Taking Control: Emerging Issues in Pain ... - Pharmacy Times
Taking Control: Emerging Issues in Pain ... - Pharmacy Times
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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 />
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Please send all questions or comments<br />
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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 />
Thank You!