katherin badke june 28, 2017...•dizziness •nausea •vomiting •constipation •allergic...
TRANSCRIPT
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Katherin Badke
BScPharm
June 28, 2017
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QUESTIONNAIRE RESULTS
25 Respondents
• Tramadol= 12
• Anticoagulation= 9
• Pain Management= 5
• Other = 4
• Antibiotics= 3
Tramadol
Pain Management
Antibiotics
Anticoagulation
Other
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QUIZ RESULTS
Question Number of correct responses
I would be concerned if a patient with
Parkinson’s Disease was prescribed
Tramadol on discharge.
9/25 =36%
I would be concerned if a patient with
cost concerns was prescribed Tramadol
on discharge.
16/25=64%
I would be concerned if a patient with a
history of seizures was prescribed
Tramadol on discharge.
18/25=72%
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WHAT PEOPLE WANT TO KNOW
• Difference between tramacet and tramadol
• Dosage
• Mechanism
• Contraindications
• Interactions
• Monitoring
• Withdrawal concerns, how to discontinue therapy
• Patient teaching and nursing intervention
• Coverage issues
• Information needed before starting tramadol
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LEARNING OBJECTIVES
• Mechanism of action of tramadol
• Effectiveness of Tramadol
• Identify patients who are at risk of adverse effects
from tramadol
• Describe symptoms of Serotonin Syndrome
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LEARNING OBJECTIVES
• Be able to provide tramadol patient counseling
• Describe symptoms of tramadol withdrawal
• Identify patients who are at risk of tramadol
withdrawal
• Recognize the cost associated with tramadol
prescriptions
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49 y/o woman post THA
PMHx: Osteoarthritis
Home meds:
Acetaminophen 1000 mg qid
In hospital:
Pain well controlled
Hydromorphone 1-3 mg q3h prn
2 mg X 3 doses in last 24 h
PATIENT SCENARIO 1: WHAT WOULD YOU DO?
Ishtpreet Virk
DOB: Jan 18, 1967
Tramadol 50-100 mg po
qid prn
X 100 tablets
ASA 160 mg po daily
X 35 days
Dr. Smith
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43 y/o man post TKA
PMHx: Treatment Resistant Depression, Seizure Disorder
Home Meds:
Bupropion 300 mg ER once daily
Sertraline 100 mg daily
Phenytoin 300 mg po qhs
In hospital:
Hydromorphone 1- 3 mg q3h prn
2 mg X 5 doses in last 24 hours
PATIENT SCENARIO 2: WHAT WOULD YOU DO?
Charles Montgomery
DOB: Feb 28, 1974
Hydromorphone 1-2 mg
q3h prn (90 tablets) (on narcotic script)
Tramadol 50-100 mg po
qid prn
X 100 tablets
ASA 160 mg po daily
X 28 days
Dr. Smith
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37 year old woman post THA
PMHx: Rheumatoid arthritis
Home meds:
Methotrexate once weekly
Folic acid 5 mg daily
Celebrex 200 mg daily
Tramadol 300 mg ER q24h (last dose yesterday morning)
In hospital:
Pain management orders
Tramadol discontinued
PATIENT SCENARIO 3: WHAT WOULD YOU DO?
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TRAMADOL AND TRAMACET
• Tramadol brand names: Ultram(IR), Durela (LA),
Ralivia(LA), Tridural (LA), Zytram XL
• Dosing: Tramadol 50-100 mg q4-6h prn
• Max: 400 mg per day (max 300mg per day in elderly)
• Tramacet Tramadol 37.5 mg + Acetaminophen 325 mg
• Dosing: Tramacet 1-2 tablets q4h prn (max 8 tabs/day)
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• Bind to μ-opioid
receptors in CNS
• Inhibits the reuptake
of norepinephrine
and serotonin
MECHANISM OF ACTION
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?ORAL DOSE EQUIVALENCIES?** PLEASE NOTE
NURSES WERE NOT GIVEN THIS SLIDE IN
HANDOUT IT WAS MERELY DISCUSSED *****Rough estimates only****
Morphine dose equivalence not reliably established
Some references stated:
Tramadol 100 mg ≈ Morphine 10-20 mg
Other references stated:
Tramadol 100 mg ≈ Morphine 10 mg (oral)
And
Morphine 10-15 mg ≈ Hydromorphone 2 mg ≈ Codeine 100 mg
*For patient specific dose conversion ask Pharmacist *
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TRAMADOL IN CHRONIC OA PAIN
Smith SR, Deshpande BR, Colins JE, Katx JN Losina E. Comparative Pain Reduction of
oral non-steriod anti-inflammatory drugs and opioids for knee osteoarthritis: a
systematic analytic review. Osteoarthritis and Cartilage. 2016: 24; p. 962-972.
Inclusion: 17 Randomized controlled trials, 2000–2015
Predominantly knee OA patients
At least 8 weeks in duration
Assessment: Western Ontario and McMaster Universities
Osteoarthritis Index (WOMAC) Pain subscale
Results: Mean improvement in WOMAC score comparable
between all therapies
• NSAIDs ( 18 points)
• Potent opioids ( 19 points)
• Less potent opioids ( 18 points)
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TRAMACET IN CHRONIC PAIN
Mullican WS, Lacy JR. Tramadol/Acetaminophen combination tablets and
codeine/Acetaminophen combination capsules for management of chronic pain: A
comparative trial. Clinical Therapeutics. 2001: 23 (9); p 1249-1443.
Trial type Randomized double-blind trial, 4 week duration
Population 462 subjects with low back pain (24%) or OA pain
(35%) or both (41%)
Intervention 309 subjects, Tramadol 37.5 mg/Acetaminophen
325 mg
1-2 tablets q4-6 h prn (max 8 per day)
Control 153 subjects, Codeine 30 mg/ Acetaminophen 300
mg
1-2 capsules q4-6 h prn (max 8 per day)
Outcome Similar pain control in both groups
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TRAMACET IN CHRONIC PAIN
Mullican WS, Lacy JR. Tramadol/Acetaminophen combination tablets and
codeine/Acetaminophen combination capsules for management of chronic pain: A
comparative trial. Clinical Therapeutics. 2001: 23 (9); p 1249-1443.
Adverse effects
Tramacet group 12% stopped due to S/E
71% of reported side effects (S/E)
17% somnolence
11% constipation
Codeine/Acetaminophen14% stopped due to S/E
76% reported side effects (S/E)
24% somnolence
21% constipation
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SAFETY QUESTIONS
• Would you be concerned if a patient with Parkinson’s
disease was prescribed Tramadol on discharge?
• Would you be concerned if a patient with a history of
seizures was prescribed Tramadol on discharge?
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SAFETY: ADVERSE EFFECTS AND PRECAUTIONS
• Standard opioid adverse effects: • Drowsiness • Dizziness • Nausea • Vomiting • Constipation • Allergic reaction
• Increases risk of seizures
• Serotonin Syndrome
• Impact on blood glucose
• Avoid in kidney and liver dysfunction
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• GI symptoms
•Nausea and
vomiting
•Diarrhea
• Mental status
changes
• Agitation
•Hallucinations
• Coma
• Autonomic instability
• Tachycardia
• Labile blood
pressure
•Hyperthermia
• Neuromuscular
changes
•Hyperreflexia
• Incoordination
SEROTONIN SYNDROME
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SWITCHING OPIOIDS DUE TO ADVERSE EFFECTS
• No opioid is optimal for all patients
• Tolerance to sedation, nausea and vomiting
generally occurs in 3-5 days
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TRAMADOL PHARMACOKINETICS
• Immediate release
• Onset: Within 1 hour
• Peak effect: 2 to 3 hours
• Half life
• Immediate release:
• ~ 6.3 hours; active metabolite (M1) ~ 7.4 hours
• Extended-release:
• ~7.9-10 hours; active metabolite (M1): ~8.8- 11
hours
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TRAMADOL WITHDRAWAL SYNDROMES
• 422 patients with tramadol withdrawal
(April 1995-March 2000)
• 367 had typical withdrawal symptoms
• 55 had atypical withdrawal symptoms
Senay E et al. Physical dependence on Ultram
(tramadol hydrochloride): both opioid-like and
atypical withdrawal symptoms occur. Drug and
Alcohol Dependence. 2003;69: p 233 -241.
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• Anxiety, depression, insomnia, and restlessness
• Rhinorhea (runny nose) and mydriasis (tearing)
• Nausea, vomiting, abdominal cramping, diarrhea
• Bone pain and muscle aches
• Gooseflesh and sweating
TYPICAL OPIOID WITHDRAWAL
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ATYPICAL WITHDRAWAL:
• Documented “Atypical” withdrawal signs
and symptoms:
• Extreme anxiety, panic attacks, CNS
(Confusion, delusions, paranoia) unusual
sensory experiences (numbness,
tingling, parathesia, tinnitus),
hallucinations (tactile, auditory, visual)
Senay E et al. Physical dependence on
Ultram (tramadol hydrochloride): both opioid-
like and atypical withdrawal symptoms occur.
Drug and Alcohol Dependence. 2003;69: p
233 -241.
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ATYPICAL WITHDRAWAL:
• Could potentially also experience:
• Depression, aggressiveness, insomnia, vivid
dreams/nightmares, headache, sneezing,
• Palpitations, tremors, sweating, restless
legs syndrome and electric shock-like
sensations
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Typical Withdrawal (Info from 63% of cases)
Dose range: 50-2000 mg , 92% of cases occurred on
doses below 400 mg/day
Withdrawal usually resolved in 2-3 days
Atypical Withdrawal (Info from 78% of cases)
Dose range: 50-1300 mg per day, 25% of cases
occurred in patients more than 400 mg/day
Withdrawal lasted longer
TRAMADOL WITHDRAWAL
Senay E et al. Physical dependence on Ultram (tramadol hydrochloride):
both opioid-like and atypical withdrawal symptoms occur Drug and Alcohol
Dependence. 2003;69: p 233 -241.
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NON-FORMULARY USE IN HOSPITAL
• Options: Tramacet or Tramadol 50 mg IR
• Restricted to those who were on
tramadol/tramacet regularly at home and are
at risk of withdrawal
• Restricted to patients who have not tolerated
at least 2 other opioids
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49 y/o woman post THA
PMHx: Osteoarthritis
Home meds:
Acetaminophen 1000 mg qid
In hospital:
Pain well controlled
Hydromorphone 1-3 mg q3h prn
2 mg X 3 doses in last 24 h
PATIENT SCENARIO 1: WHAT WOULD YOU DO?
Ishtpreet Virk
DOB: Jan 18, 1967
Tramadol 50-100 mg po
qid prn
X 100 tablets
ASA 160 mg po daily
X 35 days
Dr. Smith
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43 y/o man post TKA
PMHx: Treatment Resistant Depression, Seizure Disorder
Home Meds:
Bupropion 300 mg ER once daily
Sertraline 100 mg daily
Phenytoin 300 mg po qhs
In hospital:
Hydromorphone 1- 3 mg q3h prn
2 mg X 5 doses in last 24 hours
PATIENT SCENARIO 2: WHAT WOULD YOU DO?
Charles Montgomery
DOB: Feb 28, 1974
Hydromorphone 1-2 mg
q3h prn (90 tablets) (on narcotic script)
Tramadol 50-100 mg po
qid prn
X 100 tablets
ASA 160 mg po daily
X 28 days
Dr. Smith
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37 year old woman post THA
PMHx: Rheumatoid arthritis
Home meds:
Methotrexate once weekly
Folic acid 5 mg daily
Celebrex 200 mg daily
Tramadol 300 mg ER q24h (last dose yesterday morning)
In hospital:
Pain management orders
Tramadol discontinued
PATIENT SCENARIO 3: WHAT WOULD YOU DO?
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COST QUESTIONS
Would up be concerned if a patient with cost
concerns was prescribed Tramadol on
discharge?
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COST IN HOSPITAL
• Tramadol 50 mg= $ 0.17
• Morphine 5 mg= $ 0.11
• Hydromorphone 1 mg= $ 0.14
• Hydromorphone 2 mg= $ 0.21
• Tramacet= $ 0.16 (in blister)
• Tylenol #3= $ 0.13 (in blister)
• Codeine 30 mg= $ 0.05
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OUTPATIENT COST
•Hydromorphone 1 mg (100 tablets)=$27.91* • Tramadol 50 mg (100 tablets)= $90.15* • Tylenol #3 (30 tablets)=$14.50* • Tramacet (30 tablets)=$31.35*
*Includes $11.60 dispensing fee
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OUTPATIENT COST: PHARMACARE COVERAGE
Morphine, Codeine, Hydromorphone IR, Oxycodone and
Tylenol#3: Yes
Hydromorphone LA: Requires special authority
Tramadol: No
Tramacet: No
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COST OF STREET MEDICATIONS STREETRX.COM
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COST OF STREET MEDICATIONS STREETRX.COM
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TRAMADOL IN REVIEW
• What was the most important thing that you
learned today?
• What was the most difficult point?
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REFERENCES
Vergnion M, Degesves S, Garcet L, Magotteaux V. Tramadol, an alternative to morphine for treating posttraumatic pain in the prehospital situation. Anesth Analg. 2001 Jun;92(6):1543-6.
Senay E et al. Physical dependence on Ultram (tramadol hydrochloride): both opioid-like and atypical withdrawal symptoms occur Drug and Alcohol Dependence. 2003;69: p 233 -241.
Up-to-date. Tramadol monograph
RX-files
Smith SR, Deshpande BR, Colins JE, Katx JN Losina E. Comparative Pain Reduction of oral non-steriod anti-inflammatory drugs and opioids for knee osteoarthritis: a systematic analytic review. Osteoarthritis and Cartilage. 2016: 24; p. 962-972.
Mullican WS, Lacy JR. Tramadol/Acetaminophen combination tablets and codeine/Acetaminophen combination capsules for management of chronic pain: A comparative trial. Clinical Therapeutics. 2001: 23 (9); p 1249-1443.
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REFERENCES
Zarling B, Yokhana SS, Herzog DT, Markel MD. Preoperative and Postoperative Opiate
Use by the Arthroplasty Patient. The journal of arthroplasty. 2016; 31: p2081-
2084.
Lanier R, Lofwall, Mintzer M, Bigelow G, Strain E, Physical Dependence potential of
daily tramadol dosing in humans
Gana et al. Extended-release tramadol in the treatment of osteoarthritis: a
multicenter, randomized, double-blind, placebo controlled clinical trial. Current
Medical Research and opinion. 22(7). P1391-1401
El-Hadidy MA, Helaly AMN. Medical and Psychiatric Effects of Long-term Dependence
on High Dose tramadol. Substance Use and Misuse. 2015
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DRUG ABUSE
• Centers for Disease Control
• Prescription drug abuse fastest growing drug problem in the United States
• From 1999 to 2013
• Number of deaths from pain killer overdose in the US quadrupled
• 16000 deaths in 2013
• From 1997 to 2007
• Total amount of opioid medication prescribed and distributed through the pharmaceutical system in the United States increased by 600%
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EXAMPLES OF MEDICATIONS WHICH RAISE
TRAMADOL LEVELS
C Y P 3 A 4 I N H I B I T O R S
Clarithromycin
Antifungals
HIV medications
C Y P 2 D 6 I N H I B I T O R S
Antidepressants
(bupropion)
HIV medications
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TRAMADOL IN ACUTE PAIN
Vergnion M, Degesves S, Garcet L, Magotteaux V. Tramadol, an alternative to morphine for
treating posttraumatic pain in the prehospital situation. Anesth Analg. 2001
Jun;92(6):1543-6.
Trial type Randomized double-blind
Population Trauma patients in pre-hospital setting
Intervention Tramadol group: 53 patients (severe pain in 56%)
Initially received iv tramadol 100 mg X 1 dose iv then, a further dose
of 50 mg tramadol q5min to a max of 200 mg
Comparator Morphine group: 48 patients (severe pain in 49%)
Initially received iv morphine 5 mg (body weight 70 kg) or 10 mg
morphine (body weight 70 kg), then morphine 5 mg q5min to a max
morphine 15 mg (body weight 70 kg) or 20 mg (weight 70 kg)
Outcome Similar mean decrease in pain score between baseline and 40 min
mark
Adverse effects Nausea: 9 patients (17%) on tramadol and 7 patients (15%) on
morphine experienced at least one episode of nausea
Vomiting: Three patients on tramadol experienced at least one
episode of vomiting, no patient on morphine vomited
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EXAMPLES OF MEDICATIONS WHICH RAISE
TRAMADOL LEVELS
C Y P 3 A 4 I N H I B I T O R S
Clarithromycin
Antifungals
HIV medications
C Y P 2 D 6 I N H I B I T O R S
Antidepressants
(bupropion)
HIV medications
C Y P 3 A 4 I N D U C E R S
Phenytoin
Rifampin
Carbamazepine
St. John’s Wart
C Y P 2 D 6 I N D U C E R S
Genetic polymorphisms