Pain & Palliative Care Pharmacist Dot Phrases

GABAPENTINOIDS

Pregabalin and gabapentin share a similar mechanism of action, inhibiting 
calcium influx and subsequent release of excitatory neurotransmitters; however, 
the compounds differ in their pharmacokinetic and pharmacodynamic 
characteristics. Gabapentin is absorbed slowly after oral administration, with 
maximum plasma concentrations attained within 34 hours. Orally administered 
gabapentin exhibits saturable absorption  a nonlinear (zero-order) process 
making its pharmacokinetics less predictable. Plasma concentrations of 
gabapentin do not increase proportionally with increasing dose. In contrast, 
orally administered pregabalin is absorbed more rapidly, with maximum plasma 
concentrations attained within 1 hour. Absorption is linear (first order), with 
plasma concentrations increasing proportionately with increasing dose. The 
absolute bioavailability of gabapentin drops from 60% to 33% as the dosage 
increases from 900 to 3600 mg/day, while the absolute bioavailability of 
pregabalin remains at <-90% irrespective ofthe dosage. Both drugs can be given 
without regard to meals. Neither drug binds to plasma proteins. Neither drug is 
metabolized by nor inhibits hepatic enzymes that are responsible for the 
metabolism of other drugs. Both drugs are excreted renally, with elimination 
half-lives of approximately 6 hours.A comparison of the pharmacokinetics and 
pharmacodynamics of pregabalin and  gabapentin Clin Pharmacokinet. 2010 
Oct;49(10):661-9.

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Gabapentin has an apparent dose related benefit for decreasing both alcohol 
ingestion and craving versus placebo. Improved abstinence rates at 900mg/day 
(NNT 8) and 1800mg/day (NNT 5) have been observed. There also appears to be a 
dose related improvement in sleep and mood. Reference: CNS Drugs 2015;29:293-311

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Gabapentin is recommended first-line for neuropathic pain syndromes. The most 
common adverse reactions include somnolence (sleepiness), ataxia (decreased 
coordination), and fatigue. Recommend slow up-titration to minimize dose-related 
adverse effects. Gabapentin is recommended to be increased in ~300mg increments 
every 3-7 days depending on pt tolerability, up to goal dose of at least 
1800mg/day in 3 divided doses (1800mg/day is the minimum effective dose for pain 
syndromes identified in clinical trials).

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- Consider further increasing GABAPENTIN in 300mg weekly increments until 
clinical effective dose is reached or dose of 3600mg/day is reached . 
        ^ alternately, can consider switching to pregabalin 300mg/day divided in 
          2-3 doses (150mg bid or 100mg tid) and titrate to effect

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Pregabalin showed beneficial effects for alcohol relapse prevention; in the two 
Studies, the authors concluded that pregabalin 150-450 mg/day may represent a 
safe and efficacious option for the long-term management of moderate-to-severe 
alcoholics with also a great duration of disease [Adv Ther.2008;25:608-18]. 
Compared to naltrexone, an approved drug for the treatment of alcohol 
dependence, pregabalin has been shown to be equally effective and also have some 
advantages (reduction in anxiety, hostility) Journal of Psychopharmacology 24(9) 
(2010) 13671374 


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Gabapentin dosing (max)-
Est CrCl >79 ml/min
3,600 mg/day in 3 divided doses
Est CrCl 50 to 79 ml/min
1,800 mg/day in 3 divided doses
Est CrCl 30 to 49 ml/min
900 mg/day in 2 to 3 divided doses
Est CrCl 15 to 29
600 mg/day in 1 to 2 divided doses
 
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pregabALIN  dosing (max)-
 Renal impairment (CrCl 60 mL/min or greater) in adults: No adjustment required
 Renal impairment (CrCl 30 to 60 mL/min) in adults: 75 to 300 mg/day in 2 to 3
divided doses [3
 Renal impairment (CrCl 15 to 30 mL/min) in adults: 25 to 150 mg/day given once
daily or in 2 divided doses
 Renal impairment (CrCl less than 15 mL/min) in adults: 25 to 75 mg once daily
 
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- If veteran is willing to retrial GABAPENTIN, would recommend taking with food 
  in attempt to lessen GI disturbance and titrating to a dose of at least 
  1800mg/day divided into several doses.  Could start at 300mg qhs x 1 
  weekincreasing in 300mg increments weekly. Lengthen time between dose 
  increases if needed based on pt tolerability
- If veteran is unwilling to trial GABAPENTIN, consider initiating PREGABALIN 
  50MG QHS x
 
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SNRIs

Duloxetine has many advantages for complex chronic pain conditions to include 
neuropathic and nociceptive pain. The main advantages of duloxetine over other 
SNRIs (such as venlafaxine) are dosing convenience, simpler dosage titration 
(which may require fewer clinic visits) and larger body of evidence for chronic 
pain disorders. With more FDA-approved indications, duloxetine may be useful for 
simultaneously treating the chronic pain disorder and co-occurring disorders 
(such as depression) with one drug ("dual use"). Doses of duloxetine 20-60mg/day 
are all therapeutic, therefore titrate to effect.
 
 
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OPIOIDS

Tapering strategies should be individualized to the patient and so tapering regimens can vary widely. In general, a decrease of 5-20% every 2-4 weeks is recommended. Patients on higher OMMEs or who have been on opioid therapy for longer durations may require slower tapers. 

It seems patient has been taking _@@@_ every _@@@_ hours, which equates to _@@@_mg oral _@@@_ per day = 30mg oral morphine equivalents per day. A decrease of 5% of the current dose would represent _@@@_mg of _@@@_, whereas a decrease of 20% would represent _@@@_mg of _@@@_. 

An example tapering regimen could be:
@@@
then STOP

If patient begins exhibiting s/sx of opioid withdrawal, taper can be slowed further by extending duration at each dose and/or decreasing % reduction. Oxycodone 5mg tablets are scored to allow for half-tablet (2.5mg) dosing if needed.

Signs/symptoms of opioid withdrawal:
- Early symptoms (begins within hours to days)
	> anxiety / restlessness
	> rapid, short respirations
	> runny nose, tearing eyes, sweating
	> insomnia
	> dilated reactive pupils

- Late symptoms
        > rapid, short respirations
        > runny nose, tearing eyes, sweating
	> yawning
	> tremor, diffuse muscle spasms/aches
	> piloerection
	> nausea, vomiting, diarrhea, abdominal pain
	> fever, chills
	> increased white blood cells if sudden withdrawal

- Prolonged symptoms
	> irritability
	> fatigue
	> bradycardia
	> hypothermia
	> cravings
	> insomnia

Early symptoms typically resolve within 5 to 10 days, though may take longer depending on the half-life of the opioid being discontinued. Some symptoms, such as dysphoria, insomnia, and prolonged craving may take longer to resolve. 

For information regarding symptom management during opioid tapers, please see page 10 of https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/Pain_Opioid_Taper_Tool_IB_10_939_P96820.pdf

Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose.

For more information about opioid tapering, please see the Opioid Taper Decision Tool by Academic Detailing published here: https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/Pain_Opioid_Taper_Tool_IB_10_939_P96820.pdf 

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CHRONIC OPIOIDS

Opioid agreement/consent?:
Last UDS:
UDS due again:
Last provider visit:
Provider visit due again:
Next provider visit:
Active naloxone prescription?:

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5 A's of Opioid Treatment

1.Activity 
   What progress has been made in the patient’s functional goals? 
      •Sitting tolerance 
      •Standing tolerance 
      •Walking ability 
      •Ability to perform activities of daily living 

2.Analgesia 
   How does the patient rate the following over the last 24 hours? 
       •Average pain? 
       •Worst pain? 
       •How much relief have pain medications provided? 

3.Adverse effects 
   Has the patient experienced any adverse effects from medication?
      [ ] Constipation
      [ ] Nausea
      [ ] Dizziness
      [ ] Drowsiness 

4.Aberrant behaviors 
   [ ] Has the patient been taking medication/s as prescribed? 
   [ ] Has the patient exhibited any signs of problematic behaviors or medication abuse/misuse? 
      [ ] •Signs of drug and alcohol use 
      [ ] •Unsanctioned dose escalations 
      [ ] •Has the patient reported lost prescriptions or requested early repeats? 

5.Affect 
   Have there been any changes to the way the patient has been feeling? 
      [ ] •Is pain impacting on the patient’s mood? 
      [ ] •Is the patient depressed or anxious? 
      
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DSM-5 Criteria for Diagnosis of Opioid Use Disorder
Diagnostic Criteria*
These criteria not considered to be met for those individuals taking opioids
solely under appropriate medical supervision.
 
Check all that apply
(x)Opioids are often taken in larger amounts or over a longer period of time
   than intended.
( )There is a persistent desire or unsuccessful efforts to cut
   down or control opioid use.
(x)A great deal of time is spent in activities necessary to obtain the opioid,
   use the opioid, or recover from its effects.
( )Craving, or a strong desire to use opioids.
( )Recurrent opioid use resulting in failure to fulfill major role obligations
   at work, school or home.
(x)Continued opioid use despite having persistent or
   recurrent social or interpersonal problems caused or exacerbated by the
   effects of opioids.
(x)Important social, occupational or recreational activities are given up or
   reduced because of opioid use.
(x)Recurrent opioid use in situations in which it is physically hazardous
( )Continued use despite knowledge of having a persistent or recurrent physical
   or psychological problem that is likely to have been caused or exacerbated by
   opioids.
( )*Tolerance, as defined by either of the following:
     (a) a need for markedly increased amounts of opioids to achieve
         intoxication or desired effect
     (b) markedly diminished effect with continued use of the same amount
         of an opioid
(x)Withdrawal, as manifested by either of the following:
     (a) the characteristic opioid withdrawal syndrome
     (b) the same (or a closely related) substance are taken to relieve or avoid
         withdrawal symptoms
Total Number Boxes Checked: ___6______________
Severity: Mild: 2-3 symptoms. Moderate: 4-5 symptoms. Severe: 6 or more symptoms      
      
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NSAIDs

- Consider use of celecoxib 100mg PO BID x 7 days to help with inflammation and 
pain. Celecoxib does not require renal dose adjustment for current CrCl, 
however NSAIDs should be used at the lowest dose for the shortest duration of 
time. Given celecoxib's elimination half-life of ~11 hours, reasonable to choose 
BID dosing over once daily dosing.  

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BUPRENORPHINE

For patients already receiving daily opioids for the treatment of chronic pain,
VA/DoD guidelines suggests the use of buprenorphine instead of full agonist
opioids due to lower risk of overdose and misuse.

Buprenorphine is a partial mu opioid agonist that has higher binding affinity
but lower intrinsic activity at the mu opioid receptor than traditional full mu
opioid agonists. The partial mu opioid activity allows buprenoprhine to have
sufficient analgesic activity while also providing a ceiling effect for
respiratory depression, making it preferable in patients with comorbidities that
increase their risk with full mu opioid agonists (e.g. high BMI, OSA,
concomitant psychiatric diagnoses, pulmonary disease, concomitant CNS depressant
medications). Buprenorphine also has a unique mechanism of action at other
receptors, such as ORL1 which may contribute to analgesia, and antagonistic
effects at the delta and kappa opioid receptors which theoretically lessens
constipation, and lessens dysphora, abuse potential, and depression.

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More information on the pharmacokinetics of Butrans:
-Initial analgesic response: ~17 hours (shown with 10mcg/hr patch)
-Steady-state/therapeutic drug concentration: ~3 days after application
-After removal of patch: concentration decreases by ~50% in 12hr (range 10-24hr)
-Elimination half-life: 24-48 hours
 
   **Butrans medication administration counseling
        - total 8 application sites (R&L upper outer arm, upper chest, upper
          back, side of chest)
        - Wait at least 21 days before going back to same skin spot
        - Clean, dry, hairless/nearly hairless skin
        - Clean application site with lukewarm water, air dry
        - Avoid soaps, alcohol, oils, lotions, or abrasives on site
        - Avoid shaving site or applying to hairy/sweaty areas
        - Do not apply to irritated skin
        - Do not cut patch
        - During dose adjustments, use no more than 2 patches at a time
          (adjacent to each other)
        - Avoid external heat sources, prolonged hot water, direct sunlight
          Ok to tape edges
        - Disposal: fold adhesive edges on self, flush down toilet

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Buprenorphine and FMAs (full mu agonists) can be used safely in conjunction when 
dosed appropriately avoiding precipitated withdrawal. 

Per the studies from Greenwald et al.(2003) and Cormer et al (2005), they 
reviewed receptor binding of buprenorphine in vivo and found it is dose 
dependent as follows:
        1mg = 79-85%
        2mg = 53-72%
        4mg = 36-55%
        8mg = 11-22%
       12mg = 13-24%
       16mg =  9-20%
       24mg =  4-15%
       32mg =  2-12%
Another study by Greenwald et al (2004) showed drug un-binding from the receptor 
to be time-dependent as follows:
        30% at 4hr 
        54% at 28hr
        67% at 52hr
        82% at 76hr
In order for buprenorphine to produce complete withdrawal suppression, 80% of 
receptors must be blocked. This includes effects such as euphoria, respiratory 
depression, pruritus, and nausea.

Using this information, it was concluded that 8-16mg is the range for which FMA 
could be utilized concurrently in patients who suffer from OUD and acute pain 
conditions such as surgery or trauma. Depending on the level of addiction of the 
patient and the severity of the pain, the BUP dose can be individualized within 
this range. 
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        Buprenorphine products for pain still require long term opioid consent, 
        UDS monitoring, PDMP query, risk review, and q3 month f/u however F2F is 
        needed 1x/year and the rest of the q3 month f/u can be via VVC. 
        Buprenorphine products for pain can have up to 5 refills (C-3 opioid).

-Belbuca buccal film
   **Belbuca medication administration counseling
        - Wet inside of cheek or rinse with water to moisten area
        - Hold film with clean, dry finger and yellow side up
        - Place yellow side toward inside middle of cheek, hold for 5 seconds, 
        leave in place until fully dissolved (~30min)
        - Avoid application to open sores, too high or far back in cheek
        - Avoid touching /moving film until dissolved
        - If not fully dissolved after 30min, remove residual & rinse with water
        - Do not chew or swallow film
        - Avoid eating, drinking acidic beverages and using toothpaste 30min 
        before,during or after application
        - Gently rinse water around teeth after full dissolved
        - Wait at least 1 hour to brush teeth
        - Max 2 films per cheek, side by side  
        
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LOW DOSE NALTREXONE

Naltrexone at low doses (1-5mg) have been shown to reduce glial inflammatory 
response by modulating Toll-like receptor 4 signaling which reduces synthesis of 
pro-inflammatory cytokines, consequently attenuating activating microglial cells 
resulting in analgesic and anti-inflammatory effects. In addition, the lower 
dose actually upregulates endogenous opioid signaling by transient opioid-
receptor blockade (e.g. opioid rebound effect).  Naltrexone is an inexpensive 
medication with a low side effect profile, with some reported incidences of 
vivid dreams, nightmares, headaches, and anecdotal reports of anxiety and 
tachycardia. Even at much larger dosages, naltrexone does not significantly 
affect liver function, and there has not been any observed toxicity or 
withdrawal symptoms with chronic use. Therefore, current evidence supports the 
safety and tolerability of LDN in several chronic pain and inflammatory 
disorders.


Name of Drug/Food/Medical Supply/Other Counseled On:
  LOW DOSE NALTREXONE 4.5mg qdaily 
 
  The following topics were discussed:
   - Indication: 
   - Directions and proper technique (when applicable): self-compounding steps 
        reviewed. Clearly label bottle and store in the refrigerator. 
   - Monitoring for precautions and side effects and expected results: 
        Vivid dreams, insomnia, muscle twitching, upset stomach and nausea. 
        These are much less likely at these low doses and should be temporary.

   - What to do about missing doses: take as soon as you remember. If it is too 
        close to the next administration time, can skip, do not double the dose

   - How to contact the hospital if problems occur: 352-548-6000 x106429

  The following additional topics were discussed:
   - How to administer medication.
 
  Educational Tools/Patient Preference Utilized: (Medication-specific
  educational tools/preferences reviewed previously), Explanation
  Handouts
 
  Teaching Outcome:
   Teaching explained to: Patient
   Readiness to learn: Eager/Asking questions
   Methods: Handouts, Demonstration, Verbal
   Response: Verbalized understanding - patient able to verify teach back
  information 
  
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VITAMIN D

The mechanism of vitamin D and its role in pain is largely unknown; however,
studies suggest multiple possible mechanisms including influence on
prostaglandin E2 action, inhibiting T-helper cells, inhibiting synthesis of
nitric oxide synthase, and effects on inflammatory pathways. The most likely
mechanism of vitamin D on pain processes involves its anti-inflammatory
properties (Int J Mol Sci. 2017 Oct 18;18(10)). Consistent with National
Institutes of Health (NIH) recommendations, pharmacy pain team suggests
supplementation of serum vitamin D levels to above 50nmol/L.


   ^needs ergo load for vit d level 17 this am- 50k weekly x 8 weeks plus 
    supplemental/chronic dosing to ensure that is not missed when load completed
     ca/vit d 600/400 BID_WM and cholecalciferol 50mcg/day (D3=2000iu/day)
 
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TOPIRAMATE

Topiramate is not FDA approved for AUD but is well-supported by evidence. Recent
guidelines recommend it as a first line treatment option.
 
Evidence suggests Topiramate
*Reduced cravings
*Reduced heavy drinking days
*Promoted abstinence
*Doses studied range between 75-300 mg/day given in divided doses.
 
VA/DoD guidelines recommend a max of 200 mg/day
*Co-occurring PTSD and AUD
*Small pilot trial found that topiramate:
*Reduced alcohol consumption, alcohol craving
*Reduced PTSD symptom severity?particularly hyperarousal symptoms

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The measurement of carbohydrate-deficient transferrin (CDT) is serum is useful
for detecting chronic alcohol consumption (more than 50g/day [4-5drinks/day] for
2 weeks). Transferrin is an iron-transport glycoprotein produced in hepatocytes
and it exists in a number of different isoforms. Chronic alcohol use markedly
increases the concentrations of 2 isoforms that together are referred to as CDT.
Alcohol consumption has little effect on other transferrin isoforms. CDT values
greater than 2% may be associated with heavy alcohol consumption. There are 
limitations to this test- pts with advanced liver disease may have elevated CDT 
levels. Further, some antiepileptic medications may also increase CDT levels. 
Levels return to normal with 2 weeks of low /no use.

 

 
ACUTE POST-OPERATIVE PAIN

Multimodal pain mgmt is recommended for post-procedure pain. Opioids may be 
indicated, and if utilized are recommended to be dosed at the lowest effective 
dose and continued for shortest duration of time as clinically indicated to 
prevent unintentional prolonged use.  Taper to discontinuation is recommended at 
earliest opportunity.

 
ASSESSMENT

Patient prefers conservative approach to medication changes. Therefore, will defer consideration of other medication changes until next visit.

Realistic pain goals should be reviewed with the veteran. Pain management with 
medications alone may not provide full pain relief without treatment of the 
substance use disorder(s) - alcohol. Pharmacological modalities provide some 
benefit in chronic pain management but the majority of chronic pain mangement 
rests on the patient engaging in active therapies for pain. This includes SUD 
treatment, MH treatment, pain psychology, PT and exercise. 
OPIOID RISK TOOL

The Opioid Risk Tool (ORT) is an office-based assessment designed to predict which patients may develop aberrant, drug-related behaviors based on known risk factors associated with abuse or addiction. The ORT can either be self-administered by the patient at the initial clinic visit or completed by the physician as part of the patient interview.
The ORT displayed excellent discrimination in predicting opioid abuse-related behaviors in a single-site study of 185 chronic-pain patients. Of the low-risk patients studied, 94% did not demonstrate any aberrant behavior, while in the  high-risk patients, 91% did display an aberrant behavior. Of the medium risk patients, only 28% showed any opioid-related aberrant behavior.

Opioid Risk Tool – The SOAPnote Project
Opioid Monitoring A’s – The SOAPnote Project

COWS Score for Opiate Withdrawal
 
Resting Pulse Rate (BPM)
 [ ] 0 - less than or equal to 80
 [ ] 1 - 81-100
 [ ] 2 - 101-120
 [ ] 3 - greater than 120
Sweating
 [ ] 0 - No report of chills or flushing
 [ ] 1 - Subjective report of chills or flushing
 [ ] 2 - Flushed or observable moistness on face
 [ ] 3 - Beads of sweat on brow or face
 [ ] 4 - Sweat streaming off face
Restlessness Observation During Assessment
 [ ] 0 - Able to sit still
 [ ] 1 - Reports difficulty sitting still, but is able to do so
 [ ] 3 - Frequent shifting or extraneous movements of legs/arms
 [ ] 5 - Unable to sit still for more than a few seconds
Pupil Size
 [ ] 0 - Pupils pinned or normal size for room light
 [ ] 1 - Pupils possibly larger than normal for room light
 [ ] 2 - Pupils moderately dilated
 [ ] 5 - Pupils so dilated that only the rim of the iris is visible
Bone or Joint Aches
 [ ] 0 - Not present
 [ ] 1 - Mild diffuse discomfort
 [ ] 2 - Patient reports severe diffuse aching of joints/muscles
 [ ] 4 - Patient is rubbing joints or muscles and is unable to sit still because
         of discomfort
Runny Nose or Tearing
 [ ] 0 - Not present
 [ ] 1 - Nasal stuffiness or unusually moist eyes
 [ ] 2 - Nose running or tearing
 [ ] 4 - Nose constantly running or tears streaming down cheeks
GI Upset
 [ ] 0 - No GI symptoms
 [ ] 1 - Stomach cramps
 [ ] 2 - Nausea or loose stool
 [ ] 3 - Vomiting or diarrhea
 [ ] 5 - Multiple episodes or vomiting or diarrhea
Tremor Observation of Outstretched Hands
 [ ] 0 - No tremor
 [ ] 1 - Tremor can be felt, but not observed
 [ ] 2 - Slight tremor observable
 [ ] 4 - Gross tremor or muscle twitching
Yawning Observation During Assessment
 [ ] 0 - No yawning
 [ ] 1 - Yawning once or twice during assessment
 [ ] 2 - Yawning three or more times during assessment
 [ ] 4 - Yawning several times/minute
Anxiety or Irritability
 [ ] 0 - None
 [ ] 1 - Patient reports increasing irritability or anxiousness
 [ ] 2 - Patient obviously irritable/anxious
 [ ] 4 - Patient so irritable or anxious that participation in the assessment is
         difficult
Gooseflesh Skin
 [ ] 0 - Skin is smooth
 [ ] 3 - Piloerection of skin can be felt or hairs standing up on arms
 [ ] 5 - Prominent piloerection
 
TOTAL [  ]
  No active withdrawal: less than 5
  Mild withdrawal: 5-12
  Moderate withdrawal: 13-24
  Moderately severe withdrawal: 25-36
  Severe withdrawal: greater than 36
Citation for COWS: Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale
(COWS) Psychoactive Drugs.2003;35:253-259
 
Opioid withdrawal can be extremely uncomfortable but is not felt to be life
threatening in absence of other drug withdrawal and/or severe comorbidities.
Opioid withdrawal symptoms can last anywhere from one week to one month. The
first phase (acute withdrawal) can begin within hours of last opioid use.  The
acute stage has mostly physical symptoms:
  *Low energy, Irritability, Anxiety, Agitation, Insomnia
  *Runny nose, Teary eyes
  *Hot and cold sweats, Goose bumps
  *Yawning
  *Muscle aches and pains
  *Abdominal cramping, Nausea, Vomiting, Diarrhea
The acute phase is thought to peak around 3 - 5 days after last opioid use and
can last for approximately 1 - 4 weeks. The second phase (post-acute withdrawal)
can last weeks to months. The symptoms include mood swings, anxiety, variable
energy, low enthusiasm, variable concentration, and disturbed sleep.
 
DRONABINOL

Local Criteria for Use for dronabinol (P&T approved 06/2018)

INCLUSION LOCAL CRITERIA FOR USE:
[ ] Anorexia associated with weight loss in patients with AIDS 
[ ] Cancer chemotherapy-induced nausea and vomiting (CINV) who failed or
    intolerant to combined treatment of at least 3 of the following classes 
    of first line conventional antiemetic treatments as described in the
    NCCN Guidelines 2018 'Pharmacologic Considerations for Antiemetic 
    Prescribing' such as NK1-RA, 5HT3-RA, glucocorticoid, dopamine agonist, 
    and an antihistamine. *** Choice of antiemetic(s) should be based on 
    the emetic risk of the therapy and patient-specific factors
[ ] Appetite stimulation in cancer patients related to anorexia/cachexia 
    or therapeutic failure of, intolerance of, or contraindication to 
    megestrol therapy and requested by VA Oncology***
[ ] Muscle spasticity from multiple sclerosis in patients who have trialed 
    and failed at least one agent from each of the following classes of drugs
    at conventional therapeutic doses: gabapentinoid, antispasmodic, or
    benzodiazepine

*** If dual care, recommend obtaining non-VA oncology records/factors indicating 
anorexia-cachexia. Recommend consulting nutrition for alternative options before 
trialing dronabinol if deemed appropriate by reviwing pharmacist.

 
EXCLUSION CRITERIA:
[ ] Pregnant or nursing 
[ ] History of a serious hypersensitivity reaction to cannabinoids,
    sesame oil, gelatin, glycerin, and/or titanium dioxide.
[ ] Diagnosis of mania, schizophrenia, depression, psychosis and bipolar 
    disorder. *In rare cases, approval is possible with close monitoring* 
    Dronabinol can exacerbate these psychiatric disorders. Consultation by 
    psychiatrist is highly recommended. 
DOCUMENTATION

 
Cardiovascular:

Dermatologic: 

Endocrine:

Gastrointestinal:
 
Genitourinary:

Hematologic/Oncologic:

Immunologic: 

Musculoskeletal/Rheumatologic:
 
Neurological:
 
Psychiatric: 

Pulmonary: 


PAIN TREATMENT HISTORY: 

Previous Interventional treatment: 
    []Spinal cord stimulator
    []Injection (trigger point, ESI, steroid, etc.)  
    []Surgery 
    []Other: 

Previous Non-pharmacological treatment: 
    []PT/OT 
    []Yoga/Tai Chi 
    []Acupuncture 
    []CBT/Psychotherapy 
    []Mindfulness 
    []MOVE 
    []Heating pad 
    []Cold packs 
    []TENS unit 
    []Other e-stim device 
    []Chiropractor 
    []Others: 

Previous Medication Trials: 
  ANALGESICS/NSAIDS  
   []Aspirin 
   []Acetaminophen
   []Celecoxib
   []Diclofenac
   []Diflunisal
   []Etodolac
   []Fenoprofen
   []Flurbiprofen    
   []Ibuprofen
   []Indomethacin
   []Meloxicam   
   []Naproxen
   []Oxaprozin
   []Piroxicam 
   []Salsalate
   []Sulindac  
   []Tolmetin 

  OPIOIDS  
   []Codeine
   []Fentanyl   
   []Hydrocodone  
   []Hydromorphone
   []Levorphanol 
   []Morphine  
   []Methadone
   []Oxycodone
   []Oxymorphone     
   []Buprenorphine
   []Tramadol
   []Tapentadol   

  TRIPTANS 
   []Almotriptan
   []Eletriptan
   []Rizatriptan   
   []Sumatriptan 
   []Zolmitriptan 
   []Ergotamine/dihydroergotamine 

  TOPICALS 
   []Capsaicin cream/patch 
   []Lidocaine patch/ointment/cream/gel 
   []Diclofenac gel  
   []Menthol/methyl-salicylate cream/patch 

  ANTICONVULSANTS
   []Carbamazepine
   []Gabapentin 
   []Lamotrigine 
   []Levetiracetam
   []Pregabalin  
   []Topiramate   
   []Valproate
        
  MUSCLE RELAXANTS    
   []Baclofen  
   []Carisoprodol  
   []Cyclobenzaprine  
   []Metaxalone  
   []Methocarbamol  
   []Tizanidine  

  ANTIDEPRESSANTS 
   []Duloxetine   
   []Venlafaxine   
   []Milnacipran   
   []Amitriptyline    
   []Nortriptyline 

  OTHER
   []Propranolol      
   []Verapamil 


 
TOPICALS

- Consider PADR for lidocaine 5% patch if lidocaine ointment is effective but 
  not long-lasting 
GABAPENTINOIDS

Pregabalin and gabapentin share a similar mechanism of action, inhibiting
calcium influx and subsequent release of excitatory neurotransmitters; however,
the compounds differ in their pharmacokinetic and pharmacodynamic
characteristics. Gabapentin is absorbed slowly after oral administration, with
maximum plasma concentrations attained within 34 hours. Orally administered
gabapentin exhibits saturable absorption a nonlinear (zero-order) process
making its pharmacokinetics less predictable. Plasma concentrations of
gabapentin do not increase proportionally with increasing dose. In contrast,
orally administered pregabalin is absorbed more rapidly, with maximum plasma
concentrations attained within 1 hour. Absorption is linear (first order), with
plasma concentrations increasing proportionately with increasing dose. The
absolute bioavailability of gabapentin drops from 60% to 33% as the dosage
increases from 900 to 3600 mg/day, while the absolute bioavailability of
pregabalin remains at <-90% irrespective ofthe dosage. Both drugs can be given
without regard to meals. Neither drug binds to plasma proteins. Neither drug is
metabolized by nor inhibits hepatic enzymes that are responsible for the
metabolism of other drugs. Both drugs are excreted renally, with elimination
half-lives of approximately 6 hours.A comparison of the pharmacokinetics and
pharmacodynamics of pregabalin and gabapentin Clin Pharmacokinet. 2010
Oct;49(10):661-9.

--------------------------------------------------------------------------------

Gabapentin has an apparent dose related benefit for decreasing both alcohol
ingestion and craving versus placebo. Improved abstinence rates at 900mg/day
(NNT 8) and 1800mg/day (NNT 5) have been observed. There also appears to be a
dose related improvement in sleep and mood. Reference: CNS Drugs 2015;29:293-311

--------------------------------------------------------------------------------

Gabapentin is recommended first-line for neuropathic pain syndromes. The most
common adverse reactions include somnolence (sleepiness), ataxia (decreased
coordination), and fatigue. Recommend slow up-titration to minimize dose-related
adverse effects. Gabapentin is recommended to be increased in ~300mg increments
every 3-7 days depending on pt tolerability, up to goal dose of at least
1800mg/day in 3 divided doses (1800mg/day is the minimum effective dose for pain
syndromes identified in clinical trials).

--------------------------------------------------------------------------------

- Consider further increasing GABAPENTIN in 300mg weekly increments until
clinical effective dose is reached or dose of 3600mg/day is reached .
^ alternately, can consider switching to pregabalin 300mg/day divided in
2-3 doses (150mg bid or 100mg tid) and titrate to effect

--------------------------------------------------------------------------------

Pregabalin showed beneficial effects for alcohol relapse prevention; in the two
Studies, the authors concluded that pregabalin 150-450 mg/day may represent a
safe and efficacious option for the long-term management of moderate-to-severe
alcoholics with also a great duration of disease [Adv Ther.2008;25:608-18].
Compared to naltrexone, an approved drug for the treatment of alcohol
dependence, pregabalin has been shown to be equally effective and also have some
advantages (reduction in anxiety, hostility) Journal of Psychopharmacology 24(9)
(2010) 13671374 


--------------------------------------------------------------------------------

Gabapentin dosing (max)-
Est CrCl >79 ml/min
3,600 mg/day in 3 divided doses
Est CrCl 50 to 79 ml/min
1,800 mg/day in 3 divided doses
Est CrCl 30 to 49 ml/min
900 mg/day in 2 to 3 divided doses
Est CrCl 15 to 29
600 mg/day in 1 to 2 divided doses

--------------------------------------------------------------------------------

pregabALIN dosing (max)-
Renal impairment (CrCl 60 mL/min or greater) in adults: No adjustment required
Renal impairment (CrCl 30 to 60 mL/min) in adults: 75 to 300 mg/day in 2 to 3
divided doses [3
Renal impairment (CrCl 15 to 30 mL/min) in adults: 25 to 150 mg/day given once
daily or in 2 divided doses
Renal impairment (CrCl less than 15 mL/min) in adults: 25 to 75 mg once daily

--------------------------------------------------------------------------------

- If veteran is willing to retrial GABAPENTIN, would recommend taking with food
in attempt to lessen GI disturbance and titrating to a dose of at least
1800mg/day divided into several doses. Could start at 300mg qhs x 1
weekincreasing in 300mg increments weekly. Lengthen time between dose
increases if needed based on pt tolerability
- If veteran is unwilling to trial GABAPENTIN, consider initiating PREGABALIN
50MG QHS x

================================================================================

SNRIs

Duloxetine has many advantages for complex chronic pain conditions to include
neuropathic and nociceptive pain. The main advantages of duloxetine over other
SNRIs (such as venlafaxine) are dosing convenience, simpler dosage titration
(which may require fewer clinic visits) and larger body of evidence for chronic
pain disorders. With more FDA-approved indications, duloxetine may be useful for
simultaneously treating the chronic pain disorder and co-occurring disorders
(such as depression) with one drug ("dual use"). Doses of duloxetine 20-60mg/day
are all therapeutic, therefore titrate to effect.


================================================================================ 

OPIOIDS

Tapering strategies should be individualized to the patient and so tapering regimens can vary widely. In general, a decrease of 5-20% every 2-4 weeks is recommended. Patients on higher OMMEs or who have been on opioid therapy for longer durations may require slower tapers.

It seems patient has been taking _@@@_ every _@@@_ hours, which equates to _@@@_mg oral _@@@_ per day = 30mg oral morphine equivalents per day. A decrease of 5% of the current dose would represent _@@@_mg of _@@@_, whereas a decrease of 20% would represent _@@@_mg of _@@@_.

An example tapering regimen could be:
@@@
then STOP

If patient begins exhibiting s/sx of opioid withdrawal, taper can be slowed further by extending duration at each dose and/or decreasing % reduction. Oxycodone 5mg tablets are scored to allow for half-tablet (2.5mg) dosing if needed.

Signs/symptoms of opioid withdrawal:
- Early symptoms (begins within hours to days)
> anxiety / restlessness
> rapid, short respirations
> runny nose, tearing eyes, sweating
> insomnia
> dilated reactive pupils

- Late symptoms
> rapid, short respirations
> runny nose, tearing eyes, sweating
> yawning
> tremor, diffuse muscle spasms/aches
> piloerection
> nausea, vomiting, diarrhea, abdominal pain
> fever, chills
> increased white blood cells if sudden withdrawal

- Prolonged symptoms
> irritability
> fatigue
> bradycardia
> hypothermia
> cravings
> insomnia

Early symptoms typically resolve within 5 to 10 days, though may take longer depending on the half-life of the opioid being discontinued. Some symptoms, such as dysphoria, insomnia, and prolonged craving may take longer to resolve.

For information regarding symptom management during opioid tapers, please see page 10 of https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/Pain_Opioid_Taper_Tool_IB_10_939_P96820.pdf

Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose.

For more information about opioid tapering, please see the Opioid Taper Decision Tool by Academic Detailing published here: https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/Pain_Opioid_Taper_Tool_IB_10_939_P96820.pdf 

================================================================================

CHRONIC OPIOIDS

Opioid agreement/consent?:
Last UDS:
UDS due again:
Last provider visit:
Provider visit due again:
Next provider visit:
Active naloxone prescription?:

--------------------------------------------------------------------------------
5 A's of Opioid Treatment

1.Activity
What progress has been made in the patient’s functional goals?
•Sitting tolerance
•Standing tolerance
•Walking ability
•Ability to perform activities of daily living

2.Analgesia
How does the patient rate the following over the last 24 hours?
•Average pain?
•Worst pain?
•How much relief have pain medications provided?

3.Adverse effects
Has the patient experienced any adverse effects from medication?
[ ] Constipation
[ ] Nausea
[ ] Dizziness
[ ] Drowsiness

4.Aberrant behaviors
[ ] Has the patient been taking medication/s as prescribed?
[ ] Has the patient exhibited any signs of problematic behaviors or medication abuse/misuse?
[ ] •Signs of drug and alcohol use
[ ] •Unsanctioned dose escalations
[ ] •Has the patient reported lost prescriptions or requested early repeats?

5.Affect
Have there been any changes to the way the patient has been feeling?
[ ] •Is pain impacting on the patient’s mood?
[ ] •Is the patient depressed or anxious? 

--------------------------------------------------------------------------------

DSM-5 Criteria for Diagnosis of Opioid Use Disorder
Diagnostic Criteria*
These criteria not considered to be met for those individuals taking opioids
solely under appropriate medical supervision.

Check all that apply
(x)Opioids are often taken in larger amounts or over a longer period of time
than intended.
( )There is a persistent desire or unsuccessful efforts to cut
down or control opioid use.
(x)A great deal of time is spent in activities necessary to obtain the opioid,
use the opioid, or recover from its effects.
( )Craving, or a strong desire to use opioids.
( )Recurrent opioid use resulting in failure to fulfill major role obligations
at work, school or home.
(x)Continued opioid use despite having persistent or
recurrent social or interpersonal problems caused or exacerbated by the
effects of opioids.
(x)Important social, occupational or recreational activities are given up or
reduced because of opioid use.
(x)Recurrent opioid use in situations in which it is physically hazardous
( )Continued use despite knowledge of having a persistent or recurrent physical
or psychological problem that is likely to have been caused or exacerbated by
opioids.
( )*Tolerance, as defined by either of the following:
(a) a need for markedly increased amounts of opioids to achieve
intoxication or desired effect
(b) markedly diminished effect with continued use of the same amount
of an opioid
(x)Withdrawal, as manifested by either of the following:
(a) the characteristic opioid withdrawal syndrome
(b) the same (or a closely related) substance are taken to relieve or avoid
withdrawal symptoms
Total Number Boxes Checked: ___6______________
Severity: Mild: 2-3 symptoms. Moderate: 4-5 symptoms. Severe: 6 or more symptoms

================================================================================

NSAIDs

- Consider use of celecoxib 100mg PO BID x 7 days to help with inflammation and
pain. Celecoxib does not require renal dose adjustment for current CrCl,
however NSAIDs should be used at the lowest dose for the shortest duration of
time. Given celecoxib's elimination half-life of ~11 hours, reasonable to choose
BID dosing over once daily dosing.  

================================================================================

BUPRENORPHINE

For patients already receiving daily opioids for the treatment of chronic pain,
VA/DoD guidelines suggests the use of buprenorphine instead of full agonist
opioids due to lower risk of overdose and misuse.

Buprenorphine is a partial mu opioid agonist that has higher binding affinity
but lower intrinsic activity at the mu opioid receptor than traditional full mu
opioid agonists. The partial mu opioid activity allows buprenoprhine to have
sufficient analgesic activity while also providing a ceiling effect for
respiratory depression, making it preferable in patients with comorbidities that
increase their risk with full mu opioid agonists (e.g. high BMI, OSA,
concomitant psychiatric diagnoses, pulmonary disease, concomitant CNS depressant
medications). Buprenorphine also has a unique mechanism of action at other
receptors, such as ORL1 which may contribute to analgesia, and antagonistic
effects at the delta and kappa opioid receptors which theoretically lessens
constipation, and lessens dysphora, abuse potential, and depression.

--------------------------------------------------------------------------------

More information on the pharmacokinetics of Butrans:
-Initial analgesic response: ~17 hours (shown with 10mcg/hr patch)
-Steady-state/therapeutic drug concentration: ~3 days after application
-After removal of patch: concentration decreases by ~50% in 12hr (range 10-24hr)
-Elimination half-life: 24-48 hours

**Butrans medication administration counseling
- total 8 application sites (R&L upper outer arm, upper chest, upper
back, side of chest)
- Wait at least 21 days before going back to same skin spot
- Clean, dry, hairless/nearly hairless skin
- Clean application site with lukewarm water, air dry
- Avoid soaps, alcohol, oils, lotions, or abrasives on site
- Avoid shaving site or applying to hairy/sweaty areas
- Do not apply to irritated skin
- Do not cut patch
- During dose adjustments, use no more than 2 patches at a time
(adjacent to each other)
- Avoid external heat sources, prolonged hot water, direct sunlight
Ok to tape edges
- Disposal: fold adhesive edges on self, flush down toilet

--------------------------------------------------------------------------------

Buprenorphine and FMAs (full mu agonists) can be used safely in conjunction when
dosed appropriately avoiding precipitated withdrawal.

Per the studies from Greenwald et al.(2003) and Cormer et al (2005), they
reviewed receptor binding of buprenorphine in vivo and found it is dose
dependent as follows:
1mg = 79-85%
2mg = 53-72%
4mg = 36-55%
8mg = 11-22%
12mg = 13-24%
16mg = 9-20%
24mg = 4-15%
32mg = 2-12%
Another study by Greenwald et al (2004) showed drug un-binding from the receptor
to be time-dependent as follows:
30% at 4hr
54% at 28hr
67% at 52hr
82% at 76hr
In order for buprenorphine to produce complete withdrawal suppression, 80% of
receptors must be blocked. This includes effects such as euphoria, respiratory
depression, pruritus, and nausea.

Using this information, it was concluded that 8-16mg is the range for which FMA
could be utilized concurrently in patients who suffer from OUD and acute pain
conditions such as surgery or trauma. Depending on the level of addiction of the
patient and the severity of the pain, the BUP dose can be individualized within
this range.
--------------------------------------------------------------------------------

Buprenorphine products for pain still require long term opioid consent,
UDS monitoring, PDMP query, risk review, and q3 month f/u however F2F is
needed 1x/year and the rest of the q3 month f/u can be via VVC.
Buprenorphine products for pain can have up to 5 refills (C-3 opioid).

-Belbuca buccal film
**Belbuca medication administration counseling
- Wet inside of cheek or rinse with water to moisten area
- Hold film with clean, dry finger and yellow side up
- Place yellow side toward inside middle of cheek, hold for 5 seconds,
leave in place until fully dissolved (~30min)
- Avoid application to open sores, too high or far back in cheek
- Avoid touching /moving film until dissolved
- If not fully dissolved after 30min, remove residual & rinse with water
- Do not chew or swallow film
- Avoid eating, drinking acidic beverages and using toothpaste 30min
before,during or after application
- Gently rinse water around teeth after full dissolved
- Wait at least 1 hour to brush teeth
- Max 2 films per cheek, side by side  

================================================================================

LOW DOSE NALTREXONE

Naltrexone at low doses (1-5mg) have been shown to reduce glial inflammatory
response by modulating Toll-like receptor 4 signaling which reduces synthesis of
pro-inflammatory cytokines, consequently attenuating activating microglial cells
resulting in analgesic and anti-inflammatory effects. In addition, the lower
dose actually upregulates endogenous opioid signaling by transient opioid-
receptor blockade (e.g. opioid rebound effect). Naltrexone is an inexpensive
medication with a low side effect profile, with some reported incidences of
vivid dreams, nightmares, headaches, and anecdotal reports of anxiety and
tachycardia. Even at much larger dosages, naltrexone does not significantly
affect liver function, and there has not been any observed toxicity or
withdrawal symptoms with chronic use. Therefore, current evidence supports the
safety and tolerability of LDN in several chronic pain and inflammatory
disorders.


Name of Drug/Food/Medical Supply/Other Counseled On:
LOW DOSE NALTREXONE 4.5mg qdaily

The following topics were discussed:
- Indication:
- Directions and proper technique (when applicable): self-compounding steps
reviewed. Clearly label bottle and store in the refrigerator.
- Monitoring for precautions and side effects and expected results:
Vivid dreams, insomnia, muscle twitching, upset stomach and nausea.
These are much less likely at these low doses and should be temporary.

- What to do about missing doses: take as soon as you remember. If it is too
close to the next administration time, can skip, do not double the dose

- How to contact the hospital if problems occur: 352-548-6000 x106429

The following additional topics were discussed:
- How to administer medication.

Educational Tools/Patient Preference Utilized: (Medication-specific
educational tools/preferences reviewed previously), Explanation
Handouts

Teaching Outcome:
Teaching explained to: Patient
Readiness to learn: Eager/Asking questions
Methods: Handouts, Demonstration, Verbal
Response: Verbalized understanding - patient able to verify teach back
information 

================================================================================

VITAMIN D

The mechanism of vitamin D and its role in pain is largely unknown; however,
studies suggest multiple possible mechanisms including influence on
prostaglandin E2 action, inhibiting T-helper cells, inhibiting synthesis of
nitric oxide synthase, and effects on inflammatory pathways. The most likely
mechanism of vitamin D on pain processes involves its anti-inflammatory
properties (Int J Mol Sci. 2017 Oct 18;18(10)). Consistent with National
Institutes of Health (NIH) recommendations, pharmacy pain team suggests
supplementation of serum vitamin D levels to above 50nmol/L.


^needs ergo load for vit d level 17 this am- 50k weekly x 8 weeks plus
supplemental/chronic dosing to ensure that is not missed when load completed
ca/vit d 600/400 BID_WM and cholecalciferol 50mcg/day (D3=2000iu/day)

================================================================================ 

TOPIRAMATE

Topiramate is not FDA approved for AUD but is well-supported by evidence. Recent
guidelines recommend it as a first line treatment option.

Evidence suggests Topiramate
*Reduced cravings
*Reduced heavy drinking days
*Promoted abstinence
*Doses studied range between 75-300 mg/day given in divided doses.

VA/DoD guidelines recommend a max of 200 mg/day
*Co-occurring PTSD and AUD
*Small pilot trial found that topiramate:
*Reduced alcohol consumption, alcohol craving
*Reduced PTSD symptom severity?particularly hyperarousal symptoms

--------------------------------------------------------------------------------

The measurement of carbohydrate-deficient transferrin (CDT) is serum is useful
for detecting chronic alcohol consumption (more than 50g/day [4-5drinks/day] for
2 weeks). Transferrin is an iron-transport glycoprotein produced in hepatocytes
and it exists in a number of different isoforms. Chronic alcohol use markedly
increases the concentrations of 2 isoforms that together are referred to as CDT.
Alcohol consumption has little effect on other transferrin isoforms. CDT values
greater than 2% may be associated with heavy alcohol consumption. There are
limitations to this test- pts with advanced liver disease may have elevated CDT
levels. Further, some antiepileptic medications may also increase CDT levels.
Levels return to normal with 2 weeks of low /no use.




ACUTE POST-OPERATIVE PAIN

Multimodal pain mgmt is recommended for post-procedure pain. Opioids may be
indicated, and if utilized are recommended to be dosed at the lowest effective
dose and continued for shortest duration of time as clinically indicated to
prevent unintentional prolonged use. Taper to discontinuation is recommended at
earliest opportunity.


ASSESSMENT

Patient prefers conservative approach to medication changes. Therefore, will defer consideration of other medication changes until next visit.

Realistic pain goals should be reviewed with the veteran. Pain management with
medications alone may not provide full pain relief without treatment of the
substance use disorder(s) - alcohol. Pharmacological modalities provide some
benefit in chronic pain management but the majority of chronic pain mangement
rests on the patient engaging in active therapies for pain. This includes SUD
treatment, MH treatment, pain psychology, PT and exercise. 
OPIOID RISK TOOL

The Opioid Risk Tool (ORT) is an office-based assessment designed to predict which patients may develop aberrant, drug-related behaviors based on known risk factors associated with abuse or addiction. The ORT can either be self-administered by the patient at the initial clinic visit or completed by the physician as part of the patient interview.
The ORT displayed excellent discrimination in predicting opioid abuse-related behaviors in a single-site study of 185 chronic-pain patients. Of the low-risk patients studied, 94% did not demonstrate any aberrant behavior, while in the high-risk patients, 91% did display an aberrant behavior. Of the medium risk patients, only 28% showed any opioid-related aberrant behavior.

Opioid Risk Tool – The SOAPnote Project
Opioid Monitoring A’s – The SOAPnote Project

COWS Score for Opiate Withdrawal

Resting Pulse Rate (BPM)
[ ] 0 - less than or equal to 80
[ ] 1 - 81-100
[ ] 2 - 101-120
[ ] 3 - greater than 120
Sweating
[ ] 0 - No report of chills or flushing
[ ] 1 - Subjective report of chills or flushing
[ ] 2 - Flushed or observable moistness on face
[ ] 3 - Beads of sweat on brow or face
[ ] 4 - Sweat streaming off face
Restlessness Observation During Assessment
[ ] 0 - Able to sit still
[ ] 1 - Reports difficulty sitting still, but is able to do so
[ ] 3 - Frequent shifting or extraneous movements of legs/arms
[ ] 5 - Unable to sit still for more than a few seconds
Pupil Size
[ ] 0 - Pupils pinned or normal size for room light
[ ] 1 - Pupils possibly larger than normal for room light
[ ] 2 - Pupils moderately dilated
[ ] 5 - Pupils so dilated that only the rim of the iris is visible
Bone or Joint Aches
[ ] 0 - Not present
[ ] 1 - Mild diffuse discomfort
[ ] 2 - Patient reports severe diffuse aching of joints/muscles
[ ] 4 - Patient is rubbing joints or muscles and is unable to sit still because
of discomfort
Runny Nose or Tearing
[ ] 0 - Not present
[ ] 1 - Nasal stuffiness or unusually moist eyes
[ ] 2 - Nose running or tearing
[ ] 4 - Nose constantly running or tears streaming down cheeks
GI Upset
[ ] 0 - No GI symptoms
[ ] 1 - Stomach cramps
[ ] 2 - Nausea or loose stool
[ ] 3 - Vomiting or diarrhea
[ ] 5 - Multiple episodes or vomiting or diarrhea
Tremor Observation of Outstretched Hands
[ ] 0 - No tremor
[ ] 1 - Tremor can be felt, but not observed
[ ] 2 - Slight tremor observable
[ ] 4 - Gross tremor or muscle twitching
Yawning Observation During Assessment
[ ] 0 - No yawning
[ ] 1 - Yawning once or twice during assessment
[ ] 2 - Yawning three or more times during assessment
[ ] 4 - Yawning several times/minute
Anxiety or Irritability
[ ] 0 - None
[ ] 1 - Patient reports increasing irritability or anxiousness
[ ] 2 - Patient obviously irritable/anxious
[ ] 4 - Patient so irritable or anxious that participation in the assessment is
difficult
Gooseflesh Skin
[ ] 0 - Skin is smooth
[ ] 3 - Piloerection of skin can be felt or hairs standing up on arms
[ ] 5 - Prominent piloerection

TOTAL [ ]
No active withdrawal: less than 5
Mild withdrawal: 5-12
Moderate withdrawal: 13-24
Moderately severe withdrawal: 25-36
Severe withdrawal: greater than 36
Citation for COWS: Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale
(COWS) Psychoactive Drugs.2003;35:253-259

Opioid withdrawal can be extremely uncomfortable but is not felt to be life
threatening in absence of other drug withdrawal and/or severe comorbidities.
Opioid withdrawal symptoms can last anywhere from one week to one month. The
first phase (acute withdrawal) can begin within hours of last opioid use. The
acute stage has mostly physical symptoms:
*Low energy, Irritability, Anxiety, Agitation, Insomnia
*Runny nose, Teary eyes
*Hot and cold sweats, Goose bumps
*Yawning
*Muscle aches and pains
*Abdominal cramping, Nausea, Vomiting, Diarrhea
The acute phase is thought to peak around 3 - 5 days after last opioid use and
can last for approximately 1 - 4 weeks. The second phase (post-acute withdrawal)
can last weeks to months. The symptoms include mood swings, anxiety, variable
energy, low enthusiasm, variable concentration, and disturbed sleep.

DRONABINOL

Local Criteria for Use for dronabinol (P&T approved 06/2018)

INCLUSION LOCAL CRITERIA FOR USE:
[ ] Anorexia associated with weight loss in patients with AIDS
[ ] Cancer chemotherapy-induced nausea and vomiting (CINV) who failed or
intolerant to combined treatment of at least 3 of the following classes
of first line conventional antiemetic treatments as described in the
NCCN Guidelines 2018 'Pharmacologic Considerations for Antiemetic
Prescribing' such as NK1-RA, 5HT3-RA, glucocorticoid, dopamine agonist,
and an antihistamine. *** Choice of antiemetic(s) should be based on
the emetic risk of the therapy and patient-specific factors
[ ] Appetite stimulation in cancer patients related to anorexia/cachexia
or therapeutic failure of, intolerance of, or contraindication to
megestrol therapy and requested by VA Oncology***
[ ] Muscle spasticity from multiple sclerosis in patients who have trialed
and failed at least one agent from each of the following classes of drugs
at conventional therapeutic doses: gabapentinoid, antispasmodic, or
benzodiazepine

*** If dual care, recommend obtaining non-VA oncology records/factors indicating
anorexia-cachexia. Recommend consulting nutrition for alternative options before
trialing dronabinol if deemed appropriate by reviwing pharmacist.


EXCLUSION CRITERIA:
[ ] Pregnant or nursing
[ ] History of a serious hypersensitivity reaction to cannabinoids,
sesame oil, gelatin, glycerin, and/or titanium dioxide.
[ ] Diagnosis of mania, schizophrenia, depression, psychosis and bipolar
disorder. *In rare cases, approval is possible with close monitoring*
Dronabinol can exacerbate these psychiatric disorders. Consultation by
psychiatrist is highly recommended. 
DOCUMENTATION


Cardiovascular:

Dermatologic:

Endocrine:

Gastrointestinal:

Genitourinary:

Hematologic/Oncologic:

Immunologic:

Musculoskeletal/Rheumatologic:

Neurological:

Psychiatric:

Pulmonary:


PAIN TREATMENT HISTORY:

Previous Interventional treatment:
[]Spinal cord stimulator
[]Injection (trigger point, ESI, steroid, etc.)
[]Surgery
[]Other:

Previous Non-pharmacological treatment:
[]PT/OT
[]Yoga/Tai Chi
[]Acupuncture
[]CBT/Psychotherapy
[]Mindfulness
[]MOVE
[]Heating pad
[]Cold packs
[]TENS unit
[]Other e-stim device
[]Chiropractor
[]Others:

Previous Medication Trials:
ANALGESICS/NSAIDS
[]Aspirin
[]Acetaminophen
[]Celecoxib
[]Diclofenac
[]Diflunisal
[]Etodolac
[]Fenoprofen
[]Flurbiprofen
[]Ibuprofen
[]Indomethacin
[]Meloxicam
[]Naproxen
[]Oxaprozin
[]Piroxicam
[]Salsalate
[]Sulindac
[]Tolmetin

OPIOIDS
[]Codeine
[]Fentanyl
[]Hydrocodone
[]Hydromorphone
[]Levorphanol
[]Morphine
[]Methadone
[]Oxycodone
[]Oxymorphone
[]Buprenorphine
[]Tramadol
[]Tapentadol

TRIPTANS
[]Almotriptan
[]Eletriptan
[]Rizatriptan
[]Sumatriptan
[]Zolmitriptan
[]Ergotamine/dihydroergotamine

TOPICALS
[]Capsaicin cream/patch
[]Lidocaine patch/ointment/cream/gel
[]Diclofenac gel
[]Menthol/methyl-salicylate cream/patch

ANTICONVULSANTS
[]Carbamazepine
[]Gabapentin
[]Lamotrigine
[]Levetiracetam
[]Pregabalin
[]Topiramate
[]Valproate

MUSCLE RELAXANTS
[]Baclofen
[]Carisoprodol
[]Cyclobenzaprine
[]Metaxalone
[]Methocarbamol
[]Tizanidine

ANTIDEPRESSANTS
[]Duloxetine
[]Venlafaxine
[]Milnacipran
[]Amitriptyline
[]Nortriptyline

OTHER
[]Propranolol
[]Verapamil



TOPICALS

- Consider PADR for lidocaine 5% patch if lidocaine ointment is effective but
not long-lasting 

Result - Copy and paste this output:

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