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Appropriate Opioid Medication Use as Part of a Comprehensive Pain Management Approach MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

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Page 1: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Appropriate Opioid Medication Use as Part of

a Comprehensive Pain Management Approach

MPhA MTM Fall SymposiumKathryn Perrotta, PharmD, MBA, BCPS

November 16, 2012

Page 2: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Disclosure Statement

Page 3: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Define the health economic impact of the use of opioid analgesics in the treatment of pain

Apply evidence based guidelines in moderate to severe chronic non-cancer pain management

Address abuse, misuse and diversion reduction strategies (proper disposal options and PMP)

Explore the role of ambulatory care pharmacists in primary care pain management and opportunities for collaboration with other professionals in the health care team

Objectives

Page 4: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Concern: significant increase in opioid prescriptions

Sales of opioids quadrupled between 1999 and 2010 (government statistics)

The annual cost associated with all types of pain, both direct and indirect costs, is estimated to be in the range of $560 to $635 billion annually in the United States

Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492.

Health Economic Impact of Opioids in the Treatment of Pain

Page 5: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

~60 million Americans have some type of chronic nonmalignant pain

~40% of patients do NOT receive adequate pain relief

Health Economic Impact of Opioids in the Treatment of Pain

Page 6: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Detailed History◦ Onset, duration, quality, character of pain◦ Ameliorating and provoking factors

Pain Rating◦ Patient self report: most reliable indicator of pain◦ Numerous assessment tools available for pain in adults

Numeric rating scales (1-10)

Assessment◦ Is pain due to reversible etiology?◦ Identify cause of pain

Reason for specialist? Rheumatoid arthritis, knee pain, headache, etc.

www.icsi.org Assessment and Management of Acute Pain guidelines and Assessment and Management of Chronic Pain Guidelines

Assessment of Pain

Page 7: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Acute vs. Chronic Pain◦ Has pain persisted longer than 6 weeks?

IAP defines chronic pain as “pain that persists beyond normal tissue healing time, which is assumed to be 3 months”

Determine Pain Mechanism (3 general types)◦ Somatic◦ Visceral◦ Neuropathic

Different symptoms Different treatment indicated

www.icsi.org Assessment and Management of Acute Pain guidelines and Assessment and Management of Chronic Pain Guidelines. Fifth Edition, November 2011.

Assessment of Pain

Page 8: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Result of tissue damage Release of chemicals from injured cells that

mediate pain and inflammation via nociceptors Typically recent onset and well localized

www.icsi.org Assessment and Management of Acute Pain guidelines and Assessment and Management of Chronic Pain Guidelines. Fifth Edition, November 2011.

Somatic (Inflammatory) Pain

Description of Somatic Pain

Examples

SharpAching

StabbingThrobbing

LacerationsSprains

FracturesDislocations

Page 9: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Result from visceral nociception◦ Solid and Hollow organs

Fewer nociceptors◦ Result in poorly localized, diffuse and vague

complaints

www.icsi.org Assessment and Management of Acute Pain guidelines and Assessment and Management of Chronic Pain Guidelines. Fifth Edition, November 2011.

Visceral Pain

Description of Visceral Pain

Examples

Generalized ache/pressureAutonomic symptoms:

N/V, hypotension, bradycardia, sweating

Ischemia/necrosisLigamentous stretchingHollow viscous or organ

capsule distension

Page 10: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Injury to a neural structure leading to aberrant processing Typically chronic pain caused by damage to peripheral nerves

www.icsi.org Assessment and Management of Acute Pain guidelines and Assessment and Management of Chronic Pain Guidelines

Neuropathic Pain

Description of Neuropathic Pain

Examples

RadiatingBurningTingling

“Electrical Like”

DiabetesShingles

MSHerniated discs

From radiation/chemo

Page 11: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Determine Patient’s Pain Goals ◦ If chronic pain patient may need to counsel on

expectations of pain relief◦ Assess for risk of substance abuse, misuse, or addiction

Avoid Unrealistic Expectations in Chronic Pain Patients◦ Improvement with opioids generally average < 2-3 points

on average 0-10 scale◦ Concentrate on quality of life and improving therapeutic

goals

Stress importance of utilizing other modalities◦ Medications that are multi-modal in treating pain

Alternative therapies www.icsi.org Assessment and Management of Acute Pain guidelines and Assessment and Management of Chronic Pain

Guidelines. Fifth Edition, November 2011.

Assessment of Pain

Page 12: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Assessment is Key!

Page 13: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Most Responsive Treatments

Somatic Pain Visceral Pain Neuropathic Pain

•acetaminophen•cold packs•corticosteroids•lidocaine patches•NSAIDs•opioids•tactile stimulation

•corticosteroids•intraspinal localanesthetic•NSAIDs•opioids

•gabapentin•pregabalin•corticosteroids•neural blockade•NSAIDs •opioids •TCAs•duloxetine

www.icsi.org Assessment and Management of Acute Pain guidelines and Assessment and Management of Chronic Pain Guidelines. Fifth Edition, November 2011.

Page 14: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

McCaffery M, Pasero C. Pain Clinical Manual. 1999:21.

3. Perception of Pain

Page 15: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Analgesia and the Pain Pathway

Descending modulation

Dorsal horn

Ascendinginput

Spinothalamic tract

Dorsal root ganglion

Peripheral nerve

Peripheral nociceptors

Pain

Trauma

Local anestheticsOpioids 2-agonistsCOX-2 selective inhibitors

Opioids 2 -agonists Centrally acting analgesicsAnti-inflammatory agents (COX-2 selective inhibitors, nonselective NSAIDs

Local anesthetics

Adapted by Dr. Todd Hess (United Pain Center) from Gottschalk et al. Am Fam Physician. 2001;63:1979-1984.

OpioidsLocal anesthetics Anti-inflammatory agents (COX-2 selective inhibitors, nonselective NSAIDs)

Page 16: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

“Wind-up ” Phenomenon

0

20

40

60

80

100

|----0.5 Hz----|

neu

ron

res

po

nse

Repetitive stimulation of spinal neurons evokes an increasing level of response

NMDA receptor antagonists block this effect

Page 17: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Intense pain worsening over time Causes: most frequently trauma to extremity or

surgery/infection

Pathophysiological mechanism of CRPS is ongoing nociceptor input from periphery to CNS. ◦ Characterized by hyperalgesia, allodynia, vasomotor changes,

abnormal regulation of blood flow and sweating, joint stiffness, localized skin edema

Treatment of CRPS can be difficult; ◦ Often misdiagnosed and can be irreversible if undiagnosed

◦ Recommended that combined analgesic regimens (multimodal analgesia) be used to prevent CRPS

• Reuben, S. Anesthesiology. 2004;101:1215-1224. Burns, A. J Orthop Surgery. 2006; 14(3):280-3.

Complex Regional Pain Syndrome

Page 18: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

A variety of different and integrated disciplines:

◦Pharmacologic Complementary/synergistic mechanisms of

action to inhibit effects of pain mediators and enhance the effects of pain modulation

Non-opioids used in combination with opioids can decrease the total amount of opioid needed for pain control

Applying the Multimodal Approach of Therapy to Chronic Pain Patients

Page 19: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Acetaminophen

Cox-2s, NSAIDs

Modulating agents◦Duloxetine, TCAs, tramadol, etc.

Topical agents◦Lidocaine patches

Gabapentin ◦neuropathic pain prevention and treatment

Applying the Multimodal Approach of Therapy to Chronic Pain Patients

Page 20: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

A variety of different and integrated disciplines:◦Non-Pharmacologic: Exercise Massage Acupuncture Reiki Cognitive Behavioral Therapy Physical Therapy TENS therapy

Applying the Multimodal Approach of Therapy to Chronic Pain Patients

Page 21: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Incomplete Cross tolerance of opioids:

A) A physiological phenomenon following use of opioids for > 2 weeks

B) State of adaptation in which exposure to a drug decreases its effect over time

C) Due to the different molecular entities of opioids, a person on an opioid for a long perioid of time will not be as tolerant to the effects of a new opioid

Page 22: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Adjunctive Therapy Options

Assess if the opioid is right for patient◦ Effectiveness◦ Adverse Effects: N/V, puritis, constipation, respiratory

depression◦ Renal metabolism/use in liver failure

Be aware of incomplete cross tolerance effect of opioids◦ Tolerance may develop to the opioid in use but may not be as

marked relative to other opioids

Opioid Management

Page 23: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

fentanyl synthetic to

non-synthetic

hydromorphone, hydrocodone

oxycodone

morphine,

codeine

Page 24: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Comparison of ORAL OpioidsOxycodone

Hydromorphone(Dilaudid)

Tramadol

Onset of Action

(minutes)10-15 (IR)60-90 (CR)

15-30

60

Peak Response

1 hour 60-90 mins 2-3 hours

Duration of Effect

(hours)

4-6 (IR)8-12 (CR)

4-6 4-6

Renal Elimination

Yes Yes Yes

Prolonged in Hepatic Failure

Yes Yes Yes

Page 25: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Comparison of Opioids

Opioid Oral Onset of action Duration of Action

Codeine 200 mg 15-30 min 3-4 hrs

Hydrocodone 30 mg 15-30 min 4-8 hrs

Hydromorphone 7.5 mg 15-30 min 4-6 hrs

Methadone Varies* 30-60 min Varies

Morphine 30 mg 15-60 min 3-6 hrs

Morphine ER 30 mg 60-90 min 8-12 hrs

Oxycodone 20 mg 10-15 min 4-6 hrs

Oxycodone CR 20 mg 60-90 min 8-12 hrs

*Consult APS Guidelines

Page 26: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Morphine and Metabolites

Morphine

liver

M-3-GM-6-G, normorphine

Analgesia

Confusion, Sedation, Respiratory Depression

kidney

Hyperalgesia, myoclonus

Page 27: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Methadone◦ 1/3 of opioid related overdose deaths while only a

few percent of total opioid prescriptions◦ Do NOT use for mild, acute or “break through pain”◦ NOT for opioid naïve patients

Clinical Aspects◦ Long and unpredictable ½ life ◦ Multiple drug interactions◦ QT prolongation

ECG before starting and when doses >200mg/day Switching from another opioid: 70-90% reduction of

equianalgesic dose

Morbidity & Mortality Weekly Report. 2012;61(26):493-497. © 2012 Centers for

Disease Control and Prevention (CDC)

Opioid Management

Page 28: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Fentanyl (Duragesic®) Transdermal system

◦ Onset of action: 12-18 hours, used Q 48 or 72 hrs

◦ Chronic, stable pain only

◦Elimination after patch removal: 13-22 hrs

◦ Fever can result in up to 30% ↑ in drug levels ⊘ Heating pad or hot tub

◦ Not best option for catechetic pt weighing <50kg; unpredictable absorption +/or elimination

Page 29: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Opioid Rotation: Change in opioid drug with the goal of improving outcomes

Indications for Opioid Rotation:◦ Occurrence of intolerable adverse effects◦ Poor analgesia despite aggressive dose titration◦ Change in clinical status◦ Financial or drug availability consideration

Deciding Next Specific Opioid:◦ Past experience with different opioids,

sensitivities, efficacy, etc.

Fine, G. Opioid Rotation: Definition and Indications. Pain Management Today eNewsletter series. American Pain Foundation. , Quadrant HealthCom Inc. ; 2010: (1): 9. http://newsletter.qhc.com/JFP/JFP_pain032411.htm

Opioid Management

Page 30: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Opioid Rotation Guidelines:◦ Calculate equianalgesic dose of new opioid◦ Identify automatic dose reduction of 25-50% lower than

calculated equianalgesic dose 50% reduction if high current opioid dose, elderly, non-white,

or frail 25% reduction if patient not above

◦ Strategy to frequently assess initial response and titrate new dose◦ Supplemental “rescue” dose for prn: calculate 5-15% and

administer at appropriate intervalFine, G. Opioid Rotation: Definition and Indications. Pain Management Today eNewsletter series. American Pain Foundation. , Quadrant HealthCom Inc. ; 2010: (1): 9.

http://newsletter.qhc.com/JFP/JFP_pain032411.htm

Opioid Management

Page 31: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

American Pain Society (APS). Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain, 6th edition. 2008. Glenview, IL 60025.

Equianalgesic DosingStandard Opioid-PO Opioid Parenteral

Oxycodone 20mg

Hydrocodone 30mg NA

Hydromorphone 7.5mg Hydromorphone 1.5mg

Methadone: Consult Expert

Morphine 30mg Morphine 10mg

Page 32: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

51 year old white female patient with chronic pain due to MVA

Current Medications:MS Contin 30mg TID

Hydrocodone/APAP 5/500 1-2 tabs qid prn (patient states she take 6 tabs/day)

Atenolol 50mg qday Senokot-S 1 tab bid

MD asks you to convert this patient to oxycodone due to recent increased itching and ineffective control of pain.

Opioid Rotation: Patient Case

Page 33: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

1) Conversion:Total oxycodone equivalent/day: 90mg morphine + 30mg hydrocodone

90mg morphine = 60mg oxycodone

30mg hydrocodone = + 20mg oxycodone 80mg (total oxycodone

dose)

2) Should we suggest the total oxycodone dose or reduce?

Opioid Rotation: Patient Case

Page 34: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

2) Reduction of Dose:Total oxycodone equivalent/day: 80mg

80mg x 0.25 = 20 mg so reducing by 25% the total daily dose would be 60mg oxycodone

3) How do we want to give the oxycodone 60mg?Slow versus immediate release?

Opioid Rotation: Patient Case

Page 35: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

3) How do we want to give the oxycodone 60mg?

◦ Oxycontin 15mg TID plus oxycodone 5-10mg tid prn (start with 5mg)

◦ Patient would be taking 45mg + 15-30mg = 60-75mg

◦ Could switch morphine to oxycodone, keep on hydrocodone prn dose for first few days, reassess then switch to oxycodone

Opioid Rotation: Patient Case

Page 36: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Other considerations:

1. What other medications may this patient benefit from?

2. How would you have established this?

3. Does patient need high dose of opioid?

4. Has patient tried other modes of therapy such as stretching (Physical therapy involvement), massage, TENS unit or cognitive behavioral therapy (non-drug methods)?

Opioid Rotation: Patient Case

Page 37: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Essential to identify if:◦ Patient successful ◦ Patient might benefit more with restructuring of

treatment◦ Need treatment for addiction◦ Benefits outweighed by harm

Frequency of monitoring:◦ Patient on stable doses

Every 3-6 months

◦ After initiation of therapy, changes in opioid doses, with a prior addictive disorder, psychiatric conditions, unstable social environments Weekly basis may be necessary

Chou, R, Fanciullo, G, Fine, P, et. al. Opioid Treatment Guidelines: Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain: an update of Society-American Academy of Pain Medicine Opioids Guidelines Panel. The Journal of Pain.  2009 Feb;10(2):113-130.

Monitoring Patients on Opioids

Page 38: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Should include:◦ Assessment and documentation of pain severity and

functional ability◦ Progression towards achieving therapeutic goals◦ Presence of adverse effects◦ Clinical assessment and detailed documentation for

aberrant drug related behaviors, substance use and psychological issues If suspect above may need to implement:

Pill counts Urine drug screening Family member/caregiver interviews Use of prescription monitoring plans

Chou, R, Fanciullo, G, Fine, P, et. al. Opioid Treatment Guidelines: Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain: an update of Society-American Academy of Pain Medicine Opioids Guidelines Panel. The Journal of Pain.  2009 Feb;10(2):113-130.

Monitoring Patients on Opioids

Page 39: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Most predictable factor for drug abuse, misuse, or other aberrant drug related behavior:◦ Personal or family history of alcohol or drug abuse

Other factors associated with aberrant drug related behaviors:◦ Younger age◦ Presence of psychiatric conditions

Opioid therapy in these patients requires intense structured monitoring and management by professionals with expertise in both addiction medicine and pain management ***DOCUMENT***

Chou, R, Fanciullo, G, Fine, P, et. al. Opioid Treatment Guidelines: Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain: an update of Society-American Academy of Pain Medicine Opioids Guidelines Panel. The Journal of Pain.  2009 Feb;10(2):113-130.

Assessment of Patient for Addictive Risk

Page 40: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Assessment Tools Available:◦ Webster's Opioid Risk Tool (ORT)◦ DIRE Tool◦ Screener and Opioid Assessment for Patients in Pain

(SOAPP®)◦ Current Opioid Misuse Measure (COMMTM)◦ Prescription Drug Use Questionnaire (PDUQ)◦ Screening Tool for Addiction Risk (STAR)◦ Screening Instrument for Substance Abuse

Potential (SISAP)◦ Pain Medicine Questionnaire (PMQ)www.icsi.org Assessment and Management of Acute Pain guidelines and Assessment and Management of

Chronic Pain Guidelines. Fifth Edition, November 2011.

Assessment of Patient for Addictive Risk

Page 41: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Pseudoaddiction to Opioids:

A) A drug seeking behavior occurring in patients who are receiving inadequate pain control

B) State of adaptation in which exposure to a drug decreases its effect over time

C) Characterized by behaviors that include impaired control over drug use and continuation despite harm to self or others

Page 42: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Repeated Opioid Dose Escalations: When repeatedly occur, evaluate for potential causes:

◦ Assess for treatment control (pseudoaddiction?)◦ Possible marker for substance abuse disorder or

diversion

Theoretically no maximum or ceiling◦ High dose definition = >200mg po morphine/day

AAP Opioid Consensus Panel

Some studies suggest higher doses of opioids lead to:◦ Hyperalgesia◦ Neuroendocrinologic dysfunction◦ Possible immune suppression

Chou, R, Fanciullo, G, Fine, P, et. al. Opioid Treatment Guidelines: Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain: an update of Society-American Academy of Pain Medicine Opioids Guidelines Panel. The Journal of Pain.  2009 Feb;10(2):113-130.

Opioid Management

Page 43: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Weaning/Tapering Off Opioids:

Institute when:◦ Patient engages in serious or repeated

aberrant drug-related behaviors or diversion◦ Experience of intolerable side effects◦ Making no progress towards meeting therapeutic goals

Approaches to Weaning Opioid:◦ Slow: 10% dose reduction per week◦ Rapid: 25-50% reduction every few days◦ Slower rate may help reduce unpleasant symptoms of

opioid withdrawal

Chou, R, Fanciullo, G, Fine, P, et. al. Opioid Treatment Guidelines: Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain: an update of Society-American Academy of Pain Medicine Opioids Guidelines Panel. The Journal of Pain.  2009 Feb;10(2):113-130.

Opioid Management

Page 44: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Diagnosing Addiction in Patients Taking Opioids:

Evidence of compulsive drug use, characterized by:◦ Unsanctioned dose escalation◦ Continued dosing despite significant side effects◦ Use to treat for symptoms not targeted by therapy◦ Use during periods of no symptoms

Evidence of one or more associated behaviors:◦ Manipulation of MDs or medical system to obtain

additional opioids◦ Acquisition of drugs from other medical sources or non-

medical sources◦ Drug hoarding or sales◦ Unapproved use of other drugs (alchohol or other)

Hojsted, J, Sjogren, P. Addiction to Opioids in Chronic Pain Patients: A Literature Review. European Journal of Pain.  2007;11:490-518.

Opioid Management

Page 45: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Consider for patient not well known and/or higher risk of misuse

Example of components of opioid agreement:◦ Specified the conditions under which opioids would

or would not be prescribed ◦ Patient responsibilities

Only receive opioids from Dr. ________ Will not give medications to anyone else If my prescription runs out early for any reason;

have to wait until next prescription is due.

Example of an Opioid Management Agreement: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1829426/figure/Fig1

Opioid Management Agreement

Page 46: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Random urine drug screening performed if recommended by the physician to monitor adherence and possible use of illicit substances.

Patients informed that the agreement would be discontinued if patient responsibilities were not met.

Responsibilities of the physician and/or clinic staff included providing monthly prescriptions on the due date, monitoring the effects of therapy, and providing ongoing care.

Patient signs agreement

Opioid Management Agreement

Page 47: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Pharmacies licensed by the MN Board of Pharmacy and other dispensing facilities are required to report the dispensing of controlled substances listed in the state’s Schedules II-IV. ◦ Data is submitted electronically.

Patient controlled substance prescription history is available to

prescribers and pharmacists Available 24/7, 365 days a year, with information such as:

◦ Quantity and dosage of controlled substance dispensed, ◦ Pharmacy that dispensed the prescription◦ In some cases, the practitioner

Assists in checking for potential drug interactions, patterns of misuse, potential diversion or abuse and generally to assist in determining the appropriateness in dispensing.

For pharmacist access: http://pmp.pharmacy.state.mn.us/pharmacist-

rxsentry-access-form.html

Prescription Monitoring Program

Page 48: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Rational Use

1. Reassure patients prescribed opioids or benzos are taking as directed, evidenced by positive results

2. Make sure not being misused Stockpiling or selling to unauthorized others Evidenced by negative results

3. Detect presence of illicit non-prescribed drugs Heroin, cocaine, non-prescribed opioids, etc.

Tenore, P. Advanced Urine Toxicology Testing. Journal of Addictive Diseases, 2010;29:436-448.

Urine Drug Screening

Page 49: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Two types of tests used:

1. Immunoassay ◦ Classify drug as present or absent◦ Any response above the cutoff is deemed positive◦ Any response below the cutoff is negative ◦ Subject to cross-reactivity◦ Some detect specific drugs, while others classes,

i.e. opioids

Gourly D, Helt H, Yale C. Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care. Stanford, CT: California Academy of Family Physicians, PharmaCom Group, Inc; 2010.

Urine Drug Screening

Page 50: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Immunoassay Pearls:

Human urine has a creatinine concentration greater than 20 mg/dL.

In the clinical setting it is important that 300 ng/mL or less be used for initial screening of opiates (Food stuff and poppy seed can make +); Confirm with laboratory test

Opiate Class; lower sensitivity to hydromorphone , hydrocodone, oxycodone , oxymorphone, fentanyl, meperidine, and methadone

Gourly D, Helt H, Yale C. Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care. Stanford, CT: California Academy of Family Physicians, PharmaCom Group, Inc; 2010.

Urine Drug Screening

Page 51: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Metabolites

Gourly D, Helt H, Yale C. Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care. Stanford, CT: California Academy of Family Physicians, PharmaCom Group, Inc; 2010.

Page 52: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Immunoassay Pearls (continued):

Amphetamine/methamphetamine are highly crossreactive◦ may detect other ephedrine and pseudoephedrine◦ Further testing may be required by a more specific

method, i.e. GC Opiate class: morphine and codeine Ability of opiate immunoassays to detect semisynthetic/

synthetic opioids varies among assays because of differing cross-reactivity patterns.

Specific immunoassay tests for some semisynthetic/ synthetic opioids may be available (eg, oxycodone, methadone).

Gourly D, Helt H, Yale C. Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care . Stanford, CT: California Academy of Family

Physicians, PharmaCom Group, Inc; 2010.

Urine Drug Screening

Page 53: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

2. GC/MS (Laboratory Testing) Generally, a more definitive laboratory-based

procedure Identify specific drugs; may be needed: (1) Specifically confirm the presence of a given

drug; i.e. morphine is the opiate causing the + IA response(2) to identify drugs not included in an immunoassay test(3) when results are contested.

Gourly D, Helt H, Yale C. Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care. Stanford, CT: California Academy of Family Physicians, PharmaCom Group, Inc; 2010.

Urine Drug Screening

Page 54: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Examples of cross-reacting compounds for certain immunoassays

Interfering drug Immunoassay affected

Quinolone antibiotics OpiatesTrazodone FentanylVenlafaxine PhencyclidineQuetiapine MethadoneEfavirenz THCPromethazine AmphetamineDextromethorphan PhencyclidineProton pump inhibitors THC

Gourly D, Helt H, Yale C. Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care. Stanford, CT: California Academy of Family Physicians, PharmaCom Group, Inc; 2010.

Urine Drug Screening

Page 55: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Approximate windows of detection of drugs in urine

Detection time Drug in urineAmphetamines Up to 3 daysTHC (Single use) 1 to 3 days (Chronic use) Up to 30 daysCocaine use 2 to 4 daysOpiates (morphine, codeine) 2 to 3 daysMethadone Up to 3 daysEDDP (methadone metabolite) Up to 6 daysBenzodiazepines Days to weeks

Gourly D, Helt H, Yale C. Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care. Stanford, CT: California Academy of Family Physicians, PharmaCom Group, Inc; 2010.

Urine Drug Screening

Page 56: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Consult lab regarding anything unexpected

Schedule appointment to discuss with patient◦ Be positive and supportive

Use to strengthen the healthcare professional-patient relationship

Support positive behavior change

What to do with UDT Results?

Page 57: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

FDA recommendations for disposal◦ Locate medication take back program in

community

◦ Example: Dakota County Sherriff’s Office has a drop box at the Burnseville Police Department and the Hastings Sherriff’s Office where people can drop off their prescriptions anonymously

◦ Many drop box locations in Hennepin county: http://www.hennepin.us/medicine

Drug Disposal

Page 58: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Hennepin County Drop Box Example:

http://www.hennepin.us/medicine

Page 59: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

FDA recommendations for disposal◦ If no medication take back program

Mix medications with unpalatable substance Place mixture in container such as sealed bag Throw container in household trash

◦ Exception: List of meds recommended to dispose by flushing http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm

Drug Disposal

Page 60: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

FDA recommended for flushing (examples):◦ Fentanyl (SL tabs, film, lozenge, patch)◦ Morphine◦ Meperidine◦ Hydromorphone◦ Methadone◦ Oxycodone◦ Tapentadol

Others listed on FDA updated website:http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm

Drug Disposal

Page 61: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Federal controlled substance laws and rules prohibit a pharmacy from receiving controlled substances from anyone who is not a registrant of the US DEA.

Pharmacists are not allowed to accept controlled substances from patients or members of the public.

Drug Disposal

Page 62: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

Assessment of pain is key every time you see a patient

Opioids can be part of a comprehensive pain management approach for a non-cancer chronic pain patient; document all assessment and communication regarding opioids each office visit

Ensure pain is being treated appropriately with a multimodal approach using the best medications and therapy for the individual patient

Utilize expertise of other non-pharmacy professionals for additional therapy to synergistically treat pain

Summary

Page 63: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

  Guidelines:Assessment and management of chronic pain. 2005 Nov (revised 2011 Nov). NGC:008967Institute for Clinical Systems Improvement - Nonprofit Organization.  Adult acute and subacute low back pain. 1994 Jun (revised 2012 Jan). NGC:008959Institute for Clinical Systems Improvement - Nonprofit Organization

  Diagnosis and treatment of headache. 1998 Aug (revised 2011 Jan). NGC:008263Institute for Clinical Systems Improvement - Nonprofit OrganizationPain (chronic). 2003 (revised 13 May 2011). NGC:008519 Work Loss Data Institute - For Profit Organization.Guideline for the evidence-informed primary care management of low back pain. 2009 Mar. [NGC Update Pending] NGC:007704Institute of Health Economics - Nonprofit Research Organization; Toward Optimized Practice - State/Local Government Agency [Non-U.S.]. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. 2009 Feb. NGC:007852 American Academy of Pain Medicine - Professional Association; American Pain Society. Other References: 1) American Pain Society (APS). Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain, 6th edition. 2008. Glenview, IL 60025.2) Anderson AV, Fine PG, Fishman SM. Opioid Prescribing: Clinical Tools and Risk Management Strategies. Sonora, CA: American Academy of Pain Management; December 31, 2009. http://www.state.mn.us/mn/externalDocs/BMP/New_Article_on_Pain_Management_020110034248_monograph_dec_07_final.pdf. Accessed June 2012

3) Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492.4) Chou, R, Fanciullo, G, Fine, P, et. al. Opioid Treatment Guidelines: Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain: an update of Society-American Academy of Pain Medicine Opioids Guidelines Panel. The Journal of Pain.  2009 Feb;10(2):113-130.

5) Clark LG, Upshur CC. Family medicine physicians’ views of how to improve chronic pain management. J Am Board Fam Med. 2007;20(5):479-482.

6) Evans L, Whitham JA, Trotter DR, Filtz KR. An evaluation of family medicine residents’ attitudes before and after a PCMH innovation for patients with chronic pain. Fam Med. 2011;43(10):702-711

References

Page 64: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

7) Fine, G. Opioid Rotation: Definition and Indications. Pain Management Today eNewsletter series. American Pain Foundation. , Quadrant HealthCom Inc. ; 2010: (1): 9. http://newsletter.qhc.com/JFP/JFP_pain032411.htm

8) Gourly D, Helt H, Yale C. Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care. Stanford, CT: California Academy of Family Physicians, PharmaCom Group, Inc; 2010.

9) Hojsted, J, Sjogren, P. Addiction to Opioids in Chronic Pain Patients: A Literature Review. European Journal of Pain.  2007;11:490-518.

10) Katz NP. Opioid Prescribing Toolkit. Oxford/New York: Oxford University Press; 2010. 11) Leverence RR, Williams RL, Potter M, et al. Chronic non-cancer pain: a siren for primary care—a

report from the PRImary care MultiEthnic Network (PRIME Net). J Am Board Fam Med. 2011;24(5):551-561.

12) Matthias MS, Parpart AL, Nyland KA, et al. The patient-provider relationship in chronic pain care: physicians’ perspectives. Pain Med. 2010;11(11):1688-1697

13) The Management of Opioid Therapy for Chronic Pain Working Group. VA/DoD clinical practice guidelines: management of opioid therapy for chronic pain. 2010. Version 2.0-2010. http://www.healthquality.va.gov/COT_312_Full-er.pdf. Accessed June 2012.

14) Patanwala, et. al. Comparison of Opioid Requirements and Analgesic Response in Opioid-Tolerant versus Opioid-Naïve Patients After Total Knee Arthroplasty. Pharmacotherapy 2008;28(12):1453-1460

ne 2012. 15) Pizzo PA, Clark NM, Carter-Pokras O, et al; Institute of Medicine Committee on Advancing Pain

Research, Care, and Education. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington, D.C.: National Academies Press; 2011:119-120.

16) Project Lazarus. Community-based overdose prevention from North Carolina and the Community Care Chronic Pain Initiative. http://www.projectlazarus.org. Accessed Ju

17) Reuben, S. Anesthesiology. 2004;101:1215-1224. Burns, A. J Orthop Surgery. 2006; 14(3):280-3. 18) Tenore, P. Advanced Urine Toxicology Testing. Journal of Addictive Diseases, 2010;29:436-448.

19) Upshur CC, Luckmann RS, Savageau JA. Primary care provider concerns about management of chronic pain in community clinic populations. J Gen Intern Med. 2006;21(6):652-655.

20) Wismer B, Amann T, Diaz R, et al. Adapting Your Practice: Recommendations for the Care of Homeless Adults with Chronic Non-Malignant Pain. Nashville, TN: Health Care for the Homeless Clinicians’ Network, National Healthcare for the Homeless Council, Inc; 2011.

References (continued)

Page 65: MPhA MTM Fall Symposium Kathryn Perrotta, PharmD, MBA, BCPS November 16, 2012

QUESTIONS????????????