As Naloxone Accessibility Increases, Pharmacist's Role Expands

OCTOBER 25, 2016
In 2012, around 259,000 prescriptions were written for opioids, which is enough for every adult in the United States to have their own personal opioid prescription. More than 25% of the patients who are prescribed one of these prescriptions struggle with addiction. The highest rate of overdose occurs in non-Hispanic whites between the ages of 25 and 54 years old. Opioid dependence has become an alarming epidemic over the past decade. Deaths due to opioid overdose have quadrupled since 1999. From 1999 to 2014, more than 165,000 individuals have died in the United States due to overdoses from a prescribed opioid. Up to 50% of all opioid overdose deaths are due to prescription opioids, while the other half are due to recreational use of opioids. The most commonly abused opioids include methadone, oxycodone, and hydrocodone. Each day, 1000 individuals are treated in emergency departments (ED) for misuse of prescription opioids.1 There's a growing need to be prepared and alert to treat and manage patients with an opioid overdose. Pharmacists are starting to see an increasing need for action and education regarding patient care in overdose situations.

Naloxone was originally approved in 1971 to treat opioid overdose. It’s been used to reverse the fatal effects of excess opioid ingestion in hospitals and EDs, as well as by emergency medical responders in the field for decades.2 Naloxone can be administered intramuscularly, intravenously, subcutaneously, and as a nasal spray. Although several different formulations of naloxone currently exist, the intravenous form is preferred due to its quick onset of action.3 Hospitals may also use a continuous infusion of naloxone for patients who have overdosed on long-acting opioids such as methadone or are requiring several bolus doses to maintain response.4 Naloxone is the generic name for Narcan®, and the auto injector is under the brand name Evzio®4. The auto injector was FDA approved on April 3, 2014, and the nasal spray was approved on November 18, 2015. The nasal spray was granted fast-track, priority approval in order to aid in reducing the number of opioid overdose deaths in this nationwide epidemic.5,6

The regulations for dispensing naloxone varies state to state. Some states allow for standing orders written by physicians allowing the patient to receive naloxone without a traditional written prescription. The order allows for the medication to be written without knowing who will be administering the drug. This is often done in hospitals or health care facilities to allow for nurses and other staff members to administer naloxone. Standing orders have expanded into outpatient practices, and 40 states have an authorized standing order for naloxone.7 In outpatient pharmacies, there’s usually an agreement between the pharmacy and a local physician—similar to standing orders with influenza. In some states, like Alabama, the public health officer serves as the physician on file for standing orders. There must be a copy of the standing order from the physician maintained on file at pharmacies and locations that allow for standing orders. A few states permit pharmacists to dispense naloxone through a collaborative practice agreement.7 The first naloxone Collaborative Drug Therapy Agreement was established in Washington in 2012. It allowed pharmacists to dispense naloxone to patients at high-risk of opioid overdose without a prescription from their physician. Under this agreement, pharmacists are required to document all patients to whom they dispense naloxone, in addition to attaching a training checklist with the patient’s initials, acknowledging that they were trained in the appropriate administration techniques. In this structure, the pharmacist and physician perform regular quality assurance reviews together.7
 
The importance of community involvement and training in preventing opioid overdoses has long been recognized. New Mexico was the first state to amend their Good Samaritan law to include overdoses.8 Since then, the majority of states have followed suit to varying degrees. As of June 2016, all but 3 states (Kansas, Montana, and Wyoming) have passed legislation that improves access to naloxone while also protecting laypeople from legal repercussions. Most states have implemented naloxone rescue kit programs and training for designated nonmedical professionals in the community at specific locations, such as schools, law enforcement and first responder organizations, or government or nonprofit agencies. By the end of 2014, 150,000 laypeople had been trained and had reversed more than 26,000 overdoses.

The community programs and increased access have made naloxone more readily available, putting it in the hands of witnesses who can act quickly in the event of an overdose. Naloxone first became available to the community in Chicago in 1996 after physicians affiliated with the Chicago Recovery Alliance group distributed naloxone to some of its members and trained them in the proper administration of it.9 In the early 2000s, new laws and organizations were established to help optimize naloxone’s role in opioid overdose. One example is the New York State Opioid Overdose Prevention Program established in order to be able to prescribe, dispense, and educate patients more effectively on naloxone use. The program allows naloxone to be administered by nonmedical professionals in order to prevent a potentially fatal opioid overdose. Programs may be set up at schools, by local law enforcement, medical professionals and facilities, and other community government and nonprofit agencies. Each program has a clinical director responsible for ensuring that individuals responsible for administering naloxone are properly trained. By 2010, more than 10,000 overdoses were reported to have been reversed due to the efforts of these administration training programs.7

To date, 46 states have laws that address access to naloxone for opioid overdose (Missouri, Kansas, Montana, Arizona, and Wyoming don’t).10 There are 36 states that provide criminal immunity for prescribers who prescribe, dispense, or distribute naloxone to laypersons.8 The Prescription Drug Abuse System provides details about the laws in your state.

Third-party prescriptions are given to someone other than the patient who could be potentially administering the drug to the patient in the event of an overdose. Third-party prescriptions concern some health care professionals that making naloxone more available to the public provides a false sense of safety while abusing narcotics. These prescriptions were intended for caregivers or those in community positions, but they could conceivably be obtained by individuals with more surreptitious intentions. However, the potential benefit of preventing overdose deaths has motivated advocates to champion for these types of prescriptions to be made available. Not all states allow for third-party prescribing. To date, 41 states have authorized third-party prescriptions (Minnesota, Missouri, Kansas, Arizona, Montana, Wyoming, Kentucky, Virginia, and Delaware don’t allow it).7

New Mexico was also the first state to allow pharmacists to dispense naloxone to patients without physician involvement.7 Trained pharmacists can dispense Naloxone Rescue Kits (NRK) through a collaborative prescription authority.11,12 A cross-sectional analysis on emerging trends in NRK prescribing patterns by pharmacists was conducted using data from the Prevention of Opioid Overdose by New Mexico Pharmacists (POINt-Rx) Registry.11 This database is maintained by the University of New Mexico and the New Mexico Pharmacists Association. More than 133 NRKs have been distributed since 2013. Most NRKs (89.5%) were first-time prescriptions, and 56.4% were requested by the patient. The remaining were dispensed by pharmacists to patients with high-dose pain medications (28.6%) or to patients with a history of opioid abuse (15%). The authors concluded that the data suggest that patients may feel comfortable requesting NRK from a pharmacist. More than 43% of the NRKs were dispensed based on the pharmacists’ judgment of overdose potential, which lends support to their important role in reducing overdose deaths and the opportunity for pharmacists to have a positive impact in every community.11

Takeda et al. conducted a trial that used coadministered naloxone prescriptions for patients who were prescribed chronic opioid prescriptions.12 The study had a primary goal of developing a universal precautions model for co-prescribing naloxone with chronic opioid therapy. There were 164 patients who participated in the study and were provided NRKs. No overdoses occurred in the study population over the year the trial was conducted. The study concluded that co-prescribing could be a useful practice in health care, preventing death from overdose and slowing the nationwide epidemic.12
 
Some of the larger pharmacy chains, along with some support from the FDA, are looking at an end goal for naloxone to be available OTC in all states.13-17 However, this could increase prices, especially for patients whose insurances don’t cover OTC medicatons.7 Nevertheless, there are different companies making naloxone a part of their company policy. CVS sells it without a prescription in 14 states.13 Walgreens is currently selling it without a prescription in Massachusetts, Rhode Island, New York, Indiana, Ohio.14 Rite Aid now offers naloxone for purchase without a patient-specific prescription in 13 states.15 Depending on state and company regulations, more pharmacies may also offer naloxone OTC, such as Publix in Florida or Kroger in Kentucky.16-17

Pharmacists play a key and evolving role in dispensing naloxone, but that role requires additional training and education. In states where pharmacists can prescribe naloxone, they must complete sanctioned training. Often times the training is online provided by the employer or a local school of pharmacy. 18-19 Pharmacists must be educated to properly counsel patients on the use of naloxone. Naloxone is perceived as a life-saving, emergency medication by the lay public who may not consider or be fully educated on the aftermath of administration.20 Family members, caregivers, and other third parties must be counseled on the signs and symptoms of opioid overdoses, such as difficulty breathing. It’s important to inform both patients and caregivers that naloxone should only be used in an emergency. Health care personnel should always be contacted after naloxone is administered, even if the patient wakes up. Naloxone provides a rapid reversal of opioid toxicity, and caregivers should know that patients may wake up fighting and be very irritable due to severe withdrawal.9

Patients should also be counseled on how to administer naloxone based on the dosage form that’s dispensed. Administration varies greatly by dosage form. For example, Evzio® is dispensed with an auto-injector for training purposes and 2 true auto-injectors. The trainer has audible step-by-step instructions for injection. It’s necessary to continue to monitor the breathing of the patient and administer another dose with the second auto-injector within 2 to 3 minutes if they don’t wake up.21 The nasal spray should be administered when the patient is lying on their back. The nozzle should be placed inside either nostril while pressing the plunger to release the dose. After naloxone administration, the patient should be turned onto their side.21-22

Naloxone dispensing and counseling is just one more area that has the potential to expand collaborative practice in order to effectively care for our patients. Pharmacists are readily accessible health care providers who can play a vital role in reducing fatal opioid overdoses through the administration and provision of naloxone to both patients and caregivers in a safe and nonintimidating environment.
 
Acknowledgements
Written with Ashleigh Cutcliff, Alexandria Stringberg, and Caitlin Atkins, student pharmacists and 2017 Doctor of Pharmacy candidates at the Auburn University Harrison School of pharmacy.
 
References
1. CDC. Prescription opioid overdose data. CDC website. 2016. cdc.gov/drugoverdose/data/overdose.html.
2. Yardley, W. Jack Fishman dies at 83; saved many from overdose. New York Times. Decemeber 14, 2013. nytimes.com/2013/12/15/business/jack-fishman-who-helped-develop-a-drug-to-treat-overdoses-dies-at-83.html?_r=0.
3.  Naloxone: Lexi-Comp Online Databse. Hudson, OH: Wolters Kluwer Health/Lexi-Comp, Inc. online.lexi.com/lco/action/home/switch.
4. Narcan, Evzio (naloxone) dosing, indications, interactions, adverse effects, and more. 2016. Healthbrk website. http://healthbrk.com/health-problems/drug/12057-narcan-evzio-naloxone-dosing-indications-interactions-adverse-effects-and-more.
5. FDA. FDA approves new hand-held auto-injector to reverse opioid overdose. FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm.
6.  FDA. FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose. FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473505.htm.
7.  The Network for Public Health Law. Using law to support pharmacy naloxone distribution. Website. 2016. networkforphl.org/_asset/qdkn97/Pharmacy-Naloxone-Distributions.pdf.
8. Prescription Drug Abuse Policy System. Good Samaritan overdose prevention laws. PDAPS website. pdaps.org./dataset/overview/good-samaritan-overdose-laws/5790f6e3d42e07010ce24439.
9.  Wheeler E, et al. Guide to developing and managing overdose prevention and take-home naloxone projects. 2012. Harm Reduction Coalition website. harmreduction.org/wp-content/uploads/2012/11/od-manual-final-links.pdf.
10. Prescription Drug Abuse Policy System. Naloxone overdose prevention PDAPS website. pdaps.org./dataset/overview/laws-regulating-administration-of-naloxone/57aa45f8d42e072d7513050.
11. Bachyrycz A, et al. Opioid overdose prevention through pharmacy-based naloxone prescription program: innovations in healthcare delivery. Subs Abus. 2016;10:0.  
12. Takeda MY, et al. Co-prescription of naloxone as a universal precautions model for patients on chronic opioid therapy – observational study. Subs Abus. 2016;19:1-6. Available at:
13. Join Together Staff. CVS will sell naloxone without prescription in 14 states. Partnership for Drug-Free Kids website.  September 24, 2015. drugfree.org/news-service/cvs-will-sell-naloxone-without-prescription-14-states/.
14. Walgreens makes naloxone available without prescription in Indiana pharmacies. Walgreens Newsroom website. news.walgreens.com/press-releases/general-news/walgreens-makes-naloxone-available-without-prescription-in-indiana-pharmacies.htm.
15. American Pharmacists Association. Rite Aid enables access to naloxone without prescription in 13 states. APhA website. pharmacist.com/rite-aid-enables-access-naloxone-without-prescription-13-states.
16. WKRC Cincinnati. Kroger pharmacies to offer naloxone without a prescription in the tri-state. WKRC Local 12 website. local12.com/news/local/kroger-pharmacies-to-offer-naloxone-without-a-prescription-in-the-tri-state.
17. Erickson B. New Florida law allows pharmacists to sell overdose antidote without prescription. July 20, 2016. Sun Sentinel. sun-sentinel.com/news/florida/fl-naloxone-available-20160719-story.html
18. Department of Consumer Protection. Training for pharmacists to prescribe naloxone is now available. State of Connecticut website. ct.gov/dcp/cwp/view.asp?Q=570138.
19. American Pharmacists Association. New naloxone training program for pharmacists take aim at opioid epidemic. AphA website. https://www.pharmacist.com/new-naloxone-training-program-pharmacists-takes-aim-opioid-epidemic.
20. American Pharmacists Association. Pharmacists gain recognition for role in naloxone access. APhA website. pharmacist.com/pharmacists-gain-recognition-role-naloxone-access.
21. Narcan (naloxone HCl) product website. narcan.com/?gclid=Cj0KEQjwx96-BRDyzY3GqcqZgcgBEiQANHd-nmj3RJsQVsZUeKkeYe0U1i4EvbF9hKBRh9rBW0lxUiUaAsUX8P8HAQ.
22. College of Psychiatric & Neorologic Pharmacists. Pharmacy basics. Prescribe to prevent website. prescribetoprevent.org/pharmacists/pharmacy-basics/.

Marilyn Bulloch, PharmD, BCPS
Marilyn Bulloch, PharmD, BCPS
Marilyn Novell Bulloch, PharmD BCPS, is an Associate Clinical Professor of Pharmacy Practice at the Auburn University School of Pharmacy and an Adjunct Assistant Professor at the University of Alabama School of Medicine College of Community Health Sciences Department of Internal Medicine. She completed a post-graduate pharmacy practice residency at the University of Alabama-Birmingham Hospital and a post-graduate specialty residency in critical care pharmacy at Charleston Area Medical Center in Charleston, West Virginia. Dr. Bulloch also completed a Faculty Scholars Program in geriatrics through the University of Alabama-Birmingham Geriatric Education Center in 2011. She serves on multiple committees and in leadership positions for many local, state, and national pharmacy and interdisciplinary medical organizations.
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