Roles and Issues in Advance Practice Nursing

A Safer Approach to Post-Operative Prescribing of Opioids Transcript

Slide 1

Welcome to Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists.

Slide 2

This program consists of three presentations and illustrative videos. Through the program, you will need a prescriber and a pharmacist in their patient.

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At the conclusion of the program, if you wish to receive CME, CME, or a CPE credit you must register in order to take a posttest and complete an evaluation. With a passing score of 70% or greater you will be able to prove your certificate.

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This program is provided by Boston University School of Medicine, and is supported by a grant from the Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services.

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You will learn from expert faculty including a prescriber, a pharmacist, and a lawyer how to educate your patients about overdose prevention and how to prescribe naloxone rescue kits. At the conclusion of this activity, participants will be better able to explore the epidemiology of overdose; explain the rationale for and scope of overdose prevention education and naloxone rescue kit distribution; incorporate overdose prevention education and naloxone rescue kits into medical and pharmacy practice by educating patients about overdose risk reduction and furnishing naloxone rescue kits; and explain the legal issues around furnishing naloxone rescue kits.

Slide 6

Embedded within this presentation are illustrative video vignettes showing interactions among a pharmacist, patient, and prescriber that demonstrate the core concepts of overdose prevention education including naloxone rescue kits. Videos will pop up automatically and will have a play button at the bottom of their screen. To view the video, please click on the play button.

Slide 7

Hi, my name is Alex Walley. I'm a general internist, and an addiction medicine specialist on faculty at Boston University School of Medicine. I take care of patients in Primary Care, where I prescribe buprenorphine, and I take care of patients at a methadone maintenance program. At the Department of Public Health in Massachusetts, I serve as the Medical Director for the Opioid Overdose Prevention Pilot Program. I'm going to start off talking today about the epidemiology of overdose.

Slide 8

Drug overdose is the leading cause of accidental injury death in the United States, surpassing deaths caused by motor vehicle crashes, and firearms.

Slide 9

The yearly increases in drug overdoses have been driven by opioids since 2000 with prescription opioids, like oxycodone and hydrocodone, responsible for the increases early on. More recently, since 2010, illicit opioids, like heroin, have surged.

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Increasing numbers of deaths are associated with fentanyl, which is produced illicitly and sold as heroin, or fentanyl that is sold as diverted, counterfeit prescription opioids.

Slide 11

As the leading cause of injury death, overdose is reducing overall survival among Americans. A 2015 study from Ann Case and Nobel Laureate, Angus Deaton, demonstrated that middle-aged white Americans have a worsening overall mortality rate since 2000, whereas people from other countries have had yearly improvements. This worsening mortality is largely driven by dramatic increases in poisonings, which are mostly overdoses.

Slide 12

Opioid overdose not only causes deaths; it also costs a lot of money. In a study of opioid overdose in 2009, opioid overdoses cost over $20 billion to society; $2.2 billion were from direct costs for inpatient emergency department physician and ambulance services, and $18.2 billion was connected to indirect costs from lost productivity from absenteeism, and from mortality. The cost to society per opioid overdose was $37,000. By preventing opioid overdoses, and providing access to addiction treatment, there is great potential for saving individual lives, and saving cost to society.

Slide 13

People using prescription opioids without a prescription most commonly get those opioids from a family, or a friend: the people in their social network. Buying prescription opioids from a drug dealer, or off the Internet is much less common.

Slide 14

But where do family and friends get their prescription opioids? Not often from the Internet, or from drug dealers. The great majority of friends and family get their prescription opioids from one doctor, and so as prescribers and pharmacists, we have a responsibility to think about what's happening to the opioids that we're prescribing to patients.

Slide 15

Both qualitative and epidemiologic studies have also demonstrated that heroin addiction is often preceded by prescription opioid misuse. A person in the qualitative study titled "Every 'Never' I Ever Said Came True: Transitions from Opioid Pills to Heroin Injecting" explains that when long-acting oxycodone changed its formulation in 2010 to become tamper-resistant, he was triggered to transition to injecting heroin. "I was big into OxyContin at first, and I still used heroin a little bit when OxyContin was crushable, but at that point I only sniffed, and I only did it when I had problems finding OxyContin. It wasn't until the OxyContin switched to the tamperproof versions that I really just went straight to heroin, and immediately started shooting it, which I guess was a little over a year ago."

Slide 16

A slowing in the growth of prescription opioid-related overdoses has been accompanied by a surge in heroin, and more recently fentanyl-related overdoses. This transition may be due in part to a reduction in the supply, and misuse potential of prescription opioids through the switch over to abuse-deterrent formulations, and more restrictive prescribing practices that started around 2010.

Slide 17

Benzodiazepines are an important contributor to opioid overdose deaths. Benzodiazepines are present in 31% of opioid-related overdoses. Opioids are present in 75% of benzodiazepine-related overdoses. Among people prescribed opioids, the risk of overdose death is 3.8 times higher for people prescribed benzos, also.

Slide 18

How do opioids affect breathing and cause overdose? Let's first review where opioid receptors are found throughout the nervous system and their effects.

Slide 19

In the brain, opioid receptors in the cerebellum, nucleus acumbens, and hypothalamus control pain perception, emotion, reward and addiction.

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In the spinal cord, opioids dampen transmission of peripheral pain signals through the dorsal horn.

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In peripheral neurons opioids bind pain receptors in the peripheral tissues, reducing pain sensation.

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In the intestines, opioids inhibit peristalsis, which can lead to constipation.

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The brainstem is where opioids most directly affect breathing and can cause overdose. Opioid receptors in the medulla oblongata control breathing and heartrate. When these are flooded with opioids, they are completely stimulated, eliminating the drive to breathe.

Slide 24

The drive to breathe stops, because of reduced sensitivity to changes in oxygen, and carbon dioxide levels. There is decreased tidal volume, and respiratory rate. Respirations decrease, leading to a decrease in oxygenation, and then loss of consciousness. When breathing stops, the blood is no longer oxygenated, and the heart and brain will shut down, and the person dies. This process develops over minutes to hours with most opioids, like heroin or oxycodone but can happen over seconds with faster-acting opioids like fentanyl. Decreased respiratory rate, decreased level of consciousness is accompanied by lower blood pressure, heart rate, and body temperature, as well as myosis or pinpoint pupils. The skin takes on a blue or gray tinge, including the lips, and the nail beds.

Slide 25

As prescribers and pharmacists, we need to understand the risks of opioid overdose, and convey those risks to our patients. Many of the risks for opioid overdose are well established, and these can be helpful in educating patients. We need to ask our patients, and learn their history to understand what their risks are.

Slide 26

Higher opioid doses, such as daily doses higher than 50 morphine mEq, increase overdose risk. Also, changes in dose, or formulations increase overdose risk. People who use heroin are thus frequently at risk due to unpredictable changes in substance purity from, for example, adulteration with fentanyl.

Slide 27

Polypharmacy and mixing substances contribute to overdose risk, as opioid overdoses commonly involve other substances. Psychoactive medications of particular concern include barbiturates, stimulants, and benzodiazepines. Other medications that can have synergistically central nervous system depressive effects include clonidine, promethazine, and gabapentin.

Slide 28

We also need to think about people who are socially isolated. Whether they are using heroin or prescribed opioids they are at increased risk of dying from overdose, because if and when they overdose, there is no one there to rescue them. So we need to educate patients that if they are going to use opioids, someone else should be around so that they can respond if they use too much. Isolation is also associated with depression, which is itself associated with overdose.

Slide 29

We should also consider chronic medical illness, particularly diseases of lung, liver, and kidney that compromise their function. These increase the risk of overdose because they are the organs that metabolize substances and are responsible for oxygenization. Also, mental illness such as depression and anxiety increase overdose risk.

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Patients who have had a prior non-fatal overdose are at increased risk of having fatal overdose, similar to how patients who have had suicide attempts are at increased risk for completing a suicide.

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Patients who have a previous addiction history have increased risk. They are subject to relapse and are therefore at increased risk of overdose.

Slide 32

Periods of abstinence should trigger us to educate our patients about overdose. We often think of abstinence as the goal for our patients with addiction and that over the long term it really should decrease their risk of overdose. But abstinence often comes with reduced opioid tolerance, which is actually a risk for overdose. Thus it is important that we educate patients about that. So we are particularly concerned about people who are released from incarceration and patients leaving detox. We also need to think about patients in recovery, and who are abstinent from opioids, and educate them about their increased risk if they relapse.

Slide 33

Here's some messages that you can convey to your patients, and that they can take home with them: Only take prescription opioids prescribed to you, and take them only as directed. If you have an opioid problem, I can help you find treatment. Make sure your prescribers, and pharmacists know all the medications you are on. Don't mix opioids with other drugs or alcohol.

Slide 34

Be careful, if you miss or change doses, feel ill, or start new medications. Store medication in a safe and secure place, and dispose of unused medications. Abstinence, meaning not taking opioids for a period of time, can reduce tolerance, and increase overdose risk. Teach friends and family how to respond to an overdose, and the role of naloxone in an overdose.

Slide 35

Mrs. Barkley picks up a prescription and the pharmacist provides some counseling.

Pharmacist: Good to see you today, Mrs. Barkley. Are you here to pick up your prescription?

Mrs. Barkley: Yes, I am.

Pharmacist: What questions do you have today about your prescription?

Mrs. Barkley: None, I'm all set.

Pharmacist: Okay, I want to let you know that in the prescription monitoring program I can see that you are also being prescribed clonazepam by Dr. Drexler. I wanted to make sure that you understand that combining pain medications, like your oxycodone, and anxiety medications (like the clonazepam) can increase your risk of drowsiness, sedation, and even overdose.

Mrs. Barkley: Thanks for the information. I have been taking these meds for a long time. I know what I'm doing.

Pharmacist: Okay. I'm glad to hear that you are aware of these combinations and their risks. To her, they can cause overdose. If it's okay with you, I'm going to call your prescribers and talk with them about the medication and the possible interactions. That way together we can monitor your risk.

Mrs. Barkley: You can go ahead and do whatever you need to do, I'm fine.

Pharmacist: Have a good day.

Slide 36

Okay. Next, we're going to talk about taking an overdose history, and delivering prevention education.

Slide 37

I want to reiterate the prevention messages that your patients need to know. They need to know that mixing substances, abstinence which lowers tolerance, using alone or being socially isolated, being on a high dose of opioids or getting illicit opioids from an unknown source, chronic medical and mental health illness, or being on longer-acting opioids all increase one's risk of an opioid overdose.

Slide 38

Prescribers should assess overdose risk as part of a patient's history by, number one, reviewing medications, and checking the prescription-monitoring program; two, reviewing medical and social history for above-mentioned risk factors; three, taking a focused substance use history, and four, obtaining an overdose, or over-medication history.

Slide 39

You want to ask directly, and specifically about these issues with your patients. For patients prescribed opioids, or benzodiazepines, I start by asking, "Have you ever taken enough medication that you were drowsy, and could not wake up?" For patients who are using heroin, I ask more directly, "Have you ever overdosed?" If the answer in either case is, "Yes," then you want to ask, "What were you taking, and how did you survive?" Then discuss a safety plan. "What strategies do you use to protect yourself from oversedation or overdose?" Don't forget about the medications and how they keep them safe.

Slide 40

You want to ask the patient about overdoses that they have witnessed. "How many overdoses have you witnessed? Were any fatal? And what did you do? What is your plan if you witness an overdose in the future?" then at this point, you want to hit on the specific recognition, and response options that we are going to cover later in the talk. "How do you recognize an overdose? How do you call for help? How do you rescue-breathe? Are you trained in CPR? How do you give naloxone?" Ask specifically about a naloxone rescue kit. "Do you have a naloxone rescue kit? Do you feel comfortable using it?" Understanding the patient's experience, and knowledge should guide the education you provide.

Slide 41

For patients filling prescriptions, pharmacists should assess overdose risk by reviewing the list of medications, optimizing medication safety, and providing patient education. "Have you checked the prescription monitoring program? Is the patient on multiple psychoactive, or sedating medications? Are these medications coming from multiple prescribers?

Slide 42

Are these prescribers aware of all the prescriptions? Is the patient aware of the risks? Does the patient and their family or friends know what to do if there is an overdose? Are they equipped with a naloxone rescue kit?"

Slide 43

The pharmacist contacts the prescriber.

Dr. Byrd: Hello, this is Dr. Byrd.

Pharmacist: Hi, Dr. Byrd. This is Tracy Johnson calling from Main Street pharmacy downtown. Mrs. Barkley came in today to fill her prescription for oxycodone, and I noticed in the prescription monitoring program that she also has a prescription for clonazepam. I informed her of the risk of combining these two medications and also let her know that I would be in contact with you just so that you would know.

Dr. Byrd: Thanks for calling. I actually wasn't aware. I have no record of her taking clonazepam. Do you know who is prescribing that to her?

Pharmacist: It's Dr. Drexler, and it looks like he has been prescribing it every month for the past year.

Dr. Byrd: Oh, that makes sense. He's actually a psychiatrist that I refer many of my patients too. I will have to talk to her and get some more history and kind of explained to her further the risks involved. We have an appointment with her coming up so I will see her then. Thank you so much for the phone call!

Pharmacist: Sure, thank you. Goodbye.

Slide 44

Now, I'm going to summarize and introduce overdose prevention interventions.

Slide 45

There are several existing strategies that improve opioid prescribing safety, access to medication-assisted treatment, and reduce the harms of injection drug use. They include prescription monitoring programs, safe storage strategies, safe opioid prescribing education, opioid agonist treatment, and supervised injection sites.

Slide 46

Prescription monitoring programs are mandated in most states for prescribers, and pharmacists to integrate into their practice in order to monitor the medications that patients are prescribed by all prescribers. How they can be used best as tools to address opioid overdose needs to be worked out further, but these are powerful tools to help us figure out how to best keep our patients safe, and prescribe responsibly.

Slide 47

Many communities have safe disposal kiosks that are often hosted at local police stations. The Drug Enforcement Administration, or DEA, now also permits manufacturers, distributors, treatment programs, pharmacies, and health care facilities to become authorized collectors of prescription medications. DEA and local law enforcement continue to host prescription drug takeback events twice yearly.

Slide 48

There is safe opioid prescribing education, which has received substantial support from federal agencies and is also mandated in some states, like Massachusetts, for prescribers to participate in in order to re-license. So here is one example, which is our affiliated online program called "SCOPE of Pain." There is free CME available at SCOPE of Pain, and at Opioid Prescribing.org.

Slide 49

Let's not forget medication for opioid use disorders, specifically methadone, buprenorphine, and naltrexone, is supported by evidence for increased abstinence, and decreased opioid use. Methadone and buprenorphine treatment are also associated with decreased criminal activity, improved birth outcomes, and less overdose.

Slide 50

A public health intervention that has been associated with reduced overdose death rates is supervised injection facilities. Supervised injection facilities are available in parts of Canada like Vancouver, Europe, and Australia. Here, people are able to inject illicit drugs under the supervision of a nurse. They have been successfully implemented with the collaboration of local enforcement, government, and public health leaders, businesses, and people who inject drugs, themselves. The photograph above is from Insight, the Vancouver supervised injection site, which was featured in a Boston Globe editorial calling for a supervised injection facility in Boston.

Slide 51

We're going to spend much of the remainder of this presentation focused on naloxone rescue kits, as another strategy for addressing opioid overdose. The rationale for overdose education and naloxone rescue kits? First of all, most opioid users do not use alone, so there is somebody, often, there who can help the victim who undergoes an overdose. We know many of the risk factors, which we have already reviewed in detail. There's an opportunity window. Opioid overdose takes minutes to hours to develop, which means there is time to respond, and help someone. In the case of fentanyl, remember, this window is narrower, like seconds to minutes, because fentanyl is faster acting, and often more potent than other opioids.

The overdose has an antidote, which is naloxone, which can be administered, and restore breathing, and consciousness. Bystanders we know are trainable to recognize and respond to overdose. There's a fear of public safety, specifically fear of being arrested, so in the cases when people don't call for help, it's important to have the tools to address an overdose.

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Naloxone Rescue Kits Naloxone rescue kits have been recognized by several important professional organizations, like the American Medical Association, the American Pharmacists Association, World Health Organization, and American Society of Addiction Medicine

Slide 53

As well as the Substance Abuse Mental Health Services Administration, which produces, since 2013, this opioid overdose toolkit, which includes descriptions of medication safety, and overdose prevention, including naloxone rescue kits. The Office of National Drug Control Policy, which includes naloxone in its annual strategy, the Centers for Disease Control and Prevention, which recommends co-prescription of naloxone in its 2016 guidelines on chronic opioid therapy, and the Department of Health and Human Services, which recognized increased access to naloxone as one of its three priority areas in addressing the opioid crisis in 2015, along with safe opioid prescribing, and increasing access to medication for opioid use disorders.

Slide 54

Overdose education and naloxone distribution programs have existed since the late 1990s. These were largely community-based programs that started through harm reduction programs. A substantial body of research that looks at these programs. Specifically, we have seen multiple feasibility studies in several populations and venues. There's been increased knowledge and skills of bystanders who can be trained to respond to an overdose. We haven't seen any increase in use in opioids. However, we have seen an increase in drug treatment in a few studies. In several communities there has been a reduction in overdose rates, where the overdose education and naloxone distribution programs were implemented. Overdose education and naloxone rescue kits have been shown to be highly cost effective.

Slide 55

In Massachusetts, there were some communities where there was widespread rollout of naloxone rescue kits and overdose prevent and other communities where there was not. We used the opportunity of this heterogeneous rollout to conduct a natural experiment, an observational study where we compared those communities that had no naloxone distribution to those communities with low levels of implementation, and those communities that had high levels of implementation. On this slide you can see the baseline opioid overdose death rate as represented by 100%.

Slide 56

In the communities with low levels of implementation (between 1 and 100 people per 100,000 people who had received naloxone rescue kits) we saw a decrease in the opioid overdose death rate by 27% compared to those communities with no implementation.

Slide 57

Then, in the communities that had a higher level of implementation, greater than 100 naloxone rescue kits per 100,000 people, we saw a further reduction in the opioid overdose death rate 46%. These improved opioid overdose ratios are strong observational evidence that the distribution of naloxone rescue kits, along with overdose education in the community, can result in reduced opioid overdose death rates.

Slide 58

A 2016 San Francisco implementation study investigated the impact of providing overdose prevention education and co-prescribing naloxone rescue kits to primary care patients treated with opioids for chronic pain. This program succeeded in co-prescribing naloxone kits to 38% of eligible chronic pain patients. Patients with higher opioid doses and previous opioid -related emergency department visits were most likely to receive kits. Among those who did receive kits, emergency department visits for opioid -related problems were subsequently reduced by 47% at 6 months and 63% at 12 months.

Slide 59

Mrs. Barkley visits Dr. Byrd

Dr. Byrd: I'm glad to see that your pain is under control on the oxycodone.

Mrs. Barkley: It's great. Thank you so much for starting me on that.

Dr. Byrd: I just wanted to mention, I got a call from your pharmacist about a day ago. They were concerned about the combination of clonazepam and oxycodone in the risk of drowsiness, sedation, and overdose. I wasn't aware that Dr. Drexler had prescribed the clonazepam.

Mrs. Barkley: Yeah, I wasn't trying to hide anything from you, and I don't know why people are so worried about this. When I was drinking, I had a lot of problems with anxiety and panic, and once I stopped drinking Dr. Drexler put me on clonazepam and it has helped greatly with that. I see Dr. Drexler for my emotional problems, and I see you for my medical problems, and I don't want to bother you with things that aren't medical.

Dr. Byrd: It's not a bother at all. I'm your doctor. I'm supposed to look at your pills and look at the risk and benefits that may exist with these pills, so together we can kind of determine whether or not these are helping rather than hurting you, and if they are we will keep your regimen as is. But I have to ask you about substances such as alcohol and drugs. Do you ever drink beer, wine, or any other alcoholic beverages?

Mrs. Barkley: I haven't had anything to drink in over 10 years, and my husband has been a great support with that.

Dr. Byrd: Congratulations!

Mrs. Barkley: Thank you, thanks.

Dr. Byrd: How about any other substances like heroin, cocaine, marijuana, or pills that are not prescribed to you?

Mrs. Barkley: No. I don't use any drugs. Dining, back when I was in high school, I smoked some pot but that's it.

Dr. Byrd: So, when you take your medications that are prescribed, do you ever feel drowsy or sedated or have you ever overdosed in the past?

Mrs. Barkley: No. I haven't overdosed. Actually, there was one time that I had a very difficult day. I was very stressed out about my son. I had two panic attacks in one day, and I was in a lot of pain, so that day I took an extra clonazepam and an extra oxycodone and my husband came home from work and he said it was quite difficult to wake me up. He actually thought about calling 911, but I eventually woke up after a couple of hours.

Dr. Byrd: That sounds really scary. So what are you going to do to try to prevent that from happening again?

Mrs. Barkley: It was very scary. Now I never take any more medication than is exactly what is prescribed for me, and you know that if I'm having a lot of pain I will call you. I'm having a lot of anxiety, I contact Dr. Drexler and that is how I have been able to keep myself safe.

Dr. Byrd: These are good strategies to limit your risk. What are you doing to keep your medications safe at home?

Mrs. Barkley: Actually, I've had to start hiding my medication in my house. I don't think I've told you that my son has started using drugs. I'm pretty sure that he has gotten into my pills. On a couple of occasions, I've been missing some, so I started hiding them.

Dr. Byrd: Wow. I'm so sorry. This must be so difficult for you and your husband.

Mrs. Barkley: This is a terrible thing. He had his wisdom teeth out and he was given pain medication and then he sprained his ankle playing basketball and he was given more pain medication. He started trying to get more. He was taking it out of the house and using it with his friends. I'm pretty sure he has switched heroin.

Dr. Byrd: Do you think he's ever overdosed?

Mrs. Barkley: Not at home. He's currently in detox. The last two times he came out of detox he relapsed immediately afterward. I'm really worried about what's going to happen when he comes out this time because we know when you first get out of detox your tolerances down and your risk of overdose is elevated.

Dr. Byrd: So, I'm really glad that you understand that his risk of overdose is high. What is your plan if he overdose at home?

Mrs. Barkley: My husband and I took a CPR class so we know that we would call 911 and we would start rescue breathing, but what else can we do?

Slide 60

Greetings; I am Jeff Bratberg. I am a Clinical Professor of Pharmacy Practice at the University of Rhode Island, College of Pharmacy. I am also an infectious disease specialist Roger Williams Medical Center in Providence, Rhode Island, and a past President of the Rhode Island Pharmacist Association with whom I began implementing pharmacy based naloxone education and opioid overdose prevention programs across the state of collaborations at the Department of Health. I am going to talk about overdose rescue and response with naloxone.

Slide 61

So first, let's talk first about naloxone reverse opioid poisoning. We have opioid receptors in the brain and opioids, whether illicitly manufactured as heroin or prescription opioids, they bind it to the receptors to cause and effect. Naloxone has a greater binding affinity for these receptors and competitively knocks off the whole opioid whether heroin or prescription opioids and lets the person breathe again.

Slide 62

Naloxone works in about 2 to 3 minutes. We always dispense naloxone in packages of at least two so that a second dose may need be administered after that two minutes has gone by. Importantly, naloxone wears off between 30 and 90 minutes after administration. Patients can go back and overdose of long-acting opioids were taken such as a fentanyl patch or methadone or extended release versions of common opioids like oxycodone or morphine. Patients should avoid taking more opioids after naloxone so they don't go back and overdose after naloxone wears off. However, it is important to educate patients in that the person who is administered naloxone may want to take more opioids at this time because they may feel withdrawal symptoms. The shelf life varies depending on the naloxone product. It is between 12 and 24 months and best to store at room temperature to avoid degradation of the active ingredient.

The shelf life of naloxone is about twelve to twenty four months depending on the formulation. It is important to store it at room temperature to minimize degradation.

Slide 63

Several organizations have different orders of the steps to respond to an opioid overdose. The steps are basically the same, but the order is slightly different. The American Heart Association guidelines starts with recognizing overdose and checking for response, calling 911, beginning CPR, including rescue breathing and chest compressions, giving the locks on and if no response to continue CPR for 2 to 3 minutes, repeat naloxone, place in the recovery position and stay until help arrives from that 911 call. The package inserts for the branded naloxone products start with recognizing overdose but make the recommendation to give naloxone first and then call 911, place the person in the recovery position. If no response repeat after 2 to 3 minutes and stay with the patient. The New York State Department of Health again starts with recognizing overdose, calling 911, giving naloxone or beginning CPR if that person knows it, repeat naloxone after 2 to 3 minutes, placing the patient in the recovery position and staying to help arrives. Finally the World Health Organization starts with recognizing overdose, checking for response, goes to placing the patient in the recovery position first, then 911, and then just rescue breathing, giving naloxone, and if no signs of life to perform chest compressions and then as the other steps have said to repeat naloxone into the three minutes and staying until help arrives.

Slide 64

To reiterate, there are 5 essential steps in responding to an overdose: recognizing the person has reduced breathing, is unresponsive; 2) call or text 911; steps 3) and 4) administer naloxone as soon as it is available and initiate rescue breathing and/or chest compressions depending on the rescuer's level of training; and 5) to stay with the victim until help arrives. For individuals who do respond and start to breathe, they can be placed in the recovery position and for those who don't respond it is advised to repeat naloxone after 3 to 5 minutes and continue rescue breathing and/or chest compressions depending on the rescuer's training.

Slide 65

How to recognize and overdose: This is steps to teach patients, family, friends, and caregivers. Call out the victim's name if you know it and rub the knuckles of a closed fist over the sternum. Look for signs of drug use in the area (pills, needles, cookers-anything that may be involved in this patient's appearance) disease. If they have slower absent breathing, if they are gasping for breath or possibly snoring or even more concerning a bluish or grayish discoloration of their lips and nail beds and pinpoint pupils, this is someone for whom you need to call for help immediately.

Slide 66

It is important that overdose responders understand the difference between intoxication and overdose. The intoxicated person may have small pupils with slurred speech, but it is arousable with a sternal rub and breathing more than 8 times a minute.

Slide 67

This person should be stimulated with a sternal rub and observing until help arrives (the intoxicated person) whereas the person who is not arousable or responsive to a sternal rub or not speaking and breathing at less than 8 times per minute-

Slide 68

Should receive naloxone as soon as it is available and given rescue breathing and/or chest compressions.

Slide 69

Regarding overdose education and naloxone rescue, what your patients need to know is that there are steps to prevent the overdose, to recognize it, and respond to it, so we start with mixing substances puts patients at very high risk, things like benzodiazepine medications with opioids, alcohol with opioids etc. Anyone whose tolerance has changed because of a period of abstinence, they are using alone or using an unknown source, and their chronic medical conditions put them at risk or higher risk of overdose, or if they have used longer acting opioids. Recognition again is that sternal rub, slowed breathing, recognition of pinpoint pupils in blue or grayish lips in the response, the steps again, call 911 or text 911. Administer naloxone and give rescue breathing and/or chest compressions depending on the ability of the rescuer, the rescue position and breathing again and staying with the patient until help arrives.

Slide 70

So, once you have identified the overdose, you need to call or text 911 immediately or send someone to call or text 911 if you are unable to at that time. That medical help is crucial to saving lives in quicker response improve survival. When you talk to the 911 operator, you need to report that someone is not responsive or struggling or unable to breathe. They are not responding to the name being called at her sternal rub. Give a clear address and location.

Slide 71

The next step is to administer naloxone. At prescribetoprevent.org, there are several demonstration videos at the patient education videos page for you to review and share with your patients and the patient caregivers. In addition, there are many other educational materials and resources for you and your patients. That is prescribetoprevent.org.

Slide 72

Steps 3 and 4 are about rescue breathing. The rescue breathing you have to check to make sure the airway is clear the victim. Place one hand on the chin, tilted her head back to open the airway, and make sure you pinch the nose closed so when you put your mouth over the victim's lips and give 2 slow breaths into the mouth that the chest is going up and it rises with each breath. It is not going out the nose. You give 1 breath every 5 seconds until the person can read on their own. If you have a victim who is still unresponsive after rescue breathing, and you haven't given naloxone, you can give it at this time.

Slide 73

After you have called 911, provided rescue breathing, and administer naloxone you need to stay with the patient until help arrives. Naloxone only lasts between 30 and 90 minutes and especially patients who have taken long acting opioids.

Slide 74

They may seek out opioids and not receive that care. For patients who still aren't breathing after naloxone, you need to continue to provide that rescue breathing. Make sure that patient doesn't take anymore opioids.

Slide 75

If you have to leave (if you or the responder that you are educating has to leave at any time) call 91 want to get naloxone, you put the patient into the rescue position. You put the person on their side with their top leg and arm crossed over their body. This makes the victim less likely to roll over and choke on vomiting that may be caused by withdrawal.

Slide 76

Mrs. Barkley's Office Visit with Dr. Byrd Continues

Dr. Byrd: I think that you and your husband have a great overdose prevention plan for you and your son. However, I would like to add a few things.

Mrs. Barkley: Yes, please.

Dr. Byrd: First of all, for you I would like to really monitor your medications closely. I'm going to call your psychiatrist about the oxycodone and clonazepam, and we may actually reduce your dose. We may give you a new medication that's a little safer. I also would recommend that you get a lockbox to secure your medications if that's okay.

Mrs. Barkley: Where would I get a lockbox?

Dr. Byrd: You can find it at the pharmacy, and you know regarding your son, he has had some relapses. I think that he might benefit from medication such as methadone or buprenorphine. I'm actually going to give you a card to contact the state treatment hotlines you can actually get some more information about that.

Mrs. Barkley: Thank you so much. This will be so helpful.

Dr. Byrd: You're welcome. Lastly, for you and your son I would like to prescribe a naloxone rescue kit. This actually is a kit that comes with instructions on how to both recognize and respond to an overdose. It comes with a medication called naloxone, and when someone overdoses on opioids you give them this medication. What happens is that the overdose is reversed, and they are able to breathe normally again. When this is given, you have to still call 911 and you have to continue rescue breaths.

Mrs. Barkley: Thank you so much. I mean, I just really-I can't thank you enough.

Dr. Byrd: You're welcome. Good luck!

Slide 77

Let's talk about naloxone rescue kits themselves.

Slide 78

So who do we prescribe naloxone to? To people at risk for overdose, and those risks again opioid combinations, anyone using opioids that has a dose change or purity change, anyone who has experienced a previous overdose, lives alone, or has social isolation, someone you suspect has a substance use disorder and not just an opioid use disorder, anyone whose tolerance has changed due to abstinence, and anyone with chronic medical and/or mental illnesses. If you are in a state that permits third-party prescribing, also prescribed to friends or family of people who are at risk of an overdose who have these risks.

Slide 79

Prescribers and pharmacists can approach different types of patients in different ways, focusing on either the safety of their medications, the safety of opioids in their home, and/or recommendations from the CDC and FDA. One could say the CDC recommends that we offer you naloxone. Naloxone is an antidote you can have on hand to keep you and your family safe with this medication in your home. Is it okay to provide you with naloxone today? Pharmacists and prescribers can comfortably use these conversation starters with the patients and their patient's caregivers.

Slide 80

There are 4 main types of naloxone. There are 2 branded products and 2 generic products. There are 2 intranasal products and 2 intramuscular products. The generic intranasal form is the multistep form that is assembled. There is an intranasal product that is 4 mg. The generic intranasal is 2 mg, and the 4 mg form is a one-step one nostril nasal spray. There are several kinds of injectable generic drugs that are dispensed with syringes, and there is also an autoinjector that is dispensed with 2 active forms as well as a trainer that we will talk rescuers through the steps of responding to in overdose. Importantly, the generic intranasal product requires dispensing with a mucosal atomizer device to screw on the top of the plastic syringe.

Slide 81

Here are some examples available prescribed with the prescribing information that you can print out to use with your patients.

Slide 82

On this slide we provide the ordering information for each of the naloxone formulations. Included is how they are supplied, the name of their manufacturers, customer service members, and the NDC codes for the specific products. Note that the intranasal generic product, the mucosal atomizer device that is dispensed with it, does not have an NDC code and is considered durable medical equipment. Again, all of the information at the bottom is details about the device and national suppliers of that device with their contact numbers.

Slide 83

Now let's talk about naloxone and billing for naloxone. A growing number of public and private insurers cover at least one naloxone formulation, and one state (Rhode Island) has mandated that all state insurers cover certain forms of naloxone for patients and their caregivers. If patients do not have insurance coverage for any form of naloxone, they can buy them for cash. Over-the-counter syringes vary in their availability and quantity for purchase, and they may need to be prescribed in certain places. Importantly, mucosal atomizer devices are not prescription products and currently cost around $5 each and can be billed only as durable medical equipment, not as a prescription product.

Slide 84

Now let's talk about naloxone distribution models. The order of events is the same, but the implementation is a little different for each one. I'm going to give you the big overview here. This is in an open access article in the Harm Reduction Journal, and the citation is at the bottom to read about each of these steps in more detail. But you start with the patient, either the patient themselves or third party or carer of that patient. They see a provider either a typical prescriber like a doctor, MD, DO, nurse practitioner, physician's assistant, or a pharmacist in some states who trained in overdose prevention. They screen for risk factors through the prescription history, medical history, physical exam, or maybe even a protocol criteria. A prescription is initiated and it is dispensed by a pharmacist. It is billed to the insurance where allowed. The patient is provided overdose and naloxone assembly education if necessary and medication counseling, and the prescriber is notified and the prescription is documented in the medical record.

Between screening for risk factors and then product selection either the pharmacist can initiate a prescription either directly through protocol, through a standing order, or a collaborative agreement, or the prescriber writes a prescription which happens in all 50 states and the pharmacist fills it and in one instance the prescriber can write the prescription and also dispense it.

Slide 85

Now, we have invited Corey Davis, of the Network for Public Health Law to answer questions raised by pharmacists and prescribers.

Hi, I'm Corey Davis. I'm a Deputy Director of the Network for Public Health Law, a national nonprofit that provides legal technical assistance on the ways in which law and policy can be used to improve public health. My work specifically focuses on laws and policies that affect the health and safety of people who use drugs as well as their friends and family members.

Slide 86

Question: Corey, it seems like there are a lot of questions and misperceptions about the legality of prescribing and dispensing naloxone. Can you walk us through the basics?

Corey: Sure, great question.

Slide 87

The most important thing to understand is that the legal environment for naloxone prescribing is, in general, no different than the legal environment for prescribing any other prescription drug. Naloxone isn't a controlled substance, so none of the laws and regulations governing controlled substances apply. Anyone who can otherwise prescribe, which often includes nurse practitioners and physician's assistants, can prescribe naloxone. It is a generic drug that has been on the market for more than 45 years, so naloxone can be prescribed to your patient exactly like any other medication.

The general liability risk of prescribing naloxone is no higher than any other drug. In fact, because it is a pure opioid antagonist with no abuse potential, the liability risk is probably even lower than with many other medications such as opioids. We recently published research showing that there hasn't been a single case, as far as we could find, here outpatient naloxone prescribing or dispensing with the grounds for a lawsuit. Further, as I will describe, most states have actively encouraged clinicians to prescribe naloxone by providing additional liability protections for prescribers, dispensers, and administrators. Most states have also changed their laws to permit naloxone to be prescribed outside of the traditional clinician-patient relationship; for example, to a friend or family member or person at risk. Most states also permit naloxone to be dispensed by pharmacists without the patient first seeing a prescriber through a variety of means. I will go over that in more depth in a minute.

Slide 88

The general considerations for naloxone prescribing are no different than any other prescription medication. As an overview, just like with any other medication, the naloxone prescription must be written in good faith in the usual course of professional practice and for a legitimate medical purpose. All of those terms are pretty self-explanatory. It basically means that the prescriber must believe that, in his or her professional medical opinion, supported where relevant by peer-reviewed literature and expert opinion, that a particular medication is indicated for a particular condition and a particular patient. A naloxone prescription issued for a patient at risk of overdose clearly satisfies all three criteria.

Slide 89

As with any medication, following best practices will reduce any potential risk associated with naloxone prescribing.

As a prescriber, you should make sure that the patient understands how to identify an opioid overdose so they will know when to use the medication. You also want to make sure that they understand how to administer naloxone, which might include a discussion of the pros and cons of the different formulations. You also want to discuss the risk of side effects, particularly precipitated withdrawal, and the importance of calling 911 after naloxone is administered, and you should consider discussing with the patient other ways of reducing opioid overdose risk. These are all things that should also be covered if the pharmacist provides counseling or consultation to the patient.

So let's review the general legal background. The important thing to remember is that prescribing naloxone is no different than prescribing any other medication.

Slide 90

Nothing that a clinician does is without some liability risk but naloxone prescribing is no riskier than any other medication and probably lower than many. As we will discuss in a bit, many states have also taken action to further reduce any potential liability risk. The outpatient prescription naloxone is a mainstream practice supported by the American Medical Association, the American Pharmacist Association, the American Society of Addiction Medicine, and many others. As I noted, we haven't found a single case in which the outpatient prescription or dispensing naloxone has been the basis of a lawsuit. Of course, as with any medication, you should ensure that the patient understands when and how to use naloxone.

Question: Corey, if I have a patient whose son is coming home from rehab, and who is worried about his overdose risk, but she herself doesn't have any overdose risk, can I prescribe a naloxone rescue kit to her?

What you are asking about is called third party prescribing.

Slide 91

Can you prescribe naloxone to a third party; that is someone who isn't themselves at risk of overdose-

Slide 92

So that they will have naloxone available to use on someone else?

Slide 93

As you know, in traditional medical practice, you have a 3-step process. The medical professional examines the patients, diagnoses the patients, and then prescribes the medication that is indicated for that condition and that patient. In third-party prescription, the clinician skips the first 2 steps, generally relying on the report of a person with whom he or she has a professional relationship to determine that naloxone is appropriate for the third party.

Slide 94

This is important because often times the person who is themselves at risk of overdose is not the person who comes in contact with the prescriber. There are a number of reasons for that. The person at risk might be uninsured or underinsured. It might be just be difficult to get an appointment or they might feel stigmatized or ashamed, but for whatever reason, often times it is not the person who is at risk that comes in contact with the prescriber; rather, it is a friend or family member or loved one who is concerned about them.

Slide 95

To address this problem, most state legislatures have taken action to increase the universe of people to whom the prescriber can write the prescription for naloxone. These laws vary a little bit by state but essentially, they wave that general requirement if the physician or other prescriber and the person for whom the medication is prescribed have a provider-patient relationship. In the state that has one of these laws, the legal risk of prescribing for a third party is no different than the legal risk of prescribing naloxone for use on your own patient.

Slide 96

It is just expanding that group of people for whom a legitimate prescription can be issued and it is going to vary a little bit by state but typically, the actual prescription is written in the name of the patient, not the name of the person at risk. In most cases, it is not necessary that you even know the name of the person for whom the medication is intended. The prescription is just in the name of the person to whom it is issued.

I put up a slide of example language of what one of these laws looks like so you can see how simple it is. It just says that a practitioner acting in good faith and exercising reasonable care, which is just the general prescribing requirement, may directly or by standing order prescribe an opioid antagonist to person at risk of overdose as well as a family member, friend, or other person in a position to assist a person at risk of experiencing an opioid-related overdose.

You can see that this particular law also removes civil and criminal liability for the practitioner who issues the prescription. As I will touch on in a minute, most third party laws have a similar provision.

Slide 97

Question: Corey, can someone get naloxone directly from a pharmacist, without seeing a physician, nurse practitioner, or physician's assistant?

Slide 98

Another great question. In an increasing number of states it is possible to receive naloxone from a pharmacy without first seeing another medical professional. There are a few different ways that this is possible. In a handful of states, some or all pharmacists are committed to prescribe naloxone on their own authority. Typically, they have to complete some sort of training in order to prescribe naloxone. Some pharmacists who work for the federal government have prescribing authority as well. In about eleven states, it may be possible for a pharmacist to dispense naloxone under a collaborative practice agreement with a prescriber. In practice though, this only happens in a handful of states. By far, the most prevalent means of increased pharmacy naloxone access is through a standing order. It is legal for pharmacists to dispense naloxone via a non-patient specific standing order in at least 34 states. The number has been increasing every year. I am going to go over this more in just a minute.

Slide 99

First, pharmacist collaborative practice, where the pharmacist and the prescriber (typically but not always a physician) work together to manage a patient's medications. There is a large amount of variation between states with regarding the details of collaborative practice agreements. In all states, there must be a written agreement between the prescriber and the pharmacist that sets up the duties and responsibilities of the pharmacist. In the naloxone-specific context, we have seen successful implementations of these collaborative practice agreements in several states. The billing and reimbursement rules vary by state and by payer; that's no different than with any other drug.

Slide 100

The majority of naloxone that is dispensed from pharmacies without a prior prescription is dispensed via standing orders. Another way to think of these is non-patient specific orders. Instead of writing a prescription for a specific patient, the prescriber authorizes naloxone to be dispensed to any person who meets criteria permitted by law and specified by the prescriber, which can be as broad as any person at risk of overdose or might be in a position to assist a person at risk of overdose. The standing order should be written and it should be clear as to who it covers, what it authorizes, any reporting requirements, and any other important information. There are good examples of standing orders online at prescribetoprevent.org. Many major pharmacy chains now dispense naloxone via standing order in states where it's permitted by law, and as of July 2016, officials in 3 states (Maryland, North Carolina, and Pennsylvania), have issued standing orders that permit naloxone dispensing by essentially any pharmacist in the state.

Slide 101

Question: How does community-based distribution (meaning naloxone rescue kits that are distributed outside of a medical setting) how does that work?

Slide 102

At some level you have the same problem with people accessing pharmacists that you have with them accessing prescribers. Just like how many people high risk don't see a doctor, many are also not going to go to a pharmacist, but they might have regular contact with some other organization like a needle exchange program or a social service agency or even a drug treatment program, so being able to reach those people where they are at is really important. In recognition of that fact, 17 states have now modified their laws to permit standing orders to authorized people or organizations who aren't otherwise authorized to dispense drugs to distribute naloxone. There is variation between state laws but in general, where the law permits the practice, the liability risk to the prescriber is no different than with traditional prescriptions. That means if the prescriber is given an additional immunity for prescribing in the traditional setting, that immunity typically also applies to standing orders that authorize community dispensing. As with all such orders, the specifics are set with the prescriber within the bounds of the law, and he or she is ultimately responsible for the actions of the people acting under the order. This practice is rapidly expanding. The CDC reported that as of 2014, over 150,000 people had received naloxone via community distribution channels.

Slide 103

Question: One of the things that I hear a lot about is some providers are worried about legal liability. Can you talk more about how these laws address that?

Slide 104

Absolutely. That is a concern that I hear as well. Luckily, it is a concern that was also heard by legislators, and most of the states that have expanded naloxone access have accompanied those expansions with liability protections. Those protections vary by state but in most states, they are very broad making it essentially impossible to win a lawsuit alleging that the person was harmed by naloxone prescribed or dispensed by a medical professional unless, in layperson terms, a medical professional did something very wrong. That means that in these states, the liability risks associated with prescribing or dispensing naloxone are lower than with any other drug. Forty-one states also provide civil immunity delay administrators, which can encourage organizations like social service agencies to feel comfortable having naloxone on hand where the law permits it and administering naloxone in an emergency.

Slide 105

Of equal importance, I think, are what are referred to as overdose Good Samaritan laws. The reason for these laws is that there is good peer-reviewed research as well as a lot of anecdotal information that overdose bystanders often times don't call 911. They don't want to risk getting arrested by responding officers. And in many jurisdictions when you call 911, an ambulance is dispatched and police officers are dispatched as well, particularly if you report that there is an overdose.

Slide 106

The Good Samaritan law is intended to encourage overdose bystanders to call 911 or to otherwise summon emergency first responders by providing limited criminal immunity to the person who makes the call and typically also the overdose victim. The particulars vary a little bit by state but in most states, the immunity is limited to relatively minor crimes, although some laws also provide protection from probation and parole violations. In all states, the person making the call must actually have the goal of summoning first responders to provide emergency overdose response.

The important thing to remember with these laws is simply that they exist and to make sure that the person you are prescribing naloxone to knows that they exist. This is because it is important that after naloxone is administered that the person who administered it calls 911 so that the victim can be evaluated and treated further if necessary.

Slide 107

It is also important to educate law enforcement officers about these laws so that they don't inadvertently arrest people who should have immunity under them.

One of the interesting things I found in my work around these laws is that by and large law enforcement officials support them. In North Carolina, for example, a Good Samaritan law was recently championed by the state sheriff's association. You can also see on this slide, quotes from two law enforcement professionals who are supportive of Good Samaritan laws. I think law enforcement is increasingly understanding that the problem of drug abuse, misuse, and overdose isn't something that we can arrest our way out of; it is primarily a public health problem that needs a public health response. Law enforcement officers and officials increasingly seeing themselves as part of that public health solution.

Slide 108

This last slide is a visual representation of the state of the laws throughout the country regarding naloxone access and Good Samaritan. This is up to date as of July 2016. You can always see the most current version at pdaps.org.

I should note that everything in this presentation is intended to be informational. It is not legal advice. If you have a specific question, please contact an attorney in your state. That said, I am always happy to answer general questions about the laws in any particular state. My email address is available in the course materials.

Thank you for participating in Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists. You can receive CME, CNE, or ACPE credit for this activity by completing a post-test with a score of 70% or greater, and an evaluation. To do so, click on CME posttest just to the left of the video player in the left-hand navigation bar.