in its calculations of supply versus demand when it considers something on shortage.

So, one of the things that I think could help shortages in the future is if the FDA did expand information that it uses to determine if a medication is in shortage, because sometimes there's things like regional shortages that aren't reflected on the drug shortage list, where compounding pharmacies can't step in and help those shortages because they're only legally allowed compound when something is on the FDA drug shortage list. So, I think that, you know, we all should have a vested interest in patient having access to medications that they need, and so expanding that, expanding the FDA scope of what they can use to determine if a medication is on shortage, I think would be beneficial to everybody.