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Guidelines for Prescription of Opioids

Dealing with the Opioid & Heroin Epidemic -

A Training Resource

By Jim Messina, Ph.D., CCMHC, NCC, DCMHS-T

What is Chronic Pain?


Chronic Pain Syndrome (ICD-10 CM G89.4)

Pain for at least 3 months AND:

  • Extreme focus on and/or amplification of pain
  • Major inactivity and/or deconditioning
  • Disrupted sleep
  • Multiple work ups and/or failed treatments
  • Depression and irritability
  • Significant reduction in social activities

 

Prevalence of Chronic Pain

  • 50 million American adults with chronic pain
  • 25 million had daily chronic pain
  • 23 million more reported severe pain   (affecting their activities of daily living- ADLs)

 

Pain Conditions

  • Low back pain 35%
  • Migraine 7.5%
  • Fibromyalgia 7%
  • Lumbar radiculopathy 4.5%
  • Cervical radiculopathy 3.5%
  • Neuropathy 5%
  • Other neurologic condition 5%

 

Biopsychosocial Model of Pain

  • Pain is a subjective experience
  • It is a physical sensation, but it is an unpleasant and therefore emotional experience
  • Pain impacts and is impacted by various factors
  • Necessary to address all to impact the development, maintenance, and impact of chronic pain

 

Psychological Factors and Pain

  • A mild degree of depression, anxiety, and irritability is abnormal psychological response to pain
  • 30-40% of those with chronic pain in Primary Care fall into the subgroup with significant psychiatric comorbidity
  • 50-75% in pain specialty settings with major depression or anxiety disorder

Opioids Prescribed in the USA

 

Brand Name Products

Avinza - morphine sulfate ER capsules

Butrans - buprenorphine transdermal system

Dolophine - methadone hydrochloride tablets

Duragesic - fentanyl transdermal system

Embeda - morphine sulfate/naltrexone ER capsules

Exalgo - hydromorphone hydrochloride ER tablets

Hysingla - ER (hydrocodone bitartrate) ER tablets

Kadian - morphine sulfate ER capsules

Methadose - methadone hydrochloride tablets

MS Contin - morphine sulfate CR tablets

Nucynta - ER tapentadol ER tablets

Opana - ER oxymorphone hydrochloride ER tablets

OxyContin - oxycodone hydrochloride CR tablets

Targiniq - oxycodone hydrochloride/naloxone hydrochloride ER tablets

Zohydro - hydrocodone bitartrate ER capsules

 

Generic Products

Fentanyl ER transdermal systems

Methadone hydrochloride tablets

Methadone hydrochloride oral concentrate

Methadone hydrochloride oral solution

Morphine sulfate ER tablets

Morphine sulfate ER capsules

Oxycodone hydrochloride ER tablets

Prescribers of Extended Release/Long Acting Opioids (ER/LA) Should Balance


The benefits of prescribing ER/LA         VS        The risks of serious adverse outcomes

opioids to treat pain


ER/LA opioid analgesics should be prescribed only by health care professionals

who are knowledgeable in the use of potent opioids for the management of pain


Balance Risks Against Potential Benefits


First: Conduct thorough Heath & Physical Exam and appropriate testing


Benefits include:

Analgesia (adequate pain control)                            

Improved Function


Risks Include:

Overdose

Life Threatening respiratory depression

Addiction

Physical dependence including tolerance

Interactions with other medications & Substances

Risk of neonatal withdrawal syndrome with prolonged use during pregnancy

Misuse by patient or household contacts

Inadvertent exposure/ingestion by household contacts, especially children

Importance of Documentation

Adequately document all patient interactions, assessments, test results, & treatment plans

 

Clinical Interview: Patient Medical History           

Illness relevant to (1) effects or (2) metabolism of opioids

1. Pulmonary disease, constipation, nausea, cognitive impairment

2. Hepatic, renal disease

Illness possibly linked to addiction, e.g.:

  • Hepatitis
  • HIV
  • Tuberculosis
  • Cellulitis
  • Sexually Transmitted Infections (STI’s)
  • Trauma, Burns
  • Cardiac Disease
  • Pulmonary Disease    

 

Clinical Interview: Pain & Treatment History

Description of Pain

  • Location
  • Intensity
  • Quality
  • Onset/Duration
  • Variations/Patterns/Rhythms

What relieves pain?

What causes or increases pain?

Effects of pain on physical, emotional, and psychosocial function

Patient’s pain and functional goals

Pain Medications

Past Use

Current Use

  • Query Prescription Drug Monitoring Programs (PDMPs) where available to confirm patient report
  • Contact past providers & obtain prior medical records
  • Conduct Urine Drug Testing (UDT)
  • Dosage
  • General effectiveness

Nonpharmacologic strategies & effectiveness

 

Perform Thorough Evaluation & Assessment of Pain

  1. Seek objective confirmatory data
  2. Components of patient evaluation for pain
  3. Order diagnostic tests (appropriate to complaint)

 

General: vital signs, appearance, posture, gait, & pain behaviors

Neurologic exam

Musculoskeletal Exam

  • Inspection
  • Palpation
  • Percussion
  • Auscultation
  • Provocative maneuvers

Cutaneous or trophic findings

Assess Risk of Misuse and Addiction, Including Substance Use & Psychiatric History

Obtain a complete History of current & past substance use

  • Prescription medications
  • Illegal substances
  • Alcohol & Tobacco (Substance misuse/addiction history does not prohibit treatment with ER/LA opioids but may require additional monitoring and expert consultation and referral)
  • Family history of substance abuse & psychiatric disorders
  • History of trauma, especially physical or sexual abuse

 

Be knowledgeable about risk factors for opioid use disorder

Personal or family history of substance use disorder

Younger age

Presence of psychiatric condition

 

Understand and use screening tools

Assess potential risks associated with chronic opioid therapy

Manage patients using ER/LA opioids base on risk assessment

 

Conduct a Urine Drug Testing (UDT)

Understand its limitations

 

Screening Tool:

Opioid Risk Tool (ORT) (Administer on initial visit and Prior to Opioid Treatment)

Check each line that applies        Female     Male

Family History of SUD/Addiction       

Alcohol                                                __ 1     __ 3

Illegal Drugs                                        __ 2     __ 3    

Prescription Drugs                              __ 4     __ 4

 

Personal History of SUD/Addiction

Alcohol                                                __ 3     __ 3

Illegal Drugs                                        __ 4     __ 4

Prescription Drugs                              __ 5     __ 5

 

Age between 16 & 45 yrs                   __ 1     __ 1

 

History of Preadolescent Sexual

Abuse                                                 __ 3     __ 0

 

Psychological Disease

ADD, OCD, bipolar, schizophrenia     __ 2     __ 2

Depression                                         __ 1     __ 1

Scoring (Risk)

0 – 3: Low

4 – 7: Moderate

8 or higher: High

 

When to Consider a Trial of an Opioid

Potential benefits are likely to outweigh risks

Failed to adequately respond to nonopioid & nondrug interventions

Continuous, around-the-clock opioid analgesic is needed for an extended period of time

Pain is chronic and severe

No alternative therapy is likely to pose as favorable a balance of benefits to harms

 

Patient Counseling Document on Extended- Release / Long-Acting Opioid Analgesics

The DOs and DON’Ts of

Extended-Release / Long - Acting Opioid Analgesics

DO:

  • Read the Medication Guide
  • Take your medicine exactly as prescribed
  • Store your medicine away from children and in a safe place
  • Flush unused medicine down the toilet
  • Call your healthcare provider for medical advice about side effects.
  • You may report side effects to FDA at 1-800-FDA-1088.

 

Call 911 or your local emergency service right away if:

  • You take too much medicine
  • You have trouble breathing, or shortness of breath
  • A child has taken this medicine

 

Talk to your healthcare provider:

  • If the dose you are taking does not control your pain
  • About any side affects you may be having
  • About all the medicines you take, including over-the- counter medicines, vitamins, and dietary supplements


DON’T:

  • Do not give your medicine to others
  • Do not take medicine unless it was prescribed for you
  • Do not stop taking your medicine without talking to your healthcare provider
  • Do not cut, break, chew, crush, dissolve, snort, or inject your medicine. If you cannot swallow your medicine whole, talk to your healthcare provider.
  • Do not drink alcohol while taking this medicine
  • For additional information on your medicine go to: dailymed.nlm.nih.gov

 

Specific Information on Extended- Release / Long-Acting Opioid Analgesics You have been Prescribed

  1. ______________________________
  2. ______________________________
  3. ______________________________
  4. ______________________________
  5. ______________________________
  6. ______________________________


Take this information with you every time you see your healthcare provider and tell him/her:

  • Your complete medical and family history, including any history of substance abuse or mental illness
  • If you are pregnant or are planning to become pregnant
  • The cause, severity, and nature of your pain
  • Your treatment goals
  • All the medicines you take, including over-the- counter (non-prescription) medicines, vitamins, and dietary supplements
  • Any side affects you may be having

 

Take your opioid pain medicine exactly as prescribed by your healthcare provider.

Benefit of the Tools for Monitoring the Prescription of Opioids

Prescription Drug Monitoring Programs (PDMP) state by state

Record of a patient’s controlled substance prescriptions

Some are available online 24/7

Opportunity to discuss issues of over use of drugs with patient


PDMP’s Provide warnings of potential misuse

Existing prescriptions not reported by patient

Multiple prescribers/pharmacies

Meds that increase overdose risk when taken together

Patient pays for controlled medications with cash

Prescribers can check their own prescribing History


PDMP Unsolicited Patient Threshold Reports

Reports automatically generated on patients who cross certain thresholds when filling prescriptions. Available in some states.

E-mailed to prescribers to whom prescriptions were attributed

Prescribers review records to confirm it is the patient of the prescribing physician and if the physician had written the prescription(s) attributed to them

 

If PDMP Report is Inaccurate,

Contact PDMP If the physician wrote the prescription(s), patient safety may dictate need to discuss the patient with other prescribers listed on report

The physicians decide which of the prescribers will continue to prescribe for the patient & if they might address drug abuse concerns with the patient

 

Rationale for Urine Drug Testing (UDT)

Help to identify drug misuse/addiction

  • Prior to starting opioid treatment

Assist in assessing adherence during opioid therapy

  • As requirement of therapy with an opioid

Support decision to refer

 

UDT frequency is based on clinical judgment

Depending on patient’s display of aberrant behavior and whether it is sufficient to document adherence to treatment plan

Check state regulations for requirements

Main Types of UDT Methods

1.    Initial testing drug panels such as:

Use of a One Step Drug Test for Marijuana, Cocaine, Opiates, Amphetamine, Methamphetamine, and Benzodiazepines

Classify substance as present or absent according to cutoff

Many do not identify individual drugs within a class

Subject to cross-reactivity

Either lab based or at Point of Care testing


2.    Identify Specific Drugs &/or metabolites with sophisticated lab-based testing; e.g.,GC/MS or LC/MS (GC/MS=gas chromatography/ mass spectrometry & LC/MS=liquid chromatography/ mass spectrometry)

Specifically confirm the presence of a given drug– e.g., morphine is the opiate causing a positive IA(IA=immunoassay)

Identify drugs not included in IA tests (IA=immunoassay)

When results are contested

 

Detecting Opioids by Urine Drug Testing (UDT)

Most common opiate IA (IA=immunoassay) drug panels

Detect “opiates” morphine & codeine, but doesn’t distinguish

Do not reliably detect semisynthetic opioids

Specific IA (IA=immunoassay) panels can be ordered for some

Does not detect synthetic opioids (e.g., methadone, fentanyl), Only a specifically directed IA

panel will detect synthetics

 

GC/MS or LC/MS will identify specific opioids

(GC/MS=gas chromatography/ mass spectrometry & LC/MS=liquid chromatography/ mass spectrometry)

Confirm presence of a drug causing a positive IA (IA=immunoassay)

Identify opioids not included in IA drug panels, including semisynthetic & synthetic opioids

 

Specific Windows of Drug Detection

How long a person excretes drug &/or metabolite(s) at a concentration above a cutoff

Detection time of drugs in urine

Governed by various factors; e.g., dose, route of administration, metabolism, fat solubility, urine volume, & pH

For most drugs it is 1-3 days

Chronic use of lipid-soluble drugs increases detection time; e.g., marijuana, diazepam, ketamine

 

Interpretation of Urine Drug Testing (UDT) results

Positive Results:

Demonstrates recent use

Most drugs in urine have detection times of 1-3 days

Chronic use of lipid-soluble drugs: test positive for a week or more

Does not diagnose: Addiction, physical dependence or impairment

Does not provide enough information to determine • Exposure time, dose, or frequency of use

 

Negative Results:

Does not diagnose diversion - More complex than presence or absence of a drug in urine

May be due to maladaptive medication-taking behavior

-       Bingeing, running out early

-       Other factors: eg, cessation of insurance, financial difficulties

 

Be aware: Testing technologies & methodologies evolve

Time taken to eliminate drugs – document times of last use & quantity of drugs taken

 

Differences exist between IA (IA=immunoassay) test menu panels vary

Cross reactivity patterns – maintain list of all patient’s prescribed & Off the counter (OFC) drugs to assist in identifying false-positive results and cut off levels

 

Opioid metabolism may explain presence of apparently unprescribed drugs

Be Ready to Refer

Be familiar with referral sources for misuse or addiction that may arise from use of ER/LA opioids


SAMHSA substance use disorder treatment facility locator: http://findtreatment.samhsa.gov/TreatmentLocator/faces/quickSearch.jspx


SAMHSA substance use Mental Health treatment facility locator: http://findtreatment.samhsa.gov/MHTreatmentLocator/faces/quickSearch.jspx

 

Consider Prescribing Naloxone

Naloxone:

An opioid antagonist

Antidote to acute opioid toxicity

Instruct patients to use in event of known or suspected overdose, in addition to calling emergency services

 

Candidates for Naloxone include those

Taking high-doses of opioids

Taking opioid preparations that may increase risk of overdose; eg. ER/LA opioids

Undergoing opioid rotation

Discharged from emergency medical care following opioid intoxication/ poisoning

Medical need for analgesia, coupled with suspected/confirmed substance misuse/addition

Education of Patients and Families

Prescription medicines should only be taken when prescribed to you by a provider

Taking a pill prescribed for someone else is unsafe and illegal, “even just once”

Misusing prescribed drugs can be as dangerous as illegal “street” drugs

Mixing prescribed opioids w/ alcohol or with sedatives / hypnotics is potentially fatal

 

Educate Parents: Not in My House

Step 1: Monitor

Note how many pills in each prescription bottle or pill packet

Keep track of refills for all household members

If your teen has been prescribed a drug, coordinate & monitor dosages & refills

Make sure friends & relatives—especially grandparents—are aware of the risks

If your teen visits other households, talk to the families about safeguarding their medications

 

Step 2: Secure

Do not store prescription meds in the medicine cabinet

Keep meds in a safe place (e.g., locked cabinet)

Tell relatives, especially grandparents, to lock meds or keep in a safe place

Encourage parents of your teen’s friends to secure meds

 

Step 3: Dispose

Take inventory of all prescription drugs in your home

Discard expired or unused meds

 

Prescribed Opioid Disposal

“Disposal Act” expands ways for patients to dispose of unwanted/expired opioids

Decreases amount of opioids introduced into the environment, particularly into water

Collection receptacles Call DEA Registration Call Center at 1-800-882-9539 to find a local collection receptacle

Mail-back packages Obtained from authorized collectors

Local take-back events Conducted by Federal, State, tribal, or local law enforcement & partnering with community groups

Other Methods of Opioid Disposal

If collection receptacle, mail-back program, or take-back event unavailable, throw out in household trash

Take drugs out of original containers

Mix with undesirable substance, e.g., used coffee grounds or kitty litter making it less appealing to children/pets, & unrecognizable to people who intentionally go through your trash

Place in sealable bag, can, or other container which prevent leaking or breaking out of garbage bag

Before throwing out a medicine container scratch out identifying info on label

 

Prescription Drug Disposal

FDA lists especially harmful medicines – in some cases fatal with  just 1 dose – if taken by someone other than the patient

Instruct patients to check medication guide

As soon as they are no longer needed - So cannot be accidentally taken by children, pets, or others

Includes transdermal adhesive skin patches - Used patch worn for 3 days still contains enough opioid to harm/kill a child 

Dispose used patches immediately after removing from skin - Fold patch in half so sticky sides meet, then flush down toilet

Do NOT place used or unneeded patches in household trash - Exception is Butrans: can seal in Patch-Disposal Unit provided & dispose of in the trash

 

Key Instructions: ER/LA Opioids

1. Individually titrate to a dose that provides adequate analgesia & minimizes

adverse reactions

2. Times required to reach steady-state plasma concentrations are product-specific

3. Refer to product information for titration interval

4. Continually re-evaluate to assess maintenance of pain control & emergence of Addictive Adverse Effects

5. During chronic therapy, especially for non-cancer- related pain, periodically reassess the continued need for opioids 

6. If pain increases, attempt to identify source, while adjusting dose

7. When an ER/LA opioid is no longer required, gradually titrate dose downward to prevent signs & symptoms of withdrawal in physically dependent patients

8. Do not abruptly discontinue

 

Final Tips

Patients MUST be opioid-tolerant in order to safely take most ER/LA opioid products

Be familiar with drug-drug interactions, pharmacokinetics and pharmacodynamics of ER/LA opioids

Central nervous system depressants (alcohol, sedatives, hypnotics, tranquilizers, tricyclic antidepressants) can have a potentiating effect on the sedation and respiratory depression caused by opioids.

 

Resources

A Patient Prescriber Agreement (PPA) http://www.namsdl.org/library/7440DB2D-FE8C- 5D71-83963097CEEE4A1F/

 

For a list of treatment programs in this state: http://americanaddictioncenters.org/rehab-guide/state-funded/#how-to-find-state-funded-rehab

 

SAMHSA substance use disorder treatment facility locator: http://findtreatment.samhsa.gov/TreatmentLocator/faces/quickSearch.jspx 

 

SAMHSA substance use Mental Health treatment facility locator: http://findtreatment.samhsa.gov/MHTreat mentLocator/faces/quickSearch.jspx