In 2004, the National Association of Boards of Pharmacy (NABP) established the Verified-Accredited Wholesale Distributors (VAWD) process in order to keep the country’s supply of prescription drugs and medical devices safe from counterfeit products. The NABP process is a rigorous one. In order to receive VAWD-certification, a drug wholesale company must show that they have a legitimate operation, their license is in good standing, they have employees, and utilize best practices when it comes to handling, storing, and shipping prescription drugs and medical devices.
It is in a pharmacy’s best interests – as well as their customers’ – to always purchase medications and devices from a VAWD-certified company. Although it may be tempting to purchase from a secondary wholesaler because it has lower prices than an accredited company, you have no idea where the products are coming from or how the company operates since there is no oversight. Recent events emphasize just how dangerous this can be.
Owner Indicted on Federal Charges
Last month, federal prosecutors announced they had indicted the owner of a Plainfield, IL wholesale drug company for purchasing unregulated prescription drugs and then reselling these medications to unsuspecting pharmacies. The man was charged with six counts of mail fraud, four counts of wire fraud, and three counts of money laundering.
Prosecutors allege that over a six-year period, the man purchased $57 million of diverted and unregulated prescription medications, directed his employees to clean the bottles in order to make it appear the drugs did come from a regulated source, and then sold them to other wholesalers and pharmacies. Some of the pharmacies he sold these medications to were located in Chicago and Joliet.
Risks of Purchasing from a Non-VAWD-Certified Wholesaler
When a pharmacy purchases product from a drug wholesaler that is not VAWD-certified, there is a wide array of issues that it could find itself dealing with, including:
Medications illegally imported into the U.S. to evade inspection
Medications that have false documentation
Medications that are counterfeit
Medications that are contaminated
Medications that are stored in non-temperature controlled or unsanitary conditions
Medications that were previously dispensed and now re-entering the drug channel
One of the most dangerous risks a pharmacy takes by purchasing prescription drugs from a wholesaler that is not VAWD-certified is that a patient could be harmed by bad medication because the safety of drugs coming from the wholesaler could be compromised. This has led some pharmacy benefits managers (PBM) to require their clients only purchase from VAWD-certified drug wholesalers.
Another major factor for a pharmacy to consider is the role that their drug wholesaler plays in audits and any other actions initiated by its PBM, state boards, and federal agencies. A drug wholesaler that cannot respond quickly and with the appropriate information could have dire legal consequences for the pharmacy.
Contact an Illinois PBM Audit Lawyer for Assistance
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