Pharmacists, Public Air Concerns About Risk Management Programs
FDA is drafting a guidance document for the pharmaceutical industry on the development, implementation, and evaluation of safety programs intended to minimize a drug or biological products risk to patients.
Under the Prescription Drug User Fee Amendments of 2002 (PDUFA III), FDA agreed to meet certain performance goals, including issue formal guidance for the industry on risk management activities, in exchange for user feespayments the agency collects from firms to reduce the approval time of their new drug and biological license applications.
The government recently proposed that the sponsor of every pharmaceutical submitted for marketing approval consider how to minimize risks to patients.
FDA is also developing for the industry guidance documents for assessing the risks of products before they reach the market and conducting pharmacovigilance practices and pharmacoepidemiologic assessments once products are on the market. Blood products other than plasma derivatives would be excluded from the guidance.
The regulatory agency said it plans to produce the three documents by September 30, 2004. Drafts of the documents are expected to be released and available for public comment this fall.
FDA released concept papers in March outlining its proposed approach for the documents and heard comments from the public at a three-day workshop held April 911 in Washington, D.C.
Representatives of some groups at the April 10 workshop clashed on who should pay for a centralized computer network that would link pharmacists, prescribers, and the pharmaceutical industry to information about patients and products covered by a risk management program.
A computerized system that accesses real-time information about patients and their medications is more accurate than a paper trail of fragmented information, said pharmacist Kim Swiger of the National Association of Chain Drug Stores (NACDS).
Current risk management programs, said pharmacist Thomas Menighan of the American Pharmacists Association (APhA), formerly the American Pharmaceutical Association, were designed without considering that many hospitals and other health care organizations are changing from paper to computerized prescriber order-entry systems.
Swiger and Menighan suggested that the pharmaceutical industry develop and pay for a computer network that tracks information related to risk management programs.
But Janice Bush, representing the Pharmaceutical Research and Manufacturers of America (PhRMA), argued that third-party payers, not the pharmaceutical industry, should be responsible for such a system.
No one from the insurance industry came forward to suggest who should pay for such a network.
Likewise, no physician group offered suggestions.
In fact, as one audience member noted, although there were some physicians in the audience, physician groups, such as the American Medical Association, did not send a representative to the workshop to speak on behalf of the medical establishment.
Representatives of several pharmacy groups, including the American Society of Health-System Pharmacists (ASHP), APhA, and NACDS, attended the meeting and provided comments about FDAs proposed approach for risk management activities.
Some attending the workshop expressed fear that FDA-mandated risk management programs would unnecessarily limit patients access to certain medications and that physicians would grow frustrated with such red tape and avoid prescribing those drugs.
But Anne Trontell, deputy director of FDAs Office of Drug Safety, insisted that the government is not attempting to interfere with prescribers practices.
Gary Stein, ASHPs director of federal regulatory affairs, voiced concerns that current restrictive drug distribution systemsone of the tools that the FDA has been relying on more and more frequently to manage the risk of new drugsoften exclude hospitals and community pharmacies from distributing medications directly to patients.
Restrictive distribution systems, Stein said, make it difficult for hospital pharmacies to acquire medications in those programs through normal supplier channels and provide those drugs to patients in a timely manner.
Stein expressed hope that FDAs plan to survey about 5000 randomly chosen pharmacists to discover how risk management programs affect the practice of pharmacy will lead to the agency addressing concerns about potential barriers raised by risk management.
FDA announced its intention to survey pharmacists in a February 12 notice in the Federal Register.
Other audience members attending the April workshop worried that FDA was attempting to change the drug approval process by initiating risk management programs.
But FDAs Trontell asserted that risk management programs would not interfere with or change the drug approval process.
Risk management for most products, according to FDA, consists of the package insert, which is directed to health care professionals, and postmarketing surveillance.
But a package insert alone, FDA declared in its concept paper, is not always sufficient to minimize a products risks.
Risk management programs, the agency stated, should use one or more interventions or tools in addition to the package insert, including specialized educational materials for health care practitioners or patients, processes or forms to increase compliance with reduced-risk prescribing and use, and systems that modify conventional prescribing, dispensing, and use of the product to minimize specific risks.
FDA noted that some of the tools used for educational outreach to health care professionals in current risk management programs include letters to practitioners, training programs, and public notices.
Systems that guide prescribing and dispensing include informed-consent patient agreement forms, certification programs for practitioners, and stickers indicating that certain safety measures have been met.
But NACDSs Swiger complained that various colored stickers with information about each drug in a restricted distribution program could confuse pharmacists and physicians.
Stickers are designed for the past, not the future, said APhAs Menighan, alluding to pharmacies current use of computerized systems to process prescriptions and claims.
FDAs product-by-product approach may yield success for a specific medication, but that success is short-lived in the real world, he added.
The variety of FDA-mandated programs for risk managment, said Menighan, makes medication use more complicated than it already is.
Most physicians, he noted, generally prescribe one, maybe two, of the drug products covered by the current risk management programs.
Pharmacists, however, serve broader patient populations and must deal with several and a growing number of programseach program with a different structure and requirements that tend to focus attention on red tape rather than appropriate medication use, he added.
PhRMAs Bush argued that FDA has not provided critical evidence for the rationale on which to base its risk management initiative. That evidence, she suggested, could be achieved by completing a review of all current and past risk management programs.
Risk management programs should be considered for pharmaceuticals on a case-by-case basis using standardized criteria, Bush said.
Since some drug companies may differ in their ideas for risk management, she added, FDA should publicly detail how the government plans to ensure that products in the same class with similar safety profiles meet the same risk management expectations.
Many attending the workshop voiced concerns about FDAs recommendation that risk management programs should be categorized into four levels to reflect how much the tools used in the [program] diverge from conventional prescribing, dispensing, and use.
Each advance in level, according to FDA, would reflect an increase in the severity, frequency, or duration of the products risks:
- Level 1 would include the package insert only.
- Level 2 would include the package insert and educational outreach to health professionals and consumers.
- Level 3 would include all the requirements of level 2 plus systems that guide the circumstances under which practitioners prescribe and dispense the product and patients receive it.
- Level 4 would require adherence to specific program elements from level 2 or 3.
The levels seem to be based completely on risk and not the benefitrisk balance, said Bush. The levels may be subject to misinterpretation. If it is clear when a risk management program beyond the [package insert] and postmarketing surveillance is needed, then the rest of the program should be determined on a case-by-case basis using specific risks as the driver for what tools are needed.
Florence Houn, director of FDAs Office of Drug Evaluation III, said that the agency must rethink the level scheme.
The issue of compensation for pharmacists was also raised by many attending the workshop.
Pharmacists are asked to assume the liability of ensuring that the physician and patient have met all requirements of a risk management program, noted NACDSs Swiger. Yet a fundamental question that FDA has not addressed, she said, is how pharmacists will be compensated for taking on this additional liability.
Payments must be commensurate with liability that the pharmacy is asked to assume, she said. Providing additional risk management services to patients results in additional costs to providers.
FDA has traditionally steered clear of financial and compensation issues related to prescription drugs, Swiger said.
However, if the agency is going to require that health professionals perform certain additional activities relating to the management of a drug product, then it is logical to assume that pharmacists will be compensated for these services, she said.
Proposals of risk management programs, she suggested, should include an explanation of the additional costs of training pharmacists who provide the services and a plan for compensation.