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Ohio Law Governing Drugs and Prescriptive Therapy

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

Outcomes

92% of participants will know how to apply best practices and Ohio law in prescribing controlled substances, including awareness of drug diversion.

Objectives

After completing this course, the student will be able to:

  1. Identify state and federal laws related to prescribing drugs
  2. Discuss OARRS
  3. Discuss the Center for Disease Control and Prevention guideline for prescribing opiates
  4. Apply assessment and treatment strategies for the use of opiates
  5. Discuss risk factors for opiate abuse and misuse
  6. Discuss schedule II controlled substances
  7. Discuss the fiscal and ethical implications of prescribing drugs and therapeutic devices
  8. Recognize drug diversion

Introduction

Note: Many regulations refer to an exclusionary formulary. That regulation has been rescinded. It has been replaced with prescribing based on the scope of practice and standard care arrangements.

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 for opioid abuse are needed.1

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, almost 11% reported crushing or chewing opioids in the past and 60% of patients self-reported abuse, misuse or diversion.2

Prescriber 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, 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.3

Prescribers receive little training in how to prescribe scheduled substances, how to screen for substance abuse, and how to refer patients who need treatment for substance abuse. Proper continuing education is one way to address this problem.4

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 there are withdrawal symptoms such as anxiety, tachycardia, hypertension, diaphoresis, a volatile mood, or dysphoria after the rapid discontinuation of the substance. Psychological dependence is the perceived need for the substance. It makes the individual feel as though they cannot function if they do not have the substance. Psychological dependence often kicks in after physical dependence wears off. Psychological dependence typically lasts much longer than physical dependence and often is a substantial contributing factor to relapse. Physical dependence is not addiction.

Addiction is psychological dependence, along with extreme behavior patterns associated with drug usage. At this point, there is typically a loss of control regarding drug use. The drug is continued despite 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 drug 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 in concert with a specialist.5

Opioid use disorder is a use pattern of opioids that result in problems or distress. It may include tolerance, impaired social functioning, loss of control of opioid use, dangerous opioid use, and withdrawal. To meet diagnostic criteria, patients with an opioid use disorder must have at least 2 of the 11 symptoms over 12 months.6 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.7
  • In 2016, 48.5 million individuals in the United States misused prescription drugs or used illicit drugs. 66%of the 630,000 drug overdose deaths were due to illicit or prescription opioids. The number of opioid overdoses to the emergency department increased by 30% from July 2016 to September 2017.8
  • Opioid misuse affects 34.2 million Americans over the age of 12. According to the Center for Disease Control and Prevention (CDC), 46 people die each day in the United States from an overdose of prescription painkillers.
  • In 2012, healthcare providers wrote 259 million prescriptions for painkillers.9 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 people per 100,000 people in 2016.10
  • Between the years of 1999 and 2015 drug overdose deaths have tripled.11
  • Of U.S. veterans treated in primary care settings, 4.8% reported opioid analgesic misuse.12
  • 12.2% of 12th graders reported ever abusing opioid, and 7.9% reported past-year use.13
  • Of those who were prescribed opioids, dependence may be as high as 26%.
  • The number of individuals who sought treatment for non-heroin opioid substance abuse increased from 1.0% in 1995 to 8.7% in 2010.14
  • Research shows that white individuals account for 88% of those who reported non-heroin opioid substance abuse, and the majority of these individuals lived in rural settings.14
  • Of overdose deaths from opioid analgesia, 30% also involved benzodiazepines.

Opioid dependence costs the United States healthcare system one billion dollars annually.15 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 phrase8:

“…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 advance practice registered nurses16:

  • 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 practice.16

A standard care arrangement includes at least16:

  • Signatures of each nurse, and collaborator, indicating a review and agreement to abide by the terms
  • The date when the arrangement is initially executed
  • The date of the most recent review of the arrangement
  • 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 provisions16:

  • 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 available upon request at each site where the practice of the occurs. 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 be following the policies and procedures of the hospital governing body and the bylaws, policies, and procedures of the hospital medical staff.

A nurse must notify the board of the identity of a collaborating physician or podiatrist any change in the name and business address of a collaborating physician or podiatrist within 30 days.

ARNP may prescribe any drug or therapeutic device in any form or route of administration if16:

  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 one that is 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 drug, 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.16

flowchart_aprn_prescribing_process

PDF available here

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

An ARNP may delegate the administration of a drug to an unlicensed person. Before delegating this authority, the APRNs with prescriptive authority is 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.16

An APRN with prescriptive authority has many requirements and limitations. These include15:

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

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

Formulary and Prescribing Standards

The formulary for ARNPs is found at codes.ohio.gov/oac/4723-9-10. The Exclusionary formulary list has been rescinded. Drugs are to be prescribed within the ARNP scope of practice and agreed upon in the standard care arrangement.

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.17

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

Extended-release or long-acting opioid analgesics means an opioid analgesic that is administered via a transdermal route or contains 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 ARNP 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 a controlled substance, the following apply17:

  • The ARNP has obtained a US drug enforcement administration registration, except if not required to do so as provided in rules adopted by the agency
  • The prescription indicates the days' supply of the controlled substance prescription
  • The patient is not a family member; and
  • The ARNP shall not self-prescribe a controlled substance

An ARNP can prescribe schedule II controlled substances and gabapentin only in situations where all of the following apply17:

  • 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 ARNP can prescribe a schedule II control substance if the prescription is issued from any of the following17:

  • 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 ARNP 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 ARNP 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.17

For the treatment of acute pain, an ARNP must comply with the following17:

  • 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 prescribe17:

  • 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 ARNP that arrangement must state the understanding of the physician as to when the ARNP can exceed the thirty MED average and when the ARNP 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 situations17:

  • 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 is approved by the FDA for opioid detoxification or maintenance treatment
  • Inpatient prescriptions

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

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

Before prescribing an opioid analgesic for sub-acute or chronic pain, complete or update patient record assessment. Complete an OARRS review. Offer the patient a prescription for naloxone if the following circumstances exist17:

  • 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 assessment and documentation of the patient's17:

  • 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 ARNP may prescribe these drugs.17

An ARNP shall not prescribe any drug or device to perform or induce an abortion.17

Opioid Use for Subacute or Chronic Pain for Work-Related Injury or Occupational Disease

The subacute phase of pain treatment means that an injured worker is experiencing pain that has persisted after reasonable medical efforts have been made to relieve it. Also, the pain has continued, either continuously or episodically, for longer than six continuous weeks but less than twelve continuous weeks after the date of injury, or occupational disease, or after surgery.18

Clinically meaningful improvement in pain and function (CMIF) is a measured and meaningful improvement in the ability of the injured worker to engage in activities of daily living or to make progress toward accomplishing any daily activity goals. The goals need to emphasize a possible return to work.

Long term use of opioids in workers' compensation claims is associated with an increased length of time until an injured worker returns to work. Therefore, it is highly recommended that prescribers consider and apply appropriate opioid prescribing guidelines before initially prescribing opioids to treat an injured worker, and continuously throughout the injured worker's course of opioid therapy.

These rules are a guide and are not a substitute for the prescriber's sound clinical judgment in light of current best medical practices and appropriate opioid prescribing guidelines. However, reimbursement may be withheld.

Continuous use of opioids in the chronic phase of pain treatment is associated with substantial risk for harm. Opioid prescribing or dose increases that do not result in CMIF are considered not medically necessary or appropriate in the Ohio workers' compensation system. That means no reimbursement.

Extra documentation or action is required in the following situations to get reimbursement.18

For doses higher than 50 milligrams MED per day, before escalating the dosing regimen, or prescribing opioids more than six weeks after the date of injury or surgery.

  • Develop a treatment plan that is justified by the clinical rationale
  • Conduct a risk assessment using a clinically validated tool for screening and assessment
  • Review OARRS
  • Implement a clinically validated and appropriate drug testing methodology
  • Documented response to treatment as demonstrated by CMIF

For doses higher than 80 milligrams MED per day, before escalating the dosing regimen, or prescribing opioids more than 12 weeks after the date of injury or surgery

  • Document reasonable alternative has been tried and failed

For doses higher than one hundred twenty milligrams MED per day, the patient is in the chronic phase of pain treatment, before escalating the dosing regimen, or prescribing opioids more than twelve weeks after the date of injury or surgery:

  • Document a risk-benefit assessment of the injured worker to determine whether to continue opioid prescribing or to initiate weaning
  • Consultation with a pain management specialist if:
    • The dose is above 120 milligrams MED per day and
    • There is no demonstrated improvement in CMIF or
    • Special situations like compassionate care are indicated
  • Evidence of the injured worker's informed consent and provision of written education materials regarding opioid abuse
  • Appropriate additional consultations if the injured worker has a co-morbid substance use issue or poorly controlled mental health disorder
  • Discontinue opioids in the chronic phase of pain treatment

For treatments assisting with stopping opioids in the chronic phase of pain treatment more than 12 weeks after the date of injury or surgery

  • Monthly documentation of adherence with the plan
  • Document a clear plan for tapering as measured by daily MED
  • Document intent to discontinue opioid treatment following a timeframe consistent with the standard dose tapering schedules. The recommended standards are below
Table 1: Opiate Weaning Schedule17
Daily MED (mg) Weaning Period (Days)
<60 N/A
60-120 30
121-180 60
181-260 60

261-340

60
341-440 60
441-640 90

641-740

90
741-840 90

840-1000

90

1001-1200

120

1201-1400

120

1401-1600

150
1601-1800 150
1801-2200 180
>2200 180
Table 2: Benzodiazepine Weaning Table17
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
2-4mg30 days plus 30 days for every 1mg above 2 mg90
>1<2mg30 days30
</=1mgNo 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
</=2mgNo 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
</=15mgNo weaningN/A

Long Acting

DiazepamValium®>40mg90 days plus 30 days for every 10mg above 40mg180
20-40mg30 days plus 30 days for every 10mg 20mg90
10-20mg30 days30
<10mgNo weaning periodN/A
Long ActingChlordiazepoxideLibrum®>100mg90 days plus 30 days for every 25mg above 100mg180
50-100mg30 days plus 30 days for every 25mg above 50mg90
>30<50mg30 day30
</=30mgNo weaningN/A
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®>30mg90 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
</=7.5mgNo weaning periodN/A

For 18 months after the date of a documented plan to stop opioid treatment, the following must be done for reimbursement.18

  • Appropriate and medically necessary medications as adjuncts to withdrawal must be pre-approved
  • Inpatient treatment for detoxification for up to thirty days
  • Outpatient treatment for an opioid disorder, according to patient placement criteria of the American Society of Addiction Medicine (ASAM)
  • Document agreement with the plan of treatment by the injured worker's physician of record or treating physician
  • All medications prescribed for treatment of pain and opioid must be prescribed by a single designated prescriber selected by the injured worker
  • The administrator must approve any change in prescriber during this period
  • Document compliance by the injured worker as indicated by monthly OARRS reports
  • At least bimonthly use of a clinically validated and appropriate drug testing method

Evidence of more than two events of non-compliance by the injured worker will result in withheld reimbursement for all clinical interventions for treating opioid withdrawal.18

Compassionate care can be approved by the administrator to continue reimbursement. Compassionate care is if the injured worker's injuries or treatment history is such that strict application of this rule would offer no improvement in the injured worker's overall health, safety, or quality of life, or continuing care of the injured worker will require a prolonged course of surgeries or multiple surgical interventions.

Prescribe Drugs to Sexual Partners

An ARNP 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 met19:

  • 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 ARNP 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 following19:

  • 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 ARNP contacts the individual19:

  • 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 ARNP who in good faith prescribes or personally furnishes a drug under this situation is not liable for or subject to any of the following19:

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

Ohio Automated RX Reporting System (OARRS)

An OARRS report is information related to a patient-generated by the drug database. The state board of Pharmacy manages that database. The system is available at ohiopmp.gov/.

In this regulation, there is reference to a reported drug regulation. That reported drug regulation has been rescinded. 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 consider20:

  • 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 the course of 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 flags20:

  • 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 clinical basis
  • Traveling with a group of other patients to the APRN's office, where all or most of the patients 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 situations20:

  • 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. Request a drug database report from another state if the county adjoins another state.20

OARRS reports may be requested by the APRN's delegate but must be personally reviewed by the APRN. Document evaluation and actions are taken due to 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 is20:

  • 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 document16:

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

Results of the consultation could include20:

  • 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, along with 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 removal of the prescription is likely the best course. If a substance abuse disorder is suspected, a referral to an addiction specialist is recommended.

Medication-Assisted Treatment

Medication-assisted treatment is alcohol or drug addiction services that are 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 the attainment of a medically stable, fully supported substance-free state, which may include the use of medications.21

Office-based opioid treatment (OBOT) is medication-assisted treatment of opioid dependence or addiction using controlled substances, in a private office or public sector clinic. Also, the office or clinic is not otherwise regulated by practitioners who are 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 settings21:

  • 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 ARNP for medication-assisted treatment must have one of the following21:

  • National certification in psychiatric mental health
  • Certified addictions ARNP 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 education in substance abuse and addiction during each renewal period is required.

A qualified ARNP may provide OBOT under the following circumstances21:

  • The standard care arrangement statement of services offered includes OBOT
  • The ARNP 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. For other than the toxicology tests for drugs and alcohol, appropriate history, substance abuse history, and pregnancy test, the ARNP 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 following21:

  • 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 ARNP
  • A plan for psychosocial treatment

OBOT should be provided an acceptable treatment protocol for assessment, induction, stabilization, maintenance, and tapering. Acceptable protocols are any of the following21:

  • 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 drug 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 interventions21:

  • 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 ARNP 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 on-going participation is required. If the ARNP refers the patient to another provider, the ARNP's meaningful interactions with the provider must be documented.

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

If the OBOT is using 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 situations21:

  • When the patient is pregnant or breast-feeding
  • When converting the patient from 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 ARNP shall only co-prescribe these substances when it is medically necessary, and only if the following happens22,48:

  • Verify the diagnosis for which the patient is receiving the other drug
  • Coordinates care with the prescriber for the other drug, including whether it is possible to taper the drug to discontinuation. If the ARNP prescribing buprenorphine is the prescriber of the other drug, the ARNP 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

During the induction phase, do not prescribe a dosage that exceeds FDA recommendations except for medically indicated circumstances, as documented. 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. Starting with the 91st day of treatment and 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 per quarter 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 who has the education and experience to provide substance abuse counseling.

The ARNP may treat a patient using the administration of extended-release, injectable, or implanted buprenorphine under the following circumstances21:

  • 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 ARNP or another Ohio licensed healthcare provider licensed to administer the drug

If using naltrexone to treat opioid use disorder, comply with the following additional requirements21:

  • 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
  • Patient is no longer physically dependent before treatment with naltrexone

Use oral naltrexone only for the treatment of patients who can be closely supervised and who are highly motivated. Comply with the FDA approved labeling for naltrexone hydrochloride tablets.

Encourage the patient to have a support person to assist with the administration and supervision of 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 thereafter.21

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 ARNP can personally furnish to a patient a drug or therapeutic device, only if the following requirements are met23 :

  • 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 furnishing
  • Dangerous drugs are labeled
  • OARRS requirements are met
  • Maintains a record of all drugs and devices furnished
  • ARNP maintains current knowledge of and complies with all applicable state and federal laws or rules related to personally furnishing drugs and therapeutic devices

An ARNP with prescriptive authority can furnish a sample drug if24:

  • Sample drug is furnished free of charge to the patient
  • Sample drug is furnished to the provider free of charge by the manufacturer, dealer, 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 ARNP with prescriptive authority can supply naloxone and a complete or partial supply of a drug to treat chlamydia, gonorrhea, or trichomoniasis.24

State and Federal Laws and CDC Recommendations

In 2011, the White House Office of National Drug Control Policy was introduced with the intent of addressing prescription drug abuse. It provided support to states to expand prescription drug monitoring programs, worked to eliminate “pill mills” and educated healthcare providers and patients.

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 any suspicious or known illegitimate prescriptions.

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

The Environmental Protection Agency (EPA) helps ensures that there is proper disposal of pharmaceutical waste. This prevents pharmaceutical waste in the environment, such as the ground and drinking water. The EPA has regulations that the pharmacy must follow.25

Every legislator and government agency seems to be presenting their unique plan on how 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 them26,27

  • 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 be 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, 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 pushed forward with plans for a five-fold approach to containing the Opioid Crisis28

  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.28

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 that pain control is an important part of quality healthcare. They acknowledge that pain is considered the fifth vital sign and should be assessed with other vital signs. According to the JC, patients have the right to assessment and treatment of pain. Additional 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 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 are advocating this throttled down introduction to opioids become the law of the land.28

US Centers for Disease Control and Prevention Guidelines for Prescribing Opioids

The Center for Disease Control (CDC) and Prevention developed guidelines for prescribing opioids in chronic pain. It offers guidance to the clinician regarding safe and effective prescribing of opioids and assistance in the management of chronic pain. This guideline focuses on patients over the age of 18 who 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 that deal with daily pain.29 It was developed because primary care clinicians reported insufficient training in opioid prescribing and concern regarding addiction. The guideline focuses on three main areas29:

  1. Determining when to start/continue opioids for chronic pain and includes looking at treatment goals, discussing 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 therapies and nonopioid pharmacologic therapies.29 Opioid therapy should be considered only when consideration given to 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.29

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.29 Also, patient education given that opioid therapy would discontinue if risks of therapy 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.29 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 benefits greater than harm when receiving chronic opiate therapy.

When opioid therapy initiated, the prescriber should determine the assessment protocol of the effectiveness of therapy. Also, treatment goals should be established with the patient before starting therapy.29 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, the consideration of the social and emotional well-being of patients should impact that assessment as well.

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 and anxiety as well as 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.29 Situations, where opioids should be tapered or discontinued, include when opioids are not needed, side effects become too severe, or treatment goals 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.29

Key teaching points29:

  • 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 that 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.29 Extended-release and long-acting opioids drugs should not be used on an as needed basis.

Certain drugs are only appropriate for opioid-tolerant patients. An opioid-tolerant patient is defined as someone who has taken 60 mg daily of oral morphine, 30 mg daily of oral oxycodone, or equianalgesic dosages of other opioids for at minimum one week.29

There is not enough evidence to determine if taking immediate-release opioids for breakthrough pain when using ER/LA opioids is safe outside of palliative care, end of life care, and active cancer.29

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

Research suggests Methadone having the highest number of overdose deaths when compared to other opioids when 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 complicate 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 that are very familiar with the unique pharmacodynamics and are 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.29 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 who have severe pain and 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.29 If dosages above 90 MME/day used careful documentation of its justification should be accomplished.

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.29 According to the CDC document, when dosages 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 the age of 65 or those with kidney or liver insufficiency.

When dosages are increased above 50 MME/day, the prescriber should29:

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

Even 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 that the patient needs. Three days or less is often enough, and more than seven days 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 after that, smaller pain reductions are noted. Opioids should not be prescribed “just in case. 29

Recommendation 7

Recommendation number 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 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.29 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.29 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 who had a severe adverse event, such as an overdose, rapid discontinuation of 2-3 weeks could be utilized.29 For individuals who have utilized opioids for extended periods, reducing dosages slowly may be appropriate. 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 number eight suggests that risk factors for opioid-related harms should be assessed before starting therapy 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 has the potential to bring on acute withdrawal symptoms in patients who are physically dependent on opioids.

Other factors that place patients at high risk for overdose including those with sleep-related breathing disorders such as sleep apnea or congestive heart failure, pregnancy, mental health issues, those with renal or liver insufficiency, and those greater than age 65.29

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, it is essential to discuss a possible consequence of opioids during pregnancy.

Prescribing drugs, including opioids, can be challenging in older adults. Some of the 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.29 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 the management of pain is recommended.

Recommendation 9

Recommendation number nine suggests that the clinician should review the PDMP database to determine previous/current opioid prescriptions as well as other drugs that may interact and place the patient at higher risk for overdose.29 The clinician should review this data at a minimum of 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 and 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 received from these databases. Doing so has the potential to have adverse health outcomes. The PDMP provides the provider and opportunity to intervene to reduce the risk of overdose by providing interventions as providing education, considering alternative therapies, or prescribing naloxone.

Recommendation 10

Recommendation number ten suggests that when prescribing opioids for chronic pain, the use of urine drug testing should be used before the start of therapy, and at least once a year. The use of 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.29

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 with 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 any unanticipated results and should 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 an unexpected drug) are not explained, then confirmatory testing should occur.

Confirmed unexpected results can lead to one of the following outcomes29:

  • 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 have withdrawal or 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.29

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 include29:

  • Opioid dependence is estimated to be present in between 3-26% of primary care patients on opioids for chronic pain. The use of MAT is effective in preventing relapse in those with opioid use disorder.29
  • MAT can occur with buprenorphine or methadone and, in some cases, naltrexone. Naltrexone blocks opioids effects and can be given as daily oral therapy or as monthly injections.
  • Providers should be aware of community resources available to help patients get treatment for opioid use disorder.
  • The use of 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 substances that are controlled. The list describes chemicals that may be classified as controlled substances. The Controlled Substance Act divides the drugs and other substances into five schedules, which is updated annually at www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm.

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, 3,4-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®).30

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 that have less than 90 milligrams of codeine per dosage unit, such as Tylenol® with Codeine. Drugs that are 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®).30

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 per 100 grams such as Robitussin® AC, lacosamide (Vimpat®), and pregabalin (Lyrica®).30

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

This tool is not validated in individuals without pain. The five questions include asking about family and personal history of substance abuse (alcohol, prescription drugs or illegal drugs), age (risk is 16 - 45 years old), psychological disease, and history of preadolescence sexual abuse. The questions are scored with different points assigned for each question, which is variable between men and women, and a total score is tallied. The patient is placed at low, moderate, or high risk.

Educating clinicians has been the primary focus of the medical community over the last number of years. This has led to increased awareness and safer prescribing of controlled substances. Practice guidelines disseminated among the emergency providers in Ohio was linked to a 12% reduction in opioid prescriptions per month.24 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 was prescribed, 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 review of the drug list.

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

  • Onset:
    • When did the pain start?
    • Describe the mechanism of injury?
    • What was the causative factor?
  • Location:
    • Where is the pain?
  • Duration:
    • How long has the pain persisted?
    • Is the pain intermittent or constant?
  • Characteristics:
    • Describe the pain (dull, sharp, lancing, burning, throbbing, or squeezing).
  • Associated symptoms:
    • Are there any other symptoms associated with the pain such as spasms, reduced range of motion, edema, diaphoresis, weakness, or changes in skin, nails, or hair?
  • Radiation:
    • Does the pain radiate? If so, where?
  • Temporal:
    • What are the aggravating/causative factors?
    • What factors alleviate or diminish pain?
  • Severity:
    • Rate the severity of the pain?

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

The best scales are brief, valid, require minimal training to use, and use both behavioral and descriptive measures of pain.31 A scale commonly used rates pain from 0 to 10. Another scale allows the patient to rate their pain as no pain, mild pain, moderate pain, severe pain, or unbearable pain. Other scales have the patient select the degree of pain on a pictorial scale with facial expressions. Pain maps are helpful in individuals who have a difficult time speaking. Pain maps have a front and rear view of the body on a piece of paper, and the patient marks the location of the pain and rates the severity of the pain.

The patient’s perception of the pain should be reviewed:

  • What are the patient’s treatment goals?
  • Why does the patient think they have persistent pain?
  • Does the patient feel there was sufficient 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 an elevated erythrocyte sedimentation rate is often present in individuals with polymyalgia rheumatica, infection, or rheumatoid arthritis.

Imaging can be useful in some cases of chronic pain. X-rays, computed tomography, and magnetic resonance imaging can 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 the diagnosis of 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 12 weeks is considered chronic. This guideline may not apply to acute pain resulting from exacerbations of underlying chronic conditions.

Assessment and Diagnosis of Patient Presenting with Pain For assessing patients presenting with acute pain includes7:

  • 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 a plan together with the patient that includes7:

  • 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 are7:

  • 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 pain7:

  • 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 or 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.7

Healthcare providers need to 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 pain7:

  • 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
  • Avoid long-acting opioids (e.g., methadone®, oxycodone ER®, fentanyl®)
  • Use caution with prescribing opioids with 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 the initial diagnosis and consider the following7:

  • 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 seen in primary care, with about 20% of outpatient visits being for pain issues.32 Chronic pain affects about one in two long-term care residents.31

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.33

Chronic pain is defined as pain lasting more than three months and may affect any part of the body. Chronic pain is most frequently caused by back pain (10%), leg/foot pain (7%), arm/hand pain (4.1%), headache (3.5%), and widespread pain (3.6%). Many individuals affected by chronic pain have more than one type of pain.34

Pain is defined as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.35

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.35

Chronic pain is defined as “pain that lasts beyond the usual duration of time that an insult or injury to the body needs to heal.35” 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.6

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.32 When deciding to prescribe opioids, the risks versus benefits must be considered.

The use of high dose long-acting opioids is used only in specific circumstances with severe, intractable pain that has not responded to short-acting or moderate doses of long-acting opioids. No evidence exists as to who responds better between long-acting and short-acting opioids concerning the effect and side effects.36

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 the sedative-hypnotics and amphetamines. Individuals who seek these drugs are more likely to use more than one physician and more than one pharmacy. This survey showed that seventy-five patients feigned symptoms to get prescriptions, two of thirty-six used falsified MRI images, three patients paid the prescribers, and three harmed themselves to get the prescriptions.34

Follow-Up

Regular follow-up is essential and should occur at a minimum of every three months and more frequently in individuals who are 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 is having on a patient's physical and psychological function will help in assessing the effectiveness of the treatment.

When assessing the patient experiencing pain, the six A’s should be assessed: analgesia, addiction, activities of daily living, adherence, aberrant behaviors, and adverse effects. Part of the follow-up should include urine drug testing, which can be used to 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, as indicated by the patient’s improved ability to function physically or psychologically. It should include what goals are recommended (e.g., improved level of function and improved quality of life). It should also include the plan of care and methods to help patients meet their goals.

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

Written treatment agreements, between prescribers and patients when controlled substances are used, help guide the conversation between patient and prescriber. It discusses expectations, the risks, and the monitoring that will occur to limit the complications of controlled substances (Table 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 for each patient by pharmacies. The prescriber should check the database before prescribing controlled substances. If a patient has an undisclosed prescription for controlled substances, it can be considered prescription drug misuse.

Termination Strategies for Chronic Therapy

Discontinuation of opioid therapy may be considered if problematic patterns are noticed, opioid therapy is not effective, or goals are not being achieved. 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, at which time a 5% reduction every 2-4 weeks may be made.

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

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 the management of chronic pain result in approximately a 30% reduction in pain.38 One of the problems encountered is that general practitioners have limited training in the management of chronic pain.39 The use of 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 the safe and effective care of their patient.

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

The treatment plan should be established before initiating treatment. In this plan, the patient and the provider should discuss 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; goal setting was discussed, and a monitoring plan was defined.40

When high doses of opioid prescriptions are given, there is an increased risk of overdose death. Therefore, the clinician must discuss and limit the number of opioids prescribed. The CDC recommends that providers prescribed no more than 90 morphine milliequivalents per day.41

The World Health Organization (WHO) analgesic ladder was created for the management of cancer pain and published in the 1980s.43 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 are used to enhance the analgesic effect, reduce side effects, and assist with co-existent symptoms. Different patients will respond distinctively to different treatments regarding efficacy and side effects. Trial and error are often used in the treatment of chronic pain.

When starting therapy, the dose should be initiated at a low dose and titrated to obtain pain control and minimize side effects. Tolerance often develops as a patient gets used to the 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 then be converted to a sustained release form and be administered once or twice a day. When a long-acting drug is used, a breakthrough drug can be given.

A periodic review 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.38

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, it 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 outcomes of the trial, 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, and this risk 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 shallow, and CO2 retention can exacerbate the sedating effects of opioids. If this is noted, the family should call 911.

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

Opioid rotation – changing from one opioid regime to another to reduce adverse events and improve therapeutic outcomes - may be considered. Tolerance to one opioid can lessen the analgesic effects, and the use of a different opioid may result in an improved analgesic effect and fewer adverse effects.

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

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

  • 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 erratic follow up, suffer from current untreated addiction, or have poorly controlled mental illness.35

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 for or those who engage in aberrant drug-related behaviors. Those with a substance abuse disorder are also candidates for referral. A pain management consultation may be helpful for those on high dose opioids. 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 are unable to tolerate NSAIDs due to side effects and pre-existing co-morbid conditions. The risks associated with NSAIDs is one reason many prescribers choose an opioid to manage pain. Opioid therapy is useful in the management of many chronic pain conditions, including cancer, osteoarthritis, low back pain, neuropathic pain, and postherpetic neuralgia.

In recent times, opioid therapy has fallen out of favor as a commonly prescribed drug. In the distant past, it was only used for severe acute pain and cancer pain. In the early 2000s, opioids were one of the most commonly prescribed drugs, but now only hydrocodone with acetaminophen falls in the top ten drugs that are prescribed.44

A position paper from the American Academy of Neurology suggested that there is evidence for good short-term pain relief with opioids, but no good evidence exists for continuation of pain relief or improved function for an extended time without sustaining serious risks of dependence, overdose, or addiction.45

When non-opioid therapy is ineffective, or there is severe nociceptive pain, opioid therapy is often used. In chronic back pain, opioids do not improve pain scores any more than non-opioid therapy.46 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

There are many known risk factors of opioid abuse, misuse, diversion, addiction, and overdoses.47 Evaluating these risk factors is an essential aspect in 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 older age, those with intra-abdominal pathology, and those who eat a low fiber diet. Patients on opiates should be encouraged to increase fiber intake, drink plenty of fluids, and exercise. Stool softeners (e.g., docusate sodium) and stimulants (e.g., bisacodyl) may be needed to manage constipation. An osmotic laxative such as polyethylene glycol or lactulose may also be considered and may be added to stools softeners/stimulants for resistant constipation.

Antiemetic 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 opioid 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 when the drug is used carefully. Starting with a low dose and slowly titrating the dose higher will reduce the risk of respiratory depression. Problems arise with rapid titration, the addition of another drug that may depress the respiratory drive (benzodiazepines, alcohol, or a barbiturate) or the patient overdoses. Sedation precedes respiratory depression, so when starting a patient on opioid therapy, the patient should be encouraged to take the first dose in the office to be monitored or in the presence of a responsible adult who can help monitor the patient.

The level of consciousness should be assessed at least every 30-60 minutes after the opioid is given. The next dose should be held, and the prescriber should be contacted immediately if a reduced level of consciousness occurs, hypoxia develops, or the respiratory rate is less than 10 per minute.

Drug Interactions

Drug interactions have the potential to lead to significant health concerns in those taking opioids. Many individuals with chronic pain have co-morbid conditions that necessitate the use of other drugs. A study showed that drug-to-drug interactions in those with chronic low back pain on long-term opioid analgesics had a prevalence of 27%.48

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 has the potential to increase levels of multiple opioids such as fentanyl, codeine, hydrocodone, and methadone. Ginkgo Biloba, Valerian Root, and St. John’s Wort have the potential to reduce levels of multiple opioids. Some individuals have an allelic variant in CYP-2D6, making them inefficient at converting codeine to its active metabolite morphine, thus resulting in a less analgesic effect to codeine.

Patient Education on Opioid Drugs

Patient education is essential as it will reduce the risks associated with these drugs and result in improved 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, as well as risks of abuse, misuse, and addiction.

An overdose occurs when someone takes a higher dose than the body can tolerate leading to a significant adverse effect. Respiratory depression is the primary risk. This risk is highest in those who are not tolerant to opioids, take other respiratory depressants, have multiple health conditions, or have debilitated health and an 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 overestimation of the dose when converting from one opioid to another. Overdoses also occur when the drug is taken by someone it was not prescribed for, especially children. Therefore, safe storage and disposal are critical.

Information on abuse should be taught to the patient. Many patients, who end up abusing opioid drugs, usually got a valid initial prescription.49

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

Patients should also be taught that drug diversion will not be tolerated. It will result in immediate termination of the prescription with 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 persistent use despite harm.

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

Key points in patient education include:

  • 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 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 pills whole that are meant to be swallowed – do not crush, snort, chew, inhale, or take by any other means other than the method prescribed.
  • Maintain contact with the prescriber for monitoring and titration.
  • Teach about drug-to-drug interactions. 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 may affect driving ability or safety at work, especially if 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 it is illegal and dangerous to give away or sell their drugs to others.
  • Patients should keep track of the number of pills, capsules, etc. - so it can be determined if any are missing.
  • Do not store them in a pill reminder container.
  • 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. It is not safe to drive, operate machinery, or perform other hazardous tasks while taking a benzodiazepine. Alcohol may potentiate these effects. Patients who are co-prescribed benzodiazepines and opioids are at higher risk of overdose.50

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.50

Table 4:Common Benzodiazepines Available in the US51
Generic NameBrand NameCommon Uses
alprazolam Niravam®, Xanax®, Xanax XR® anxiety, panic disorders
chlordiazepoxide Librax anxiety, alcohol withdrawal
clobazam Onfi® Lennox-Gastaut syndrome, adjunct (seizures)
clonazepam Klonopin® seizure disorder, panic disorder, neuralgia (nerve pain)
clorazepate Tranxene T-Tab® anxiety, alcohol withdrawal, partial seizures
diazepam Valium® anxiety, sedation, alcohol withdrawal, muscle spasm, seizure disorders
estazolam ProSom® insomnia (short-term use)
flurazepam Dalmane® insomnia (short-term use)
lorazepam Ativan® anxiety, insomnia (short-term use), seizures, sedation
midazolam Versed® sedation, preoperative; general anesthesia induction; seizures
oxazepam Serax® anxiety, alcohol withdrawal
temazepam Restoril® insomnia (short-term use)
triazolam Halcion® insomnia (short-term use)

Side effects of benzodiazepines51:

  • 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, including51:

  • 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 the treatment of pain. The healthcare provider has to do no harm and must guard against overmedicating the patient. The healthcare provider has to be aware of the negative consequences of pharmacotherapy, 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 in 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 receiving 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, those who have insurance, a college degree or have 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, the treatment of 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. The use of 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 on any level from the patient, prescriber, other healthcare providers, or pharmacist.

Slightly more than 40% of patients who abuse prescription pain drugs got it from a relative or friend without having to pay for the drugs.51 36.4% of abusers of prescription drugs got them through their healthcare provider either by prescription or by stealing.26 Ten percent stole drugs from a relative or friend.51

Methods that patients use to obtain drugs for illicit use include influencing or forcing prescribers to write the prescription, changing the prescription, getting multiple prescriptions for the same drug, or writing their prescription.

Some patients get drugs through doctor shopping, but the majority of patients receive their drugs through one doctor.51 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 engaged in drug trafficking or selling drugs for money or sexual favors. Healthcare providers who are abusing drugs may be irritable, defensive, or isolated. Other signs or symptoms suggestive of prescription drug abuse or misuse problem include frequent bathroom trips, coming into the office when not scheduled, working overtime, multiple 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 methods of diversion include theft, losses during transportation, or internet pharmacies.

Techniques to reduce drug diversion are:

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

It is very difficult to deal with the patient who has a chief complaint of severe pain and 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 his/her drug habits. Prescribers want their patients to be happy. Also, time is often a factor, and taking time to assess the patient, including their physical, psychological, and social state, takes much more time than just writing a prescription.

Good communication is 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, 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 the management of patients being prescribed opioids. Generally, prescribing opioids at the first visit should be avoided. The policies should include the frequency and timing of refills. It should be documented that patients are aware of these policies.

The use of a pain management contract should be utilized. Providing the patient with an understanding of how long the drug will be prescribed should be done. This is particularly true for an acute injury or a surgical procedure where pain typically gets better.

Prescribers must be aware of 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 need, 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, and 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 the hydrocodone /acetaminophen 1 - 2 times a day for over three years. About three months ago, he presented to the Emergency Department with a similar presentation and was discharged after six hours with no definitive diagnosis but was given a prescription for more hydrocodone /acetaminophen for pain.

Mr. T’s son reports that Mr. T. has not been coming to as many social events over the last month because his pain level has increased. The Emergency Department nurse practitioner notes that the vital signs (including oxygen saturation) are stable, but the patient is somnolent. He does wake when stimulated and answers only yes/no questions. His blood work, including liver/kidney function tests, glucose, and metabolic profile, are 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 his impaired kidney function, leading to a buildup of metabolites. He is discharged from the hospital and is seen by his primary care provider the next day.

His primary care provider recognizes that his pain is poorly controlled, leading to him overdosing on opioids. Due to his CKD, NSAIDs are not appropriate options. Managing his depression/anxiety, along with closely monitored opioid therapy, with extensive counseling on safe use, is implemented.

The patient is given a treatment plan that includes:

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

The patient returns to his primary care provider after two weeks. He reports that he has started therapy is sleeping better. He is only using one hydrocodone/acetaminophen a day – typically after exercise. After four more weeks, he reports that he is using about 3 - 4 doses of hydrocodone/acetaminophen per week, feels less anxious and depressed, and is sleeping “just fine.” After another four weeks, he says he no longer uses his opioid 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, which was first diagnosed after lifting a patient four years ago. She currently rates the severity of her back pain as an 8/10 and has been unable to work due to her pain. The pain is described as dull and constant, with occasional sharp exacerbation in the low back with the pain increasing with bending, prolonged standing, and walking. The patient denies any loss or change of bowel/bladder control, history of IV drug use, recent infection, progressive neurological complaints, night pain, night sweats, weight loss, or fever. The pain occasionally radiates into the right buttock. The patient can do all of her ADLs but does report poor sleep at night.

She has no significant past medical or surgical history.

She has had multiple rounds of physical therapy, chiropractic treatment, and numerous 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 there is no family history of alcohol or substance abuse.

Physical examination showed a patient with a slow, deliberate gait, a limited range of motion in the spine with no obvious deformity, swelling, or erythema. There is mild tenderness on the right side of the spine from the area of L4 to S1, as well as tenderness in the right sacroiliac joint. Normal reflexes, normal sensation, ordinary strength, and no atrophy is noted in the lower extremities. The straight leg raise test is normal.

An MRI was done one year ago that was significant for a herniated disc at the L5/S1 level and mild spinal stenosis.

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

The patient is prescribed hydrocodone/acetaminophen 5 mg/500 mg; two tablets every six hours as needed (56 tablets) for 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 was obtained that 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 pain specialist appointment was three weeks out. The patient saw the psychiatrist, and he diagnosed the patient with depression and started her on duloxetine (which may also help with pain). The psychiatrist was unable to make an assessment related to opioid abuse.

With the help of the pain specialist, oxymorphone ER 5 mg was ordered every 12 hours. The patient was told to follow-up in one week to assess effectiveness. After one week, the patient reports she is more functional but still in a lot of pain. The dose of oxymorphone ER was increased to 10 mg every 12 hours. After one more week, she was given oxymorphone IR 5 mg to be used one hour before exercise. This allowed the patient not only to function well but begin participating in an exercise program. The patient was ordered a bowel stimulant (Senna) with a stool softener (Colace) to prevent constipation.

The patient is prescribed fourteen pills oxymorphone ER 10 mg (to be taken twice a day) and seven pills of oxymorphone IR 5 mg (to be taken once a day before exercise) once a week.

Conclusion

The use of controlled substances is laced with risks for the prescriber and the patient. Abuse, misuse, drug diversion, and overdose are all potential complications of opioid use.

Prescribers must be knowledgeable in pain assessment, knowledge of addiction, and the appropriate management of pain. Multiple techniques are important to implement to reduce the risks associated with opioid therapy, including informed 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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