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FDA launches safe medication use initiative

The FDA plans to work with the healthcare industry and the public as it develops new guidelines intended to prevent harm from medication use. The agency has also released a new safety guidance statement for OTC liquid-drug products.

The agency announced the "Safe Use Initiative," a program for prevention of medication abuse, unintended exposure to prescription drugs such as opioids, and other medication errors, in early November.

"Only through coordinated interventions across all sectors of the healthcare system can we substantially reduce preventable injuries from using medications," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research.

To that end, the FDA will collaborate with healthcare professionals and "other stakeholders" to identify drugs and drug classes linked to preventable harm. Then the agency will develop a list of specific problems, cross-sector interventions for reducing harm from those problems, and metrics for success.

Meanwhile, the FDA has released new requirements for manufacturers of OTC liquid products that are packaged with calibrated cups, droppers, syringes, and spoons. Some dosage-delivery devices are unclear or are inconsistent with the labeled dosing instructions, according to the agency.

"Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications ... especially for children," Woodcock said.

For information on the Safe Use Initiative, visit

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The Centers for Medicare & Medicaid Services and the Office of the Inspector General of the federal Department of Health and Human Services are going after perpetrators of medical identity theft as part of a broader effort to reform healthcare.

Community Health Care, a center in Bridgeton, New Jersey, serving 43,000 uninsured and underinsured patients at 18 sites across the state, is teaming up with SunRx to expand its pharmacy services to include more 340B program patients.

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Retail pharmacy managers are discovering that many third-party administrators do not agree that their inventory information approval systems meet compliance requirements set by the Internal Revenue Service for customers' use of flexible spending accounts.