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Should drugs be pedigreed to prevent counterfeiting?

The Pharmaceutical Research & Manufacturers of America is on record as supporting the implementation of pedigree regulations to protect our medicine supply from drug counterfeiting. We believe the Food & Drug Administration should act immediately to require wholesalers to provide their pharmacy customers with a pedigree establishing the sales history of the drugs they sell. This action is one part of a five-point program PhRMA has identified to combat prescription-drug counterfeiting.

The drug pedigree regulations are part of the Prescription Drug Marketing Act of 1988. Congress passed the PDMA to assure American consumers that the medicines they receive are genuine and that these quality attributes are preserved throughout the distribution system down to the local pharmacy. As a result of eight days of Congressional hearings, the Energy & Commerce Committee came out with a report in 1987 describing the purpose of the PDMA as follows:

"American consumers cannot purchase prescription drugs with the certainty that the products are safe and effective. This is not to say that the shelves of the nation's pharmacies are lined with substandard products, or that there are inadequate controls in the manufacturing process. Rather, the integrity of the distribution system is insufficient to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit pharmaceuticals.

"Specifically, the existence and method of operation of a wholesale submarket, herein referred to as the 'diversion market,' prevents effective control over or even routine knowledge of the true sources of merchandise in a significant number of cases. As a result, pharmaceuticals which have been mislabeled, misbranded, improperly stored or shipped, have exceeded their expiration dates, or are bald counterfeits are injected into the national distribution system for ultimate sale to consumers.... The legislation is designed to restore the integrity and control over the pharmaceutical market necessary to eliminate actual and potential health and safety problems before serious consumer injury results."

The linchpin of this federal approach to pharmaceutical quality assurance is the so-called pedigree requirement. This provision requires "... each person who is engaged in the wholesale distribution of a drug ... and who is not the manufacturer or an authorized distributor of record of such drug ... [to] provide to the person who receives the drug a statement (in such form and containing such information as the Secretary may require) identifying each prior sale, purchase, or trade of such drug (including the date of the transaction and the names and addresses of all parties to the transaction)." The information the FDA requests in the pedigree includes the name of the drug, dosage, container size, lot or control number, name of the business selling the drug, and the date of the transaction. All of this information is readily available on the transaction order between the pharmaceutical manufacturer and the authorized wholesaler. This provision establishes a chain of custody from the manufacturer to the wholesaler to the pharmacy even in those cases where there may be multiple transactions on the secondary market.

Although the PDMA included provisions requiring drugs to be pedigreed, they have not been implemented because, on the request of affected parties, FDA has time and again postponed the effective date of these regulations. The latest effective date is April 1, 2004.

PhRMA member companies manufacture pharmaceuticals to exacting standards to ensure their safety, purity, and potency. The cornerstone of the development of safe and effective prescription medicines is the original manufacturer's full compliance with an FDA-approved New Drug Application and total control of the process from the selection of raw materials, design of the manufacturing process, packaging of the final product, evaluation of the conditions for storage (including the establishment of an expiration date after which the medication should be discarded), and careful selection of the distribution pathway. American patients expect FDA and manufacturers to ensure that the medicines they receive will be of the highest quality.

Without a legal document assuring traceability back to the original manufacturer, there is no guarantee that the pharmaceutical product is genuine rather than counterfeit or has been properly stored. For many products, exacting storage conditions identified in the new drug application must be maintained to ensure product quality. Without these safeguards, American consumers will be placed at risk of receiving counterfeit pharmaceuticals that are subpotent or even have no activity, or are adulterated by dangerous by-products or other contaminants toxic to patients' health.

PhRMA believes that implementation of these pedigree requirements, along with other strategies to thwart counterfeiting, are essential to assuring consumers that the prescription drugs they receive from their pharmacists meet all exacting FDA-approved specifications.

The AUTHOR is associate VP, regulatory affairs, at the Pharmaceutical Research & Manufacturers of America, which represents the country's leading research-based pharmaceutical and biotechnology companies.

As the conduit between pharmaceutical makers and the health professionals who dispense prescriptions to patients, the 89 distributor members of the Healthcare Distribution Management Association (HDMA), who handle more than 90% of all distributed drugs in the United States, are dedicated to patient safety. It is through our hands that lifesaving and life-improving medications pass, and we take our safety role extremely seriously.

That is the reason that HDMA and its members stand behind the establishment of a 21st-century pedigree system for pharmaceuticals. While expanding the pedigree system is one way to prevent drug counterfeiting, it is, unfortunately, based on an outmoded technology: paper. That system may appear to provide greater patient safety, but, in fact, it provides greater opportunities for the unscrupulous to tamper with the system—everywhere from the factory floor to the medicine cabinet. Expanding such a system would create a false sense of security for patients, when what is needed is a system that will truly improve drug safety.

HDMA members work hand-in-hand with federal and state regulators to ensure that Americans enjoy the safest, most reliable distribution system in the world. Distributors take every step possible to ensure that the medicines they distribute are genuine, unadulterated, and unexpired.

At the same time, while medications are in the facilities of HDMA members, every effort is made to ensure that they are transported and stored in optimum conditions to preserve their effectiveness.

Even so, more needs to be done to further reduce the chance of any patient receiving any errant dose of medicine, whatever the cause. We believe the application of the latest technology in the manufacturing process and computerized tracking systems in the supply and distribution chain will ensure that patients receive the health care that they deserve.

Clearly, this necessitates the use of an electronic "serial number," such as an electronic product code (EPC), instilled at the factory, which follows a medicine throughout its journey to the patient who eventually consumes it. Modern technology provides several ways in which such a serial number can be created, and in a fashion that prevents almost all attempts to tamper with it. Immediately, such a system would minimize any chance that counterfeit product could be introduced.

Combining that serial number with computerized systems can provide a wealth of information about a medicine at any stage in its travels. It would allow authorities to "backtrack" the route of a product and discover any anomalies that might indicate improper storage or adulteration potential or determine that the medicine had passed its expiration date.

Contrast this secure technology with a paper-based system similar to a bill of lading. At every stage in the process, a paper system is far more easily altered or faked than a tamper-resistant serial number. Papers can become lost; serial numbers cannot, and if they are not apparent, then it is an immediate signal that something is amiss. High-tech systems can be programmed to identify data errors and issue warnings, providing an immediate alert about a particular product. That allows quick action to be taken to determine if there is a problem and to prevent problem products from ever reaching a patient.

As a key participant in the Food & Drug Administration's recently announced program to keep counterfeit drugs out of the marketplace, HDMA will lead a task force consisting of manufacturers, distributors, pharmacies, consumer groups, and key trade associations to develop a comprehensive plan to implement various industrywide technological solutions to eliminate the threat of counterfeit drugs from the healthcare system. These technological solutions will also prove critical to providing a viable, technology-based answer to pedigree, thereby ensuring patient safety.

That, ultimately, is the goal of any pedigree system: guaranteeing the safety of patients by ensuring that only genuine, effective medications reach them. Adopting modern technology that identifies each legitimate product individually and uniquely will provide that safety margin. Such a system will allow HDMA members, and everyone in the pharmaceutical delivery chain, to continue operating a system whose safety has no equal.

The AUTHOR is president & CEO of the Healthcare Distribution Management Association, which represents drug wholesalers throughout the country.

Alan Goldhammer. Should drugs be pedigreed to prevent counterfeiting?

Drug Topics

Sep. 1, 2003;147:19.