HEALTH

FDA develops Web resource outlining proper sharps disposal

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday launched a website for patients and caregivers on the safe disposal of needles and other “sharps” that are used at home, at work and while traveling.

“Safe disposal of used needles and other sharps is a public health priority,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “This website provides information about how to keep used sharps from ending up in places where they could harm people.”

The U.S. Environmental Protection Agency estimates that more than 3 billion needles and other sharps are used in homes in the United States each year.

After being used, many sharps end up in home and public trash cans or flushed down toilets. This kind of improper disposal puts people, such as sanitation workers, sewage treatment workers, janitors, housekeepers, family members and children at risk for needle stick injuries or infection with viruses, such as hepatitis B and C and HIV, the agency noted.
 
Sharps is defined by the FDA as medical devices with sharp points or edges that can puncture or cut the skin. Such medical devices include hypodermic needles and syringes used to administer medication; lancets or fingerstick devices to collect blood for testing; needle and tubing systems for infusing intravenous and subcutaneous medicines; and connection needles used for home hemodialysis.

With more diseases and conditions, such as diabetes, cancer, allergies, arthritis and HIV, being managed outside of hospitals and doctors’ offices, the number of sharps used in homes and work offices is increasing. In addition, pets are being treated in homes and livestock are being treated on farms, which also are contributing to the increased number of sharps outside of veterinary hospitals.

Sharps disposal guidelines and programs vary by jurisdiction. For example, in 2008, California passed legislation banning throwing needles in household trash. Florida, New Jersey and New York have established community drop off programs at hospitals and other healthcare facilities. People using sharps at home or work or while traveling should check with their local trash removal services or health department to find out about disposal methods available in their area, the agency suggested.

For the safe disposal of needles and other sharps used outside of the health care setting, the FDA recommends the following:

  • Immediately place used sharps in an FDA-cleared sharps disposal container to reduce the risk of needle-sticks, cuts or punctures from loose sharps;

  • If an FDA-cleared container is not available, some associations and community guidelines recommend using a heavy-duty plastic household container as an alternative. The container should be leak-resistant, remain upright during use and have a tight fitting, puncture-resistant lid, such as a plastic laundry detergent container;

  • Call your local trash or public health department in your phone book to find out about sharps disposal programs in your area;

  • Do not throw loose sharps into the trash or flush sharps down the toilet;

  • Do not try to remove, bend, break or recap sharps used by another person; and

  • Do not attempt to remove a needle without a needle clipper device.


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Sentinel Capital Partners acquires WellSpring

BY Alaric DeArment

NEW YORK — Sentinel Capital Partners has acquired Sarasota, Fla.-based WellSpring Pharmaceutical, the private equity firm said Monday.

Sentinel, which describes itself as investing in lower middle-market companies, said it bought the manufacturer of prescription and OTC drugs, which manufactures its products in Ontario, alongside Ancor Capital Partners. Financial terms of the deal were not disclosed.

"WellSpring is an innovator that provides quality pharmaceutical products and related services across a diverse set of end markets," Sentinel partner Eric Bommer said. "The opportunity to invest alongside Ancor was also a strong incentive for us."


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Preliminary study: Vitamin D helped improve cell counts associated with lupus

BY Michael Johnsen

CHICAGO — The first study to report the effects vitamin D has on the immune system of people with lupus was unveiled Saturday at the American College of Rheumatology Annual Scientific Meeting here.

The small sample study determined that vitamin D supplementation helped improve cell level counts associated with the disease.

“This preliminary study provides encouraging results and suggests the beneficial role of vitamin D supplementation in patients with SLE, with an increase of regulatory T cells and a decrease of memory B cells and effector T cells,” lead researcher Benjamin Terrier said. “However, these findings need to be confirmed in large randomized controlled trials.”

Systemic lupus erythematosus, also called SLE or lupus, is a chronic inflammatory disease that can affect the skin, joints, kidneys, lungs, nervous system and/or other organs of the body. The most common symptoms include skin rashes and arthritis, often accompanied by fatigue and fever. Lupus occurs mostly in women, typically developing in individuals in their twenties and thirties.

There is a connection between lupus and the disturbance of regulatory T cells (which play an important role in maintaining a healthy immune system), T helper lymphocytes (white blood cells that assist other white blood cells in the immune system) and B cells (which make antibodies that fight off attacks on the immune system). Vitamin D has been shown to affect the numbers and function of many of these immune cells.

Only patients with no or mild lupus activity were included in this study.

All of the participants in the study were taking a stable dose of prednisone and/or immunosuppressive drugs. Each participant with vitamin D deficiency received vitamin D supplementation (100,000 IU of cholecalciferol) each week for four weeks followed by the same amount each month for six months. Researchers evaluated each participant at the beginning of the study, at two months, and again at six months to see how well they were tolerating the supplementation and how it was affecting their immune systems.

Among the 24 patients in the study, 20 (who were around 30 years old) had low levels of vitamin D and received supplementation. The clinical activity of lupus did not change significantly and none of the patients showed a flare of the disease or required an increase in corticosteroids or immunosuppressive drugs. However, the levels of anti-DNA antibodies, which are abnormal and pathogenic antibodies produced by B cells, decreased at two months and six months.

The number of regulatory T cells increased with vitamin D supplementation at both two and six months, with a similar trend for both naïve and activated memory regulatory T cells, which represent two subsets of regulatory T cells. This increase of regulatory T cells also was associated with an increased expression of molecules associated with their suppressive function.

A decrease in T helper lymphocytes, previously shown to be increased in lupus, was noted after two months of vitamin D supplementation. Finally, researchers observed a decrease in memory B cells (which produce antibodies) at two months and in activated CD8+ T cells (which may contribute to the disease process in lupus) at six months. Taken together, these results provide evidence of normalization of abnormal lymphocyte numbers in these patients.


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