Drug Topics - October 8, 2007 - (Page 4)

4 DRUG TOPICS OCTOBER 8, 2007 www.drugtopics.com Latebreakers Tamper-resistant rule delayed Just two days before the tamper-resistant Rx pad rule was scheduled to take effect, President Bush signed into law legislation to delay the implementation of the requirement to use tamper-resistant pads for Medicaid Rxs. The law pushes back the start date to April 1, 2008, but does not change other provisions of the new requirement. The rule, which was part of an Iraq War supplemental spending bill, is aimed at reducing fraud. While pharmacy and medical groups did not dispute the importance of eliminating prescription fraud, they complained that healthcare providers had not been given enough notice and were not prepared to make the changes. (For more on this issue, see earlier article on page 14.) New indication for Norditropin Somatropin (rDNA origin) injection (Norditropin, Novo Nordisk) can now be used for the treatment of children with short stature associated with Turner syndrome, a condition caused by a complete or partial absence of the second X chromosome in females. Earlier this year, the drug was approved for treating short stature related to Noonan syndrome and is also indicated for the treatment of children with inadequate secretion of endogenous growth hormone and for replacement of the hormone in adults with growth hormone deficiency meeting certain criteria. The new approval also gives the option of dosing somatropin at a higher dosage level. In a clinical trial, the higher dosage resulted in 80% of Turner syndrome patients reaching their normal height versus only 53% who were dosed at a lower level. channel blocker amlodipine and Daiichi’s angiotensin receptor blocker olmesartan (Benicar) and is indicated as a once-daily treatment of hypertension. In a trial that led to the product’s approval, the 10 mg/40 mg strength reduced systolic blood pressure an average of 30.1 mmHg and diastolic by 19 mmHg, compared with 19.7 mmHg and 12.7 mmHg, respectively, for amlodipine (10 mg) alone. Azor can be used alone or in combination with other antihypertensive agents; however, it should not be used as an initial therapy. Medicare to reject claims without NPIs CMS has announced that it will begin to reject Medicare claims without proper National Provider Identifier (NPI) numbers. Earlier this year, CMS delayed its requirement for using NPIs. Individual health and Rx plans have begun to contact R.Ph.s and other providers to specify exactly when claims will be rejected. CMS also said claims will be rejected if NPIs are not properly used. In some cases individual NPIs have been paired with Medicare Provider Identification Numbers (PIN) for organizations or organizations’ NPIs have been used with individual PIN numbers. To help pharmacies trying to ensure they have a prescriber’s correct NPI number, SK&A introduced its NPI Verified service. The program verifies all NPIs by phone. Pharmacists can also look up NPIs on-line with NCPDP’s NPI database. DEA proposes new rules on meth certification DEA wants to mandate that manufacturers, distributors, and importers of scheduled listed chemical products obtain and maintain the certification number issued by DEA to regulated sellers in their sales records. This change will ensure registrants verify that the regulated sellers to whom they distribute products have completed the self-certification process imposed by the Combat Methamphetamine Epidemic Act. Kevin Nicholson, NACDS VP of pharmacy regulatory affairs, said, “DEA is concerned that some retailers … haven’t gone through the self-certification process and are selling these products.… Pharmacies are already registered for controlled substances and used to dealing with the DEA registration process.” Electronic comments must be sent before Nov. 20 to dea.diversion.policy@usdoj.gov or submitted to www.regulations.gov. DT FDA bill draws approval The President signed into law a bill that gives the FDA sweeping new responsibilities, drawing praise from pharmacy and consumer groups. The FDA Amendments Act strengthens the agency’s enforcement power and requires greater disclosure from drugmakers. It also renews the Prescription Drug User Fee Act, which will be used to pay for new systems to track drug safety even after approval. Backers also expect it to speed up the approval of generics. NACDS issued a statement applauding the removal of language from the Senate version of the bill that would have required drug pedigree requirements as well as provisions that would have legalized drug importation. Blood pressure combo OK’d A two-in-one tablet has been approved for Daiichi Sankyo. The product, Azor, contains calcium- http://www.drugtopics.com http://www.regulations.gov

Table of Contents Feed for the Digital Edition of Drug Topics - October 8, 2007

Drug Topics - October 8, 2007 Latebreakers Latebreakers in Depth Letters Rx Care Community Practice JP at Large 150 Years of American Pharmacy Hospital Practice Are You Getting Pharmacy's Message Across? Self-Care Government and Law Legal Q&A The Pharmacist as First Responder in Disaster Relief Technology Update New Products Advertisers Index Statement of Ownership Classified Viewpoint

Drug Topics - October 8, 2007

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