About those hospitals needing shortage drugs for COVID patients ...
It's a hard story to miss: Many hospitals across America continue to be unable to find drugs essential for treating patients with COVID19. Axios this week reported that only 53% of those scripts for ventilator and other COVID treatment meds are being filled. Ideally, 503Bs should be meeting this need, but some hospitals can't find outsourcing facilities to provide the medication.
APC is working on two temporary ways to address this dire situation.
"W e   recognize and respect that the FDA's preferred solution to the current shortage situation is for health systems to source the drugs from 503Bs," said APC President Shawn Hodges. "But clearly, many are unable to do so - either they're unable to find a B or the Bs they're finding don't have the needed drugs in production."
To address that first issue - hospitals' inability to know which 503Bs are making which drugs - APC is working on an online solution to match health systems with specific needs to a 503B that is making the needed drug - and to do it quickly. "We hope to have more to say about that soon," said Hodges. "For now, we concur that 503Bs should be the first source for distributions of COVID-19 meds that are in shortage, and we want to help connect the two entities."
But there remain situations in which a hospital cannot find a 503B to meet its urgent need for COVID treatment drugs, Hodges said. "Remember, the first priority here must be the patient, and hospitals must be able to access essential drugs. In situations in which 503Bs are not producing the shortage drug, 503As must be allowed to meet the need, within strict guardrails to ensure no patient harm."
Three weeks ago, APC anticipated this need and urged FDA to issue temporary guidance announcing enforcement discretion to allow certain certain 503A pharmacies meet this need under the "Rx Lookback" model. In Rx Lookback , a  patient specific prescription information is provided by the hospital to the 503A pharmacy within seven days after receipt of the drug. That model can and should serve as a template for states. "It is tightly constrained, so that 503Bs remain the first go-to source for the medications," said Hodges.
The model is already being employed in one state to confront current shortages. Until 503Bs can meet the need, 503A compounding pharmacies in that state that are accustomed to preparing sterile medications (intravenous or IV medicine) can compound and provide these products to health systems in that state, adhering to USP Standards. By compounding under USP, certain 503As can provide hospitals with high quality products in short order. State regulators there, as well as the DEA, have been instrumental in facilitating production of those shortage drugs within the parameters of state and federal law.
APC continues to encourage FDA to act on this common-sense proposal. At the same time, we're reaching out to state boards of pharmacy to urge them to consider Rx Lookback.
On Thursday, FDA released a temporary guidance for 503Bs (Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During COVID-19 Public Health Emergency)  that is little more than a rehash of its January 2020 cGMP light GFI for outsourcing facilities, and which does not sufficiently address regulatory and financial barriers that make it difficult for 503Bs to address the current drug shortage issues.
"We urge the FDA to pay attention. The goal is to fill the gap until the drug manufacturers have ramped up production," said Hodges. "Without it, patients are at risk."
APC is the voice for pharmacy compounding, representing compounding pharmacists, technicians, educators, students, researchers and suppliers. Compounding exists for patients and animals who are not served by traditional pharmaceutical manufacturers. Every day, APC members play a critical, often life-or-death role in patients' lives, creating essential medications unavailable elsewhere for a range of issues, including autism, oncology, dermatology, ophthalmology, pediatrics, women's health, and others.  Learn more at www.a4pc.org.