Trumm Drug

April 2010 Drug News

Among Top Part D Plans, Community CCRx Only One to Cut Premiums in ’10
In sharp contrast to other large national Medicare Part D plans, Community CCRx’s Basic plan was the only one to lower its average premium in 2010, according to analysis by Avalere Health. The report found that the 10 insurers with the largest numbers of Part D members raised premiums an average of 10% this year to $34.30. In contrast, Community CCRx Basic’s average premium decreased by 2% to $28.86, making it the only top 10 PDP to lower its premium.

The top 10 plans insure 70% of all people enrolled in Part D plans, according to the report, which is based on enrollment data from the Centers for Medicare & Medicaid Services. The Avalere study also found that the average monthly premiums across all PDPs increased by more than 40% since the inception of the prescription drug program. By contrast, Community CCRx Basic has a lower average premium in 2010 than in 2006, according to a Kaiser Family Foundation study published earlier this year.

Health Care Reform Law Will Shrink ‘Donut Hole’
A process to eventually eliminate the Medicare Part D coverage gap known as the “donut hole” will start Jan. 1, 2011 when eligible beneficiaries will receive a $250 rebate to help pay for their prescriptions. Under the new health care reform law, the gap will gradually shrink until it disappears in 2020.

The donut hole is the difference between the initial coverage limit ($2,830 in 2010) and the catastrophic coverage threshold ($6,440 in 2010).

FDA cracks down on unapproved nitroglycerine tablets
Two companies instructed to stop marketing unapproved tablets; no supply problems anticipated.

Earlier this month, FDA ordered Glenmark Generics of Mawhah, NJ, and Konec Inc. of Tucson, AZ, to cease marketing unapproved nitroglycerine tablets. The tablets, available in 0.3-, 0.4-, and 0.6-mg strengths, are prescribed to relieve chest pain and prevent heart attack.

Because Pfizer Inc. markets FDA-approved nitroglycerine tablets in these strengths and in sufficient quantities, the agency does not anticipate any supply problem for the drug. FDA will work with patient organizations and health professionals to ensure that they are aware of the approved product’s availability.

FDA took this action as part of the Unapproved Drugs Initiative, which was announced in 2006. The unapproved nitroglycerine tablets have not been proven safe and effective, and FDA has not reviewed the quality and labeling. The unapproved products may differ from approved nitroglycerine products in formulation, labeling, or other respects. FDA has reported significant quality and efficacy problems with some unapproved nitroglycerine products.

Patients using the unapproved products should continue taking their medication and consult a health professional for guidance on alternative treatment options. The drugs will not be recalled from the market. FDA gave Glenmark and Konec 15 days to respond with a plan for removing their products from the market, 90 days to stop manufacturing new products, and 180 days to stop further shipment of existing products.

Electronic Health Records Coming – Where Do Pharmacists Fit In?
Earlier this year, the federal government proposed two regulations that would set interim standards for electronic health records (EHRs) and proposed a definition of “meaningful use” (MU) for them. They represent the first step towards setting the foundation for a comprehensive nationwide system of interoperable, certified EHR technology. The goals are to share and transmit health information among health care professionals and systems, payers, federal and state agencies, public health agencies, consumers, and other health care entities and organizations beginning in 2011 with full implementation by 2015.

To meet the MU goals of EHRs, pharmacy associations made a number of recommendations to CMS and the Office of the National Coordinator for Health Information Technology (ONC) including:

Provide a standardized framework with EHRs for pharmacist medication therapy management delivery without specifically dictating the provision of care.

Recognize pharmacists’ role in helping EPs (eligible professionals) achieve MU by using established patient care services that correlate with proposed 2011 objectives.

Expand the definition of medication reconciliation to include requirements for the clinical decision making of the pharmacist.

“medication reconciliation”, the proposed rule describes as “the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage, frequency and route, by comparing the medical record to an external list of medications obtained from a patient, hospital or other provider.”

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