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Ohio Law Governing Drugs and Prescriptive Therapy

This nursing continuing professional development activity was approved by the Ohio Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation. (OBN-001-91) ONA #: 2020-0000000558

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Authors:    Raymond Lengel (MSN, FNP-BC, RN) , Julia Tortorice (RN, MBA, MSN, NEA-BC, CPHQ)

Introduction

Note: Many regulations refer to an exclusionary formulary. The exclusionary formulary no longer exists as a list. It has been replaced with (OBN, 2019):

  1. Do not exceed the prescriptive authority of the collaborating providers.
  2. Do not prescribe or furnish and drug or device in violation of Federal or Ohio law or rules adopted by the board.

Using prescribed drugs, not as directed describes potentially aberrant drug-taking behaviors. In a study of 202 patients, only 44.1% were screened for potential aberrant drug-taking behaviors. It was concluded that screening for abuse or misuse of opioids does not frequently occur in large family drug training programs. More training and set policies for risk evaluation and monitoring of opioid abuse are needed (Colburn et al., 2012).

Healthcare providers tend to under-assess patients at risk for opioid-related aberrant behaviors. One study showed that providers assessed the risk of misuse, abuse or diversion at less than 2% when in reality, 10.4% of patients had prior illicit drug use, 23.4% had abnormal urine drug tests, and almost 11% reported crushing or chewing opioids in the past and 60% of patients self-reported abuse, misuse or diversion (Setnik et al., 2017).

Prescribers' lack of training and inexperience can have a profound impact on the misuse of drugs. One study showed that resident physicians (when compared to attending physicians) more often prescribed opioids for more than three months, were more likely to have their patients report that their prescriptions were lost/stolen, and 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 et al., 2012).

Prescribers receive little training in prescribing scheduled substances, screening for substance abuse, and referring patients who need treatment. Proper continuing education is one way to address this problem (Brown et al., 2012).

Key Definitions

Drug abuse occurs when drugs are not used medically or socially appropriately. Controlled substances may lead to dependence, either physical or psychological. Physical dependence transpires when withdrawal symptoms such as anxiety, tachycardia, hypertension, diaphoresis, a volatile mood, or dysphoria after the rapid discontinuation of the substance. Psychological dependence is the perceived need for a 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 contributes substantially to relapse. Physical dependence is not addiction.

Addiction is psychological dependence and 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 severe medical and social consequences. Tolerance, defined as the need to increase the doses of the drug 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 drugs may be dependent on the drug but not addicted.

Addiction is a primary concern in those taking opioids. When prescribing opioids, it is essential to determine who is likely to participate in aberrant drug-related behaviors. At higher risk for aberrant drug-related behaviors are individuals with significant depression, psychotropic drug use, younger age, or those with a family or personal history of drug or alcohol misuse. Those at high risk for addiction would be better managed with a specialist (Sehgal et al., 2012).

Opioid use disorder is a use pattern of opioids that results in problems or distress. It may include tolerance, impaired social functioning, loss of control of opioid use, dangerous opioid use, and withdrawal. To meet diagnostic criteria, patients with an opioid use disorder must have at least 2 of the 11 symptoms over 12 months (CDC, 2016). These symptoms include:

  • Taking opioids in larger amounts or over a longer time than intended
  • A strong desire for opioids, using in physically dangerous circumstances
  • Stopping or reducing activities due to opioids use
  • Withdrawal
  • Unsuccessful attempts to control the use
  • Problems fulfilling obligations
  • Spending a significant amount of time obtaining drugs or recovering from the drugs
  • Tolerance
  • Continued use despite social/personal problems
  • Continued use despite psychological or physical problems

Aberrant drug-related behaviors may include abuse, misuse, diversion, or addiction. Examples of aberrant drug-related behaviors include:

  • Requests for early refills
  • Not taking drugs as prescribed
  • Failure to keep appointments
  • Healthcare visits in distress
  • Frequent reports of a lost drug
  • 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
  • Requests for specific drugs

Opioids have the potential to provide analgesia and improve function. These benefits must be weighed against the potential risks, including misuse, addiction, physical dependence, tolerance, overdose, abuse by others, and drug-to-drug and drug-to-disease interactions.

Prevalence

  • In 2014, 2,482 individuals in Ohio died from an unintentional opioid-related overdose. That was a four-fold increase over ten years. Unintentional opioid overdose has become one of the leading causes of injury-related death in Ohio over the past decade (CDC, 2016).
  • In 2016, 48.5 million individuals in the United States misused prescription or illicit drugs. 66%of the 630,000 drug overdose deaths were due to illicit or prescription opioids. The number of opioid overdoses in the emergency department increased by 30% from July 2016 to September 2017 (Governor's cabinet, 2016).
  • Opioid misuse affects 34.2 million Americans over the age of 12. According to the Center for Disease Control and Prevention (CDC), people die each day in the United States from an overdose of prescription painkillers (Franklin, 2014).
  • In 2012, healthcare providers wrote 259 million prescriptions for painkillers (SAMHSA, 2011). Two times as many painkiller prescriptions are written in the United States as in Canada.
  • Overdoses from synthetic opioids increased from 3.1 per 100,000 people in 2015 to 6.2 per 100,000 people in 2016 (Hedegaard et al., 2016).
  • Between 1999 and 2015, drug overdose deaths have tripled (Manchikanti et al., 2017).
  • Of U.S. veterans treated in primary care settings, 4.8% reported opioid analgesic misuse (Becker, 2009).
  • 12.2% of 12th graders reported ever abusing opioids, and 7.9% reported past-year use (Merikangas and McClair, 20012).
  • Of those prescribed opioids, dependence may be as high as 26%.
  • The number of individuals seeking treatment for non-heroin opioid substance abuse increased from 1.0% in 1995 to 8.7% in 2010 (SAMSHA, 2013).
  • Research shows that white individuals account for 88% of those who reported non-heroin opioid substance abuse, and most of these individuals lived in rural settings (SAMSHA, 2013).
  • Of overdose deaths from opioid analgesia, 30% also involved benzodiazepines.

Opioid dependence costs the United States healthcare system one billion dollars annually (Jones et al., 2015). Also, opioid dependence leads to decreased work productivity, increased legal costs, and lasting psychological effects experienced by the victims of the crimes caused by opioid abuse. Also, opioid misuse may lead to other diseases such as HIV, hepatitis, and sexually transmitted diseases.

DSM-5 Substance Use Disorders
According to the fifth edition of the Diagnostic and Statistical Manual from the American Psychiatric Association, the essence of a substance use problem may be summed up by the phrase (Governor's cabinet, 2016):

“…cognitive, behavioral, and physiological symptoms indicating the individual continues using the substance despite significant substance-related problems.”

APRN Practice Standards

In this course, the term APRN includes clinical nurse specialists and certified nurse-midwife.

In Ohio, the nurse practice act (NPA) recognizes that nurses can be found everywhere, doing many different tasks at all levels of care. For that reason, it has specifically addressed the standards it expects from advanced practice registered nurses (ADSM 2013):

  • Certified nurse-midwife
  • Certified nurse practitioner
  • Certified registered nurse anesthetist
  • Clinical nurse specialist

Before beginning practice, a standard care arrangement shall be entered into with each physician or podiatrist with whom the specialist collaborates. The standard care arrangement can be revised to add or delete a physician or podiatrist within that employment setting instead of making a new arrangement. A new standard care arrangement is needed when the nurse is employed in a different setting and engages in practice with different collaborators. The collaborating physician's or podiatrist's practice must be the same or similar to the nurse's (ADSM 2013).

A standard care arrangement includes at least (ORC 4723):

  • Criteria for referral of a patient by the APRN to a collaborating provider (physician or podiatrist) or another physician or another provider
  • A process for the APRN to obtain a consultation with a collaborating provider or another provider
  • A plan for coverage in an emergency or planned absences
  • The process for resolution of disagreements regarding matters of patient management Signatures of each nurse, and collaborator, indicating a review and agreement to abide by the terms
  • Signatures of the nurse, and each collaborator, indicating a review and agreement to abide by the terms
  • The date when the arrangement is initially executed
  • The complete name, specialty and practice area, business address, and business phone number or number at which the individual can be reached at any time for all participants
  • A statement of services offered, a certificate to prescribe, and a description of the scope of prescriptive practice
  • A plan for incorporation of new technology or procedures

Quality assurance provisions (ADSM 2013):

  • Periodic review and reapproval of the standard care arrangement
  • Criteria for referral of a patient by the nurse to a collaborating physician or podiatrist
  • Collaborating physician or podiatrist must be within an acceptable travel time between their location and the APRN's location when the APRN is prescribing drugs
  • Other criteria recommended by the committee on prescriptive governance

The most current copy of the standard care arrangement and any legal authorization signed by a physician must be retained by the nurse’s employer and available but may be maintained elsewhere. Upon request of the board, the nurse must provide a copy of the standard care arrangement to the board. Retain copies of previously effective standard care arrangements for three years. The copies may be retrained longer since the statute of limitations on many legal cases is seven years.

When a hospital negotiates a standard care arrangement, the review and approval of the standard care arrangement must follow the hospital governing body's policies and procedures and the hospital medical staff's bylaws, policies, and procedures.

An APRN cannot practice without a standard care arrangement executed. A nurse must notify the board of the identity of a collaborating physician or podiatrist or any change in the name and business address of a collaborating physician or podiatrist within 30 days of the change (ADSM 2013).

ARNP may prescribe any drug or therapeutic device in any form or route of administration if (ADSM 2013):

  1. The ability to prescribe the drug or therapeutic device is within the scope of practice in the nurse's specialty area
  2. The prescription is consistent with the terms of a standard care arrangement
  3. The prescription would not exceed the prescriptive authority of the collaborating physician
  4. The individual drug or subtype or therapeutic device is not excluded from the Formulary
  5. The prescription meets the requirements of state and federal law
  6. A valid prescriber-patient relationship exists. This relationship may include, but is not limited to:
    1. Obtaining a thorough, relevant history of the patient
    2. Conducting a physical or mental examination of the patient
    3. Rendering a diagnosis
    4. Prescribing drugs, ruling out the existence of any recognized contraindications
    5. Consulting with the collaborating physician when necessary
    6. Documenting these steps in the patient's medical records

Below is a Prescribing Process Flow chart recommended by the Ohio Board of Nursing. An error on the flowchart is that the previous exclusionary formulary is no longer in effect. ARNP must prescribe according to the standard care agreement with their collaborating physician, consistent with national certification and state and federal laws (ADSM 2013).

flowchart_aprn_prescribing_process

PDF available here

Ohio Board of Nursing Prescribing Resources are available at nursing.ohio.gov/practice-resources/prescribing-resources/

An APRN may delegate the administration of a drug to an unlicensed person if the following conditions are met:

  • The drug is within the APRN's ability to prescribe
  • The drug is not a controlled substance
  • The drug is not to be administered intravenously
  • The drug cannot be administered at
    • A hospital inpatient care unit
    • A hospital emergency department or a freestanding emergency department
    • An ambulatory surgical facility
  • The person has completed education based on a recognized body of knowledge concerning drug administration and demonstrates to the person's employer the knowledge, skills, and ability to administer the drug safely
  • The person's employer has given the APRN access to documentation, in written or electronic form, showing that the person has completed the education and competency in administering drugs
  • The APRN is physically present at the location where the drug is administered (ORC 4723.43)

Before delegating this authority, the APRNs with prescriptive authority are required to assess the patient, determine that the drug is appropriate for the patient, and determine that the person to whom the authority will be delegated has met the conditions (ORC 4723)

An APRN with prescriptive authority has many requirements and limitations. These include:

  • Limitation on prescribing Schedule II controlled substance
  • Limitations on prescribing controlled substances
  • Limitations on the delegation to administer a drug
  • Authority may not exceed the prescriptive authority of the collaborating physician or podiatrist (ADSM 2013).

Morphine equivalent daily dose (MED) means a conversion of various opioid analgesics to a morphine equivalent dose by using accepted conversion tables provided by the state board of pharmacy at www.ohiopmp.gov/MED_Calculator.aspx.

Formulary and Prescribing Standards

The formulary for APRNs is found at codes.ohio.gov/oac/4723-9-10. The exclusionary formulary no longer exists as a list. It has been replaced with:

  • Do not exceed the prescriptive authority of the collaborating providers
  • Do not prescribe or furnish and drug or device in violation of Federal or Ohio law, or rules adopted by the board

Acute pain fades with healing, is related to tissue damage, alters a patient's function, and is time-limited, usually not more than six weeks (ORC, 4723-9-10).

Chronic pain persists after efforts have been made to relieve it and continue for twelve or more weeks. Chronic pain may be intermittent or continuous. Chronic pain is not used with a terminal condition or a progressive disease that is expected to result in a terminal condition.

Extended-release or long-acting opioid analgesics means an opioid analgesic administered via a transdermal route or containing methadone.

Extended-release or long-acting opioid analgesics is an opioid analgesic that are FDA approved and labeled as extended-release or long-acting opioids, administered via a transdermal route or containing methadone.

Sub-acute pain persists after treatment for more than six weeks but less than twelve weeks. Sub-acute pain may be intermittent or continuous.

If the patient is a family member, the ARNP cannot prescribe to a family member unless:

  • The APRN can maintain a detached professional judgment in reaching diagnostic or therapeutic decisions
  • The prescription is documented in the patient's record.

To prescribe drugs that are controlled substances, the following applies (ORC, 4723-9-10):

  • The APRN has obtained a US drug enforcement administration registration
  • The prescription indicates the day's supply of the controlled substance prescription

The patient is not a family member; and

The ARNP shall not self-prescribe a controlled substance

An APRN can prescribe schedule II controlled substances and gabapentin only in situations where all of the following apply (ORC, 4723-9-10):

A patient has a terminal condition

A physician initially prescribed the substance for the patient; and

The prescription is for a quantity that does not exceed the amount necessary for the patient's use in a single, seventy-two-hour period

An APRN can prescribe a schedule II control substance if the prescription is issued from any of the following:

  • A Hospital
  • An entity owned or controlled, in whole or in part, by a hospital or by an entity that owns or controls, in whole or in part, one or more hospitals
  • A healthcare facility operated by the department of mental health or the department of developmental disabilities
  • A nursing home
  • A county home or district home certified under the Medicare or Medicaid program
  • A hospice care program
  • A community mental health agency
  • An ambulatory surgical facility
  • A freestanding birthing center
  • A federally qualified health center
  • A federally qualified health center look-alike
  • A healthcare office or facility operated by the board of health of a city or general health district
  • A site where medical practice is operated, but only if the practice is comprised of one or more physicians who also are owners of the practice; the practice is organized to provide direct patient care
  • The APRN has a standard care arrangement and collaborates with at least one of the physician owners who practices primarily at that site
  • A residential care facility

An APRN cannot prescribe a schedule II controlled substance from a convenience care clinic even if the clinic is owned or operated by an entity specified above (ORC, 4723-9-10).

For the treatment of acute pain, an APRN must comply with the following (ORC, 4723-9-10):

  • Extended-release or long-acting opioid analgesics shall not be prescribed
  • The ARNP must first consider non-opioid treatment options
  • The prescription should be for the minimum quantity and potency needed to treat the expected duration of pain, with a presumption that a three-day supply or less is enough

In all circumstances where opioid analgesics are prescribed for acute pain, an ARNP can prescribe:

  • For adults, not more than a seven-day supply with no refills
  • For minors, not more than a five-day supply with no refills
  • The seven-day limit for adults and a five-day limit for minors may be exceeded for pain that is expected to persist for longer than seven days based on the pathology causing the pain

If a patient is intolerant of or allergic to an opioid medication initially prescribed, a prescription for a different opioid medication may be issued at any time during the initial seven-day or five-day dosing period.

The patient, or a minor's parent or guardian, must be advised of the benefits and risks of the opioid analgesic, including the potential for addiction, and counseling must be documented.

The total morphine equivalent dose (MED) of a prescription for opioid analgesics for the treatment of acute pain shall not exceed an average of thirty MED per day, except when the patient's treating physician has entered a standard care arrangement with the APRN that arrangement must state the understanding of the physician as to when the APRN can exceed the thirty MED average and when the APRN must consult with the physician before exceeding the thirty MED average. Document the reason for exceeding the thirty MED average and the reason it is the lowest dose consistent with the patient's medical condition.

The above rules apply to the treatment of acute pain only and do not apply when an opioid analgesic is prescribed to a patient in the following situations (ORC, 4723-9-10):

  • In hospice care
  • Who is receiving palliative care
  • Who has been diagnosed with a terminal condition
  • Who has cancer or a condition associated with the individual's cancer or history of cancer
  • Addicted and opioids are prescribed using a controlled substance that the FDA approves for opioid detoxification or maintenance treatment
  • Inpatient prescriptions

For sub-acute and chronic pain, first, consider and document non-drug options.

The APRN shall prescribe the minimum quantity and potency needed to treat the expected duration of pain and improve the patient's ability to function.

Complete or update patient record assessment before prescribing an opioid analgesic for sub-acute or chronic pain. Complete an OARRS review. Offer the patient a prescription for naloxone if the following circumstances exist (ORC, 4723-9-10):

  • History of opioid overdose
  • Co-prescribed a benzodiazepine, sedative-hypnotic drug, carisoprodol, tramadol, or gabapentin
  • Concurrent substance use disorder
  • Dosage exceeds eighty MED

Consider offering a prescription for naloxone if the dosage exceeds fifty MED. During treatment with an opioid at doses below the average of fifty MED per day, provide periodic follow-up assessments and documentation of the patient (ORC, 4723-9-10):

  • Functional status
  • Progress toward treatment objectives
  • Indicators of possible addiction, drug abuse or diversion
  • Adverse drug effects

Drugs approved by the FDA but not yet reviewed and approved by the committee on prescriptive governance may be prescribed, unless later disapproved by the committee on prescriptive governance, if the collaborating physician has agreed in the standard care arrangement that the APRN may prescribe these drugs (ORC, 4723-9-10).

An APRN shall not prescribe any drug or device to perform or induce an abortion (ORC, 4723-9-10).

Prescribe Drugs to Sexual Partners

An APRN may issue a prescription for or personally furnish a complete or partial supply of a drug to treat chlamydia, gonorrhea, or trichomoniasis without having examined the individual for whom the drug is intended if all of the following conditions are met (ORC, 4723.4810):

  • The individual is a sexual partner of the nurse's patient
  • The patient has been diagnosed with chlamydia, gonorrhea, or trichomoniasis
  • The patient reports that the individual is unable or unlikely to be evaluated or treated

An APRN may prescribe or personally furnish a drug for not more than a total of two individuals who are sexual partners of the nurse's patient. For each drug prescribed or personally furnished under this situation, the nurse shall do all of the following (ORC, 4723.4810):

  • Provide the patient with information concerning the drug to share the information with the individual, including:
    • Directions for the use of the drug
    • Side effects
    • Adverse reactions
    • Known contraindications
  • Recommend to the patient that the individual seek treatment from a health professional
  • Document

If the APRN contacts the individual (ORC, 4723.4810):

  • Inform the individual they may have been exposed to chlamydia, gonorrhea, or trichomoniasis
  • Encourage the individual to seek treatment from a health professional
  • Explain the treatment options available to the individual
  • Document in the patient's record that the nurse contacted the individual

An APRN who in good faith prescribes or personally furnishes a drug under this situation is not liable for or subject to any of the following (ORC, 4723.4810):

  • Damages in any civil action
  • Prosecution in any criminal proceeding
  • Professional disciplinary action

Ohio Automated RX Reporting System (OARRS)

OARRS is a database that tracks the dispensing and personal furnishing of controlled prescriptions to patients. The state board of Pharmacy manages that database. The system is available at ohiopmp.gov/.

The accepted and prevailing standards of care require that when prescribing or personally furnishing a controlled substance schedules II, III, IV, V, an APRN shall consider (ORC, 4723-9-12):

  • Potential for abuse
  • Possibility that the drug may lead to dependence
  • Possibility, the patient, will obtain the drug for nontherapeutic use or distribute it to other persons
  • Potential existence of an illicit market for the drug

When considering these circumstances in determining whether to prescribe or personally furnish a controlled substance to a patient, the APRN shall use sound clinical judgment and consider obtaining and reviewing an OARRS report consistent with the requirements of this rule.

The APRN must obtain and review an OARRS report when a patient shows any of the following red flags (ORC, 4723-9-12):

  • Selling prescription drugs
  • Forging or altering a prescription
  • Stealing or borrowing reported drugs
  • Increasing the dosage of reported drugs in amounts that exceed the prescribed amount
  • Suffering an overdose, intentional or nonintentional
  • Having a drug screen result that is inconsistent with the treatment plan or refusing to participate in a drug screen
  • Having been arrested, convicted, or received diversion or intervention instead of conviction for a drug-related offense while under the APRN's care
  • Receiving reported drugs from multiple prescribers without a clinical basis
  • Traveling with a group of other patients to the APRN's office, where all or most of the patient's request controlled substances prescriptions
  • Traveling an extended distance or from out of state to the APRN's office
  • Having a family member, friend, law enforcement officer or healthcare professional express concern related to the patient's use of illegal or reported drugs
  • Known history of chemical abuse or dependency
  • Appearing impaired or overly sedated during an office visit or examination
  • Requesting reported drugs by a specific name, street name, color, or identifying marks
  • Frequently requesting early refills of reported drugs
  • Frequently losing prescriptions for reported drugs
  • History of illegal drug use
  • Sharing reported drugs with another person
  • Recurring visits to non-coordinated sites of care, such as emergency departments, urgent care facilities, or walk-in clinics, to obtain reported drugs

Obtain and review an OARRS report covering at least the last 12 months when prescribing opioid analgesics and benzodiazepines in the following situations (ORC, 4723-9-12):

  • Before initially prescribing to a patient an opioid analgesic or benzodiazepine
  • When prescribing opioid analgesics for the treatment of sub-acute and chronic pain

If the patient continues to receive opioid analgesics or benzodiazepines after the initial prescription, review an OARRS report at least every 90 days. If your county is adjacent to another state, request a drug database report from that state (ORC, 4723-9-12).

OARRS reports may be requested by the APRN's delegate but must be personally reviewed by the APRN. Document your evaluation of the OARRS report. Also, document any actions you take because you evaluate using an OARRS report. Also, document if a drug database report cannot be obtained, why, and efforts to obtain a report.

An OARRS report is not required if the patient is (ORC, 4723-9-12):

  • In hospice
  • Terminal
  • In a hospital, nursing home or residential care facility
  • If not prescribed for more than seven days
  • If prescribed for treatment of non-terminal cancer or another condition associated with non-terminal cancer, except if prescribed for sub-acute or chronic pain

If an OARRS report indicates red flags, consult with a physician before prescribing or furnishing the drug. The consultation should include the review and document (ORC 4723):

  • Reason for suspicion of the red flag
  • Patient’s progress toward treatment objectives
  • Functional status of the patient

Results of the consultation could include (ORC, 4723-9-12):

  • Treatment agreement
  • More frequent OARRS reports
  • More frequent office visits
  • Different treatment options
  • Drug screens
  • Use of one pharmacy
  • Use of one provider for the prescription or provision of the drug
  • Consequences for non-compliance with the terms of the agreement
  • Consultation with or referral to a substance use disorder specialist

When abuse/misuse is detected, how should the clinician respond? If it is a single, minor deviation, then counseling and more intensive monitoring might 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 prescription removal is likely the best course. A referral to an addiction specialist is recommended if a substance abuse disorder is suspected.

Medication-Assisted Treatment

Medication-assisted treatment is alcohol or drug addiction services accompanied by medication for the treatment of substance use disorder, prevention of relapse of a substance use disorder, or both. The induction phase is the part of opioid treatment when maintenance medication dosage levels are adjusted until a patient is stable. The stabilization phase is the medical and psychosocial process of assisting the patient through acute intoxication and withdrawal management to attain a medically stable, fully supported, substance-free state, which may include the use of medications (OAC, 4723-9-13).

Office-based opioid treatment (OBOT) is the medication-assisted treatment of opioid dependence or addiction using controlled substances in a private or public sector clinic. Also, the office or clinic is not otherwise regulated by practitioners authorized to prescribe outpatient supplies of medications for the treatment of opioid addiction or prevention of relapse.

OBOT includes treatment with all controlled substance medications approved by the FDA for such treatment. OBOT does not include treatment that occurs in the following settings (OAC, 4723-9-13):

  • A state or local correctional facility
  • A hospital
  • A provider certified to provide residential and inpatient substance use disorder services, including withdrawal management, by the Ohio department of mental health and addiction services
  • An opioid treatment program certified by SAMHSA and accredited by an independent, SAMHSA-approved accrediting body
  • A youth services facility

A qualified APRN for medication-assisted treatment must have one of the following (OAC, 4723-9-13 ):

  • National certification in psychiatric mental health
  • Certified addictions APRN by the addictions nursing certification board
  • Clinical nurse specialist who was not required to obtain national certification and whose specialty is a psychiatric mental health

Eight hours of continuing substance abuse and addiction education during each renewal period are required.

A qualified ARNP may provide OBOT under the following circumstances (OAC, 4723-9-13 ):

  • The standard care arrangement statement of services offered includes OBOT
  • The APRN performs or confirms the completion of and documents a patient assessment that includes all of the following:
    • A comprehensive medical and psychiatric history
    • A brief mental status history
    • Substance abuse history
    • Family history and psychosocial supports
    • Appropriate physical examination
    • Urine drug screen or oral fluid drug testing
    • Pregnancy test for women of childbearing age and ability
    • Review of patient's prescription information in OARRS
    • Testing for human immunodeficiency virus
    • Testing for hepatitis B
    • Testing for hepatitis C

Consider screening for tuberculosis and sexually-transmitted diseases in patients with known risk factors. Other than the toxicology tests for drugs and alcohol, appropriate history, substance abuse history, and pregnancy test, the APRN may satisfy the assessment requirements by reviewing records from a physical examination and laboratory testing of the patient that was conducted within a reasonable time before the visit. If any part of the assessment cannot be completed before the initiation of OBOT, the advanced practice registered nurse shall document the reasons in the medical record.

A documented treatment plan should include all of the following (OAC, 4723-9-13 ):

  • The rationale for selection of the specific drug to be used
  • Patient education
  • informed consent
  • Random urine-drug screens or oral fluid drug testing
  • A signed treatment agreement with the patient that outlines the responsibilities of the patient and the APRN
  • A plan for psychosocial treatment

OBOT should provide an acceptable treatment protocol for assessment, induction, stabilization, maintenance, and tapering. Acceptable protocols are any of the following (OAC, 4723-9-13 ):

  • United States substance abuse and mental health services administration (SAMSHA) protocols available at store.samhsa.gov
  • National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use approved by the American society of addiction Drugs, available at www.asam.org/

A different protocol can be used if a qualified behavioral healthcare provider, community mental health services provider, or community addiction services provider determines the optimal type and intensity of psychosocial treatment. The treatment shall, at a minimum, include a psychosocial needs assessment, supportive counseling, links to existing family supports, and referral to community services. The treatment shall include at least one of the following interventions (OAC, 4723-9-13 ):

  • Cognitive-behavioral treatment
  • Community reinforcement approach
  • Contingency management/motivational incentives
  • Behavioral couples counseling
  • A structure for renegotiation of the treatment plan if the patient does not adhere to the original plan

If the patient refuses the recommended plan, the APRN shall ensure that the OBOT treatment plan requires the patient to participate in a twelve-step program or appropriate self-help recovery program. Documentation of ongoing participation is required. If the APRN refers the patient to another provider, the APRN's meaningful interactions with the provider must be documented.

The patient should be offered a prescription for a naloxone kit. Patient education includes using the kit, recognizing signs and symptoms of an overdose, and calling 911. If the patient refuses the prescription, the APRN shall provide the patient with information on where to obtain a kit without a prescription.

If the OBOT uses buprenorphine products, apply the Risk Evaluation and Mitigation Strategy for buprenorphine products, available at the FDA website at the following address: www.accessdata.fda.gov/scripts/cder/rems/index.cfm.

Buprenorphine without naloxone (buprenorphine mono-product) can only be prescribed in the following situations (OAC, 4723-9-13 ):

  • When the patient is pregnant or breast-feeding
  • When converting the patient from a buprenorphine mono-product to a buprenorphine/naloxone combination product
  • In formulations other than tablet or film form for indications approved by the FDA
  • For withdrawal management, when a buprenorphine/naloxone combination product is contraindicated, document the rationale
  • When the patient has an allergy to or intolerance of a buprenorphine/naloxone combination product

Due to a higher risk of fatal overdose when buprenorphine is prescribed with other opioids, benzodiazepines, sedative-hypnotics, carisoprodol, and tramadol, the APRN shall only co-prescribe these substances when it is medically necessary, and only if the following happens (OAC, 4723-9-13 ):

  • Verify the diagnosis for which the patient is receiving the other drug
  • Coordinates care with the prescriber for the other drug, including whether it can taper the drug to discontinuation. If the APRN prescribing buprenorphine is the prescriber of the other drug, the APRN shall taper the other drug to discontinuation if it is safe
  • Educate the patient about the serious risks of the combined use
  • Document progress in achieving the tapering plan

As documented during the induction phase, do not prescribe a dosage that exceeds FDA recommendations except for medically indicated circumstances. See the patient at least once per week.

During the stabilization phase, when using an oral formulation of buprenorphine, increase the daily dosage in safe and effective increments to achieve the lowest dose that avoids intoxication, withdrawal, or significant drug craving.

During the first ninety days of treatment, prescribe no more than a two-week supply of the buprenorphine product containing naloxone. From the 91st day of treatment until the completion of twelve months of treatment, prescribe no more than a thirty-day supply.

Take steps to reduce the chances of buprenorphine diversion by using the lowest effective dose, appropriate frequency of office visits, pill counts, and checks of OARRS. Require urine drug screens, serum medication levels, or oral fluid testing at least twice per quarter for the first year of treatment and at least once after that.

When using an oral formulation of buprenorphine, document the rationale for prescribed doses exceeding sixteen milligrams of buprenorphine per day. Do not prescribe a dose of buprenorphine exceeding twenty-four milligrams per day.

Incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare provider with the education and experience to provide substance abuse counseling.

The APRN may treat a patient using the administration of extended-release, injectable, or implanted buprenorphine under the following circumstances (OAC, 4723-9-13 ):

  • Strictly complies with any required risk evaluation and mitigation strategy program for the drug
  • Prescribe an extended-release buprenorphine product according to FDA's approved labeling
  • Document the rationale for the use of the extended-release product
  • If an extended-release, injectable, or implanted buprenorphine is ordered, the drug must be administered by the APRN or another Ohio licensed healthcare provider licensed to administer the drug

If using naltrexone to treat opioid use disorder, comply with the following additional requirements (OAC, 4723-9-13 ):

  • Before treating with naltrexone, inform the patient about the risk of an opioid overdose if the patient ceases naltrexone and then uses opioids
  • Take measures to ensure that the patient is adequately detoxified from opioids
  • The patient is no longer physically dependent before treatment with naltrexone

Use oral naltrexone only to treat patients who can be closely supervised and highly motivated. Comply with the FDA-approved labeling for naltrexone hydrochloride tablets.

Encourage the patient to have a support person to assist with administering and supervising the medication. Require urine drug screens, serum medication levels or oral fluid testing at least every three months for the first year of treatment and at least every six months after that (OAC, 4723-9-13 ).

Incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare or mental health services provider. Treat a patient with extended-release naltrexone for opioid dependence or concurrent opioid and alcohol use disorders. Consider treatment with extended-release naltrexone for patients who have issues with treatment adherence.

Safety Standards for Personally Furnishing Drugs and Therapeutic Devices

An APRN can personally furnish to a patient a drug or therapeutic device only if the following requirements are met (ORC, 3719.81) :

  • Only supply controlled substances up to a seventy-two-hour supply, and the patient is not prescribed controlled substances during any thirty days, two thousand five hundred dosage units that were not personally furnished
  • Dangerous drugs are labeled
  • OARRS requirements are met
  • Maintains a record of all drugs and devices furnished
  • APRN maintains current knowledge of and complies with all applicable state and federal laws or rules related to personally furnishing drugs and therapeutic devices

An APRN with prescriptive authority can furnish a sample drug if (Modern HealthCare, 2018):

  • Sample drug is furnished free of charge to the patient
  • Sample drug is furnished to the provider free of charge by the manufacturer, dealer, or provider authorized to prescribe
  • Sample drug is in the original container and marked as a sample
  • Sample drug has been stored under the proper conditions to prevent its deterioration or contamination
  • Expiration date is marked clearly on a sample drug
  • Sample drug is distributed, stored, or discarded in such a way that the sample drug cannot be acquired or used by any unauthorized person or by any person, including a child
  • Restrict the furnishing of any sample of a nonnarcotic substance if the substance can be sold over the counter without a prescription
  • Cannot furnishing a sample drug to a charitable pharmacy

An APRN with prescriptive authority can supply naloxone and a complete or partial drug supply to treat chlamydia, gonorrhea, or trichomoniasis (Modern HealthCare, 2018).

State and Federal Laws and CDC Recommendations

In 2011, the White House Office of National Drug Control Policy was introduced to address prescription drug abuse. It supported states in expanding prescription drug monitoring programs, worked to eliminate “pill mills,” and educated healthcare providers and patients.

Hospitals and pharmacies are essential players in assuring the safe use of controlled substances. The Food and Drug Administration (FDA) is responsible for assuring the safety of the drug supply in the United States. They require the pharmacy to confirm that prescribers and organizations they work with are licensed and registered with the FDA. Under the FDA, the hospital must investigate and handle suspicious or known illegitimate prescriptions.

The Drug Enforcement Agency (DEA) regulates the distribution of controlled substances. The DEA is responsible for enforcing laws and regulations related to controlled substances. They also have the authority to bring about criminal or civil charges to individuals or organizations involved in illicit traffic of controlled substances.

The Environmental Protection Agency (EPA) helps ensure the proper disposal of pharmaceutical waste. This protection prevents pharmaceutical waste in the environment, such as in the ground and drinking water. The EPA has regulations that the pharmacy must follow (President Donald J. Trump's Initiative, 2018).

Every legislator and government agency seems to be presenting its unique plan to combat the opioid epidemic. Below are some of the concepts that have either been already implemented or stand a good chance of being seen by healthcare professionals across the nation.

President Trump’s Plan

In a March 19, 2018, public address on the current opioid crisis, President Donald Trump outlined an initiative to confront the driving forces behind the opioid crisis. President Trump’s plan contains three core focus points, each with progressive actions under them Obama Administration, 2015).

  • Reduce opioid demand
    • Launch a nationwide evidence-based public awareness campaign about the dangers of prescription and illicit opioids (and other narcotics) use
    • Support research and development of therapies and technologies to prevent addiction and decrease the need for opioids in pain management. (e.g., non-addictive pain management options, the potential for a vaccine-specific in the prevention of opioid addiction)
    • Reduce overall opioid prescriptions (e.g., ensure that within three years, 75% of opioid prescriptions reimbursed by federal dollars are issued using best practices, with 95% compliance within five years)
    • Ensure that the nationwide Prescription Drug Monitoring Program advocated in the Affordable Care Act is completed and operational throughout all states
  • Stop the flood of illicit drugs across borders and within communities
    • Secure land borders, ports of entry, and waterways against smuggling
    • Require electronic advance documentation for 90% of all international goods-by-mail shipments and consignment shipments within three years
    • Utilize advanced screening technologies and drug-sniffing canines with all high-risk international packages to interdict illegal shipments
    • Engage with opioid source countries such as China and Mexico to cooperate with stopping the movement of opioids, precursor chemicals, and other illicit drugs
    • Expand efforts to prosecute corrupt or criminally negligent doctors, pharmacies, opioid manufacturers, and distributors
    • Strengthen enforcement and penalties for drug traffickers
  • Save lives with proven treatments for opioid addictions and overdose
    • Ensure first responders are supplied with naloxone to reverse an opioid overdose
    • Improve nationwide overdose tracking to shift resources to areas of need
    • Expand evidence-based addiction treatment in every state, focusing on drug-assisted treatment for opioid addiction
    • Provide on-demand evidence-based addiction treatment to service members, veterans, and their families
    • Identify and treat criminal offenders struggling with addiction. Screen every federal inmate for opioids on intake, and facilitate treatment for federal inmates while supporting state, tribal, and local drug courts to provide evidence-based treatment as an alternative or in conjunction with incarceration and supervised release

U.S. Department of Health and Human Services Plan

The U.S. Department of Health and Human Services (HHS) has proposed a five-fold approach to containing the Opioid Crisis (Dowell et al., 2016).

  1. Nationwide improvement of treatment and recovery services
  2. Promoting the availability and use of an opioid overdose-reversing drug
  3. Strengthening public health surveillance to gain a better understanding of opioid-related problems
  4. Research support on both controlling pain and minimizing addiction
  5. Advocating for the actual use of better methods of pain management

NIH, the National Institute of Health, through a branch agency of the massive HHS system, has already been meeting with academic researchers and the big pharmaceutical companies who bear a goodly portion of the blame for the current opioid flood pushing the crisis forward (Dowell et al., 2016).

The plans NIH is busy implementing include:

  • Finding and instituting safe, effective, non-addictive methods of managing chronic pain
  • Innovative new technologies and drugs for the treatment of opioid use disorders
  • Methods to improve and distribute both overdose prevention and reversal interventions that save lives and work to support recovery

Joint Commission

The Joint Commission (JC) recognizes pain control is an important part of quality healthcare. They acknowledge that pain is the fifth vital sign and should be assessed with other vital signs. According to the JC, patients have the right to assess and treat pain. Other beliefs of the JC include:

  • Patients should be educated about pain
  • Providers must be competent in the assessment and treatment of pain
  • Pain should not interfere with the function
  • Managing pain should be included in the plan for the discharge of a patient

Say what you will about the pharmaceutical industry’s actions relating to this generation’s opioid epidemic. Some of the large corporations are stepping up with initiatives to slow the growth of addiction. Pharmacy chain CVS Caremark, for example, began implementing a filling restriction for new pain drug patients prescribed opioids, limiting them to a seven-day supply of drugs. Other drug dispensaries are considering coming on board with this self-limitation, and some legislative plans advocate that this throttled introduction to opioids become the law of the land (Dowell et al., 2016).

US Centers for Disease Control and Prevention Guidelines for Prescribing Opioids

The Center for Disease Control (CDC) and Prevention developed guidelines for prescribing opioids for chronic pain. It offers guidance to the clinician regarding the safe and effective prescribing of opioids and assistance in managing chronic pain. This guideline focuses on patients over 18 who are seen in the primary care setting. The guideline focuses on chronic pain that does not involve end-of-life care, active cancer treatment, or palliative care.

This guideline is meant to help primary care clinicians deal with the 11% of adult patients with daily pain (FDA, 2014). It was developed because primary care clinicians reported insufficient training in opioid prescribing and concern regarding addiction. The guideline focuses on three main areas (FDA, 2014):

  1. Determining when to start/continue opioids for chronic pain includes looking at treatment goals, discussing the benefits/risks of therapy, and the utilization of not only opioid therapy but nonopioid therapy and nonpharmacological therapy
  2. The selection, duration, dosage, follow-up, and discontinuation of opioids
  3. Assessing the risk and addressing the harms of opioid use, which includes the use of methods to evaluate risks and reduce risk

It discusses the use of urine drug testing, the prescription drug monitoring program (PDMP), treatment of opioid use disorder, and precautions regarding co-prescriptions of benzodiazepines.

Recommendations 1-12

Recommendation 1

The first recommendation suggests that chronic pain should be managed primarily with nonpharmacologic and nonopioid pharmacologic therapies (FDA, 2014). Opioid therapy should be considered only when considering both the potential benefit in pain control and functional improvement versus the risks. When opiates are used, they should be combined with nonopioid and nonpharmacological therapy.

Appropriate non-pharmacological therapies include weight loss, physical therapy, exercise, psychological therapies, and selected intervention procedures (joint injections). Nonopioid pharmacotherapy may include NSAIDs, acetaminophen, cyclo-oxygenase (COX)-2 Inhibitors, some anticonvulsants, and some antidepressants. The use of nonopioid pharmacotherapy is associated with a significantly reduced risk of overdose (FDA, 2014).

Recommendation 2

The second recommendation suggests that before initiating opioid therapy in chronic pain patients, it is essential to establish realistic goals for pain and function (FDA, 2014). Also, patient education given that opioid therapy would discontinue if therapy risks are deemed more significant than the benefits. Opioid prescriptions should only continue when there is a meaningful improvement in function and pain, and the benefit outweighs the risk to patient safety.

Research suggests that long-term use of opioids is associated with severe risks (FDA, 2014). Research shows weak evidence that opioid therapy beyond six months results in clinically significant pain relief or clinically significant improvements in quality of life. Many patients who use long-term opiate therapy discontinue therapy due to adverse effects or inadequate pain control. Because of these facts, it is hard to predict which patient will have greater benefits than harm when receiving chronic opiate therapy.

When opioid therapy is initiated, the prescriber should determine the assessment protocol of the effectiveness of the therapy. Also, treatment goals should be established with the patient before starting therapy (FDA, 2014). Goals should include relief in both pain and improvement in function. Conditions that lead to progressive functional impairment or injuries such as spinal cord trauma may have a primary goal of pain relief as opposed to improvements in physical function. Also, considering patients' social and emotional well-being should impact that assessment.

Functional goals may include returning to work, attending specific recreational activities, walking around the block, or taking the dog for a walk. Assessing for depression, anxiety, and other psychological conditions is an important aspect of managing the whole patient. Generally, if pain and function are not improved on opioid therapy, tapering or discontinuing the opioid should be strongly considered.

A written agreement should also be used that discusses how opioids will be prescribed and monitored and how they will be tapered or discontinued (FDA, 2014). Situations where opioids should be tapered or discontinued, including when opioids are not needed, side effects become too severe, or treatment goals are not being met.

Recommendation 3

The third recommendation suggests that providers should discuss the risks and benefits of opioid therapy both before and during treatment. Also, the responsibilities of both patient and clinician merit mandatory discussion before and during therapy (FDA, 2014).

Key teaching points (FDA, 2014):

  • Functional improvement is the primary goal, even if pain still is present
  • The use of opioids generally does not improve pain and function in the long term, but opioids may reduce pain in the short-term
  • Discuss common side effects include nausea, vomiting, mental status changes, constipation, dry mouth, drowsiness, tolerance, physical and psychologic dependence, and withdrawal symptoms upon ceasing opioids
  • Discuss potentially fatal respiratory depression, especially with higher doses or when used with other depressants such as benzodiazepines
  • Chronic opioid use may lead to a lifelong opioid use disorder
  • Increase fluid intake and fiber to reduce the risk of constipation
  • Opioids reduce the ability to operate motor vehicles safely
  • Discuss the need for periodic review with consideration given to reducing or discontinuing the opioid
  • Discuss the importance of not sharing prescriptions among family or friends
  • Discuss safe storage, such as in a locked location
  • Discuss the safe disposal of controlled substances
  • Discuss monitoring that will include the use of urine drug testing and the use of the prescription drug monitoring program
  • Consider discussing the use of naloxone

Recommendation 4

Recommendation four suggests that when starting opiates for chronic pain, immediate-release opioids are recommended over longer-acting drugs. Longer-acting opioids are associated with a higher risk of overdose when compared to immediate-acting opioids.

The Food and Drug Administration (FDA) reported in 2014 that extended-release or long-acting opioid pain drugs should be used when pain is severe enough to necessitate daily, around-the-clock, long-term opiate treatment when other options are not effective, not tolerated, or would not offer adequate pain management (FDA, 2014). Extended-release and long-acting opioid drugs should not be used as needed.

Certain drugs are only appropriate for opioid-tolerant patients. An opioid-tolerant patient is someone who has taken 60 mg daily of oral morphine, 30 mg daily of oral oxycodone, or an equianalgesic dosage of other opioids for at least one week (FDA, 2014).

There is not enough evidence to determine if taking immediate-release opioids for breakthrough pain when using ER/LA opioids is safe outside palliative care, end-of-life care, and active cancer (FDA, 2014).

Using abuse-deterrent technologies makes it more difficult and less rewarding to manipulate opioids. While they can still be abused, it is more challenging to do so. The abuse-deterrent technology does not prevent unintentional overdose, and the Center for Disease Control document does not make recommendations regarding abuse-deterrent formulations.

Research suggests Methadone has the highest number of overdose deaths compared to other opioids prescribed for chronic pain. Methadone also has cardiac complications such as QT prolongation and cardiac arrhythmias. Also, methadone has a variable and long half-life, which can be complicated when peak respiratory depression occurs. There is more interindividual variability in the pharmacodynamics of methadone when compared to other opioids. Methadone should only be used by prescribers familiar with the unique pharmacodynamics and willing to monitor patients on it carefully.

The pharmacodynamics of transdermal fentanyl is also complicated. A gradual increase in serum concentration can occur over the first 72 hours (FDA, 2014). Absorption can be variable based on factors such as external heat.

Initiation of Opioid treatment should not occur with ER/LA dosing, and this type of drug should not be used for intermittent use. They should be considered only in those with severe pain who have used intermediate-release opioids daily for at least seven days.

Recommendation 5

Recommendation five suggests that when starting opiates, the lowest effective dosage should take precedence. Extreme caution should be used when prescribing opiates. The risks versus benefits should be reevaluated with dosages above 50 morphine milligram equivalents (MME)/day used (FDA, 2014). If dosages above 90 MME/day are used, careful documentation of its justification should be accomplished.

The benefits of high-dose opioids are not well established, and higher doses are associated with more harm, such as opioid use disorder, overdose, and motor vehicle accidents. While lower doses of opiates reduce the risk, there is no dose threshold eliminating the risk of overdose. Dosage above 90 MME/day is linked to a high risk of overdose, with lower dosages associated with less risk (FDA, 2014). According to the CDC document, when dosages are pushed to over 50 MME/day, the risk of overdose increases without improving pain control or functional benefit.

When increasing the dosages of opioids, the increase should occur in the smallest amount possible to reduce the risk of overdose. There is no firm evidence on how long to wait before increasing dosages, but waiting for at least five half-lives before increasing the dosage has been recommended. Also, extreme caution should be used in individuals over 65 or those with kidney or liver insufficiency.

When dosages are increased above 50 MME/day, the prescriber should (FDA, 2014):

  • Assess if the opiate is helping to meet the treatment goals
  • Increase the frequency of follow-ups
  • Consider providing naloxone
  • Provide overdose education

Even for patients who have been on high doses for many years, the offer to wean their dosage should occur. The patient should have education regarding recent clinical evidence suggesting that patients on high doses of opiates are at higher risk for overdose, and the provider should offer the patient an opportunity to wean dosage slowly if indicated.

Recommendation 6

Recommendation six suggests that when using an opioid for acute pain, the provider should use the lowest dose of immediate-release opioids and provide a quantity that is no more than the expected duration the patient needs. Three days or less is often enough, and more than seven days is rarely indicated.

Some research suggests that for back pain managed in a primary care setting, the use of opioid drugs results in a large reduction in pain until the fourth day of treatment, and smaller pain reductions are noted. Opioids should not be prescribed “just in case (FDA, 2014).”

Recommendation 7

Recommendation seven suggests that patients using opioids for chronic pain should have the benefits and harms evaluated within one to four weeks of beginning therapy or when there is a dose increase. After that, the benefits and harms should be evaluated at least every three months. If the benefits do not outweigh the harms, the provider should consider tapering opioids to a lower dosage or discontinuing opioids.

Individuals who continue opioid therapy for three months or more are at increased risk of developing opioid use disorder (FDA, 2014). Therefore, frequent follow-up in the first three months may help reduce the risk of opioid use disorder. Another argument for close follow-up is that the risk of overdose is high during the first two weeks of treatment with ER/LA opioid use. The risk is especially high with methadone or fentanyl.

Research suggests that individuals who do not have pain relief from opioids at one month will likely not have pain relief at six months. Therefore, assessment within the first month is important to determine who will likely benefit from opioid therapy. Frequent assessments should reduce the risk of complications of long-term opioid use such as overdose, opioid use disorder, and other injuries.

Specific individuals are at higher risk for opioid use disorder or overdose, and this includes individuals with a history of a substance use disorder, individuals with depression or another mental health condition, patients taking greater than 50 MME/day, those with a history of overdose, and those taking other central nervous system depressant drugs (FDA, 2014). These individuals should be evaluated more frequently. If found to be without benefit from the opiate, strong consideration should occur in reducing the dose or discontinuing the opiate.

When tapering opioids, the dose should be reduced weekly by 10-50%. In individuals with a severe adverse event, such as an overdose, rapid discontinuation of 2-3 weeks could be utilized (FDA, 2014). Reducing dosages slowly may be appropriate for individuals who have utilized opioids for extended periods. Reducing as slowly as 10% a month may be utilized in individuals who have been taking opioids for years.

A slow reduction in opioid doses reduces the signs of opioid withdrawal such as anxiety, nausea, vomiting, diarrhea, tremor, increased heart rate, insomnia, drug craving, and abdominal pain.

Recommendation 8

Recommendation eight suggests that opioid-related harm risk factors should be assessed before and during opioid therapy. Also, clinicians should implement strategies to reduce risk in individuals at high risk. The strategies would include individuals on greater than 50 MME per day, those with a history of an overdose, a history of a substance use disorder, or those on concurrent benzodiazepines.

One strategy to reduce the risk of overdose death includes prescribing naloxone. Naloxone can reverse the opioid when there is severe respiratory depression. Naloxone can potentially bring on acute withdrawal symptoms in patients who are physically dependent on opioids.

Other factors that place patients at high risk for overdose include sleep-related breathing disorders such as sleep apnea or congestive heart failure, pregnancy, mental health issues, renal or liver insufficiency, and those greater than age 65 (FDA, 2014).

Pregnancy puts both mother and fetus at risk because it can increase the risk of poor fetal growth, congenital disabilities, stillbirth, and preterm delivery. It can also lead to neonatal opioid withdrawal. When prescribing opioids for anyone of childbearing age, discussing a possible consequence of opioids during pregnancy is essential.

Prescribing drugs, including opioids, can be challenging in older adults. Some concerns include reduced renal or hepatic function, higher risk of respiratory depression, increased risk of side effects including cognitive impairment, more comorbid medical problems, polypharmacy, higher risk of falls, and constipation.

Extra caution should be utilized in individuals with mental health problems when prescribing opioids (FDA, 2014). This group of individuals is at higher risk for opioid use disorder and increased risk for drug overdose (especially in those with depression). For individuals with significant psychiatric instability or high suicide risk, opioid therapy should not be initiated. Also, individuals who have been prescribed benzodiazepines should very cautiously be prescribed opiates, if at all.

The patient should be asked about drug and alcohol use. Also, the prescriber should use the prescription drug monitoring program (PDMP) database before prescribing. For individuals with a substance use disorder obtaining outside consultation with a substance use disorder specialist or pain specialist regarding pain management is recommended.

Recommendation 9

Recommendation number nine suggests that the clinician should review the PDMP database to determine previous/current opioid prescriptions and other drugs that may interact and place the patient at higher risk for overdose (FDA, 2014). The clinician should review this data at least every three months, but as often as every prescription is written.

Research is limited on the benefits of PDMPs. However, evidence suggests that individuals who received opioid prescriptions from multiple prescribers at high doses are at the highest risk for overdose. The PDMP can help detect these situations.

Providers should not dismiss patients from their practice based on data from these databases. Doing so has the potential to have adverse health outcomes. The PDMP allows the provider to intervene to reduce the risk of overdose by providing interventions such as education, considering alternative therapies, or prescribing naloxone.

Recommendation 10

Recommendation number ten suggests that when prescribing opioids for chronic pain, urine drug testing should be used before therapy and at least once a year. Urine drug testing will ensure the patient is taking the drugs as prescribed and that there are no illicit drugs in the patient’s system (FDA, 2014).

The use of other controlled substances increases the risk of overdose. Urine drug testing has the potential to identify these patients and reduce risk. Urine drug testing also can determine when patients are not utilizing prescriptions as prescribed, which may point to diversion or side effects that limit compliance.

While urine drug testing should be done before starting opioid therapy, there is disagreement on how frequently testing should be done during long-term therapy. It should be done at least once a year. In high-risk individuals, more frequent testing should ensue.

Patients should have educated regarding the purpose of drug testing – to improve patient safety. Before testing, the provider should ask about the use of other drugs and if there might be any unexpected results. The clinician should be prepared for unanticipated results and have a plan for dealing with them. Unexpected results should be discussed with the patient to determine if there is a logical explanation. If the unexpected results (for example, negative for a prescribed drug or positive for a random drug) are not explained, then confirmatory testing should occur.

Confirmed unexpected results can lead to one of the following outcomes (FDA, 2014):

  • Modification of the pain management strategy
  • More frequent evaluations
  • Tapering/stopping the opioids. When testing for expected drugs is repeatedly negative, then abrupt discontinuation is appropriate (as the patient is not taking the drug)
  • More frequent re-evaluation
  • Giving naloxone
  • Referral for substance use disorder treatment

Clinicians should not remove the patient from care due to an unexpected urine drug test. The abrupt removal from treatment is a safety measure as the patient could withdraw, obtain drugs from another source, or even start heroin. It could also be construed as patient abandonment. Lastly, it may miss a chance to get the patient into treatment for substance abuse disorder.

Recommendation 11

Recommendation eleven suggests avoiding prescribing an opioid and benzodiazepine together. This combination reduces respiratory drive and significantly increases the risk of overdose. The recommendation is not an ultimatum to never prescribe these two agents together but should be done rarely and with extreme consideration (FDA, 2014).

For example, a patient who has been on a long-term, low-dose benzodiazepine and develops severe acute pain may be a candidate for a low-dose opiate drug.

Other drugs that suppress the central nervous system should be avoided in those on opiates. These may include sedatives, hypnotics, muscle relaxants, some antidepressants, and sedating antihistamines.

Recommendation 12

Recommendation number twelve recommends using an evidence-based treatment in those with opioid use disorder, which may include drug-assisted treatment (MAT) with behavioral therapy.

Points discussed under this recommendation include (FDA 2014):

  • Opioid dependence is estimated to be present in 3-26% of primary care patients on opioids for chronic pain. MAT is effective in preventing relapse in those with opioid use disorder (FDA, 2014).
  • MAT can occur with buprenorphine or methadone and, in some cases, naltrexone. Naltrexone blocks opioid effects and can be given daily oral therapy or monthly injections.
  • Providers should be aware of community resources available to help patients get treatment for opioid use disorder.
  • MAT in pregnant women with opioid use disorder improves maternal outcomes. Treatment should be with buprenorphine or methadone, not naltrexone.

The CDC guideline aims to enhance the communication between patient and provider regarding the risks and benefits of opioid treatment in chronic pain. It also looks to reduce the risks of long-term opioid therapy and improve effectiveness and safety.

Schedules of Controlled Substances

In 1970, section 812 of the Controlled Substance Act was enacted, which lists controlled substances. The list describes chemicals that may be classified as controlled substances. The Controlled Substance Act divides the drugs and other substances into five schedules, updated annually at here.

Schedule I controlled substances have no accepted medical use in the United States, have a high potential for abuse, and lack safety data. Substances in this class include heroin, marijuana, methylenedioxymethamphetamine ("Ecstasy"), and lysergic acid diethylamide (LSD).

Schedule II and IIN substances may potentially be abused and may lead to severe physical or psychological dependence. Schedule II narcotics include oxycodone (OxyContin®, Percocet®), hydrocodone (Vicodin®, Zohydro ER®), fentanyl (Sublimaze®, Duragesic®), methadone (Dolophine®), hydromorphone (Dilaudid®), morphine, opium, and codeine. Examples of Schedule IIN stimulants include methylphenidate (Ritalin®) and amphetamine (Dexedrine®, Adderall®) (NIDA, 2018).

Schedule III or IIIN substances have less abuse potential than those substances that are Schedule I or II. They are at high risk for psychological dependence and low to moderate risk of physical dependence. Examples of drugs in this class include buprenorphine (Suboxone®) and products with less than 90 milligrams of codeine per dosage unit, such as Tylenol® with Codeine. Drugs considered Schedule IIIN include: anabolic steroids such as Depo-Testosterone and ketamine.

Schedule IV controlled substances have a lower potential for abuse when compared to Schedule III controlled substances. Examples of drugs in this class include benzodiazepines, midazolam (Versed®), modafinil (Provigil®), tramadol (Ultram®), and carisoprodol (Soma®) (FDA, 2014b).

Schedule V controlled substances have a low abuse potential relative to Schedule IV substances. Examples of drugs in this class include cough preparations that contain less than 200 milligrams of codeine per 100 milliliters or 100 grams, such as Robitussin®, AC, and lacosamide (Vimpat®), and pregabalin (Lyrica®) (FDA, 2014b).

The Controlled Substance Act regulates five classes of drugs: anabolic steroids, depressants, hallucinogens, narcotics, and stimulants. Each class has different properties, and substances in each class typically produce similar effects. Most controlled substances alter mood, feeling, or thought due to their effect on the central nervous system. Drugs likely to produce euphoria are more likely to be abused, but drugs may be abused to aid sleep, reduce pain, reduce anxiety, reduce depression, and improve energy.

Assessment of a Patient in Pain

When taking a patient history, document the opioid currently prescribed, its dose, frequency, and duration of use. It is important to query the state prescription drug monitoring program, OARR, to confirm the patient’s report of prescription use. Also, it is important to contact past providers to obtain medical records.

Before controlled substances are prescribed, a history of illegal substance use, alcohol use, tobacco use, prescription drug use, family history of substance abuse and psychiatric disorders, history of sexual abuse, legal trouble history, behavioral problems, employment history, marital history, social network, and cultural background should be assessed. History of substance abuse does not prohibit treatment with opioids but may necessitate more intensive monitoring or referral to an addiction specialist.

Multiple tools to evaluate opioid addiction risk are available. The Opioid Risk Tool is a tool that is used in primary care to screen adults for the risk of aberrant behaviors when they are prescribed opioids for chronic pain. It is a copyrighted tool, encompasses five questions, and takes about one minute to administer. It classifies a patient as low, moderate, or high risk for opioid abuse. Those at high risk have a higher likelihood of aberrant drug-related behavior.

This tool is not validated in individuals without pain. The five questions include family and personal history of substance abuse (alcohol, prescription drugs or illegal drugs), age (risk is 16 - 45 years old), psychological disease, and 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.

Over the last few years, educating clinicians has been the primary focus of the medical community. This focus has led to increased awareness and safer prescribing of controlled substances. Practice guidelines disseminated among the emergency providers in Ohio were linked to a 12% reduction in opioid prescriptions per month (Modern HealthCare, 2018). This guideline included multiple positive steps, including assuring the clinician reviewed the prescription drug monitoring database, the patient was referred for further evaluation, reduced quantities of the drug, and education was provided about the risks versus benefits of the opioid.

A comprehensive medical history is the first step in the workup of an individual experiencing chronic pain. Many healthcare providers believe that pain is the fifth vital sign. A comprehensive medical history should include an evaluation of the patient’s medical and surgical history and a drug list review.

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 other symptoms associated with the pain, such as spasms, reduced range of motion, edema, diaphoresis, weakness, or changes in skin, nails, or hair?
  • Radiation:
    • Does the pain radiate? If so, where?
  • Temporal:
    • What are the aggravating/causative factors?
    • What factors alleviate or diminish pain?
  • Severity:
    • Rate the severity of the pain?

Document the impact the pain has on the patient’s 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 pain intensity is often done on scales and is meant to compare the intensity of the patient’s pain at different points, not to compare one person’s pain to another. The use of pain scales helps the prescriber assess the effectiveness of pain treatment.

The best scales are brief, valid, require minimal training, and use both behavioral and descriptive measures of pain (AMDA, 2012). A scale commonly used rates pain from 0 to 10. Another scale allows the patient to rate their pain as no, mild, moderate, severe, or unbearable. Other scales have the patient select the degree of pain on a pictorial scale with facial expressions. Pain maps are helpful 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 pain's location and rates the pain's severity.

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 workup done on their condition?

Psychological factors that contribute to the pain should also be assessed. Patients need to have reasonable expectations about the pain and its management.

All patients with chronic pain should have a complete physical examination. It is crucial 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 before 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
  • 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
  • Any signs of chronic liver disease
  • An abdominal examination for any tenderness, mass, or distention
  • A skin examination that looks for any track marks
  • Any signs of acute intoxication, withdrawal signs, or over sedation

Diagnostic testing is often part of the workup of painful conditions. It is essential to realize that an abnormal diagnostic test does not necessarily diagnose the source of the pain. Blood tests may be helpful in certain diseases that cause pain. For example, an elevated C-reactive protein or erythrocyte sedimentation rate is often present in individuals with polymyalgia rheumatica, infection, or rheumatoid arthritis.

Imaging can be useful in some cases of chronic pain. X-rays, computed tomography, and magnetic resonance imaging can help determine the cause of the pain. Remember, diagnostic testing needs to be interpreted carefully as some abnormalities may be incidental and not the source of the pain.

Caution should be used when evaluating patients as overuse of imaging or other diagnostic modalities may lead to increased use of opioids, activity restriction, and increased fear.

An electromyogram (EMG) or a nerve condition study (NCS) assesses the cause of pain. The EMG measures the electrical activity of the muscle and can help find damaged muscle, nerves, or neuromuscular abnormalities such as herniated disc or myasthenia gravis. The NCS measures the capacity of the nerves to transmit electrical signals and assists in diagnosing multiple types of neuropathies.

Ohio Guidelines for the Management of Acute Pain Outside of Emergency Departments

Acute pain normally fades with healing, is related to tissue damage, and significantly alters a patient’s typical function. Acute pain is expected to resolve within days to weeks. Pain that continues for 12 weeks is considered chronic. This guideline may not apply to acute pain resulting from exacerbations of underlying chronic conditions.

Assessment, documentation and Diagnosis of Patient Presenting with Pain For assessing patients presenting with acute pain include (Sehgal et al., 2012):

  • Medical history and physical exam
  • Location, intensity, and severity of the pain and associated symptoms
  • Quality of pain, e.g., somatic (sharp or stabbing), visceral (ache or pressure) and neuropathic pain (burning, tingling, or radiating)
  • Psychological factors, including personal and family history of substance use disorder

A specific diagnosis should be made to facilitate the use of an evidence-based approach to treatment. Develop and document a plan together with the patient that includes (CDC, 2016):

  • Measurable goals for pain reduction
  • Use of non-pharmacologic and pharmacologic therapies, with a clear path for progression of treatment and mutually, understood expectations for the degree and duration of the pain during therapy

The goal is to improve function to baseline as opposed to complete resolution of pain.

Examples of non-pharmacological therapy are (Sehgal et al., 2012):

  • Ice, heat, positioning, bracing, wrapping, splints, stretching, and directed exercise are available through physical therapy
  • Massage therapy, tactile stimulation, acupuncture/acupressure, chiropractic adjustment, manipulation, and osteopathic neuromuscular care
  • Biofeedback and hypnotherapy

Non-opioid medications should be used with non-pharmacologic therapy. When initiating pharmacologic therapy, educate patients on the proper use of medication, the importance of maintaining other therapies and expectations for the duration and degree of symptom improvement.

Treatment options by the quality of pain (Sehgal et al., 2012):

  • Somatic Pain
    • Acetaminophen
    • Non-steroidal anti-inflammatory drugs (NSAIDs)
    • Corticosteroids
    • Alternatives include the following: gabapentin/pregabalin, skeletal muscle relaxants, serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, and tricyclic antidepressants
  • Visceral Pain
    • Acetaminophen
    • Non-steroidal anti-inflammatory drugs (NSAIDs)
    • Corticosteroids
    • Alternatives include the following: dicyclomine, skeletal muscle relaxants, serotonin-norepinephrine reuptake inhibitors, topical anesthetics, and tricyclic antidepressants
  • Neuropathic Pain
    • Gabapentin/pregabalin
    • Serotonin and norepinephrine reuptake inhibitors
    • Tricyclic antidepressants
    • Alternatives include the following: other antiepileptics, baclofen, bupropion, low-concentration capsaicin, selective serotonin reuptake inhibitors, and topical lidocaine

Reserve opioids for acute pain resulting from severe injuries, medical conditions, surgical procedures, or when non-opioid options are ineffective or contraindicated. Short-term opioids may be first-line therapy in specific circumstances, like immediately post-operative. Opioids should usually be used as adjuncts to additional therapies rather than alone (Sehgal et al., 2012)

Healthcare providers must communicate with one another if the patient receives an opiate prescription from more than one provider.

Recommendations for the general use of opioids to manage acute pain (Sehgal et al., 2012):

  • Appropriate risk screening (e.g., age, pregnancy, high-risk psychosocial environment, personal or family history of substance use disorder)
  • Use the least potent opioid that is effective
  • Prescribe the minimum quantity needed with no refills
  • Check OARRS for all patients who will receive an opiate prescription
  • Use caution with prescribing opioids to patients
    • On medications causing central nervous system depression (e.g., benzodiazepines and sedative-hypnotics)
    • Patients are known to use alcohol, as combinations can increase the risk of respiratory depression and death
  • Discuss with the patient a planned wean off opioid therapy, concomitant with reduction or resolution of pain
  • Discuss proper secure storage and disposal of unused medication to reduce risks to the patient and others
  • Remind the patient that it is both unsafe and unlawful to give away or sell opioid medication, including unused or leftover medication

Reevaluate patients who receive opioid therapy for acute pain if opioid therapy exceeds 14 days and again at six weeks.

If pain persists, reevaluate and document the initial diagnosis and consider the following (Sehgal et al., 2012):

  • Pain characteristics (consider using a standardized tool [e.g., Oswestry Disability Index])
  • Treatment methods used
  • Reason(s) for continued pain
  • Additional management options, including consultation with a specialist

Chronic Pain

Chronic pain affects approximately 76.2 million Americans. Pain is a common problem in primary care, with about 20% of outpatient visits being for pain issues (Stewart et al., 2013). Chronic pain affects about one in two long-term care residents (AMDA, 2012).

Persistent pain is often associated with anxiety, depression, functional impairment, sleep disturbances, disability, and impairment in activities of daily living. Every year, chronic pain leads to more than 50 million lost workdays in the United States and costs the American taxpayer over 100 billion dollars (Hardt et al., 200

Chronic pain is defined as pain lasting more than three months and may affect any body part. Chronic pain is most frequently caused by back pain (10%), leg/foot pain (7%), arm/hand pain (4.1%), headache (3.5%), and widespread pain (3.6%). Many individuals affected by chronic pain have more than one type of pain (Merskey& Bogduk, 1994).

Pain is “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage (Alford et al., 2008).”

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 (Alford et al., 2008).”

Chronic pain is “pain that lasts beyond the usual duration of time that an insult or injury to the body needs to heal (Alford et al., 2008).” 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 (Sehgal et al., 2012).

Opioids are indicated for pain conditions. An expert panel concluded that chronic opioid therapy might be effective for some individuals with chronic non-cancer pain that have been thoughtfully selected (Alford et al., 2008). When deciding to prescribe opioids, the risks versus benefits must be considered.

The use of high-dose of long-acting opioids is used only in specific circumstances with severe, intractable pain that has not responded to short-acting or moderate doses of long-acting opioids. No evidence exists as to who responds better between long-acting and short-acting opioids concerning the effect and side effects (Manchikanti et al., 2012).

A recent survey showed that individuals would go to extreme lengths to obtain specific prescription drugs. Opioids were the most commonly obtained drugs, followed by sedative-hypnotics and amphetamines. Individuals seeking these drugs are more likely to use more than one physician and 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 (Alford et al., 2008).

Follow-Up

Regular follow-up and documentation are essential and should occur at least every three months and more frequently in individuals at high risk for abuse or during periods of drug adjustment. Baseline evaluation of the nature and intensity of the pain and the underlying effects pain has on a patient's physical and psychological function will help assess the treatment's effectiveness.

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 the follow-up should include urine drug testing, which can detect drug adherence, as well as illicit and non-prescription drug use. The prescriber should adequately document any interactions with patients, assessments, results of testing, and treatment plans.

Documentation should include the amount of pain relief experienced by the patient’s improved ability to function physically or psychologically. It should include recommended goals (e.g., improved level of function and improved quality of life). It should also include the plan of care and methods to help patients meet their goals.

Treatment should not be continued if the patient is not making adequate progress toward their goals. In this case, modification of treatment should be considered.

Written treatment agreements between prescribers and patients when controlled substances are used help guide the conversation between patient and prescriber. It discusses expectations, the risks, and the monitoring that will occur to limit the complications of controlled substances (Table 3).

Table 3: 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 drugs
  • Common side effects of the drug will be discussed

Prescription monitoring programs are available in 49 states. They provide an online database that lists all prescriptions of controlled substances dispensed to each patient by pharmacies. The prescriber should check the database before prescribing controlled substances. A patient with an undisclosed prescription for controlled substances can be considered prescription drug misuse.

Termination Strategies for Chronic Therapy

Discontinuation of opioid therapy may be considered if problematic patterns are noticed, opioid therapy is ineffective, or goals are not being achieved. The prescriber and patient must agree on reasons to terminate therapy before initially prescribing the drugs. This should be part of the initial agreement.

The clinician should have a method for addressing prescription drug misuse. Minor infractions may result in patient counseling and intensifying monitoring activities. More severe behaviors may require the clinician to discontinue prescribing controlled substances. If patients are found to be diverting prescription drugs, immediate cessation of the prescriptions is appropriate. In most other cases, it is appropriate to taper the controlled substances to reduce the risk of inducing a withdrawal syndrome.

When stopping the drug, the patient and the prescriber must agree. For patients who decide to continue treatment with another prescriber, the prescriber may consider maintaining the current dose for four weeks.

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

Table 4: Opiate Weaning Schedule
Daily MED (mg)Weaning Period (Days)
<60N/A
60-12030
121-18060
181-26060
261-34060
341-44060
441-64090
641-74090
741-84090
840-100090
1001-1200120
1201-1400120
1401-1600150
1601-1800150
1801-2200180
>2200 180
Table 5: Benodiazepine Weanig Table (ORC 4723)
Drug TypeGeneric Drug NameBrand Name (Example)Daily DoseWeaning Period for BWC Orders (Based on Daily Dose)Maximum Weaning Period (Days)
Short-ActingAlprazolamXanax®>4mg90 days plus 30 day for every 1mg above 4mg180
2-4 mg30 days plus 30 days for every 1mg above 2 mg90
>1<2mg30 days30
No weaning periodN/A
Short ActingLorazepamAtivan®>8mg90 days plus 30 days for every 1mg above 8mg180
4-8mg30 days plus 30 days for every 1mg above 4mg90
>2<4mg30 days30
No weaning periodN/A
Short ActingOxazepamSerax®>120mg90 days plus 30 days for every 30mg above 120180
60-120mg30 days plus 30 days for every 30mg above 60mg90
>15<60mg30 days30
No weaningN/A
Long-ActingDiazepamValium®>40mg90 days plus 30 days for every 10mg above 40mg180
20-40mg30 days plus 30 days for every 10mg 20mg90

<10mg

No weaning periodN/A
Long-ActingChlordiazepoxideLibrium®>100mg90 days plus 30 days for every 25mg above 100mg180
50-100mg30 days plus 30 days for every 25mg above 50mg90
>30<50mg30 day30
No weaningNo weaning
Long ActingClonazepamKlonopin®>4mg90 days plus 30 days for every 1mg above 4mg180
2-4mg30 days plus 30 days for every 1mg above 2mg90
>1<2mg30 days30
>/=1mgNo weaning periodN/A
Long ActingClorazepateTranxene®>30mg 90 days plus30 days for every 7.5mg above 30mg180
15-30mg30 days plus 30 days for every 7.5mg above 15mg90
>7.5<15mg30 days30
No weaning periodN/A

Individuals who have shown aberrant behavior should be offered other non-opioid options. 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 drugs, behavioral interventions, physical drugs, neuromodulation, medical interventions, or surgery. A multidisciplinary approach is typically used in the management of chronic pain.

Current treatments in managing chronic pain result in approximately a 30% reduction in pain (VA, 2016). One of the problems encountered is that general practitioners have limited training in managing chronic pain (Turk, 2018). A pain management specialist is often needed to manage pain properly.

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 the prescriber needs to realize that a primary goal of prescribing opioids should be to maintain patient safety. A responsible prescriber should follow multiple steps to ensure their patient's safe and effective care.

Therapeutic goals should be established and documented regarding pain control and improvement in function. Pain goals typically involve a reduction in pain, not necessarily an elimination of pain. Functional goals may include improved sleeping, increased ability to perform activities of daily living, progress in physical therapy, and increased social interactions.

The treatment plan should be established before initiating treatment. In this plan, the patient and the provider should discuss and document the benefits, risks, and alternatives before starting treatment. Also, the clinician needs to discuss how the patient will be monitored, including how the patient will be evaluated for potential misuse of the prescribed drug. The use of written documents is often included in the plan. This may include agreements, treatment plans, and informed consent. The clinician must document that decision-making was implemented, including informed consent, discuss goal setting, and define a monitoring plan (IM, 2011).

When high doses of opioid prescriptions are given, there is an increased risk of overdose death. Therefore, the clinician must discuss, document and limit the number of opioids prescribed. The CDC recommends that providers prescribe no more than 90 morphine milliequivalents per day (Chou et al., 2009).

The World Health Organization (WHO) analgesic ladder was created to manage cancer pain and published in the 1980s (WHO, 2019). Key points of the analgesic ladder include:

  1. Drugs are given through the most comfortable route (preferably orally).
  2. A stepwise approach should be followed, starting with non-opioid drugs with or without adjuvant drugs.
  3. Managing mild to moderate enduring or progressive pain with opioids, with or without adjuvant drugs, with or without non-opioids.
  4. Considering the use of more potent opioids such as morphine with or without adjuvant drugs with or without non-opioids for persistent pain or pain that is increasing, notwithstanding the previous step 3 above.
  5. Administering analgesic pain drug used for moderate to severe chronic pain on a fixed schedule (not as needed).

This approach is 80-90% effective.

Adjunctive drugs enhance the analgesic effect, reduce side effects, and assist with co-existent symptoms. Different patients will respond distinctively to different treatments regarding efficacy and side effects. Trial and error are often used in the treatment of chronic pain.

When starting therapy, the dose should be initiated at a low dose and titrated to obtain pain control and minimize side effects. Tolerance often develops as a patient gets used to the drug.

Treatment is typically started with a short-acting drug, and the drug is then titrated upwards to control pain while side effects are monitored. After determining the dose of the drug required to provide adequate pain relief with minimal side effects, the drug can be converted to a sustained release form and administered once or twice a day. When a long-acting drug is used, a breakthrough drug can be given.

A periodic review and documentation of the patient’s pain and clinical status is essential to assure that opioids need to be continued or should be discontinued. Any change in the patient’s state of health, degree or nature of pain, mental health, and overall function should be noted. The clinician and patient should review the proper dosage and schedule of the drug. Decisions on the benefits of pain management should focus on previously decided upon goals. Positive response to treatment can include a reduction in pain, improvement in the quality of life, or improved function.

An important role of the practitioner is prescribing controlled substances. Controlled substances have inherent risks, so the prescriber needs to realize that a primary goal of prescribing opioids should be to maintain patient safety. A responsible prescriber should follow multiple steps to ensure the safe and effective care of the patient.

Tips to Reduce Iatrogenic Harm

Have an upper dosing threshold. The 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 (VA, 2016).

Use caution with certain drugs. For example, methadone should only be used by a prescriber who is exceptionally comfortable with the drug. Fentanyl is another drug 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 of the typical starting dose in at-risk patients. Titration should be done carefully. Constipation is likely, and a bowel regime should be prescribed when opioids are used.

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

The most significant risk of opioid use is respiratory arrest and death, which is highest when therapy is started, or the dose is increased. Opioid-induced respiratory depression is manifested by the reduced desire to breathe and reduced respiratory rates. The patient will be breathing shallowly, 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 to reduce adverse events and improve therapeutic outcomes - may be considered. Tolerance to one opioid can lessen the analgesic effects, and using a different opioid may result in an improved analgesic effect and fewer adverse effects.

When opioid rotation is done, the prescriber must determine the approximate equianalgesic dose. This 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 devices are available to help with this conversion.

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

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

To prevent prescription drug abuse, the prescriber needs to ensure:

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

Patient risks should be assessed, and contraindications should be immediately identified. Contraindications to opioid treatment include those who have an erratic follow-up, suffer from current untreated addiction, or have poorly controlled mental illness (VA, 2016).

Informed consent provides written documentation regarding the benefits and risks of the therapy and discusses the legal responsibilities of both the patient and the prescriber. Informed consent improves adherence, improves the effectiveness of a treatment plan, reduces the risk of inadvertent drug misuse, lays out the potential adverse effects, including side effects and addiction, discusses how refills will happen as well as the policy of early refills and lost prescriptions/drugs and discuss reasons for discontinuing therapy.

Referrals 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 or 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. Goals should also include limiting side effects and minimizing adverse drug events.

Opioids

Non-steroidal anti-inflammatory drugs (NSAIDs) are laced with risks, and some patients cannot tolerate NSAIDs due to side effects and pre-existing co-morbid conditions. The risks associated with NSAIDs are one reason many prescribers choose an opioid to manage pain. Opioid therapy is useful in managing many chronic pain conditions, including cancer, osteoarthritis, low back pain, neuropathic pain, and postherpetic neuralgia.

Recently, opioid therapy has fallen out of favor as a commonly prescribed drug. In the distant past, it was only used for severe acute and cancer pain. In the early 2000s, opioids were one of the most commonly prescribed drugs, but now only hydrocodone with acetaminophen falls in the top ten prescribed drugs (Fuentes et al., 2018).

A position paper from the American Academy of Neurology suggested that there is evidence for good short-term pain relief with opioids. However, no good evidence exists for continuing pain relief or improved function for an extended 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 more than non-opioid therapy (Martell et al., 2014). Opioid therapy is often used to manage neuropathic pain but is commonly thought to be the second line to antidepressants and anticonvulsants.

Risk Factors for Opioid Abuse

Many known risk factors of opioid abuse, misuse, diversion, addiction, and overdoses (Pergolizzi et al., 2018). Evaluating these risk factors is an essential aspect of the evaluation of a patient. Factors that increase the risk of problematic opioid use include:

  • A prior history of misuse or abuse
  • Younger age
  • Untreated psychiatric disorder
  • Living in a social and family environment that encourages misuse
  • Genetics
  • Physical, sexual, or emotional abuse
  • Using nicotine, alcohol, or other drugs at an early age
  • Substance use/abuse in the family or among friends
  • Stress
  • Access to addictive substances
  • Highly impulsive personality
  • Family or personal history of drug/alcohol abuse and mental health issues, including depression, anxiety, eating disorders, or personality disorders
  • History of legal trouble/incarceration
  • White race

Side Effects of Opioids

Opioid drugs 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 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 constipation. An osmotic laxative such as polyethylene glycol or lactulose may also be considered and added to stool softeners/stimulants for resistant constipation.

Antiemetic drugs 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 drug may be added to the lower dose of opioids to help manage the pain. Rarely the use of a stimulant can be used to manage sedation due to opioid use.

Respiratory depression may occur, but it is uncommon to use the drug 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.

Drug Interactions

Drug interactions can lead to significant health concerns in those taking opioids. Many individuals with chronic pain have co-morbid conditions that necessitate using other drugs. A study showed that drug-to-drug interactions in those with chronic low back pain on long-term opioid analgesics were 27% (Pergolizzi et al., 2018).

Drug-to-drug interactions are variable among products. Drugs 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 drugs can affect various cytochrome P450 enzymes. Codeine, oxycodone, hydrocodone, and tramadol levels may be increased when given with selective serotonin reuptake inhibitors (SSRIs), protease inhibitors, diltiazem, verapamil, diazepam, clarithromycin, fluoroquinolones, and diphenhydramine. Levels may be decreased with carbamazepine and phenytoin. Fentanyl levels may be increased by SSRIs, protease inhibitors, diltiazem, verapamil, diazepam, and clarithromycin. Some opioids used with anticholinergic drugs may increase the risk of constipation and urinary retention.

Grapefruit juice can potentially increase levels of multiple opioids such as fentanyl, codeine, hydrocodone, and methadone. Ginkgo Biloba, Valerian Root, and St. John’s Wort can potentially 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.

Patient Education on Opioid Drugs

Patient education is essential as it will reduce the risks associated with these drugs and improve pain management. Patients need education in the safe use, storage, and disposal of opioid drugs. Safe use of opioids requires the patient to know about adverse events and risks of abuse, misuse, and addiction.

An overdose occurs when someone takes a higher dose than the body can tolerate leading to a significant adverse effect. Respiratory depression is the primary risk. This risk is highest in those who are not tolerant to opioids, take other respiratory depressants, have multiple health conditions, or have debilitated health and impaired respiratory function.

Drugs associated with a high risk of respiratory depression are schedule II opioids. Fentanyl, a synthetic opioid pain reliever, is 50 to 100 times more potent than morphine and has been implicated in many cases of overdose death. Drugs that are altered for administration also increase the risk of overdose. Snorting, injecting, inhaling, chewing, or dissolving drugs that should be swallowed whole (particularly extended-release opioids) increases the risk. Other methods that may lead to overdose include rapid titration of opioids and overestimating the dose when converting from one opioid to another. Overdoses also occur when the drug is taken by someone it was not prescribed, especially children. Therefore, safe storage and disposal are critical.

Information on abuse should be taught to the patient. Many patients who abuse opioid drugs usually get a valid initial prescription (CDC, 2014).

Patients should also be taught about misuse. Many patients will misuse drugs because they seek to improve function, have uncontrolled pain, or are using them to manage stress or mental disease. Aberrant behavior may be seen in those who are undertreated for pain. In the absence of addiction, these behaviors cease when pain is adequately controlled.

Patients should also be taught that drug diversion will not be tolerated. It will immediately terminate the prescription with a referral to a substance abuse program and possible legal action.

Patients should be taught about addiction. Addiction is a chronic disease with psychological, social, genetic, and environmental factors influencing its presentation and development. Addiction presents with a drug craving, compulsive use, impaired control, and continued use despite harm.

Drug Take-Back Programs provide a convenient way for patients to dispose of unneeded, expired, or unused controlled substances. If no program is available, the patient must use extreme caution when disposing of controlled substances. Improper disposal may lead to environmental complications or drug diversion. Controlled substances can be mixed with cat litter or coffee grounds and then sealed in a non-leaking container.

Key points in patient education include:

  • Goals of treatment.
  • Alternative treatment options.
  • Patients should be encouraged to read their drug guide and package insert every time they get a new prescription.
  • Teach about abuse, addiction, misuse, and diversion.
  • Risks of overdose and death if the dose is not taken as prescribed or if someone else takes the drug.
  • Pain drugs may impair breathing.
  • Do not give the drug to anyone else.
  • If anyone else takes the mediation, emergency services should be contacted.
  • Swallow whole pills that are meant to be swallowed – do not crush, snort, chew, inhale, or take any other means other than the method prescribed.
  • Maintain contact with the prescriber for monitoring and titration.
  • Teach about drug-to-drug interactions. Drugs that should be avoided in combination with opioids include alcohol or any drug that has not been prescribed. Drugs that should only be taken after a careful review and counseling by a prescriber include sedatives, hypnotics, anxiolytics, antidepressants, and antihistamines.
  • Opioids may lead to cognitive impairment and affect driving ability or safety at work, especially when operating heavy equipment.
  • Opioids should be stored safely and away from family members, acquaintances, and friends.
  • Drugs should be locked up in a drawer, cabinet, or safe – so no one else will get them.
  • Educate patients that giving away or selling their drugs to others is illegal and dangerous.
  • 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.
  • 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 the prescription drug monitoring program. Unfavorable results may lead to termination of treatment or alteration in the treatment plan.

Benzodiazepine

All benzodiazepines are schedule IV controlled substances. As controlled substances, all benzodiazepines have the potential for abuse, addiction, and diversion. Driving, operating machinery, or performing other hazardous tasks while taking a benzodiazepine is unsafe. Alcohol may potentiate these effects. Patients who are co-prescribed benzodiazepines and opioids are at higher risk of overdose ( Ayers & Paquin, 2017).

Benzodiazepine should be prescribed for a short course of treatment, no more than two to four weeks. Expectations of clinical benefits must be clear. Do not escalate the dosage without a clear clinical benefit ( Ayers & Paquin, 2017).

Table 4:Common Benzodiazepines Available in the US
Generic NameBrand NameCommon Uses
alprazolamNiravam®, Xanax®, Xanax XR®anxiety, panic disorders
chlordiazepoxideLibraxanxiety, alcohol withdrawal
clobazamOnfi®Lennox-Gastaut syndrome, adjunct (seizures)
clonazepamKlonopin®seizure disorder, panic disorder, neuralgia (nerve pain)
clorazepateTranxene T-Tab®anxiety, alcohol withdrawal, partial seizures
diazepamValium®anxiety, sedation, alcohol withdrawal, muscle spasm, seizure disorders
estazolamProSom®insomnia (short-term use)
flurazepamDalmane®insomnia (short-term use)
lorazepamAtivan®anxiety, insomnia (short-term use), seizures, sedation
midazolamVersed®sedation, preoperative; general anesthesia induction; seizures
oxazepamSerax®anxiety, alcohol withdrawal
temazepamRestoril®insomnia (short-term use)
triazolamHalcion®insomnia (short-term use)

Side effects of benzodiazepines:

  • Drowsiness
  • Sleepiness
  • Dizziness
  • Amnesia (forgetfulness)
  • Confusion
  • Constipation
  • Nausea
  • Sexual dysfunction
  • Unsteadiness when walking or standing
  • Unusually slow and shallow breathing
  • Vision problems (blurred or double vision)

Stop the drug if side effects are not tolerable. Benzodiazepine should be tapered, not abruptly stopped. Withdrawal symptoms may occur with abrupt discontinuation. These symptoms may include convulsions, cramps, insomnia, sweating, tremors, and vomiting.

Some people develop a paradoxical reaction to benzodiazepines. This is the opposite reaction to what would be expected, including:

  • Become agitated
  • Very anxious
  • Develop hallucinations
  • Have difficulty sleeping
  • Exhibit bizarre behavior
  • Taking unnecessary risks

Ethics and Fiscal Implications

Multiple ethical issues surround pain and its management. Healthcare providers should attempt to minimize pain and suffering while maintaining a balance between adequate pain management and minimizing harm from pain treatment. The healthcare provider must not harm and guard against overmedicating the patient. The healthcare provider must be aware of pharmacotherapy's negative consequences, including physical dependence, tolerance, and abuse.

Some think that pain management is a human right. Medical organizations do not consider pain management an explicit duty of the prescriber, except for a part of proper medical care. If pain is considered a human right, it will force the government into the middle of the patient-physician relationship.

Access to healthcare is not equitable and brings up questions of justice. Specific populations are at a disadvantage when it comes to access to pain management. Individuals who do not have insurance may lack the means to receive medical care and pain management. Individuals who are more likely to have access to care include those who are older, those who live in a suburb, and those who have insurance, a college degree, or a high income. Those with less access to care include those with financial problems and those of Hispanic ethnicity.

Ethical issues surround the end of life care. The management of pain at the end of life is a moral duty for the provider caring for a terminal patient. While opioid use may suppress respiration and may even hasten death, treating pain is an important part of care for intractable pain as death nears. The goal of giving pain management is to relieve suffering, not accelerate death. Palliative sedation may be considered to manage refractory pain at the end of life.

Drug Diversion

Drug diversion is the use of legal drugs for illegal purposes or the use of prescription drugs for recreational purposes and is a key concern in the use of controlled substances. Removing prescription drugs from legitimate channels is drug diversion and can occur in many ways. Diversion may occur from the patient, prescriber, other healthcare providers, or pharmacist.

Slightly more than 40% of patients who abuse prescription pain drugs get it from a relative or friend without paying for them. 36.4% of abusers of prescription drugs got them through their healthcare provider either by prescription or by stealing (ORC, 3719.81). Ten percent stole drugs from a relative or friend.

Patients use methods to obtain illicit drugs, including influencing or forcing prescribers to write the prescription, changing the prescription, getting multiple prescriptions for the same drug, or writing their prescription.

Some patients get drugs through doctor shopping, but most patients receive their drugs through one doctor. Fraudulent prescriptions are another method of obtaining prescription drugs. This can occur in many ways. Methods include altering an already written prescription, stealing a prescription pad, or creating falsified computer prescriptions.

The prescriber can be drug trafficking, selling drugs for money, or sexual favors. Healthcare providers abusing drugs may be irritable, defensive, or isolated. Other signs or symptoms of prescription drug abuse or misuse include frequent bathroom trips, coming into the office when not scheduled, working overtime, multiple drug errors, incorrect counts of controlled substances, poor judgment, neglect of patients, long sleeves in warm weather, and strange behavior.

The pharmacist may be the source of diversion. The pharmacist may dispense drugs based on incomplete information on the prescription, not catch obvious fraudulent attempts by the patient, or not check the accuracy of the physician’s DEA number.

Other diversion methods include theft, transportation losses, or internet pharmacies.

Techniques to reduce drug diversion are:

  • Write in ink
  • Writing out numbers makes it difficult to modify numbers on prescriptions
  • Use electronic prescribing
  • Mark the number of refills – mark through the unused portions
  • Lock up the prescription pad

It is very difficult to deal with a patient with a chief complaint of severe pain who wants opioid therapy. It is essential to understand the motivations of patients who seek drugs. Do the patients have pain or are they looking for controlled substances for non-medical purposes?

Prescribers often want to trust their patients, or they do not want to confront the patient about / their drug habits. Prescribers want their patients to be happy. Also, time is often a factor, and assessing the patient, including their physical, psychological, and social state, takes much more time than just writing a prescription.

Good communication is essential to help deal with drug-seeking patients. Prescribers must be empathetic and acknowledge that the patient is suffering. Providers must maintain confidentiality and privacy to ensure that the patient is comfortable.

Communicating with the patient is most successful when the provider confidently presents information and question patients using open-ended questions to promote honesty and documents well, including the patient’s assessment and any agreements.

Having firm office policies is essential in managing patients being prescribed opioids. Generally, prescribing opioids at the first visit should be avoided. The policies should include the frequency and timing of refills. 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 drug will be prescribed should be done. This is particularly true for an acute injury or a surgical procedure where pain typically improves.

Prescribers must be aware of problematic behaviors. Behaviors highly suggestive of a substance abuse disorder include legal problems, using drugs not as prescribed, getting drugs through nonmedical channels, reduced function at work or home, and concurrent abuse of other drugs or alcohol. Behaviors that may suggest addiction include requesting specific drugs, increased dosage, missed appointments, and requesting more drugs.

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 hypertension, hyperlipidemia, Stage III CKD, anxiety/depression, osteoarthritis of his knees and low back pain. He is currently on daily aspirin, amlodipine, citalopram, atorvastatin, and hydrocodone/acetaminophen.

Mr. T. has been taking hydrocodone /acetaminophen 1 - 2 times daily for over three years. About three months ago, he presented to the Emergency Department with a similar presentation and was discharged after six hours with no definitive diagnosis but was given a prescription for more hydrocodone /acetaminophen for pain.

Mr. T’s son reports that Mr. T. has not been coming to as many social events over the last month because his pain level has increased. The Emergency Department nurse practitioner notes that the vital signs (including oxygen saturation) are stable, but the patient is somnolent. He does wake when stimulated and answers only yes/no questions. His blood work, including liver/kidney function tests, glucose, and metabolic profile, are high, except he is shown to have Stage III CKD (but at baseline for the patient). His drug screen is positive for opioids.

Mr. T. reports 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 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 an appropriate option. 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. He reports that he has started therapy and is sleeping better. He only uses one hydrocodone/acetaminophen a day – typically after exercise. After four more weeks, he reports 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 drug, has gotten a part-time job, and is regularly exercising.

Case Study 2

Sara is a 42-year-old physical therapy assistant with chronic back pain due to a herniated disc and spinal stenosis, first diagnosed after lifting a patient four years ago. She currently rates the severity of her back pain as an 8/10 and has been unable to work due to her pain. The pain is described as dull and constant, with occasional sharp exacerbation in the low back, with the pain increasing with bending, prolonged standing, and walking. The patient denies any loss or change of bowel/bladder control, history of IV drug use, recent infection, progressive neurological complaints, night pain, night sweats, weight loss, or fever. The pain occasionally radiates into the right buttock. The patient can do all her ADLs but reports 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 drugs. She tried to control the back pain on acetaminophen, naproxen, ibuprofen, the lidocaine patch, and topical NSAIDs without relief. The patient experienced a possible seizure while on tramadol. Epidural injections did not help. Surgery was discussed, but the patient refused this option.

Sara is single, and now that she is not working, she has limited financial means. She reports having a problem with drinking in her twenties but has not had a drink in three years. She currently smokes. She denies any history of substance abuse and has 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, and no obvious deformity, swelling, or erythema. There is mild tenderness on the right side of the spine from L4 to S1, as well as tenderness in the right sacroiliac joint. Normal reflexes, sensation, ordinary strength, and no atrophy are noted in the lower extremities. The straight leg raise test is normal.

ONE YEAR AGO, an MRI was done that was significant for a herniated disc at the L5/S1 level and mild spinal stenosis.

The Opioid Risk Tool was administered and determined that the patient is at low risk for opioid abuse. She signed a written opioid treatment agreement that outlines the conditions of opioid therapy. The state prescription drug monitoring program was queried and showed no suspicious activity.

The patient is prescribed hydrocodone/acetaminophen 5 mg/500 mg; two tablets every six hours as needed (56 tablets) for one week.

Five days later, she calls for an early refill and reports that the drug is not helping her pain, and she just lies around all day.

She comes back into the office for re-evaluation and reports she needed to take more pain drugs than prescribed. It was reviewed with the patient that she violated the opioid agreement. A urine sample showed no illicit substances or drugs 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 specialist pain appointment was three weeks out. The patient saw the psychiatrist, and he diagnosed the patient with depression and started her on duloxetine (which may also help with pain). The psychiatrist was unable to make an assessment related to opioid abuse.

With the help of the pain specialist, oxymorphone ER 5 mg was ordered every 12 hours. The patient was told to follow up in one week to assess effectiveness. After one week, the patient reports she is more functional but still in much 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 function well and begin participating in an exercise program. The patient was ordered a bowel stimulant (Senna) with a stool softener (Colace) to prevent constipation.

The patient has been prescribed fourteen pills of 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 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 consent, controlled substance agreements, screening for drug abuse, patient education, teaching patients about proper storage and disposal of drugs and monitoring patients using controlled substance monitoring programs.

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