In 1999, a report from the Institute of Medicine (IOM; Washington) titled To Err is Human: Building a Safer Health System sent shock waves through the U.S. medical community with its estimate that medical errors may cause 98,000 deaths each year in America's hospitals. Last month, in a direct response to that report, the Agency for Healthcare Research and Quality (AHRQ; Washington) unveiled its own study, offering the initial recommendations as potential correctives to the many errors that take place. At a National Press club gathering AHRQ introduced the 640-page report, titled Making Health Care Safer: A Critical Analysis of Patient Safety Practices, offering some immediate proposals for reducing adverse events in treating patients and laying out the main paths for future research in these areas.

However, rather than saying the proposals were quick-fix prescriptions, AHRQ Director John Eisengerg, PhD, said that any strategy for reducing hospital errors can't be based on a set of specific behaviors but rather, will require a new "culture of safety." This new culture, he said, ought to be driven by a system of management that, like modern clinical practice, will be more "evidence-based."

He called the strategy "a different kind of evidence-based approach ... that evaluates management of health care as rigorously as clinical management." And he called on all sectors of the health care industry to translate the recommended practices into action to produce this new health care culture, primarily in hospitals but in all other health care venues as well.

Overall, the report looks at 73 practices that AHRQ's research indicated might reduce medical errors, identifying 11 of these as most effective and most capable of being implemented. But Eisenberg several times indicated that these practices should be seen through "the lens" of the particular facility and adapted only as applicable. Additionally, he noted that the report stopped short of making recommendations where researchers felt there was limited evidence on a topic, emphasizing that these areas offer opportunities for further research and evaluation. "These conclusions," Eisenberg said, "are about what the evidence says. They will be converted into decisions by people who work in health care institutions with a culture of safety."

Eisenberg called the development of the new AHRQ report as a first step in laying the evidence-based foundation for addressing concerns in the IOM's 1999 report. The next steps, he said, would be further research, with the AHRQ contributing up to $50 million in new funding to pursue the research paths identified in the report.

Some of the top 11 suggestions for greater health care safety focus on better ways to employ pharmaceuticals and devices, and thus may translate to additional costs for hospitals. One of these is the increased use of computerization for prescribing and order-entry tasks, and thus will require a cost-benefit analysis. But other practices suggested by the report would require only changes in behavior, for instance, requiring care givers to ask patients to "recall and restate what they have been told during the informed consent process."

Besides this recommendation, of the 11 practices rated as most effective for improving patient safety, four relate primarily to changes in the use of drug regimens, four relate primarily to the use of devices or materials, one relates to a drug/device combination (specifically, the use of antibiotic-impregnated central venous catheters), and one relates to improved nutrition, emphasizing early enteral nutrition in critically ill and surgical patients.

Greg Meyer, MD, director of AHRQ's Center for Quality Improvement and Patient Safety, noted that the suggested practices should not be considered as independent activities but rather as part of larger systems that need to be put in place. They should, he said, "require us to think about how we can build in systems to make sure that the care is provided safely."

During a question-and-answer period, several questions focused on nurse staffing, an issued not referred to in the list of the top 11 safest practices.

In response, Eisenberg said that the study had failed to find a preponderance of evidence on nursing issues related to patient safety. But he granted the importance of nurse staffing patterns and said the report laid the groundwork for addressing the types of organizational changes necessary to carry out the safe practices recommended.

Bush echoes Medicare complaints

President George Bush last month unveiled his long-awaited plan for seniors to buy prescription drugs at reduced prices and – certainly more importantly to medical technology companies – called for a restructuring of Medicare. Bush called Medicare a "binding commitment," but said that its current funding structure "doesn't make sense" and that its costs are rising too fast. He added that, as medicine advances and the needs of seniors are changing, "Medicare too must advance and it too must change."

That undoubtedly came as music to the ears of the associations representing the medical device and broader biotech industries, especially since Bush backed his call for reform with arguments honed over the past two years by the major industry groups. "We need to bring Medicare into the 21st century, to expand its coverage, improve its services, strengthen its financing and give seniors more control over the health care they receive," the president said. While Bush said his first priority was a prescription drug plan, he identified greater efficiency by the Medicare system as his ultimate goal. "Today, hardly a day goes by without news of an exciting development," he said. "Yet Medicare takes way too long to authorize new treatments." And he said that the government must act to ensure that the next generation of medical technology "is readily available to America's seniors."

The Advanced Medical Technology Association (AdvaMed; Washington) praised Bush's commitment to reducing delays in giving Medicare patients access to innovative technology. "The president's comments today underscore the importance of reducing delays of 15 months to five years in Medicare patients' access to new technologies," AdvaMed President Pamela Bailey said. AdvaMed said it also supports broader reforms to the Medicare program to give consumers the ability to choose among a range of competing health plans, as well as the traditional Medicare program, an issue that was touched on in Bush's presentation. "Consumers who are empowered to choose among competing health plans will make sure they have access to the high-quality, innovative medical technologies and procedures they need," Bailey said.

Stephen Northrup, executive director of the Medical Device Manufacturers Association (MDMA, Washington), said, "When the president says, 'we need to modernize Medicare so that we can get new technologies to seniors,' I support that 100%. What's important is that if there is going to be [any] privatization of the industry there should be competition." He added, "Turning Medicare into a private monopoly isn't going to do much good – it's already a private one." Northrup told The BBI Newsletter that competition within the industry could be beneficial. "That will encourage health plans to incorporate the newest technologies and procedures and services into their benefits packages."

The news of Bush's proposed pharmacy discounts, not unsurprisingly, met with mixed reviews from the medical field. The Pharmacy Benefits All Coalition (Alexandria, Virginia) called Bush's plan "the wrong prescription to curb rising prescription drug prices for seniors." The organization said the plan offers false hopes for Medicare recipients.

Craig Fuller, president and CEO of the National Association of Chain Drug Stores, a member of the coalition, said that the Bush plan doesn't address the pharmaceutical industry's primary issue: "We need a pharmacy benefit that addresses the real problem, the rising cost of prescription drugs." The coalition went on to say that the proposed program would do nothing to reduce the prices that pharmacies are charged by the drug companies for the medications. They say these charges represent about 78% of the average prescription price.

Backing Bush's plan was the Pharmaceutical Care Management Association (PCMA; Arlington, Virginia). That group "continues to support any plan that moves toward our goal of offering [seniors] the same quality, convenience and cost effective pharmaceutical care coverage that is currently offered in the private," said LaVerne Burton, PCMA president.

Gartner urges delay of HIPAA

U.S. health care is on a collision course with the deadline for compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations and it isn't prepared, according to a new survey just issued by Gartner (Stamford, Connecticut), a health care research and consulting firm.

Citing a massive lack of industry readiness, Gartner has called for a one-year extension of the deadline – to October 2003 – saying that the additional year would allow health care organizations "enough time to implement standardized electronic data interchange [EDI] transactions" and therefore meet the HIPAA requirements.

The company has released a new study and survey of the industry's HIPAA preparedness and reports that 85% of providers have not yet completed the assessments or gap analyses considered necessary for reaching compliance with the regulations.

Spine Arthroplasty Society organizes

A new global medical society is being formed for physicians and scientists involved in the advancement of spinal arthroplasty as a means of restoring mobility and comfort in spine function. The Spine Arthroplasty Society (SAS) opened a membership drive last month from offices in New York and said it expects to initially attract upwards of 800 members.

Charles Ray, MD, chairman of SAS, said: "This is a big step forward for those of us who view spine arthroplasty as a major evolution in surgery to more effectively attack what most of world knows as 'back pain.' This society is committed to finding a cure, not just temporary relief."

The decision to form the society was initiated last year and confirmed earlier this year during a three-day symposium on spine arthroplasty in Munich, Germany, attended by 450 physicians and spine care industry representatives. Steven Lapp, executive director of the organization, said that membership would be open to all qualified physicians and scientists "whose common cause is the advancement of spine arthroplasty and other non-fusion technological advancements."

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