FDA Launches Safety Program

The Food and Drug Administration launched a pilot program aimed at ensuring the safety of drugs produced outside the United States. The agency said it plans to select 100 companies that volunteer to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to maintain control over drugs and active ingredients from the time of manufacture through entry into the United States. The FDA said it's testing the practicality of a comprehensive supply chain program that could identify foreign products that fail to comply with U.S. standards. The pilot program will run for 2 years, the FDA said.

CMS IDs Protected Drug Classes

The Centers for Medicare and Medicaid Services tried to guarantee that Medicare beneficiaries with certain conditions—including HIV infection, some cancers, and mental illness—may confidently enroll in Medicare Part D prescription plans. In June 2005, the CMS directed that Part D formularies include nearly all drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. A new CMS rule notified Part D plans that they must continue to provide coverage of these drugs through 2010, consistent with the policy already in place. For 2011 and beyond, the CMS may propose further steps to ensure availability of drugs in the six specified classes, the agency said.

Mixed Grades on Tobacco Control

Smoking in workplaces and public spaces has been banned in 23 states, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits—important because the Medicaid population smokes at a rate that's 50% higher than the national average, according to the association. The group's state-by-state report card on tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the FDA in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

School Embraces Medical Home

A family practice residency program at the University of Kansas, Wichita, will establish a patient-centered medical home model of care, making it one of the first residency programs in the nation to offer training in a medical home environment, the university said. The transformation of the Smoky Hill Family Medicine Residency Program in Salina, Kan., will be supported in part by a $49,500 grant from the United Methodist Health Ministry Fund. The program is to focus on electronic health records and other health information technology, increased support for patients, better chronic disease management, scheduling innovations, and alternatives to routine office visits. “The adoption of the medical home model at the residency level is particularly important because the office practices [that] physicians learn in residency—good or bad—tend to translate into their 'real life' practice upon graduation,” Dr. Rick Kellerman, professor and chair of family and community medicine, said in a statement.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said Dr. William F. Jessee, MGMA president. For example, because most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process that's prone to error. Many cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to the MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

Policy & Practice