In the News
for the Week of 9-30-08
- Drug companies go public with payments to physicians
- Anticholinergics linked to greater cardiovascular risk in COPD
- MKSAP quiz: worsening nasal symptoms
Prevention and screening
- Large colon polyps more common in blacks than whites, study finds
- Warfarin linked to larger intracerebral hematomas
- FDA orders companies to stop making unapproved eye washes, topical creams
- Hepatorenal syndrome, hepatic failure cases reported in erlotinib patients
- Filter must be used with sodium phenylacetate and sodium benzoate injection
- Financial incentives for EHR adoption on the rise
- Medicaid tamper-proof prescription requirements start Oct. 1
From the College
- International Council holds first meeting after Board of Governors' conference
- House introduces legislation to support primary care
From ACP Internist
- On the blog: extreme calorie restriction, Part D
- Update to flu vaccine insert
- Cartoon caption contest: September's winning entry
Drug companies go public with payments to physicians
Two drug companies last week announced plans to disclose publicly payments made to physicians for speaking and consulting services.
On Wednesday, the president and CEO of Eli Lilly and Company outlined the manufacturer's plans to launch an online registry of physician payments. The registry, which Lilly plans to launch during the second half of 2009, would include all 2009 payments made to physicians who serve as speakers or advisors for the company, a press release said. The listing would likely include doctors' names, or some other identifying information, and the reason for the payments, the Sept. 25 New York Times reported.
Merck then announced plans to expand its payment disclosures. In October, the company will begin posting grants made to patient organizations, medical professional societies and other organizations for professional education, including CME. At some point in 2009, payments to physicians who speak on behalf of the company's products will start, a press release said.
Both companies have endorsed pending federal legislation, the Physician Payments Sunshine Act, which would establish a national registry of payments made to physicians by medical device, supply and pharmaceutical companies. The bill was introduced by Sens. Charles Grassley (R-Iowa) and Herbert Kohl (D-Wisc.) in September, but is not expected to be taken up until next year, according to the New York Times.
The New York Times also reported other drug companies' responses to the announcements:
- Johnson & Johnson expressed support for a revised version of the Sunshine Act and plans to disclose educational grants by early 2009.
- AstraZeneca currently posts grants and nonprofit contributions, but has not made a decision on other areas.
- Pfizer supports the Sunshine Act.
Anticholinergics linked to greater cardiovascular risk in COPD
Inhaled anticholinergics (ipratropium bromide and tiotropium bromide) are associated with a significantly increased risk of cardiovascular death, myocardial infarction (MI) or stroke among patients with chronic obstructive pulmonary disease (COPD) according to a study in the Sept. 24 Journal of the American Medical Association.
Researchers conducted a meta-analysis that included 103 articles and 17 controlled trials enrolling 14,783 patients, with a follow-up duration ranging from six weeks to five years. Included trials involved any anticholinergic for treatment of COPD that had at least 30 days of treatment and reported on cardiovascular events. They found that cardiovascular death, MI, or stroke occurred in 1.8% (135 out of 7,400) receiving inhaled anticholinergics and 1.2% (86 out of 7,300) receiving control therapy, and that inhaled anticholinergics significantly increased the risk of MI and cardiovascular death. An analysis restricted to trials with a duration exceeding six months reported a significantly increased risk of cardiovascular death, MI and stroke with a ratio of 2.9% of patients treated with anticholinergics vs 1.8% of the control patients.
In related news, a recent Veterans Affairs study reported an increased incidence of cardiovascular death among those using ipratropium within six months of death compared with matched controls who had not had exposure to the anticholinergic in the same time period.
An industry-sponsored analysis of 30 placebo-controlled, double-blind, randomized trials with data from 19,545 COPD patients (tiotropium 10,846, placebo 8,699), contradicts the JAMA findings. This analysis demonstrates that there is no increased risk of death of any cause or death due to cardiovascular events or stroke in patients treated with tiotropium, nor is there any increased risk for MI associated with tiotropium. The assertion that there is no increased risk of stroke associated with tiotropium contradicts earlier industry data (supplied to the FDA) showing that in 29 placebo-controlled studies the estimated risk for stroke was 8 cases per 1,000 patients treated for one year with tiotropium, compared with 6 cases per 1,000 for patients taking placebo.
Authors of the JAMA study said clinicians should closely monitor patients for the development of cardiovascular events and carefully consider the potential long-term cardiovascular risks of anticholinergics. Benefits of inhaled anticholinergics for COPD include increased exercise capacity, reduction in the frequency of exacerbations, fewer hospitalizations, improvements in dyspnea sensation, and improvement in health-related quality-of-life.
MKSAP quiz: worsening nasal symptoms
A 37-year-old man is evaluated for frontal headaches, nasal congestion, and mucopurulent nasal drainage that have persisted intermittently for several years. He also has fatigue, a nighttime cough, and decreased sense of smell. Over the past four months, he has received three successive courses of antibiotics for worsening symptoms—initially with weeklong courses of trimethoprim–sulfamethoxazole and doxycycline. Most recently, he completed a three-week course of amoxicillin–clavulanate in combination with a nasal steroid inhaler, nasal saline irrigation, and an oral decongestant. This treatment regimen provided only partial relief. He has no history of allergic rhinitis, eczema, or drug allergy.
On physical examination, he is afebrile. The turbinates are edematous, with yellowish mucus between the right middle turbinate and lateral nasal wall. The septum is deviated to the right but with no nasal polyps. Percussion of his right maxillary sinus elicits mild tenderness.
Which of the following is the most appropriate management for this patient's condition?
A) Allergy testing
B) Nasal swab cultures
C) Sinus MRI
D) Sinus CT
E) Sinus radiography
Scroll to the bottom or click here to review the answer.
Prevention and screening.
Large colon polyps more common in blacks than whites, study finds
A large prospective study of black and white men and women who underwent colonoscopy screening found that blacks were more likely than whites to have polyps larger than 9 mm.
Using a database of 80,061 white and 5,464 black patients who received screening colonoscopy over a two-year period, researchers found that the presence of polyps more than 9 mm was 7.7% in blacks vs. 6.2% in whites. Compared with whites, the adjusted odds ratio was 1.16 for black men (95% confidence interval [CI], 1.01-1.34) and 1.62 for black women (95% CI, 1.39-1.89). In addition, proximal polyps more than 9 mm were more common after age 60 in all groups. The study appears in the Sept. 24 Journal of the American Medical Association.
The findings emphasize the importance of timely screening for black patients, the authors noted. Before the age of 50, black women have similar risk for large polyps to white and black men between age 50 and 60, suggesting that it may be beneficial to screen black women younger than age 50. However, they added that the sample of younger black women in the study was too small to be conclusive.
The results lend support to the American College of Gastroenterology's guidelines to start screening earlier in blacks, at age 45, compared with the American Cancer Society's recommendation of age 50 for average-risk patients, said an accompanying editorial. The primary care physician's role should be as advocate, the editorial continued, since lack of physician recommendations and patient awareness are major reasons that patients do not undergo recommended screenings.
Warfarin associated with larger intracerebral hematomas
A new study associates warfarin use with increased bleeding in the brain and higher mortality during hemorrhagic stroke.
The retrospective study included 258 Cincinnati-area patients who were hospitalized with intracerebral hemorrhage (ICH) in 2005. The volumes of the patients' ICH were measured on the first available brain scan using the abc/2 method. Of the 258 patients, 51 were taking warfarin. The researchers analyzed whether international normalized ratio (INR) influenced initial ICH volume.
The study found a trend toward a difference in hematoma volume by INR category. However, when broken down by INR category, the increased risk was only seen among patients with an INR greater than 3. Patients on warfarin who had a hemorrhage while their INR was above 3 had about twice as much initial bleeding as those not on the drug. Other predictors of larger hematoma were ICH location and shorter time from stroke onset to scan. The study was published in the Sept. 30 issue of Neurology.
Previous research has shown that warfarin users have higher than average mortality from ICH, and this research may explain why, a study author said in a press release. He noted that for most patients the goal INR is between 2 and 3. The results of the study show the importance of good monitoring and adjustment of warfarin dose, the author concluded.
Companies ordered to stop making unapproved eye washes, topical creams
The FDA last week gave companies until Nov. 24 to stop manufacturing and marketing unapproved ophthalmic balanced salt solutions (BSS) and topical drugs containing papain, due to reports of serious adverse reactions to the products, a news release said.
Providers should use only approved eye wash solutions made by Alcon Laboratories and Akorn, Inc. Unapproved solutions have led to eye inflammation, cloudy vision, and permanent loss of visual acuity. Contaminants were found in unapproved eye washes during product inspections, the FDA said.
Meanwhile, the topical creams containing papain can cause hypersensitivity reactions that lead to hypotension and tachycardia. There are no approved topical creams that contain papain, which is derived from the papaya plant and used to treat ulcers and wounds. Trade names for these unapproved products include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox; others are marketed under the names of the active ingredients, such as "papain-urea ointment," the FDA said.
The agency has received more than 300 reports of serious reactions to the eye washes, and about 40 reports on the creams, the Washington Post reported. Companies that violate the FDA order could face product seizures and injunctions, the FDA said..
Hepatorenal syndrome, hepatic failure cases reported in erlotinib patients
Patients with hepatic impairment who receive erlotinib (Tarceva) should be closely monitored during therapy, as hepatic failure, hepatorenal syndrome and fatalities have been reported in patients who used the drug, an FDA safety alert said.
Providers should also exercise extra caution when using the drug in patients with total bilirubin >3x ULN (upper limit of normal). Dosing should be interrupted or discontinued if liver function changes are severe, such as doubling of total bilirubin and/or tripling of transaminases when pretreatment values are outside the normal range.
Prescribing information has been revised to reflect these issues, the alert said. The new safety information comes from a study of 15 patients with advanced solid tumors and moderate hepatic impairment. Ten of the 15 patients died on treatment or within 30 days of the last erlotinib dose—eight from progressive disease, one from hepatorenal syndrome and one from rapidly progressing liver failure. Six of the 10 patients had baseline total bilirubin > 3x ULN suggesting severe, rather than moderate, hepatic impairment due to liver cancer, a manufacturer's letter said..
Filter must be used with sodium phenylacetate and sodium benzoate injection
Providers need to use a specific filter when preparing a sodium phenylacetate and sodium benzoate (Ammonul 10%/10%) injection, because the drug maker found particulate matter that could compromise the product's safety, an FDA safety alert said.
Providers should use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm) during the admixture process when injecting sodium phenylacetate and sodium benzoate into a 10% Dextrose IV bag. The filter must be used in all cases, regardless of whether particulate matter is visible.
Injection manufacturer Ucyclyd Pharma has confirmed through testing that using this filter will remove the particulate, and will package the filter with shipments of the injections until further notice, the company said in a letter to providers.
Financial incentives for EHR adoption on the rise
Incentives for physicians to adopt electronic health records (EHR) have grown to 90 programs representing at least $700 million in potential funding, the Certification Commission for Healthcare Information Technology (CCHIT) reported last week.
Of those 90 programs, 50 have been launched by hospitals in response to federal safe harbor regulations allowing hospitals to subsidize up to 85% of physician costs to acquire, implement and maintain CCHIT-certified EHRs, according to a Sept. 25 CCHIT news release. Another 40 programs are offered by government agencies, insurance plans, employer coalitions and public-private partnerships, the release added.
Examples of incentive programs include:
- Physicians participating in Bridges to Excellence's Physician Office Link, using CCHIT-certified EHRs, can earn up to $50 bonus per year for each patient who meet expectations of at least one clinical improvement program for conditions such as diabetes, and $125 per year for each patient treated under the medical home care model.
- The $150 million Medicare demonstration project provides incentives to 1,200 physician practices for using certified EHRs to improve care.
- New York City's Primary Care Information project has committed $60 million to physicians who work in high-poverty areas.
A complete list of incentives in the CCHIT Incentive Index is online..
Medicaid tamper-proof prescription requirements start Oct. 1
Medicaid prescriptions that are hand-written or printed from a computer application must contain at least one feature from each of three different categories of tamper-resistance, according to new CMS rules.
Previously, paper prescriptions only needed to contain one tamper-resistant feature. The new regulations require paper prescriptions to use at least one feature designed to prevent each of the following:
- unauthorized copying of a completed or blank prescription;
- the erasure or modification of information written on the prescription by the prescriber; and
- the use of counterfeit prescription.
CMS also clarified how to handle prescriptions printed from computers. Tamper-resistant paper is not necessary, as long as appropriate software and printer modifications are made.
The tamper-resistant regulation does not apply to prescriptions electronically transmitted to pharmacies via e-prescribing, prescriptions faxed to pharmacies, or prescriptions communicated to a pharmacy by telephone. The regulation also does not apply to beneficiaries who are enrolled in both Medicare and Medicaid, prescriptions to individuals in nursing and similar facilities, or state Medicaid programs which employ a managed care entity to pay for the prescription.
This Medicaid regulation stipulates the minimum standards for compliance and allows states to require more stringent standards. As these standards currently vary greatly by state, ACP recommends that members contact their state's Medicaid directors for more information.
From the College.
International Council holds first meeting after Board of Governors' conference
The ACP's International Council, established by the Board of Regents (BOR) in July 2008, met for the first time in Minneapolis at the end of the College's recent Board of Governors conference.
The purpose of the International Council is to provide strategic direction that will enable the College to actively participate in the international medical community and to consolidate and coordinate international leadership, input and direction for the College, and provide a direct link between international leadership and the BOR. The Council will work to ensure that the views and concerns of its international members are reflected in all College deliberations and discussions.
During the Board of Governors meeting, the Governors passed resolutions requesting that the Board of Regents do the following:
- Seek federal policy to direct the CMS to begin immediately-- and finish by Jan. 1, 2010-- rebalancing the disparity between reimbursement for evaluation and management codes and procedural codes.
- Seek legislation requiring Durable Medical Equipment (DME) companies to provide patients with information on costs as well as purchase and rental options; to supply patients with equipment prescribed by their physician; and to obtain approval from the prescribing physician if a substitution is required.
- Seek federal legislation or regulation that requires Medicare coverage for home infusion of antibiotics, including medication, administration, and monitoring services.
- Clarify how subspecialists will function within the Patient Centered Medical Home (PCMH).
- Provide seed grants to qualified chapters that will initiate, lead, design, collaborate and/or implement a PCMH demonstration project.
House introduces legislation to support primary care
Rep. Allyson Schwartz (D-PA) last week introduced the Preserving Patient Access to Primary Care Act (HR 7192) in the House of Representatives. The legislation is designed to help reverse the growing shortage of primary care physicians.
The College worked closely with Ms. Schwartz in crafting the new legislation, which addresses the reasons for the shortfall in access to primary care services in a comprehensive fashion. The legislation provides data showing the growing crisis in access to primary care and explains the critical role that primary care medicine plays in improving outcomes and reducing costs. The bill then outlines a series of different measures designed to help support the field of primary care.
- requires a study to recommend the designation of primary care as a shortage profession, as long as certain criteria are met;
- provides recruitment and retention incentives, through grants, scholarships, and loan forgiveness, to encourage medical students to choose careers in primary care;
- establishes measures to support and expand the patient centered medical home (PCMH) model of care, to ensure that practices are able to achieve the infrastructure and capability to provide patient-centered, physician-guided coordinated care; and,
- proposes improvements to payment systems under Medicare, to support, sustain, and enhance the practice of primary care.
A study published in September in the Journal of the American Medical Association reported that only 2% of 1,200 fourth-year medical students planned to go into primary care internal medicine. In a similar survey in 1990, the figure was 9%.
While the introduction of this legislation is an important signal that Congress understands the immediacy of the situation with primary care, the bill won’t be acted upon until 2009. Congress is expected to adjourn for the year shortly, and it is more than likely that this bill will not be acted on before that time. Ms. Schwartz has indicated that she will reintroduce the bill at the beginning of 2009 after Congress reconvenes. At that time the College also expects that Sen. Maria Cantwell (D-Wash.) will be introducing a companion piece in the Senate.
From ACP Internist.
On the blog: extreme calorie restriction, Part D
Extreme calorie restriction may be a basis for longevity in animals, but what effect does it have on humans? And a new study finds that those humans who live the longest, America’s seniors, are switching from brand-name drugs to generics when they reach Medicare’s “doughnut hole” and then switching back to brand names. These stories and Medical News of the Obvious every Monday on ACP Internist’s blog..
Update to flu vaccine insert
“It's flu season. Are you ready?” an insert in the September ACP Internist, omitted information on the following approved vaccine: Afluria (CSL Biotherapies); Presentations: 0.5 ml preservative-free pre-filled syringe single dose and 5.0 ml multi-dose vial. Age group: >18 years; Route: Intramuscular; Billing code: 90656 for preservative free single-dose flu vaccine. Members may order free Flu HEALTH TiPS for their patients at http://foundation.acponline.org/hl/htips.htm..
Cartoon caption contest: September's winning entry
ACP InternistWeekly has compiled the results from its latest cartoon contest, where readers are invited to match wits against their peers to provide the most original and amusing caption.
This issue's winning cartoon caption was submitted by Stephanie Streit, a third-year medical student at the University of Cincinnati College of Medicine. She will receive a copy of "Medicine in Quotations," ACP Press' comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history. Readers cast 290 ballots online to choose the winning entry. Thanks to all who voted!
The winning entry:
“It’s the 1920s. They’re calling about their head reflector.”
The winning caption received 45.5% of the votes cast. The runners-up were:
"It's Microsoft. They're worried about their virus." (36.6%)
"It's the residents. They're confused about their paycheck." (17.9%)
The cartoon contest continues in the Oct. 7 issue of ACP InternistWeekly..
D) Sinus CT
The complete MKSAP critique on this topic is available to subscribers in General Internal Medicine, Item 118.
ACP's Medical Knowledge Self-Assessment Program (MKSAP) allows you to:
- Update your knowledge in all areas of internal medicine
- Prepare for ABIM certification or recertification
- Support your clinical decisions in practice
- Assess your medical knowledge with 1,200 multiple-choice questions
To order the latest edition of MKSAP, go online.
Return to the rest of ACP InternistWeekly.
About ACP InternistWeekly
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Copyright 2008 by the American College of Physicians.
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