OR WAIT null SECS
Upstart organization seeks to create another pathway for acceptance by regulators and pharmacy benefit managers
In the mid-2000s, when a recurring spate of counterfeit-drug incidents occurred, the National Board of State Pharmacies (NABP) stepped in by establishing the Verified-Accredited Wholesaler-Distributor (VAWD) program. It is now well recognized within the pharma supply chain as a measure of quality for pharmaceutical distribution and handling practices; wholesaler-distributors pay a fee, get inspected by industry experts, and earn a three-year accreditation. According to NABP, 24 states have written VAWD into their state rules; additionally, a number of pharmacy benefit managers (PBMs), pharmacy chains and others require VAWD accreditation to do business with them.
Now, a new organization, the National Council of Drug Quality and Security (NCDQS) is offering an alternative accreditation process: the Quality and Security (QAS) accreditation, announced in early September. Already, the Iowa Board of Pharmacy has allowed a wholesaler-distributor to be approved under a waiver to its existing VAWD requirement, according to Denise Frank, a director of NCDQS; other wholesaler-distributors are lining up to undergo the QAS accreditation, and the hope is that other states and private entities will recognize QAS as equivalent—if not better—than VAWD.
QAS apparently has some features lacking or under-represented in VAWD, notably a review of OTC practices in addition to ethical-pharmaceutical policies, and some recognition of how suspicious-order monitoring (SOM) of controlled substances is conducted. (NABP has a separate program for OTC business practices.) But the main driver seems to be disenchantment with how NABP is managing the VAWD program, with excessive delays for some companies seeking accreditation, according to industry sources. Just over a year ago, NABP posted a statement describing the accreditation process, noting that “Some facilities that seek accreditation have minimal knowledge of the VAWD criteria and/or have no experience going through an accreditation process. If a facility has stalled in the VAWD process, it is likely due to a lack of transparency about their supply chain, a lack of compliant policies and procedures, and/or an inability or indisposition to implement compliant policies and procedures.”
NCDQS’ QAS announcement is practically a rejoinder: “I come from an independent, rural pharmacy background, and I understand the plight of small operations that do not have large compliance teams to assist in improving their operations and complying with federal and state regulations. Our goal is to protect the public by working not only with the large players, but with the smaller operators to assist them in achieving the level of compliance and quality to meet the accreditation standards and ultimately protect the public,” stated Frank. And while NABP’s statement says that accreditation takes 3-6 months, NCDQS claims a 90-day turnaround. “A facility that is knowledgeable about the VAWD Standards, prepared (defined process and procedures), and is able to schedule a site survey can achieve VAWD accreditation in as little as three months,” Carmen Catizone, executive director of NABP, tells Pharmaceutical Commerce.
Overall, says Catizone, “The decision as to what accreditation program(s) a state chooses to recognize is entirely the responsibility and prerogative of the state. How a state assesses equivalence of other accreditation programs to NABP’s VAWD program rests, again, entirely with the individual state. If other programs are equivalent to VAWD, then there would be no dilution of the integrity of the medication supply system.”
The VAWD/PBM contretemps has cropped up before; a group called the Assn. of Independent Pharmacies filed suit in federal court against OptumRx in 2016 over OptumRx’ restriction of non-VAWD distributors; the case was settled out of court in 2018.
For her part, Denise Frank is very experienced in VAWD processes; between 2006-2013, she was a consultant to NABP, and moved into the full-time position of Accreditation and Inspection Services manager until 2016. Perhaps the larger context of this friction is the continual efforts of small wholesalers (many of whom are secondary wholesalers, who do not buy product directly from manufacturers) to continue to do business. The Healthcare Distribution Alliance restricts its membership to primary wholesalers only; and laws ranging from the Drug Supply Chain and Security Act to state pharmacy regulations make life difficult for them.
NABP has been an aggressive beat cop of the pharmaceutical supply chain in recent years. In addition to the VAWD program, it runs the Verified Internet Practice Sites (VIPPS) program along with the .Pharmacy program (in effect, it verifies any entity that seeks to use “.pharmacy” in its URL)—and all of this is alongside various pharmacy and pharmacist programs. The organization says that 634 entities currently have VAWD accreditation. (It’s worth noting that many companies, including pharmacies and pharma manufacturers, obtain wholesaler-distributor licensing in conjunction with their business practices.) Most recently, it announced a grant from FDA to improve the interstate data collection from compounding pharmacies.