AMA urges Supreme Court to overturn ruling upholding pay-for-delay deals.

American Medical News (2/11, Gallegos) reports that "the American Medical Association is among those weighing in on a U.S. Supreme Court case that could set an important precedent for how quickly patients can access generic versions of medications." According to the article, "the high court will hear arguments March 25 about so-called pay-for-delay deals, in which brand-name drugmakers pay generic companies to end patent litigation and delay the introduction of equivalent generics." The report adds, "in a Jan. 29 friend-of-the-court brief, the AMA urged the Supreme Court to overturn a ruling by the 11th U.S. Circuit Court of Appeals upholding such agreements."

Readmission causes, timing and reductions analyzed

Readmissions of recently hospitalized patients were the focus of several studies published last week in the Jan. 23/30 Journal of the American Medical Association.

The first study assessed Medicare patients who were hospitalized between 2007 and 2009 for heart failure (HF), acute myocardial infarction (MI) or pneumonia. Within 30 days of discharge, 24.8% of HF patients had been readmitted, as had 19.9% of MI patients and 18.3% of pneumonia patients. However, most of these patients were readmitted for a reason other than the primary diagnosis of their initial hospitalizations. Researchers also looked at the timing of readmissions, finding that the median time to readmission was 10 days for MI and 12 for HF and pneumonia, but that readmissions were frequent throughout the month. Based on these findings, the authors called for broader approaches to preventing readmissions, rather than efforts focused on specific diseases or limited time periods after discharge.

The second study looked at how often recently hospitalized patients had treat-and-release visits to emergency departments (EDs), in addition to being readmitted. The prospective study included more than four million patients 18 and older hospitalized in California, Florida and Nebraska in 2008 to 2009. Researchers found that 17.9% of hospitalizations resulted in another acute care encounter within 30 days. Most of these encounters were hospital readmissions, but 39.8% were treat-and-release ED visits. The rate of ED visits varied by condition, with digestive disorders and psychosis being the highest-volume causes. The most common reasons for returning to the ED were related to the diagnosis of the initial hospitalization. Study authors concluded that the many studies and interventions focused solely on 30-day readmissions miss these common ED encounters.

Finally, the third study reported on a successful effort to reduce readmissions, conducted by the Centers for Medicare and Medicaid Services. A multicomponent care transitions intervention was applied in 14 communities in 2009 to 2010, and 30-day readmission rates were compared before and after in the intervention communities and 50 control communities. The mean rate of 30-day readmissions dropped in both groups, but more significantly in the intervention communities; intervention communities dropped from 15.21 readmissions per 1,000 beneficiaries per quarter in 2006 to 2008 to 14.34 in 2009 to 2010 versus from 15.03 per 1,000 to 14.72 in control communities over the same time periods (P=0.03). The overall mean rate of hospitalizations followed a similar trend, with the result that readmissions didn't decrease as a percentage of all hospitalizations. The authors noted that the project's interventions (such as better elder care in the community, palliative care counseling, disease management, and care plans) were intended to improve the quality of care transitions.

Combined, the findings of these studies support a patient-centered approach to improving care and reducing readmissions, concluded an accompanying editorial. The studies highlight the fragmentation of care under the current system. Attempts to correct this and reduce readmissions should be broadly focused, using multiple solutions and engaging the community, the editorialist wrote.

Updated sepsis guidelines released

San Juan, Puerto Rico—The 2012 Surviving Sepsis Guidelines Committee officially released updated guidelines for managing severe sepsis and septic shock during the Society of Critical Care Medicine's 42nd Congress here last week.

Recommendations were designated as strong (1) or weak (2) based on evidence that ranged from high (A) to very low (D). A new category of "ungraded" or "UG" evidence was introduced to signify recommendations the guidelines committee felt were not conducive to grading. Changes in the new version from the 2008 version include:

• Initial fluid resuscitation with crystalloid (1B). The 2008 guidelines didn't specify a preference for crystalloid vs. colloid fluid resuscitation (1B).
• Norepinephrine as the first-choice vasopressor to maintain mean arterial pressure ≥65 mm Hg (1B). The 2008 guidelines didn't specify a preference for norepinephrine vs. dopamine (1C).
• Avoidance of neuromuscular blockers if possible in patients without acute respiratory distress syndrome (ARDS) (1C) and a short course (≤48 hours) of neuromuscular blockers for patients with early ARDS and a Pao₂/Fio₂ <150 mm Hg (2C). The 2008 guidelines suggested blanket avoidance of neuromuscular blockers if possible (1B).
• A protocolized approach to blood glucose management that starts insulin dosing when two consecutive blood glucose levels are >180 mg/dL and targets an upper blood glucose ≤180 mg/dL (1A). The 2008 guidelines suggested targeting a blood glucose <150 mg/dL after initial stabilization (1C).
• Oral or enteral (if necessary) feedings, as tolerated, rather than either complete fasting or provision of only intravenous glucose within the first 48 hours after a diagnosis of severe sepsis/septic shock (1C). The 2008 guidelines didn't discuss feedings.
• Addressing goals of care, such as treatment plans and end-of-life planning as appropriate (1B), as early as possible, but within 72 hours of ICU admission (2C). The 2008 guidelines didn't specify a time period for advance care planning (1D).

Though many recommendations remained unchanged from the 2008 version, their quality of evidence grades were updated. For example, the strong recommendation to institute protocols for weaning and sedation was upgraded from "B" in 2008 to "A" in 2012 based on newer clinical trials. Likewise, the strong recommendation to promptly perform imaging studies to confirm a potential source of infection went from "C" to "UG".

"Most of these recommendations are appropriate for the severe sepsis patient in the ICU and non-ICU settings," the committee wrote. "In fact, the committee believes the greatest outcome improvement can be made through education and process changes for those caring for severe sepsis patients in the non-ICU setting and across the spectrum of acute care."

The guidelines committee comprised representatives of 30 international groups, with co-chairs and executive members appointed by the Society of Critical Care Medicine and European Society of Intensive Care Medicine governing bodies. The guidelines, based on literature published through fall 2012, also appear in the February issue of Critical Care Medicine and will appear in February'sIntensive Care Medicine .

—Jessica Berthold

FDA advisory panel recommends new restrictions on hydrocodone products.

An FDA advisory panel's recommendation regarding hydrocodone restrictions received a substantial amount of coverage in print, online, and on two of last night's national news broadcasts. Some sources pointed out that the FDA was likely to adopt the recommendation. Additionally, many sources pointed out that the recommendation did face some criticism, particularly from pain patient advocacy groups.

        The CBS Evening News (1/25, story 9, 0:15, Pelley, 5.58M) reported that "an FDA advisory panel" has "recommended new restrictions on prescriptions and refills" of products containing hydrocodone.

        ABC World News (1/25, story 8, 0:30, Sawyer, 7.43M) reported, "The FDA is expected to follow the recommendation making it more difficult to get those drugs prescribed because of all the abuse."

        The Los Angeles Times (1/26, Girion, 692K) reports that the panel "recommended Friday that the agency reclassify hydrocodone...as a Schedule II narcotic, placing it in the same category as other widely abused medications," such as "fentanyl." Should the agency approve "the change, patients would be able to get fewer hydrocodone pills at one time, and there would be more restrictions on refills. In addition, pharmacies would have to follow stricter procedures for handling and storing the drug."

        The New York Times (1/26, Tavernise, Subscription Publication, 1.68M) reports, however, that "at 19 to 10, the vote was far from unanimous, with some opponents expressing skepticism that the change would do much to combat abuse." Still, the Times points out that "the drug agency is likely to follow" the recommendation.

        The AP (1/25) reports, "FDA officials closed the meeting by acknowledging the difficulty of combating hydrocodone abuse, while keeping the drugs available for patients who legitimately need them." Douglas Throckmorton, the agency's deputy director for regulatory programs, said, "There is an unquestioned epidemic of opioid abuse, overdose and death in this country, an epidemic we need to address as a society."

        The Wall Street Journal (1/26, Catan, Martin, Subscription Publication, 2.29M) points out that the FDA has previously rejected prior requests by the Drug Enforcement Administration to reclassify products containing hydrocodone.

        CNN (1/25, Smith) reports that "pain patient advocacy groups and pharmaceutical companies, among others, fear that reclassification will make it harder for patients to get medications they need." Bloomberg News (1/26, Edney) also covers the story.

FDA approves OTC overactive-bladder treatment.

Reuters (1/26, Berkrot) reported that the US Food and Drug Administration on Friday announced it has approved an over-the-counter version of Merck's Oxytrol (oxybutynin) as a treatment for overactive bladder in women ages 18 years and older. The agency noted that findings from nine trials involving 5,000 study participants, showed that consumers readily understand information on the drug-product's labeling and that they are able to use oxybutynin appropriately. The Whitehouse Station, New Jersey-based pharmaceutical company said it expects to launch the OTC version on the market in the fall. However, the FDA said that for men with overactive bladder, only the prescription version of Oxytrol will be available.

        According to MedPage Today (1/26, Gever), Merck "did not seek OTC status for the product in men." The nine studies showed that men were "relatively poor at correctly determining whether oxybutynin was the appropriate treatment for their urination problems. A key worry is that incorrect self-diagnosis in men could delay detection of prostate cancer."

        The Triangle Business Journal (1/26, Ohnesorge, Subscription Publication) noted that the FDA's approval made Oxytrol the first, overactive bladder treatment in the anticholinergics class to become available OTC. Oxytrol is a "patch applied to the skin every four days."

        WebMD (1/26, Doheny) also covered the story, noting that according to Merck, "more than 20 million American women" have overactive bladders.

FDA approves OTC overactive-bladder treatment.

Reuters (1/26, Berkrot) reported that the US Food and Drug Administration on Friday announced it has approved an over-the-counter version of Merck's Oxytrol (oxybutynin) as a treatment for overactive bladder in women ages 18 years and older. The agency noted that findings from nine trials involving 5,000 study participants, showed that consumers readily understand information on the drug-product's labeling and that they are able to use oxybutynin appropriately. The Whitehouse Station, New Jersey-based pharmaceutical company said it expects to launch the OTC version on the market in the fall. However, the FDA said that for men with overactive bladder, only the prescription version of Oxytrol will be available.

        According to MedPage Today (1/26, Gever), Merck "did not seek OTC status for the product in men." The nine studies showed that men were "relatively poor at correctly determining whether oxybutynin was the appropriate treatment for their urination problems. A key worry is that incorrect self-diagnosis in men could delay detection of prostate cancer."

        The Triangle Business Journal (1/26, Ohnesorge, Subscription Publication) noted that the FDA's approval made Oxytrol the first, overactive bladder treatment in the anticholinergics class to become available OTC. Oxytrol is a "patch applied to the skin every four days."

        WebMD (1/26, Doheny) also covered the story, noting that according to Merck, "more than 20 million American women" have overactive bladders.

Study: NSAIDs can cause kidney damage in children.

The Huffington Post (1/26, Reid) reported, "Giving children painkillers such as Advil [ibuprofen] and Aleve [naproxen] instead of Tylenol [acetaminophen] or no drugs at all can lead to serious kidney damage, according to a new study."

        HealthDay (1/26, Reinberg) reported, "For the study, which was published in the Jan. 25 online edition of the Journal of Pediatrics," researchers "looked at the medical records of children admitted to Riley Hospital for Children in Indianapolis from 1999 through mid-2010. Over that time, they identified more than 1,000 cases of children being treated for kidney damage."

        MedPage Today (1/26, Neale) reported that "2.7% of" the "acute kidney injury cases identified...were determined to be caused by NSAID exposure," including "21 patients who had clinical, laboratory, radiographic, or pathologic findings suggestive of NSAID-associated acute tubular necrosis and six who had findings indicative of NSAID-associated acute interstitial nephritis." The investigators found that "the most common agent used in the cases of NSAID-associated acute kidney injury was ibuprofen (67%)."

        CBC News (CAN) (1/26) adds, "The researchers called nonsteroidal anti-inflammatory or NSAIDs such as ibuprofen, perhaps the most common avoidable risk for acute kidney failure in children. The drugs are given to relieve pain and fever."