In the News for the Week of 3-2-04
- FDA orders bar codes for inpatient medications and blood supplies
- Medical liability bill fails in Senate
CMS nominee/drug reimportation
- ACP supports confirming CMS nominee who has a controversial stance on reimportation
Clinical news in the headlines
- FDA approves first angiogenesis inhibitor
- Highlights of the March 2 Annals of Internal Medicine
- Pulmonary hypertension increases risk of sudden death in sickle cell patients
- Proposed regulation would restrict FICA exemption for residents, teaching hospitals
- Concierge physicians establish new medical society
- College supports Senate bill to reduce racial disparities
- ACP joins coalition to name March as DVT awareness month
- Wanted: young physicians interested in networking at Annual Session
The FDA ordered drug companies and blood suppliers to add bar codes to their products within two years, a major step toward harnessing technology to prevent inpatient medication errors.
The ruling, which applies to thousands of prescription drugs as well as to some over-the-counter drugs and blood supplies intended for transfusion, has the potential to substantially cut the 7,000 deaths per year linked to inpatient medication errors, the Feb. 25 Washington Post reported. Hospitals favor the coding system but in the past have been slow to spend money on setting up computerized scanning systems because few drugs were packaged with bar coding.
A fully automated system would allow hospital nurses to scan both a patient's identification bracelet and prescriptions to ensure that they matched.
The Washington Post reported that Veterans Affairs hospitals have been using a bar code system since 1997. In one Veterans Affairs' study, a bar code system delivered more than 5 million prescriptions without a medication error, according to a Feb. 25 FDA press release.
The FDA said that newly-approved drugs must be packaged with bar codes within 60 days of being approved. Hospital officials said there are several hurdles to implementing bar code systems. For example, drug companies can still send products in bulk with one bar code instead of in individual packs, and hospitals can delay adopting systems if they decide the systems are too costly.
The FDA release is online at http://www.fda.gov/bbs/topics/news/2004/hhs_022504.html.
The Washington Post is online at www.washingtonpost.com/ac2/wp-dyn/A6995-2004Feb25.
The Senate last week failed to approve liability reform that would have imposed limits on noneconomic damage awards in medical liability cases arising from obstetric services related to childbirth.
The Senate voted down a procedural motion that would have ended debate on the legislation and allowed it to go to the full Senate for a vote, effectively killing the legislation. The vote largely followed party lines, with 48 senators voting against the motion and 45 voting for it, according to the Feb. 25 New York Times. Two Republican senators voted with a unanimous Democratic minority. ACP declined to take a position on the legislation because its narrow focus on obstetric care would have left out most services provided by internists.
Medical liability reform is part of the administration's tort reform agenda, with Senate Republicans claiming they will introduce another bill.
Last July, the Senate failed to pass a medical liability reform bill that had been approved in the House to limit noneconomic damages in malpractice cases to $250,000. Last week's bill targeted only obstetric services, with the hope that a narrower focus would allow the bill to be passed.
The New York Times is online at: http://www.nytimes.com/2004/02/25/politics/25MEDI.html.
CMS nominee/drug reimportation
The College last week urged U.S. senators to confirm internist Mark B. McClellan, MD, PhD, as the new administrator of CMS. Dr. McClellan's nomination has become controversial because of his stance against reimporting prescription drugs from Canada.
Several senators announced last week that they would stall Dr. McClellan's confirmation because of his strong opposition to drug reimportation. Dr. McClellan, who has been head of the FDA since November 2002, has repeatedly said that reimporting drugs from Canada and other countries is unsafe.
In a Feb. 26 letter sent to members of the Senate, ACP President Munsey S. Wheby, FACP, said it would be "highly unfortunate" if the nomination was blocked because of Dr. McClellan's stance on drug reimportation. In his letter, Dr. Wheby cited Dr. McClellan's efforts to reduce the cost of medications and halt the spread of counterfeit prescription drugs.
Prior to heading the FDA, Dr. McClellan was a member of the president's Council of Economic Advisors. He also served in the Clinton administration as a deputy assistant secretary of the Treasury.
According to the Feb. 26 New York Times, the administration last week announced that it would conduct a study into the issue of reimported drugs. It angered critics, however, by appointing Dr. McClellan to head that study, because of Dr. McClellan's opposition to reimportation.
New York Times coverage is online at http://www.nytimes.com/2004/02/25/politics/25GOVS.html and at http://www.nytimes.com/2004/02/26/politics/26DRUG.html.
A College press release on ACP's support of Dr. McClellan is online at http://www.acponline.org/college/pressroom/mcclellan.htm.
In related news, poll results published last week found that almost two-thirds of poll participants said the government should make it easier to buy cheaper drugs from Canada and other countries. According to the Feb. 24 Associated Press, the poll of 1,000 adults also found that one-third of respondents find it difficult to pay for prescription drugs and many cut drug dosages as a result. Almost half of those polled said the high cost of prescription drugs would be a "very important" issue in the presidential campaign.
The Associated Press is online at http://www.nytimes.com/aponline/health/AP-AP-Poll-Prescription-Drugs.html.
Clinical news in the headlines
The FDA last week approved the monoclonal antibody bevacizumab (Avastin) as a first-line treatment for metastatic colorectal cancer.
The milestone approval marked the culmination of several decades of research aimed at fighting cancer by preventing angiogenesis, the process by which new blood vessels are formed to supply nutrients to solid tumors. Part of a new wave of "targeted" cancer therapies, bevacizumab inhibits a protein that promotes the growth of new blood vessels. It is the first angiogensis inhibitor to be approved.
According to a Feb. 26 FDA press release, the drug in combination with chemotherapy was found to extend the life of colorectal cancer patients an average of five months and prevent the regrowth of tumors for an average of four months.
The drug should be available to physicians within days, according to the Feb. 27 Washington Post, which said the drug—manufactured by Genentech—could cost as much as $40,000 a year. Like other targeted therapies, the drug has fewer side effects than standard chemotherapy drugs. However, because tumors can become resistant to targeted therapies, researchers want to find effective drug combinations using bevacizumab and other new cancer therapies.
The Washington Post also reported that bevacizumab's effectiveness against other cancers is now being tested and that more than 70 angiogenesis inhibitors are now in clinical trials.
The FDA press release is online at http://www.fda.gov/bbs/topics/NEWS/2004/NEW01027.html.
The Washington Post is online at http://www.washingtonpost.com/ac2/wp-dyn/A10689-2004Feb26.
For more on targeted therapies, see "In cancer treatment, targeted therapies are giving physicians and patients hope" in the December 2003 ACP Observer at http://www.acponline.org/journals/news/dec03/cancer.htm.
The following articles appear in today's Annals of Internal Medicine. The full text of the issue is available to College members and subscribers online at http://www.annals.org?wkly.
Antibacterial products don't reduce symptoms of infections. A study has found that using antibacterial household cleaning and personal hygiene products does not reduce the risk of infectious disease symptoms in healthy patients. Researchers followed more than 220 urban households, with some using household products with antibacterial ingredients, while others did not. Researchers found no significant difference between the two groups in symptoms of fever, cough, diarrhea and vomiting. An accompanying editorial said the best way to prevent the spread of infections is to cover the mouth and nose when coughing and to wash hands frequently. http://www.annals.org/cgi/content/full/140/5/321
Insufficient evidence to recommend for or against family violence screening. The U.S. Preventive Services Task Force has issued updated recommendations, saying the group found insufficient evidence both for and against recommending routine screening for family violence, including physical abuse, partner violence and elder abuse. The Task Force pointed out that no studies have been done that address the potential harms of screening and interventions, although they urge clinicians to be alert to physical and behavioral signs of neglect or abuse. http://www.annals.org/cgi/content/full/140/5/387
A study released last week found that high blood pressure in the lungs is a major risk factor for sudden death in adults with sickle cell disease. The study's authors recommended that all patients with the disease be screened for pulmonary hypertension.
Researchers followed 195 sickle cell patients, with an average age of 37, for two years. They found that almost one-third of those patients—32%—had mild to severe pulmonary hypertension that had not previously been detected.
Of those patients, 20% died after 18 months, while only two of the 128 patients without pulmonary hypertension died. Quoted in the Feb. 26 New York Times, the study's authors said that pulmonary hypertension appeared to be the "No. 1 predictor" of sudden death in sickle cell patients. The study appeared in the Feb. 26 New England Journal of Medicine (NEJM).
The authors also suggested studying patients with thalassemia and other kinds of anemias caused by red-cell destruction to see if those patients run an increased risk of pulmonary hypertension. Researchers also recommended further studies, including trials with warfarin, transfusion and pulmonary vasodilator medications, to find interventions to reduce mortality from pulmonary hypertension in sickle cell patients.
Sickle cell disease affects 80,000 patients in this country, the New York Times reported.
An NEJM abstract is online at http://content.nejm.org/cgi/content/extract/350/9/857. (Full text is available only to subscribers.)
The New York Times is online at http://www.nytimes.com/2004/02/26/health/26SICK.html.
In a potential defeat for academic medical centers and teaching hospitals, the IRS last week proposed severely limiting the number of resident physicians who would be eligible for exemption from Federal Insurance Contributions Act (FICA) taxes.
The proposed regulation would clarify the student employment exemption under FICA. FICA now requires employers to deduct—and pay themselves—7.65% of employees' wages to fund Social Security and Medicare.
Beginning in 1997, academic medical centers and teaching hospitals have sought exemptions from paying FICA taxes for residents, claiming residents are students and not employees, according to the Feb. 26 Modern Physician. More than 225 organizations have sought more than $160 million in FICA refunds, with potential refunds also being available to individual residents.
The IRS' proposal says the exemption should apply only when education, not employment, dominates the relationship between resident and employer. A resident would be considered an employee, for example, if he or she works more than 40 hours per week and needs a license to work.
A process for resolving outstanding FICA appeals will be announced within 90 days. Comments on the proposed regulation are due May 25 while a public hearing on the issue will be held June 25.
Modern Physician is online at http://www.modernphysician.com/news.cms?newsId=1844
Physicians who have established concierge or "boutique" medical practices have now formed a new medical society to support clinicians who adopt the practice model.
The American Society of Concierge Physicians (ASCP) is a new, Michigan-based nonprofit that will provide advocacy and act as an information clearinghouse for physicians who practice concierge medicine. The concierge business model entails charging individual patients retainer fees—often several thousand dollars a year—in exchange for guaranteed access and more personalized medical service.
The group will hold its first national conference on May 27-28 in Denver, according to a Feb. 23 ASCP press release. While the business model encompasses only a small percentage of practicing physicians, concierge medicine is now being practice by about 200 groups, ASCP said.
Although concierge practices have been criticized for limiting patients' access to care, many physicians who adopt the model appreciate being able to see fewer patients, having no managed care restraints and spending more time with patients.
More information about ASCP is online at http://www.conciergephysicians.org.
In a letter sent last week to several U.S. senators, the College expressed support for the Closing the Health Care Gap Act of 2004 (S. 2091), a bill that seeks to eliminate racial and ethnic health care disparities.
In his Feb. 26 letter, College President Munsey S. Wheby, FACP, said that the bill would help alleviate some of the problems faced by minorities, such as limited access to quality health care. The bill establishes priorities such as increasing access to care, improving the competence of providers and creating a more diversified medical workforce.
The College supports the creation of grants to educate minorities about health care options and encourage enrollment under Medicaid and SCHIP. However, legislation should go further and guarantee coverage to all low-income individuals to eliminate health care disparities, Dr. Wheby said.
The College praised the bill's emphasis on research and data collection to identify disparities in quality of care. The legislation would also provide for strong national leadership by making the Office of Minority Health permanent within HHS.
The College's letter is online at http://www.acponline.org/hpp/s2091.htm.
More than 30 organizations, including ACP and the Society of Hospital Medicine, have formed a coalition to raise awareness of the dangers of deep-vein thrombosis (DVT). The coalition has designated March as the first annual Deep-Vein Thrombosis Awareness Month.
DVT strikes as many as 2 million patients annually in the United States, while one of its primary complications—pulmonary embolism—may cause as many as 200,000 deaths every year. While DVT symptoms include pain, tenderness or swelling, as many as half of all DVT episodes have few or no symptoms.
As part of the awareness month campaign, the coalition intends to air public service announcements, as well as launch local and national information initiatives.
For more information, see the coalition's Web site at http://www.preventdvt.org/.
The College's Young Physicians Subcommittee invites young internists attending this year's Annual Session to network and get advice from experienced colleagues during a breakfast meeting on Friday, April 23 in New Orleans.
Mentors at the breakfast meeting will offer personal guidance on topics such as balancing career and family, changing careers, women physicians' issues, academic medicine and starting a new practice. There is no charge for the breakfast, but interested attendees are asked to pre-register by April 2, 2004.
More information is available at http://www.acponline.org/private/committees/yps/ment_break04.htm. (Free registration on ACP Online is required.)
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Copyright 2004 by the American College of Physicians.
A 55-year-old man is evaluated in follow-up after a recent routine screening for antibody to hepatitis C virus (HCV) was positive. His medical history is unremarkable; he has not used illicit drugs or had any history of blood transfusions. He currently feels well and takes no medications. Following a physical exam and lab studies, what is the most appropriate diagnostic test to perform next?
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