Specialty Pharmacy & the Accreditation Process

Lesley Pink: Hello and welcome to the second episode of The Strategic Dose: Driving Your Pharmacy Mission. I’m Lesley Pink, your host. Today I’ll be talking about specialty pharmacy and the accreditation process with Tyler Clay, Senior Director of Pharmacy and Infusion Services at Conway Medical Center in South Carolina, and Bonnie Dugie, Vice President of Pharmacy Accreditation Services at VytlOne.

Conway Medical Center, based in Conway, South Carolina, is an independent nonprofit health system with about 222 inpatient beds and about 200 doctors. Conway has both an on-site pharmacy and an on-site specialty pharmacy, which has been accredited by the Accreditation Commission for Healthcare (ACHC) and URAC. Conway has been working with VytlOne since 2019. Tyler and Bonnie, welcome to the podcast.

Tyler Clay: Thank you for having me.

Lesley: Tyler, why did Conway decide to open a specialty pharmacy as part of the campus offering?

Tyler: It’s a great question. To answer it, we really have to look at the trends and what’s been happening with medication development over the last several years. When you look at the most recent FDA approvals for new medications, we see that about 75% of new medications approved fall into the specialty pharmacy category. And on the flip side of that, medications that have been provided in locations such as infusion centers for a number of years — mainly in the monoclonal antibody space — are starting to be reformulated to self-injectable medications that are also falling into that specialty pharmacy realm. That’s really taking over a lot of the medication-driven treatments in our specialty physician practices: rheumatology, neurology, and the oncology setting.

When you look at those, we really see that space growing within our health system. It just made sense to continue to provide the best care we could for our patients. With having our specialty pharmacy on site, it allows us to coordinate with our providers in a way that we can have direct communication, and it keeps the patient’s healthcare in one setting, which we know decreases errors because we all have visibility to what’s happening with that patient’s care.

Lesley: And Tyler, could you explain a little more about your role and how accreditation fits into it?

Tyler: My title is Senior Director of Pharmacy and Infusion Services here at Conway Medical Center. I have oversight of everything spanning pharmacy — our medication reconciliation program, our inpatient pharmacy, our 340B program, our infusion centers, and the specialty pharmacy. Within the specialty pharmacy, we work very closely with VytlOne to make sure we’re meeting all of the measures and outcomes outlined to maintain our compliance with accreditation from both ACHC and URAC.

Lesley: And Bonnie, can you explain what you do as VP of Pharmacy Accreditation Services?

Bonnie Dugie: As Vice President of Pharmacy Accreditation Services at VytlOne, I get to collaborate with health systems like Conway Medical Center, various vendors, and accrediting bodies. Together we design, launch, and continually improve pharmacy operations all across the country. My main focus is creating pharmacy programs that are both scalable and truly patient-centered — ensuring they’re compliant and ready to achieve and maintain ACHC and URAC accreditation, regardless of the practice setting.

Lesley: Can you explain a little more what accreditation means, and why it’s important for a pharmacy to have it?

Bonnie: Accreditation from organizations like ACHC or URAC is basically an official stamp of approval that says a pharmacy is meeting some pretty high standards. It’s not just about checking boxes. It means the pharmacy is committed to best practices, which translates to safer and more reliable care for patients. When a pharmacy is accredited, it’s like telling patients, doctors, and insurers: “Hey, we take your health seriously.” Plus, it encourages pharmacies to constantly improve, so patients with challenging health conditions get better support and education — making it easier for them to stay on track with their treatments and ultimately have a better experience.

Lesley: Great. And how do you two work together on accreditation? What pieces would you take, Bonnie, and what pieces would you take, Tyler?

Tyler: It’s very much a collaborative effort. To follow up on the previous question — when we think about accreditation, the primary driver is making sure we’re providing the best quality care we can for our patients. That’s number one. But there’s another element to it, and that’s being able to provide that care. Accreditation from those accrediting bodies is required to gain access to what we call LDDs — limited distribution drugs. These are drugs with a high cost or some sort of restriction, only available through a smaller network of pharmacies because of the increased monitoring.

Going through this accreditation process is really like validating that you’re able to take care of the patients on those medications. It proves to drug companies that you can successfully handle those, as well as to payers. A lot of times the dual accreditation — your ACHC plus one additional accrediting body — really drives having access into payer networks, to also prove to those payers that you’re able to provide high-quality care.

We work very closely with VytlOne, and it’s a collaborative effort. VytlOne does a very good job of setting the stage for us and teeing it up, so to speak. And then my side of that comes in as: how does that fit into our health system? Every health system is unique. Every health system is a little bit different. We need to take some of those best practices and industry-leading KPIs and goals that VytlOne is helping us develop, and make them fit within our organization and the patient population we’re serving.

Lesley: Bonnie, do you have anything to add on that?

Bonnie: Tyler’s got it exactly right. Our team at VytlOne works hand-in-hand with Tyler and his group, really focusing on optimizing the specialty pharmacy workflow. We’re delivering the highest possible quality of care to patients. We make sure that everyone on staff is thoroughly trained and credentialed, and we oversee the quality management program — tracking trends, measuring performance, and rolling out action plans to keep raising the bar on quality. We’re also on top of all the relevant laws and regulations, making sure we’re always in compliance with agencies like boards of pharmacy and the DEA. At the end of the day, our goal is to create a culture where accreditation isn’t just a box to check, but something that’s woven fully into the daily routine of the pharmacy.

Lesley: As you’re going about the accreditation process, what are some challenges that you might encounter, and how do you work through those?

Bonnie: There are definitely a few common challenges. First, the standards are always changing. We put a lot of effort into staying up-to-date and making sure our team is trained. Gathering all the necessary documents means coordinating closely with different departments — clear communication really makes a difference here. Limited resources can be tough too. We’re asking pharmacy staff to balance their daily work with the demands of accreditation, so we try to make it as easy as possible by creating an accreditation-friendly workflow, using specialized software and customized tools to help ensure compliance. And keeping everyone motivated throughout the process is important. We celebrate milestones and always try to remind the team of why accreditation matters and how it helps improve patient care.

Lesley: Can you and Tyler think of a specific challenge that you encountered and how you worked together to handle it?

Bonnie: One specific challenge we faced was ensuring that our processes were aligned with the rigorous standards required for specialty pharmacy accreditation while also prioritizing optimal patient care. To address this, our teams collaborated closely, holding regular meetings to share insights and identify potential gaps in the workflow. By pooling our expertise and communicating openly, we were able to design and implement a workflow that not only met all the accreditation requirements but also streamlined patient services — resulting in positive outcomes and satisfaction for both patients and staff.

Tyler: To add on to that — another piece worth highlighting is the timeline in which we did that. Bonnie’s exactly right. These are very rigorous standards. They have very specific measures. They have very specific call-outs on things that you must be doing to ensure high-quality patient care. There is no cutting corners. There is no taking shortcuts. It really comes down to hard work.

When you look at the amount of time it takes a lot of health systems to implement that and get going, a lot of times it’s years. I’ve seen health systems open their specialty pharmacy and be 12 to 18 months before their first accreditation, and then another 6 to 12 before they achieve their second. Now pivot and look at what we did here at Conway. We identified the need for our community. We identified the need for our patients and our health system and decided this was an initiative we were going to go forward with. Once we made that decision, we were really looking at: how do we stand this up as a fully compliant and fully thought-out pharmacy, but also do it quickly to meet the needs of our patients?

When you look at what we actually did here — we opened our doors, and if you look 45 days forward, we had dual accreditation from URAC and ACHC in 45 days from opening, with zero citations on either accrediting body. That really speaks to the power of the partnership here, because these are all things that, if you look at what other institutions are facing, take a lot more time to really develop those well-thought-out processes. We achieved that without shortcuts — but also in a way that’s able to serve our patients and the community much quicker.

Lesley: Yeah — 45 days seems very, very fast. As you’re going through the accreditation process, what is one surprising lesson that you have learned from doing this?

Bonnie: One surprising lesson I’ve learned from the accreditation process is how much it elevates the standards for pharmacy operations beyond what is required for basic licensure. Pharmacies might meet the minimum requirements to be licensed by their state board of pharmacy, but accreditation pushes them further — focusing not just on compliance, but on quality, safety, and continuous improvement. It’s made clear to me that accreditation isn’t simply a box to check. It’s about an ongoing commitment that encourages pharmacies to consistently deliver better patient care and operate with excellence.

Lesley: And when we’re talking about better patient care — how has accreditation improved patient care or outcomes?

Tyler: I really like to think of patient care and outcomes and the accreditation process as something that specialty pharmacy shines in. Accreditation caused us to step back and think through the way we interact with our patients and the way we deliver care in a pharmacy setting. When you think about your traditional pharmacy, a lot of times you’re dropping off a prescription, you may have a brief interaction with the pharmacist at the time of the pickup, and then you’re on your way. In specialty pharmacy, we’re really looking at complex disease states as well as a significant cost of these medications. So our pharmacy team really focuses on the outcome side of the measures — making sure that patients are finding the answers to the questions they have, that they’re working toward an improved quality of life based on the medication they’re initiating. Our pharmacists are very much tied to these patients along the journey they face on these medications. We’re really tying the medication to the improved quality of life, or the outcome — not just the dispensation at the time the patient picks it up.

Lesley: Got it. We talked about some of the requirements of the accreditation process. Do you see more requirements becoming part of the process?

Bonnie: Absolutely — it’s very likely. Accreditation standards are not static. They are continually evolving. Most accrediting bodies have their own rhythm for updating requirements, and many actively seek feedback from industry experts before rolling out new standards. Sometimes they’ll even pilot optional requirements to see how they work in practice before making them mandatory. Other accrediting bodies might introduce changes annually — especially as they respond to industry trends, pharmacy input, or regulatory updates. So staying flexible and informed is key.

Lesley: How do you see accreditation evolving over the next 3 to 5 years?

Bonnie: Looking ahead, for this year, 2026, it’s very clear that specialty pharmacy is going to play an even bigger role — making up more than half of US drug spending. That’s largely thanks to the rise of biologics and advanced therapies. Both payers and manufacturers will be laser-focused on making sure specialty pharmacies are putting those dollars to good use and delivering the best possible outcomes for their patients.

We’re also seeing continued growth in areas like rare diseases and cell and gene therapy. I expect accreditations that zero in on these fields will continue to expand over the next few years. And on the regulatory side, changes from CMS will keep shaking things up — including shifting the pharmacy survey process for select accreditations from 36 months to every 12 months, and moving toward on-site unannounced surveys. It’s going to be a very exciting and dynamic time for accreditation over these next few years.

Lesley: As things evolve over the next three years, how could technology or data affect future accreditation requirements? And how do you see AI fitting in, if at all?

Tyler: I think AI is really the elephant in the room. We all know it’s coming. We all know that it’s going to begin to find its way deeper and deeper into healthcare. When it pairs up with accreditation, one of the first things we’re really going to see is focus on oversight of that AI. As AI begins to make its way into the place where it’s potentially making recommendations — sweeping patient charts to provide information — someone has to oversee that AI. Someone has to dig into: what is the methodology behind how it’s extracting this data? How does it weigh different elements within the patient’s chart, within the patient’s health, to come to what it thinks is the best recommendation? My guess is we’re going to see that accrediting bodies will want some sort of committee that has oversight into how that AI is operationalized, and someone that’s really validating that any AI-based recommendations are founded in medical fact, medical literature, and clinical trials — and that it’s really implemented in a responsible way across health systems and the pharmacy space.

Bonnie: That’s right, Tyler. We’re already seeing that AI is making a real impact on specialty pharmacy practice, and that influence is only going to continue to grow. Accrediting organizations are already starting to respond. We’re seeing the introduction of accreditations specifically focused on AI in healthcare. Looking ahead, I think we’ll see these requirements related to AI gradually woven into existing accreditation standards. I think we’ll see areas like risk management, privacy and data security, and oversight of how AI is used and developed within specialty pharmacy as part of those changes. It’s absolutely an evolving landscape, and staying ahead of these changes will be important for everyone in the field.

Lesley: Great. Thank you, Tyler and Bonnie, for joining us for the March episode of The Strategic Dose. Please join us for the next podcast in April. And remember that you can find us on Apple Podcasts, Spotify, and YouTube.