RESPONSIBLE OPIOID PRESCRIBING

Responsible prescribing involves individual prescribers following best practices and taking action to balance the risks and benefits of opioid pain management for each patient. Three important components to responsible prescribing include

  • Thorough patient assessment
  • Treatment plan design
  • Periodic monitoring

Both the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain and the West Virginia Safe and Effective Management of Pain (SEMP) Guidelines provide recommendations for prescribing opioid pain medications.

Patient Assessment

A thorough patient assessment is critical prior to prescribing opioid medication for chronic pain. It is important to properly diagnose the condition to determine if opioid medication is an appropriate treatment. A well-documented patient history that includes past medical history, medication history, social history, family history, and psychosocial history is critical. Assessing and documenting a personal or family history of substance misuse is also important.

ASSESSING PAIN

Proper diagnosis of the painful condition helps to assure that opioid medication is an appropriate treatment. It can be challenging, however, since pain is subjective and multidimensional. The patient’s self-report of pain is the most reliable indicator, recognizing that perceptions of pain are influenced by culture, environment, emotional state, sleep patterns, and habits.

Any provider must conduct a pain assessment before they can determine what type of pain management is needed. Assessment of pain should include:

  • Context (How did the pain begin?)
  • Location (Where is the pain felt?)
  • Severity (How does the pain rate on a 0-10 scale?)
  • Quality (Is the pain sharp, stabbing, dull, pulsating, etc.?)
  • Timing (How often does the pain occur?)
  • Duration (How long has the pain been persisting?)
  • Modifying factors (What makes the pain better or worse?)
  • Chronic illness status (What conditions might impact or worsen the pain?)
  • Associated signs and symptoms (What else occurs with the pain?)

ASSESSING RISK

When clinicians assess patients with chronic pain, it is important to recognize two categories of risk due to opioid therapy: medical conditions that increase their risk for adverse events (e.g., respiratory depression) and risk of misuse, abuse, or addiction.

Risk of Adverse Events

Risk due to medical conditions are assessed and documented as part of the patient’s history and physical examination and the treatment plan adjusted accordingly to reduce risk of adverse events with opioid therapy. Older adults may be at higher risk because of cognitive decline and increased potential for falls. Patients with impaired renal or hepatic function, cardiopulmonary disease, mental health conditions, obesity, and sleep apnea are also at higher risk for adverse consequences when prescribed opioid medications.

REMS

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that may be required by the U.S. FDA to help ensure that benefits outweigh risks of certain drugs with significant safety concerns. REMS are designed to help reduce the occurrence and/or severity of certain serious risks by informing and/or supporting the execution of the safe use conditions described in the medication’s FDA-approved prescribing information. REMS have been approved for dozens of opioid analgesic medications.

(U.S. FDA, 2019)

Risk for Misuse, Abuse, and Addiction

Variables that have been associated with a higher risk for misuse, abuse, and addiction include history of addiction in biological parents, current drug addiction in the family, regular contact with high-risk groups or activities, and personal history of illicit drug use or alcohol addiction. (See also “Recognizing Aberrant Drug-Related Behaviors” later in this course.)

The use of screening tools is recommended, and multiple tools are available that can help healthcare providers to assess these risks. The specific tool to be used is determined based on:

  • The type of substance of risk (or whether the patient is at a generalized risk to misuse numerous substances)
  • The age of the patient (as certain tools are specific to children or adolescents)
  • Whether it is preferred to have the patient self-administer the screening or to have a healthcare professional do so

Examples of screening tools include:

  • Opioid Risk Tool: Administered at initial visit prior to beginning opioid therapy; questions address age, family, and personal history of substance abuse, history of preadolescent sexual abuse, and psychological diseases
  • Screening to Brief Intervention (S2BI): A series of questions regarding frequency-of-use in adolescent patients of substances most commonly used
  • Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS): A combined screening and brief assessment that addresses use-related behaviors and generates a risk level for each substance class

(See also “Resources” at the end of this course.)

Treatment Plan

Responsible opioid prescribing requires clinicians to develop treatment plans that focus on patient-centered outcomes that improve quality of life. A function-based treatment strategy that aims to maximize the patient’s quality of life and minimize the burden of their pain includes a mutual understanding between prescriber and patient covering the following principles:

  • Complete elimination of all pain is often not possible.
  • The goal of treatment is to successfully manage pain and not exclusively to reduce a pain scale score.
  • Functional goals will be collaboratively set, with the aim of improving quality of life; these goals must be realistic, achievable, verifiable, and meaningful.
  • Risks, benefits, side effects, and potential adverse consequences of opioid use will be fully disclosed.
  • Education about safe use, storage, and disposal of opioid medication will be provided.

This treatment plan must be documented, together with informed consent and patient education.

SAMPLE PATIENT AGREEMENT FORM FOR LONG-TERM CONTROLLED SUBSTANCE PRESCRIPTIONS

Patient Name: __________________

Medication(s): __________________

The use of this medication(s) may cause addiction and is only one part of the treatment for (insert name of condition): __________________

The goals of this medicine are:

  • To improve my ability to work and function at home
  • To help my condition (e.g., pain, anxiety, etc.) as much as possible without causing dangerous side effects

I have been told that:

  • If I drink alcohol or use street drugs, I may not be able to think clearly and I could become sleepy and risk personal injury.
  • I may get addicted to this medicine.
  • If I or anyone in my family has a history of drug or alcohol problems, there is a higher chance of addiction.
  • If I need to stop this medicine, I must do it slowly or I may get very sick.

I agree to the following:

  • I am responsible for my medicines. I will not share, sell, or trade my medicine. I will not take anyone else’s medicine.
  • I will not increase my medicine until I speak with my doctor or nurse.
  • My medicine may not be replaced if it is lost, stolen, or used up sooner than prescribed.
  • I will keep all appointments set up by my primary care provider (e.g., primary care, physical therapy, mental health, substance abuse treatment, pain management).
  • I will bring the pill bottles with any remaining pills of this medicine to each clinic visit.
  • I agree to give a blood or urine sample, if asked, to test for drug use.

Refills:

  • Refills will be made only during regular office hours. No refills on nights, holidays, or weekends.
  • I must call at least three (3) working days ahead to ask for a refill of my medicine. No exceptions will be made.
  • I must keep track of my medications. No early or emergency refills may be made.

Pharmacy:

  • I will only use one pharmacy to get my medicine.
  • The name of my pharmacy is: _____________________.
  • My primary care provider may talk with the pharmacist about my medicines.

Prescriptions from other doctors: If I see another healthcare provider who prescribes a controlled substance for me (e.g., dentist, emergency room doctor, provider at another hospital, etc.), I must bring this medicine to my primary care provider in the original bottle, even if there are no pills left.

Privacy: While I am taking this medicine, my primary care provider may need to contact other healthcare providers or family members to get information about my care and/or use of this medicine. I will be asked to sign a release at that time.

Termination of Agreement: If I break any of the rules or if my primary care provider decides that this medicine is hurting me more than helping me, this medicine may be stopped by my primary care provider in a safe way.

Patient signature: _________________________
Date: _______________________

(NIDA, n.d.)

Periodic Monitoring

It is critical to regularly reevaluate the appropriateness of continuing opioid therapy due to changes in pain etiology, health condition, progress toward functional goals, and addiction risk. To corroborate self-reports, review of data within the prescription drug monitoring program should be conducted at each visit (see “Prescription Drug Monitoring Programs” later in this course). Periodic monitoring should also include urine tests and pill counts when appropriate.

Clinicians must utilize screening and monitoring for all patients on chronic opioid therapy to document patient outcomes and progress toward functional goals. The Pain Assessment and Documentation Tool (PADT) is a practical tool that clinicians can use at each patient visit and incorporate into electronic records (see “Resources” at the end of this course). It offers a simple checklist to monitor the “Five As” of pain management.

THE FIVE As OF PAIN MANAGEMENT
(Bazzo et al., 2019)
Analgesia A reduction in pain
Activities of daily living Improvement in level of function
Affect Changes in mood
Adverse effects Falls, decreased cognitive function, constipation, etc.
ADRBs Aberrant drug-related behaviors

Periodic monitoring timing will vary with each patient. The CDC (n.d.-a) recommends checking monitoring every three months at the minimum, and before refilling an opioid prescription at any time. State requirements may vary. The State of West Virginia Office of the Attorney General’s “Best Practices for Prescribing Opioids in West Virginia” (2016) follows the exact same periodic monitoring timing as the CDC.

CDC Clinical Practice Guideline for Prescribing Opioids for Pain

In 2022, the CDC updated its guidelines for prescribing opioids for the treatment of pain. Whereas the 2016 guideline focused on recommendations for primary care physicians, the newer guideline expands the scope to additional clinicians whose scope of practice includes prescribing opioids (e.g., physicians, nurse practitioners and other advanced-practice registered nurses, physician assistants, and oral health practitioners). The 2022 guidelines address four main issues, including:

  • Making a determination about whether or not to initiate opioids for pain
  • Selecting the appropriate opioid and determining the dosage
  • Deciding the duration of the initial opioid prescription and conducting follow-up
  • Assessing the risk and addressing the potential harms of opioid use with the patient

The recommendations in the 2022 guidelines aim to improve communication between clinicians and patients about the risks and effectiveness of pain treatment; improve pain, function, and quality of life for persons with pain; and reduce the risks associated with opioid pain treatment (including opioid use disorder, overdose, and death) as well as with other pain treatment.

The practice guidelines include 12 recommendations for clinicians who are prescribing opioids for outpatients ages 18 years and older with pain that is acute (duration of <1 month), subacute (duration of 1–3 months), or chronic (duration of >3 months), excluding pain management related to sickle cell disease, cancer-related pain treatment, palliative care, and end-of-life care.

  1. Nonopioid therapies are at least as effective as opioids for many common types of pain. Maximize the use of nonpharmacologic and nonopioid pharmacologic therapies appropriate for the condition and the patient, and only consider opioid therapy for acute pain if benefits are expected to outweigh risks to the patient. Discuss benefits and risks with the patient prior to prescribing opioid therapy.
  2. Nonopioid therapies are preferred for subacute and chronic pain. Maximize use of nonpharmacologic and nonopioid pharmacologic therapies as appropriate for the specific condition and patient. Consider opioid therapy if expected benefits are anticipated to outweigh risks, and work with the patient to establish treatment goals for pain and function. Consider how opioid therapy will be discontinued if benefits do not outweigh risks.
  3. When starting opioid therapy for acute, subacute, or chronic pain, prescribe immediate-release opioids instead of extended-release and long-acting (ER/LA) opioids.
  4. When opioids are initiated for opioid-naive patients with acute, subacute, or chronic pain, prescribe the lowest effective dosage. If opioids are continued for subacute or chronic pain, prescribe the lowest effective dosage. Avoid increasing dosage above levels likely to yield diminishing returns in benefits relative to risks.
  5. For those patients already receiving opioid therapy, carefully weigh benefits and risks and exercise care when changing opioid dosages. Work closely with patients to optimize nonopioid therapies while continuing opioid therapy. If benefits do not outweigh risk of continued opioid therapy, optimize other therapies and work closely with patients to gradually taper to lower dosages, or appropriately taper and discontinue opioids. Unless there are indications of a life-threatening issue such as warning signs of impending overdose (e.g., confusion, sedation, slurred speech), opioid therapy should not be discontinued abruptly, and clinicians should not rapidly reduce opioid dosages from higher dosages.
  6. When opioids are needed for acute pain, prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids.
  7. Evaluate benefits and risks with patients within 1–4 weeks of starting opioid therapy for subacute or chronic pain or of dosage escalation. Regularly re-evaluate benefits and risks of continued opioid therapy with patients.
  8. Before starting and periodically during continuation of opioid therapy, evaluate risks for opioid-related harms and discuss risks with patients. Work with patients to incorporate into the management plan strategies to mitigate risk, including offering naloxone.
  9. When prescribing initial opioid therapy for acute, subacute, or chronic pain, and periodically during opioid therapy for chronic pain, review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program data to determine whether the patient is receiving opioid dosages or combinations that put the patient at high risk for overdose.
  10. When prescribing opioids for subacute or chronic pain, consider the benefits and risks of toxicology testing to assess for prescribed medications as well as other prescribed and nonprescribed controlled substances.
  11. Use particular caution when prescribing opioid pain medication and benzodiazepines concurrently and consider whether benefits outweigh risks of concurrent prescribing of opioids and other central nervous system depressants.
  12. Offer or arrange treatment with evidence-based medications for patients with opioid use disorder. Detoxification on its own, without medications for opioid use disorder, is not recommended because of increased risks for resuming drug use, overdose, and overdose death.

(Dowell et al., 2022)

HOW TO CALCULATE MORPHINE MILLIGRAM EQUIVALENTS PER DAY (MME/DAY)
  1. Calculate the total daily amount of opioid the patient is prescribed.
  2. Convert each opioid to MMEs by multiplying the daily dosage for each opioid by its specific conversion factor (see table).
  3. Add all opioid MMEs together to obtain the patient’s MME.

    OPIOID CONVERSION FACTORS
    * Dose conversions are estimated and cannot account for all individual differences in genetics and pharmacokinetics.
    (CDC, n.d.-b)
    Opioid (doses in mg/day except where noted) Conversion Factor*
    Codeine 0.15
    Fentanyl transdermal (mcg/hr) 2.4
    Hydrocodone 1
    Hydromorphone 4
    Methadone: 1–20 mg/day
    21–40 mg/day
    41–60 mg/day
    ≥61–80 mg/day
    4
    8
    10
    12
    Morphine 1
    Oxycodone 1.5
    Oxymorphone 3

Example:

A patient with chronic back pain for more than 3 years is currently taking oxycodone 30 mg twice daily (BID). Calculate the MME.

  1. Calculate the total daily amount the patient is prescribed.
    30 mg X 2 times daily (BID) = 60 mg/day
  2. Multiply the total daily amount by the conversion factor for oxycodone.
    60 mg/day X 1.5 = 90 MME per day
TAPERING OPIOID MEDICATIONS

An opioid-tapering flowchart is available from the U.S. DHHS that is useful in making determinations about ongoing opioid use or cessation. Tapering is recommended when:

  • Pain improves
  • The patient requests dosage reduction or discontinuation
  • Pain and function are not meaningfully improved
  • The patient is receiving higher opioid doses without evidence of benefit from the higher dose
  • The patient has current evidence of opioid misuse
  • The patient experiences side effects that diminish quality of life or impair function
  • The patient experiences an overdose or other serious event (e.g., hospitalization, injury) or has warning signs for an impending event such as confusion, sedation, or slurred speech
  • The patient is receiving medications (e.g., benzodiazepines) or has medical conditions (e.g., lung disease, sleep apnea, liver disease, kidney disease, fall risk, advanced age) that increase risk for adverse outcomes
  • The patient has been treated with opioids for a prolonged period (e.g., years), and current benefit-harm balance is unclear

(U.S. DHHS, 2019)

West Virginia Safe and Effective Management of Pain (SEMP) Guidelines

In 2016, a diverse panel of West Virginia experts was convened to build upon the 2016 CDC guidelines for prescribing opioids for chronic pain. The panel developed the following Safe and Effective Management of Pain (SEMP) Guidelines for prescribers and dispensers, with a focus on clinical treatment of pain and risk reduction strategies (CDC, 2017; WVEPMP, 2016).

CLINICAL TREATMENT OF PAIN GUIDELINES

The pain treatment algorithms described in the tables below were developed by the WV SEMP panel to provide the best course of action for progression through escalating levels of pain based on current evidence and experience. These algorithms are meant to be referred to along with the CDC guidelines (see above).

1st LINE PAIN TREATMENT ALGORITHMS
Nociceptive Pain Neuropathic Pain Mixed Pain
  • Nonpharmacologic
    (active & passive)
  • OTC APAP then +/- NSAID (based on GI/cardio pt. history
  • Topical agents (NSAID, lidocaine, or capsaicin)
  • Nonpharmacologic
    (active & passive)
  • Acute trial of NSAID/APAP (based on GI/cardio pt. history)
  • Add-on topical agent (lidocaine or capsaicin)
  • L-methylfolate
  • Gabapentinoids (gabapentin* or pregabalin) (*abuse potential as a non-controlled substance)
  • SNRIs (duloxetine, venlafaxine, etc.)
  • TCAs (2° class: nortriptyline, etc.)
  • Nonpharmacologic (active & passive)
  • Acute trial of NSAID/APAP (based on GI/cardio pt. history)
  • Topical agent (NSAID, lidocaine, or capsaicin)
2nd LINE PAIN TREATMENT ALGORITHMS
Nociceptive Pain Neuropathic Pain Mixed Pain
  • SNRIs (duloxetine, venlafaxine, etc.)
  • TCAs (2° class: nortriptyline, etc.)
  • Controlled substance class 4 (tramadol or pentazocine/naloxone)
  • Consider referral to specialist
  • Anti-epileptic drugs or AEDs (CBZ*, VPA, lamotrigine, topiramate, etc.) (*trigeminal neuralgia only)
  • Controlled substance class 4 (tramadol or pentazocine / naloxone)
  • Consider referral to specialist
  • Gabapentinoids (gabapentin* or pregabalin) (*abuse potential as a non-controlled substance)
  • SNRIs (duloxetine, venlafaxine, etc.)
  • TCAs(2° class: nortriptyline, etc.)
  • Controlled substance class 4 (tramadol or pentazocine / naloxone)
  • Consider referral to specialist
3rd LINE PAIN TREATMENT ALGORITHMS
Nociceptive Pain Neuropathic Pain Mixed Pain
  • Combination 1st & 2nd line agents
  • Acute add-on: muscle relaxer PRN (antispasticity sub-class) (watch for concomitant CNS depression)
  • Controlled substance class 3 (buprenorphine or APAP/codeine)
  • Interventional therapy
  • Controlled substance class 2 (IR)
  • Referral to specialist needed
  • Combination 1st & 2nd line agents
  • Acute add-on: muscle relaxer PRN (antispasticity sub-class) (watch for concomitant CNS depression)
  • Controlled substance class 3 (buprenorphine or APAP/codeine)
  • Interventional therapy
  • Controlled substance class 2 (IR)
  • Referral to specialist needed
  • Combination 1st & 2nd line agents
  • Acute add-on: muscle relaxer PRN (antispasticity sub-class) (watch for concomitant CNS depression)
  • Controlled substance class 3 (buprenorphine or APAP/codeine)
  • Interventional therapy
  • Controlled substance class 2 (IR)
  • Referral to specialist needed
4th LINE PAIN TREATMENT ALGORITHMS
Nociceptive Pain Neuropathic Pain Mixed Pain
  • Spinal cord/dorsal root ganglion stimulation
  • Controlled substance class 2 (ER)
  • Implantable/intrathecal (IT) morphine/baclofen/ziconotide
  • Consider clinical trial
  • Spinal cord/dorsal root ganglion stimulation
  • Controlled substance class 2 (ER)
  • Implantable/intrathecal (IT) morphine/baclofen/ziconotide
  • Botox injection
  • Consider clinical trial
  • Spinal cord/dorsal root ganglion stimulation
  • Controlled substance class 2 (ER)
  • Implantable/intrathecal (IT) morphine/baclofen/ziconotide
  • Consider clinical trial
(WVEPMP, 2016)

RISK REDUCTION STRATEGIES

The SEMP guidelines provide healthcare professionals with a risk reduction process to improve patient care and minimize provider anxiety. Elements of this risk-reduction strategy include:

  1. Opioid Risk Screenings. All patients being considered for chronic opioid therapy should be screened for risk of substance misuse before opioids are prescribed. Screening tools include the Opioid Risk Tool (ORT) and the Drug Abuse Screening Test (DAST). Patients who have been on long-term opioid therapy should also be routinely screened for misuse. Screening tools include the Current Opioid Misuse Measure (COMM), Pain Medication Questionnaire (PMQ), and Prescription Drug Use Questionnaire (PDUQ). (See also “Resources” at the end of this course.)
  2. Drug Interaction and Pharmacologic Review. Recognizing that genetic variability can alter drug responses for a variety of pain medications, it is suggested that pharmacogenic testing be used when available and appropriate to the treatment regimen.
  3. Pain Reduction and Function Improvement Goal. Pain should be thoroughly evaluated before prescribing medications or other pain treatments. Treatment of chronic pain requires a long-term process of monitoring and adjusting treatment as necessary. While severity of pain is important to evaluate, it is equally important to evaluate how pain affects a patient’s functional status and performance of daily activities.
  4. End of Therapy Goal. An appropriate timeline regarding achieving and maintaining a reduction in pain is necessary. For acute pain treatment, an end of therapy goal for any pain medication should be consistent with the expected timeframe for the healing process. For chronic pain conditions, the elimination of pain may not be realistic. However, there should still be an end of therapy goal for any pharmacologic interventions to reduce unnecessary long-term effects (i.e., adverse effects, dependency, etc.).
  5. Initial and Annual Psychological Evaluations. Patients who are prescribed opioid medications should have initial psychological evaluations that should be repeated annually. This allows for objective quantification of the benefits of opioid therapy and for reassessment of modifiable risk factors such as depression. The PHQ-2 depression screening instrument is a suggested tool to be used as a first step for depression screening.
  6. Proper Medication Storage and Disposal. Education about safe use, storage, and disposal of controlled prescription drugs should be part of the conversation between patients and clinicians whenever controlled substances are prescribed. Patients should be reminded that if there are children or individuals with a history of substance abuse in the household, medications should be locked in a safe place. Excess medications should be returned through DEA-sponsored “take-back” programs.
  7. Naloxone Prescribing and Administration. West Virginia Senate Bill 431, passed in 2016, makes naloxone (an antidote or reversal agent for opioid overdose) available without a prescription. A pharmacist or pharmacy intern who dispenses naloxone must provide education to the patient who receives naloxone, to include: 1) proper administration, 2) importance of contacting EMS after administering naloxone, 3) risks associated with failure to contact EMS following administration of naloxone, and 4) educational material on opioid-related overdose prevention and treatment. (See also “Prescribing and Administration of Opioid Antagonist” later in this course.)
  8. Prescription Drug Monitoring Program (PDMP). West Virginia Senate Bill 437, passed in 2012, requires healthcare prescribers to utilize the PDMP. All licensees who dispense controlled substances to residents of West Virginia must provide the dispensing information to the WV Board of Pharmacy at least every 24 hours. All licensed prescribers must also check the PDMP at the initiation of opioid therapy and at minimum every year thereafter. (See also “Prescription Drug Monitoring Programs” later in this course.)
  9. Urine Drug Screening/Testing. Urine drug screening/testing should be utilized to monitor compliance of patients who are prescribed controlled substances. Urine drug screening can help detect use of illicit substances and trigger reassessment of the treatment plan when indicated.
  10. Pill Counts. Pill counts are one way of improving medication adherence and preventing/detecting diversion of medication. Pill counts can be random or scheduled based on scheduled appointments.
  11. DEA “Red Flags.” Healthcare professionals have an ethical and legal obligation to both prevent prescription drug diversion and to ensure safe and effective care to patients. The U.S. DEA has provided a number of “red flags” for healthcare professionals to be aware of so that they can report suspected drug diversion by both prescribers or dispensers (see box below).
  12. Patient and Provider Agreements. Providers and patients should review treatment goals and have realistic expectations of therapy (e.g., pain reduction and improved functional status), and a mutual understanding of elements 1 through 11 above. Patient and provider agreements are an invaluable tool to ensure mutual commitment to the treatment goals. (See also “Sample Patient Agreement Form” earlier in this course.)
    (WVEPMP, 2016)
DEA RED FLAGS FOR DRUG DIVERSION

Prescribers

  • Cash-only patients and/or no acceptance of worker’s compensation or private insurance
  • Prescribing of the same combination of highly abused drugs
  • Prescribing the same, typically high, quantities of pain drugs to most or every patient
  • High number of prescriptions issued per day
  • Out-of-area patient population

Dispensers

  • Dispensing a high percentage controlled to non-controlled drugs
  • Dispensing high volumes of controlled substances generally
  • Dispensing the same drugs and quantities prescribed by the same prescriber
  • Dispensing to out-of-area or out-of-state patients
  • Dispensing to multiple patients with the same last name or address
  • Sequential prescription numbers for highly diverted drugs from the same prescriber
  • Dispensing for patients of controlled substances form multiple practitioners
  • Dispensing for patients seeking early prescription refills
    (WVEPMP, 2016)