June 29, 2010

On June 28 the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) issued a clinical alert to physicians regarding the new FDA warning about patient response to the anti-platelet drug clopidogrel (Plavix).

The FDA requires a new warning on the box of clopidogrel products stating that, based on genetic make-up, some patients can’t metabolize the drug into its active form and won’t respond to the drug. The FDA estimates that between 2 percent and 4 percent of patients won’t be able to metabolize the drug. But there is not yet enough information available for developing recommendations on genetic testing of patients, the ACCF and AHA stated in their report.

“What do you do with that FDA warning?” asked Rita Redberg M.D., a professor of medicine in the cardiology division at the University of California San Francisco.

“The specific impact of genetic differences on clinical outcome is really not known. Genetics is not at a point where we can make clinical recommendations based on genetics,” Redberg said.

There are also questions about how genetic testing should be used and if the cost of that would be reimbursed.

Redberg said doctors were really confused by the FDA warning and were wondering if they should be ordering these genetic tests. But they can be expensive and take a while to process and they don’t all fall under FDA supervision, she said.

“It’s very unclear how reliable that information is and what you do with that information once you get it,” Redberg said.

Some alternative drugs seem to have less dependence on genetic factors, but they may cause more bleeding and cost more, the report states. One alternative was recently found to have a significantly higher rate of solid tumors.

Redberg feels the ACCF/AHA report helped ease doctors’ confusion by essentially recommending that they keep doing what they are currently doing.

Some of the recommendations the ACCF/AHA report does make are that genetic testing might be done if a patient is at moderate or high risk of a poor outcome. And in patients who have been taking clopidogrel as prescribed, yet had problems due to the drug not working or working too well and causing bleeding, the report states that might warrant genetic testing, switching to another drug or adjusting the clopidogrel dose.

June 25, 2010

Local and national elder care leaders convened at a conference in Sacramento this week, the culmination of a yearlong project to explore the expansion of an all-inclusive healthcare program for seniors in rural California counties.

The Program of All-inclusive Care for the Elderly (PACE), a national, federally funded program, has 20 centers in urban areas of California but none in rural regions. Now senior service organizations in Humboldt, San Joaquin and Riverside counties are working with their communities to determine the feasibility of opening PACE centers.

“It’s to keep frail seniors away from nursing homes, to keep them in their own homes as long as possible,” said Robert Edmondson, CEO of On Lok Inc., which hosted the conference, “Making PACE a Reality in Rural California.”

The SCAN Foundation of Long Beach made a $100,000 grant to On Lok Inc., a San Francisco-based  nonprofit organization, that forged the way for the (PACE) program to develop more than 25 years ago. The grant was for On Lok to identify three rural counties that could research the feasibility of having a PACE center in their region. On Lok is focusing on Humboldt, San Joaquin and Riverside counties. Currently there are 71 PACE organizations in 31 states, California has 20 of those, run by five organizations, but PACE has yet to be expanded to any rural counties.

“Our goal is to make certain that every senior in the sate has access to a PACE program,” Edmondson said. On Lok operates 10 PACE programs in San Francisco, Fremont and San Jose and will open another one in Fremont at the end of 2011.

PACE programs are funded through Medicare and Medicaid and in California they are also licensed through the California Department of Healthcare Services, Division on Long-Term Care.

PACE is a center-based managed care program that serves people 55 or older who have been determined by the state to be nursing-home-eligible. Most of them qualify for both Medicare and Medicaid. PACE has centers that members can visit from one to five days a week. Transportation is provided and PACE members get all of their health needs taken care of there including doctors, dentist and physical therapy appointments. PACE centers also provide meals, recreational activities, laundry and facilities for bathing members.

In Humboldt County the Humboldt Senior Resource Center is the lead agency coordinating with On Lok to research the costs, number of members they’d need, which community services would need to be involved and the barriers to forming a PACE center in Humboldt County.

Because rural counties have much less dense populations state regulators may need to be flexible on some regulations to make this feasible, said Joyce Hayes, Executive Director of the Humboldt Senior Resource Center.

“We may need to ask for some waivers in terms of staffing structure or transportation requirements and we may need some financial support for the first few years,” Hayes said. The Humboldt Center does not currently offer medical services and Hayes said PACE seems like a great program to explore.

“It’s shown to be a very high quality program that saves dollars and provides high quality care to elders, she said. Although some PACE centers around the country are run by for profit companies, in California all PACE centers must be operated by nonprofits.

On Lok is wrapping up this year-long project funded by the SCAN Foundation and the partnership in Riverside County, headed by the Riverside County Office on Aging, which On Lok has been working with, has notified the state that it will apply for the PACE program, said Gretchen Brickson, Director of Technical Assistance for On Lok.