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January 2015

1

Pain as the 5th vital sign: Pain scales and their use

Anabel Sedeno, Pharm.D., BCPS

PGY-2 Oncology Resident

Objectives

� Review different types of pain

� Describe the importance of assessing pain for effective pain management

� Compare and contrast different pain scales

Definition

“An unpleasant sensory and emotional experience associated with actual or potential tissue damage or

described in terms of such damage”

“When you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, your knowledge is of a

meager unsatisfactory kind” - Lord Kelvin 1824-1907

Pain

� Most common symptom for which patients seek medical attention

� ~100 million Americans have chronic pain conditions

� ~80% of patients who visit a physician report pain

� 50% of patients with moderate to severe pain get inadequate relief

� Lack of pain assessment is the most common cause of inadequate pain management

Impact of Pain

� Financial impact

� ~$100 billion in added healthcare costs

� ~$60 billion of lost productive time

� Physiological Impact

� Affects all major body systems

• Endocrine, cardiovascular, immune

� Leads to chronic pain syndromes

� Psychological consequences

� Affects quality of life

• Anxiety, depression

Unnecessary suffering

The 5th Vital Sign

1995

• American Pain Society (APS)• Pain as the 5th vital sign

1999

• Veterans Health Administration (VHA)• Adopted pain as the 5th vital sign initiative

2001

• The Joint Commission (TJC)• Pain assessment became an accreditation standard

2010

• Hospital Consumer Assessment of Healthcare Providers & Systems (HCAHPS)• Pain scores used as quality measures

January 2015

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Pain Standards

� All patients must be screened for pain

� Pain intensity must be quantified and described by the patient

� A comprehensive pain assessment must be performed

� New pain is present

� Regularly for persisting pain

� Reassessment of pain must be performed

� Regularly to monitor the level of pain

� Evaluate the effectiveness of treatment

Pain Physiology

Nociceptive

Somatic Injury to

body tissuesPost-op pain

Visceral Injury to

body organsAppendicitis, Cholecystitis

Neuropathic

Peripheral Peripheral

nerve lesionPost-herpetic

neuralgia

CentralAbnormal

CNS activity

Phantom limb, Spinal cord

injury

Pain Classification

Characteristic Acute Pain

Chronic

Nonmalignant Pain

Chronic

Malignant Pain

DurationHours to weeks

Months to years Unpredictable

DescriptionSharp, welllocalized

Dull, poorly localized

Similar to both

Pathology Present Little or none Usually present

ExamplesSurgeryTrauma

ArthritisBack painHeadache

CancerMultiple sclerosisCHF

Treatment Analgesics Multimodal Multimodal

Pain Assessment Goals

� Capture the patient’s pain experience

� Determine the impact of pain on the patient

� Determine etiology & type of pain

� Aid communication between interdisciplinary team members

� Establish the most effective treatment plan

Patient Outcomes

� Pain assessment is the gateway

� Effective pain management

� Promotes earlier mobilization

� Prevents chronic pain syndromes

� Shortens hospital stay

� Reduces overall costs

� Improves patient satisfaction

� Improves quality of life

Indicators of Pain

Vital

signs

Family members

Pain-related behaviors

Conditions or procedures

Patient

January 2015

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Comprehensive Pain Assessment

PPrecipitate & Palliate

What makes pain better or worse?

What relieves the pain?

QQuality

What does the feel like?

Is it sharp, dull, stabbing, burning?

RRegion & Radiation

Does the pain radiate, referred, and where to?

SSeverity

How severe is the pain?

Use pain scale to rate pain

TTime

When did it start? Does it come and go?

Is it increasing in frequency/duration?

U

You

How is the pain affecting your life?

Types of Pain Scales

Unidimensional

Scales

Known as pain rating scales

Measure pain intensity

Used to assess acute pain

Feedback about effect of treatment

Not a comprehensive pain assessment

Multidimensional

Scales

Known as pain assessment questionnaires

Measure multiple components

Used to assess chronic pain

More complex and lengthy

Requires language and verbal skills

Pain Scales

Unidimensional

Numeric Rating Scale (NRS)

Visual Analog Scale (VAS)

Wong-BAKER Faces Pain

Scale (FPS)

Verbal Rating Scale (VRS)

Face Legs Arm Cry Consolability Scale (FLACC)

Multidimensional

Initial Pain Assessment Inventory (IPAI)

Brief Pain Inventory (BPI)

McGill Pain Questionnaire (MPQ)

Neuropathic Pain Scale (NPS)

Chronic Pain Grade (CPG)

Numeric Rating Scale (NRS)Unidimensional Scale

Advantages

� Easy to use

� Simple to describe

� High rate of adherence

� Flexible administration

� Validated for various settings and pain types

Disadvantages

� Decreased reliability in

� Very young

� Elderly

� Visual impairment

� Hearing loss

� Dementia

Visual Analog Scale Unidimensional Scale

Advantages

� Efficient to administer

� Extensively studied

� Patient not restricted by categories or numbers

� Valid in chronic pain

� May use > 5 years of age

Disadvantages

� Time consuming scoring

� May cause confusion

� Poor reproducibility with cognitive function

� Need printed form

� Inaccuracies when photocopying

Faces Pain Scale Unidimensional Scale

Advantages

� Perceived as easier than NRS or VAS

� Useful in individuals with difficulty communicating

� No literacy requirement

� May be preferred by children

Disadvantages

� Potential for distorted assessment

� Tendency to point to the center of scale

� Need for a printed form

January 2015

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Initial Pain Assessment Inventory Multidimensional Scale

� Used in the initial patient evaluation

� Characteristic of pain

� Aspect’s of patient’s life

� Diagram of pain location

� Pain rating scale

� May be completed by patient or clinician

Brief Pain Inventory Multidimensional Scale

� Validated in multiple clinical conditions

� Available in multiple languages

� Quantifies intensity and associated disability

� Completed by patient or clinician

� Short form (5 mins)

� Long form (10 mins)

McGill Pain Questionnaire Multidimensional Scale

� Most extensively tested

� Assesses sensory and affective dimensions of pain

� May be combines with other tools to improve accuracy

� Patient may confused by vocabulary

� Short form (2-3 mins)

� Long form (5-15 mins)

Pain Scales Tips

� Allow sufficient time

� Speak slowly and clearly

� Appropriate aids available

� Involve family members and/or caregivers

� Use enlarged copies of the pain scale

� Teach how to use the pain rating scale

� Explain the use of the scale every time

� Use the same scale each time

Use of Pain Scores

Pai

n p

ersi

stin

g:

Mo

ve u

p o

ne

step

Pain

sub

sidin

g o

r toxicity:

Mo

ve do

wn

on

e step

Step 2: Moderate painWeak opioids+ non-opioids+/- adjuvant

Step 3: Severe painStrong opioids+ non-opioids+/- adjuvant

Step 1: Mild painNon-opioids+/- adjuvant

Pain score 1-3

Pain score 4-6

Pain score 7-10

Adapted from The World Health Organization Analgesic Stepladder Approach

Barriers to Pain Management

• Reluctance to report pain

• Fear of addiction

• Medication cost

Patient

• Lack of awareness

• Lack of time

• Inadequate trainingProvider

• Reimbursement

• Gaps in continuity of care

• Shortage of pain specialists

Healthcare System

January 2015

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Pharmacist Role

� Establish a trusting patient-provider relationship

� Conduct pain assessment when possible

� Provide therapy recommendations

� Monitor response to therapy

� Communicate & collaborate with other professionals

Summary

� Pain is a subjective, multidimensional experience

� Pain assessment is the gateway to effective pain management

� Pain scales must be appropriate for the intended population

� Pharmacists have a crucial role in pain management

Assessment Questions

� Referred pain is confined to the site of origin

False

� Pain assessment approaches, including pain scales, must be appropriate for the patient population

True

� The most commonly used pain scale is the numeric rating scale

True

References

1. American Pharmacist Association. A pharmacist’s guide to the clinical assessment and management of pain. 2004

2. The Joint Commission on Accreditation of Healthcare Organizations, National Pharmaceutical Council. Pain: Current understanding of assessment, management, and treatments. 2001. Available at http://www.npcnow.org/system/files/research/download/Pain-Current-Understanding-of-Assessment-

Management-and-Treatments.pdf. [Last accessed January 5th, 2015]

3. Veterans Health Administration. Pain as the 5th vital sign toolkit. 2000. Available at http://www.va.gov/painmanagement/docs/toolkit.pdf [Accessed January 4h, 2015]

4. Cleveland Clinic. Vital signs. Available at http://my.clevelandclinic.org/health/healthy_living/hic_Pre-participation_Evaluations/hic_Vital_Signs [Last accessed: January 8th, 2015]

5. Wells N, Pasero C, McCaffery M. Improving the quality of care through pain assessment and management. Agency for Healthcare Research and Quality April 2008. Available at

http://www.ncbi.nlm.nih.gov/books/NBK2658/pdf/ch17.pdf. [Last accessed January 6th, 2015]

6. Morone N.E., Weiner D.K. Pain as the 5th vital sign: exposing the vital need for pain education. Clin Ther. 2013; 35(11): 1728-1732

7. Institute of Medicine. Relieving pain in America: A blueprint for transforming prevention, care, education, and research. Washington, DC: The National Academies Press; 2011

8. American Pharmacists Association. Transforming the future of pain management. August 2012. Available at http://elearning.pharmacist.com/Portal/Files/LearningProducts/fa99e954a0814a5eb4e1f50d881150c6/assets/120

716_CE_final.pdf. [Last accessed January 7th, 2015]

9. Wood S. Factorst influencing the selection of appropriate pain assessment tools. Nursing Times. 2004; 100: 35, 42-47

10. Hooten WM, Timming R, Belgrade M, Gaul J, Goertz M, Haake B, Myers C, Noonan MP, Owens J, Saeger L, Schweim K, Shteyman G, Walker N. Institute for Clinical Systems Improvement. Assessment and Management of

Chronic Pain. Updated November 2013.

11. http://www.uptodate.com/contents/definition-and-pathogenesis-of-chronic-pain

12. Vancouver Island Health Authority. Principles of pain assessment. 2008 July. Available at

http://www.viha.ca/NR/rdonlyres/FB1E3BDD-2D23-4C53-A4D3-0F9D2DCE1081/0/PrinciplesOfPainAssessment.pdf. [Last accessed January 4th, 2015]

13. Images: http://www.goodbye2pain.com/about-pain-management/

14. Images: http://www.canstockphoto.com

Pain as the 5th vital sign: Pain scales and their use

Anabel Sedeno, Pharm.D., BCPS

PGY-2 Oncology Resident

January 2015

1

Optimal Use of Pain Medication in the Treatment

of Chronic Pain

By: Matt Sherman Pharm.D.

PGY-2 Psychiatry Pharmacy Practice Resident

Nova Southeastern University

Objectives

� Understand the pathophysiology of pain

� Identify indications for opioids in chronic pain treatment

� Understand initiation and ongoing management of chronic pain in patients treated with opioid based therapies

Pain Pathway Overview

Inhibiting

Ascending Pathway

• Opioids

• Local Anesthetics

• Anti-epileptics

• NSAIDs

• APAP

Enhancing

Descending Pathways

• SNRI

• TCA

• Opioids

Peripheral Pathway

• Local Anesthetics

• Anti-epileptics

• Alpha Agonists

Stahl SM. Stahl’s Essential Psychopharmacology. 2013.

Nociceptive Pain Pathology

Stahl SM. Stahl’s Essential

Psychopharmacology. 2013.


To higher centers

Descending neurons

Projection Neurons

Primary afferent neuron

InterneuronsStahl SM. Stahl’s Essential

Psychopharmacology. 2013.



January 2015

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Neuropathic Pain Pathophysiology

� Pain that arises from damage to, or dysfunction of, any part of the:

� Peripheral nervous system

• Primary afferent neuron

� Central nervous system

• Doral horn “Segmental central sensitization”

• Numerous brain regions “Suprasegmentalcentral sensitization”

� +/- peripheral causes


Chronic Pain Treatment

� Initial patient assessment

� Comprehensive medical and social history

• Includes both general and pain specific info.

� Pain treatment history

• Pharmacologic and non-pharmacological

� Co-morbid health conditions

� Comprehensive pain assessment

� Diagnostic exams (indication specific)

Chou R, et al. J Pain. 2009.

Comprehensive Pain Management Plan Components

� Physical Intervention

� Home exercise program

� Physical and occupational

therapy

� Chiropractic and osteopathic

manipulation

� Interventional and surgical approaches

� Psychological Intervention

� Cognitive behavioral therapy

� Resolving social issues

� Psychotherapy and individual

or group counseling

� Medications

Medications

Psychological Intervention

Physical

Intervention

Allegrante JP. Am J Med. 1996.

Treatment Algorithm for Chronic Nociceptive Pain

Non-pharmacologic

therapy

Pharmacologic

therapy

Specific diagnosis;

targeted treatment

Risk factors?

• CKD, elderly

• Avoid NSAIDs and COX-2

inhibitors

• Peptic ulcer disease,

glucocorticoid use

• Avoid NSAIDs

• Hepatic disease

• Avoid NSAIDs, COX-2

inhibitors, and APAP

• Use TCAs or duloxetine first

line

• CV disease or risk

• Use lowest effective dose of

NSAIDs (naproxen)

Yes

No

Rosenquist E. UpToDate. 2015.

Treatment Algorithm for Chronic Nociceptive Pain

Mild to

moderate pain

Topical agents

APAP

NSAIDs + PPI

or COX-2 inh. +/- PPI

Moderately severe to severe pain

Non-inflamm.,

NSAIDs RF

Active

inflamm.

APAP

TCA or duloxetine

Opioids +/- baclofen or tizanidine if

spasmodic component

(If no NSAID risk)

NSAIDs + PPI

or COX-2 inh. +/- PPI


Treatment Algorithm for Chronic Neuropathic Pain

Non-pharmacologic

therapy

Pharmacologic

therapy

Specific diagnosis;

targeted treatment

First line agents

(Use with adjunctive topical agents e.g. lidocaine, capsaicin)

Ca2+ channel alpha 2 SNRIs TCAs

delta ligands


January 2015

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Treatment Algorithm for Chronic Neuropathic Pain

Second line agents

Other antiepileptic Opioids Tramadol

Third line agents

NMDA antagonist Combo Tizanidine

(e.g. dextromethorphan) Baclofen

Fourth line agents

Consider botulinum Consider intrathecal

toxin injections ziconotide


“Reasonable Trial” Pearls

� Patients counseled appropriately on goals and expectations

� Side effects appear at initiation

� 4 – 6 weeks before optimal improvement in pain

� Dosage and duration of therapy adequate

� Switch between agents in the same class

� 4 - 6 weeks at stable optimal doses

� Dosing schedule is optimized (QAM, QHS)

� One drug targeting multiple indications

Patient Cases

Pain Syndrome

1. Chronic Low Back Pain

2. Diabetic Neuropathic Pain

3. Migraine Headache

Psychiatric Disorder

1. Generalized Anxiety (with Insomnia)

2. Major depression

3. Bipolar disorder

Who are Opioids Indicated for?

� Well established role in treating:

� More severe forms of acute pain requiring rapid relief

� Malignant pain

� End of life care

� Chronic non-malignant pain� Moderate to severe impacting their function or quality of life

+

� Persists despite reasonable trials of non-opioid and adjuvant

analgesics

+/-� Patient characteristics contraindicate use of other analgesics

Von Korff M, et al. Ann Intern Med. 2011.Ballantyne JC, et al. N Engl J Med. 2003.

Initial Assessment

� Assess risk of abuse

� Questionnaires

� Urine drug screens (UDS)

� Check state Prescription Drug Monitoring Program (PDMP)

� Comorbid conditions may be a red flag

� Compare risks against expected benefit


When is a Referral to a Pain Specialist Warranted?

� When the risk outweighs the benefit for the patient such as:

� Previous failure with opioids or other analgesics

� Significant psychosocial issues

� Conviction of a drug-related crime

� Current use of illicit drugs

� Regular contact with drug high-risk groups

� History or family hx of substance abuse

� Psychiatric comorbidities or family history of psychiatric disorders

� Children (<18 years old)

� Substance use disorder is a major barrier to adequate pain management


January 2015

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Initiating Opioid Therapy� Should be considered a “therapeutic trial”

� Consider cost, tolerability and ease of administration

� Develop and document a chronic opioid therapy (COT) management plan and exit strategy

� Decide whether to start:• A short-acting (SA) opioid � convert to long-acting (LA)

opioid +/- SA opioid doses if breakthrough pain occurs

OR• A low dose of a LA opioid +/- SA opioid doses if

breakthrough pain occurs


Initiating Opioid Therapy

Opioid Naïve Patient

� Start at low dose

� Start at lowest possible

dose for

• Frail older patients

• Patients with comorbidities

� Certain opioids and formulations are not recommended

Opioid Tolerant Patient

� No restrictions on opioid

selection

� Considerer tolerant if > 1 week on:

� 60 mg oral morphine/day

� 25 mcg transdermal fentanyl/hr

� 30 mg oral oxycodone/day

� 8 mg oral hydromorphone/day

� 25 mg oral oxymorphone/day

� An equianalgesic dose of

another opioid

� Use caution when switching to

a different formulation or agent


Initiating Opioid Therapy: Opioid Naïve

Recommended

� Morphine

� Oxycodone

� Hydrocodone

� Tramadol

Not Recommended

� Oxymorphone

� Hydromorphone

� Levorphanol

� Buprenorphine

� Tapentadol

� Codeine

� Methadone

� Fentanyl

Anticipate & Treat Common Side Effects

� Constipation

� Nausea and vomiting

� Drowsiness, sedation and confusion

� Balance/ataxia and dizziness

� Pruritus and myoclonus

� Itching

� Endocrine dysfunction/ reduced libido


Initiating Opioid Therapy:Develop COT Management Plan

� May include:

� Goals of therapy

� How opioids will be

prescribed and taken

� Expectations for clinic

follow-up

� Alternatives to COT

� Expectations regarding use of concomitant therapies

� Potential indications for

discontinuing COT

� For higher risk patients-helpful to reinforce expectations:

� One prescriber and filling at

one pharmacy

� Random urine drug screens

� Office visit interval

� Pill counts

� Limited prescriptions

� Enumeration of behaviors

that may lead to discontinuation


Initiating Opioid Therapy:Create an Exit Strategy

� Agreement with patient on criteria for failure of the trial

� Common failure criteria include:

• Lack of significant pain reduction

• Lack of improvement in function

• Persistent side effects

• Persistent non-compliance

� Document method for tapering off opioids

� Opioid withdrawal reactions are not life-threatening


January 2015

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Patient Reassessment:To continue or not to continue?

� “Four A’s of Pain”

� Decision to proceed w/ long-term treatment should be intentional and based on consideration of outcomes:

� Progress toward meeting therapeutic goals

� Changes in underlying pain condition

� Changes in psychiatric or medical comorbidities

� Identification of aberrant drug-related behavior

� Presence of opioid related AEs

Chou R, et al. J Pain. 2009.Passik SD, et al. Adv Ther. 2000.

Opioid Trial

Cellular

Mechanisms

Pharmacological

Tolerance

Opioid induced

Pain Sensitivity

Apparent Tolerance

Opioid Dose

Escalation

**Disease

progression**

Options for Continuing Opioid Therapy

� Opioid dose escalation

� Opioid rotation

� Change in opioid drug or route of administration with the goal of improving outcomes

• Establish an opioid regimen that is more effective

than the prior therapy

� Continue current regimen

� Discontinue opioid therapy

� Refer to a specialist

Reasons for Opioid Rotation

� Poor opioid responsiveness

� Dose titration yields intolerable AEs

� Poor analgesic efficacy despite dose titration

� Other issues:

� Need to try a new formulation

� Cost or insurance issues

� Adherence issues

� Concern about abuse or diversion

� Change in clinical status

� Problematic drug-drug interaction

Fine PG, et al. J Pain Symptom Manage. 2009.Knotkova H. J Pain Symptom Manage. 2009.

Opioid Rotation Theory

� Incomplete cross-tolerance to the analgesic and other effects across opioids

� Many mu receptor subtypes

� May help explain:

� Inter-patient variability in

response to mu opioids

� Incomplete cross-tolerance among mu opioids

Chou R, et al. J Pain. 2009.Pasternak GW. Trends Pharmacol Sci. 2001.

Guidelines for Opioid Rotation

� Closer to 50% reduction if patient is

� Receiving a relatively high dose of current opioid regimen

� Elderly or medically frail

1. Calculate equianalgesic dose of new opioid from Equianalgesic Dose Tables (EDT)

2. Reduce calculated equianalgesic dose by 25%-50%

� Closer to 25% reduction if patient

� Does not have these characteristics

� Is switching to a different administration route of same drug

Fine PG, et al. J Pain Symptom Manage. 2009.

January 2015

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Guidelines for Opioid Rotation

� Have a strategy to frequently assess analgesia, AEs and withdrawal symptoms

� Titrate new opioid dose to optimize outcomes & safety

� Dose for breakthrough pain using a short-acting preparation

� 5%-15% of total daily opioid dose

Fine PG, et al. J Pain Symptom Manage. 2009.

Implement Exit Strategy

� If patient fails trial:

� Document reason for discontinuation

� Follow plan agreed upon at initiation

� Opioid Disposal

� Collection receptacles (1-800-882-9539)

� Mail-back packages

� Local take-back events

� Mix w/ undesirable substance

� Flush down sink/toilet (last resort)

Take Home Pearls

� Pain management is complex and needs to be individualized

� Opioid analgesics are but one component of a comprehensive treatment plan

� Initiate as a “Therapeutic Trial”

� Patient reassessment is KEY to ongoing monitoring of opioid therapy

� Don’t mask worsening disease state

True or False?

� A comprehensive assessment for safe and appropriate use of opioids at a minimum includes history and physical examination, patient’s and family’s substance abuse history, appropriate lab testing, and abuse potential risk assessment.

� Gaps in knowledge, negative attitudes toward prescribing opioids, and inadequate pain assessment are major barriers to optimal chronic pain treatment.

� Opioid exit strategies should only be used when the provider feels their patient may be resistant to titrating off their opioid if treatment objectives are not met.

References

� Allegrante JP. The role of adjunctive therapy in the management of chronic nonmalignant pain. Am J Med. 1996;101(1A):33S.

� Ballantyne JC, Mao J. Opioid therapy for chronic pain. N Engl J Med.

2003;349(20):1943.

� Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of

chronic opioid therapy in chronic noncancer pain. J Pain. 2009 Feb;10(2):113-30.

� Fine PG, Portenoy RK. Establishing "best practices" for opioid rotation: conclusions of an expert panel. J Pain Symptom Manage 2009;38:418-

425.

� Knotkova H, Fine PG, Portenoy RK. Opioid rotation: the science and the

limitations of the equianalgesic dose table. J Pain Symptom Manage 2009;38:426-439.

� Passik SD, Weinreb HJ. Managing chronic nonmalignant pain: overcoming obstacles to the use of opioids. Adv Ther. 2000;17:70-83.

References

� Pasternak GW. Incomplete cross tolerance and multiple mu opioid

peptide receptors. Trends Pharmacol Sci 2001;22:67-70.

� Rosenquist E. Neuropathic pain: Pharmacologic approach. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. (Accessed on

January 4, 2015.)

� Rosenquist E. Nociceptive pain: Pharmacologic approach. In:

UpToDate, Post TW (Ed), UpToDate, Waltham, MA. (Accessed on January 4, 2015.)

� Stahl SM. Stahl’s Essential Psychopharmacology: Neuroscientific

Basis and Practical Applications, Fourth Edition. Cambridge

University Press: New York, NY, 2013.

� Von Korff M, Kolodny A, Deyo RA, Chou R. Long-term opioid therapy reconsidered. Ann Intern Med. 2011;155(5):325.

January 2015

1

Pain in the Pediatric Population

Noor Daghistani, Pharm.D.

Objective

� Define and discuss types of pain

� Discuss barriers in the treatment of pain in the pediatric population

� Describe age appropriate strategies and assessment tools for measuring pain in the pediatric population

� Review non-pharmacological and pharmacological treatment modalities for pain in the pediatric population

� Describe specific pharmacokinetic characteristics of commonly used pain medications in pediatric patients

Definition

� “An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”

� “The inability to communicate verbally does not negate the possibility that an individual is experiencing pain”

Beliefs, attitudes, spiritual, and

cultural attitudes

Emotions

Changes in Behavior

Pain Pathway

Dimensions of Pain

Dimensions of Pain CognitiveCognitive

AffectiveAffective

Behavioral Behavioral

Overallexperience

of Pain

Noxious stimuliNoxious stimuli

Physiological transmission

of pain

Physiological transmission

of pain

Sensory perception of

pain

Sensory perception of

pain

Pathophysiological Mechanism of PainPathophysiological Mechanism of Pain

Duration of PainDuration of Pain

Etiology of PainEtiology of Pain

Anatomic Location of PainAnatomic Location of Pain

Classification of Pain

Pathophysiological Classification

� Nociceptive Pain

� Protective

� Tissue injury activates nociceptors

� Divided into Somatic vs Visceral pain

� Neuropathic

� Harmful

� Structural damage and nerve cell dysfunction

� Mixed Pain

� Neuropathic pain with nociceptive pain

January 2015

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Duration of Pain

• Sudden onset

• Short-lastingAcuteAcute

• Continuous

• Negatively affects all aspects of lifeChronic Chronic

• Intermittent

• Intensity, quality, and frequency fluctuate EpisodicEpisodic

• Temporary increase in pain severityBreakthroughBreakthrough

• Pain due to simple movementsIncidentalIncidental

• Pain due to medication blood levels falling below minimum effective analgesic level End of doseEnd of dose

Secondary Classifications

� Etiology of Pain� Little relevance to mechanism and

treatment of pain

� Based on underlying disease• Malignant

• Non-malignant

� Anatomic Location� Body location or anatomic function of

affected tissue

� Does not offer bases for clinical management of pain

Barriers to Treatment

� Myth that children & infants do not feel pain the way adults do

� Lack of assessment & reassessment� Belief that addressing pain in children takes

too much time and effort

� Difficulty with understanding & quantifying a subjective experience

� Fears of adverse effects of analgesic medications

� Lack of knowledge of pain treatmentThe American Academy of Pediatrics and the American Pain Society- The Assessment and Management of Acute Pain in Infants, Children, and Adolescents

General Pain Assessment Principles

� Gather information on the usual behavior of the child when not in pain

� Asses cognitive developmental level� Tools used depend on child’s age and

cognitive level.• Can use self-report, behavioral observation,

& physical measures

� Assess pain regularly� Inquire about the character, location,

intensity, & duration of the pain

Pain Expression

• Inability to verbally express pain or discomfort

• Rely on behavioral features and vital signs

Neonates & Infants

Neonates & Infants

• Limited ability to differentiate types of pain

• May have limited knowledge of numbers and colors

Toddlers

(1-2 years)

Toddlers

(1-2 years)

•Ability to indicate presence of pain verbally

•Gradually learn to distinguish levels of pain, and by 5 years can describe pain and pain intensity

Early Childhood (2-5 years)

Early Childhood (2-5 years)

•At 6 years: can clearly differentiate levels of pain intensity

•7-10 years: can explain why it hurts

Middle Childhood (6-11 years)

Middle Childhood (6-11 years)

•Have the highest capacity to describe painAdolescents

(12-18 years)

Adolescents

(12-18 years)

Behavioral/Physiologic Scales

� Recommended Age: premature to full-term infants

� Neonatal Facial Coding System (NFCS)

� Neonatal Infant Pain Scale (NIPS)

� Premature Infant Pain Profile (PIPP)

January 2015

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Behavioral/Physiological Scales

Face Legs Activity Cry Consolability (FLACC)

� Recommended Age: 2 months – 7 years

Categories Scoring0 1 2

Face No particular expression or smile

Occasional grimace or frown, withdrawn, disinterested

Frequent to constant quivering chin, clenched jaw

Legs Normal position or relaxed

Uneasy, restless, tense Kicking, or legs drawn up

Activity Lying quietly, normal position, moves easily

Squirming, shifting back and forth, tense

Arched, rigid or jerking

Cry No cry, (awake or asleep)

Moans or whimpers, occasional complaint

Crying steadily, screams or sobs, frequent complaint

Consolability Content, relaxed

Reassured by occasional toughing, hugging, or being talks to,

distractible

Difficult to console or comfort

Self-Report Scales

� FACES Scales (3 years and older)

� Wong-Baker

� Faces Pain Scale- Revised (FSP-R)• Recommended

� Poker Chip tool/Pieces of Hurt tool (3-12 years)

Visual Analogue Scale

(≥8 years)

Numerical Rating Scale

(≥8 years)

Self-Report Scales

The Oucher Photographic (3-12 years)

Other Parameters to Assess

� The extent of the child’s restriction in physical and social activities

� Emotional disturbances

� Fear

� Anxiety

� Emotional stress

� Sleeping difficulties

� Coping skills

Management of Acute Pain

Treatment of Pain

PharmacologicalTreatment

Non-opioid Treatment

Acetaminophen NSAIDs

Opioid Treatment

Non-Pharmacological

Treatment

� Neonates & Infants:� Cognitive strategies are visual or auditory

� Behavioral strategies: Swaddling, facilitated tucking, rocking, pacifier use, and positioning

� Toddlers & Preschoolers� Explain procedure using age appropriate

vocabulary

� Distraction: • Active: bubbles, therapeutic play, distracting

conversations, deep breathing

• Passive: television, read age appropriate books

NonpharmacologicManagement

January 2015

4

� School-Aged Children

� Provide with age-appropriate information regarding procedure

� Give children choices

� Educate on passive and active distraction techniques

� Adolescents

� Ensure a private setting for procedure

� Give power to chose type of distraction and who can be present for procedure

NonpharmacologicManagement

Principles of Pharmacologic Pain Management

� “By the clock”

� “By the mouth”

� “By the individual”

Mild Pain

• Acetaminophen

• Ibuprofen

Moderate to severe Pain

• Consider Opioids

Special Considerations

� � capacity to metabolize medications

� � glomerular filtration and tubular secretion

� Thinner stratum corneum and greater hydration to the epidermis� Topical medications

� Higher % of body weight as water

� � concentrations of albumin & alpha-1 acid glycoprotein

� Premature infants, have � ventilatoryresponses

� Children < 50 kg and < 18 years:

� Use weight-based dosing

� Children ≥ 50 kg

� Single-dose medications: use weight-based dosing unless patient’s dose or dose per day exceeds adult dose for indication

� Continuous intravenous medication: avoid weight-based dosing strategies and use adult dosing strategies

Special Considerations

Teething Pain

� Non-pharmacologic treatment:

� Teething ring chilled in refrigerator

� Gently rub or massage gums with finger

� Pharmacologic treatment

� Acetaminophen or ibuprofen

� FDA does NOT recommend:

� Benzocaine- methemoglobinemia

• OTC: Anbesol, Hurricaine, Orajel

� Lidocaine 2%- seizures, brain injury, heart problems

Procedural-Related Pain

� Key to management: anticipation� Multimodal approach� Use of local anesthetics and strategies to

soothe, even in simple procedures, like venipuncture's � Eutectic Mixture of Local Anesthetics (EMLA)� Ionotophoresis� Liposomal lidocaine� Vapocoolant spray

� Use systemic agents for procedures which usually cause severe pain, such as bone marrow aspirations� Do not use sedatives or anxiolytics alone

January 2015

5

Acetaminophen

� Most common due to safety profile

� Available in many formulations (eg: tabs, caps, oral liquids, sup, IV) � Beware of concentrated solutions

� General dosing principles� PO: 10-15mg/kg

� Rec: 20mg/kg• Loading dose needed: 30-40mg/kg

� IV: 15mg/kg• Not FDA approved for use in children < 2 years

� MAX: 3G or 4G?

� Hepatically cleared

Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

� Most common NSAIDs in hospital settings: ibuprofen, naproxen, ketorolac

� FDA indication: Ibuprofen & ketorolac

• Exceptions: � Neoprofen- PDA;

� Caldalor only approved for ≥ 17 years

� Ketorolac- only single dose in < 2 years

� WHO only recommends the use of ibuprofen

� Adverse Events:

� Increased incidence of bleeding

� Gastrointestinal bleeding

� Nephropathy

� Edema

� Caution in children with:

� Asthma

� Orthopedic injuries

NSAIDs

Opioid Analgesics

� Mainstay of treatment for moderate to severe pain� Golden Standard: Morphine

� Gradual titration needed

� No ceiling analgesic effect

� Respiratory depression

� Administration: PO or IV� Intravenous route of administration is

favored for acute onset of severe pain• Bolus

• Continuous infusion

• Patient/Nurse Controlled Analgesia

� Morphine

� Most common opioid prescribed

� Safety:

• Hypotension

• Histamine release

� Hydromorphone

� 5 times more potent than morphine

� Preferred for intermittent dosing in patients with renal failure

Opioid Analgesics

� Fentanyl

� 70-100 times more potent than morphine

• More lipophilic and quicker onset

� Structurally similar to meperidine

� Shorter half-life in children: ~2h

� Methadone

� Long-acting opioid

� Same potency as morphine

� Safety:

• Bradycardia, hypotension, cardiac arrythmias

Opioid Analgesics

January 2015

6

� Hydrocodone

� Oral administration

� Used for moderate pain

� Oxycodone

� Oral administration

� Used for moderate to severe pain

� Safety: Acetaminophen overdose in combination products

Opioid Analgesics

� Meperidine� No longer recommended for treatment of

acute pain

� Codeine� Weak opioid� Should not be routinely recommended� 2013 BW: respiratory depression in children

following tonsillectomy and/or adenoidectomy

� Tramadol� May have role in some types of pain in

adolescents� Use is limited in children� Safety: seizures and drug-interaction with

serotonin reuptake inhibitors

Opioid Analgesics

Opioid Dosing

Medication Initial IV< 40 kg ≥ 40 kg

Initial PO< 40 kg ≥ 40 kg

Morphine B: 0.05-0.2 mg/kg/dose q 2-4h; max 15 mg/doseCI: 0.01-0.03 mg/kg/h

B: 5-10mg q 2-4hCI: 0.8-1.5 mg/h

0.2-0.5 mg/kg/dose q 4-6h

10-30mg q 4h IR

Hydromorphone B: 0.015 mg/kg/dose q 3-6hCI: 0.003-0.005 mg/kg/h

B: 1-2mg q 2-4hCI: 0.3-0.5 mg/h

0.03-0.08 mg/kg/dose q 3-4h; max 5 mg/dose

2-4 mg q 3-4h

Fentanyl B: 1-2 mcg/kg/dose q 1-2hCI: 1-2 mcg/kg/h

B: 25-100mcg q 1-2hCI: 25-100 mg/h

___ ___

Methadone B: not recommendedCI: not recommended

0.1 mg/kg/dose q 4h x two or three doses; then 0.1 mg/kg/dose q 6-12h; max 10 mg/dose

5-10mg q 4-12h

Oxycodone ___ ___ 0.05-0.15 mg/kg/dose q 4-6h; max 5mg/dose of oxycodone

1-2 tabs (5mg of oxycodone) q 4-6h

Hydrocodone ___ ___ 0.2 mg/kg/dose q 4-6h 1-2 tabs (5mg ofhydrocodone) q 4-6h

B= bolus, CI= continuous infusion, h= hours, IV= intravenous, max= maximum, PO= oral, q= every,

Summary

� Pediatric patients feel pain, even neonates

� Comprehensive pain management is multidisciplinary

� Pain assessments should be done regularly, using self-report scales when possible

� Appropriate analgesic dosing is based on patient’s weight and/or age

Assessment: True or False?

Infants and children suffer less from pain than adults.Infants and children suffer less from pain than adults.

Self-Report Scales, when possible, are the preferred strategy for gathering information about pain levels in the pediatric population.

Self-Report Scales, when possible, are the preferred strategy for gathering information about pain levels in the pediatric population.

Preterm and term infants clear acetaminophen faster than older children and therefore require a higher dosing frequency.

Preterm and term infants clear acetaminophen faster than older children and therefore require a higher dosing frequency.

FALSE

FALSE

TRUE

References1. American Society of Anesthesiologists Task Force on Acute Pain Management: Practice

guidelines for acute pain management in the perioperative setting: An updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. ANESTHESIOLOGY 2004; 100:1573– 81.

2. American Academy of Pediatrics and American Pain Society. The assessment and management of acute pain in infants, children, and adolescents. Pediatrics. 2001; 108: 793-797.

3. Johnson PN. Chapter 53: Pain Management. In: Benavides S & Nahata MC, Eds. Pediatric Pharmacotherapy. Lenexa, Kansas: American College of Clinical Pharmacy; 2013:835-857.

4. Lavonas EJ, Reynolds KM, and Dart RC. Therapeutic acetaminophen is not associated with liver injury in children: a systematic review. Pediatrics. 2010; 126: 1430-1444.

5. Srouji R, Ratnapalan S, Schneeweiss S. Pain in Children: Assessment and

Nonpharmacological Management. International Journal of Pediatrics

2010;2010:474838. doi:10.1155/2010/474838.

6. US Food and Drug Administration. Drug Safety Communications: FDA recommends not

using lidocaine to treat teething pain and requires new boxed warning. 2014. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm402240.htm

7. WHO guidelines on the pharmacological treatment of persisting pain in children with

medical illnesses. Available at: http://whqlibdoc.who.int/publications2012/9789241548120_Guidelines.pdf

January 2015

1

Pain Management in the Elderly

Leah Loeffler Pharm.D.

PGY1- Pharmacy Resident

Broward Health Medical Center

Objectives

� Review the physiologic and pharmacokinetics changes in the elderly population

� Identify barriers to pain assessment

� Discuss treatment options

� Identify the role of the pharmacist in pain management in the elderly

Epidemiology

� Elderly patients are the fastest growing population in the world

� In 2008, 506 million people ≥ 65 y/o

� In 2040, 1.3 billion people ≥ 65 y/o

� Increase in life expectancy

� 5.8% increase in centenarians from year 2000 to 2010

DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eChapter 8. Geriatrics. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 9e. New York, NY: McGraw-Hill; 2014.

Physiologic Changes with Aging


Changes in Pharmacokinetics


Changes in Pharmacokinetics


January 2015

2

Absorption

� ↓First-pass metabolism affects on

medication

� ↑Bioavailability: Propranolol and labetalol

� ↓Bioavailability: Enalapril and Codeine

� Slowing of GI tract

� ↑effects of continuous-release drugs

� ↑opioid related bowel dysmotility


Metabolism

� ↓Hepatic blood flow � ↓Hepatic

clearance

� High extraction ratio: Amitriptyline, lidocaine, and morphine

� Capacity-limited drugs: Ibuprofen and Naproxen


Elimination

� Creatinine clearance < 30 mL/min �↓renal clearance

� Meperdine and Gabapentin

� Renally excreted metabolites: Normeperidine and morphine-6-glucuronide


Pharmacodynamics

� Effects on age very complex

� Trends of altered drug response or increased sensitivity

� Possible mechanisms

� Changes in concentrations of the drug at the receptor

� Changes in receptor numbers

� Changes in receptor affinity

� Postreceptor alterations

� Age-related impairment of homeostatic mechanisms


Definitions of Pain

� Pain: � An unpleasant sensory and emotional experience

and “whatever the experiencing person says it is, existing whenever he says it does.”

� Acute pain: � Results from injury, surgery, or trauma and can

be associated with tachycardia and diaphoresis

� Persistent pain: � Last for more than 3-6 months and associated

with chronic disease or injury like osteoarthritis. Presents with functional loss, mood disruptions, behavior changes, and reduced quality of life.

Swafford KL, Miller LL, Herr K, et al. Geriatric pain competencies and knowledge assessment for nurses in long term care settings. Geriatr Nurs. 2014 Jul 15

Definitions of Pain

� Nociceptive pain:

� Caused by stimulation of peripheral or visceral pain receptors and associated with disease process, soft-tissue injuries, and medical treatment.

� Neuropathic pain:

� Caused by damage to the peripheral or central nervous system and associated with diabetic neuropathies, post-herpetic and trigeminal neuralgias, stroke, and chemotherapy treatment for cancer.


January 2015

3

Understanding Pain

� Persistent pain increases with age� ↑ Joint pain, ↑neuralgias

� Chronic pain� Significant if persistent, recurrent, and affects

functional capacity or quality of life

� Under treatment� 66% of nursing home patients had chronic pain,

34% of cases not detected by treating physician

Makris UE, Abrams R, Gurland B, et al. Management of persistent pain in the older patient a clinical review. Jama. 2014; 312 (8): 825-836.

Barriers to Pain Assessment

� Physical accessibility to treatment

� Cost of drugs

� Coexisting illness

� Concomitant medication

� Cognitive impairment

DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eChapter 8. Geriatrics. In: Pharmacotherapy: A Pathophysiologic Approach, 9e. New York, NY: McGraw-Hill; 2014.

Pain Assessment

1. Initial:

� Assess pain localization, intensity, duration, quality, and onset

� Assess vital signs

2. Comprehensive:

� Review medical history, physical exam, laboratory and diagnostic test to understand events contributing to pain.

� Assess cognitive status (e.g., dementia, delirium), mental state (e.g., anxiety, agitation, depression), and functional status.


Pain Assessment

2. Comprehensive (cont.)

� Review medications, including current and previously used prescription drugs, over-the-counter drugs, and home remedies

� Use a standardized tool to assess self-reported pain

� Monitor pain intensity after giving medications to evaluate effectiveness

� Gather information from family members about the patient's pain experiences


Wong-Baker Faces® Pain Rating Scale

Wong-baker Face Foundation. Wong-Baker Faces® Pain Rating Scale. 2014. http://wongbakerfaces.org

Pharmacologic Treatment Guidelines

� Administer pain medication on a regular basis to maintain therapeutic levels

� Use (as needed) medication for breakthrough pain

� Use equianalgesic dosing and the World Health Organization three-step ladder to obtain optimal pain relief

January 2015

4

WHO 3 Step Ladder

The World Health Organization three-step analgesic ladder comes of age Palliative Medicine 2004; 18: 175-176.

Pharmacotherapy Treatment

� Non-opioids (mild-to-moderate)

� Acetaminophen (musculoskeletal pain)

� Nonselective NSAIDs/ COX-2 selective

inhibitors

� Opioids (moderate-to-severe)

� Codeine (mild-to-moderate)

� Oxycodone (moderate-to-severe)

� Adjuvant Analgesics

Acetaminophen� Starting Dose:

� 325 mg PO every 4 hrs, MAX 3000 mg

� Indication: � Mild-to-moderate pain

� Contraindications: � Do not use with other OTC drug products containing

acetaminophen

� Adverse Reactions: � Increased serum alkaline phosphatase, increased

serum bilirubin, hypersensitivity

� Monitoring Parameters: � Serum acetaminophen levels: if acute overdose

suspected or with long-term use in patients with

hepatic disease; relief of pain or fever

Ferrel B, Argoff C, Fine P, et al. Pharmacological Management of Persistent Pain in Older Persons. J Am Geriatr Soc. 2009; 57(8): 1331-1346.

Oral NSAIDs� Starting Dose:

� Naproxen sodium: 220 mg PO every 12 hrs

� Ibuprofen: 200 mg PO every 8 hrs� Diclofenac IR: 50 mg PO twice daily

� Celecoxib: 100 mg PO daily

� Indication: � Analgesic or inflammatory disease

� Contraindications: � History of asthma, urticaria, allergic-type reaction to aspirin or

other NSAIDs, active PUD, CKD, HF

� Adverse Reactions: � Edema, epigastric pain, GI bleed

� Monitoring Parameters: � Response (pain, range of motion, grip strength, mobility, ADL

function), renal function (urine output, serum BUN and

creatinine), evaluate gastrointestinal effects


Topical NSAIDs� Starting Dose:

� Voltaren gel/ diclofenac gel: apply 4 g to affected area

every 6 hrs; MAX 32 g

� Indication: � Non-neuropathic persistent pain

� Contraindications: � Same as prior slide

� Adverse Reactions: � Pruritus, application site rash, increased serum

transaminases

� Monitoring Parameters:

� Liver enzymes (4-8 weeks after initiation), BUN/serum

creatinine; monitor urine output; occult blood loss;

blood pressure


Tramadol

� Starting Dose:� 50 mg PO every night, then 25-50 mg immediate

release every 6 hrs; MAX 300 mg

� Indication: � Diabetic neuropathy, osteoarthritis

� Contraindications: � Hypersensitivity to tramadol or opioids

� Adverse Reactions: � Flushing, dizziness, drowsiness, constipation

� Monitoring Parameters: � Pain relief, respiratory rate, blood pressure, and

pulse


January 2015

5

Opioids� Starting Dose:

� Oxycodone: 2.5 mg PO every night, then 2.5- 5 mg

every 4-6 hrs

� Hydrocodone: 2.5 mg PO every night, then 2.5- 5 mg

every 4-6 hrs� Morphine: 2.5-10 mg PO every 4 hrs

� Indication: � Moderate to severe pain

� Contraindications: � Hypersensitivity, respiratory depression, severe

bronchial asthma, paralytic ileus, GI obstruction

� Adverse Reactions: � Drowsiness, pruritus, constipation

� Monitoring Parameters: � Pain relief, respiratory and mental status, blood pressure


Adjuvant Medications

� Examples of adjuvant analgesics

� Antidepressants

� Anticonvulsants

� Topical anesthetics

Tricyclic Antidepressants

� Starting Dose:� Nortriptyline: 25 mg PO every night to start;

MAX 200 mg (if comorbid depression is present and

depending on serum level)

� Indication: � Chronic pain, neuropathic pain (unlabeled)

� Contraindications: � Use of MAO inhibitors (within 14 days)

� Adverse Reaction: � Arrhythmia, tachycardia, anticholinergic effects

� Monitoring Parameters: � Blood pressure (ECG, cardiac monitoring) prior to and

during initial therapy in older adults


Anticonvulsants� Starting Dose:

� Pregabalin: 50 mg PO every night, then 50 mg every

8 hrs; MAX 300 mg

� Gabapentin: 100 mg PO every night, then 100 mg every

8 hrs; MAX 3600 mg

� Indication: � Diabetic neuropathy (unlabeled use with gabapentin),

postherpetic neuralgia

� Contraindications: � Hypersensitivity

� Adverse Reactions: � Peripheral edema, dizziness, somnolence

� Monitoring Parameters: � Measures of efficacy (pain intensity), weight

gain/edema, ataxiaFerrel B, Argoff C, Fine P, et al. Pharmacological Management of Persistent Pain in Older Persons. J Am Geriatr Soc. 2009; 57(8): 1331-1346.

Serotonin-norepinephrine reuptake inhibitors

� Starting Dose:� Duloxetine: 20 mg PO daily; MAX 60 mg

� Venlafaxine: 37.5 mg PO daily; MAX 300 mg (if

comorbid depression is present)

� Indication: � Diabetic peripheral neuropathic pain (unlabeled use for

venlafaxine), chronic musculoskeletal pain

� Contraindications: � Use of MAO inhibitors (within 14 days )

� Adverse Reactions: � Headache, somnolence, fatigue

� Monitoring Parameters: � BP, creatinine, BUN, transaminases


Topical Lidocaine

� Starting Dose: � 5% 1-3 patches for 12 hrs/day

� Indication: � Use in older patients with localized neuropathic pain

� Adverse Effects:� Headache, rash, skin irritation

� Monitoring:� Decreases osteoarthritic knee pain and stiffness,

increases physical function


January 2015

6

Non-pharmacologic Treatment Options

� Non-pharmacological strategies to manage pain

1. Cognitive-behavioral strategies:

• Relaxation therapy

• Education

• Distraction

2. Physical pain relief:

• Massage

• Heat/cold

• Transcutaneous electrical nerve stimulation

(TENS) units


Monitoring Parameters

� Follow up

� Treatment effects: within 1 hour and at least every 4 hours

� Evaluate: pain relief and side effects

� Re-evaluate: 1-4 weeks/ situational based

Kaye A, Baluch A, Scott J. Pain management in the elderly population: a review. Ochnser J. 2010; 10 (3): 179-187.

Pain Medication to Avoid (Beer’s Criteria)

AGS beers criteria for potentially inappropriate medication use in older adults. AGS. 2012; 1-8.

True or False?

� Meperidine (Demerol) is renally excreted.

True

� Tertiary amine tricyclic antidepressants are preferred in the elderly population.

False

� NSAIDS are safe to use in patients who are greater than 75 years old and taking warfarin.

False

References1. Makris UE, Abrams R, Gurland B, et al. Management of persistent pain in the older patient a

clinical review. Jama. 2014; 312 (8): 825-836.

2. DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eChapter 8. Geriatrics. In:

Pharmacotherapy: A Pathophysiologic Approach, 9e. New York, NY: McGraw-Hill; 2014.

3. Kaye A, Baluch A, Scott J. Pain management in the elderly population: a review. Ochnser J.

2010; 10 (3): 179-187.

4. AGS beers criteria for potentially inappropriate medication use in older adults. AGS. 2012;

1-8.

5. Swafford KL, Miller LL, Herr K, et al. Geriatric pain competencies and knowledge

assessment for nurses in long term care settings. Geriatr Nurs. 2014 Jul 15

6. Horgas A, Yoon S, and Grall M. Nursing standard of practic eprotocol: pain management in

older adults. Hartford Institute for Geriatric Nursing.

7. Ferrel B, Argoff C, Fine P, et al. Pharmacological Management of Persistent Pain in Older

Persons. J Am Geriatr Soc. 2009; 57(8): 1331-1346.

8. Lexicomp Online Website. http://0-online.lexi.com.liucat.lib.liu.edu. Accessed December

2014.

9. Wong-baker Face Foundation. Wong-Baker Faces® Pain Rating Scale. 2014.

http://wongbakerfaces.org

10. The World Health Organization three-step analgesic ladder comes of age

Palliative Medicine 2004; 18: 175-176.

January 2015

1

Laws Affecting Pain Management

Johanna Rivera Anazagasty, PharmD

University of Miami Health System DCPA Residency Meeting 2015

January 25, 2015

Educational Objectives

� Describe the role of the Florida Prescription Drug Monitoring Program, E-FORCSE

� Discuss the pharmacist's role in dispensing a controlled substance

� Identify the proper procedure and record-keeping requirements for dispensing controlled substances

� Identify recent changes to the scheduling of medications and evaluate what reclassification can mean to pharmacists, prescribers and patient care

"Pain is a significant public health problem. Chronic pain alone affects

approximately 100 million U.S. adults. Pain reduces quality of life, affects specific population groups disparately, costs society at least

$560-635 billion annually, and can be appropriately addressed through

population health-level interventions.”

"Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research." National Academy of Sciences, 2011."Achieving Balance in State Pain Policy: A Progress Report Card (CY 2013)." University of Wisconsin Carbone Cancer Center, 2014.

A MULTIFACETED BALANCING ACT

"Facts about Pain Management." The Joint Commission, 2014.

Pain Management

Health care

standard

Public safety

Prescriber

Patient

Pharmacist

Deaths Caused by Hydrocodone, Oxycodone, and Methadone in Florida

2004 to 2013

“Drugs Identified in Deceased Persons, Annual Report 2013.” Florida Department of Law Enforcement, Medical Examiner’s Commission, 2014.

"Urine Drug Testing In Chronic Pain." American Society of Interventional Pain Physicians 2011.

Picture obtained from: <http://www.browardcountypainclinics.com/pain-management.html>

Picture obtained from: <http://www.nbcnews.com/business/consumer/mcdonalds-tests-seasoned-fries-burger-king-adds-breakfast-burgers-n100786>

Picture obtained from: <http://janaburson.wordpress.com/tag/florida-pain-clinics/>

Picture obtained from: <http://www.fort-lauderdale-injury-lawyer-blog.com/product-liability/>

January 2015

2

Laws Affecting Pain Clinics in Florida

� Created to prevent facilities the prescribing of controlled substances (C.S.) indiscriminately or inappropriately

� Since July 1, 2011, pain management clinics arerequired to report to the Florida Department of Healththe number of:

� new and repeat patients

� patients discharged due to drug abuse

� patients discharged due to diversion

� patients who live outside of Florida

"Law: Regulating Pain Clinics." Centers for Disease Control and Prevention, 2012.Fla. Stat. § 458.3265 F.A.C. 64B8-9.0132F.A.C. 64B8-9.0131

� E-FORCSE® (Electronic-Florida Online Reportingof Controlled Substance Evaluation) Program

� Implemented in 2011

� Database that collects prescribing and dispensingdata for C.S. Scheduled II, III, and IV

� Purpose: Collect information for health carepractitioners to guide their prescribing and/ordispensing of C.S.

Prescription Drug Monitoring Program (PDMP)

"E-FORCSE®, Florida's Prescription Drug Monitoring Program." n.d. Website.

� Each time a C.S. Scheduled II-IV is dispensed the

pharmacy must report the following to the PDMP:

� Name of the prescriber

� Practitioner’s Drug Enforcement Administration (DEA) registration number or National Provider Identification (NPI)

� Date the prescription was written

� Date the prescription was filled

� Method of payment (e.g. cash, insurance coverage, or Medicaid)

� Full name, address, and date of birth of the patient

� Name, national drug code (NDC), quantity, and strength

� Full name, DEA number, and address of the pharmacy

� Name of the pharmacist dispensing the C.S.

� Data must be reported no more than 7 days after

the dispense date

Fla. Stat. § 893.055

PDMP Requirements

� The following are exempt from reporting:

� Directly administering to a patient in a treatment session

� When dispensing/administering a C.S. to a resident receiving care at a hospital, nursing home, ambulatory surgical center, hospice, or in the health care system of the Department of Corrections

� When administering/dispensing a C.S. to a person < 16 years old

� When dispensing a one-time, 72-hour emergency resupply

� A pharmacy, prescriber, or dispenser may access information in the PDMP for the purpose of reviewing a patient’s specific C.S. prescription history

� A pharmacist before releasing a C.S. to any person NOT known, shall request a valid photographic identification

or other verification of his or her identity

PDMP Requirements

Fla. Stat. § 893.055

Comparison of Drug Caused Deaths in Florida

2012 to 2013

Note: Not all drugs are included in the above chart.


Historical Overview of Heroin Related Deaths in Florida

1999 to 2013


January 2015

3

Reduction in Doctor Shopping2012 to 2014

Number of individuals obtaining C.S. prescriptions in

Schedules II-IV from 5 or more prescribers and 5 or more dispensers within a 90-day period.

"2013-2014 Prescription Drug Monitoring Program Annual Report." Electronic-Florida Online Reporting of Controlled Substances Evaluation, 2014.

Rescheduling of Controlled Substances

� Attorney general has delegated authority to reschedule

drugs based on:

a) Rescheduling or deletion from any controlled substance schedule

b) Substance’s actual or relative potential for abuse

c) Scientific evidence of the substance’s pharmacological effect, if known

d) The state of current scientific knowledge regarding the substance

e) Substance’s history and current pattern of abuse

f) Scope, duration, and significance of abuse

g) Risk to the public health

h) Substance’s physiological or psychological dependence liability

Fla. Stat. § 893.0355“Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II.” Federal Register, 2014.

“Important changes to pain management/controlled substances law 2012”. Florida Academy of Family Physicians, 2012.“Schedules of Controlled Substances: Placement of Tramadol into Schedule IV.” Federal Register Rules and Regulations, 2014.

Recent Changes in Scheduling of Medications Used in Pain

Management

� Hydrocodone combination

products (HCPs)

� From Scheduled III to Scheduled II

� Effective October 6, 2014

� Tramadol and tramadol

containing products (TCPs)

� From legend to Scheduled IV

� Effective August 18, 2014

Fla. Stat. § 893.0355“Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II.” Federal Register, 2014.

“Important changes to pain management/controlled substances law 2012”. Florida Academy of Family Physicians, 2012.“Schedules of Controlled Substances: Placement of Tramadol into Schedule IV.” Federal Register Rules and Regulations, 2014.

� Unable to call in or fax a prescription for a HCPs

� Exception: Resident of a Long Term Care Facility (LTCF)

� However, a prescribers are allowed to call-in prescriptions for HCPs in the event of an emergency

� No refills for HCPs

� However, a prescriber may issue multiple Schedule II prescriptions in order

to provide up to 90-day supply of a medication

� Registration with DEA is now required to dispense tramadol and TCPs

� Mid-level practitioners in FL cannot prescribe tramadol and TCPs

� Concern for patients living in LTCFs

� Tramadol prescriptions may be filled up to 6 months

after the date prescribed21 CFR 290.10

21 CFR 1306.11 21 CFR 1306.12

“Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II.” Federal Register, 2014.“Schedules of Controlled Substances: Placement of Tramadol into Schedule IV.” Federal Register Rules and Regulations, 2014.

Effect of Rescheduling Medications

� Patient access to appropriate treatment for pain

� Increase visits, associated time, and cost to receive medical care

� Concerns that rescheduling could result in doctors changing prescriptions to alternative medications which might be less effective for the treatment of certain types of pain

� Impact on prescribing practices

� Fear to prescribe HCPs and other C.S. Scheduled II narcotics

� Emergency departments usually don’t prescribe C.S. Scheduled II

� Reluctance to contribute to drug abuse, addiction, and diversion

� Possibility of being investigated or disciplined by regulatory agencies

Effect of Rescheduling Medications (cont.)

21 CFR 290.10 21 CFR 1306.11 21 CFR 1306.12


� Impact on drug availability

� Wholesalers may be limiting distributions to pharmacies

� Rural areas may be more affected

� Acquisition of C.S. once ordered can be delayed depending on the ordering system used resulting in local shortages

� DEA does NOT limit the quantity of C.S. that may be distribute

� DEA does impose requirements for distributors to operate a system to disclose suspicious orders of C.S.

� Rescheduling of HCPs HAS NO impact on PDMP reporting

requirements

Effect of Rescheduling Medications (cont.)

21 CFR 290.10 21 CFR 1306.11 21 CFR 1306.12


"E-FORCSE®, Florida's Prescription Drug Monitoring Program." n.d. Website

January 2015

4

“The responsibility for the proper prescribing and dispensing of controlled

substances is upon the prescribing practitioner, but a corresponding

responsibility rests with the pharmacist who fills the prescription”.

21 CFR § 1306.04 (a)“Pharmacist's Manual: An Informational Outline of the Controlled Substances.” Drug Enforcement Administration, 2010.

Pharmacist’s Role in Dispensing Controlled Substances

• Do not dispense a C.S. listed in Schedules II, III, or IV to any patient without first determining that the order is valid

• A pharmacist who knowingly fills a non-legitimate prescription shall be subject to penalties for violations of the law

Evaluate if a prescription was

issued for a legitimate

medical purpose

Evaluate if a prescription was

issued for a legitimate

medical purpose

• Report to the sheriff within 24 hours if a person obtained or attempted to obtain a C.S. fraudulently

• Report to the Department of Health prescribers who are thought to be involved in diversion of C.S.

Report fraudulent

prescriptions

Report fraudulent

prescriptions

Fla. Stat. § 893.04 F.A.C. 64B16-27.831

CS/CS/HB 7095 (lines 1261-1283)


• Write initials on the prescription face

• Write date filled on the prescription face

Assign a prescription

number

Assign a prescription

number

• Date may vary by no more than 6

months from the biennial date that would otherwise apply

Biennial InventoryBiennial

Inventory

Fla. Stat. § 893.04 Fla. Stat. § 893.07

Fla. Stat. § 465.022 (12)(b)


• Prescriptions should be retained for at

least 4 years

Retain Prescriptions

Retain Prescriptions

• Prescription records of all C.S. received, sold, lost, stolen, or destroyed

• Hardcopy summary of records from the previous 60 days shall be made available within 72 hours following a request

Maintain a computerized record of C.S. prescriptions

Maintain a computerized record of C.S. prescriptions

F.A.C. 64B16-28.140F.A.C. 64B16-27.831

Fla. Stat. § 893.07

“Law enforcement officers are not required to obtain a subpoena,

court order, or search warrant in order to obtain access to or copies

of such records.”

Balancing Pain Management with Diversion Risk

� Availability is governed by a combination of state andfederal regulations

� These policies have been created for:

� Drug control as well as diversion and abuse prevention

� Adequate drug availability for legitimate medical purpose

"Achieving Balance in State Pain Policy: A Progress Report Card (CY 2013)." University of Wisconsin Carbone Cancer Center, 2014.Picture obtained from: https://m360.azpharmacy.org/CONTENT/1686424/hygeia_scales.jpg

Drug Control

Drug Availability

January 2015

5

Identify Aberrant Drug-Seeking Behavior

Criteria that should cause a pharmacist to question

whether a prescription is legitimate:

1. Frequent loss of C.S. medications

2. Only C.S. medications are prescribed for a patient

3. One person presents C.S. prescriptions with different patient names

4. Same or similar C.S. medication is prescribed by >2 prescribers at

same time

5. Patient always pays cash

6. Patient always insists on brand name product

“Topics in Palliative Care.” Oxford University Press, 1997.F.A.C. 64B16-27.831

What Should You do if you Notice a Drug-Seeking Behavior?

� Ask to see a picture identification

� Pharmacist should make a photocopy for the records

• Picture identification is not required if dispensed by mail

� If a photocopier is not available, document the information on the back of the prescription

� If the person does not have a picture identification, confirm the person’s identity and document on the back of the prescription

� Verify the prescription with the prescriber

� If unable to verify:

• May determine not to supply the full quantity and may dispense a partial supply, not to exceed a 72-hour supply

• May insist the patient to provides a picture identification (Fla. Stat. § 893.04)

• After verification, the pharmacist may dispense the remaining balance within 72 hours

F.A.C. 64B16-27.831Fla. Stat. § 893.04

Who is Allowed to Prescribe Controlled Substances in Florida?

The following MAY:� Physicians (MD and DO)

� Dentists� Veterinarians� Podiatrists� Optometrists*

*Optometrists may ONLY prescribe a 72-hour supply maximum of:

1. Tramadol hydrochloride2. Acetaminophen 300 mg with

codeine 30 mg

…for the relief of pain due to ocular conditions of the eye

The following CANNOT:

�Mid-level practitioners

� Nurse practitioners

� Physician assistants

� Homeopathic and naturopathic physicians

� Psychologists

� Oriental medicine doctors

Fla. Stat. § 893.02 (21)Fla. Stat. § 463.0055

Physicians who prescribe C.S. are required to have a DEA license

Self-Prescribing

Dr. Lebron suffers from terrible headaches since Medical School. Dr. Lebron self-prescribed Percocet #30 for his ailment.

� Is this a violation of Chapter 893?

Medical Practice

�Prescribing, dispensing, oradministering any medicinaldrug appearing on anyschedule by the physician tohimself or herself is groundsfor denial of a license ordisciplinary action

Fla. Stat. § 458.331(r)Case Scenario: Courtesy of Dr. Matthew Seamon

Dr. Lebron prescribes for hischildren and sister

� Is this allowed?

� Must document in chart

What’s Wrong with this Prescription?

Can you identify the 9 Errors?

Incomplete nameDate without abbreviated

month written

Illegible physician name

Missing DEA Number

Missing Address

CII prescription with refills

Scratch marks make prescription invalid

Quantity must be written in numerical and text

format

Strength Not available

?

Controlled Substances Prescription Requirements

Correct Format for CII Prescriptions

January 2015

6

Federal and State Laws on Prescribing and Dispensing Controlled Substances

� A prescription for a C.S. listed in Schedules II-IV MUST include 1: 1. Written AND a numerical notation of the quantity (BOTH)

2. Notation of the date WITH the abbreviated month written

� Upon verification by the prescriber the pharmacist may clarify any of this information

� A prescription for a C.S. Scheduled II-IV must be written on a counterfeit-proof prescription blank or must be electronically prescribed 2

� In FL prescriptions for C.S. listed in Schedule II must be filled within one year 3

� Dispense Medication Guide with each extended-release or long acting opioid analgesic prescription 4

1 Fla. Stat. § 893.042 Fla. Stat. § 456.42

3 F.A.C. 64B16-27.2114 21 CFR § 208.24

Controlled Substance Prescriptions

CII CIII-V

Oral prescription In case of emergency only 1 Yes 2

Electronic prescriptionYes, subject to security

requirementsYes, subject to security

requirements

Facsimile prescriptionFax may be received in

preparation, but original hard-copy required to dispense 3

Facsimile acceptable under Federal Law

Transfer of prescription between pharmacies

No transfers permitted 1 allowed

Transfer of bulk drugs between registrants (i.e. pharmacies)

Requires 222 Requires complete invoice

Refills No refills allowed 5 within 6 months 4

Emergency refill NO 1 allowed 5

Emergency fill YES YES

Expiration date 1 year 6 months

1 Except in case of an emergency situation, in which such C.S. may be dispensed upon oral prescription. Central fill pharmacies are NOT authorized to prepare prescriptions for a C.S. Scheduled II upon oral authorization from a retail pharmacist or an individual practitioner.2 Maximum supply for C.S. Scheduled III upon oral prescription is 30-days3 Exceptions: 1) Home infusion/IV pharmacies (if compounded for pain) 2) Residents of LTCFs 3) State licensed hospice facility4 No prescription for a C.S. listed in Schedules III-V may be filled or refilled more than 5 times within a period of 6 months following prescription date (F.A.C. 64B16-27.211)5 One time emergency refill for C.S. Scheduled III-V is permissible, up to 72 hour supply

Fla. Stat. § 465.026Fla. Stat. § 465.035Fla. Stat. § 893.04

F.A.C. 64B16-27.211F.A.C. 64B16-27.1003

C.F.R. §1305.21 C.F.R. §1306.21

Case Study

� Miami Heat Pharmacy receives a prescription for a C.S. written by a Podiatrist in California, licensed by the DEA, for a patient living in California who is down in FL visiting her granddaughter.

Case Scenario: Courtesy of Dr. Matthew Seamon

Emergency Dispensing

� Definition of emergency situation (21 CFR 290.10 )

� Immediate administration is necessary

� No appropriate alternative treatment is available

� Not possible for the prescriber to provide a written prescription

� Limited amount to treat during the emergency period � 72 hour-supply (Fla. Stat. § 893.04)

� Prescription shall be immediately reduced to writing � Write “Authorization for Emergency Dispensing” and date

� If prescriber is not known to the pharmacist, verify if the order came from a registered individual

� Within 7 days the prescriber shall deliver a written prescription � Attach it to the oral emergency prescription

� Pharmacist MUST notify if the prescriber fails to deliver

“Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II.” Federal Register, 2014.21 CFR 290.10

21 CFR 1306.11Fla. Stat. § 893.04

Take Home Points

� Laws and regulations on C.S. are aimed to prevent harm to the consumer from dangerous prescription drugs that are diverted for non-medical purposes

� Prescriptions for opioids in the treatment of pain should be evaluated for legitimate medical uses

� Evaluation must be based on documented diagnosis and treatment rather than on the drug dosage or number of prescriptions written

� Appropriate pain management can improve the quality of life of many Floridians and reduce the morbidity and costs associated with abuse and untreated pain

� Concerns about regulatory scrutiny should not prevent pharmacists from dispensing C.S. for legitimate medical purposes

TRUE/FALSE QUESTIONS

January 2015

7

Registration as a controlled substance prescriber is required only if the physician prescribes controlled

substances in schedules II-IV for the treatment of chronic non-malignant pain.

True

The Drug Enforcement Administration now controls tramadol including its

salts, isomers, and salts of isomers, as a schedule III of the Controlled

Substances Act.

False

The Drug Enforcement Administration rescheduled hydrocodone combination products from schedule III to schedule

II of the Controlled Substances Act.

True

Additional Resources

� Legal Tips for Physicians to Manage Pain Patients

� http://www.thehealthlawfirm.com/resources/health-law-articles-and-documents/Legal-Tips-for-physicians-to-manage-pain-patients.html

� E-FORCSE

� http://www.floridahealth.gov/statistics-and-data/e-forcse/

� The Merck Manual: Treatment of Pain

� http://www.merckmanuals.com/professional/neurologic_disorders/pain/treatment_of_pain.html

"Facts about Pain Management." Pain Management. The Joint Commission, Feb. 2014. Web. 16 Dec. 2014. <http://www.jointcommission.org/topics/pain_management.aspx>.

Institute of Medicine. "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and

Research." Washington, DC: National Academy of Sciences, 2011. Print.

Pain & Policy Studies Group. "Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation (CY 2013)."

Madison, WI: University of Wisconsin Carbone Cancer Center, 2014:17. Print. <www.gpo.gov/fdsys/pkg/FR-2014-07-02/pdf/2014-15548.pdf>.

Jae Kennedy, John M. Roll, Taylor Schraudner, Sean Murphy, and Sterling McPherson. "Prevalence of Persistent Pain in the U.S. Adult Population: New Data from the 2010 National Health Interview Survey." The Journal of Pain

2014;15(10):979-984. Web. 18 Dec. 2014.

Paul J. Christo, Laxmaiah Manchikanti, Xiulu Ruan, et al. "Urine Drug Testing In Chronic Pain." Paducah, KY: American Society of Interventional Pain Physicians 2011;14(2):124. Web. 30 Dec. 2014

Florida Medical Examiner’s Commission. “Drugs Identified in Deceased Persons, Annual Report 2013.” Florida Department of Law Enforcement, Medical Examiner’s Commission, October 2014. Web. 30 Dec. 2014. <http://www.fdle.state.fl.us/Content/getdoc/05c6ff97-00cc-49b2-9ca5-5dacd4539b1a/2013-Annual-Drug-Report.aspx>.

"FDA Approves Extended-release, Single-entity Hydrocodone Product with Abuse-deterrent Properties." U.S. Food and

Drug Administration. U.S. Department of Health and Human Services, 20 Nov. 2014. Web. 31 Dec. 2014. <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm423977.htm>.

Heins, James. "Purdue Pharma L.P. Receives FDA Approval for HysinglaTM ER (hydrocodone Bitartrate) Extended-Release Tablets CII, A Once-Daily Opioid Analgesic Formulated with Abuse-Deterrent Properties." Purdue Pharma

News and Media, 20 Nov. 2014. Web. 31 Dec. 2014. <http://www.purduepharma.com/news-media/2014/11/purdue-pharma-l-p-receives-fda-approval-for-hysinglatm-er-hydrocodone-bitartrate-extended-release-tablets-cii-a-once-daily-opioid-analgesic-formulated-with-abuse-deterrent-properties/>.

References

"2013-2014 Prescription Drug Monitoring Program Annual Report." E-FORCSE®, Electronic-Florida Online Reporting of

Controlled Substances Evaluation, 1 Dec. 2014. Web. 30 Dec. 2014. <http://www.floridahealth.gov/statistics-and-data/e-forcse/news-reports/2014PDMPAnnualReportFinal.pdf>.

General Accounting Office. "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion."

Washington, DC: Government Printing Office, May 2002, GAO-PO-634, p. 18. Web. 1 Jan. 2015.

Ronald T. Libby. "Treating Doctors as Drug Dealers The DEA’s War on Prescription Painkillers." Washington, DC: CATO Institute, June 2005, p. 21. Web. 30 Dec. 2014.

“Pharmacist's Manual: An Informational Outline of the Controlled Substances.” Drug Enforcement Administration.

2010. Web 1 Jan. 2015. <http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf>.

Leonhart MM. “Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II.” Federal Register, August 2014; 79 (163):49661-49682. Web. 31 Dec. 2014. <http://www.gpo.gov/fdsys/pkg/FR-2014-08-22/pdf/2014-19922.pdf>.

Portenoy RK, Bruera E. “Topics in Palliative Care.” New York, NY: Oxford University Press, 1997. Web. 16 Dec. 2014.

Legislative Session CS/CS/HB 787. “Important changes to pain management/controlled substances law 2012”. Florida

Academy of Family Physicians, May 2012. Web. 1 Jan. 2015. <http://www.fafp.org/news/FP_News_R/important_changes_to_pain_management_controlled_substances_law>.

Harrigan, TM. “Schedules of Controlled Substances: Placement of Tramadol into Schedule IV.” Federal Register Rules

and Regulations, July 2014; 79(127). Web. 31 Dec. 2014. <http://www.gpo.gov/fdsys/pkg/FR-2014-07-02/pdf/2014-15548.pdf>.

"Law: Regulating Pain Clinics." Centers for Disease Control and Prevention, 9 July 2012. Web. 22 Dec. 2014. <http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/pain_clinic.html#features>.

"Welcome to E-FORCSE®, Florida's Prescription Drug Monitoring Program." E-FORCSE®, the Florida Prescription Drug

Monitoring Program, n.d. Web. 30 Dec. 2014. <http://www.floridahealth.gov/statistics-and-data/e-forcse/>.

References

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