Medicare Prescription Drug Benefit Data Will Help Determine Risks, Benefits of Medications
The data that the federal government will collect as part of the new Medicare prescription drug benefit will help FDA, health care providers and others determine the risks and benefits of medications prescribed to beneficiaries, CMS Administrator Mark McClellan said on Wednesday at a meeting of the Pharmaceutical Care Management Association, CQ HealthBeat reports. In January 2006, when the Medicare prescription drug benefit takes effect, CMS will begin to collect 36 pieces of data for beneficiary prescriptions, including information on the form, dosage and quantity of the medications, as well as the date of refills.
"This will be the largest-scale implementation ever of such electronic data on prescription drugs," McClellan said. He added, "Instead of relying on 'spontaneous' reporting of adverse events by health care providers who already face tremendous paperwork burdens, we can use large-scale, standardized, deidentified data to determine much more quickly if certain drugs are associated with important complications in particular kinds of patients."
McClellan said that the data will provide "a foundation for much more effective post-market surveillance of FDA-approved drugs" and help determine the risks and benefits of medications prescribed for "off-label" uses. "There simply are many questions that can't be easily answered until a treatment is on the market," McClellan said, adding, "Information from the new drug benefit will allow questions to be answered involving many different subpopulations with different demographics."
He also said that CMS will not issue warnings about prescription drugs, adding, "We don't want or intend to create a system of 'black box' government pronouncements about drugs. Instead, we must have a collaborative partnership, supported jointly by the public and private sectors" (CQ HealthBeat, 5/11).
Additional information on the Medicare drug benefit is available online.