controlled substance management or doctor i need oxy tony tommasello, ph.d. university of maryland...
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Controlled Substance Management or
“Doctor I need Oxy”Tony Tommasello, Ph.D.
University of Maryland School of Pharmacy
Office of Substance Abuse Studies
410 706-7513
Program Objectives
At the end of this program participants will be better able to:Screen for substance abuseAssess the severity of a patient’s involvement with
alcohol or illicit drugsDetermine the legitimacy of a patient’s request for
opioid analgesicsJustify and document the decision to prescribe or
refuse to prescribe CDS
Lawnmower AddictL.A. is a 42 Y.O. male who broke his ankle while mowing wet grass across an incline. After several surgical attempts including failed pinning operations, his foot is rotated 60 degrees out of alignment and he has chronic pain. Prior to this injury L.A. had a history of opioid addiction. He states that he is committed to recovery and participates in 12-step N.A. meetings but he abused his last oxycodone prescription and experienced a relapse. His goal is to achieve pain relief without relapse to opioid abuse.
Enduring pain to avoid relapseE.P. is a 40 y.o. married male with 4 children, He has been in opioid addiction recovery for over 9 years. I received a tearful midnight call from his wife stating the E.P. was lying in bed in a fetal position, moaning in pain and refusing to take opioid analgesics after incurring a back injury while wrestling with his son who is a star member of the high school wrestling team. His goal is to never relapse to active opioid addiction.
Scope of the Public Health Problem
An estimated 2.4 million people have used heroin at some time in their lives(NHSDA, 1998)
During 1996 through 1998, an estimated 471,000 persons used heroin for the first time. Of them, 25% were under age 18 and another 47% were age 18 - 25 (NHSDA, 1999)
Heroin Price Falls, Purity Increases1980 through 1998
0
5
10
15
20
25
30
35
40
45
1980 1981 1982 1983 1984 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998
$4
$3
$2
$1
$0
Pri
ce in
$U
S
Pu r
i ty (
% h
e ro i
n) Purity (% heroin)
Price in $US
Data from U.S. Department of Justice: Drug Enforcement Administration
What about abuse?
According to the National Institute on Drug Abuse (NIDA), in 1999 Four million Americans reported current use of prescription drugs for non-medical purposes
The most dramatic increases were found among the 12 to 25 year olds
Oxycontin® and Ritalin® were among the most cited abused medications
Oxycontin 80mg sustained release tablet
Source: www.samhsa.gov/oas/2k3/pain/dawnpain.pdf
Number of U.S. Narcotic Analgesic-Related ED Visits, 1994-2001
Narcotic Abuse Taxes ED Resources In 2001 there were an estimated 90,232 ED
visits, a 117% increase since 1994 “Dependence” was the most frequently
mentioned motive for abuse (44% of cases) Between 2000 and 2001 Oxycodone mentions
increased 70% and accounted for 53.7% of the overall increase in narcotic abuse cases during that year.
Source: The DAWN report January 2003. http://www.samhsa.gov/oas/2k3/pain/DAWNpain.pdf
Teen Abuse of Rx DrugsNational figures
37
20 19
4
0
5
10
15
20
25
30
35
40
marijuana pain meds inhalants heroin
% of teens who haveever used drugs toget high
Curran JJ: Prescription for Disaster – The growing problem of prescription drug abuse in Maryland. Sept 2005.
Access to treatment is limited
Of the estimated 810,000 opioid dependent persons in the U.S. only 170,000 maintenance treatment slots exist.
0100000200000300000400000500000600000700000800000900000
Capacity
Need
Numberofpersons
The Journey Matters
Therapeutic drug use:
Drug use to treat or diagnose illness. Almost everyone has taken a drug at one time or another because they were sick.
A direct and reliable drug effect is expected. Antibiotics kill bacteria regardless of the sick person’s belief in the medicine. The drug is a known entity.
There are rules. The prescription tells: what to take, how much to take, and when to take it. A person who violates the rules must own the consequences.
Social Drug Use
Drugs are used to increase social interactions.
Rules are vague or non-existent. Drug supply is uncertain Most cases of addiction result from social
drug use that gets out of control.
A Basic Distinction
High seeking = Pain relief seeking “Because 6 to 15% of the U.S. population
abuses drugs, the history of pain management is marked by the undertreatment [of pain in] the other 85 to 94%.”
Passik SD quoted in: Gilson AM and Joranson DE (2002) U.S. Policies Relevant to the Prescribing of Opioid Analgesics for the Treatment of Pain in Patients with Addiction Disease Clinical Journal of Pain 18:S91-S98. available at http://www.medsch.wisc.edu/painpolicy/
Pain Statistics
Most common reason that people seek medical care 50 million Americans are partially or totally disabled
due to pain Annual cost to U.S. society estimated to exceed $100
billion 50-80% of patients with pain report that their pain
is inadequately managed Risk of undertreatment is increased among those
with a history of substance abuse
Addiction Defined
Addiction is compulsive use with loss of control and continued use despite adverse consequences.
Elements of Compulsivity:
Constant thought of drug acquisition Anticipation of opportunities to use Defer other priorities of life Unable to resist desire to use
Aspects of Loss of Control
Inability to use in moderation consistently
Easier to abstain completely Frequent episodes of excessive use
Continued use despite problems
Loss associated with use Multiple crisis not seen as drug-related Sincere promises to self and others to quit
Signs of Psychological Dependence
Carrying Drugs Using Drugs alone Stockpiling Drugs Concern over supply Changing friends Finding excuses to use Using at inappropriate times Willingness to take increasing risks
The Memory of DrugsThe Memory of Drugs
Nature VideoNature Video Cocaine VideoCocaine Video
Front of BrainFront of Brain
Back of BrainBack of Brain
AmygdalaAmygdalanot lit upnot lit up
AmygdalaAmygdalaactivatedactivated
DSM IV: Substance Dependence
3 of following in 12 month period:ToleranceWithdrawalDifficulty cutting down (loss of control)Time spent drug seeking (compulsive use)Decrease in activitiesContinued use despite knowledge of persistent physical or psychological
problems
Addiction Characteristics
First priority is drug acquisition and use Negative consequences occur in order
1) Interpersonal relationships suffer2) Productivity declines3) Self-Esteem plummets4) Health problems emerge or worsenNote: Legal problems can occur at any time.
Why Treatment ?
Dysfunctional lifestyle of opioid addiction makes treatment a desired alternative
Oral methadone and buprenorphine sublingual tablets are approved for both medical withdrawal and medical maintenance
Rewards
Negative consequences
Utility Theory
Addictive Behaviors
Selling prescription drugs Prescription forgery Stealing drug from others Injecting oral formulations Buying drugs on the street Resistance to change therapy despite
evidence of adverse effects from the drug
Drug-seeking behavior misidentified by health providers as addictive behavior, when it is actually relief-seeking behavior
Behaviors resembling those of drug addiction disappear when patient is given adequate doses of analgesia
Pseudo-addiction
Pseudoaddiction Behaviors
Complaints for more drug Hoarding drug during pain free periods Specific drug requests Openly seeking other sources of help Occasional unsanctioned dose increases Resistance to change in therapy
Principles
Physical Dependence = Addiction
Pain Management with opioids
Physical dependence (common)
Addiction (<3%)*
* Brushwood et al. (2002) Pharmacists’ Responsibilities in Manageing Opioids: A Resource APhA Special Report American Pharmacists Association.
SummaryDifferentiating factors
Motivation for use Route of administration Frequency of use and dose Pseudo-addiction? Continued use despite problems
Types of Pain
NociceptivePain resulting from actual or potential tissue
damageResults from ongoing activation of primary afferent
nociceptive neurons by noxious stimuli Neuropathic
Results from a disturbance in function or pathologic change in a neuron
Can be peripheral or central
Pain Characteristics
Pain Acute Chronic
Onset Rapid, discrete Rapid or insidious
Duration Brief (weeks) Prolonged (months)
Pattern Usually most intense soon after onset
Usually continuous with exacerbations
Psyc Anxiety most common
Depression common
Other Sympathetic hyperactivity
Sleep disturbance, loss of function
Non-Verbal Signs of Pain
Aggressive behavior Changes in daily activities Facial expression Bodily movements Vocal Mood Physical Assessment Values Change in vital signs
Symptom Analysis
Precipitating events Palliating events Quality Severity Pain location and radiation Temporal relationships Associated symptoms Previous treatments and their effects
Pain Scales
No ______________________________________ Worst PainPain 0 1 2 3 4 5 6 7 8 9 10 Imaginable
Numerical Pain Scale
Faces Pain Scale
No ______________________________________ Worst Pain Pain 0 1 2 3 4 5 6 7 8 9 10 Imaginable
Pain Assessment
Accept the patient’s description Thorough assessment of each pain
History, examination, investigation Assess impact of pain on ADLs and
functional status Assess other factors that influence pain
Physical, psychological, social, cultural, spiritual Reassessment
Adapted from: World Health Organization. Cancer Pain Relief. 1996.
Mild
Moderate
SevereMorphine
Hydromorphone
Methadone
Levorphanol
Fentanyl
Oxycodone
± Adjuvants
APAP/Codeine
APAP/Hydrocodone
APAP/Oxycodone
APAP/Dihydrocodeine
Tramadol
± Adjuvants
Aspirin
Acetaminophen
NSAIDs
± Adjuvants
WHO-Step Ladder
Patient Centered Treatment Goals
“What would you like to do that you can’t do because of your pain?”“I’d like to be able to do my needlework”“I’d like to walk to the bathroom – alone”“I want to sleep through the night”“I want to go back to work”“I want to be able to play with my children”
With Uncontrolled Pain …
Emotional EffectsDepression, anxiety, anger
Cognitive EffectsSomatic focus, helplessness,
“catastrophization”
Behavioral EffectsInacitvity, social/sexual dysfunction, poor
sleep, loss of productivity
Physical ChangesMuscle tension, poor posture, circulatory
impairment, obesity
Increased PAIN and
DysfunctionPAIN
Four kinds of patientsTwo kinds of pain
No History of Abuse (Group 1)*
Substance abuser in the past (Group 2)*
Addict in recovery including opioid maintenance patient
Active substance abuser (Group 3)*
Nociceptive pain Acute Chronic Somatic Visceral
Neuropathic pain Chronic Acute
* Gourlay et al. (2005) Pain Medicine 6(2) 107-112
The CAGE Screen
Have you ever felt the need to Cut Down on your drinking
Have you ever been Annoyed by criticism of your drinking
Have you ever felt Guilty about your drinking
Have you ever needed an Eye Opener to get going in the morning.
Toxicology Screening Tests
Purposes To identify surreptitious use To monitor known users
Clinical Examples Prenatal Care Impaired Professionals Trauma/ER
Qualitative results
Legitimate patient with no Hx of addiction (Group 1*) Manage pain (analgesic ladder) Recognize low addiction risk Differentiate physical dependence from
addiction Don’t mistake pain relief seeking for drug
seeking - pseudoaddiction
* Gourlay DL et al. (2005) Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Medicine 6(2), 107-112.
Pain Management and Addiction
Confusion over the distinction between physical dependence (a state of adaptation that produces withdrawal signs upon abrupt drug discontinuation) and addiction (DSM-IV Substance Dependence) has confounded approaches to the patient in pain.
Misconception: Therapeutic use of opioids is commonly associated with substance abuse or addiction
Reality: In patients with no history of substance abuse the risk of addiction following therapeutic use appears to be less than 3%
Misconception regarding pain management with opioids
Clinical Features Distinguishing Opioid Use in Patients With Pain Versus Patients Who Are Addicted to Opioids (TIP 40)
Clinical features Pain Pt. Addicted Pt.
Compulsive drug use
Crave drug (when not in pain)
Obtain or purchase drugs from nonmedical sources
Procure drugs through illegal activities
Escalate opioid dose without medical instruction
Supplement with other opioid drugs
Demand specific opioid agent
Cease use when effective alternatives are available
Prefer specific routes of administration
Can regulate use according to supply
Rare
Rare
Rare
Absent
Rare
Unusual
Rare
Usually
No
Usually (break through pain)
Common
Common
Common
Common
Common
Frequent
Common
Not usually
Yes
No
Patient populations under-treated for pain Elderly Minorities Children Terminally ill patients with HIV/AIDS Chronic non-cancer pain Perceived as high addiction risk Gilson AM and Joranson DE (2002) U.S. Policies Relevant to the Prescribing of Opioid
Analgesics for the Treatment of Pain in Patients with Addiction Disease Clinical Journal of Pain 18:S91-S98. available at http://www.medsch.wisc.edu/painpolicy/
Addict in solid recovery (Group 2*) May refuse adequate pain pharmacotherapy Use of buprenorphine Suggest increased support group work while
on analgesic pharmacotherapy Conduct urine or saliva screens for
unauthorized substances Utilize pain management contract
* Gourlay DL et al. (2005) Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Medicine 6(2), 107-112.
Misconception: it is illegal to prescribe or dispense opioids for a patient with a history of substance abuse
Reality: It is not illegal and the regulatory agencies do not intend to restrict appropriate therapeutic use
Misconception regarding pain
management with opioids
Management Guideline for Recovering Addicts
Relapse prevention: “Relapse occurs most often when practitioners are unaware of their patients’ opioid addiction history” (TIP43 p174)
Education regarding the need for drug Patient’s fear and staff reluctance may
conspire to under-medicate “A patient’s previous drug of abuse should not
be prescribed for pain treatment” (TIP 43 p176)
TIP 43 Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs DHHS Publication No. (SMA) 05-4048 Rockville, Md.
Undiagnosed substance abuse or addiction – active users (Group 3*) Screen all patients for substance use
disorders with CAGE Ask Make pain management contingent on
thorough assessment and treatment if warranted
Utilize pain management contract* Gourlay DL et al. (2005) Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Medicine 6(2), 107-112.
Management Guidelines for High Risk
(Group 2) and Active User (Group 3) Identify and treat underlying medical problem(s). Use appropriate drug, dose, and route Employ non-opioids when possible Recognize abuse behaviors Don’t negotiate Refer to substance abuse and pain services Disclose plan for prescription abuse (Pain
management contract)
Drug Diverter – Not a patientMedico-legal nightmare Do a thorough pain assessment Document, document, document First time patients who request specific
agents Abide by pain management ladder – don’t
trade off good medical practice for convenience
Policy Barriers to Effective Pain Management Lack of training or expertise by healthcare
practitioners and limited access to pain specialists Regulatory steps to prevent drug diversion may
also impede pain management (Electronic CDS prescriptions)
Perceived risk by physicians that sanctions may be imposed by regulatory boards for over prescribing opioids for non-malignant conditions (Chilling Effect)
Poor communication
Federal Food Drug Cosmetic Act and the Controlled Substances Act
FFDCA
CSA
“Pain specialists may treat a chronic pain patient currently enrolled in a narcotic treatment program with narcotics. The CSA does not set standards of medical practice. It is the responsibility of individual practitioners to treat patients according to their professional judgment for a legitimate medical purpose in accordance with generally acceptable medical standards.”
P. Good (2000) Chief; Liaison and Policy Section, Office of Diversion Control DEA.
The Pharmacist’s Dilemma To fill or not to fill
Yes No
Yes OK
Dispense
Resolve problem (dose, route interaction)
No Resolve document problem
Don’t dispense
Legally Valid
Therapeutically Appropriate
Corresponding Responsibility Rule21 CFR 1306.04 A prescription for a CDS to be effective must be issued for a
legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of CDS is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription and the person knowingly filling such a purported prescription as well as the person issuing it shall be subject to the penalties provided for violations of the provisions of law relating to CDS.
Federal CDS schedules
I High abuse potential
No current accepted medical use
May be used in research
Heroin, LSD, MDMA
II High abuse potential
Accepted medical uses
Morphine, hydromorphone, methadone, oxycodone, cocaine, amphetamines
III Less abuse potential than I and II
Accepted medical uses
Opioid combined with non-opioids, anabolic steroids, buprenorphine
IV Less abuse potential than III
Accepted medical uses
Benzos, Chloral hydrate, phenobarb, fenfluramine.
V Less abuse potential than IV
Accepted medical uses
Antitussives with limited amounts of codeine
CDS Requirements
II Signed prescriptions*; no refills; prescriber must be registered with DEA
III & IV
Written, oral, or faxed prescription; refill 5 times in 6 months; prescriber must be registered with DEA
V Written, oral, or faxed prescription; refill as authorized; prescriber must be registered with DEA
* - Emergency prescriptions require follow up prescription, Fax may be used for home infusion/intravenous therapy, long term care facility, and hospice patients
Model PrescriptionSchedule II medication
Ralph Amado, M.D.3862 North Hampton LaneRudolph, PA 38216
AA620395
Roger Bacon1063 Eastlight Dr.Essex, PA 38604
Physician name, address, and DEA number
Patient name and address
Oxycontin 20mgs Tablets #60 (sixty)
Drug name and strength
Dosage form and quantity
SIG: for pain take one tablets every 12 hours.
Date issued: 4/18/06
Patient:
Refill x 0 (none) Physician signature: Ralph Amado
Red Flags for Prescription Forgery
The prescription is “too legible” Standard abbreviations are not used The prescription appears to be photocopied More that one ink color or handwriting used Erasure marks visible Paper appears to have been wet. (acetone) Odd combinations of medications Someone other than the patient presents the
prescription for dispensing\
Prescription Drug Monitoring Programs Electronic PDMP passed in 2006 Maryland
general session (SB 333 & HB 1287) and was vetoed by Gov. Ehrlich on May 26, 2006.
As of April 2005, 22 states already adopted electronic PDMPs
Of the various PDMP approaches (serial Rx, triplicate) electronic systems are the least intrusive and “chilling” on prescribing practices.
Brushwood DB, Hahn KL and Rickert ED (2005) Pharmacists’ Responsibilities in Managing Opioids: 2005 update. American Pharmacists Association CE Monograph
Federation of State Medical Boards “The board will judge the validity of prescribing
on the physician’s treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing”
Evaluation of patient, treatment plan, informed consent and agreement for treatment, periodic review, consultation,medical records, compliance with regulations
Case: Acute Pain
Patient with hx of heroin addiction who is currently receiving buprenorphine sublingual tablets (Suboxone®) comes to Acute Care Center with compound fracture of the right femur.
Case: Acute Pain - Issues
Ability to control pain in patient receiving chronic partial antagonist therapy
Risk of relapse Uncontrolled pain may delay/impair
rehabilitation and recovery
Case: Acute Pain- Strategies
Non-pharmacologic and non-opioid interventions should be optimized first
Engage patient in strategies that have aided in their recovery as soon as possible
Consult addiction medicine specialist When opioids are necessary, use long-acting,
slower onset formulations when possible Must D/C buprenorphine in order to obtain full
agonist effect of mu agonists.
Examples of Nonpharmacologic Interventions for Pain
Cognitive-Behavioral
education/instruction relaxation imagery music distraction biofeedback
Physical Agents
heat or cold compress massage, exercise,
immobilization transcutaneous
electrical nerve stimulation
Mechanistic stratification of antineuralgic agents. PNS = peripheral nervous system; CBZ = carbamazepine; OXC = oxcarbazepine; PHT = phenytoin; TPA = topiramate; LTG = lamotrigine; TCA = tricyclic antidepressant; NE = norepinephrine; SSRI = selective serotonin re-uptake inhibitor; SNRI = serotonin and norepinephrine re-uptake inhibitor; GBP = gabapentin; LVT = levetiracetam; NMDA = N-methyl-D-aspartate; NSAID = nonsteroidal anti-inflammatory drug.Beydoun A. Neuropathic pain: from mechanisms to treatment strategies. [Journal Article] Journal of Pain & Symptom Management. 25(5 Suppl):S1-3, 2003
Case: Acute Pain- Strategies
Begin tapering of opioids as soon as possible but gradually to avoid any withdrawal symptoms
Treat relapse if it occurs Re-start buprenorphine therapy
Misconception regarding pain management with opioids Misconception: patients on methadone
maintenance therapy should not be experiencing pain
Reality: “Reluctance to provide adequate pain treatment to patients on medication assisted therapy usually is based on the mistaken belief that a maintenance dose of opioid addiction treatment medication also relieves acute pain” (TIP43 p174)
TIP 43 Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs DHHS Publication No. (SMA) 05-4048 Rockville, Md.
Guidelines for Methadone Patients Don’t expect the patient’s methadone
maintenance dose to provide analgesia Continue patient’s maintenance dose Add analgesic (opioid and otherwise)
starting with usual doses Anticipate tolerance and the need for
higher dose requirement
Conclusions
There is no easy formula for dealing with this common yet complex area of patient care
Engage addiction specialists sooner rather than later
Conclusions
Consider referral to pain management specialist when standard approaches fail and discomfort sets in – before the situation has escalated out of control.
Employ the assistance and cooperation of a competent pharmacist who maintains a patient centered pharmacy practice.
Recommended Readings and Websites Gilson AM and Joranson DE. (2002) U.S. Policies Relevant to the
Prescribing of Opioid Analgesices for the Treatment of Pain in Patients with Addictive Disease Clin J Pain 18: S91-S98.
Brushwood DB, Finley R, Giglio JG and Heit HA (2002) APhA Special Report: Pharmacists’ Responsibilities in Managing Opioids: A Resource. (American Pharmacists Assocition)
Gilson AM, Ryan KM, Joranson DE and Dahl JL (2004) A Reassessment of Trends in the Medical Use and Abuse of Opioid Analgesics and Implications for Diversion Control: 1997-202. J. Pain and Symptom Management 28(2)
Websites of interest: http://www.medsch.wisc.edu/painpolicy/ http://www.deadiversion.usdoj.gov/ Brushwood DB (2002): The Pharmacist’s Duty to Dispense Legally
Prescribed and Therapeutically Appropriate Opioid Analgesics. Pharmacy Times January 2002 C.E. program.
Gourlay DL et al. (2005) Universal Precautions in Pain Medicine: A Rational Approach to the Treatment of Chronic Pain. Pain Medicine 6(2) 107-112.
Recommended Readings and Websites TIP 43 Center for Substance Abuse Treatment.
(2005) Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs DHHS Publication No. (SMA) 05-4048 Rockville, Md
TIP 40 Center for Substance Abuse Treatment. (2004) Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction DHHS Publication No. (SMA) 04-3939 Rockville, Md
DEA
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