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

www.drugtopics.com JANUARY 7, 2008 DRUG TOPICS 7 NEWS Roundup update addresses findings from studies published through the end of 2006 that showed DES placement is associated with a slightly higher risk of clot formation. The guideline authors emphasize that prescribers should consider whether a patient is capable of being medication-compliant when choosing between a DES or a bare-metal stent. Future planned surgeries or other medical procedures where patients could not take the two anticoagulants should also be considered before stent placement. The guideline update also addresses timing of stent placement in certain groups of patients and emphasizes the importance of tobacco cessation, blood pressure control, and low cholesterol in the prevention of heart attacks. The “2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention” can be accessed at www.scai.org. vaccinations for sixth graders. Preschoolers will be required to receive immunizations for pneumonia and the flu, while sixth graders will be required to get shots for meningitis and a booster for tetanus and whooping cough. The shots, recommended by the Centers for Disease Control & Prevention and the American Academy of Pediatrics, will be required beginning September 2008. The new vaccinations were approved by the state Public Health Council despite protest by a number of parents who said the mandate impedes on their rights as parents. Government/Law Injunction puts brakes on AMP A Federal District Court Judge has issued a preliminary injunction that prevents the Centers for Medicare & Medicaid Services from collecting data on the average manufacturer price for Medicaid drugs. The injunction effectively, if temporarily, halts CMS from implementing the new payment formula for multi-source generic medications in the program that was set to go into effect in January. In November, NACDS and NCPA jointly filed the suit accusing CMS of violating numerous aspects of the Social Security Act, including its definition of AMP. Officials at NCPA and NACDS are still pushing for a legislative fix for the AMP rule, but it is now unlikely that anything will pass before the Congressional winter recess. Judge Royce Lamberth will issue his written ruling on the preliminary injunction Wednesday and the case will commence in January. Questionable sterility leads to Hib vaccine recall Merck & Co. has announced a voluntary recall of its haemophilus b conjugate- containing vaccines, PedvaxHB and COMVAX. The precautionary measure comes after the company identified the presence of bacteria Bacillus cereus on the manufacturing equipment used to produce the vaccines. Although sterility tests of the vaccine lots did not show any contamination, the company issued a recall of 10 lots of PedvaxHIB and two lots of COMVAX. According to the CDC, distribution of the lots began in April 2007 and affects a total of about one million doses that were distributed in the U.S. and to the CDC stockpile. A child immunized with an affected lot could be at increased risk for developing a localized or disseminated infection within one week of vaccination, according to the agency. In addition, immunocompromised patients may be at greater risk for these infections. However, no reports of infection have been detected by the Vaccine Adverse Event Reporting System (VAERS). Efficacy of the vaccines has not been compromised, so children already vaccinated are protected against haemophilus b infection. More information and lot numbers of affected vaccine can be accessed at www.cdc.gov/vaccines/vac-gen/ shortages/downloads/hib-faqs-recall-12-12-07.doc FDA’s final rule require warning for nonoxynol 9 OTC contraceptives The FDA has issued a final rule that requires manufacturers of OTC stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) to include a warning that the chemical N9 does not provide protection against infection from HIV or other sexually transmitted diseases (STDs). Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception. In addition, FDA is requiring that the labels warn consumers that the chemical N9 in standalone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDs from an infected partner. The full text of the final rule is posted at www.fda.gov/OHRMS/DOCKETS/98fr/ 80n-0280-nfr0003.pdf. Children in New Jersey required to get new vaccinations New Jersey has become the first state in the country to require annual flu shots for preschoolers and several new http://www.drugtopics.com http://www.scai.org http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/hib-faqs-recall-12-12-07.doc http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/hib-faqs-recall-12-12-07.doc http://www.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0003.pdf http://www.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0003.pdf

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Drug Topics - January 7, 2008

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