In 2004, California passed legislation to mandate use of a 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 recently 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. Experts agree this can be achieved technologically.
The bigger issue is that 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.
Pedigrees 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, cholesterol levels, osteoporosis and many other diseases.
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 1 to 2 percent are at risk for counterfeiting.
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 1 percent problem makes no fiscal sense whatsoever.
The U.S. House Energy and Commerce Committee is addressing this very issue and considering adding drug tracking requirements to new safety legislation. The provisions being discussed under committee chairman John Dingell (D-Mich.) would require drug makers to adopt pedigree technology to track drugs and active pharmaceutical ingredients through the supply chain, focusing on drugs that are most often counterfeited or sold on the black market.
An additional provision being considered is to give the FDA the discretion to require pedigrees for other drugs.
The same approach is right for California. The National Association of Cancer Patients urges our elected officials to address this issue and fine tune the proposed legislation so it makes sense for both patient safety and our pocketbooks.
” Nekita (Nicki) Hobson served as executive director of the National Association of Cancer Patients from 1993 to 2002 and is currently chairman of the organization’s California chapter. She is also a co-founder and chairman of Cancer Survivorship: San Diego!, an umbrella organization dedicated to providing free information on cancer prevention and treatment to cancer patients, their families and the general public. Hobson has a master’s degree in political science from San Diego State University.