|Specialty pharmacy accreditation is as important as ever. Here are some highlights of what is new in specialty pharmacy accreditation.|
Online Pharmacies Continue to Expand Along with an Expansion of Fraud
Fortune reports that the worldwide market for ePharmacies had annual revenues of nearly $5 billion in 2018. Revenues are estimated to reach $17.7 billion in 2026. For the period between 2019 and 2026, the compound annual growth rate (CAGR) expectation is 17.3% per year.
As more patients use online pharmacies for the convenience of buying from home and regular deliveries, ePharmacies need to be accredited by one of the three accrediting bodies of ACHC, NAPB, or URAC. Accreditation can distance an online pharmacy from the massive amounts of online fraud that plagues the industry.
Marjorie Clifton, Director of the Center for Safe Internet Pharmacies notes that the National Association of Boards of Pharmacy and the FDA report that 97% of the online pharmacies are not legitimate. They are not certified under US law.
Patients are advised only to get their prescriptions filled by accredited pharmacies online and offline. Patients are encouraged to use the verify before you buy system to check for a pharmacy’s legitimacy and certification as a licensed pharmacy.
Accredited specialty pharmacies that sell online should feature their accreditation prominently on their website.
URAC’s Accreditation Standards are More Streamlined
URAC started a process, which is ongoing in 2022, for continuous improvement in its accreditation processes. It released a new version of its Specialty Pharmacy Accreditation.
Across the board, the number of accreditation standards for pharmacy operations decreased by 15% to 35%. This streamlined improvement came from combining multiple standards related to each other into one standard and by retiring standards that were no longer useful or necessary for quality care.
For the first time, URAC’s policy changed regarding reviewer activities to meet standards. Some standards do not have reviewer activities needed for the Validation Review. For a considerable number of standards, after a reviewer signs off for that standard during the Desktop Review phase, it is completely satisfied. This new method makes the process move more smoothly through the Validation Review stage.
URAC’s Rare Disease Designation for Specialty Pharmacies
URAC has a new specialty pharmacy accreditation designation of Rare Disease Designation for specialty pharmacies. This designation is useful for pharmacies working with patients with rare diseases who require specialty medications approved through the FDA’s orphan drug program.
Even though the Rare Disease Designation came into being in 2018, only a few specialty pharmacies, so far, have achieved this designation. This niche may now represent an opportunity for others, since approximately 90% of rare diseases have no approved therapy. Advancements in medical and pharmaceutical science make new therapies possible to provide healthcare for these patients.
Achieving the Rare Disease Designation is challenging due to the high skills necessary to support these patients. There are comprehensive reporting requirements and stringent storage and handling procedures needed for the delicate and expensive medications for rare diseases.
URAC offers the Rare Disease Pharmacy Center of Excellence designation for specialty pharmacies that demonstrate customized, high-touch, coordinated, and compassionate patient care in providing a specialty pharmacy access for a rare disease.
For more pharmacy insight regarding accreditation, licensing or regulatory compliance issues, we have designed a technology-based solution to ease your concerns and administrative investment. You can also contact an expert at D2 Solutions to personally discuss your needs.