To prepare nurses to identify Drug diversion and apply best practices in prescribing controlled substances.
After completing this course, the learner will be able to meet the following 5 objectives:
Prescription opioid abuse takes a heavy toll on the patient, healthcare provider and society. Abuse and misuse of controlled substances occur for multiple reasons including self-medication, use for reward, diversion for profit and compulsive use. Opioid use has increased in recent times leading to an increase in abuse and opioid overdoses. Proper screening lowers the risk of iatrogenic addiction. Unfortunately, no currently available screening method accurately predicts who is at high risk to abuse or misuse opiates.1
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 for opioid abuse are needed.2
Health care 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% and abnormal urine drug tests, almost 11% reported crushing or chewing opioids in the past and 60% of patients self-reported abuse, misuse or diversion.3
Prescriber lack of training and inexperience can have a profound impact on the misuse of medications. One study showed that resident physicians (when compared to attending physicians) more often prescribed opioids for more than three months, were more likely to have their patients report that their prescriptions were lost/stolen, were more likely to have patients who exhibited substance misuse and were more likely to have their patients get opioids prescribed by a different prescriber in addition to them.4
Prescribers receive little training in how to prescribe scheduled substances, how to screen for substance abuse and how to refer patients who need treatment for substance abuse. Proper continuing education is one way to address this problem.5
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 major 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.6 Those at high risk for addiction would be better managed in concert with a specialist.1
Opioid use disorder is a use pattern of opioids that result in problems or distress. It may include tolerance, impaired social functioning, loss of control of opioid use, dangerous opioid use and/or withdrawal. To meet diagnostic criteria patients with an opioid use disorder must have at least 2 of the 11 symptoms over 12 months.7 These symptoms include: taking opioids in larger amounts or over a longer period of time than intended, a strong desire for opioids, using in physically dangerous circumstances, stopping or reducing activities due to opioids use, withdrawal, unsuccessful attempts to control use, problems fulfilling obligations, spending a significant amount of time obtaining medications or recovering from the medications, tolerance, continued use despite social/personal problems, or continued use despite psychological or physical problems.
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.
Opioid dependence costs the United States health care system one billion dollars annually.17 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.
According to the fifth edition of the Diagnostic and Statistical Manual from the American Psychiatric Association, 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.”
(American Psychiatric Association DSM-5, 2013)7
Chris T. is a 58-year-old widowed male. He presents to the Emergency Department upon being found on the couch by his son in an unresponsive state. His son was able to wake him, but his speech was incoherent.
Mr. T’s past medical history is positive for hypertension, hyperlipidemia, Stage III CKD, anxiety/depression and osteoarthritis of his knees and low back pain. He is currently on a daily aspirin, amlodipine, citalopram, atorvastatin and hydrocodone/acetaminophen.
Mr. T. has been taking the hydrocodone /acetaminophen 1 - 2 times a day for over three years. About three months ago, he presented to the Emergency Department with a similar presentation and was discharged after six hours with no definitive diagnosis, but was given a prescription for more hydrocodone /acetaminophen for pain.
Mr. T’s son reports that Mr. T. has not been coming to as many social events over the last month because his pain level has increased. The Emergency Department nurse practitioner notes that the vital signs (including oxygen saturation) are stable, but the patient is somnolent. He does wake when stimulated and answers only yes/no questions. His blood work, including liver/kidney function tests, glucose, and metabolic profile, are negative except he is shown to have Stage III CKD (but at baseline for the patient). His drug screen is positive for opioids.
Mr. T. is admitted to the hospital, and the next day is back to his baseline. He does report that his pain has been worse and that he has been taking more than his prescribed dose of oxycodone/acetaminophen.
The patient’s symptoms are thought to be caused by sedation due to the opioids and his impaired kidney function leading to a buildup of metabolites. He is discharged from the hospital and is seen by his primary care provider the next day.
His primary care provider recognizes that his pain is poorly controlled leading to him overdosing on opioids. Due to his CKD, NSAIDs are not appropriate options. Managing his depression/anxiety along with closely monitored opioid therapy, with extensive counseling on safe use is implemented.
The patient is given a treatment plan that includes:
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.
Chronic pain affects approximately 76.2 million Americans.18 Pain is a common problem seen in primary care with about 20% of outpatient visits being for pain issues.19 Chronic pain affects about one in two long-term care residents.20
Persistent pain is often associated with anxiety, depression, functional impairment, sleep disturbances, disability and impairment in activities of daily living. Every year, chronic pain leads to more than 50 million lost workdays in the United States and costs the American taxpayer over 100 billion dollars.21
Chronic pain is defined as pain lasting more than 3 months and may affect any part of the body. Chronic pain is most frequently caused by back pain (10%), leg/foot pain (7%), arm/hand pain (4.1%), headache (3.5%), and widespread pain (3.6%). Many individuals affected by chronic pain have more than one type of pain.22
Pain is defined as “An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.”23
Acute pain is defined as “Pain that has an abrupt onset and offers a warning of a disease process or a threat to the body.”23
Chronic pain is defined as “Pain that lasts beyond the usual duration of time that an insult or injury to the body needs to heal.”23 Chronic pain can also be viewed as pain without apparent biologic value that has lasted beyond the usual tissue healing time (typically at least three months). Some define chronic pain as pain that continues for at least six months.7
Opioids are indicated for pain conditions. An expert panel concluded that chronic opioid therapy may be effective for some individuals with chronic non-cancer pain that have been thoughtfully selected.24 When deciding to prescribe opioids, the risks versus benefits must be considered.
The use of high dose long-acting opioids is used only in specific circumstances with severe, intractable pain that has not responded to short-acting or moderate doses of long-acting opioids. No evidence exists as to who responds better between long-acting and short-acting opioids in relation to effect and side effects.25
A recent survey showed that individuals would go to extreme lengths to obtain certain prescriptions medications. Opioids were the most commonly obtained medications, followed by the sedative-hypnotics and amphetamines. Individuals who seek these medications are more likely to use more than one physician and more than one pharmacy. This survey showed that seventy-five patients feigned symptoms to get prescriptions, two of thirty-six used falsified MRI images, three patients paid the prescribers and three harmed themselves to get the prescriptions.26
A comprehensive medical history is the first step in the workup of an individual experiencing chronic pain. Many healthcare providers believe pain is the fifth vital sign. A comprehensive medical history should include an evaluation of the patient’s medical and surgical history and a review of the medication list.
The comprehensive medical history must include a detailed description of the pain. The pneumonic: OLD CARTS is sometimes used to evaluate pain.
Document the impact the pain is having on the patient’s quality of life. Ask:
Measuring the intensity of pain is often done on scales and are meant to compare the intensity of the patient’s pain at different points in time, 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 to use, and use both behavioral and descriptive measures of pain.20 A scale commonly used rates pain from 0 to 10. Another scale allows the patient to rate their pain as no pain, mild pain, moderate pain, severe pain, or unbearable pain. Other scales have the patient select the degree of pain on a pictorial scale with facial expressions. Pain maps are helpful in 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 location of the pain and rates the severity of the pain.
The patient’s perception of the pain should be reviewed:
Psychological factors that contribute to the pain should also be assessed. It is important for patients to have reasonable expectations about the pain and its management.
All patients with chronic pain should have a complete physical examination. It is important to have a baseline physical examination, so ensuing evaluations will permit the healthcare team to establish progress in how well the pain is being managed.
Other key features that should be assessed prior to treatment include:
The physical examination should include:
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 an elevated erythrocyte sedimentation rate is often present in individuals with polymyalgia rheumatica, infection or rheumatoid arthritis.
Imaging can be useful in some cases of chronic pain. X-rays, computed tomography and magnetic resonance imaging can be helpful in determining the cause of the pain. Remember diagnostic testing needs to be interpreted carefully as some abnormalities may be incidental and not the source of the pain.
Caution should be used when evaluating patients as overuse of imaging or other diagnostic modalities may lead to increased use of opioids, activity restriction, and increased fear.
An electromyogram (EMG) or a nerve condition study (NCS) assess the cause of pain. The EMG measures the electrical activity of the muscle and can be helpful in finding damaged muscle, nerves or neuromuscular abnormalities such as a herniated disc or myasthenia gravis. The NCS measures the capacity of the nerves to transmit electrical signals and assists in the diagnosis of multiple types of neuropathies.
An important 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 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 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.
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.27
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.28
In 2018, the Joint Commission changed their standards in the management and assessment of pain.29 Some of their modifications included:
Risk Factors for Opioid Abuse
There are many known risk factors of opioid abuse, misuse, diversion, addiction, and overdoses.30 Evaluating these risk factors are an important aspect in the evaluation of a patient. Factors that increase the risk of problematic opioid use include:
How do Drug Abusers Get Drugs?
Removing prescription medications from legitimate channels is drug diversion and can occur in many ways.
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.
Opioid medications are associated with multiple side effects including constipation, nausea, vomiting, pruritus, abdominal cramping, sedation and mental status changes. Multiple interventions are available to reduce or eliminate the side effects of opioids.
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%.32
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.33 One of the problems encountered is that general practitioners have limited training in the management of chronic pain.34 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 include 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.35
When high doses of 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.36
The World Health Organization (WHO) analgesic ladder was created for the management of cancer pain and published in the 1980s.37 Key points of the analgesic ladder include:
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 schedule 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 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 include25:
To prevent prescription drug abuse, the prescriber needs to assure:
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.24
Informed consent provides written documentation regarding the benefits and risks of the therapy and discusses the 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 addiction 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 of 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.40 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 adjustment36. 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.
When abuse/misuse is detected, how should the clinician respond? If it is a single, minor deviation, then counseling, along with more intensive monitoring, may be all that is needed. Tapering controlled substances to reduce the risk of withdrawal is appropriate in more severe or persistent cases of misuse. When diversion is the cause of misuse, immediate removal of the prescription is likely the best course. If a substance abuse disorder is suspected, a referral to an addiction specialist is recommended.
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 postherpetic 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.41
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.42
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.43 Opioid therapy is often used to manage neuropathic pain but is commonly thought to be second line to antidepressants and anticonvulsants.
In 2011, the White House Office of National Drug Control Policy was introduced with the intent of addressing prescription drug abuse. It provided support to states to expand prescription drug monitoring programs, worked to eliminate “pill mills” and educated healthcare providers and patients.
In West Virginia, multiple bills were passed regarding substance abuse and controlled substances. This was likely in response, at least in part, to the 550% increase in death rates from unintentional poisoning between 1999 and 2004.44 State Bill 437 required providers who dispense, prescribe or administer controlled substances to have education. State Bill 365 provided online access to a controlled substance database which is available in all pharmacies. State Bill 362 provided more legislation that prohibited patients from obtaining prescriptions by providing false information. State Bill 81 required prescriptions to be written on tamper-proof pads.
Hospitals and pharmacies are important players in assuring safe use of controlled substances. The Food and Drug Administration (FDA) is responsible for assuring the safety of the drug supply in the United States. They require the pharmacy to confirm that prescribers and organizations they work with are licensed and registered with the FDA. Under the FDA, the hospital must investigate and handle any suspicious or known illegitimate prescriptions.
The Drug Enforcement Agency (DEA) regulates the distribution of controlled substances. The DEA is responsible for enforcing laws and regulations related to controlled substances. They also have the authority to bring about criminal or civil charges to individuals or organizations that are involved in illicit traffic of controlled substances.
The Environmental Protection Agency (EPA) helps assure that there is proper disposal of pharmaceutical waste to help ensure that there is little pharmaceutical waste in the environment such as the ground and drinking water. The EPA has regulations that the pharmacy must follow.45
Patient education is important 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 than 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).46
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 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:
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 made.
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.
West Virginia has a controlled substance monitoring act that records and retains information about the prescribing, consumption and dispensing of controlled substances. This is established in West Virginia Code, Chapter 60A, Article 9. This Chapter/Article discusses access to the West Virginia Controlled Substance Monitoring Program database.
The database must be registered for and accessed when a pain-relieving controlled substance is prescribed as part of the management of chronic, nonmalignant pain, in individuals not suffering from a terminal illness. The database should be evaluated for undisclosed prescriptions of controlled substances, which is a sign of misuse or may indicate diversion or addiction. In addition, at least annually, the prescriber who continues to treat the patient should access the database for information regarding the patients they are treating with controlled substances for nonmalignant pain. The information obtained from the database should be documented in the patient’s medical record. It can also be used to confirm controlled substance prescriptions when a patient presents in an acute care setting.
The goal of the program is to keep the prescribers/dispensers informed, which allows them to evaluate patients better and identify patients who may be abusing, misusing, or diverting controlled substances.
The data is secure and is only able to be accessed by prescribers and dispensers which have been credentialed, and they must agree to maintain confidentiality to use the information. Misuse of the site may lead to civil penalties and disciplinary action.
Prescribers in West Virginia must register at www.csappwv.com.
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:
Techniques to reduce drug diversion are:
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.
When communicating, 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.
Sara is a 42-year-old physical therapy assistant with chronic back pain due to a herniated disc and spinal stenosis, which was first diagnosed after lifting a patient four years ago. She currently rates the severity of her back pain as an 8/10 and has been unable to work due to her 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 is able to do all of her ADLs but does report poor sleep at night.
She has no significant past medical or surgical history.
She has had multiple rounds of physical therapy, chiropractic treatment and numerous medications. She tried to control the back pain on acetaminophen, naproxen, ibuprofen, the lidocaine patch and topical NSAIDs without relief. The patient experienced a possible seizure while on tramadol. Epidural injections did not help. Surgery was discussed, but the patient refused this option.
Sara is single, and now that she is not working she has limited financial means. She reports having a problem with drinking in her twenties but has not had a drink in three years. She currently smokes. She denies any history of substance abuse, and there is no family history of alcohol or substance abuse.
Physical examination 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 was significant for 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 low risk for opioid abuse. She signed a written opioid treatment agreement that outlines the conditions of opioid therapy. The state prescription drug monitoring program was queried and showed no suspicious activity.
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, she calls for an early refill and reports that the medication is not helping her pain and she just lies around all day.
She comes back into the office for re-evaluation and reports she needed to take more pain medication than prescribed. It was reviewed with the patient that she violated the opioid agreement. A urine sample was obtained that showed no illicit substances or medications that would not be expected in the urine. The prescription drug monitoring program did not show that she got any other prescriptions in the interim.
She was referred to a psychiatrist and a pain specialist. She was agreeable to both. She 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 her on duloxetine (which may also help with pain). 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 she 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, she 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.
The use of controlled substances is laced with risks for the prescriber and the patient. Abuse, misuse, drug diversion and overdose are all potential complications of opioid use.
Prescribers must be knowledgeable in pain assessment, knowledge of addiction and the appropriate management of pain. Multiple techniques are important to implement to reduce the risks associated with opioid therapy including: informed consents, 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.