In the News for the Week of 8-28-07
- New guidelines from CMS on tamper-resistant prescription pads
- Nearly a fifth of U.S. adults take aspirin regularly
- WHO issues report on global infectious disease
- Bariatric surgery lengthens life span
- As-needed relaparotomy lowers costs, improves length of stay in severe peritonitis
- ACP Journal Club: Intensive smoking cessation program reduced mortality in high-risk smokers
- ESRD posts 'staggering' costs despite decline in incidence
- HHS announces grants initiative for improving emergency care
- NCI DVD gives free training in end-of-life care
- Annals editor receives decision-making award
Editorial note: ACP Observer Weekly will not be published the week of Sept. 3 due to the Labor Day holiday.
New guidelines from CMS on tamper-resistant prescription pads
CMS released specifics on the new Medicaid requirement for tamper-resistant prescription pads. 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.
The new policy applies to all outpatient drugs but provides for several exceptions. These include prescriptions written and used within nursing facilities, intermediate care facilities for the mentally retarded and other specified institutional and clinical settings. The regulation also does not apply to e-prescriptions transmitted to the pharmacy, prescriptions faxed to the pharmacy or prescriptions communicated by the prescriber to the pharmacy over the phone.
The College recommends that physicians contact their state Medicaid directors to determine the specific requirements for tamper-resistant prescription pads, to learn whether there are preferred vendors for these pads and to learn whether their state has plans to purchase these pads and provide them to Medicaid-participating physicians at a discounted rate.
A list of state Medicaid directors and their contact information is online.
Further guidance and a complete list of exceptions are available from the College’s Practice Management Center.
About 19% of U.S. adults take aspirin regularly, with older adults and those with heart conditions more likely to take it, according to a new study.
The Agency for Healthcare Research and Quality found that about 43 million people age 18 and older took aspirin every day or every other day in 2005. Of the roughly 26 million adults who were told by a physician that they may have heart disease, 54% took aspirin regularly, compared with 15% of those who hadn’t been told of heart conditions.
Nearly 49% of adults age 65 and older took aspirin, and 64% in this age group who had symptoms of heart disease took it. Only 27% of adults age 45-64 took aspirin regularly, though 56% in this group took it if they had symptoms of heart disease. Whites with heart disease indicators were more likely to take aspirin regularly than Hispanics, Asian-Americans or African-Americans, and men were more likely to take it than women.
Separately, retail sales of five top painkillers rose 90% from 1997 to 2005, according to U.S. Drug Enforcement Administration statistics, said the Aug. 20 Washington Post. Oxycodone made up the bulk of the increase, with sales up almost sixfold. Once most common in Appalachia, oxycodone is now most popular in various suburbs, as is codeine, said the report, based on an analysis by the Associated Press.
Emergency room visits due to painkiller abuse have increased more than 160% since 1995, the article said. Reasons for the increase in use of pain medicine include an aging population, increased spending on drug marketing campaigns and a change in attitudes toward pain management, the report said. The increase has slowed in recent years, however: While there was a 150% jump in painkiller sales in 2001, the year-to-year increase in 2005 was 2%.
The AHRQ report is online.
The Washington Post is online.
Infectious diseases are spreading faster than ever around the globe and will require greater international cooperation to protect public health, warned a report released last week by the World Health Organization (WHO).
WHO officials reported that new diseases are emerging at the unprecedented rate of one per year, said the Aug. 22 Washington Post. Since 1967, at least 39 new pathogens have been identified, including HIV, Ebola and SARS. The WHO’s World Health Report 2007 also expressed concern about the impact of international travel on disease spread, given that airlines are currently carrying more than 2 billion passengers per year.
The report sets out WHO’s strategic action plan for pandemic influenza, which it calls the most feared threat to current health security. The agency also urges continued vigilance in managing the international spread of polio and extensively drug-resistant tuberculosis (XDR-TB). In the report, governments are asked to cooperate in the sharing of disease information and to implement the revised International Health Regulations, which came into effect in June.
Despite the new regulations, WHO is currently struggling to get complete samples of H5N1 virus from Indonesia, the Washington Post noted. Indonesian officials had been sharing the virus with vaccine makers instead of international agencies based on concerns that any pandemic vaccines developed would not be affordable for developing countries. The country has since agreed to send samples to WHO, but they have not been fully shared, the Washington Post said.
The World Health Report 2007 is online.
The Washington Post is online.
Bariatric surgery significantly reduces mortality among obese patients, according to two new studies published in the Aug. 23 New England Journal of Medicine.
The first study was a retrospective cohort comparison of 7,925 patients who underwent gastric bypass surgery with 7,925 severely obese people who did not have surgery. During the mean follow-up of seven years, the surgery group had a 40% lower mortality rate from all causes. The differences in mortality rates from specific causes were even more dramatic: 92% reduced for diabetes, 60% for cancer and 56% for coronary artery disease. However, the surgery group’s rate of death not from disease was 58% higher than controls.
A Swedish study compared outcomes in 4,047 obese patients who received either bariatric surgery or conventional treatment. After almost 11 years of follow-up, surgery patients had lost 14% to 25% of their weight, compared with about 2% among the conventional treatment group. Surgery patients had a 24% decreased risk of death compared to the other group, which widened to 29% when adjusted for sex, age and risk factors.
These studies provide the missing link that proves a connection between intentional weight loss and life span, said an accompanying editorial. The editorial writer noted that during the study periods laparoscopic techniques largely replaced open operations, so that surgical mortality should be even lower today than it was at the time of the studies. The author also suggested that, based on the study results, it may be appropriate to re-evaluate current guidelines, which recommend surgery only for patients with a body mass index of at least 40, or 35 if they have coexisting illness.
Relaparotomy performed on an as-needed rather than a scheduled basis led to lower costs and shorter hospital stays in patients with severe peritonitis, a new study found.
Researchers from the Netherlands performed the randomized, nonblinded multicenter trial to compare the effect of as-needed and scheduled relaparotomy on 12-month mortality and major morbidity related to peritonitis in patients who had had emergency surgery. Health care utilization and costs were the secondary end points. The study was published in the Aug. 22/29 issue of the Journal of the American Medical Association.
Two hundred thirty-two patients at seven hospitals who had received emergency surgery for severe peritonitis were randomly assigned to receive relaparotomy either every 36 to 48 hours after the initial laparotomy until the abdomen was found to be clean, or only if their clinical condition did not improve and intra-abdominal factors were thought to be the cause or if their clinical condition deteriorated.
The as-needed and scheduled groups did not differ significantly in the primary end point (57% vs. 65% died or experienced peritonitis-related morbidity) or in mortality or morbidity alone (29% vs. 36% and 40% vs. 44%, respectively). Relaparotomy was performed in 42% of patients in the as-needed group and 94% of patients in the scheduled group; results of the surgery were negative in 31% and 66%, respectively. Median stays in the intensive care unit and in the hospital were shorter in the as-needed group (7 vs. 11 days and 27 vs. 35 days, respectively), and costs were 23% lower.
Although the as-needed strategy did not significantly change mortality and morbidity rates, it may still be preferable because it led to fewer surgeries and lower health care utilization and costs, the authors noted. Because nearly a third of the as-needed surgeries yielded negative results, the authors said, future studies should focus on selecting patients for relaparotomy, determining variables that predict positive findings on repeated surgery and evaluating imaging and biomarkers to aid in diagnosis.
The JAMA article is online.
Recent progress in preventing and treating end-stage renal disease (ESRD) in the U.S. provides "cautious optimism," but skyrocketing costs are a major concern, said researchers at the U.S. Renal Data System (USRDS).
According to researchers, 104,364 (0.03%) Americans started dialysis or received a kidney transplant in 2004, a nearly 1% decline in renal replacement therapy compared with 2003. The study will appear in the October Journal of the American Society of Nephrology.
The decline in renal replacement therapy came during an increase in type 2 diabetes, a major contributor to kidney disease. The study suggested that improvements in preventive care may be helping to reduce diabetes-related kidney disease, although several years of new data will be needed to confirm this trend.
Also, data from the USRDS show improvement in the quality of dialysis care, including evidence that patients are starting renal replacement therapy at less severe stages of kidney disease. And probabilities of survival for ESRD patients have improved steadily since the late 1980s-- especially remarkable since today's dialysis patients are older and sicker than the dialysis population of 20 years ago.
"While most of these findings are grounds for cautious optimism, the same cannot be said for issues of cost," the authors said. Continued growth of the ESRD population caused spending to increase by 57% between 1999 and 2004. Medicare costs for ESRD reached an estimated $20.1 billion, or 6.7% of total Medicare expenditures, while non-Medicare costs rose to $12.4 billion.
A new study found that an intensive smoking cessation program increased quit rates and reduced hospitalizations and mortality in high-risk smokers hospitalized with cardiovascular disease.
The study involved 209 patients aged 30 to 75 years who were admitted to a coronary care unit with acute coronary syndrome or decompensated heart failure, had smoked for at least five years, and had a Fagerstrom score of greater than 7. About half received usual care, including written self-help materials and a 30-minute counseling session before discharge. The other half received an intensive intervention of weekly 60-minute counseling sessions for at least three months after discharge and individualized nicotine replacement therapy and/or bupropion at no cost. In addition, patients in the latter group were re-treated if they started smoking again.
Results showed 33% hadn’t smoked since the first follow-up compared to 9% of the control patients (RBI 267%, CI 91 to 621, NNT 5). All-cause mortality for the intervention group was 2.8% versus 12% for the control group (RRR 77%, CI 27 to 93, NNT 11), and all-cause hospital admissions were 23% for the treatment group and 41% for the control group (RRR 44%, CI 16 to 63, NNT 6). The study was abstracted in the July/August ACP Journal Club.
Few hospitals provide the kind of inpatient counseling described in the study, and outpatient counseling is unavailable or not covered for most Americans, noted Journal Club reviewer Charles J. Bentz, FACP, of Providence St. Vincent Hospital and Medical Center in Portland, Ore. Noting that identification and intervention costs for smokers are minimal compared to those for hospitalization, Dr. Bentz said the study should serve as a call to all payers to reevaluate coverage for intensive tobacco cessation interventions.
Peer ratings for this review: GIM/FP/GP, Pulmonology, Hospitalists: 6/7 stars. Cardiology: 5/7 stars.
ACP Journal Club is online.
Doctors should talk about the possible risks and signs of morphine overdose in infants when prescribing codeine-containing drugs to nursing women, the FDA said in a recent alert.
A report of an infant death has raised concern that mothers with a rare metabolic genotype who take codeine may convert the drug to its active metabolite, morphine, faster than most people. In nursing mothers, this type of metabolism can leader to high serum and breast milk morphine levels, the FDA said.
When prescribing codeine to nursing mothers, doctors should choose the lowest effective dose for the shortest period of time and closely monitor patients, the FDA said. They should advise the mothers to watch their infants and get immediate medical help if their child exhibits unusual sleepiness, difficulty breastfeeding or breathing, or limpness. Nursing mothers should also monitor themselves for extreme sleepiness, confusion, shallow breathing or severe constipation.
The FDA alert is online.
The FDA approved the first once-a-year intravenous injection of zoledronic acid (Reclast) for women with postmenopausal osteoporosis.
The drug is already used to treat Paget disease, but will be given as a 15-minute IV infusion for osteoporosis, manufacturer Novartis said. A three-year trial of the drug found it reduced the risk of spine fractures by 70% and hip fractures by 41%. Bone mineral density increased in the spine by 6.7% and in the hip by 6% in women who were treated versus placebo, the trial found. Serious atrial fibrillation was more common in women on the drug versus placebo (1.3% vs. 0.4%). The trial was published in the May 7 New England Journal of Medicine.
The FDA approval record is online.
The Novartis press release is online.
The New England Journal of Medicine study is online.
The U.S. Department of Health and Human Services (HHS) recently announced the availability of $25 million in competitive grants for improving emergency care.
Interested hospitals can apply for grant money to fund projects focused on preparing for public health emergencies, improving the capability of emergency care systems and addressing surge capacity. A maximum of three grants will be awarded.
"We are asking the health care community to propose innovative approaches to public health emergencies," an HHS official said in a press release. "By identifying new projects that could be replicated across the country, we are looking to strengthen the overall resiliency of our nation's emergency care."
The application deadline is Sept. 7.
The HHS press release is online.
Applications can be filed online.
The National Cancer Institute (NCI) has released an end-of-life care self-study curriculum for health care providers who care for cancer patients.
The Education in Palliative and End-of-Life Care for Oncology (EPEC™-O) CD-ROM and DVD is a comprehensive multimedia program developed specifically for any medical provider who treats patients with cancer.
The curriculum provides information and strategies necessary to provide palliative interventions: three plenary sessions and 15 content modules offering lecture text with associated slides, video vignettes and commentary, and two teaching skill modules providing tools and materials to use in teaching the core competencies of palliative care to trainees.
Information and free copies of the CD-ROM and DVD are available online.
Harold C. Sox, MACP, editor of Annals of Internal Medicine, has been selected as this year’s recipient of the Society of Medical Decision Making’s John Eisenberg Award.
The award recognizes exemplary leadership in translating medical decision making research into practice and communicating the principles and/or findings of medical decision making research to policy makers, clinical decision makers and the general public. The award will be presented during the SMDM’s annual meeting in October.
The SMDM is online.
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Copyright 2007 by the American College of Physicians.
A 66-year-old man is evaluated for vague abdominal pain of several months' duration and a 10-kg (22-lb) weight loss. He drinks alcohol socially but does not smoke. The patient is otherwise well, has good performance status, and takes no medications. Following a physical exam, lab studies, and a CT scan, what is the most appropriate initial management of this patient?
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