In the News for the Week of 7-25-06
- HIT Commission gives 'seal of approval' to 20 EHR systems
Clinical news in the headlines
- ACP Journal Club: Folic acid, vitamin B fail to reduce risk of major heart events
- New test automates blood screening for hepatitis B
- IOM shines spotlight on medication errors
Flu vaccine update
- Novartis planning state-of-the-art U.S. manufacturing plant
- Liability discount for Members who recertify
Health information technology
When deciding which electronic health records (EHR) system to buy for their practice, physicians can now look for a government-sanctioned “seal of approval.”
The Certification Commission for Healthcare Information Technology (CCHIT) last week released its first list of 20 certified ambulatory EHR products, said a July 18 CCHIT news release. CCHIT, a private, nonprofit group, was awarded $2.7 million in 2005 by the U.S. Department of Health and Human Services (HHS) to develop a set of standards and certify vendors who meet those requirements.
To become certified, products must meet 100% of CCHIT's criteria, including providing broad functionality, offering security features and the ability to eventually become interoperable with other systems. Its standards and certifications have been endorsed by ACP and many other professional medical organizations.
“CCHIT has simplified the selection process for physicians,” said ACP Executive Vice President and CEO John Tooker, FACP. “We believe our constituents—and the entire healthcare community—should look to certification to help ensure their EHR needs are met today and to lay the groundwork for future interoperability.”
Advocates of electronic health records hope that product certification will provide physicians and hospitals with the assurance they need to justify significant investments of time and money in new systems, said the news release. A list of CCHIT’s certified products is available online. Additional certifications will be announced at the end of July and quarterly thereafter.
The CCHIT news release is online.
Clinical news in the headlines
The findings of two large randomized controlled trials concluded that giving patients folic acid and vitamin B supplements to lower their plasma homocysteine levels did not reduce their risk of suffering major vascular events.
In one trial, called HOPE 2, 5,522 men and women age 55 or older with a history of heart disease or diabetes were randomly assigned to take either folic acid and vitamin B or placebo once a day. After a follow-up period of five years, patients who took the supplements had no reduced risk for myocardial infarction, stroke or death from cardiovascular causes compared with the placebo group.
In a second study, known as NORVIT, 3,749 patients between age 30 and 85 with acute MI in the past seven days were given folic acid and vitamins B6 and B12 in various combinations, or placebo. After a median of 3.3 years, there was no reduced risk of MI, stroke or death from heart disease in patients taking any combination of folic acid and vitamin B. The studies are abstracted in the July-August ACP Journal Club.
Even though patients who took the folic acid/vitamin B supplement had from 22% to 27% reductions in their plasma homocysteine levels, there was no benefit in terms of outcomes, said Journal Club reviewer Paul Shekelle, ACP Member, of the RAND Corp. in Santa Monica, Calif. These results are reinforced by two other large trails, he said, which also found that the intervention had no effect on reducing coronary events.
Similar to the Women's Health Initiative—which determined that postmenopausal hormone therapy did not prevent heart disease—these results highlight the importance of conducting large randomized controlled trials that measure clinical endpoints, said Dr. Shekelle. Only these highly rigorous trials, he suggested, produce the level of evidence needed for physicians to recommend therapies to patients.
Peer ratings for this review: general internal medicine, family practice, general practice, 7/7 stars; cardiology, neurology, endocrinology, 6/7 stars.
The FDA last week approved the first fully automated test to screen donated blood, organs and tissues for hepatitis B surface antigen (HBsAg), further improving safety of the nation’s blood supply.
The approval combines two tests by Abbott Laboratory, one that screens blood and the other that confirms the presence of the antigen in samples that tested positive, said a July 18 FDA news release. The new PRISM HBsAg test will automatically screen and confirm that blood samples are free of HBsAg. Automation reduces the potential for operator errors, according to the FDA.
The FDA news release is online.
Medication errors and preventable adverse drug events—which harm an estimated 1.5 million people each year—are still significant problems in the nation's hospitals, according to a report released last week by the Institute of Medicine (IOM).
For physicians, addressing the problem means completely embracing e-prescribing, dramatically improving the way they communicate with patients about medications and reassessing the practice of distributing free samples from drug companies, said a July 20 IOM news release. An estimated 400,000 preventable drug-related injuries occur each year in hospitals alone, resulting in at least $3.5 billion in extra medical costs this year alone, said the “Preventing Medication Errors" report.
The following were among the report's recommendations:
- Improve communication between health care professionals and patients
- Create consumer-friendly information resources to allow patients to obtain objective drug information, an effort that should be coordinated by the National Library of Medicine.
- Create a national telephone network to assist patients who cannot access or understand printed medication information.
- Implement electronic prescribing systems in all provider settings and pharmacies by 2010
- Improve the naming, labeling and packaging of drugs to reduce confusion
- Study the impact of distributing free drug samples—which bypasses standard drug-interaction checks and counseling—on overall medication safety
The IOM news release is online.
Read the FDA's guidance on how to create more useful consumer drug information online.
Flu vaccine update
Novartis has announced plans to build its first cell culture-derived influenza vaccine U.S. manufacturing plant. Construction will start in 2007 and the first doses of vaccine should be available by the end of the decade.
The vaccines, to be produced in Holly Springs, N.C., will use new cell-culture technology that is expected to result in a faster and more reliable production process than the existing egg-based technology, said a July 18 Novartis news release. The $600 million plant is being built with a $220 million grant from the U.S. Health and Human Services Department, which has been offering drug companies financial incentives to improve their ability to produce adequate supplies of flu vaccine.
Once completed, Novartis says the plant will produce up to 50 million doses of seasonal trivalent flu vaccine for sale in the U.S. each year. In case of an influenza pandemic, the plant will have the capacity to produce up to 150 million monovalent doses annually within six months of a pandemic declaration.
Novartis, a Swiss drug company, entered the vaccine business last year when it acquired Chiron Corp., which had already built a cell-culture flu vaccine plant in Marburg, Germany. Novartis said it will also expand capacity at that plant.
The Novartis news release is online.
There was some confusion over the discount available to ACP Members who purchase liability insurance through The Doctor's Company. The maximum discount available to Members who recertify is 10%—5% for recertifying and a 5% program discount. There is no additional discount for recertifying in both internal medicine and a subspecialty.
Information on The Doctor's Company program is online.
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A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?
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