Showing posts with label medical ethics. Show all posts
Showing posts with label medical ethics. Show all posts

Saturday, 22 June 2013

Kentucky and online audiences hear discussion of proposed system for patients to report medical errors; comments due July 8

By Molly Burchett
Kentucky Health News

The Obama administration is creating a new system for patients to report medical mistakes because existing systems fail to do so, and if all goes as planned, the pilot program will launch this fall, a federal official told a Health Watch USA meeting in Kentucky and online Wednesday night.

Research suggests that many adverse medical events go unreported in current systems that don't allow patients to provide input about their care, said James Battles, Ph.D., of the Agency for Healthcare Research and Quality. To fix this problem, AHRQ has funded the development of a prototype patient reporting system through a contract with RAND Corp.

Called the Consumer Reporting System for Patient Safety, the project is designed to collect information from patients "about medical errors that resulted or nearly resulted in harm or injury” and can also secure reports from family members, said Battles. The data will be available for use by providers and health systems that wish to create or enhance their own local reporting systems.

Here's how the system will work: When a patient recognizes a medical error, an intake form will ask what happened, including questions about the details of the event and the health care provider(s). Providers and patient safety officers are expected to follow up with the patient, which AHRQ estimates would add 28 hours to the provider's annual work load. The collected data will be analyzed to produce estimates about the patient safety events, which will be shared with health institutions.

There is concern about how the project findings will be used and that "frivolous" patient reports may lead to increased medical malpractice liability for providers. Despite apprehension that findings could possibly be linked to financial or legal penalties for poor performance, hospitals say they are receptive to the idea, Robert Pear of the New York Times reported last fall when project was first posted in the Federal Register.

"The question then would become, frivolous to whom?" Battles said when asked what he would say to concerned providers. Patient input is critical to gaining a full understanding of an adverse event, he said, and the overall project will include public awareness campaigns to let patients know their care experience is valued: "The purpose of the system is to improve patient safety, develop ways to prevent future harm and inform policy."

Patients, physicians, hospitals and other health care providers have until July 8 to comment on revisions to the government proposal, says the notice published in the Federal Register. (Click here for more information.) Battles said AHRQ has made substantial changes to the proposed reporting system's data collection tools, based on comments received last fall when the project was originally outlined.

After approval from the federal Office of Management and Budget, Battles said, a pilot program will be launched this fall near Philadelphia, then the system will be tested on a regional basis while considering reports from providers and patients.

Health Watch USA, based in Somerset, was founded by Dr. Kevin Kavanagh to promote health care transparency and patient advocacy, says its website. The organization's next meeting will be held July 31 at 5 p.m. and will feature Dr. Patrick Conway, chief medical officer for the federal Center for Medicare and Medicaid Services.

Thursday, 3 January 2013

Painkiller epidemic was driven in part by drug makers' financial relationships with researchers who discounted the risks

For almost a decade, medical officials and experts claimed OxyContin rarely posed problems of addiction for patients. The drug's label, which was approved by the Food and Drug Administration, said addiction risks were small. Research published in the New England Journal of Medicine also said OxyContin wasn't addictive; so did a study in another journal, which OxyContin manufacturer Purdue Pharma reprinted 10,000 times. Since the drug first hit the market, it has fueled a large-scale swath of prescription pain killer addiction, beginning in Central Appalachia, that has grown into a national epidemic, especially in rural areas.

The epidemic was driven in no small part by doctors' lack of knowledge about OxyContin, which was perpetuated by the drug's manufacturer through false claims that became scientific consensus. But now, "Many in the medical profession have rediscovered the destructive power of opiates," and are calling that consensus into question, Peter Whoriskey of The Washington Post reports. "A closer look at the opioid painkiller binge, in which retail prescriptions have roughly tripled in the past 20 years, shows that the rising sales and addictions were catalyzed by a massive effort by pharmaceutical companies to shape medical opinion and practice."

Doctors were wary of prescribing painkillers to any patient except those with cancer for years. But manufacturers and some pain specialists "helped create a body of scientific research assuaging the long-standing worries about opioids and pushed to expand the use of the drugs in people with chronic pain: bad backs, arthritis, sore knees," Whoriskey reports.

Through an examination of key scientific papers, court documents and FDA records, the Post found that many of the studies claiming OxyContin wasn't addictive were supported by Purdue Pharma. The conclusions those studies reached were sometimes not supported by data, and when the FDA needed to develop an opioid policy, it turned to a panel of doctors who had financial relationships with Purdue Pharma and other drug makers. (Read more)