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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_392"
                     title="Parents Often Err in Dosing Kids (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/Pediatrics/Parenting/tb/18290?impressionId=1265781845915"
                     
      &lt;p&gt;Adults tasked with giving their children liquid medications often gave them too much, especially when the dosing device was a cup instead of a spoon or oral syringe, researchers said.&lt;/p&gt;
&lt;p&gt;Asked to prepare a 5-mL dose for a child, adult caregivers in a study were almost always within 20% of the target when using a 5-mL syringe, according to a report in the February &lt;em&gt;Archives of Pediatric and Adolescent Medicine.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;But about 70% of the 302 parents in the trial put more than 6 mL in cups that were packaged with the medication, H. Shonna Yin, MD, of New York University, in New York City, and colleagues reported.&lt;/p&gt;
&lt;p&gt;Cups with etched markings gave the adults nearly as much trouble, the researchers found, but droppers and dosing spoons were more accurate.&lt;/p&gt;
&lt;p&gt;Yin and colleagues also found that dosing errors were nearly twice as common among caregivers who tested poorly for health literacy (adjusted OR 1.7, 95% CI 1.1 to 2.8).&lt;/p&gt;
&lt;p&gt;Given that many liquid medications come with cups, it may be necessary to reconsider how products intended for young children are packaged, the researchers suggested.&lt;/p&gt;
&lt;p&gt;&quot;Redesign of dosing devices as well as instructions for their use, with a focus on standardization and consistency, has the potential to decrease medication errors and improve safety and efficacy,&quot; Yin and colleagues wrote.&lt;/p&gt;
&lt;p&gt;The researchers recruited adults who brought children to a pediatric clinic in New York&apos;s Bellevue Hospital in late 2008. Participants were given each of six dosing instruments in random order and asked to fill it with one teaspoon (5 mL) of acetaminophen suspension.&lt;/p&gt;
&lt;p&gt;Some 95% of participants were the children&apos;s mothers, with the remaining 5% split between fathers and legal guardians. Most were Hispanic, foreign-born, and poor, and 56% spoke Spanish as their first language. Half were not high school graduates.&lt;/p&gt;
&lt;p&gt;The instruments included the cup packaged with Children&apos;s Tylenol Suspension Liquid, which has printed markings on the side; a cup with etched markings bought from a local drugstore; a 5-mL dropper; a 10-mL dosing spoon; a 5-mL syringe; and a 5-mL syringe with bottle adapter.&lt;/p&gt;
&lt;p&gt;Mean doses actually put into the cups were 6.7 mL (SD 1.7) for those with printed markings and 7.0 (SD 3.2) for those with etched markings.&lt;/p&gt;
&lt;p&gt;Although the mean doses were similar with these devices, fewer parents made errors when using the etched cup. Some 50% of doses measured with it were in the range of 4 to 6 mL, compared with only 30.5% of doses put into the cup with printed markings.&lt;/p&gt;
&lt;p&gt;Small errors (20% to 40% more or less than the target) were also less common with the etched cup: 26.6% of doses, versus 43.7% of doses measured with the printed cup. But the rate of large errors was nearly the same with the two cups, at about 25%.&lt;/p&gt;
&lt;p&gt;With the other instruments, mean doses were close to the target, ranging from 4.6 for the oral syringe with bottle adapter to 5.5 for the spoon.&lt;/p&gt;
&lt;p&gt;From 86% to 94% of doses prepared with these devices were within 20% of the 5-mL target. When errors were made, they were usually small and on the low side of the target, Yin and colleagues found.&lt;/p&gt;
&lt;p&gt;Adjusted odds ratios for making large errors, with the oral syringe as reference, were: &lt;ul&gt; &lt;li&gt;Cup with printed markings: 7.3 (95% CI 4.1 to 13.2)&lt;/li&gt; &lt;li&gt;Cup with etched markings: 6.3 (95% CI 3.5 to 11.2)&lt;/li&gt; &lt;li&gt;Dropper: 0.8 (95% CI 0.5 to 1.5)&lt;/li&gt; &lt;li&gt;Dosing spoon: 0.3 (95% CI 0.1 to 0.9)&lt;/li&gt; &lt;li&gt;Oral syringe with bottle adapter: 0.8 (95% CI 0.5 to 1.5)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;But the spoon was more often associated with dosing errors, both small and large, than the syringe, with an adjusted odds ratio of 1.7 (95% CI 1.1 to 2.7).&lt;/p&gt;
&lt;p&gt;Adjustments included caregivers&apos; age, relationship to child, marital status, language, ethnicity, U.S. birth, socioeconomic status, presence of young child, and presence of child with a chronic medical problem.&lt;/p&gt;
&lt;p&gt;Caregivers were given the Newest Vital Sign test to evaluate their health literacy, which turned out to be a factor in dosing errors, the researchers found.&lt;/p&gt;
&lt;p&gt;Scores of 0 or 1 reflected a high likelihood of limited literacy, 2 or 3 was considered &quot;possible limited literacy,&quot; and 4 to 6 was deemed adequate literacy.&lt;/p&gt;
&lt;p&gt;About 40% of participants had scores of 0 or 1 and 38% scored in the range of 2 to 3.&lt;/p&gt;
&lt;p&gt;Both levels of low health literacy predicted dosing errors, and poor literacy was also significantly associated with increased risk of large errors.&lt;/p&gt;
&lt;p&gt;Adjusted odds ratios for any dosing error and large errors associated with poor literacy were 1.7 (&lt;em&gt;P&lt;/em&gt;=0.02) and 2.3 (&lt;em&gt;P&lt;/em&gt;=0.01), respectively.&lt;/p&gt;
&lt;p&gt;Possible limited literacy predicted any dosing error and large errors with adjusted odds ratios of 1.6 (&lt;em&gt;P&lt;/em&gt;=0.04) and 1.9 (&lt;em&gt;P&lt;/em&gt;=0.07), respectively.&lt;/p&gt;
&lt;p&gt;These findings on health literacy and medication errors have important implications for the design of dosing instruments, Yin and colleagues indicated.&lt;/p&gt;
&lt;p&gt;&quot;Provision of instruments designed to place fewer literacy demands on families is one strategy to decrease dosing errors,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;Limitations to the study included its setting in a clinic, which may not reflect parents&apos; performance at home; the largely Hispanic immigrant sample with low socioeconomic status; and the use of a written test to assess health literacy, which does not measure verbal comprehension and other skills that may contribute to health literacy.&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 from internal sources. Yin received partial support from the Pfizer Fellowship in Health Literacy/Clear Health Communication.&lt;/p&gt;&lt;p&gt;No potential conflicts of interest were reported.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_272"
                     title="Feds Find Twice Max Dose of Stimulant in Weight Drug Fake"
                     score="0.004"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18129?impressionId=1265781845915"
                     
      &lt;p&gt;WASHINGTON  --  FDA laboratory tests showed counterfeit samples of the weight-loss drug Alli contain twice the maximum recommended dose of sibutramine, the potentially dangerous active ingredient in another diet pill.&lt;/p&gt;
&lt;p&gt;Patients exposed to such high levels of sibutramine can experience anxiety, nausea, heart palpitations, tachycardia, insomnia, and increased blood pressure, the agency said.&lt;/p&gt;
&lt;p&gt;Those with a history of heart disease are at an even greater health risk, as the excessive levels of the ingredient may cause a stroke or myocardial infarction.&lt;/p&gt;
&lt;p&gt;Sibutramine is an ingredient in the FDA-approved weight-loss drug Meridia, but it is only available through prescription, in specific doses, and under the supervision of a healthcare professional. The FDA considers it a controlled substance.&lt;/p&gt;
&lt;p&gt;On Jan. 28 the FDA first alerted healthcare professionals and patients to the fake drug, which is primarily available over the Internet.&lt;/p&gt;
&lt;p&gt;The warning included a list of several visible differences in packaging and capsule makeup between the legitimate and counterfeit product, aside from the replacement of orlistat with sibutramine. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/18011&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/18011&quot; target=&quot;_blank&quot;&gt;FDA Warns of Fake OTC Weight-Loss Drug&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;The updated warning noted that the imitation is primarily peddled through online auction sites.&lt;/p&gt;
&lt;p&gt;Patients with the fake should still dispose of it immediately and contact the FDA&apos;s Office of Criminal Investigations, as well as the manufacturer of the real product, GlaxoSmithKline, the FDA said in the warning.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_178"
                     title="FDA Warns of Fake OTC Weight-Loss Drug"
                     score="-0.002"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18011?impressionId=1265781845915"
                     
      &lt;p&gt;WASHINGTON  --  The FDA is warning consumers about a counterfeit version of the over-the-counter weight-loss drug Alli that replaces the drug&apos;s active ingredient, orlistat, with potentially harmful sibutramine.&lt;/p&gt;
&lt;p&gt;The sibutramine in the fake 60 mg capsules is contraindicated in some patient populations  --  including those with coronary artery disease or a history of stroke  --  and may cause adverse interactions with other medicines, the agency said. Sibutramine is an appetite suppressant but is also a controlled substance available by prescription only.&lt;/p&gt;
&lt;p&gt;The real Alli differs in several ways from its imitator, aside from the dangerous switch of active ingredients, the FDA said. The counterfeit product has: &lt;ul&gt; &lt;li&gt;No &quot;Lot&quot; code on its cardboard packaging&lt;/li&gt; &lt;li&gt;An expiration date that includes month, day, and year (such as 06162010) instead of month and year (such as 06/10)&lt;/li&gt; &lt;li&gt;Taller and wider caps with coarser ribbing than the real product&lt;/li&gt; &lt;li&gt;Plain foil inner safety seals as opposed to the genuine article&apos;s printed, &quot;SEALED for YOUR PROTECTION&quot;&lt;/li&gt; &lt;li&gt;Larger capsules filled with a white powder instead of small white pellets&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Consumers reported the counterfeit to drug manufacturer GlaxoSmithKline. The company found the drug was being marketed over the Internet but has found no evidence the imitation has made its way onto store shelves, the FDA said in a release.&lt;/p&gt;
&lt;p&gt;Pictures comparing the fakes with the original product can be seen on the &lt;a href=&quot;http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm&quot; mce_href=&quot;http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm&quot; target=&quot;_blank&quot;&gt;FDA&apos;s Web site&lt;/a&gt;.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_163"
                     title="Obama Pushs for Change on Biologics in Healthcare Bill"
                     score="-0.004"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/17996?impressionId=1265781845915"
                     
      &lt;p&gt;WASHINGTON  --  President Obama has signaled his support for renegotiating a provision in the healthcare reform bill to allow generic versions of biologics to hit the market more quickly.&lt;/p&gt;
&lt;p&gt;Both the House and the Senate bills include provisions to establish a pathway that would allow generic companies to have biologics approved. Currently, no such pathway exists. The provisions would offer brand-name biologic companies a 12-year period during which generic companies would be barred from introducing a competing product.&lt;/p&gt;
&lt;p&gt;In a Thursday closed-door question-and-answer session with members of the House, Obama suggested that a shorter exclusivity period might be in order, even though &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/15108&quot; mce_href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/15108&quot; target=&quot;_blank&quot; title=&quot;Biotech&amp;#8200;Industry&amp;#8200;Flexes&amp;#8200;Muscle&amp;#8200;in&amp;#8200;Biologics&amp;#8200;Debate&amp;#8200;on&amp;#8200;the&amp;#8200;Hill&quot;&gt;Senate&lt;/a&gt; and &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/15336&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/15336&quot; target=&quot;_blank&quot; title=&quot;Week&amp;#8200;7:&amp;#8200;House&amp;#8200;Panel&amp;#8200;Approves&amp;#8200;Health&amp;#8200;Reform&amp;#8200;Bill&quot;&gt;House&lt;/a&gt; committees voted strongly in support of 12-year exclusivity.&lt;/p&gt;
&lt;p&gt;Members of Congress who have biologic companies in their districts  --  such as Rep. Anna Eshoo (D-Calif.)  --  support the 12-year period, arguing that biologics are so complex that it would take at least that long for generic companies to produce so-called &quot;biosimilars.&quot;&lt;/p&gt;
&lt;p&gt;But some, including Rep. Henry Waxman (D-Calif.), have said the long exclusivity period will harm patients who will have to wait years to see cheaper versions of drugs for diseases like cancer and multiple sclerosis. In addition, some argue that if significantly less expensive biosimilars come to the market earlier, the nation&apos;s drug costs would be reduced.&lt;/p&gt;
&lt;p&gt;The Obama administration has signaled his support for a shorter exclusivity period all along, said &lt;span&gt;&lt;span&gt;Katie Huffar&lt;/span&gt;, a spokesperson for Coalition for a Competitive Pharmaceutical Market (&lt;span&gt;CCPM&lt;/span&gt;), a group comprised of generic drug companies, pharmacies, several insurance companies, and other corporations.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&quot;The administration has been saying they think it&apos;s too much,&quot; she said.&lt;/p&gt;
&lt;p&gt;There don&apos;t appear to be any supporters of the 12-year exclusivity period at the negotiating table as members of the House and the Senate work with the White House to hammer out a final bill. What&apos;s more, Waxman, who is the House&apos;s biggest opponent of the long exclusivity period, has a seat at that table.&lt;/p&gt;
&lt;p&gt;A spokesperson for Waxman declined to discuss details of negotiation process.&lt;/p&gt;
&lt;p&gt;However, the powerful pharmaceutical lobby, PhRMA, supports the longer exclusivity period, and it&apos;s unclear what effect shortening the period would have on the deal that PhRMA struck with the White House earlier in the healthcare reform process. Under that deal, the drug companies agreed to support reform if the White House promised to limit the industry&apos;s losses to $80 billion over 10 years.&lt;/p&gt;
&lt;p&gt;Huffar said her group has been assured that biogenerics were not part of the deal.&lt;/p&gt;
&lt;p&gt;&quot;No one on the government side of that deal shook on 12 years,&quot; she said.&lt;/p&gt;
&lt;p&gt;A spokesperson for PhRMA said the deal hadn&apos;t changed as of Friday, and the group issued a statement reiterating its support for the 12-year period.&lt;/p&gt;
&lt;p&gt;&quot;...At least 12 years of data protection is needed to help recoup the significant development costs for biologic innovators and to fund research on future treatments and cures,&quot; said PhRMA senior vice president Ken Johnson in the statement. &lt;/p&gt;
&lt;p&gt;During Thursday&apos;s Q&amp;amp;A with the president, Eshoo told Obama that Congress had already overwhelmingly backed the 12-year exclusivity period, a source familiar with the exchange told &lt;em&gt;MedPage Today. &lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Indeed, the House Energy and Commerce Committee voted 47 to 11 to add the biologics amendment to the heatlhcare reform bill and the Senate Health, Education, Labor and Pensions Committee approved the amendment 16 to 7.&lt;/p&gt;
&lt;p&gt;Eshoo criticized healthcare reform negotiators&apos; willingness to ditch the 12-year period when other pharmaceutical elements of the reform bill seem to be &quot;sacrosanct,&quot; the source said.&lt;/p&gt;
&lt;p&gt;Obama replied that &quot;nothing is sacrosanct,&quot; according to a House aide.&lt;/p&gt;
&lt;p&gt;In a letter to Speaker of the House Nancy Pelosi (D-Calif.) that is currently gaining signatures, Eshoo writes:&lt;/p&gt;
&lt;p&gt;&quot;While so many issues are still left unresolved in the debate over healthcare in both the House and Senate, this is an issue that has had overwhelming support from both sides. Additionally, it is an issue both Democrats and Republicans have found agreement on. Changing language that is virtually identical for purpose of a final agreement would be unheard of in a traditional conference approach.&quot;&lt;/p&gt;
&lt;p&gt;But healthcare reform is not moving along according to tradition. Congressional leaders decided to &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17812&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17812&quot; target=&quot;_blank&quot; title=&quot;Congress&amp;#8200;Likely&amp;#8200;to&amp;#8200;Combine&amp;#8200;Healthcare&amp;#8200;Bills&amp;#8200;Informally&quot;&gt;informally combine&lt;/a&gt; the Senate and House bills instead of using the traditional conference approach, which would likely result in a Republican filibuster.&lt;/p&gt;
&lt;p&gt;As of now, it appears that no deal on the biosimilar language has been reached.&lt;/p&gt;
&lt;p&gt;Negotiators are still finalizing details of the healthcare reform bill and are expected send it to the Congressional Budget Office (CBO) in the next few days for a cost estimate.&lt;/p&gt;
&lt;p&gt;Congressional leaders have promised that the bill would be posted for 72 hours before any major vote is taken on it.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_153"
                     title="McNeil Expands OTC Drug Recall"
                     score="-0.004"
                     href="http://www.medpagetoday.com/InfectiousDisease/PublicHealth/tb/17980?impressionId=1265781845915"
                     
      &lt;p&gt;A recall of Tylenol Arthritis Pain Caplet 100-count bottles started in November has been expanded to include about 500 lots of other popular over-the-counter drugs, the FDA announced today.&lt;/p&gt;
&lt;p&gt;Affected are certain lots of various adult and children&apos;s Tylenol products, Motrin IB tablets and caplets, Benadryl Allergy tablets, Rolaids antacid tablets, Simply Sleep mini-caplets, and St. Joseph chewable and safety-coated aspirin, all made by McNeil Consumer Healthcare.&lt;/p&gt;
&lt;p&gt;Not all of the lots have been linked to consumer complaints of &quot;an unusual, moldy, musty, or mildew-like odor,&quot; but they all have the potential to be affected, according to the company.&lt;/p&gt;
&lt;p&gt;Specific lot numbers affected by the recall can be found at a Web page set up to provide information about the &lt;a href=&quot;http://www.mcneilproductrecall.com&quot; mce_href=&quot;http://www.mcneilproductrecall.com&quot; target=&quot;_blank&quot;&gt;McNeil Product Recall&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;The FDA urged McNeil to perform a thorough investigation into the complaints, which eventually resulted in the expanded voluntary recall. By law, the FDA cannot force a company to withdraw products.&lt;/p&gt;
&lt;p&gt;In a small number of cases, the smell resulted in temporary and nonserious reactions, such as nausea, vomiting, stomach pain, and diarrhea, Deborah Autor, director of the office of compliance in FDA&apos;s Center for Drug Evaluation and Research, said on a conference call with reporters.&lt;/p&gt;
&lt;p&gt;Autor scolded McNeil for taking too long to expand their investigation upon learning of the complaints. She said the company became aware of the problem in September 2008 but did not inform the FDA until about a year later. The FDA has sent the company a warning letter.&lt;/p&gt;
&lt;p&gt;&quot;McNeil should have acted faster,&quot; she said. &quot;When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem.&quot;&lt;/p&gt;
&lt;p&gt;An investigation by McNeil determined that the smell is caused by a chemical called 2,4,6-tribromoanisole (TBA), which is formed when a chemical used to treat wood pallets breaks down.&lt;/p&gt;
&lt;p&gt;The wood pallets are used to transport and store materials used in packaging drugs.&lt;/p&gt;
&lt;p&gt;Autor said the FDA is looking into whether any other companies used the same pallets.&lt;/p&gt;
&lt;p&gt;McNeil initially recalled five lots of Tylenol Arthritis Pain Caplet 100-count bottles in November, and subsequently expanded the recall in December to all available lots of the product. (See &lt;a href=&quot;http://www.medpagetoday.com/PainManagement/PainManagement/17713&quot; mce_href=&quot;http://www.medpagetoday.com/PainManagement/PainManagement/17713&quot; target=&quot;_blank&quot;&gt;Company Recalls Tylenol for Arthritis&lt;/a&gt;)&lt;/p&gt;

    </recommendedItem>
</recommendedContent>