News & Trends
Flu Season Off to Latest Start in 24 Years
The Centers for Disease Control and Prevention (CDC) officially announced the start of flu season on February 24, 2012, after 3 straight weeks in which more than 10% of reported respiratory specimens tested positive for influenza. This is the latest start to a flu season in 24 years.
As of February 18, the spread and impact of the flu had been unusually mild. Only 2 states—California and Colorado—had reported widespread geographic influenza activity. Hospitalizations due to flu were down, at just 1.3 per 100,000 people compared with 10.6 per 100,000 people at the same point in the 2010-2011 flu season. Influenza-related pediatric deaths were down sharply as well, with just 3 reported so far this season compared with 122 in 2010-2011 and 282 during the H1N1 swine flu pandemic of 2009-2010.
The CDC notes, however, that flu season can last as late as May and encourages everyone 6 months and older to get the flu vaccine. In addition, the CDC advises the use of antiviral medication as soon as possible by flu patients who are severely ill and those at greatest risk of complications from influenza. The CDC estimates that influenza virus infections in the United States result in an average of 200,000 hospitalizations and 3300 to 49,000 deaths per year.
Supreme Court Keeps California Medicaid Lawsuit Alive
The US Supreme Court has voted 5 to 4 to send a long-running case back to a federal appeals court regarding whether Medicaid recipients and medical providers, including pharmacists, can sue the state of California to block cuts to reimbursement rates.
The case, Douglas v Independent Living Center of Southern California, was filed in 2008 in reaction to cuts of up to 10% in Medicaid reimbursement rates instituted by California’s legislature to help close the state’s yawning budget deficit. The plaintiffs argue that the US Constitution’s supremacy clause gives them the right to sue on the grounds that the cuts violate federal law because they would impact access to care for Medicaid patients.
Since oral arguments in the case were heard last October, many of the reimbursement cuts have been approved by the Centers for Medicare & Medicaid Services, a fact that the Supreme Court instructed the appeals court to take into account in determining whether the lawsuit can go forward. The state of California and the federal government have both argued that only the federal government has the right to enforce federal law, and the federal law in question does not explicitly give those involved in the Medicaid program a right to sue.
The American Pharmacists Association (APhA), the National Association of Chain Drug Stores, the National Community Pharmacists Association, and the National Alliance of State Pharmacy Associations all expressed their approval of the Supreme Court decision. “We are gratified that today the Supreme Court kept the door open for pharmacists to challenge unfair reimbursement cuts that would deny patients access to care,” said Thomas Menighan, BSPharm, MBA, ScD (Hon), FAPhA, APhA executive vice president and chief executive officer.
“We want to recognize the constrained budgets that states are under, but these reimbursement cuts will further disrupt the relationships between patient and pharmacist that are essential to effective medication use.”
Congress Urged to Help Increase Antibiotic Production
A coalition of 51 organizations led by the Infectious Diseases Society of America has sent a letter to congressional leaders urging them to help in the fight against drug-resistant bacteria by including provisions in the FDA Prescription Drug User Fee Act (PDUFA) aimed at encouraging the development of new antibiotics.
The coalition points out that, over the past 2 decades, the incidence of infection with antibiotic-resistant bacteria such as methicillin-resistant Staphylococcus aureus, Escherischia coli, Acinetobacter baumannii, and Klebsiella has increased dramatically, to the point where these infections kill 100,000 US hospital patients per year. Over the same time period, the number of large companies with active antibiotic research and development programs has plummeted from 20 to 2 or 3.
Increased incentives for development of antibiotics are required, the group argues, so pharmaceutical companies will give them the same level of attention they give other drug categories, which offer smoother passage to FDA approval and the promise of greater profits.
The letter also urges the establishment of incentives to develop diagnostic tests to help identify patients for clinical trials, detect emerging patterns of drug resistance, and determine the best medication to treat a given infection.
The PDUFA is considered one of this year’s few “must-pass” bills, and congressional leaders hope to complete work on it by June. Provisions likely to be included in the finished version will not completely fix the antibiotic pipeline, but the coalition sees them as a step in the right direction.
The coalition’s ultimate goal is the development of 10 new systemic antibiotics by 2020, known as “The 10 x ’20 Initiative.”
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