The statistics are staggering: Opioids kill more people in the U.S. each year than the total number of soldiers the country lost in the Iraq war. In 2017 alone, the CDC reported1 over 47,000 opioid-related deaths compared to the 4,541 American soldiers who lost their lives fighting in Iraq between 2003 and 2018, according to Statista2.
These are troubled times with a conflict-like casualty rate, and pharmacists are on the front lines. They have a unique position from which to directly help save lives and curb the increasing death toll. Since legislators took notice of the opioid epidemic in the late ’90s, a number of changes have been adopted to fight against its effects. One such measure was to place more power in the hands of pharmacists, who can now sell naloxone without a patient-specific prescription.
Known as an opioid antagonist, naloxone is a medication used to reverse the effects on an opioid overdose. It is available as a generic injection as well as under the brand names Evzio, a prefilled auto-injection device, and Narcan, a prefilled, needle-free nasal spray. When taken, it quickly restores normal breathing in a person who overdosed on opioids by binding to opioid receptors, blocking further intake and reversing the drug’s effects. Its availability without a patient-specific prescription serves to increase the number of people who have access to a life-saving medication at crucial times.
How did we get here?
Three major waves contributed to the current state of the opioid epidemic. The first began in 1991 when companies began targeting patients looking to ease non-cancerous pains. By 1999, a reported 86 percent of opioid users were buying them to treat non-cancerous pains. The sale of prescription pain relievers grew in the years that followed, reaching four times its rate by 2010, according to a study by the American Society of Addiction Medicine3.
The second wave began in 2010 when states made prescription opioids harder to obtain in an attempt to combat the effects of the previous wave. Restricting access to prescription opioids led people to turn to heroin in greater numbers. In a 2014 survey4 of people in treatment for opioid addiction, 94 percent said they chose heroin over prescription opioids because the latter was cheaper and easier to obtain.
The third — and worst — wave to date hit in 2013 when synthetic opioids, mainly fentanyl, caused a spike in overdose deaths. Originally designed to be an anesthetic for surgery, fentanyl is up to 100 times more powerful than morphine, which makes it incredibly dangerous for everyday use. Even a small dose can be fatal, so it’s not at all surprising that the increase in usage brought with it an increase in reported deaths.
Naloxone and the FDA
To combat the opioid epidemic, the FDA has taken remarkable steps to make naloxone easily available at pharmacies to both opioid users at risk of overdosing and to the people in their support group.
In the ’70s, ’80s and ’90s, switching a drug from prescription to over-the-counter (OTC) was fairly commonplace. However, heightened regulations in the past 15 years have made it such that only 15 drugs have gone from prescription-only to OTC during this time.
Three main factors are taken into consideration for a drug to make the switch to OTC: the presence of a consumer-friendly label, the patient’s ability to self-diagnose correctly without the aid of a professional physician, and the risk-benefit ratio.
So far, the Drug Facts Label needed for all OTC medication has proven to be a major setback for companies looking to join the naloxone arming race. To send a strong signal, the FDA designed its own DFL5 for pharmaceutical companies looking to have a naloxone drug approved, effectively annulling the biggest hurdle they previously had to face.
The FDA’s actions are part of the Department of Health and Human Services’ five-step plan6 to combat the opioid epidemic and target the decrease of overdose-related deaths directly. Among other goals, the initiative aims to improve prevention, treatment, and recovery options and increase the availability of overdose-reversing drugs in communities around the country.
The Pharmacist’s Role in the Community
With the opioid epidemic reaching monumental heights, it is important that pharmacists continue to take action to help their communities understand the resources available to them.
In all states, pharmacists either have prescriptive authority to both prescribe and dispense naloxone, or they are allowed to dispense naloxone using a non-patient specific mechanism such as a standing order, a protocol order, or a collaborative practice agreement7.
Pharmacists are also well-equipped to guide patients on opioid use, from helping them recognize the signs of an overdose to educating them on how to properly administer naloxone. By leaning into this role as healthcare providers, pharmacists can positively affect the health outcomes in their communities and continue the fight to end the opioid epidemic.