In the News for the Week of 10-10-06
- Government eases restrictions on prescriptions mailed from Canada
- Flu vaccine update
- CMS releases 2007 Part D plan information
- ACP Journal Club: Fondaparinux works as well as enoxaparin with less risk of bleeding
- Ranibizumab improves wet age-related macular degeneration
- CDC fellowships for medical students
- ACP President responds to Institute of Medicine reports
- ACP International Update in Mexico City
- New edition of ICD9 codes available
The federal government will no longer seize small amounts of prescription drugs mailed from Canada, U.S. Customs and Border Protection officials announced last week. The new policy, effective Oct. 9, is a reversal of the government's prior practice of intercepting and destroying the drugs.
Enforcement of the standing regulations against prescription imports will be turned over to the FDA, which held this responsibility until November 2005. The FDA had generally not applied import restrictions to small personal mail orders, unlike Customs officials, who seized 40,000 packages over their 11 months of enforcement, according to the Oct. 5 Washington Post. Customs officials destroyed the packages and notified intended recipients by mail that the purchases violated laws against importing drugs.
Mail-order drug imports are still illegal; however, FDA officials quoted in the Oct. 4 New York times offered assurances that the agency will not act on small individual drug shipments. Customs officials will continue to intercept suspected counterfeit medicines, narcotics and illegal drugs.
The policy change was made in response to Congressional and public pressure, FDA officials told the New York Times. A week earlier, Congress passed legislation allowing Americans traveling from Canada to bring in a 90-day supply of prescription drugs for personal use.
The Washington Post is online.
The New York Times is online.
More than 100 million doses of the flu vaccine are expected to be produced and distributed between now and January 2007, according to the CDC. That would be at least 17 million more doses than has ever been distributed in the past (the previous high was 83.1 million doses in 2003).
The CDC's recent statement said that manufacturers will distribute about 75 million doses by the end of October, an increase of about 15 million over the number of doses distributed by the end of October 2005. If vaccine produced in Canada is licensed for distribution in the US, there may be more than 110 million doses available. Because the supply projections are robust, the CDC is not recommending any tiering on vaccination this season.
The supply also will be supplemented by last week's FDA approval of a fifth flu vaccine. The new vaccine, sold under the brand name Flulaval, is indicated for active immunization of adults and is produced by a subsidiary of GlaxoSmithKline. In the Oct. 5 New York Times, company officials said that they expect to produce 25 million doses of the new vaccine this season.
To aide in the visibility of vaccine distribution, the CDC will be providing jurisdiction-specific reports of vaccine distribution data to state and local public health officials. The CDC is working closely with the manufacturers and distributors of influenza vaccine to provide distribution information on a weekly basis throughout flu season. The information provided includes the zip code of the entity to which the vaccine was shipped, product type, number of doses and provider type.
Again this year, the American Lung Association and Maxim Health Systems will offer their national Flu Clinic Locator for both influenza clinics and persons seeking a vaccination. Healthcare providers interested in advertising their clinics can register on the program's website.
The CDC release is online.
Registration for the Flu Clinic Locator is online.
The New York Times is online.
On Sept. 29, the Centers for Medicare and Medicaid Services (CMS) released information on the cost, coverage and convenience (pharmacy and mail-in options) of drug plans that have been approved to provide Part D services beginning Jan. 1, 2007.
The information indicates that the average monthly premium for the 2007 benefit will remain the same as in 2006 at $24. Furthermore, beneficiaries will have more plan options that provide coverage throughout the doughnut hole period, with a majority of such plans offering monthly premiums below $50. Finally, CMS indicated that most low-income beneficiaries who currently receive a supplement to pay for this coverage, including "dual eligibles" who were auto-enrolled in plans in 2006, will be able to keep their current plans for a zero-dollar premium if they were satisfied with their coverage.
The open enrollment period for 2007 runs from Nov. 15-Dec. 31, 2006. A list of all 2007 approved Part D plans and related information divided by geographic area is online.
Fondaparinux works as well as enoxaparin with less risk of bleeding
A recent trial concluded that enoxaparin and fondaparinux are equally effective in preventing nonfatal myocardial infarction(MI) in patients with unstable angina or non-ST segment elevation MI, but that fondaparinux may have lower risk for major bleeding.
In the randomized controlled trial, researchers followed more than 20,000 patients for six months who met at least two of the following criteria: age 60 or older, high troponin or creatine kinase MB isoenzyme levels, or electrocardiographic changes indicating eschemia. Patients were given either 2.5 mg of fondaparinux or 1 mg/kg of body weight of enoxaparin twice daily, or placebo.
Both drugs were effective in reducing the composite endpoints of death, MI and refractory ischemia, but fondaparinux was associated with lower bleeding risk. The study is abstracted in the September-October ACP Journal Club.
It is not surprising that fondaparinux was associated with less bleeding in this trial because a "DVT prophlaxis" dose of fondaparinux was compared with a "therapeutic" dose of enoxaparin, said Journal Club reviewer David Massel, MD, of the London Health Sciences Center in London, Ontario. The two drugs, while similarly effective in reducing death or MI, both had potential downsides, he added. Fondaparinux was associated with excess catheter-related thrombus while enoxaparin was associated with major bleeding, especially in patients older than age 65.
Fondaparinux should be used in patients with ACS, said Dr. Massel. Its once-daily fixed dose reduces the chance of dosing errors and it is less expensive than enoxaparin. However, fondaparinux may be most appropriate for patients with lower-risk ACS because of the potential for catheter-related thrombus.
Peer ratings for this review: Emergency medicine, hospitalists, cardiologists: 6/7 stars. General internal medicine/ family practitioners/ general practitioners: 5/7 stars.
ACP Journal Club is online.
Two newly published studies, found that injections of ranibizumab could prevent vision loss and improve mean visual acuity in patients with neovascular (wet) age-related macular degeneration. Both studies were two-year, double-blinded, multicenter trials.
In the first study, 716 patients with either minimally classic or occult choroidal neovascularization received 24 monthly intravitreal injections of ranibizumab or sham injections. The researchers found that over the course of the study, the average patient receiving ranibizumab gained more than one line of visual acuity, while the average patient receiving sham injections lost more than two lines. The studies appear in the Oct. 5 New England Journal of Medicine.
The other study, of 423 patients with predominantly classic choroidal neovascularization, evaluated two different doses of ranibizumab, compared with photodynamic therapy. The study found ranibizumab to be superior to verteporfin, with the average ranibizumab patient gaining about two lines of acuity in a year, compared with a loss of two lines in verteporfin patients.
While lauding the results of the study, an accompanying editorial suggested that more research is needed to determine whether effective results could be obtained with fewer injections. The editorial also discussed the findings of several small studies which found bevacizumab to be a reasonably safe, effective treatment for macular degeneration. Given the significantly lower cost of bevacizumab, a head-to-head study of the two drugs is probably the most useful next step, the editorial said.
Immediately after the studies' publication, the National Eye Institute, of the National Institutes of Health, announced that it would finance such a study. In the Oct. 6 New York Times, NIH officials said the head-to-head trial would cost about $16 million and involve 1,200 patients, who would be divided into four groups. Over the two-year study, one group will get ranibizumab injections every four weeks and another bevacizumab at the same intervals. Patients in the other two groups will get either treatment on an as-needed basis in an effort to see whether vision can be adequately maintained with less frequent injections.
The New York Times is online.
The Centers for Disease Control and Prevention is looking for rising third and fourth-year medical students who want to explore applied epidemiology. The CDC Experience is a one-year fellowship designed to increase the pool of physicians with a population health perspective. Eight competitively selected fellows spend 10-12 months at CDC offices in Atlanta, where they carry out epidemiologic analyses in areas of public health that interest them.
Projects range from investigating outbreaks of tuberculosis among the homeless, to investigating an outbreak of leptospirosis among adventure racers in a Florida swamp, or assessing risk factors for reproductive-health visits to emergency departments. CDC's environment provides multiple opportunities to enhance skills in research and analytic thinking, written and oral scientific presentations, and preventive medicine and public health. All fellowship assignments offer opportunities to complete epidemiologic analyses which may lead to scientific publications.
Experience in public health is not required to apply for this program. CDC staff will help fellows acquire practical tools useful for approaching population-based health problems. The first class of fellows entered in 2004; graduates have followed varying paths--residencies in clinical specialties, even anesthesia and orthopedics. Applications for next year's fellowship class must be postmarked by Dec. 4, 2006.
Information and applications are online.
On Sept. 25 and 30, ACP President Lynne M. Kirk, FACP, sent letters to the Institute of Medicine (IOM) to provide ACP's perspective on two new reports.
In reaction to the IOM's "Rewarding Provider Performance: Aligning Incentives in Medicare" report, released on Sept. 21, Dr. Kirk agreed with the assertion that physician payment under Medicare is broken and a pay-for-performance program could be one way to improve the situation. However, she went on to say that while the program could transform the payment system, any program must be carefully designed since it would influence many things beyond payment.
In her Sept. 30 letter, Dr. Kirk commented on "Preventing Medication Errors," a report that IOM report released in July as part of their Quality Chasm series. Dr. Kirk noted that the degree of medication errors seen in the IOM report is unacceptable, and agreed with the report that a series of strategies needs to be implemented in order reduce the number of medication errors.
"What is most striking about the magnitude of medication errors made evident by the IOM is that these errors are preventable," said Dr. Kirk. "While most errors can be prevented, we will not find a real solution until the culture of medicine changes. . . ACP continues to encourage its members to let go of the notion of individual physician control in favor of a team-based approach and enhanced health care system accountability."
Registration is now open for the second annual ACP International Update, to be held on March 9-10, 2007 in Mexico City. The Update is a two-day scientific meeting presented by the College and the LiveMed Institute, a continuing medical education provider based in Mexico City. The 2007 meeting builds on the success of last year's International Update, which brought over 1,100 physicians to Mexico City, with an additional 450 physicians participating by live satellite broadcast to seven locations throughout Mexico.
The 2007 meeting will be held in the World Trade Center, Mexico City's state-of-the-art meeting facility conveniently located near major hotels and cultural attractions. Expert faculty from the United States and Latin America will present concise updates of evidence-based recommendations for the treatment of common medical conditions and acute illnesses seen on both sides of the border. This intense two-day program will help practitioners integrate current recommendations into day-to-day patient care. Sessions will be simultaneously translated into English and Spanish.
A total of 2,000 physicians are expected to attend the meeting--1,300 on site and another 700 connected by satellite broadcast from cities in Mexico and other Spanish-speaking countries. As was the case last year, approximately 90% of the audience will be from Mexico and other Latin American countries.
Attendees who register before Oct. 31 will receive a $50 discount.
Registration and information are online.
The College's Practice Management Center has revised its popular product, "Commonly Used ICD9 Codes." This single page, two-sided laminated sheet lists the ICD-9 codes that are most commonly used by internists. The codes appear in alphabetical order within disease categories. The new ICD-9 codes are effective Oct. 1, 2006 through Oct. 1, 2007. The code sheets can be used in examination rooms for easy reference.
One copy of the new codes is available free to ACP members. For nonmembers and additional copies, the cost is $3 per card. The commonly used codes are also available from the College's PDA Portal for download to your PDA.
Members can also extract codes from the Microsoft Word version of Commonly Used ICD-9 Codes. This document provides your practice with a tool to create a shorter list of codes, or it can be formatted to be incorporated into your practice's computer system.
To order laminated copies of the codes, call ACP Customer Service at 800-523-1546, extension 2600 or 215-351-2600 (M-F, 9 am - 5pm ET).
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Copyright 2006 by the American College of Physicians.
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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