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, nature and intensity of the pain, 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 (WVBM, 2017).

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 (WVBM, 2017).

Prescribers of 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.

The patient evaluation should include most of the following elements:

• Medical history and physical examination targeted to the pain condition
• Nature and intensity of the pain
• Current and past treatments, including interventional treatments, with response to each treatment
• Underlying or co-existing diseases or conditions, including those that could complicate treatment (ie, obesity, renal disease, sleep apnea, COPD)
• Effect of pain on physical and psychological functioning
• Personal and family history of substance use disorder
• History of psychiatric disorders (bipolar, ADD/ADHD, sociopathic, borderline, major depressive disorder)
• Post-traumatic stress disorder (PTSD)
• Medical indication(s) for use of opioids
• Review of the PDMP results
• Obtain consultation with other clinicians when applicable
• Urine, blood or other types of biological samples and diagnostic markers (WVBM, 2017)

Clinicians should use caution when prescribing opioids in women of childbearing age, as chronic opioid therapy during pregnancy increases risk of harm to the newborn. Further, opioids should be administered with caution in breastfeeding women, as some opioids may be transferred to the baby in breast milk. When chronic opioid therapy is used for an elderly patient, clinicians should carefully consider the initial dose, titrating slowly upwards if necessary, using a longer dosing interval, and monitoring more frequently. Patients at risk for sleep disordered breathing are at increased risk for harm with the use of chronic opioid therapy. Clinicians should consider the use of a screening tool for obstructive sleep apnea and refer patients for proper evaluation and treatment when indicated (WVBM, 2017).

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 the following categories of risk factors for opioid abuse and addiction:

• Genetic predisposition
• Certain brain characteristics that can make someone more vulnerable to addictive substances than the average person
• Psychological factors (eg, stress, personality trait like high impulsivity or sensation seeking, depression, anxiety, eating disorders, personality, other psychiatric disorders)
• Environmental influences (eg, exposure to physical, sexual, or emotional abuse or trauma, substance use or addiction in the family or among peers, access to an addictive substance; exposure to popular culture references that encourage substance use)
• Starting alcohol, nicotine, or other drug use at an early age (CASA, 2017)

One factor that is strongly predictive of opioid abuse, misuse, or other aberrant drug-related behavior is a personal or family history of alcohol or drug abuse. 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 extended release 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 PEG 3-question scale, 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, tobacco, and over-the-counter medicines. Useful screening tools include NIAAA, AUDIT, USPSTF, and ASSIST. 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, 2016a).

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, slurred speech, respiratory depression, stupor, and coma
• Signs of opioid withdrawal, including goose bumps, sweating, diarrhea, sniffles, dilated pupils, lacrimation, muscle tenderness, increased bowel sounds, rapid heartbeat, shivering, nausea, emesis, restlessness, and hypertension
• Signs of liver disease, including jaundice, enlarged liver and spleen, “stigmata” of chronic liver disease, and ascites (Dixon, 2018)
• 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. Nonpharmacologic therapies may include cognitive behavioral therapy, massage, exercise, multimodal pain treatment, and osteopathic manipulative treatment (WVBM, 2017). The Physicians 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, containing do’s and don’ts for acute and chronic pain management (PROP, 2014).

Cautious, Evidence-Based Opioid Prescribing for Chronic Pain

Do’s

• Do screen patients for depression and other psychiatric disorders before initiating COT (chronic opioid therapy)
• Do talk with patients about therapeutic goals, opioid risks, realistic benefits, and prescribing ground rules.
• Do realize that patients are reluctant to disclose a history of substance abuse.
• Do perform a thorough medical evaluation and a urine drug screen before initiating COT.
• Do explain to patients that discontinuing opioids may be difficult.
• Do perform random urine drug screens on patients receiving COT.

Don’ts

• Don’t initiate chronic opioid therapy (COT) before considering safer alternatives.
• Don’t continue with COT with patients who show no progress toward treatment goals.
• Don’t assume patients know how to use opioids safely.
• Don’t assume patients use opioids as you intend.
• Don’t start a treatment that you are not prepared to stop.
• Don’t assume patients are doing well with COT without careful evaluation.
• Don’t abandon patients with a prescription drug problem. (PROP, 2014)

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