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Vet-VIPPS Contributes to Security of Evolving Veterinary Drug Supply Chain
Originally published in the September 2010 NABP Newsletter
The standards of the Vet-VIPPSCM (Veterinary-Verified Internet Pharmacy Practice SitesCM) program help to assure that accredited online veterinary pharmacies safely dispense prescription pet medications that are acquired through verified sources. At the same time, certain distribution practices, as well as the variation in state regulations pertaining to the veterinary drug supply chain, can create opportunities for diversion and for counterfeit drugs to enter the distribution path. Such vulnerabilities in the veterinary drug distribution channel arise from circumstances similar to those that contribute to the risk of counterfeits in the human drug supply chain. Fortunately, the Vet-VIPPS accreditation process, as well as NABP’s extensive experience with accreditation, has helped to identify the potential emerging vulnerabilities in the veterinary drug supply chain.
Veterinary Drug Distribution Channel
Since establishing the Vet-VIPPS accreditation program in 2009, NABP has learned that the current distribution channels for veterinary pharmaceuticals differs extensively from the flow of products in the supply chain for human drugs. Currently, veterinary drugs may change hands three or four times before reaching the inventory of a licensed veterinary pharmacy or licensed veterinary Internet pharmacy. Drug manufacturers producing veterinary prescription pharmaceuticals typically sell these drugs directly to veterinarians, or to wholesale distributors that only sell directly to veterinarians. In turn, these veterinarians, some of whom purchase prescription drugs from manufacturers in bulk, may resell the drugs to wholesale distributors or to veterinary Internet pharmacies.
While some manufacturers are beginning to bypass this more complicated supply chain, by selling directly to veterinary pharmacies or veterinary Internet pharmacies, this modified distribution flow is occurring only in limited instances.
Securing the Human Drug Supply Chain
As seasoned pharmacists, pharmacy regulators, law enforcement, and industry professionals will remember, complexities in the human drug supply chain have been shown to raise the risk of counterfeit drugs entering the supply chain. Food and Drug Administration’s (FDA) Counterfeit Drug Task Force Report of October 2003 described three drug distribution models. In the most complex model, as the report explains, a drug may be handled by one or more wholesalers, and sometimes a repackager, before it reaches the retailer, and such intermediate steps in the supply chain create more opportunity for compromised security of the supply chain. The report emphasizes that a “drug product undergoing multiple transactions between the time it is sold by the manufacturer and the time it is bought by an end user, should be properly authenticated . . . by each purchaser in order to minimize the possibility that a counterfeit product has been substituted by an unscrupulous entity during one of the transactions.” Specific weak spots in the human drug distribution chain included failures by some wholesale distributors to authenticate prescription products and perform effective due diligence on inventory that was acquired from secondary sources, as noted in the September 2003 NABP Newsletter.
In response to the security issues plaguing the human drug supply chain, NABP established the Task Force on Counterfeit Drugs and Wholesale Distributors, which met on October 29-30, 2003. The report of the task force recommended revisions to the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act), and specifically to the Model Rules for Licensure of Wholesale Distributors section and to related definitions in the Model Act. The revisions were intended to provide better guidance to the state boards of pharmacy to assist in regulating wholesale distributors, and were intended to combat the influx of counterfeit drugs into the United States medication distribution system. NABP also developed the Verified-Accredited Wholesale DistributorsCM (VAWDCM) accreditation program, a plan that was supported by FDA, which requires accredited wholesale distributors to operate legitimately, remain licensed in good standing, and employ security and best practices for safely distributing prescription drugs from manufacturers to traditional and Internet pharmacies and other institutions. Currently, more than 400 facilities are VAWD accredited and 22 states recognize VAWD accreditation.
State Regulation of Veterinary Drugs
As was the case with the human drug supply chain, the regulations governing the veterinary supply chain vary from state to state, which can complicate efforts to ensure the security of the supply chain. In some states, the practice of veterinarians obtaining and reselling prescription drugs to pharmacies is legal, as long as they obtain a wholesale drug distributor license. Limited state board resources can make it difficult to regulate such licensees, however. Such circumstances, in combination with the additional step in the supply chain, can increase the risk to the supply chain security.
Vet-VIPPS Protects Veterinary Drug Supply Chain
Currently, the Vet-VIPPS accreditation program helps to assure that better security procedures are followed as drugs make their way to accredited veterinary Internet pharmacies. Vet-VIPPS standards require accredited pharmacies to be licensed or registered in good standing, compliant with state and federal regulations, and to implement and maintain necessary policies and procedures. Currently, six veterinary Internet pharmacies have achieved Vet-VIPPS accreditation.
While, by and large, manufacturers are not selling directly to veterinary Internet pharmacies, some are beginning to follow this practice. This trend may help to lower the risk to the security of the veterinary drug supply chain. In fact, the Model Act, section 105, Definitions, (mmmm), describes a “normal distribution channel” as one in which a prescription drug goes from a manufacturer to a pharmacy, or only passes through one wholesale distributor before going to the pharmacy. With this standard in mind, as the veterinary drug supply chain landscape evolves, the Vet-VIPPS program will continue striving to help improve the safety of veterinary medications dispensed by accredited Internet pharmacies through an accreditation process that incorporates thorough professional standards and procedures.
