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ASHP fighting National Drug Code problems
The American Society of Health-system Pharmacists (ASHP) says it has intensified its fight against what it sees as a costly and burdensome requirement that hospital outpatient departments report National Drug Code (NDC) numbers. ASHP and Safety Net Hospitals for Pharmaceutical Access (SNHPA) said they have asked Congress to help resolve the issue. They asked the House Energy and Commerce Committee and Senate Finance Committee to secure an exemption from the Centers for Medicare and Medicaid Services' (CMS) rule that outpatient departments report the 11-digit NDC numbers on single-source drugs and 20 multiple-source drugs when submitting Medicaid claims. CMS has refused to grant the exemption. The Deficit Reduction Act requires states to collect NDC numbers to secure rebates on physician-administered drugs beginning Jan. 1, 2008. CMS ordered outpatient departments to comply with the rule.
In writing to the committees, ASHP and SNHPA questioned the accuracy of CMS' interpretation of the law governing Medicaid drug rebates, which currently exempts drugs administered by hospital clinics. ASHP also said it believes the requirement will be costly for outpatient pharmacy departments since many will have to upgrade technology to accurately report the NDC numbers.
Some 60% of health systems responded to an ASHP survey by indicating they did not have the information systems to report all the NDC numbers. While CMS estimated the cost to comply with the requirement at $ 0.09 per claim, ASHP's survey found an estimated cost of $10.80 per claim.
Chain store druggist says firing caused by Plan B
A Target store pharmacist who opposes abortion says the chain fired him for refusing to fill prescriptions for the Barr Pharmaceuticals Plan B emergency contraceptive. In a suit filed in Detroit federal court, Brian Bundy said that "as a result of his sincerely held belief that life begins at conception, [he] cannot dispense a drug that would terminate that life if used."
Bundy says he informed Target of his strong Christian beliefs before he was hired in April 2006 and was told he could refer customers wanting Plan B to another pharmacy. He was fired seven months later after Plan B became available over-the-counter to customers older than age 18. He says he did not want to dispense it with or without a prescription and the company insisted he dispense it to OTC customers.
A Target spokeswoman said the store values the diversity of its pharmacists and their religious beliefs but also has an obligation to meet the needs of its customers, especially health care needs. She said the company's policy on Plan B sales accommodates both pharmacist religious beliefs and customer needs, but would not state the policy for the Detroit News, citing the pending litigation. Legal observers say no cases involving refusal to dispense Plan B have yet been decided by a federal appeals court.
No increased Nexium/Prilosec heart risk
FDA says its comprehensive, scientific review of known safety data for AstraZeneca's gastroesophageal reflux disease (GERD) drugs omeprazole (Prilosec®) and esomeprazole (Nexium®) did not find an increased risk of heart problems.
FDA says it recommends that health care providers continue to prescribe and patients continue to use the products as instructed in their labeling.
FDA looked at two long-term studies that did not specify how heart problems, such as heart attacks, were defined or verified. As a result, the agency says, evaluating the information that was gathered about the safety of both drugs in the studies was challenging. The assessment of the information from the data gathered was further supported, FDA says, by an additional analysis of 14 comparative studies of omeprazole, four of which were placebo-controlled.
Although those studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they did not suggest an increased risk of heart problems with using omeprazole and esomeprazole.