IIn the early days of the Covid pandemic, seriously ill patients began filling American hospitals. Hospitals were running out of essential therapeutic drugs and were unable to source those drugs from manufacturers or the outsourcing facilities that were authorized by Congress in 2013 to fill the gap in such situations.
At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued interim guidance that allows traditional compounding pharmacies, within strict regulatory barriers, to prepare 13 Covid drugs from pure ingredients to meet the urgent needs of hospitals. In a 2021 APC survey, more than 80 pharmacies nationwide reported providing compounded versions of those essential drugs to hospitals under temporary guidance. That guidance had almost certainly saved hundreds of lives, and at a September 2022 industry conference, an FDA official indicated that no adverse events had been reported.
More recently, many children have suffered because pharmacies across the country have been unable to source FDA-approved over-the-counter ibuprofen and acetaminophen suspensions. Here too traditional compounders can help by creating suspensions composed of pure ingredients. But not without special action and guidance from FDA guidance that has not been issued.
Amid ongoing disruptions to the drug supply chain, pharmaceutical compounders can play an essential role in alleviating temporary shortages of urgently needed drugs if authorized to do so. The example of Covid proves it. When patient health is at stake, we need a more agile system, one that doesn’t require special action from the FDA to address it. Changes to federal law are needed so that when there is an urgent need for drug shortages, compounders can intervene immediately, without delays and bureaucratic impediments.
That is why I urge Congress to include in any legislation addressing drug supply chain issues provisions that will allow state-licensed drug compounders to supply urgent-use drugs to hospitals and for clinic administration within strict barriers regulations when such drugs are clearly in short supply and not available from the manufacturer or an authorized outsourcing facility.
A good model is HR 167, introduced by Rep. Morgan Griffith (R-Va.), which would make the 2020 interim guidance permanent and expand it to include all drugs listed as currently in shortage on the FDA drug shortage list . Griffiths’ bill would allow traditional compounders to prepare shortage drugs not only for hospitals but also for medical clinics if they cannot source the drugs needed for in-clinic administration, such as for cataract surgery from the manufacturer or a outsourcing structure.
Griffiths’ bill also recognizes that the FDA’s drug shortage list tends to lag behind the market and requires it to be supplemented by the drug shortage list maintained by the American Society of Health-System Pharmacists, which is a better real-time indicator of national and regional medicines. deficiencies. (If the ASHP list were currently a legal indicator of shortages, pharmacies could now combine ibuprofen withdrawal to meet the need.)
I know what you might be thinking: Compounding? Given the past history, isn’t that risky?
But the profession of pharmacist has come a long way since a 2012 New England Compounding Center criminal conspiracy left more than 60 patients dead and hundreds of other patients harmed. Federal legislation in response to that tragedy greatly strengthened the regulatory framework within which compounders operate. Additionally, states now require compounders to adhere to stringent U.S. Pharmacopoeia compliance and process standards to keep patients safe.
Also, I’m just talking about allowing temporary composition of urgently needed medicines during times when they cannot be purchased from the normal supply chain. Let’s go back to the current situation with acetaminophen withdrawal: why would we allow a child to suffer without treatment when there is a means of providing that child with a compound version of the drug—a version that has been prepared in a well-regulated state-pharmaceutical laboratory? inspected that uses certified pure ingredients from FDA registered suppliers?
Pharmaceutical compounding critics like to point out that compounded drugs are not individually approved by the FDA. It is true. The absence of FDA approval, however, does not mean it is unsafe, and as recent adverse events associated with eye drops demonstrate, FDA approval does not automatically guarantee that a drug is wholesome or safe.
We have a choice here: We can either choose to live with the drug shortage and the patient suffering that comes with it, or we can make modest adjustments to federal law that will create a path for compound pharmacies, on a temporary basis and within strict regulations. , to fill the gap during drug shortages, alleviate suffering and even save lives.
Scott Brunner, CAE, is CEO of the Alliance for Pharmacy Compounding.
#Compound #pharmacies #offer #solution #shortage #essential #medicines