Patient Evaluation and Health History

To adequately address pain and best outcomes, a physician must complete a thorough patient evaluation before any treatment plan can be made or medications prescribed. Such an evaluation must include a complete medical history and a physical examination. The physician should make a thorough examination of the patient’s medical record, current and past treatments for pain, underlying or co-existing diseases or conditions, the effect of the pain on the patient’s physical and psychological functioning, and history of substance abuse. One or more recognized indications for the use of a controlled substance should be present in the medical record to justify prescribing (MSD, 2013).

The use of opioid analgesics for other than legitimate medical purposes poses a significant health risk to individual patients and to society. Inappropriate prescribing can lead to drug diversion and abuse by individuals seeking to use opioids nonmedically. It falls to physicians, nurses, and other health professionals to use systematic precautions to minimize the possibility for abuse and diversion of controlled substances (MSD, 2013).

Prescribers of extended-release and long-acting (ER/LA) opioid pain relievers must balance the benefits of these drugs to treat chronic pain against the risks of serious adverse outcomes including addiction, unintentional overdose, and death. Health professionals have an obligation to ensure that these medications are used safely and effectively by their patients to control pain, and to mitigate risks.

Risk Evaluation and Mitigation Strategy (REMS)

The FDA requires that extended-release oral forms of pain medications containing hydromorphone, morphine, oxycodone, oxymorphone, or tapentadol; fentanyl and buprenorphine-containing transdermal delivery systems; and methadone tablets or liquid that are indicated for use as pain medicines are subject to a risk management program to ensure that the benefits of a drug for a patient outweigh its risks.

REMS involves:

• Knowing how to assess patients for treatment with opioid analgesics.
• Knowing how to initiate therapy, modify dose, and discontinue use of opioid analgesics.
• Knowing how to manage ongoing opioid therapy.
• Knowing how to educate patients and caregivers about the safe use of opioids analgesics, including proper storage, protection from theft, and disposal.
• Knowing general and product-specific drug information. (FDA, 2014)

All opioids are powerful medications; however, extended-release long-acting (ER/LA) opioid analgesics contain more opioid than immediate-release formulations, which carries a high potential for accidental overdose, life-threatening respiratory depression, abuse by patient or people known to the patient, misuse and addiction, physical dependence and tolerance, interactions with other medications, risk of neonatal opioid withdrawal syndrome with prolonged use during pregnancy, and inadvertent exposure/ingestion by household contacts, especially children (FDA, 2014).

Risk Factors of Opioid Abuse

Research shows that there are three main categories of risk factors for opioid abuse and addiction:

• Psychosocial factors
• Substance-related factors
• Genetic factors (Ferrari et al., 2012)

The factor that is the most strongly predictive of opioid abuse, misuse, or other aberrant drug-related behavior is a personal or family history of alcohol or drug abuse (Chou, 2009).

Although family history of substance abuse and psychiatric disorders are relevant to the appropriateness of opioid pain medications, prescribers should recognize that “a history of substance abuse does not prohibit treatment with ER/LA opioid analgesics but may require additional monitoring and expert consultation” (FDA, 2014).

Pain Assessment Tools

When treating chronic pain, healthcare providers must assess the nature and level of patient pain. Common assessment tools include a numeric pain rating scale (0–10), the Wong-Baker FACES Pain Rating Scale, and the 20-question Pain Quality Assessment Scale (PQAS). Other useful tools help clinicians evaluate patient risk for adverse effects when considering prescribing opioid analgesics.

These tools allow healthcare providers to ask useful, clinically relevant questions in order to gain a full understanding of the patient before prescribing a potent drug. Here are brief summaries of some assessment tools that healthcare providers can use before initiating opioid therapy:

• National Institute on Drug Abuse (NIDA) Quick Screen: This is a free online tool that helps primary care providers screen patients for drug use in general medical settings. The tool asks a pre-screening question regarding alcohol, tobacco, non-medical prescription drug, and illegal drug use.
• Screener and Opioid Assessment for Patients in Pain (SOAPP-R): This is a brief tool to facilitate assessment and planning for patients being considered for long-term opioid treatment for chronic pain. Before initiating opioid pain analgesics, providers can distinguish between high-risk and low-risk patients.
• Diagnosis, Intractability, Risk, Efficacy (DIRE): This primary care tool assesses the risk of opioid abuse and whether patients are suitable candidates for long-term opioid therapy.
• Opioid Risk Tool (ORT): This tool assesses the risk that patients will develop aberrant drug behaviors when using opioid medication for chronic pain.

SAMHSA’s Opioid Overdose Prevention Toolkit recommends that a thorough patient assessment and health history include specific questions. For example:

• “In the past 6 months, have you taken any medications to help you calm down, keep from getting nervous or upset, raise your spirits, make you feel better, and the like?”
• “Have you been taking any medications to help you sleep? Have you been using alcohol for this purpose?”
• “Have you ever taken a medication to help you with a drug or alcohol problem?”
• “Have you ever taken a medication for a nervous stomach?”
• “Have you taken a medication to give you more energy or to cut down on your appetite?
• “Have you ever been treated for a possible or suspected opioid overdose?”

Further, a patient history should include questions about the patient’s use of alcohol and over-the-counter medicines. Caution must be observed because many OTC medications and alcohol can depress the central nervous system and must not be used in combination with prescription opioid analgesics (SAMHSA, 2014d).

Physical Examination

During a physical examination, providers and nurses should also be on the lookout for the following signs in patients being seen for chronic pain:

• Needle marks in neck, hands, feet, and antecubital fossae
• Signs of opioid intoxication, including pinpoint pupils, sweating, drowsiness, nodding off
• Signs of opioid withdrawal, including goose bumps, sweating, sniffles, dilated pupils, muscle tenderness, increased bowel sounds, rapid heartbeat, restlessness, and hypertension
• Signs of liver disease, including jaundice, enlarged liver and spleen, “stigmata” of chronic liver disease, and ascites (CAMH, 2011c)

Review of Medical Records

When considering prescribing opioid analgesics for a new patient, clinicians should carefully review the patient’s medical records. Consulting with the patient’s previous physician could reveal important information.

Treatment Plans with Functional Goals

After a thorough examination, a clinician must develop a written treatment plan. The plan must include goals that can be used to measure treatment success. Goals might include pain relief and improved physical and psychosocial function. The treatment plan should also indicate other diagnostic evaluations or treatments.

Treatment plans should incorporate pharmacologic and nonpharmacologic pain management modalities. Physical options for nonpharmacologic treatments for chronic pain include bandage wraps, exercise, heat or cold application, limitation of activities, postural changes, hydrotherapy, massage therapy, mechanical devices such as splits, range-of-motion exercises, and physical and occupational therapy. Options for psychological treatments for chronic pain include attention control exercise, biofeedback, cognitive-behavioral therapy, hypnosis, distraction, and psychotherapy, among others. Other interventions for chronic pain are bracing, injection and radiation therapy, nerve blocks, surgery, transcutaneous electrical nerve stimulation (TENS), and vertebroplasty (Gourlay & Heit, 2005).

“Universal Precautions”

The goal of pain treatment is to decrease pain and improve patient functioning while monitoring for adverse effects. Universal Precautions is an idea derived from infection control but applied to the use of powerful pain analgesics (Gourlay & Heit, 2005). Universal Precautions advocates a step-by-step approach to prescribing opioids for optimal pain management and minimal patient risk for adverse outcomes:

1. Diagnosis. Identify causes of chronic pain and whether the pathophysiology for the pain supports the use of opiate therapy.
2. Conduct a psychological assessment, including risk of addictive disorders.
   • Assess for depression, which may lead to misuse or abuse of prescription drugs.
   • Screen for patient/family history of any substance abuse.
3. Informed consent. Discuss the risks and benefits of opiate therapy, including:
   • Side effects
   • Severe respiratory depression
   • Risk of addiction
   • Risk that the opioid analgesic may not reduce pain, and may need to be discontinued if pain and function does not improve
4. Make a treatment agreement, also called a patient-physician contract. This specifies the conditions under which opiate therapy will be continued or discontinued. Both the patient and the provider should retain a copy of the agreement. The patient agrees to the following:
   • To obtain prescriptions for opiates through one provider
   • To take only the prescribed amount, only when instructed
   • To undergo random urine drug testing
   • To abstain from using illicit substances or alcohol with the prescribed drug
5. Assess pain level and function both before and after intervention. The medical provider should document baseline pain scores and level of function before opioid analgesics are started. A set of simple questions about patient functioning in the areas of work, household duties, and self-care can be rated on a 1 to 10 scale, and then reassessed during treatment, along with a pain score, to determine continuation or discontinuation of opioid therapy.
6. Conduct an appropriate trial of opioid analgesic therapy with or without adjunctive medication. Certain medications (antidepressants, muscle relaxants, neuropathic medications, and anti-inflammatory medications) can improve the response to opioids. Titrate the opiate dose to obtain pain relief and minimize side effects. If there is no improvement in pain and function, the medication should be titrated back down and discontinued.
7. Reassess pain score and level of function. At each visit, the patient’s pain and level of function should be checked. Therapy should be continued, adjusted, or discontinued based on the assessment.
8. Regularly assess the “4 A’s” of pain medicine. Ongoing, routine assessment of analgesia, activity, adverse effects, and aberrant drug behaviors will support the current therapy and/or alert the physician to prescription drug misuse, abuse, tolerance, and addiction.
9. Periodically review pain diagnosis and other conditions, including possible addiction disorders. Ongoing pain management involves periodic diagnostic procedures and assessment for worsening or improving pathology. Clinicians should also assess for new disease processes and assess for addiction disorder, especially if the patient is displaying aberrant behaviors.
10. Documentation. Careful documentation of all aspects of patient evaluation, assessment, treatment, medication, response to treatment and followup is necessary to protect the clinician and the patient. Appropriate documentation showing a standard approach to chronic pain management can reduce malpractice risk and risk of regulatory sanction. (Gourlay & Heit, 2005)

The Clinicians for Responsible Opioid Prescribing advocate a cautious approach to pain management. They believe that the increased prescribing of opioid analgesics for chronic noncancer pain lacks high-quality evidence to justify the therapeutic change and that, while opioids may provide short-term pain relief, the long-term benefits of opioid therapy have not been established. They advocate that low doses should be considered only for carefully evaluated, closely monitored patients when a structured approach is employed and clear benefits for pain and function are documented. To better educate prescribers about the risks versus benefits of opioids for chronic pain, they have published the Cautious, Evidence-Based Opioid Prescribing Myth versus Fact Sheet, containing do’s and don’ts for acute and chronic pain management (PROP, 2012).

Cautious, Evidence-Based Opioid Prescribing

Do’s

Don’ts