Candidate metrics for evaluating the impact of prescriber education on the safe use of extended-release/long-acting (ER/LA) opioid analgesics

Pain Medicine (United States)

Volumn 15, Issue 9, 2014, Pages 1558-1568

  Willy, Mary E ^a   Graham, David J ^a   Racoosin, Judith A ^a   Gill, Rajdeep ^a   Kropp, Garner F ^b   Young, Jessica ^b   Yang, Jeff ^b   Choi, Joyce ^b   Macurdy, Thomas E ^b   Worrall, Chris ^c   Kelman, Jeffrey A ^c  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Acumen LLC   (United States)

^c Center for Medicare and Medicaid Services   (United States)

Author keywords

Evaluation; Metrics; Opioids; REMS

Indexed keywords

OXYCODONE; DELAYED RELEASE FORMULATION; NARCOTIC AGENT;

ADOLESCENT; ADULT; AGED; ANALGESIA; ARTICLE; CHILD; COHORT ANALYSIS; CONTROLLED DRUG RELEASE; CROSS-SECTIONAL STUDY; DISABILITY; DRUG SAFETY; DRUG SCREENING; DRUG TOLERANCE; ELECTRONIC PRESCRIBING; FEMALE; GROUPS BY AGE; HEALTH CARE UTILIZATION; HUMAN; INAPPROPRIATE PRESCRIBING; INFANT; MAJOR CLINICAL STUDY; MALE; MEDICARE; MUSCULOSKELETAL DISEASE; NEWBORN; PAIN; PATIENT EDUCATION; POSTOPERATIVE PAIN; PRACTICE GUIDELINE; PRESCRIPTION; SENSITIVITY ANALYSIS; STATISTICAL SIGNIFICANCE; CHRONIC PAIN; CLINICAL PRACTICE; COMORBIDITY; DELAYED RELEASE FORMULATION; DOSE RESPONSE; DRUG MONITORING; KIDNEY FAILURE, CHRONIC; MEDICAL EDUCATION; MIDDLE AGED; PREVENTION AND CONTROL; STATISTICS AND NUMERICAL DATA; UNITED STATES; UTILIZATION; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; CHRONIC PAIN; COMORBIDITY; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; DRUG PRESCRIPTIONS; DRUG TOLERANCE; EDUCATION, MEDICAL, CONTINUING; FEMALE; HUMANS; INAPPROPRIATE PRESCRIBING; KIDNEY FAILURE, CHRONIC; MALE; MEDICARE; MIDDLE AGED; NARCOTICS; OXYCODONE; PHYSICIAN'S PRACTICE PATTERNS; PRACTICE GUIDELINES AS TOPIC; UNITED STATES;

EID: 84925934802     PISSN: 15262375     EISSN: 15264637     Source Type: Journal    
DOI: 10.1111/pme.12459     Document Type: Article

References (21)

1. Office of National Drug Control Policy, The White House. Epidemic: Responding to America's prescription drug abuse crisis. 2011. Available at: http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/prescription-drugs/rx_abuse_plan_0.pdf (accessed April 2014).
2. Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, U.S. Centers for Disease Control. Policy impact: Prescription painkiller overdoses [Internet] Atlanta (GA). 2011. Available at: http://www.cdc.gov/HomeandRecreationalSafety/rxbrief/ (accessed April 2014).
3. Jones CM, Mack KA, Paulozzi LJ. Pharmaceutical overdose deaths, United States, 2010. JAMA 2013;309:657-659.
4. Substance Abuse and Mental Health Services Administration. The DAWN Report: Highlights of the 2010 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits, Center for Behavioral Health Statistics and Quality. Rockville, MD, 2012.
5. Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.
6. U.S. Food and Drug Administration. Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids; Approval Letters [Internet] Silver Spring (MD): U.S. Food and Drug Administration. 2012. Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm (accessed April 2014).
7. U.S. Food and Drug Administration. July 22-23, 2010 Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. Outpatient Prescription Opioid Utilization in the U.S., Years 2000-2009 [Internet] Silver Spring (MD): U.S. Food and Drug Administration. 2010. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM220950.pdf (accessed April 2014).
8. U.S. Food and Drug Administration. FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics [Internet], Silver Spring (MD): U.S. Food and Drug Administration. 2013. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf (accessed April 2014).
9. Chou R, Fanciullo GJ, Fine PG, etal. Opioid treatment guidelines: Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10:113-130.
10. Peppin JF, Passik SD, Couto JE, etal. Recommendations for urine drug monitoring as a component of opioid therapy in the treatment of chronic pain. Pain Medicine 2012;13:886-896.
11. Federation of State Medical Boards of the United States. Model policy on the use of opioid analgesics in the treatment of chronic pain. 2013.
12. Purdue Pharma L.P. OxyContin® [package insert]. Stamford, CT: Purdue Pharma L.P.; 2013.
13. Foley KM. The treatment of cancer pain. N Engl J Med 1985;313:84-95.
14. Salzman RT, Roberts MS, Wild J, etal. Can a controlled-release oral dose form of oxycodone be used as readily as an immediate-release form for the purpose of titrating to stable pain control? J Pain Symptom Manage 1999;18:271-279.
15. Purdue Pharma L.P. OxyContin® [package insert]. Stamford, CT: Purdue Pharma L.P.; 2011.
16. Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub.L. 91-513 (Oct. 27, 1970).
17. White AG, Birnbaum HG, Schiller M, Tang J, Katz NP. Analytic models to identify patients at risk for prescription opioid abuse. Am J Manag Care 2009;15:897-906.
18. Starrels JL, Becker WC, Weiner MG, etal. Low use of opioid risk reduction strategies in primary care even for high risk patients with chronic pain. J Gen Intern Med 2011;26:958-964.
19. Bhushan B, Brown D, Hariharan J, etal. Survey of select practice behaviors by primary care physicians on the use of opioids for chronic pain. Curr Med Res Opin 2006;22:1859-1865.
20. Hartzema AG, Racoosin JA, MaCurdy TE, Gibbs JM, Kelman JA. Utilizing Medicare claims for real-time drug safety evaluations: Is if feasible? Pharmacoepidemiology and Drug Saf 2011;20:684-688.
21. U.S. Food and Drug Administration. Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications [Internet] Silver Spring (MD): U.S. Food and Drug Administration. 2009. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf (accessed April 2014).