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ACP HospitalistWeekly 5-6-09

Highlights

• Swine flu information from CDC, ACP
• Computerized drug reconciliation tool helps reduce adverse events

Critical care

• SOFA score in the ED helps predict in-hospital survival for some sepsis patients

Cardiology

• Aspirin plus clopidogrel associated with infection after CAB

FDA update

• Boxed warning ordered for all botulinum toxin products
• OTC pain relievers, fever reducers must revise labels to reflect liver, bleeding risks
• Golimumab approved for three kinds of immune-related arthritis
• Libimax supplement recalled for containing tadalafil

From ACP Hospitalist

• Suggest a colleague as a Top Hospitalist

From ACP Internist

• May's ACP Internist is online and coming to your mailbox

Cartoon caption contest

• And the winner is …
• Put words in our mouth

Physician editor: A. Scott Keller, MD

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Highlights

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Swine flu information from CDC, ACP

ACP Hospitalist has compiled a list of resources to help physicians and their patients stay up-to-date about the outbreak of swine-origin (H1N1) influenza A.

According to the CDC, clinicians should suspect swine-origin influenza A (H1N1) in persons with an acute febrile respiratory illness who:

• have had close contact with a person who is a swine-origin influenza confirmed case,
• have traveled to a community domestically or internationally where there are one or more confirmed swine-origin influenza cases, or
• reside in a community where there are one or more confirmed cases.

Patients with uncomplicated disease due to confirmed infection from the virus have experienced fever, headache, upper respiratory tract symptoms (cough, sore throat, rhinorrhea), myalgia, fatigue, vomiting, or diarrhea. In suspected cases, clinicians should obtain a nasopharyngeal synthetic-tip swab/aspirate or nasal wash/aspirate as soon as possible, place it in sterile viral transport media and place on dry ice or refrigerate at 4° C, and transport to the state l health department for testing. The virus is treated with either zanamivir (Relenza) or oseltamivir (Tamiflu). It is resistant to amantadine (generic) and rimantadine (Flumadine).

More information about screening, specimen collection, identifying patients, treating young children and pregnant women, and infection control is available on the CDC's swine flu guidance site.

The ACP Foundation, in collaboration with ACP, has developed Swine Flu
HEALTH TiPS. HEALTH TiPS are developed at or below a fifth-grade reading level in English and Spanish. The clinical content is evidence-based and tested with patients. A Spanish version is in development and will be available soon.

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Computerized drug reconciliation tool helps reduce adverse events

Using a computerized medication reconciliation tool at discharge led to fewer adverse drug events at two hospitals that participated in a recent study.

Researchers enrolled 322 patients admitted to two academic hospitals and randomly assigned 14 medical teams to test a computerized medication reconciliation tool and process redesign involving physicians, nurses and pharmacists. Among 160 control patients there were 230 potential adverse drug events (PADEs) (1.44 per patient) compared with 170 PADEs (1.05 per patient) in the 162-patient intervention group, a 28% relative reduction. However, a significant benefit was only found at one of the two hospitals. The results are published in the April 27 Archives of Internal Medicine.

The authors said the intervention's success was due to effective process redesign combined with information technology. The process encouraged interdisciplinary communication and cross-checks, they explained, while the IT application facilitated accurate medication histories and displayed the preadmission medication list with the current inpatient medications during the discharge ordering process. However, the authors acknowledged that their system was “far from perfect” given the number of PADEs in the intervention group.

The intervention was more successful in patients at high risk for medication discrepancies, they added, and worked to reduce PADEs at discharge but not at admission. They attributed the latter in part to PADEs being more common at discharge and a tendency for errors of reconciliation to occur at discharge.

The authors speculated that the different outcomes between the two hospitals may have been due to a better, phased rollout process at one hospital, which also had greater involvement of nurses in confirming accuracy of medication lists at admission. In addition, reducing reconciliation errors at one hospital was aided by a better computer system that made it easier to see inpatient and preadmission medications simultaneously and order medications from either list at discharge.

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Critical care

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SOFA score in the ED helps predict in-hospital survival for some sepsis patients

The Sequential Organ Failure Assessment (SOFA) score can help predict in-hospital survival rates when used in the emergency department (ED) for certain sepsis patients, a new study reports.

Few simple tools are available to predict outcomes of sepsis in the ED. Researchers performed a prospective observational study in a single ED to determine whether SOFA score accurately predicts survival for patients with severe sepsis and evidence of hypoperfusion, and whether change in SOFA was related to changes in mortality rates. Eligible patients were those with suspected infection, at least two criteria for systemic inflammation, and systolic blood pressure less than 90 mm Hg after receipt of a fluid bolus or a lactate level of at least 4 mmol/L. Patients were excluded if they were younger than 18 years of age or needed immediate surgery. The researchers calculated SOFA score at the time of ED recognition and 72 hours after ICU admission, with a primary outcome of in-hospital mortality. The results appear in the May Critical Care Medicine.

Two hundred forty-eight patients were included in the study, and 51 (21%) died in the hospital. The mean SOFA score was 7.1 ± 3.6 points at ED recognition and 7.4 ± 4.9 points at 72 hours after admission. The area under the receiver-operating characteristic curve was 0.75 (95% CI, 0.68 to 0.83) for predicting mortality at ED recognition and 0.84 (95% CI, 0.77 to 0.90) for predicting mortality at 72 hours. Change in SOFA score was correlated with survival: Scores that worsened over 72 hours were associated with a 35% in-hospital mortality rate, and scores that improved in the same time period were associated with a 10% in-hospital mortality rate.

The authors adapted the SOFA score by substituting the Sao2/Fio2 ratio for the Pao2/Fio2 ratio, and noted that this may have affected their results. They also pointed out that their study sample was small and included only severely ill patients, limiting generalizability. However, they concluded that the SOFA score had fair to good accuracy for predicting in-hospital mortality rates when used in the ED for patients with severe sepsis and hypoperfusion, and "appears to be a potentially useful tool for either the clinician during bedside assessment or for purposes of clinical research trials of sepsis."

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Cardiology

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Aspirin plus clopidogrel associated with infection after CAB

Preoperative dual antiplatelet therapy with aspirin and clopidogrel was associated with an increased risk of infection after coronary artery bypass surgery, according to a recent retrospective study.

Researchers looked at 1,677 patients undergoing CAB and compared the preoperative use of aspirin plus clopidogrel versus aspirin alone. The cumulative incidence of infection at 30 days was 23.1% in patients receiving dual antiplatelet therapy compared with 16.1% for patients who received only aspirin, even after adjustment for demographic, socioeconomic, preoperative and intraoperative risk factors.

Transfusion rates were also higher among patients who were receiving dual antiplatelet therapy than among patients who were receiving aspirin monotherapy (68.4% vs. 60.4%; P= 0.04), but this did not have a significant impact on the risk of infection. Mortality rates at 30 days also were higher in the dual antiplatelet versus the aspirin group, 5.2% versus 3.1%, respectively, although the difference was not statistically significant. The results appear in the April 27 Archives of Internal Medicine.

The authors noted that the relationship between dual therapy and infection risk appeared to be independent of the severity of atherosclerosis or previous revascularization. In addition, blood loss, reoperation and transfusion had only a limited impact on the association between dual therapy and infection.

"The absence of randomized controlled trials that assess the risks and benefits of a short-term withdrawal of dual antiplatelet therapy in surgical patients has created considerable uncertainty regarding the appropriate management of antiplatelet therapy in the perioperative period," the authors said. More research is needed, they concluded, to clarify the risks and benefits of uninterrupted dual antiplatelet therapy in surgical patients and others at high risk for infection.

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FDA update

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Boxed warning ordered for all botulinum toxin products

All botulinum toxin products must get a boxed warning on their labels and a Risk Evaluation and Mitigation Strategy (REMS) due to reports of serious adverse events, the FDA said last week.

Specifically, reports indicate the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to botulism like unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. Effects have been reported as early as several hours and as late as several weeks after treatment. Physicians should tell patients to seek immediate medical attention if any of these symptoms develop, the FDA said.

The products affected by the FDA action include Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.

Adverse symptoms have mostly been reported in children with cerebral palsy being treated for muscle spasticity, an unapproved use, although symptoms have also been reported in adults treated for both approved and unapproved uses. Botox, Myobloc, and Dysport are approved to treat cervical dystonia, while Botox Cosmetic and Dysport are approved to treat glabellar lines (frown lines). Botox is also approved to treat primary axillary hyperhidrosis, strabismus and blepharospasm.

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OTC pain relievers, fever reducers must revise labels to reflect liver, bleeding risks

All over-the-counter (OTC) pain relievers and fever reducers must revise their labels to include warnings about potential safety risks like internal bleeding and liver damage, the FDA said last week.

Affected products include acetaminophen and NSAIDs, as well as cold medicines that contain fever reducers or pain relievers. The active ingredients of these drugs must also be prominently displayed on the drug labels. The revisions must occur by April 28, 2010.

Taking too much acetaminophen can increase the risk for severe liver damage, as can alcohol use. Stomach bleeding risks may also increase in people who combine NSAIDs with anticoagulants or steroids, take multiple NSAIDs at once, use alcohol, or take NSAIDs longer than directed, the FDA said.

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Golimumab approved for three kinds of immune-related arthritis

The FDA last week approved golimumab (Simponi) as a monthly injectable for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

The drug, a TNF-α blocker, is meant for use in combination with methotrexate in patients with rheumatoid arthritis. It may also be used with or without methotrexate for psoriatic arthritis, and alone in patients with ankylosing spondylitis. The most common adverse reactions are upper respiratory tract infection, sore throat and nasal congestion.

Like other TNF-α blockers, golimumab has a boxed warning about the risk of tuberculosis and invasive fungal infections. The drug also has a Risk Evaluation and Mitigation Strategy (REMS) which includes a Medication Guide for patients and a communication plan to help prescribers understand the drug’s risks.

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Libimax supplement recalled for containing tadalafil

Libimax, a libido supplement, is being voluntarily recalled by its manufacturer because it contains tadalafil, the FDA said.

Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), may interact with the nitrates in some prescription drugs (like nitroglycerin), and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates, and ED is a common problem in men with these conditions, who may seek products like Libimax to enhance sexual performance, the FDA said.

The recalled Libimax is sold as a one-capsule individual pack, or in 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas and Ohio. The product label neither states it contains tadalafil nor warns consumers with high blood pressure not to ingest the product.

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From ACP Hospitalist

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Suggest a colleague as a Top Hospitalist

ACP Hospitalist is seeking candidates for our second annual Top Hospitalists issue. We're looking for the hospitalists who made notable contributions to the field in 2009, whether through cost savings, improved work flow, patient safety, leadership, mentorship or quality improvement.

Do you know a colleague who might qualify? Fill out our form and tell us who and why. All recommendations must be received by July 13, 2009, when our editorial advisory board will pick the winners. Top Hospitalists will be profiled in our November 2009 issue.

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From ACP Internist

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May's ACP Internist is online and coming to your mailbox

The May issue of ACP Internist is online. Highlights include:

• Internist follow-up key for breast cancer survivors. Breast cancer survivors may recover from their illness only to face the same diseases as their "well" peers, such as hypertension and diabetes. Experts suggest a shared care model to keep breast cancer survivors healthy.
• It's just old age—or is it? Would you make the same diagnosis in a 50-year-old patient that you would in an 80-year-old? This and a vague history led one internist to press for a better answer to a patient's anemia and SED rate.
• Practice hassles have more docs going locum. Economic factors and bureaucratization are prompting more internists to adopt locum tenens employment as a career path. Read the stories of doctors who have made the switch successfully.

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Cartoon caption contest

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And the winner is ...

The winner of April's cartoon caption contest was announced in Saturday's daily e-mail update from Internal Medicine 2009. In case you missed it, click here for the winning caption. All of the ACP news staff's coverage from Internal Medicine 2009 is also available online.

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Put words in our mouth

ACP HospitalistWeekly wants readers to create captions for this cartoon and help choose the winner.

E-mail all entries by May 21. ACP staff will choose three finalists and post them in the May 27 issue of ACP HospitalistWeekly for an online vote by readers. The winner will appear in the June 3 edition of ACP HospitalistWeekly. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.

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About 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