US drugmakers and wholesalers have welcomed California’s decision to delay for another two years the requirement that all prescription drugs should be tracked electronically, from the beginning to the end of the supply chain, in order to reduce the risk of counterfeit and substandard drugs reaching patients.

In 2004, California enacted the law which sought to make it the first US state to require medicines to be tracked through their “e-pedigree,”,and the system was due to take effect last year. The state Board of Pharmacy then agreed to delay its introduction until January 1, 2009, but, following continued warnings from drugmakers, suppliers and pharmacists that they would still not be ready to implement the new controls by then, the Board now says it has “reluctantly” agreed a further postponement until January 1, 2010.

Without such a delay, there were fears that some drugmakers would decide not to make their medicines available in California, and the Board concluded that the state drug supply and potentially, that of the entire USA, "may very well be negatively impacted,” it said.

The Pharmaceutical Research and Manufacturers of America welcomed the decision as “an acknowledgement of the complex regulatory and technological challenges that still must be overcome.” Moreover, it is possible that even by 2011, some of the key challenges will remain and still need to be resolved, warned PhRMA senior vice president Ken Johnson.

The additional two years will enable extra time for “a number of things to happen,” said Mr Johnson; for example, it will allow makers of blood products to test the effects of radio-frequency identification (RFID) on these treatments and encourage the Food and Drug Administration to provide guidance on how they should test to determine whether heat generated by RFID affects blood products’ safety or effectiveness.

“What’s more, researchers will have more time to address the technology compatibility problem that confronts those trying to implement the law. The fact is, the technology exists to track medicines, but we do not have one standard electronic serialisation system everyone can use to monitor medications throughout the pharmaceutical supply chain,” he added.

The board’s unanimous vote to delay the programme was necessary to preserve patient safety, value and access to medicines, added the Healthcare Distribution Management Association (HDMA). “We share the Board’s view that technologies that track and trace individual units of medication from the beginning to the end of the supply chain hold the most promise for deterring criminal counterfeiters and promoting patient safety,” said HDMA chief executive John Gray.

California’s first-in-US law would require each prescription medicine to be uniquely identified. The information electronically tracked throughout the entire supply system will have to include the medicine’s name, its dosage, container size, number of containers, the product lot or control number, names and addresses of each company that bought and sold the medicine, dates of all previous sales and shipping information. Neither federal law nor that of any other state requires tracking of prescription medicine at this unique level, the HDMA points out, and, ahead of the California Board’s vote, the state was described “the bellwether" for the nation by Carmen Catizone, executive director of the National Association of Boards of Pharmacy, who opposed the delay.

The state Board says it has been given "concrete assurances" by drugmakers, distributors and pharmacists that “they can and will be ready for full implementation by January 1, 2011.” However, it adds: “recent incidents involving contamination or counterfeiting by overseas suppliers of the blood thinner Heparin underscores the importance of a safe and secure supply chain. Yet federal and state efforts to date have not brought an end to the efforts of counterfeiters or others to impact the US supply chain.”

Meantime, on the same day as the California Board vote, a new network was launched to deliver drug safety alerts online to US physicians. The Health Care Notification Network (HCNN) replaces a “widely criticised and decades-old system” which, “in 2008, is indefensible and unsafe,” as it has relied on “paper-based US mail and weeks of delay to deliver time-urgent patient safety alerts to doctors,” said Nancy Dickey, chair of the iHealth Alliance which governs the new service.

“We are finally moving from the Paper Age into the Internet Age in terms of patient safety alerts. We encourage all US physicians to take two minutes and enroll today at www.hcnn.net. Physicians and their patients will realise immediate benefit,” said Dr Dickey, who is a former president of the American Medical Association.