HEALTH

Consumer Product Safety Commission requests comments on iron shipping compliance requirements

BY Michael Johnsen

SILVER SPRING, Md The American Herbal Products Association on Thursday noted that certain dietary supplements containing iron may fall under the Consumer Product Safety Improvement Act of 2008, passed in January, which requires that products subject to a consumer product safety rule (like those containing iron) include a Certificate of Compliance when shipped in commerce on and after Nov.12.

For dietary supplement manufacturers, products subject to a consumer product safety rule are those that contain over 250 mg of elemental iron and are required to be in childproof closures by regulations promulgated under the “Poison Prevention Packaging Act,” a statute administered by the U.S. Consumer Product Safety Commission, AHPA noted.

CPSC has issued a “Request for Comments and Information,” seeking, in particular, comments on the use of electronic certificates to facilitate the “accompanying” and “furnishing” requirements as well as comments on the issue of multiple certifications for the same product, AHPA reported. “The American Herbal Products Association is reviewing CPSC’s request for comments to determine what comments if any to submit,” stated AHPA president Michael McGuffin. “The association is committed to keeping members abreast of any developments and will provide guidance as needed.”

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ASCP launches chronic constipation education initiative

BY Michael Johnsen

ALEXANDRIA, Va. The American Society of Consultant Pharmacists on Thursday launched a comprehensive continuing medical education initiative for physicians, nurses, pharmacists and other health-care providers about chronic constipation.

Known as E-IMPACCT, Elderly IMProvements and Advances in Chronic Constipation Treatment, the program presents educational activities on evaluating and managing CC, and offers a range of tools to help clinicians in everyday practice.

 “Because of the cascade of complex health issues that can be triggered by chronic constipation, clinicians have expressed their need for targeted education about CC,” stated ASCP executive director and chief executive officer John Feather. “Clinicians need to identify, recognize and differentiate CC and have a clear understanding of the pros and cons of each of the treatments and medications, the side effects and administration and efficacy data.”

“For all clinicians, the management strategies for treating chronic constipation in the elderly should include a combination of patient and caregiver education and communication, dietary modifications, and treatment options,” commented ASCP director of professional and educational affairs Trish D’Antonio Mazzuca. “Educational outcomes from E-IMPACCT will measure changes in clinician knowledge and behavior and improvements in patient care.”

E-IMPACCT provides outcomes-based knowledge through an ongoing, thorough awareness campaign with educational components that will roll out over a 12-month period. Through this initiative, participants are presented with new information and certified continuing education activities, patient cases and guidelines designed to help clinicians better manage CC and improve outcomes in today’s seniors.

Chronic constipation is the most common digestive complaint in the general population. In seniors, roughly 26 percent of men and 34 percent of women complain of constipation. Americans spend approximately $800 million per year on over-the-counter laxatives, the society reported.

The ASCP E-IMPACCT initiative is supported by an educational grant from Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America.

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GlaxoSmithKline wins recommendation to sell Alli in Europe

BY Michael Johnsen

LONDON GlaxoSmithKline won a recommendation from European regulators Thursday that it be allowed to sell its weight loss drug Alli over-the-counter in Europe.

The European Medicines Agency said it had recommended the switch from prescription-only to nonprescription for a 60-milligram dose of alli, the same dose approved for sale OTC in the United States. The European Commission now needs to rubber-stamp the recommendation.

The European Medicines Agency said it had recommended the switch from prescription-only to nonprescription for a 60-milligram dose of alli, the same dose approved for sale OTC in the United States. The European Commission now needs to rubber-stamp the recommendation.

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