new drugs & delivery techniques keith b. thomasset, pharmd, bcps clinical manager – pharmacy...
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New Drugs & Delivery Techniques
New Drugs & Delivery Techniques
Keith B. Thomasset, PharmD, BCPSClinical Manager – Pharmacy Services
Keith B. Thomasset, PharmD, BCPSClinical Manager – Pharmacy Services
Boston University School of Medicine
May 19, 20063:30- 4:00pm3:30- 4:00pm
2nd Annual Ellison Pierce Symposium Positioning Your ORs For The Future
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10%
20%
60%
10%
1 2 3 4
Which of the following is not an approved indication for utilizing morphine sulfate extended release liposomal injection:
Which of the following is not an approved indication for utilizing morphine sulfate extended release liposomal injection:
1. Elective cesarean section
2. Lobectomy
3. Total knee arthroplasty
4. Lower abdominal surgery
1. Elective cesarean section
2. Lobectomy
3. Total knee arthroplasty
4. Lower abdominal surgery
QUESTION:QUESTION:
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20%
30% 30%
20%
1 2 3 4
Sugammadex (Org 25969) is a reversal agent for rocuronium and contains what type of carrier matrix?
Sugammadex (Org 25969) is a reversal agent for rocuronium and contains what type of carrier matrix?
1. Lipid emulsion
2. Propylene glycol
3. Cyclodextrin
4. Tween-80
1. Lipid emulsion
2. Propylene glycol
3. Cyclodextrin
4. Tween-80
QUESTION:QUESTION:
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70%
10%
20%
0%
1 2 3 4
When administering the first dose of cefazolin as an agent for surgical infection prophylaxis at 6:30AM for a case of 5 hours duration, assuming normal blood loss, the next dose should be administered:
When administering the first dose of cefazolin as an agent for surgical infection prophylaxis at 6:30AM for a case of 5 hours duration, assuming normal blood loss, the next dose should be administered:
1. At 9:00AM
2. At 10:30AM
3. At 2:30 PM
4. Another dose is not required
1. At 9:00AM
2. At 10:30AM
3. At 2:30 PM
4. Another dose is not required
QUESTION:QUESTION:
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ObjectivesObjectives
• Describe the advantages of liposomal based morphine sulfate for anesthesia practice
• Appraise the role of Sugammadex (Org 25969) in the reversal of rocuronium muscle relaxation
• Outline the importance of proper antimicrobial timing prior to surgical incision
• Describe the advantages of liposomal based morphine sulfate for anesthesia practice
• Appraise the role of Sugammadex (Org 25969) in the reversal of rocuronium muscle relaxation
• Outline the importance of proper antimicrobial timing prior to surgical incision
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DepoDur®
(Morphine sulfate extended release liposomal injection)
DepoDur®
(Morphine sulfate extended release liposomal injection)
• Liposomal formulation of morphine sulfate– Epidural administration – lumbar level– 48 hour pain relief
• Studied in:– Hip arthroplasty– Knee arthroplasty– Lower abdominal surgery– Elective cesarean section
• Liposomal formulation of morphine sulfate– Epidural administration – lumbar level– 48 hour pain relief
• Studied in:– Hip arthroplasty– Knee arthroplasty– Lower abdominal surgery– Elective cesarean section
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DepoDur®DepoDur®
SkyePharma. Data on File. Endo Pharmaceuticals Inc.: Chadds Ford, PA; April 21, 2004.
DepoFoam®
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Liposomal vs. Conventional Epidural Opioids
Liposomal vs. Conventional Epidural Opioids
• Difficult to provide prolonged pain relief– Multiple injections– Epidural continuous
infusion
• High doses result– Adverse effects
• Indwelling epidural catheter– Infection risk– Spinal hematoma
• Difficult to provide prolonged pain relief– Multiple injections– Epidural continuous
infusion
• High doses result– Adverse effects
• Indwelling epidural catheter– Infection risk– Spinal hematoma
• Liposomal formulation– Single injection– No indwelling catheter
• Decreases post operative pain requirements– PCA– Decrease rescue opioid
doses– Decreased adverse effects
• No indwelling catheter– Decrease infection risk– Decrease spinal
hemoatome risk
• Liposomal formulation– Single injection– No indwelling catheter
• Decreases post operative pain requirements– PCA– Decrease rescue opioid
doses– Decreased adverse effects
• No indwelling catheter– Decrease infection risk– Decrease spinal
hemoatome risk
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AdvantagesAdvantages
• Decreased post operative opioid use– Decreased utilization of rescue doses
– Decreased time to rescue therapy• Potential to prevent rescue therapy requirements
• Decrease adverse effects
• Potential decreased post operative nausea and vomiting
• Potential improvement in patient flow– Quicker movement through the system
• Quicker movement through the system
• Decreased post operative opioid use– Decreased utilization of rescue doses
– Decreased time to rescue therapy• Potential to prevent rescue therapy requirements
• Decrease adverse effects
• Potential decreased post operative nausea and vomiting
• Potential improvement in patient flow– Quicker movement through the system
• Quicker movement through the system
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Post-Op Opioid UsePost-Op Opioid Use
Anesth Anal 2005;100:1069.
Lower Abdominal SurgeryLower Abdominal Surgery
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Time to Rescue TherapyTime to Rescue Therapy
Anesthesiology 2005;102(5):1018.
Hip ArthroplastyHip Arthroplasty
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Patients Requiring No Rescue TherapyPatients Requiring No Rescue Therapy
Anesth Anal 2005;100:1155.
Elective Cesarean DeliveryElective Cesarean Delivery
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Adverse Effects & PrecautionsAdverse Effects & Precautions
• Greater than 10% incidence– Decreased oxygen saturation– Hypotension– Urinary retention– N/V/H– Constipation– Pruritis– Pyrexia– Dizziness
• Greater than 10% incidence– Decreased oxygen saturation– Hypotension– Urinary retention– N/V/H– Constipation– Pruritis– Pyrexia– Dizziness
• Incidence between 5-10%– Hypoxia– Tachycardia– Insomnia
• Incidence < 5%– Paralytic ileus– Abdominal distention– Hypertension– Bladder spasm
• Potential interaction with epidural anesthetics– Reduced sustained release
activity• Under further investigation
• Incidence between 5-10%– Hypoxia– Tachycardia– Insomnia
• Incidence < 5%– Paralytic ileus– Abdominal distention– Hypertension– Bladder spasm
• Potential interaction with epidural anesthetics– Reduced sustained release
activity• Under further investigation
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DepoDur®DepoDur®
• Administration
– Lumbar epidural administration
• prior to surgery
• after clamping of umbilical cord during cesarean section
• Dosing
– Orthopedic surgery of lower extremity – 15mg
– Lower abdominal or pelvic surgery – 10-15mg
– Elective cesarean section – 10mg
• Administration
– Lumbar epidural administration
• prior to surgery
• after clamping of umbilical cord during cesarean section
• Dosing
– Orthopedic surgery of lower extremity – 15mg
– Lower abdominal or pelvic surgery – 10-15mg
– Elective cesarean section – 10mg
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Neuromuscular Blockade ReversalNeuromuscular Blockade Reversal
• •
www.medlib.med.utah.edu/ kw/mg/mml/ms_illus002.gif
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Common AgentsCommon Agents
Acetylcholinesterase inhibitorAcetylcholinesterase inhibitor
Antimuscarinic agentAntimuscarinic agent
ReversalReversal
Neostigmine0.5-2mg IV
Edrophonium10mg IV
Atropine0.6-1.2mg IV
Glycopyrrolate0.2-0.4 mg IV
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Limitations Limitations
• Not agent specific
• Nonselective acetylcholine neurotransmission
– Bradycardia
– Hypersalivation
– Bronchoconstriction
• Interpatient variability of effect
• Lack of effect against profound neuromuscular block
• Require recurrence of first twitch during train-of-four stimulation
• Not agent specific
• Nonselective acetylcholine neurotransmission
– Bradycardia
– Hypersalivation
– Bronchoconstriction
• Interpatient variability of effect
• Lack of effect against profound neuromuscular block
• Require recurrence of first twitch during train-of-four stimulation
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Agent Specific ReversalAgent Specific Reversal
Sugammadex (Org 25969)– Cyclodextrin compound
• Encapsulate lipophilic molecules• Highly water soluble• No endogenous targets• Biological tolerance
Sugammadex (Org 25969)– Cyclodextrin compound
• Encapsulate lipophilic molecules• Highly water soluble• No endogenous targets• Biological tolerance
Anesthesiology 99(3) p. 633
J Med Chem 45(9) p. 1807
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Agent Specific ReversalAgent Specific Reversal
• Mechanism of Action
– Hydrophillic exterior and hydrophobic interior
• Encapsulation of rocuronium molecule
• Prevention of interactions with nicotinic receptors
– Increased excretion of complex
• 1:1 complex
• Mechanism of Action
– Hydrophillic exterior and hydrophobic interior
• Encapsulation of rocuronium molecule
• Prevention of interactions with nicotinic receptors
– Increased excretion of complex
• 1:1 complex
Anesthesiology 103(4), p. 696
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Other Potential Exogenous TargetsOther Potential Exogenous Targets
• Affinity highest with aminosteroid NMBAs
• Others– Atropine– Verapamil– Non-NMBA Steroid Compounds
• Hydrocortisone• Prednisone• Methylprednisone
• Affinity highest with aminosteroid NMBAs
• Others– Atropine– Verapamil– Non-NMBA Steroid Compounds
• Hydrocortisone• Prednisone• Methylprednisone
Anesthesiology 2006; 104(4)
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LimitationsLimitations
• Not agent specific
• Non-selective acetylcholine neurotransmission
– Bradycardia
– Hypersalivation
– Bronchoconstriction
• Interpatient variability of effect
• Lack of effect against profound neuromuscular block
• Only effective once partial spontaneous recovery has occurred
• Not agent specific
• Non-selective acetylcholine neurotransmission
– Bradycardia
– Hypersalivation
– Bronchoconstriction
• Interpatient variability of effect
• Lack of effect against profound neuromuscular block
• Only effective once partial spontaneous recovery has occurred
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Sugammadex® (Org 25969)Sugammadex® (Org 25969)
• Not agent specific – specific to amniosteroid NMBAs
• Adverse effects
– Bradycardia – not identified to date
– Hypersalivation – not identified to date
– Bronchoconstriction – not identified to date
• Interpatient variability of effect – scant data
• Lack of effect against profound neuromuscular block – scant human data
• Not agent specific – specific to amniosteroid NMBAs
• Adverse effects
– Bradycardia – not identified to date
– Hypersalivation – not identified to date
– Bronchoconstriction – not identified to date
• Interpatient variability of effect – scant data
• Lack of effect against profound neuromuscular block – scant human data
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DosingDosing
• •
Anesthesiology 103(4), p. 701
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Time to ReversalTime to Reversal
Dose
(mg/kg)Placebo 0.1 0.5 1 2 3 4 8
Avg. time to reversal (min)
15-60 43 1.3-8.5 1.4-31 1-17 0.7-3.2 1-3.3 1-1.2
Anesthesiology 2005; 103(4)
Anesthesiology 2006;104(4)
Br J of Anesthesia 2006;96(1)
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Dosing and Data DilemmaDosing and Data Dilemma
• Mostly dose finding studies
– 0.1mg/kg - 8mg/kg
– Single vs. multiple dose per patient
• All human studies with rocuronium
– Intermittent/single bolus or continuous infusion
• All placebo controlled
• Mostly dose finding studies
– 0.1mg/kg - 8mg/kg
– Single vs. multiple dose per patient
• All human studies with rocuronium
– Intermittent/single bolus or continuous infusion
• All placebo controlled
Anesthesiology 2005; 103(4)
Anesthesiology 2006;104(4)
Br J of Anesthesia 2006;96(1)
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ConclusionConclusion• Elimination half life is ~ 100 min
– Totally agent removal at 400 min (6.5 hours)
– Renal failure???
• Data suggests no recurarization for 90 minutes
– Any for time period > 90 minutes?
• More safety and efficacy data needed
• Ideal dose yet to be determined
• Impact on daily practice
– Cost effectiveness
STAY TUNED
• Elimination half life is ~ 100 min
– Totally agent removal at 400 min (6.5 hours)
– Renal failure???
• Data suggests no recurarization for 90 minutes
– Any for time period > 90 minutes?
• More safety and efficacy data needed
• Ideal dose yet to be determined
• Impact on daily practice
– Cost effectiveness
STAY TUNED
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Decreasing the Risk of Surgical Site Infections
Decreasing the Risk of Surgical Site Infections
• Maintain high levels of inspired oxygen
• Maintain peri-operative normothermia
• Avoid shaving operative site
• Maintain adequate glucose control
• Appropriate use of peri-operative antibiotics
• Maintain high levels of inspired oxygen
• Maintain peri-operative normothermia
• Avoid shaving operative site
• Maintain adequate glucose control
• Appropriate use of peri-operative antibiotics
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Goal OutcomesAntimicrobial Specific
Goal OutcomesAntimicrobial Specific
• Evidence-based recommendations
• Correct drug
• Correct dose
• Correct duration
– Including intra-operative dosing
• Evidence-based recommendations
• Correct drug
• Correct dose
• Correct duration
– Including intra-operative dosing
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Bratzler, D. W. et al. Arch Surg 2005;140:174-182.
It’s All About TimingIt’s All About Timing
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Timing of DosesTiming of Doses
Incision should occur within 60 minutes of antimicrobial administration
• Initial Dosing– Cefazolin, Cefoxitin, Cefotetan, Clindamycin
• Administer over 10-15 minutes
– Vancomycin, Gentamicin, Metronidazole• Administer over at least 1 hour (1 gm/hr for
vancomycin)
Incision should occur within 60 minutes of antimicrobial administration
• Initial Dosing– Cefazolin, Cefoxitin, Cefotetan, Clindamycin
• Administer over 10-15 minutes
– Vancomycin, Gentamicin, Metronidazole• Administer over at least 1 hour (1 gm/hr for
vancomycin)
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• Intra-operative Dosing– Redose
• Large amount of intra-operative blood loss (~1500mL)• Approximately 2X half life of antimicrobial
– Cefazolin, Cefoxitin, Clindamycin• Q4 hours intra-op
– Vancomycin• Q6 hours intra-op
– Cefotetan, Levofloxacin, Gentamicin• Not needed intra-op due to prolonged duration
• Intra-operative Dosing– Redose
• Large amount of intra-operative blood loss (~1500mL)• Approximately 2X half life of antimicrobial
– Cefazolin, Cefoxitin, Clindamycin• Q4 hours intra-op
– Vancomycin• Q6 hours intra-op
– Cefotetan, Levofloxacin, Gentamicin• Not needed intra-op due to prolonged duration
Timing of DosesTiming of Doses
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Bratzler, D. W. et al. Arch Surg 2005;140:174-182.
Antimicrobial ChoiceAntimicrobial Choice
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When to StopWhen to Stop
Bratzler, D. W. et al. Arch Surg 2005;140:174-182.
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BMC Antimicrobial Prophylaxis Plan
BMC Antimicrobial Prophylaxis Plan
• Develop agreement– Choice
– Dosing
– Administration
– Redosing
– Intergroup• Surgery• Anesthesia• ID• Pharmacy• ITS
• Develop agreement– Choice
– Dosing
– Administration
– Redosing
– Intergroup• Surgery• Anesthesia• ID• Pharmacy• ITS
• Implementation– Adminstration time– Intraop reminders
• Stickers• Pagers
– Standard Orders• Physician order entry• Orders per guidelines
– Auto stops
• Implementation– Adminstration time– Intraop reminders
• Stickers• Pagers
– Standard Orders• Physician order entry• Orders per guidelines
– Auto stops
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Figure based on compliance of the following combined points:
antibiotics (correct agent, correct timing, correct discontinuation)Figure based on compliance of the following combined points:
antibiotics (correct agent, correct timing, correct discontinuation)
Boston Medical Center ScorecardBoston Medical Center Scorecard
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Boston Medical Center ScorecardBoston Medical Center Scorecard
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Boston Medical Center ScorecardBoston Medical Center Scorecard