In the News for the Week of 9-18-07
- New studies analyze risks and benefits of diabetes drugs
- U.S. life expectancy hits record high
- Drug-related injury, death reports to FDA nearly tripled in eight years
- CMS releases further guidance on tamper-resistant prescription pads
- Infection control measures inadequate in many hospitals, survey finds
- Annals of Internal Medicine:
- Aerobic and resistance exercise improved blood sugar control in people with diabetes
- ACP: Set blood sugar targets for people with diabetes
- Drugs dangerous to fetuses often prescribed to women of childbearing age
- Joint panel backs aprotinin, votes against anemia drug restrictions
- Ceftriaxone shouldn’t be mixed with calcium solutions, products
- Higher education associated with lower cancer mortality
- U.S. nursing homes segregated by race, study finds
- ACP releases new paper on state initiatives to expand health care
- New book from ACP on health needs of sexual and gender minorities
- Associate and Medical student abstract competition
- Cartoon caption contest: Put words in our mouth
Correction: Doctors' communication skills predict patient complaints
Two meta-analyses released last week add to the growing array of data on the cardiovascular effects of diabetes drugs rosiglitazone and pioglitazone.
The meta-analysis of rosiglitazone included four studies of 14,000 people and concluded that use of the drug for at least 12 months was associated with a significantly increased risk of myocardial infarction (MI) and heart failure, but the study did not find a significantly increased risk of cardiovascular mortality compared with controls.
The second meta-analysis used a database of 19 trials involving 16,000 patients provided by the manufacturer for independent analysis. Researchers found that pioglitazone was associated with a significantly lower risk of death, MI or stroke than controls. The drug did increase serious heart failure, although without an associated increase in mortality.
Authors of both analyses noted that it is unclear why the drugs—both thiazolidinediones—have such different effects on cardiovascular outcomes. The authors of the pioglitazone research concluded that the net clinical benefit of therapy with the drug is favorable. In their view, the reduction in irreversible ischemic events is not attenuated by the risk of more frequent heart failure complications.
The authors of the rosiglitazone analysis said that their research suggests a reversal of the benefit-to-harm balance that led the FDA to approve the drug. They propose that regulatory agencies reevaluate whether the drug belongs on the market. Physicians should not wait for a government decision, the authors advised, and should avoid prescribing the drug for patients who are at risk of cardiovascular events. Both meta-analyses were published in the Sept. 12 Journal of the American Medical Association.
Life expectancy in the U.S. has hit a new record, with children born in 2005 expected to live almost 78 years, according to a new preliminary report from the CDC’s National Center for Health Statistics.
The increase follows a long-running trend, CDC officials said, with life expectancy up from 69.6 years in 1955 to 75.8 in 1995 and 77.9 in 2005. The age-adjusted death rate also fell, dropping below 800 deaths per 100,000 population for the first time ever. Death rates for the three leading causes of death in the U.S.--heart disease, cancer and stroke--also declined between 2004 and 2005. However, the overall number of deaths increased, a change that health officials attributed to an unusually mild flu season in 2004, the Sept. 13 Washington Post said.
The age-adjusted death rates for Alzheimer’s disease and Parkinson’s disease both increased about 5% between 2004 and 2005. The preliminary figures also indicate a slight increase in the U.S. infant mortality rate from 6.79 per 1,000 live births to 6.89, but CDC officials said the difference was not statistically significant.
Women continue to outlive men, surviving an average of 5.2 years longer, but that is the smallest gender gap reported since 1946, according to the Sept. 12 Washington Post. The statistics also reported continuing racial disparities in life expectancy. Between 2004 and 2005, the life expectancy of white Americans held steady at 78.3 years, while for blacks it increased from 73.1 to 73.2.
A press release on the CDC report is online.
Reports of drug-related deaths and injuries to the FDA increased nearly three-fold from 1998 to 2005, the Sept. 10 Archives of Internal Medicine reported.
Voluntary reports of serious drug events to the FDA’s Adverse Event Reporting System rose 2.6 times, to 89,842 from 34,966, while fatal events rose 2.7 times, to 15,107 from 5,519. The increase was fueled by relatively few drugs, with 20% of the total drugs identified accounting for 87% of the events. A disproportionate number of the drugs associated with fatal events were pain medications or drugs that modify the immune system. Oxycodone and fentanyl were linked with the most deaths, while estrogens, insulin and infliximab topped the list for other serious outcomes.
Adverse events were seen more often with women (55.5%) than men (46.5%), and occurred disproportionately among elderly patients, the authors reported. Increasing population and greater use of drug therapy may account for 25% of the increase, while another 15% of the rise is accounted for by 13 new biotechnology products, including immunomodulators, the authors said. Reported adverse events increased four times faster than did the number of outpatient prescriptions.
Drugs related to safety withdrawals had less of an effect on results than expected, and their influence declined over time. The authors examined whether the increase could be explained by a trend toward increased reporting of events by health professionals, but determined it was unlikely. The results illustrate that widespread improvements to drug safety systems are needed, the authors concluded.
The Archives of Internal Medicine is online.
The Washington Post is online.
The CMS provided further guidance on the new Medicaid tamper-resistant prescription pad policy through a list of FAQs released last week. As of Oct. 1, all handwritten (non-electronic) prescriptions for Medicaid patients must be written on tamper-resistant prescription paper. The federal government will not pay for prescriptions that do not follow the new regulation.
Included in the list of questions is a section that addresses the characteristics of tamper-resistant prescription pads, such as that a prescription written in ink does not satisfy the standard of a feature that “prevents the erasure or modification” of information on a prescription. Also, a computer-generated prescription that is given to the patient to take to the pharmacy, such as one that is generated by and printed from an electronic health records system, must be printed on tamper-resistant printer paper.
The list also includes questions that address exceptions to the new regulation. For example, the law does not apply to non-written prescriptions such as e-prescriptions, or prescriptions that are faxed or phoned in to the pharmacy. The new guidance from CMS clarifies that these prescriptions do not have to be communicated by the physician. A nurse or administrative staff may communicate with the pharmacy on the physician’s behalf.
The complete list of FAQs can be found on the CMS Web site.
Further guidance from ACP is available from the Practice Management Center.
Hospitals may not be doing enough to prevent avoidable infections, according to a new survey by the Leapfrog Group, a voluntary quality improvement initiative.
The survey asked representatives from 1,256 hospitals about their processes for avoiding aspiration-associated and ventilator-associated pneumonia (VAP), bloodstream infection related to central venous catheters (CVCs) and surgical site infection (SSI). It also inquired about rates of influenza vaccination among health care workers, as well as adherence to hand hygiene protocol. Hospitals were also asked about surveillance of and accountability for these factors, as well as quality improvement efforts.
Of the hospitals surveyed, 38.5%, 35.4% and 32.3% reported full compliance with recommended measures to prevent aspiration-associated pneumonia and VAP, CVC-associated bloodstream infection and SSIs, respectively. In addition, 35.6% reported full compliance with hand hygiene and 30.7% reported full compliance with influenza vaccination of health care workers.
In a press release, the Leapfrog Group's CEO expressed concern about the findings and called for standardized measures to better assess the overall impact of preventable hospital infections and how often they occur. The group plans to release a complete analysis of its survey data today.
The Leapfrog Group's press release is online.
The following articles will appear in the Sept. 18, 2007 issue of Annals of Internal Medicine. The full text is available to College members and subscribers online.
Aerobic and resistance exercise improved blood sugar control in people with diabetes. In a randomized, controlled trial, both aerobic and resistance exercise improved glycemic/blood sugar control in people with type 2 diabetes. The greatest improvements came from combined aerobic and resistance training. The study included 251 adults who were not exercising regularly and had type 2 diabetes. Participants were assigned to one of four groups: performing 45 minutes of aerobic training three times per week, 45 minutes of resistance training three times per week, 45 minutes each of both three times per week, or no exercise. Both the aerobic and the resistance training groups had improved blood sugar control; their A1c values decreased by about 0.5%. The group that did both kinds of exercise had about twice as much improvement as either of the other groups alone; A1c value decreased by 0.97% compared to the control group. The report is also available in streaming video format.
ACP: Set blood sugar targets for people with diabetes. In a new guidance statement, the College advised physicians to set targets for the A1c values of patients with type 2 diabetes based on individualized assessment of risk of complications from diabetes, comorbidity, life expectancy, and patient preferences. A hemoglobin A1c level of less than 7% is a reasonable goal for many but not all patients to prevent microvascular complications.
Drugs dangerous to fetuses often prescribed to women of childbearing age. A study of prescription class D or class X drugs (which the FDA says can potentially damage embryos and fetuses) found that many women of childbearing age were given prescriptions without documentation of concurrent birth control services. Researchers studied HMO records of nearly 500,000 women aged 15 to 44 who filled prescriptions in 2001 and observed the rates of documented birth control services and pregnancy in the women. Although the researchers did not have data available to them to be certain that all of the women prescribed potentially unsafe drugs were at risk for becoming pregnant (some may not have been sexually active) and some physicians may have provided verbal counseling not reflected in the database, study authors suggest that a substantial proportion of women who receive drugs that are potentially unsafe during pregnancy may not be receiving appropriate birth control services or advice.
A joint meeting of two FDA panels last week recommended that aprotinin (Trasylol) should stay on the market, and that the use of erythropoiesis-stimulating agents to treat anemia in kidney failure patients should not be further restricted.
Studies have indicated the anemia drugs, darbepoetin alfa (Aranesp) and epoetin alfa (Epogen, Procrit), may reduce survival and promote tumor progression in certain patients, especially when taken at higher-than-recommended doses. In March, the FDA added a black box warning to the drugs' labels citing safety concerns and recommending they be used at the lowest dose possible. This week, a joint panel voted against an FDA proposal to reset allowable hemoglobin levels for use of the drugs, the Sept. 12 New York Times said.
Aprotinin is meant to reduce perioperative blood loss and the need for transfusion in at-risk patients undergoing cardiopulmonary bypass during CABG surgery. Studies have suggested the drug may increase risk of death, kidney damage, congestive heart failure and stroke, and the FDA added a warning to the drug's label about the risk of renal dysfunction. A joint panel this week said the drug should be studied more, but there wasn’t a need to add more details to the label or pull it from the market, the Sept. 12 Washington Post reported.
The New York Times is online.
The Washington Post is online.
The antibiotic ceftriaxone (Rocephin) and calcium-containing solutions or products shouldn’t be mixed, even via infusion lines at different sites, the FDA warned this week. Further, the two should not be administered within 48 hours of each other, the agency said.
The warning applies to patients of all ages. Cases of neonate deaths with calcium-ceftriaxone precipitates in the lungs and kidneys have been reported. Hyperbilirubinemic neonates--especially prematures--shouldn’t be treated with ceftriaxone at all. There are no data on the potential interaction between ceftriaxone and oral calcium-containing products, the FDA said.
The FDA Medwatch alert is online.
College-educated Americans have a lower risk of dying of cancer before age 65 than those who only completed high school, according to a new study.
Researchers used census data to collect race and education information on 137,000 white and black people from around the U.S. who died of cancer between ages 25 and 64. They evaluated the relationship between the subjects’ race and education and mortality from cancers of the lung, breast, prostate, colon and rectum and all sites combined. The study found that educational attainment was strongly and inversely associated with mortality from all cancers combined in black and white men and women.
The greatest cancer mortality differences were found between people with 12 or fewer years of school and those with more than 12 years. White women with a college education had a 76% reduced risk of mortality compared to their less-educated peers. White and black men with less education had more than double the risk of dying from cancer of those who attended college. Trends were less consistent among black women, although overall college-educated black women had a 43% lower risk of cancer mortality. The study was published in the Sept. 11 online edition of the Journal of the National Cancer Institute.
Study authors concluded that the differences likely reflect relationships between education and more obvious cancer mortality risk factors, including tobacco use, cancer screening and health care access. In addition to building the knowledge base, the data from this study could be used to determine how public health interventions--such as smoking cessation campaigns--could be designed to have the greatest impact, noted an accompanying editorial.
Nursing homes in the U.S. are often segregated by race, and blacks are more likely to live in poorer-quality homes, according to a new study.
Researchers examined CMS data from calendar year 2000 on nursing home quality and residents' ethnic backgrounds. The sample included 7,196 non-hospital-based nursing homes and 837,810 residents. The authors used dichotomous indicators of inspection deficiencies, staffing and financial viability to determine segregation and quality disparities. The results appear in the September/October Health Affairs.
According to the study, two-thirds of black nursing home patients in the U.S. in 2000 resided in 10% of all facilities. Black patients were less likely to live in highly staffed nursing homes and more than twice as likely to live in facilities that included mostly Medicaid patients. In addition, black patients were 1.41 times more likely than whites to live in a nursing home cited for a deficiency that could immediately harm patients and 1.70 times as likely to live in a deficient facility whose participation in Medicare and Medicaid was subsequently terminated. Segregation was more likely in nonprofit than in for-profit nursing homes.
The researchers pointed out that their study used secondary data sources and that their results should be interpreted with caution. However, they recommended changes in policy, such as disproportionate-share payment adjustments for nursing homes with more Medicaid patients, to try to address racial disparities.
Health Affairs is online.
The College has released a new policy paper that examines various state initiatives to expand access to health insurance, as well as proposals by the President and Congress to support state-based efforts. The paper, “State Experimentation with Reforms to Expand Access to Health Care,” also identifies key elements that should guide any state-based efforts to expand access.
“ACP recognizes that all states cannot use the same framework to achieve universal coverage and that experimentation with various models is desirable,” noted ACP President David C. Dale, FACP. “In this paper, the College offers 10 recommendations to states as they develop models to expand access to care for their residents.”
ACP has a long-standing commitment to making affordable health insurance available to all Americans. Earlier papers documented the cost of lack of health insurance and the impact of lack of health insurance coverage on health outcomes and proposed core principles for evaluating proposals to expand coverage. In 2002, the College outlined a national framework to achieve universal coverage that includes a combination of premium subsidies, tax credits, purchasing groups, insurance market reforms, and expansion of Medicaid and the State Children’s Health Insurance Program. The plan also includes a state opt-out program that allows states to opt out of the national framework and establish their own programs for universal coverage.
The complete paper is online.
The College will publish The Fenway Guide to LGBT Health to teach current and future medical providers about the unique health care needs of sexual and gender minorities. LGBT (lesbian, gay, bisexual and transgender) Americans, in addition to having the same basic health needs as the general population, often experience health disparities due to discrimination and ignorance related to sexual orientation or gender identity. For example:
- LGBT people are 40% to 70% more likely to smoke than non-LGBT people;
- Gay and bisexual men continue to be at increased risk for HIV and other STD acquisition and transmission;
- Lesbians may be at greater risk than other women for certain kinds of cancer.
Despite these disparities, many medical providers are unaware of specific health issues impacting LGBT people or are unskilled in making their practices welcoming and inclusive of LGBT patients. Chapters cover critical topics like:
- health promotion and disease prevention,
- health disparities,
- mental health issues,
- the basics of transgender and intersex health,
- parenting and raising families, and
- demographic and epidemiologic information.
The Guide draws on Fenway Community Health’s more than 35 years providing medical and mental health care to the LGBT community to address this common disconnect between doctor and patient. It is edited by Harvey Makadon, ACP Member, Ken Mayer, FACP, and Hilary Goldhammer of The Fenway Institute at Fenway Community Health, and Jennifer Potter, ACP Member, of Beth Israel Deaconess Medical Center.
“We as medical providers need to be as knowledgeable as possible about health issues impacting all of our patients, especially groups with unique health disparities, like LGBT people,” said Dr. Makadon. “We also need to be comfortable talking to sexual and gender minorities in a non-judgmental way about behaviors and situations that result in these disparities so that they are comfortable being honest and open with us. Doctor-patient communication is an essential component of providing quality health care.”
The Fenway Guide to LGBT Health will be distributed by all major distributors and medical book sellers, including Ingram Book Group. It is also available to readers at www.acponline.org/fenway, www.amazon.com, and www.barnesandnoble.com, or by calling ACP Customer Service at 800-523-1546, ext. 2600, or 215-351-2600.
More information is online.
ACP's Associate and Medical Student Members will have the opportunity to showcase their skills and knowledge in this year's National Abstract Competitions. Participants may submit abstracts in four categories: Clinical Vignette, Basic Research, Clinical Research, and Quality Improvement. Winning entries are selected by a team of ACP members who judge abstracts prior to the annual meeting.
The top 10 winners will be awarded free registration to Internal Medicine 2008 and will have the chance to give oral presentations of their work. The next highest scoring abstracts in each category will be invited to compete in a poster competition during the meeting. Each year, hundreds of Associates and medical students take advantage of this member benefit and submit an abstract. More than 2,500 abstracts were submitted by Associates and Medical Student Members during last year's competition.
The deadline for the Associate competition is Oct. 1 and the deadline for medical students is Nov. 1. For more information about the national competitions, please contact ACP Membership Development at 800-523-1546 ext. 2666 or send an e-mail to email@example.com.
You can submit an abstract through the electronic abstract system online.
To introduce a new cartoon feature for ACP Observer, ObserverWeekly is inviting its readers to submit their wit. Add a caption to the image below and e-mail it to firstname.lastname@example.org by Oct. 1. Staff will select a winning caption and print it in an upcoming issue. The author of the winning quip will receive a complimentary copy of "Medicine in Quotations," ACP's comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history. Look for new caption contests each month in this space.
An article in last week’s ObserverWeekly which reported on a study of the relationship between physician communication skills and patient complaints incorrectly stated one of the study’s findings. The sentence should have read as follows:
The research found that patient-physician communication scores from the exam were significantly predictive of retained complaints, with scores in the bottom quartile representing an additional 9.2% of complaints.
About ACP ObserverWeekly
ACP ObserverWeekly is a weekly newsletter produced by the staff of ACP Observer. It is automatically sent to all College members who have an e-mail address on file with ACP.
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Copyright 2007 by the American College of Physicians.
A 54-year-old woman is evaluated for shortness of breath of 3 months' duration and a 4.5-kg (10-lb) weight loss over the preceding 2 months. She has a 35-pack-year smoking history. Following a physical exam and further testing, what is the most appropriate treatment?
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