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HospitalistWeekly 10-1-08

Highlights

• Joint Commission to enforce anticoagulant safety goals
• Study says drug-coated stents are better than bare-metal stents

Stroke interventions

• Another study supports r-tPA use more than three hours after stroke

Tools and resources

• Web tool helps hospitals predict emergency response needs

FDA news

• Companies ordered 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

From ACP Internist

• On the blog: extreme calorie restriction, Part D

Cartoon caption contest

• September's winning entry

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Highlights

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Joint Commission to enforce anticoagulant safety goals

The Joint Commission has issued safety suggestions for anticoagulants and will step up their enforcement, the agency announced last week.

High profile errors related to commonly used blood thinners have harmed or even killed patients, according to a Joint Commission alert that offers solutions to this medication safety issue.

The Joint Commission’s Sentinel Event Database includes 446 medication-related sentinel events (9.3% of all events) reported from January 1997 through December 2007. Of these, 7.2% (32) involve anticoagulants; of those, two-thirds (21) involve heparin.

The Joint Commission addressed these errors in its 2008 National Patient Safety Goals, and requires full implementation of them by Jan. 1 for hospitals, outpatient clinics, home care and long term care organizations. Commission investigators will make unannounced visits to ensure hospitals adopt strict measures to prevent blood thinner errors, and those who fail to do so could see their accreditation revoked, The Joint Commission president told the AP in its published article.

The Joint Commission’s highlighted factors that contribute to anticoagulant medication errors, including lack of standardized labeling and packaging, failure to document and communicate patient instructions during hand-offs, and inappropriate dosing for pediatric patients. To reduce the risk of errors related to commonly used anticoagulants, The Joint Commission recommends that health care organizations take a series of 15 specific steps, including:

• Assess the risks of using anticoagulants;
• Use best practices or evidence-based guidelines regarding anticoagulants;
• Establish standard dose limits on anticoagulants and require that a doctor confirm any exceptions;
• Clearly label syringes and other containers used for anticoagulants; and
• Clarify all anticoagulant dosing for pediatric patients, who are higher risk because these drugs are formulated and packaged for adults.

A Podcast is also available.

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Study says drug-coated stents are better than bare-metal stents

Drug-eluting stents appear to be superior to bare-metal stents in patients undergoing coronary-artery stenting for acute myocardial infarction (MI), according to a prospective observational study in the New England Journal of Medicine. The overall mortality rate among study subjects was 2% lower for patients with drug-eluting stents compared with patients who received bare-metal stents.

Prior studies were small or had no more than a year of follow-up, so in an effort to access large numbers of subjects with lengthy follow-up, researchers analyzed a state-mandated quality-of-care database that included all percutateous coronary interventions performed at acute care, nonfederal hospitals in Massachusetts. Based on this review of approximately 7,200 patients who underwent coronary-artery stenting for acute MI, researchers found that drug-eluting stents were associated with decreased mortality rates and a reduced need for repeat revascularization procedures. Drug-eluting stents were used in an estimated 55% of the patients, while bare-metal stents were used in the remainder.

Adjusted analysis of matched pairs was used to compare recipients of drug-eluting stents with recipients of bare-metal stents. Three propensity-matched cohorts—all patients with acute MI, all those with acute MI with ST-segment elevation, and all those with acute MI without ST-segment elevation—were grouped based on clinical, procedural, hospital and insurance information.

The 2-year, risk-adjusted mortality rates were lower for drug-eluting stents than for bare-metal stents among all patients with MI (10.7% vs. 12.8%); among patients with MI with ST-segment elevation (8.5% vs. 11.6%); and among patients with MI without ST-segment elevation (12.8% vs. 15.6%). Mortality rates and repeat target-vessel revascularization rates at 2 years were significantly lower with drug-eluting stents. The rates of reinfarction were reduced in patients with MI without ST-segment elevation who were treated with drug-eluting stents.

The authors stressed the need for large, long-term, randomized studies to confirm these observational findings.

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Stroke interventions

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Another study supports r-tPA use more than three hours after stroke

Intravenous thrombolysis with alteplase improves clinical outcomes in acute ischemic stroke patients, even when administered later than three hours after stroke onset, according to an industry-sponsored study in the New England Journal of Medicine.

In this randomised, double-blind, placebo-controlled trial designed to evaluate whether the safety and efficacy of alteplase was maintained up to 1.5 hours beyond the standard three-hour time window, researchers at 130 sites in 19 countries randomized a cohort of approximately 800 subjects to placebo or to alteplase (to 0.9 mg/kg) administered at a median of 3 hours and 59 minutes. They found that those treated with alteplase had a 34% improvement in the odds of having a favorable outcome (52.4% vs. 45.2%) compared with those treated with placebo. Patients who had brain hemorrhage or major infarction were excluded from the study.

The incidence of intracranial hemorrhage was higher with alteplase than placebo at 27.0% vs. 17.6% respectively, as well as for symptomatic intracranial hemorrhage at 2.4% vs. 0.2%, respectively. There was no significant difference in mortality between the two groups, with a rate of 7.7% in the alteplase group and 8.4% in the placebo group.

This study, in combination with findings of a recent retrospective analysis published in Lancet, provides evidence that “withholding thrombolytic treatment [because the three-hour window has closed] engenders greater risk than giving it at up to 4.5 hours after symptom onset,” according to commentary in the Journal Watch Emergency Medicine. Meanwhile, an NEJM editorial stresses that every minute counts during stroke treatment and that delaying intervention is unacceptable in instances when patients can be treated within the three-hour window.

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Tools and resources

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Web tool helps hospitals predict emergency response needs

A new AHRQ Web-based interactive tool for hospitals and emergency planners helps identify resource requirements for treating an influx of patients due to major disasters such as an influenza pandemic or a terrorist attack.

The Hospital Surge Model allows hospitals to estimate the number and flow of casualties needing medical attention during various scenarios, including:

• How many patients each hospital unit will need to treat each day following an event;
• Casualty arrival patterns and peak days of patient care;
• Day- by-day use of the personnel, equipment, and supplies needed by each hospital to treat casualties; and
• A daily count of anticipated deaths and patient discharges.

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FDA news

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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.

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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.

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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.

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From ACP Internist

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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.

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Cartoon caption contest

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September's winning entry

ACP HospitalistWeekly 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. 8 issue of ACP HospitalistWeekly.

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ACP Hospitalist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP. All published material, which is covered by copyright, represents the views of the contributor and does not reflect the opinion of the American College of Physicians or any other institution unless clearly stated