Jeffrey Fudin, PharmD, DAIPM, FCCP, FASHP
Jeffrey Fudin, PharmD, DAIPM, FCCP, FASHP
Dr. Jeff Fudin graduated from Albany College of Pharmacy & Health Sciences with a BS and PharmD. He is a Diplomate to the Academy of Integrative Pain Management, a Fellow to ACCP and ASHP, and a member of several other professional organizations. He is President and Director, Scientific and Clinical Affairs for Remitigate, LLC (remitigate.com), a software platform for interpreting urine drug screens (Urintel) and risk for opioid-induced respiratory depression (Naloxotel). Dr. Fudin is a section editor for Pain Medicine and serves on the editorial board for Practical Pain Management. He practices as a clinical pharmacy specialist (WOC) and director of PGY-2 pharmacy pain residency programs at the Stratton Veterans Administration Medical Center in Albany, New York and has academic affiliations with Western New England University and Albany Colleges of Pharmacy.

Pharmacists as Champions for Opioid Overdose Prevention and Naloxone Counseling

OCTOBER 23, 2014
An estimated 100 million American adults suffer from chronic pain—more than the total number of individuals with diabetes, heart disease, and cancer combined.1 Therefore, it should come as no surprise that the US Centers for Disease Control (CDC) has estimated at least a 10-fold increase in the medical use of opioids in the last 20 years to address the widespread problem that is chronic pain.2

Related to the increased prescribing of opioids, a recent Agency for Healthcare Research and Quality (AHRQ) report identified a total of 16,917 fatal overdoses that included prescription opioids in 2011.3 In fact, for every 1 opioid-related death, there are 10 treatment admissions for abuse, 32 emergency department visits, 130 persons that abuse or are dependent on opioids, and 825 nonmedical users.4 In addition, prescription opioid misuse and abuse resulted in approximately 660,000 emergency department visits in 2010, double the number seen in 2004.3 Could some of these fatal opioid overdoses have been prevented with an opioid reversal agent in the hands of family, friends, or caregivers with formal counseling and education from a pharmacist?
 
Risks for opioid overdose exist outside of substance abuse, some of which include high daily morphine equivalent dose (MED), age, gender, concomitant use of benzodiazepines and/or alcohol with or without other sedative-hypnotics, chronic lung disease, chronic kidney and/or liver impairment, sleep apnea, and accidental exposure to young children in the home.5-7 In fact, patients on lower doses of opioids (e.g. 20 MED daily)3 and even those on chronic opioid therapy for several years remain at risk for opioid overdose as their medical status changes.

Acute treatment of opioid overdose is indistinguishable insofar as it relates to intentional or accidental causation. Potential substance abuse history has no relevance in emergency treatment procedure, other than the usual protocol for universal precautions to avoid infectious risk of the caregiver. Naloxone is considered the standard of care and works as an opioid antagonist by competing for the same mu receptor site and ultimately reversing the opioid effects.6 Of note, the reversal of buprenorphine, a partial opioid agonist, may not be effective with naloxone, given buprenorphine’s higher binding affinity for the opioid receptors.7

Naloxone is not a new or novel drug; in fact, it was developed in the 1960s and has been available generically for quite some time. In the hospital setting, naloxone is often administered intravenously, but it can also be administered intranasally, intramuscularly, and subcutaneously.6,8 The most recent naloxone product to hit the market is the Evzio Auto-Injector, a unique delivery device that may have several benefits over previously available naloxone products.
 
The Evzio Auto-Injector is similar to the EpiPen in that it contains 1 dose of a potentially lifesaving medication and its administration is accomplished by intramuscular injection. While the EpiPen contains epinephrine for the treatment of anaphylaxis, Evizio contains one dose of naloxone 0.4 mg/ml in a pre-filled auto-injector for the treatment of opioid overdose. The Evzio package dispensed by a pharmacist contains 2 auto-injectors plus 1 “dummy” Evzio trainer for teaching on how to use the product.6

In order to effectively use Evzio, or any naloxone product for opioid overdose, one must first recognize the signs and symptoms of opioid narcosis. It is incumbent upon the pharmacist to educate the patient and any available caregivers on how to recognize such an emergency and act swiftly to prevent opioid-induced death at the point of dispensing Evzio. Should a patient present with an especially high overdose risk, as outlined above, the pharmacist may even want to intervene by suggesting a naloxone auto-injector to the prescriber. This is easily accomplished with a telephone call.

Teaching points for the patient or family member involve the common signs and symptoms of opioid overdose, which include extreme sleepiness or drowsiness, mental confusion, slurred speech, breathing problems (slow or shallow breathing, as well as no breathing), slow heartbeat, low blood pressure, and difficulty arousing the patient.6-7 If these signs or symptoms are identified, the patient or a bystander should activate the Evzio Auto-Injector by removing the red safety cap. Once this is done, the electronic voice system will instruct the user on how to properly administer naloxone. Using this product, naloxone can be administered intramuscularly through clothing, similar to the EpiPen, and then the needle retracts automatically, eliminating the risk of accidental needle stick.

If the patient does not respond within 2 to 3 minutes, another Evzio dose can be administered. If there is still no response, additional Evzio doses may be administered every 2 to 3 minutes until emergency assistance arrives. Bystanders may consider supportive or resuscitative measures, as well, while waiting for help.6 Note, however, that it is especially important to instruct the patient and caregiver in advance that naloxone has a short half-life. Reversal is temporary and potentially lifesaving, but it requires immediate and close follow-up attention within a short period of time, as a naloxone intravenous infusion may be necessary to overcome a longer half-life of the causative opioid.
 
Back in 2001, New Mexico became the first state to amend its laws, permitting easier access to naloxone through various medical professionals to promote administration by lay people without fear of possible legal ramifications. As of August 2014, a total of 24 other states and the District of Columbia have made similar amenities. Additionally, there are 21 states with amendments to regulation that encourage Good Samaritans to call for help in the event of an overdose.9
 
But what about providing access to naloxone without a prescription? At time of this posting, there are 6 states with current or pending legislation allowing for the distribution of naloxone without a prescription, including both the patient and caregiver.  In fact, pharmacists in California are now authorized to provide naloxone to patients upon request without a prescription. In some other states, including Washington, Rhode Island, and New Mexico, pharmacists and physicians have naloxone collaborative practice agreements.10

This will likely be a growing area of interest in the coming years to expand naloxone access without the requirement of a prescription. Moreover, the National Association of Boards of Pharmacy (NABP) released a policy statement earlier this month advocating for the pharmacist’s role in an effort to increase access of the life-saving opioid reversal drug: “NABP recognizes the value of pharmacists in assuring optimal medication therapy and promotes the pharmacist’s role in delivering opioid overdose reversal therapy.”
 
As pharmacists, we have a professional and ethical obligation to discuss the safe use of opioids which includes treatment for potential overdose in applicable patients. Whether it is an opioid analgesic or the Evzio Auto-Injector, the pharmacist can educate both the patient and any loved ones, friends, or caregivers at the point of dispensing. Asking the patient, “Do you have any questions for the pharmacist and, if not, please sign here,” is not an acceptable option.
 
Finally, it is noteworthy that this injector is very easy for children to understand and administer. The patient should be encouraged to share this information with frequent visitors, perhaps even neighbors, to mitigate against potential disaster in the event that an overdose does occur. Arming our patients with this knowledge most certainly will be lifesaving for some. After all, pharmacists already teach patients to use and inject insulin, the EpiPen, and any other number of injectables such as erythropoietin or darbepoetin, and administer vaccines in outpatient pharmacies. We are, without question, the most accessible health care professionals and exceedingly qualified to discuss and demonstrate Evzio administration.
 
In summary, the potential for opioid overdose is very real and the risk can be stratified according to dose, concomitant sedating medications, and comorbid medical conditions with or without the presence of a substance abuse disorder. It is therefore compulsory for pharmacists to recognize these risks, counsel all patients receiving opioids, evaluate the potential benefit of a naloxone reversal device, contact the opioid prescriber if such a device is deemed appropriate, and ultimately counsel and teach the patient and/or caregiver(s) about opioid risks and how to mitigate against potential overdose.
 
This article was collaboratively written with Abigail Brooks, PharmD, BCPS who attended the University of Florida for both undergraduate studies and pharmacy school. She completed a Post-Graduate Year 1 Pharmacy Residency in Pharmacy Practice at the West Palm Beach Veterans Affairs Medical Center, during which time she became a Board Certified Pharmacotherapy Specialist (BCPS). Subsequently, she completed a Post-Graduate Year 2 Pharmacy Residency in Pain Management and Palliative Care at the West Palm Beach Veterans Affairs Medical Center. Dr. Brooks currently is a Clinical Pharmacy Specialist in Pain Management at the Minneapolis Veterans Affairs Health Care System.

This article is the sole work of the authors and stated opinions/assertions do not reflect the opinion of employers, employee affiliates, and/or any pharmaceutical companies listed or not listed, including but not limited to Kaléo Pharma.
 
References:
  1. Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press, 2011.
  2. Unintentional Drug Poisoning in the United States, 2010. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control; 2010. http://www.cdc.gov/HomeandRecreationalSafety/pdf/poison-issue-brief.pdf. Reviewed July 2010. Last accessed 14 October 2014.
  3. Chou R, Deyo R, Devine B, Hansen R, Sullivan S, Jarvik JG, Blazina I, Dana T, Bougatsos C, Turner J. The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain. Evidence Report/Technology Assessment No. 218. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2012-00014-I.) AHRQ Publication No. 14-E005-EF. Rockville, MD: Agency for Healthcare Research and Quality; September 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
  4. Policy Impact: Prescription Painkiller Overdoses. Centers for Disease Control and Prevention. National Center for Injury Prevention and Control; 2013. http://www.cdc.gov/homeandrecreationalsafety/rxbrief/. Updated July 2013. Last accessed 21 October 2014.
  5. Opioid Overdose Risk Assessment Checklist. Kaleo, Inc. May 2014. http://www.evzio.com/pdfs/Evzio-Opioid-Overdose-Risk-Assessment-Checklist.pdf. Last accessed 14 October 2014.
  6. Evzio [package insert]. Richmond, VA: kaleo, Inc.; 2014.
  7. Substance Abuse and Mental Health Services Administration. SAMHSA Opioid Overdose Prevention Toolkit. HHS Publication No. (SMA) 14-4742. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014.
  8. Beletsky L, Ruthazer R, Macalino GE, Rich JD, Tan L, Burris S. Physicians’ knowledge of and willingness to prescribe naloxone to reverse accidental opiate overdose: challenges and opportunities. J Urban Health. 2007 Jan;84(1):126-36.
  9. The Network for Public Health Law. Legal interventions to reduce overdose mortality: Naloxone access and overdose Good Samaritan laws. https://www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf. August 2014. Last accessed 22 October 2014.
  10. Drug Policy Alliance. Press release: Governor Jerry Brown signs overdose law expanding naloxone access in California pharmacies. http://www.drugpolicy.org/news/2014/09/governor-jerry-brown-signs-overdose-law-expanding-naloxone-access-california-pharmacies. September 2014. Last accessed 22 October 2014.


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