Risk assessment and counseling behaviors of healthcare professionals managing patients with chronic pain: a national multifaceted assessment of physicians, pharmacists, and their patients.

INTRODUCTION: Due to the significant and increasing problem of chronic pain in the United States, pain management is a frequent need in many healthcare settings. At the same time, there has been rising concern with the abuse/misuse and potential for addiction to opioid therapies. This study was conducted to better understand healthcare professionals' current knowledge, perceptions, and clinical practice patterns regarding prescribing of extended-release or long-acting opioid therapy to patients with chronic pain. METHODS: This study was conducted from March 2011 to May 2011; it utilized a nationally distributed case vignette survey of primary care physicians (PCPs), pain specialists, and pharmacists, along with nested chart reviews and surveys of patients with chronic pain. RESULTS: Many PCPs are inadequately performing opioid risk assessments and there is variability in interpreting a patient's opioid risk, resulting in misestimated risk. Physicians underutilize urine drug screens and written opioid use agreements when initiating opioid therapy in patients. Physicians and pharmacists often omit key messages during patient counseling about safe use of opioids and safe medication storage. Among pharmacists, safety counseling is generally limited to alerting patients to potential side effects. For most PCPs, difficulty managing patients with risk factors for opioid use and uncertainty about managing first line opioid efficacy failure are significant barriers to effective management of chronic pain. CONCLUSIONS: Patients having chronic pain and concomitant risk factors for opioid abuse, misuse, and diversion are prevalent, yet many physicians, especially PCPs, are uncomfortable managing opioid therapy in such patients. Education on best practices for risk assessment, patient monitoring during treatment, strategies for more effective counseling, patient chart documentation, and management strategies to enhance effective treatment of chronic pain are essential to ensure that PCPs and specialists maximize effective and safe use of opioid medications. Pharmacists could be a valuable member of this interdisciplinary team and should be involved in patient counseling and monitoring for aberrant behavior.

Extended-release/long-acting opioid REMS may fill the need for prescribers' appropriate use education.

The Food and Drug Administration (FDA) is requiring manufacturers of long-acting and extended-release opioids to have a class-wide Risk Evaluation and Mitigation Strategy (REMS). The comprehensive risk management plan will include training for prescribers on the appropriate and safe use of these pain medications. The letter dated April 19, 2011 from FDA to manufacturers outlining the REMS requirements describes voluntary training that should be certified education "where practicable." The current report includes data from a recent comprehensive study of healthcare professionals and patients and highlights key insights that can guide the development of the opioid REMS training.