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<strong>Tak<strong>in</strong>g</strong> <strong>Control</strong>: <strong>Emerg<strong>in</strong>g</strong><br />

<strong>Issues</strong> <strong>in</strong> Pa<strong>in</strong> Management<br />

and Implications of the<br />

New REMS on Long-Act<strong>in</strong>g<br />

Opioids – Part I<br />

Ebtesam Ahmed, PharmD<br />

Assistant Cl<strong>in</strong>ical Professor<br />

St. John’s University College of <strong>Pharmacy</strong> and Health Sciences<br />

Cl<strong>in</strong>ical Pharmacist Specialist<br />

Beth Israel Medical Center<br />

Department of Pa<strong>in</strong> Medic<strong>in</strong>e and Palliative Care<br />

New York, NY<br />

Faculty Information<br />

Presenter:<br />

Ebtesam Ahmed, PharmD<br />

Assistant Cl<strong>in</strong>ical Professor<br />

St. John’s University College of <strong>Pharmacy</strong> and Health Sciences<br />

Cl<strong>in</strong>ical Pharmacist Specialist<br />

Beth Israel Medical Center<br />

Department of Pa<strong>in</strong> Medic<strong>in</strong>e and Palliative Care<br />

New York, New York<br />

Moderator:<br />

Elena Beyzarov, PharmD<br />

Director of Scientific Affairs<br />

<strong>Pharmacy</strong> <strong>Times</strong> Office of CPE<br />

Pla<strong>in</strong>sboro, New Jersey<br />

This activity is supported by educational grants from Endo<br />

Pharmaceuticals and Purdue Pharma L.P.<br />

Disclosures<br />

Ebtesam Ahmed, PharmD, has Participated <strong>in</strong> a speakers bureau for<br />

Bristol-Myers Squibb<br />

<strong>Pharmacy</strong> <strong>Times</strong> Office of Cont<strong>in</strong>u<strong>in</strong>g Professional Education<br />

Plann<strong>in</strong>g Staff—Judy V. Lum, MPA, Elena Beyzarov, PharmD, David<br />

Heckard, and Donna W. Fausak—have no f<strong>in</strong>ancial relationships with<br />

commercial <strong>in</strong>terests to disclose.<br />

PTOCPE uses an anonymous peer reviewer as part of content validation<br />

and conflict resolution. The peer reviewer has no relevant f<strong>in</strong>ancial<br />

relationships with commercial <strong>in</strong>terests to disclose.<br />

The content of this web<strong>in</strong>ar may <strong>in</strong>clude <strong>in</strong>formation regard<strong>in</strong>g the use<br />

of products that may be <strong>in</strong>consistent with or outside the approved<br />

label<strong>in</strong>g for these products <strong>in</strong> the United States. Pharmacists should note<br />

that the use of these products outside current approved label<strong>in</strong>g is<br />

considered experimental and are advised to consult prescrib<strong>in</strong>g<br />

<strong>in</strong>formation for these products.<br />

Please send all questions or comments<br />

concern<strong>in</strong>g this web<strong>in</strong>ar to:<br />

CEINFO@pharmacytimes.com<br />

Or<br />

You can call 800-597-6372 and leave a<br />

message.<br />

All emails and messages will be answered<br />

with<strong>in</strong> 48-hours <strong>in</strong> the order that they are<br />

received.<br />

Objectives<br />

At the completion of the activity, participants should<br />

be able to:<br />

• Discuss the role of long-act<strong>in</strong>g opioids <strong>in</strong> the management<br />

of chronic pa<strong>in</strong><br />

• Exam<strong>in</strong>e monitor<strong>in</strong>g and assessment of treatment<br />

outcomes <strong>in</strong> relation to opioid therapy<br />

<strong>Tak<strong>in</strong>g</strong> <strong>Control</strong>: <strong>Emerg<strong>in</strong>g</strong><br />

<strong>Issues</strong> <strong>in</strong> Pa<strong>in</strong> Management<br />

and Implications of the<br />

New REMS on Long-Act<strong>in</strong>g<br />

Opioids – Part I<br />

Ebtesam Ahmed, PharmD<br />

Assistant Cl<strong>in</strong>ical Professor<br />

St. John’s University College of <strong>Pharmacy</strong> and Health Sciences<br />

Cl<strong>in</strong>ical Pharmacist Specialist<br />

Beth Israel Medical Center<br />

Department of Pa<strong>in</strong> Medic<strong>in</strong>e and Palliative Care<br />

New York, NY


The Problem Is Pa<strong>in</strong><br />

Ag<strong>in</strong>g population = <strong>in</strong>creased need for pa<strong>in</strong> relief<br />

Appropriate use of opioid therapy for pa<strong>in</strong><br />

management <strong>in</strong>creased <strong>in</strong> recent years<br />

90% of chronic pa<strong>in</strong> patients receive opioids<br />

Borowitz SM et al. Pediatrics. 2005;115:873-877; Tass<strong>in</strong>ari D et al. J Palliat Med. 2008;11:492-501;Benyam<strong>in</strong> R et<br />

al. Pa<strong>in</strong> Physician. 2008;11:S105-S120; Bell TJ et al. Pa<strong>in</strong> Med. 2009;10:35-42;<br />

Background and Significance<br />

• Prevalence of chronic pa<strong>in</strong> among general population<br />

believed to be high:<br />

• 56 million (~1 <strong>in</strong> 6) Americans suffer from chronic pa<strong>in</strong><br />

• Recent large survey 1<br />

• Exam<strong>in</strong>ed general populations (N=18,980) across several<br />

European countries<br />

• Prevalence of chronic, pa<strong>in</strong>ful physical conditions estimated at<br />

17.1%<br />

• World Health Organization study 2<br />

• Exam<strong>in</strong>ed 26,000 primary care patients across 15 countries<br />

• Prevalence of chronic pa<strong>in</strong> estimated at 22%<br />

• Prevalence of pa<strong>in</strong> <strong>in</strong> US sites (Seattle, Wash<strong>in</strong>gton)<br />

estimated at 17%<br />

1. Ohayon MM et al. Arch Gen Psychiatry. 2003 ;60(1):39-47. 2. Gureje O et al. JAMA. 1998;280(2):147-151.<br />

Undertreatment of Pa<strong>in</strong>:<br />

Impact<br />

• Economic impact<br />

• $61.2 billion/year <strong>in</strong> lost productivity 1<br />

• Quality of life<br />

• Persistent pa<strong>in</strong> reduces quality of life 2<br />

• Pa<strong>in</strong> associated with psychological disorders<br />

(eg, depression, anxiety) 3,4<br />

• Health outcomes<br />

• Pa<strong>in</strong> is predictor of poor health and depression 5<br />

• Families with 1 migra<strong>in</strong>eur experience 6<br />

• 70% higher total unadjusted medical costs<br />

• 80% higher outpatient costs<br />

Prevalence of Pa<strong>in</strong> Associated With<br />

Medical Conditions<br />

HRS (1996) 1<br />

Age 54-64 y<br />

N=6837<br />

AHEAD (1993) 2<br />

Age 70 y<br />

N=5807<br />

Overall prevalence (%) 27 33<br />

Condition (%)<br />

Lung disease<br />

Stroke<br />

Heart disease<br />

Arthritis<br />

Diabetes<br />

Cancer<br />

Hypertension<br />

50<br />

44<br />

41<br />

40<br />

39<br />

35<br />

33<br />

44<br />

41<br />

41<br />

60<br />

39<br />

34<br />

37<br />

1. Stewart WF et al. JAMA. 2003;290:2443-2454. 2. Skev<strong>in</strong>gton SM. Pa<strong>in</strong>. 1998;76:395-406. 3. Elliott TE et al. Pa<strong>in</strong> Med.<br />

2003;4:331-339. 4. McWilliams LA et al. Pa<strong>in</strong>. 2004;111:77-83. 5. Reyes-Gibby CC et al. Pa<strong>in</strong>. 2002;95:75-82. 6. Stang PE<br />

et al. Am J Manag Care. 2004;10:313-320.<br />

HRS = Health and Retirement Study; AHEAD = Asset and Health Dynamics Study Among the Oldest Old.<br />

1. Data from HRS. Analyses courtesy of C. Reyes-Gibby, MD, Houston, Texas, 2005. 2. Reyes-Gibby CC et al. Pa<strong>in</strong>. 2002;95:75-82.<br />

APS Survey:<br />

Reason for Chang<strong>in</strong>g Providers<br />

Disparities <strong>in</strong> Pa<strong>in</strong> Management<br />

Age<br />

Ethnicity<br />

Older nurs<strong>in</strong>g home patients received appropriate pa<strong>in</strong><br />

assessment 3.9% of time 1<br />

26% of older patients with daily pa<strong>in</strong> did not receive any<br />

analgesic agents 2<br />

Emergency department study<br />

• Black patients: 57% received analgesics 3<br />

• White patients: 74% received analgesics 3<br />

• Hispanic patients: half as likely as non-Hispanic white patients<br />

to receive analgesics 4<br />

APS = American Pa<strong>in</strong> Society.<br />

Persistent<br />

pa<strong>in</strong><br />

Cl<strong>in</strong>ician not<br />

knowledgeable<br />

APS. Chronic pa<strong>in</strong> <strong>in</strong> America: roadblocks to relief. Available at:<br />

http://www.ampa<strong>in</strong>soc.org/whatsnew/summary2_road.htm. Accessed Jan 15, 2011.<br />

Did not take<br />

patient’s pa<strong>in</strong><br />

seriously<br />

Unwill<strong>in</strong>g<br />

to treat<br />

aggressively<br />

Gender Women received less medication for cancer pa<strong>in</strong> than men 5<br />

Women received more sedatives than men (men received<br />

analgesics <strong>in</strong>stead) 6<br />

1. Baier RR et al. J Am Geriatr Soc. 2004;52:1988-1995. 2. Bernabei R et al. JAMA. 1998;279:1877-1882. 3. Todd KH et al.<br />

Ann Emerg Med. 2000;35:11-16. 4. Todd KH et al. JAMA. 1993;269:1537-1539. 5. Cleeland CS et al. N Engl J Med.<br />

1994;330:592-596. 6. Unruh AM. Pa<strong>in</strong>. 1996;65:123-167.


Barriers to Pa<strong>in</strong> Management<br />

• Hear<strong>in</strong>g patients, but not<br />

listen<strong>in</strong>g<br />

• Low priority given to pa<strong>in</strong><br />

treatment<br />

• Lack of consistent<br />

documentation<br />

• Abuse concerns by<br />

cl<strong>in</strong>icians, patients, family<br />

• Enforcement: laws and<br />

regulation constra<strong>in</strong>ts<br />

• Judgment issues<br />

• Mean<strong>in</strong>g of pa<strong>in</strong> to patient<br />

• Need to follow up<br />

• F<strong>in</strong>ancial implications<br />

• Fear of not be<strong>in</strong>g viewed as<br />

“good” patient<br />

• Hesitation to seek medical<br />

attention<br />

• Dangers: adverse effects,<br />

management, awareness<br />

Differences Between Acute<br />

and Chronic Pa<strong>in</strong><br />

Acute (Nociceptive) Pa<strong>in</strong><br />

Has biologic function 1<br />

Chronic Pa<strong>in</strong><br />

No biologic value 1-3<br />

Acts as warn<strong>in</strong>g system Detrimental effects 1-3<br />

<strong>in</strong>dicat<strong>in</strong>g tissue <strong>in</strong>jury 1 Persists beyond usual course<br />

Recent onset 2<br />

of acute illness or <strong>in</strong>jury<br />

F<strong>in</strong>ite duration (days<br />

(months to years) 1-3<br />

to weeks) 2<br />

Chronic pathologic process;<br />

Remits when underly<strong>in</strong>g<br />

may recur at <strong>in</strong>tervals 1-3<br />

pathology resolves 1<br />

1. Brookoff D. Hosp Pract. 2000;35:45-52,59. 2. Portenoy RK, Kanner RM, eds. Pa<strong>in</strong> Management: Theory and Practice.<br />

Philadelphia, PA: FA Davis Co; 1996:248-276. 3. Turk DC, Melzack R, eds. Handbook of Pa<strong>in</strong> Assessment. 2nd ed. New<br />

York, The Guilford Press; 2001:3-11.<br />

Pa<strong>in</strong> classification<br />

Diagnostic classification<br />

A. Nociceptive pa<strong>in</strong><br />

I. Somatic: well localized; e.g. sk<strong>in</strong>, bones<br />

II. Visceral: poorly localized; e.g. organs<br />

B. Neuropathic pa<strong>in</strong><br />

I. Central: Localized and diffused; burn<strong>in</strong>g, stabb<strong>in</strong>g pa<strong>in</strong><br />

e.g. CNS<br />

II. Peripheral: localized neuropathies<br />

Pa<strong>in</strong> Management Guidel<strong>in</strong>es<br />

World Health<br />

Organization’s<br />

Pa<strong>in</strong> Relief<br />

Ladder<br />

C. Idiopathic pa<strong>in</strong><br />

usually <strong>in</strong> head, shoulders, or pelvic areas<br />

Cancer Pa<strong>in</strong> Relief and Palliative Care. Geneva, Switzerland; World Health Organization; 1990.<br />

Therapeutic Strategies<br />

<strong>in</strong> Pa<strong>in</strong> Management<br />

Equianalgesic Dose Table<br />

• Lifestyle changes<br />

• Rehabilitative<br />

• Psychological<br />

• Complementary and <strong>in</strong>tegrative medic<strong>in</strong>e<br />

• Educational<br />

• Pharmacotherapy<br />

• Injection, surgical, neuromodulation<br />

• Googl<strong>in</strong>g “Equianalgesic Dose Table”<br />

yields 27,400 citations<br />

• Many different versions<br />

• Based on short-term trials of acute post-op<br />

pa<strong>in</strong> or low doses <strong>in</strong> cancer patients<br />

• Patient-specific variables<br />

• Unidirectional vs bidirectional<br />

equivalencies<br />

F<strong>in</strong>e PG, Portenoy RK. A Cl<strong>in</strong>ical Guide to Opioid Analgesia.<br />

M<strong>in</strong>neapolis, MN: McGraw-Hill; 2004.


Equianalgesic Dose Table:<br />

Conclusions<br />

• Equianalgesic dose table is only start<strong>in</strong>g po<strong>in</strong>t for<br />

creation of guidel<strong>in</strong>es for opioid rotation<br />

• Selection of start<strong>in</strong>g dose of new drug based on<br />

table must be followed by dose reduction because<br />

of :<br />

- Concern about generalizability of relative potency<br />

estimate <strong>in</strong> heterogeneous population<br />

- Concern about <strong>in</strong>complete cross-tolerance<br />

• Un<strong>in</strong>formed use of table is dangerous<br />

Opioid Classification<br />

Category Benefits Drugs*<br />

Short-act<strong>in</strong>g:<br />

for <strong>in</strong>termittent<br />

and<br />

breakthrough<br />

pa<strong>in</strong> 1<br />

Easier to titrate<br />

More rapidly atta<strong>in</strong>ed<br />

steady-state plasma<br />

concentrations 2<br />

Morph<strong>in</strong>e sulfate<br />

Code<strong>in</strong>e<br />

Hydrocodone<br />

Oxycodone<br />

Hydromorphone<br />

Fentanyl<br />

Oxymorphone<br />

Levorphanol<br />

Extended-Release Opioids May Be Better<br />

Suited for Treatment of Chronic Pa<strong>in</strong><br />

• Extended-release opioids may have greater utility than<br />

immediate-release opioids <strong>in</strong> treat<strong>in</strong>g chronic pa<strong>in</strong> patients<br />

• Fewer peaks = less risk for overmedication, side effects,<br />

euphoria<br />

• Fewer troughs = less end-of-dose breakthrough pa<strong>in</strong><br />

Long-act<strong>in</strong>g:<br />

For treat<strong>in</strong>g<br />

chronic pa<strong>in</strong> <strong>in</strong><br />

patients with<br />

consistent pa<strong>in</strong><br />

levels 3,4<br />

Makes around-theclock<br />

therapy<br />

possible<br />

Dos<strong>in</strong>g convenience<br />

and flexibility<br />

Relative steady-state<br />

concentrations of<br />

opioid concentrations<br />

<strong>in</strong> the blood 3,4<br />

Morph<strong>in</strong>e<br />

(susta<strong>in</strong>ed-release)<br />

Oxycodone<br />

(susta<strong>in</strong>ed-release)<br />

Transdermal fentanyl<br />

Hydromorphone<br />

(susta<strong>in</strong>ed-release)<br />

Methadone<br />

Oxymorphone<br />

Levorphanol<br />

1.NPC/JCAHO. Pa<strong>in</strong>: Current Understand<strong>in</strong>g of Assessment, Management, and Treatments. December 2001. 2. Cherny NI. CA—<br />

Serum<br />

Level<br />

Dose<br />

Immediate-release<br />

Toxic<br />

Pa<strong>in</strong><br />

Relief<br />

No<br />

Relief<br />

Dose<br />

Time End-of-dose<br />

BTP<br />

Serum<br />

Level<br />

Dose<br />

Extended-release<br />

Time<br />

Toxic<br />

Pa<strong>in</strong><br />

Relief<br />

No<br />

Relief<br />

Cancer J Cl<strong>in</strong>. 2000;50:70-116. 3. McCarberg BH, Bark<strong>in</strong> RL. Am J Ther. 2001;8:181-186. 4. AGS Panel on Chronic Pa<strong>in</strong> <strong>in</strong> Older<br />

McCarberg BH, et al. Am J Ther. 2001;8:181-186.<br />

Persons. J Am Geriatr Soc. 1998;46:635-651.<br />

Short-Act<strong>in</strong>g vs. Long-Act<strong>in</strong>g<br />

Opioids<br />

Conventional Practice:<br />

Opioid Treatment<br />

Advantages<br />

Disadvantages<br />

Short-Act<strong>in</strong>g<br />

Opioids<br />

Fast-act<strong>in</strong>g;<br />

appropriate for<br />

acute pa<strong>in</strong>,<br />

breakthrough pa<strong>in</strong><br />

Need for repetitive<br />

dos<strong>in</strong>g<br />

Long-Act<strong>in</strong>g Opioids<br />

May be more<br />

appropriate for<br />

patients with a<br />

constant pa<strong>in</strong><br />

component;<br />

analgesic stability<br />

Initial delayed onset<br />

of action<br />

• Role of opioid therapy <strong>in</strong> chronic pa<strong>in</strong> controversial<br />

• Trial of opioid therapy may be considered <strong>in</strong> all cases of<br />

moderate-to-severe pa<strong>in</strong> but decision to proceed<br />

requires case-by-case analysis:<br />

• Conventional practice<br />

• Availability of other therapies with equal or better<br />

therapeutic <strong>in</strong>dex<br />

• Risk of adverse drug effects<br />

• Assessed risk of drug abuse, addiction, diversion<br />

F<strong>in</strong>e P, Portenoy RK. Opioid Analgesia. New York: McGraw Hill; 2004.


Conventional Practice:<br />

Opioid Treatment (cont.)<br />

• Opioid therapy potentially analgesic <strong>in</strong> all types of<br />

acute and chronic pa<strong>in</strong>:<br />

• Consensus: Opioid therapy used first-l<strong>in</strong>e for severe<br />

acute pa<strong>in</strong><br />

• Consensus: Opioid therapy used first-l<strong>in</strong>e for moderateto-severe<br />

chronic pa<strong>in</strong> related to:<br />

o<br />

o<br />

o<br />

Cancer<br />

HIV/AIDS<br />

Advanced medical illness of any type<br />

Opioids for Chronic Pa<strong>in</strong>:<br />

Status of Data<br />

• Opioids for noncancer pa<strong>in</strong>:<br />

• Systematic review of open-label prospective studies<br />

through April 2007<br />

• 17 studies (N=3079) of oral, transdermal, or neuraxial<br />

opioid for any type of pa<strong>in</strong><br />

• Study duration at least 6 months<br />

• Results:<br />

• Many patients discont<strong>in</strong>ued treatment due to side effects<br />

or poor response (oral, 32.5%; transdermal, 17.5%;<br />

neuraxial, 6.3%)<br />

• Signs of addiction <strong>in</strong> 0.05% of patients<br />

• Signs of abuse <strong>in</strong> 0.43% of patients<br />

F<strong>in</strong>e P, Portenoy RK. Opioid Analgesia. New York: McGraw Hill; 2004.<br />

Noble M et al. J Pa<strong>in</strong> Symptom Manage. 2008;35:214-228 .<br />

• Results:<br />

Opioids for Chronic Pa<strong>in</strong>:<br />

Status of Data (cont.)<br />

• Small but significant pa<strong>in</strong> reduction for oral therapy (mean,<br />

1.99 po<strong>in</strong>ts) and neuraxial therapy (mean, 1.33 po<strong>in</strong>ts)<br />

• Insufficient data on transdermal therapy<br />

• Conclusion:<br />

• Many patients discont<strong>in</strong>ue therapy<br />

• Among patients who cont<strong>in</strong>ue therapy, weak evidence on<br />

pa<strong>in</strong> relief over time<br />

• Insufficient data regard<strong>in</strong>g other long-term outcomes,<br />

<strong>in</strong>clud<strong>in</strong>g function and drug abuse<br />

Opioid Treatment of Chronic Pa<strong>in</strong><br />

Patient<br />

Assessment<br />

Trial of Opioid<br />

Therapy<br />

Patient<br />

Reassessment<br />

Other Therapies<br />

for Pa<strong>in</strong><br />

Cont<strong>in</strong>ue Opioid<br />

Therapy<br />

Exit Strategy<br />

Noble M et al. J Pa<strong>in</strong> Symptom Manage. 2008;35:214-228.<br />

Prescription Abuse Across<br />

the Lifespan<br />

Prevalence of Substance Use<br />

Disorders – US General Population<br />

• 8.7% of general population ≥ age 12 classified with<br />

substance dependence or abuse<br />

• Alcohol: 15 million<br />

• Illicit drugs: 4.2 million<br />

• 20.5 million needed treatment but did not receive it<br />

• Number of people receiv<strong>in</strong>g treatment for<br />

nonmedical pa<strong>in</strong> reliever use more than doubled<br />

from 2002-2010<br />

Substance Abuse and Mental Health Services Adm<strong>in</strong>istration, Results from the 2010 National Survey on Drug Use and Health: Summary of National<br />

F<strong>in</strong>d<strong>in</strong>gs, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Adm<strong>in</strong>istration; 2011.


The Opioid Pendulum<br />

Opioid Abuse and Addiction<br />

Opiophobia<br />

Balance of Addiction<br />

Medic<strong>in</strong>e and Pa<strong>in</strong><br />

Management<br />

Pr<strong>in</strong>ciples 1<br />

Opiophillia<br />

• In past, estimated ˂1% of <strong>in</strong>dividuals treated for<br />

pa<strong>in</strong> became addicted to opioids<br />

• Now estimated 6%-15% of Americans addicted to<br />

drugs<br />

• 2010: estimated 22.1 million Americans, or 8.7% of<br />

the population of persons ≥ age 12 have substance<br />

dependence and abuse<br />

1 Gourlay, D.L. et al. (2005). Universal precautions <strong>in</strong> pa<strong>in</strong> medic<strong>in</strong>e: A rational approach to the treatment of<br />

chronic pa<strong>in</strong>. Pa<strong>in</strong> Medic<strong>in</strong>e, 6(2), 107-112.<br />

Marks RM, et al. Ann Intern Med. 1973;78:173-181.<br />

Commonly Used Terms<br />

What are the differences<br />

• Physical dependence: Withdrawal syndrome would occur if<br />

medication discont<strong>in</strong>ued abruptly, dose reduced rapidly, or<br />

antagonist adm<strong>in</strong>istered 1,2<br />

• Tolerance: Greater amount of medication needed to ma<strong>in</strong>ta<strong>in</strong><br />

therapeutic effect, or loss of effect over time 2<br />

• Pseudoaddiction: Behavior suggestive of addiction caused by<br />

undertreatment of pa<strong>in</strong> 2 ; can be major barrier to appropriate<br />

treatment of patients <strong>in</strong> pa<strong>in</strong><br />

• Addiction (psychological dependence): Biopsychosocial<br />

disorder characterized by cont<strong>in</strong>ued compulsive use of substance<br />

despite harm 2,3<br />

Who is abus<strong>in</strong>g prescription opioids<br />

We don’t know specific subpopulations who are<br />

abus<strong>in</strong>g…do they <strong>in</strong>clude<br />

• Persons who abuse or are dependent on only prescription<br />

opioids<br />

• Hero<strong>in</strong> abusers who use prescription opioids when hero<strong>in</strong><br />

unavailable<br />

• Abusers of other drugs who abuse opioids either alone (for<br />

alternative high) or <strong>in</strong> comb<strong>in</strong>ation with other drugs (poly-drug<br />

abuse)<br />

• Pa<strong>in</strong> patients who, dur<strong>in</strong>g course of legitimate treatment,<br />

develop iatrogenic addiction<br />

• Number thought to be low, but def<strong>in</strong>itive studies unavailable<br />

1. APS. Guidel<strong>in</strong>e for the Management of Cancer Pa<strong>in</strong> <strong>in</strong> Adults and Children. Glenview, Ill: American Pa<strong>in</strong> Society; 2005.<br />

2. Savage SR et al. APS Consensus Statement. Glenview, Ill: American Pa<strong>in</strong> Society; 2001. 3. Fishba<strong>in</strong> DA et al. Cl<strong>in</strong> J Pa<strong>in</strong>. 1992;8:77-85.<br />

Aberrant Drug-Related<br />

Behaviors<br />

Probably more predictive<br />

• Sell<strong>in</strong>g prescription drugs<br />

• Prescription forgery<br />

• Steal<strong>in</strong>g or borrow<strong>in</strong>g another patient’s drugs<br />

• Inject<strong>in</strong>g oral formulation<br />

• Obta<strong>in</strong><strong>in</strong>g prescription drugs from non-medical sources<br />

• Concurrent abuse of related illicit drugs<br />

• Multiple unsanctioned dose escalations<br />

• Recurrent prescription losses<br />

Aberrant Drug-Related<br />

Behaviors (cont.)<br />

Probably less predictive<br />

• Aggressive compla<strong>in</strong><strong>in</strong>g about need for higher doses<br />

• Drug hoard<strong>in</strong>g dur<strong>in</strong>g periods of reduced symptoms<br />

• Request<strong>in</strong>g specific drugs<br />

• Acquisition of similar drugs from other medical sources<br />

• Unsanctioned dose escalation 1-2 times<br />

• Unapproved use of drug to treat another symptom<br />

• Report<strong>in</strong>g psychic effects not <strong>in</strong>tended by cl<strong>in</strong>ician<br />

Passik and Portenoy, 1998.<br />

Passik and Portenoy, 1998.


Addiction or Chronic Pa<strong>in</strong><br />

Source of Divert<strong>in</strong>g Drugs<br />

Addiction<br />

• Medication use<br />

• Out of control<br />

• Impairs quality of life<br />

• Cont<strong>in</strong>ues despite adverse effects<br />

• Unaware/<strong>in</strong> denial of any problems<br />

• Doesn’t follow agreement<br />

• Doesn’t have leftover med<br />

• Loses prescriptions<br />

• Always has a story<br />

Chronic Pa<strong>in</strong><br />

• Medication use<br />

• Not out of control<br />

• Improves quality of life<br />

• Desire to decrease meds with<br />

adverse effects<br />

• Concerned about physical<br />

problem<br />

• Follows agreements<br />

• Frequently has leftover meds<br />

• Forged and Altered Prescriptions<br />

• “Doctor Shoppers”<br />

• Prescribers/ Dispensers of Rx Drugs<br />

• Theft (Health Facility and Other)<br />

• Package Theft/ Diversion (UPS/DHL/FedEx)<br />

• Internet<br />

• <strong>Pharmacy</strong> Robbery & Burglary<br />

• International Smuggl<strong>in</strong>g<br />

Fishman S. Responsible Opioid Prescrib<strong>in</strong>g. 2nd ed. Wash<strong>in</strong>gton DC, Waterford Life Science, 2012:30.<br />

Top RX Drug Abuse<br />

• Hydrocodone (Lortab, Vicod<strong>in</strong>, Lorcet) $6-$8<br />

• Vicod<strong>in</strong>: #1 prescribed drug (2006-2010)<br />

• Oxycodone (Percocet, Percodan) $6-$8<br />

• Oxycodone IR- $1 mg<br />

• Oxymorphone (Opana/Opana ER) $10- $40<br />

• Methylphenidate (Rital<strong>in</strong>) $10- $12<br />

• Hydromorphone (Dilaudid) 4 mg - $60<br />

• Alprazolam (Xanax) $3<br />

• Fentanyl (Duragesic/ Actiq) $8- $40<br />

• Methadone ($10- $40 per dose)<br />

The Growth of<br />

Prescription Monitor<strong>in</strong>g Programs<br />

2003<br />

• 14 states had<br />

monitor<strong>in</strong>g programs<br />

• 36 states had no<br />

prescription monitor<strong>in</strong>g<br />

programs<br />

Data collected from http://www.pmpalliance.org/content/data<br />

2012<br />

• 41 states had<br />

prescription drug<br />

monitor<strong>in</strong>g programs<br />

• 9 states had no<br />

monitor<strong>in</strong>g program<br />

Management of Risk:<br />

A “Package Deal”<br />

Screen<strong>in</strong>g for<br />

Substance-Abuse Potential<br />

• Screen<strong>in</strong>g & risk stratification<br />

• Compliance monitor<strong>in</strong>g:<br />

• Ur<strong>in</strong>e screen<strong>in</strong>g<br />

• Pill/patch counts<br />

• Education on drug storage & shar<strong>in</strong>g<br />

• Psychotherapy<br />

• Highly “structured” approaches<br />

• Abuse-deterrent formulations<br />

Predictive of Aberrant Behavior<br />

Alcohol consumption<br />

Drug use<br />

Smok<strong>in</strong>g<br />

Age<br />

Use Caution With:<br />

Men who dr<strong>in</strong>k >4 alcoholic beverages<br />

per day or >16 per week<br />

Women who dr<strong>in</strong>k >3 alcoholic<br />

beverages per day or >12 per week<br />

Persons who admit to recreational<br />

use of marijuana or hashish <strong>in</strong> previous<br />

year<br />

Persons who are


Assessment of Addiction Risk<br />

• Screen<strong>in</strong>g measures for addiction risk:<br />

• STAR/SISAP<br />

• CAGE AIDD<br />

• Opioid Risk Tool (<strong>Emerg<strong>in</strong>g</strong> Solutions <strong>in</strong> Pa<strong>in</strong>)<br />

• SOAPP (see pa<strong>in</strong>edu.org)<br />

• Psychiatric assessment of risk:<br />

• Chemical<br />

• Psychiatric<br />

• Social/Familial<br />

• Genetic<br />

• Spiritual<br />

Position<strong>in</strong>g Opioid Therapy<br />

Opioid Risk Tool<br />

Mark each box that applies. Female Male<br />

1. Family history of substance abuse<br />

– Alcohol<br />

– Illegal drugs<br />

– Prescrib<strong>in</strong>g drugs<br />

2. Personal history of substance abuse<br />

– Alcohol<br />

– Illegal drugs<br />

– Prescrib<strong>in</strong>g drugs<br />

1<br />

2<br />

4<br />

3<br />

4<br />

5<br />

3<br />

3<br />

4<br />

3<br />

4<br />

5<br />

3. Age (mark box if 16-45 years) 1 1<br />

4. History of preadolescent sexual abuse 3 0<br />

5. Psychological disease<br />

– Attention deficit disorder, obsessive compulsive<br />

disorder, bipolar, schizophrenia<br />

– Depression<br />

Scor<strong>in</strong>g: 0-3: low risk; 4-7: moderate risk; ≥8: high risk<br />

2<br />

1<br />

2<br />

1<br />

Webster LR, Webster RM. Pa<strong>in</strong> Med. 2005;6:432-442.<br />

♦No past/current<br />

history of<br />

substance abuse<br />

♦Noncontributory<br />

family history of<br />

substance abuse<br />

♦No major or untreated<br />

psychological<br />

disorder<br />

Stratify Risk<br />

Low Risk Moderate Risk High Risk<br />

♦Significant family<br />

history of<br />

substance abuse<br />

♦Past/co-morbid<br />

psychological<br />

disorder<br />

♦History of treated<br />

substance abuse<br />

♦Active substance<br />

abuse<br />

♦Active addiction<br />

♦Major untreated<br />

psychological<br />

disorder<br />

♦Significant risk<br />

to self and<br />

practitioner<br />

Current Opioid Misuse Measure<br />

(COMM)<br />

• 17-item patient self-assessment : for those<br />

currently on long-term opioid therapy<br />

• S/S <strong>in</strong>toxication, emotional volatility, poor<br />

response to medications, addiction, healthcare<br />

use patterns, problematic medication behavior<br />

• NOT used prior to therapy<br />

Gourlay DL, et al. Pa<strong>in</strong> Med. 2005;6:107-112.<br />

Meltzer et al. Pa<strong>in</strong>. 2011;152:397-402.<br />

Risk Factors for Aberrant<br />

Behaviors/Harm<br />

Restructur<strong>in</strong>g Therapy<br />

to Reduce Risk<br />

Biological<br />

• Age ≤ 45 years<br />

• Gender<br />

• Family history of<br />

prescription drug<br />

or alcohol abuse<br />

• Cigarette smok<strong>in</strong>g<br />

Psychiatric<br />

• Preadolescent sexual<br />

abuse (<strong>in</strong> women)<br />

• Major psychiatric<br />

disorder (eg, personality<br />

disorder, anxiety or<br />

depressive disorder,<br />

bipolar disorder)<br />

• Substance use disorder<br />

Social<br />

• Prior legal problems<br />

• History of motor<br />

vehicle accidents<br />

• Poor family support<br />

• Involvement <strong>in</strong> a<br />

problematic<br />

subculture<br />

• Consider discont<strong>in</strong>uation of opioid<br />

• Cont<strong>in</strong>ue opioid but consider reactive strategies to<br />

improve control over drug use:<br />

• Written agreement (“contract”)<br />

• Frequent visits, small quantities<br />

• Long-act<strong>in</strong>g drugs with no rescue doses<br />

• One pharmacy, pill counts, no replacements<br />

or early scripts<br />

• Ur<strong>in</strong>e drug screens<br />

• Required referrals<br />

Katz NP, et al. Cl<strong>in</strong> J Pa<strong>in</strong>. 2007;23:103-118; Manchikanti L, et al. J Opioid Manage. 2007;3:89-100. Webster LR,<br />

Webster RM. Pa<strong>in</strong> Med. 2005;6:432-442.


Opioid Therapy: Exit Strategy<br />

Risks vs Benefits of Opioids<br />

• When is it appropriate to give up on opioid therapy<br />

• No conv<strong>in</strong>c<strong>in</strong>g benefit despite attempts at optimal therapy<br />

• Occurrence of comorbidity (eg, substance abuse) that<br />

substantially <strong>in</strong>creases burden or risk<br />

• Persistent adherence problems<br />

• High <strong>in</strong>dex of suspicion for diversion<br />

• Cl<strong>in</strong>ical Benefits<br />

• Demonstrated efficacy <strong>in</strong><br />

numerous randomized<br />

cl<strong>in</strong>ical trials and chronic<br />

pa<strong>in</strong> conditions<br />

• Low risk for end-organ<br />

damage<br />

• Risks<br />

• Side effects (eg,<br />

constipation, nausea,<br />

sedation)<br />

• Addiction<br />

• Abuse potential, physical<br />

dependence, tolerance<br />

Must evaluate risks vs benefits <strong>in</strong> each patient be<strong>in</strong>g<br />

considered for long-term treatment<br />

Portenoy RK. Opioid analgesics. In: Portenoy RK, Kanner RM, eds. Pa<strong>in</strong> Management: Theory and Practice.<br />

Philadelphia, PA: FA Davis Co; 1996:248-276..<br />

Long-Term Opioid Therapy:<br />

Key Po<strong>in</strong>ts<br />

Questions<br />

• Always monitor multiple outcomes:<br />

• Analgesia<br />

• Adverse effects<br />

• Activities, other functional outcomes, quality of life<br />

• Aberrant drug-related behavior<br />

• “Document for an audit”<br />

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