Donna Young

Medicare Part D creates challenges for safety-net providers and law enforcement

While the new Medicare Part D prescription drug benefit will give 43 million American seniors substantial help in paying for medications, said Elizabeth M. Duke, administrator of the Health Resources and Services Administration (HRSA), the law has created several reimbursement challenges for safety-

New alliance to tackle medical errors, define safety

Three health systems — Wellmont Health System of Tennessee, Adventist Health System of Florida, and Novant Health of North Carolina — announced in May that they are aiming to do something that the U.S. health care community has yet to do: define what it means to be a safe hospital. Various

Regulators, groups engage in user fee debate.

The reauthorization of the Prescription Drug User Fee Act (PDUFA)—a system where drug companies pay fees to FDA to support its process for reviewing applications for new drugs and biologicals—is “an extremely important step” for the agency, said Commissioner Andrew C. von Eschenbach.

New law targets disaster response confusion

If public health agencies and hospitals have not yet been affected by the Pandemic and All-Hazards Preparedness Act, signed into law on December 19, 2006, they soon will be, said Gerald W. Parker, principal deputy assistant secretary for preparedness and response at the Department of Health and

Regulatory experts debate FDA’s authority

FDA’s authority and enforcement powers have been interpreted differently by various administrations, commissioners, and agency lawyers over the past several decades, said Christopher H. Schroeder, professor of law at Duke University Law School. “The agency’s authority has exhibited an

Experts examine problems with labels on parenteral infusion products.

Even though premixed parenteral infusion products can reduce the potential for mixing errors, the container labels of those products have contributed to medication errors in acute, ambulatory, and home care settings, according to drug safety experts. Container labels that look similar and use

FDA’s sentinel network: A monumental task

Even though FDA has not yet fixed problems with its dysfunctional system for tracking adverse events and lacks the funding to do so, the agency is leaping into a larger venture to create a nationwide electronic medical product safety network. The so-called sentinel network is planned as a

FDA mulls over paperless labeling

Electronic medication package inserts (PIs), or “paperless” labeling, would give health care providers immediate access to the most current prescribing information, said Thomas F. Willer, director of global regulatory affairs for Hospira. Electronic PIs would allow manufacturers to rapidly

Medication guides scrutinized

Effective communication of the risks and benefits of medications to patients is essential to the appropriate use of the drugs, said Paul Seligman, associate director for safety policy and communication at FDA’s Center for Drug Evaluation and Research. “It has been, is, and will continue to be a

Plans to reduce drug risks examined.

Despite the often burdensome and confusing nature of risk minimization action plans (RiskMAPs), they help to reduce the potential for a patient to unnecessarily be exposed to a risky medication while ensuring that those who need access to essential therapies get them, said Brian L. Strom, professor