# Presentation: 473235

## PalladoneTM CapsulesRisk Management Program Food and Drug AdministrationCenter for Drug Evaluation and ResearchAnesthetic and Life Support Drugs Advisory Committee MeetingSeptember 10, 2003

## Speakers

- J. David Haddox, DDS, MD
- Vice President, Health Policy
- Purdue Pharma L.P.
- Sidney H. Schnoll, MD, PhD
- Executive Medical Director, Health Policy
- Purdue Pharma L.P.
- Herbert D. Kleber, MD
- Director, Division on Substance Abuse
- Professor of Psychiatry
- College of Physicians and Surgeons
- Columbia University
- Formerly Deputy Director, Demand Reduction
- White House Office of National Drug Control Policy

## Consultants

- Theodore J. Cicero, PhD
- Vice-Chancellor for Research
- Professor, Neurobiology
- Washington University in St. Louis
- James A. Inciardi, PhD
- Director, Center for Drug and Alcohol Studies
- Professor, Criminal Justice
- University of Delaware
- Richard C. Dart, MD, PhD
- Director, Rocky Mountain Poison and Drug Center
- Professor, Surgery (Emergency Medicine)
- University of Colorado

## Agenda

- Introduction
- PalladoneTM Capsules
- Risk Management Program
-   Goals and Objectives
-   Elements of Palladone RMP
-  Palladone RMP Tools: Examples
-   RADARSTM System
- Prescription Drug Abuse

## Purdue Pharma L.P. PositionRisk Management Programs (RMPs) for Opioid Analgesics

- Must protect patients
- Must balance the legitimate needs of patients against the risks posed to abusers
- Needed for all opioid medications
- Must be consistent within the same schedule in the Controlled Substances Act (CSA)
- Must consider three distinct populations
-  Patients
-  Abusers
-  Criminals

## Purdue Pharma L.P. Position(continued)

- No single group can implement an effective risk management program for opioid analgesics that addresses all three populations
- This is a multifaceted challenge requiring coordinated, cooperative and consistent efforts from
- 	     Industry		            Law Enforcement
- Regulators		  	  Educators
- Government 		  Community Leaders
- Healthcare		  	  Patients and Professionals		     Caregivers

## PalladoneTM Capsules

## PalladoneTM Capsules  Introduction 

- Oral opioid analgesics are an effective therapy for appropriately selected patients
- Modified-release opioids have been proven safe and effective in those patients
- Due to variability of response to opioids and the need for individualized treatment strategies, healthcare professionals need a variety of opioid formulations

## PalladoneTM Capsules contain pellets each of which has hydromorphone HCl embedded in an extended-release matrix
Hydromorphone is a full mu agonist with reported equianalgesic potency compared to morphine ranging from 1:3 to 1:10 po
Formulated for once-a-day oral administration
Strengths: 12 mg, 16 mg, 24 mg, 32 mg

- PalladoneTM Capsules contain pellets each of which has hydromorphone HCl embedded in an extended-release matrix
- Hydromorphone is a full mu agonist with reported equianalgesic potency compared to morphine ranging from 1:3 to 1:10 po
- Formulated for once-a-day oral administration
- Strengths: 12 mg, 16 mg, 24 mg, 32 mg

## Provides healthcare professionals an important therapeutic option 
Only extended-release hydromorphone
Formulated for once-daily administration
Provides a choice among extended release opioids 
Contents may be sprinkled on soft food for those with swallowing difficulty
Less fluctuation in blood levels compared to IR hydromorphone 
No food effect or pH effect
Studied in cancer and noncancer pain in doses ranging from 12 to 500 mg/day

- Provides healthcare professionals an important therapeutic option
- Only extended-release hydromorphone
- Formulated for once-daily administration
- Provides a choice among extended release opioids
- Contents may be sprinkled on soft food for those with swallowing difficulty
- Less fluctuation in blood levels compared to IR hydromorphone
- No food effect or pH effect
- Studied in cancer and noncancer pain in doses ranging from 12 to 500 mg/day

## Steady-State Pharmacokinetics

-                PalladoneTM 12 mg q24h                 IR hydromorphone 3 mg q6h

## PalladoneTM Capsules Risk Management Program

## Disease Burden of Pain 

*Research!America*, 2003 National Survey
- 57% of American adults experienced chronic or recurrent pain during the past year
- Of those currently dealing with chronic pain
- 39% have had to make major adjustments in their activities of daily living due to pain
- 66% expect to live with pain for the rest of their lives

## NHSDA / NSDUH EstimatesFirst-Time Non-Medical Use

- 	The number of pain reliever initiates have been increasing since 1980

| Year |       Number  of Initiates |
| --- | --- |
| 1980 | 484,000 |
| 1985 | 409,000 |
| 1990 | 554,000 |
| 1995 | 983,000 |
| 2000 | 2,033,000 |
| 2001* | 2,400,000 |

- *Different methods were used for the 2002 survey

| Drug | 2000 | 2001 | 2002* |
| --- | --- | --- | --- |
| Vicodin®, Lortab®, Lorcet® | 6,708,000 | 9,453,000 | 13,093,000 |
| Percocet®, Percodan®, Tylox® | 6,902,000 | 7,780,000 | 9,659,000 |
| Hydrocodone | 1,788,000 | 2,781,000 | 4,529,000 |
| Morphine | 1,536,000 | 1,640,000 | 2,073,000 |
| OxyContin® | 399,000 | 957,000 | 1,924,000 |
| Dilaudid® | 757,000 | 837,000 | 1,116,000 |
| Methadone | 819,000 | 732,000 | 928,000 |

- NHSDA / NSDUH EstimatesLifetime Non-Medical Use

- *Different methods were used for the 2002 survey

|  | Lifetime | Past Year | Past Month |
| --- | --- | --- | --- |
| 2000 | 19,210,000 | 6,466,000 | 2,782,000 |
| 2001 | 22,133,000 | 8,353,000 | 3,497,000 |
| 2002* | 29,611,000 | 10,992,000 | 4,377,000 |

- NHSDA / NSDUH EstimatesPain Reliever Non-Medical Use

- *Different methods were used for the 2002 survey

## NHSDA EstimatesNon-Medical Use of Hydromorphone

***Results from analysis of National Household Survey of Drug Abuse, 1999-2001 data released by SAMHSA***

| Drug Use Behaviors | No Lifetime Use of Hydromorphone |  |  | Any Lifetime Use of Hydromorphone |  |  |
| --- | --- | --- | --- | --- | --- | --- |
| Survey Year: | 1999 | 2000 | 2001 | 1999 | 2000 | 2001 |
| % Using Multiple Rx Analgesics Nonmedically | 42.5 | 44.0 | 47.2 | 88.6 | 93.1 | 93.3 |
| % Using Cocaine or Heroin | 42.6 | 41.2 | 42.5 | 95.4 | 88.8 | 94.0 |
| % Using Needles | 8.3 | 6.6 | 7.2 | 84.1 | 84.2 | 88.2 |

## Pharmacological Considerations for Abuse Liability of Hydromorphone

- Pharmacological profile
- Typical morphine-like
- Human and animal abuse liability
- Typical morphine-like
- No evidence of differential abuse liability among full mu agonists
- Potency not relevant to abuse liability

## Hydromorphone Abuse Liability 

- Patients
- No evidence of differential abuse liability compared with other full mu agonists
- Abusers
- No evidence of greater abuse liability compared with morphine
- “In all of the studies the profile of subjective effects of hydromorphone were similar to those previously reported for morphine” (Preston and Jasinski, 1991)

## Single-Dose Pharmacokinetics

-           PalladoneTM 24 mg           Dilaudid® 8 mg              IV Hydromorphone 1.5 mg

## Ensure proper use
Reduce abuse
Minimize diversion

- Reduce abuse
- Minimize diversion

- PalladoneTM CapsulesRisk Management ProgramGoals

## Ensure proper use
Proper patient selection
Proper prescribing 
Prevention of unintentional exposure

- Proper patient selection
- Proper prescribing
- Prevention of unintentional exposure

- PalladoneTM CapsulesRisk Management ProgramObjectives

## Reduce abuse 
Community-based interventions 
Healthcare professional education

- Community-based interventions
- Healthcare professional education

- PalladoneTM CapsulesRisk Management ProgramObjectives

## Minimize diversion
Law enforcement support
Supply chain integrity
Healthcare professional education

- Law enforcement support
- Supply chain integrity
- Healthcare professional education

- PalladoneTM CapsulesRisk Management ProgramObjectives

## Schedule II restrictions
Supply chain integrity 
Communication of key safety messages
Interventions
Multifaceted surveillance 

- Supply chain integrity
- Communication of key safety messages
- Interventions
- Multifaceted surveillance

- PalladoneTM CapsulesRisk Management Program

## Schedule II restrictions
Supply chain integrity 
Communication of key safety messages
Interventions
Multifaceted surveillance 

- Supply chain integrity
- Communication of key safety messages
- Interventions
- Multifaceted surveillance

- PalladoneTM CapsulesRisk Management Program

## Communication of key safety messages
Package insert
Patient package insert 
Medical communications
Promotion

- Package insert
- Patient package insert
- Medical communications
- Promotion

- PalladoneTM CapsulesRisk Management Program

## Proposed Package Insert

- CII designation
- Boxed warning
- Indications and usage
- Misuse, abuse, diversion of opioids
- Drug abuse and addiction
- Information to patients/caregivers to avoid unintentional exposure
- Instructions for safe handling, storage and disposal

## Proposed Package Insert

- CII designation
- Boxed warning
- Indications and usage
- Misuse, abuse, diversion of opioids
- Drug abuse and addiction
- Information to patients/caregivers to avoid unintentional exposure
- Instructions for safe handling, storage and disposal

## Proposed Package Insert Boxed Warning

-   **WARNING:**
** **
- 	**PalladoneTM (hydromorphone HCl extended-release) Capsules are indicated for the management of persistent moderate to severe pain in patients requiring continuous around-the-clock opioid analgesia for an extended period of time.  PalladoneTM Capsules should only be used in patients who are already receiving opioid therapy and who require and can tolerate a minimum total daily dose equivalent to 12 mg of oral hydromorphone.**

## Proposed Package Insert Boxed Warning (continued)

-  **PalladoneTM Capsules are NOT intended to be used on an as needed basis or as the first opioid product prescribed for a patient.**
** **
**	****PalladoneTM Capsules are only for use in OPIOID-TOLERANT patients.  Use in non-opioid-tolerant patients may lead to fatal respiratory depression.**
** **
**	****PalladoneTM Capsules contain an opioid agonist that is a Schedule II controlled substance with high potential for abuse similar to morphine, oxycodone, oxymorphone, fentanyl and methadone.  In addition, the high drug content in the extended release formulation may add to the risk of adverse outcomes from abuse.**

## Proposed Package Insert Boxed Warning (continued)

-  Palladone can be abused in a manner similar to other opioid agonists, legal or illicit.  This should be considered when prescribing or dispensing Palladone in situations where the physician or pharmacist is concerned about increased risk of misuse, abuse, or diversion.
**	****TAKING CHEWED, DISSOLVED, OR CRUSHED PALLADONETM CAPSULES OR ITS CONTENTS CAN LEAD TO THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF HYDROMORPHONE.**

## 	PalladoneTM (hydromorphone hydrochloride extended-release) Capsules are indicated for the management of persistent moderate to severe pain in patients requiring continuous around-the-clock opioid analgesia for an extended period of time.  Palladone Capsules should only be used in patients who are already receiving opioid therapy and who require and can tolerate a minimum total daily dose equivalent to 12 mg of oral hydromorphone.

- 	PalladoneTM (hydromorphone hydrochloride extended-release) Capsules are indicated for the management of persistent moderate to severe pain in patients requiring continuous around-the-clock opioid analgesia for an extended period of time.  Palladone Capsules should only be used in patients who are already receiving opioid therapy and who require and can tolerate a minimum total daily dose equivalent to 12 mg of oral hydromorphone.

## 	PALLADONETM CAPSULES ARE NOT INTENDED TO BE USED ON AN AS NEEDED BASIS OR AS THE FIRST OPIOID PRODUCT PRESCRIBED FOR A PATIENT.  

- 	PALLADONETM CAPSULES ARE NOT INTENDED TO BE USED ON AN AS NEEDED BASIS OR AS THE FIRST OPIOID PRODUCT PRESCRIBED FOR A PATIENT.

## 	Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen, to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Health Research and Quality, the Federation of State Medical Boards Model Guidelines, or the American Pain Society.

- Proposed Package Insert Indications and Usage (continued)

## Proposed Patient Package InsertKey Messages

- Do not crush, dissolve, or chew PalladoneTM Capsules before swallowing
- Keep Palladone Capsules in a safe place away from children
- Palladone Capsules contain an opioid (narcotic) pain medicine
- Palladone Capsules are not for occasional (“as needed”) use
- Prevent theft and misuse

## A single telephone number staffed around the clock by trained healthcare professionals to
Provide product information for healthcare professionals
Receive adverse event information
Address product inquiries and complaints 

- Provide product information for healthcare professionals
- Receive adverse event information
- Address product inquiries and complaints

- Medical Communications

## Phased Launch 

- PalladoneTM Capsules will be initially promoted by a subset of the sales force to a limited group of healthcare professionals for approximately four months
- Evaluation of promotional message retention and understanding by healthcare professionals will be conducted by independent third party
- Introduction will be gradually expanded based on the first four months experience and on subsequent evaluations

- Understanding patient selection criteria
- Understanding dosage and administration
- Understanding the significance of the CII designation
- Understanding how to recognize abuse and minimize diversion

- Will help ensure that healthcare professionals understand our messages
- Will enhance the quality of our promotional activities
- Should be applied to all future approvals for CII opioid analgesics

## Schedule II restrictions
Supply chain integrity 
Communication of key safety messages
Interventions
Multifaceted surveillance 

- Supply chain integrity
- Communication of key safety messages
- Interventions
- Multifaceted surveillance

- PalladoneTM CapsulesRisk Management Program

## Interventions
Education
Community outreach
Law enforcement support 

- Education
- Community outreach
- Law enforcement support

- PalladoneTM CapsulesRisk Management Program

## Healthcare Practitioner Education
Monographs
Teleconferences
Distance Learning 
CD ROMs
Slide Kits
Guidelines for assessment and treatment

- Monographs
- Teleconferences
- Distance Learning
- CD ROMs
- Slide Kits
- Guidelines for assessment and treatment

- Risk Management Tools

## Healthcare Practitioner Education Monographs

- > 100,000 distributed
- Most requested enduring material

## Healthcare Practitioner Education Slide Kits

- Created with an external advisory board
- Pain specialists
- Addiction specialists
- NADDI and NASCSA
- >10,000 produced
- Revision with images of “track marks”, etc. ready for reproduction and distribution

## Law Enforcement SupportRxPATROLTM

- Joint program of NACDS, NADDI and PSI
- An Internet-based clearinghouse for information on pharmacy robberies and burglaries to aid in apprehension of criminals

## Purdue Helps DAMMADD Nab Drug Dealers

- Seed money provided
- 65,000 tent cards with URL for distribution to pharmacies
- To date the program has generated 924 tips, resulting in:
- 37 arrests
- 21 convictions

## Law Enforcement Support

- NADDI Brochure

- Over 100,000 distributed
- “These brochures have been one of the hottest projects we have ever done” **- ****Commander John Burke, Vice President, NADDI**

- Abused Controlled Substances

## Tamper-Resistant Pads

**“****VOID”**
- appears
- on
- photocopied
- or
- scanned
- blanks

## Slide 50

## Community PartnershipsCommunities That Care®

- Structured planning system based on 20+ years of NIH funded prevention science research
- Provides strategic consultation, training, and research-based tools to help communities work together
- Directs communities to choose programs to help prevent problem behaviors, including prescription drug abuse, substance abuse, delinquency, teen pregnancy, school dropout, and violence

## Target: Middle School Students
Strategy: Make “tweens” feel sorry for people who abuse prescription drugs because they have no self-respect/dignity  
Key Message:  If you abuse prescription drugs, you’ll lose your dignity

- Target: Middle School Students
- Strategy: Make “tweens” feel sorry for people who abuse prescription drugs because they have no self-respect/dignity
- Key Message:  If you abuse prescription drugs, you’ll lose your dignity

## Painfully Obvious Education and Awareness Program

## Anti-Drug Abuse Messages

- The most recent National Survey of Drug Use and Health data suggest that youth who have heard anti-drug abuse messages have lower rates of abuse than those who have not heard the messages (11.3% vs. 13.2%)

## Schedule II restrictions
Supply chain integrity 
Communication of key safety messages
Interventions
Multifaceted surveillance 

- Supply chain integrity
- Communication of key safety messages
- Interventions
- Multifaceted surveillance

- PalladoneTM CapsulesRisk Management Program

## Systems to monitor for patient safety
Pharmacovigilance (including scientific literature surveillance)
Systems to monitor for abuse and diversion
National surveys (DAWN, NHSDA, MTF)
Media surveillance
RADARSTM System

- Systems to monitor for patient safety
- Pharmacovigilance (including scientific literature surveillance)
- Systems to monitor for abuse and diversion
- National surveys (DAWN, NHSDA, MTF)
- Media surveillance
- RADARSTM System

## RADARSTM System

- Researched Abuse Diversion
- and Addiction-Related Surveillance
- Sidney H. Schnoll, MD, PhD

## Media reports suggested that OxyContin® abuse was becoming a public health concern
Purdue recognized the importance of outside expertise
External Advisory Board (EAB) was formed Jun-01
EAB reviewed existing methods and data
EAB recognized need for timely, geographically sensitive data and developed studies to achieve this end

- Purdue recognized the importance of outside expertise
- External Advisory Board (EAB) was formed Jun-01
- EAB reviewed existing methods and data
- EAB recognized need for timely, geographically sensitive data and developed studies to achieve this end

- RADARSTM System Formation and Evolution

## RADARSTM System External Advisory Board (EAB)

- Edgar Adams, ScD		Harris Interactive
- Cmdr. John Burke		NADDI
- Theodore Cicero, PhD		Washington Univ.
- Richard Dart, MD, PhD		Rocky Mountain PDC
- Danna Droz, RPh, JD		NASCSA
- Ann Geller, MD			Columbia Univ.
- James Inciardi, PhD		Univ. of Delaware
- Herbert Kleber, MD		Columbia Univ.
- Alvaro Muñoz, PhD		Johns Hopkins Univ.
- Edward Senay, MD		Univ. of Chicago
- George Woody, MD		Univ. of Pennsylvania

## RADARSTM System Goals

- Study the nature and extent of abuse of scheduled prescription opioid medications of interest to Purdue:
-                  “RADARSTM System Drugs”
**	**Buprenorphine 		 Hydromorphone
- 	Fentanyl			 Methadone
- 	Hydrocodone			 Morphine
- 	 					 Oxycodone
**	**
- Develop and suggest interventions to Purdue to reduce diversion and abuse

## RADARSTM System Objectives

- Proactively collect timely and geographically specific data on the abuse and diversion of RADARSTM System Drugs
- Develop methods to calculate the rates of abuse and diversion at national and local levels
- Develop and implement interventions in collaboration with Purdue to reduce abuse and diversion and monitor the outcomes
- Review existing databases and new data as they are published

## RADARSTM System Levels of Activity

**Signal Detection**

**Signal Verification**

**Focused Studies**

**Interventions**

**Outcomes**

**Relative Rate **

**Determination**

**Other Purdue **

**Signals**

## Signal Detection Components Rationale 

- Serves as an early warning system
- Timely collection
- Geographically sensitive
- Useful for monitoring newly approved drugs
- Low threshold for potential signals
-  5 cases per 100,000 persons per 3-digit zip code
- selected as starting point by EAB

## Signal Detection Studies

- Funded by Purdue Pharma L.P.
- Studies conducted at major research universities under direction of Principal Investigators
- Data independently housed at universities
- Data reports presented to the EAB and Purdue on a quarterly basis

## Signal Detection Network

## Key Informant NetworkTheodore Cicero, PhD, Principal InvestigatorWashington University

- Rationale:
- 	Need to establish an extensive network of specialists to proactively seek out documented cases of abuse
- Objectives:
- 	Use key informants to proactively count the cases of abuse & addiction of RADARSTM System Drugs in specific geographic locations
- 	Monitor the number of cases of abuse and addiction of the RADARSTM System Drugs over time

## Key Informant NetworkPotential Signals of Abuse 

- Zip Code 062xx

**Rate of Abuse**

- ®

## Law Enforcement Drug DiversionJames Inciardi, PhD, Principal InvestigatorUniversity of Delaware

- Rationale:
- 	Determine relative diversion of RADARSTM System Drugs compared to other drugs in a specific geographic locale
- Objectives:
- 	Determine the extent of diversion from a national sample of police diversion units
- 	Determine “signal sites” for these drugs over time
- 	Identify “epicenters of diversion” (3-digit zip code locations where a signal is detected _>_ 1Q per year)

## National Diversion Survey 2002 and 1-2Q03

|  | 1Q02 | 2Q02 | 3Q02 | 4Q02 | 1Q03 | 2Q03 |
| --- | --- | --- | --- | --- | --- | --- |
| Sites 
Contacted | 202 | 202 | 200 | 200 | 207 | 223 |
| Sites   Responding | 135 | 134 | 131 | 125 | 147 | 136
 (ongoing) |
| 
Total Diversion Cases Reported | 2954 | 3106 | 2498 | 2400 | 3075 | 2592 |

## National Diversion Survey -Total Diversion Mentions for All Sites 2002 and 1- 2Q03

**Total Mentions**

- ®

## Drug Evaluation Network SystemThomas McLellan, PhD, Principal InvestigatorUniversity of Pennsylvania

- Rationale:
- 	Collection of data on abuse of prescription drugs by those entering drug abuse treatment programs will aid in tracking trends over time
- Objectives:
-    Gather data on prescription drug abuse in admissions to treatment programs
-     Track trends in prescription drugs abused over time

## DENS DataLifetime Prescription Opioid Abuse

- n = 11,116 admissions for substance abuse
-               November 2001 thru June 2003

## DENS Past 30-Day and Lifetime Use Hydromorphone

## Poison Control Centers (PCCs)Richard Dart, MD, PhD, Principal InvestigatorUniversity of Colorado

- Rationale:
- 	PCC network will provide another sensitive means of detecting emerging abuse trends in a timely manner
- Objectives:
-    Prospectively monitor exposure and information
-    calls involving the RADARSTM System Drugs
-    reported to 8 PCCs in the pilot study
-    Monitor the changes in these calls over time

## PCC Pilot Study Coverage25.4% of US population

- PCC Pilot Study Coverage25.4% of US population

## Intentional ExposureCall Rates 2002 - 2Q03  

- * Not including OxyContin®

- Rate per 100,000

- ®

## Signal Detection Studies Analysis of Data 

- Results (numerators)
- Processed through comprehensive database at Washington Univ.
- Potential denominators
- Patient-day exposure, kg sold, 			        no. of units dispensed, and other metrics
- Relative rates calculated at Johns Hopkins Univ.
- Rates of abuse and diversion at local (3-digit zip codes) and national levels
- Between drugs and within drugs over time

## DAWN ED Mentions/Total Kg Sold

- ®

##  RADARSTM System Signal Verification and Evaluation

- Signal  5 cases per 100,000 population within a 3-digit zip code, whether from one study, or summed from more than one study
- Field researchers use structured interview with sites to verify nature of signal
- Results of field interviews are presented to EAB for evaluation

- SW Virginia Study – Janet Knisely, PhD
- Virginia Commonwealth University
- Maine Ethnographic Study – Robert Heimer, PhD
- Yale University
- Eastern Kentucky Study - Carl Leukefeld, DSW (soon to be implemented)
- University of Kentucky

-  RADARSTM System In-Depth Focused Studies

## Local Interventions and Evaluation of Outcomes

- Interventions
- Specific to the problems in the area
- Recommended by EAB or initiated by Purdue
- Outcomes Evaluation
- Monitor signal detection data
- Analyze other indicators of change

## RADARSTM System Interim Conclusions

- Characteristics of prescription drug abuse in these
- studies:
- Abusers of a given opioid are similar to abusers of other prescription opioids
- Typically seen in those with a history of abuse of multiple drugs, both licit and illicit
- Generally not a problem of ethnic minorities
- Endemic in some rural areas

## RADARSTM SystemSummary

- Establishes a standard for *proactive *collection of data on abuse and diversion
- Provides relative rates of abuse and diversion for drugs of interest
- Able to detect abuse and diversion of drugs that are infrequently prescribed
- Generates timely and geographically specific data

## Prescription Drug AbuseHerbert D. Kleber, MD

## Prescription Drug Abuse

- Prescription drug abuse is not a new problem
- The under-treatment of pain remains a serious national problem
- How are we to keep these effective pain relievers available for appropriate medical use while decreasing abuse?

## Attempts at Legal Control

- Legal efforts at control try to reduce avenues of abuse through improved law enforcement
- In the late 1800s, patent medicines containing opiates and cocaine were readily available
- The Pure Food and Drug Act (1906) required labeling of ingredients in patent medicines

## Attempts at Better Coordination 

- Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act,1970)
- White House Special Action Office for Drug Abuse Prevention (SAODAP, 1971)
- National Institute on Drug Abuse (NIDA, 1973)
- Office of National Drug Control Policy (ONDCP, 1988)

## Who are the Abusers?

- Most non-medical users of prescription opioids are polydrug abusers
- Most pain patients do not abuse these medications nor become addicts

## Since the patient is not the key person at risk for prescription drug abuse, how much interference with legitimate medical need should be tolerated to reduce abuse?

## Important Considerations

- Quick fixes do not work for complex problems
- There are often unanticipated consequences of good intentions
- Patterns of drug abuse continually shift and preferences change
- We continue to search for technological fixes
- The struggle to reduce abuse will continue with evolutionary, not revolutionary, changes

## Strategies to Reduce Prescription Opioid Abuse

- Improved training of healthcare professionals
- System improvements, e.g., tamper-proof prescription pads, electronic prescription monitoring programs
- Improved post-marketing surveillance and risk management strategies
- The entire Risk Management Program for Palladone Capsules, including The RADARSTM System, is one of the most comprehensive I have ever encountered

## Strategies to Reduce Prescription Opioid Abuse (continued)

- Increased and improved treatment for opioid abuse/dependence
-    “There is no other medical condition for which we would tolerate such huge numbers unable to obtain the treatment they need. . .” *(September 2003)*
- 		  *Tommy G. Thompson*
*	**	**	**Secretary HHS*

##  The past decade has witnessed the pendulum swinging toward adequate pain relief for patients but it is critical that risk management strategies do not reverse this trend

## PalladoneTM CapsulesRisk Management ProgramAnesthetic and Life Support Drugs Advisory Committee MeetingSeptember 10, 2003