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Case Studies: Principles in Practice: Mary [patient profile]

Mary: Explaining Universal Precautions for Opioid Prescribing

Mary is a 64-year-old woman who has experienced continuous low back pain since she underwent a L4/L5 laminectomy for a herniated disk 1 year ago. She received a morphine pump postoperatively, with successful relief of her pain until it was discontinued. Subsequent pharmacologic treatments for Mary’s chronic pain have included trials of a prescription strength nonsteroidal anti-inflammatory drug combined with a low-dose tricyclic antidepressant for several months, as well as a serotonin-norepinephrine reuptake inhibitor for 8 weeks.

None of these treatments sufficiently relieved Mary’s pain, and she was unable to tolerate the side effects of these medications. Mary has taken a muscle relaxant in the past as well, with no significant relief of her pain.

After being referred to a pain specialist 6 months ago, Mary underwent epidural corticosteroid injections, which provided temporary relief, and facet-joint injections, which were of no benefit. Her previous primary care physician subsequently provided a prescription for an immediate-release (IR) opioid, which she has been using daily with some reduction in pain and improved activity tolerance at work.

Now Mary presents to a new physician because of a change in her health insurance coverage. She has just started working for a state government agency (a “desk job”) and leads a sedentary lifestyle.

The new physician examines Mary, reviews her previous medical records, and assesses the severity of her pain.

Note: Representative case example. This case is not based on an actual patient.

Mary: Explaining Universal Precautions for Opioid Prescribing

“Why I Apply Universal Precautions When I Prescribe Opioids”


The physician advises Mary that, given her lack of response to nonopioid medications and her need for repeated daily dosing of the opioid medication, he is considering an extended-release (ER) prescription opioid to help relieve her chronic pain. Mary is in agreement. However, he also advises her that he needs to assess her potential risks associated with opioid use (see video). Although Mary seems taken aback by the implied scrutiny, the physician explains the importance of applying universal precautions with prescription opioids and how these measures may help protect people like Mary and her family.

The physician then proceeds to assess Mary’s risk for aberrant behavior with prescription opioids (see Glossary). He asks her to complete the Opioid Risk Tool, performs a psychological assessment, reviews the available data from the states, and performs an in-office urine drug test. Based on this thorough assessment, Mary appears to be at low risk.

Universal precautions in opioid prescribing for chronic pain are recommended. As yet, there is no empiric evidence of their effectiveness in reducing the abuse of prescription opioids or the outcomes related to the abuse, misuse, or diversion of prescription opioids.1


  1. Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11(7):602-611. PMID: 20444651

Mary: Explaining Universal Precautions for Opioid Prescribing

After conducting the risk assessment, the physician decides to proceed with opioid therapy. He considers Mary’s overall condition, medical status, and prior opioid experience. He determines that a low-dose ER prescription opioid is appropriate, and selects an agent. The physician plans to prescribe an abuse-deterrent opioid as part of his universal precautions approach to opioid therapy.

The physician explains to Mary what an abuse-deterrent opioid is and why he is prescribing one. He also urges Mary to consider ways to improve her mobility and advises that the pain relief provided by the opioid should help her escalate her activity, particularly in conjunction with physical therapy.

Abuse-deterrent formulations do not address oral overconsumption of prescription opioids, which is the most common form of prescription opioid abuse.1 There are limited data available to assess the impact of abuse-deterrent formulations on drug abuse, misuse, and diversion, and further studies are needed.2,3


  1. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84(7):593-601. PMID: 19567713
  2. US Food and Drug Administration. Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling [draft guidance]. Silver Spring, MD: FDA; 2013.
  3. Stanos S. Continuing evolution of opioid use in primary care practice: implications of emerging technologies. Curr Med Res Opin. 2012;28(9):1505-1516. PMID: 22937723

Mary: Explaining Universal Precautions for Opioid Prescribing

“Let’s Review Risks and Responsibilities Regarding the Opioid Medication”


After gaining Mary’s agreement to use an abuse-deterrent opioid, the physician discusses expectations for treatment, including the potential benefits and side effects of the specific opioid medication being prescribed (see video). After this informed consent discussion, the physician introduces a written treatment agreement with respect to opioid therapy. Mary questions the need to sign what looks to her like “a legal document.” The physician reviews the key points of the treatment agreement and emphasizes its importance to help prevent misunderstandings about how the medication should be used. After this discussion, Mary indicates that her questions have been answered, and she signs the agreement. The physician asks Mary to return in 1 month for a follow-up visit.

Mary: Explaining Universal Precautions for Opioid Prescribing

At Mary’s follow-up appointment 1 month later, the physician reviews the “4 A’s” of patient assessment: analgesia, activity, adverse effects, and aberrant behavior. To assess analgesia and activity, the physician administers the Brief Pain Inventory (BPI). The BPI suggests, and Mary confirms, that her pain is much improved. She has been taking the prescribed opioid every day. She has modest improvement in her mobility and says that she would like to start physical therapy. However, she also reports frequent constipation.

The physician recommends treatment for Mary’s constipation (stool softeners, fiber, and an occasional laxative) and informs her that her constipation may improve as she increases her activity. He provides a referral for physical therapy and discusses with Mary the possibility of specialty referrals in the future, depending on her progress.

To help identify any potential aberrant behavior relating to the ER opioid prescription (ie, signs of substance abuse or addiction), the physician re-checks the data from the prescription drug monitoring program (PDMP), which reveals no evidence of “doctor shopping” or “pharmacy shopping.” The physician also asks Mary to complete a questionnaire that inquires about her behavior and mood over the past 30 days; the results suggest a low likelihood of aberrant behaviors relating to her prescription.