An FDA panel has voted against the current version of the opioid risk evaluation and mitigation strategies (REMS) plan. Such a plan is critical to curb the misuse, abuse, and accidental overdoses related to these agents and to ensure opioids are used appropriately. However, experts feel the proposed approach does not go far enough to protect patients. It is unclear if the FDA agrees with this.
Drug overdose death rates in the United States are at an all-time high. According to some reports, there are more deaths from oral opioid overdoses than from heroin and cocaine overdoses combined. In some states, these rates are higher than deaths from automobile accidents. In addition to the clear human costs, an estimated 60% of hospital costs related to opioid overdoses are paid for with public funds.
This is clearly a risk management problem that needs urgent attention. Over the past year I have seen a dramatic increase in medical malpractice and toxicology litigation in this area.
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