Conference Sheds Light on Supply Chain Challenges
FDA expects the drug industry by 2007 to widely embrace the use of tamper-evident packaging, covert authentication technology, and electronic track-and-trace devices, such as radio frequency identification (RFID).
But until then, health-system pharmacists should take steps to ensure that the drug products they are purchasing are genuine and safe, Douglas Scheckelhoff, director of pharmacy practice sections for the American Society of Health-System Pharmacists (ASHP), told participants at the Institute for International Research's Pharmaceutical Supply Chain Summit in Washington, D.C.
Several makers of RFID devices and authentication technologies were onhand at the three-day conference in July to demonstrate their products.
The use of such technologies, according to FDA, will help secure the integrity of the drug supply chain and provide assurance that a product was manufactured and distributed under safe and secure conditions.
But since most pharmaceutical companies and distributors have yet to adopt RFID and high-tech authentication tools, health systems should verify the security and legitimacy of the wholesale distributors that supply their drug products, Scheckelhoff counseled.
Pharmacists should do business only with distributors for which they have an established business relationship, he added.
Mike Kaufmann, deputy vice president of supply chain management for Cardinal Health—one of the "big three" primary wholesalers, which also includes McKesson and AmerisourceBergen—proclaimed that his company is now limiting the wholesalers with whom it conducts business.
ASHP advises health systems to avoid buying products from unfamiliar secondary distributors, Scheckelhoff said. Unfortunately, he said, when certain medications are in short supply, health-system pharmacists, who may be pressured by prescribers who have concerns about using an alternate product, tend to purchase products from unknown secondary distributors.
One ploy used by secondary wholesalers attempting to find buyers for their products, he noted, is to fax to pharmacies a price list of medications known to be in short supply.
But, Scheckelhoff warned, "receiving a fax of some great drug deal that comes across from some wholesaler you've never heard of should not be the starting point of that business relationship."
Health-system pharmacy leaders, he said, should teach staff members, "especially the people who handle a lot of the buying transactions," how to properly inspect product packages and to look for signs of anything that might be "out of the norm."
Staff should also be instructed about purchasing policies and be made aware of the dangers of going outside the health system's normal buying practices, Scheckelhoff said.
Pharmacists should be highly skeptical of wholesalers who are offering prices for products that seem "too good to be true."
Health systems, he said, should heed the lessons learned by the University of Texas M.D. Anderson Cancer Center, which had millions of dollars worth of injectable products, including filgrastim and epoetin alfa, stolen in 2002 in a scheme that involved a pharmacist, four pharmacy technicians, and two "gray-market" wholesalers.
"Those people are now spending their time in prison," Scheckelhoff noted.
Pharmacists should identify products that may be at high risk for diversion or theft, he advised, and, as one M.D. Anderson pharmacist suggested, immediately open boxes of expensive drugs upon delivery or mark the boxes with something identifying them as belonging to the hospital, which would reduce the "street value" of the product.
Health systems should take proper security measures, Scheckelhoff said, such as monitoring access to expensive products by using automated dispensing machines, surveillance cameras, and identification readers.
Pharmacies should also have good inventory methods in place and should monitor purchases for unusual trends, he recommended.
If a patient is not responding to therapy, he said, counterfeit drugs are often overlooked as a possible reason, he noted.
Health care providers should always take seriously a patient's complaint about a drug product, such as if the person reports that a product has an unusual taste or appearance, Scheckelhoff said.
It could be a counterfeit, he warned.
Open doors. Counterfeit products have many doors through which to enter the supply chain or reach consumers, Scheckelhoff said.
The spread of importation of drugs by consumers and the use of Internet pharmacies has increased the risk of counterfeit drugs reaching a patient, he maintained.
Patients who order products over the Internet without consulting their health care provider risk being exposed to adulterated, misbranded, or expired products that are being sold by unscrupulous vendors, Scheckelhoff warned.
While there are legitimate online pharmacies that require a prescription to order medications, he noted, many Internet pharmacies only ask patients to complete online questionnaires, and some do not require any medical history information for customers ordering a drug.
Internet pharmacies pose new challenges for the patient-prescriber relationship, Scheckelhoff said.
When patients order products online without a prescription or advice from their physician, he contended, they lose the value of their health care provider's evaluation and diagnosis.
The driver behind the growing use of Internet pharmacies, he maintained, is the high cost of many prescription drug products and the enticement of low prices advertised online.
U.S. Attorney for the Eastern District of Virginia Paul J. McNulty said that his office has had an increase in the number of investigations involving fraudulent online pharmacies and trafficking of prescription drugs on the Internet.
"One factor that has unquestionably contributed to the problem of prescription drug abuse is the use of the Internet by drug traffickers," he said. "The limitless promise of cyberspace is unfortunately very attractive to the criminal mind. Drug trafficking on the Internet is as dangerous as drug trafficking on street corners. In fact, perhaps it's even more dangerous because of the anonymity that the Internet provides."
The prevalence and worldwide use of the Internet with a demographic that is "only getting larger" poses a challenge for law enforcement agencies in detecting and prosecuting online pharmacies that are involved in illegal sales of prescription drugs and controlled substances, McNulty said.
Advertisements for such products are ubiquitous, he declared.
"They bombard your e-mail accounts and often appear in pop-up ads," he lamented. "It seems that wherever you go on the Internet, you will find advertisements for drugs."
Web-search results for painkillers and sexual performance drugs turn up "thousands or even in the millions of hits," McNulty asserted.
After a well-publicized indictment of an Internet pharmacy, he said, his office received "a ton of fan mail from individuals around the country who applauded us for the indictment because they were sick of the spam they were getting from Internet pharmacies and they thought this would slow that process down. I'm not sure if it has."
While law enforcement is continuing to get illicit drugs such as heroine, crack, and ecstasy off the streets, McNulty said, it is now facing "a much more insidious and uncontrollable drug epidemic: One that is taking root in America's living room."
"The Internet has become the street corner for many drug users and traffickers," he said.
But to be clear, he added, there is "nothing wrong" with using the Internet as a marketplace for pharmaceuticals.
Indeed, McNulty noted, an increasing number of health care companies have begun to use the Web to reach consumers in the United States and around the world.
"Over the last half decade, health insurers, medical suppliers, and pharmaceutical companies have employed the Internet in attempts to cut costs and reach new consumers and improve services," he said. "In response to this effort, millions of adults in the United States now use the Internet for various health-related needs."
Online pharmacies began as an experiment in customer convenience as drug providers looked to afford consumers less cumbersome means for filling prescriptions and accessing medical advice, McNulty maintained.
But, he added, as Internet commerce in the health care industry became more widespread, "more and more pharmacies began to open their proverbial doors on the World Wide Web targeting America's baby-boom generation with such midlife crisis drugs" as Pfizer's erectile dysfunction product Viagra, Merck's hair-loss treatment Propecia, and Abbott's weight-loss drug Meridia.
"Online pharmacies have built a strong business niche by capitalizing on shifting demographics and a growing American dependence on prescription drugs," McNulty declared. "Pharmacies operating on the Internet are able to generate millions of dollars in revenue each year, and there will certainly be more to follow. With 35% of the population over the age of 50 by 2015, the United States has warmly embraced the growing online pharmacy industry."
The convenience of being able to order prescription drugs quickly and discreetly over the Internet appeals to many U.S. residents, especially those who have limited access to pharmacies, he noted.
Discount prices are another benefit to ordering medications through "cybercommerce," he added.
"But with this opportunity comes responsibility," McNulty said. "Consumer safety must be a top priority."
To help safeguard the public, government has "jumped into action," he proclaimed.
"State governments have begun to take significant steps to combat the abuse of prescription drugs on the Internet," he declared. "The medical boards of 39 states require a physical exam prior to the prescription of medicine. Nine states have passed laws specifically regulating online pharmacies, and eight state attorneys general have taken legal action against online pharmacies."
The attorney general of Missouri, McNulty noted, recently sued several Internet pharmacy sites for prescribing drugs to residents without a license from that state, and the New Jersey attorney general also filed suit against eight Internet pharmacies on "similar grounds and for basing prescriptions on inadequate physical examinations."
But because of the interstate nature of online pharmacies, he said, the federal government is "often in a better position to combat the challenges of Internet pharmacies."
State boards of pharmacy in many states have reported difficulty identifying Internet pharmacies located outside their borders and have limited ability and authority to investigate and act against pharmacies that do not comply with state pharmacy laws, McNulty said.
Hunting down a single Internet pharmacy may require prosecutorial action in several states, he contended.
"Federal prosecution can cause these organizations to be shut down through a single prosecution," McNulty asserted. "At this point, states are active, states are doing what they can, but this type of industry is the type of business that is uniquely situated for federal attention."
But, he admitted, the "international nature" of online pharmacies poses multiple challenges for federal investigators.