E-pedigree: Effective Safety Efforts Too Important to Rush
Bryan A. Liang, MD, PhD, JD
The pharmacy board met 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. The law’s intent to protect the consumer against counterfeits is sound. However, technological and other practical realities must be taken into account. Thankfully, the Board of Pharmacy recognized these concerns and moved the deadline out for two years.
The Board engaged in sound policymaking. 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 was wise to extend the deadline for two years.
But the e-pedigree effort should be the start of the effort to ensure the safety of drugs, not the end. The key problem unaddressed by this law is the Internet. Hence, the Legislature should take the time represented by the Board of Pharmacy delay to enact effective legislation to address this growing problem.
To protect against harmful drugs from this growing source, we need to ban Internet sales of drugs unless these facilities are licensed to practice pharmacy in California. They should also be subject to rigorous oversight standards. The latter 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.
And finally, penalties for illegal drug sales should be heightened to fit the crime of assault, battery, and murder if patients are injured.
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.
Bryan A. Liang, MD, PhD, JD is E. Donald Shapiro Distinguished Professor, Executive Director of the Institute of Health Law Studies, California Western School of Law; Co-Director, San Diego Center for Patient Safety, UCSD School of Medicine; and Vice President of the Partnership for Safe Medicines.
Links and Resources:
E-pedigree information from the California Board of Pharmacy
Overview of e-pedigree requirements
Current e-pedigree requirements - SB 1307 (2004)
Changes to requirements - SB 1307 (Ridley-Thomas) | Amended
Proposes changing implementation date - SB 1270 (Cedillo) | Amended