Guides for high-risk drugs undergoing FDA scrutiny

The agency is seeking appropriate ways to reach patients with vital information on the risks and benefits of certain drugs.

By Susan J. Landers — Posted July 2, 2007

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Medication guides were considered a good idea in 1995 when proposed by the Food and Drug Administration to help patients assess the risk level they faced from particular drugs. But problems have ensued.

The guides aren't always provided to patients, nor are they read and understood, agency representatives were told at a recent public hearing.

Patients, physicians, pharmaceutical companies, researchers and others provided input during the June 12-13 hearing on the handouts, which are given to patients by pharmacists each time certain prescription and biological products are dispensed. Drafted by pharmaceutical companies in collaboration with the FDA, they are intended to prevent serious adverse events.

Risk communication is a particularly timely topic given recent disclosures of serious side effects from drugs long on the market. Reports that the diabetes drug Avandia (rosiglitazone maleate) may increase heart attack risk is the latest in a string of such revelations.

As a result, drug safety has been a front-burner issue in Congress and has been addressed in major Institute of Medicine reports.

"How we communicate about drugs is absolutely critical to ensuring the proper balance between benefits and risk for the products we regulate," said Steven Galson, MD, MPH, director of the Center for Drug Evaluation and Research.

Communication between the FDA, health care professionals and consumers is in "a state of flux," Dr. Galson added, and Internet capabilities are making traditional methods of communicating, including medication guides, look antiquated.

The guides, which are of varying length and complexity, are available for about 240 products. They are required if data they contain could prevent serious side effects, if the product has serious risks relative to its benefits or if it is crucial to a drug's effectiveness that patients adhere closely to directions, said Paul Seligman, MD, MPH, FDA's associate director for safety policy and communications at CDER. Dr. Seligman served as the moderator at the hearing.

Among the medications with guides are Accutane (isotretinoin), an acne medication that can cause birth defects and mental health problems; prescription nonsteroidal anti-inflammatory drugs, or NSAIDs, which also have been found to increase the risk of heart attacks or strokes; and antidepressants that can cause suicidal thoughts in children and teens.

A multitude of guides

The number of guides has greatly multiplied in recent years, Dr. Seligman said. When the regulation calling for the information was finalized about a decade ago, it was thought that guides would be necessary for only a handful of products each year. Over the last two or three years medication guides were issued for two widely used drug classes, NSAIDs and antidepressants, thus increasing their number substantially, he said.

This proliferation has created a major burden for pharmacists, said Marcie Bough, PharmD, federal regulatory affairs director for the American Pharmacists Assn. Three-quarters of nearly 400 members polled recently said the program was working poorly, Dr. Bough told the FDA panel.

Rep. Mike Ferguson (R, N.J.) told the panel about a "potentially alarming situation" described to him by constituents in which young patients and their parents hadn't received the guides when antidepressants were prescribed. A panel of parents and a young patient appeared with Ferguson at the hearing and presented accounts of teen suicides and self-mutilations that they attributed to antidepressant use.

In testimony for the American Academy of Child and Adolescent Psychiatry, David Fassler, MD, clinical professor of psychiatry at the University of Vermont in Burlington, cautioned that the medication guide for the class of popular SSRI antidepressants was "relatively one-sided, addressing primarily the potential risks of treatment while minimizing the benefits." Untreated depression can also increase suicide risk.

Plus, the guide doesn't answer the questions asked by parents and young patients, Dr. Fassler said. The academy since has worked with other advocacy groups to develop its own resource, he said. It also supports the continued development and distribution of the guides, but they must accurately address both the risks and the benefits of treatment.

He noted that guides for drugs used to treat attention-deficit/hyperactivity disorder that were made available online last February provide more balanced and accurate information about risks and benefits.

Several of those who testified recommended that doctors -- rather than pharmacists -- distribute the guides in their offices and discuss risks and benefits of a drug with patients.

The American Medical Association has published guidelines for physicians to use when counseling patients about prescription medications. The guidelines cover the need to discuss the name of a medication and its purpose, when and how long to take it, the relevant side effects that should be reported to the physician and whether there is anything unusual about the medication, such as off-label use.

Another paper in the works by the AMA includes strategies for helping patients better understand their medications and become partners with their physicians in safely using pharmaceuticals.

During the hearing, though, medication guides were criticized by researchers as being difficult to understand and for failing to attract patients' attention.Laying out the guides in ways that emphasize important information could improve readership and comprehension, said Ruth Day, PhD, associate professor of psychology at Duke University Medical School in Durham, N.C.

Nancy LaPointe, PharmD, program director of the Center for Education and Research on Therapeutics at Duke, studied the medication guide for Accutane (isotretinoin) and graded it "poor" for reading, since only 41% of 200 patients studied said they had read the entire guide.

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Rx drug talk

AMA guidelines for physicians on prescription medication counseling for patients include the following:

Medication record: Physicians should attempt to maintain and update a record of all medications that a patient is currently taking.

Treatment plan: The physician should discuss with the patient expectations of treatment and appropriate information regarding risk, benefits and alternatives for all prescribed medications.

Oral counseling: Physicians should emphasize what is medically significant, including a drug's name and what it is supposed to do, how and when to take it and for how long, and the relevant side effects.

Written information: Physicians may provide patients with written information about medications, including the drug's name and side effects.

Follow-up: During subsequent office visits, the physician should question the patient about compliance and any beneficial or adverse effects of the medication.

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External links

Information on antidepressant use by children and teens developed by the American Academy of Child & Adolescent Psychiatry and other groups (link)

National Council on Patient Information and Education (link)

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