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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 12-31-2004

Second Opinion: As Drug-Safety Worries Grow, Looking Overseas for Solutions - French Vigilance Centers Spot Problems, and U.K. Traces Issues With 'Green Cards' - A High-Tech Prescription Pad
Wall Street Journal, 12-31-04

“The U.S. spends more on pharmaceuticals, devotes more resources to medical research and discovers more new drugs than any other country.” This is certainly all to the good. Still, our system for “monitoring and responding to safety issues after drugs are approved” is more ad-hoc than state of the art. This article illustrates some ways that regulators abroad and innovative companies at home are using information technology and active communication with clinical practitioners to improve drug safety.

The current FDA system relies on a two-stage voluntary reporting program: first, doctors are expected to forward serious adverse drug events to the manufacturer, who then has a binding duty to alert the FDA. However, given the time constraints on doctors, there is a real concern that many drug side effects go unreported.

By comparison, in France “a network of ‘pharmaco vigilance centers’ serves as a sentinel and a resource for doctors,” ensuring that information flows freely from regulators to doctors and back again. In Britain, researchers concerned about drug side effects will send “green cards” to doctors who routinely prescribe the drug in question, allowing them to quickly collect data on potential concerns. In Australia “independent drug-safety experts meet regularly to ponder new information about drugs on market.”

In the U.S., hospitals and health care providers are finding ways to integrate more information and drug safety protocols directly into their daily routines. At the Intermountain Health Care hospital in Salt Lake City “an advanced [computer] system automatically informs pharmacists of events that may signal problems with a drug…Each alert brings a pharmacist to the patient’s bedside to look for signs of a possible bad drug reaction.” Intermountain also regularly screens its patient database to look for “links between drugs and side effects, or to impose tight surveillance on a new drug to scan for unforeseen problems.”

With many options to choose from, the FDA is sure to improve on its current passive reporting program. The real challenge is how to “make [post marketing analysis] be constructive and improve decision making without it just being Monday-morning quarterbacking.”

[permanent link]

The Nation; Medicare to Screen for Alcoholism; The coverage is part of a move toward prevention of several costly conditions that some say is overdue. Participation could be the big hurdle.
Los Angeles Times, 1-2-05

“Problem drinking among the elderly may cost Medicare more than $230 million a year to treat liver disease and other ailments, but only now will [Medicare] start covering routine screening for alcoholism.”

A greater emphasis on preventative medicine is part and parcel of the Bush administration’s efforts to revolutionize Medicare, beginning with “newly enrolled Medicare beneficiaries who are [now] eligible for an introductory physical that emphasizes prevention of conditions including alcoholism, depression, high blood pressure and diabetes.”

Increasingly, policymakers and researchers are recognizing that a handful of very expensive chronic conditions (heart disease and diabetes among them) account for enormous Medicare outlays. This program is intended to help doctors identify potential problems among new Medicare patients before the first warning signs of disease mushroom into enormous financial liabilities for the already strained federal program.

[permanent link]



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