It is critical for any healthcare institution to understand the details of applicable laws and regulations to structure its approach to specialty pharmacy practices. The first step is to do a gap analysis of state and federal regulations pertaining to specialty pharmacy services. Risk Evaluation and Mitigation Strategies (REMS) requirements for specific products must also be considered. The company should then develop policies and procedures consistent with that gap analysis to support the identified scope of operations, to ensure and monitor adherence to established internal policy and procedure documents, and FDA-mandated REMS and regulatory requirements.
Accreditation Programs Confirming Adherence to Regulations
Specialty pharmacy accreditation targets standardization and improvement of patient care services. There are three primary accreditation agencies focused on specialty pharmacy operations and pharmacy accreditation:
1 – Accreditation Commission for Health Care, Inc. (ACHC)
ACHC standards focus mainly on patient care providers (home health, hospice and including specialty pharmacy). It is an authorized “Medicare Deeming Authority,” which figures in CMS processes. In addition to a specialty pharmacy accreditation, it provides for infusion pharmacy, long-term care pharmacy, community pharmacy, etc.1
2 – Center for Pharmacy Practice Accreditation (CPPA)
The CPPA provides community-practice accreditation program and specialty-pharmacy accreditation process. “CPPA standards are focused on recognition of specialty pharmacy practices, which provide care that enables patients to reach cost effective, therapeutic outcomes,” notes Lynnae Mahaney, Executive Director of CPPA.2
3 – URAC
The URAC accreditation program designed for specialty pharmacy3 includes five modules:
- Core organizational quality standards
- Customer service
- Communications and disclosure standards
- Specialty drug management standards
- Pharmacy operations standards and patient management
Accreditation should be pursued after conducting a gap analysis and operating procedures are in place. If there are gaps found during the accreditation process, your organization may have restrictions placed on it, such as limiting scope of services or types of disease states that can be covered by your specialty pharmacy program.4
Accreditation is good for three years, and then will need to be renewed based on a review of standing procedures, and documenting their compliance with them.5
Mesa Labs provides packaging, monitoring and compliance services for specialty pharmacies and their partner organizations. Solutions for these organizations include single dose, up to pallet sized temperature controlled packaging. Mesa’s temperature monitoring systems monitor environmental conditions related to storage and shipment using refrigeration equipment, vehicles and warehouses. Services cover the gamut from compliance gap analysis to development of storage and handling operating procedures, sustainability programs, training plans and Risk Evaluation and Mitigation Strategies (REMS).
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