Clinical trial NCT02920762: Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Related Disorders
Opiate Addiction
Narcotic Abuse
Drug Abuse
Lead sponsor: ER/LA Opioid REMS Program Companies (RPC)
Sponsor class: INDUSTRY
First posted: 2016-09-30
Enrollment: 5575834
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects filling a prescription for a product of interest indicated for opioid-tolerant patients, filling prescriptions early and determining concomitant use of products as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™

Brief summary: A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids

Detailed description: A study will be performed to evaluate changes in prescribing behavior of prescribers.

1. For products that are indicated for use in opioid-tolerant patients only (i.e., fentanyl transdermal patches, extended-release hydromorphone pills and extended-release morphine pills \>90mg), describe trends in the proportion of prescriptions for these products to opioid-non-tolerant patients in the year preceding the availability of REMS-compliant CE courses and compare the proportion of prescriptions to opioid non-tolerant patients pre- versus post-REMS CE course availability
2. For products whose labels indicate that higher dosage strengths should only be used in opioid-tolerant patients, describe trends in the proportion of prescriptions prescribed to opioid non-tolerant patients with a high starting dosage strength; compare the proportion of prescriptions for such products that are prescribed to opioid non-tolerant patients with a high starting dosage strength pre- versus post-REMS CE course availability
3. Describe trends in the proportion of prescriptions for ER/LA opioids prescribed to patients that have early refills of prescriptions and compare this proportion pre- versus post-REMS CE course availability.
4. Compare the concomitant use of benzodiazepines with ER/LA opioids before and after REMS implementation.

Eligibility criteria: Inclusion Criteria:

* Subjects filling a prescription for a product of interest during the specified time period will be included.

Exclusion Criteria:

* None

Primary outcomes:
measure: Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
timeFrame: Monthly over 54 months
measure: Monthly volume of opioid non-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
timeFrame: Monthly over 54 months
measure: Monthly volume of high-starting dose prescriptions in opioid-tolerant patients
timeFrame: Monthly over 54 months
measure: Monthly volume of high starting dose prescriptions in non-opioid tolerant patients
timeFrame: Monthly over 54 months
measure: Proportion of opioid non-tolerant patients that have high-starting dose prescriptions
timeFrame: Monthly over 54 months
measure: Volume of early refills by monthly patient cohort
timeFrame: Monthly over 54 months
measure: Volume of normal refills (non-early refills) by monthly patient cohort
timeFrame: Monthly over 54 months
measure: Proportion of patients receiving early refills
timeFrame: Monthly over 54 months
measure: Early refill rate by monthly patient cohort
timeFrame: Monthly over 54 months
measure: Monthly volume of patients who are using a REMS product and a Benzodiazepine concomitantly
timeFrame: Monthly over 54 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: