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NCT02920762 Clinical Trial

Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers

Drug Abuse Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02920762
Other study ID # Assessment 7
Secondary ID
Status Enrolling by invitation
Phase N/A
First received September 28, 2016
Last updated September 28, 2016

Study information
Verified date September 2016
Source ER/LA Opioid REMS Program Companies (RPC)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 5575834
Est. completion date
Est. primary completion date July 2019
Accepts healthy volunteers
Gender Both
Age group N/A to 100 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• on-interventional study - retrospective database review

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
ER/LA Opioid REMS Program Companies (RPC)

Outcome
Type Measure Description Time frame Safety issue
Primary Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients Monthly over 54 months
Primary Monthly volume of opioid non-tolerant patients prescribed products indicated for use only in opioid-tolerant patients Monthly over 54 months
Primary Monthly volume of high-starting dose prescriptions in opioid-tolerant patients Monthly over 54 months
Primary Monthly volume of high starting dose prescriptions in non-opioid tolerant patients Monthly over 54 months
Primary Proportion of opioid non-tolerant patients that have high-starting dose prescriptions Monthly over 54 months
Primary Volume of early refills by monthly patient cohort Monthly over 54 months
Primary Volume of normal refills (non-early refills) by monthly patient cohort Monthly over 54 months
Primary Proportion of patients receiving early refills Monthly over 54 months
Primary Early refill rate by monthly patient cohort Monthly over 54 months
Primary Monthly volume of patients who are using a REMS product and a Benzodiazepine concomitantly Monthly over 54 months
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