Breaking News

February 21, 2005

The drug cost threshold for Medicare beneficiaries to qualify for medication therapy management (MTM) services was pegged at $4,000 in an operations manual distributed at a recent briefing for potential drug plan sponsors. However, the final rule recently issued by CMS indicated a separate guidance would be issued on the specific dollar amount that would have to be spent in order to qualify beneficiaries taking multiple drugs for multiple disease states for MTM.

MTM cost threshold may be $4,000 The drug cost threshold for Medicare beneficiaries to qualify for medication therapy management (MTM) services was pegged at $4,000 in an operations manual distributed at a recent briefing for potential drug plan sponsors. However, the final rule recently issued by CMS indicated a separate guidance would be issued on the specific dollar amount that would have to be spent in order to qualify beneficiaries taking multiple drugs for multiple disease states for MTM.

Maine seeks to license sales reps At a pubic hearing set for the end of February, the state of Maine's business research and economic development committee will hear arguments calling for pharmaceutical sales reps who hand out samples to physicians to be licensed by the state as pharmaceutical detailers. Anne Head, director of the office of licensure for the department of professional and financial regulations, said if the proposal were adopted, pharmaceutical detailers would need, in addition to licensure requirements, a minimum level of education such as a B.S. degree in science. While the pharmaceutical industry hasn't officially commented on this unprecedented proposal, industry sources report that big pharma is keeping a close eye on the activities in Maine.

GM drops Walgreen as drug provider General Motors has informed its 1.1 million employees, retirees, and their spouses and dependents in the U.S. that effective March 1, they won't be able to fill prescriptions at Walgreen's stores. GM is dropping Walgreen from its network of prescription drug providers because it feared the chain might drop GM, as it did last month with the state of Ohio, due to its policy of requiring mail-order purchases of some maintenance drugs. The automaker's prescription provider, Medco Health Services, informed enrollees that they could have their Rxs filled at chains such as CVS or Rite Aid. Walgreen spokesman Michael Polzin said the chain did not intend to cut ties with GM; it hopes it can continue filling Rxs for GM.

CDC supports use of meningococcal vaccine A CDC advisory committee has concluded that young adolescents (11- to 12-year-olds), teens at high school entry (15-year-olds), and college freshmen living in dorms should receive the meningococcal vaccine. The recommendation is good news to Sanofi Pasteur, maker of the new Menactra vaccine

Beware of ritonavir/saquinavir with rifampin Roche and the FDA have notified healthcare professionals that drug-induced hepatitis with marked transaminase elevations have been observed in healthy volunteers receiving rifampin 600 mg once daily in combination with ritonavir (Norvir, Abbott Laboratories) 100 mg/ saquinavir (Invirase, Roche) 1000 mg (ritonavir-boosted saquinavir) twice daily. Roche advised clinicians that rifampin should not be given to patients also receiving ritonavir-boosted saquinavir as part of combination antiretroviral therapy for HIV infection. The MedWatch 2005 safety summary is available at: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Invirase.

Public hearing to look at color on labels, packaging Does color on pharmaceutical labels and packages help reduce drug errors? The FDA is holding a hearing on March 7 on this issue on the campus of NIH. Written or electronic comments will be accepted after the hearing until April 7. Send your e-mail comments to FDADockets@oc.fda.gov
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Errors reported with Zyprexa and Zyrtec Healthcare professionals have been notified by Eli Lilly and the FDA about reports of medication dispensing or prescribing mix-ups involving olanzapine (Zyprexa, Lilly) and the antihistamine cetirizine (Zyrtec, Pfizer). Olanzapine is indicated for the short-term and maintenance treatment of schizophrenia and for the short-term treatment of acute mixed or manic episodes associated with bipolar I disorder. Cetirizine is indicated for the treatment of allergic rhinitis or chronic urticaria. The MedWatch 2005 safety summary is available at http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#ZyPREXA.