Drug Topics - January 7, 2008 - (Page 8)

8 DRUG TOPICS JANUARY 7, 2008 www.drugtopics.com NEWS Roundup NACDS commends House for passing pro-soldier, pro-savings bill The National Association of Chain Drug Stores applauded the U.S. House of Representatives for passing the pro-soldier, pro-savings bill that will preserve access to community pharmacies for military families. The portion of the bill related to the TRICARE pharmacy program extends the current freeze on increases to retail pharmacy co-payments. It also includes language that would clarify that the Department of Defense may negotiate with drug manufacturers for federal pricing discounts for TRICARE prescriptions filled at retail pharmacies, in the same manner as they do today for TRICARE prescriptions filled at military bases or by mail order. equipment against established company policy. The employees were found to have loaded, unloaded, or operated a paper baler in violation of company policy and without permission to do so. None of the employees were injured during the course of these unapproved activities. The settlement agreement includes implementation of manager training during manager orientation; training of minors in regard to these work limitations and provision of information to parents of minors upon hire; and posting stickers, restricting keys, and prohibiting minors from entering areas that have restricted equipment over which CVS/pharmacy does not have control. Although CVS/pharmacy disputes the findings of the investigations concerning payment of wages, the decision was made to pay 51 employees back wages that in most instances ranged from $39 to $300. CVS/pharmacy has a policy of paying for all time worked, including payment in accordance with federal requirements for time worked over 40 hours in a single work week, and takes timely action to correct any errors. The company also provides a mechanism for employees to timely report any payroll concerns or questions.” Many PDPs not tracking beneficiary expenses According to a report by the Office of Inspector General (OIG), many Medicare prescription drug plans are not meeting requirements for tracking beneficiaries’ true out-of-pocket spending (TrOOP). These TrOOP costs are essential for determining when a beneficiary is eligible for catastrophic coverage after entering the donut-hole gap in coverage. In 2007, after paying a deductible, beneficiaries pay 25% of their eligible drug costs up to total plan and beneficiary payments of $2,400. Then beneficiaries enter a coverage gap and are required to pay 100% of drug costs until their TrOOP costs reach $3,850. The report found that 29% of Part D plans did not submit all TrOOP information to CMS as required. In the report, Inspector General Daniel Levinson called on CMS to “place more emphasis on conducting Part D oversight activities.” FDA advisory panel rejects OTC status for Merck’s Mevacor A panel of FDA advisors has voted 10-2 to recommend that the FDA reject Merck & Co.’s latest bid to take its cholesterol-lowering prescription drug Mevacor over-the-counter. The advisors felt that patients may not understand how to use the drug properly. This was Merck’s third request to make the medication available OTC. During a press briefing at the conclusion of the panel meeting, Andrea Leonard Segal, M.D., and director of the Division of Nonprescription Clinical Evaluation, at FDA’s Office of Nonprescription Products, said, “We’ve just heard the advisory committee’s views on the application to make Mevacor 20 mg, which is currently a prescription drug, an OTC drug. The committee discussed the safety of 20 mg and the ability of consumers to make a proper choice to use Mevacor if it were to be an OTC drug. Now we are going to take what we’ve heard from the committee and we are going to go back and think about it and discuss it.” Although the FDA is not bound by the committee’s recommendation, it usually follows the recommendation. DT CVS Caremark Corp. fined for violations in child labor laws CVS Caremark Corp. has been fined more than $226,000 after an investigation found dozens of stores changed employee timecards and violated child labor laws. Violations were found at 43 stores, including stores in New Jersey. CVS was accused of allowing 78 underage workers to do hazardous work with cardboard compactors and balers and allowing seven 15year-olds to work longer or later than the law allows. CVS/pharmacy issued the following statement: “CVS/pharmacy has entered into a settlement agreement with the U.S. Department of Labor in regard to wage violations and workplace violations involving teenage employees found to be operating certain http://www.drugtopics.com http://www.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0003.pdf

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Drug Topics - January 7, 2008

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