2018 Pharmacy Education Seriess3.proce.com/res/pdf/CHS2018Nov14Handout.pdf · 2018-11-06 · Raniah Aljadeed, PharmD Raniah Aljadeed, PharmD is an Emergency Pharmacy resident at Northwest

2018 Pharmacy Education Series

November 14, 2018Pharmacy Pearls 2018

Today’s Presenters

Raniah Aljadeed, PharmD

Raniah Aljadeed, PharmD is an Emergency Pharmacy resident at Northwest Medical Center in Tucson, Arizona. She has completed her Doctor of Pharmacy at the University Illinois at Chicago and her a pharmacy postgraduate year one residency program (PGY1) residency at Northwest Medical Center in Tucson, Arizona. Her areas of interest include emergency medicine, toxicology, neurology, and critical care.

Sara Brandon, PharmD

Sara is currently completing a postgraduate year two (PGY2) residency program in Health System Pharmacy Administration with Community Health Systems Professional Services Corporation. She serves as the Assistant Director of Pharmacy at Tennova Healthcare in Clarksville, Tennessee. Sara received her Doctor of Pharmacy degree from East Tennessee State University and completed a pharmacy postgraduate year one (PGY1) residency at Maury Regional Medical Center in Columbia, Tennessee.

Renee S. Brown, PharmD, BCPS

Renee Brown is the Manager of Clinical Pharmacy Services at Southside Regional Medical Center in Petersburg, Virginia. Renee earned her B.A. in psychology at Wittenberg University and received her Doctorate of Pharmacy at Virginia Commonwealth University. Renee went on to complete a PGY1 residency at New Hanover Regional Medical Center in Wilmington, North Carolina and earned her board certification in pharmacotherapy. Renee is also a Clinical Assistant Professor at VCU School of Pharmacy and precepts P4 students in her Acute Care hospital rotation.

Lance Hagler, PharmD

Lance Hagler, PharmD, is the Clinical Coordinator and Assistant Director of Pharmacy at Flowers Hospital in Dothan, Alabama. He received his B.S. in Biomedical Sciences from Auburn University in 2002, and doctor of pharmacy from the Auburn University’s Harrison School of Pharmacy in 2006. Immediately upon graduation he accepted the role of clinical pharmacist at Flowers Hospital where he was hired to revamp the pharmacy’s clinical responsibilities. Starting out as a one man clinical department, he has helped the department grow by working with hospital administration to add an Antimicrobial Stewardship pharmacist, 2 Home Medication Reconciliation pharmacists, 1 ER pharmacist and 1 clinical pharmacist who rounds with the hospital’s intensivist team.

Ashley Lockwood, PharmD, BCPS

Ashley M Lockwood, PharmD, BCPS is an Infectious Diseases Pharmacist at Bayfront Health St. Petersburg in St. Petersburg, Florida. She received her doctor of pharmacy from the University of Florida. She has completed a pharmacy postgraduate year one residency program (PGY1) at St. Vincent’s Medical Center Riverside in Jacksonville, Florida and a postgraduate year two residency program (PGY2) specializing in Infectious Diseases at Houston Methodist in Houston, Texas. Her focus is Infectious Diseases along with Antimicrobial Stewardship and is the pharmacist leader for the Antimicrobial Stewardship Program at Bayfront Health. She is also a member of the Community Health Systems Professional Services Corporation Antimicrobial Stewardship Task Force. She is an active member of the Society of Infectious Diseases Pharmacists and serves on the committee for SIDP Education Center. She precepts for student pharmacists completing advanced pharmacy practice rotations and residents completing a pharmacy postgraduate year one residency program (PGY1) with Bayfront Health St. Petersburg.

David Martin, PharmD, FACN, CNS, FASCP

David Martin is Clinical Coordinator at Gadsden Regional Medical Center and was previously Director of Pharmacy at DeKalb Regional Medical Center in Fort Payne, Alabama. Dr. Martin completed a Hospital Residency at Grady Hospital in Atlanta. He was Director of Infusion Home Care in Mexico for 7 years. Dr. Martin is a tenured Associate Professor at Mercer University School of Pharmacy. He has been a CMS Surveyor for pharmacy accreditation for 11 years. His specialty areas of interest include Antimicrobial Stewardship, Metabolic and Nutritional support, and pharmacogenomics.

Danielle Moore, PharmD, BCPS

Danielle Moore is an Emergency Medicine Clinical Pharmacist at Bayfront Health in St. Petersburg, Florida. She received her Doctorate of Pharmacy from Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy in Bradenton, Florida in 2015. She then went on to complete pharmacy postgraduate training (PGY1) at Bayfront Health, the only Level II Trauma Center in Pinellas County, upon graduation. Danielle actively provides specialized education and training to pharmacy residents, pharmacy students, trauma nurses, and nursing students. Interdisciplinary support and her passion for fast‐paced, emergent care of patients is what drives her continued involvement in the emergency department setting.

Alexis Schrieber, PharmD

Alexis Schrieber is the health outcomes and analytics fellow with Wolters Kluwer Health and Community Health Systems. She graduated from Drake University College of Pharmacy and Health Sciences in 2018. She enjoys working on the interdisciplinary healthcare team at the Community Health Systems headquarters in Franklin, Tennessee. Her main interest areas are pharmacoeconomics, health care law, and billing and reimbursement. Alexis also has a passion for medication safety. She currently is the secretariat on the corporate Medication Safety Council and is pursuing her medication safety certificate through ISMP and ASHP.

Pharmacy Pearls 2018CHS Pharmacy Education Series

ProCE, Inc.www.ProCE.com 1



Submission of an online post‐test and evaluation is the only way to obtain CE credit for this webinar

Go to www.ProCE.com/CHSRx

Print your CE statement of completion online

– Credit for live or enduring (not both)

Deadline: December 14, 2018

Pharmacists and Pharmacy Technicians: CE credit uploaded to CPE Monitor

– User must complete the “claim credit” step

Online Evaluation, Self-Assessmentand CE Credit

Attendance Code

Code will be provided at the end of today’s activity 2



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It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. None of the presenters have any relevant commercial or financial relationships to disclose.

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5

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist and Pharmacy Technician CE)This CE activity is jointly provided by ProCE, Inc. and CHSPSC, LLC. ProCE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221‐9999‐18‐396‐L04‐P/T has been assigned to this knowledge‐based live CE activity (initial release date 11‐14‐18). This CE activity is approved for 2.0 contact hours (0.2 CEU) in states that recognize ACPE providers. This CE activity is provided at no cost to participants. Successful completion of the online post‐test and evaluation at www.ProCE.com/CHSRx is required to receive CE credit. CE credit will be uploaded to NABP/CPE Monitor. No partial credit will be given.

Funding:This activity is self‐funded through CHSPSC.

6



Pharmacy Pearls 2018Introductory Remarks

Trent A. Beach, PharmD, MBA, MHA, BCPS, FASHP, FACHE

Director; Clinical Services and Education

CHS Professional Services Corporation, Franklin, Tennessee

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Esmolol for Refractory Ventricular Fibrillation

Raniah AljadeedPGY2‐ EM Pharmacy Resident

University of Arizona/Northwest Medical Center November 14th, 2018

8



Disclosure

9

I have no financial interest or affiliation with the manufacturer or any marketed product herein

Disclosure

2

I have no financial interest or affiliation with the manufacturer or any marketed product herein

9

At the end of this presentation, you should be able to:

Identify the role and pharmacokinetics of beta‐blockade in refractory Vfib

Discuss the available evidence and practical implication of esmolol in refractory Vfib

Learning Objectives

10



Abbreviations CPR: Cardiopulmonary Resuscitation

IO: Intraosseous

PEA: Pulseless Electrical Activity

ROSC: Return of Spontaneous Circulation

Vf: Ventricular Fibrillation

Vfib: Ventricular Fibrillation

RVF: Refractory Ventricular Fibrillation

VT: Ventricular Tachycardia

OHCA: Out‐Of‐Hospital Cardiac Arrest

ACLS: Advanced Cardiac Life Support

SCD: Sudden Cardiac Death

ED: Emergency Department

PMH: Past Medical History 11

▷ You’re the resident responding to a code for a patient in ED

▷ On arrival, you found a 65 year old male with cardiac arrest and ongoing CPR

▷ Unknown PMH

▷ Pre‐hospital Management: • Defibrillation x5• Epinephrine 1mg x2 • Amiodarone 300 mg x1• Amiodarone 150 mg x1

Patient Case: MJ

Credit: martek.marine.com 12



Patient Case: MJ

▷ EKG monitor shows the following:

Are there any additional agents that can be utilized in hopes of achieving ROSC?

13

Definitions

▷ Vfib is a rapid, disorganized ventricular arrhythmia, resulting in no uniform ventricular contraction, no cardiac output, and no recordable blood pressure

▷ Refractory Vfib refers to Vfib that persists or recurs after 1 or more shocks

AHA guidelines. Circulation 2015;132:S315‐S589.

14



Adult Cardiac Arrest Algorithm‐2015 Update

1. Start CPR (give oxygen; attach monitor/defibrillator)

GO to Algorithm for Pulseless Ventricular

Tachycardia or Fibrillation

GO to Algorithm for Asystole/ PEA

2. Rhythm shockable?

YES NO

AHA guidelines. Circulation 2015;132:S315‐S589.

15

Algorithm for Pulseless Ventricular Tachycardia or Fibrillation

3. ⚡Defibrillation (shock 1) ⚡

4. CPR 2 min Establish IV/IO access

5. Reassess rhythm; shock if appropriate


7. CPR 2 min Epinephrine 1 mg IV/IO every 3–5 min Consider advanced airway, capnography

8. Reassess rhythm; shock if appropriate


10. CPR 2 min Amiodarone 300 mg IV/IO × 1; may repeat at 150 mg bolus × 1

AHA guidelines. Circulation 2015;132:S315‐S589.16



Effect of Epinephrine in Cardiac Arrest

Epinephrine

Alpha adrenergic receptors

Beta‐1 adrenergic receptors

Increase myocardial oxygen

demand

Increase coronary perfusion pressure

Ischemia

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Esmolol in Refectory Vfib

▷ Beta‐1 selective

▷ It has the fastest onset and shortest half‐life of any Beta‐blocker

Little R, et al. Arch Emerg Med. 1986;3(1):20‐27.

18



Clinical Evidence for Beta‐blocker in Refectory Vfib

Supportive literature limited to animal studies, case reports and 2 human retrospective trials

Driver BE. et al. (2014)

Lee YH. et al. (2016)

Animal studies

Nademanee K, et al. Circulation. 2000;102(7):742‐747.Driver BE. et al. Resuscitation. 2014 Oct;85 (10):1337‐41.Lee YH. et al. Resuscitation. 2016 Oct;107:150‐5.

Case reports

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Animal Studies

Beta‐blockade can:

1) Reduce in the number of shocks for defibrillation

2) Diminish cardiac ischemia

3) Reduce recurrences of arrhythmias

4) Prolong survival

Nademanee K, et al. Circulation. 2000;102(7):742‐747.T. Pellis, et al. Circulation, 108 (2003), pp. 2716‐2721.W.Tang, et al. Circulation, 92 (1995), pp. 3089‐3093.R.V. Ditchey, et al. J Am Coll Cardiol, 24 (1994), pp. 804‐812.

20



Case Reports

Author (year)Population

SizeAge (median)

Beta‐ blocker (bolus dose)

Results

Schmidt, et al. (2003)

N= 1

18 Metoprolol (5mg)

• Resolution of the VF and no recurrence

• The patient survived to discharge

Srivatsa, et al. (2003) 20 Esmolol (500 μg/kg)

• The VF episodes ceased immediately after esmolol administration

• The patient survived to discharge

Tsagalou, et al.(2005) 60 Propranolol (0.5 mg)

• VF immediately subsided

T.D. Schmidt,et al. Transplant Proc, 35 (2003), pp. 1437‐1438.U.N. Srivatsa,et al. J Cardiovasc Pharmacol Ther, 8 (2003), pp. 237‐246E.P. Tsagalou, et al. Int J Cardiol, 99 (2005), pp. 341‐342.

21

Retrospective TrialsStudy Intervention Results

Comparisons are esmolol vs. no esmolol groups

Driver BE, et al (2014)(n= 25)

Esmolol (n= 6) No esmolol (n= 19)

Sustained ROSC:4 of 6 (66.7%) vs 6 of 19 (31.6%)

Survival to hospital discharge: 3 of 6 (50%) vs 3 of 19 (15.8%)

Good neurologic outcomes: 3 of 6 (50%) vs 2 of 19 (10.5%)

Lee YH, et al (2016)(n= 41)

Esmolol (n= 16)No esmolol (n= 25)

Sustained ROSC:9 of 15 (56.3%) vs 4 of 25 (16%) P= 0.007

Survival at 30 days: 3 of 16 (18.8%) vs 2 of 25 (8%) P= 0.36

Good neurologic outcomes: 3 of 16 (18.8%) vs 2 of 25 (8%) P= 0.36

Driver BE. et al. Resuscitation. 2014 Oct;85 (10):1337‐41.Lee YH. et al. Resuscitation. 2016 Oct;107:150‐5.

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Dose: A loading dose of 0.5 mg/kg over 1 minute, followed by infusion up to 0.1 mg/kg/min

Pharmacokinetics:

How supplied: 1. 10mg/ml vial*2. 10mg/ml premixed bag*3. 20mg/ml premixed bag

Onset of action (IV) Duration of effect Half‐life elimination

2‐10 minutes 10‐30 minutes 9 minutes

*Available at NMC Pharmacy Brevibloc (esmolol) package insert. Deerfield, IL: Baxter Healthcare Corporation; April 2018.

How to Administer?

23

▷ A 65 year old male with cardiac arrest and ongoing CPR

▷ Unknown PMH

▷ Pre‐hospital Management: • Defibrillation x5• Epinephrine 1mg x2 • Amiodarone 300 mg x1• Amiodarone 150 mg x1

Back to Patient Case: MJ

24



Assessment Question

The team decided to give the patient esmolol, which of the following doses would be appropriate to initiate for MJ?

a) 1 mg/kg over 30 seconds, followed by a 0.15 mg/kg/minute infusion

b) 1 mg/kg over 1 minute, followed by a 0.05 mg/kg/minute infusion

c) 0.5 mg/kg over 1 minute, followed by a 0.05 mg/kg/minute infusion

d) 1 mg/kg over 1 minute

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Summary

▷ High levels of endogenous or exogenous catecholamines may cause deleterious effects to the myocardium

▷ Esmolol is the ideal beta blocker for refractory Vfib due to its pharmacokinetic and pharmacodynamic profile

▷ Limited evidence suggests the use of esmolol in the setting of refractory Vfib may result in a higher rate of sustained ROSC

26



References1) Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O’Neil BJ, Paxton JH, Silvers SM,

White RD, Yannopoulos D, Donnino MW. Part 7: adult advanced cardiovascular life support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation.2015; 132(suppl 2):S444–S464.

2) Nademanee K, Taylor R, Bailey WE, Rieders DE, Kosar EM. Treating electrical storm: sympathetic blockade versus advanced cardiac life support‐guided therapy. Circulation 2000;102:742–7.

3) Soar J, Nolan JP, Bottiger BW, et al. European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult advanced life support. Resuscitation 2015;95:100–47.

4) Neumar RW, Otto CW, Link MS, et al. Part 8: adult advanced cardiovascular life support: 2010 American Heart Association Guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation 2010;122:S729–67

5) Bassiakou E, et al. Atenolol in combination with epinephrine improves the initial outcome of cardiopulmonary resuscitation in a swine model of ventricular fibrillation. Am J Emerg Med. 2008 Jun;26(5):578‐84.

6) Driver BE, et al. Use of esmolol after failure of standard cardiopulmonary resuscitation to treat patients with refractory ventricular fibrillation. Resuscitation. 2014 Oct;85(10):1337‐41.

7) Lee YH, et al. Refractory ventricular fibrillation treated with esmolol. Resuscitation. 2016 Oct;107:150‐5.

8) Brevibloc (esmolol) [prescribing information]. Deerfield, IL: Baxter Healthcare Corporation; April 2018.

9) Brevibloc (esmolol) [prescribing information]. Mississauga, Ontario, Canada: Baxter Corporation; June 2016.

10) De Oliveira FC, Feitosa‐Filho GS, Ritt LE. Use of beta‐blockers for the treatment of cardiac arrest due to ventricular fibrillation/pulseless ventricular tachycardia: a systematic review. Resuscitation 2012;83:674–83.

11) Little R, Frayn K, Randall P, et al. Plasma catecholamines in the acute phase of the response to myocardial infarction. Arch Emerg Med. 1986;3(1):20‐27.

27

Thank you

28



Tech Check Tech Program

Sara Brandon, PharmD

PGY2 Health System Pharmacy Administration Resident, Community Health Systems

29

Learning Objective

• Develop a program to enhance the practice of certified pharmacy technicians

30



Tech Check Tech

• Allows pharmacy technicians to perform final verification of medications prepared by other technicians– Automated dispensing cabinets

– Unit dose cart fills

• Enhance pharmacy technician practice– Skills Development

– Professional Development

Hosp Pharm 2017;52(4):280‐285.AJHP 2011;68:1820‐1835. 31

Regulations

• Not all states with active Tech Check Tech rules and regulations– At least 16 states have programs or a process to appeal to state board

– All differ slightly on requirements

• Competencies– May be dictated by state board of pharmacy

– Requires investment in time and resources

AJHP 2011;68:1824‐1833. 32



Impact on Pharmacy Operations

Accuracy of Validation

Pharmacy technician 99.6%

Pharmacist 99.3%

Technician Time

Reduction in time to restock automated dispensing cabinets

7.37 hours/week,P < 0.0001

Pharmacist Time

Reduction in STAT order verification 1 minute, p < 0.0001

Reduction in ROUTINE order verification 5 minutes, p < 0.0001

Hosp Pharm 2017;52(4):280‐285.AJHP 2011;68:1820‐1835.

33

Tennova Healthcare ‐ Clarksville

• Tech check tech allowed per Tennessee Rules of the Board

• Automated dispensing machine fills

• Certified technicians with inpatient pharmacy experience

TNBOP 2018. 34




Didactic Training

• Study materials created by administration

• Written exam ≥ 90% accuracy

Experiential Validation

• Check 1000 line items filled by another technician

• Checked by pharmacist for ≥ 98% accuracy

Quality Assurance

• Remediation available at every step of the process

• Random audits after completion of training

35


• Training began October 11, 2018

• Voluntary participation

• Impact on pharmacy operations

36



Renee S Brown, PharmD, BCPS

Clinical Pharmacy Manager

Southside Regional Medical Center

Petersburg, Virginia

Calcitonin Clinical Initiative: Engaging Staff to Maximize Results

37

Objective

• At the conclusion of this presentation, participants will be able to implement the calcitonin usage criteria at their facility by successfully engaging both Pharmacists and Technicians in this initiative

38



CHS Definition Approved Indications

• Severe, symptomatic hypercalcemia ORhypercalcemia of malignancy:

– Corrected calcium > 14 mg/dL AND

– Moderate to severe cardiac or neurologic symptoms

• Examples: abnormal heart rhythm, cardiac arrest, confusion, lethargy, coma, etc.

• Paget’s Disease of the Bone

– With documented intolerance to bisphosphonate therapy

39

Treatment of Hypercalcemia

• First Line Treatments:– Aggressive IV hydration with normal saline starting at 200‐300 mL/hr, then adjusted to urine output at 100‐150 mL/hr

– Bisphosphonate therapy (i.e., pamidronate)• Alternative Treatment:

– Calcitonin should be considered if:• Patient has not responded (or has a contraindication) to aggressive IV hydration and/or bisphosphonate therapy

• Patient has severe, symptomatic hypercalcemia

40



Limitations to First Line Treatments

• Aggressive IV Hydration – Saline dilutes serum calcium and helps to facilitate calcium excretion through the urine– “Gently” reduces calcium levels– Examples of relative contraindications: Patients at high risk for

fluid overload (CHF); renal failure; liver disease; etc.

• IV Bisphosphonates ‐More effective than calcitonin at lowering serum calcium– Take several days to reduce calcium levels– Bisphosphonates are not recommended in renal failure.

Patients can receive pamidronate up to a MAX of 90 mg/month. https://www.pharmacytimes.com/contributor/brandon‐dyson‐pharmd‐bcps/2017/04/hypercalcemia‐pharmacotherapy‐a‐review

https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0082773/http://labeling.pfizer.com/ShowLabeling.aspx?id=4560

41

Calcitonin Dosing

• Treatment for severe, symptomatic hypercalcemia ORhypercalcemia of malignancy:– Calcitonin 4 units/kg IM or

SQ every 12 hours x 4 doses (48 hours total)

• Treatment for Paget’s Disease:– Calcitonin 50‐100 units SQ

daily, with a maintenance regimen of 50 units daily or 50‐100 units every 1‐3 days

42



Calcitonin Effects

• Optimal effect is achieved using HIGH DOSE (4 units/kg) twice daily dosing

• Typically lowers serum calcium by 1‐2 mg/dL, and works within 1‐2 hours of administration

• Effects on calcium levels diminish after 24‐48 hours due to rapidly developing tachyphylaxis(tolerance); thus evidence supports a maximum duration of 48 hours for calcitonin therapy

https://www.pharmacytimes.com/contributor/brandon‐dyson‐pharmd‐bcps/2017/04/hypercalcemia‐pharmacotherapy‐a‐review

Carroll, Mary; Schade, David. A Practical Approach to Hypercalcemia. Am Fam Physician. 2003 May 1;67(9):1959‐1966. Accessed from: http://www.aafp.org/afp/2003/0501/p1959.html

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Pharmacists’ Role

• VERIFY– Verify a hypocalcemia response– If minimal or no response after 2 doses, consider increasing to MAX dose of 8 units/kg for the remaining 2 doses

• MONITOR– Monitor corrected calcium levels/ symptoms. If a patient’s calcium level approaches a normal range and/or symptoms resolve, recommend discontinuing therapy

• FOLLOW UP– If the patient remains symptomatic even after calcium has responded to therapy, consider an alternative cause for patient’s symptoms

44



Technicians’ Role

• EDUCATE

– Calcitonin dosing should be EVERY 12 HOURS

– Orders should only be x 4 DOSES (48 hours)

• EMPOWER

– Notify a pharmacist if labels print for ONCE DAILY dosing

– Notify a pharmacist if orders continue PAST 4 doses

– Notify a pharmacist of the order(s) to ensure follow up

45

Don’t Forget the Medical Staff!

• EDUCATE– Provide CHS‐approved usage criteria for appropriate indications and dosing

– Provide an explanation regarding the HIGH‐DOSE (weight‐based) regimen and 48‐hour duration

– Ensure patients are on optimal therapy, including IV hydration and IV bisphosphates (if clinically appropriate)

– Let Medical Staff know that Pharmacy will be following calcitonin patients to monitor labs and symptoms

– Follow up on patients who are not showing a significant hypocalcemia response after 2 doses – CONTACT PRESCRIBER to increase dosage (MAX 8 mg/kg), if clinically appropriate

46



Patient Case #1

60 year old patient with hypercalcemia of malignancy is ordered calcitonin 4 units/kg SQ daily with directions to “continue until corrected calcium is less than 10 mg/dL”.

– Nephrology notes that the patient’s corrected calcium has come down over the past few days from 12.3 mg/dL to 11.2 mg/dL with IV hydration and pamidronate

– No hypercalemia‐related symptoms are documented

47

Patient Case #2

78 year old patient admitted for acute DVT and acute kidney injury. Patient is receiving IV hydration and Nephrology notes that “Once kidney function is better, a bisphosphonate will be ordered”. Calcitonin 4 units/kg every 12 hours x 4 doses was ordered.

– Patient’s corrected calcium is 11.6 mg/dL– No cardiac/ neurological symptoms documented– Upon review of the previous days’ labs, the patient’s serum calcium had come down from 10.8 mg/dL to 10.0 mg/dL

48



Take Home Points

• Verify that the patient has been put on appropriate IV hydration and IV bisphosphonate therapy (if clinically appropriate)

• Communicate during shift‐change any patient(s) on calcitonin to ensure appropriate monitoring/ follow up

• Educate and Empower Technicians to identify patients on the appropriate frequency and/or duration of calcitonin therapy

• Collaborate with Medical Staff to ensure optimal therapeutic outcomes with appropriate calcitonin treatment

49

“Don’t expect what you don’t inspect.”

~ W. Clement Stone,

The Success System that Never Fails (1962)

50



Local Infiltration Anesthesia (LIA) Cocktails for Surgery Patients

Lance Hagler, Pharm.DClinical Coordinator and Assistant Director of

Pharmacy

Flowers Hospital‐ Dothan, AL

51

• ON‐Q Pain Relief Systems (aka “Pain Balls”)– 3 to 4 days of continuously flowing bupivacaine or ropivacaine to surgical site

– Cost ~ $300 per pain ball

• Exparel (liposomal bupivacaine) – One time single dose injection(s) to surgical site

– Cost ~ $270 per dose

• Anesthesia Cocktails– One time single dose injection(s) to surgical site

– Cost ~ $20

Flowers Hospital history of LIA in Surgery cases

52



• In 2015‐2016 we were looking at ways to decrease and/or eliminate Exparel use due to cost

• Discussions with our orthopedic surgeons led to an article found in the Journal of the American Academy of Orthopaedic Surgeons from February of 2016.


53

• Different formulations in the article were compared but our surgeons decided on a formula from a study from Parvataneril et al.

• The formula consisted of the following:– 200‐400mg of bupivacaine (although now we use a max dose of 2.5mg/kg unless that is greater than what is ordered)

– 4‐10mg of morphine – 0.3mg of epinephrine– 40mg of methylprednisolone (contraindicated in diabetic or immunocompromised patients)

– 750mg of cefuroxime (sub vancomycin 1g for cephalosporin allergies)


54



55

• Once the orthopedic surgeons started effectively and routinely using these cocktails, other groups of surgeons started using them as well

• The include but are not limited to general surgeons, OB‐GYNs, and cosmetic surgeons

• Many of these different surgeons change their formulations slightly to meet their needs


56



• Since 2016 we have used around 1769 cocktails on surgery patients

• Cost savings

– For Exparel, that would have cost the hospital $477,630

– For the cocktails the cost is $35,380

– Total cost savings of $442,250!


57

• Questions:

– Email: [email protected]

–Phone: 334‐794‐5000 Ext. 7335

58



Ashley M Lockwood, PharmD, BCPS

Clinical Specialist ‐ Infectious DiseasesPharmacy Department

Bayfront Health St. Petersburg 701 6th Street South

St. Petersburg, FL 33701

ANAEROBES:

59

Disclosure(s)

• There are no financial interest/arrangement or affiliation concerning material discussed in this presentation

60



Objectives

• Analyze the evidence for the use of double coverage with anaerobic pathogens

• Understand strategies for decreasing the use of anaerobic double coverage

61

Anaerobes• An organism that grows without air, or requires oxygen‐free conditions to live

• Normal flora of the oral cavity and the gastrointestinal tract

https://www.asp.mednet.ucla.edu/files/view/guidebook/MacroMicroMisconceptions.pdfDrugs. 2010 May 7;70(7):841‐58.

Clin Microbiol Rev. 2007 Oct; 20(4): 593–621.

Gram‐positive organisms:

Peptococcus

Peptostreptococcus spp.

Gram‐negative bacilli:

Bacteroides fragilis

Prevotella melaninogenica

Fusobacterium spp.

62



Anaerobic Coverage• Gram‐positive oral anaerobes are widely covered by most of the orally‐available agents

• Antibiotic activity against the most common intestinal anaerobic bacteria is variable

• Anaerobic coverage is indicated in a variety of infectious processes, including but not limited to • Aspiration pneumonia• Intra‐abdominal infection• Gynecologic infection• Diabetic foot ulcer infection

https://www.asp.mednet.ucla.edu/files/view/guidebook/MacroMicroMisconceptions.pdfSolomkin JS. Clin Infect Dis. 2010;50:133‐164.

Anaerobe. 2012 Apr;18(2):235‐9. 63

Double Coverage• Two antibiotics used to provide coverage for the same

organism• Based upon the following assumptions the combination:

• Provides a broad spectrum of coverage for empiric treatment, before you know the identification and susceptibility of the offending pathogen

• May provide additive or synergistic effects against the pathogen• May decrease or prevent the emergence of resistant bacteria

https://www.asp.mednet.ucla.edu/files/view/guidebook/MacroMicroMisconceptions.pdfJ Antimicrob Chemother. 2011 Nov;66(11):2655‐8.

64



Specific Coverage• Double anaerobic coverage is not necessary and

puts the patient at risk for additional drug toxicities. No data or guidelines support double anaerobic coverage in clinical practice, with two clinical exceptions:

• Exceptions: 1. Metronidazole can be added to another agent with anaerobic activity when being used to treat Clostridium difficile infection. 2. Clindamycin can be added to another agent with anaerobic activity when being used for the treatment of necrotizing fasciitis or toxic shock.

Amox‐Clav

Amp‐Sulb

Pip‐tazo

Carbap

enem

s

Cefotetan

Cefoxitin

Clin

dam

ycin

Tigecycline

Metronidazole

B. fragilis ++ + ++ ++ ± ± ± + ++

F. necrophorum + + + + + + + + ++

P. Melaninogencia + + + + + + + + ++

Actinomyces spp. + + + + ? + ++ ? 0

Clostridium spp. + + + + + + + + +

P. Acnes + + + + + + ± + 0

Peptostreptococci + + + + + + + + ±

C. Difficile 0 0 0 0 0 0 0 0 ++

Sanford gu

ide to

antim

icrobial th

erap

. Antim

icrobial Th

erap

y, Inc., [2

018]

Per IDSA 2017 Clostridium difficile Guideline Update metronidazole is NO LONGER as first line agent and should be only used:• In initial non‐severe episode when alternatives

agents are not available • Intravenously in combination with oral or rectal

vancomycin if an ileus is present in a initial fulminant episode

‐

+

Resistance over the years

Clin Infect Dis. 2010 Jan 1;50 Suppl 1:S26‐33.

• Found resistance to antibiotics was greater among non–B. fragilis Bacteroides species than among B. fragilis

• Especially greater among species with a low frequency of isolation, such as Bacteroides caccae and B. uniformis

66



Evidence• There are no data or national guidelines to support double anaerobic coverage

• Some confusion IDSA with intra‐abdominal infection guidelines

Solomkin JS. Clin Infect Dis. 2010;50:133‐164.Anaerobe. 2012 Apr;18(2):235‐9.

67

IDSA Guidelines

Solomkin JS. Clin Infect Dis. 2010;50:133‐164.68



Why is it so prevalent?

• Confusion with guidelines

• Spectrum familiarity/Unavailable susceptibilities

• Belief little harm comes from using multiple antibiotics

• “More is better”

J Antimicrob Chemother. 2012;67(6):1537‐1539Duke Antimicrobial Stewardship Outreach Network. 2016; August: 4(8)

https://encrypted‐tbn0.gstatic.com/images?q=tbn:ANd9GcTkgKJ03‐HZd_ieBudFl9o‐zKgUhLv0pO2NZhIkRDrnezdyP6Ei

69

ASP Strategies

• Education

• Protocols

Automatic discontinuation of metronidazole

when used concomitantly with:

Automatic discontinuation of metronidazole

when used concomitantly with:

Ampicillin/sulbactam

Amoxicillin/clavulanate

Pipercillin/tazobactam

Meropenem

Exception when a patient has one of the following diagnoses requiring metronidazole therapy for which β‐lactam/β‐lactamase inhibitors or carbapenems are not acceptable as treatment alternatives:

Exception when a patient has one of the following diagnoses requiring metronidazole therapy for which β‐lactam/β‐lactamase inhibitors or carbapenems are not acceptable as treatment alternatives:

Bacterial vaginosis

Trichimoniasis

Amebiasis

Giardiasis

H. pylori eradication

70



Summary• Double anaerobic coverage is not necessary and puts the

patient at risk for additional drug toxicities.

• No data or guidelines support double anaerobic coverage in clinical practice, with two clinical exceptions: • Metronidazole can be added to another agent with anaerobic activity

when being used to treat infections that beta‐lactams cannot be used such as bacterial vaginosis, trichimoniasis, amebiasis, giardiasis, H. pylori eradication BUT NOT Clostridium difficile infection

• Clindamycin can be added to another agent with anaerobic activity when being used for the treatment of necrotizing fasciitis or toxic shock

71

Category B ‐‐ Samsca

Gadsden Regional Medical CenterGadsden, AL

David Martin Pharm.D. FACN CNS FASCP

72



346 Acute care – 32 IC beds

73

Samsca (tolvaptan)

• Category B mfg Otsuka

• 15 mg tablet HPG $ 429.33 AWP $ 515.20/tablet

• 30 mg tablet HPG $ 445.38 AWP $ 534.46/tablet

• ALC + Test (Pharmacist competency)

• Form for the order entry pharmacist

• References

74



Form for order entry Pharmacists

Non‐Formulary, Category B: Tolvaptan (Samsca) & Conivaptan (Vaprisol)

Required Criteria for use at GRMC

Note: complete all information – mandatory reporting – for all orders – approved or rejected

Pharmacist___________ Date _________ Time ___________

Patient ______________ FIN ______________ Physician _________ Time rejected ______ Time accepted _______

Pharmacist’s Signature __________________ (Signature verifies all 5 criteria or 4 and 1 NA have been met prior to approval)

Note: Mandatory reporting to CHS; requires Pharmacist’s signature

75

Must meet appropriate criteria for Approval (Order may be held for 2 hours for review)

Yes/No 1. Documented euvolemic or hypervolemic (e.g. SIADH, Heart Failure or Cirrhosis) must meet both a & b.

a. Serum sodium < 124 mEq/L

b. Serum osmolality < 284 mOsm/Kg [ Calc _________ mOsm/L DM ___________ mOsm/Kg ]

Yes/No 2. Urine output > zero

Yes/No 3. Patient not receiving strong CYP3A4 inhibitors – list from package insert on back page

Yes/No 4. Failed fluid restriction (< 2.4 liters in 48 hours)

Yes/No/NA 5. If Heart Failure: documented failure of diuretics (helpful: echocardiogram; ejection fraction;

BNP >500pg/ml) (>120 mg IV furosemide or equivalent daily x 2 days). If NA 5 is not necessary for approval.

Criteria 1. Key information is serum sodium < 124 (less than 125 in the package insert) this information is from a lab test in Cerner. Look at the sodium trend and also the chloride. If the chloride is low you best replace sodium chloride with 3% 100 ml over 1 hr with or without Samsca.

The serum osmolality is done with an osmometer using freezing point depression and reported eg 285 mOsm/Kg DM (direct measure) this is osmolality. Normal physiological range is approximately 280 to 310. Low osmolality is seen in hypervolemia. You can calculate the Osmolarity mOsm/L manually or use the website on the back of the form to calculate it online. In studies at GRMC Osmolarity is within 1 to 5 mOsmof the measured Osmolality. The serum sodium concentration is the most important information.

Criteria 2. The answer is yes unless the patient is anuric or has zero output of urine.

Criteria 3. The strong CYP3A4 inhibitors listed on the back of the form can increase serum levels and increase the risk of hepatotoxicity very quickly.

76



Criteria 4. Has fluid restriction been tried ? The instructions are to cut fluids by 1.2 Liter a day for 2 days and it serum sodium decreases by 5 mEq fluid restriction has failed.

Criteria 5. Has > 120 mg IV lasix or equivalent been tried daily for 2 days yes or no? If not diagnosed with heart failure – answer NA

If patient meets all 5 criteria or 4 and NA it may be approved by the pharmacist. The pharmacist

must order or insure the following orders are placed:

a. Serum Sodium q 4 – 6 hours for the 1st 24 hours then daily (most cases q 6 would be adequate)

b. Regular neurological status monitoringc. Orders for Samsca or Vaprisol should not be continued past 96 hours. (stop and re‐evaluate patient)d. Effective daily supply of sodium (at least 154 mEq sodium chloride – 1 liter NS)

If order is rejected by the pharmacist the physician should be offered an alternative:

___ Sodium Chloride 0.9% (NS) 50 to 125 ml/hr___ 100 ml bolus IVPB 3% sodium chloride over 30 minutes x 3 prn (prepared by pharmacy)___ Loop Diuretics (furosemide 40 mg iv‐push every 12 hours prn)___ 1 gm sodium chloride tablets one q 6 hours PO

77

If prescriber insists on using Samsca anyway

Their request will be forwarded to the physician chairman of the P & T Committee, CEO and pharmacy Director for collaboration.

A case report will be sent to QA/PI Committee and Potential Peer Review

78



Non‐formulary, Category B: Tolvaptan (Samsca PO) and Conivaptan (Vaprisol IV)

Background: Both are vasopressin (ADH) antagonist which promote excretion of free water without electrolytes which is reserved for patients with normal fluid volume (euvolemic) or hypervolemic (fluid overload) hyponatremia when other therapies have failed.

1. Calculations: Serum Osmolarity : http://www.medcalc.com/osmol.html

or [2x (Na + K)] + (BUN/2.8) + (glucose/18)

Note: Sodium replacement with too rapid correction (greater than 6 to 12 mEq/L per 24 hours) can result in osmotic demyelination (OD) of the brain.

79

2. Both Samsca & Vaprisol are hepatotoxic with extended use and should be avoided in patients (dehydrated) hypovolemic hyponatremia, in patients unable to sense or respond to thirst, or if patient is receiving any strong CYP3A4 inhibitors that would block the metabolism of the drug leading to toxic levels.

Strong CYP3A4 inhibitors:

Clarithromycin ‐ BiaxinTelithromycin ‐ KetekNefazodone ‐ Serzone (antidepressant)Itraconazole ‐ SporanoxKetoconazole ‐ NizoralAtazanavir ‐ ReytazzDarunavir ‐ PrezistaIndiavir ‐ ViraceptLopinavir ‐ RitonavirNelfinavir ‐ Viracept

80



3. Reference tables

Sodium replacement: size Sodium (mg) Sodium (mEq) mOsm/L CommentsAverage US intake ‐‐‐‐‐‐ 5,000 217 ‐‐‐‐‐‐ AHA ideal 1,500 mg/d Normal Saline (0.9%) 1000 ml 3,542 154 3083% Sodium Chloride 1000 ml 11,799 513 1027Sodium Chloride 1 Gm tablet 400 17 ‐‐‐‐‐‐Sodium Chloride teaspoon 2,300 100 ‐‐‐‐‐‐

Clinical Pearl – Sodium Paradox: Normal adult sodium requirement is 154 mEq or 1 liter of Normal Saline/day.

Hospitalized patients may receive 3 liters NS & 500 ml + as IVPB’s. Some patients this exceeds their physiological ability to excrete the excess sodium resulting in sodium accumulation with the following metabolic effects:

‐ Water retention resulting in a lower serum sodium (paradox)‐ A false increase in CrCl due to creatinine dilution‐ Increase in weight (each liter retained weighs 2.2 lbs)‐ I & O’s show increased fluid retention

The bottom line is if adding additional sodium and if sodium is going down ,volume restriction may help. If sodium and chloride are both low that generally indicates a need for more sodium chloride.

81

82



THIS BITES!RABIES POST-EXPOSURE PROPHYLAXIS (PEP)

Danielle Moore, PharmD, BCPSEmergency Medicine Clinical Pharmacist

Bayfront Health – St. Petersburg, FL

83

Learning Objective

■ At the conclusion of this presentation, participants will be able to appropriately identify exposed patients requiring rabies immune globulin and vaccination therapy.

84



Disclosure

■ There are no financial interests, arrangements or affiliations concerning material discussed in this presentation.

85

BACKGROUNDTransmission, Signs and Symptoms

86



What is Rabies?

■ Viral disease transmitted through saliva of a rabid mammal– Not transmitted through urine, feces, or blood

■ Infects the central nervous system resulting in death

87

Transmission

Infected Animal

Exposure

• Bite punctures muscle• Virus travels from site to brain• No symptoms at this time

Incubation Period

• May last for 3-12 weeks• Unable to transmit virus until saliva

infected• No symptoms at this time

Virus Reaches

Brain

• Severe inflammation occurs• Moves into salivary glands• Symptoms evident at 3 -5

days• Death within 7 days

88



Transmission

Infected Animal

Exposure

• Bite punctures muscle• Virus travels from site to brain

via nerves• No ill appearance at this time

Incubation Period

• Lack of symptoms• May last for 3-12 weeks• Unable to transmit virus until

saliva infected

Virus Reaches

Brain

• Severe inflammation occurs

• Moves into salivary glands

• Symptoms evident at 3 -5 days

• Death within 7 days

Transmission can occur 4 days prior to symptom

onset!

89

Signs and Symptoms

InitialNon-Specific

– Flu-like symptoms– Generalized

weakness– Discomfort– Headache – Bite-site irritation

Rapid Progression

– Anxiety– Confusion– Agitation – Delirium– Abnormal behavior– Hallucinations– Insomnia – Hydrophobia

90



PATIENT EVALUATIONRisk Assessment

91

Patient Interview

■ Who: Talk to the patient!– Get the real story by asking open-ended questions

■ What animal bit the patient?

■ When did the bite occur?

■ Where is the bite? Did it break the skin?

■ Has the patient been previously vaccinated against rabies?

92



Exposure Type

Provoked■ Threatening or injuring the animal

or the pet owner(s)

■ Handling or removing the animal’s food

■ Disturbing the animal while eating

■ Invading the animal’s living space

■ Restraining or handling sick or injured animals

■ Disturbing the animal’s offspring

■ Startling a sleeping animal

Unprovoked■ Behavior that cannot be explained

by any other means

93

Risk Assessment

High Risk Moderate Risk Low RiskUnprovoked bites, including scratches from:

Known, unvaccinated animals• Includes scratches

from self-grooming animals

Provoked exposures, including scratches from:

• Stray dog, cat, ferret • Rats, mice, hamsters

• Raccoon • Rabbits

• Bat • Armadillos

• Skunk • Opossums

• Coyote • Caged monkeys

• Fox • Immunized pets

• Bobcat • Farm animals

• Otter

94



Risk Assessment

High Risk Moderate Risk Low RiskUnprovoked bites, including scratches from:

Known, unvaccinated animals• Includes scratches

from self-grooming animals

Provoked exposures, including scratches from:

• Stray dog, cat, ferret • Rats, mice, hamsters

• Raccoon • Rabbits

• Bat • Armadillos

• Skunk • Opossums

• Coyote • Caged monkeys

• Fox • Immunized pets

• Bobcat • Farm animals

• Otter

High-risk bites necessitate PEP,

UNLESS animal is captured for 10-day observation

95

PEP TREATMENTDrug Products and Pharmacist’s Role

96



Available Drug Products

Rabies Vaccine

■ Single (1 mL) injection – RabAvert®

– Imovax®

■ Powder for reconstitution

■ IM only (deltoid)– Site distant from

immune globulin

■ 4 or 5 doses total

Immune Globulin

■ Intramuscular solution (150 units/mL)

– HyperRAB S/D®

– Imogam Rabies – HT®

– Kedrab®

■ Weight-based dosing

■ Infiltrated at bite site

– multiple injections

■ Once

97

Treatment – Unvaccinated Adult

98



Treatment – Previously Vaccinated

99

Treatment – Immunocompromised

100



Pharmacist’s Role■ Ask patient and/or provider key questions

■ Risk assessment and exposure type

■ Vaccination status– Tetanus current?

■ Appropriate rabies immune globulin dosing– Use total body weight

■ Nursing education on appropriate administration– Vaccine and immunoglobulin administered at distant sites

■ Patient education and follow-up vaccinations– Patient PEP packet for subsequent doses

101

Pharmacist’s Role■ Ask patient and/or provider key questions

■ Risk assessment and exposure type

■ Vaccination status– Tetanus current?

■ Appropriate rabies immune globulin dosing– Use total body weight

■ Nursing education for appropriate administration– Vaccine and immunoglobulin administered at distant sites

■ Patient education and follow-up vaccinations– Patient PEP packet for subsequent doses

When in doubt, contact the

rabies nurse at your local health

department!

102



Pharmacy Leadership■ Construct a policy to guide appropriate hospital

utilization of rabies vaccination and immune globulin

■ Provide resources– Post-Exposure Prophylaxis (PEP) decision tree

– Rabies immune globulin and vaccination dosing card

– Patient PEP packet

– Health department contact information

103

ReferencesRabies Prevention and Control in Florida (2014). Florida Department of Health, Division of Disease Control and Health Protection. Available at: http://www.floridahealth.gov/diseases-and-conditions/rabies/_documents/rabiesguide2014final2.pdf

Center for Disease Control and Prevention (2018). Rabies. Available at: https://www.cdc.gov/rabies/index.html

RabAvert. In: Micromedex. Greenwood Village (CO): Truven Health Analytics; 2018 [cited 2018 Oct 15]. Available from: www.micromedexsolutions.com. Subscription required to view.

Imogam Rabies-HT. In: Micromedex. Greenwood Village (CO): Truven Health Analytics; 2018 [cited 2018 Oct 15]. Available from: www.micromedexsolutions.com. Subscription required to view.

104



THIS BITES!RABIES POST-EXPOSURE PROPHYLAXIS (PEP)

Danielle Moore, PharmD, BCPSEmergency Medicine Clinical Pharmacist

Bayfront Health – St. Petersburg, FL

105

Keeping our patients safe: a review of recent ISMP safety alerts

Alexis Schrieber, Pharm.D.

Health Outcomes and Analytics Fellow

106



Objective

• Discuss ways to increase patient safety recognized by ISMP

107

Segregate, sequester, and differentiate all neuromuscular blocking agents (NMB) from other

medications wherever they are stored in the organization

Goal

• Prevent errors related to accidental administration of NMBs to patients

Recommendation

• Segregate NMBs from all other medications in the pharmacy by placing them in separate lidded containers

Recommendation

• Place auxiliary labels on all storage bins and/or ADC pockets and drawers that contain NMBs that state “WARNING: PARALYZING AGENT –CAUSES RESPIRATORY DEPRESSION – PATIENT MUST BE VENTILATED”

108



Ensure all appropriate antidotes, reversal agents, and rescue agents are readily available.

•Ensure best practice for administration of an antidote, reversal agent, or rescue agent

Goal

•Identify which antidotes, reversal agents, and rescue agents can be administered immediately to prevent patient harm

Recommendation•Develop directions for use/administration readily available in all clinical areas where such agents are used

Recommendation

109

Eliminate the prescribing of fentaNYL patches for opioid naïve patients or patients with acute pain

Goal

• Prevent death and serious harm from the inappropriate use of fentaNYLpatches to treat acute pain in opioid naïve patients

Recommendation

• Ensure there is a process to routinely document patient’s opioid status and type of pain

Recommendation

• Implement a process to verify and prevent orders for fentaNYLpatches in patients who are opioid naïve or with acute pain

110



Seek out and use information about medication safety risks and errors that have occurred outside of your facility and take action to prevent similar errors

Recommendations:

Determine appropriate actions to be taken to minimize the risks of

these types of errors

Document the decisions reached and gain approval for required

resources as necessary

Examples: CHS SBAR Events

Goal: Learn from errors that have occurred and use that information to identify potential risk points within your

organization

111

SBAR: Neulasta OnPro System & Imaging Safety

112



SBAR: Ketamine

113

SBAR: Look‐Alike Medication

114



ISMP Medication Safety Alert! Articles on the Legacy CHS Intranet Page

115

ISMP Medication Safety Alert! Articles on the CHS14 Intranet Page

116



117

Jerry H. Reed, MS, RPh, FASCP, FASHP

Vice President, Pharmacy Services

Community Health Systems

Update on Current Pharmacy Initiatives and Strategies

119

Non‐Formulary, Category B: Tolvaptan (Samsca) & Conivaptan (Vaprisol)

Required Criteria for use at GRMC

Note: complete all information – mandatory reporting – for all orders – approved or rejected

Pharmacist_________________________________________ Date ____________ Time ___________

Patient ___________________________________________________ FIN _________________

Physician __________________________________ Time rejected ___________ Time accepted ____________

Pharmacist’s Signature ____________________________________

(Signature verifies all 5 criteria or 4 and 1 NA have been met prior to approval)

Must meet appropriate criteria for Approval (Order may be held for 2 hours for review)

Yes/No 1. Documented euvolemic or hypervolemic (e.g. SIADH, Heart Failure or Cirrhosis) must meet both a & b.

a. Serum sodium < 124 mEq/L

b. Serum osmolality < 284 mOsm/Kg [ Calc _________ mOsm/L DM ___________ mOsm/Kg ]

Yes/No 2. Urine output > zero

Yes/No 3. Patient not receiving strong CYP3A4 inhibitors – list from package insert on back page

Yes/No 4. Failed fluid restriction (at least 2.4 liters in 48 hours)

Yes/No/NA 5. If Heart Failure: documented failure of diuretics (helpful: echocardiogram; ejection fraction;

BNP >500pg/ml) (>120 mg IV furosemide or equivalent daily x 2 days). If NA 5 is not necessary for approval.

If patient meets all 5 criteria or 4 and NA it may be approved by the pharmacist. The pharmacist must order or insure

the following orders are placed:

a. Serum Sodium q 4 – 6 hours for the 1st 24 hours then daily

b. Regular neurological status monitoring

c. Orders for Samsca or Vaprisol should not be continued past 96 hours.

d. Effective daily supply of sodium

If order is not approved by the pharmacist the physician should be offered an alternative:

Sodium Chloride 0.9% (NS) 50 to 125 ml/hr

100 ml bolus IVPB 3% sodium chloride over 30 minutes x 3 prn (prepared by pharmacy)

Loop Diuretics (furosemide 40 mg iv‐push every 12 hours prn)

1 gm sodium chloride tablets one q 6 hours PO

If prescriber insists on using Samsca anyway

o The request will be forwarded to the physician chairman of the P & T Committee, CEO and pharmacy

Director for collaboration

o A case report will be sent to QA/PI Committee and Potential Peer Review

Non‐formulary, Category B: Tolvaptan (Samsca PO) and Conivaptan (Vaprisol IV)

Background: Both are vasopressin (ADH) antagonist which promote excretion of free water without electrolytes which

is reserved for patients with normal fluid volume (euvolemic) or hypervolemic hyponatremia when other therapies have

failed.

Calculations:

1. Serum Osmolarity : http://www.medcalc.com/osmol.html or [2x (Na + K)] + (BUN/2.8) + (glucose/18)

Notes: Sodium replacement with too rapid correction (greater than 12 mEq/L per 24 hours) can result in osmotic

demyelination (OD) of the brain.

2. Both Samsca & Vaprisol are hepatotoxic with extended use and should be avoided in hypovolemic hyponatremia, in

patients unable to sense or respond appropriately to thirst, or if patient is receiving any strong CYP3A4 inhibitors.

Strong CYP3A4 inhibitors:

o Clarithromycin ‐ Biaxin

o Telithromycin ‐ Ketek

o Nefazodone ‐ Serzone (antidepressant)

o Itraconazole ‐ Sporanox

o Ketoconazole ‐ Nizoral

o Atazanavir ‐ Reytazz

o Darunavir ‐ Prezista

o Indiavir ‐ Viracept

o Lopinavir ‐ Ritonavir

o Nelfinavir ‐ Viracept

Sodium replacement: size Sodium (mg) Sodium (mEq) mOsm/L Comments

Average US intake ‐‐‐‐‐‐ 5,000 217 ‐‐‐‐‐‐ AHA ideal 1,500 mg/d

Normal Saline (0.9%) 1000 ml 3,542 154 308

3% Sodium Chloride 1000 ml 11,799 513 1027

Sodium Chloride 1 Gm tablet 400 17 ‐‐‐‐‐‐

Sodium Chloride teaspoon 2,300 100 ‐‐‐‐‐‐

Clinical Pearl – Sodium Paradox: Normal adult sodium requirement is 1 liter of Normal Saline/day. Hospitalized patients

may receive 3 liters NS & 500 ml+ NS as IVPB. Some patients this exceeds their physiological ability to excrete the

excess resulting in sodium accumulation with the following metabolic effects:

Water retention resulting in a lower serum sodium (paradox)

A false increase in CrCl due to creatinine dilution

Increase in weight

I & O’s show increased fluid retention

The bottom line is if adding additional sodium and if sodium is going down ,volume restriction may help. If sodium and

chloride are both low that generally indicates a need for more sodium chloride.

Page1�

September 2017 David Martin

(9 questions ) Pharmacist Competency for Non‐Formulary, Category B

Required Criteria for use of Samsca & Vaprisol

1. 1000 ml NS = Sodium Chloride 0.9% Molecular weight of sodium is 23

1 Liter contains – which answer is correct?:

a. Sodium 154 MEq or 3,542 mg Na

b. Has Osmolarity = 308 mOsm/L

c. 9 Gm sodium chloride

d. Average US oral daily intake of sodium is 5,000 mg or 217 mEq

e. all are correct

2. 1 gm sodium chloride tablet has 400 mg sodium or 17 mEq?

a. True

b. False

3. 100 ml of 3% sodium chloride injection contains:

a. 51.2 mEq of Na+

b. 3 Gm sodium chloride

c. 1.2 Gm Sodium (1,178 mg)

d. all are correct

4. Normal physiological osmolality is approximately 280 to 310 mOsmol/kg.

a. True

b. False

Page2�

5. Replacing sodium in hyponatremia the following can be used initially?

a. 1000 ml 0.9% sodium chloride injection

b. 100 ml 3% sodium chloride injection over 1 hour x 3 prn

c. 1 gm sodium chloride tablets q 4 to 6 hours

d. all the above

6. In replacing sodium with serum sodium increasing greater than 4 to 8 mEq in

24 hours increases the risk for ODS (osmotic demyelination syndrome of the

brain).

a. True

b. False

7. Both Samsca and Vaprisol are vasopressin (ADH) antagonists and are

hepatotoxic with extended use or if receiving any strong CYP3A4 inhibitors.

a. True

b. False

8. An osmometer measures:

a. mOsm/Kg (osmolality)

b. mOsm/L (Osmolarity)

c. both

9. If a patient meets criteria for Samsca, a source of sodium should also be

provided.

a. True

b. False

Documents

2018 Pharmacy Education Seriess3.proce.com/res/pdf/CHS2018Nov14Handout.pdf · 2018-11-06 · Raniah Aljadeed, PharmD Raniah Aljadeed, PharmD is an Emergency Pharmacy resident at Northwest