Drug Abuse Clinical Trial
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
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.
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