Running Head: COMMUNITY-BASED NALOXONE AND EDUCATION
Community-based Naloxone and Education
Paige Lawson
Virginia Commonwealth University
This essay was prepared for Focused Inquiry 112, Section 014, taught by
Professor Corner.
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Drug overdose surpasses motor vehicle accidents as the leading cause of adult
injury related death in the U.S., with prescription opioid drugs being the most common
(Green et al., 2015, p. 1). Drug overdose death rates in the U.S. have also increased fivefold since 1980 (U.S. Department of Health, 2013, p. 5). Opioid drugs (ex.oxycodone,
hydrocodone, heroin) are primarily associated with the chronic pain epidemic circulating
the nation as health care professionals often prescribe these drugs to help combat some of
their patients’ misery (Katzman et al., 2014, p. 1352). Despite opioid drug’s prescription
status, these drugs are readily abused and this misuse results in over 35,000 deaths
nationwide per year (CDC, 2010, 101) and has even caused certain states in the U.S. to
declare a state of emergency as a result of the large amount of fatal overdoses (Green, et
al. 2015, p. 6).
Although there is seemingly no hope for combating this drug overdose problem,
in the 1990s, the drug naloxone was introduced as the first-line treatment to help reverse
the effects of opioid drugs to prevent fatal overdose. Naloxone is a prescription
medication that reverses the effects of an opiate overdose characteristically associated
with suppressed respiratory efforts (Green, et al., 2015). Naloxone only works on opioid
drug overdoses and is not effective for other types of overdoses. Naloxone is very
effective in saving lives, as cited in the CDC’s report on community-based overdose
prevention programs, “Since beginning naloxone access programs in in 1996, respondent
programs reported training and distribution of naloxone to 53,032 persons with 10,171
reversals” (Green, et al., 2015, p.1). A reversal in this case means an overdose victim’s
life was saved. Although federal and statewide support for access to naloxone is steadily
growing, there needs to be more measures taken to support access to this drug. With
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many deaths related to drug overdose, and significant evidence to suggest naloxone’s
success, there should be community-based naloxone access to all persons in the United
States and most importantly, more education on drug overdose abuse.
Before looking specifically at drug overdoses, it is important to understand why
opioid medications are necessary for treatment of pain. It would be very easy to simply
wipe out opioid medications from the U.S. to resolve the overdose problem, but opioid
medications are seemingly more important than many realize. Academic medial centers,
state medical boards and accrediting agencies recognized that pain was being under
treated among patients, and in the 1990s, more opioid prescriptions were suggested to
alleviate this pain. The recognition of this “under treatment” is what many people refer to
as the catalyst that began the over prescribing of opioid drugs (Green, et al., 2015).
Although many health care professionals would argue that there is likely an over
prescription rate of opioid drugs, the need for these drugs is becoming more prevalent as
more and more people are affected by chronic pain. It is estimated that 100 million
Americans suffer from chronic pain, which is more than citizens suffering from cancer,
diabetes and vascular diseases combined (Green, et al., 2015).
Chronic pain is debilitating both physically and mentally, but it is unfortunately
also linked with a surplus of opiate medications, which can then lead to more opiate
overdoses. Opiate overdoses occur nationwide and are characterized by a depression in
the central nervous system (CNS) as seen through decreased respiratory rate (typically 24 per minute), unconsciousness, and eventual decrease of heart rate leading to cardiac
arrest. The telltale sign of overdose is constricted pupils commonly referred to as
“pinpoint pupils”. When coming out of an overdose, the patient will often vomit, become
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and agitated and sweat. The CDC has identified opiate overdose deaths as an epidemic in
America (Green, et al. 2015, p.2), and recognizes oxycodone, hydrocodone, methadone
cocaine and heroin as the leading causes of unintentional, intentional and unknown drug
overdoses (CDC, 2010, p.101).
There seems to be an ethical issue at play here in regards to both the chronic pain
epidemic and the availability of naloxone. It would be unethical to withhold opiate drugs
from those who suffer from chronic pain because for many people, these drugs are their
only relief. That being said, the overprescribing of these drugs puts more pills in the
population leading to a greater potential for fatal overdose. Naloxone has proven to save
lives and this has been seen through community-based naloxone access programs that
typically allow broader naloxone access to people in different communities (rural, low
socioeconomic settings, etc.), and allow access to third party persons such as family,
friends, pharmacists, law enforcement and EMS using standing orders (Davis et al., 2015;
Green et al., 2015).
In one study looking at Rhode Island community-naloxone use, standing orders
proved to decrease opioid death rates. In Rhode Island, Walgreens pharmacies
incorporated an online training module accompanied by naloxone distribution as a result
of standing orders (Traynor, 2014, p. 1328). The training video was developed by a
student at the University of Rhode Island College of Pharmacy and Jeffery Bratberg, a
professor there describes it: “it’s been used worldwide-there’s people in Australia who’ve
done it”(as cited in Traynor, 2014, p. 1330). This is significant because it shows that the
opioid epidemic is more than just nationwide; it is worldwide. Opioid use and opioid
overdose is a growing problem that is occurring in more than just the United States.
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Rhode Island has also issued orders to organizations such as police departments, and
because of this, “the police department in May announced that a trooper had administered
an intranasal dose of the drug to an overdose victim during a traffic stop and saved a
person’s life” (Traynor, 2014, p. 1330). The victim was lucky the police officer was
trained and ready even at an unexpected place like a traffic stop.
Massachusetts like Rhode Island also used pharmacy standing orders to increase
naloxone access. Massachusetts warranted immediate action to be taken on it’s drug
overdose problem as there were over 8,000 deaths between the years 2000-2014 in the
state alone (Green, et al., 2015, p.6). Because of the high number of deaths, MA governor
even declared a state of emergency in 2014. Community access permitted naloxone to be
distributed without direct interaction between the prescriber and the person receiving the
medication through standing orders (Davis et al., 2015, p. 19). It also allowed for third
party individuals to receive prescriptions to assist in administration of naloxone.
Third party individuals gaining prescription rights is seemingly more important
than the abuser gaining prescription rights. Ultimately, drug overdose puts someone in an
incapacitated state, which normally quickly leads to altered mental status and eventual
unconsciousness. In this state, it would be much harder to self-administer naloxone, but if
a family member or friend were present, they could then have the capability to administer
the much needed drug. Third party prescription capabilities are just another way that
community-based access to naloxone is allowing for more lives to be saved.
Due to four different standing orders that allowed community access to naloxone,
of which include: NRKs (Naloxone Rescue Kit) by public health workers, EMTs and first
responders, pharmacy NRKs and hospital pharmacy NRKs, there were over 30,000
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individuals trained by 2014, and 3500 successful reversals (Davis et al., 2015, p. 19).
This data shows that the standing order system is very successful and enabled many more
people to both have access to administer naloxone and many people to also receive the
drug.
In a separate study that focused on naloxone access in North Carolina, the Orange
County Health Department was the first county health department in the state to create a
naloxone distribution program after there was a 300% increase in unintentional drug
overdose deaths (Davis et al., 2015, p.20). This county gave out free NRKs while also
developing new ways to educate about them and track them (Davis et al. 2015). Many
non-profit organizations also helped to expand naloxone access.
The results of this study revealed that 7500 NRKs were distributed in a 20-month
period and there were 325 successful reversals (Davis, et al. 2015, p.20). This statistic
may seem not very significant, but it is important to remember that just because an NRK
is distributed does not necessarily mean that it was used. Hypothetically, of the 7500
people who had NRKs, there could have been only 325 overdoses all of which were
successful reversed, but ultimately, the study did not go into how many overdoses
occurred for the amount of kits distributed.
The community-based naloxone programs shown in Rhode Island, Massachusetts
and North Carolina show how increased naloxone access in various different forms such
as standing orders, law enforcement use, and pharmacy-based naloxone greatly decreased
opioid overdose related death.
The North Carolina study also discussed a possible reason for why there is a lack
of support for community-based naloxone programs. It recognized that the bandwagon
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approach to starting community-based naloxone programs is not enough to convince
other states to participate and that there is often not enough convincing evidence or
statistics in favor of naloxone programs. It said the evidence is not as convincing as “seat
belts save lives”. There is some validity in what the North Carolina study cites as a
reason for lack of support. Ultimately, “seat belts save lives” has much more support
because there are countless examples of seat belts saving lives (Davis, et al., 2015).
Because there are not as many community- based naloxone programs, there are not as
many examples or as much evidence for the importance of naloxone. If there were more
programs, it would be fair to argue that the phrase “naloxone saves lives” could have the
same power as “seat belts save lives”.
This rationale for lack of naloxone support is likely a result of lack of opioid
overdose and naloxone education being offered to the general public and in general lack
of knowledge about the overdose epidemic. The U.S. Department of Health and Human
Services recognizes that in Americans today, young adults do not understand how severe
drug overdose can really be. They have preconceived misconceptions that prescription
drugs are safer, less addictive and not nearly as risky as elicit drugs. They believe drugs
obtained from the medicine cabinet are harmless (U.S. Department of Health, 2013,
p.21). These misconceptions are likely linked to substance abuse.
The U.S. Department of Health has taken steps in the right direction for opioid
education and overdose prevention education. The FDA has released a REMS Program
(Risk Evaluation and Mitigation Strategy) that requires companies to provide a
medication guide that comes with opioid prescriptions obtained at the pharmacy. This
REMS program is one of the most wide-reaching methods of education being used
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nationwide. Many organizations are also releasing educational materials for a general
audience like the National Institute of Health who started PEERx initiatives, which help
warn teens of the harmful effects of prescription drug abuse. There are also other drug
education programs such as the National Take-Back Initiative and Get Smart About
Drugs (U.S. Department of Health, 2013, p.21). Although the U.S. Department of Health
has taken some measures to increase opiate education, there needs to be even more
nationwide outreach for education and more statewide initiatives taken to be sure people
from all communities receive this much-needed education.
The Evzio, a naloxone auto-injector, is another step in the right direction for
increased education and community access to naloxone. (Beletsky et al., 2015). It is also
a product that allows more support federally; it is the “first naloxone product user tested
and meant for the lay person”(Beletsky et al., 2015, p.357). Because of the product, the
FDA has given prescription rights to family members, friends, caregivers or bystanders.
The product itself provides the user with information on naloxone drug properties, basic
life support measures needed to support an overdose victim and instructions prompting
the administrator to call 911, and it requires no assembly (Beletsky, et al., 2015,p.357).
Education is crucial when dealing with community-based naloxone programs, and
lack of education is one of the key issues critics cite as reasons not to put naloxone in the
hand of untrained individuals. I sat down with one of the creators of the Evzio, Eric
Edwards. Eric is co-owner of Kaleo Pharmaceuticals; a company that also recently
released an epinephrine auto-injector. He told me that the Evzio is not just another
product but instead it represents a mission to both educate laypersons about naloxone
administration and educate physicians. Because, although the FDA has given prescription
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rights to more than just the patient, this does not necessarily mean doctors will chose to
prescribe naloxone beyond this scope (Beletsky, et al., 2015, p.359). The creators of
Evzio hope that this product will instill change and allow more people to be educated
about the overdose epidemic and allow greater access to this product.
Although there is evidence supporting community-based naloxone programs,
there are also arguments against access to naloxone. From the article “Lessons Learned
from the Expansion of Naloxone Access in Massachusetts and North Carolina”, critics
said, “ existing naloxone formulations either require assembly (intranasal), pose a risk of
needle stick injury (intramuscular) or cost a lot (Evzio)”(Davis et al., 2015, p.20).
Currently, the Evzio is being sold at prices between $450-$600 while the generic
naloxone medication runs for about $7 (Beletsky et al., 2015, p. 358). That is a pretty
significant cost difference, but when considering the product in of itself and its
capabilities to educate, avoid assembly problems and be available to many different
people through prescription rights, the benefits seem to outweigh the cost. The person
who accidentally overdosed on prescribed oxycodone will not care that someone spent
$600 on the Evzio administered to him or her. There is really no price on saving
someone’s life.
Another study, “ Overdose Rescues by Trained and Untrained Participants and
Change in Opioid Use Among Substance-using Participants in Overdose Education and
Naloxone Distribution Programs: A Retrospective study”, offers other counterarguments
for community naloxone use and lack of American education. Many people argue that
laypersons should not be allowed to administer naloxone because they are not properly
educated. In order to disprove this, the Massachusetts Opioid Overdose Prevention Pilot
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Program took trained individuals (trained through OEND or “opioid overdose education
and naloxone) and untrained individuals (obtained own training through social media)
(Doe-Simikins, 2014, p. 3) and showed how accurately and successfully they
administered naloxone to overdose victims. The results of the study revealed that there
were 599 overdose rescues in total, and the study found “no statistically significant
differences in help-seeking, rescue breathing, staying with the victim or in success of
naloxone administration by trained versus untrained rescuers”(Doe-Simikins, 2014, p. 6).
This study also looked at how many clinicians argue that naloxone could enable
opioid drug use and possibly increase opioid use. When evaluating previous studies and
data, “ no studies of existing OEND programs have demonstrated increased drug use by
participants”, and one small study even reported decreased heroin injections at a 6-month
follow up (Doe-Simikins, 2014, p.2). Within the new study, the pilot programs showed
no decrease or increase in heroin use, and “findings provide reassurance that training
active substance users in overdose management and distributing naloxone rescue kits
does not lead opioid user to increase their overall opioid use” (Doe-Simikins, 2014, p. 8).
Two of the main counterarguments of community-naloxone use are both
discussed and refuted in this study. Clinicians and other policy makers argue against
community-naloxone use as it puts naloxone in uneducated hands. This study showed
that layperson and trained individuals administer naloxone and treat overdose victims
with relatively the same measures. And although health care professionals also argue that
naloxone can enable more drug use, this study showed that is not the case either.
Although the second counterargument showed that untrained people can assemble
and administer naloxone, there still needs to be more education about opioid overdose in
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general. As stated in previous sections, many American teenagers do not understand the
seriousness of drug use and drug abuse. Hopefully, if more people are educated on the
seriousness of drug abuse, there will be less instances of drug overdose and less need for
administration of naloxone.
These counterarguments bring up the ethical considerations of community-based
naloxone and are some of the reasons why naloxone is not currently being offered over
the counter. Ultimately, more nationwide education of the opioid epidemic and more
evidence to refute these counterarguments will hopefully lead to more support for
naloxone access everywhere.
Although naloxone access and support is still up and coming, I believe that as
time goes on and there is more evidence for its necessity to combat overdose related
death, it too will became prevalent in society as a very important drug. Through the
community-based naloxone programs and the emergence of a naloxone auto-injector, it is
apparent that naloxone works and is being accessed by many people who would not
normally have prescription access to it. The rise of chronic pain and the prescription rate
of opiates go hand-in-hand, but naloxone can be the first step in the right direction to
protect people from preventable deaths. At the end of the day, no price is put on
someone’s life, and lack of education cannot be considered a counterargument as the
overdose problem in America just incites each and every one us to educate others about
this epidemic and how we can respond. More education on substance abuse will
hopefully reduce opiate abuse rates and thus overdose related death, and communitybased naloxone will make naloxone accessible to those who need it.
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References
Beletsky, L. (2015). The benefits and potential drawbacks in the approval of EVZIO
for lay Reversal of opioid overdose. American Journal of Preventative
Medicine. 48(3). 357-359.
Center for Disease Control, Community-based overdose prevention programs
providing naloxone- United States, 2010. 61(6). 101-105.
Davis, C.S., Walley, A.Y., Bridger, C.M.(2015). Lessons learned from the expansion of
naloxone access in massachusetts and north carolina. Journal of Law,
Medicine and Ethics. 43. 19-22. doi: 10.1111/jlm3.12208.
Doe-Simikins, M., Quinn, E., Xuan, E., Sorensen-Alawad, A., Hackman, H., Ozonoff, A.,
Walley, A.Y. (2014). Overdose Rescues by Trained and Untrained Participants
and Change in Opioid Use Among Substance-Using Participants in Overdose
Education and Naloxone Distribution Programs: A Retrospective Study. BMC
Public Health. 297. doi: 10.1186/1471-2458-14-297.
Green, T.C., Dauria, E.F., Bratberg, C.S., Walley, A.Y. (2015). Orienting patients to
greater opioid safety: models of community pharmacy-based naloxone.
Harm Reduction Journal. 12(1), 1-9. doi: 10.1186/s125954-015-0058-x.
Katzman, J., Comerci, G., Landen, M., Loring, L., Jenkusky, S., Sanjeev,A., Kalishman,S.,
Marr, L., Camarata, C., Duhigg, D., Dillow, J., Koshkin, E., Taylor,
D.,Geppert,C.(2014). The public health crises of chronic pain and addiction.
American Journal of Public Health. 104(8). 1356-1362. doi:
10.2105/AJPH.2014.301881.
Traynor, Kate (2014). Rhode island’s opioid epidemic response features
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collaborative practice model. American Journal of Health-System Pharmacy.
71(16). 1328-1332. doi: 10.2146/news140057.
U.S. Department of Health and Human Services, Addressing prescription drug abuse
in the United States. (2013). Retreived from:
http://www.cdc.gov/drugoverdose/pdf/hhs_prescription_drug_abuse_repor
t_09.2013.pdf