This morning, the FDA announced that it is proposing new rules that would require the manufacturers of emergency defibrillator systems to conduct clinical trials on their products before they would receive marketing approval.
The proposal comes on the heels of increased reports of the devices malfunctioning during use.
To learn more, click here.
Friday, March 22, 2013
Thursday, March 21, 2013
Congress Introduces Bills to Limit Hydrocodone Access
After receiving notice from the FDA that reclassifying hydrocodone to be a Schedule II drug (it's currently Schedule III) would be a lengthy process, Congress has taken the agency's recommendation and introduced a bill to more quickly reclassify the drug.
Bipartisan bills have been introduced in both houses of Congress. The bills are cosponsored by 42 members of both parties.
The goal of the bills is to combat growing prescription drug abuse. If the legislation passes, people will no longer be able to refill hydrocodone prescriptions by fax or phone and long-term care operators might have to store the drug differently. Opponents have argued that the reclassification will just make it more difficult for people who are in pain to receive the drug.
To learn more, click here.
Bipartisan bills have been introduced in both houses of Congress. The bills are cosponsored by 42 members of both parties.
The goal of the bills is to combat growing prescription drug abuse. If the legislation passes, people will no longer be able to refill hydrocodone prescriptions by fax or phone and long-term care operators might have to store the drug differently. Opponents have argued that the reclassification will just make it more difficult for people who are in pain to receive the drug.
To learn more, click here.
Wednesday, March 20, 2013
SNFs Fall Short on Antipsychotic Reduction Goal, But Still Making Progress
The bad news: Skilled nursing facilities are expected to fall far short on the goal of reducing off-label use of antipsychotics by 15 percent.
The good news: They're still making progress.
CMS and the American Health Care Association teamed up with the goal of reducing off-label antipsychotic use by 15 percent by the end of 2012. According to CMS, facilities have only averaged around a 4 percent reduction. The good news, she noted, is that use is going down steadily in every region, even if the goal wasn't met.
Some facilities are meeting the goal, however, and have even reported up to a 50 percent reduction in the use of antipsychotics.
According to a 2010 CMS quality indicator report, 39.4 percent of residents nationwide who had cognitive impairment and behavioral issues but no diagnosis of psychosis or related conditions received antipsychotic medications.
To learn more, click here.
The good news: They're still making progress.
CMS and the American Health Care Association teamed up with the goal of reducing off-label antipsychotic use by 15 percent by the end of 2012. According to CMS, facilities have only averaged around a 4 percent reduction. The good news, she noted, is that use is going down steadily in every region, even if the goal wasn't met.
Some facilities are meeting the goal, however, and have even reported up to a 50 percent reduction in the use of antipsychotics.
According to a 2010 CMS quality indicator report, 39.4 percent of residents nationwide who had cognitive impairment and behavioral issues but no diagnosis of psychosis or related conditions received antipsychotic medications.
To learn more, click here.
Tuesday, March 19, 2013
Study: Nurse Retention, Reduced Rehospitalizations Linked
A new study published in Gerontology shows that skilled nursing facilities that retain their licensed nurses are also more likely to have fewer rehospitalizations.
The study's authors looked at staffing reports for 680 Florida nursing homes. They discovered that SNFs that increased their retention of licensed nurses by 10 percent during the study period also saw a 0.2 percent reduction in rehospitalizations, which works out to being about two fewer hospitalizations per facility per year.
To learn more, click here.
The study's authors looked at staffing reports for 680 Florida nursing homes. They discovered that SNFs that increased their retention of licensed nurses by 10 percent during the study period also saw a 0.2 percent reduction in rehospitalizations, which works out to being about two fewer hospitalizations per facility per year.
To learn more, click here.
Monday, March 18, 2013
FDA Investigating Link Between Popular Diabetes Drugs and Pancreatic Cancer
The popular diabetes drugs Januvia and Byetta, which were previously connected to an increased risk of pancreatitis, are now under investigation by the FDA to determine if they are associated with pancreatic cancer.
The FDA said that researchers have found precancerous changes on the cellular level in pancreatic tissue specimens from deceased users of Januvia and Byetta.
The FDA is encouraging users of the drugs to continue taking them as directed by their healthcare providers, but they are encouraging users and physicians to be alert to adverse events and report them to the FDA MedWatch program.
To learn more, click here.
The FDA said that researchers have found precancerous changes on the cellular level in pancreatic tissue specimens from deceased users of Januvia and Byetta.
The FDA is encouraging users of the drugs to continue taking them as directed by their healthcare providers, but they are encouraging users and physicians to be alert to adverse events and report them to the FDA MedWatch program.
To learn more, click here.
Friday, March 15, 2013
FDA: It's a Long Process to Restrict Access to Painkillers
Advocates for restricting access to hydrocodone painkillers might need to cool their heels for a while. The FDA has told lawmakers that it will be a lengthy process unless Congress takes action.
In February of 2013, a bipartisan group of five senators and two representatives urged the FDA to promptly change hydrocodone painkillers, such as Vicodin, from Schedule III to Schedule II drugs to help address the nationwide epidemic of painkiller addiction. For this to happen, the Drug Enforcement Agency (DEA) would first need to publish information about the change in the Federal Register and then wait for public comment. The FDA would also be required to conduct additional research as part of the reclassifying process.
To speed up the process, the FDA said that Congress would need to pass legislation mandating the change.
To learn more, click here.
In February of 2013, a bipartisan group of five senators and two representatives urged the FDA to promptly change hydrocodone painkillers, such as Vicodin, from Schedule III to Schedule II drugs to help address the nationwide epidemic of painkiller addiction. For this to happen, the Drug Enforcement Agency (DEA) would first need to publish information about the change in the Federal Register and then wait for public comment. The FDA would also be required to conduct additional research as part of the reclassifying process.
To speed up the process, the FDA said that Congress would need to pass legislation mandating the change.
To learn more, click here.
Thursday, March 14, 2013
Popular Antibiotic Azithromycin Could Lead to Potentially Fatal Heart Rhythms
The FDA issued a warning on Tuesday that azithromycin (also known as Zithromax, Zmax or the Z-Pak) can cause abnormal changes in the electrical activity of the heart that might lead to a potentially fatal irregular heart rhythm. The drug's label has been updated to include this risk.
The FDA is encouraging physicians to consider this risk when prescribing the drug to patients who are already at risk for cardiovascular events. Such patients include those with existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate or use of certain drugs used to treat abnormal heart rhythms.
To learn more, click here.
The FDA is encouraging physicians to consider this risk when prescribing the drug to patients who are already at risk for cardiovascular events. Such patients include those with existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate or use of certain drugs used to treat abnormal heart rhythms.
To learn more, click here.
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