PHARMACY

NACDS submits comments to FDA on MedGuides

BY Drew Buono

ALEXANDRIA, Va. The National Association of Chain Drug Stores on Monday submitted comments to the Food and Drug Administration stating that it was concerned about the effectiveness of Medication Guides and regulations that could make their distribution increasingly inefficient and difficult.

NACDS believes pharmacists face large obstacles in complying with current requirements. The MedGuides are given to patients to inform them about health information for certain products that pose serious public health concerns.

“In recent years, the FDA has expanded the MedGuide program without evidence that MedGuides are the best way to communicate risk to patients,” the letter states. “Further, there is no organized, efficient, or uniform approach to assuring their distribution by manufacturers to retail pharmacies. Despite hearing from industry and provider groups that the program is seriously flawed, the FDA continues to underestimate the burdens faced by pharmacists in complying with the program.”

In the letter, NACDS proposes a “full and transparent review of the MedGuide program before imposing the burden associated with compliance on pharmacists and patients.”

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GSK survey finds asthma sufferers lax in controlling condition

BY Drew Buono

RESEARCH TRIANGLE PARK, N.C., and TORONTO According to a new survey conducted by GlaxoSmithKline, nearly half of adult Americans and more than a quarter of children with asthma do not have their disease well controlled.

The Asthma USA survey examined over 81,500 households by using the Asthma Control Test, which assessed asthma control using a questionnaire. Of the more than 10,000 adults that took the ACT, 41 percent had a score of 19 or less, which indicates asthma that is not well controlled.

Children were given the Childhood Asthma Control Test and the ACT to determine their level of asthma control. According to the findings, of the 3,000 children that responded, 31 percent of the children between the ages of 4 and 11 and 25 percent of those between 12 and 17 did not have well-controlled asthma.

The survey also found that asthma that wasn’t well controlled had significant medical consequences. Adults with uncontrolled asthma were more likely to require treatment with oral corticosteroids, visit the emergency department or be admitted to the hospital than those whose asthma was well controlled. Children with uncontrolled asthma were also more likely to require urgent medical care.

“We have made quantum leaps in asthma treatment in the last decade, but the Asthma USA results demonstrate that enormous numbers of patients are living with asthma that is still not well controlled, putting them at significant health risk,” said David Stempel, director of clinical medicine for GlaxoSmithKline. “These findings remind us that improvements in care have not been uniform and underscore the critical need to improve education for both patients and healthcare providers in the management of asthma.”

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FDA warns against use of CellCept and Myfortic during pregnancy

BY Drew Buono

WASHINGTON The Food and Drug Administration has again warned that Roche’s CellCept and Novartis’ Myfortic which are prescribed to organ transplant patients can cause miscarriages and birth defects when used by pregnant women, according to published reports. The drugs are used to suppress the body’s immune system to avoid organ rejection in transplant patients

Last October the agency said it had received reports of miscarriages and infants born with ear and mouth birth defects after their mothers took CellCept. At the time, FDA added a black-box warning to CellCept and Myfortic.

The FDA said most of the reported problems came from mothers who were taking CellCept before their pregnancies were detected. Some of the patients were taking the drug for conditions it was not approved to treat including rheumatoid arthritis and lupus.

A spokesman for Roche said it has not received any new reports of miscarriages or birth defects since updating the drug’s labeling. The company previously reported 25 miscarriages among 77 women exposed to the drug between 1995 and 2007.

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