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Naloxone: Front and Center

– This article was initially printed in Physician’s Practice

The U.S Food and Drug Administration (FDA) has recommended that all opioid prescriptions include an advisory to trigger healthcare professionals to discuss and more frequently prescribe naloxone, the opioid antagonist that can rapidly reverse an overdose.

The new advisories are welcome considering that more than 40 states have reported increases in opioid-related overdoses, according to the American Medical Association. This upward trend is being fed by the anxiety created by COVID-19 and the resulting social isolation and disruption in care access, even though this spike appears to have begun last year. After several years of stability in opioid-related overdose deaths, 2019 marked a sharp uptick and record year for fatalities – some 51,455 people died, based on data from the Centers of Disease Control and Prevention (CDC).

Unsurprisingly, the FDA, CDC, and the U.S. Surgeon General have advocated for expanded production of and access to naloxone. In an advisory, the FDA even indicated that it was working with manufacturers to potentially make the drug available over-the-counter, after approving the first generic version of naloxone nasal spray in April of last year. Unfortunately, that could take years.

Naloxone underutilized

Although naloxone prescriptions have increased significantly in recent years, including an increase of 106% between 2017 to 2018, they are still falling short of the public need. In 2018, only one naloxone prescription was dispensed for every 69 high-dose opioid prescriptions, which are classified as 50 or more morphine milligram equivalents (MME). Another study found that less than 2% of patients in various risk groups, such as those receiving a high-dose opioid prescription or concurrent benzodiazepines, received naloxone along with their opioid medication.

These troubling statistics remain despite naloxone being highly effective and safely administered by non-clinicians. A CDC study published in 2015 estimated that between 1996 and 2014, naloxone kits distributed to 152,283 non-clinicians at community-based programs resulted in 26,463 reported overdose reversals. The number of overdoses reversed, and lives saved, is significantly higher today than five years ago, likely due to greater public awareness of the opioid epidemic and naloxone. Still, overdose scenarios have continued to grow, largely due to the massive increase of synthetic opioid consumption, such as fentanyl.

The lack of access to naloxone in the home poses risks not only to patients but also their families. In a survey of more than 100,000 children ages 12 to 17, as many as 33% reported obtaining prescription opioids for misuse from a family member or friend, and nearly 8% stole the drugs. Non-intentional consumption of opioids is also a concern. Emergency department (ED) visits involving accidental ingestion of opioid pain relievers by children ages 1 to 5 more than doubled between 2004 and 2011. With naloxone in the home, there is an added layer of protection for family members as well.

 

How prescribers, pharmacists, and health plans can help

Increasing patient access, public education, and the use of naloxone requires a collective effort.

Physicians are the primary resource in co-prescribing the medication along with a high-dose opioid prescription, as recommended by the CDC. For the time being, physicians and pharmacists should leverage the regulatory support as an opportunity to expand access by prescribing naloxone for each high-dose prescription and instructing patients and their loved ones on administration. Moreover, pharmacists should feel empowered to prescribe naloxone where state laws allow and collaborate with patients’ physicians if they determine naloxone is warranted, but not ordered.

Pharmacists filling opioid prescriptions should consider the new opioid directives as part of their clinical evaluation for potential counseling and education with patients, and their families, about the need for naloxone and how to administer it. Pharmacists also can play a critical role in the coordination and communication with the physician to help these at-risk patients.

Greater public distribution of naloxone will help first responders, patients, and their families to reverse more overdoses and save more lives. However, naloxone presents a unique challenge. Administration of the lifesaving drug is rarely executed by the patient and often requires the successful intervention of family or friends. Successfully increasing the use of naloxone requires prescribers and pharmacists to consult, educate, and train those who will be near to the patient in case of an overdose. Because the touchpoints with family and friends are often erratic, improved collaboration and coordination between prescribers and pharmacists are vital to this work.

Health plans can bolster efforts to improve naloxone use by reimbursing pharmacists and physicians to educate patients and families about naloxone administration. This simple upfront cost offers staggering potential healthcare cost savings, based on a reported  $92,400 average cost of care per opioid admission in 2015 – a nearly $34,000 increase from 2009.

Patients on lower opioid doses also may warrant a naloxone prescription. As is required in nearly all states and territories, physicians ordering opioid prescriptions should check their state’s prescription drug monitoring program (PDMP) database to review the patient’s controlled-substance prescribing history. Many physicians also benefit from a clinical decision support tool that offers a data-driven “risk” score (based on the patient’s controlled-substance and medical history) indicating the patient’s increased chance of having an overdose event. If a physician chooses to prescribe opioids in such a case, a naloxone co-prescribing would be warranted.

 

Progress is evident, but we can, and should, do more

Unlike a vaccine, no single remedy exists for reversing the nation’s opioid epidemic. Rather, reducing opioid use disorder and opioid-related overdoses, while still ensuring those who need opioids use them as intended, requires a collective effort across public and private healthcare professionals, educators, community leaders, first responders, and families.

Progress has been made on the prescription opioid front. The U.S. opioid prescription rate fell to the lowest level in 13 years by 2018, and deaths from prescription opioids fell to just over 12,100 in January 2020, which was nearly 3,000 fewer deaths just three years prior. Unfortunately, the pandemic appears to have erased much of those gains and the U.S. has seen an 18% spike in overdoses. It is imperative that we continue to make additional strides to reduce prescription and other opioid-related fatalities by increasing the availability of naloxone to patients’ with improved education for family and friends.

Brian Eidex

Author

Brian Eidex

Brian Eidex is the general manager of pharmacy for Appriss Health.

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