New York Mandatory Education for Prescribing Controlled Substances - 3 Contact Hours
This course will not fulfill NP inital licensure requirement, including Form 2b. This course will review the appropriate use of controlled substances and discuss the management of patients in palliative care and at the end of life. The course will also discuss the role of prescriber in preventing and assessing for drug abuse and addiction.
Course Outline
- Outcomes
- Objectives
- Introduction
- Management of Acute and Chronic Pain with Opioids
- Opioids
- Techniques for Safe and Effective Treatment
- Case Study 1
- Substance Abuse
- Substance Use Evaluation
- New York State Laws
- Patient Education on Opioid Medications
- Termination Strategies for Chronic Therapy
- Palliative Care and End-of-Life Care
- Legal Issues Surrounding Palliative Care
- Most Common Diagnoses Managed by Palliative Care Team
- Palliative Care Guidelines
- Case Study 2
- Conclusion
- References
Outcomes
This course aims to prepare healthcare providers to deliver care to patients experiencing acute and chronic pain. The course reviews the appropriate use of controlled substances and discusses the management of patients in palliative care and at the end of life. The course also discusses the role of prescribers in preventing and assessing drug abuse and addiction.
Objectives
After completing this course, the learner will be able to meet the following objectives:
List five principles in the management of acute and chronic pain.
Define five principles of the appropriate use of controlled substances.
Explain methods to deal with the abuse of prescription drugs.
Identify methods to assess, screen, and prevent drug addiction.
Outline New York state and federal requirements for prescribing controlled substances.
Summarize five principles of palliative and end-of-life care.
Introduction
Pain is a subjective experience, and the context in which it happens influences how the pain is experienced and its meaning to the individual. Defining and quantifying pain has never been easy. As part of the human experience, pain has been described from the earliest times. Prehistorically, pain and pain relief was related to the acceptance or anger of the gods. Early Greek histories describe pain in the context of injuries received during battles; the Greek physician Hippocrates was the first to regard pain as a symptom, a sensory experience that the patient could explain to the practitioner.
The issue of pain during childbirth was hotly debated, with many in the medical profession supporting that experiencing pain during delivery was a religious principle. However, in 1853 and 1855, the British Monarch, Queen Victoria was given chloroform during childbirth. She described the experience of giving birth with the addition of anesthesia as “soothing, quieting, and delightful beyond measure” (Barry, 2019). The positive affirmation from Queen Victoria was an important first step in changing the prevailing views about pain relief during childbirth. The French physician Dr. Albert Schweitzer proclaimed in 1931, “Pain is a more terrible lord of mankind than even death itself.” However, from a positive viewpoint, pain is an important diagnostic marker of injury or disease and is significant in formulating a diagnosis.
Acute Pain
The Centers for Disease Control (CDC) suggests that opioids should only be used when necessary and at the lowest effective dose. Less than three days of opioid medication is appropriate for nontraumatic nonsurgical pain (Dowell et al., 2022). Immediate-release opioids are recommended for short-term use. Although, some instances of acute pain may require more than three days.
New York City has published guidelines for the use of opioids. They recommend that most patients require three or fewer days of therapy, be given short-acting medication, and should be evaluated for addiction or misuse. The guidelines also recommend avoiding administering benzodiazepines and opiates together and using extreme caution with stolen, lost, or destroyed prescriptions (NYC Health, n.d.).
When too many pills are prescribed, there are “left-over pills.” These “left-over pills” may be used for diversion or abuse. Nonetheless, it is often difficult to predict how much acute pain each patient has and how many pills to prescribe.
One study showed that continuous opioid use occurred after surgery between 5.9 and 6.5% of the time (Brummett et al., 2017). Factors that increase the risk of continued opioid use include a history of alcohol or drug abuse, lower socioeconomic status, multiple medical comorbidities, depression, prescriptions for benzodiazepines or antidepressants, and preoperative pain.
When prescribing opioids for acute pain, it is important to differentiate between opioid-naïve patients and opioid-experienced patients. Opioid naïve patients have not had opioids in the last 30 days.
The goal of pain management should be tolerable pain levels with good function. Here are some guidelines for how long medications should be given to those with acute pain (Pino & Wakeman, 2023).
- Mild pain syndrome should generally be treated with acetaminophen or nonsteroidal anti-inflammatories and nonpharmacological therapy.
- For individuals who suffer from moderate pain, such as after minimally invasive surgery, simple fractures, and soft tissue surgery, a three to five-day course of a short-acting opiate may be appropriate.
- For individuals who suffer from severe pain, such as a major surgical procedure, total joint replacement, or compound fracture, higher doses of opioids may be used for about one week.
- One study examined the number of pills needed after procedures for 80% of patients. It showed that after laparoscopic cholecystectomy, laparoscopic inguinal hernia repair, or an open inguinal hernia repair, patients required 15 pills of oxycodone 5 mg, whereas partial mastectomy patients required five pills (Hill, 2017).
- Predicting the number of medications patients will need after discharge from their procedure can be ascertained from the number of pills the patient took the day before discharge. One study showed that patients who received 1-3 pills on the day before they were discharged from the hospital took a mean of 7.6 pills after they were discharged from the hospital. Individuals who took four pills on the day before discharge took 21.2 pills after being released from the hospital (Hill et al., 2018).
Chronic Pain
Chronic pain affects an estimated 20.4% of adults, with 7.4% experiencing pain that frequently limits activities over the last three months (Zelaya et al., 2020). Persistent pain is often associated with anxiety, depression, functional impairment, sleep disturbances, disability, and impairment in activities of daily living. Every year, pain costs the American taxpayer between $560 billion to $635 billion (Smith & Hilner, 2019).
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage (IASP, 2023). Chronic pain is defined as pain that lasts beyond the usual duration that an insult or injury to the body needs to heal (IASP, 2023). Chronic pain can also be viewed as pain without apparent biological value that has lasted beyond the usual tissue healing time.
Opioids are indicated for pain conditions, and the long-term effectiveness of opioids has limited evidence. Opioid therapy is no more effective for pain control for chronic musculoskeletal pain than non-opioid pain medication, but adverse events are higher with opioids (Dowell et al., 2022). When deciding to prescribe opioids, the risks versus benefits must be considered.
High-dose, long-acting opioids are used only in specific circumstances with severe, intractable pain that has not responded to short-acting or moderate doses of long-acting opioids. No definitive evidence exists of who responds better between long-acting and short-acting opioids in relation to effects and side effects (Manchikanti et al., 2017).
A recent survey showed that individuals would go to extreme lengths to obtain certain prescription medications. Opioids were the most commonly obtained medications, followed by sedative-hypnotics and amphetamines. Individuals seeking these medications are more likely to use multiple physicians and pharmacies. The survey showed that 75 patients feigned symptoms to get prescriptions, two of 36 used falsified MRI images, three paid the prescribers, and three harmed themselves to get the prescriptions (Bouland et al., 2015).
Management of Acute and Chronic Pain with Opioids
Medical Assessment
Many healthcare providers believe pain is the fifth vital sign. A comprehensive medical history is the first step in the workup of an individual experiencing pain. It should include an evaluation of the patient’s medical and surgical history and a medication list review.
The comprehensive medical history must include a detailed description of the pain.
Onset - When did the pain start?
- Describe the mechanism of injury.
- What was the causative factor?
Location - Where is the pain?
Duration - How long has the pain persisted?
- Is the pain intermittent or constant?
Characteristics - Describe the pain (dull, sharp, lancing, burning, throbbing, or squeezing).
Associated symptoms - Are other symptoms associated with the pain, such as spasms, reduced range of motion, edema, diaphoresis, weakness, or changes in skin, nails, or hair?
Radiation - Does the pain radiate? If so, where?
Temporal - What are the aggravating/causative factors?
- What factors alleviate or diminish pain?
Severity - Rate the severity of the pain.
The impact of pain on the patient’s quality of life should also be examined. Ask the following:
- Does the pain affect activities of daily living or instrumental activities of daily living?
- Does the pain limit exercise or activity?
- Does the pain affect your mood?
- Is there a reduction in your energy?
- Does the pain lead to a strain on relationships?
- Does the pain affect your sleep?
- Does the pain lead to mood alterations?
- Does the pain affect your social life?
Measuring pain intensity is often done on scales and is meant to compare the severity of the patient’s pain at different points, not to compare one person’s pain to another. The use of pain scales helps the prescriber assess the effectiveness of pain treatment.
The best scales are brief, valid, require minimal training, and use both behavioral and descriptive measures of pain. Some scales commonly rate pain from zero to ten. Another scale allows the patient to rate their pain as none, mild, moderate, severe, or unbearable. Other scales have the patient select the degree of pain on a pictorial scale with facial expressions. Pain maps are helpful for individuals who have a difficult time speaking. Pain maps have a front and rear view of the body on a piece of paper, and the patient marks the pain's location and rates the pain's severity.
The patient’s perception of the pain should be reviewed by the following:
- What are the patient’s treatment goals?
- Why does the patient think they have persistent pain?
- Does the patient feel there was sufficient workup done on their condition?
Psychological factors that contribute to the pain should also be assessed. Patients need to have reasonable expectations about pain and its management.
All patients with chronic pain should have a complete physical examination. It is essential to have a baseline physical examination so the ensuing evaluations permit the healthcare team to establish progress in managing the pain.
Current and past treatments History of substance abuse Underlying conditions such as depression
The physical examination should include the following:
- Hygiene, dress, and appearance - those in severe pain often have poor hygiene and are unkempt
- A detailed neurological examination
- Assessment of skin and joints for redness, swelling, or deformities, which may help determine the location and etiology of the pain
- Assessing for joint range of motion
- Inspecting for any splinting
- Looking for signs of chronic liver disease
- Performing an abdominal examination for any tenderness, mass, or distension
- Performing a skin examination that looks for any track marks
- Evaluating for any signs of acute intoxication, withdrawal signs, or over-sedation
- Assess for infection, particularly among individuals administering by self-injection
- Looking for a productive cough – substance users are at higher risk for tuberculosis and community-acquired pneumonia
- Assessing for respiratory problems from smoking or snorting substances
- Evaluation for a sudden exacerbation of a previously well-controlled disease state, such as hypertension or diabetes
- Looking for unexplained weight loss
- Assessing for sleep disturbances
Mental Health and Psychiatric Findings
Individuals with a substance use disorder (SUD) often present with sudden changes in mental health, frequently manifesting as social, occupational, work, or school issues. Other findings that can assist health professionals in an accurate evaluation include the following:
- Depression
- Lack of energy
- Loss of interest in eating
- Weight loss
- Anxiety
- Agitation
- Sleep difficulties
- Behavioral changes
- Psychosis
- Hearing, seeing, or smelling things that are not there, often with a feeling of being followed
Evaluation of the pain management patient relies heavily on clinician experience, histories, and interviews. Laboratory drug screening is a good confirmation of suspicion for some commonly abused substances. However, it does not replace the depth of information from a thorough diagnostic workup and interview. One useful interview tool is the RAFFT questionnaire for substance abuse.
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(Bastiaens et al., 2002) |
Testing
Diagnostic testing is often part of the workup of painful conditions. It is important to realize that an abnormal diagnostic test does not necessarily diagnose the source of the pain. Blood tests may be helpful in certain diseases that cause pain. For example, an elevated C-reactive protein or erythrocyte sedimentation rate is often present in individuals with polymyalgia rheumatica, infection, or rheumatoid arthritis.
When the reliability and validity of urine drug test samples are a concern, please be aware of the following tampering practices:
- Substitution with another sample
- Direct dilution of sample (e.g., watering down)
- Additives to the sample that interfere with the assay
- Sample source ingesting large amounts of fluids to dilute concentration levels
- Use of a secondary substance to prompt false positives and invalidate useful data from the sample (e.g., using a Vicks inhaler to create false amphetamine positives, non-steroidal anti-inflammatory drugs (NSAIDs) for false barbiturates or cannabinoids positives, and poppy seeds or fluoroquinolones for false opiate positives)
Strict observation during sample collection and a written chain of custody document for the specimen should be the standard of practice.
Goals of Treatment
An essential role of the practitioner is prescribing controlled substances.
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.
Opioids
NSAIDs are laced with risks, and some patients cannot tolerate NSAIDs due to side effects and pre-existing co-morbid conditions. The risks associated with NSAIDs are one reason many prescribers choose an opioid to manage pain. Opioid therapy effectively manages many chronic pain conditions, including cancer, osteoarthritis, low back pain, neuropathic pain, and post-herpetic neuralgia.
Recently, 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 prescribed medications (Fuentes et al., 2018).
A position paper from the American Academy of Neurology suggested there is no convincing evidence for chronic pain relief with opioids, particularly neuropathic pain, and they may worsen migraines (Goadsby et al., 2018). In addition, it was noted that no good evidence exists for enhanced pain relief or improved function with opioids for extended periods without sustaining serious risks of dependence, overdose, or addiction (Dowell et al., 2022).
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 more than non-opioid therapy (Krebs et al., 2018). Opioid therapy is often used to manage neuropathic pain but is commonly considered a second line to antidepressants and anticonvulsants.
Side Effects of Opioids
- Constipation is a frequent issue for those who use opioids. Risk factors for constipation include those with intra-abdominal pathology and those with 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 added to stool 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, and patients 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 opioids to help manage the pain. Rarely, a stimulant can be used to manage sedation due to opioid use.
- Respiratory depression may occur, but it is uncommon if 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, adding 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 ten beats per minute.
Drug Interactions
Drug interactions can lead to significant health concerns for those taking opioids. Many individuals with chronic pain have co-morbid conditions that necessitate using other medications. A study showed that drug-to-drug exposure (which may lead to drug interactions) in those with chronic low back pain on long-term opioid analgesics was 27% (Pergolizzi et al., 2011).
Drug-to-drug interactions are variable among products. Medications that depress the central nervous system, such as alcohol, benzodiazepines, and tricyclic antidepressants, may potentiate respiratory depression and the sedative effects of opioids. Some extended-release formulations of opioids may rapidly release the opioids when given with alcohol. Methadone may prolong the QT interval.
Many medications can affect various cytochrome P450 enzymes. Codeine, oxycodone, hydrocodone, and tramadol levels may increase with selective serotonin reuptake inhibitors (SSRIs), protease inhibitors, diltiazem, verapamil, diazepam, clarithromycin, fluoroquinolones, and diphenhydramine. Levels may be decreased with carbamazepine and phenytoin. SSRIs, protease inhibitors, diltiazem, verapamil, diazepam, and clarithromycin may increase fentanyl levels. Some opioids used with anticholinergic medications may increase the risk of constipation and urinary retention.
Techniques for Safe and Effective Treatment
Pain management may include medications, behavioral interventions, physical medicine, neuromodulation, medical interventions, or surgery. A multidisciplinary approach is typically used in the management of chronic pain.
The treatment plan should be established before initiating treatment. In this plan, the patient and the provider should discuss the benefits, risks, and alternatives before starting treatment. In addition, the clinician needs to discuss how the patient is monitored, including how the patient is evaluated for potential misuse of the prescribed medication. The use of written documents is often included in the plan. The plan may consist of agreements, treatment plans, and informed consent. It is important that the clinician document that decision-making was implemented, including informed consent, goal setting, and a defined monitoring plan.
When high doses of opioid prescriptions are given, there is an increased risk of overdose death. Therefore, the clinician must discuss and limit the number of opioids prescribed. The CDC recommends that providers prescribe no more than 90 morphine milliequivalents per day (Dowell et al., 2022).
The World Health Organization (WHO) analgesic ladder, published in the 1980s, was created to manage cancer pain (WHO, n.d.).
Medications are given through the most comfortable route (preferably orally). A stepwise approach should be followed, starting with non-opioid medications with or without adjuvant medications. Managing mild to moderate enduring or progressive pain with opioids, with or without adjuvant medications, and with or without non-opioids. 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. Administering analgesic pain medication for moderate to severe chronic pain on a fixed schedule (not as needed).
This approach is 80-90% effective.
Adjunctive medications enhance the analgesic effect, reduce side effects, and assist with co-existent symptoms. Patients respond distinctly to treatments regarding efficacy and side effects, and trial and error are often used to treat 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 typically starts with a short-acting medication, which 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 be converted to a sustained release form and administered once or twice a day.
A periodic review of the patient’s pain and clinical status is important to ensure that opioids should be continued or discontinued. Any change in the patient’s health, degree or nature of pain, mental health, and overall function should be noted. The clinician and patient should review the proper dosage and schedule of medication. Decisions on the benefits of pain management should focus on previously decided upon goals. Positive responses to treatment can include reduced pain, improved quality of life, or improved function.
Controlled substances have inherent risks, so the prescriber should realize that the primary goal of prescribing opioids should be to maintain patient safety. A responsible prescriber should follow multiple steps to ensure safe and effective patient care.
Safe Prescribing Tips
Steps a prescriber can take include the following (Manchikanti et al., 2017; Dowell et al., 2022):
Assess and document a comprehensive history, including medical history, substance abuse history, current medications, dosages, route, and time, and psychiatric and psychosocial history.
Establish a physical and psychological diagnosis and medical necessity before starting or maintaining opioid therapy. Those with mental illness are at a higher risk of abusing medications.
Screen for substance abuse history because substance abusers are at increased risk of misusing controlled substances.
Establish goals in therapy regarding pain control and functional goals.
Use prescription monitoring programs to help determine prescription use patterns and reduce abuse of medications. These state-run databases track controlled substance prescriptions and help find issues with overprescribing and misuse patterns.
Urine drug testing can be used to identify noncompliance or aberrant drug use.
Consider contraindications before 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.
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.
A written agreement between prescriber and patient when opioids are used reduces the risk of abuse, diversion, misuse, and overuse.
Discuss the risks and benefits of the medications.
Obtain informed consent prior to prescribing controlled substances.
In general, start opioid therapy at low doses with short-acting medications.
Use 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.
Use caution when titrating with long-acting opioids and consider the potential for overdose and misuse.
Consider consultation for those who require high-dose opioid therapy.
If possible, be the only prescriber of all opioids for a given patient.
Monitor and manage constipation.
Prescribe the lowest effective dose and the smallest quantity needed based on the expected length of the pain.
Periodically review the treatment plan, including any new information about the patient, their condition, pain, and progress toward their goals.
Keep accurate records.
Demonstrate compliance with all laws and regulations related to controlled substances.
Individualize treatment based on the patient’s prior exposure to opioids, response to treatment, and adverse events.
Monitor for aberrant drug-related behaviors.
Discontinue chronic opioid therapy in those who repeatedly engage in aberrant drug-related behaviors, do not progress toward established goals, or experience significant side effects. Patients 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 (Department of Veteran Affairs and Department of Defense, 2022).
Tips to Reduce Iatrogenic Harm
- Have an upper dosing threshold. The risk of accidental overdose increases with higher doses of opioids. High-dose opioids (more than 50 to 90 morphine milligram equivalents [MME] per day) are not associated with greater improvement in pain but are associated with more risk (Dowell et al., 2022).
- 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, and titration should be done carefully. Constipation is more likely, and a bowel regimen should be prescribed when opioids are used.
- Chronic opioid therapy should initially be a therapeutic trial lasting one to four weeks. The decision to continue the therapy must be carefully considered based on the outcomes of the trial, such as progress toward meeting goals, side effects, changes in the underlying condition causing pain, and any concern for medication misuse or addiction.
- The greatest risk of opioid use is respiratory arrest and death, which is greatest when therapy is started or the dose is increased. Opioid-induced respiratory depression is manifested by the reduced desire to breathe and decreased respiratory rates. The patient will be breathing shallowly, and carbon dioxide (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 regimen to another to reduce adverse events and improve therapeutic outcomes - may be considered. Tolerance to one opioid can lessen the analgesic effects, and using a different opioid may result in an improved analgesic effect and fewer adverse effects.
- When opioid rotation is done, the prescriber must determine the approximate equianalgesic dose; this dose is the ratio used to get 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.
- Generally, avoid combinations of opioids and benzodiazepines. When these two classes are combined, the risk of accidental overdose is high. Use caution with opiates and co-prescribed gabapentinoids (e.g., gabapentin or pregabalin), as this combination is associated with increased overdose risk (Mattson et al., 2022).
- Pay attention to drug-to-drug and drug-to-disease interactions.
Referrals and Consultations
- Not all patients on chronic opioid therapy need a referral, but some do. Consider a referral to psychology, psychiatry, or an addiction expert for high-risk individuals engaging in aberrant drug-related behaviors. Those with a SUD are also candidates for referral. A pain management consultation may be helpful for those on high-dose opioids.
Case Study 1
John is a 38-year-old male with chronic back pain due to three herniated discs and spinal stenosis, 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 dull and constant with occasional sharp exacerbation in the lower back, increasing with bending, prolonged standing, and walking. The patient denies any loss or change of bowel/bladder control, history of intravenous 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 activities of daily living but reports poor sleep at night.
He has a past medical history of hypertension and recently 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 with acetaminophen, naproxen, ibuprofen, the lidocaine patch, and topical NSAIDs without relief. The patient experienced significant tremors and increased 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 history of alcohol abuse but has not had a drink in five years and is currently a smoker. He denies any history of prescription substance abuse and has no family history of alcohol or substance abuse.
A physical exam showed a patient with a slow, deliberate gait and 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 L4 to S1 and tenderness in the right sacroiliac joint. Normal reflexes, sensation, strength, and no atrophy are noted in the lower extremities. The straight leg raise test is normal.
One year ago, an MRI found a herniated disc at the L5/S1 level and mild spinal stenosis.
The Opioid Risk Tool (ORT) was administered, and it was determined that the patient was 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.
The patient has been prescribed hydrocodone/acetaminophen 5 mg/500 mg, two tablets every six hours as needed (56 tablets) for one week.
Five days later, he calls for an early refill and reports that the medication is not helping his pain, even though he is lying around all day.
He comes back into the office for a re-evaluation. He reports that he needed to take more pain medication than prescribed. His wife confirms that he has been lying around all day, believing it is because he has so much pain. It was reviewed with the patient that he violated the opioid agreement. A urine sample showed no illicit substances or medications that would not be expected in the urine.
While the patient is at moderate risk of abusing the medication, his past medical history was confirmed. He was referred to a psychiatrist and a pain specialist and 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, who diagnosed him with depression and prescribed him sertraline, but the patient refused to take the medication due to side effects. The psychiatrist was unable to make an assessment related to opioid abuse.
With the help of the pain specialist, oxymorphone extended release of 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 being more functional but in much pain. The dose of oxymorphone extended release was increased to 10 mg every 12 hours. After one more week, he was given oxymorphone immediate release 5 mg to be used one hour before exercise. This change allowed John to function well and participate in an exercise program. He was ordered a bowel stimulant, senna, and a stool softener, docusate sodium, to prevent constipation.
John was prescribed fourteen pills of oxymorphone extended release 10 mg (to be taken twice a day) and seven pills of oxymorphone immediate release 5 mg (to be taken once a day before exercise) per week. Part of the agreement was that the medications were to be given by the patient’s wife to reduce the risk of misuse.
John is given a treatment plan that includes the following:
- A list of goals:
- Improved pain and increased function
- Improved anxiety and depression
- Eventual cessation of opioid therapy
- Regular exercise program
- Lidocaine patches to be used for 12 hours a day and taken off at night
- The use of acetaminophen 1000 mg two times a day
- Evaluation and treatment by a pain psychologist
- Physical therapy
- He is prescribed duloxetine to help treat his depression, which also helps with musculoskeletal pain.
After two weeks, the patient returns to his primary care provider and reports that he has started physical and psychological therapy, is sleeping better, and wants to start to wean the oxymorphone. After four more weeks, he has weaned off the extended-release oxymorphone and is just using oxymorphone immediate release for breakthrough pain. In addition, he reports feeling less anxious and depressed and is sleeping “just fine.” After another four weeks, he says he no longer uses his opioid medication, has secured a part-time job, and regularly exercises.
Substance Abuse
Prescription opioid abuse heavily affects the patient, healthcare provider, and society. Abuse and misuse of controlled substances occur for multiple reasons, including self-medication, use for reward, diversion, and use for profit. Opioid use has recently increased, leading to increased abuse and opioid overdoses. Proper screening lowers the risk of iatrogenic addiction.
Multiple tools are available to screen for opioid misuse, including the ORT, the Screening Instrument for Substance Abuse Potential (SISAP), the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R), and the Diagnosis, Intractability, Risk, and Efficacy (DIRE) score (Cheattle, 2019). The ORT, SISAP, and SOAPP-R are self-administered tools, and the DIRE is a clinician-administered tool. Each tool leads to a score that predicts who is most likely to be a suitable candidate for opiate use and the risk of misuse.
Using prescribed medications, not as directed, describes potentially aberrant drug-taking behaviors. In a study of 202 patients, only 44.1% were screened for potential aberrant drug-taking behaviors. It was concluded that screening for abuse or misuse of opioids does not frequently occur in large family medicine training programs. More training and set policies for risk evaluation and monitoring of opioid abuse are needed (Colburn et al., 2012).
Healthcare providers tend to under-assess patients at risk for opioid-related aberrant behaviors. One study showed that providers assessed the risk of misuse, abuse, or diversion at less than 2% when in reality, 10.4% of patients had prior illicit drug use, 23.4% had abnormal urine drug tests, almost 11% reported crushing or chewing opioids in the past, and 60% of patients self-reported abuse, misuse, or diversion (Setnik et al., 2017).
Prescribers receive little training in prescribing scheduled substances, screening for substance abuse, and referring patients who need treatment. Proper continuing education is one way to address this problem.
Key Definitions
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 withdrawal symptoms such as anxiety, tachycardia, hypertension, diaphoresis, a volatile mood, or dysphoria occur after the rapid discontinuation of the substance.
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 or social consequences.
Addiction is a primary concern for 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 (Boscarino et al., 2010). Those at high risk for addiction may be better managed with a specialist.
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Severity of the SUD - Indicated by the number of symptom categories present
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(APA, 2013) |
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.
Prevalence
- As of 2020, over 59 million Americans over the age of 12 misused prescriptions or used illicit drugs over the previous year. Almost ten million Americans misuse prescription pain medication (National Center for Drug Abuse Statistics [NCDAS], 2021).
- Almost 25% of individuals with a drug use disorder suffer from opioid use disorder (OUD), accounting for about 1% of individuals over 12. Of Americans over 12, 3.4% have misused opioids at least once in the past 12 months (NCDAS, 2021).
- More than 70,000 people die each year in the United States due to a drug overdose, increasing at an annual rate of 4% (NCDAS, 2021).
- In 2012, healthcare providers wrote 255 million prescriptions for painkillers, decreasing to 143 million in 2020 (CDC, 2021).
- Overdoses from synthetic opioids increased from 0.3 per 100,000 people in 1999 to 6.2 per 100,000 in 2016 (Hedegaard et al., 2017).
- Between 1999 and 2015, drug overdose deaths tripled (Manchikanti et al., 2017).
- Of those prescribed opioids, dependence may be as high as 26% (Boscarino et al., 2010).
- In 2021, first-time misuse of prescription pain medication occurred in 1.8 million people, first-time heroin use occurred in 26,000 people, first-time alcohol use occurred in 4.1 million people, and first-time marijuana use occurred in 2.6 million people (SAMHSA, 2021).
- While many pain medications may be misused, the most commonly misused drugs include hydrocodone, oxycodone, and codeine (SAMHSA, 2021).
Opioid dependence costs the United States healthcare system one billion dollars annually (NCDAS, 2021). 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.
According to the fifth edition of the Diagnostic and Statistical Manual from the American Psychiatric Association (APA), the essence of a substance use problem may be summed up by the phrase: “…cognitive, behavioral, and physiological symptoms indicating the individual continues using the substance despite significant substance-related problems.” (APA, 2013) |
Diagnostic Evidence
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 in TV dramas. Frequently, people find themselves in uncomfortable situations regarding prescription pain medications, social drinking, or recreational substances. Often, they voice concerns to healthcare 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 a trusted 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 healthcare system. Presenting symptoms can vary greatly depending on the individual and the substance involved, although each SUD shares some key diagnostic criteria.
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(APA, 2013) |
Substance Use Evaluation
All patients should be evaluated for SUDs. Unfortunately, many people do not receive treatment for SUD, and it is estimated that 94% of individuals with a SUD may not receive treatment (SAMHSA, 2016). Health professionals must view all new clients as having the potential for a SUD.
Locating clues, signs, and symptoms of a SUD depends on good screening, history taking, physical findings, psychiatric findings, and laboratory testing.
Opioid Use Disorders
Opioids are old friends to the healthcare professional. So much relief from pain and suffering can be attributed to the proper use of the opioid family that it saddens the industry that there is a flip side - misuse and abuse.
OUD involves the desire to acquire or consume opioids notwithstanding negative consequences and is based on the APA’s DSM-5 criteria (APA, 2013). OUD is associated with opioid tolerance, an overwhelming desire to take opioids, and withdrawal if opioids are stopped. Multiple treatment options for OUD exist and include individual and group therapy, 12-step programs, and pharmacotherapy, including naltrexone, methadone, and buprenorphine. The disease is associated with exacerbations and remissions, but the desire to use and the potential for relapse always exist.
Not everyone taking a particular medication or street substance is an addict. With opioids especially, many label anyone on prescription analgesics as either an addict or an addict in the making. Opioids are an acceptable means of managing pain for short and long periods. It is an expectation that an individual utilizing them for legitimate reasons will, over time, begin to develop a physical tolerance for the medication. Upon abrupt discontinuation, they experience withdrawal-type symptoms as their metabolism adjusts to the absence of the opioid. Neither tolerance nor withdrawal makes an addict.
The motivation for use has an important role in opioids. During an assessment, ask your client whether they benefit from their opioid beyond the relief of pain, including feelings of well-being, euphoria, relaxation, or a rise in mood beyond what may be attributed to pain relief. Frequently, those who utilize opioids for 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 SOAPP are available when client motivation for opioid use is uncertain.
OUD focuses on the detrimental consequences of repeated opioid use along with an observable pattern of compulsion or cravings to use. OUD is diagnosed when opioid use persists and causes significant educational, occupational, or social impairment. Commonly abused opioids include heroin, codeine, fentanyl, morphine, opium, methadone, oxycodone, and hydrocodone.
Individuals with an OUD 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 with 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. However, mild or moderate ongoing users may not have progressed to an appearance of reduced health.
Orally – either in a 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 opioids with cannabis or tobacco.
Opioids purchased illegally risk contamination by improper handling or purposeful “cutting” or diluting the substance by other compounds. Injection users run a high risk of infection, both localized and systemic. HIV, hepatitis B, and hepatitis C are 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.
Depressed mental status Decreased respiratory rate Decreased lung tidal volume Decreased bowel sounds Constricted pupils
Drowsiness tends to follow the euphoria, and the sedation effect may progress to a coma. Inattention resulting from perceptual changes and the 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 without delirium.
For suspected acute opioid intoxication, laboratory studies should be included in the workup:
- Check immediate blood glucose for hypoglycemia, a condition that is often mistaken for opioid intoxication.
- Prescription opioids are often combined with acetaminophen; serum acetaminophen concentration should be checked along with liver enzymes to assess for acetaminophen hepatotoxicity.
- Serum creatine phosphokinase, kidney function, and electrolytes help assess for rhabdomyolysis (muscle breakdown) secondary to prolonged immobility, which is always a concern due to the intense sedative effects of opioids.
- Urine toxicology screens for opioids.
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(CDC, n.d.) |
Opioid intoxication diagnosis focuses on a significant negative impact and psychological and behavioral changes accompanying or following substance use. The presence of alcohol or sedatives in the person’s system can muddy the diagnosis; therefore, a naloxone challenge may be administered.
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(CDC, n.d.) |
Opioid withdrawal can be a brutal affair. Withdrawal symptoms may begin immediately after administering 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 a long-acting opioid, such as methadone. The peak of withdrawal tends to be within 24-48 hours yet persists for up to ten days for the short-acting agents and up to 2-3 weeks for methadone, with sleep and mood disturbances often persisting for months. Many who have undergone opioid withdrawal compare it to severe influenza or viral gastroenteritis.
Drug Epidemic
The healthcare industry should shoulder some of the burdens of the opioid epidemic. The 1990s were a time when pharmaceutical companies aggressively marketed pain medications. Healthcare providers, encouraged by the Joint Commission (TJC), were encouraged to assess pain and manage it appropriately. The combination of intense assessment and pharmaceutical companies marketing pain medication was partially responsible for the increased use of opioid pain medications. In addition, multiple medical organizations lobbied for aggressive identification and management of pain (Baker, 2017).
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 substances to 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 (CDC, 2017).
TJC modified recommendations for managing and assessing pain. Some of their modifications included the following (TJC, 2017):
- Identify patients at high risk of misusing opioids.
- Encourage 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 a prescription drug monitoring program.
- Refer addicted patients to treatment programs.
- Engage in improvement activities regarding pain management.
Risk Factors for Opioid Abuse
Many known risk factors for opioid misuse, diversion, addiction, and overdose exist (Webster, 2017). Evaluating these risk factors is an important aspect of evaluating a patient.
A prior history of misuse or abuse Younger age Untreated psychiatric disorder Living in a social 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
How do Substance Abusers Obtain Drugs?
Removing prescription medications from legitimate channels is drug diversion and can occur in many ways, including the following (SAMSA, 2016):
- Slightly more than 40% of patients who abuse prescription pain medication got it from a relative or friend without paying for the drugs.
- 36.4% of abusers of prescription medications got them through their healthcare provider either by prescription or by stealing.
- Approximately ten percent stole drugs from a relative or friend.
- About five percent of patients got their last opioid by buying them from a drug dealer or stranger.
- Some patients get drugs through doctor shopping, but most receive them through one doctor.
- Fraudulent prescriptions are another method of obtaining prescription drugs. Fraudulence can occur in many ways, and methods include altering an already written prescription, stealing a prescription pad, or creating falsified computer prescriptions.
Healthcare professionals are also known to divert, misuse, or abuse drugs. Healthcare providers abusing drugs may be irritable, defensive, or isolated. Other signs or symptoms of prescription drug abuse or misuse 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.
Patients are assessed and reassessed. Treatment agreements are used. Prescription monitoring occurs. Safe prescription methods are practiced. Informed consent is used.
Patient risk should be assessed, and contraindications should be immediately identified. Contraindications to opioid treatment include those with an erratic follow-up, untreated addiction, or poorly controlled mental illness.
Informed consent provides written documentation regarding the therapy's benefits and risks and discusses the patient's and prescriber's responsibilities. 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 occur as well as the policy on early refills and lost prescriptions/medications, and discusses reasons for discontinuing therapy.
Assessment including Addiction Risk Assessment
When taking a patient history, document the opioid currently prescribed, its dose, frequency, and 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. A 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 opioid risk are available, including the COMM and the ORT. The ORT is a tool used in primary care to screen adults for the risk of aberrant behaviors when prescribed opioids for chronic pain. It is a copyrighted tool, encompasses five questions, and takes one minute to administer. It classifies a patient as low, moderate, or high risk for opioid abuse. Those at high risk have a higher likelihood of aberrant drug-related behavior. The ORT is not validated in individuals without pain. The five questions include 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 varies between men and women, and a total score is tallied. The patient is placed at low, moderate, or high risk.
Over the last few years, educating clinicians has been a primary focus of the medical community, which has led to increased awareness and safer prescribing of controlled substances. Practice guidelines disseminated among the emergency providers in Ohio were linked to a 12% reduction in opioid prescriptions per month (Weiner et al., 2017). The guideline included multiple positive steps, including assuring the clinician reviewed the prescription drug monitoring database, encouraging referral for further evaluation, reducing quantities of medications prescribed, and encouraging education about the risks versus benefits of opioids.
Follow-Up
Regular follow-up is important and should occur at least every three months and more frequently in individuals at high risk for abuse or during periods of medication adjustment (Dowell et al., 2022). A baseline evaluation of the nature and intensity of the pain and the underlying effects pain is having on a patient's physical and psychological function helps assess the treatment's effectiveness.
Documentation should include the amount of pain relief experienced by the patient’s improved ability to function physically or psychologically. It should include recommended goals (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).
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(CDC, n.d.) |
All fifty states have prescription monitoring programs. They provide an online database that lists all prescriptions of controlled substances dispensed to 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 may be considered prescription drug misuse.
New York State Laws
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 for treating their addiction for habitual use.
- Before 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. Some exceptions include prescribing in the emergency department of a general hospital when no more than a five-day supply is prescribed for hospice care and when it is not reasonably possible to access the registry promptly (technology failure).
- Follow-up examinations should occur using accepted medical standards before 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 a seven-day supply. Specific rules apply to this (see the link above).
Patient Education on Opioid Medications
Patient education is crucial as it reduces the risks associated with these medications and improves pain management. Patients need education on the safe use, storage, and disposal of opioid medications. Safe use of opioids requires the patient to know about adverse events and abuse, misuse, and addiction risks.
An overdose occurs when someone takes a higher dose than the body can tolerate, leading to a significant adverse effect. Respiratory depression is the primary risk, which is highest in those who are not tolerant to opioids, take other respiratory depressants, have multiple health conditions, have debilitated health, or have impaired respiratory function.
Medications associated with a high risk of respiratory depression are schedule II opioids.
Information on abuse should be taught to the patient. Many patients abusing opioid medications usually get a valid initial prescription. Many patients who abuse medications get them by buying or stealing from an acquaintance (typically a friend or relative).
Patients should also be taught about misuse.
Patients should also be taught that drug diversion will not be tolerated. It may terminate 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 continued 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, and improper disposal may lead to environmental complications or drug diversion. Controlled substances can be mixed with cat litter or coffee grounds and sealed in a non-leaking container before disposal.
Key points in patient education:
- Goals of treatment.
- Alternative treatment options.
- Patients should be encouraged to read their medication guide or package insert every time they get a new prescription.
- Teach about abuse, addiction, misuse, and diversion.
- Risks of overdose or death if the dose is not taken exactly as prescribed or if someone else takes the medication.
- Pain medications may impair breathing.
- Do not give the medication to anyone else.
- If anyone else takes the medication, emergency services should be contacted.
- Swallow pills whole – do not crush, snort, chew, inhale, or take them by any means other than the prescribed method.
- 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 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 affect driving ability or safety at work, especially when 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 gets them.
- Educate patients that giving away or selling their medications to others is illegal and dangerous.
- Patients should keep track of the number of pills/capsules - 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 takes 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.
Termination Strategies for Chronic Therapy
Discontinuation of opioid therapy may be considered if problematic patterns are noticed, opioid therapy is ineffective, or goals are not being achieved. The prescriber and patient must agree upon reasons to terminate therapy before initially prescribing the medications, and this termination plan 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, the patient and prescriber must agree. For patients who decide to continue treatment with another prescriber, the prescriber may consider maintaining the current dose for four weeks.
When appropriate, a tapering schedule should be implemented to avoid withdrawal. A reduction of 10% every seven to 14 days until the patient gets to a lower dose may be done, and then a 5% reduction every 2-4 weeks.
Individuals who have shown aberrant behaviors should be offered other non-opioid options. Patients who have engaged in aberrant behaviors such as diverting drugs or altering prescriptions should be referred to a substance abuse treatment program and discharged from the practice.
Drug Diversion
Drug diversion is the use of legal drugs for illegal purposes or prescription drugs for recreational purposes and is a key concern in the use of controlled substances.
Patients use multiple methods to obtain medication for illicit use, including 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 diversion methods include theft, losses during transportation, or internet pharmacies.
Methods to obtain drugs illegally include the following:
- Burglary/robbery
- Stealing prescription pads and writing prescriptions
- Faking injuries
- Doctor shopping
- Prescription forgery – photocopying, changing numbers on the prescription
- Fraudulently phoned-in prescriptions
When possible, write in ink. Writing out numbers makes it difficult to modify numbers on prescriptions Use electronic prescribing Mark the number of refills – mark through the unused portions Lock up the prescription pad
It is very difficult to deal with a patient with a chief complaint of severe pain who wants opioid therapy. It is important to understand the motivations of patients who seek drugs. Do the patients have pain, or are they seeking controlled substances for non-medical purposes?
Good communication is important to help deal with drug-seeking patients. Prescribers must be empathetic and acknowledge that the patient is suffering. Providers must maintain confidentiality and privacy to ensure that the patient is comfortable.
Communication with the patient is successful when providers confidently present information, question patients using open-ended questions to promote honesty, and document thoroughly, including the patient’s assessment and any agreements.
Having firm office policies is important in managing patients being prescribed opioids. Generally, prescribing opioids at the first visit should be avoided. The policies should include the frequency and timing of refills, and 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. The contract is particularly true for an acute injury or a surgical procedure where pain typically improves.
Prescribers must be aware of problematic behaviors. Behaviors highly suggestive of a SUD 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 needs, missed appointments, and requesting more medications.
Palliative Care and End-of-Life Care
Palliative care focuses on improving the quality of life of gravely ill patients. It not only aims to improve the lives of sick patients, but it also focuses on improving the lives of the caretakers and family members impacted by the patient’s illness.
Definition of Hospice Care
Hospice is essentially a philosophy and practice of healthcare that focuses on symptom management, optimizing the quality of life for patients and loved ones and a supported transition toward the end of a patient’s life. Hospice care aims to improve quality of life rather than prolong or cure an illness.
Hospice versus Palliative Care
Palliative medicine provides a framework for pain and symptom management in all seriously ill patients, and it can be seamlessly merged with curative therapies such as organ transplantation. On the other hand, hospice shares the same philosophy with palliative care to alleviate suffering in the life of a seriously ill patient. It also places the utmost importance on patient-centered care and encourages shared decision-making to provide care to patients that is 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 six months or less, and the Medicare Hospice Benefit largely defines this anticipated lifespan.
Consequently, hospice services have very strict admission criteria; a physician would certify that the patient has six months or less to live if the disease follows the natural course. In hospice, unlike palliative care, the treatment goal is more toward comfort 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 six months, the hospice benefits can be renewed through Medicare using their recertification process.
Another 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 long-term care facilities. Palliative care, on the other hand, is a medical subspecialty. 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.
Members of the Palliative Care/Hospice Team
The palliative care and hospice teams include a multidisciplinary group comprised 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 to optimize the quality of life for 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
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 often the primary case manager, coordinates the interdisciplinary team, and provides skilled nursing care. In the ideal setting, hospice nurses are 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 practical nurses 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, or referrals to other support systems.
Chaplain
The chaplain addresses the patient’s and family’s spiritual needs in structured and unstructured religious formats.
Home Health Aides or Nurse’s Aides
Aides provide direct assistance with activities of daily living, food preparation, light housekeeping, and shopping.
Bereavement Counselors
Bereavement counselors typically counsel the patient and the patient’s loved ones. Counseling can occur 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.
Epidemiology of Palliative Care
According to the WHO (2020a), palliative care primarily focuses on non-contagious causes of death, as noncontagious diseases represent a significant majority of worldwide deaths.
The WHO estimates that 76% of adults and over 97% of children requiring palliative care live in low to middle-income countries. However, palliative care availability and utilization are highest among adults in higher-income countries (WHO, 2020).
The international availability of palliative care is limited, and as many as 56.8 million people need palliative care, with only 14% of people who need it receiving its services (WHO, 2020b). For non-communicable diseases, financing for palliative care was offered in 68% of countries, and only 40% of countries stated services were available to at least half of the patients who needed it (WHO, 2020b). Opioid pain medication is less available in low- and middle-income countries. The WHO has identified the most common illnesses that require palliative care for adults and children (WHO, 2020b).
In adults, the most common illnesses that require palliative care include Alzheimer's 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). The most common illnesses requiring palliative care in children include cancer, cardiovascular diseases, liver cirrhosis, congenital anomalies, blood and immune disorders, HIV/AIDS, meningitis, kidney diseases, neurological disorders, and neonatal conditions.
Legal Issues Surrounding Palliative Care
Palliative care is a challenging area of medicine for many reasons. Caring for patients near their end of life requires compassionate consideration of their medical and psychosocial health and understanding the legal and ethical implications of 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 is important to understand some standard definitions and terms.
Advance Directives
Healthcare Proxy (Durable Power of Attorney for Healthcare)
The healthcare proxy or durable power of attorney for healthcare (DPOA) indicates a person has selected someone else to make medical decisions on their behalf should they become unable to communicate. The DPOA clarifies to the healthcare team whom medical decisions should be referred to when a patient becomes incapacitated. It should also be noted that the patient or the court can appoint a DPOA.
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 they be unable to make decisions for themselves. Examples include withholding feeding tubes/artificial nutrition in the event of a grave or terminal illness.
Do-not-resuscitate Status (DNR)
A DNR order indicates 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 DNI 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 can refuse medical care, even if it results in death. Regarding decision-making capacity, the complexity of this topic is out of the scope of this learning module. Still, it is typically determined by a physician who 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 are 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, domestic partner, 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 next of kin order is commonly used.
Medical Record Documentation
An important part of palliative care is ensuring patients and their families receive clear communication regarding their care. Many end-of-life care treatment decisions are based upon the patient’s understanding of their prognosis, treatment options, and the implications of their medical decisions. It is also essential that these communications are well documented, particularly when a patient does not have advanced directives. Communication documentation within the medical record should include involved parties, their relationship to the patient, their capacity, discussion details, and any medical decisions made. Documented communication, along with other clinical factors, aids in determining the treatment course for a terminally or gravely ill patient should the patient become incapacitated.
Determining Functional Status
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 in the 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, such as the Eastern Cooperative Oncology Group (ECOG) performance status scale and the Karnofsky Performance Status (KPS), have been developed to stratify performance status. As a healthcare team member, 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:
- Grade 0: Fully active; no performance restrictions.
- Grade 1: Strenuous physical activity restricted; fully ambulatory and can carry out light work.
- Grade 2: Able to do all self-care but incapable of carrying out any work activities. Up and about at least half of waking hours.
- Grade 3: Capable of limited self-care; restricted to bed or chair for over half of waking hours.
- Grade 4: Entirely disabled; unable to perform self-care; confined to bed or chair.
- Grade 5: Dead
Karnofsky Performance Status Scale:
- 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 issues reported, no indication of disease.
- 90: Capable of normal activity, slight signs or symptoms of disease.
- 80: Typical activity with effort, minor signs/symptoms of disease.
- Value 50 – 70: Unable to work; able to live at home and care for most personal needs; diverse degrees of assistance required.
- 70: Able to care for self, cannot engage in normal activity or do active work.
- 60: Requires intermittent help but can care for most of their needs.
- 50: Needs substantial assistance and regular medical care.
- Value: 40 – 0: Unable to care for self; needs a comparable degree of institutional or hospital care; disease may progress quickly.
- 40: Disabled, needs special care and assistance.
- 30: Significant disability, hospitalization is indicated, death is not impending.
- 20: Hospitalization is needed; very ill, and active and supportive treatment is needed.
- 10: Very ill, fatal processes progressing rapidly.
- 0: Dead
Most Common Diagnoses Managed by Palliative Care Team
As mentioned previously, palliative care addresses the “total pain” of the patient, including their psychosocial and spiritual needs. There are common symptoms/diagnoses that end-of-life patients face that become a pivotal part of the palliative care physicians' 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.
Pain
After assessing a patient’s pain and addressing any causes of the pain, the next step is determining which pharmacologic interventions are appropriate. Generally, there are three categories of oral medications used to treat pain and these are opioids, non-opioids (including NSAIDs), and additive or adjunctive analgesics.
Opioids are used for moderate to severe pain and can include medications such as morphine, oxycodone, fentanyl, hydromorphone, and methadone. Patients’ responses and tolerance to these medications greatly vary, so utilization of these medications for chronically ill and suffering patients is challenging. Non-opioids include NSAIDs and acetaminophen and are used to treat mild to moderate pain or as an adjunct to opioids. Examples of NSAIDs include ibuprofen, naproxen, ketorolac, indomethacin, and aspirin. Adjunctive analgesics are not typically used as the primary medication to address pain but are used in supplementation with opioids and non-opioids. Examples of adjunctive analgesics include gabapentin, pregabalin (for neuropathic pain), and dexamethasone (for general inflammatory conditions). The palliative care physician may proceed with palliative sedation for some patients with advanced illness and intractable pain.
Shortness of Breath
In many instances with terminally ill patients, it is more appropriate to correlate the patient’s goals of care with the management of their dyspnea. In those cases, the goals of care may only be for symptom alleviation rather than a definitive cure. Modes of intervention other than supplementary oxygen could include breathing exercises, guided meditation/relaxation, activity level adjustments (i.e., encouraging wheelchair usage), or chest wall physiotherapy. Opioids can also be used to alleviate discomfort caused by dyspnea.
Nutrition Challenges
Many terminally ill patients suffer from cachexia and anorexia.
Other treatment considerations for cachexia might include artificial nutrition and hydration; however, no evidence has been found to suggest that artificial nutrition prolongs or improves the quality of life and is not considered a standard of care for terminally ill patients or those with advanced dementia (Schwartz et al., 2014). There are some scenarios where it may provide a clear benefit to the patient, such as total parenteral nutrition (TPN) for patients with gastrointestinal cancers who can tolerate oral feeds or feeding tubes such as percutaneous endoscopic gastrostomy tubes (PEG tubes) for patients with neurodegenerative diseases who are too impaired to eat food orally. In addition to providing a mechanism of nutritional delivery, PEG tubes may benefit the patient by providing access to medication administration and hydration.
Palliative Care Guidelines
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. Several organizations have put forth guidelines for this purpose, including the Institute for Clinical Systems Improvement (ICSI) and the National Cancer Care Network (NCCN).
The ICSI guideline (2020) aims to increase the early identification of patients who could benefit from palliative care services, improve the clinician’s comfort with discussing palliative care services with the patients and their families, increase the percentage of patients with a serious illness who have an identified and documented healthcare proxy and healthcare directive, improve on reassessing and adjusting the patient’s plan of care as their conditions change, and lastly, to enhance care effectiveness and patient/family comfort level.
The ICSI (2020) recommends that organizations assess their existing systems and processes to aid palliative care services before making major changes. Secondly, implementation plans must include a strategy to adequately train and educate the staff. They recognize that organizations may need a culture shift to implement the necessary recommendations.
The ICSI (2020) put forth certain key strategies for the successful implementation of these guidelines, which include:
- Educating clinicians, patients, and families regarding the elements and appropriateness of palliative care and hospice services
- Clearly defining and addressing the differences between palliative care and hospice services
- Developing and implementing an effective system that easily allows clinicians to identify and assess patients needing palliative care services – which should include a screening tool
- Creating scripts for referring clinicians to assist them in initiating the discussion for a palliative care services referral
- Establishing a process for the timely evaluation of patients referred to palliative care services
Case Study 2
Ms. L is a 52-year-old female with a history of bilateral knee pain; she currently rates the pain as 8/10 in her right knee and 5/10 in her left knee. She takes meloxicam 7.5 mg twice daily and uses 1000 mg of acetaminophen for breakthrough pain about three times a day. She has been using this regimen for the past six months, but over the last month, she has not been getting adequate relief from her pain, has been progressively disabled, and has stopped exercising.
The pain is attributed to osteoarthritis and has progressively worsened over the last 1-2 years. She has a past medical history of hypertension, dyslipidemia, depression, obesity, and osteoarthritis. She has a past surgical history of a hysterectomy approximately five years ago. She is currently on simvastatin, lisinopril, meloxicam, acetaminophen, and aspirin. She has no known allergies.
She has no history of alcohol, drug, or substance abuse. She has a strong family network, including a supportive husband of 25 years and two sons who live within twenty miles of her home. She has a history of depression but is currently not depressed.
The physical exam is significant for obesity (BMI of 34). She has crepitus in both her knees and cannot reach full extension in the right knee due to pain.
An x-ray demonstrates moderate arthritic changes in both knees. The patient is unwilling to consider surgery on her knees.
The prescriber offers tramadol immediate-release 25 mg in the morning, which is titrated every three days in 25 mg increments as distinct doses to 100 mg/day (25 mg four times daily). Pain control was still inadequate, and the dose increased to 50 mg every 6 hours.
Pain control was significantly improved, and the patient was given tramadol sustained-release (SR) 200 mg once a day. The patient could function and exercise, and her quality of life was much improved.
Conclusion
The use of controlled substances is laced with risks for the prescriber and the patient. Abuse, misuse, drug diversion, and overdose are potential complications of opioid use.
Prescribers must be knowledgeable in pain assessment, addiction, and the appropriate management of pain. Multiple techniques are important to implement to reduce the risks associated with opioid therapy, including informed consent, controlled substance agreements, screening for drug abuse, patient education, teaching patients about proper storage and disposal of medications, and monitoring patients using controlled substance monitoring programs.
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