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    <recommendedItem id="20100101_19_296"
                     title="FDA Okays Morphine for Tolerant Patients"
                     score="0.002"
                     href="http://www.medpagetoday.com/PainManagement/PainManagement/tb/18157?impressionId=1265759543749"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the first high-concentration, oral morphine sulfate solution as part of its unapproved drugs initiative.&lt;/p&gt;
&lt;p&gt;The drug is indicated for opioid-tolerant patients with moderate-to-severe acute and chronic pain, as well as end-of-life care.&lt;/p&gt;
&lt;p&gt;Opioid tolerance was defined as a patient using 60 mg of an opioid per day, Sharon Hertz, MD, deputy director of the Division of Anesthesia, Analgesics, and Rheumatoid Products at the Center for Drug Evaluation and Research, said in a conference call.&lt;/p&gt;
&lt;p&gt;The new solution is available in 100 mg per 5 mL and 20 mg per 1 mL concentrations.&lt;/p&gt;
&lt;p&gt;Although morphine use in pain management has been a common practice, this form and concentration of the drug was not previously FDA approved.&lt;/p&gt;
&lt;p&gt;Approval for the new drug was based on efficacy and safety data already available, which applicants can use when seeking approval for unapproved formulations of drugs with a known safety profile, Hertz said.&lt;/p&gt;
&lt;p&gt;The FDA initiated the unapproved drugs initiative in March, 2009, when it sent warning letters to nine companies requesting they pull a number of morphine sulfate, oxycodone, and hydromorphone products from the market. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13526&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13526&quot; target=&quot;_blank&quot;&gt;FDA Acts Against Unapproved Narcotic Drugs&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Seven of the warned companies produced unapproved concentrated morphine sulfate, but the FDA granted a reprieve from the initiative when it could not find a suitable approved replacement for the drug without disrupting patient care. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13682&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13682&quot; target=&quot;_blank&quot;&gt;FDA Gives Temporary Reprieve to Unapproved Morphine Elixir&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;The agency worked with manufacturer Roxane Laboratories to ensure that a sufficient supply of the drug was available and to develop a prescription and use guide for the medication.&lt;/p&gt;
&lt;p&gt;As part of the approval, the manufacturer needed to establish a safety profile prior to approval to address the risks of morphine misuse, abuse, and overdose.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_236"
                     title="Prenatal Counseling Reduces Domestic Violence (CME/CE)"
                     score="-0.003"
                     href="http://www.medpagetoday.com/OBGYN/DomesticViolence/tb/18085?impressionId=1265759543749"
                     
      &lt;p&gt;Pregnant African-American women who received counseling to improve their physical and psychological health and safety were less likely to be the victims of domestic violence during pregnancy and postpartum, a new study found.&lt;/p&gt;
&lt;p&gt;Women who received the cognitive and behavioral integrated intervention were less likely to experience recurrent episodes of intimate partner violence victimization (OR 0.48, 95% CI 0.29 to 0.80), according to a report in the Jan. 21 issue of &lt;em&gt;Obstetrics &amp;amp; Gynecology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Counseled women who had reported previous minor intimate partner violence were significantly less likely to experience further episodes during pregnancy (OR 0.48, 95% CI 0.26 to 0.86) and after they gave birth (OR 0.56, 95% CI 0.34 to 0.93).&lt;/p&gt;
&lt;p&gt;Furthermore, counseled women were less likely to give birth very preterm (&amp;lt;33 weeks gestation) than mothers who received no counseling (1.5% versus 6.6% respectively; &lt;em&gt;P&lt;/em&gt;=0.03), and the babies of counseled women had a longer mean gestational age at delivery.&lt;/p&gt;
&lt;p&gt;&quot;A relatively brief intervention during pregnancy had discernible effects on intimate partner violence and pregnancy outcomes,&quot; Michele Kiely, DrPH, of Eunice Kennedy Shriver National Institute of Child Health and Human Development, and colleagues wrote.&lt;/p&gt;
&lt;p&gt;&quot;Screening for intimate partner violence as well as other psychosocial and behavioral risks and incorporating similar interventions in prenatal care is strongly recommended.&quot;&lt;/p&gt;
&lt;p&gt;Intimate partner violence is a pattern of assault and coercion that includes the threat or infliction of physical, sexual, or psychological abuse.&lt;/p&gt;
&lt;p&gt;Approximately 4.8 million episodes of intimate partner violence occur every year in the U.S. in women 18 years and older, according to the CDC.&lt;/p&gt;
&lt;p&gt;Victims are at higher risk for a range of psychobehavioral and health problems, including complications during pregnancy and adverse pregnancy outcomes, such as preterm delivery and low birth weight.&lt;/p&gt;
&lt;p&gt;Kiely and colleagues set out to determine whether a cognitive behavioral intervention administered during pregnancy could reduce intimate partner violence and improve birth outcomes in a population of African-American residents of Washington, DC.&lt;/p&gt;
&lt;p&gt;Of the 1,044 women enrolled in the study between July 2001 and October 2003, 521 were randomly assigned to receive the intervention and 523 to receive usual care. At an initial interview, 336 of the women reported intimate partner violence victimization in the past year, evenly divided between the intervention group and usual care.&lt;/p&gt;
&lt;p&gt;The women in the intervention group received individually tailored counseling and information that addressed the problems they reported.&lt;/p&gt;
&lt;p&gt;The counselors provided information about the types of abuse and the cycle of violence and assessed the level of danger to which the women were exposed.&lt;/p&gt;
&lt;p&gt;They discussed preventive options the women might consider, such as filing a protection order, and the development of a safety plan. The women also received a list of community resources and information on the health risks of smoking and how to cope with depression.&lt;/p&gt;
&lt;p&gt;The complete intervention included eight prenatal sessions delivered during routine prenatal care visits, and researchers conducted follow-up interviews over the phone with the women.&lt;/p&gt;
&lt;p&gt;They found that women in the intervention group who had previously experienced severe intimate partner violence showed a significant reduction in episodes after giving birth (OR 0.39, 95% CI 0.18 to 0.82) and that women who experienced physical violence specifically showed significant reductions by their first follow-up prenatal visit (OR 0.49, 95% CI 0.27 to 0.91) and postpartum (OR 0.47, 95% CI 0.27 to 0.82).&lt;/p&gt;
&lt;p&gt;&quot;There is evidence that this intervention for pregnant African-American women reduced intimate partner violence victimization during pregnancy and improved pregnancy outcome,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;If generalizable, our results should encourage healthcare providers and third party payers to go beyond screening for psychosocial and behavioral risks to providing services during prenatal care to address such risks. The potential cost savings associated with reduction of births within the highest risk category may be substantial.&quot;&lt;/p&gt;
&lt;p&gt;The authors cautioned that the study was not designed to test whether the intervention was effective at reducing adverse pregnancy outcomes but rather focused on reducing psychobehavioral risks.&lt;/p&gt;
&lt;p&gt;They also noted that only 59% of the women in the intervention group completed all eight sessions, indicating that as a group they were only modestly committed to participating in the program.&lt;/p&gt;
&lt;p&gt;Further improvements to the intervention strategy could be made to address other issues, such as alcohol and drug use, they wrote. &quot;Had we addressed these, we might have been even more successful,&quot; they concluded.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center on Minority Health and Health Disparities.&lt;/p&gt;&lt;p&gt;The authors reported no financial conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_212"
                     title="No Need for Most Moms to Fast During Labor (CME/CE)"
                     score="-0.004"
                     href="http://www.medpagetoday.com/OBGYN/Pregnancy/tb/18059?impressionId=1265759543749"
                     
      &lt;p&gt;Although conventional wisdom has long held that women shouldn&apos;t eat or drink during labor, the scientific evidence suggests there&apos;s no reason for the prohibition, according to a new meta-analysis.&lt;/p&gt;
&lt;p&gt;&quot;Since the evidence shows no benefits or harms, there is no justification for the restriction of fluids and food in labor for women at low risk of complications,&quot; Mandisa Singata, MBA, RM, RN, of the University of the Witwatersrand in East London, South Africa, and colleagues concluded in a Cochrane review.&lt;/p&gt;
&lt;p&gt;They identified five studies involving 3,130 women that examined whether food and drink during labor affected outcomes such as rates of cesarean section, operative vaginal births, or Apgar scores. No significant advantage was found for restricting access to food or liquids on any outcome, Singata and colleagues found.&lt;/p&gt;
&lt;p&gt;Until the 1940s, women were generally encouraged to eat and drink during labor  --  often specific foods and fluids  --  to keep up their strength.&lt;/p&gt;
&lt;p&gt;But a 1946 paper and other publications by Curtis Lewis Mendelson suggested that access to food increased the risk that women under anesthesia would aspirate acidic stomach contents during labor, potentially causing serious lung injury and even death.&lt;/p&gt;
&lt;p&gt;Mendelson&apos;s work persuaded many obstetricians to urge that women fast until after delivery, according to Singata and colleagues.&lt;/p&gt;
&lt;p&gt;The researchers cited a 1988 survey of U.S. hospitals that found almost half allowed only ice chips, although more recent trends suggested that access to food and liquids had increased, at least in Great Britain.&lt;/p&gt;
&lt;p&gt;They noted that some women in labor don&apos;t feel like eating but others regard restrictions as &quot;unpleasant and sometimes harrowing.&quot;&lt;/p&gt;
&lt;p&gt;One reason for revisiting Mendelson&apos;s research is that anesthesia procedures have changed markedly since the 1940s, with regurgitation of stomach contents now considered very rare.&lt;/p&gt;
&lt;p&gt;&quot;The policy of routine restriction of foods and fluids in labor in many hospitals across the world generally does not reflect women&apos;s preferences or cultural expectations,&quot; Singata and colleagues wrote. &quot;It is critical that any policy should be based on evidence of overall benefit to women and babies.&quot;&lt;/p&gt;
&lt;p&gt;Searching the literature, Singata and colleagues found five randomized trials that had compared more versus less restrictive nutrition regimens.&lt;/p&gt;
&lt;p&gt;Only one of the trials tested free access to any kind of food and drink against restriction to ice chips or sips of water. The other four examined particular classes of nutritive foods or drinks.&lt;/p&gt;
&lt;p&gt;Two tested electrolyte-carbohydrate sports drinks and two others evaluated low-fat and/or low-residue foods, all against water or ice chips.&lt;/p&gt;
&lt;p&gt;Pooling data from the five studies, Singata and colleagues calculated relative risks for three major adverse outcomes for allowing access to nutrition, versus water or ice chips: &lt;ul&gt; &lt;li&gt;Cesarean section: RR 0.89, 95% CI 0.63 to 1.25&lt;/li&gt; &lt;li&gt;Operative vaginal birth: RR 0.98, 95% CI 0.88 to 1.10&lt;/li&gt; &lt;li&gt;Apgar scores &amp;lt;7 at five minutes: RR 1.43, 95% CI 0.77 to 2.68&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The meta-analysis also examined eight other outcomes, such as maternal ketosis and nausea and vomiting, infant admission to intensive care, and augmentation of labor. There were no significant differences in any of these outcomes between allowing and restricting access to nutrition.&lt;/p&gt;
&lt;p&gt;The sole study comparing unlimited access to food and drink to water or ice chips, which had 330 participants, also found no effects on either primary or secondary outcomes in either direction.&lt;/p&gt;
&lt;p&gt;None of the studies examined women&apos;s perceptions of the labor experience based on whether or not they had access to nutrition.&lt;/p&gt;
&lt;p&gt;Singata and colleagues called the overall quality of evidence &quot;reasonable.&quot; But they noted that none of the studies enrolled women at increased risk of needing general anesthesia, so the conclusions should be interpreted as applying only to women at low risk of complications.&lt;/p&gt;
&lt;p&gt;The studies also left some questions unanswered. For example, one of the two sports drink studies found that C-section rates were lower in participants who drank plain water, but no such result was seen in the other.&lt;/p&gt;
&lt;p&gt;&quot;It would be worth comparing the use of carbohydrate drinks ... with freedom to eat and drink at will during labour to see if this really is a problem,&quot; Singata and colleagues wrote.&lt;/p&gt;
&lt;p&gt;Moreover, they suggested, &quot;a better approach&quot; to the rare problem of inhaling regurgitated material while under anesthesia during labor may be to test treatments intended to reduce acidity and volume of stomach contents, now used during elective C-sections.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;External funding for the study came from the World Health Organization and the U.K. National Institute for Health Research.&lt;/p&gt;&lt;p&gt;One author of the review was principal author of one of the studies included in the meta-analysis, but did not participate in decisions regarding data from that study. No other potential conflicts were reported.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_10_6"
                     title="Fetal Pain Called Unlikely Before Third Trimester"
                     score="-0.006"
                     href="