Breaking News for Sept. 13, 2004
The Medicare Rx drug benefit will, on average, nudge the retail pharmacy industry's revenue upward anywhere from 0.6% to 1.9%, according to an analysis by CMS. Higher Medicare drug utilization will boost average pharmacy revenues between 0.7% and 3%, but lower dispensing fees will offset some of that revenue increase, CMS official Tom Hutchinson told attendees at the recent NACDS Pharmacy & Technology Conference in San Diego. Noting that the projected impact on small entities such as retail pharmacy has received very little scrutiny, he urged chain drugstores to examine CMS' impact analysis and comment on the proposed final rule before the Oct. 4 deadline.
The FDA recently announced that RxBazaar and its wholly owned subsidiary, FPP Distribution, each pled guilty in U.S. District Court to one misdemeanor for not providing required documentation, so-called drug pedigree, identifying each prior sale, purchase, or trade of prescription drugs they distributed. The two Cincinnati-area Rx drug wholesalers were sentenced to five years' probation and a $100,000 fine each. This marks one of the first convictions of its kind.
Humana has agreed to settle a lawsuit filed by 200 independent Tennessee R.Ph.s over its practice of providing differential reimbursement to different providers. According to the R.Ph.s, all members of the National Independent Pharmacy Coalition (NIPC), offering greater reimbursement to high-volume pharmacies violates the state any-willing-provider law. The terms of the settlement are sealed. According to a spokesman for NIPC, a nonprofit group set up to promote the interests of independent R.Ph.s, other states could bring similar suits, since unequal reimbursement rates exist elsewhere and many states have passed any-willing-provider laws.
Are drugmakers conspiring to keep drug prices high in the United States and low abroad? That's what some 14 independent pharmacists in California have charged in an antitrust suit against 15 drug companies. The R.Ph.s said they're tired of losing patients to Internet pharmacies as a result of the inflated prices drugmakers charge domestically. Companies named in the suit include Pfizer, Johnson & Johnson, Bristol-Myers Squibb, and others. They countered that the suit is without merit.
Should Medicare cover antiobesity drugs? That was the question on the Instant Poll posted on Drug Topics' Web site during the month of August. More than half of respondents (54%) said No, 44% said Yes, and 2% answered Don't know. Some 945 people took part in the survey.
The FDA and Pfizer recently notified healthcare professionals of a revision to the "Warnings" section of the labeling for ziprasidone (Geodon). The label notes the risk of hyperglycemia and diabetes in those taking the drug. The agency has asked all manufacturers of atypical antipsychotic medications to add this warning statement to the labeling. The MedWatch 2004 safety summary, including a link to the Dear Healthcare Professional letter, is at: www.fda.gov/medwatch/SAFETY/2004/safety04.htm#geodon.
Sen. Chuck Grassley (R, Iowa) held a press conference during the Republican National Convention to call on 527 groups to stop airing negative ads that dissuade seniors from taking advantage of savings from Medicare discount cards. Citing studies by the Kaiser Family Foundation, American Enterprise Institute, and Healthcare Leadership Council, Grassley said that senior citizens are experiencing real savings with the Medicare Rx drug cards.
Carbidopa/levodopa (Parcopa, Schwarz Pharma) orally disintegrating tablets were approved for the treatment of symptoms of idiopathic Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide or manganese poisoning. The product, a unique formulation designed to dissolve rapidly on the tongue, will be available in pharmacies on Sept. 27.
A study in the September issue of Pediatrics has found that Nuvo, a new lotion, dry-on, suffocation-based pediculicide, was effective in treating head lice. The wet lotion is applied to the dry scalp, then blown-dry to create a "shrink-wrapped" film that completely covers the hair shaft and louse, suffocating lice. Researchers found that nit removal was unnecessary and that a high cure rate could be obtained without extensive household cleaning. Nuvo, from Family Dermatology Medical Office, is currently available only to patients of Dale Pearlman, M.D., in Menlo Park, Calif. For more information, visit www.nuvoforheadlice.com.
The FDA has approved revised labeling for budesonide (Rhinocort Aqua, AstraZeneca) for the treatment of seasonal and year-round nasal allergy symptoms in adults and children six years and older. The pregnancy rating for budesonide is now upgraded to Category B. This is the first intranasal corticosteroid approved for this indication to receive a Pregnancy Category B rating.
Pemetrexed (Alimta, Eli Lilly) has been granted accelerated approval for the treatment of locally advanced or metastatic non-small cell lung cancer in previously treated patients. Pemetrexed was previously approved for use in combination with cisplatin for the treatment of malignant pleural mesothelioma, a condition often associated with asbestos exposure.
Illinois Gov. Rod Blagojevich has signed a law, SB 2244, that will limit Illinois shoppers from buying more than two packages of cold medicine at a time beginning Jan. 1, 2005. The new law will make it harder for illicit methamphetamine manufacturers to get the ingredients ephedrine or pseudoephedrine. In addition to the limits on the number of cold medicine packages one person may buy, the new law also requires retailers to place adult-strength cold medicines that have ephedrine or pseudoephedrine as their sole active ingredient either behind the counter or in locked cases. The measure also requires special training for store employees and prohibits the sale of any amount of cold medicine if the retailer believes it will be used to manufacture meth. (See related story "DEA to drug firms: Step up security for pseudoephedrine".)
CVS is helping customers take advantage of the flexible spending accounts (FSAs) they may have through their jobs for OTC products. CVS customers who use the company's ExtraCare card when buying OTCs can obtain a detailed list of these purchases to submit to their employers for reimbursement. The list can also help customers plan ahead so they can better estimate how much money to set aside in their FSAs.
Docetaxel (Taxotere, Aventis Pharmaceuticals) injection concentrate in combination with doxorubicin and cyclophosphamide has been approved for the adjuvant treatment of early-stage, operable, node-positive breast cancer. The FDA granted the supplemental NDA priority review status. Docetaxel was previously approved for the treatment of locally advanced or metastatic breast cancer after failure of prior chemotherapy, and unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin in chemotherapy-naive patients. It was also approved for treating unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. Docetaxel was approved last spring for use in combination with prednisone for the treatment of androgen-independent (hormone-refractory) metastatic prostate cancer.
Oregon has applied for a federal waiver to allow residents to import Canadian drugs through their local retail pharmacy. The Pioneer Prescription Drug Project contains measures to ensure drug safety and affordability, according to Gov. Ted Kulongoski. The state pharmacy board would oversee the licensure of Canadian wholesalers that would have to meet the standards for U.S. wholesalers. Drugs would have to be imported from board-approved Canadian manufacturing sites. Pharmacists who opted to participate would have to register with the board, use only approved wholesalers, and store Canadian drugs separately. The board would set a fixed dispensing rate to ensure savings were passed through to consumers.
Female teaching staff at pharmacy schools face disparities in administrative positions, salary, and advancement opportunities, according to a new study, "The Status of Women in Pharmacy Education: Persisting Gaps and Issues." The study, published in the on-line edition of the American Journal of Pharmaceutical Education, also revealed the following: for the academic year 2002-2003, female assistant professors earned an average of 7.6% less than their male counterparts; female associate professors earned an average of 6.4% less than their male counterparts; and female full professors earned an average of 11.2% less than their male counterparts. The report can be found at www.ajpe.org.
CDC is creating guidelines for the reporting of nosocomial infections. Debate during an August meeting of CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) suggests hospitals will likely see two reports in one. HICPAC members expect public attention to focus on a summary document with bullet points and specific reporting recommendations. The healthcare community and legislative staffers will pay more attention to a detailed review of the literature on hospital-acquired infections that emphasizes definitions and data collection standards. A draft guidance is planned for October. CDC said HICPAC is trying to catch up with states that already require hospitals to report nosocomial infection data as quality-of-care indicators.
Breaking News. Drug Topics Sep. 13, 2004;148:12.