Healthcare

In July 23, 2010, committee members of US Food and Drug Administration (FDA) panel told to regulators that drug overdose death rates in the United States are at an all-time high.
According to some reports, there are more deaths from opioid overdoses than from heroin and cocaine overdose combined.
In some states, these rates are higher than deaths from automobile accidents.
In addition to clear human costs, an estimated 60% of hospital costs related to opioid overdoses are paid for with public funds.

Due to this condition, The US FDA panel has voted overwhelmingly against the controversial Opioid – Risk Evaluation and Mitigation Strategies (REMS).

Most committee members said safety measures for opioids are urgently needed, but voiced concern that the current approach doesn’t go far enough to protect the public.

The FDA dropped a number of earlier ideas such as prescriber accreditation and patient registration program.
Bob Rappaport, MD, from the office of drug evaluation, said those plans were left out of the proposal because of concerns over how onerous it might be to track an estimated 700,000 prescribers. He said, some patients also complained about possible registration requirements.

Prescriber education is in the proposed plan, but regulators decided it would not require any formal enrollment or real-time verification of training.

Committee chair, Jeffrey Kirsch, MD, from the Oregon Health and Science University in Portland, said in the meeting, “I voted no. I fully support that REMS is a critical requirement of provider learning, but these initiatives will need to establish definite competencies and assessments.”

This was a view echoed by the majority of the unusually large 35-members advisory committee. Regulators brought together members from multiple committees to tackle this important issue, which is expected to affect an estimated 4 million patients.

In that meeting, committee member, John Markman, MD, from the University of Rochester Medical Center in New York, said, “we are not currently in balance. We are very much out of balance, and continuing the status quo is unacceptable.”

The FDA proposal also concentrated on extended-release and long-acting opioids.
It was a focus that did not sit well with many committee members, who raised concerns about the risk with immediate-release formulations.
Dr. Kirsch said that many suggested both product groupings be included in future safety initiatives. He said, “both immediate-release and extended-release formulations have a huge impact on public