Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday issued a safety communication on HeartStart automated external defibrillators from Philips Healthcare, noting that certain HeartStart AED devices may be unable to deliver needed defibrillator shock in a cardiac emergency situation.

The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation.

NEW YORK — The program to vaccinate children against chickenpox introduced in 1996 does not seem to be behind an increase in recent years in the number of cases of shingles, according to a new study.

PETALUMA, Calif. — The Food and Drug Administration has approved a new topical drug for treating scars made by Oculus Innovative Sciences, the drug maker said Wednesday.

The FDA has approved Microcyn scar-management hydrogel, used to treat scars resulting from burns, surgery and trauma wounds. Oculus and a partnering company, Quinnova Pharmaceuticals, intend to start selling the drug in the first half of next year.

ALEXANDRIA, Va. — Mail-order pharmacies frequently charge Medicare prescription drug plans more — as much as 83% — than community pharmacies do for filling prescriptions, a new analysis by the U.S. Centers for Medicare and Medicaid Services has concluded.

CMS examined claims from March 2012 and found 21 drug plans that routinely paid more for prescriptions filled through the mail compared to a community pharmacy.

WASHINGTON — The Pharmacy Compounding Accreditation Board is looking for a new executive director following the departure of Joe Cabaleiro, the group said Wednesday.

The formal search will start in January, and the new executive director will oversee accreditation programs for compounding pharmacies and lead compounding initiatives to enhance patient care and improve quality practices. Interested parties may contact National Community Pharmacists Association chief of staff Beverly Martin.

WASHINGTON — Elderly and disabled people nationwide have saved almost $9 billion on prescription drugs thanks to the Patient Protection and Affordable Care Act, according to a new study by the Centers for Medicare and Medicaid Services.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

According to the FDA's website, the agency granted the preliminary authorization for Roxane Labs' linezolid oral suspension in the 100-mg-per-5-mL strength.

NEW YORK — Officials in Rhode Island may set up a registry that would allow doctors and pharmacists to track patients who have problems with drug abuse, according to published reports.

The Associated Press reported that the proposed registry would track prescriptions for drugs that are controlled substance and allow healthcare professionals to track their usage, similar to a monitoring program set up in New York this year. A task force that includes state lawmakers, health officials and healthcare professionals met Monday to look at the idea.