Specialty Pharmacy-Specific URAC Standards
Preparation for URAC accreditation requires a careful review of a specialty pharmacy's customer service, specialty drug management, operations, and patient management procedures.
Preparation for URAC accreditation requires a careful review of a specialty pharmacy’s customer service, specialty drug management, operations, and patient management procedures.
In a past issue of Specialty Pharmacy Times, I focused on the Pharmacy Core URAC accreditation standards, and here will discuss the specialty pharmacy—specific standards. These standards make up the other 50% of the standards. There are 4 sections of standards:
- Customer Service, Communications, and Disclosure (CSCD)
- Specialty Drug Management (SDrM)
- Pharmacy Operations (Pharm-Op)
- Patient Management (PM)
URAC has a total of 13 standards in the CSCD section. These standards focus on the call center and operations for assisting patients. To meet the standards, your company will have to provide your call center representative availability, as well as on-call support information. One specific standard addresses the health literacy and cultural sensitivity communication requirements. You will have to provide details on how you help patients with low literacy level and undergo a review of any patient communications.
The review of the patient communications can be done by utilizing the Flesch—Kincaid readability tests. You can find more information on how to do this review at the following link: http://office.microsoft.com/en-us/word-help/test-your-document-s-readability-HP010148506.aspx.
If you have a well-written “Frequently Asked Questions” document in your welcome kit, this can help you meet multiple standards for CSCD. Drug substitutions and recalls and how you communicate these specific situations to patients are also covered in these standards.
The next section of standards for URAC is SDrM. There are a total of 5 standards in this section. These standards focus on the drug management policies for your organization. One area of focus is drug utilization review (DUR). You will have to document your DUR process that occurs when processing prescriptions.
Another focus in these standards is the issue of how you handle patient education on medications and disease states. This leads to a topic that you will need to prepare for during your implementation for URAC specific to patient assessments. Putting a process in place can be quite an undertaking if you are not already performing these services for your patients. Some pharmacies will utilize applications or tools to help manage the patient assessments. Others may use more manual management techniques to help manage patient assessments. You will want to make sure you have an initial assessment and a reassessment process that is documented.
During the on-site inspection, URAC will spend time going through patient records with your staff and validate that assessments are occurring. The assessment process also includes reporting of adverse events. It is recommended that you track and trend adverse events to see if you need to modify your assessments to help drive better patient outcome results.
The next section of standards is Pharm-Op, and it has 15 standards. These standards are specific to the operational aspects of your specialty pharmacy. This includes your scope of services that you provide. If you focus on specific disease states, it may make sense that your assessments are focused on these disease states. URAC will look for you to utilize evidence-based clinical criteria to help develop the assessments. Most of the standards in Pharm-Op are specific to your operating system and how you handle the processing of prescriptions: intake, order review, pharmacist verification, shipping, product storage, and compounding, to name a few areas.
URAC also looks for security measures in these standards as well as machine and any equipment maintenance (clean room equipment, automated counting machines, scales/balances, etc). Lastly, you will want to make sure you address proper disposal of medication. You can find some information on this on the FDA.gov website.
Finally, the last section of URAC standards is patient management or PM. If you properly create documents and policies for the other URAC standards, you may be able to address some of these standards with the same documents and policies. This section will also focus in more detail around your assessment process for patients. For example, how do you handle at-risk patients during the recruitment process?
One standard is specific to evidence-based research and practices for your organization. URAC also has a focus in this section of standards around your quality program and the evaluation of the program. One area that is focused on again in this section is the patient education measures and processes for your organization. Patient education is a great example of where a well-written policy can meet multiple standards for several categories of URAC standards. SPT
URAC, an independent, nonprofit organization, is a well-known leader in promoting health care quality through its accreditation, education, and measurement programs. URAC offers a wide range of quality benchmarking programs and services that model the rapid changes in the health care system and provide a symbol of excellence for organizations to validate their commitment to quality and accountability. Through its broad-based governance structure and an inclusive standards development process, URAC ensures that all stakeholders are represented in establishing meaningful quality measures for the entire health care industry. For more information see www.urac.org.
About the Author
Quintin Jessee, RPh, DPh, is senior consultant, specialty and mail order operations, at D2 Consulting. Prior to joining D2, Quintin was the vice president of mail order operations for BioScrip Pharmacy. Also while at BioScrip, he was director of quality assurance, pharmacist-in-charge, and special projects manager. He implemented and managed the first medication therapy management program (MTM) at BioScrip and was in charge of facility accreditations and CQI program management.
Quintin specializes in accreditation support as well as specialty pharmacy management and works with specialty pharmacies on build-out support and overall business needs including access to specialty products, managed care strategies, MTM services, work flow management, staffing models, and policy development.
Quintin received a bachelor’s degree in pharmacy from Ohio Northern University and has served on the faculty of The Ohio State University School of Pharmacy as a professor and mentors pharmacy students there. Quintin is a registered pharmacist in Ohio and Tennessee and currently resides in Columbus, Ohio. He volunteers with the Franklin County disaster relief team.