New York Mandatory Education for Prescribing Controlled Substances

An essential role of the practitioner is prescribing controlled substances. Establishing treatment goals is an important aspect of opioid therapy. Goals should focus on pain relief and improvement in function. Controlled substances are laced with risks, and it is important for the prescriber to realize that the primary purpose of prescribing opioids should be to maintain patient safety. A responsible prescriber should follow multiple steps to assure safe and effective care of their patient.

Therapeutic goals should be established regarding pain control and improvement in function. Pain goals typically involve a reduction in pain, not necessarily an elimination of pain. Functional goals may include: improved sleeping, increased ability to perform activities of daily living, progress in physical therapy, increased social interactions, returning to work, and improved regular exercise. In addition, goals should also include limiting side effects and minimizing adverse drug events.

Non-steroidal anti-inflammatory drugs (NSAIDs) are laced with risks and some patients are unable to tolerate NSAIDs due to side effects and pre-existing co-morbid conditions. The risks associated with NSAIDs is one reason many prescribers choose an opioid to manage pain. Opioid therapy is effective in the management of many chronic pain conditions including cancer, osteoarthritis, low back pain, neuropathic pain, and post herpetic neuralgia.

In recent times, opioid therapy has fallen out of favor as a commonly prescribed medication. In the distant past, it was only used for severe acute pain and cancer pain. In the early 2000s, opioids were one of the most commonly prescribed medications, but now only hydrocodone with acetaminophen falls in the top ten medications that are prescribed.¹⁸

A position paper from the American Academy of Neurology suggested that there is evidence for good short-term pain relief with opioids, but no good evidence exists for continuation of pain relief or improved function for extended periods of time without sustaining serious risks of dependence, overdose, or addiction.¹⁹

When non-opioid therapy is ineffective or there is severe nociceptive pain, opioid therapy is often used. In chronic back pain, opioids do not improve pain scores any more than non-opioid therapy.²⁰ Opioid therapy is often used to manage neuropathic pain but is commonly thought to be second line to antidepressants and anticonvulsants.

Opioid medications are associated with multiple side effects including constipation, nausea, vomiting, pruritus, abdominal cramping, sedation and mental status changes. Numerous interventions are available to reduce or eliminate the side effects of opioids.

• Constipation is a frequent issue for those who use opioids. Risk factors for constipation include older age, those with intra-abdominal pathology and those who eat a low fiber diet. Patients on opiates should be encouraged to increase fiber intake, drink plenty of fluids and exercise. Stool softeners (e.g., docusate sodium) and stimulants (e.g., bisacodyl) may be needed to manage constipation. An osmotic laxative such as polyethylene glycol or lactulose may also be considered and may be added to stools softeners/stimulants for resistant constipation.
• Antiemetic medications can help treat nausea.
• Antihistamines can relieve or lessen pruritus.
• Opioids are associated with somnolence and other mental status changes. Patients do develop tolerance to these symptoms over weeks. Reducing the dose of opioids may lessen the mental status changes. An adjunctive medication may be added to the lower dose of opioid to help manage the pain. Rarely, the use of a stimulant can be used to manage the sedation due to opioid use.
• Respiratory depression may occur, but it is uncommon when the medication is used carefully. Starting with a low dose and slowly titrating the dose higher will reduce the risk of respiratory depression. Problems arise with rapid titration, the addition of another drug that may depress the respiratory drive (benzodiazepines, alcohol or a barbiturate) or the patient overdoses. Sedation precedes respiratory depression so when starting a patient on opioid therapy the patient should be encouraged to take the first dose in the office to be monitored or in the presence of a responsible adult who can help monitor the patient. The level of consciousness should be assessed at least every 30-60 minutes after the opioid is given. The next dose should be held and the prescriber should be contacted immediately if a reduced level of consciousness occurs, hypoxia develops, or the respiratory rate is less than 10 per minute.

Drug interactions have the potential to lead to significant health concerns in those taking opioids. Many individuals with chronic pain have co-morbid conditions that necessitate the use of other medications. A study showed that drug-to-drug interactions in those with chronic low back pain on long-term opioid analgesics had a prevalence of 27%.²¹

Drug-to-drug interactions are variable among products. Medications that depress the central nervous system, such as alcohol, benzodiazepines and tricyclic antidepressants, may potentiate the respiratory depression and sedative effects of opioids. Some extended-release formulations of opioids may rapidly release the opioids when given with alcohol. Methadone and buprenorphine may prolong the QT interval.

Many medications can affect various cytochrome P450 enzymes. Codeine, oxycodone, hydrocodone and tramadol levels may be increased when given with selective serotonin reuptake inhibitors (SSRIs), protease inhibitors, diltiazem, verapamil, diazepam, clarithromycin, fluoroquinolones and diphenhydramine. Levels may be decreased with carbamazepine and phenytoin. Fentanyl levels may be increased by SSRIs, protease inhibitors, diltiazem, verapamil, diazepam and clarithromycin. Some opioids used with anticholinergic medications may increase the risk of constipation and urinary retention.

Grapefruit juice has the potential to increase levels of multiple opioids such as fentanyl, codeine, hydrocodone and methadone. Ginkgo Biloba, Valerian Root and St. John’s Wort have the potential to reduce levels of multiple opioids. Some individuals have an allelic variant in CYP-2D6, making them inefficient at converting codeine to its active metabolite morphine, thus resulting in a less analgesic effect to codeine.

Not all patients on chronic opioid therapy need to have a referral but some do. Consider a referral to psychology, psychiatry or an addiction expert for those at high risk for or those who engage in aberrant drug-related behaviors. Those with a substance abuse disorder are also candidates for referral. A pain management consultation may be helpful for those on high dose opioids.

The management of pain may include medications, behavioral interventions, physical medicine, neuromodulation, medical interventions or surgery. A multidisciplinary approach is typically used in the management of chronic pain.

Current treatments in the management of chronic pain result in approximately a 30% reduction in pain.²² One of the problems encountered is that general practitioners have limited training in the management of chronic pain.²³ The use of a pain management specialist is often needed to manage pain properly.

The treatment plan should be established prior to initiating treatment. In this plan, the patient and the provider should discuss the benefits, risks and alternatives before starting treatment. In addition, it is important for the clinician to discuss how the patient will be monitored, including how the patient will be evaluated for potential misuse of the prescribed medication. Use of written documents is often included in the plan. This may consist of agreements, treatment plans, and informed consents. It is important that the clinician document that decision making was implemented, including informed consent; goal setting was discussed, and a monitoring plan was defined.²⁴

When high doses opioid prescriptions are given there is an increased risk of overdose death. Therefore, it is important that the clinician discuss and limit the number of opioids prescribed. The CDC recommends that providers prescribed no more than 90 morphine milliequivalents per day.²⁵

The World Health Organization (WHO) analgesic ladder was created for the management of cancer pain and published in the 1980s.²⁶ Key points of the analgesic ladder include:

1. Medications are given through the most comfortable route (preferably orally).
2. A stepwise approach should be followed, starting with non-opioid medications with or without adjuvant medications.
3. Managing mild to moderate enduring or progressive pain with opioids, with or without adjuvant medications, with or without non-opioids.
4. Considering the use of more potent opioids such as morphine with or without adjuvant medications with or without non-opioids for persistent pain or pain that is increasing, notwithstanding the previous step 3 above.
5. Administering analgesic pain medication used for moderate to severe chronic pain on a fixed schedule (not as needed).

This approach is 80-90% effective.

Adjunctive medications are used to enhance the analgesic effect, reduce side effects and assist with co-existent symptoms. Different patients will respond distinctively to different treatments regarding efficacy and side effects. Trial and error are often used in the treatment of chronic pain.

When starting therapy, the dose should be initiated at a low dose and titrated to obtain pain control and minimize side effects. Tolerance often develops as a patient gets used to the medication.

Treatment is typically started with a short-acting medication, and the medication is then titrated upwards to control pain while side effects are monitored. After determining the dose of the medication required to provide adequate pain relief with minimal side effects, the medication can then be converted to a sustained release form and be administered once or twice a day. When a long-acting medication is used, breakthrough medication can be given.

Periodic review of the patient’s pain and clinical status is important to assure opioids need to be continued or should be discontinued. Any change in the patient’s state of health, degree or nature of pain, mental health, and overall function should be noted. The clinician and patient should review the proper dosage and scheduling of medication. Decisions on benefits of pain management should focus on previously decided upon goals. Positive response to treatment can include a reduction in pain, improvement in the quality of life, or improved function.

An important role of the practitioner is prescribing controlled substances. Controlled substances have inherent risks, so it is important for the prescriber to realize that a primary goal of prescribing opioids should be to maintain patient safety. A responsible prescriber should follow multiple steps to assure safe and effective care of the patient.

Steps a prescriber can take include¹⁶:

1. Assessment and documentation of a comprehensive history including medical history, substance abuse history, current medications including dosages, route and time (including opioids), psychiatric and psychosocial history.
2. Establishing a physical and psychological diagnosis and establish medical necessity before starting or maintaining opioid therapy. Those with mental illness are at higher risk to abuse medications.
3. Screening for substance abuse history because substance abusers are at increased risk to misuse controlled substances.
4. Establishing goals in therapy regarding pain control and functional goals.
5. Using prescription monitoring programs to help determine patterns of prescription use and reducing abuse of medications. These are state-run databases that track controlled substance prescriptions and help find issues with overprescribing and misuse patterns.
6. Urine drug testing can be used to identify noncompliance or aberrant drug use.
7. Consider contraindications prior to prescribing opioids such as acute psychiatric instability, uncontrolled suicide risk, opioid allergy, respiratory instability, history or current abuse of substances or alcohol, current use of benzodiazepines, current use of heavy doses of other central nervous system depressants, current use of other medications that have severe drug interactions or those who practice diversion of controlled substances.
8. Judicious utilization of imaging tests and other evaluations as some testing may increase fear, foster activity restriction, encourage maladaptive behaviors and encourage requests for more opioids.
9. A written agreement between prescriber and patient when opioids are used that reduce the risk of abuse, diversion, misuse and overuse.
10. Discussing the risks and benefits of the medications.
11. Obtaining an informed consent prior to prescribing controlled substances.
12. In general, starting opioid therapy at low doses with short-acting medications.
13. Using long-acting opioids in high doses only for severe, intractable pain that cannot be adequately managed with short-acting opioids or moderate doses of long-acting opioids.
14. Using caution when titrating with long-acting opioids and consider the potential for overdose and misuse.
15. Considering consultation for those who require high-dose opioid therapy.
16. Being the only prescriber of all opioids for a given patient.
17. Monitoring for and managing constipation.
18. Prescribing the lowest effective dose and the smallest quantity needed based on the expected length of the pain.
19. Periodically reviewing the treatment plan, including any new information about the patient, their condition and their pain and progress toward their goals.
20. Keeping accurate records.
21. Being compliant with all laws and regulations related to controlled substances.
22. Individualizing treatment based on the patient’s prior exposure to opioids, response to treatment and adverse events.
23. Monitoring for aberrant drug-related behaviors.
24. Discontinuing chronic opioid therapy in those who repeatedly engage in aberrant drug-related behaviors, do not progress toward established goals, or those who experience significant side effects. Patients who have been taking the opioid for an extended time should have the medication tapered slowly. A 10% taper per week will minimize the symptoms of withdrawal. Some recommend a faster taper such as 20 – 50% per week for those who are not addicted.²⁷

• Have an upper dosing threshold. Risk of accidental overdose increases with higher doses of opioids. Prescribers should generally avoid doses of morphine or morphine equivalents more than 90 - 200 mg/day.²⁸
• Use caution with certain medications. For example, methadone should only be used by a prescriber who is extremely comfortable with the medication. Fentanyl is another medication that requires extreme caution as there is unpredictable absorption – especially with the patch.
• With opioid use, respiratory depression is more likely in the older population and those who are cachectic or debilitated. Patients at high risk should be monitored more closely and opioids should not be given in combination with other respiratory depressants. The dose of opioids should be started at one-third to one-half the typical starting dose in at-risk patients. Titration should be done carefully. Constipation is more likely, and a bowel regime should be prescribed when opioids are used.
• When starting opioid therapy, it should be initially started as a therapeutic trial that may last from several weeks to several months. The decision to continue the therapy must be carefully considered based on the outcomes of the trail such as progress toward meeting goals, side effects, changes in the underlying condition causing pain and any concern for medication misuse and/or addiction.
• The greatest risk of opioid use is respiratory arrest and death, and this risk is greatest when therapy is started, or the dose is increased. Opioid-induced respiratory depression is manifested by the reduced desire to breath and reduced respiratory rates. The patient will be breathing shallow, and CO2 retention can exacerbate the sedating effects of opioids. If this is noted, the family should call 911.
• Opioids should not be used in those with respiratory depression. Titration must be done slowly and when changing formulations do not overestimate the converting dosage.
• Opioid rotation – changing from one opioid regime to another with the goal of reducing adverse events and improving therapeutic outcomes - may be considered. Tolerance to one opioid can lessen the analgesic effects, and the use of a different opioid may result in an improved analgesic effect and less adverse effects.
• When opioid rotation is done, it requires the prescriber to determine the approximate equianalgesic dose. This is the ratio used to get about the equivalent analgesic effect. When switching from one opioid to another, the dose should be reduced by 25 – 50% to prevent adverse effects. Multiple computer programs or applications for mobile devices are available to help with this conversion.
• Avoid combinations of opioids and benzodiazepines. When these two classes are combined, particularly if more than 100 mg of morphine or morphine equivalents per day is used, the risk of accidental overdose is high.
• Pay attention to drug-to-drug and drug-to-disease interactions.

Drug abuse occurs when drugs are not used medically or socially appropriately. Controlled substances may lead to dependence, either physical or psychological. Physical dependence transpires when there are withdrawal symptoms such as anxiety, tachycardia, hypertension, diaphoresis, a volatile mood, or dysphoria after the rapid discontinuation of the substance. Psychological dependence is the perceived need for the substance. It makes the individual feel as though they cannot function if they do not have the substance. Psychological dependence often kicks in after physical dependence wears off. Psychological dependence typically lasts much longer than physical dependence and often is a strong contributing factor to relapse.

Addiction is psychological dependence along with extreme behavior patterns associated with drug usage. At this point, there is typically a loss of control regarding drug use. The drug is continued despite serious medical and/or social consequences. Tolerance, defined as the need to increase the doses of the medication in order to produce an equivalent effect, is typically seen by the time addiction is present. Physical dependence can occur without addiction. Individuals who take chronic pain medication may be dependent on the medication but not addicted.

Addiction is a primary concern in those taking opioids. When prescribing opioids, it is important to determine who is likely to participate in aberrant drug-related behaviors. At higher risk for aberrant drug-related behaviors are individuals with major depression, psychotropic medication use, younger age, or those with a family or personal history of drug or alcohol misuse.³⁴ Those at high risk for addiction would be better managed in concert with a specialist.²⁹

Aberrant drug-related behaviors may include abuse, misuse, diversion or addiction. Examples of aberrant drug-related behaviors include: requests for early refills, not taking medications as prescribed, failure to keep appointments, healthcare visits in distress, frequent reports of lost medication, using multiple prescribers, positive urine drug test for illicit substances, altering prescriptions, resistance to referrals, resistance to providing prior medical records, resistance to change in therapy, increasing the dose without telling the prescriber, or requests for specific drugs.

Opioids have the potential to provide analgesia and improve function. These benefits must be weighed against the potential risks, including misuse, addiction, physical dependence, tolerance, overdose, abuse by others, and drug-to-drug and drug-to-disease interactions.

• In 2016, 48.5 million individuals in the United States misused prescription drugs or used illicit drugs. Sixty-six percent of the 630,000 drug overdose deaths were due to illicit or prescription opioids. The number of opioid overdoses to the emergency department increased by 30 percent from July 2016 to September 2017.³⁵
• Opioid misuse affects 34.2 million Americans over the age of 12.³⁶ According to the Center for Disease Control and Prevention (CDC), 46 people die each day in the United States from an overdose of prescription painkillers.
• In 2012, healthcare providers wrote 259 million prescriptions for painkillers.³⁷ Two times as many painkiller prescriptions are written in the United States as in Canada.
• Overdoses from synthetic opioids increased from 3.1 per 100,000 people in 2015 to 6.2 people per 100,000 people in 2016.³⁸
• Between the years of 1999 and 2015, drug overdose deaths have tripled.³⁹
• Of U.S. veterans treated in primary care settings, 4.8% reported opioid analgesic misuse.⁴⁰
• 12.2% of 12th graders reported ever abusing opioid, and 7.9% reported past-year use.⁴¹
• Of those who were prescribed opioids, dependence may be as high as 26%.³⁴
• The number of individuals who sought treatment for non-heroin opioid substance abuse increased from 1.0% in 1995 to 8.7% in 2010.⁴²
• Research shows that white individuals account for 88% of those who reported non-heroin opioid substance abuse, and the majority of these individuals lived in rural settings.⁴²
• Of overdose deaths from opioid analgesia, 30% also involved benzodiazepines.⁴³

Opioid dependence costs the United States health care system one billion dollars annually.⁴⁴ In addition, opioid dependence leads to decreased work productivity, increased legal costs and lasting psychological effects experienced by the victims of the crimes caused by opioid abuse. In addition, opioid misuse may lead to other diseases such as HIV, hepatitis and sexually transmitted diseases.

John is a 38-year-old male with chronic back pain due to three herniated discs and spinal stenosis, which was first diagnosed after a motor vehicle accident three years ago. He currently rates the severity of his back pain as a 9/10 and has been unable to work as a plumber due to his pain. The pain is described as dull and constant with occasional sharp exacerbation in the low back with the pain increasing with bending, prolonged standing and walking. The patient denies any loss or change of bowel/bladder control, history of IV drug use, recent infection, progressive neurological complaints, night pain, night sweats, weight loss or fever. The pain occasionally radiates into the right buttock. The patient can do all his ADLs but does report poor sleep at night.

He has a past medical history of hypertension and recently has developed stage II chronic kidney disease thought to be secondary to hypertension and excessive use of ibuprofen. His only current medication is lisinopril to control his blood pressure.

He has had multiple treatment modalities including four rounds of physical therapy, chiropractic treatment and numerous medications. He tried to control his back pain on acetaminophen, naproxen, ibuprofen, the lidocaine patch and topical NSAIDs without relieve. The patient experienced significant tremor and an increase in blood pressure while on tramadol. A series of epidural injections did not help. Surgery was discussed, but the patient refused this option.

John is married and has one daughter. He has limited financial means and lives paycheck to paycheck. He has a prior history of alcohol abuse but has not had a drink in five years. He is currently a smoker. He denies any history of substance abuse and there is no family history of alcohol or substance abuse.

Physical exam showed a patient with a slow, deliberate gait, a limited range of motion in the spine with no obvious deformity, swelling or erythema. There is mild tenderness on the right side of the spine from the area of L4 to S1 as well as tenderness in the right sacroiliac joint. Normal reflexes, normal sensation, normal strength and no atrophy is noted in the lower extremities. The straight leg raise test is normal.

An MRI was done one year ago that found a herniated disc at the L5/S1 level and mild spinal stenosis.

The Opioid Risk Tool was administered, and it was determined that the patient is at moderate risk for opioid abuse. The prescription drug monitoring database was queried and showed that he had not had a controlled substance prescribed in the last two years. He signs a written opioid treatment agreement that outlines the conditions of opioid therapy. His past medical records were verified, suggesting he is not lying.

The patient is prescribed hydrocodone/acetaminophen 5 mg/500 mg, two tablets every six hours as needed (56 tablets) for 1 week.

Five days later, he calls for an early refill and reports that the medication is not helping his pain, and he just lies around all day.

He comes back into the office for a re-evaluation. He reports he needed to take more pain medication than prescribed. His wife confirms that he has been lying around all day, and she believes it is because he is having so much pain. It was reviewed with the patient that he violated the opioid agreement. A urine sample was obtained that showed no illicit substances or medications that would not be expected in the urine.

While the patient is at a moderate risk to abuse medication, his past medical history was all confirmed. He was referred to a psychiatrist and a pain specialist. He was agreeable to both. He was able to get into the psychiatrist within one week, but the pain specialist appointment was three weeks out. The patient saw the psychiatrist, and he diagnosed the patient with depression and started him on a sertraline. The psychiatrist was unable to make an assessment related to opioid abuse.

With the help of the pain specialist, oxymorphone ER 5 mg was ordered every 12 hours. The patient was told to follow up in one week to assess effectiveness. After one week, the patient reports he is more functional but still in a lot of pain. The dose of oxymorphone ER was increased to 10 mg every 12 hours. After one more week, he was given oxymorphone IR 5 mg to be used one hour before exercise. This allowed the patient not only to function well but begin participating in an exercise program. The patient was ordered a bowel stimulant (Senna) with a stool softener (Colace) to prevent constipation.

The patient is prescribed fourteen pills oxymorphone ER 10 mg (to be taken twice a day) and seven pills of oxymorphone IR 5 mg (to be taken once a day before exercise) once a week. Part of the agreement was that they are to be given by the patient’s wife to reduce the risk of misuse.

The patient is given a treatment plan that includes:

• A list of goals:
  • Improved pain and increased function
  • Improved anxiety and depression
  • Eventual cessation of opioid therapy
  • Regular exercise program
• Physical therapy
• The addition of mirtazapine to his citalopram

The patient returns to his primary care provider after two weeks and reports that he has started therapy, is sleeping better and is only using one hydrocodone/acetaminophen a day – typically after exercise. After four more weeks, he reports that he is using about 3 - 4 doses of hydrocodone/acetaminophen per week, feels less anxious and depressed and is sleeping “just fine.” After another four weeks, he says he no longer uses his opioid medication, has gotten a part-time job and is regularly exercising.

The best situation is the client who approaches their care provider with concerns about a substance they are taking and the negative consequences they are experiencing.

Yes, this happens!

Substance misuse scenarios are not confined to what is portrayed on TV dramas. Frequently people find themselves in uncomfortable situations regarding prescription pain medications, social drinking, recreational substances, and so on. Often, they voice concerns to health care providers that they have never voiced to anyone else, even their families, about adverse circumstances they are facing or unusual cravings that concern them.

Families and friends may also be the ones to bring a substance use concern up to the affected individual or to a trusted health care provider. The perceptions and concerns voiced by someone who knows the individual well should always be considered for follow up.

Both acute symptoms and chronic health consequences of substance use may bring the matter to the awareness of the health care system. Presenting symptoms can vary greatly depending on the individual and the substance involved, although some key diagnostic criteria are shared by each of the substance use disorders.

All patients should be evaluated for substance use disorders. Studies demonstrate that eight of every 100 adults in the United States will have had at least one substance use disorder within the prior 12 months.³⁶ Health professionals are obligated to view all new clients as having the potential for a substance use disorder.

Locating clues, signs and symptoms of a substance use disorder, depends on a combination of good screening, history taking, physical findings, psychiatric findings, and laboratory testing.

Opioids are old friends to the health care professional. So much relief from pain and suffering can be attributed to the proper use of the opioid family that it saddens us there is a flipside of misuse and abuse that also occurs.

The term opioid use disorder (OUD) is the new diagnostic standard. It combines opioid dependence and opioid abuse, also pulling in the wide range of related opioid prescriptions and illicit chemicals. Though it may seem generic, opioid use disorder guidelines by the American Psychiatric Association express the expectation that the specific agent will be added to the diagnosis once identified – e.g., Opioid Use Disorder; Heroin, or, Opioid Use Disorder; Oxycontin, LAAM (Leo alpha acetylmethadol), or others.

Please remember substance use and abuse basics. Not everyone taking a particular medication or street substance is an addict. With opioids especially, the current trend in health care is to label anyone on prescription analgesics either an addict or an addict in the making. Opioids are an acceptable means of managing pain, both for short periods and long. It is an expectation that an individual utilizing them for legitimate reasons will, over time, begin to develop a physical tolerance for the medication, and upon abrupt discontinuation, experience withdrawal-type symptoms as their metabolism adjusts to the absence of the opioid. Neither tolerance nor withdrawal makes an addict. The DSM-5 emphasizes that the use of a substance does not make a person an addict.

The motivation for use has an important role for opioids. During an assessment, ask your client whether they gain benefit from their opioid beyond the relief of pain, feelings of well-being, euphoria, a feeling of relaxation, or a rise in mood beyond what may be attributed to pain relief. Frequently those who utilize opioids for the purpose of mood elevation or dissociation with current troubles will tell you outright if asked. Client survey tools such as the Current Opioid Misuse Measure (COMM) or Screener and Opioid Assessment for Patients with Pain (SOAPP) are available for use when client motivation for opioid use is uncertain.

Opioid Use Disorder focuses on the detrimental consequences of repeated opioid use along with an observable pattern of compulsion or cravings to use. OUD is only diagnosed when opioid use becomes persistent and causes significant educational, occupational or social impairment. Commonly abused opioids include heroin, codeine, fentanyl, morphine, opium, methadone, oxycodone, and hydrocodone.

Individuals with opioid use disorder may show no acute symptoms that would trigger an inquiry into that person’s health history. Opioid users may also appear intoxicated or show signs of substance withdrawal. Opioid intoxication may appear as slurred speech, the appearance of being sedated, and the presence of pinpoint pupils. Those who have developed a tolerance may show few acute signs of opioid intoxication. Ongoing use of opioids tends to lead to a look of general poor health and debilitation, though mild or moderate ongoing users may not have progressed to an appearance of reduced health.

Opioids may be ingested in many ways:

• Orally – either in solution or as tablets or powders
• Intranasal – “sniffing” or “snorting”
• Subcutaneous injection – “skin-popping”
• Intramuscular – “muscling”
• Intravenous – “mainlining” or “shooting up”
• Smoked – smoking opioids is the fastest way to the brain and is generally a mix of opioid with cannabis or tobacco

Opioids purchased illegally run the risk of contamination by improper handling or purposeful “cutting” or dilution of the substance by other compounds. Injection users run a high risk of infection, both localized and systemic. HIV, hepatitis B, and hepatitis C are all associated with opioid and other injectable substance use. Hepatitis C infection is also associated with intranasal inhalation of opioids and other substances, particularly in group settings where users pass around a shared beverage straw for snorting.⁴⁷

Physical examination for suspected opioid intoxication or opioid poisoning should include a search for the classic signs of opioid overdose:

• Depressed mental status
• Decreased respiratory rate
• Decreased lung tidal volume
• Decreased bowel sounds
• Decreased (miotic – constricted) pupils

Drowsiness tends to follow the euphoria sought after by users of opioids, and the sedation effect may progress to a coma for some. Inattention resulting from perceptual changes and ability to concentrate may progress to ignoring potentially harmful events. In rare instances, intoxication may cause hallucinations with intact reality testing or auditory, visual or tactile illusions occurring in the absence of delirium.

For suspected acute opioid intoxication, laboratory studies should be included in the workup:

• Immediate blood glucose for hypoglycemia, a condition often mistaken for opioid intoxication.
• Serum acetaminophen concentration due to marketing prescription opioids in combination with acetaminophen leading to a heightened risk of acetaminophen hepatotoxicity.
• Serum creatine phosphokinase and electrolytes to exclude rhabdomyolysis (muscle breakdown) secondary to prolonged immobility, always a concern due to the intense sedative effects of opioids.
• Urine toxicology screens for opioids.

Some, but not all, individuals with opioid use disorder show positive for opioid drugs for 12-36 hours on routine urine toxicology tests. Opioids not detected by routine urine toxicology and must be specifically tested for are:

• Methadone, buprenorphine, and LAAM (which can be detected for several days to more than a week).
• Fentanyl (which can be detected for several days).

Please be aware 80 - 90% of injection opioid users screen positive for hepatitis A, B or C. HIV is prevalent especially amongst injection Heroin users.⁴⁷

Opioid intoxication diagnosis focuses on the presence of significant negative impact, psychological and behavioral changes accompanying or following substance use. The presence of alcohol or sedatives in the person’s system can muddy diagnosis, and therefore, a naloxone challenge may be administered. Naloxone is a short-acting opioid antagonist that temporarily counters the respiratory depressant and to a small degree, the sedative effects of opioids. Use of naloxone may put an opioid user suddenly into physical withdrawal, so caution should be used when administering.⁴⁸

Opioid withdrawal can be a brutal affair, and contrary to conventional shared wisdom amongst health providers, opioid withdrawal can indeed be life-threatening. Withdrawal symptoms may begin immediately after the administration of an opioid antagonist (e.g., naloxone or naltrexone) or a partial opioid antagonist (e.g., buprenorphine). Stopping opioids after a prolonged period of use results in withdrawal symptoms around 6 hours after the last dose of a short-acting opioid, and up to 48 hours after stopping the longest acting opioid, methadone. The peak of withdrawal tends to be with 24-48 hours yet persists several days for the short-acting agents and up to 2 weeks for methadone, with sleep and mood disturbances often persisting for months. Many who have undergone opioid withdrawal compare it with the “worst case of flu imaginable” and with some justification as symptoms of withdrawal parallel those of food poisoning or the gastrointestinal effects of influenza. Muscle and abdominal cramping, nausea, diarrhea, runny nose, tearing eyes, dizziness and restlessness to name a few of the more common opioid withdrawal symptoms.

Opioid withdrawal is known to cause brief, but severe, episodes of depression that can lead to suicide attempts and completed suicide. Accidental opioid overdose, particularly among those desperate to avoid withdrawal, is common and should not be mistaken for a suicide attempt.

The health care industry should shoulder some of the burden of the opioid epidemic. The 1990s were a time when pharmaceutical companies aggressively marketed pain medications. Healthcare providers, encouraged by the Joint Commission, were encouraged to assess pain and manage it appropriately. The combination of intense assessment and pharmaceutical companies marketing pain medication were partially responsible for the increased use of opioid pain medications. In addition, support was given to multiple medical organizations, including the American Pain Society, the Federation of State Medical Boards and the American Academy of Pain Medicine that lobbied for aggressive identification and management of pain.⁴⁹

Research from 2015 showed that six times more opioids were dispensed in counties with high prescribing rates versus counties with low prescribing rates. Certain characteristics make prescribing controlled substances more likely. The CDC reported risk factors for counties at higher risk for prescribing more controlled substance include: a higher percentage of white people, more patients with diabetes, arthritis, or disability, when a higher percentage of people were unemployed or uninsured, counties with more dentists or primary care physicians, and counties with small cities or large towns.⁵⁰

In 2018, the Joint Commission changed their standards in the management and assessment of pain.⁵¹ Some of their modifications included:

• Identify patients at high risk to misuse opioids
• Encouraged the use of nonpharmacological pain management techniques
• Identify a leadership team to help manage pain
• Focus on function
• Educate patients about misuse and proper medication disposal and storage
• Set realistic goals with the help of the patient
• Use the prescription drug monitoring program
• Refer addicted patients to treatment programs
• Engage in improvement activities regarding pain management

There are many known risk factors for opioid abuse, misuse, diversion, addiction, and overdoses.⁵² Evaluating these risk factors are an important aspect in the evaluation of a patient. Factors that increase the risk of problematic opioid use include:

• A prior history of misuse or abuse
• Younger age
• Untreated psychiatric disorder
• Living in a social and/or family environment that encourages misuse
• Genetics
• Physical, sexual or emotional abuse
• Using nicotine, alcohol or other drugs at an early age
• Substance use/abuse in the family or among friends
• Stress
• Access to addictive substances
• Highly impulsive personality
• Family or personal history of drug/alcohol abuse and mental health issues including depression, anxiety, eating disorders, or personality disorders
• History of legal trouble/incarceration
• White race

Removing prescription medications from legitimate channels is drug diversion and can occur in many ways.

• Slightly more than 40 percent of patients who abuse prescription pain medication got it from a relative or friend without having to pay for the drugs.⁵³
• 36.4 percent of abusers of prescription medications got them through their health care provider either by prescription or by stealing.⁵³
• Ten percent stole drugs from a relative or friend.⁵³
• Some patients get drugs through doctor shopping, but the majority of patients receive their drugs through one doctor.⁵³
• Fraudulent prescriptions are another method of obtaining prescription drugs. This can occur in many ways. Methods include: altering an already written prescription, stealing a prescription pad, or creating falsified computer prescriptions.

Health care professionals are also known to divert, misuse or abuse drugs. Health care providers who are abusing drugs may be irritable, defensive or isolated. Other signs or symptoms suggestive of prescription drug abuse or misuse problem include frequent bathroom trips, coming into the office when not scheduled, working overtime, multiple medication errors, incorrect counts of controlled substances, poor judgment, neglect of patients, long sleeves in warm weather, and strange behavior.

In preventing prescription drug abuse, the prescriber needs to assure:

• Patients are assessed and reassessed
• Treatment agreements are used
• Prescription monitoring occurs
• Safe prescription methods are practiced
• Informed consent is used

Patient risks should be assessed, and contraindications should be immediately identified. Contraindications to opioid treatment include those who have erratic follow up, suffer from current untreated addiction or have poorly controlled mental illness.¹⁵

Informed consent provides written documentation regarding the benefits and risks of the therapy and discusses legal responsibilities of both the patient and prescriber. Informed consent improves adherence, improves the effectiveness of a treatment plan, reduces the risk of inadvertent drug misuse, lays out the potential adverse effects including side effects and addiction, discusses how refills will happen as well as the policy of early refills and lost prescriptions/medications and discusses reasons for discontinuing therapy.

When taking a patient history document the opioid currently prescribed, its dose, the frequency of use and the duration of use. It is important to query the state prescription drug monitoring program (PDMP) to confirm the patient’s report of prescription use. In addition, it is important to contact past providers to obtain medical records.

Before controlled substances are prescribed a history of illegal substance use, alcohol use, tobacco use, prescription drug use, family history of substance abuse and psychiatric disorders, history of sexual abuse, legal trouble history, behavioral problems, employment history, marital history, social network and cultural background should be assessed. History of substance abuse does not prohibit treatment with opioids but may necessitate more intensive monitoring or referral to an addiction specialist.

Multiple tools to evaluate for opioid risk are available. The Opioid Risk Tool is a tool that is used in primary care to screen adults for the risk of aberrant behaviors when they are prescribed opioids for chronic pain. It is a copyrighted tool, encompasses five questions and takes about one minute to administer. It classifies a patient as low, moderate or high risk for opioid abuse. Those who are at high risk have a higher likelihood for aberrant drug-related behavior. This tool is not validated in individuals without pain. The five questions include asking about family and personal history of substance abuse (alcohol, prescription drugs or illegal drugs), age (risk is 16 - 45 years old), psychological disease and a history of preadolescence sexual abuse. The questions are scored with different points assigned for each question, which is variable between men and women, and a total score is tallied. The patient is placed at low, moderate or high risk.

Educating clinicians has been a primary focus of the medical community over the last number of years. This has led to increased awareness and safer prescribing of controlled substances. Practice guidelines disseminated among the emergency providers in Ohio was linked to a 12% reduction in opioid prescriptions per month.⁵⁴ This guideline included multiple positive steps including assuring the clinician reviewed the prescription drug monitoring database, the patient was referred for further evaluation, reduced quantities of medication was prescribed, and education was provided about the risks versus benefits of the opioid.

Regular follow-up is important and should occur at a minimum of every 3 months and more frequently in individuals who are at high risk for abuse or during periods of medication adjustment.²⁵ Baseline evaluation of the nature and intensity of the pain and the underlying effects pain is having on a patients physical and psychological function will help in assessing the effectiveness of the treatment.

When assessing the patient experiencing pain, the six A’s should be assessed: analgesia, addiction, activities of daily living, adherence, aberrant behaviors and adverse effects. Part of follow-up should be urine drug testing, which can be used to detect medication adherence, as well as, illicit and non-prescription drug use. The prescriber should adequately document any and all interactions with patients, assessments, results of testing and treatment plans.

Documentation should include the amount of pain relief experienced, as indicated by the patient’s improved ability to function physically or psychologically. It should include what goals are recommended (e.g., improved level of function and improved quality of life). It should also include the plan of care and methods to help patients meet their goals.

Treatment should not be continued if the patient is not making adequate progress toward their goals. In this case, modification of treatment should be considered.

Written treatment agreements, between prescribers and patients when controlled substances are used, help guide the conversation between patient and prescriber. It discusses expectations, the risks and the monitoring that will occur to limit the complications of controlled substances (Table 1).

Prescription monitoring programs are available in 49 states. They provide an online database which lists all prescriptions of controlled substances dispensed for each patient by pharmacies. The prescriber should check the database before prescribing controlled substances; if a patient has an undisclosed prescription for controlled substances, it can be considered prescription drug misuse.

Important points in the New York Rules and Regulations of Controlled Substances (which can be found here) include:

• It is generally unlawful to distribute free samples of controlled substances
• Personal use of controlled substances by prescribers is prohibited
• Prior to prescribing a controlled substance (Schedule II-IV), the practitioner should consult the prescription monitoring program registry and document the consultation. If the registry is not consulted, it must be documented as to why. Some exceptions include: prescribing in the emergency department of a general hospital when a no more than a five-day supply is prescribed, hospice care, when it is not reasonably possible to access the registry in a timely manner (technology failure)
• Follow up examinations should occur, using accepted medical standards, prior to prescribing more controlled substances
• No prescriptions can be written for Schedule I substances
• Controlled substances generally can only be written for a 30-day supply and cannot be rewritten unless the user has less than a seven-day supply based on the previous prescription. There are some exceptions. A three month supply of a controlled substance may be written if it is written for panic disorder, attention deficit disorder, narcolepsy, chronic debilitating neurological conditions, some gynecological conditions, hormone deficiency in men, metastatic breast cancer in women, and relief of pain in those with a disease/condition that is incurable or chronic.
• Practitioners can dispense 30 days or less of a controlled substance and may not dispense again until the user has exhausted all but seven-day supply. Specific rules apply to this (see the link above)

Patient education is crucial as it will reduce the risks associated with these medications and result in improved pain management. Patients need education in the safe use, storage and disposal of opioid medications. Safe use of opioids requires the patient to know about adverse events, as well as risks of abuse, misuse and addiction.

An overdose occurs when someone takes a higher dose then the body can tolerate leading to a significant adverse effect. Respiratory depression is the primary risk. This risk is highest in those who are not tolerant to opioids, take other respiratory depressants, have multiple health conditions or have debilitated health and/or an impaired respiratory function.

Medications associated with a high risk of respiratory depression are Schedule II opioids. Fentanyl, a synthetic opioid pain reliever, is 50 to 100 times more potent than morphine and has been implicated in many cases of overdose death. Medications that are altered for administration also increase the risk of overdose. Snorting, injecting, inhaling, chewing, or dissolving medications that should be swallowed whole (particularly extended-release opioids) increases the risk. Other methods that may lead to overdose include rapid titration of opioids and overestimation of the dose when converting from one opioid to another. Overdoses also occur when the medication is taken by someone it was not prescribed for, especially children. Therefore, safe storage and disposal are critical.

Information on abuse should be taught to the patient. Many patients, who end up abusing opioid medications, usually got a valid initial prescription. Most patients who abuse medications get them - either by buying or stealing - from an acquaintance (most typically a friend or relative).⁵⁵

Patients should also be taught about misuse. Many patients will misuse medications because they are seeking to improve function, have uncontrolled pain or are using them to manage stress or mental disease. Aberrant behavior may be seen in those who are undertreated for pain. In the absence of addiction, these behaviors cease when pain is adequately controlled.

Patients should also be taught that drug diversion will not be tolerated. It will result in immediate termination of the prescription with referral to a substance abuse program and possible legal action.

Patients should be taught about addiction. Addiction is a chronic disease with psychological, social, genetic, and environmental factors influencing its presentation and development. Addiction presents with a drug craving, compulsive use, impaired control, and persistent use despite harm.

Drug Take-Back Programs provide a convenient way for patients to dispose of unneeded, expired, or unused controlled substances. If no program is available, the patient must use extreme caution when disposing of controlled substances. Improper disposal may lead to environmental complications or drug diversion. Controlled substances can be mixed with cat litter or coffee grounds then sealed in a non-leaking container.

Key points in patient education include:

• Goals of treatment.
• Alternative treatment options.
• Patients should be encouraged to read their medication guide and/or package insert every time they get a new prescription.
• Teach about abuse, addiction, misuse and diversion.
• Risks of overdose and/or death if dose not taken exactly as prescribed or someone else takes the medication.
• Pain medications may impair breathing.
• Do not give the medication to anyone else.
• If anyone else takes the mediation, emergency services should be contacted.
• Swallow pills whole that are meant to be swallowed – do not crush, snort, chew, inhale or take by any other means other than the method prescribed.
• Maintain contact with the prescriber for monitoring and titration.
• Teach about drug-to-drug interactions. Medications that should be avoided in combination with opioids include alcohol or any medication that has not been prescribed. Medications that should only be taken after a careful review and counseling by a prescriber include sedatives, hypnotics, anxiolytics, antidepressants and antihistamines.
• Opioids may lead to cognitive impairment and may affect driving ability or safety at work, especially if operating heavy equipment.
• Opioids should be stored safely and away from family members, acquaintances, and friends.
• Medications should be locked up in a drawer, cabinet or safe – so no one else will get them.
• Educate patients that it is illegal and dangerous to give away or sell their medications to others.
• Patients should keep track of the number of pills, capsules, etc. - so it can be determined if any are missing.
• Do not store them in a pill reminder container.
• Teach about common side effects: sedation, drowsiness, respiratory problems, dizziness, mental status changes, nausea, vomiting, constipation, anxiety, tremors and diaphoresis.
• Monitoring will take place in the form of pill counts, urine drug screens, and the use of the prescription drug monitoring program. Unfavorable results may lead to termination of treatment or alteration in the treatment plan.

Discontinuation of opioid therapy may be considered if problematic patterns are noticed, opioid therapy is not effective, or goals are not being achieved. It is important that the prescriber and patient have agreed upon reasons to terminate therapy before initially prescribing the medications. This should be part of the initial agreement.

The clinician should have a method for addressing prescription drug misuse. Minor infractions may result in patient counseling and intensifying monitoring activities. More severe behaviors may require the clinician to discontinue prescribing controlled substances. If patients are found to be diverting prescription medication, immediate cessation of the prescriptions is appropriate. In most other cases, it is appropriate to taper the controlled substances to reduce the risk of inducing a withdrawal syndrome.

When stopping the medication, it is important that the patient and prescriber agree. For patients who decide to continue treatment with another prescriber, the prescriber may consider maintaining the current dose for 4 weeks.

When appropriate, a tapering schedule should be implemented to avoid withdrawal. A reduction of 10% every 7 to 14 days until the patient gets to a lower dose at which time a 5% reduction every 2-4 weeks may be done.

Individuals who have shown aberrant behavior should be offered other non-opioid options. For patients who have engaged in criminal activity (such as diverting drugs or altering prescriptions), should be referred to a substance abuse treatment program and discharged from the practice.

Drug diversion is the use of legal drugs for illegal purposes or the use of prescription drugs for recreational purposes and is a key concern in the use of controlled substances.

Drugs can be diverted through multiple methods. Diversion may occur on any level from the patient, prescriber, other healthcare providers or pharmacist.

Methods that patients use to obtain medication for illicit use include: influencing or forcing prescribers to write the prescription, changing the prescription, getting multiple prescriptions for the same drug, or writing their own prescription.

Healthcare professionals may also be the source of diversion. The prescriber can be engaged in drug trafficking or selling medications for money or sexual favors. The prescriber may also steal the drugs, make poor decisions or may not recognize diversion.

The pharmacist may be the source of diversion. The pharmacist may dispense medications based on incomplete information on the prescription, not catch obvious fraudulent attempts by the patient or not check the accuracy of the physician’s DEA number.

Other methods of diversion include theft, losses during transportation or internet pharmacies.

Methods to obtain drugs illegally include:

• Burglary/robbery
• Stealing prescription pads and writing prescriptions
• Faking injuries
• Doctor shopping
• Prescription forgery – photocopying, changing numbers on the prescription
• Fraudulently phoned in prescriptions

Techniques to reduce drug diversion are:

• Write in ink
• Writing out numbers make it difficult to modify numbers on prescriptions
• Use electronic prescribing
• Clearly mark the number of refills – mark through the unused portions
• Lock up the prescription pad

It is very difficult dealing with the patient who has a chief complaint of severe pain and wants opioid therapy. It is important to understand the motivations of patients who seek drugs. Do the patients have pain or are they looking for controlled substances for nonmedical purposes?

Prescribers often want to trust their patients, or they do not want to confront the patient about his/her medication habits. Prescribers want their patients to be happy. In addition, time is often a factor, and taking time to assess the patient, including their physical, psychological and social state takes much more time than just writing a prescription.

Good communication is important to help deal with patients who are drug-seeking. Prescribers must be empathetic and acknowledge that the patient is suffering. Providers must maintain confidentiality and privacy to assure that the patient is comfortable.

Communication with the patient is successful with providers confidently present information, question patients using open-ended questions to promote honesty, and document well, including the patient’s assessment and any agreements.

Having firm office policies is important in the management of patients being prescribed opioids. Generally, prescribing opioids at the first visit should be avoided. The policies should include the frequency and timing of refills. It should be documented that patients are aware of these policies.

The use of a pain management contract should be utilized. Providing the patient with an understanding of how long the medication will be prescribed should be done. This is particularly true for an acute injury or a surgical procedure where pain typically gets better.

Prescribers must be aware of behaviors that are problematic. Behaviors highly suggestive of a substance abuse disorder include legal problems, using medications not as prescribed, getting medications through nonmedical channels, reduced function at work or home and concurrent abuse of other drugs or alcohol. Behaviors that may suggest addiction include: requesting specific medications, increased dosage need, missed appointments and requesting more medications.

Hospice is essentially a philosophy and practice of healthcare that focuses on symptom management, optimization of the quality of life for patients and loved ones, and a supported transition towards the end of a patient’s life.⁵⁸ The goal of hospice care is to provide an improved quality of life rather than prolong life or cure an illness.

The hospice philosophy understands that a dying patient not only suffers from their terminal illness, but also from impairments their prognosis has upon their physical, psychological, spiritual, and social status. These multifaceted impairments experienced by most terminally ill patients have been termed the patient’s “total pain.”⁵⁹ As such, the hospice practice is one involving an interdisciplinary team that aims to address the patient physical, psychological, spiritual, and social needs.

Hospice care is most often provided in the patient’s home but can also be provided in a dedicated facility. According to the National Hospice and Palliative Care Organization (NHPCO) 2015 Facts and Figures on hospice, hospice patients received care in the following distribution: private home (35.7%), nursing home (14.5%), residential living facility (8.7%), hospice inpatient facilities (32%), and acute care hospitals (9.3%).⁶⁰

Palliative medicine provides a framework for pain and symptom management in all patients who are seriously ill, and it can be very seamlessly merged with curative therapies such as organ transplantation. Hospice, on the other hand, shares the same philosophy with palliative care to alleviate suffering in the life of a seriously ill patient. It also places the utmost importance to patient-centered care and encourages shared decision making to provide care to patients that are in keeping with the patient’s goals and values. In the United States, the financial reimbursement system dictates that patients on hospice must have an anticipated lifespan of 6 months or less. This is largely defined by the Medicare Hospice Benefit. Consequently, hospice services have very strict admission criteria; a physician would certify that the patient has 6 months or less to live if the disease follows the natural course. Additionally, in hospice, unlike palliative care, the treatment goal is directed more towards comfort rather than cure. It is important to recognize that the Medicare Hospice Benefit does not mandate or require patients to forgo the desire to pursue heroic life-prolonging measures, including experimental research interventions or even a desire for future hospitalizations. If a patient lives beyond the estimated 6 months, the hospice benefits can be renewed through Medicare using their recertification process.

The second difference between Hospice and palliative care focuses on where the care is provided. Hospice care is mostly provided in a patient’s home in the United States. Occasionally, it is provided in residential facilities or in long term facilities. Palliative care, on the other hand, is a medical subspecialty, and like other subspecialties such as pulmonology and oncology, there are strict guidelines for reimbursement, including where the care is provided. In general, most palliative care services occur in an inpatient setting. In summary, hospice care incorporates palliative care but not all palliative care is hospice care. In other words, hospice care is a subset of palliative care.

The palliative care and hospice teams are made up of a multidisciplinary group which consists of physicians, physician assistants, nurse practitioners, registered nurses, certified nurse’s assistants, home health aides, social workers, chaplains, bereavement counselors and sometimes community volunteers. Although the palliative care team works closely with the primary medical team, it does not replace the primary care team. The focus of the palliative care team is to relieve and prevent suffering in order to optimize the quality of life for both patients and their families. The multidisciplinary team has this goal as a target irrespective of the patient’s overall prognosis be it days, weeks, months or years.

Hospice/Palliative Care physician:

This physician has medical and administrative roles. In the ideal setting, the hospice physician is board-certified in Hospice and Palliative Medicine. Many hospice physicians provide care in the patient’s home and can act as a liaison between the patient and other physician providers (such as the patient’s primary care physician) in assisting with the patient’s symptom management. Occasionally the board-certified Hospice or Palliative Care physician will have mid-level clinical providers such as Advanced Registered Nurse Practitioners as well as Physician Assistants working under their supervision.

Primary Care physician or referring provider (Nurse Practitioner or Physician’s Assistant):

It is not typical for the referring or primary care doctor to remain consistently involved in a patient’s end of life care. However, they may become involved with monitoring symptoms, ordering skilled nursing care, or medications.

Registered Nurse:

The registered nurse is typically the primary case manager and coordinates the interdisciplinary team in addition to also providing skilled nursing care. In the ideal setting, hospice nurses are ideally certified in hospice and palliative care and visit patients regularly based on the patient’s needs. Occasionally, hospice or palliative care teams may opt to use Licensed Vocational Nurses (LVN) to provide intermediate level nursing care for patients under the delegation of a Registered Nurse.

Social Worker:

The social worker assures the patient’s psychosocial needs are being adequately met. They address housing, nutrition, transportation, and family caregiver support needs. They also arrange for counseling, bereavement support, burial/funeral planning, and/or referrals to other support systems.

Chaplain:

The chaplain addresses the patient’s and family’s spiritual needs in both structured and unstructured religious formats.

Home health aides or Nurse’s aides:

Home health aides provide direct assistance with activities of daily living, food preparation, and shopping in the patient’s home.

Bereavement counselors:

Bereavement counselors provide counseling to the patient, and to the patient’s loved ones for up to 13 months after the patient’s death.

Community volunteers:

Volunteers provide any extra support, such as companionship, visiting, and assisting with errands.

Palliative care primarily focuses on non-contagious causes of death, as noncontagious diseases represent a significant majority of worldwide deaths, according to the World Health Organization.⁶² Most adult patients needing palliative care suffer from progressive, non-cancerous diseases, followed by patients that suffer from cancerous diseases. However, an exception is made for Africa, where the vast majority of patients needing palliative care suffer terminal illness related to HIV/AIDS.⁶¹

The WHO estimates that 78% of adults and 98% of children requiring palliative care live in low to middle income countries, however, palliative care availability and utilization are highest among adults who are in higher-income countries.⁶²

Studies have been performed to evaluate the international availability of palliative care. One study found that 58% of the 230 countries evaluated had one or more palliative care systems available.⁶¹ Other studies indicate that specialty-level palliative care was only available in 30-45% of countries.^62,63 It was also noted in another study that up to 83% of the world’s population live in countries with limited or no access to opioid medications that are critical in addressing end of life pain relief.⁶⁴

The WHO has identified the most common illnesses that require palliative care for adults and children:⁶²

Adults:

Alzheimer and miscellaneous dementias, cancer, cardiovascular diseases, liver cirrhosis, chronic obstructive pulmonary diseases (COPD), diabetes, HIV/AIDS, kidney failure, multiple sclerosis, Parkinson’s disease, rheumatoid arthritis, and drug-resistant tuberculosis (TB).

Children:

Cancer, cardiovascular diseases, liver cirrhosis, congenital anomalies (excluding heart abnormalities), blood and immune disorders, HIV/AIDS, meningitis, kidney diseases, neurological disorders, and neonatal conditions.

Palliative care is a challenging area of medicine for many reasons. Caring for patients near their end of life requires compassionate consideration of the patient’s medical and psychosocial health, as well as understanding the legal and ethical implications in end of life care. In the United States, legalities concerning end-of-life care vary by state, but there are some precedent national legal standards. When addressing legal issues in palliative care, it’s important to understand some standard definitions and terms.

Advance directives:

Advanced directives are legal documents that address the wishes a patient has regarding the management of their healthcare should the patient become incapacitated and unable to communicate. Examples of different types of advanced directives include: a healthcare proxy (or durable power of attorney for healthcare), living will, do not resuscitate orders, and do not intubate orders.

Health care proxy (durable power of attorney for healthcare):

The health care proxy or durable power of attorney for healthcare (DPOA) document indicates a person has selected someone else to make medical decisions on their behalf, should they become unable to communicate. This creates clarity for the healthcare team regarding whom medical decisions should be referred when a patient becomes incapacitated. It should also be noted that a DPOA can be either appointed by the patient or by the court.

Living Will:

A living will is a legal document wherein a patient details what type of medical care/interventions are or are not desired should the patient be unable to communicate. Examples include withholding feeding tubes/artificial nutrition in the event of grave or terminal illness.

Do Not Resuscitate status (DNR):

A do not resuscitate order is an order indicating that a person has decided not to have cardiopulmonary resuscitation (CPR) attempts performed if they cease breathing or their heart ceases to function.

Do Not Intubate status (DNI):

A do not intubate order is indicated when a person has decided not to have efforts towards mechanical ventilation performed if they cease breathing.

Review the order of next of kin:

When a patient is approached with end-of-life issues, it is important to understand that a patient with decision-making capacity has the constitutional right to be free of bodily invasion and as such can refuse medical care, even if it results in their death. Regarding decision-making capacity, the complexity of this topic is out of the scope of this learning module, but it is typically determined by a physician that can assess a patient’s understanding, expression of a choice and its consequences, and reasoning. Once a physician determines a patient is capable of sound understanding and reasoning, the patient is said to have decision-making capacity and can make their own healthcare decisions. If a patient cannot make their own healthcare decisions, and there is no advanced directives to guide treatment, then a surrogate decision-maker must be utilized. A surrogate decision-maker that is not appointed within the advanced directives is typically selected from a family member, and in the following order of next of kin: Spouse, adult child or a majority of the adult children reasonably available, parents of the patient, siblings of the patient, and finally the nearest living relative. It should be noted that this order of next of kin varies by state, but in general, the above mentioned next of kin order is commonly used.

Medical Record Documentation:

An important part of palliative care is making sure a patient and their family receive clear communication in regard to their healthcare, as many end-of-life care treatment decisions are based upon the patient’s understanding of their prognosis, treatment options, and what are the implications of their medical decisions. It is also essential that these communications are well documented, particularly in the event of a patient not having advanced directives in play. Documentation of communication within the medical record should include involved parties, and their relationship to the patient, the patient’s capacity, details of the discussion and any medical decisions that were made. Documented communication, along with other clinical factors, aid in determining the treatment course for a terminally or gravely ill patient should the patient become incapacitated.

If a patient develops a rapid or sudden poor prognosis and is faced with potential end-of-life medical-legal issues, determining the patient’s functional capacity can help clarify if palliative care measures would be deemed to be in patient’s best interest. Functional capacity has become defined and quantified using established performance scales.

ECOG Performance Status and the Karnofsky Performance Status:

• Performance status is a measure of a patient’s functional capacity. Performance status has been found to predict survival, particularly in patients with cancer. Quantitative methods have been developed to stratify performance status, such as the Eastern Cooperative Oncology Group (ECOG) performance status scale and the Karnofsky Performance Status (KPS). As a member of the healthcare team, it is important to become familiar with these scales and their definitions, as a physician might rely on a nurse or nurse aide’s assessment to determine a patient’s functional capacity.

ECOG performance status scale:⁶⁵

• Status 0: Fully active; no performance restrictions.
• Status 1: Strenuous physical activity restricted; fully ambulatory and able to carry out light work.
• Status 2: Capable of all selfcare but unable to carry out any work activities. Up and about >50 percent of waking hours.
• Status 3: Capable of only limited selfcare; confined to bed or chair >50 percent of waking hours.
• Status 4: Completely disabled; cannot carry out any selfcare; totally confined to bed or chair.

Karnofsky Performance Status Scale:⁶⁵

• Reported as a value between 0-100 with incremental values of 10. Each level of functional capacity is defined below along with the corresponding numerical value.
• Value 80 - 100: Able to carry on normal activity and to work; no special care needed
  • 100: Normal, no complaints, no evidence of disease
  • 90: Able to carry on normal activity, minor signs or symptoms of disease
  • 80: Normal activity with effort, some signs or symptoms of disease
• Value 50 – 70: Unable to work; able to live at home and care for most personal needs; various degrees of assistance needed
  • 70: Cares for self, unable to carry on normal activity or to do active work
  • 60: Requires occasional assistance but can care for most needs
  • 50: Requires considerable assistance and frequent medical care
• Value: 40 – 0: Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly.
  • 40: Disabled, requires special care and assistance.
  • 30: Severely disabled, hospitalization is indicated although death is not imminent.
  • 20: Hospitalization is necessary, very sick, active supportive treatment necessary.
  • 10: Moribund, fatal processes progressing rapidly.
  • 0: Dead

As mentioned previously, palliative care address the “total pain” of the patient, which is inclusive of their psychosocial and spiritual needs. There are common symptoms/diagnoses that end-of-life patients face that becomes a pivotal part of palliative care physician’s assessment and treatment plans. These common problem areas include pain management, pressure ulcers/wound care, fatigue, weaknesses, exhaustion, nausea/vomiting, mouth care, nutrition, anxiety/depression, and shortness of breath. In this course, we will review pain management, the management of dyspnea, as well as the nutritional challenges faced by palliative care and hospice patients.

Considering great variations in clinical practice around the country among different palliative care groups and variations in clinical practice by clinicians in the same clinical practice, there is a need for actionable guidelines to help direct clinical practice in palliative care and hospice medicine. As a matter of fact, several organizations have put forth guidelines for this very purpose. These organizations include the Institute for Clinical Systems Improvement (ICSI) and the National Cancer Care Network (NCCN).

The aims of the ICSI guidelines are to increase the early identification of patients who could benefit from palliative care services, improve the referring physician’s comfort with discussing palliative care services with the patients and their families, increase the percent of patients with a chronic illness who have an identified and documented plan of care in the early stages of the disease, improve on reassessing and adjusting the patient’s plan of care as their conditions change, and lastly, to increase the completion and documentation of advanced directives for patients with a serious illness.⁶⁹

The ICSI recommends that organizations should first assess their systems and processes put in place to aid palliative care services prior to engaging in any implementation of the recommendation. Secondly, any implementation plans must include a strategy to train and educate the staff adequately. They recognize that organizations may need to undergo a culture shift in order to implement the necessary recommendations.⁶⁹

The ICSI put forth certain key strategies for the successful implementation of these guidelines which include:⁶⁹

• Providing education to clinicians, patients and families regarding the elements and appropriateness of palliative care and hospice services
• Clearly define and address the differences between palliative care and hospice services.
• Develop and implement an effective system which easily allows clinicians to identify and assess patients in need of palliative care services. They recommend that this system should include a screening tool.
• Create scripts for referring clinicians to use to assist them in initiating the discussion for a palliative care services referral.
• Establish a process for the timely evaluation of patients referred to palliative care services.