By Dr. DAVID H. AIZUSS
In 2004, California passed legislation to mandate use of an e-pedigree system to electronically track drugs from the manufacturer to the patient as a means of stopping the sale of counterfeit drugs in the state through the gray or secondary market.
Enactment has been delayed twice by the state Board of Pharmacy first to Jan. 1, 2009, from 2007, and at its March 25 hearing to Jan. 1, 2011 largely because of implementation issues. The delays will provide time to set standards for the technology necessary to carry out such a massive tracking requirement. The bigger issue is the scope of the tracking goes beyond what is required to ensure patient safety. If implemented under the current law, the technology will cost more than the medicines being tracked.
Who pays? Patients. To what benefit? None.
Pedigree can be used to effectively track the medicines that are most likely to be counterfeited, such as Viagra and Oxycontin. Under current law, however, everyone in the supply chain, from manufacturer to distributor to medical clinic and pharmacist, would be required to track medicines that will never be counterfeited, including antibiotics and thousands of medicines for treating diabetes, allergies, osteoporosis and many other diseases.
Expensive procedure
Spokesmen for the generic drug industry and pharmacy distribution associations testified before the Board of Pharmacy about the high cost of the technology and how it will increase costs to patients with no added benefit. Out of some 3,000 medicines used by patients in California, just one percent to two percent are at risk for counterfeiting. The challenge for California then becomes how to use technology to ensure patient safety but without adding costs for everyone in the health care system. This includes state-run facilities that would suffer the same added burdens.
Legislation is currently being proposed in the California Senate to address the problems with the current law. The bill, SB 1307, from Sen. Mark Ridley-Thomas (D-Los Angeles), is a good first step at setting new standards and timelines for protecting the drug supply, including allowing those in the pharmacy supply chain more time to comply.
However, the bill needs to go one important step further in preventing higher medical costs for patients. The bill should be modified to apply only to medicines at risk of being counterfeited. Why spend millions of dollars to track $4 generic drugs or any other medicine where there is no profit incentive for counterfeiters? A 100 percent solution for a one percent problem makes no fiscal sense whatsoever.
Federal attention
New legislation is also being proposed in both the U.S. House and Senate to use pedigree technology to track drugs and active pharmaceutical ingredients through the supply chain, focusing on drugs that are most often counterfeited, such as Viagra, or sold on the black market. A potential provision being considered is to give the FDA the discretion to require future pedigrees for other drugs entering the distribution system.
The same approach is right for California. With more than 10 million residents in Los Angeles County, we stand to pay more than any other area in the state in wasted time and money in tracking 100 percent of our medicines when just two percent is needed. With only minor fine-tuning to his proposed legislation, Sen. Ridley-Thomas can do all Angelenos a huge favor and advance legislation that makes sense for both patient safety and our pocketbooks.
By Dr. David H. Aizuss is president of the Los Angeles County Medical Association. He is an ophthalmic surgeon who practices in Encino and West Hills, and teaches at the UCLA School of Medicine.
