"An FDA advisory committee voted 25-10 to reject the agency's proposed plan to prevent inappropriate prescribing, misuse, and abuse of extended-release opioid painkillers, saying the plan lacks the teeth to stem the 'public health crisis' of opioid addiction, overdose, and death."

"The agency's plan to put a risk evaluation and mitigation strategy (REMS) in place would have required drug companies that make extended-release opioids to develop educational programs to guide physicians in patient selection, dosing, and patient monitoring. Prescribers were also to have been trained to counsel their patients on how to safely store and dispose of opioids."

"FDA has to have a more robust plan," said Mori Krantz, MD, director of the prevention department at the University of Colorado in Denver. "This is a huge public health issue," Krantz said.

"The advisory committee meeting comes about a month after new data showed that painkiller abuse now matches abuse of illegal drugs."

Read the entire MedPage article at the site.

The study referred to in the MedPage article follows, in part, from DAWN 2008, Drug Abuse Warning Network:

Drug-related deaths

Since 2003, a DAWN case is any death reviewed by an ME/C that was related to recent drug use. Findings in this publication pertain to drug-related deaths and drug-related suicide deaths reported by participating death investigation jurisdictions as DAWN cases.

DAWN cases are identified through a retrospective review of decedent case files in each participating death investigation jurisdiction. A DAWN case is any death that is determined by the ME/C as being related to drug use. The relationship between the death and the drug need not be causal; the drug need only be implicated in the death. The drug use may have been for legitimate, therapeutic purposes or for the purpose of drug abuse or misuse, but in either case, the drug use must have been recent.

These eligibility criteria for a DAWN case are intentionally broad and inclusive. Since death record documentation varies in clarity and comprehensiveness across jurisdictions, broad criteria reduce the potential for judgment calls that could cause data to vary systematically and unexpectedly across reporters and jurisdictions. Broad criteria also capture a diverse set of drug-related deaths that support a wide variety of analytical purposes and interests.

For decedents under the age of 21, DAWN cases include deaths where the only drug involved was alcohol. For those 21 or older, there must be at least one other drug involved besides alcohol for the death to be a DAWN case.

Drugs

Drugs that make a death eligible for DAWN include:

• Illegal or illicit drugs, such as heroin, cocaine, marijuana, and Ecstasy;
• Prescription drugs, such as Prozac^®, Vicodin^®, OxyContin^®, alprazolam, and methylphenidate;
• Over-the-counter medications, including aspirin, acetaminophen, ibuprofen, and multi-ingredient cough and cold remedies;
• Dietary supplements, including vitamins, herbal remedies, and nutritional products;
• Psychoactive, nonpharmaceutical inhalants;
• Alcohol in combination with other drugs; and
• For those under age 21, alcohol without any other drug.

Deaths included in this publication

Findings in this publication focus on two major categories of drug-related deaths, based on the manner of death as determined by the ME/C.

1. Drug-related deaths (other than drug-related suicide deaths) include the following: 
   
   
   • Natural or accidental deaths with drug involvement. These two categories capture deaths involving medical use, nonmedical use, overuse, and misuse of prescription and over-the-counter medications and drug abuse.
   • Homicide by drug. This category was designed to capture malicious poisonings; that is, the decedent was administered a drug(s) by another person for a malicious purpose.
   • Deaths with drug involvement when manner of death denoted by the ME/C was "could not be determined" (CNBD). This manner of death is assigned by the ME/C when a definitive ruling of suicide, homicide, natural, or accidental death is not possible.

The entire report can be viewed at DAWN's site: Drug Abuse Warning Network, 2008: Area Profiles of Drug-Related Mortality. The study was directed by the US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Office of Applied Studies

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