Managing Compliance in Specialty Pharmacy From a Regulatory, Accreditation Perspective

In an ever-changing regulatory health care landscape, specialty pharmacies must continuously ensure they are adapting to evolving industry standards. From changing regulations to going through the accreditation process, all pharmacies must focus on compliance. The importance of managing regulations was the focus of a session at the National Association of Specialty Pharmacy (NASP) Annual Meeting and Expo in Washington, DC.

“Regulation and accreditation are 2 sides of the same coin because the thing they have in common is compliance,” speaker Bradley W. Howard, attorney at Brown and Fortunato, PC, explained.

In the session, Howard, along with Heather Bonome, PharmD, director of pharmacy for URAC, and Tim Safley, MBA, clinical manager, Accreditation Commission for Health Care, discussed how specialty pharmacies can ensure they have the proper best practices in place from a regulatory and accreditation perspective.

For example, the looming USP requirements coming into play on December 1, 2019, will force pharmacies to adopt compliance practices that align with the updates. Although some specialty pharmacies may question whether the new standards apply to them, Howard assured the audience that they most likely do.

“I can count on 1 hand the number of pharmacies I work with that USP might not apply to,” Howard said.

He noted that pharmacies should continuously address their compliance by examining how they assess and manage their risk. From a legal risk management perspective, Howard noted that focusing on USP will be especially crucial in the immediate future. For those who are regional or national players, understanding all individual state requirements is vital.

Moreover, these best practices can be imperative for supporting the satisfaction of accreditation requirements When USP changes their standards, maintaining compliance is important not just from a regulatory perspective, but from an accreditation perspective as well, according to Bonome. Even if some states don’t enforce USP, accrediting bodies might.

According to Bonome, URAC references USP standards when evaluating a pharmacy, specifically how pharmacies comply with the standards, how they make sure they’re upto-date, and practices for implementation. In many cases, such as USP, regulatory and accreditation requirements overlap, but there are some differences, according to the speakers. Most of the time, accreditation is not a regulatory requirement, but it helps pharmacies put the infrastructure in place to remain compliant with regulations, according to the speakers.

Pharmacies should create policies and procedures that work best for them, are accessible by everyone in the organization, and move the practice forward, Bonome added. “When you put together a policy or process, don’t do that so you have a document to upload. Do it so it works for you,” she said.

When asked about the accreditation standards that specialty pharmacies struggle with the most, Bonome and Safley pointed to documentation of human resources (HR) records and quality improvement. Conducting internal audits to review HR files and planning quarterly meetings for quality improvement will help put better processes in place so that there are no surprises when an accreditor shows up, they suggested.

Careful documentation that demonstrates comprehensive care of patients is proof of the compliance culture of the pharmacy and can be used to respond to regulatory concerns.

“We want to see that reliability and that consistency in making sure those patients are getting those clinical assessments,” Bonome said.

In the end, pharmacies whose processes and documentation reflects that their primary focus is the patient will be successful in the accreditation process, the speakers concluded