prescription opioid abuse - pfizer medical information

Prescription Opioid Abuse: Working together to address a public health concern

For your personal use. Not for further distribution

Content of presentation

• The problem of prescription opioid misuse, abuse, and diversion

• Who is at risk for opioid misuse and abuse? • What is being done to reduce the risk of opioid

abuse? • A pharmaceutical industry approach:

Abuse-deterrent opioids


The Problem of Prescription Opioid Misuse, Abuse, and Diversion


The important role of prescription opioids

~100 million adult Americans are affected by a chronic pain condition1

Patients deserve access to effective medications to treat pain, including prescription opioids when appropriate1

1. Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press; 2011.


There is potential for misuse, abuse, and diversion of prescription opioids

Removing a medicine from legitimate circulation: can involve sharing, purchasing, and theft among family and friends

Any use of an illicit drug or use of a prescription drug for a nonmedical purpose

Use of a medicine other than as directed or as indicated to treat an illness

Misuse

Abuse

Diversion

Webster LR, Fine PG. J Pain. 2010;11(7):602–11. Webster L, et al. J Opioid Manag. 2011;7(3):235–45.

For example:

Sharing prescription opioids among friends or family

Ingesting medicine to get high

Taking more than your prescribed dose


Increased use of opioids in treating pain has led to a significant rise in prescriptions

Adapted from: Centers for Disease Control and Prevention. Prescription drug abuse and overdose: public health perspective. www.cdc.gov/primarycare/materials/opoidabuse/docs/pda-phperspective-508.pdf. Published October 24, 2012. Accessed December 3, 2015. Data from: Source™ Prescription Audit (SPA) and IMS Health Vector One®: National (VONA).

In 2011, the number of pharmacy prescriptions for opioids nearly tripled

Rise in Prescription Opioids

+175% 1991–2011

219 million

2011

76 million

1991


Prescription opioid misuse and abuse are associated with serious health consequences

In 2013, 44 people died from opioid overdoses every single day

Deaths from unintentional and intentional overdose of prescription opioids1,2

+300% 1999–2013

1. Centers for Disease Control and Prevention. Deaths from prescription opioid overdose. www.cdc.gov/drugoverdose/data/overdose.html. Updated October 16, 2015. Accessed December 3, 2015.

2. Centers for Disease Control and Prevention. MMWR Morbid Mortal Weekly Rep. 2013;62(12):234.

16,235

2013

4030

1999

The number of opioid overdose deaths quadrupled


Opioid overdose deaths are only the tip of the iceberg

In 2010, for every 1 opioid overdose death there were…

*Treatment admissions are for primary use of opioids from the Treatment Exposure Data Set. †Emergency department visits are from the Drug Abuse Warning Network (https://dawninfo.samhsa.gov/default.asp). ‡Abuse/dependence in the past year and nonmedical use in the past month are from the 2012 National Survey on Drug Use and Health. Centers for Disease Control and Prevention. Prescription drug abuse and overdose: public health perspective. www.cdc.gov/primarycare/materials/opoidabuse/docs/pda-phperspective-508.pdf. Published October 24, 2012. Accessed December 3, 2015.

who abused/were dependent‡

abuse treatment admissions* emergency department visits†

nonmedical users‡

10 26

108 733


Oral ingestion is the major route of abuse, but injection and inhalation are the most dangerous

Oral (chewed

and whole) 92% Inhalation

5% (includes snorting)

Injection 3%

Routes of abuse

• Higher rates of major health effects* or death are associated with inhalation (10.2%) and injection (16.5%) compared with oral ingestion (8.6%)1

• Injecting may result in rise in blood-borne infections (HIV, hepatitis C)

*Major health effect refers to symptoms that are life threatening or result in residual disability. 1. Katz N, et al. Am J Drug Alcohol Abuse. 2011;37(4):205–17.


Extended Release (ER) opioids are tampered with for purposes of misuse and abuse

55 38 47 53 62 25 6 <1 <1 36 9 46 0

20

40

60

80

ER oxycodone ER oxymorphone ER morphine

Pers

ons

abus

ing,

%

Oral Snorting Smoking Injecting

Nonoral routes of abuse are common with ER opioids*

ER, extended release. Percentages for each drug (also shown as text in bars) do not add up to 100% because respondents could report multiple routes of administration. *Before introduction of reformulated ER oxycodone and ER oxymorphone. Adapted from: Butler SF, et al. J Pain. 2013;14(4):351–8.

This data was collected from a sample of individuals who were at risk for opioid abuse and assessed for substance abuse treatment


Who Is at Risk for Opioid Misuse and Abuse?


Misuse or abuse of prescription opioids can happen to anyone

~1 out of 5 patients misuse or abuse their opioid medications1

Anyone, regardless of age, sex, race, ethnicity, income, or educational level, is at risk for prescription opioid misuse or abuse

Patients with chronic pain are susceptible: an estimated 50–80% of people who die from prescription opioid overdoses have a history of chronic pain2

1. Vowles KE, et al. Pain. 2015;156(4):569–76. 2. US Department of Health and Human Services. Addressing prescription drug abuse in the United States. www.cdc.gov/drugoverdose/pdf/hhs_prescription_drug_abuse_report_09.2013.pdf. Published September 2013. Accessed December 3, 2015.


Free from friend or

relative, 53%

Bought/taken from friend or relative, 15%

Drug dealer or stranger, 4%

Internet, 0%

Other,† 4% 1 doctor, 21%

>1 doctor, 3%

~70% of nonmedical users of prescription opioids obtain them from friends or relatives*

*Nonmedical use is defined as “using without a prescription of the individual’s own or simply for the experience or feeling the drugs caused.” †Includes “wrote fake prescription,” “stole from doctor’s office/clinic/hospital/pharmacy,” and “some other way.” Adapted from: Center for Behavioral Health Statistics and Quality. Results From the 2013 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2014. http://archive.samhsa.gov/data/NSDUH/2013SummNatFindDetTables/DetTabs/NSDUH-DetTabsSect6peTabs1to54-2013.htm#tab6.47b. Accessed December 3, 2015. For your personal use. Not for further distribution

What Is Being Done to Reduce the Risk of Opioid Abuse?


Health care professionals

State government

Federal government Pharmaceutical industry

• Avoid overprescribing • Risk assessment for

patient opioid abuse • Patient

medication/drug monitoring

• Drug abuse treatment programs

• Opioid prescribing guidelines

• Prescription Drug Monitoring Programs

• Naloxone availability • Targeting “pill mills” • Opioid prescribing

rules

• White House Prescription Drug Abuse Prevention Plan

• FDA guidance on the development of abuse-deterrent opioids

• CDC draft guidelines for Opioids prescribing

• Development of abuse-deterrent opioids

• Nationwide education programs

Groups are taking specific actions against prescription opioid abuse

FDA, US Food and Drug Administration.


Law enforcement

Patients and advocacy groups

Educational institutions

Managed care

• Prevention of illegal drug distribution

• Appropriate disposal of opioids

• Abuse awareness • Appropriate use,

storage, and disposal of opioids

• Advocacy for patient access to medications

• Youth and teacher education, with a focus on prevention

• Monitoring for opioid misuse or abuse

• Patient access to abuse-deterrent opioids

Groups are taking specific actions against prescription opioid abuse (cont’d)


One approach health care providers can utilize to standardize their prescribing practice*

*Once other treatments have been tried and the decision has been made to initiate opioid therapy, a standardized set of steps should be applied to all patients. As of yet, there is no empirical evidence of the effectiveness of universal precautions in reducing the abuse of prescription opioids or the outcomes related to the misuse, abuse, or diversion of prescription opioids.

Dialogue

with patient

3 Assess

risk

1 Select agent

2 Monitor

treatment

4

Assess how likely the patient is to abuse opioid medication

Choose the right medication for the

patient. If opioids are appropriate, consider an abuse-deterrent

opioid

Before starting medication, let the patient know about benefits and risks

of medication through a patient written agreement

Continue to see the patient to assess

whether the medication works, that the side

effects are minimal, and whether the patient is

using the medication as prescribed


A Pharmaceutical Industry Approach: Abuse-Deterrent Opioids


Physical/chemical barrier*

Agonist/antagonist combination*

Abuse-deterrent opioids are designed to provide the same pain relief, while providing an obstacle against tampering

*Only 2 types of abuse-deterrent formulations are shown; others are described in the FDA guidance. US Department of Health and Human Services; US Food and Drug Administration; Center for Drug Evaluation and Research. Abuse-Deterrent Opioids—Evaluation and Labeling. Guidance for Industry. Silver Spring, MD: US Food and Drug Administration; 2015. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm334743.pdf. Accessed December 3, 2015.

“One potentially important step towards the goal of creating safer opioid analgesics has been the development of opioids that are formulated to deter abuse. FDA considers the development of these products a high public health priority.”

Abuse-deterrent opioids do not address all routes of abuse, but are an important approach

Some examples of Types of Abuse deterrent technology:


Several opioids with physical/chemical abuse-deterrent technology are currently on the market

Abuse-deterrent technology: physical/chemical approach

• Opioids with physical and/or chemical barriers have built-in properties that make the pills difficult to crush, chew, or dissolve

• This aims to deter abuse through intranasal and intravenous routes of administration

Images are from: Abuse-deterrent opioids advances in technology. Pain Medicine News. 2015. www.painmedicinenews.com/download/BB157_WM.pdf. Accessed December 3, 2015.

Crushed gelatin capsule Crush-resistant tablet


Abuse-deterrent technology: example of an agonist/antagonist approach

• The agonist/antagonist combination contains an isolated antagonist (eg, naltrexone) at the core

• When taken as directed, the antagonist is not released • Upon tampering (chewing, crushing), the antagonist is released

and causes a reduction in euphoric effects (eg, high) of the opioid (agonist)

At least one opioid with an agonist/antagonist abuse-deterrent design is on the market

Opioid

Antagonist core

Extended-release coating


• Prescription opioid abuse is a significant public health concern with serious health and economic consequences

• Reducing opioid abuse may involve multiple approaches

Summary

Reducing opioid abuse

Law enforcement efforts

Patient advocacy

State/federal efforts

Use of medications, including abuse-deterrent opioids

Prescriber education and treatment

guidelines

Drug treatment programs


prescription opioid abuse - pfizer medical information

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