Innovations in Pharmaceutical Technology: Compounding Pharmacies Have a New App from the FDA
Have you ever had a line queue up at your pharmacy window only to have to tell your customers the medications they order every month are not in stock, delayed, or simply no longer available? The reason could be due to any number of factors — from manufacturing to distribution to unanticipated demand — but that doesn’t matter to the customer. They only know that you aren’t able to provide the service they urgently need.
Drug shortages are frustrating to patients, doctors, and pharmacists, particularly when the medication is life-saving. It turns out that tracking shortages can be predicted and managed, and there’s a new app available through iTunes and through Google Play to help compounding pharmacies out.
How Big Is the Problem?
The new mobile app is a brainchild of the FDA and is designed to speed public access to drug shortages, resolved shortages, and discontinuations of drug products. Years of research into what drugs face shortages and why have revealed a predictable pattern, namely that the drugs affected each year typically fall into one of the following classes:
- Older sterile injectable drugs, including those used for cancer treatment;
- Anesthetics for patients undergoing surgery
- Emergency and cardiovascular medicines; and
- IV electrolytes and antimicrobials.
The larger impact of these shortages is felt through the healthcare system, from loss in physician and pharmacist time to patient health, evident in lack of preferred treatment, postponement of needed medications, and even development of new conditions needing attention. Patients may suffer increased adverse events and premature death, and may turn to gray market suppliers for drugs that are not pure.
Compounding pharmacists encounter and manage drug shortages every day. Erin R. Fox, PharmD, FASHP, Director of the Drug Information Service University of Utah Health Care, comments “We have been stuck at about 300 ongoing active drug shortages” per quarter. The problem is complex and includes industry consolidation, limited raw material supplies, changes in practices regarding inventory and distribution, production delays, increases in demand, manufacturing site closings and production discontinuations.
How Will This New App Help?
Researchers have noted that the best way to address drug shortages is an advanced early warning system. Valerie Jensen, associate director of the Drug Shortage Staff in the FDA’s Center for Drug Evaluation and Research, says, “The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions.”
The new app is part of the FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages and is designed to improve our response to existing or imminent shortages, as well as to implement strategies for preventing long-term shortages. Although the public has access to the app, it is primarily geared toward professionals and helps identify current drug shortages, resolved shortages, and discontinuation of drug products. Compounding pharmacies can search by drug name or active ingredient, and browse by therapeutic category to retrieve information or report shortages. The FDA further hopes that the app will help prevent similar drug shortages through better communication from manufacturer to bulk supplier to doctor and pharmacist.
What Role Should Compounding Pharmacies Play?
Strategies for managing drug shortages rely on multiple approaches:
- Verify the shortage;
- Assess inventory;
- Identify alternative treatments;
- Establish network for drug sharing; and
- Prioritize patients needing drugs that are in short supply.
The FDA’s mobile app provides the information compounding pharmacies need to manage a drug shortage, as well as a tool to report ongoing issues. However, that’s not where our role should end. How we deal with shortages with the new app should inform further iterations of the app, and new policies going forward:
- Monitor communications between physicians and local pharmacies to determine information uptake;
- Allow limited approval of non-US sources for the short term, and test these drugs thoroughly, where needed; and
- Bring together all stakeholders in a given shortage to see the whole extent of the problem.
Compounding pharmacies often deal with the results of drug shortages and we need to be a bigger part of the solution, not just in the short term but in avoiding the problem in the first place.
In all circumstances, Pharmaceutica North America wants to be your source for safe and effective compounding ingredients. We are committed to helping you help your customers. Please contact us today for information.