Candidate metrics for evaluating the impact of prescriber education on the safe use of extended-release/long-acting (ER/LA) opioid analgesics.
OBJECTIVE
The objective of this study was to develop metrics to assess opioid prescribing behavior as part of the evaluation of the Extended-Release/Long-Acting (ER/LA) Opioid Analgesic Risk Evaluation and Mitigation Strategies (REMS).


METHODS
Candidate metrics were selected using published guidelines, examined using sensitivity analyses, and applied to cross-sectional rolling cohorts of Medicare patients prescribed with extended-release oxycodone (ERO) between July 2, 2006 and July 1, 2011. Potential metrics included prescribing opioid-tolerant-only ER/LA opioid analgesics to non-opioid-tolerant patients, prescribing early fills to patients, and ordering drug screens.


RESULTS
Proposed definitions for opioid tolerance were seven continuous days of opioid usage of at least 30 mg oxycodone equivalents, within the 7 days (primary) or 30 days (secondary) prior to first opioid-tolerant-only ERO prescription. Forty-four percent of opioid-tolerant-only ERO episodes met the primary opioid tolerance definition; 56% met the secondary definition. Fills were deemed "early" if a prescription was filled before 70% (primary) or 50% (secondary) of the prior prescription's days' supply was to be consumed. Five percent (primary) and 2% (secondary) of episodes had more than or equal to two early fills during treatment. At least one drug screen was billed in 14% of episodes. Stratified analyses indicated that older patients were less likely to be opioid tolerant at the time of the first opioid-tolerant-only ERO prescription.


CONCLUSIONS
Investigators propose three metrics to monitor changes in prescribing behaviors for opioid analgesics that might be used to evaluate the ER/LA Opioid Analgesics REMS. Low frequencies of patients, particularly those >85 years, were likely to be opioid tolerant prior to receiving prescriptions for opioid-tolerant-only ERO.
Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Mary E
ME
Willy
David J
DJ
Graham
Judith A
JA
Racoosin
Rajdeep
R
Gill
Garner F
GF
Kropp
Jessica
J
Young
Jeff
J
Yang
Joyce
J
Choi
Thomas E
TE
MaCurdy
Chris
C
Worrall
Jeffrey A
JA
Kelman
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059350:Chronic Pain / Q000188:drug therapy / Q000453:epidemiology; D015897:Comorbidity; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring / Q000706:statistics & numerical data; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D004361:Drug Tolerance; D004502:Education, Medical, Continuing; D005260:Female; D006801:Humans; D057970:Inappropriate Prescribing / Q000517:prevention & control / Q000706:statistics & numerical data; D007676:Kidney Failure, Chronic / Q000453:epidemiology; D008297:Male; D006278:Medicare / Q000706:statistics & numerical data; D008875:Middle Aged; D009294:Narcotics / Q000008:administration & dosage* / Q000032:analysis / Q000627:therapeutic use; D010098:Oxycodone / Q000008:administration & dosage* / Q000032:analysis / Q000627:therapeutic use; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D014481:United States
D003692:Delayed-Action Preparations; D009294:Narcotics; D010098:Oxycodone
Evaluation; Metrics; Opioids; REMS