a b s t r a c t

Objective: This study sought to answer the question, “Can police officers administer intranasal naloxone to drug overdose victims to decrease the opioid overdose death rate?” Methods: This prospective interventional study was conducted in Lorain County, OH, from January 2011 to Octo- ber 2014. Starting October 2013, trained police officers administered naloxone to suspected opioid overdose vic- tims through a police officer naloxone prescription program (NPP).

Those found by the county coroner to be positive for opioids at the time of death and those who received nalox- one from police officers were included in this study. The rate of change in the total number of opioid-related deaths in Lorain County per quarter year, before and after initiation of the NPP, and the trend in the survival rate of overdose victims who were given naloxone were analyzed by linear regression. Significance was established a priori at P b .05.

Results: Data from 247 individuals were eligible for study inclusion. opioid overdose deaths increased significant- ly before initiation of the police officer NPP with average deaths per quarter of 5.5 for 2011, 15.3 for 2012, and

16.3 for the first 9 months of 2013. After initiation of the police officer NPP, the number of opioid overdose deaths decreased each quarter with an overall average of 13.4. Of the 67 participants who received naloxone by police officers, 52 (77.6%) survived, and 8 (11.9%) were lost to follow-up. Conclusions: Intranasal Naloxone administration by police First responders is associated with decreased deaths in opioid overdose victims.

(C) 2015

Introduction

Background

Drug overdoses are a leading cause of preventable mortality. Unin- tentional poisoning, primarily due to drug overdose, is now the leading cause of injury-related death among Americans aged 25 to 64 years, sur- passing deaths caused by motor vehicle accidents [1]. Approximately 45 deaths per day in the United States involve prescription painkillers. The

? Financial support: Mercy Regional Medical Center in Lorain, OH; university hospitals Elyria Medical Center in Elyria, OH; and various local police departments in Lorain, OH, provided funding for the Narcan rescue kits.

?? Meetings: Abstract poster presented at Ohio American College of Emergency Physi-

cians, ACEP, meeting in Columbus, OH, on August 14, 2014.

* Corresponding author at: 3525 Southern Blvd, Kettering, OH, USA 45429. Tel.: +1 937 395 8839.

E-mail addresses: [email protected] (J. Rando), [email protected] (D. Broering), [email protected] (J.E. Olson), [email protected]

(C. Marco), [email protected] (S.B. Evans).

rapidly rising number of deaths secondary to drug overdoses constitutes an epidemic in the United States. Overdose of Prescription opioids, such as oxycodone, hydrocodone, and methadone, is largely responsible for this epidemic, now killing more Americans than heroin and cocaine combined [2].

Ohio’s Death rate due to unintentional drug overdoses increased 372% from 1999 to 2010 [3,4] with 1544 deaths recorded in 2010 [3]. In large part, this increase in the number of drug overdose deaths is due to the rise in opioid-related overdose deaths (Fig. 1). In 2010, 63% of fatal drug overdoses involved an opioid, either prescription or heroin, an increase from 55% in 2009 [3]. Specifically, prescription opioid fatal overdoses as a percentage of the total number of overdose deaths were fairly constant at 37% from 2001 to 2009 but increased to more than 42% from 2010 to 2012. This increase represents an additional 261 deaths in Ohio. Similarly, the percentage of heroin overdose deaths nearly doubled from an average of 14% from 2001 to 2009 to more than 27% from 2010 to 2012 [3,5].

Naloxone hydrochloride (Narcan), an opioid antagonist, is a medica- tion that can be safely administered via intravenous, intramuscular, sub- cutaneous, or intranasal routes. Within minutes, naloxone blocks the central effects of opioids, thus reversing respiratory depression and

http://dx.doi.org/10.1016/j.ajem.2015.05.022

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2000

Total Drug Overdose

Total Opioid Overdose

1500

Number of Deaths

1000

500

0

2000 2002 2004 2006 2008 2010 2012

Date

Fig. 1. Number of drug overdose-related deaths in Ohio by year.

restoring normal breathing [6]. Naloxone has been used by emergency medical professionals safely for over 40 years. Intranasal naloxone has shown to be an effective and safe alternative to intramuscular adminis- tration, as it is quick acting and offers a needleless option for administra- tion [7]. Its only contraindication is known hypersensitivity to the medication [6].

Importance

Multiple programs have been initiated across the United States to re- duce the incidence of opioid overdose-related deaths. Naloxone pre- scription programs (NPPs) provide training and take-home naloxone rescue kits to individuals at high risk of opioid overdose [4,8,9]. Since 1996, NPPs have reportedly trained more than 53000 individuals and resulted in more than 10000 overdose reversals using the naloxone res- cue kits [4,8,9]. In Ohio, Project DAWN (Deaths Avoided with Naloxone) was initiated in 2012. Like other NPPs, Project DAWN trains at-risk indi- viduals and provides them with home naloxone rescue kits [3].

Bystanders who witness a drug overdose often are reluctant to call emergency medical services (EMS) for fear of police involvement [1]. However, because police officers routinely patrol neighborhoods and are available for quick response, they frequently are the first to arrive at the scene. Thus, although the Project DAWN program could decrease drug overdose-related deaths, Lorain County Coroner, Stephen B Evans, MD, PhD, saw a means for further intervention against the current opi- oid overdose epidemic. He petitioned the Ohio State Senate to create a pilot project in Lorain County, which would allow first responders to carry naloxone rescue kits and intervene when necessary (police officer NPP). To implement this program, State Senator Gayle Manning peti- tioned for a change in Ohio law, which prohibited anyone from prescrib- ing a medication to someone with the Intended use by a third party [4]. This law had precluded police officers from carrying naloxone for the purpose of administrating the medication to an overdose victim. The police officer NPP program described in this report sought to take ad- vantage of the rapid police response to 911 calls as a means of providing early intervention through naloxone administration.

Goals of this investigation

This study sought to answer the question, “Can police officers ad- minister intranasal naloxone to drug overdose victims to decrease the opioid overdose death rate?”

Materials and methods

Study design and setting

This prospective interventional study was conducted in Lorain Coun- ty, OH, from January 2011 to October 2014. Data on countywide opioid deaths and naloxone administration by police officers were obtained from Lorain County Coroner’s Office and the Alcohol and Drug Addiction services Board of Lorain County.

Selection of participants

All individuals who tested positive for opioids at the time of death and were deemed by the coroner to have died as a result of opioid over- dose plus those who received naloxone from police officers were in- cluded for analysis. This study was reviewed by the Wright State University Institutional Review Board and deemed exempt from human subjects research review.

Interventions

local hospitals were enlisted to provide funding to defray the approximate $20 cost of each naloxone rescue kit. Police units were trained by one of the authors (SBE) and volunteer nursing staff from the local county health department. Police officers attended a 2-hour training session in which they watched a demonstration video, learned basic lifesaving techniques, were taught how to identify victims who might benefit from naloxone administration, learned about naloxone’s use and effect on victims, and practiced administration of the intranasal naloxone using expired kits on mannequins. Police offi- cers were instructed to give 2 mg of naloxone to patients with suspected opioid overdose and were told to contact EMS for further medical care as warranted.

Starting October 2013, 511 Lorain County police officers from the county sheriff’s office and city jurisdictions received training and began administering naloxone to suspected opioid overdose victims. Of the total 18 police units in Lorain County, 10 have received training since October of 2013. This training program is ongoing.

Methods and measurements

Participating police officers reported all cases of naloxone adminis- tration and results of the intervention to the Alcohol and Drug Addiction Services Board of Lorain County. Every time a police officer adminis- tered naloxone, he or she was responsible for reporting the demo- graphics of the victim who received naloxone as well as the clinical outcome. To assess the effectiveness of this program, the Alcohol and Drug Addiction Services Board for Lorain County verified self-reports by the participating local police departments taking part in the program at monthly intervals. The number of patients who received naloxone from police officers and the clinical outcomes and demographics of the patients were abstracted from these records. Data were also collect- ed from the Lorain County Coroner’s Office at monthly intervals for all deaths in Lorain County, OH. Those deaths confirmed by laboratory tests and deemed by the coroner to be a result of an opioid overdose were included in this study. American Institute of Toxicology, Inc Labo- ratories was used by the coroner’s office for testing of blood samples. American Institute of Toxicology, Inc screens all specimens by mass spectrometers and confirms all positives with an applicable secondary test. It can detect the following opioids and levels: morphine, 5 ng/mL; codeine, 5 ng/mL; hydrocodone, 5 ng/mL; hydromorphone, 0.5 ng/mL; oxycodone, 5 ng/mL; 6-monoacetylmorphine, 2.5 ng/mL; and oxymorphone, 0.5 ng/mL [10].

Outcomes

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Before Study

During Study

1203

The primary outcome during the study period was the clinical re- sponse of the overdose victim after police officer intervention (death or survival). Outcomes were reported to and validated by the Alcohol and Drug Addiction Services Board of Lorain County.

Analysis

The primary analysis compared opioid-related deaths during the 13-month police officer NPP (the study period) with similar data from 33 months before initiation of the program (January 2011 to September 2013). The number of opioid deaths and outcomes after police encoun- ters with overdose victims was grouped in 3-month periods to smooth out month-to-month variabilities. Trends in the number of overdose deaths were determined by separate linear regression analyses for the 11 quarters before initiation of the police officer NPP and the 4 quarters after initiation of the police officer NPP. For statistical calculations, data from patients lost to follow-up were combined with data from those who died. We also compared the age distribution of participants before and during the study period using the Kolmogorov-Smirnov test and analyzed trends in the percentage of male overdose victims over the en- tire period of data collection and the outcomes of police officer NPP en- counters during the study period by linear regression. Statistical significance was determined a priori for P b .05. GB Stat software (1997; Dynamic Microsystems Inc) was used for analyses.

Theory/calculation

We theororize that the police officer NPP program will decrease the rate of opiod-related deaths in Lorain County. This program might be extrapolated to other counties in the future to help decrease the rate of opioid-related deaths in the United States.

Results

Characteristics of study subjects

Data from 247 individuals were included in the study. One hundred thirty-two subjects were identified as an opioid overdose by the Lorain County Coroner before initiation of the police officer NPP in October 2013. Of the remaining 115 individuals, 67 received naloxone by police first responders between October 2013 and October 2014. From 2011 to 2014, opioid overdose patients and those who received police interven- tion were predominantly male (65.3%). There was no statistically signif- icant trend in this percentage over the study period. Patients ranged in ages from 18 to 71 years with approximately one-half between 21 and 40 years old. The distributions of patient age before and during the study period were statistically similar.

Main results

Data from 187 patients who died of an opioid-related overdose were gathered from Lorain County Coroner records over the period of January 2011 to October 2014 (Fig. 2). Fifty-five of these patients died during the study period with 48 dying without police officer naloxone administra- tion. Sixty-seven individuals were administered naloxone by police offi- cers from October 2013 to October 2014 with 52 (77.6%) surviving,

7 (10.5%) dying, and 8 lost to follow-up (11.9%) (Fig. 3). There was no significant trend in the survival rate per quarter for police encounters during the study period.

Before initiation of the police officer NPP, the number of opioid over- dose deaths in Lorain County was increasing at a rate of 1.5 +- 0.3 deaths per quarter (P b .002). Opioid overdose deaths per quarter averaged 5.5 for 2011, 15.3 for 2012, and 16.3 for the first 9 months of 2013. After the police officer NPP began in October 2013, the number of opioid

20

15

Number of Deaths

10

5

0

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3

2011 2012 2013 2014

Date

Fig. 2. Number of opioid-related deaths in Lorain County by quarter year. Two additional deaths were recorded in October 2014 but are not included in this figure.

overdose deaths decreased at a rate of -4.1 +- 1.0 individuals per quar- ter (P b .025), averaging 13.4 deaths per quarter during the 13-month study period.

Limitations

This study has several limitations. First, police officers had to deter- mine if the patient would benefit from intervention. As police officers have limited medical training, their recognition of opioid overdose may have been inaccurate. This may have resulted in inappropriate ad- ministration of naloxone (overutilization or underutilization). Second, there may be difficulties that could affect generalizability of the police officer NPP described here. Program implementation requires that offi- cers in each police department receive specific training on the identifi- cation of victims and the administration of naloxone. We have not examined whether police officers would need periodic training to iden- tify victims or to practice administering naloxone to ensure continued appropriate use of the drug. There may also be funding or legal issues af- fecting implementation of this program into other areas of the United States. If funding is limited in some areas, it may not be possible to ade- quately train police officers or supply them with naloxone rescue kits.

25

Deaths Saves Unknown

20

Number of Encounters

15

10

5

0

Q4 Q1 Q2 Q3

2013 2014

Date

Fig. 3. Outcome of police officer naloxone administrations in Lorain County by quarter after initiation of the police officer NPP. Two additional deaths and 6 additional saves were recorded in October 2014 but are not included in this figure.

1204 J. Rando et al. / American Journal of Emergency Medicine 33 (2015) 1201-1204

Laws in other states, which restrict distribution of naloxone by police of- ficers to a third party also may limit the generalizability of this program. Finally, this study depended on accurate reporting by the Lorain County Coroner’s Office, police officers, and the Alcohol and Drug Addiction Ser- vices Board for Lorain County and does not reflect survival of patients who received naloxone by EMS or in a hospital. American Institute of Toxicology, Inc Laboratories was used in the testing of the victims’ blood samples. This test can detect small levels of opioids in the blood, but it is possible that this could miss some victims with very small levels of opioids in their blood; however, one would postulate that if the victim’s blood level was low enough to not be detected, he or she likely did not pass from opioid overdose.

Discussion

We found that intranasal naloxone administration by police first re- sponders is associated with decreased deaths in opioid overdose vic- tims. Our study demonstrated not only a reversal in the rise of opioid- related deaths after program implementation but also suggested a net decrease in the average number of deaths per quarter. In contrast, ac- cording to the 2012 Ohio drug overdose death data, heroin-involved deaths increased from 16% of all unintentional drug overdoses in 2008 to 36% of all unintentional drug overdose deaths in 2012 [5]. Similarly, deaths due to prescription opioids also have risen, with nearly one- fourth of total unintentional drug overdose deaths associated with oxy- codone, hydrocodone, and morphine in 2012 [5]. Data for 2013 and 2014 are not yet available.

Previous studies have shown that NPPs can help decrease the amount of opioid-related deaths [4]. However, in most jurisdictions, the naloxone rescue kits can be supplied only to the at-risk individual and thus cannot be given to a concerned family member or friend of the patient [4]. The Massachusetts Department of Public Health operates an overdose educa- tion and Naloxone distribution pilot program, similar to the police officer NPP described here, which has expanded naloxone access to emergency

medical technicians, firefighters, and police officers [11]. This program has administered naloxone to more than 700 individuals since its institu- tion in 2010; although data on death rates or other measures of program efficacy are not currently available [11].

Conclusions

This study showed that intranasal naloxone administration by police first responders is associated with decreased death rates of opioid overdose victims. This pilot program may provide valuable insight to system approaches to decrease the incidence of opioid-related drug overdose deaths.

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