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Protection against counterfeit drugs too important to rush

The pharmacy board will meet on March 25 in San Diego to consider whether or not it is necessary to move the deadline to implement an electronic pedigree system back to 2011. Although the law’s intent to protect the consumer against counterfeits is sound, practical realities may force a reconsideration of the deadline.

While a tracking system is a good idea, the devil is in the details. Those participating in the supply chain — from pharmaceutical companies to community clinics to mom-and-pop drugstores — are greatly concerned about implementing a law that won’t work because of the unanswered questions of what an e-pedigree would entail — including what standard is right for the entire chain, what technology to use, what frequencies are mandated, how pill containers versus injectables would be treated, how to weather the costs of pedigree readers and writers, and, critically, who would be the owner, guardian and steward of the information. The law says the e-pedigree needs to be interoperable, but no federal or state standards exist. Additionally, there is no technology in place that is interoperable and compatible throughout all stages of distribution.

This raises another concern: California is the only state to require e-pedigree down to the unit level. Yet as more and more states start passing their own, different statutes, the potential for chaos in trying to fulfill all these different rules may become increasingly costly. These costs, as well as the direct costs associated with pharmacy implementation of just the California law, estimated by Rite-Aid to be $80,000 per pharmacy, will fall upon consumers.

Because of these issues, the Board of Pharmacy should extend the deadline for two years.

But in addition, during this time, the legislature should see the e-pedigree law as the beginning of drug safety efforts in the state, not the end. The key problem unaddressed by this law is the Internet. To protect against harmful drugs from this growing source, we need to ban Internet sales of drugs unless these facilities are licensed to practice in California and are subject to rigorous oversight standards. This can be done through the Verified Internet Pharmacy Practice Sites accreditation program of the National Association of Boards of Pharmacy. This safety effort can also be effectively promoted by prohibiting credit card companies from executing any transactions associated with online sales of drugs unless the site is approved by the VIPPS program.

The bottom line is that we all want our drugs to be safe. We need an e-pedigree law implemented that works, and we need legislation to address problems with the Internet. By extending the deadline for the e-pedigree law so the practical concerns can be addressed while simultaneously dealing with the problem of online drug sales, we in California can lead in the effort to ensure safety in the drug supply chain — a leadership role we should aspire to.


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