Wholesale Standards Address Drug Safety and Pedigree
IMPAC announced a new accreditation process for the wholesale pharmaceutical industry to address the safety of the drug supply domestically and internationally. The accreditation process includes a set of quality and safety standards for pharmaceutical wholesalers and an on-site inspection to verify compliance with the standards.
“IMPAC developed the Wholesale Standards and Accreditation to address the safety issues in the U.S. drug supply and to prepare for the passage of federal legislation on drug importation which includes wholesale importation,” noted Dana Noble, Executive Officer for Operations. As noted in HHS Task Force on Drug Importation, there are vulnerabilities in the U.S. drug distribution system including diversion, incomplete pedigree or incomplete chain of custody, counterfeiting, repackaging and reselling. While the U.S. currently has a closed system for pharmaceutical wholesale where a wholesaler buys directly from the manufacturer and sells directly to the purchaser, there is a secondary wholesale market where brokers buy drugs when there is an oversupply, may repackage them and resell them. The chain of custody or traceability of these drugs is compromised with changed labels, repackaging, and reselling. Diversion, counterfeiting and tampering can occur during this process.
The Giuliani Partners’ Report, Examination and Assessment of Prescription Drug Importation from Foreign Sources to the United States noted “On its face it appears that the distribution chain for prescription drugs in the United States is fairly straightforward-manufacturers sell their products to wholesalers, who in turn sell the products to retail pharmacies or stores, who in turn dispense medicines to patients with prescriptions. It is not until the system is studied in greater detail that one begins to appreciate both the complexities and the vulnerability of the distribution chain and the potential for exploitation and abuse.” Jennifer Fels, Executive Officer for Standards and Surveys at IMPAC noted, “The numerous gaps in quality assurance and inconsistent processes within the United States, from the time a drug is manufactured to the time a drug reaches the consumer, has left the U.S. health care system open to errors and contributed to rising health care costs.”
The IMPAC Wholesale Standards include 4 categories and 63 quality standards. The first category is Quality Assurance that addresses the manufacturer, tracking mechanisms, competency, and performance improvement efforts. The Product Management standards address the drug integrity. Drug safety, security, and traceability are outlined in the Product Security standards. The last category is Information Management. Compliance to Wholesale Standards is verified during an on-site inspection completed by two surveyors including a pharmacist. For a pharmaceutical wholesaler to be accredited, all distribution sites will be surveyed and will need to be in full compliance. Accreditation will be for two years. Fels stated, “IMPAC Wholesale Accreditation, coupled with the proposed new technologies, will be key to a safer U.S. drug supply.”
“The need for national and international standards for the wholesale pharmaceutical distribution is obvious. It can not be left up to each individual state,” noted Noble. The wholesale pharmaceutical industry is a national, not regional or state run, business. When the federal legislation on drug importation passes, the wholesale pharmaceutical industry will be international. It is inefficient, ineffective and costly to leave it up to each individual state. As the Giuliani Report also notes currently ‘wholesalers or distributors are primarily regulated by states with no uniform standards across state borders. States have a comparatively small number of investigators to monitor licensed wholesalers; given the sheer number of wholesalers, oversight is minimal.” An international gold standard for wholesalers such as IMPAC Wholesale Accreditation will provide quality oversight for all states at no cost to the states and will improve the performance of wholesale pharmaceutical industry.
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