14
© 2012 by the American Pharmacists Association. All rights reserved. Transforming the Future of Pain Management Chris Herndon, PharmD, BCPS, CPE Phyllis Grauer, PharmD, CGP, CPE Supported by independent educational grants from Pfizer 2 and Purdue Pharma L.P. Disclosures Dr. Grauer has served as a consultant for Johnson & Johnson within the past 12 months Dr. Herndon has served as a consultant to Incline Therapeutics within the past 12 months 4 The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Learning Objectives Discuss the findings and recommendations of the Institute of Medicine’s report, Relieving pain in America: A blueprint for transforming prevention, care, education and research. Describe opportunities for pharmacists to support improved pain management for their patients. E plain the components of the REMS for long acting 5 Explain the components of the REMS for long-acting and extended-release opioids, and its impact on pharmacists. Describe the characteristics of medications recently approved for the management of pain. Discuss the clinical impact of recent published data describing the risks and benefits of analgesics. The Prevalence of Pain is Staggering 20% 25% 30% of U.S. adults last 3 months 6 CDC and NCHS. 2010. Health. United States, 2010. Chartbook, Special features on death and dying, Hyattsville, MD:CDC and NCHS. 0% 5% 10% 15% Low Back Neck Knee Headache Shoulder Finger Hip Age adjusted rates o reporting pain in the The Disability of Pain is Crippling 25.0% 30.0% 35.0% 40.0% 45.0% ity among adults with United States, 2009 7 CDC and NCHS. 2010. Health. United States, 2010. Chartbook, Special features on death and dying, Hyattsville, MD:CDC and NCHS. 0.0% 5.0% 10.0% 15.0% 20.0% Low Back Knee Headache Neck Shoulder Finger Hip Basic Actions Complex Activities Extent of pain-related disabili pain in the last 3 months, U

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Page 1: Transforming the Future of Pain Management FINAL w VC 030612elearning.pharmacist.com/Portal/Files... · 6/12/2003  · Transforming the Future of Pain Management Chris Herndon, PharmD,

© 2012 by the American Pharmacists Association. All rights reserved.

Transforming the Future of Pain Management

Chris Herndon, PharmD, BCPS, CPEPhyllis Grauer, PharmD, CGP, CPE

Supported by independent educational grants from Pfizer

22

and Purdue Pharma L.P.

Disclosures• Dr. Grauer has served as a consultant for Johnson & Johnson

within the past 12 months• Dr. Herndon has served as a consultant to Incline Therapeutics

within the past 12 months

44

The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Learning Objectives• Discuss the findings and recommendations of the

Institute of Medicine’s report, Relieving pain in America: A blueprint for transforming prevention, care, education and research.

• Describe opportunities for pharmacists to support improved pain management for their patients.

• E plain the components of the REMS for long acting

55

• Explain the components of the REMS for long-acting and extended-release opioids, and its impact on pharmacists.

• Describe the characteristics of medications recently approved for the management of pain.

• Discuss the clinical impact of recent published data describing the risks and benefits of analgesics.

The Prevalence of Pain is Staggering

20%

25%

30%

of U

.S. a

dults

la

st 3

mon

ths

66CDC and NCHS. 2010. Health. United States, 2010. Chartbook, Special features on death and dying, Hyattsville, MD:CDC and NCHS.

0%

5%

10%

15%

Low Back Neck Knee Headache Shoulder Finger Hip

Age

adj

uste

d ra

tes

ore

porti

ng p

ain

in th

e

The Disability of Pain is Crippling

25.0%

30.0%

35.0%

40.0%

45.0%

ity a

mon

g ad

ults

with

U

nite

d St

ates

, 200

9

77CDC and NCHS. 2010. Health. United States, 2010. Chartbook, Special features on death and dying, Hyattsville, MD:CDC and NCHS.

0.0%

5.0%

10.0%

15.0%

20.0%

Low Back Knee Headache Neck Shoulder Finger Hip

Basic Actions

Complex Activities

Exte

nt o

f pai

n-re

late

d di

sabi

lipa

in in

the

last

3 m

onth

s, U

Page 2: Transforming the Future of Pain Management FINAL w VC 030612elearning.pharmacist.com/Portal/Files... · 6/12/2003  · Transforming the Future of Pain Management Chris Herndon, PharmD,

© 2012 by the American Pharmacists Association. All rights reserved.

The Prevalence of Pain is Increasing

25.0%

30.0%

35.0%

40.0%

99‐00

Uni

ted

Stat

es, 1

999-

2004

88Institute of Medicine. Relieving pain in America: A blueprint for transforming prevention, care, education, and research.

http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx. Accessed January 3, 2012.

0.0%

5.0%

10.0%

15.0%

20.0%

All > 20 yrs 20‐44 yrs 45‐64 yrs > 65 yrs Men Women

01‐02

03‐04

Tren

ds in

pai

n pr

eval

ence

, U

Pain is a Chronic Problem

40.0%

50.0%

60.0%

70.0%

20 years and over

Uni

ted

Stat

es, 1

999-

2004

99

0.0%

10.0%

20.0%

30.0%

3 months to less than 1 year 1 year or more

20‐44 years

45‐64 years

65 years and over

Institute of Medicine. Relieving pain in America: A blueprint for transforming prevention, care, education, and research. http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx. Accessed

January 3, 2012.

Tren

ds in

pai

n pr

eval

ence

, U

Self Assessment –“Elements to Assure Safe Use” or ETASU is a

component of REMS programs for most opioids.

50%50%

1.True2.False

10101 2

Self Assessment -

33% 33%33%

Which of the following best describes the trend in prescription drug overdose deaths in the US over the past decade?

1. They are increasing2. They are decreasing

11111 2 3

y g3. They are unchanged

Self-Assessment Questions• An elderly female comes in for her monthly

medication refills and you notice that she has not been routinely refilling her gabapentin 600mg TID for her postherpetic neuralgia. She tells you that although she is still experiencing pain, she has fallen several times so she only takes it at bedtime.

1212

What action should the pharmacist take?

Self Assessment-Remember, gabapentin 600mg TID for post-herpetic neuralgia

25% 25%25%25%1. Refer to physician regarding falls

2. Educate on fall prevention and counsel med adherence

3. Discontinue gabapentin and

13131 2 3 4

3. Discontinue gabapentin and offer OTC ibuprofen

4. Call prescriber with recommendation for slower titration

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© 2012 by the American Pharmacists Association. All rights reserved.

A patient comes in with a new prescription for transdermalbuprenorphine (Butrans) 10mg. He has previously been taking hydrocodone/acetaminophen 10mg/325mg, 2 tablets every 6 hours around the clock. Which of the following is the most important action.

25% 25%25%25%1. Dispense Rx2. Recommend laxative3. Call prescriber4 C l ddi ti

14141 2 3 4

4. Counsel on addiction

A 37 year old male reporting back pain is routinely bringing in new prescriptions for CR oxycodone (OxyContin) five to six days before his previous prescription should be out. What is the best method for initially addressing this situation?

25% 25%25%25%

1. Refill the Rx2. Call prescriber3

15151 2 3 4

3. Call police4. Assess pain

Epidemiology and a Call to Action

Chris Herndon, PharmD, BCPS, CPE, FASHPAssistant Professor, School of PharmacySouthern Illinois University Edwardsville

Clinical Assistant Professor, School of MedicineSt. Louis University

1717

National Center for Health Statistics; Health, United States, 2007With Chartbook on Trends in the Health of Americans; Hyattsville, MD: 2007

Pain in Previous 30 Days

1818

Disparities in Care

1919

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© 2012 by the American Pharmacists Association. All rights reserved.

Institute of Medicine Blueprint

• Commissioned by NIH as a result of 2010 Patient Protection and Affordable Care Act

– Pain as a public health problem– Care of people with pain– Education challenges

R h h ll

2020

– Research challenges

Institute of Medicine. Relieving pain in America: A blueprint for transforming prevention, care, education, and research. http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx. Accessed January 3, 2012.

Pain Affects Quality of Life

Type of Pain Difficulty Basic Actions

DifficultyComplex Actions

Headache or migraine

31.0% 33.5%

Low back pain 51.6% 55.0%Neck pain 30.2% 34.4%

2121

Knee pain 37.3% 38.6%Shoulder pain 17.7% 21.4%Finger pain 14.3% 16.3%Hip pain 15.0% 18.4%

Adapted from: Institute of Medicine. Relieving pain in America: A blueprint for transforming prevention, care, education, and research. http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx. Accessed January 3, 2012.

Pharmacists are Called to Action

• Recommendation 4-3. Increase the number of health professionals with advanced expertise in pain care. Educational programs for medical, dental, nursing, mental health, physical therapy, pharmacy, and other health professionals who will participate in the delivery of pain care should have

2222

participate in the delivery of pain care should have increased capacity to train providers who can offer advanced pain care.

Institute of Medicine. Relieving pain in America: A blueprint for transforming prevention, care, education, and research. http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx. Accessed January 3, 2012.

IOM Final Recommendations

• Create a population-health level strategy for pain prevention, treatment, management, and research

• Develop strategies for reducing barriers to pain care• Support collaboration between specialists and primary care• Institute designation at the NIH• Improve collecting and reporting of data

2323

Improve collecting and reporting of data• Promote and enable self-management of pain• Provide educational opportunities in pain assessment &

treatment in primary care• Revise reimbursement policies• Provide complete and consistent pain assessments• Improve curriculum for HCPs• Increase number of HCPs with advanced expertise in pain

Opportunities for YOU!

• Create a population-health level strategy for pain prevention, treatment, management, and research

• Develop strategies for reducing barriers to pain care• Support collaboration between specialists and primary care• Institute designation at the NIH• Improve collecting and reporting of data

2424

Improve collecting and reporting of data• Promote and enable self-management of pain• Provide educational opportunities in pain assessment &

treatment in primary care• Revise reimbursement policies• Provide complete and consistent pain assessments• Improve curriculum for HCPs• Increase number of HCPs with advanced expertise in painRed font denotes areas identified as potential opportunities for pharmacists with an interest in pain mgmt

What the Patients Want

2525

Swick ES, Herndon CM. Providing optimal care to the chronic pain patient in the community pharmacy: A patient survey. Poster presentation at the 45th American Society of Health-System Pharmacists Midyear Clinical Meeting, Dec 2010, Anaheim, CA.

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© 2012 by the American Pharmacists Association. All rights reserved.

Key Points

• Pain is a public health problem• The disparate care of pain is a human rights

problems• Access to pain care is diminishing• Pharmacists are uniquely poised to get involved

2626

a ac s s a e u que y po sed o ge o ed

Which pain problem results in the greatest disability according to IOM report?

1.Neck pain2.Headache3 Back pain

2727

1 2 3 4

0% 0%0%0%

3.Back pain4.Knee pain

Approximately what percentage of adults over 65 years of age experience chronic pain?

1.< 10% 2 10 25%

28281 2 3 4

0% 0%0%0%

2.10-25% 3.~ 50% 4.> 80%

Opportunities for Pharmacists to Support Improved Pain

Management for their Patientsg

Phyllis Grauer, PharmD, GGP, CPEClinical Assistant Professor, College of Pharmacy

The Ohio State University Columbus, OH

Who Can Help?

• Training– Generalists– Specialists

• Pain Management and Palliative Care

• Settings

3030

– Community– Ambulatory– Long term care– Inpatient– Managed care– Academia

The Challenge

3131

Reduce Prescription Abuse,

Addiction and Diversion

Provide Appropriate Pain Management

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© 2012 by the American Pharmacists Association. All rights reserved.

When filling and dispensing pain medication, particularly opioid

analgesics, which is NOT a responsibility of the pharmacist?

1 Screening for misuse

3333

1 2 3 4

0% 0%0%0%

1. Screening for misuse2. Understanding analgesic

pharmacotherapy3. Confirming legitimate use4. Educating on use,

storage, & disposal

The Pharmacist: Advocate or Barrier

• The Case of Pain and the PharmacistJanuary 2003

3434

PAIN MEDICINE Volume 4 • Number 2 • 2003

Pharmacist Responsibilities

• Active interdisciplinary participation– Share drug therapy knowledge– Provide medication therapy management

support• Patient education

3535

• Patient education– Assessment– Education– Monitoring

Pharmacist Interventions in Pain Management

Intervention No. (%) InterventionsChange as-needed analgesic to

ATC analgesic25 (45)

Add or change non-analgesic 11 (20)Di ti l i 9 (16)

3636

Discontinue analgesic 9 (16)Increase dosage of analgesic 4 (7)

Change route of administration 3 (5)Add ATC analgesic 2 (4)

Decrease dose 1 (2)Add as-needed analgesic 1(2)

ATC = Around-the-clock

Lynn MA. Am J Health-Syst Pharm. 2004; 61:1487-9

Assessment Questions• How well are you doing with pain medicines?• Are you having any problems with constipation or sleepiness?• How comfortable are you?• How is your pain right now?• Where do you hurt?• What makes the pain better? What makes the pain worse?

3737

• If you were to rate your pain on a scale from 0 to 10, where 0 is no pain, 5 is moderate pain, and 10 is the worst pain, what number would you give to the pain you are having right now?

• What drugs have worked in the past?• How often do you think you need pain medicine?• Would you prefer to receive pain medicines regularly and not

have to ask for them each time you are in pain?

Lynn MA. Am J Health-Syst Pharm. 2004; 61:1487-9

Pharmacy Continuing Education• Organization Programs and Traineeships

– Pharmacy Organizations• APhA, ASHP, ASCP, ACCP

– Pain Management Organizations• ASPE, APS. AAPM, AAHPM, APF, NHPCO, Mayday

Pain Project

3838

Pain Project– Commercial CE providers

• RX School• Power-Pak CE• US Pharmacist• Medscape• Pharmacy Times

• Caveats – presenter bias and knowledge/experience

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© 2012 by the American Pharmacists Association. All rights reserved.

An elderly female comes in for her monthly medication refills and you notice that she has not been routinely refilling her gabapentin 600mg TID for her postherpetic neuralgia. She tells you that although she is still experiencing pain, she has fallen several times so she only takes it at bedtime. What action should the pharmacist take?

3939

0%

0%

0%

0% 1. Tell the patient to talk to her physician about the falls2. Educate the patient on fall prevention and encourage her to

take the medication as prescribed3. Tell the patient to discontinue the medication and

recommend OTC ibuprofen for pain4. Call the physician and suggest a decreased starting dose

and slow titration of the gabapentin to allow for tolerance to develop to the side effects.

Risk Evaluation and Mitigation Strategies for Opioids (REMS)

Chris Herndon, PharmD, BCPS, CPEAssistant Professor, School of PharmacySouthern Illinois University Edwardsville

Clinical Assistant Professor, School of MedicineSt. Louis University

4141Unintentional Drug Poisoning in the United States, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, July 2010.

REMS History and Significance

• Enacted September 2007• FDA Amendments Act (FDAAA)• Expanded authority of FDA over drug life cycle• Previously “gentleman’s agreement” between FDA

and Pharma

4242

a d a a– Risk minimization action plans

Why REMS?

4343American Pharmacists Association. APhA 2011 REMS white paper: Summary of the REMS stakeholder meeting on improving program design and implementation. J Am Pharm Assoc 2011;51:340-358.

What is REMS?

• Medication guide• Patient package insert• Communication plan for health care providers• Implementation system• Elements to assure safe use (ETASU)

4444

Elements to assure safe use (ETASU)– Certification and specialized training of prescribers, pharmacies /

pharmacists, and other dispensers– Restricted distribution of a drug to limited settings– Dispensing to a patient based on evidence or other

documentation of safe use conditions, such as labs– Patient monitoring and/or patient registry– Prescriber and/or pharmacist registry

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© 2012 by the American Pharmacists Association. All rights reserved.

Current REMSMedication

GuideCommunication

planElements to Assure Safe Use (ETASU)

Prescribercertification/

training

Pharmacy / wholesaler certification

Agreement submission

Limited distribution

Abstral x x x x x

Actiq x x x x x

Butrans x x x

4545

Embeda x x

Exalgo x x x

Fentora x x x x x

Lazanda x x x x

Morphine(soln)

x

Onsolis x x x x x

OxyContin x x x

Oxycodone(soln)

x

Example of Current REMSLong Acting Opioid

• Long acting hydromorphone• Prescriber login• Pharmacist login

– Inpatient pharmacist– Outpatient pharmacist representing pharmacy dispensing

4646

– Outpatient pharmacist not representing dispensing pharmacy

• Ten question quiz with immediate self-assessment following

– Questionable assessment of safe use knowledge– Psychometric evaluation unknown

Example of Current REMSFast Acting Fentanyl Products

• Fentanyl nasal spray REMS• Prescriber login

– Take knowledge assessment– Provide DEA, NPI, and state license number– Must personally educate patient on risk / benefit and use

4747

– Must personally execute a signed prescriber-patient agreement

– Re-register every 2 years

• Pharmacist login– Knowledge assessment– State license number

4848

What does REMS mean for Pharmacists?

• Inpatient pharmacists different than outpatient• Responsible for:

– Registering with REMS programs– Training staff– Confirming compatible software for registration of patient

4949

– Confirming physician is enrolled– ? Providing medication safety guide?

• Does added time equal added safety or just avoidance?

Which of the following opioids has a limited distribution plan as part of its

REMS

25% 25%25%25%1.Lazanda2.Onsolis3 Abstral

5050

1 2 3 4

3.Abstral4.OTFC

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© 2012 by the American Pharmacists Association. All rights reserved.

Which of the following best describes the trend in prescription drug overdose deaths in the US over the past decade?

1 They are

51511 2 3

0% 0%0%

1.They are increasing

2.They are decreasing

3.They are unchanged

Recently Approved Medications for the Management of Pain

Phyllis Grauer, PharmD, CGP, CPEClinical Assistant Professor, College of Pharmacy

The Ohio State University Columbus, OH

Recently Approved Medications for the Management of Pain

• Non-opioids• Opioids

5353

Non-Opioids Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

• SPRIX: ketorolac tromethamine nasal spray– Indications: short-term for moderate to

moderately severe pain +/- IV/IM ketorolac up to 5 days in adults D 31 5 SPRIX ( 15 75 i

5454

– Dosage: 31.5 mg SPRIX (one 15.75 mg spray in each nostril) every 6 to 8 hours.

• maximum daily dose is 126 mg (four doses)– Tmax ≈ 0.75 hrs – T1/2 ≈ 5 hrs

Non-Opioids Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

• Pennsaid : diclofenac sodium 1.5% topical solution (16.05 mg/ml)– Indication: treatment of signs and symptoms of

osteoarthritis of the knee(s)

5555

( )– Dosage: 40 drops ( 1.2ml) per knee four times a

day• Tmax ≈ 4 hrs (multiple dose)• T1/2 ≈ 80 hrs• Bioavailability ≈ 1/3 of Solaraze 3% Gel

(diclofenac sodium for actinic keratoses )

Non-OpioidsGaBapentinoids

• Horizant : gabapentin enacarbil 600mg ER tablets– Gabapentin prodrug

• Indication: restless leg syndrome• Dosage: 600-1200mg daily

5656

• Tmax ≈ 8 hrs 7.3 hrs with food, 5 hrs fasting• T1/2 ≈ 5-6 hrs• Bioavailability ≈ 75% with food, 42-65% fasting

• Gralise : gabapentin ER tablets– Indication: postherpetic neuralgia

• 300 + 600mg tablets• Tmax ≈ 8 hrs

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© 2012 by the American Pharmacists Association. All rights reserved.

• Nucynta ER– Dosage: 50 mg, 100 mg, 150 mg, 200 mg, 250 mg

• Tmax ≈ 3-6 hrs• T1/2 ≈ 5-6 hrs• Dosage frequency: twice daily

OpioidsTapentadol Extended Release

5757

Dosage frequency: twice daily

OpioidsMorphine

• Embeda - voluntary withdrawal for stability issues– Extended release morphine pellets surrounding

a natrexone HCl core

N lt l d if d t h d

5858

• Naltrexone released if product crushed, chewed or dissolved

– 20mg/0.8mg, 30mg/1.2mg, 50mg/2mg, 60mg/2.4mg, 80mg/3.2mg, 100mg/4mg

Opioids Fentanyl Products

Fentanyl Products

Route of Administration Dosage BA (%)

Time toPeak

(median)T1/2 hrs

Actiq Transmucosal200, 400, 600,

800, 1200, 1600 mcg

47 20-40 min 7

Fentora Buccal tablet 100, 200,400, 600 800 mcg 65 47 min 100-200 ≈ 3-4

400-800 ≈ 11-12

5959

600, 800 mcg 400-800 ≈ 11-12

Onsolis Buccal film 200, 400, 600, 800, 1200 mcg 71 1 hr 14

Abstral Sublingual tablet100, 200,

300,400, 600, 800 mcg

54 30-60 min

100-200 ≈ 5-7400-800 ≈ 10-14

Lazanda Intranasal 100, 400mcg/spray 60 20-40

min 15-25 hrs

BA = Bioavailability

Opioids Fentanyl Products

6060

Opioids Oxycodone

• Oxycodone Extended Release– OxyContin (reformulated)

• Oxycodone Immediate Release– Oxecta

6161

• 5mg + 7.5mg tablets

• Both are formulated to reduce misuse when crushed by forming a gel instead of powder

Opioids Hydromorphone

• Hydromorphone– Exalgo : 8, 12, 16mg tablets

• Tmax: 12-16 hrs (4-30)• Duration: 24 hrs• T1/2: 10 11 hrs

6262

• T1/2: 10-11 hrs

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© 2012 by the American Pharmacists Association. All rights reserved.

Opioids Buprenorphine Transdermal Patch

• Butrans : 5, 10 and 20/mcg – Schedule III Controlled Substance

• Partial mu agonist, weak kappa antagonist and agonist at delta opioid receptors, and a partial agonist at ORL‐1 (nociceptin) receptors

– May have an antihyperalgesic effect and may be of benefit

6363

May have an antihyperalgesic effect and may be of benefit in neuropathic pain.

• Dosing interval: 7 days• Steady state: 3 days• Bioavailability: 15%• T1/2: 26 hrs• Increased risk of QTc prolongation ≥ 20mcg/hr• Must titrate previous opioid down to ≤ 30mg OME to prevent

withdrawal symptoms

Buprenorphine patch dosingDaily morphine equivalents Starting dose of buprenorphine

patch< 30mg / 24 hours 5 mcg/hr buprenorphine patch

30-80mg / 24 hours 10 mcg/hr buprenorphine patchMorphine equivalents > 80mg / 24 hours may not be suitable candidates

Patients should be weaned to < 30mg morphine equiv. / 24 hours for 7 days

D tit ti 72 h

6464

Dose titration may occur every 72 hours

Butrans [package insert]. Stamford, CT: Purdue Pharma, 2010.

You are counseling a 70 year old female regarding her diabetes. Today the patient tells you that in addition to her CR hydromorphone (Exalgo) 16mg, two tablets daily, she is taking approximately 12 ibuprofen 200mg tablets to help ease her burning foot pain and to help with her arthritic pain. What are your first thoughts concerning her pain regimen?

6565

0%0%0%0% 1. Change ibuprofen to celecoxib

2. Start IR hydromorphone for breakthrough pain3. Current regimen is inappropriate due to diabetes diagnosis4. CR hydromorphone dose should be increased

Risks and Benefits of Analgesics

Phyllis Grauer, PharmD, CGP, CPEChris Herndon, PharmD, BCPS, CPE

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs

• Gastrointestinal risk– American Gastroenterology Assoc. Guidelines– NSAID induced upper GI bleed prevention

• Cardiovascular risk– Proposed pathophysiology of risk

6767

– American Heart Association Guidelines– Stepwise recommendations

1. Wilcox CM, et al. Consensus development conference on the use of nonsteroidal anti-inflammatory agents, including cyclo-oxygenase-2 inhibitors and aspirin. Clinical Gastroenterology and Hepatology 2006;4:1082-1089.

2. Antman EM. Use of nonsteroidal antiinflammatory drugs. A scientific statement from the American Heart Association. Circulation 2007:DOI: 10.1161/CIRCULATIONAHA.106.181424.

NSAID induced GI bleed

• Risk Factors– Prior peptic ulcer disease– Prior NSAID GI complication– Advanced age– Concurrent corticosteroid or anticoagulant use

6868

g– High doses of NSAIDs– Combinations of NSAIDs

• Prevention– Eradication of H. Pylori– Proton Pump Inhibitors or Misoprostol

Wilcox CM, et al. Consensus development conference (AGA) on the use of NSAIDs.

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© 2012 by the American Pharmacists Association. All rights reserved.

NSAID associated CV risks

• Pathogenesis– Appears to be COX-selective associated– Blood pressure and edema assoc?– Thromboxane vs. prostacyclin (PGI2)– Cardiac collateralization

“St i i ”

6969

– “Stress priming”

• American Heart Association Recommendations– Specifically for those with musculoskeletal pain– Recommendations for those with known cardiovascular

disease or significant risk factors

Antman EM. Use of nonsteroidal antiinflammatory drugs. A scientific statement from the American Heart Association. Circulation 2007:DOI: 10.1161/CIRCULATIONAHA.106.181424.

AHA Recommendations for acute musculoskeletal pain

1st• acetaminophen, tramadol• aspirin, short term opioid

• Non-acetylated salicylates

7070

2ndy y

• (salsalate, choline magnesium trisalicylate)

3rd• Non-selective NSAIDs• Selective NSAIDs

Antman EM. Use of nonsteroidal antiinflammatory drugs. A scientific statement from the American Heart Association. Circulation 2007:DOI: 10.1161/CIRCULATIONAHA.106.181424.

Opioids• Efficacy – do they work long term?• Side Effects – does the benefit outweight the risk

– Respiratory depression and hypoventilation risk– Hypogonadism– Hyperalgesia

• Abuse liabiliity – use in noncancer pain?

7171

• Abuse liabiliity – use in noncancer pain?– CDC data– DAWN database

• Managing risk – strategies and opportunities– REMS– Screening for risk– Drug screening, treatment agreements, pill counts, PDMP– Legislation

Opioid Risk ToolFamily history of substance abuse Female MaleAlcohol 1 point 3 pointsIllegal drugs 2 points 3 pointsPrescription drugs 4 points 4 pointsPersonal History of Substance abuse Female MaleAlcohol 3 points 3 points

7272

Alcohol 3 points 3 pointsIllegal Drugs 4 points 4 pointsPrescription Drugs 5 points 5 pointsAge (16 yrs to 45 yrs) 1 point 1 pointPreadolescent sexual abuse 3 points 0 pointsDepression 1 point 1 pointADD, OCD, Bipolar, or Schizophrenia 2 points 2 points

Low Risk 0 – 3 points, Moderate Risk 4 – 7 points, High Risk > 8 points

Webster LR, Webster RM. Predicting aberrant behaviors in opioid treated patients. Pain Med 2005;6(6)432-42.

Monitoring outcomes

• The 4 “A”s of pain management monitoring– Analgesia– Adverse effects (of opioids)– Aberrant drug taking behavior– Activity

H l i REALISTIC l

7373

• Help patient set REALISTIC treatment goals• Trust, but verify• Treat to activity, not the pain score

73

“Elements to Assure Safe Use” or ETASU is a component of REMS programs for most opioids.

1 True

74741 2

0%0%

1.True2.False

Page 13: Transforming the Future of Pain Management FINAL w VC 030612elearning.pharmacist.com/Portal/Files... · 6/12/2003  · Transforming the Future of Pain Management Chris Herndon, PharmD,

© 2012 by the American Pharmacists Association. All rights reserved.

Which of the following best describes the trend in prescription drug overdose deaths in the US over the past decade?

1 They are

75751 2 3

0% 0%0%

1.They are increasing

2.They are decreasing

3.They are unchanged

Self-Assessment Questions• An elderly female comes in for her monthly

medication refills and you notice that she has not been routinely refilling her gabapentin 600mg TID for her postherpetic neuralgia. She tells you that although she is still experiencing pain, she has fallen several times so she only takes it at bedtime.

7676

What action should the pharmacist take?

Remember, gabapentin 600mg TID for post-herpetic neuralgia

1. Refer to physician regarding falls

2. Educate on fall prevention and counsel med adherence

3 Discontinue gabapentin and

7777

1 2 3 4

0% 0%0%0%

3. Discontinue gabapentin and offer OTC ibuprofen

4. Call prescriber with recommendation for slower titration

A patient comes in with a new prescription for transdermal buprenorphine (Butrans) 10mg. He has previously been taking hydrocodone/acetaminophen 10mg/325mg, 2 tablets every 6 hours around the clock. Which of the following is the most important action.

1. Dispense Rx2

7878

1 2 3 4

0% 0%0%0%

2. Recommend laxative3. Call prescriber4. Counsel on addiction

A 37 year old male reporting back pain is routinely bringing in new prescriptions for CR oxycodone (OxyContin) five to six days before his previous prescription should be out. What is the best method for initially addressing this situation?

1. Refill the Rx2 Call prescriber

79791 2 3 4

0% 0%0%0%

2. Call prescriber3. Call police4. Assess pain

Approximately what percentage of adults over 65 years of age experience chronic pain?

1.< 10% 2 10 25%

80801 2 3 4

0% 0%0%0%

2.10-25% 3.~ 50% 4.> 80%

Page 14: Transforming the Future of Pain Management FINAL w VC 030612elearning.pharmacist.com/Portal/Files... · 6/12/2003  · Transforming the Future of Pain Management Chris Herndon, PharmD,

© 2012 by the American Pharmacists Association. All rights reserved.

You are counseling a 70 year old female regarding her diabetes. Today the patient tells you that in addition to her CR hydromorphone (Exalgo) 16mg, two tablets daily, she is taking approximately 12 ibuprofen 200mg tablets to help ease her burning foot pain and to help with her arthritic pain. What are your first thoughts concerning her pain regimen?

8181

0%0%0%0% 1. Change ibuprofen to celecoxib

2. Start IR hydromorphone for breakthrough pain3. Current regimen is inappropriate due to diabetes diagnosis4. CR hydromorphone dose should be increased

You are counseling a 70 year old female regarding her diabetes. Today the patient tells you that in addition to her CR hydromorphone (Exalgo) 16mg, two tablets daily, she is taking approximately 12 ibuprofen 200mg tablets to help ease her burning foot pain and to help with her arthritic pain. What are your first thoughts concerning her pain regimen?

8282

0%0%0%0% 1. Change ibuprofen to celecoxib

2. Start IR hydromorphone for breakthrough pain3. Current regimen is inappropriate due to diabetes diagnosis4. CR hydromorphone dose should be increased

Pain agreements have been shown to greatly decrease risk of misuse and diversion of opioids.

1.True2.False

83831 2

0%0%

Take home….

• Pain is a significant public health problem• New opportunities and treatments continue to

emerge• New legislated barriers continue to emerge• Access to treatment and risk of misuse and

8484

ccess o ea e a d s o suse a ddiversion is a balancing act

• Pharmacists are an integral component of the pain management health care team