Secular trends in opioid prescribing in the USA

Edmund J Pezalla,1 David Rosen,2 Jennifer G Erensen,2 J David Haddox,2,3 Tracy J Mayne2 1Bioconsult, LLC, Wethersfield, 2Purdue Pharma L.P., Stamford, CT, 3Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA Abstract: Opioid abuse and misuse in the USA is a public health crisis. The use of prescription opioid analgesics increased substantially from 2002 through 2010, then plateaued and began to decrease in 2011. This study examined prescriptions of branded and generic immediate- and extended-release opioid analgesics from 1992 to 2016. This was juxtaposed against state and federal policies designed to decrease overutilization and abuse, as well as the launch of new opioid products, including opioids with abuse-deterrent properties (OADPs). The data indicate that these health policies, including the utilization and reimbursement of OADPs, have coincided with decreased opioid utilization. The hypothesis that OADPs will paradoxically increase opioid prescribing is not supported. Keywords: OADP, prescription, utilization trends, legislation, opioid

Voices that may not otherwise be heard: a qualitative exploration into the perspectives of primary care patients living with chronic pain

Lorraine S Wallace,1 Randell K Wexler,1 Leon McDougle,1 W Frederick Miser,1 J David Haddox2,3 1Department of Family Medicine, the Ohio State University, Columbus, OH, USA; 2Health Policy, Purdue Pharma L.P., Stamford, CT, USA; 3Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA Background: Although psychometrically sound pain assessment tools are available, there is a paucity of research that comprehensively defines chronic pain from the perspective of patients. The purpose of this study was to examine the utility of a combination of qualitative methods (Photovoice, one-on-one interviews, and focus groups) in examining the daily experiences of primary care patients living with chronic pain. Methods: A sample of English-speaking primary care patients aged 30 years or older, who had been prescribed an opioid for long-term, noncancer pain management, participated in the study. Each patient took photographs that best reflected both his/her experiences with chronic pain and what he/she would like his/her life to be without chronic pain. Results: Patients submitted an average of 20.2±3.1 photographs (range =8–27 photographs). Analysis of one-on-one interviews illuminated five dominant themes: daily need for multiple medications, including opioids; difficulties climbing a flight of stairs; struggling to get out of bed in the morning; extreme challenges with participating in day-to-day life activities; and experiencing feelings of hopelessness and helplessness on a regular basis. Seven themes emerged from the focus groups: undesired effects/burdens of medications, loss of/striving for independence, effect on social interactions/relationships, pain effect on activities of daily living, constant search for convenience/a better situation, interactions with physicians, and frustration/depression with pain. Conclusion: The qualitative methods employed in this study provide deep insight into perceptions and experiences of patients living with chronic pain that is vital for informing future clinical interventions. Keywords: opioid, Photovoice, qualitative researc

Development and validation of the Patient Opioid Education Measure

Lorraine S Wallace,1 Randell K Wexler,1 W Frederick Miser,1 Leon McDougle,1 J David Haddox2,3 1The Ohio State University, Department of Family Medicine, Columbus, OH, 2Purdue Pharma LP, One Stanford Forum, Stanford, CT, 3Tufts University School of Medicine, Department of Public Health and Community Medicine, Boston, MA, USA Background: Although there are screening tools to aid clinicians in assessing the risk of opioid misuse, an instrument to assess opioid-related knowledge is not currently available. The purpose of this study was to develop a content-valid, understandable, readable, and reliable Patient Opioid Education Measure (POEM). Methods: Using concept mapping, clinicians caring for patients with chronic pain participated in brainstorming, sorting, and rating need-to-know information for patients prescribed opioids. Concept mapping analyses identified seven clusters addressing knowledge and expectations associated with opioid use, including medicolegal issues, prescribing policies, safe use and handling, expected outcomes, side effects, pharmacology, and warnings. Results: The 49-item POEM was verbally administered to 83 patients (average age 51.3 ± 9.8 years, 77.1% female, 47.1% African American) taking opioids for chronic nonmalignant pain. Patients averaged in total 63.9% ± 14.3% (range 23%–91%) correct responses on the POEM. The POEM demonstrated substantial test-retest reliability (interclass correlation coefficient 0.87). The POEM had a mean readability Lexile (L) score of 805.9 ± 257.3 L (equivalent to approximately a US fifth grade reading level), with individual items ranging from 280 L to 1370 L. Conclusion: The POEM shows promise for rapidly identifying patients' opioid-related knowledge gaps and expectations. Correcting misunderstandings and gaps could result in safer use of opioids in a clinical care setting. Keywords: opioid, knowledge, pain, questionnair

Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations

Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development