By Lee Ann Runy

The recent incidents of tainted dog food and toothpaste imported from other countries point up the vulnerabilities of the U.S. supply chain. The volume of products imported from overseas far exceeds the government’s ability to inspect and ensure product integrity. Health care is not immune.

The U.S. drug supply is considered among the safest in the world. The World Health Organization estimates that less than 1 percent of the U.S. drug supply is counterfeit. The rare occasions that counterfeit medications reach hospital shelves can usually be traced to purchasers that have turned to third-party suppliers for a product that is in short supply. The bottom line: If it’s too good to be true, it probably is. Sticking to recognized wholesalers and distributors is the best bet for reducing the risk of obtaining counterfeit products. “Materials managers, among others, are responsible for the introduction of safe and effective product into our care centers,” says Jim Smoker, director of materials resource services, WellSpan Health System, York, Pa. “The first thing we can do is to screen the vendor to ensure they are reputable.”

Radio-frequency identification technology or electronic pedigrees can further bolster security of the U.S. drug supply. A few manufacturers are using RFID on select products, such as Viagra and OxyContin. The Food and Drug Administration had pushed for widespread RFID adoption by this year, but now says it’s up to manufacturers to develop a timetable.

A greater challenge for hospitals is managing the integrity of the medical devices and supplies that come through the loading docks. The hospital supply chain typically accounts for one-third or more of a hospital’s budget. That translates to a lot of product and effort for hospitals to ensure that counterfeit or defective items either do not make their way into the supply chain or are removed from the supply chain prior to being used in patient care. “Product integrity means a lot of things,” says Bill Stitt, corporate director of materials management at University Community Health in Tampa, Fla. “It’s not just about whether a product is counterfeit. It’s also about how a product is manufactured, stored and used.”

This gatefold examines what hospitals can do to guarantee product integrity. It’s a multilayered process that requires executive support and buy-in from front-line providers. “At times, many organizations don’t take this as seriously as it needs to be,” Stitt says. “We need to be proactive to educate staff on how things need to be handled, documented and used within the organization.”

Dealing with Recalls

Ensuring product integrity doesn’t stop once a product hits the hospital shelf. Heightened awareness, along with the increasing use and complexity of medical products, has led to a significant increase in recalls and advisories. That creates a challenge for hospitals, the majority of which still rely on manual recall systems that are labor-intensive and time-consuming. The ECRI Institute reports that the number of medical device recalls grew from 241 in 2001 to 953 in 2006. “Manufacturers are doing a better job of proactively working with their customers,” says Eric Sacks, ECRI’s director of health care product alerts. “That’s creating an incredible burden on hospitals. Informal processes may have worked before, but the high number of alerts places strain on the system.”

 The timely and effective dissemination of recall notices and safety alerts has direct implications for patient safety. Defective products can result in harm to patients, clinicians and other users. But most problems result from user error, rather than a defect in the product, notes Sacks. That’s why it’s important that safety or usage alerts also be actively distributed. The alerts highlight common mistakes associated with the products’ use.

Executive support is key to the development of a successful recall management program. Senior leadership involvement establishes the recall process as a priority and gets the necessary resources. Other key features are education, communication and standardization. The staff needs to be educated about the potential for problems, as well as on the organization’s policies and procedures related to recalls. The policy and procedures should map out how recall notices will be distributed throughout the organization.

Product standardization can also help. “We are very standardized,” says Judith Holbein, program manager for purchasing at the Ohio State University Medical Center in Columbus. “Everyone’s using the same dressing, the same syringe. If we have a problem, we have a system to notify everyone at once.”

Another challenge is addressing products that enter hospitals via other avenues—for example, items that vendors provide directly to physicians. These will not show up on the item master so recall notifications won’t be distributed. In many instances, clinicians believe they are saving the hospital money by accepting a free product, Holbein says. OSU Medical Center holds a class for sales representatives that sell certain types of products to address these issues and has a process in place for clinicians to request participation in product trials. At WellSpan Health, York, Pa., any products provided by vendors are considered to be gifts and the foundation sends a thank-you note to the sales representative. “That usually stops them in their tracks,” says Jim Smoker, the director of materials resource services.

Automated recall notification and safety alert systems are one way hospitals can address the issue. Alerts come from multiple sources, including manufacturers, the FDA and group purchasing organizations. Automated systems consolidate the source of information, making it easier for hospitals to know what issues may impact them and helping them disseminate the message appropriately within the hospital. The case studies on the following page show two different approaches to recall management.

Real-Time Lessons

University Health System I  Durham, N.C.

Duke University Health System has a two-tier process for managing recalls. Duke installed a Web-based alert program to help coordinate the multiple notices it receives from various sources. “Notices were coming in at all points, from the loading dock to the risk management department,” says Brooke Berson, director of clinical resource management. The Web-based system provides a centralized process that directs all notices to the procurement team. “It doesn’t make sense to send out a recall notice and have everyone determine if it impacts them,” says Jane Pleasants, assistant vice president for procurement and supply chain management. Now, procurement takes a first look at the notice and notifies the affected areas. The second tier of the process is a senior team for critical recalls that may have a direct impact on patient safety, such as human tissue or an implantable device. This team includes Pleasants, along with the vice president of medical affairs, the chief patient safety officer and the director of clinical risk management. They identify the appropriate clinical response to the recall and develop a uniform communication plan for patients, employees and providers.

Vanderbilt University Medical Center I  Nashville, Tenn.

The installation of a Web-based alert system a year ago has transformed the recall process at Vanderbilt University Medical Center. Previously, the organization had an ad hoc, informal process. When recalls were announced, notices were distributed on paper to numerous locations throughout the hospital. The new system  notifies necessary departments through the Internet of alerts and notices that may impact them. Vanderbilt assigned a coordinator for each alert category. “The alerts go straight to the person who has the most information about the product,” says Amie Loyer, program coordinator. “In doing so, we’ve been able to respond faster.” It takes about 2.3 days to respond to an alert; without the real-time notification service it took about 20 days per alert. “We take recalls seriously,” she says. “It’s a normal part of providing safe patient care.”

A Role for Everybody

Ensuring supply chain integrity requires active involvement from all parties: The federal and state governments, manufacturers, wholesalers, distributors, providers and patients. Here’s a look at what is being done to ensure product integrity in the U.S. health care supply chain.

Federal

The Food and Drug Administration does not develop or test products prior to approval for sale and use in the United States. Instead, the FDA bases its decisions on reviews of studies and tests done by companies. To ensure product integrity, the FDA relies on reports of adverse experiences with products after they are in the marketplace. The reporting process is voluntary, but encouraged. Clinicians can report problems directly to the FDA or through the manufacturer. The alerts help identify common problems so corrective action can be taken. On the pharmacy side, the FDA continues to monitor progress on the deployment and use of RFID and electronic pedigrees to help track medications throughout the supply chain. “The FDA anticipated that RFID use would be widespread in 2007,” says Llisa Bernstein, the administration’s director of pharmacy affairs. “It’s up to the industry to come up with its own timetable. Our bottom line is that we want an electronic pedigree that tracks the prescription from point of manufacture to when it hits the pharmacy shelves.”

States

States govern and license wholesalers and distributors of medical products and pharmaceuticals. Organizations can check with the appropriate state agency to find out if any reports have been filed against their wholesaler or distributor. The states have been proactive in ensuring the integrity of the pharmacy supply chain, says Doug Scheckelhoff, vice president of professional development for the American Society of Health-System Pharmacists. By the end of 2006, at least 10 states had laws requiring some form of drug pedigree. California, for example, will require manufacturers to include electronic pedigrees on prescription drugs by Jan. 1, 2009. “The benefit will be the ability to view the chain of custody for a product,” Scheckelhoff says. The implication for hospitals, however, is unclear. “At some point, the pedigree will need to be deactivated so it can’t be reused,” he says, adding that the details still need to be worked out.

Manufacturers, wholesalers and distributors

Manufacturers are required to recall devices if they are found to violate FDA law. Manufacturers most often issue voluntary recalls and notify the FDA upon doing so. Wholesalers and distributors are not required to notify their customers of recalls, but most do so as a sign of good faith. The adoption of RFID or electronic pedigrees is viewed as an effective approach to ensure product integrity. The ability to track medications and medical devices from the point of manufacture to the point of use will provide additional protection against counterfeiting and will assist the recall and safety notification process.

Providers

Providers can take a number of steps to ensure product integrity. The most important is buying items only from recognized group purchasing organizations

and distributors. Hospitals are required to have a recall process in place under the Joint Commission’s Environment of Care Standards. Given the number and complexity of medical devices in use today, a thorough recall management process is necessary to ensure the timely removal of products. Hospitals should also report any product concerns to the manufacturer or FDA. Education and training is also key. “We need to be more proactive and educate staff about the importance of this issue,” says Bill Stitt of University Community Health. “To an extent, there’s a level of complacency when purchasing from authorized distributors.”

Patients

Patients can play an important role by paying close attention to the medications they take and alerting their providers or pharmacist should they no-tice any changes in the shape, color, taste or packaging of their prescriptions. Patients should also avoid purchasing medications from the Internet.

Reporting Problems

Following product approval, the Federal Drug Administration continues to regulate the safety and effectiveness of medical products, from the point of manufacture to the point of use and beyond, as in the case of implantables. Medical device manufacturers must follow current best practices, such as the maintenance of a sterile environment, to ensure the safety and effectiveness of their products. Regulations are also in place to cover how products are stored, shipped and used. Problems are usually identified after the product enters the marketplace, typically through reports to the FDA or state agencies by providers or manufacturers. Hospitals are required to report to the FDA and manufacturers any deaths suspected to be related to a medical device. Hospitals are required to report suspected injuries to the manufacturer only, and file an annual report to the FDA summarizing their adverse event reports. Manufacturers, in turn, are required to send any adverse event reports to the FDA. Distributors are not required to report any device-related deaths or injuries to the FDA, but must keep a record of complaints and be able to provide that information to the FDA upon request.

Summary of reporting requirements for Hospitals and Other Providers

Summary of reporting requirements for Manufacturers

Response to problems

Once a problem is identified, manufacturers work with the FDA to determine the appropriate response. In some instances, the product can be repaired in the field or returned to the manufacturer for repair. Or, a user alert may be issued to caution providers on the proper use of the product. If it is determined to pose a risk to patients, the FDA can remove it from the marketplace. In April, for example, the FDA seized all medical products from Shelhigh Inc., a medical device manufacturer in Union, N.J. The FDA cited significant deficiencies in the manufacturing process that may compromise the safety of the products, particularly the sterility of the products. Recalls are issued when a product is found in violation of federal regulations. The FDA issues a recall when a product is defective, if it’s determined to be a risk to health or both. In most cases, manufacturers issue voluntary recalls. According to the Advanced Medical Technology Association, 99 percent of recalls are voluntary and initiated by the company. The FDA has a tiered recall process, based upon the potential risk to patients.

Class I recalls are the most serious type of recall. They are issued when the product may cause serious harm to patients. When the FDA issues a Class I recall, the manufacturer has 24 hours to issue a press release to alert the public. The manufacturer must also alert its customers and have them contact the recipients of the device.

Class II recalls are issued when a device may cause a temporary or reversible health problem, or if there is a remote chance that the device could cause a serious health problem. Under a Class II recall, the manufacturer notifies its customers of the recall and may ask the customers to notify the recipients of the device. In most cases, the manufacturer does not need to issue a press release unless the device could affect the health of a large number of people, among other considerations. 

Class III recalls are issued when there is little chance a device could cause health problems. The product is, however, found to be in violation of FDA law. The company is required to notify its customers of the recall. The manufacturer is not expected to issue a press release.

Sources: FDA and AdvaMed, 2007

14 Common Counterfeit Drugs

According to the National Association of Boards of Pharmacy, the top counterfeits are:

Although the risks are low, hospitals can take steps to prevent counterfeit medications from reaching patients and to protect the security of the pharmaceutical supply chain as a whole. Among other things, hospitals should have drugs delivered directly to the pharmacy and should report adverse reactions to medications or suspicions about potential counterfeit products to the state board of pharmacy, the manufacturer and/or the FDA.

Resources

Advanced Medical Technology Association I www.advamed.org
American Society of Health-System Pharmacists I www.ashp.org 
MedWatch I www.fda.gov/medwatch
National Association of Boards of Pharmacy I www.nabp.net

This article first appeared in the August 2007 issue of Materials Management in Health Care.

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