SGIM 2007 Annual Meeting Workshop: Opioids for Chronic ...impak.sgim.org/userfiles/file/AMHandouts/AM07/handouts/WFO6.pdf · SGIM 2007 Annual Meeting Workshop: Opioids for Chronic

SGIM 2007 Annual Meeting Workshop: Opioids for Chronic Pain

Electronic Handout to Supplement Workshop on Initiation, Maintenance, and Discontinuation of Opioids for Patients with Chronic Pain

Section Title Author PagesPart 1 Symptom and Function

Assessment Bridget Martell, MD 2

Part 2 Communication Tools Laura Morgan, Pharm D Part 3 Pharmacology of Long Acting

Opioids Leanne M. Yanni, MD Laura Morgan, Pharm D

Part 4 Pain Contracts Michael Picchioni, MD Part 5 Urine Toxicology Jennifer Gibson, MD Part 6 Legal Considerations in Practice Leanne M. Yanni, MD Part 7 Prescription Diversion William Becker, MD Part 8 Aberrant Behaviors: Is My Patient

Addicted to Opioids? Bridget Martell, MD

References Appendix Slide Presentation (Preliminary) Workshop Faculty, Coordinator: Jane Liebschutz, MD MPH FACP, Boston University [email protected] (617)414-3846 Karina Berg, MD, MS, Albert Einstein College of Medicine William Becker, MD Yale University Jennifer Gibson, MD Legacy Portland Hospitals Matt Holon, MD University of Washington Bridget Martell, MD Yale University Joseph Merrill, MD MPH University of Washington Laura Morgan, Pharm D, Virginia Commonwealth University Christina Nicolaidis, MA, MPH, Oregon Health & Science University Michael Picchioni, MD, Tufts University Leanne Yanni, MD, Virginia Commonwealth University

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Part 1: Symptom and Function Assessment in Chronic Non-Malignant Pain In addition to relieving clinical symptoms and prolonging survival, the objectives of health care interventions include improvement of function. This is particularly true for the use of opioids for chronic nonmalignant pain. There are validated instruments that can be used to assess and document functional outcomes that support the initiation and titration of opioid medications for CNMP. Assessment instruments are useful in the primary care setting. They are easy to administer, easily understood by a majority of the literate population, easily interpreted and provide both diagnostic and prognostic value.

I. Domains to consider when assessing patients1 a. Symptom Assessment

i. Visual Analog Scale ii. Numeric Rating from 1-10

b. Function Assessment i. Graded Chronic Pain Scale2

ii. Brief Pain Inventory3 iii. Roland Morris Disability Questionnaire4, 5

c. Emotional Assessment i. PHQ-9 for depression6

d. Improvement Rating i. Patient’s Goals for pain relief

ii. Patient’s impression of symptom/function change iii. Comparison of pre- treatment to post-treatment symptom and

function instruments that are administered e. Rescue Medications

i. Assess the amount and type needed in addition to standard assigned therapy

f. Non-Medication Treatments i. Assess need for combined treatment modalities in addition to

medication (e.g. TENS, PT, Local Injections, etc.) The Roland-Morris Disability Questionnaire http://www.schechtermd.com/docs/roland_morris_disability_questionnaire.pdf http://www.srisd.com/Roland-Morris.pdf Graded Chronic Pain Scale http://www.rdc-tmdinternational.org/booklet/PainScale.pdf (facial pain but can substitute any pain) Brief Pain Inventory http://www.mdanderson.org/pdf/bpilong.pdf http://www.mdanderson.org/pdf/bpisf.pdf http://www.ama-cmeonline.com/pain_mgmt/module08/pop_up/pop_bpi.htm PHQ-9 (Depression Symptom Checklist) http://www.pfizer.com/pfizer/download/do/phq-9.pdf

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Part 2: Essential Elements of Communication in Medical Encounters7

I. Build the Relationship

a. Elicit the patient’s story of illness while guiding the interview through a process of diagnostic reasoning. It requires awareness that the ideas, feelings, and values of both the patient and the physician influence the relationship.

II. Open the Discussion

a. Allow the patient to complete his or her opening statement b. Elicit the patient’s full set of concerns c. Establish/maintain a personal connection

III. Gather Information

a. Use open-ended and closed-ended questions appropriately b. Structure, clarify, and summarize information c. Actively listen using nonverbal (e.g.,eye contact) and verbal (e.g., words

of encouragement) techniques

IV. Share Information a. Use language the patient can understand b. Check for understanding c. Encourage questions

V. Reach Agreement on Problems and Plans

a. Encourage the patient to participate in decisions to the extent he or she desires

b. Check the patient’s willingness and ability to follow the plan c. Identify and enlist resources and supports

VI. Provide Closure

a. Ask whether the patient has other issues or concerns b. Summarize and affirm agreement with the plan of action c. Discuss follow-up (e.g., next visit, plan for unexpected outcomes)

Part 3: Long-Acting Opioid Medications in Chronic Nonmalignant Pain

Long-acting opioids can be effective in reducing pain and improving function in a variety of CNMP syndromes. Patients should be well-selected for opioid therapy; should be informed of the effects, side effects, and risks of treatment; should be monitored for improvement in pain and function; and should be monitored frequently for effects, side effects, and potential misuse. The medical record should provide clear documentation of this as well. Principles of initiating long-acting medications used in CNMP

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All long-acting opioids are SCHEDULE II. The CLASS of opioid is an important consideration if there is a true allergic reaction to 1 class of opioid as another class of opioid can be tried. Morphine ER and Oxycodone ER are both phenanthrenes while methadone and transdermal fentanyl are in separate classes. The 4 long-acting opioids used commonly in CNMP are FULL AGONISTS to the opioid receptor (mainly Mu). This means that there is no CEILING DOSE and that the dose can be escalated to pain relief limited only by side effects (and potential misuse). However, note that there is minimal evidence to support the use of unusually high doses of long-acting opioids when used for CNMP. There is wide INDIVIDUAL VARIABILITY in pain response to long-acting opioids as well as in side effect response. • Part of this has to do with BIOAVAILABILITY:

o A HIGHER BIOAVAILABILITY (higher %) means a more predictable response to the drug from patient to patient while a LOWER BIOAVAILABILITY (lower %) means a less predictable response.

• Part of this also has to do with METABOLISM:

o Some have ACTIVE METABOLITES which are responsible for binding to the opioid receptors and producing pain relief while others have INACTIVE METABOLITES which have no effect on pain relief.

o In general long-acting opioids are METABOLIZED in the liver and EXCRETED in the kidneys.

o Liver METABOLISM of long-acting opioids is generally responsible for drug interactions if the opioid requires one of the P450 enzyme systems that other drugs may induce or inhibit.

• Because of this variability, TITRATING long-acting opioids is expected and should

occur according to report of pain relief and increased function but not at an interval more frequent than it takes to reach a STEADY STATE (to avoid serious side effects such as respiratory depression).

• The concept of OPIOID ROTATION is based on the development of TOLERANCE to a particular opioid medication. When converting between opioid medications, there is variability in CROSS-TOLERANCE to the receptors and therefore, a conservative starting dose of long-acting opioid should be initiated with close monitoring for side effects and TITRATION as appropriate to steady state and pain control.

• Adverse reactions of opioid medications are generally NOT allergic reactions. They

are common between opioids, however, there is drug variability as well as individual variability.

Table 3.1: Adverse Opioid Reactions8

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System Reaction Example CNS Drowsiness, sedation,

hallucinations CNS side effects more common with morphine Tolerance develops to sedation

Respiratory Respiratory depression Tolerance develops to respiratory depression

Ocular Miosis GI Nausea, constipation, delayed

emptying Morphine/Codeine due to 6-hydroxyl group Hydromorphone and oxycodone lack 6-hydroxyl group Tolerance DOES NOT develop to constipation

Cardiovascular Hypotension, bradycardia High opioid doses Musculoskeletal Muscle rigidity, myoclonus High opioid doses Immune Pruritis from mast cell

histamine release Morphine/Codeine (natural opioids) More common with IV Tolerance develops to pruritis

Physical dependence (results in withdrawal symptoms)

Results in withdrawal symptoms: restlessness, yawning, lacrimation, rhinorrhea, piloerection, perspiration, chills/myalgias

Tolerance (basis for opioid rotation)

Decreased duration of pain response over time Decreased effectiveness of pain relief over time

Pharmacology of long-acting medications used in CNMP Morphine ER, Oxycodone ER, Methadone, Transdermal Fentanyl

1. Morphine Extended Release: Morphine ER (generic), MS Contin, Avinza, Kadian, Oramorph SR9

Morphine ER is a first-line long-acting opioid in opioid-naïve patients with CNMP due to its low cost and relatively low abuse potential. Additionally, it has few drug interactions. However, side effects such as sedation, pruritis, and constipation may be limiting. Morphine ER is a phenanthrene and a full agonist at the Mu receptor. It has a relative low bioavailability (20-40%). Morphine ER is dependent on glucuronidation in the liver to produce active metabolites for analgesic activity - 90% is converted to active metabolites including morphine-6-glucuronide which provides the most analgesia. Other metabolites include morphine-3-glucuronide (inactive metabolite).

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Initiating doses vary with Morphine ER formulations. While MS Contin and Oramorph SR are initiated at 15mg every 12 hours, Avinza and Kadian have a longer t½ life and are initiated at slightly higher doses at longer intervals (20-30mg every 24 hours). Due to liver metabolism, the dosing interval should be extended in hepatic insufficiency and due to renal elimination the total dose should be reduced in renal insufficiency. The rate of titration of Morphine ER is based on achieving a steady state as well as side effect tolerance (except constipation). In general this occurs in 5-7 days. Therefore, the total daily dose of MS Contin and Oramorph SR for example can be increased by 15-45 mg every 7-14 days. While there is no ceiling dose for Morphine ER (because it is a full agonist), the maximum dose is limited by adverse effects. Note, however, that daily doses above 180mg of Morphine ER have not been validated in clinical trials. 10

Morphine is a natural opioid with a 6-hydroxyl group that is responsible for increased CNS and gastrointestinal side effects. Other adverse reactions are consistent with those listed in Table 1. Pruritis from mast cell histamine release is not an allergic reaction and can be treated with pre-dose anti-histamines. True allergic reactions to morphine are rare. In general, there are few drug interactions with Morphine ER due to the lack of liver enzyme metabolism. Common medications that decrease conversion of morphine to its active metabolites include ranitidine and potentially tri-cyclic antidepressants. Additionally, the metabolism of desipramine may be decreased by morphine, leading to increased desipramine blood levels. What should the URINE DRUG SCREEN of someone taking Morphine ER show? Opiate-positive and specifically: morphine, morphine-6-glucuronide, morphine-3-glucuronide, hydromorphone (if the chronically on ER formulation at relatively high doses due to slow GI motility/GI conversion)

2. Oxycodone Extended Release: Oxycodone ER (generic) and Oxycontin11 Oxycodone ER is a first or second line long-acting opioid in opioid-naïve patients with CNMP. However, it should be avoided in patients with high risk behaviors including a current or past history of substance abuse and/or addiction due to its high abuse potential. Its high abuse potential stems from its relatively high bioavailability, decreased side effects, and the ability to alter the extended release mechanism. Oxycodone ER is a phenanthrene and a full agonist at both Mu and Kappa receptors. It has a moderate bioavailability (>60%) making patient response to equivalent dosing variable. As with Morphine ER, Oxycodone ER is dependent on active metabolites for analgesic effect. It is converted to active metabolites (oxymorphone) via the P450 2D6

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liver enzyme system. It is also converted to noroxycodone (active metabolite) and noroxymorphone (inactive metabolite). Importantly, there may be reduced analgesic effect in 5-10% of Caucasians due to diminished P450 2D6 enzyme activity. The initiating dose for opioid naïve patients is 10mg every 12 hours. Generally, peak response occurs in about 3 hours after oral ingestion. Because its half-life is about 8 hours, it takes anywhere from 24 to 48 hours to reach steady state (4-6 half-lives) though tolerance to side effects may take 5-7 days. Therefore, the total daily dose should not be increased more frequently than every 7-14 days. The initiating dose and titration dose should be reduced by 1/3 to ½ in patients with either hepatic or renal insufficiency. While there is no ceiling dose for Oxycodone ER (because it is a full agonist), the maximum dose is limited by adverse effects. Note, however, that daily doses above 120mg of Oxycodone ER for CNMP have not been validated in clinical trials. 10

Because Oxycodone ER is a synthetic opioid, there are generally fewer adverse effects than with Morphine ER. However, other medications may significantly interfere with Oxycodone’s analgesic effect. Inhibitors of the P450 2D6 enzyme will decrease oxycodone’s conversion to its active metabolite. Common drugs P450 2D6 inhibitors include: celecoxib, fluoxetine, paroxetine, amiodarone, ritonivir, and quinidine. There are case reports of serotonin syndrome with the combination of oxycodone and SSRI’s. The provider should be aware of this potential. What should the URINE DRUG SCREEN of someone taking Oxycodone ER show? General screen: • Opiate negative at doses less than 100-150mg oxycodone/24 hours (if used in

combination, urine should be tested to detect co-medication) o The reason oxycodone does not produce an opiate positive UDS unless >100-

150mg/24 hours is because less than 10% of oxycodone is excreted unchanged in the urine.

o If patients are taking a combination medication the co-medication can be detected on a standard UDS even if lower doses of oxycodone are consumed (oxycodone exists in short-acting formulations with acetaminophen, aspirin, or ibuprofen).

• Opiate positive at doses greater than 100-150mg/24 hours Specific/sensitive confirmation screen: • Oxycodone and Oxymorphone positive

3. Methadone: Methadone (generic), Methadose, Dolophine12-16 Methadone is a first line long-acting opioid for patients with neuropathic pain due to its NMDA antagonist effects. It is also a first line long-acting opioid for patients with a history of high risk behaviors including substance abuse or addiction due to its low abuse

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potential (lack of euphoria secondary to its long half-life, lack of ability to disrupt its long-acting mechanism). However, when used as a first or second line agent in opioid-naïve patients it must be started at very low doses and titrated very slowly due to its dose-accumulating side effects. While the analgesic effect may last from 2 to 10 hours, methadone may circulate in the body (causing potential side effects such a respiratory depression) for much longer. Patients should be monitored very closely during the titration period. It also has significant drug interactions as described below. Methadone must be used with caution in the following situations: • Elderly and patients with reduced clearance (liver insufficiency) • Patients with significant drug-drug interactions • Patients on other sedative medications including benzodiazepines, including alcohol • Patients with unreliable adherence to prescribed dosing (self-titration can cause

serious/life-threatening adverse effects) • Patients with history of arrhythmia (prolonged QT – Torsades de Pointes) Methadone is a diphenylheptane and a full agonist at the Mu receptor. Additionally, it is an antagonist at the NMDA receptor which may explain its effectiveness in neuropathic pain. Methadone has a wide range of bioavailability (40-100%) which results in an unpredictable patient response. Its half-life therefore ranges from approximately 9 to 50 hours so its steady state may be achieved anywhere from 3 to 10 days. While methadone does not depend on active metabolites for analgesic effect, it is metabolized by several different liver enzyme systems ((P450 3A4, 2D6) which may be responsible for its variable half-life. It also explains why methadone has multiple drug interactions. Methadone should be initiated at very low doses in opioid naïve patients: 2.5 to 5mg every 8 to 12 hours. Additionally, doses may need to be reduced once steady state is reached (7-10 days) due to side effects. Initial pain response occurs approximately 2 hours after oral ingestion and the analgesic effect lasts from 2 to 10 hours. When titrating, the total daily dose may be increased by 30% every 10-14 days. However, because a steady state may take as long as 10 days and because of its accumulation potential, methadone should not be titrated more frequently than every 10-14 days. Frequent face-to-face visits are suggested while titrating to evaluate potential side effects from dose accumulation. Converting from other long-acting opioids to methadone is not standardized due to the wide variability in response to analgesic effect and side effects. Conservative conversions are appropriate with slow titration and frequent monitoring as described. Methadone has multiple drug interactions because it is metabolized by several different liver enzyme systems (P450 3A4, 2D6).

• Inhibitors of P450 enzymes will increase methadone concentrations (reduce methadone dose and rate of titration): fluoxetine, paroxetine, erythromycin, fluconazole, ketaconazole, diazepam, grapefruit juice

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• Inducers of P450 enzymes will decrease methadone concentrations (may reduce effectiveness or precipitate withdrawal): protease inhibitors, rifampin, risperidone, carbamazepine, phenytoin, St. John’s wort

Adverse reactions are consistent with other opioid medications. However, there is generally less nausea. Additionally, there is risk of prolonged QT interval, reports of Torsades de Pointes. Because it is in a different class than Morphine ER and Oxycodone ER, it can be used in patients with true allergies to these medications. What should the URINE DRUG SCREEN of someone taking Methadone show? • Methadone requires SPECIFIC UDS, so patients on methadone will have an opiate-

negative UDS. • Methadone and EDDP (methadone metabolite) will be positive on specific UDS with

an average daily dose of at least 40mg. 4. Fentanyl TTS (transdermal therapeutic system): Fentanyl TTS (generic

available for most strengths except 12.5mcg/hr), Duragesic17-21 Fentanyl can be used in stable chronic nonmalignant pain as it allows a stable pharmacokinetic profile due to its high bioavailability and release of fentanyl from the subcutaneous reservoir at a nearly constant rate. Though there is a wide inter-patient variability, once a stable dose has been achieved in a single individual, a consistent concentration can be relied on. It has moderate abuse potential because active drug remains on the patch even when the patch is removed: package insert recommendations state to dispose of the patch by folding the sticky surface together after use and flushing it. Fentanyl is a potent opioid analgesic (80x more potent than morphine) with a high bioavailability (92%) that exists in transdermal form. It is a phenylpiperidine and a full agonist at the Mu receptor. It is highly lipophilic which may result in significant CNS side effects. It also has significant plasma protein binding which may interfere with standard dosing and titration recommendations if other medications that also bind to plasma proteins are prescribed. Fentanyl has no active metabolites though it is metabolized in the liver to inactive metabolites (hydroxyfentanyl and norfentanyl).

Initiating dose should be a 12.5 or 25mcg/hr patch applied every 72 hours. Lower initial doses should be considered for elderly patients and those with moderate to severe renal insufficiency. The patch should be placed on the patient’s chest, back, flank, or upper arm in an area without hair. Before applying the patch, the patient should clean the area with plain water only and pat the skin dry. It is important to relay these instructions in order to avoid miscommunication, evaluate efficacy, and titrate appropriate. After the first application, a fentanyl depot concentrates in the upper skin layers. Therefore, it takes several hours to see clinical effects. A short-acting medication may be prescribed along with fentanyl TTS due to the delayed onset of action which may be 6-12 hours. Maximal concentration from the patch is reached in 12-48 hours and a steady state

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reached in 3-6 days. When the patch is removed, a reservoir of drug remains in the subcutaneous tissue and clearance may take up to 24 hours. Titration should not be more frequent than every 6 days (2 patch cycle). Also, although standard dosing is every 72 hours, if patients experience an increase in pain at the end of the 72 hour period and the increased dose results in side effects, the dosing interval can be changed to every 48 hours. While there is not a ceiling dose, the highest dose used will be determined by side effects. Additionally, a study on fentanyl TTS for low back pain reported 80% of patients with pain control using the 25mcg/hr patch.18 While dose adjustment is not necessary in hepatic insufficiency, the dose should be adjusted for moderate to severe renal failure (75% of normal dose for GFR 10-50ml/min and 50% of normal dose for GFR <10mL/min). Fentanyl is metabolized through the liver enzyme system 3A4, so any medication inhibiting 3A4 will increase its concentration. These include ritonavir, nelfinavir, ketoconazole, itraconazole, clarithromycin, erythromycin, diltiazem, and grapefruit juice. Conversely, 3A4 inducers will decrease its concentration though there are few commonly used; carbamazepine and St, John’s wort are examples. Adverse effects are consistent with other opioid analgesics. However, fentanyl’s lipophilic properties may enhance CNS side effects. Additionally, patients may have a local skin reaction to the silicone base. This is not considered an allergy to fentanyl. Treatment may include frequent rotation and/or an oral anti-histamine or anti-histamine cream or low potency corticosteroid cream after each patch removal. What should the URINE DRUG SCREEN of someone using Fentanyl TTS show? Patients will have an opiate negative UDS. Fentanyl must be detected by specialized testing using gas chromatography/mass spectroscopy. The lab may or may not report the presence of the metabolite norfentanyl as well.

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Part 4: Using Contracts for Chronic Long-term Opioid Prescriptions (see Appendix for an Example) What is it? What should it be called? Since a “contract” is a written and binding agreement between two parties, many providers feel more comfortable calling a document regarding long-term opioid therapy a prescribing “agreement” or an “informed consent”. In many cases this is more appropriate since it really is a unilateral statement of the rules for using this type of medication. However, if the purpose of the agreement is to ensure that the patient receives reliable access to a potentially controversial therapy because the patient and provider both agree that this is a reasonable risk (to both parties) to take in order for the patient to receive the potential benefit of this therapy, then the term contract may be completely appropriate. The word also has a certain seriousness associated with it as well as a familiarity to most lay persons that may be important in establishing the foundation for this type of treatment. Why use a contract? One simple argument for using a written contract is that many guidelines including those from the American Academy of Pain Medicine call for one. When it comes to controlled drugs, the responsibilities of prescribers are considerably different than with other therapies and hence, there is justification for the added step. Furthermore, an explicit written statement makes the rules and expectations very clear up front. This can be extremely useful in avoiding such conflicts as well as in confronting problems if deviations from these expectations later occur. Another advantage is that such a form can serve as excellent documentation of full informed consent. This can protect both the patient and provider from some of the potential risks associated with long-term opioid therapy in the management of chronic non-malignant pain.

Arguments against using written contracts often focus around concerns of creating tension between provider and patient. Using the contract with all patients minimizes this and discussing the risks to the provider in providing access to this kind of medicine for this indication can often serve as a way of further building a partnership with patients. It should be kept in mind that no good empiric evidence exists to support the use of written contracts, however, neither is there any good evidence against. Therefore, reliance on judgment and what makes sense is the best alternative. General Considerations Numerous examples of contracts exist including the appendix provided. Several important elements are recommended and well illustrated in these examples and in the reference below. If written contracts are used they should be used universally and not only for selected “bad” patients. Deviations from the agreement must be confronted and addressed with action or the agreement becomes meaningless. Reference: Fishman SM, Kreis PG The Opioid Contract, The Clinical Journal of Pain, Vol 18(4): S70-S75, 2002.

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Part 5: Urine Toxicology Screening

I. Rationale for random, urine drug screens a. Can’t rely on patient report of current drug abuse (8.8% false report)22 b. Can’t rely on aberrant behavior to trigger a UDS (miss 50% of problems)23

c. Inexpensive and non-invasive means of testing d. Best window of detection compared to other drug tests (1-3 days for most

drugs)

II. Frequency of testing a. Can be infrequent (1-2/year) in many patients but most equitable if applied

to all b. Increased frequency of screening suggested for aberrant behaviors

III. Type of urine drug screen a. Can use point of care or lab based immunoassay as first screen b. Follow this with confirmatory test to identify specific drugs and confirm

results c. Specify to lab which drugs of abuse & which prescription drugs to

look for d. Suggested screen: all opiates, cocaine, amphetamine, marijuana,

benzodiazepines

IV. Immunoassays a. Laboratory based or at point of care b. Usually detect classes only (i.e. opiate, benzo), substances list as present

or absent c. Can get false positives and negatives d. May have cross reaction with other drugs - false (+) e. Don’t always show some opioids e.g. methadone, oxycodone, fentanyl -

false(+) f. Therapeutic drug level may fall below a test’s cutoff concentration -

false (-)

V. Immunoassay cross reactivity (causing false positive on first screen only) a. Low cross reactivity for cocaine (unlikely to get false positives) b. Amphetamine false (+): ephedrine, pseudoephedrine, selegiline, Vicks

inhaler c. Opiate false (+): quinolones, poppy seeds d. PCP false (+): ambien, benadryl and dextromethorphan e. Fentanyl false (+): trazadone f. PCP false (+): effexor

VI. Gas (GC/MS) or liquid (HPLC) chromatography a. Detect specific drugs within classes b. No cross reaction with other drugs

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c. Therapeutic drug level may still fall below a test’s cutoff concentration - false (-)

VII. UDT may show traces of unexplained opioids which are metabolites of

prescribed drug a. High doses of codeine may also produce hydrocodone, morphine,

dilaudid b. Patients on hydrocodone often also have hydromorphone in urine c. Secondary metabolites are present in characteristic ratios which lab can

confirm

VIII. Reasons for absence of prescribed drug a. Patient has run out early (make sure to ask patient when last dose was

taken) b. Patient is diverting medication or urine is adulterated or substituted c. Cutoff set too high to detect this drug or initial screen doesn’t detect this

drug

IX. Reasons for presence of non-prescribed drug a. Patient illicitly using other drug b. False positive on original screen (mostly only an issue for immunoassay) c. Legitimate byproduct of prescribed drug (hydromorphone when using

vicodin) d. Lab error or urine may be too dilute and thus fall below screening cutoff

X. If suspect tampering check urine pH, temperature and creatinine a. Can use temperature strips for collecting cups or ask lab to routinely check

this

XI. To avoid false negatives a. Make sure to ask that all opioids are screened for initially b. Make sure to ask that opioids be reported at lowest limit of detection/no

cutoff

XII. How to address problem UDS a. Discuss with patient (opportunity to identify and treat new diagnosis of

addiction) b. Tighter limits (more frequent visits and screens, pill counts, limited

dispensing) c. Refer to addiction specialist

XIII. Caveats to UDS of specific opioids a. Codeine

i. May show both codeine and morphine but not morphine alone ii. High doses of codeine may produce small doses of hydrocodone,

hydromorphone

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b. Hydrocodone i. May produce small quantities of hydromorphone

c. Morphine i. May be produced from codeine but not from hydrocodone,

oxycodone ii. Cannot account for the presence of codeine

d. Heroin i. Shows up on UDS as morphine

ii. Can look for 6-MAM (specific for heroin) but only present for a few hours

e. Synthetic and semisynthetic opioids are not always detected by immunoassay

i. Oxycodone, methadone, fentanyl, demerol, dilaudid, buprenorphine

XIV. Caveats to UDS of specific benzodiazepines

a. Klonopin i. May not be detected on immunoassay (false negative)

ii. May not show up on GC/MS (benzo may be present on original but then neg)

iii. Other benzodiazepines highly variable, many are metabolites of each other

XV. Caveats to UDS of other medications

a. Amphetamines i. Won’t get positive methamphetamine from pseudoephedrine on

GC/MS b. Marijuana

i. Cannot get positive test by passive inhalation or from intake of hemp products

ii. Proton pump inhibitor may cause false positive immunoassay (but not GC/MS)

c. Cocaine i. Not positive with lidocaine but is used in some medical

procedures24-26

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Part 6: Legal Considerations in Controlled Substance Prescribing Adapted from the VCU Chronic Nonmalignant Pain Management27

A scheduled medication, also known as a controlled substance, is a pharmaceutical preparation that is designated as having a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect. Schedule I substances such as heroin, marijuana, and lysergic acid diethylamide (LSD) are illegal and cannot be prescribed in the U.S. Schedule II-V substances such as morphine, methylphenidate, and diazepam can be prescribed by licensed physicians who have registered with the U.S Drug Enforcement Administration (DEA).

The U.S. Attorney General determines whether a medication will be scheduled and into which classification it will fall based on the Federal Food, Drug, and Cosmetic Act of 1970. This determination is based on both the abuse potential of the medication (confirmed in human laboratory studies and clinical trials), as well as the accepted medical use of the medication. The DEA has released a manual to help practitioners better understand the Controlled Substances Act, its purpose, and its practical application.28

A major barrier to the use of controlled substances in the treatment of chronic nonmalignant pain is the fear of law enforcement investigation. A survey of physicians reported that over half would reduce the dose or quantity, reduce the number of refills, or choose a medication in a lower schedule due to concerns about regulatory scrutiny.29 However, fewer than 1% of health care providers who prescribe controlled substances are ever investigated. Both healthcare providers and law enforcement personnel share responsibility for assuring availability of prescription pain medications while preventing them from becoming a source of harm or abuse. In 1996, a consensus statement from the American Academy of Pain Medicine (AAPM) and the American Pain Society (APS) legitimized the use of opioids in chronic pain. Additionally, in 1998 the Federation of State Medical Boards released guidelines for the use of opioids in medical practice.30 If providers consistently follow these guidelines, it is unlikely that an investigation will occur, and if it does occur, unlikely that it will result in significant consequences to the physician. In a recent review, Fishman states, "…physicians who maintain ongoing vigilance by exercising consistent and transparent risk management practices for all of their patients on opioid therapies are not at substantial risk of regulatory action".31

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Table 1: Federation of State Medical Board Criteria when evaluating a physician’s treatment of pain

Evaluation of the Patient H&P including detailed history of pain Medical indication for use of controlled substance

Treatment Plan Objectives used to determine treatment success

Informed consent and agreement for treatment

Discussion of risks and benefits Consider use of a written agreement (Samples from AAPM)

Periodic Review New health information Improvement, stability, or progression of pain Changes in treatment plan

Consultation if/when appropriate

Willingness to refer patients with complex issues or if not meeting treatment objectives

Accurate and complete medical records

Accessible documentation of criteria listed above

Compliance with laws and regulations

Licensed to dispense controlled substances

Clinical Practice Tools Consistency in office policies and procedures, including the use of clinical practice tools, can avert or identify misbehaviors associated with the use of controlled substances for chronic nonmalignant pain. These include:

• Controlled substance policies • Office visit templates for pain (documentation prompts for initial pain assessment,

follow-up and monitoring) • Controlled substance agreements • Controlled substance flow charts • Access to pharmacy records (including state prescription monitoring programs) • Utilization of urine drug screening (with appropriate interpretation of results)

Other recommendations for consistency in practice include:

• Obtaining prior medical and pharmacy records as well as direct communication with other current or prior providers

• Develop provider consistency for patients prescribed opioids for chronic pain • Choose long-acting opioids and opioids of lesser street value • Schedule frequent visits for pain assessment, titration, and monitoring • Document assessment, treatment, and monitoring according to the FSMB’s

Guidelines • Follow safe prescribing practices

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Safe Prescribing Practices For a prescription to be valid an appropriate physician-patient relationship must be established, which requires documentation of a pertinent medical history and physical examination prior to prescribing. Additionally, a practitioner may not prescribe for himself or his immediate family. Finally, prescribing must be within the general scope of practice of a physician; i.e. prescriptions should not be written if the medication is outside a provider's area of training or expertise. There are no legal restrictions on the quantity of medication to be dispensed with a prescription (most limits on quantity are set by insurance companies or third-party payers), but a general guideline—especially for opioid analgesics—is to limit the quantity to no more than a 30-day supply of medication or exactly enough medication to last until the next scheduled visit (if within a reasonable time period). Concerns about misuse or abuse should prompt stricter dispensing parameters. Required Elements of Writing Prescriptions:

• Date of issue • Patient's name and address • Practitioner's name, address, and DEA registration number • Drug name, strength, dosage form, quantity prescribed, directions for use, and

number of refills (if any) authorized • Manual signature of prescriber

Suggestions for Writing Prescriptions • Hand write prescriptions on watermark paper • Date prescriptions the day they are written • Hand write patient name and date of birth: do not use adhesive labels • Do not sign incomplete prescriptions • Use numbers and letters to document quantity and strength of medication • Provide exactly enough medication until follow-up • Copy all controlled substance prescriptions for chart documentation

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Part 7: Pharmaceutical Diversion

Background: • Definition of Diversion:

o “Selling, trading or giving away prescription medication (or a prescription itself) to another person for whom the medication is not intended.”

• Why it’s a concern: o “We may be contributing to the sustenance of an underground criminal

subculture. We may also be unintentionally responsible for opioid overdoses and deaths and for the possible addiction of persons who acquire these drugs illegally.”23

• Prevalence among adults is unknown but thought to be most common with prescription opioids

• Risk factors, based on scientific evidence, are also unknown • Little is known about the market for illicit sale/trade of prescription opioids • Prescription drug monitoring programs and radiofrequency identification

technology to track medications through the supply chain may offer more information in the future 32

Practical Information for Providers

• How do I identify patients who are diverting medications? o Monitor for aberrant behaviors that may indicate diversion

“New patients with stories that don’t seem quite right; reluctance to cooperate; strange symptoms; specific drug requests.”33

o Perform routine urine toxicology looking for absence of prescribed medications

One study of UDS attempted to incorporate this but concluded that assays were not sensitive enough to draw reliable conclusions23

Also, there may be patients who take some of the medication and also sell a portion

Ultimately, no study exists to validate this method • How do I discourage diverters?

o “Provide thorough care; Document prescriptions; Use medication agreements; Protect your prescriptions; Work with local pharmacists.”33

• What do I do if I have a diverter? o Execute terms of medication agreement o Contact Drug Enforcement Administration

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Part 8: Aberrant Behaviors: Is My Patient Addicted to Opioids? Definitions: Misuse If use of a substance is thought to be potentially clinically significant but does not meet diagnostic criteria for abuse or dependence, it may be characterized as "misuse," although this is not a formal DSM IV diagnostic category.

Substance Abuse A diagnosis is made if a maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by one (or more) of the following, occurring within a 12-month period:

1. recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (e.g., repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; neglect of children or household)

2. recurrent substance use in situations in which it is physically hazardous (e.g., driving an automobile or operating a machine when impaired by substance use)

3. recurrent substance-related legal problems (e.g., arrests for substance-related disorderly conduct)

4. continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (e.g., arguments with spouse about consequences of intoxication, physical fights)

5. NOTE: The symptoms have never met the criteria for Substance Dependence for opioids

Substance Dependence A diagnosis is made if a maladaptive pattern of substance use, leads to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same 12-month period:

1. tolerance, as defined by either of the following: a. a need for markedly increased amounts of the substance to achieve

intoxication or desired effect b. markedly diminished effect with continued use of the same amount of the

substance 2. withdrawal, as manifested by either of the following:

a. the characteristic withdrawal syndrome for the substance (refer to Criteria A and B of the criteria sets for Withdrawal from the specific substances)

b. the same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms

3. the substance is often taken in larger amounts or over a longer period than was intended

4. there is a persistent desire or unsuccessful efforts to cut down or control substance use

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5. a great deal of time is spent in activities necessary to obtain the substance (e.g., visiting multiple doctors or driving long distances), use the substance (e.g., chain-smoking), or recover from its effects

6. important social, occupational, or recreational activities are given up or reduced because of substance use

The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance (e.g., current cocaine use despite recognition of cocaine-induced depression, or continued drinking despite recognition that an ulcer was made worse by alcohol consumption) Specify if: • With Physiological Dependence: evidence of tolerance or withdrawal (i.e., either Item

1 or 2 is present) • Without Physiological Dependence: no evidence of tolerance or withdrawal (i.e.,

neither Item 1 nor 2 is present) Pseudoaddiction A term used to describe patient behaviors that may occur when pain is undertreated. Patients with unrelieved pain may:

• become focused on obtaining medications • may "clock watch" • may inappropriately manifest drug seeking behaviors • exhibit behaviors such as illicit drug use and deception

Pseudoaddiction can be distinguished from true addiction in that the behaviors resolve when pain is effectively treated.

Remember, physical dependence and tolerance to prescribed medications does not constitute sufficient evidence of psychoactive substance use disorder or dependence. When drugs that induce physical dependence are no longer needed, they should be carefully tapered while monitoring clinical symptoms to avoid withdrawal phenomena and such effects as rebound hyperalgesia. A patient who is physically dependent on opioids may sometimes continue to use these despite resolution of pain only to avoid withdrawal. Such use does not necessarily reflect addiction.

20


What to do if you discover your patient has substance abuse or dependence? 1. Consider the following factors before confronting the patient:

• Use of other illicit substances (alcohol, benzodiazepines, etc.) • Genetic vulnerability for developing substance use disorder(s) • Severity of the disorder, rapidity with which it developed, and degree of

associated functional impairment(s) • Individual's awareness of the substance use disorder as a problem • Individual's readiness for change and motivation to enter into treatment for the

purpose of change (see Stages of Recovery) • Associated general medical and psychiatric conditions (either co-occurring or

induced by substance use) • Individual's strengths (protective and resiliency factors) and vulnerabilities • Social, environmental, and cultural context in which the individual lives and will

be treated

2. Confront the patient

3. Assess Stages of “Recovery” • Pre-contemplation • Contemplation • Preparation • Action

4. Make Appropriate Referral

• Addiction Specialist referral: List of qualified physicians available at http://www.asam.org/

o It is often best if the patient or the physician partnering with the patient makes the initial call to a rehabilitation or detoxification program.

• General Psychiatry Referral: If your area lacks addiction specialist 5. Treatment Settings for an Addiction Diagnosis

• The choice of treatment setting depends on the clinical characteristics and preferences of the patient, the patient's perceived treatment needs, and the available alternatives. As in the treatment of all patients, the least restrictive setting that is likely to facilitate safe and effective treatment is preferred.

• Five settings or modalities in which most treatment of opioid-related disorders occurs

o Inpatient hospital settings o Outpatient clinics and offices o Opioid treatment programs, self-help programs o Therapeutic communities (Narcotics Anonymous, Religious

Organizations)

6. Treatment Settings for Opioid Detoxification

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• Inpatient setting • Outpatient clinics and offices • Primarily methadone maintenance programs

7. Methods for Monitoring Success

• Evaluate craving for opioid • Random drug screens • Asking patient about success in their referral program • Asking patient for verification of success (e.g. permission to contact psychiatrist

or support group administrator)

8. Additional Treatment Considerations • It is important to realize that abstinence does not in itself constitute evidence of

satisfactory treatment

34-36

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2. Von Korff M, Ormel J, Keefe FJ, Dworkin SF. Grading the severity of chronic pain. Pain. 1992;50:133-149.

3. Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain. 2004;20:309-318.

4. Roland M, Morris R. A study of the natural history of low-back pain. part II: Development of guidelines for trials of treatment in primary care. Spine. 1983;8:145-150.

5. Roland M, Morris R. A study of the natural history of back pain. part I: Development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983;8:141-144.

6. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: The PHQ primary care study. primary care evaluation of mental disorders. patient health questionnaire. JAMA. 1999;282:1737-1744.

7. Makoul G. Essential elements of communication in medical encounters: The kalamazoo consensus statement. Acad Med. 2001;76:390-393.

8. Trescot AM, Boswell MV, Atluri SL, et al. Opioid guidelines in the management of chronic non-cancer pain. Pain Physician. 2006;9:1-39.

9. Lugo RA, Kern SE. Clinical pharmacokinetics of morphine. J Pain Palliat Care Pharmacother. 2002;16:5-18.

10. Ballantyne JC, Mao J. Opioid therapy for chronic pain. N Engl J Med. 2003;349:1943-1953.

11. Kalso E. Oxycodone. J Pain Symptom Manage. 2005;29:S47-56.

12. Ferrari A, Coccia CP, Bertolini A, Sternieri E. Methadone--metabolism, pharmacokinetics and interactions. Pharmacol Res. 2004;50:551-559.

13. Fredheim OM, Borchgrevink PC, Klepstad P, Kaasa S, Dale O. Long term methadone for chronic pain: A pilot study of pharmacokinetic aspects. Eur J Pain. 2006.

14. Mannino R, Coyne P, Swainey C, Hansen LA, Lyckholm L. Methadone for cancer-related neuropathic pain: A review of the literature. J Opioid Manag. 2006;2:269-276.

15. Lugo RA, Satterfield KL, Kern SE. Pharmacokinetics of methadone. J Pain Palliat Care Pharmacother. 2005;19:13-24.

16. U.S. Food and Drug Administration. Methadone hydrochloride public health advisory. Available at: www.fda.gov/cder/drug/advisory/methadone.htm. Accessed March 25, 2007.

17. Stanley TH. Fentanyl. J Pain Symptom Manage. 2005;29:S67-71.

18. Simpson RK,Jr, Edmondson EA, Constant CF, Collier C. Transdermal fentanyl as treatment for chronic low back pain. J Pain Symptom Manage. 1997;14:218-224.

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19. Kornick CA, Santiago-Palma J, Moryl N, Payne R, Obbens EA. Benefit-risk assessment of transdermal fentanyl for the treatment of chronic pain. Drug Saf. 2003;26:951-973.

20. Babic-Naglic D, Jajic Z, Gnjidic Z, Stambuk B. Treatment of chronic pain--use of transdermal fentanyl (durogesic TTS). Reumatizam. 2002;49:33-37.

21. Jeal W, Benfield P. Transdermal fentanyl. A review of its pharmacological properties and therapeutic efficacy in pain control. Drugs. 1997;53:109-138.

22. Fishbain DA, Cutler RB, Rosomoff HL, Rosomoff RS. Validity of self-reported drug use in chronic pain patients. Clin J Pain. 1999;15:184-191.

23. Katz NP, Sherburne S, Beach M, et al. Behavioral monitoring and urine toxicology testing in patients receiving long-term opioid therapy. Anesth Analg. 2003;97:1097-102, table of contents.

24. Heit HA, Gourlay DL, Caplan YH, eds. Urine Drug Testing in Primary Care: Dispelling the Myths and Designing Strategies. PharmCom Group, Inc.; 2006.

25. Hammett-Stabler CA, Pesce AJ, Cannon DJ. Urine drug screening in the medical setting. Clin Chim Acta. 2002;315:125-135.

26. Heit HA, Gourlay DL. Urine drug testing in pain medicine. J Pain Symptom Manage. 2004;27:260-267.

27. Yanni LM, Johnson BA, Morgan LA, Weaver MF, Harrington SE, Wolf CE. VCU chronic nonmalignant pain management. Available at: www.vcu-cme.org. Accessed March 26, 2007.

28. Rannazzisi JT, Caverly MW. Practitioner's manual: An informational outline of the controlled substances act. Available at: http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual090506.pdf. Accessed March 26, 2007.

29. Joranson DE, Gilson AM. Controlled substances, medical practice, and the law. In: Schwartz HI, ed. Psychiatric Practice Under Fire: The Influence of Government, the Media and Special Interests on Somatic Therapies. 1st ed. Washington, DC: American Psychiatric Press, Inc.; 1994:173.

30. Federation of State Medical Boards of the United States, Inc. Model policy for the use of controlled substances for the treatment of pain. J Pain Palliat Care Pharmacother. 2005;19:73-78.

31. Fishman SM, ed. Legal Aspects in Pain Medicine for Primary Care Physicians. New York, NY: Elsevier INC. and the Academy for Healthcare Education, Inc. (AHE); 2006. Davis A., ed.

32. Fudala PJ, Johnson RE. Development of opioid formulations with limited diversion and abuse potential. Drug Alcohol Depend. 2006;83 Suppl 1:S40-7.

33. Cole BE. Recognizing preventing and medication diversion. Fam Pract Manag. 2001;8:37-41.

34. American Psychiatric Association. American Psychiatric Association Practice Guidelines for the Treatment of Psychiatric Disorders. Compendium 2006. American Psychiatric Publishing, Inc.; 2006.

35. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV - TR). 4th ed. Washington, DC: American Psychiatric Association; 2000.

36. The American Psychiatric Publishing Textbook of Clinical Psychiatry, Fourth Edition. 4th ed. American Psychiatric Publishing, Inc.; 2003.

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Appendix: Example of Contract High Street Health Center – Adult Medicine

CONTRACT FOR CONTROLLED SUBSTANCES PRESCRIPTIONS IN THE

MANAGEMENT OF CHRONIC CONDITIONS (Place Pt. label here) My provider, _______________________, and I agree that a controlled substance is a necessary part of the treatment for my chronic condition. I understand that medication only one part of the overall treatment plan and I agree to participate in all recommended treatments and follow-up. RISKS • I am aware that this medication has a potential for addiction, abuse, or dangerous

consequences if taken improperly. • I have been informed of the specific risks and side effects of my medication

including:

_____________________________________________________________________ _____________________________________________________________________

• (For women) I understand that if I become pregnant while taking this medication, my

baby may be born dependent on the medication and other risks to the child may exist. CONDITIONS • I will take the medication only as prescribed:

________________________________ (medication and dosing instructions)

• I will not get prescriptions for this or any similar medication from anywhere except the IMC.

• If an emergency occurs or I get hospitalized and for some reason another doctor must

prescribe my medications, I will inform the IMC as soon as possible. • I will use only one pharmacy to fill these prescriptions and that will be: ______________________________________. Phone number: ________________.

My provider has permission to speak with the pharmacy about prescriptions at any time. If I choose to change pharmacies for any reason, I will first notify my provider.

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• I have fully informed my provider of any current or prior use of alcohol, medications,

or illegal drugs. • I will not abuse alcohol or use any illegal drugs while taking this medication. I agree

to let my provider check my pill count or my urine or blood at any time for alcohol or drugs upon request.

• I will not sell these medications or share them with anyone. • I understand that prescriptions will not be refilled before they are due even if lost or

stolen. It is my responsibility to keep track of the medication. • I am aware that prescriptions will not be provided for more that one month at a time

and that refills are not available at nights, on weekends, or by telephone. It is my responsibility to obtain prescription refills before they run out.

• I will inform the IMC immediately if I learn that I am pregnant. • I give the IMC permission to communicate with any of my other providers about my

use of controlled substances. • I will refrain from any abusive, threatening or inappropriate behavior with any clinic

staff or patients. I understand that if I fail to meet all the agreements of this contract that the IMC may need to stop prescribing any of this type of medication for me and that I may need to enter a chemical dependence program to avoid withdrawal. Patient: ______________________________________ Date: ____________ Physician: ______________________________________ Date: ____________ Nurse: ______________________________________ Date: ____________ last revised 5/21/04

26

A Comprehensive A Comprehensive Approach to Managing Approach to Managing PatientPatient’’s Chronic Pain s Chronic Pain

(and Yours)(and Yours)

Christina Nicolaidis, MD, MPHChristina Nicolaidis, MD, MPHDivision of General Internal MedicineDivision of General Internal MedicineOregon Health & Science UniversityOregon Health & Science University

Goal #2:

Make pain management less painful

for you

Goal #1:

Help manage patient’s chronic

pain

ObjectivesObjectives

Understand a framework for making and Understand a framework for making and communicating decisions regarding the communicating decisions regarding the initiation, continuation, and cessation of initiation, continuation, and cessation of narcotics in patients with chronic pain.narcotics in patients with chronic pain.

Narcotics for chronic pain:Narcotics for chronic pain:What is the providerWhat is the provider’’s role?s role?

VS.

The RiskThe Risk--Benefit Benefit Framework:Framework:

Judge the treatment, not the Judge the treatment, not the patientpatient

• Is the patient good or bad?

• Does the patient deserve pain meds?

• Should this patient be punished or rewarded?

Do the benefits of this treatment outweigh the untoward effects and risks in this patient*?

*(or to society)

Factors Affecting Factors Affecting Experience of PainExperience of Pain

Pain

Underlying disease

Treatment

Spirituality / Sources

of Strength & Meaning Social Stressors

/ SupportsMental Health

Past or Current Violence & Abuse

Addiction

Assessing Factors Affecting PainAssessing Factors Affecting Pain

Listen to ptListen to pt’’s pain history, show empathy, and s pain history, show empathy, and validate that you believe pain is real FIRST.validate that you believe pain is real FIRST.Discuss how many factors may make pain Discuss how many factors may make pain ““more more severesevere”” or or ““harder to treatharder to treat”” ((ieie I will take your I will take your pain more seriously, not discount it).pain more seriously, not discount it).Find something to admire in every patient Find something to admire in every patient –– make make it really clear what that is. Reinforce strengths. it really clear what that is. Reinforce strengths. Partner with pt. Share control wherever poss.Partner with pt. Share control wherever poss.(especially in patients with a history of abuse.)(especially in patients with a history of abuse.)

Setting the StageSetting the Stage

Discuss possible FUNCTIONAL benefit pt Discuss possible FUNCTIONAL benefit pt anticipates from initiation/change of narcoticsanticipates from initiation/change of narcotics

What can pt expect to do with What can pt expect to do with txtx that s/he cannot that s/he cannot do now?do now?

Jointly decide how you will measure itJointly decide how you will measure itSet actionSet action--oriented, realistic, measurable, pertinent oriented, realistic, measurable, pertinent selfself--management goals.management goals.

Offer all prescriptions/changes as a Offer all prescriptions/changes as a ““testtest””Continuation will depend on whether we can see Continuation will depend on whether we can see clear benefit.clear benefit.

Setting the stage Setting the stage –– contcont’’ddDiscuss possible risks Discuss possible risks of medicationof medication (good pt; bad (good pt; bad med) including sedation, constipation, nausea, med) including sedation, constipation, nausea, dependence and addiction.dependence and addiction.

Assign responsibility to pt to look out for early signs Assign responsibility to pt to look out for early signs that meds may be harming him/her.that meds may be harming him/her.Discuss how you will monitor for these risks (LFT Discuss how you will monitor for these risks (LFT analogy)analogy)

Pain contract, 1 doc, 1 pharmacy, scripts timed to visits, Pain contract, 1 doc, 1 pharmacy, scripts timed to visits, no early/phone refills, urine drug tests, etc.no early/phone refills, urine drug tests, etc.

Use consistent approach with every patient Use consistent approach with every patient regardless of risk profile. (regardless of risk profile. (““AntiAnti--discrimination discrimination policy.policy.””))

MaintenanceMaintenanceRegularly scheduled followRegularly scheduled follow--up visits (q1up visits (q1--3 3 months)months)-- Review ptReview pt’’s goals; is s goals; is ““testtest”” is working?is working?Link decisions to continue narcotics to clear Link decisions to continue narcotics to clear functional benefit associated with med.functional benefit associated with med.

Not Not ““I still have pain, so I still need I still have pain, so I still need narcsnarcs,,”” but but ““My My meds allow me to do X, so it is worth it to me to meds allow me to do X, so it is worth it to me to keep taking them.keep taking them.””

Reassess factors affecting experience of pain.Reassess factors affecting experience of pain.Specifically asses for constipation, sedation, Specifically asses for constipation, sedation, addiction. addiction. Document 4 ADocument 4 A’’s.s.

What if it isnWhat if it isn’’t working?t working?

Reassess factors affecting pain; reReassess factors affecting pain; re--attempt to attempt to treat underlying disease and cotreat underlying disease and co--morbidities.morbidities.If pt selfIf pt self--escalated or ran out early, consider escalated or ran out early, consider addiction vs. pseudoaddiction vs. pseudo--addiction.addiction.If more likely treatment failure or pseudoIf more likely treatment failure or pseudo--addiction, further escalate dose, again as a addiction, further escalate dose, again as a ““testtest””..If escalation fully or partially improves pain, If escalation fully or partially improves pain, continue.continue.No effect = no benefit, hence benefit cannot No effect = no benefit, hence benefit cannot outweigh risks outweigh risks –– so STOP narcotics. so STOP narcotics.

No Benefit ScenarioNo Benefit Scenario

Stress how much you believe / empathize with Stress how much you believe / empathize with patientpatient’’s pain severity and its pain severity and it’’s terrible impact.s terrible impact.Express frustration re. lack of good pill to fix it.Express frustration re. lack of good pill to fix it.Taper narcotics to avoid withdrawal/rebound.Taper narcotics to avoid withdrawal/rebound.Focus on patientFocus on patient’’s strengths, need to use them s strengths, need to use them for participating in selffor participating in self--help, therapy, etc.help, therapy, etc.Some return saying pain is no different now.Some return saying pain is no different now.Some return with better appreciation for medsSome return with better appreciation for meds’’benefits and more realistic expectations.benefits and more realistic expectations.

Breach of Contract ScenarioBreach of Contract Scenario

Explain why breach of contract raises your Explain why breach of contract raises your concern for addiction.concern for addiction.Benefits no longer outweighing risks. Cannot Benefits no longer outweighing risks. Cannot responsibly continue prescribing narcotics as I responsibly continue prescribing narcotics as I feel it would cause you more harm than good.feel it would cause you more harm than good.Stay 100% in Stay 100% in ““Benefit/Risk of MedBenefit/Risk of Med”” mindset, mindset, (even if pt angry, threatening, accusatory, etc.)(even if pt angry, threatening, accusatory, etc.)Visit may be unpleasant, but no where near as Visit may be unpleasant, but no where near as bad as when in bad as when in ““need to reprimandneed to reprimand”” mode.mode.

Breach of Contract Breach of Contract –– ContCont’’d.d.

Always offer referral to substance abuse Always offer referral to substance abuse treatment.treatment.Not o.k. to treat addiction (except for Not o.k. to treat addiction (except for bupinorphinebupinorphine exemption), but o.k. to treat pain, exemption), but o.k. to treat pain, as long as addiction getting addressed.as long as addiction getting addressed.

Bridge / taper to last until entry into programBridge / taper to last until entry into programLeave door open for return after successful Leave door open for return after successful addiction treatment. (It does happen!)addiction treatment. (It does happen!)

You do not have to taper meds or bridge to new You do not have to taper meds or bridge to new PCP PCP –– narcotic withdrawal not lifenarcotic withdrawal not life--threatening.threatening.

Concern for DiversionConcern for Diversion

Negative urine drug screen in pt on Negative urine drug screen in pt on narcsnarcs..Talk to your lab to understand your local test Talk to your lab to understand your local test ––some not sensitive at all to lowsome not sensitive at all to low--dose narcotics.dose narcotics.I usually bring pt back and ask details of when I usually bring pt back and ask details of when last took meds, without telling them why (easy last took meds, without telling them why (easy to hide diversion if pt knows you suspect it), to hide diversion if pt knows you suspect it), then repeat then repeat UtoxUtox..If still high concern, d/c narcotics. Same If still high concern, d/c narcotics. Same approach, but risk is to society. approach, but risk is to society.

SummarySummary

Chronic pain is influenced by many factors.Chronic pain is influenced by many factors.Understanding and treating these factors is a Understanding and treating these factors is a necessary step to pain management.necessary step to pain management.You can use information about patientsYou can use information about patients’’strengths, history of abuse, control issues, etc. to strengths, history of abuse, control issues, etc. to improve your therapeutic relationship and ptimprove your therapeutic relationship and pt’’s s selfself--efficacy.efficacy.

SummarySummary

Tie narcotic prescribing to measurable, realistic, Tie narcotic prescribing to measurable, realistic, functional benefits. Present all prescriptions as functional benefits. Present all prescriptions as trials.trials.Monitor for adverse effects including signs of Monitor for adverse effects including signs of addiction (and give responsibility to pt to detect addiction (and give responsibility to pt to detect early signs).early signs).Use a Use a ““Risk/BenefitRisk/Benefit”” model to stay in caring model to stay in caring provider role, even when provider role, even when d/cd/c’’inging meds.meds.

And honestly, And honestly,

A coordinated approach to pain management A coordinated approach to pain management is possible is possible -- and and really rewardingreally rewarding -- in a in a

primary care setting.primary care setting.

For more info, or copies of any of our For more info, or copies of any of our forms, contact me at forms, contact me at [email protected]@ohsu.edu

Documents

SGIM 2007 Annual Meeting Workshop: Opioids for Chronic ...impak.sgim.org/userfiles/file/AMHandouts/AM07/handouts/WFO6.pdf · SGIM 2007 Annual Meeting Workshop: Opioids for Chronic