Issues in Pain Management

In recent years, medical standards of care have shifted regarding the use of opioids for the treatment of pain. Not long ago, the medical community followed a very conservative approach to opioid prescribing. An unintended consequence was the under-treatment of patients with legitimate pain. As a result, new clinical guidelines now emphasize the need to accurately assess and effectively treat pain in all patients. This desire for more effective pain management along with aggressive marketing of prescription opioids to physicians by drug manufacturers has led to more liberal prescribing of these agents for the conventional, as well as off-label treatment, of pain. As a result, the use of prescription opioids has soared. Between 1997 and 2006 overall opioid use increased 127 percent while oxycodone use increased by 899 percent.4

This trend is most evident in the United States. Although Americans constitute just 4.6 percent of the world's population, they consume 80 percent of the global opioid supply, and 99 percent of the global hydrocodone supply. From 1997-2006, U.S. sales of hydrocodone increased 244 percent and oxycodone sales increased 732 percent.4

As opioid prescribing increases so does the related potential for fraud and abuse. Research indicates that overall opioid abuse is up 85 percent, with oxycodone abuse up 166 percent over a six-year period.5

The issue of opioid abuse and diversion is troubling in workers' compensation due to its negative impact on claims costs and return to work. The challenge for prescribers, patients and employers alike is to promote the appropriate use of opioids while preventing misuse, with the goal being the achievement of an optimal level of pain control that promotes return to work and improved quality of life.

One barrier to the more appropriate use of opioids is the lack of communication between and among physicians and pharmacies. It is not surprising that patients utilizing multiple prescribers and/or multiple pharmacies may be at risk for medication-related problems. That risk is intensified when managing chronic pain with opioids. PMSI's clinical programs detect the presence of two opioid prescribers in almost seven percent of the injured worker population suffering from chronic pain. A smaller number of individuals see three, four or even five prescribers for their opioid medications. These patients are at risk for overdose and drug interactions that can lead to significant morbidity and mortality.

This issue is likely a contributing factor to a recent FDA advisory board recommendation to ban the use of prescription opioids combination products containing acetaminophen (such as Vicodin and Lortab) due to increased reports of overdose, resulting in severe complications and death.6

The complexity of medication therapy represents another challenge in managing pain. It was not long ago that a physician would prescribe one medication to treat pain. Common practice now is to prescribe two or three. Injured workers' prescription use often moves beyond opioids to include adjunctive or supportive therapy for pain management. Rather than a pain medication alone, patients may take antidepressants or anticonvulsants for pain control. As with the use of multiple prescribers, patients on complex medication regimens are inherently at risk for drug therapy complications. Caution must be exercised by the prescriber and the pharmacist to avoid drug interactions, duplication of the therapy, and cumulative side effects such as sedation that could impair the patient's functional status and hamper the likelihood of return to work.

Finally, there is the issue of unsafe pain medication use, a growing problem in managing chronic pain. Although off-label prescribing of medications (for indications not approved by the Food and Drug Administration) is common place in medicine, overzealous marketing practices by drug manufacturers and lack of prescriber knowledge regarding potential complications can lead to serious and sometimes fatal consequences for patients. For example, deaths associated with Fentora, a rapid-acting form of fentanyl used primarily in an off-label fashion in workers' compensation, prompted a manufacturer warning letter to prescribers in 2007 urging them to use Fentora only for approved indications.7 This drug, already FDA-approved for cancer pain, was recently denied an expanded indication for the treatment of chronic back pain due to FDA concerns regarding the potential for unsafe use.8

Getting Pain (and Costs) Under Control

What can a payer do to facilitate the effective treatment of pain for high-risk injured workers while maintaining control over drug costs? The most direct and effective strategy is to participate in a Pain Management Program (PMP) specifically designed to address the complex issues and challenges associated with pain in workers' compensation.

The purpose of a PMP is to facilitate the appropriate treatment of pain via integrated interventions that involve all stakeholders in the care continuum. PMPs provide various levels of services and interventions with the goal of improving pain control, reducing risk and controlling costs. To achieve these objectives, they deploy a highly integrated effort designed to identify inappropriate medication use and implement interventions that will avoid poor health outcomes for injured workers and unnecessary costs for payers. The program must detect and resolve drug therapy problems on an ongoing basis throughout the injury lifecycle.

A PMP requires a clinically solid, evidence-based foundation, an experienced clinical team, and robust data management capabilities for optimal results. A Pharmacy Benefit Management (PBM) company that leverages its unique visibility of all the prescription claims processed for the payer's claimants with the pharmaceutical expertise of the clinical pharmacist can provide intelligent oversight to mitigate high-risk medication issues and improve patient care. Early detection and intervention on drug therapy issues that can lead to poor health outcomes is critical to the success of the program, as is the involvement of all stakeholders including the patient, prescriber, pharmacist and payer.

Integrated Pain Management Programs

Integration of services is the underlying principle of an effective PMP, as unlinked, disparate interventions are unlikely to deliver the best results. Other important capabilities include:

Utilization Control: Benefits both acute and chronically injured workers by managing access to pain medications through the application of clinically based, workers' compensation-specific criteria to proactively evaluate medication appropriateness and cost-effectiveness at point of service.

Targeted Intervention: Applies analytics to identify high-risk and high-cost medication issues that might go unnoticed at the individual prescriber or pharmacy level. Once issues are identified, interventions focus on resolving inappropriate medication use, therapeutic duplication and potential abuse or diversion.

Care Management: Focuses on improving medication-related outcomes for chronically injured, high-risk patients by promoting the most appropriate and cost-effective treatment regimens for the long-term management of pain.

Education: Offers a solid foundation of educational materials and experienced clinicians to educate patients, prescribers and claims professionals on the appropriate use of opioids and adjuvant therapy in the treatment of pain so that successful patient outcomes and optimal cost savings can be realized.

The Bottom Line: Innovation

In order to respond effectively to the ever-changing landscape of pain management in workers' compensation, successful programs must embrace innovation. The challenges associated with pain management today are many: Escalating use of opioids, abuse and diversion, multiple prescribers, complex medication regimens, and unsafe prescribing practices. Tomorrow will bring new challenges and concerns.

Payers seeking effective pain management solutions should partner with a PBM that offers an innovative, integrated pain management program. This program should incorporate various levels of interventions throughout the injury lifecycle, be administered by a strong clinical team, and have the goal of improving pain control, reducing risk and controlling costs.

Maria Sciame, PharmD, CDE, RRT, is the executive director of clinical services for PMSI. She will be part of panel on the topic, “Is There A Doctor In The House? How Can Workers' Compensation Carriers Put A Lid On Drug Costs?” on Tuesday, Aug. 17, at the FWCI 65th Annual Workers' Compensation Educational Conference and 22nd Annual Safety and Health Conference in Orlando. Conference information is available at www.fwciweb.org.

References:

1 American Pain Foundation

2 Pain (Journal of the International Association for the Study of Pain), 142 (2009) 194-201, April 2009

3 2009 PMSI Annual Drug Trends Report

4 Manachikanti, Laxmaiah, and Singh, Angelie, “Therapeutic Opioids: A Ten-Year Perspective of the Complexities and Complications of Escalating Use, Abuse, and Nonmedical Use of Opioids.” Pain Physician, March 2008.

5 Atluri et al., “ASIPP Controlled Substance Guidelines,” Pain Physician, Vol. 6, No. 3, 2003.

6 Joint Meeting of the Drug Safety and Risk Mangement Advisory Committee, Non-prescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee Meeting, June 20-30, 2009.

7 Cephalon. Fentora Safety Information Letter to Prescribers. September 2007.

8 Cephalon Press Release. Cephalon Announces FDA Advivsory Committee Recommendations Against Approval of an Expanded Label for Fentora. May 6, 2008.