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Prescribing Controlled Substances and Drug Diversion, Best Practices

4.00 Contact Hours
A score of 80% correct answers on a test is required to successfully complete any course and attain a certificate of completion.
Author:    Raymond M. Lengel (ARNP)

Outcomes

To prepare nurses to identify Drug diversion and apply best practices in prescribing controlled substances. In June of 2012, Senate Bill 437 was passed in West Virginia and is known as the “Governor’s Substance Abuse Bill”.  The bill included a requirement for those who prescribe, dispense or administer controlled substances to have continuing education related to prescribing controlled substances and drug diversion. This course is meant to meet the requirement for continuing education for Senate Bill 437.

Objectives

After completing this course, the learner will be able to meet the following 5 objectives:

  • List five principles in the management of chronic pain with opioids.
  • Discuss five principles of effective utilization of controlled substances.
  • Discuss five methods to manage drug addiction, drug diversion and drug seeking behavior.
  • List six key points when providing patient education while prescribing opioids.
  • Discuss the use of the West Virginia Controlled Substances Monitoring Program.

Introduction

Prescription opioid abuse takes a heavy toll on the patient, healthcare provider and society.  Abuse and misuse of controlled substances occurs 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 (Sehgal, Manchikanti, & Smith, 2012).    

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 occur frequently in a large family medicine training program.  More training and set policies for risk evaluation and monitoring for opioid abuse is needed (Lewis, Herndon, & Chibnall, 2012).

Prescriber lack of training and inexperience can have a profound impact on misuse of medications. In a recent study, 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 (Colburn, Jasinski & Rastegar, 2012).

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 (Brown, Swiggar, Dewey & Ghulyan, 2012).

Drug Abuse

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

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 (Boscarino, Rukstalis, Hoffman, Han, Erlich, Gerhard, & Steward, 2010).  Those at high risk for addiction would be better managed in concert with a specialist (Sehgal, Manchikanti, & Smith, 2012).

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, drug-to-drug and drug-to-disease interactions.  

Opioid misuse and abuse is a major public health problem and it affects 34.2 million Americans over the age of 12 (SAMHSA, 2012).  According to the Center for Disease Control and Prevention (CDC) 46 people die each day in the United States from an overdose of prescription painkillers.  In 2012, healthcare providers wrote 259 million prescriptions for painkillers (CDC, 2014).  Two times as many painkiller prescriptions are written in the United States as in Canada. 

Prevalence

Abuse/misuse prevalence is variable.

  • Of individuals over the age of twelve, 4.6 % reported non-medical opioid use within the last year.
  • Of U.S. veterans treated in Primary Care settings, 4.8 % of U.S. veterans reported opioid analgesic misuse (Becker, Fiellin, Gallagher, Barth, Ross, & Oslin, 2009).
  • 12.2 % of 12th graders reported ever abusing opioid and 7.9 % reported past-year use (Merikangas & McClair, 2012). 
  • Of those who were prescribed opioids, dependence may be as high as 26% (Boscarino, Rukstalis, Hoffman, Han, Erlich, Gerhard & Stewart, 2010).

The number of individuals who sought treatment for non-heroin opioid substance abuse increased from 1.0% in 1995 to 8.7% in 2010 (Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, 2013).  Research also shows that white individuals account for 88% of those who reported non-heroin opioid substance abuse and the majority of these individuals lived in rural settings.  Those who live in rural settings account for 10.6% of cases and urban individuals account for 4.0% of non-heroin opioid abuse. (Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, 2012). 

In 2010, there were 16,650 cases of drug overdose deaths involving opioid analgesics out of approximately 38,000 overdoses (Jones, Mack, & Paulozzi, 2013).  Of the overdose deaths from opioid analgesia, 30% also involved benzodiazepines. 

Opioid dependence costs the United States health care system one billion dollars annually (National Consensus Development Panel on Effective Medical Treatment of Opiate Addiction, 1998).  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 the opioid abuse.  In addition, opioid misuse may lead to other diseases such as HIV, hepatitis and sexually transmitted diseases.   

DSM-5 Substance Use Disorders

According to the newly revised 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)

Chronic Pain

Chronic pain affects approximately 76.2 million Americans (National Centers for Health Statistics, 2006).  Pain is a common problem seen in Primary Care with about 20% of outpatient visits being for pain issues (Alford, Liebschutz, & Chen, 2008).  Chronic pain affects about one in two long-term care residents (American Medical Director Association, 2009). 

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 work days in the United States  and costs the American taxpayer over 100 billion dollars (Stewart, Ricci & Chee, 2003).

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 wide spread pain (3.6%).  Many individuals affected by chronic pain have more than one type of pain (Hardt, Jacobsen, & Goldberg, 2008).

Pain is defined as, “An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage (Merskey & Bogduk, 1994).

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.

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”.  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 (America Psychiatric Association, 2013). 

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 (Chou, Fanciullo, Fine, Adler, Ballantyne, Davies, Donovan, Fishbain, Foley, Fudin, Gilson, Kelter, Mauskop, O’Connor, Passik, Pasternak, Portenoy, Rich, Roberts, Todd, Miaskowski,  2012).  When deciding to prescribe opioids the risks versus benefits must be considered. 

The use of 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 evidence exists as to who responds better between long-acting and short-acting opioids in relation to effect and side effects (Manchikanti, Abdi, Atluri, Balog , Benyamin, Boswell, Brown, Bruel, Bryce, Burks, Burton, Calodney, Caraway, Cash, Christo, Damron, Datta, Deer, Diwan, Eriator, Falco, Fellows, Geffert, Gharibo, Glaser, Grider, Hameed, Hameed, Hansen, Harned, Hayek, Helm, Hirsch, Janata, Kaye, Kaye, Kloth, Koyyalagunta, Lee, Malla, Manchikanti, McManus, Pampati, Parr, Pasupuleti, Patel, Sehgal, Silverman, Singh, Smith, Snook, Solanki, Tracy, Vallejo, Wargo; American Society of Interventional Pain Physicians, 2012).

A recent survey showed that individuals will 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.  (Bouland, Fine, Withers, Jarvis, 2015).  

Management of Chronic Pain with Opioids

A comprehensive medical history is the first step in the workup of individuals experiencing chronic pain.  Many healthcare providers believe pain is the fifth vital sign (Lorenz, Sherbourne, & Shugarman, 2009).  A comprehensive medical history should include an evaluation of the patient’s medical and surgical history and a medication list. 

The comprehensive medical history must include a detailed description of the pain.  The pneumonic: OLD CARTS is sometimes used to evaluate 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 there any 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 the pain?   

Document the impact the pain is having on the patients’ quality of life.  Ask:

  • 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 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 (American Medical Director Association, 2009).   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:
  • What are the patient’s treatment goals?
  • Why does the patient think they have persistent pain?
  • Does the patient feel there was sufficient work-up done on their condition?

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:

  • Current and past treatments
  • History of substance abuse
  • Underlying conditions

The physical examination should include:

  • Hygiene, dress and appearance  - Those in severe pain will often have poor hygiene and be unkempt in appearance
  • A detailed neurological examination
  • Assessment of skin and joints for redness, swelling or deformities which may help determine the location and etiology of pain
  • Assessing for joint range of motion
  • Inspecting for any splinting
  • An abdominal examination for any tenderness, mass or distention 

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 increase use of opioids, activity restriction, and increased fear. 

An electromyogram (EMG) or other nerve condition studies assess the cause of pain.  The EMG measures 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 nerve conduction study measures the capacity of the nerves to transmit electrical signals and assists in the diagnosis of multiple types of neuropathies.

Objectives of Treatment

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 in regard to 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. 

Side Effectives of Opioids

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.

Constipation is a frequent issue for those who use opioids. Risk factors for constipation include: older age, those with intra-abdominal pathology and those who eat a low fiber diet.  Patients on opiates should be encouraged to increase fiber intake, drink plenty of fluids and exercise.  Stool softeners (e.g., docusate sodium) and stimulants (e.g., bisacodyl) may be needed to manage the constipation.  An osmotic laxative such as polyethylene glycol or lactulose may also be considered and may be added to stools softeners/stimulants for resistant constipation. 

Antiemetic medications can help treat nausea. Antihistamines can relieve or lessen pruritus. Opioids are associated with somnolence and other mental status changes. Patients do develop tolerance to these symptoms over weeks. Reducing the dose of opioids may lessen the mental status changes.  An adjunctive medication may be added to the lower dose of opioid to help manage the pain. Rarely, the use of a stimulant can be used to manage the sedation due to opioid use.   

Respiratory depression may occur but it is uncommon when the medication is used carefully. Starting with a low dose and slowly titrating the dose higher will reduce the risk of respiratory depression. Problems arise with rapid titration, the addition of another drug that may depress the respiratory drive (benzodiazepines, alcohol or a barbiturate) or the patient overdoses. Sedation precedes respiratory depression so when starting a patient on opioid therapy the patient should be encouraged to take the first dose in the office to be monitored or in the presence of a responsible adult who can help monitor the patient. The level of consciousness should be assessed at least every 30-60 minutes after the opioid is given.  The next dose should be held and the prescriber should be contacted immediately if a reduced level of consciousness occurs, hypoxia develops or the respiratory rate is less than 10 per minute (American Medical Director Association, 2009).

Drug Interactions

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. Drug interactions may occur because of hepatic metabolism.  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% (Pergolizzi, Labhsetwar, Puenpatom, Joo, Ben-Joseph, Summers, 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 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, flouroquinolones and diphenhydramine. Levels may be decreased with carbamazepine and phenytoin.   Fentanyl levels may be increased by SSRIs, protease inhibitors, diltizem, 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.

Referrrals and Consultations

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. 

Termination Strategies for Chronic Therapy

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. 

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

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

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

Techniques for Safe and Effective Treatment

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 (Turk, Wilson, & Cahana, 2011).  One of the problems encountered is that general practitioners have limited training in the management of chronic pain (Institute of Medicine, 2011). The use of a pain management specialist is often needed to manage pain properly. 

The World Health Organization (WHO) analgesic ladder was created for the management of cancer pain and published in the 1980s (World Health Organization, 2014).  Key points of the analgesic ladder include:

  • Medications are given though 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, 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 used for moderate to severe chronic pain on a fixed schedule (not as needed).

This approach is 80-90% effective.

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

While the patient is being treated for pain the prescriber should assess and document the effect on functional status, pain control, intensity of pain and side effects.   

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

Steps a prescriber can take include (Manchikanti, Abdi, & Atluri, 2012):

  1. Assessment and documentation of a comprehensive history including medical history, substance abuse history, current medications including dosages, route and time (including opioids), psychiatric and psychosocial history.
  2. Establishing a physical and psychological diagnosis and establish medical necessity before starting or maintaining opioid therapy.  Those with mental illness are at higher risk to abuse medications.
  3. Screening for substance abuse history because substance abusers are at increased risk to misuse controlled substances.   
  4. Establishing goals in therapy in regard to pain control and functional goals. 
  5. Using prescription monitoring programs to help determine patterns of prescription use and reducing abuse of medications.  These are state-run databases that track controlled substance prescriptions and help find issues with over prescribing and misuse patterns. 
  6. Considering contraindications prior to prescribing opioids such as acute psychiatric instability, uncontrolled suicide risk, opioid allergy, respiratory instability, history or current abuse of substances or alcohol, current use of benzodiazepines, current use of heavy doses of other central nervous system depressants, current use of other medications that have severe drug interactions or those who practice diversion of controlled substances.  
  7. 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. 
  8. A written agreement between prescriber and patient (see Table 1) when opioids are used that reduce the risk of abuse, diversion, misuse and overuse.
  9. Discussing the risks and benefits of the medications.
  10. Obtaining an informed consent prior to prescribing controlled substances.
  11. In generally, starting opioid therapy at low doses with short-acting medications.
  12. Using long-acting opioids in high doses only for severe intractable pain that cannot be adequately managed with short-acting opioids or moderate doses of long-acting opioids.
  13. Using caution when titrating with long-acting opioids and considering the potential for overdose and misuse.
  14. Considering consultation for those who require high-dose opioid therapy.
  15. Being the only prescriber of all opioids for a given patient.
  16. Monitoring for and managing constipation.
  17. Prescribing the lowest effective dose and the smallest quantity needed based on the expected length of the pain. 
  18. Periodically reviewing the treatment plan including any new information about the patient, their condition and their pain and progress toward their goals. 
  19. Keeping accurate records.
  20. Being compliant with all laws and regulations related to controlled substances.
  21. Individualizing treatment based on the patients prior exposure to opioids, response to treatment and adverse events.
  22. Monitoring for aberrant drug-related behaviors.

Discontinuing chronic opioid therapy in those who repeatedly engage in aberrant drug related behaviors, do not progress toward established goals, or those who experience significant side effects. Patients who have been taking the opioid for an extended time should have the medication tapered slowly.   A 10% taper per week will minimize the symptoms of withdrawal.  Some recommend a faster taper such as 20 – 50% per week for those who are not addicted (Department of Veteran Affairs and Department of Defense, 2014).  

Tips to Reduce Iatrogenic Harm

Have an upper dosing threshold. Risk of accidental overdose increases with higher doses of opioids.  Prescribers should generally avoid doses of morphine or morphine equivalents more than 90 - 200 mg/day (Nuckols, Anderson, Popescu, Diamant, Doyle, DiCapua, & Chou, 2014).

Use caution with certain medications.  For example, methadone should only be used by a prescriber who is extremely comfortable with the medication.  Fentanyl is another medication that requires extreme caution as there is unpredictable absorption – especially with the patch. 

With opioid use, respiratory depression is more likely in the older population and those who are cachectic or debilitated. Patients at high risk should be monitored more closely and opioids should not be given in combination with other respiratory depressants. The dose of opioids should be started at one-third to one-half the typical starting dose in at risk patients. Titration should be done carefully.  Constipation is more likely and a bowel regime should be prescribed when opioids are used. 

When starting opioid therapy it should be initially started as a therapeutic trail that may last from several weeks to several months. The decision to continue the therapy must be carefully considered based on the outcomes of the trail such as progress toward meeting goals, side effects, changes in the underlying condition causing pain and any concern for medication misuse and/or addiction.

The greatest risk of opioid use is respiratory arrest and death and this risk is greatest when therapy is started or the dose is increased.  Opioid induced respiratory depression is manifested by the reduced desire to breath and reduced respiratory rates.  The patient will be breathing shallow and CO2 retention can exacerbate the sedating effects of opioids.  If this is noted, the family should call 911.

Opioids should not be used in those with respiratory depression.  Titration must be done slowly and when changing formulations do not overestimate the converting dosage.    

Opioid rotation – changing from one opioid regime to another with the goal of reducing adverse events and improving therapeutic outcomes - may be considered.  Tolerance to one opioid can lessen the analgesic effects and the use of a different opioid may result in an improved analgesic effect and less adverse effects. 

When opioid rotation is done it requires the prescriber to determine the approximate equianalgesic dose.  This is the ratio used to get about the equivalent analgesic effect.  When switching from one opioid to another, the dose should be reduced by 25 – 50% to prevent adverse effects.  Multiple computer programs or applications for mobile devises are available to help with this conversion. 

Avoid combinations of opioids and benzodiazepines.  When these two classes are combined, particularly if more than 100 mg of morphine or morphine equivalents per day are used, risk of accidental overdose is high. 

Urine drug testing should be considered to assure medication adherence. 

Pay attention to drug-to-drug and drug-to-disease interactions.

To prevent prescription drug abuse the prescriber needs to assure:

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

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 (Chou, Fanciullo, Fine, Adler, Ballantyne, Davies, Donovan, Fishbain, Foley, Fudin, Gilson, Kelter, Mauskop, O'Connor, Passik, Pasternak, Portenoy, Rich, Roberts, Todd, Miaskowski, American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel, 2009).

Assessment

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 the risk of abuse, substance abuse and psychiatric history should be considered.  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 history, behavioral problems, employment history, marital history, social network and cultural background should be assessed.  History of substance abuse does not prohibit treatment with opioids but may necessitate more intensive monitoring or referral to an addiction specialist. 

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

Follow-Up

Patients prescribed regular opioid therapy should be seen for monitoring at a minimum of every three months.  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 effect treatment is having.

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 patients improved ability to function physically or psychologically.  It should include what goals are recommended (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 inadequate progress toward goals are not being achieved. 

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).

Table 1: Points Commonly Seen in Opioid Agreements
  • Early refills will generally not be given.
  • Patient will not seek controlled substances from another provider.
  • Patient will use only one pharmacy.
  • Permission for the prescriber to speak freely with other healthcare providers, pharmacists and family members regarding opioid use.
  • Patient will submit to urine drug testing.
  • The patient will safeguard the medications.
  • Common side effects of the medication will be discussed.

Prescription monitoring programs are available in the majority of states (discussed later).  They provide an online database which lists all prescriptions of controlled substances dispensed for each patient by pharmacies.  Ideally, the prescriber should check the database before prescribing controlled substances.  If a patient has an undisclosed prescription for controlled substances it is prescription drug misuse.

Clinician Response

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.   

Opiods

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 osteoarthritis, low back pain, neuropathic pain, and post herpetic neuralgia. 

In recent times, opioid therapy has become more commonly used. In the past, it was only used for severe acute pain and cancer pain.  It is now the most common class of medications prescribed in the United States (Kuehn, 2007).

A recent 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 (Franklin, 2014).  

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 (Martell, O'Connor, & Kerns, 2007).   Opioid therapy is often used to manage neuropathic pain, but is commonly thought to be second line to antidepressants and anticonvulsants.

Federal and State Laws

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 in regard to 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 (Center for Disease Control, 2007).    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. 

Patient Education on Opioid Medications

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

Medications associated with a high risk of respiratory depression are schedule II opioids.  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 extend 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 is critical. 

Information on abuse should be taught to the patient.  Many patients, who end up abusing opioid medications, usually got a valid initial prescription.  The majority of patients who abuse medications get them - either by buying or stealing - from an acquaintance (most typically a friend or relative) (CDC, 2014).   

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 as a means 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 in spite of harm.

Key points in patient education include:

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

Registration as a Prescriber in West Virginia

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.

The database must be registered for and accessed when a pain relieving controlled substance is prescribed.  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 thus allowing them to better evaluate patients 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 who have been credentialed and they have to 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 https://www.csapp.wv.gov

Drug Diversion

Methods to obtain drugs illegally include:

  • Burglary/robbery
  • Stealing prescription pads and writing prescriptions
  • Faking injuries
  • Doctor shopping
  • Prescription forgery – photocopying, changing numbers on the prescription
  • Writing out numbers make modifying numbers on prescriptions much more difficult
  • Fraudulently phoned in prescriptions

Techniques to reduce drug diversion are:

  • Write in ink
  • Use electronic prescribing
  • Clearly mark the number of refills – mark through the unused portions
  • Lock up the prescription pad

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

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

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

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 things typically get better. 

For any misuse, the prescribers’ actions should depend on the severity of the infraction.  One minor deviation should result in more monitoring and counseling.  More severe or repeated misuse may lead to discontinuation of the medication.  When diversion is the offense, abrupt withdrawal and immediate referral to an addiction specialist is typically appropriate.

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 though 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. 

Case Study 1

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 COPD, hypertension, Stage III CKD, anxiety/depression and osteoarthritis of his knees and low back pain.  He is currently on a daily aspirin, amlodipine, citalopram, an albuterol inhaler 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 he states that his pain has been worsening.  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:

A list of goals:

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

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

Case Study 2

Helen is 42 year-old nurse with chronic back pain due to two herniated discs and spinal stenosis which was first diagnosed after lifting a patient three years ago.  She currently rates the severity of her back pain as an 8/10 and has been unable to work as a floor nurse 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.

Helen 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 the 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 really 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 sertraline. The psychiatrist was unable to make an assessment related to opioid abuse.    

With the help of the pain specialist, oxymorphone ER 5 mg was ordered every 12 hours.  The patient was told to follow-up in one week to assess effectiveness.  After one week the patient reports 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 to not only 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. 

Conclusion

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.

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This course is applicable for the following professions:

Advanced Registered Nurse Practitioner (ARNP), Clinical Nurse Specialist (CNS), Licensed Practical Nurse (LPN), Licensed Vocational Nurses (LVN), Registered Nurse (RN)

Topics:

Advance Practice Nurse Pharmacology Credit, CPD: Practice Effectively, CPD: Preserve Safety, Pharmacology (All Nursing Professions), Tennessee APN requirment, Utah APN requirement, West Virginia APN Requirement


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