Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, 2008 Reported Manipulation of Oxycodone Extended-Release.

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Presentation transcript:

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, 2008 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 Richard Abate, RPh, MS Safety Evaluator Division of Medication Error Prevention and Analysis Office of Surveillance and Epidemiology

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, OverviewOverview AERS search Methods of manipulation –Oxycodone extended-release tablets –Morphine extended-release products Summary AERS search Methods of manipulation –Oxycodone extended-release tablets –Morphine extended-release products Summary

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, Voluntary, “spontaneous” reporting Facilitated by the FDA MedWatch Program Reports are stored and retrieved via Adverse Event Reporting System (AERS) database Voluntary, “spontaneous” reporting 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

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, 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 Includes all U.S. marketed products Detection of events not seen in clinical trials Especially good for events with rare background rate, short latency

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, AERS Limitations Extensive underreporting Quality of reports is variable Reporting biases Actual numerator & denominator not known Causality of drug-event association often in question Extensive underreporting Quality of reports is variable Reporting biases Actual numerator & denominator not known Causality of drug-event association often in question

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, 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 Search limited to brand name: –OxyContin® 7300 reports retrieved Narrative search for terms: –crush, chew, inhale, dissolve, inject, and snort

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, Narrative Search for Oxycodone Extended-Release Tablets Total number of reports evaluated380 Reports excluded –did not involve manipulation of OxyContin® 171 Reports further evaluated –to determine method of manipulation 209

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, 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) Medication errors (n=22) –healthcare practitioners crushing tablets for ease of administration –labeling includes warnings against crushing or chewing Abuse (n=187)

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, Methods of Manipulation OxyContin® Methods of manipulation (n=114) crush90 chew16 cut2 grind2 melt2 crack1 dissolve1 Methods of administration (n=95) inject69 snort26

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, 2008 Manipulation of Oral Morphine Extended-Release Products

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, 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 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

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, Narrative Search Morphine Extended-Release Products Total number of cases evaluated95 Cases excluded –did not involve manipulation of oral morphine extended-release products 73 Cases further evaluated –to determine method of manipulation 22

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, 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) Medication errors (n=6) –crushing tablets for ease of administration –labeling includes warnings against crushing or chewing Abuse (n=16)

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, Methods of Manipulation Morphine Extended-Release Products Methods of manipulation (n=18) crush11 chew3 boiling or heating2 dissolve2 Methods of administration (n=22) inject11 oral8 snort2 g-tube1

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, SummarySummary Manipulation associated with abuse –Manipulation is not completely representative of all abuse Injection - most prevalent method of administration reported Manipulation associated with abuse –Manipulation is not completely representative of all abuse Injection - most prevalent method of administration reported

Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees November 13 & 14, AcknowledgementsAcknowledgements 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 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