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Teva has received permission from the FDA to market rasagiline(Azilect) for the treatment of Parkinson's disease (PD). The newmolecular entity is a monoamine oxidase type B inhibitor that worksby blocking the breakdown of dopamine. Rasagiline was approved asan initial single-drug treatment in early PD and in addition tolevodopa in more advanced patients. Like other MAOIs, rasagilinehas the potential to cause a hypertensive crisis if a patientconsumes tyramine-containing foods while on therapy. The efficacyof the new drug was tested in 404 patients with early disease and1,100 patients with more advanced PD.

Bulk Rx ingredient supplier Spectrum Laboratory has recalled alllots of tacrolimus powder due to sub-potency in some lots. Allpharmacies that have received Spectrum's tacrolimus powder shouldstop using it immediately and contact the company to makearrangements to return it.

The Medicines and Healthcare Products Regulatory Agency, London,has announced that the migraine medication sumatriptan (Imigran) isto be reclassified from Prescription Only Medicine (POM) toPharmacy Medicine (P) status, making it available from pharmacieswithout the need for a prescription. With England setting aprecedent, will the United States be next?

Bausch & Lomb has decided to permanently remove from marketsworldwide its ReNu with MoistureLoc contact lens cleaning solution,based on data suggesting that the product may increasesusceptibility to Fusarium. The company has proposed theformulation as the potential root cause of the increased relativerisk of Fusarium keratitis.

An independent panel convened by the NIH Office of MedicalApplications of Research and the Office of Dietary Supplements hasassessed the available evidence of multivitamin/minerals (MVMs) andmade recommendations regarding certain supplements. The panel'srecommendations include the following: the combined use of calciumand vitamin D protects the bone health of postmenopausal women;antioxidants and zinc help nonsmoking adults with early-stage,age-related macular degeneration; and women of childbearing ageshould take folate daily.

The Consumer Healthcare Products Association has joined forces withthe Partnership for a Drug-Free America to launch an advertisingcampaign designed to curb the abuse of prescription and OTCmedicines and to draw public attention to the substance abuse trendamong teenagers. At dual press conferences held recently inWashington, D.C., and New York, TV, print, and radio public serviceads were unveiled.

CCRx will pay pharmacists as part of a medication review program tobe offered to new Medicare Part D enrollees. The program will helpnew members shift to the benefit and will feature face-to-face drugreviews with a pharmacist.

Medco Health Solutions reached a tentative agreement to pay $163million to settle federal fraud charges stemming from twowhistle-blower suits filed by pharmacists against the giant PBM.Still slated for trial in June, the Medco complaint was filed inDecember 2003 by U.S.

NCPA has charged that last year's FTC conflict-of-interest study ofPBMs and their mail-order pharmacies was flawed and has requestedan immediate correction to the agency's findings. Based on adetailed analysis it commissioned, NCPA concluded that the FTCignored much of what Congress specifically asked it to do orselectively used data and analysis to reach unsubstantiatedconclusions.

Beginning July 1, all Medicare Part D drug plans must use approvedstandardized reject codes developed by groups representingpharmacy, PBMs, and insurers. The change from best practice tomandate was announced by CMS administrator Mark McClellan, who saidit is fundamentally important to reduce administrative burdens onpharmacists.

Sullivan University is seeking to hire the founding dean for a newcollege of pharmacy in Louisville, Ky. The first class of thecollege's Pharm.D. program is scheduled to be admitted in January2008.

Boca Medical Products and the FDA have notified consumers andhealthcare professionals of an extension of an earlier recall ofUltilet insulin syringes and the additional recall of Closercareinsulin syringes because of bacterial contamination withPaenibacillus. This presents a risk of local infection due to softtissue injection with a contaminated syringe as well as a risk ofintroduction of contaminating organisms into a previously sterilevial.

Triax Pharmaceuticals has launched a patient assistance program(PAP) for the prescription acne treatment system Tretin-X(tretinoin). The program is administered through RxHope, a PAP Webportal for uninsured patients.

Results of two studies in patients aged six to 12 years have ledNovartis to update the labeling of dexmethylphenidate HCl (FocalinXR) extended-release capsules. Significant improvements in ADHDsymptoms were observed at every hour up to 12 hours afteradministration of 20 mg of the drug compared with placebo.

AstraZeneca has launched a campaign directed at healthcareproviders after receiving reports of confusion between brand-namedrugs Toprol-XL (metoprolol succinate), Topamax (topiramate,Ortho-McNeil), and Tegretol (carbamazepine, Novartis) and TegretolXR that have led to medication errors. The effort will aim toincrease awareness of the problem and reinforce accurateprescribing and dispensing of Toprol-XL.

Sanofi-Pasteur, manufacturer of the meningococcalpolysaccharide-protein conjugate vaccine (MCV4), has announced ashortage of the vaccine that will last at least through the summerof 2006. Due to the limited supply, CDC is now recommending thatproviders immunize only adolescents at high school entry who havenot previously received MCV4 as well as college freshman living indormitories.

Remember the long list of do's and don'ts CMS came up with latelast year related to how the Medicare Part D plans are to bemarketed? CMS has proposed new guidelines for the 2007 contractyear and has given only one week's time for the public to comment.

Children with active Crohn's disease will now have a new treatmentoption as the FDA has given the regulatory nod to infliximab(Remicade, Centocor) for the treatment of the disease. Themonoclonal antibody works to reduce the inflammation of the bowelassociated with Crohn's by blocking the action of tumor necrosisfactor-alpha and inducing remission of the condition.

Where once treatments were lacking for myelodysplastic syndromes,now several drugs have been approved for this bone marrow disorder

The link between tubing and catheter misconnections and serious errors, including patient deaths, has been a well-known but underreported problem for years. Hoping to get device manufacturers and healthcare organizations to take more aggressive action in order to reduce the number of adverse events, the Joint Commission on Accreditation of Healthcare Organizations recently issued a Sentinel Event Alert.

Fifty-eight percent of adults have visited a drugstore in the past30 days to make a prescription purchase, a decrease from 62% in2004 and 64% in 2000, according to the results of a recent Vertisstudy. Vertis is a Baltimore, Md.-based provider of targetedadvertising, media, and marketing services.

Electronic prescribing that includes patient-specific formularyinformation could cut a payer's drug spend by 8% to 15% anddrug-spend inflation could be reduced by as much as 1% per year,according to an analysis commissioned by RxHub. An e-prescribingnetwork, RxHub processed more than 26 million requests forpatient-specific eligibility, benefit, and formulary informationlast year and is on track to top 60 million patient events thisyear.

New Hampshire is set to become the first state to ban drugcompanies from getting physicians' prescription data. The law wouldprevent all types of pharmacies, PBMs, insurers, and data-miningcompanies from selling, transferring, using, or licensing Rxinformation for any commercial purpose.

Medco Health Solutions has reached a tentative agreement with theUnited Steelworkers union over a contract with technicians at thePBM's Las Vegas mail-order pharmacy. Terms of the deal were notannounced.

The FDA and GlaxoSmithKline are notifying healthcare professionalsof changes in the Warnings section of the prescribing informationfor both Paxil (paroxetine) and Paxil CR, after a company-performedmeta-analysis found an increased risk of suicidal behavior in youngadults (aged 18-24) taking the drug (2.19% versus 0.92% onplacebo). The clinical trials analyzed included almost 9,000patients treated with paroxetine and about 6,000 on placebo.

Since the launch of Medicare Part D, the top three PBMs have postedrecord earnings, according to the Association of CommunityPharmacists Congressional Network. At a time when Part Dreimbursements to pharmacies are slow and low, ACP*CN noted thatMedco alone generated $650 million in new Medicare sales for thefirst quarter and that Part D allows PBMs to keep any drug companyrebates instead of passing the savings on to seniors.

The Office of Inspector General (OIG) has entered into a SettlementAgreement and Corporate Integrity Agreement (CIA) with LincareHoldings and its subsidiary Lincare Inc. Lincare providesrespiratory care, infusion therapy, and medical equipment topatients in the home. The settlement resolves allegations thatLincare paid illegal kickbacks and violated the PhysicianSelf-Referral Law (also known as the Stark Law).

The Center for Substance Abuse Treatment is seeking public commentson the revised draft guidelines for the accreditation of opioidtreatment programs. The draft guideline may be obtained atwww.dpt.samhsa.gov.