More US states unveil e-pedigree plans

California’s attempt to require electronic pedigrees for medicines may have been stalled, but other states are continuing to press ahead with their own drug pedigree proposals.

New York and Pennsylvania are the latest to introduce legislation aimed at requiring electronic records to shore up the medicine supply chain.

With efforts by the US Food and Drug Administration (FDA) to introduce federal pedigree legislation held up by legal challenges, it is up to the states to enact their own e-pedigree legislation.

Many US states have put their own legislation into action in the context of the requiring anti-counterfeiting technology, strengthening the licensing requirements of wholesalers and increasing penalties for those who violate the law, although California remains the most stringent with its requirement for unit-of-use serialisation.

New York’s proposal – which has been referred to the state department of education (SED) - establishes an electronic record containing information regarding each distribution step for a prescription drug, from the manufacturer, through wholesalers, manufacturers, or pharmacies, until final dispensing to the patient.

The e-pedigree would become mandatory on January 1, 2011, according to the proposal, although it carries the rider that this will only take place if the SED “has determined that the system then available is feasible at that time.”

The proposal also covers penalties for counterfeit drugs and upgrades the status of “packaging, selling, transferring, distributing or delivering any prescription drug that is known to be adulterated, misbranded, counterfeit or rendered unfit for distribution” as a class D felony.

Pennsylvania’s proposal, referred to the Public Health and Welfare Department last month, is known as the Wholesale and Prescription Medication Integrity Act.

The bill requires the licensing of secondary wholesalers and initially a written rather than an electronic pedigree for use in tracking drugs through the supply chain and in identifying counterfeit prescription drugs.

An e-pedigree should be in place “no sooner than December 31, 2010, and may be extended by the State Board of Pharmacy in one-year increments if it appears the technology is not universally available across the entire prescription pharmaceutical supply chain,” according to the proposal.

The bill also imposes duties and responsibilities upon the Department of Health and the State Board of Pharmacy; and calls for penalties of up to $500,000 and 20 years in jail for deliberate counterfeiting activity.

A January 2009 report by the American Council on Science and Health entitled Counterfeit Drugs: Coming to a Pharmacy Near You estimates that counterfeit sales are around $39bn or 11 per cent of global pharmaceutical commerce, and are expected to climb to $75bn by 2010.