Developed in collaboration with Brian Carlson, MBA | Director of Operations | Old Derby Animal Hospital
Revisions to United States Pharmacopeia (USP) standards, especially USP <795> and <797>, are set to take effect on November 1st, 2023, which could pose some challenges for veterinary practices and pet parents. Practices that prepare now will be well-positioned to ensure uninterrupted care for their clients.
The USP revisions will result in shortened Beyond-Use Dates (BUDs) for many medications prepared at state-licensed (503A) compounding pharmacies. The BUD, which is different from an expiration date, represents USP’s thinking on the recommended usage duration of compounded medications. While USP isn’t a regulatory body, the FDA and most State Boards of Pharmacy will interpret and enforce these standards.
Pharmacies can do two things to ensure that they are able to offer the longest BUDs possible under the revised guidelines:
- Invest in extensive stability testing at state-licensed (503A) pharmacies. Not every pharmacy will be able to make that kind of investment, so you may find that a common medication ordered from one pharmacy has a much shorter BUD than the same medication ordered at another pharmacy. Wedgewood Pharmacy’s stability testing is well underway, and many have already been completed, which allows them to assign the longest BUDs possible under the new USP guidelines.
- Prepare medications at an FDA-registered 503B outsourcing facility like Wedgewood Connect. Fun fact: USP standards apply to 503A State-Licensed pharmacies. 503B outsourcing facilities like Wedgewood Connect follow current Good Manufacturing Practice (cGMP). According to the US Food and Drug Administration (FDA), cGMP “provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.” Wedgewood currently prepares many of the medications you use at their 503B outsourcing facility and will continue to expand those offerings to assign the longest BUDs possible.
The imminent BUD changes will resonate deeply with veterinarians and pet owners alike. Here's a structured approach to counteract potential challenges:
1. Establish Communication.
Reach out to clients with pets on compounded medications. Our clients and patients are the ones least prepared and yet most impacted by these upcoming changes. Tools like practice management software can help with drafting personalized emails and social media alerts. Consider this sample message: “Ms. Jones, Dr. Smith has updates on Fluffy’s medication. Due to upcoming changes, we recommend adjusting Fluffy’s auto-ship schedule beginning in October.” Wedgewood Pharmacy can help by compiling information on clients currently receiving compounded medications.
2. Reevaluate Workflow Protocols.
Inside the clinic, you may need to update your approach to handling compounded medications. The clock for BUDs starts once the medication is prepared at the pharmacy. To make the most of this window, consider refining your system for requesting, approving, and dispensing compounded medications. It's worth assessing which team members are involved and the frequency of their tasks to avoid unnecessary delays. And, to avoid gaps in patient care, consider prescribing refills when appropriate.
3. Leverage Inventory Management Systems.
Many veterinary practices haven't fully tapped into the potential of inventory management systems. As we prepare for changes in compounded medication standards, it's crucial to utilize these systems to prevent running out of or holding onto outdated medications.
Here's a simple guide:
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Determine the Lead Time of items you commonly order. The Lead Time is the number of days between when you place an order and when you receive it. Since 90% of Wedgewood’s preparations ship within one day, they have some of the shortest lead times in the industry.
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Calculate Safety Stock. Safety stock is the extra “just in case” inventory you like to keep on hand in case of an emergency. Here’s how you calculate it:
Reorder Point (When to order more): Average Daily Sales x Lead Time + Safety Stock.
Reorder Quantity (How much to order): Average Daily Sales x Lead Time.
Once these metrics are in place, consistently log and monitor BUDs when receiving compounded medications. Wedgewood will be adding alerts on their digital ordering platform to keep you informed about changes to BUDs so you know how long you can keep medications on your shelves.
4. Look for Medications Prepared at 503B Outsourcing Facilities.
Look for compounded medications prepared at a 503B outsourcing facility like Wedgewood Connect which will be able to assign longer BUDs. Alternatively, ask if the compounding pharmacy you use is investing in stability testing to assign the longest BUD dates possible.
5. Embrace Technology.
In the age of digital transformation, embracing technology is no longer a luxury—it is a necessity—especially when it comes to the intricate world of veterinary care, where every detail matters.
Consider the journey of a prescription: from a veterinarian's hand, through the pharmacy's meticulous care, and finally to your client. This complex process has been beautifully simplified by prescribing platforms, delivering prescriptions to your clients when and where they need them. Prescribing platforms also offer flexibility for veterinarians, allowing them to prescribe and send orders when and where it is most convenient during their workday. No more juggling endless phone calls, enduring lengthy hold times, or chasing missed callbacks. This streamlined approach not only enhances the efficiency of practices but also ensures that pet parents are just a few clicks away from securing their beloved pet's health.
But the beauty of these platforms extends far beyond mere convenience. They are designed with the foresight to preempt challenges. Practices can now refine the prescription process, ensuring that no pet goes a day without its required medication. Veterinarians, armed with tools to monitor Beyond-Use Dates, can prescribe the optimal dosage quantity. This diligent approach not only ensures the pet's well-being but also translates to tangible savings for pet parents.
Perhaps the most striking efficacious feature of these platforms is Autoship—a true game-changer. It is more than just a delivery system cadence; it's a commitment to uninterrupted care. Pet parents can set their preferences and then let the technology do the rest. Not only does Autoship guarantee pets receive their medications on schedule, every time, but it has been shown to increase treatment compliance by three to four times.
As the landscape of veterinary medicine evolves with these USP changes, adapting swiftly ensures uninterrupted care for our beloved pets. By embracing these recommendations, practices can continue to serve their clientele effectively, providing pets with the consistent and quality care they deserve.