Combating opioid drug abuse with naloxone
Special Pain Section
Drug overdose deaths are now the number one cause of accidental death in the United States. The rise in the number of hospitalizations and deaths resulting from prescription drug misuse and abuse, particularly opioids, gave increased access to naloxone a role in the White House Office of National Drug Control Policy’s 2014 National Drug Control Strategy, issued July 9. That same week, Kaléo announced the release of naloxone hydrochloride injection (Evzio), a newly FDA-approved prescription treatment for reversal of emergency opioid overdose that consists of a handheld auto-injector containing a single dose of naloxone.
So far in 2014, at least 44 pieces of state legislation on naloxone have been introduced, and at least 31 state laws are currently active. Many of these protect those administering naloxone from criminal and civil liabilities, require training programs, and allow first responders and police to carry and administer opioid antagonists like naloxone. New York AB 9365 proposed that every initial opioid prescription per year should be accompanied by a prescription for an opioid antagonist. New Jersey AR 113 (SR 75) encouraged FDA to allow naloxone to be available OTC. California AB 1535 proposed that a pharmacist may furnish naloxone under standardized procedures or protocols developed and approved by the board of pharmacy and Medical Board of California; at press time, the bill was headed to the governor for his signature into law.
“Naloxone only helps reduce deaths when people have it before an overdose occurs. Because of this, there is nearly unanimous support by public health experts for increased distribution of naloxone,” said Brian Warren, Vice President of the Center for Advocacy at the California Pharmacists Association. “Some of the new delivery mechanisms recently approved—such as the auto-injector—will hopefully make more consumers comfortable with using naloxone.”
Background on naloxone
Naloxone functions by blocking the opioid’s target, the mu receptor, decreasing potentially fatal respiratory depression. It comes in intravenous, intranasal, intramuscular, subcutaneous, and most recently, auto-injector dosage formulations. Emergency doses of naloxone should be followed immediately by a visit to the emergency department. Despite the benefits of using naloxone after a suspected overdose, giving an opioid antagonist to someone who is physically dependent on opioids can cause symptoms of withdrawal.
Media coverage of the issue has increased recently. But access to naloxone is not a brand-new topic. FDA’s Center for Drug Evaluation and Research, the Office of the Assistant Secretary for Health, the National Institutes of Drug Abuse, and CDC met in April 2012 with experts in academia, government, and industry, and with patient advocates, to discuss potential solutions, concerns, regulatory issues, and potential research on opioid abuse and naloxone availability. For more information, visit the FDA website.
The role of the pharmacist
In March 2014, APhA’s House of Delegates adopted policies to support developing laws and regulations permitting pharmacists to furnish opioid reversal agents and to support the pharmacists’ role in selecting therapy, dosing, initiating therapy, and providing education on proper use of opioid reversal agents in efforts to prevent opioid-related deaths due to overdose (see sidebar).
Given the expanding knowledge of how critical naloxone can be in an emergency situation, pharmacists are in a unique position. “We think that there are several opportunities for pharmacists to help reduce opioid overdose deaths by furnishing naloxone,” Warren said, “including providing it to patients who self-identify a need for naloxone, patients on high-dose opioid therapy who have not been coprescribed naloxone, and to laypersons who may be able to help someone at risk for an overdose (such as a family member or friend).”
APhA policy on controlled substances and other medications with the potential for abuse and use of opioid reversal agents (2014)
- APhA supports education for pharmacists and student pharmacists to address issues of pain management, palliative care, appropriate use of opioid reversal agents in overdose, drug diversion, and substance-related and addictive disorders.
- APhA supports recognition of pharmacists as health care providers who must exercise professional judgement in the assessment of a patient’s conditions to fulfill corresponding responsibility for the use of controlled substances and other medications with the potential for misuse, abuse, and/or diversion.
- APhA supports pharmacists’ access to and use of prescription monitoring programs to identify and prevent drug misuse, abuse, and/or diversion.
- APhA supports the development and implementation of state and federal laws and regulations that permit pharmacists to furnish opioid reversal agents to prevent opioid-related deaths due to overdose.
- APhA supports the pharmacists’ role in selecting appropriate therapy and dosing and initiating and providing education about the proper use of opioid reversal agents to prevent opioid-related deaths due to overdose.
The following sentence was corrected on September 30, 2014: California AB 1535 proposed that a pharmacist may furnish naloxone under standardized procedures or protocols developed and approved by the board of pharmacy and Medical Board of California; at press time, the bill was headed to the governor for his signature into law.
Editor's note on September 30, 2014: The bill has been signed by the governor and will become law on January 1, 2015.