# Presentation: 030707

## Prescription Opioids: the good, the bad and the ugly

- Sidney H. Schnoll, MD, PhD

## Overview

**The good**
**Pain is the most common presenting symptom**
**Opioids effective in treating pain**
**The bad**
**Prescription opioid abuse is increasing**
**The ugly**
**Increased media hyperbole**
**Increase prosecution of physicians**

## Prescription Drug Abuse Issues

**Zero tolerance policy not possible**
**Prescription drugs have legitimate medical purpose**
**Need to balance needs of patients against issues of abuse and diversion**
**Media reports influence the public, physicians, pharmacists, and patients in a negative way**

## The Good

**Approximately 50 million Americans suffer from chronic pain**
**Pain problems increase with an aging society**
**Opioids are the “gold standard” for pain treatment**
**Have few side effects**

## Top Generic Drugs by Presriptions, 2002

| 1. hydrocodone  w/APAP | 81,261 |
| --- | --- |
| 2. atenolol | 39,368 |
| 6. alprazolam | 29,236 |
| 8. propoxyphene w/APAP | 25,197 |
| 13. APAP w/codeine | 19,998 |
| 16. lorazepam | 17,453 |
| 23. clonazepam | 13,176 |
| 30. diazepam | 11,265 |
| 36. oxycodone w/APAP | 8,890 |
| 184. methadone | 1,217 |

- Units (add 000)

## The Good

**Treatment of pain**
**Reduces social costs**
**Reduces health care costs**
**Treatment of acute pain reduces the development of chronic pain**
**Treatment of chronic pain restores function**

## The Bad

**There have been periodic epidemics of prescription drug abuse**
**Prescription opioid abuse is increasing**
**Overdoses of prescription opioids  are increasing**
**There are 3 populations of concern**
**Addicts**
**Experimental abusers**
**Diverters**

## NSDUH Questionnaire Wording

**NSDUH Questionnaire Wording**

*          *

_**Assessment of “Lifetime Use”**_
- 	***“******Have you ever, even once, used <*****name of drug*****> that was not prescribed for you or that you took only for the experience or feeling it caused?”***
_**Assessment of “Current Use”**__**1**__** and “Past Year Use”**__**2**_
*	****“******What is your best guess of how long it has been since you last used <*****name of drug>***** that was not prescribed for you or that you took only for the experience or feeling it caused?”***
*	*1  Within the 30 days of the interview date
- 	2  More than 30 days ago but within the past 12 months

**Notes:**
Same wording used consistently across all three  survey years.

“Current Use” is defined as use with the past 30 days.

## Estimated Percentage of U.S. Civilian, Non-Institutionalized Population Reporting Current Illicit Drug Use in 2002 NSDUH 

- Percentage

- Source: SAMHSA (2005). Results from the 2003 National Survey on Drug Use and Health: National Findings
-  (Office of Applied Studies, NHSDA Series H-22, DHSS Publication No. SMA 03-3836). Rockville, MD.

## National Household Survey on Drug AbuseNew Nonmedical Users of Psychotherapeutics (1965-2000 NHSDA)

- 1965	1970	1975	1980	1985	1990	1995	2000

- 2.5
- 2.0
- 1.5
- 1.0
- 0.5
- 0

- Millions of new users

- Year

- www.samhsa.gov

**Notes:**
The increasing incidence of nonmedical use of pain relievers since 1965 has been more pronounced since the mid-1980s, when there were approximately 400,000 initiates annually.11 The number of initiates reached 2 million in 2000. Between 1998 and 2000, there were significantly more new users among 12-to-17-year-olds than among 18-to-25-year-olds. 

## Proportion of Non-medical Users Who Meet Clinical Criteria for Abuse or Addiction

- NSDUH, 2003

## Lifetime Nonmedical Use of Selected Pain Relievers, Age 12 or Older: 2002

**Lifetime Nonmedical Use of Selected ****Pain Relievers, Age 12 or Older: 2002**

**Numbers (in Millions)**

**Darvocet****®****, Darvon****®****, or Tylenol****®**** with Codeine**

**Vicodin****®****, Lortab****®****, or Lorcet****®**

**Percocet****®****, Percodan****®****, or Tylox****®**

**®**

**®**

**®**

**®**

## Use Characteristics by Among Those Reporting Any Lifetime Nonmedical Use of Prescription Analgesics: 2002, NSDUH

**Use Characteristics by Among Those Reporting Any Lifetime Nonmedical Use of Prescription Analgesics: 2002, NSDUH**

| Drug Use Characteristics | Lifetime Nonmedical Use of OxyContin®
 | No Lifetime Nonmedical Use of OxyContin® |
| --- | --- | --- |
| (Estimated weighted population) | (n=1,971,894) | (n=28,123,369) |
| (Actual Sample Size) | (n=792) | (n=7,486) |
|  % Lifetime use of cocaine  | 80.29** | 41.72 |
| % Lifetime use of heroin | 27.62** | 6.72 |
| Needle use for nonmedical/illicit drugs | 26.12** | 7.82 |
| % Reporting nonmedical use of prescription analgesics before age 18 | 54.14%** | 33.42 |

- **p<.01

## Past Year Prevalence of Substance Abuse/Dependence Among Those Reporting Any Lifetime Nonmedical Use of Prescription Analgesics: 2002, NSDUH

**Past Year Prevalence of Substance Abuse/Dependence Among Those Reporting Any Lifetime Nonmedical Use of Prescription Analgesics: 2002, NSDUH**

|  | Lifetime Nonmedical Use of OxyContin®
 | No Lifetime Nonmedical Use of OxyContin ® |
| --- | --- | --- |
| (Estimated weighted population) | (n=1,971,894) | (n=28,123,369) |
| (Actual Sample Size)
Past Year Abuse or Dependence: | (n=792) | (n=7,486) |
| Alcohol | 38.87** | 21.11 |
| Opioid Analgesics | 21.46** | 4.00 |
| Cocaine | 12.90** | 2.57 |
| Heroin | 4.63** | 0.35 |
| Any drug (Excluding alcohol) | 42.16** | 13.24 |

- **p<.01

## NHSDANon-Medical Use of Hydromorphone

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

## DAWN Mentions of Selected Drugs

- Source:  Drug Abuse Warning Network

## Trends in Drug Abuse Data 

## Trend in DAWN ED Mentions

## 2002 DAWN ED Mentions

- 670,307 drug-related episodes with 1,209,938 drug mentions.
-  Source: _www.DAWNinfo.samhsa.gov_

- (17.5%)

**Notes:**
Each emergency department visit is referred to as an “episode.” There were more than six hundred thousand drug-related episodes in this sample in 2002. Up to four drugs can be mentioned as being related to each emergency department episode.5 There were more than one million drug mentions. The majority (56%) of drug-related episodes involve more than one drug—an average of 1.8 drug mentions were involved per episode.  “Other” includes named drugs as well as unnamed substances.

## DAWN Opioid Analgesics, 2002

- In 2002, prescription opioids accounted for 10% of all DAWN mentions

## 2002 DAWN: Percentage of Drugs Involved in ED Visits by Opioid 

- Percentage

- _Source: Office of Applied Studies, SAMHSA, Drug Abuse Warning Network 2002 (03/2003 update).  _

**Notes:**
Polydrug use is highly prevalent among ED visits involving oxycodone/combinations and hydrocodone/combinations.  In 2002, 71% of oxycodone/combinations and 78% of hydrocodone/combinations ED visits involved multiple drugs.  
However, polydrug use patterns differed by opioid category.  For oxycodone/combinations, single drug visits were the most common (29% of 20,748 visits); for hydrocodone/combinations, 2-drug visits were most common (33% of 25,109 visits).

## DAWN 2002: Highest Number of Mentions for Prescription Opioids 

-      **Opioid****	**** ****	**** ****	****    ****	****       %****Δ**** from 2000    ****	****N  **
- Hydrocodone/combinations		    21.1% 			25,197
- Oxycodone/combinations      	 	18.8% 			22,397
- Methadone 		                     	 9.8% 			11,709
- Codeine/combinations 				4.2% 			  4,961
- Propoxyphene/combinations 		3.9% 			  4,676
- Morphine/combinations 				2.3% 			  2,775
- Opioids-NOS		 					35.4% 			 42,211

- _Source:  www.DAWNinfo.samhsa.gov_

## Oxycodone/combinations DAWN ED Mentions: 1994-2002

## Fentanyl DAWN ED Mentions:1994-2002

## Problems with Federal Data Sets

- Not timely
- Reports appear years to months later
- DAWNLive! may be an improvement
- No geographic specificity
- Assumes national data and regional data area alike
- Does not provide rates in relation to use or availability

## Rate Data Per 1000 Patients: RADARS® DATA

**Rate Data Per 1000 Patients: RADARS****® ****DATA**

## Rate Data by 3-Digit ZIP CodeRADARS® Data

**Rate Data by 3-Digit ZIP Code****RADARS****®**** Data**

## Methadone Diversion MentionsAll Quarters 2004

**Total  Mentions**

## The Ugly

## News Headlines

**Prescription Drug Abuse in Kentucky Runs Rampant**
**Regional Drug Abuse Task Force Appointed**
- 841 People Arrested for Drug Trafficking - Biggest State Police Sweep in Kentucky History

## News Headlines

**Prescription Drug Abuse In Kentucky Runs Rampant**
**Regional Drug Abuse Task Force Appointed**
**841 People Arrested For Drug Trafficking - Biggest State Police Sweep In Kentucky History**

**10/3/94**

**8/6/93**

**8/5/92**

## OxyContin abuse explodes (Sun-News) (Myrtle Beach, S.C.), 07/07/2002) 

**OxyContin abuse explodes** (Sun-News) (Myrtle Beach, S.C.), 07/07/2002)

**Florida drug deaths skyrocketing from abuse of OxyContin active ingredient** (Associated Press Newswires, 11/20/2001)

***'Hillbilly heroin' taking toll on Georgia; OxyContin painkiller addiction concern grows  ****(The Atlanta Journal-Constitution, 08/19/2001)   *

***Illicit Use of Painkiller Oxycontin `Exploding'  ****(Pittsburgh Post-Gazette, 04/08/2001)***  **

**Potent painkiller is latest drug of choice for city abusers **(Associated Press Newswires, 02/27/2001)

** **

## OxyContin Deaths Said to Be Up Sharply

**OxyContin:  Played a Role in 464 Deaths**

**DEA Ups Estimate of Deaths Linked to Purdue Pharma’s oft-abused OxyContin**

**OxyContin May Be Linked to ****464 Deaths in U.S. NYT Says**

**OxyContin Accounts for 464 Deaths in 2000-2001**

**DEA:  OxyContin Deaths Up Sharply**

**OxyContin Scare:  Federal DEA Blames Drug for 464 Drug Overdose Deaths**

**Report differentiates between OxyContin, oxycodone deaths**

## Slide 35

## Slide 36

## Fact Finding

- _Media Report_
- “Now _Maine is the second largest consumer of OxyContin_ among all the states, and had **35 deaths from overdoses** last year.”
*TIME* Magazine,
- 1/8/2001, pg. 47

## Fact Finding

## Fact Finding

- _Media Report_
- “59 deaths in KY attributed to OxyContin overdoses”

- _Facts_
- In Pikeville, KY, where 28 deaths took place, Coroner stated “the vast majority” were due to multiple drugs, some including oxycodone.  In _none_ was OxyContin identified as the cause of death.

## “There have been several articles in the newspapers here in Kentucky stipulating that a lot of people in the Commonwealth have died from ingesting OxyContin. The numbers will change depending on who you talk to. I am unaware of any reliable data in Kentucky that proves OxyContin is causing a lot of deaths. In the State M.E. Office, we are seeing an increase in the number of deaths from ingesting several different prescription drugs and mixing them with alcohol. OxyContin is sometimes one of these drugs.”

- “There have been several articles in the newspapers here in Kentucky stipulating that a lot of people in the Commonwealth have died from ingesting OxyContin. The numbers will change depending on who you talk to. _I am unaware of any reliable data in Kentucky that proves OxyContin is causing a lot of deaths_. In the _**State M.E. Office**_, we are seeing an increase in the number of deaths from ingesting several different _prescription drugs_ and _mixing_ them with alcohol. _OxyContin is sometimes one of these drugs_.”

## “The media appear neither to know nor to care 

**that such hyperbole can be counterproductive, **
**encouraging drug users to add the new substance **
**to their  repertoires.  The act of defining a new drug**
**of choice, an ultimate high, a hot drug, may lead **
**potential users to ask themselves why they are not **
**sufficiently fashionable to have experienced it.”**

**“...****the degree of panic associated with a social **
**problem depends upon the wider cultural  and **
**political context rather than on any intrinsic **
**qualities of the phenomenon itself.”**

**Jenkins, **_**Synthetic Panics: the symbolic politics of designer drugs**_**, 1999**

## Why Abuse Prescription Drugs?

**Readily available**
**Medicine cabinet**
**Scam physicians**
**Known purity**
**Believed to be safer than street drugs**
**Large amounts of drug in controlled release compounds**

## Where Do We Go from Here?

**How do we balance the benefit/risk ratio?**
**Who should take precedence?**
**Patient?**
**Addict?**
**What is the source of diverted drugs?**
**Supply chain?**
**Internet?**
**Prescribers?**
**Patients?**
**Reverse distributers?**

## Where Do We Go from Here?

**What is the problem?**
**Prescription drug abuse?**
**Drug abuse in general?**
**If all prescription opioids were taken from the market, would the problem disappear?**
**What is the effect of prosecuting physicians?**
**Do patients suffer?**

## Where Do We Go from Here?

**Do we use a public heath approach? Demand reduction.**
**Prevention?**
**Treatment?**
**Do we use a law enforcement approach? Supply reduction.**
**Make the products less available?**