# Presentation: 294945

## Reported Manipulation of Oxycodone Extended-Release Tablets and Morphine Extended-Release Products

**Richard Abate, RPh, MS**
**Safety Evaluator**
**Division of Medication Error Prevention and Analysis**
**Office of Surveillance and Epidemiology**

## Overview

**AERS search**
**Methods of manipulation**
**Oxycodone extended-release tablets**
**Morphine extended-release products**
**Summary**

## Voluntary, “spontaneous” reporting
Facilitated by the FDA MedWatch Program
Reports are stored and retrieved via Adverse Event Reporting System (AERS) database

**Facilitated by the FDA MedWatch Program**
**Reports are stored and retrieved via Adverse Event Reporting System (AERS) database**

**Adverse Event Reporting System****:**** ****Spontaneous Adverse Event Reporting**** **

## AERS Strengths

**Includes all U.S. marketed products**
**Detection of events not seen in clinical trials**
**Especially good for events with **_**rare**_** background rate, short latency**

## AERS Limitations

**Extensive underreporting**
**Quality of reports is variable**
**Reporting biases**
**Actual numerator & denominator not known**
**Causality of drug-event association often in question**

## AERS SearchOxycodone Extended-Release Tablets

**Search limited to brand name:**
**OxyContin****®**
**7300 reports retrieved**
**Narrative search for terms: **
- crush, chew, inhale, dissolve, inject, and snort

## Narrative Search for Oxycodone Extended-Release Tablets

| Total number of reports evaluated | 380 |
| --- | --- |
| Reports excluded
did not involve manipulation of OxyContin® | 171 |
| Reports further evaluated 
to determine method of manipulation | 209 |

## OxyContin® Manipulation Reports

**Medication errors (n=22)**
**healthcare practitioners crushing tablets for ease of administration**
**labeling includes warnings against crushing or chewing**
**Abuse (n=187)**

## Methods of ManipulationOxyContin®

| Methods of manipulation (n=114) |  |
| --- | --- |
| crush  | 90 |
|  chew | 16 |
| cut  | 2 |
| grind  | 2 |
| melt | 2 |
| crack  | 1 |
| dissolve  | 1 |
| Methods of administration (n=95) |  |
| inject  | 69 |
| snort  | 26 |

## Manipulation of Oral Morphine Extended-Release Products

## AERS Search  Morphine Extended-Release Products

**Search limited to brand names:**
- Capsules: Avinza®, Kadian®
- Tablets: MS Contin®, Oramorph® SR
**2063 reports retrieved**
**Narrative search for terms: **
- chew, crack, crush, cut, dissolve, grind, inhale, inject, melt, and snort.
**Duplicate reports grouped into cases**

## Narrative SearchMorphine Extended-Release Products

| Total number of cases evaluated | 95 |
| --- | --- |
| Cases excluded
did not involve manipulation of oral morphine extended-release products | 73 |
| Cases further evaluated 
to determine method of manipulation | 22 |

## Morphine Extended-Release Product Manipulation Cases

**Medication errors (n=6)**
**crushing tablets for ease of administration**
**labeling includes warnings against crushing or chewing**
**Abuse (n=16)**

## Methods of ManipulationMorphine Extended-Release Products

| Methods of manipulation (n=18) |  |
| --- | --- |
| crush  | 11 |
|  chew | 3 |
| boiling or heating | 2 |
| dissolve  | 2 |
| Methods of administration (n=22) |  |
| inject  | 11 |
| oral | 8 |
| snort | 2 |
| g-tube | 1 |

## Summary

**Manipulation associated with abuse**
- Manipulation is not completely representative of all abuse
**Injection - most prevalent method of administration reported**** **

## Acknowledgements

**LCDR Kristina Arnwine, Pharm. D**
**CDR Melina N. Griffis, R.Ph.**
**LCDR Cathy A. Miller, M.P.H., B.S.N.**
**Division of Medication Error Prevention and Analysis**
**Office of Surveillance and Epidemiology**