Details about Medicare Prescription Drug Discount Card Program released

Department of Health and Human Services Secretary Tommy G. Thompson has announced an interim final regulation for the Medicare Prescription Drug Discount Card Program.

The regulation outlining the new drug discount card program is the first action resulting from the Medicare Prescription Drug, Improve-ment, and Modernization Act of 2003. While the drug discount benefit will be available this spring, the more significant provision of the law creating new Medicare drug coverage available to all Medicare beneficiaries will take effect in 2006.

Seniors and individuals with disabilities will be able to use these cards to save about 10-15% on their total drug costs, with savings of up to 25% or more on individual prescriptions. All Medicare beneficiaries, except those who already have Medicaid outpatient drug coverage, will be able to enroll in Medicare approved drug discount card programs, with benefits beginning in June, and may continue until the Medicare prescription drug benefit is implemented.

A key component of the Medicare-approved prescription drug discount card program is a subsidy of up to $600 a year for eligible low-income beneficiaries. Individuals whose income is less than $12,124 each year or married couples whose income is less than $16,363 may qualify for this special help. In addition, Medicare will cover the cost of the enrollment fee for these low-income cardholders.

Medicare beneficiaries will have a choice of at least two Medicare-approved cards, but be allowed to enroll in only one drug card program at a time. The cost of enrollment can be no more than $30 annually. Beneficiaries can change cards during an open enrollment period prior to 2005 or under special circumstances. t

Ortho-McNeil adds warning to topiramate

Ortho-McNeil Pharmaceutical has revised the prescribing information for topiramate/topiramate capsules (Topamax) Tablets/Sprinkle Capsules to include a warning that it causes hyperchloremic, non-anion gap metabolic acidosis.

Topiramate is approved and marketed for the adjunctive treatment of partial-onset seizures, generalized tonic-clonic seizures, and seizures associated with the Lennox-Gastaut syndrome in adults and children 2 years of age and older.

Data on hyperchloremic, non-anion gap metabolic acidosis are derived from placebo-controlled trials and post-marketing experience in more than 2.5 million patients.

In clinical trials, the rate of occurrence of a persistently decreased serum bicarbonate ranges from 23% to 67% for patients treated with topiramate and 1% to 10% for placebo. The incidence of markedly low serum bicarbonate in clinical trials ranges from 3% to 11% for topiramate and 0 to less than 1% for placebo.

Generally, decreases in serum bicarbonate occur soon after initiation of topiramate, although they can occur at any time during treatment. Bicarbonate decrements usually are mild to moderate, with an average decrease of 4 mEq/L at daily doses of 400 mg in adults and approximately 6 mg/kg/day in pediatric patients. Rarely, patients can experience decrements to values below 10 mEq/L.

Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue topiramate in the face of persistent acidosis, alkali treatment should be considered. t

Pergolide mesylate (Permax) may cause patients to fall asleep

Eli Lilly & Co. is advising health care professionals of the possibility of patients falling asleep while performing daily activities, including the operation of motor vehicles, while receiving treatment with pergolide mesylate (Permax). The dopamine agonist is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson’s disease.

While somnolence is a common occurrence in patients receiving pergolide mesylate and many clinical experts believe that falling asleep while engaged in activities of daily living only occurs in the context of pre-existing somnolence, many patients who have fallen asleep have perceived no warning.

Pharmacists should be alerted to the potentially serious risks associated with the events and should carefully evaluate patients for the presence of somnolence, and should have a discussion with them.