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) Clinical Practice Guideline for Prescribing Opioids for Pain and the state of Delaware provide recommendations for prescribing opioid pain medications (see below).

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 “Delaware Prescription Drug Monitoring Program” 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)
A nalgesia A reduction in pain
A ctivities of daily living Improvement in level of function
A ffect Changes in mood
A dverse effects Falls, decreased cognitive function, constipation, etc.
A DRBs 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.

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
    Opioid
    (doses in mg/day except where noted)
    Conversion Factor*
    * Dose conversions are estimated and cannot account for all individual differences in genetics and pharmacokinetics.
    (CDC, n.d.-b)
    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.
  2. 30 mg X 2 times daily (BID) = 60 mg/day

  3. Multiply the total daily amount by the conversion factor for oxycodone.
  4. 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)

Delaware Guidelines for Use of Controlled Substances for Treatment of Pain

The Medical Society of Delaware (MSD) works closely with the Division of Public Health and other stakeholders to assure adequate pain care while reducing the potential for abuse and diversion of prescription medication. From these efforts, MSD developed the “Guidelines for the Use of Controlled Substance for the Treatment of Pain.” These clinical practice guidelines are tailored to relevant individual practice types that routinely deal with the management of various types of pain, including acute/subacute, chronic, emergency medicine, and hospice pain management.

In April 2017, Delaware issued regulations for safer opioid prescribing and better pain management practices, supporting the CDC Guideline for Prescribing Opioids for Chronic Pain, 2016 (DDPH, 2023). (See above for the 2022 update to the CDC guidelines.)

These regulations are aimed at stopping addiction before it starts by controlling the amount of opiates given to new patients and aggressively monitoring their treatment. These Delaware opioid prescribing rules stipulate that first-time opiate prescriptions are not to exceed a one-week supply . If further opiate prescriptions are deemed necessary, then further action must be taken by the prescriber, to include a query of the statewide Prescription Monitoring Program database and a physical exam with discussion of relevant patient history and the risks of opiates (DDOS, 2017a).

HelpIsHereDE.com

HelpIsHereDE.com provides Delaware healthcare providers with a number of clinical decision resources that can be easily viewed and downloaded. These include:

  • Sample addiction screening tools
  • Sample treatment agreements
  • Sample informed consent forms
  • Downloadable educational information to share with patients
  • Ob/Gyn resources
  • Alternatives to opioids
  • Signs a patient may be addicted

KEY ELEMENTS OF DELAWARE PRESCRIBING RULES

For an acute episode (injury or procedure):

  • A first-time prescription to an adult patient for an acute episode cannot exceed a 7-day supply.
  • No prescription to a minor can exceed a 7-day supply at any time.
  • If professional judgment dictates more than a 7-day supply is necessary:
    • Document the condition triggering the prescription.
    • Query the Prescription Monitoring Program to obtain a prescription history.
    • Indicate that a nonopiate alternative was not appropriate.
    • Obtain informed consent, which must include information on:
      • The drug’s potential for addiction, abuse, and misuse
      • The risks of life-threatening respiratory depression associated with the drug
      • The potential for fatal overdose as a result of accidental exposure, especially in children
      • Neonatal opioid withdrawal symptoms
      • The potential for fatal overdose when interacting with alcohol
      • Other potentially fatal drug interactions, such as with benzodiazepines
    • Administer a fluid drug screen, at the discretion of the provider.
    • Conduct a physical examination, which must include a documented discussion to elicit relevant history, explain risks/benefits of opioid analgesics and possible alternatives, and establish other treatments tried or considered.
    • Schedule periodic follow-up visits and evaluations to monitor progress, whether there is an available alternative to opiate use, and whether to refer the patient for a pain management or substance abuse consultation.

For chronic, long-term treatment with an opiate:

  • Document the condition triggering the prescription, indicating that a nonopiate alternative was considered but not appropriate, obtain informed consent, and follow up with evaluations to monitor progress toward treatment goals.
  • Query the Prescription Monitoring Program:
    • At least every six months and more frequently if clinically indicated
    • Whenever the patient is also being prescribed a benzodiazepine
    • Whenever the patient is assessed to potentially be at risk for substance abuse or misuse
    • Whenever the patient demonstrates loss of prescriptions, requests for early refills, or similar behavior
  • Administer fluid drug screens at least every six months.
  • Obtain a signed treatment agreement, which must include:
    • The patient’s agreement to take medications at the dose and frequency prescribed, with a specific protocol for lost prescriptions and early refills
    • Reasons for which medication therapy may be re-evaluated, tapered, or discontinued, including but not limited to violation of the treatment agreement or lack of effectiveness
    • The requirement that all chronic pain management prescriptions are provided by a single practitioner or a limited, agreed-upon group of practitioners
    • The patient’s agreement to not abuse alcohol or use other medically unauthorized substances or medications
    • Acknowledgment that a violation of the agreement may result in action as deemed appropriate by the prescribing practitioner such as a change in the treatment plan, a referral to a pain specialist, or referral to an addiction treatment program
    • The requirement that fluid drug screens be performed at random intervals at the practitioner’s discretion, but no less than every six months
    (DDPH, 2017)