Drug Topics - November 26, 2007 - (Page 14)

14 DRUG TOPICS NOVEMBER 26, 2007 www.drugtopics.com NEWS Roundup event associated with the use of a dietary supplement that is adverse. The nuance is that the person has to maintain records related to each report of an adverse event even if it is just a stomachache. Many manufacturers have indicated they will contract their reporting function to a third party who has greater medical expertise. You need to tabulate the information in a way that you can add it to the Medwatch Form. The form has more than 31 fields of data that require responses. That will be a challenge for some companies.” When asked to recommend the type of medical personnel that companies can tap for adverse event reporting, Kingston said, “The people who are most commonly involved in this area are often pharmacists—either clinical pharmacists or pharmacists who have specific training in this area. Nurses who may have worked in a poison center or in a clinical research trial documenting these types of incidents and certain physicians may be good options, too.” bers to its HCIdea database. The HCIdea on-line lookup tool now includes more than 1.3 million prescriber NPI numbers. All NPIs were obtained from CMS. The database also includes other prescriber information, including DEAs, state license numbers, specialties, phone numbers, and multiple practice locations. Recently CMS announced it will require NPI numbers for Medicare payments in January. The requirement for using NPIs was originally slated to begin in May, but delays forced CMS to extend a transition period. More than $300,000 worth of drugs, supplements seized by marshals At the request of the FDA, U.S. Marshals have seized more than $300,000 worth of products—including NC Solution, an antifungal product—and other drugs for human or animal use, dietary supplements, and ingredients to make those products. The reason? Some products lacked FDA approval and all were maintained under grossly unsanitary conditions by General Therapeutics Corp., St. Louis, Mo., according to FDA. The agency considers NC Solution a drug because it is intended for use in the diagnosis, cure, or treatment of disease in people or animals. The FDA recommends that consumers who have any products manufactured by General Therapeutics, including NC Solution, consult their healthcare provider about discontinuing use. FDA asks for recall of dietary supplements for men The FDA has requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men’s Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients. The products, often advertised as “all natural” alternatives to approved erectile dysfunction drugs, could interact and cause dangerously low blood pressure. They contain substances that have similar structures to active ingredients in approved prescription drugs. The FDA requested the recall of all products distributed under both labels in a letter to Yin Kao, president and owner of America True Man Health, West Covina, Calif. The products are often advertised in newspapers, retail stores, and on the Internet. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerine. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The FDA issued an alert on May 10 advising consumers not to buy or use these products. Customers who have either product in their possession should stop using it immediately and contact their healthcare providers if they have experienced any problems that may be related to taking this product. Consumers should report adverse events to www.fda.gov/medwatch/report.htm. Chains and Business Giant Eagle expands $4 generic prescription program Supermarket retailer Giant Eagle announced that effective Nov. 8 it is expanding its popular $4 generic prescription program to a total of more than 400 drugs. The program makes commonly prescribed dosages, at up to a 30-day supply, of participating generic drugs available to Giant Eagle Pharmacy customers for $4. The company originally launched its $4 drug program in late 2006 with more than 300 drugs. Rite Aid is target of protest by unions More than 500 attendees at the recent International Foundation of Employee Benefit Plans Conference in Anaheim, Calif., protested Rite Aid by carrying bags that said, “Trust Rite Aid? Think Twice.” Most of the attendees are involved in administering union healthcare NCPDP unveils NPI database The National Council for Prescription Drug Programs has added National Provider Identifier num- http://www.drugtopics.com http://www.HCIdeaLookUp.org http://www.drugtopics.com/drugtopics/Medicare+%2F+Medicaid/CMS-to-require-NPI-numbers-in-January/ArticleStandard/Article/detail/462564?contextCategoryId=6925 http://www.fda.gov/bbs/topics/NEWS/2007/NEW01633.html http://www.fda.gov/medwatch/report.htm

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Drug Topics - November 26, 2007 Contents Cough & Cold Recommendations May Impact Other Products More Novelty OTCs Elbow Onto Store Shelves Medication Reconciliation Policies Incomplete at Many Hospitals Hospitals Regress in Reconciling Drugs in 2006 Latest News Roundup

Drug Topics - November 26, 2007

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