The recent, dramatic increase in opioid addiction, which has impacted the lives of Americans from every stratum of society, as well as the health care workers who treat them, can only be described as an epidemic. As opioid analgesics have increasingly been prescribed to treat chronic pain, a corresponding trend has developed of increased rates of misuse and overdose.1 In 2010, the number of prescriptions for opioids was four-fold higher than in 1999; this increase occurred in parallel with an almost four-fold increase in opioid overdose deaths and a corresponding six-fold increase in substance abuse treatment admissions (see FIGURE 1).2

The goal of robust opioid management is to reduce the rate of non-medical use and inappropriate medical use, as well as preventing overdose and addiction, while maintaining access to prescription opioids when indicated.3 Health-system pharmacists can play a significant role in opioid management, and have a responsibility to patients to ensure best practices are utilized in this endeavor.

Challenges in Opioid Management

Pain Measurement Is Subjective

A fundamental challenge to balancing the tension between ensuring adequate access to opioids while decreasing abuse of these medications is that pain is inherently subjective, and therefore the clinician’s assessments and judgments are based on subjective data. Further complicating this is the fact that many clinicians have a poor understanding of the physiology of pain. For example, a physician recently presented a case at the University of North Carolina (UNC) Medical Center that illustrates the challenge in quantifying pain.

Two patients had almost identical tumors types in the same region; one tumor was large while the other was smaller. The physician asked the audience which tumor would cause more pain. It seemed obvious that the larger tumor would be more painful. In response, the physician pointed out that the small tumor was bundled in an area with significant nerve involvement, which would result in increased pain.

Situations such as this illustrate how the nature and intensity of pain remains poorly understood.

The Influence of Pharmacogenetics

A largely unexplored influence on pain management is genetics. Specifically, pharmacogenetics can impact a patient’s response to opioid pain medications due to alterations in key metabolic pathways as a result of genetic variation.4 Integrating pharmacogenetics into clinical practice for pain management is challenging due to its complexity and the subjective nature of pain perception and analgesia response. In addition, many pharmacists may not be aware that patients with genetic abnormalities may be unable to metabolize certain pain medications properly. Organizations should provide pain management education to pharmacists to highlight this complex issue.

The Role of Patient Satisfaction Scores

The emphasis on patient satisfaction—and the associated public physician ratings and internal utilization of patient satisfaction scores—complicates opioid management.5 Patient satisfaction surveys often include questions about how adequately providers have addressed pain. Physicians who refuse to prescribe opioid pain medication to patients suspected of abuse are likely to get a poor rating from these patients. Additionally, in some organizations patient surveys can affect reimbursement and job security.

Treating pain by writing an opioid prescription ensures quick patient throughput; conversely, treating addiction—which entails extensive patient education and counseling—requires a significant investment of time and resources. As such, it is unlikely that clinicians will be able to allocate sufficient time to educate and counsel patients until they are adequately reimbursed for doing so.

Testing Menu - Click here to see TABLE 1.

Changing Attitudes About Pain Medication

A fundamental challenge in managing opioids is addressing changing public attitudes toward opioid pain medication use. In the mid-1990s to early 2000s, powerful new opioid pain medications were developed and aggressively marketed. In addition, in the early 2000s some states passed so-called Intractable Pain Acts, designed to ensure patients’ pain is adequately treated.6 During this time, The Joint Commission on Accreditation of Healthcare Organizations (now known as The Joint Commission) also unveiled their pain management standards.7 These factors may have influenced over-prescribing of opioids and other pain medications. Now the pendulum has swung back to a more balanced approach to opioid management; our current goal is to implement effective strategies to curb excessive opioid prescribing and abuse while ensuring access for patients for whom these medications are indicated.

The Role of the Pharmacist

As the in-house medication expert, the pharmacist is well positioned to play a broad role in an organization’s opioid management activities. For example, the pharmacist may practice in a pain clinic, work in an outpatient capacity, attend inpatient rounds, visit patients with a provider to address pain management, develop an opioid storage and security plan in a centralized pharmacy, and in some states may schedule medical encounters with patients as a provider with prescriptive authority.

As an influential member of a hospital’s pain committee—which should also include physicians and nurses, as well as representation from anesthesiology and palliative care—pharmacists can play a pivotal role in helping curtail opioid abuse by helping identify strategies to minimize the risk of opioid misuse (see SIDEBAR 1: Opportunities for Pharmacists in Opioid Management on page 77). Pharmacists are ideally suited to assume a leadership role in committee decision-making, utilizing multiple tools to properly manage opioid use within their organizations, including prescription drug monitoring programs (PDMPs), toxicology screening, use of pain management contracts, developing a robust medication-use policy, and implementing a systematic approach to opioid management.

Prescription Drug Monitoring Programs

A PDMP is an electronic database that tracks a state’s controlled substance prescriptions, thereby providing health authorities timely information about prescribing and patient behaviors that contribute to the opioid epidemic in order to facilitate a targeted response.8 Currently, 49 states, the District of Columbia, and one US territory (Guam) have passed legislation authorizing the creation and operation of a PDMP, and 48 states and Guam oversee operational PDMPs.9 Among the most promising state-level interventions to improve painkiller prescribing, inform clinical practice, and protect at-risk patients, PDMPs can highlight changes in prescribing patterns, use of multiple providers by patients, and decreased substance abuse treatment admissions.

States have implemented various PDMP features, including:

• Universal Use Policies. PDMPs are useful tools that allow health care providers to see patients’ prescribing histories, thus informing prescribing decisions. Of course, the value of the PDMP is only realized if the health care provider checks the system prior to prescribing. Some states require providers to check the state PDMP prior to prescribing certain controlled substances and in specific circumstances; these universal use policies have potential for ensuring the utility of PDMPs.
• Real-Time. When pharmacists dispense controlled substances to patients, they are required to submit the prescription to the state’s PDMP. Yet, the states often provide access to this information at varying intervals—in real-time, daily, weekly, or monthly. In the interim, prescribers must provide treatment without complete information as to their patients’ most recent prescriptions. A real-time PDMP maximizes the usefulness of the prescription history data, with significant implications for medication safety.
• Actively Managed. An actively managed PDMP can be a powerful public health tool for state health departments to understand trends in opioid use and to evaluate the effectiveness of interventions. Moreover, PDMPs can be used to send proactive reports to authorized users to protect those patients at highest risk and identify inappropriate prescribing.
• Improved Access and Ease of Use. States have taken several steps to make PDMPs easier to access and use, including integrating PDMPs into electronic health records (EHRs), allowing physicians to delegate PDMP access to other health care professionals, and streamlining the process for providers to register with the PDMP. One area of opportunity is to train pharmacy technicians to compile information from the PDMP to assist the prescriber in identifying potential concerns.

North Carolina’s PDMP, for example, was established to improve the ability to identify controlled substance misusers and abusers, refer these patients to treatment, and identify and stop the illegal use of prescription drugs in an efficient and cost-effective manner, all without impeding the appropriate medical utilization of licit controlled substances.10 Information captured in the PDMP includes drug name, strength, quantity, dates prescription written and filled, provider, and dispenser.

A significant element of PDMP success is ensuring that the database is used. The NC Board of Pharmacy recently developed a free training module to help educate pharmacists on how to use the state PDMP.11 The UNC Eshelman School of Pharmacy, in cooperation with the NC Board of Pharmacy, plans to track use of this educational tool, as well as use of the NC PDMP overall, to evaluate if additional measures should be taken to increase use. Although PDMP use is not currently mandatory in North Carolina, future discussions may investigate this possibility.

It is important to note that while there are clear benefits to PDMPs, some drawbacks exist as well:

• To date there is no definitive data demonstrating benefit of PDMPs
• Concern exists that PDMPs may lead to under-treatment of pain for some patients
• Depending on how often data is entered into the state’s PDMP, information may not be available in real time
• PDMPs do not identify what happens after the prescription has been filled

Additional PDMP resources include the CDC’s Public Health Law Program12 and the National Alliance for Model State Drug Laws.13

Toxicology Screening

For patients receiving long-term opioid therapy for chronic pain, urine drug screening is a valuable tool for monitoring and assessing therapy. Existing practice guidelines recommend routine urine drug testing for these patients.14 Specific recommendations are listed in TABLE 1 (on page 78).15 Toxicology screening is particularly useful to identify drugs patients should not be taking and to confirm adherence to prescribed medications.

There are many benefits and some drawbacks to implementing toxicology screening. These tests are based on well-established analytical methods, and clinicians generally have extensive experience in result interpretation. The tests also are widely available and may be customized to patient medications. Drawbacks include the potential for tampering or adulteration, the possibility of ordering errors and inaccurate interpretation, and possible lack of sensitivity of the tests.

Knowledge of opioid metabolic pathways and assay limitations is required for appropriate use and interpretation of screening tests.16 Clinicians must be knowledgeable about the specifics of ordered tests and the metabolites of various opioids. For example, a toxicology panel may include only a limited number of opioids, and if a patient is taking an opioid that is not on that panel, the test will be negative. This is especially true for fentanyl, which is not part of a typical toxicology panel; to screen for fentanyl, the clinician must request a specific, expanded opioid panel that includes fentanyl. Therefore, it is vital to engage with colleagues from toxicology to ensure screening tests meet clinical needs and to discuss how to address unexpected results.

In addition, it is important to educate patients on the rationale, utilization, and actions of toxicology screening. A further drawback of using toxicology screening is possible damage to the clinician-patient relationship; the patient may believe that toxicology screening implies that the clinician does not trust them. Effective communication, emphasizing that testing is performed to protect and ensure patient safety, is necessary to preserve a positive relationship with the patient.

Pain Management Contracts

An opioid pain management contract is a formal written agreement between a physician and a patient that delineates key aspects of adherence to opioid therapy. The primary goal of these contracts is to promote patient adherence to the prescribed amounts and intervals of opioid therapy, and to elicit an agreement to refrain from taking any other licit or illicit substances. Other objectives include promoting informed consent and shared decision-making, and ensuring legal risk management, appropriate documentation, and practice efficiency and coordination of care.17

When developing an opioid contract, ensure the information included is balanced, has undergone review by a multidisciplinary group, and sets clear expectations for compliance as well as consequences for noncompliance. Collaboration with the legal department is recommended. In addition, make a plan to ensure electronic documentation and access. Formal evaluations of the impact of pain management contracts still need to be conducted.

(See SIDEBAR 2 on page 80 for a Sample Draft Pain Contract.)

Medication-Use Policy

Developing and implementing a robust medication-use policy is critical to appropriate opioid management.16 The policy should establish formulary restrictions to minimize the large number of available opioids while ensuring patients have access to adequate pain relief. Consider creating an opioid conversion chart to help guide clinical pharmacists in determining appropriate doses. Be sure to detail starting doses for opioid-naïve patients and provide guidance on transitions between oral and IV doses. In addition, develop a contingency plan for converting a patient’s home therapy to a medication on formulary, if clinically appropriate.

As with any policy, utilize clinical guidelines during the drafting process to ensure proper control and accountability. Review how CPOE, EMR, and clinical decision support tools can be leveraged to further the effectiveness of your policy. Incorporating dosing and frequency restrictions and including supportive medications in order sets can improve the process.

Developing a Systematic Approach to Opioid Management

Opioids should only be prescribed following a thorough patient evaluation and consideration of alternative treatments

(see SIDEBAR 3: CDC Checklist for Prescribing Opioids for Chronic Pain18). The treatment plan must be specifically tailored to the patient and should minimize adverse events. Moreover, a systematic approach to opioid management must include patient counseling, ongoing monitoring, and documentation.19

• Patient Evaluation. The initial evaluation should include a pain history and an assessment of the impact the pain has on the patient, a physical evaluation, a review of previous diagnostic studies and previous treatments, a drug history, and an assessment of coexisting diseases or conditions. If appropriate, the patient should undergo a baseline drug-screening exam.
• Treatment Plan. Tailor the treatment plan to the individual, not just to the presenting problem. When developing the plan, consider multiple treatment modalities, including an interventional approach, a formal pain rehabilitation program, a combination of physical medicine and psychological/behavioral strategies, and the use of various medications. The goal is to rely on rational prescribing, whereby opioids are only prescribed if the provider reasonably concludes that other treatments will be inadequate to address the patient’s pain. Standardized pain scales should be utilized when assessing pain.

When opioid medication is prescribed, the physician should ensure that the patient and/or the patient’s family is informed of the risks of chronic opioid treatment. When developing the treatment plan, consider the patient’s medical history, background, past prescription drug use, and past opioid abuse. Delineate the prescribed opioids, their doses, as well as any supportive medications. When determining dose parameters, consider whether the agent(s) will be long-acting or short acting, and establish dosing and frequency restraints. Moreover, include a plan for addressing possible side effects.

• Patient Counseling. Patient counseling is a role the pharmacist is ideally suited for. If an opioid medication is chosen, the patient may express concern about becoming addicted. The pharmacist must utilize a balanced approach in discussing the risks and benefits of opioid treatment, emphasizing that when taken as directed, most patients do not become addicted to opioid pain medications. Make the patient aware of possible side effects—for example, nausea, sedation, and constipation—and ensure a plan is in place to address these issues before the patient leaves the hospital or before opioids are administered to an inpatient.
• Consultation As Needed. Depending on the expertise of the practitioner and the complexity of the problem, a pain management consultation with a specialist may be warranted. Management of patients with a history of addiction or a comorbid psychiatric disorder requires special consideration.
• Monitoring and Periodic Review of Efficacy. Review treatment efficacy frequently to assess the patient’s status, quality of life, continued analgesia, adverse events, and any indications of opioid misuse. Compliance monitoring—including tools such as random urine drug screening, pill counts, and PDMP review—is critical during long-term opioid treatment. A close evaluation is required to evaluate whether opioid treatment is still indicated.
• Documentation. Documentation is required to support the evaluation, the reason for opioid prescribing, the overall pain management plan, any consultations that have occurred, and to allow review of patient status.

Future Trends

Moving forward, opioid management will be marked by increased medication tracking, both internally within hospitals and health systems, and also on the state and national levels. In addition, organizations will implement increased safety measures to ensure adherence to compliance standards. The unintended effects of patient satisfaction scores on opioid prescribing also must be addressed.

The ultimate goal is to utilize strategies to reduce the incidence and harm of inappropriate opioid use, which has reached epidemic proportions in the United States. Fortunately, multiple tools are available that can aid health system pharmacists in curtailing opioid abuse. Pharmacists are ideally positioned and trained to ensure appropriate utilization of opioids in pain management, and have a professional responsibility to ensure robust opioid management in their organizations.

SIDEBAR 4 presents a patient case study involving opioid abuse.

John M. Valgus, PharmD, MHA, BCOP, is Assistant Professor of Clinical Education at the UNC Eshelman School of Pharmacy. He received his PharmD from Philadelphia College of Pharmacy and completed a PGY1 and PGY2 from UNC Hospitals.

References

1. Weisberg DF, Becker WC, Fiellin DA, et al. Prescription opioid misuse in the United States and the United Kingdom: cautionary lessons. Int J Drug Policy. 2014;25(6):1124-1130.
2. Paulozzi LJ, Jones C, Mack K, et al. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60:1487-1492.
3. Compton WM, Jones CM, Baldwin GT. Relationship between nonmedical prescription-opioid use and heroin use. N Engl J Med. 2016;374(2):154-163.
4. Webster LR, Belfer I. Pharmacogenetics and personalized medicine in pain management. Clin Lab Med. 2016;36(3):493–506.
5. Lembke A. Why doctors prescribe opioids to known opioid abusers. N Engl J Med. 2012;367(17):1580-1581.
6. Tennessee Public Acts, 2001. Chapter No. 327, House Bill No. 1896. An Act to amend Tennessee Code Annotated, Title 39, Title 53, Title 63 and Title 68, related to intractable pain. www.tn.gov/sos/acts/102/pub/pc0327.pdf. Accessed November 3, 2016.
7. Phillips DM. JCAHO pain management standards are unveiled. Joint Commission on Accreditation of Healthcare Organizations. J Am Med Assoc. 2000;284(4):428-429.
8. What States Need to Know About PDMPs. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/drugoverdose/pdmp/states.html. Accessed October 10, 2016.
9. Prescription Drug Monitoring Program Training and Technical Assistance Center. Prescription Drug Monitoring Frequently Asked Questions (FAQs). http://www.pdmpassist.org/content/prescription-drug-monitoring-frequently-asked-questions-faq. Accessed October 10, 2016.
10. Ringwalt C, Garrettson M, Alexandridis A. The effects of North Carolina’s prescription drug monitoring program on the prescribing behaviors of the state’s providers. J Prim Prevent. 2015;36(2):131-137.
11. North Carolina Controlled Substances Reporting System Educational Program. University of North Carolina Web site. https://learn.pharmacy.unc.edu/csrs/#/csrs_home. Accessed November 3, 2016.
12. CDC’s Public Health Law Program. Centers for Disease Control and Prevention’s Web site. www.cdc.gov/phlp/publications/topic/prescription.html. Accessed October 26, 2016.
13. The National Alliance for Model State Drug Laws Web site. www.namsdl.org/prescription-monitoring-programs.cfm. Accessed October 26, 2016.
14. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130.
15. Hammett-Stabler CA, Magnani B. Supporting the pain service. In: Magnani B, Bissell MJ, Kwong TC, Wu AHB, eds. Clinical Toxicology Testing: A Guide for Laboratory Professionals. Northfield, IL: College of American Pathologists; 2012.
16. Cobaugh DJ, Gainor C, Gaston CL, et al. The opioid abuse and misuse epidemic: implications for pharmacists in hospitals and health systems. Am J Health Syst Pharm. 2014;71(18):1539-1554.
17. Arnold RM, Han PK, Seltzer D. Opioid contracts in chronic nonmalignant pain management: objectives and uncertainties. Am J Med. 2006;119(4):292-296.
18. Checklist for Prescribing Opioids for Chronic Pain. CDC Stacks. Centers for Disease Control and Prevention Web site. https://stacks.cdc.gov/view/cdc/38025. Accessed October 20, 2016.
19. Statement from the American Academy of Pain Medicine (AAPM). Use of Opioids for the Treatment of Chronic Pain. AAPM Web site. www.painmed.org/files/use-of-opioids-for-the-treatment-of-chronic-pain.pdf. Accessed October 11, 2016.

SIDEBAR 1
Opportunities for Pharmacists in Opioid Management

• „ Patient Assessment
• „ Patient Counseling
• „ Patient Background Evaluation
• „ Opioid Dispensing
• „ Rational Prescribing
• „ Opioid Monitoring
• „ Toxicology Screening
• „ Opioid Contract Management
• „ Opioid Monitoring System
• „ Institutional Policy Development
• „ Interdisciplinary Pain Committee Involvement
• „ Professional Society Guideline Development
• „ Educating Health Care Professionals

SIDEBAR 2
Sample Draft Pain Contract

The UNC Oncology Supportive Care Clinic is a comprehensive, interdisciplinary clinic that manages cancer patients with problematic symptoms from their disease or disease treatment. Treatment options for managing pain are determined by our health care providers based on multiple factors, including an individual’s past medical history. Medications may or may not be prescribed for managing your pain. Multiple types of medications may be used for pain management, of which opioids are the most closely regulated due to their potential for abuse, misuse, and/or diversion. If the decision is made by your health care provider that opioids are a treatment option for you, there are several policies you should be aware of, which are listed below.

My signature and initials on this treatment agreement indicate that I have read this agreement in full and that I understand the policies listed below. If opioids are prescribed for me for pain management, I agree to:

• „ Only receive opioids from the UNC Supportive Care Service, with whom I have this agreement (referred to as “my provider”)
• „ Not ask for opioid medications from any other provider without the knowledge and consent of my provider. If an acute need occurs (urgent care, surgery, or emergency room), I will notify my provider within 48 hours
• „ Agree to provide regular urine samples for drug screening. Positive tests for any illegal substances, opioids not prescribed by my provider, or absence of the prescribed opioids will result in ending this agreement, dismissal by my provider, and/or referral for a substance abuse evaluation. If a urine sample is requested by my provider and the sample is not provided, prescriptions will not be issued
• „ Take prescribed opioid medications as directed and not more frequently. I understand that increasing my opioid medication dose or frequency without my provider’s instruction to do so is a violation of this treatment agreement
• „ Not get prescriptions filled early
• „ Bring all of my opioid medications in the original prescription bottle to each clinic visit

Courtesy of the UNC Oncology Care Clinic.

SIDEBAR 3
CDC Checklist for Prescribing Opioids for Chronic Pain¹⁸*

When Considering Long-Term Opioid Therapy:

• „Set realistic goals for pain and function based on diagnosis (eg, walk around the block)
• „Confirm that non-opioid therapies have been tried and optimized
• „Discuss the benefits and risks (eg, addiction, overdose) with the patient
• Evaluate the risk of harm or misuse
• Discuss risk factors with patient
• Check prescription drug monitoring program (PDMP) data
• Check the urine drug screen
• „ Set criteria for stopping or continuing opioids
• „ Assess baseline pain and function (eg, PEG scale)
• „ Schedule an initial reassessment within 1-4 weeks
• „ Prescribe short-acting opioids using the lowest dosage on product labeling; match prescription duration to the scheduled reassessment

*This checklist is available in its entirety at https://stacks.cdc.gov/view/cdc/38025.

SIDEBAR 4
Patient Case Study

LW is a 55-year-old female who presents to the North Carolina (NC) Cancer Hospital for a second opinion in the management of metastatic cancer. Radiology results from an outside hospital confirm metastatic disease with liver and lung involvement. The patient has no other significant past medical history. A decision is made that her oncology care will be transferred to the NC Cancer Hospital. The patient reports significant uncontrolled chronic and acute pain, and the pharmacist is contacted to assist in the management of the patient’s pain.

Which of the following strategies are considerations to employ at this point in the management of this patient?

   a. Conduct urine toxicology screening for common controlled substances and illicit drugs

   b. Search the state controlled substance database for prescription history of controlled substances

   c. Contact previous providers to inform them that UNC will be managing pain needs

   d. Conduct thorough pain evaluation to determine best strategy to optimize pain regimen for patient

   e. All of the above

LW has a significant past social history, which includes polysubstance abuse, multiple incarcerations, and documentation from previous providers citing drug diversion. Her medications include oxycodone HCl extended-release (OxyContin) 20 mg PO BID, oxycodone 5 mg/acetaminophen 325 mg, 1-2 tablets every 4 hours as needed, and alprazolam 0.5 mg QHS.

The primary oncologist consults with the Oncology Supportive Care Consult Service for symptom management. This service takes over management of her chronic malignant pain and anxiety. Assessment and management is conducted in conjunction with each established visit at UNC. LW initiates combination chemotherapy.

After 3 months, the patient states that her pain has worsened and requests an increase in her pain medications after running out of her medications early. At 4 months, the patient reports that all of her medications were stolen and she requests refills. At 5 months, the patient does not show up for her chemotherapy appointment but requests pain medications to be mailed to her home.

At 6 months, a local pharmacy contacts the supportive care provider to notify them of unusual prescribing patterns. It is discovered that the patient has been making copies of opioid prescriptions. After 8 months, the patient has missed multiple appointments and is discharged from the care of her oncologist. The patient is encouraged to seek medical care locally for her chronic pain and is provided local resources.