ASHP Policy Position 2311
PHARMACY ACCREDITATIONS, CERTIFICATIONS, AND LICENSES
To advocate that healthcare accreditation, certification, and licensing organizations adopt consistent standards for the medication-use process, based on established evidence-based principles of patient safety and quality of care; further,
To advocate that health-system administrators allocate the resources required to support medication-use compliance and regulatory demands.
This policy position supersedes ASHP policy position 1810.
Rationale
Pharmacy leaders have years of experience managing the demands and challenges of ensuring that pharmacy services meet the standards of accreditation organizations. In the past, this responsibility was predominantly achieved through accreditation by The Joint Commission (TJC) and compliance with state laws and Board of Pharmacy regulations, as well as with federal requirements (e.g., those of the Drug Enforcement Administration). The number of accreditation standards pharmacy leaders needed to be knowledgeable about was limited. Healthcare organizations with ambulatory care services (e.g., home infusion, specialty pharmacy) have had to manage the additional accreditation process for these business units. Recent changes in healthcare have increased this challenge for pharmacy leaders: (1) TJC is no longer the only accreditor for hospitals and health systems; (2) healthcare organizations are developing or acquiring new business units that have their own accreditation processes that need to be integrated into existing ones; and (3) new accreditation, certification, or licensure processes have been created for services and businesses that fall under the responsibility of pharmacy leaders.
The expansion of healthcare organizations and the growth of the pharmacy enterprise are creating a new environment with multiple accreditors and regulators, presenting pharmacy leaders with the growing challenge of compliance with overlapping accreditation, certification, and regulatory standards. Examples include the Michigan Board of Pharmacy requirement to obtain certification to conduct compounding and the California Board of Pharmacy requirement that each IV hood have its own pharmacy license. In addition, community pharmacy accreditation processes and standards are being implemented that pharmacy leaders need to consider as well.
ASHP recognizes the difference between certifications that are the sole responsibility of and have a direct impact on a pharmacy and certifications of a healthcare organization’s service line (e.g., stroke or transplant services) that are the responsibility of the organization but have medication management components that need to be addressed by the pharmacy. Pharmacists and pharmacy departments are being challenged by a growing number of required accreditations, certifications, and licensures, which result in increased need for pharmacist-in-charge designations, workforce fatigue, and direct and indirect costs. Health-system administrators need to recognize this changing environment and allocate the resources required to support medication-use compliance and regulatory demands.