Has your veterinary hospital been challenged to source the drugs you need to care for your patients? Unfortunately, you’re not alone. Veterinary drug shortages have been an ongoing problem, and the COVID-19 pandemic is exacerbating the issue in some areas due to increased human demand for certain medications, including:
- Drugs used for pain management, like hydromorphone and fentanyl
- Sedatives/anxiolytics, like ketamine and midazolam
Because human drugs often cross over into the veterinary market through extra-label drug use, the veterinary community is facing a greater challenge in procuring these needed medications. Thankfully, the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) are taking steps to help ease the strain on the supply chain for these vital medications. We rounded up some of the changes being made to better support veterinary practices and patients.
FDA and DEA – Steps Taken to Address the Shortage
- On April 16, 2020, the FDA took the unprecedented step of issuing guidance entitled “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the Covid-19 Public Health Emergency – Guidance for Industry.” This guidance enabled outsourcing facilities like Epicur Pharma to provide a list of in-demand drugs that are experiencing drastic shortages.
- Because many of the drugs in shortage are DEA-regulated controlled substances, such as hydromorphone, strict manufacturing quotas apply to both manufacturers and outsourcing facilities. Earlier this year, the DEA began actively contacting manufacturers and outsourcing facilities to request higher quotas. In April, the DEA increased quotas for substances including hydromorphone, fentanyl, morphine, ketamine, midazolam, and ephedrine.
Swift action from the FDA and DEA has helped to meet increased demand. With increased veterinary demand along with human hospital needs, our veterinary community is likely to face challenges with drug procurement at times.
How 503B Outsourcing Facilities Can Help
To help offset the demands placed on the drug supply chain during the pandemic, 503B outsourcing facilities have been increasing the production of drugs, such as hydromorphone, ketamine, fentanyl, midazolam, and others that are experiencing shortages. Since commercially available drugs from traditional compounding pharmacies and manufacturers are typically developed for human use, veterinary hospitals and clinics can face difficulties getting drugs in the dosage levels and routes of administration required for the treatment of animal patients – even when drug shortages are less prevalent.
When filling veterinary medicine needs, veterinary hospitals and clinics have two options for purchasing products:
- Traditional compounding facilities, like Stokes Pharmacy, Wedgewood, Roadrunner, and your local pharmacy down the street, all of which are 503A compounding pharmacies
- 503B drug outsourcing facilities like Epicur Pharma
There are key differences between the two options. Depending on state regulations, 503A pharmacies may only be able to provide drugs on a patient-specific prescription-basis, not for office use. More importantly, 503A pharmacies are not required to meet the same stringent quality standards for safety and efficacy which are mandated for 503B outsourcing facilities. Therefore, 503B outsourcing facilities can help veterinary hospitals and clinics address these gaps. 503B outsourcing facilities are FDA-registered and, like pharmaceutical manufacturers, must operate in compliance with the FDA’s current Good Manufacturing Practices (21 CFR Part 210 and 211). Unlike 503A compounding pharmacies, 503B outsourcing facilities perform extensive testing in several areas to ensure quality and reliability including:
- Potency – each batch is tested to ensure the product meets the label’s claims for active drug quantities.
- Sterility – every 503B facility follows the latest guidelines for clean room and sterile environment best practices.
- Stability – each batch undergoes testing to ensure efficacy and integrity with time under the influence of environmental variables, such as temperature, humidity, and light exposure.
These testing protocols combined with a commitment to quality throughout the manufacturing process results in drugs that maintain consistency and reliability with each order and that meet the specific needs of veterinary hospitals and clinics, enabling veterinarians to provide their patients with better overall care. 503B outsourcing facilities offer an expanding variety of drugs and can dispense to veterinary hospitals and clinics, so medications can be kept in stock and are available when needed.