Medical News You May Have Missed - Week of March 11th

FDA Rejects ACS Indication for Rivaroxaban, Again

Janssen Pharmaceuticals, the marketer of the oral factor Xa inhibitor rivaroxaban (Xarelto), announced on March 4 that the FDA has issued a second complete response letter (CRL) regarding the supplemental new drug application submitted for the use of the drug in patients with acute coronary syndrome ACS. CRLs typically indicate that the FDA would like to see more data.

In response to the first CRL, received in June 2012, Janssen submitted data related to patients who had withdrawn from the ATLAS ACS 2 TIMI 51 trial, a large part of the basis for the drug’s pending approval. The company said it will continue to work with the FDA to address questions about the drug.

Rivaroxaban is currently approved for multiple indications including the treatment of stroke in patients with nonvalvular atrial fibrillation, and to reduce the risk for deep vein thrombosis or pulmonary embolism in patients undergoing hip or knee replacement surgery.

Read more at theheart.org.

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Baby Cured of HIV Infection

The first case of a “functional cure” in an HIV-infected infant was reported last week by researchers from Johns Hopkins Children's Center, the University of Mississippi Medical Center and the University of Massachusetts Medical School at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.

The infant in the report underwent antiretroviral therapy (ART) within 30 hours of birth.

“Prompt antiviral therapy in newborns that begins within days of exposure may help infants clear the virus and achieve long-term remission without lifelong treatment by preventing such viral hideouts from forming in the first place,” said Deborah Persaud, MD, Johns Hopkins Children's Center virologist and lead author on the report.

The researchers continued to test the infant for traces of viral presence until 29 days after birth when levels were undetectable. ART was continued until age 18 months. When researchers followed up with the infant 10 months after last treatment, HIV and HIV-specific antibodies could not be detected in the blood.

Currently, high-risk newborns receive a combination of antivirals at prophylactic doses to prevent infection for 6 weeks and start therapeutic doses if and once infection is diagnosed. This case, the investigators say, highlights the curative potential of very early ART and may change the focus of current practice.

The abstract presented at CROI 2013 is available here.
The news release from the Johns Hopkins Children's Center is available here.

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Survey: Honeymoon Period with EHR Ending?

Physicians are decreasingly satisfied with certified electronic health records (EHR), according to survey results released by the American College of Physicians (ACP) and AmericanEHR Partners. The survey reported a 12% decrease in user satisfaction from 2010 to 2012 and a 10% increase in users who are “very dissatisfied.”

In addition, in 2012 almost 40% of the 4,279 survey respondents reported that they would not recommend their EHR system to a colleague. This is an increase from only 24% in 2010.

The survey included a majority of practices with 10 physicians or less. Dissatisfaction or difficulty was also reported in the ability of the EHR to reduce workload and in the practice’s ability to return to pre-EHR productivity.

The ACP and American EHR Partners revealed the findings in a presentation, “Challenges with Meaningful Use: EHR Satisfaction & Usability Diminishing,” at the 2013 HIMSS Conference & Exhibition.

More findings based on the surveys are available here.

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Process Breakdowns Key in Missed Diagnoses by PCPs

Almost 80% of diagnostic errors identified in a small study of primary care physicians were the result of process breakdowns in the patient-practitioner clinical encounter, according to data published online in JAMA: Internal Medicine.

Many of the diagnoses missed were for conditions commonly seen in primary care that also carry the potential for “moderate to severe harm.”

Breakdowns during the clinical encounter most commonly occurred

• during history taking (56.3%) and physical examination (47.4%), 

• when ordering further diagnostic tests (57.4%), and

• as a result of failure to review previous documentation (15.3%).

Process breakdowns also were seen in the referral process (19.5%); follow-up and tracking of diagnostic information (14.7%); and, performance and interpretation of diagnostic tests (13.7%).

The study identified 190 unique diagnostic errors, defined as missed, delayed, or wrong diagnoses at a large Veterans Affairs facility and a large private health care system. Of the 190 cases, 68 unique diagnoses were missed including pneumonia (6.7%), decompensated congestive heart failure (5.7%), acute renal failure (5.3%), cancer (5.3%) and urinary tract infection (4.8%).

The abstract of the study is available here.
The full text of the invited commentary is available here.

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Top 10 Patient Safety Strategies Released

Clinicians can now study up on the top 10 evidence-based patient safety strategies, courtesy of Making Health Care Safer II, a report released on March 4, 2013 by the Agency for Healthcare Research and Quality as a follow-up to its initial report on patient safety in 2011.

The report discusses 41 strategies recommended for implementation, including the top 10 that physicians are strongly encouraged to implement immediately:

1. Preoperative checklists and anesthesia checklists to prevent operative and postoperative events.
2. Bundles that include checklists to prevent central line-associated bloodstream infections.
3. Interventions to reduce urinary catheter use, including catheter reminders, stop orders, or nurse-initiated removal protocols.
4. Bundles that include head-of-bed elevation, sedation vacations, oral care with chlorhexidine and subglottic suctioning endotracheal tubes to prevent ventilator-associated pneumonia.
5. Hand hygiene.
6. The do-not-use list for hazardous abbreviations.
7. Multicomponent interventions to reduce pressure ulcers.
8. Barrier precautions to prevent health care-associated infections.
9. Use of real-time ultrasonography for central line placement.
10. Intervention to improve prophylaxis for venous thromboembolism.

Ten of the 41 strategies were published today as papers in a special supplement to Annals of Internal Medicine, available here.

The entire report, including evidence reviews for all 41 patient safety strategies, can be found here.

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