Archive for March, 2010

March is Workplace Eye Wellness Month and there’s no better time than now for a little review and fast facts.

Thousands of eye injuries occur in the workplace every year. However, did you know that 90% of all workplace eye injuries can be avoided by using proper safety eyewear?

According to OSHA’s eye and face protection standard (1910.133) this is what should be enforced on the job front, “the employer shall ensure that each affected employee uses appropriate eye or face protection when exposed to eye or face hazards from flying particles, molten metal, liquid chemicals, acids or caustic liquids, chemical gases or vapors, or potentially injurious light radiation.”

Of course the workplace is only a portion of our lives and accidents at home can just as easily happen. In fact, four out of ten accidents that cause blindness happen at home. So, what is it exactly that we’re doing at home that is so dangerous? We’re cleaning, cooking, taking care of the yard, fixing the car, playing sports…you know, living. Don’t discount school and the youngsters either. Think about the playground, gym class, science class/labs, sports, the list goes on.

The moral of the story is you need to protect your eyes by properly wearing safety glasses, goggles, face shields, etc. when appropriate. Make sure your protective eyewear is not too tight or too loose. Wash it regularly with mild soap and water, or eyeglass cleaner, and polish with a soft cloth or tissue. Avoid damage to lenses by storing your protective eyewear carefully.

You’ve only got one set of eyes. Don’t lose them because the ones in the back of your head don’t count.

Sources: NSC.org, SeeClearly.com

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Media Inquiries: Karen Riley, Karen.Riley@fda.hhs.gov, 301-796-4674

FDA Committed to Addressing Growing National Overdose Problem

The U.S. Food and Drug Administration (FDA) recognizes the five-fold increase in unintentional drug overdose deaths noted by the Centers for Disease Control and Prevention between 1990 and 2006 as a serious public health concern. Much of this increase follows from increases in the deaths from the use of opioid drugs, which in 2006 accounted for more overdose deaths than heroin and cocaine combined. The agency is also concerned about misuse of benzodiazepines (e.g., Valium and Xanax), which accounted for 272,000 emergency department visits in 2008 (compared to 306,000 for opioids).

FDA is pursuing a variety of programs and initiatives in an effort to strike the right balance between ensuring patients access to important pain medications and mitigating the risks. These efforts include:

· The Safe Use Initiative: The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. Its goal is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use (see http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm). Collaborations of this kind are essential for drugs like opioids, given the diverse factors that influence their use (e.g., legal, social, medical) and the many stakeholders working to assure they are used safely and effectively.

· Risk Evaluation and Mitigation Strategies (REMS) for Opioid Drugs: In 2007, Congress provided FDA with the authority to require REMS if that was necessary to ensure that the benefits of a drug outweigh its risks. These can include, for example, requirements for prescriber, pharmacist, and patient education about the risks and appropriate use of a drug, or other tools to better manage a drug’s risks On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a REMS. The affected opioid drugs include long-acting and extended-release brand name and generic products that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone (see http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm). FDA held a series of public stakeholder meetings in 2009 and opened a docket to receive public comments. FDA continues to accept public comments on the Agency’s approach to opioid REMS and plans to hold a public advisory committee meeting in the summer of 2010 to discuss proposals for this important safety program.

· Efforts on Acetaminophen: Every year in the United States, about 30,000 people are hospitalized with overdoses associated with acetaminophen – approximately half of which are unintentional. In June 2009, FDA convened an advisory committee meeting to provide expert input on options to reduce harm while maintaining access to this effective medication for pain. Potential strategies are currently under review.

· Strategies for the safe disposal of drugs: Certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are accidentally taken. For this reason, FDA lists 26 drugs, including a number of potent opioids, that have special disposal directions indicating they should be flushed down the sink or toilet after the medicine is no longer needed. If disposed of down the sink or toilet, they cannot be accidently used by children, pets, or anybody else (Learn More: Disposal by Flushing of Certain Unused Medicines: What You Should Know).

· Evaluating the abuse potential of drugs: FDA has entered into a research collaboration with the National Institute on Drug Abuse (NIDA) to assess particular drugs for their abuse potential. The results of this research are provided to the Drug Enforcement Administration (DEA).

· Supporting efforts to identify safer pain medications. Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research recently reviewed this area in the New England Journal of Medicine. See http://content.nejm.org/cgi/content/full/361/22/2105.

Through these efforts and others, FDA will join with sister agencies, medical professionals, health care institutions, patient organizations and others to reduce the number of overdose deaths.

For more information from the Centers for Disease Control and Prevention: http://www.cdc.gov/Features/PoisonPrevention/

Presidential Proclamation — National Poison Prevention Week: http://www.whitehouse.gov/the-press-office/presidential-proclamation-national-poison-prevention-week

Source: fda.gov

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National School Breakfast Week wrapped up today however the ‘School Breakfast – Ready Set Go!’ campaign runs through the end of the month. The School Breakfast – Ready Set Go Campaign demonstrates how eating school breakfast sets students up for a busy day at school and also helps students learn about the importance of eating healthy and being active.

Did you know that an estimated half of children head off to school without eating breakfast? When you’re hungry you know it’s hard to concentrate and complete what needs to be done. You also know that hunger also leads to disruption and irritability. It’s no different for children and in the end what suffers in their education.

That is why in 1966 the School Breakfast Program (SBP) started as a pilot program severing approximately 80,000 children. Today, the SBP serves more than 10 million school children per year who are eligible for free or reduced priced meals. That’s a major increase but considering in the 2006 – 2007 school year a projected 55 million K – 12 students would be enrolled in US elementary and high schools, and an estimated half of those students missed breakfast…that’s a lot of lost education.

Does your school offer the SBP? How often do you discuss the importance of a healthy breakfast and being active with your students/children?

Source: Census.gov, Kohl.Senate.gov, SchoolNutrition.org

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LifeScan, Inc. is conducting a voluntary recall in the United States of eight lots of OneTouch® SureStep® Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

The eight lots of consumer OneTouch SureStep Test Strips being recalled are:
 

Lot #’s are located on the outer carton and test strip vial.

Patients with test strips from the recalled lots are asked to call LifeScan at 800 574-6139 between 5:00 am and 7:00 pm Pacific Time, seven days a week or visit http://www.surestep.com/ to request replacement product. Replacement product will be shipped immediately and provided free of charge.

While waiting for replacement product to arrive, it is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher.

LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.

No injuries associated with these recalled test strips have been reported. However, if patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. Patients with high blood glucose may or may not have certain symptoms including increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision and fatigue (weak, tired feeling). High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

Hospitals, clinics and other multi-patient facilities using SureStep®Pro®, SureStep®Flexx® or OneTouch® SureStep® Hospital Systems have also been notified of this issue. All three of these systems use SureStep®Pro® Test Strips which also may provide inaccurately low test results when the blood glucose reading is greater than 400 mg/dL. LifeScan has advised these facilities of the appropriate actions to take in order to continue to use these SureStepPro Test Strips. However, healthcare facilities with access to alternative means of testing should consider temporarily discontinuing their use of their SureStep Systems until replacement test strips are available.

This field action is limited to eight lots of OneTouch SureStep Test Strips sold for consumer use in the U.S., and select SureStepPro Test Strips used in healthcare facilities. Similar recall actions are being taken in other countries where the affected product was distributed.

In 2006 LifeScan stopped selling OneTouch SureStep Meters in the U.S. but continued to provide test strips. Today, OneTouch SureStep Meter users represent a very small portion of LifeScan’s total customer base. The vast majority of LifeScan’s customers now use OneTouch® Ultra® Brand Meters, which use an entirely different technology.

LifeScan, Inc. is a leading maker of blood glucose monitoring systems for people with diabetes. For information about diabetes care and LifeScan products and services, visit http://www.onetouchdiabetes.com/.

CONTACT: David Detmers, LifeScan, Inc., +1-408-942-5955

Source: fda.gov

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