Best Practices for Specialty Pharmacy Accreditation

May 2021 - Vol.18 No. 5 - Page #26
Category: Certification Services

Q&A with Heather Bonome, PharmD
URAC Director of Pharmacy


Pharmacy Purchasing & Products: What are the developing trends in specialty pharmacy accreditation?

Heather Bonome, PharmD: Over the past several years, there has been a surge in the establishment of specialty pharmacies of all sizes and practice models. Most recently, URAC has seen a significant increase in the number of health systems seeking specialty pharmacy accreditation. These organizations are looking to provide comprehensive patient care, including being able to dispense specialty medications to their clinic patients, and they see both clinical and financial benefits to launching their own specialty pharmacies. This trend has been noted in Drug Channels Institute research, which has shown a leap in the percentage of accredited specialty pharmacies (owned by a health care provider such as a hospital or health system) from 11% in 2015 to 32% in 2019.1

PP&P: What was the process behind the recent revisions of the specialty pharmacy standards?

Bonome: In October 2019, URAC released a major revision of our specialty pharmacy standards, Version 4.0. The last major revision to the standards occurred in 2015.

The first step in determining necessary revisions was to interview our URAC reviewers. Because they are full-time URAC employees, they have the most comprehensive knowledge of the current standards and presented excellent ideas for how they could be streamlined. Next, we interviewed industry experts for their insights into certain areas, such as temperature management. These interviews led to some significant updates to this topic in the revised standards.

Fundamental to every major revision of URAC standards is active engagement with an advisory panel. These industry experts share what has changed in practice since the last revision. We aim to determine best practices in patient care, operations, and outcomes management. After incorporating the expertise of this panel, the revised standards were published for comment. At the end of this process, we launched the revised program as Version 4.0, a significantly streamlined and updated version of the standards.

PP&P: What changes were made to the cold chain management section of the specialty pharmacy standards?

Bonome: The previous standard was specifically titled Cold Chain Management; the standard has now been revised and titled Temperature Management. Experts in the field reached out to us to provide recommendations to update this standard. In the prior version, the standard focused only on “cold chain” medications and on the importance of having a validated process for packaging and distributing these products. While cold chain medications do require strict temperature control, our experts noted that every medication has an optimal temperature range that is tested by the manufacturer, and to which pharmacies should adhere. The standard now requires that the pharmacy have a validated distribution process for not only cold chain medications, but all medications that the pharmacy dispenses.

Pharmacies must demonstrate that their processes for packaging and shipping medications have been tested across different geographic areas, temperature ranges, and times of year (eg, the summer and winter months, minimally). Testing must be performed prior to implementation of new packaging products and/or when packaging process instructions are modified.

In addition, requirements that were carried through from the previous standards include making sure the pharmacy has processes in place for determining whether a package should be held due to weather, tracking packages after they leave the pharmacy, and handling any breakdowns in the shipping process.

PP&P: What changes were made to the patient management section of the standards?

Bonome: A comprehensive patient management program is key to the mission of specialty pharmacy. Similar to the previous version of the standards, pharmacies must deliver a patient management program that is based on sound clinical evidence and overseen by a clinical oversight body, with services provided and documented by a qualified health professional (most often a registered pharmacist or nurse). Pharmacies must conduct initial clinical assessments and education and monitor specialty patients by performing periodic reassessments. Evaluating the effectiveness of the program by tracking clinical, financial, and quality of life benefits also remain in Version 4.0.

New to Version 4.0 is the requirement that clinical protocols within the program be specific to the drug and/or disease state. A “one size fits all” protocol will not meet the intent of the standard. Also new is the requirement that the clinical assessments include evaluation and documentation of the patient’s goal for therapy.

PP&P: What are reviewers looking for regarding product handling and security?

Bonome: The standards around product handling and security focus on where organizations source their drugs and how they are stored and managed upon receipt. Processes that reviewers will address include the following:

  • How are you monitoring inventory to ensure it is high quality?
  • How do you manage out of stock or backorder scenarios?
  • How do you store medications? Describe your temperature monitoring strategy for your refrigerators, freezers, ambient room temperature storage, and humidity monitoring.
  • Do you dispense controlled substances? If so, how are you ensuring regulatory compliance?
  • If you dispense hazardous materials or have hazardous materials in your pharmacy, are you adhering to all relevant management guidelines?
  • If you compound in your pharmacy, are you adhering to all USP guidelines?

PP&P: What is the top challenge for specialty pharmacies that has been identified during recent surveys?

Bonome: We consistently observe challenges in maintaining documentation. Oftentimes during the validation review, organizations will say that they completed the necessary requirements, but they have no corroborating documentation. If you do not document your actions, it is impossible to prove they occurred.

Developing robust policies and procedures is critical to proper documentation practices. Thus, standards that reviewers will address include:

  • How are you managing your P&Ps?
  • How do you approach regulatory compliance?
  • How do you maintain business continuity?
  • Describe your quality management program. How do you leverage that program for performance, management, and improvement?

Primary source verification of licensure prior to hire remains a standard that many pharmacies struggle to support with documentation showing compliance. This means obtaining and storing documentation directly from the state board of pharmacy confirming an active license, not a copy of a license. Similarly, some organizations struggle to achieve compliance with the standards requiring that anyone who handles or has access to medication has a drug screening and criminal background check prior to hire. These requirements are important to ensuring that patients receive care from qualified health care providers.

On the clinical side, it is not unusual to see pharmacies that fail to document the initial patient assessment and subsequent reassessments. For reassessments, reviewers will need to see documentation of certain elements, including:

  • Have you evaluated the patient for adherence to therapy?
  • Has the patient experienced any adverse events?
  • Is the patient achieving their therapeutic goals?

URAC reviews assessments and reassessments by pulling a representative sample of patient charts and verifying that all necessary documentation is included in each chart. In some cases, we find that no reassessments have been conducted, which is an issue for accreditors. In other cases, some necessary elements may be missing.

PP&P: What customer service standards do you expect pharmacies to have in place?

Bonome: URAC has a set of standards that focus on consumer empowerment. The goal is to make sure the patient has the information and the tools that they need to actively participate in their own care. Reviewers may question how the patient contacts the pharmacy. URAC requires 24/7 clinical support for patients, so there must be a backup system or clinical call support available for patients with clinical questions or concerns outside of business hours.

We require that pharmacies communicate rights and responsibilities to patients. We also have a standard around health literacy looking for plain language in all communications with patients, as well as considerations for diverse populations. For example, plans should address patients with language differences, cognitive differences, and physical impairments. All patients must receive the information they need.

In addition, there must be a process in place for handling consumer complaints. How do you capture complaints? What is your response turnaround time? Where are complaints and timing for responses documented? We will conduct a file review of consumer complaints to make sure they are handled appropriately.

Finally, there needs to be a mechanism to measure customer satisfaction. Most pharmacies meet this requirement by administering a patient satisfaction survey.

PP&P: How should an organization prepare for an accreditation review?

Bonome: URAC holds workshops to educate organizations seeking accreditation and for those already accredited. These can be powerful tools to assist pharmacists seeking accreditation for their specialty pharmacies. These workshops provide participants with an opportunity to ask questions and also hear questions from other applicants.

In addition, URAC presents educational webinars that focus on specific areas of the standards. For example, one webinar focuses on primary source verification, while another discusses patient management program documentation, as these are the areas that are most frequently missed upon review. Using the accreditation guide (to which every applicant has access when pursuing accreditation) to pinpoint the intent of the standard also is a useful strategy.

Finally, we have an interpretation portal for applicants who are going through the accreditation process where they can submit specific questions and receive a response in writing from one of our reviewers.

PP&P: What is the value of partnering with a consultant when seeking specialty pharmacy accreditation?

Bonome: A significant number of our applicants work with a consultant when seeking accreditation. Other organizations choose to seek accreditation on their own using the accreditation guide and the educational opportunities that we provide. Both approaches are equally valid.

Consultants often assist an organization with documentation creation. If your pharmacy does not have experience developing SOPs and P&Ps, engaging a consultant may be useful. However, remember that you must adhere to the P&Ps submitted to URAC, so they must be realistic and apply to your specific practices.

If you choose to work with a consultant, note that not all consultants provide the same level and quality of service. Be thorough and thoughtful in the selection process. Keep in mind that a consultant cannot serve as the point of contact between the organization and URAC; a member of the pharmacy staff must fill this role. This way, pharmacy truly owns the process.


  1. Drug Channels Institute Research. Exhibit 51: Share of Pharmacy Locations With Specialty Pharmacy Accreditation, by Corporate Ownership, 2015 vs 2019. Accessed April 22, 2020.

Heather Bonome, PharmD, URAC director of pharmacy, is responsible for the development and management of URAC’s Pharmacy Quality Management accreditation programs. She received her Doctor of Pharmacy from the University of Pittsburgh and completed a post-graduate pharmacy residency in managed care.


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