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

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

Detailed Description
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A study will be performed to evaluate changes in prescribing behavior of prescribers. 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 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 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. Compare the concomitant use of benzodiazepines with ER/LA opioids before and after REMS implementation.

Conditions
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Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse

Intervention / Treatment
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* Other: on-interventional study - retrospective database review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects filling a prescription for a product of interest during the specified time period will be included. Exclusion Criteria: None

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Buprenorphine<br> | Other: on-interventional study - retrospective database review<br> <br> |
| Fentanyl<br> | Other: on-interventional study - retrospective database review<br> <br> |
| Hydromorphone HCl<br> | Other: on-interventional study - retrospective database review<br> <br> |
| Morphine Sulfate<br> | Other: on-interventional study - retrospective database review<br> <br> |
| Morphine Sulfate Beads<br> | Other: on-interventional study - retrospective database review<br> <br> |
| Oxycodone HCl<br> | Other: on-interventional study - retrospective database review<br> <br> |
| Oxymorphone HCl<br> | Other: on-interventional study - retrospective database review<br> <br> |
| Tapentadol<br> | Other: on-interventional study - retrospective database review<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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