MASAC Recommendation #73
Medical Advisory # 302
MASAC RECOMMENDATIONS REGARDING BLOOD SAFETY POLICIES (NOVEMBER 1997)
The following recommendations were approved by the Medical and Scientific Advisory Council (MASAC) on November 1, 1997 and adopted by the NHF Board of Directors on November 2, 1997. By affirming this recommendation, NHF recognizes the importance of improving the quality of life for persons with hemophilia and other related bleeding disorders.
The Second Generation of Blood Safety Measures: Standards for an Active, Universal Patient Notification System
One of the most critical areas of concern to the bleeding disorders community is the current lack of an accurate and timely notification system signaling the recall or withdrawal of potentially tainted blood products. Thus, the establishment of an effective, early warning mechanism is a major goal of the National Hemophilia Foundation (NHF). To achieve this goal, the NHF Blood Safety Working Group and its Medical and Scientific Advisory Council (MASAC) have developed a proposal for actively monitoring and notifying consumers and healthcare providers.
Since many chronic users of blood products keep these products in their homes, the lack of a reliable notification system sometimes results in the product’s inadvertent use after it has been recalled or withdrawn from the marketplace. This can cause significant anxiety, confusion and fear. It may also result in otherwise preventable disease transmission by the product.
The blood safety notification system envisioned for consumers of plasma-derived products should be the result of a coordinated set of activities that would include surveillance, identification, investigation, determination, and disclosure of an adverse event in the blood supply. This system would be measurable and subject to continual evaluation by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), consumer organizations such as NHF, physicians, and the users of blood products. The Institute of Medicine (IOM) 1995 report entitled HIV and the Blood Supply, requested by the Department of Health and Human Services, stated that the oversight of consumer notification is the responsibility of the Food and Drug Administration. The report also calls for a more systematic approach to blood safety regulation when there is uncertainty and danger to the public.
In order to support an active surveillance system for blood products, the hemophilia treatment center network would issue to the CDC periodic reports and blood sample studies. Additional monitoring of blood safety would occur through public health and adverse events reports to the FDA’s investigative branch and stricter routine oversight of blood collection and testing by the FDA. CDC would also create a task force composed of consumers, their treaters, and the FDA’s investigative branch. This task force would provide a mechanism to enhance communication between the CDC, FDA and the hemophilia community in evaluating evidence of possible viral contamination of a product, keeping track of the status of an investigation, and monitoring the impact of these findings on blood safety and supply. By involving consumers and providers, this task force allows for the end users’ concerns and perspectives to be readily shared with the investigative agencies.
NHF recommends the establishment of a pro active, unified approach to blood product safety notification. This system would be rapid, confidential, and all-inclusive. NHF also proposes that the system be managed by an independent third party that has no connection to the pharmaceutical and home care industries or to any association representing end users of the system. NHF concurs with the FDA that the pharmaceutical industry has legal and historical responsibility to support this system. NHF proposes that financial support by the pharmaceutical industry for this system would be based on the market share of blood products sold.
Although the unanimous selection of an independent third party by the pharmaceutical industry cannot be mandated, it is essential that industry seek unanimity for the welfare of the end users. An individual consumer may use more than one product, thus making it too cumbersome and redundant if each pharmaceutical company hired its own third party. A single, independent third party under contract to all of the plasma-fractionation industry would significantly ease the worry for the consumer and the prescribing physician.
As a consumer organization, the NHF recognizes several distinct advantages to a single, centrally controlled notification system:
• confirmation that the end user is notified of a product recall/withdrawal
• ability to individualize notices to each registered consumer
• less potential for abuses of confidentiality
• increased ability to monitor system’s performance by FDA
• responsibility for safeguards and accountability would be clear-cut
• no material marketing advantage for promotion of system’s use
• increased consumer trust and confidence, which has been lacking since the HIV crisis
Performance standards for this notification system would be divided into two separate components: active and passive. Active notification to consumers and their physicians would occur within 24 hours of a product recall or withdrawal. This action would be initiated when the FDA officially declared that a recall or a voluntary withdrawal had been made by the pharmaceutical industry. The third party entity would contact the end user through a previously and individually selected method such as a phone call, fax, next-day mail or e-mail, etc. Notification would occur simultaneously to wholesale distributors, home care companies, hemophilia treatment centers, treatment physicians, and national and local organizations concerned with blood products. As part of the active model, all consumers would also receive written notice of the recall or withdrawal notice by mail for their personal records. The transmission of written notices would be based on the distribution path of the product.
The passive component would include the third party establishing a toll-free line that would allow the end user to verify the safety of a product before it is infused. This toll-free line would act as a safety net if the consumer was away from home or was unreachable. In addition, posting all lot numbers of withdrawn and recalled products on a web site would be another safety measure to ensure that all interested parties have access to recall or withdrawal notices. Similar systems, currently operated by the FDA, may be incorporated into the proposed information network.
The proposed notification system would provide a structured system of information retrieval. The information disseminated in consumer notifications would include lot number, date of manufacture, brand name of the blood product, and reason for the recall or withdrawal. It is imperative that these notices use clear and unambiguous language understandable to the majority of consumers. Therefore, it is strongly suggested that periodic meetings be held with the FDA, consumer groups, and the third party to discuss the clarity and syntax of these notices. It will also be essential for the third party entity to possess multilingual capability.
Upon establishment and assurance that the appropriate safeguards have been created, NHF will actively encourage the use of this notification system by its membership. It is imperative that any contract with the independent notification company stipulate that all consumer information it receives will remain completely confidential. Specifically, the third party must guarantee to the end user that it will not disclose patient-specific information to the pharmaceutical industry for any purpose, nor to any medical or insurance information banks, or to any other party.
An effective and rapid notification system is of utmost importance to the end users and prescribers of blood products. In the two years since the IOM report, there have been 33 recalls or withdrawals and no way to be sure that consumers or physicians have been notified about them. The time has come to put this uncertainty to rest. The NHF proposed unified system for notification is a long-awaited and much needed answer to consumers’ and providers’ questions and concerns regarding blood safety. The opportunity to implement a vital and effective system that will instill confidence among consumers and their physicians must now be seized. The bleeding disorders community deserves no less.