ASAM Testifies at FDA Meeting on Naloxone Uptake and Use

On July 1 and 2, the FDA held a public meeting to initiate a discussion about issues surrounding the uptake of naloxone in a variety of medical settings. With over 200 experts and stakeholders in attendance, issues discussed at the hearing included co-prescribing of naloxone with prescriptions for opioid analgesics as well as naloxone availability to emergency responders and persons who are recently released from prison, among others. The discussions centered on how to expand naloxone access to persons and places where the documented risk of overdose is highest.

Dr. William Morrone, ASAM member, President of AOAAM and Deputy Chief Medical Examiner spoke on ASAM and AOAAM's behalf and highlighted the public health burden of prescription opioid and heroin overdoses. In his testimony, Dr. Morrone stated, “The importance of co-prescribing and third-party prescribing cannot be understated. We need to expand access to this life saving drug.”

Drawing on his personal experience as a medical examiner and physician prescribing naloxone to patients in need, Dr. Morrone mentioned the importance of increasing access to naloxone. In his personal testimony and closing remarks he encouraged the forward evolution of naloxone into proposed mass education vehicles like REMS.

Meeting participants also discussed how to expand the usability of naloxone and the development of intranasal naloxone to make use by friends and family members even more likely. Currently many programs provide naloxone kits, which use needleless luer-lock syringes and an atomizer to allow naloxone to be delivered through the nose. More naloxone nasal spray devices are in development and physicians and public health officials at the meeting were eager to see these no-assembly, no-priming and easy-to-use single spray devices enter the market.

Many experts at the meeting cited cost as a barrier to naloxone access for those who need it. Even those in favor of transitioning naloxone from a prescription-only to an over-the-counter medication expressed cost and access concerns for their patients and public health organizations.

Doctors and public health professionals who spoke at the meeting agreed that expanding naloxone access to police officers, firefighters, EMTs and other emergency responders is not enough. The consensus at the public meeting was to expand co-prescribing and third party prescribing of naloxone, not only for those we perceive to be at risk of an overdose but for every patient prescribed an opioid medication. This way, naloxone can be readily available at the time of an overdose without the delay of waiting for an emergency responder to arrive. ASAM has a public policy statement supporting co-prescribing and will continued to provide updates about the expansion of access to lifesaving medications like naloxone.

Image curiosity of Harm Reduction Coalition. June 14, 2015.  http://harmreduction.org/issues/overdose-prevention/overview/overdose-basics/responding-to-opioid-overdose/administer-naloxone/