Roles and Issues in Advance Practice Nursing

Managing Pain and Opioid Use: New York State Prescribing Laws Video Transcript

Slide 1

Welcome to Managing Pain and Opioid Use: An Educational Program on Compliance with New York State Prescribing Laws. This one-hour educational activity consists of four brief presentations and in conjunction with scope of pain fulfills the opioid education requirement of the state of New York.

Slide 2

At the conclusion of the program, if you wish to receive CME, CNE, and/or ABIM MOC Part II credit, you must take a posttest and complete an evaluation. With a passing score of 70% or greater, you'll be able to print your certificate.

Slide 3

This program is provided by Boston University School of Medicine in partnership with New York Chapter of the American College of Physicians.

Slide 4

At the conclusion of this activity, participants will be better able to: summarize the best practices for pharmacologic management of acute pain including potential benefits and risks of opioid analgesics; describe the New York State laws governing the safe prescribing of opioids; communicate with patients about palliative care and end-of-life decisions; and appropriately document communication with patients about healthcare proxies and advanced directives and describe the appropriate use of advanced care planning CPT codes.

Slide 5

First, we will hear from Dr. Daniel Alford of Boston University's School of Medicine who will review assessing and managing acute pain.

Slide 6

Hi, I'm Daniel Alford, and I am a professor of medicine at Boston University School of Medicine at Boston Medical Center. I would like to start with the definition from the International Association Study of Pain from 1994, and the definition of pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Pain is always subjective and unpleasant. Pain symptoms may be a surrogate for or exacerbated by fear, anxiety; loss of life roles, functional and occupational disability; disrupted sleep; and substance use, for example.

Slide 7

No I want to make a distinction between acute versus chronic pain, and I will start with acute pain. Acute pain is a sudden onset symptom that is time-limited and usually linked to a specific event (injury, surgery, or trauma). It is protected by eliciting motivation to minimize harm; that is, it protects us from re-injury and allows time for healing. As Dr. Wall mentioned in 1979, "pain is not simply a signal for tissue injury, but is primarily a signal to seek repair and recuperation."

Slide 8

That is a distinction to chronic pain. Chronic pain lasts greater than three months or past the time of normal tissue healing, which could be substantially shorter than three months depending on the condition. Chronic pain can be debilitating affecting employment, relationships, and pleasure of daily living. Chronic pain is often considered a chronic disease.

Slide 9

So why do some patients who develop acute pain develop chronic pain? Well, it's complete pathophysiology is not completely not completely understood, but we are starting to get an appreciation for what is happening neurobiologically when this transition occurs. We know that when there is trauma or surgery there is immediate inflammation causing acute pain, activating the peripheral nerve receptors or nociceptors which then can lead to sustained activation, and it is that sustained activation which leads to sensitization and structural remodeling or the plasticity or changing of the nervous system, and that is alterations in the expression of neurotransmitters, receptors, ion channels, or any structure or connectivity surviving and leading to chronic pain despite the injury being completely healed.

Slide 10

How common is chronic pain after surgery? Well, it depends on the type of surgery, and this is based on certain surveys that have looked at various types of surgery and the instance of chronic pain. After amputation and coronary artery bypass surgery the estimated instruments of chronic pain is somewhere between 30% to 50% with about 5% to 10% having severe, chronic pain. It is also high after thoracotomy, somewhere between 30% to 40% with about 10% being severe. However, surgeries like inguinal hernia repair or cesarean section is much less likely to result in chronic pain and much less likely to result in severe chronic pain.

Slide 11

What are the risk factors for developing chronic pain after acute pain? Well, we certainly know there are genetic and patient-related predisposition like being younger in age, being female, having prior pain symptoms; certainly psychosocial factors such as anxiety, depression or someone who catastrophizes over their pain systems, but then there are surgical related issues like the preoperative pain is ischemic or mastalgia, which is breast pain, or if the person is on preoperative opioid analgesics already, or during surgery it depends on the surgical procedure, the surgical technique, if there is nerve ligation or injury, or even the anesthetic modality, and the postoperatively if the pain remains uncontrolled and high intensity it is a long durations of time these are all risk factors for developing chronic pain from acute pain.

Slide 12

When we assess acute pain, we will ask about intensity, the location of the pain, onset, duration, radiation, exacerbation, and alleviation, but we know that many factors influence self-reported pain ratings including gender, social support, writer characteristics, and trust.

Slide 13

So when we assess acute pain, we will use pain intensity scales such as the visual analog scale and numeric rating scale. Usually, on a 10-point scale we consider pain milder if it was somewhere between 1-3, moderate between 4-6, and severe if it is 7 or greater (7 or 10), and then we ask about time period, what is your pain now? How about over the past day or the past three days? The range of pain - what is the highest pain? What is your lowest pain? Also, how is your pain related to your activity? What is your pain at rest, sitting, walking? Unfortunately, these assessment tools are limited by a lack of assessment of a multidimensional pain experience. We know that pain is more than just a sensory phenomenon but there is also an effective component as well.

Slide 14

Now there are screening tools that can help us determine or predict which patients are going to develop chronic pain from an acute pain episode, and this is just one example of a screener that tries to predict patients with acute back pain who are going to develop chronic back pain. It's called the STaRT Back Screening Tool. It asks over the last 2 weeks, questions like "has your pain radiated?" "Do you also have pain in your shoulder or neck?" And in general "I have not enjoyed all of the things I used to enjoy," so these are all questions that have been validated to predict whether or not someone who has acute pain is going to develop pain. It helps identify modifiable risk factors for chronic back disability in the total score will stratify patients into low, medium, or high risk for developing chronic pain.

Slide 15

We also know that in the acute pain setting there is under treatment and disparities in pain care. From one national survey, less than half of the patients underwent surgery reported adequate postoperative pain relief. We know that gender, ethnicity, age, language, education, and cultural and socioeconomic backgrounds are all associated with disparities in pain treatment.

Slide 16

Let's look at how analgesics are for treating acute pain, in this case postoperative pain. This is from a Cochrane Review published in 2015 where they looked at different oral analgesics for postoperative pain involving about 50,000 participants and about 460 high-quality studies. What they looked at were different analgesics, specific dosages and what were the number of patients or subjects needed to treat versus placebo for at least a 50% maximum pain relief over 4-6 hours, so the lower the number the better the analgesic is, and what you can see is ibuprofen, naproxen, celecoxib altered around the same where they required about 2.6 to 2.7 patients in order to get one patient with 50% pain relief. Acetaminophen did worse than oxycodone; codeine and gabapentin did worse. Combination therapy actually did best. If you combined ibuprofen with acetaminophen it only required 1.5 individuals to be treated to have one patient get 50% benefit from pain relief. If you look at ibuprofen and oxycodone, 2.3; acetaminophen and oxycodone 5.4; acetaminophen and codeine 6.9.

Slide 17

According to the postoperative pain management clinical practice guidelines put out by the American Pain Society, the American Society of Regional Anesthesia Pain Medicine, the American Society of Anesthesiologists published in 2016, they highlight the importance of offering multimodal analgesia, and they state that you use a variety of analgesic medications combined with nonpharmacological interventions for postoperative pain has strong recommendation with high quality evidence, and there are a number of randomized clinical trials that have shown that multimodal analgesia involving combinations of several medications acting at different receptors is associated with superior pain relief and decreased opioid use with decreased opioid-related adverse events.

Slide 18

This is just a diagram showing multimodal analgesia where you can see a variety of different pharmacologic agents, and you can see various places in the nervous system or the pain pathways where these medications interact. You can imagine that if you target different sites in these pain pathways you are going to improve analgesia.

Slide 19

Using non-opioids, we're really talking about nonsteroidal anti-inflammatory drugs, whether they be traditional NSAIDs or COX-2 specific, aspirin or salicylate, acetaminophen, and the general considerations are that there is a ceiling analgesia affect, there is no known analgesic tolerance to these agents, there is an additive role we talked about that combining these therapies, and side effects are common especially in high doses.

Slide 20

We are also talking about adjuvant analgesics, and adjuvant analgesics mean their primary indication is for something other than pain, and they include antidepressants, anticonvulsants, antispasmodics, and neuroleptics.

Slide 21

And now I just want to finish with opioids, and opioids can reduce pain perception and the reaction to pain, and they increase pain tolerance by doing many things in the pain pathway. They turn on the descending inhibitory system in the midbrain. They prevent ascending transmission of the pain signal. They inhibit terminals of the C-fibers in the dorsal chord of the spinal cord, and they inhibit activation of peripheral nociceptors. However, they also turn on the reward pathway in the midbrain which is a dopaminergic system which could be very rewarding, and therein lies the problem with opioids; that is, some individuals will develop a reward to that in a way that they continually use in a habitual way developing an addiction.

Slide 22

We know that 99% of US surgical patients are given at least one dose postoperatively of an opioid. We know that over the past decade, titrating opioids to affect became common practice leading to high dose and long-term opioid therapy. We know that prescribing too many tablets in the acute pain setting result left over opioids that are not disposed of properly and are available for intentional or unintentional diversion.

Slide 23

What is the association between that initial opioid prescription for acute pain and long-term use? Well, here are a couple of retrospective cohort studies, one involving over 500,000 opioid-i.e. patients who filled in a pure prescription between 2012 and 2013, and 5% of that cohort became long-term users. The risk included the number of refills, so a greater number of refills and a greater cumulative dose during that first month predicted becoming a long-term user, and the second retrospective study involving almost 40,000 opioid 90 patient to have major elective surgery, 3.1% became long-term users. The highest risk was after intra-thoracic procedures, but there were other risk factors which included having lower income, having specific comorbidities like CHF or diabetes, and use of specific preoperative medications like benzodiazepines or SSRIs.

Slide 24

In the third retrospective cohort study of over 600,000 opioid naïve surgical patients, they found other risk factors associated with chronic opioid use after getting opioids for acute pain, and that include being male, being over 50 years of age, and having a preoperative history of drug abuse, alcohol use, benzodiazepine use, antidepressant use, and depression.

Slide 25

What about after minor surgery? Well, this was another cohort study looking at over 390,000 opioid naïve patients who underwent short I can stay surgery. In this case 7.7% became long-term opioid users adhere 1 from surgery, and they found that patients who received an open prescription postoperatively were 44% more likely to become chronic opioid users compared to those not given opioids.

Slide 26

Back to the clinical guidelines from 2016, they specifically say that at the time of discharge from an emergency room or a postoperative setting, there needs to be a plan for reduction and discontinuation of opioids as the acute pain resolved. The plan must also include appropriate disposal of unused opioids. They describe that most severe postoperative pain diminishes rapidly in the first few days, but there is variability so we need to individualize approaches for some pain syndromes that may last longer. They also described there is insufficient evidence to guide up your tapers but suggest that a decrease of 20%-25% of the discharge dose every 1-2 days can be tolerated by most patients when pain is improving. For some minor surgeries it is appropriate on discharge to treat with acetaminophen or NSAIDs or a combination of those two with no or very limited opioids supplied before a transition to nonopioid therapy.

Slide 27

Finally, the CDC guidelines that were published in 2016 specifically talk about how long-term opioid use often begins with the treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of an immediate release opioid; that is, not to use an extended release long-acting opioids in the setting. And they should be prescribed in no greater quantity than needed for the expected duration of pain they suggest that 3 days or less will often be sufficient and that more than 7 days of opioids in the acute pain setting will rarely be needed. Thank you very much.

Slide 28

Next, please welcome Dr. Kelly Ramsey on behalf of the New York chapter of American College of Physicians who will review the New York State prescribing laws.

Dr. Kelly Ramsey: My name is Dr. Kelly Ramsey. I work for Hudson River Healthcare in Poughkeepsie, New York, and my title there is Clinical Director of Special Programs. I'm going to be covering the section on state and federal law on the prescribing of controlled substances.

Slide 29

In New York State, we have an Internet system for tracking overprescribing. This is called I-STOP. It is essentially a prescription program monitoring registry, and it has a record of all electronic prescribing done in the state. The prescriptions are actually entered into the system by the pharmacist when they are filled, and it is essentially a real-time system. However, there is a slight delay and prescriptions are actually entered within the system within 24 hours of being filled. It updates also the New York State schedules of controlled substances, and this is what we will be addressing in the next several slides.

Slide 30

With I-STOP in New York State, a practitioner must consult the registry prior to prescribing or dispensing any controlled substance that is listed either schedule II, III, IV. Practitioners may consult the registry prior to prescribing or dispensing any other controlled substances. There are certain exceptions which apply, and these will be covered in the next several slides.

Slide 31

The Duty to Consult the registry does not apply to several categories of providers: veterinarians; methadone programs; a practitioner administering a controlled substance; a practitioner prescribing or ordering a controlled substance for use on the premises of an institutional dispenser; and a practitioner prescribing a controlled substance in the emergency department Debbie General Hospital, provided that the quantity of controlled substances prescribed does not exceed a 5-day supply.

Slide 32

Additional exceptions include a practitioner prescribing a controlled substance to a patient under the care of a hospice or a practitioner, when it is not reasonably possible for the practitioner to access the register in a timely manner; no other practitioner or designee authorized to access the registry is reasonably available; or the quantity of the controlled substance prescribed does not exceed a five day supply.

Slide 33

Additional exceptions include a practitioner acting in compliance with regulations that may be promulgated by the Commissioner as to circumstances under which consultation of the registry would result in a patient's inability to obtain a prescription in a timely manner, thus potentially adversely impacting the medical condition of such patient; a situation where the registry is not operational as determined by the department or where it cannot be accessed by the practitioner due to a temporary technological or electrical failure -

Slide 34

When a practitioner who has been granted a waiver due to technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstances demonstrated by the practitioner.

Slide 35

The Seven Day Limitation on Initial Opioid Prescribing for Acute Pain: effective July 22, 2016, in New York State, a practitioner may not initially prescribe more than a seven day supply of an opioid pain medication for acute pain. Acute pain is defined as pain whether resulting from a disease, accidental or intentional trauma, or another cause that the practitioner reasonably expects to last only a short period of time. Upon any subsequent consultations for the same pain, the practitioner may issue any appropriate renewal, refill, or new prescription for an opioid. The seven day limit does not include prescribing for chronic pain, pain being treated as part of cancer care, hospice, or other end-of-life care, or pain being treated as part of palliative care practices.

Slide 36

All prescriptions must be transmitted electronically in New York State. New York State is the only state to mandate a prescribing of both controlled and non-controlled substances. Practitioners must use e-prescribing software that has been certified by the DEA. The practitioner must also complete an identity proofing process and obtain two factor authentication in accordance with the DEA regulations.

Slide 37

Practitioners must register the controlled substance e-prescribing software with the Bureau of Narcotic Enforcement. This registration with the Bureau of Narcotic Enforcement needs to be updated at least every two years or whenever the DEA requires a new third-party audit of the software, whichever comes first. If the practitioner works at multiple locations and uses different e-prescribing software at the different sites, the practitioner will need to register each software program to prescribe controlled substances. A prescriber must make a notation in the patient's medical record if they have issued a patient a paper prescription when an e-prescription was not available.

Slide 38

E-prescribing regulations include several exceptions to the mandate, which include the following: prescriptions issued by veterinarian; when electronic prescribing is not available due to a temporary technological or electronic failure; prescriptions issued by a practitioner under circumstances where the practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient's medical condition. In addition to these circumstances, the quantity of controlled substances cannot exceed a five day supply if the controlled substance were used in accordance with the directions for use.

Slide 39

Prescriptions issued by a practitioner are to be dispensed by a pharmacy located outside the state and practitioners have received a waiver from the requirements to use electronic prescribing.

Slide 40

Federal Prescribing Requirements

A prescription for a controlled substance must include the following information: date of issue; patient's name and address; petitioner's name, address, and DEA registration number; drug name; drug strength; dosage form; quantity prescribed; and directions for use. Prescriptions must be written in ink and signed by the practitioner. In New York State, controlled substance prescriptions must be electronically prescribed.

Slide 41

A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, veterinarian, mid-level practitioner, or other registered practitioner who is authorized to prescribe controlled substances by the jurisdiction of licensure; registered with the DEA or exempted from registration via Public Health Service, Federal Bureau of Prisons, or military personnel; and an agent or employee of the hospital or other institution acting in its normal course of business or employment under the registration of the hospital or institution. Lists of Schedule II controlled substances are issued by the federal government and may vary slightly by state requirements. In New York State, there is a limit of a seven day supply for an original controlled substance prescription. Some exemptions do apply.

Slide 42

Now, we will hear from Dr. Daniel Pomerantz on behalf of the New York Chapter American College of Physicians who will revere palliative care.

Slide 43

This is Dr. Daniel Pomerantz, Director of Palliative Care at Montefiore New Rochelle Hospital. Palliative care is quite important and in recognition of its importance to you New York State residents and patients the state legislature passed two laws in 2011, the Palliative Care Information Act in February, which states that the attending healthcare practitioner must offer to patients with a terminal illness or to their surrogates information counseling regarding palliative care and end-of-life options appropriate to the patient including information about prognosis; the range of options for care appropriate to the patient; the risks and benefits of those options; and of the patient's legal rights to comprehensive pain and symptom management at the end of life.

Slide 44

Additionally, the legislature passed Palliative Care Access Act in September, which requires hospitals, nursing homes, home care agencies, special needs assisted living residencies, and enhanced assisted living residences that they provide access to information and counseling regarding options for palliative care appropriate patients with advanced life limiting conditions and illnesses or to their surrogates if the patients are unable to participate in the counseling. The care providers and residences must also facilitate access to appropriate palliative care consultation and services, including pain management consistent with the patient's needs and preferences.

Slide 45

What is Palliative Care?

The New York State laws define palliative care as healthcare treatment, including interdisciplinary end-of-life care and consultation with patients and family members, to prevent or relieve pain and suffering and to enhance the patient's quality of life, including hospice care under Article 40 of the Public Health Law. It is specialized medical care for people living with serious illnesses. It is focused on providing relief from symptoms and relief from the stress of coping with a serious illness. The goal is to improve quality of life for both patients and their family, and it is care that can be provided by a team including palliative care physicians, nurses, and other specialists who work together with the patient's primary doctors to provide an extra layer of support. It is appropriate at any stage of any serious illness and can be provided along with curative treatment.

Slide 46

Palliative care can help many, many people. Obviously palliative care can help patients with serious, chronic illnesses with almost any symptoms or difficulties about advanced directives or making treatment decisions.

Slide 47

In the intensive care unit particularly, patients who are in the ICU who have been admitted from a nursing home with one or more serious chronic illnesses like dementia, patients who have within the same hospitalization have been transferred to the ICU two or more times; patients on mechanical ventilation are having difficulty coming off of the ventilator or have required prolonged mechanical ventilator support; patients with multiorgan failure; patients who are themselves or their families are considering withdrawing the ventilator support and with the expectation that the patient will not survive; patients in the ICU with advanced metastatic cancer; patients who have suffered anoxic or hypoxic ischemic brain injury who are not showing signs of neurological recovery; and patients who are in the ICU and are being considered for transfer to long-term ventilator facilities; and any patient whose family is experiencing distress which is impairing surrogate decision-making. Obviously patients with metastatic or locally advanced cancer that is progressing despite treatment, especially those with weight loss but even those without weight loss who are experiencing severe functional decline -

Slide 48

And in the emergency departments, very early in the hospitalization consultation may be appropriate for patients who are coming to the ED with a history of multiple recent hospitalizations for the same symptoms or problems; patients coming from long-term care facilities who have do not resuscitate orders or whose goal of care is comfort; patients who are previously in the home or residential hospice programs and now being hospitalized; any patient in the ED who would like to be evaluated for hospice care or the caregiver or physician thinks that hospice care would be appropriate but has not already been evaluated; and patients in the ED have metastatic or other advanced cancer and declining function or moderate to severe dementia who appear to be headed for intensive care or mechanical ventilation and any patient with one or more serious chronic illnesses with poor functional status at baseline.

Slide 49

Palliative care can be associated with better outcomes for patients with serious illness. Dr. Temel and her colleagues at Massachusetts Gen. Hospital published a report in 2010 which showed that early to palliative care consultation led to improve patient outcomes in patients with stage 4 non-small cell lung cancer. The patient showed better quality of life scores, fewer symptoms of depression, less aggressive end-of-life care, and in this study prolonged survival.

Slide 50

How do you know when it is time for palliative care? Palliative care is about addressing the patient's symptoms and psychosocial burden. It is not about prognosis. It is almost never too soon to introduce palliative care, and relying on prognosis can be misleading, and unfortunately when doctors and patients have a long-standing relationship, physicians tend to be overly optimistic in predicting their patient survival.

Slide 51

This study by Christakis and colleagues looked at patients who the physicians read had a terminal illness. They were asked to estimate the patient's predicted survival and then they correlated that with the patient's observed survival. The very first column at the left is patients whose observed survival was only one day. Please note that on this logarithmic scale, one patient had a predicted survival of more than a year and survived only one day. The cluster of all prognosis productions was well above the line that would indicate accurate prediction of prognosis.

Slide 52

One of the things that is important in discussing palliative care is to make sure that we have good communication between physicians and patients. This is I think the very essence of palliative care. Most important is to make sure that palliative care is about what we can do for patients and not about what we won't do for patients, so for that reason it is very important to discuss the patient's agenda first. Pay attention to how the patient is handling the information we are giving them. Are they understanding what we are telling them? How are they reacting to it? What is their emotional reaction? What is there intellectual reaction? People presented with serious news frequently shut down and we may need to ask them how they are doing and we may even need to stop the conversation. We should talk to patients about the treatment agenda, considering their goals and values, using empathy, acknowledging their emotional experience, focusing on what we can do, focusing first on what is possible rather than on what can't be done and what won't be done, clarifying the patient's long-term goals if long-term goals are appropriate and talking about options that make sense with that goal. One of the most important things is to make sure that at some point during each encounter, patients have your complete undivided attention, that they know you are just there with them.

Slide 53

Questions that can help outline your understanding from your patients, tell me what you understand about your illness or your diagnosis and what it means for your future. What are you afraid of? What are you worried about? What would you like your future to look like? What are you expecting to happen? What are your hopes? Do you need help to talk to other people in your life, to your friends and family? To really help them to share their understanding with others so that they are not alone in this.

Slide 54

What about hospice care? Palliative care originated as an outgrowth of hospice care, and because of that people frequently think that palliative care like hospice care is only appropriate for patients with six-month survival or less. Hospice care under Medicare is limited to the last six months of life except in pediatrics which is a different situation, but for adults any palliative care patient who appears to have a life expectancy of six months or less should be eligible for hospice care if they have Medicare part A. It is also available under many commercial plans and through New York State Medicaid. Care is provided by hospice care agencies in coordination with the patient's primary physician. Patients do not need to give up their relationship with their doctors to go on to hospice. In fact, hospices encourage collaboration with primary care doctors.

Slide 55

It is an easy way to test whether a patient would be appropriate for hospice is a surprise question, which was coined by Ira Byock who is a Professor of Medicine and leader in palliative care, "Would you be surprised if your patient died sometime within the next six months?" If you would not be surprised, then the patient is probably appropriate for hospice care, and certainly at least worth getting a hospice agency to evaluate the patient.

Slide 56

Facing a serious or life-threatening illness and a new diagnosis, you want to show support, match the patient's needs with the treatment options and the goals of care. We need to have the conversation. We need to make sure people understand their diagnosis, their prognosis, the treatment options. We can work with patients and their caregivers to understand these things and help patients to assign the healthcare agents and complete a Healthcare Proxy form.

Slide 57

When we are addressing serious news, it is very important to make sure that you and your patient have privacy and to limit distractions and interruptions. Start with what the patient knows and understands, to make sure the patient is ready to assimilate new information before sharing it, to use empathy and show your understanding to the patient's and before finishing the visit make sure the patient understands the information you have shared with them.

Slide 58

When talking about prognosis, it is important to acknowledge how uncertain we are, as I indicated above, physician prognosis is frequently inaccurately optimistic. For that reason I generally avoid being very specific about prognosis and I am up front with that with patients because I just don't know. I tend to use ranges of time appropriate to the severity of the patient's illness. Patients who have months to a few years, weeks to a few months, days to a few weeks, and hours to a few days, and sometimes in the hospital I may even say, "minutes to hours." It is only when the patient is very close to death that you can see clinical signs which may make it reasonable to make such a prediction. Especially with very limited prognosis it is very important to recognize the emotional impact on patients and use empathy statement appeared one thing I do recommend is rather than apologizing for giving bad news to say "I wish I didn't have to tell you this," rather than "I'm sorry." Lots of times "I'm sorry feels" like you are taking responsibility and patients feel like they have to forgive us, but neither is really true. "I wish I didn't have to say this," conveys that same sense of regret without social obligations.

Slide 59

Finally, welcome Dr. Paula Lester, on behalf of the New York Chapter of American College of Physicians, who will discuss end-of-life decision-making.

Paula Lester: Hi, my name is Paula Lester, and I am an Assistant Professor of Clinical Medicine at Stony Brook University Hospital and a faculty geriatrician at Winthrop University Hospital. We will now begin the section on end-of-life.

Slide 60

When a patient is actively dying, often the focus of care needs to transition. For most patients, we encourage that IV fluids are stopped. It is important for both family members, patients, and caregivers to recognize that not eating or drinking is a natural part of the dying process. We need to recognize that giving IV fluids to someone who is actively dying can actually cause more burden without benefit. The body has to process the fluid. It is an increased strain on the heart and kidneys, and it can lead to dyspnea, pleural effusion, and edema. To help with dyspnea, you can turn on a funeral in the window. The sense of air blowing on the face can reduce the feeling of dyspnea. Also, it is important to avoid BiPAP because it usually will not resolve the underlying issue and it can be very uncomfortable for the patient because it is tight on the face. We also often will limit vital signs monitoring on patients who are actively dying. It is beneficial to monitor heart rate and respiratory rate as their mark of distress. In general the goal would be to have a heart rate of under 100 or respiratory rate of under 24, as a sign that the patient is not overworking and feeling distressed, but really checking blood pressure is both painful to the patient and really won't change management.

Slide 61

Additionally, if patients are at the end of life it is often important to refocus care. This can include discontinuing medical treatments that are not helpful for the patient, things that don't improve quality of life, that can cause excessive pain, that are expensive for the patient, or can cause burdens or side effects that outweigh the benefits. Often this includes eliminating unnecessary medications and treatments that aren't beneficial. Medications such as cholesterol medications, dementia medications, vitamins, protein supplements, minerals, DVT prophylaxis, compression devices, antibiotics (unless the patient is having active symptoms from the infection), and antidiabetic meds. These medications often can be stopped if patient are at end-of-life because the benefits are not there for them.

Slide 62

There are many medications that can be help for patients who are actively dying at the end of life and it is important to use these medications appropriately to help the patient be comfortable for the time that they have. Often people we use morphine. It is available in IV, sublingual, and subcutaneous dosing. In general the initial dose for an opioid-naïve patient with the oral morphine of 2.5 to 5 mg or an IV dose parenteral of 1 to 2 mg. If someone is much smaller or underweight you can even start at 0.5 mg. For patients who have severe dyspnea or pain, especially if it is acute and severe, parenteral is the route of choice. You can get 2 to 5 mg every 5 to 10 minutes until the patient has relief. If the patient doesn't have IV access or you are not in a hospital setting, be mindful that there is a liquid version of morphine available and it comes in various concentrations. It comes in a very concentrated dose of 20 mg per mL as well as a less concentrated dose of 5 mg per 5 ML. A very concentrated dose can be used in patients in the nonhospital setting even if they can't swallow. For some patients, a continuous opioid infusion with a p.r.n. dose as needed can provide relief in the inpatient setting. Another medication that is used for patients dying at end-of-life is lorazepam or Ativan. It is also available as IV or sublingual, and it can be very effective as an anxiolytic to reduce the anxiety component of dyspnea. The starting dose usually is 0.5 mg IV every eight hours or every 6 hours p.r.n. depending on the patient, and a liquid concentrated dose of 2 mg per mL so you can give 0.5 mg or 0.25 ML sublingual every six hours as needed. It is also important to note for patients who have impaired kidney disease or kidney function, repeated doses of morphine can be problematic as they can accumulate in the body, so for those patients liquid oxycodone or fentanyl IV is sometimes considered.

Slide 63

Patients at end-of-life and their families and caregivers need nonpharmacological treatments and interventions as well. It is helpful to offer social work or pastoral services. These can be very helpful for patients at end-of-life or difficult times of illness and provide them with support emotionally and physically and spiritually. It is also important to update the caregivers in the family. We have to provide realistic expectations along with emotional support as I go through this difficult time in their lives. As patients are at end-of-life they often stop eating and drinking. It is important for families and caregivers and patients and clinical providers to know that that is a natural part of the dying process. It is not uncomfortable for the patient. It is not a starvation state. I sometimes suggest that patients think about a time when they had the flu and they felt sick and couldn't eat, and if someone were to force food into them it would make them feel worse. Another way sometimes I explain this to families is it is not that their loved one is dying because they are not eating; they are actually not eating because they are dying. This often helps them to understand that this is a different stage of life and a different focus is necessary. Related to that, it is important help families figure out ways to express their love and concern. This could be handholding, musical therapy, massage, reading, whatever is important at patient and that family, but it doesn't always have to be food and medication.

Slide 64

Advanced directives provide a great way for patients to plan for their future healthcare and to communicate with their caregivers and family as to what they would want. There are many steps in advanced directives, and they are important at various times of illness, and it is a point to really address them early and plan for the future. One of the most important steps is probably an appointment with a Healthcare Proxy. That is where you assign someone to make medical decisions for you in the event that you can't. This is different than a living will. A living will is different because it is specific to certain situations. In the event that I have a terminal condition or permanent vegetative state, I would or would not certain conditions. The living will only applies to conditions where the Healthcare Proxy can make any decision. It is important to think about organ donation and to document appropriately if that is something that is important to you. You can have a power of attorney to make financial and other non-healthcare decisions. A MOLST is a relatively new form in New York State. It is a medical orders for life-sustaining treatment form. We will speak more about it soon as well as a nonhospital DNR form for do not resuscitate orders in the nonhospital setting.

Slide 65

Advanced directives are very important. Life expectancy is increasing in our country with people living longer and having more chronic illnesses as they live longer. Our region in particular has an aging population with increasing healthcare needs and decisions that need to be made. Healthcare is really much more complex than it used to be. It has really evolved to provide much more technologically-based treatments and interventions. These can lead to difficult decisions for patients and families to make. They need to decide if intervention makes sense, if the procedure makes sense, if it is worth the risk and benefit, and before these procedures or interventions are available there is no decision to be made. For many people, decisions about healthcare and other important issues can be much more stressful when it is a state of initial or recurrent crisis. These decisions are generally better made when communication can be had in advance and about what you would want in certain events as opposed to trying to decide these things at a stressful time, often 3 o'clock in the morning. Really, advanced planning is important for the patient and their caregivers. It allows the patient's goals and preferences to be known and honored. It lets the patient get what they want and let the families know that they are honoring their loved one's wishes and that is really what everyone wants.

Slide 66

When is it a good time to address advanced directives? There are several times when it can be appropriate. It can be done at an initial or annual outpatient visit. It should be done before any hospitalization for elective surgery or procedure. It can be done at any acute hospitalization stay. It could also be discussed after return visits from a hospitalization if it was not addressed during that time. It could be done in any office follow-up visit, especially some with a chronic illness. And certainly if it hasn't been done by this time, if there is a diagnosis of serious or life-threatening illness, advanced directives should be discussed, but really you can consider the discussion at any clinical interaction, and even patients aren't ready to have a discussion at that moment it is important to raise the idea and have them be aware of the opportunity for advanced directives and how important it is for them so that their wishes can be honored in the future.

Slide 67

Medicare now has special codes to pay physicians and other clinicians for advanced care planning discussions. There are two code levels. The CPT code 99497 covers advanced care planning for explanation and discussion of advanced directives by a physician or other qualified healthcare professional. The code is defined as the first 30 minutes and requires face-to-face with the patient, family member, and/or a surrogate. It is important to note that though the code says 30 minutes, a provider must reach at least 60 minutes in order to bill this code. You do not need to do the full 30 minutes but you must at least bill 16 minutes and document that. The documentation has to include an account of the discussion regarding the voluntary nature of the encounter, and you have to include documentation in indicates what you explained, what the advance directives are and what their choices are, and if they did complete any forms to include which forms were completed. You need to include who was present and as I said earlier the time spent in the face-to-face encounter. After the first 30 minutes is reached from the first code you can actually bill a secondary code called 99498. This is a code that you bill for at least an additional 16 minutes above the first 30 minutes, so you have to spend at least 46 minutes discussing advance care planning in order to bill both of these codes. It is important to list them separately. It is also important to note that the beneficiary or practice doesn't actually have to complete an advanced directive at the time. The patient can complete the forms later or never but if you have a discussion 60 minutes or more you can bill for it.

Slide 68

The primary advanced directive forms for adults that we have in our country are the Healthcare Proxy and the Living Will. The Healthcare Proxy is a legal document that appoints a healthcare agent to make decisions in the event a patient is unable to do so because of other illness or injury. The event which makes the patient unable to speak for themselves may or may not be permanent. A Living Will is a different type of document. It is a document that outlines the medical procedures that a patient would or would not want in the event that they are unable to say so for themselves. A Living Will applies only in the specific conditions that the paperwork states; in general, in a terminal or irreversible condition. Though the Living Will is not a legal document, it helps establish a clear and convincing evidence of the patient's preferences and helps the caregivers and clinicians make a decision based on the patient's wishes.

Slide 69

In terms of Healthcare Proxy, there are lots of steps that are appropriate important to recognize. One of them honestly is to do a Healthcare Proxy for yourself. It is very hard for us to convince patients to do something if we don't do it ourselves. It is important for us when we have our Healthcare Proxy forms completed to make sure our goals and purposes are known by the proxy. It is not just the paperwork, it is important for them to know what you would or would not want. It is important to have Healthcare Proxy forms available in your office. You can download them easily from the web, and we should really encourage our patients to assign Healthcare Proxy and make sure that a copy of that Healthcare Proxy form is given to all of their medical providers and brought with them when they go to a hospital setting. It is important for patients to know that they should be honest with their proxy about their goals and preferences. It is hard for a family member to honor someone's wishes if they don't know what their wishes are. It is also important for us as clinicians to be able to provide guidance about relevant medical interventions. There are certain cases where interventions or procedures that seem like they would be helpful but may actually not be; for example, a feeding tube to the patient with advanced Alzheimer's or the impact of dialysis on someone who has chronic kidney disease and other comorbidities. These are difficult decisions, and it is important for us to help provide guidance.

Slide 70

New York State has other advanced directive forms as well. Two of them that are important to discuss our organ donation and a power of attorney. Organ donation is when you mark off a donor box that you want to be an organ donor. You can do it either on your driver's license application or renewal form or complete an online donor registry form, as you can see on the site here. Power of attorney in New York State is a separate document that designate someone to make a financial decision. It does not cover healthcare decisions, so if you want someone to make healthcare decisions for you you need a specific healthcare proxy.

Slide 71

Now we will speak more about MOLST, which is an actionable medical order. MOLST stands for Medical Orders for Life-Sustaining Treatment. It documents patient's treatment preferences for life-sustaining treatment. It is the only authorized New York State form for documenting both nonhospital do-not-resuscitate and do-not-intubate orders, and this form is nice because it actually covers a lot of information. On the front page it covers DNR versus CPR, but on the inside there are questions about feeding tubes, IV fluids, antibiotics, comfort measures, hospitalizations, and it is important to recognize that many families and caregivers need to have this discussion early in their illness so that their wishes can be honored. It is also important to note that this form is a medical order and needs to be signed by a physician and the person consenting has to have two witnesses, and this form applies in multiple healthcare settings in New York State. It is valid in the nursing home, in the outpatient setting, and in the hospital setting.

Slide 72

Who should have a MOLST? Really if a patient has one or more serious or advanced chronic conditions or has a serious new illness with a poor prognosis, it is very important time to sit down and have the discussion about preferences for healthcare. If patient has certain preferences about their medical interventions, if they for sure know that they would never want a feeding tube or never be on dialysis, it is important to have that documented so that it is clear, and again these things can change as their condition progresses and then the MOLST form would need to be updated. It is certainly should be considered for patient to live in a nursing home or get long-term care services at home or in an assisted living facility. Another way to think about this is if a clinician would not be surprised if the patient died within a year, for those patients it is important to think about having the discussion about what they would want so that their end-of-life meets the goals that are important for them. It is also important to think about MOLST for patients with decreased function or frailty or progressive weight loss or two or more unplanned hospitalizations in the last 12 months. Those patients are at higher risk for death in the short term and it is important to know what they would or would not want. It is also important I think to recognize that MOLST is not about filling out a form. It is about the discussion. It is about speaking with patients and their families about what various treatment options are available in the future and whether or not that is something they would want so that we can provide them with the best quality of life for the time that they have.

Slide 73

In terms of preparing for the MOLST, you really want to prepare for the discussion. You want to know their health status, prognosis, and their ability to consent. You want to retrieve any completed advanced directives and update anything that needs to be updated. You want to figure out who the decision-maker is and follow the New York State public health legal requirements to do that. It is also important again to remember that the MOLST form is about the discussion, not just about filling out boxes. Know what the patient and family understand about the condition and prognosis. Do they have realistic expectations? Have they been fully informed about their condition? It is important to explore their goals, hopes, and expectations. What do they think is going to happen for them in the future? And if they are not realistic, help them set realistic goals and help them to understand what the future looks like for them. It is important to respond with empathy discussing end-of-life and personal healthcare choices can be very difficult for patients and caregivers, recognizing their own mortality can be very overwhelming and stressful, so it is important to express understanding and empathy as we have this conversation. Again the MOLST is to be used as a guide to choices and help finalize the patient's wishes. It is really supposed to help have shared and informed medical decision-making between clinicians and patients and family members, and hopefully it can resolve conflict before the conflict arises, and then the MOLST will be completed and signed and witnessed appropriately. The third page involves review and revision periodically as to any changes in the MOLST form and then there is work going on for an electronic MOLST form which would be more accessible throughout New York State.

Slide 74

Another actionable medical order is actually the Nonhospital DNR form. This is a form that is a doctor's order to be used in a nonhospital setting such as the home, and this is a form that a physician will sign. It is legally recognized in the state for DNR's but not for patients who live in Article 28 licensed facilities, so this is not the DNR to use for a hospital patient or a nursing home patient. This is for patients who are at home or in assisted living. I think the Nonhospital DNR has been used less now the people has the MOLST form because the MOLST form can be transferred and taken to be used in the hospital, in a nursing home in the office setting. The Nonhospital DNR still has the role for some patients, and copies can be kept on ambulances and made available to patients, facilities, or physicians. It is important to bring a copy of your Nonhospital DNR if you go to the hospital so that the physicians will know your wishes. It is important to make sure that other medical providers, other doctors have copies of your health care proxy, your DNR, and your MOLST if it is been completed.

Slide 75

It is also important that the directives be consistent. If a patient has a DNR order, it is important for families and caregivers and other clinicians to know that it doesn't limit the patient's access to any other life-sustaining treatment or other medical treatments. It is important that patients understand what CPR really means and that the question of 'If your heart stopped would you want us to revive you?', is really not fair. It makes it sound like you can guarantee that they will be revived back to where they were before, so it is important that when patients have a DNR, whether or not there is a DNI (do-not-intubate) present. You really can't be do-not-intubate but still want CPR because CPR requires intubation. Sometimes this requires extra time to explain what the different interventions mean so that families and patients can understand better.

Slide 76

These are a lot of difficult discussions and thoughts and even though we often provide a lot of care to patients at various stages of their illness, end-of-life can be difficult emotionally and spiritually for many people including physicians. These are some great books that you might like to read, any of them by physicians and their reflections on their experiences.

Slide 77

We would like to acknowledge the following members of the NYACP Pain Course Task Force: Dr. Efferen, myself, Dr. Pomerantz, and Dr. Ramsey. We also would like to think of other NYACP contributors Dr. Bomba and Dr. Carney. We hope you found this program to be useful and meaningful and can help you in your practice, thank you.

Slide 78

Thank you for participating in Managing Pain and Opioid Use: an Educational Program on Compliance with New York State Prescribing Laws. In order to receive CME, CME, and ABIM MOC Part II credit, you must take a posttest and complete an evaluation. With a passing score of 70% or greater, you will be able to print your certificate.