baxter iv safety - slides for handout€¦ · 4:50 p.m. faculty discussion and audience questions a...

www.ashpadvantage.com/ivsafety

Provided by ASHP

Supported by an educational grant from Baxter Healthcare Corporation

AGENDA

2:00 p.m. Introductions and Announcements

Kevin Hansen, Pharm.D., M.S., BCPS, Activity Chair

2:10 p.m. Current State of Drug Shortages

Erin R. Fox, Pharm.D., BCPS

2:50 p.m. Back to Best Practices: Patient Safety and IV Preparation and Administration

Kevin Hansen, Pharm.D., M.S., BCPS

3:30 p.m. Stretch Break/Light Refreshments

3:45 p.m. How To of Data Generation and Interpretation from Smart Infusion Devices

Richard J. Zink, M.B.A.

4:10 p.m. Using Smart Infusion Device Data to Facilitate Clinical Practice Changes

Todd A. Walroth, Pharm.D., BCPS, BCCCP

4:50 p.m. Faculty Discussion and Audience Questions

A Sunday Symposium conducted at the 2018 ASHP Midyear Cinical Meeting and Exhibition

Sunday, December 2, 2018 2:00 p.m.–5:00 p.m. Pacific Ballroom B Hilton Anaheim Anaheim, California


Assistant Director of Pharmacy ‐ Sterile Products, Special Formulations, Perioperative ServicesMoses H. Cone Memorial HospitalGreensboro, North Carolina

Erin R. Fox, Pharm.D., BCPS, FASHP

Senior Director, Drug Information and Support ServicesUniversity of Utah HealthSalt Lake City, Utah


Pharmacy Manager, Clinical ServicesClinical Pharmacy Specialist, Burn/Critical CareEskenazi HealthIndianapolis, Indiana

Richard J. Zink, MBA

Managing Director, REMEDI Operations Purdue University West Lafayette, Indiana

Provided by ASHPSupported by an educational grant from Baxter Healthcare Corporation

In accordance with ACCME and ACPE Standards for Commercial Support, ASHP policy requires that all faculty, planners, reviewers, staff, and others in a position to control the content of this presentation disclose their financial relationships. In this activity, only the individual below has disclosed a financial relationship. No other persons associated with this presentation have disclosed any relevant financial relationships.

• Kevin Hansen, Pharm.D., M.S., BCPS– Baxter, Acurity, and Pharmacy Purchasing & Products: Speakers

Bureau

Disclosures

Please be advised that this activity is being audio and/or video recorded for archival purposes and, in some cases,for repurposing of the content for enduring materials.

1

• Review recent trends in drug shortages, including best practices for mitigating them.

• Explain best practices in IV preparation and administration that promote the safety of patients and healthcare personnel.

• Illustrate how to generate and interpret the continuous data provided by smart infusion devices.

• Demonstrate how data generated from smart infusion devices can be used to drive clinical practice changes.

Objectives

Current State of Drug ShortagesErin R. Fox, Pharm.D., BCPS, FASHP

Senior Director, Drug Information and Support ServicesUniversity of Utah Health

Salt Lake City, Utah

© 2018 American Society of Health-System Pharmacists

2

Current Issues in IV Injectable Safety: Continuing the Conversation

• This presentation represents my own opinions. I am not speaking on behalf of the University of Utah

• University of Utah Drug Information Service has a contract with Vizient to provide drug shortage information. The total amount is < 5% of total budget.

Disclosure

• Review recent trends in drug shortages, including best practices for mitigating them.

Objective


3


• UUDIS provides drug shortage content to ASHP• Public website at www.ashp.org/shortages

– Partners since 2001– Voluntary reports submitted via web– UUDIS investigates / confirms shortages with

manufacturers– Frequent communication with FDA Drug Shortage Team

National Shortages and University of Utah Drug Information Service (UUDIS)

Differences Between Websites

ASHPwww.ashp.org/shortage • Drugs impacting clinical

practice (biologics, devices, dosage forms)

• How to access• Frequent updates• Alternatives, safety

FDAwww.fda.gov/cder

• Fewer products• No biologics or

devices• Information from

manufacturerhttps://www.ashp.org/Drug‐Shortages/Current‐Shortages/FDA‐and‐ASHP‐Drug‐Shortages


4


National Drug Shortages ‐ New Shortages by YearJanuary 2001 to September 30, 2018

Note: Each column represents the number of new shortages identified during that year.Data shared with permission from University of Utah Drug Information Service

12088 73 58 74 70

129149

166

211

267

204

140

185

142 154 146 139

0

50

100

150

200

250

300

01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18

National Drug Shortages ‐ New Shortages by Year January 2001 to September 30, 2018, % Injectable

Note: Each column represents the number of new shortages identified during that year.Green = injectable, yellow = non‐injectable

Data shared with permission from University of Utah Drug Information Service

0

50

100

150

200

250

300

01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18

7464 52

5664 60

61

46

46

63

57

5555 5045

45 63 58

56


5


National Drug Shortages – Active Shortages by Quarter

Note: Each point represents the number of active shortages at the end of each quarter.Data shared with permission from University of Utah Drug Information Service

299 294 288305 306 320

301265

219190 185 195 191

174 176 176 174 174 183202

238

050

100150200250300350

Q2‐

13Q

3‐13

Q4‐

13Q

1‐14

Q2‐

14Q

3‐14

Q4‐

14Q

1‐15

Q2‐

15Q

3‐15

Q4‐

15Q

1‐16

Q2‐

16Q

3‐16

Q4‐

16Q

1‐17

Q2‐

17Q

3‐17

Q4‐

17Q

1‐18

Q2‐

18

Active Shortages – Top 5 Drug Classes

Green = injectable, yellow = non‐injectableUsed with permission from University of Utah Drug Information Service

82

8 132

22

1610

2334

0

10

20

30

40

Antimicrobials Chemotherapy Cardiovascular CNS E‐Lytes,Nutrition, Fluids

Number of Active Shortages September 30, 2018


6


• The rate of new shortages is increasing and common shortages are severely impacting patient care and pharmacy operations

• Long‐term active and ongoing shortages are not resolving• The most basic products required for patient care are

short: bupivacaine, lidocaine, hydromorphone, morphine, fentanyl, ketamine, ondansetron, saline, and sterile water.

https://www.ashp.org/Drug‐Shortages/Shortage‐Resources/Roundtable‐Report http://www.nejm.org/doi/full/10.1056/NEJMp1800347

http://www.gao.gov/products/GAO‐16‐595

What do These Numbers Mean?

Why is this Happening?


7


• Profitability• Manufacturing fixes• Capacity – most factories running 24/7• Just in time production• Forecasting (contracts)• Aging facilities• Almost all shortages are due to some kind of quality problem at the manufacturing facility

Drug Manufacturing is a Business

• Contract manufacturing means we don’t always know who makes the product

• No requirement to disclose manufacturer (or location) in product label (or FDA form 483)

• No requirement to disclose source of active pharmaceutical ingredient (API)

• Why is the list of products made in a specific facility proprietary? No way to follow the quality data…

Lack of Transparency is a Problem


8


Transparency to Incentivize Quality?

Woodcock J, Wosinska M. Clin Pharmacol Ther. 2013;93:170‐66Fox ER, et al. Mayo Clinic Proc. 2014.89(3):361‐73

Quality

Not Transparent

No Incentive

• Single firm often produces 90% of total supply – common to have sole source of raw materials – Capacity is limited, “just in time,” no redundancy

• What limits competition and new entrants?– Low use products – Manufacturing expense / return on investment

• Are FDA recommendations / public health considered during mergers?

• Are essential medications critical infrastructure?

Fragile Supply Chain for Injectables


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A. Raw material supply shortagesB. CounterfeitingC. U.S. manufacturing moving overseasD. Quality and manufacturing problems

What are key causes of drug shortages?

Audience Poll

Best Practices to Minimize Impact


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• Shortages can impact every step of the medication‐use process

• Pharmacists manage drug shortages every day • Goal – minimize any impact on patient care

– Unintended consequences? Shortages may be invisible to many on the healthcare team

Role of the Pharmacist

• Electronic health record (EHR), automation, smart pumps– All designed to require the use of the same product all of the time

• Large amounts of product needed • Uncertainty about syringes / stability

– FDA says cannot store drug in syringes, yet syringe pumps are approved. 503b outsourcing facilities also store drugs in syringes

• Uncertainty about compounding regulations• Unapproved drugs (manage price hikes like shortages)• Regulatory burden of USP chapters <797>, <800>, Drug Supply Chain

Security Act (DSCSA)

Current Challenges


11


Fox ER, Am J Health‐Syst Pharm. 2018; 75:e593‐601.

Best Practice

• Team• Operational assessment• Therapeutic assessment• Impact analysis• Action plan

Disaster Planning Framework

• Mitigation• Preparedness• Response• Recovery

Hick JL. N Eng J Med. 2014; 370:1573‐1576.

N Eng J Med, March 19, 2014


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• IV fluids are both a supply and a treatment• Impact large numbers of inpatients and outpatients• Safety issues• Hospitals, infusion centers rely on specific volumes, solutions,

and concentrations• Changes to product concentrations may be high risk

– Stability issues– Administration errors– IV pump issues

Injectable Shortages – Unique Situation

• We can get some but….– It’s a different strength– It’s in different packaging – It’s a different size/volume– It’s from a different manufacturer– It’s imported– It’s not enough!

Most Common Situation


13


Complex Problem Solving

Patient Impact

Clinical

Impact

Clinical

ImpactOperations

Impact

Operations

Impact

Gather data, monitor the shortage?Make purchasing decisions?Maintain contact with local reps? Make storage, preparation, and dispensing change

decisions?Make rationing decisions? Change technology? Communicate information?

Team Checklist – Who Will…..


14


What if There’s not Enough?

Image from: Fink S. New York Times. January 29, 2016. Available at: https://www.nytimes.com/2016/01/29/us/drug‐shortages‐forcing‐hard‐decisions‐on‐rationing‐treatments.html.

• Don’t ration alone – develop a resource allocation committee

• Example tools available by drug class• Chemotherapy

Valgus J, J Oncol Pract. 2013;9:e21‐3Rosoff PM, Arch Intern Med. 2012;172:1494‐9.Jagsi R, Oncologist. 2014;19:186‐92.

• AntimicrobialsGriffith MM, Infect Control Hosp Epidemiol. 2012;33:745‐52

Rationing and Ethics


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• Make sure each member understands his or her role and shares information

• Situations can change quickly• Efficient management relies on good team

communication• Timeliness is essential• Informatics / EHR changes!!!

Shortage Management Team Communications

Fixing the Problem


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A. YesB. No

Are shortages FDA’s fault?Audience Polling

Are Shortages FDA’s Fault?

NO • FDA shortage team is

extremely collaborative• Violations must be

extreme for a shut‐down (safety first!)

• Agency works diligently to prevent shortages

YES • Enforcement actions can

cause shortages• Manufacturers may have

trouble complying with regulations

• Regulatory discretion = unintended consequences?


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• Prioritize medically necessary agents (determined on a case by case basis)

• Evaluate risks and benefits for patients• Offer assistance and advise, but up to the manufacturer to

fix• Success hinges on early notification• CANNOT require continued manufacturing or allocations – no matter how critical or life‐saving the product is

U.S. Food and Drug Administration. A Review of FDA's Approach to Medical Product Shortages. October 31, 2011. Available at: https://www.ipqpubs.com/wp‐

content/uploads/2012/02/FDA_drug_shortages_report.pdf

FDA’s Strategy

https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm418347.htm


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• Modernize drug quality oversight• Risk based inspection scheduling

– Predict drug shortages• Objective criteria including:

– Lot acceptance rate– Product quality complaint rate

• Star rating scale for manufacturers?

Quality Metrics Goals

• Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, advocates continuous manufacturing for:– Faster, improved quality, lower prices, fewer

shortages– Domestic plants – fully integrated from API to

finished product

Cox B. The Gold Sheet. July 29 2014: # 08140724006.

New Ideas for Manufacturing


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• Traditional manufacturing = batch process– At every step, product is assessed and collected– Off‐line labs test finished product– Days to weeks processing time

• Continuous manufacturing = monitoring throughout– Minutes to hours processing time

Continuous Manufacturing

• National Academies of Sciences Engineering Medicine Workshop Sept 5‐6, 2018 http://nationalacademies.org/hmd/Reports/2018/medical‐product‐shortages‐during‐disasters‐brief.aspx

• AHA / ASA / ASCO / ASHP / ISMP – Drug Shortages as a Matter of National Security – Sept 20, 2018

• FDA Listening Sessions – invitation only (October 1, 2018)• FDA Public Meeting – November 27, 2018

Action?


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• Pharmacists managing in crisis mode daily for basic injectable medications

• Continuing quality problems at manufacturing facilities

• No way to purchase based on quality• Devastating workload • Potential / actual patient harm

Key Points

Back to Best Practices: Patient Safety and IV Preparation and Administration


Assistant Director of PharmacyMoses H. Cone Memorial Hospital | Cone Health

Greensboro, North Carolina


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• Review recent trends in drug shortages, including best practices for mitigating them

• Explain best practices in IV preparation and administration that promote the safety of patients and healthcare personnel

Learning Objectives

Cone Health

• 6‐hospital health system• 1271 acute care beds • 6 cancer centers• 4 outpatient pharmacies• Stand alone emergency

center• Urgent care facilities• Specialty clinics

Photos used with permission from Cone Health

Moses H. Cone Memorial Hospital

Alamance Regional Medical Center

Wesley Long Hospital

Annie Penn Hospital

Women’s Hospital

Behavioral Health Hospital

236 beds

175 beds

110 beds

134 beds

80 Beds

536 beds


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Drug Shortage Impact on Compounding

X 12

Low High Error Potential

Ready‐to‐Administer (Premix)

Ready‐to‐Use Device

Low‐Risk Admixture

Medium‐Risk Admixture

IV Push

Graphics by K. Hansen

Drug Shortage Impact on Compounding

Patient Harm Potential Error Potential: Very High

High‐Risk Admixture

Graphics by K. Hansen


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History of IV Compounding & Administration

Myers CE. Am J Health Syst Pharm. 2013; 70:1414‐27.

1955: First availability of disposable plastic syringes

1950: Nurses added potassium chloride to LVIS 1963:

Hospital based pharmacy IV admixture services began

Mid‐1960’s: Use of laminar airflow hoods / cleanrooms began

1971: Collapsible plastic LVIS containers introduced

2001 ‐ Today: DRUG SHORTAGES!!

Concerning Trend: some IV compounding transferred back to nursing with adoption of IV Push

Concerning Trend: some IV compounding transferred back to nursing with adoption of IV Push

19401940

20182018Mid‐1970’s: Y‐site attached sterile plastic chambers devised to add drugs to LVIS; later evolved to secondary infusion containers (i.e. piggybacks)

1999: Some pharmacies using barrier isolators, excluding workers from compounding environment


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“Unfortunately, there are too many people in health care who feel that if it hasn’t happened to them, the adverse experiences of others do not apply.”

‐ Michael Cohen, MS, FASHP (ISMP)

3.375 g Doses~100/day = 337.5 g

Drug9 * 40.5 g vials = 364.5 g

Sterile Water9 * 152 mL = 1,368 mL

NS 50 mL Bags100 bags

Graphics: K. Hansen


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Dear Health Care Provider…

Graphics: K. HansenHospira (Letter to Health Care Providers) May 2018;

https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/ucm608319.pdf

One of the factors associated with an increased potential for error with IV

medications is the number of complex manipulations required when preparing

and administering these drugsHertig JB et al. J Patient Saf. 2018; 14:60‐5.

Proactive strategies

Vest TA, et al. PPPMag. 2018;15:2.

Drug Standard Shortage

Ceftriaxone 1 g Frozen IVPB(refrigerated)

1. RTU vial/bag (room temp)2. Manual Admix (refrigerated)

Norepinephrine Infusions 503B Premix (room temp)

1. Manual admixture D5W (refrigerated)

2. Manual admixture NS (refrigerated)


27


Assistant Director: Operations

Assistant Director: Clinical

System‐Wide Director:Operations

Site Pharmacy Managers

Ope

ratio

nal

PurchasingDRUG

SHORTAGETEAM

Materials Management Coordinator

Interdisciplinary involvement with specific active roles

on the team.

ADC: automated dispensing cabinetMEC: medical executive committeeGraphic: K. Hansen

A. DailyB. More than once per weekC. Once weeklyD. More than once per monthE. Monthly

How frequently does your drug shortage management team meet?

Audience Polling


28


Drug Shortage Tracker

Cone Health Drug Shortage Tracker. Image used with permission

Document operational and clinical changes with effective dates. Routinely review list for resolved

drug shortages so clinical/operational changes can be reverted to ‘normal state’

Drug Shortage Mitigation

• In most markets, shortages/surpluses are rare. Price changes keep quantity of products supply and demand in balance

• Elasticity– Measure of a variable’s sensitivity to

change in another variable (i.e.; price)– Acute care drug supply and demand are

INELASTIC• Opportunity

– Shift demand to different product– Preserve on‐hand supply

Department of Health and Human Services. 2011. Yeung K, et al. National Bureau of Economic Research. June 2016. URL: https://www.nber.org/papers/w22308

Mitigation: the action of reducing the severity, seriousness, or painfulness of somethingMitigation: the action of reducing the severity, seriousness, or painfulness of something

Pric

e

Quantity


29


Hierarchy of Controls

National Institute for Occupational Safety and Health. Hierarchy of controls. https://www.cdc.gov/niosh/topics/hierarchy/default.html

Hazardous DrugsElimination• Shift use to clinical alternativeSubstitution• Outsource to 503B• Alternative

• Package size• Manufacturer• Brand• Strength• Dosage form

Pharmacy Controls• Operational modifications• Insource compoundingAdministrative Controls• Dosing restrictions• Patient group restrictionsCommunication• Communicate shortage

Drug ShortagesMost time consuming

Least time consuming

Most effective

Least time consumingLeast

effective

STAT

“If everything is STAT, everything is routine…”


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Sterile Water for Injection Vial Shortage

Graphics: K. Hansen

Scenario: Sterile water for injection (SWFI) vials commonly used for drug reconstitution in the pharmacy and on nursing units are completely unavailable. Certain medications do not have any information available to safely dilute in alternative diluents. How do we continue to reconstitute these medications?

Alteplase 2 mg

?

Graphics: K. Hansen.Wjernikowski JT, et al. Lancet. 2000; 355:2221‐2.

Sterile Water for Injection Vial ShortageStrategy• To the maximal extent possible, preserve use of

SWFI 10 mL vials for nursing units only• Only use pharmacy bulk packages of SWFI in

pharmacy for drug reconstitution where appropriate

• Batch 2 mg alteplase vials and freeze syringes


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Sterile Water for Injection Bag Shortage

Graphic & photo: K Hansen, Illustration: Package Insert; B. Braun 2015.

Scenario: SWFI 1000 mL bags are completely unavailable. These are used routinely for sodium bicarbonate infusions. 2000 mL bags are available from two manufacturers, however they either do not have an injection port or the additive port is sealed by the manufacturer. How do we continue to provide sodium bicarbonate infusions to patients?

Compounding sodium bicarbonate infusions in 2000 mL SWFI bags using closed‐system transfer device (CSTD)

Photos & graphics: K. Hansen

Sodium Bicarbonate 300 mEq / 2000 mL Sterile Water for Injection

Strategy:Mitigating drug shortages may

require creative solutions using available tools

Closed‐System Transfer Device

Adapters


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Potassium Chloride Injection Shortage

Photos: K. Hansen


Photo: K. Hansen


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Photos: K. Hansen


Photos: K. Hansen


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Potassium Chloride Injection ShortagePharmacy Dispenses

~42 dispenses/day

~25 dispenses/day


Graphics: K. Hansen

Potassium Chloride

10mEq

10 mEq/50 mL

Premix

Potassium Chloride

30mEq

30 mEq/265 mL

Compounded Strategy:Compounded alternative that considers:• Ease of compounding• Frequency of compounding• Stability• Beyond‐use date• Pump settings• Clinical ordering• Preservation of stock• Minimization of fluid bag use• Turn‐around‐time

42 per day 14 per day


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Automated Compounder

Graphics and photo: K. Hansen

• Barcode verification• Volumetric pumping• Gravimetric verification• Batch mode

Sodium Phosphate Injection Shortage

Graphics: K. Hansen

Scenario: Sodium phosphate injection vials are completely unavailable and not expected to be in stock for months. Potassium phosphate is not a viable option for certain renal patients for phosphate replacement. How do we continue to provide intravenous phosphate to these patients?


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Sodium Phosphate Injection Shortage

Graphic: K. Hansen.https://www.nutritioncare.org/uploadedFiles/Documents/

Newsletter/Glycophos%20Dear%20Healthcare%20Professional%20letter%20Jan%202018.pdf

Sodium glycerophosphate• Phosphate: 1 mmol/mL• Sodium: 2 mmol/mL• Organic phosphate

MacKay M, et al. J Parenter Enteral Nutr 2015 Aug; 39(6):725‐8


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• Modify TPN ordering process from salt (i.e. sodium chloride) to ion (i.e., Na, Cl)

• Use salt priority list to determine proper product dispensed

• Can modify priority list as shortages change

• If sodium phosphate is needed in TPN, only use as a manual add (don’t add to automated compounder) to prevent waste.

TPN Clinical Ordering

Salt priority1. Sodium Chloride2. Sodium Acetate3. Potassium Chloride4. Potassium Acetate5. Potassium Phosphate6. Calcium Gluconate7. Magnesium Sulfate8. Sodium Glycerophosphate9. Sodium Phosphate

Strategy:Sodium phosphate prioritized last so potassium phosphate and sodium glycerophosphate will be maximized before any sodium phosphate will be needed.

Spinal Bupivacaine Injection Shortage

Graphic: K. Hansen

Scenario: An anesthesiologist calls your office and states that the spinal trays no longer contain ‘heavy bupivacaine’ and a dose is needed for a ‘patient on the table’. Spinal bupivacaine is currently on national backorder and is completely unavailable. How do we continue to provide spinal medications for patients?

Bupivacaine 0.75% inDextrose 8.25%


38


Memo, 2018; Hospira Inc. / Pfizer

Lesson:Know all sources of medication use/procurement throughout your practice setting

Spinal Anesthetics

Hadzic, A. Hadzic's Textbook of Regional Anesthesia and Acute Pain Management 2nd edition (2017) McGraw‐Hill Education

Onset(minutes)

Duration(minutes)

Commonly used:

Bupivacaine 0.75% 5 – 8 90 – 110

Lidocaine 5% 3 – 5 60 – 70

Less commonly used:

Tetracaine 0.5% 3 – 5 70 – 90

Mepivacaine 2% 2 – 4 140 – 160

Ropivacaine 0.75% 3 – 5 140 – 200

Levobupivacaine 0.5% 4 – 8 135 – 170

Chloroprocaine 3% 2 – 4 80 ‐ 120

Lesson:Understand and communicate key differences in alternative medications that are available

HyperbaricIso‐/ hypo‐baric


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Baricity

Uppal V, et al. Anesth Analg. Nov 2017. 125(5): 1627‐37.Graphics: K. Hansen

IsobaricSame density as CSF

Hypobaric Less dense than CSF

HyperbaricMore dense than CSF

Affects:• Diffusion pattern• Effectiveness• Spread (dermatome height

or block height)• Side‐effect profile of drug

“plain”

“heavy”

Baricity:The density of a substance in comparison with the density of human cerebrospinal fluid (CSF).

Distilled Water

• For planned cesarean delivery: a spinal anesthetic with hyperbaric bupivacaine 0.75% (1.6 – 2 mL) may be substituted with:

– Isobaric PF bupivacaine 0.5% at a dose between 2.5 – 2.6 mL (12 – 13 mg), if being administered with supplemental opioids. Higher doses of bupivacaine (up to 3 mL [15 mg]) may be required if supplemental opioids are not available.

• For epidural labor analgesia:– Ropivacaine may be used as an alternative to bupivacaine. Ropivacaine is 40% less

potent than bupivacaine.• If possible, request that all bupivacaine solutions be primarily made available

to OB anesthesia, and other divisions be mindful of shortage and use other local anesthetics whenever feasible.

URL: https://soap.org/2018‐bupivacaine‐shortage‐statement.pdf

Spinal Bupivacaine Injection ShortageSociety for Obstetric Anesthesia and Perinatology (SOAP) Advisory in Response to Shortages of Local Anesthetics in North America


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Drug Concentration Size Availability*

SpinalFormulationsBupivacaine / Dextrose

0.75%/8.25% 2 mL No

Lidocaine / Dextrose 5% /7.5% 2 mL NoPlainFormulations

Bupivacaine 0.25% 10 mL, 30 mL Yes0.5% 10 mL, 30 mL No

0.75% 10 mL Very LimitedRopivacaine 0.2% 10 mL, 20 mL Yes

0.5% 20 mL, 30 mL Yes0.75% 20 mL No

1% 10 mL, 20 mL YesLidocaine 1% 2 mL, 5 mL, 30

mLYes

2% 2 mL, 5 mL, 10 mL

Yes

Tetracaine 1% 2 mL YesChloroprocaine 1% 20 mL, 30 mL Very Limited

2% 20 mL, 30 mL Very Limited3% 20 mL No

Mepivacaine 1% 30 mL, 50 mL Yes1.5% 30 mL Yes2% 20 mL, 50 mL Yes

FormulationswithEpinephrineBupivacaine / Epinephrine

0.25% / 1:200K 10 mL, 30 mL No0.5% / 1:200K 10 mL, 30 mL No

Lidocaine / Epinephrine

1% / 1:100K 30 mL No1% / 1:200K 30 mL Yes

1.5% / 1:200K 5 mL Yes2% / 1:100K 10 mL Yes2% / 1:200K 10 mL, 20 mL Yes

Local Anesthetic Availability

… As of April 25 @ 10:32 AM EST

Lesson:Drug shortage availability may be extremely fluid; constant monitoring of availability and backorders is required

Single‐Dose (SDV) vs. Multiple‐Dose Vial (MDV)

Graphics: K.HansenHodgson PS, et al. Anesth Analg. 1999;88:797‐809.

Lesson:Avoid preservative containing injections in the central nervous system. Pay close attention to SDV vs. MDV when purchasing alternative products

Single‐doseSingle‐dose

Multiple‐doseMultiple‐dose

Neurotoxic preservatives:• Benzyl alcohol• Formaldehyde salts• Parabens• Phenol• Polyethylene glycol• Sodium sulfites

Administration of drugs containing preservatives (MDVs) has been linked to adverse effects when administered in the CNS.

Bupivacaine 0.5%

Bupivacaine 0.5%


41


ISMP Reported Errors during opioid shortages:• IV HYDROmorphone prescribed at the intended dose for

morphine and administered, resulting in death of two patients• HYDROmorphone 0.5 mg IV was supposed to be substituted

for morphine 4 mg IV, but HYDROmorphone 4 mg IV was given in error

• Administered 4 mg of morphine IV believing the vial held 2 mg• Administered 8 mg of morphine IV instead of 2 mg; only 8 mg

syringes available from manufacturer• Misfilled an automated dispensing cabinet pocket for 2 mg

morphine vials with 10 mg morphine vials• Wrong dose of morphine administered after 4 mg/mL prefilled

syringes were replaced with 5 mg/mL vials; bar‐coding system overridden due to the emergent switch in strengths, which had not yet been entered into the bar‐coding system

ISMP Medication Safety Alert Sept. 2010

Injectable Opioid Shortages Result in Patient Harm

Lesson:1.) Don’t underestimate importance of communication, education, trainingwhen using alternative projects

2.) Don’t bypass safety steps during drug shortage mitigation

Sound‐Alike, Look‐Alike Drugs

Graphics: K. Hansen

Morphine5 mg/mL

Hydromorphone 2 mg/mL

Morphine10 mg/mL

Naloxone0.4 mg/mL

Morphine50 mg/mL

Morphine 25 mg/mL

1 mg/mL2 mg/mL4 mg/mL

Hydromorphone Syringe Cartridges


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• Maximize use of oral therapy whenever possible• Non‐opioid pharmacologic alternatives• Nonpharmacologic alternatives• Reserve certain opioids for specific patient

populations (i.e., OR)• Use uniform opioid conversion tool across health

system ASHP. Injectable Opioid Shortage FAQ. 2018. Available at: https://www.ashp.org/Drug‐

Shortages/Shortage‐Resources/Injectable‐Opioid‐Shortages‐FAQ.

Injectable Opioids: Shortage Mitigation

• Determine which PCA/syringe sizes are compatible with your institution’s infusion pumps

• Research evidence‐based data to ensure appropriate stability, container, and storage conditions

• Take stock of what vial sizes and concentrations are available.

• Determine whether will prepare in batches or on demand• Consider plunger vs. plunger‐less PCA syringes and need

to stock appropriate materials

Compounding for Patient‐Controlled Analgesia (PCA)


43


• For State‐licensed Hospital Pharmacies, consider:– USP <797> Pharmaceutical Compounding – Sterile Preparations– USP <1079> Good Storage and Distribution Practices for Drug Products– USP <1136> Packaging Unit‐of‐Use– USP <1178> Good Repackaging Practices– USP <1191> Stability Considerations in Dispensing Practice– FDA Guidance Document (final): Repackaging of certain Human Drug Products by Pharmacies and

Outsourcing Facilities• Current interpretation: treat sterile repackaging as current USP <797> defined

‘medium‐risk’ compounding when assigning a beyond‐use date. Ensure stability testing has been performed for the exact storage container with no adverse findings (i.e., leaching of materials or precipitation)

– Room temperature: 30 hours– Refrigerated: 9 days– Frozen: 45 days– Note: in the absence of appropriate sterility testing

USP <797> 2008.Loyd A, Int J Pharm Compd. 2013. 17(1): 54‐61

Repackaging Sterile Products

How to determine Beyond‐Use Date

Considerations: Chemical degradation Physical compatibility Sterility Permeability of packaging Storage container Storage conditions Compounding risk‐level

Note: ‘Spiking’ a compounded sterile preparation bag for administration is the last aseptic manipulation. Administration is not in scope of the current USP <797>. Need to consider other organizations’ best practices (i.e., Infusion Nurses Society (INS)).

U.S. Pharmacopeial Convention. Pharmaceutical Compounding – Sterile Preparations. USP31–NF26 2nd Supplement, 2008.

Note: the shortest time should always be used

A beyond‐use date (BUD) identifies the time after which a compounded product should not be administered.


44


ISMP Guidelines; 2015. Available at: https://www.ismp.org/guidelines/iv‐push.

Adult IV Push MedicationsSafe Practice Guidelines1. Acquisition and distribution2. Aseptic technique3. Clinician preparation4. Labeling5. Clinician administration6. Drug information resources7. Competency assessment8. Error reporting

ISMP Guidelines for Safe Practice of Adult IV Push Medications

To the greatest extent possible, provide adult IV push medications in a ready‐to‐administer form

A. We have not added additional personnelB. Drug shortage coordinator or managerC. PharmacistsD. TechniciansE. Students/Interns

What additional personnel have you added due to drug shortages?

Audience Polling


45


Help!• Pharmacy students/interns can be deployed to help

meet the increased workload due to drug shortages• At our institution, 3 pharmacy interns were added

to the sterile compounding team• They perform sterile compound batch preparation

of shortage drugs• Focus efforts on non‐time critical activities to

balance availability with school schedule (i.e., evenings, weekends)

• Trained in LEAN methodologies throughout organization to minimize waste, and maximize production

• Excellent experience for students

INTERNS WANTED

• Key Takeaway #1: An effective drug shortage management team requires interprofessional involvement with clearly defined active roles for all members.

• Key Takeaway #2: While drug shortage communication is important, implementing workflow streamlined changes/alternatives is most effective.

• Key Takeaway #3: Each drug shortage for injectable products is unique and requires careful analysis to ensure safe, effective, and reasonable alternative practices

Key Takeaways


46


How To of Data Generation and Interpretation from Smart Infusion

Devices Richard A. Zink, M.B.A.

Managing Director, REMEDI OperationsRegenstrief Center for Healthcare Engineering

Purdue UniversityWest Lafayette, Indiana

• Discuss the importance of analyzing pump data• Identify types of infusion pump data• Illustrate examples of analyzing infusion pump

data• List recommended infusion pump analysis

reports

Section Objectives


47


• 2 million large volume pumps (LVPs) delivering 300 million infusions / year

• 90% of hospital patients receive infusions• Error prone• NPSG.06.01.01, Association for the Advancement of

Medical Instrumentation (AAMI)/FDA Infusion Device Summit, and other calls to action

• Patient safetyAAMI. Go with the Flow Webinar. https://vimeo.com/283045057. (accessed October 23, 2018).

Hedlund N et al. J Infus Nurs. 2017; 40: 206‐14.

Why Look at Smart Pump Data?

• Alerts: Captured when programming the pump • Compliance: Leveraging Dose Error Reduction System (DERS)?• Alarms: Air‐in‐line, patient side occlusion, etc.• Infusion details: Actual doses and concentrations used• Drug libraries: Concentrations, limits, care areas, etc.• Pump status: Are all pumps up‐to‐date?• Adverse Drug Events (ADEs): Have we caused harm using a

smart pump?

ISMP. Medication Safety Alert! July 12, 2018 Vol 23. Issue 14.

Which Data to Analyze?


48


A. Alert dataB. Compliance dataC. Drug library benchmarking dataD. Infusion details

Which type of smart infusion pump data is evaluated most frequently at your organization?

Audience Response Question

Data Sources and Analysis Tools

SystemDataSource

AnalysisTools

Pump vendorSigma Gateway (Baxter)DoseTrac (B. Braun)Knowledge Portal (BD)MedNet (ICU Medical)PharmGuard (Smiths Medical)

Electronic Health Record (EHR) Vendor ( w/ interoperability)

Custom reporting

Excel


49


How to draw Archie

Step 1: Draw some circles. Step 2: Draw the rest.

Images used with permission from R. Zink

• Looks at the alert details• Used to reinforce use of smart pump features • Identifies unexpected practice at the pump• Workflow based off most popular report

Workflow 1: Identify Problematic Alerts


50


Alert Data

• Times (the) Limit = Programmed valueLimit value

– Over the maximum limit > 1– Under the minimum limit < 1

• Example: Adult continuous dose fentaNYL– Drug library soft maximum = 250 mcg/h– Programmed value = 1000 mcg/h– Times Limit = 1000/250 = 4

“Times” Limit


51


0

2341

1

2042

117

606

74

705

2.4

176

14.57.5

1 2 3 4 5

Insulin

Dose Units/hour

Patients

Upper Hard Limit Edits‐Insulin December n=5 patients

Initial Final

Insulin Analysis

Image courtesy of Pharmfusion Consulting. Used with permission.


52


Example reports and Analysis2341

1

2341

1

0 4000 8000 12000 16000 20000

• Good catch: programmed value is more/less than X times the library limit and the resulting clinician response is to REPROGRAM

• Missed catch: programmed value is more/less than X times the library limit and the resulting clinician response is to OVERRIDE

• Other: Most often CANCEL

Good Catch / Missed Catch

790

1

2 200 400 600 800 1000 1200 1400ABOVE LIMIT


53


• Focus on highest (lowest) Times Limit alerts• Drugs – high alert medication (HAM) list and

reduce alert fatigue• Date/time ‐ Same patient and shift effects• Cancels – Exited the DERS to give the infusion?• Look at both over and under dosing “catches”

Examining the Alert Data Summary

A. The maximum duration of the infusionB. The ratio of the programmed pump value to the limit

defined in the smart pump drug libraryC. A hard limit defined in the smart pump drug library

In infusion pump data analysis, “times limit” refers to?

Outcome Question


54


Used to reinforce use of smart pump features and identify areas for improvement

Compliance* = # of infusions using DERS# of infusions

*As reported by the vendor

Workflow 2: Improving Compliance

View Compliance Trend

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

90%

85%

80%

75%

70%

65%

Com

plia

nce

Rate (%

)


55


View by Facility / Care Area

66%67%71%76%81%86%93%

59% AVG 70% AVG 74% AVG 74% AVG

75% AVG 81% AVG 83% AVG 84% AVG

100

50

0

100

50

0

Hospital Average

View by Care Area100

50

078% AVG

64%67%67%71%

Hospital Average

75%82%100%


56


View Volumes by Care AreaPROFILE TREND LAST MONTHNumber of Infusions

DERS Compliant Total

Monitor the Change

100%

95%

90%

85%

80%

75%

70%Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct

Com

plia

nce

Rate (%

)


57


• Used to address alert fatigue• Good place to start alert analysis• Initial focus on highest alerting drugs, then

specific medications (e.g. HAM list, chemo drugs, highest alerting in ICU, etc.)

Workflow 3: Reducing Alerts

View Alert Trend and Top 10

2.99k

2.79k

576

567

445

396

250

191

189

159

3.0k

2.5k

2.0k

1.5k

1.0k

0.5k

0


58


View Alert Trend by Care Area3.0k

2.5k

2.0k

1.5k

1.0k

0.5k

0

50%

12%

38%

Examine the Trend

43%

20%

16%

15%

92%90%77%

17%

99%

10.41k120

8.01k1.80k

470753618

111


59


Take a Deeper Look900

800

700

600

500

400

300

200

100

0

98%

2.72k66

Monitor the Change900

800

700

600

500

400

300

200

100

0


60


Suggested Reports

1. Alert details2. Compliance trend 3. Compliance by profile4. Compliance by volume5. Alert trend

• All reports shown in prior examples• See supplement for additional examples of suggested reports• In order of most frequently used*

*Data courtesy of the REMEDI infusion pump collaborative

6. Top 10 alerts7. Alerts by profile8. Alerts by infusion type9. Alerts by action taken10. Alerts by type

Report Usage

Data courtesy of the REMEDI infusion pump collaborative. Used with permission.

Category ReportFrequency

Notes

Alerts 67% Top 2 alert reports;‐ Alert details (40%)‐ Alert trend + Top 10 (28%)

Compliance 18% All reports ‐ graphs & tables

Drug library benchmarking

15% Comparison & analysis of concentrations, limits, etc.

100%


61


• Align pump library design to practice at the pump

• Examine your smart pump data monthly• Focus initial analysis on outliers, drugs/fluids

with high volume of alerts and compliance data• Drill down into the data for better understanding

Key Takeaways

Using Smart Infusion Device Data to Facilitate Clinical Practice Changes


Pharmacy Manager – Clinical ServicesClinical Pharmacy Specialist – Burn/Critical Care

Eskenazi HealthIndianapolis, Indiana


62


• Illustrate how to generate and interpret the continuous data provided by smart infusion devices.

• Demonstrate how data generated from smart infusion devices can be used to drive clinical practice changes.

Objectives (Re‐visited)

• Drug Error Reduction Software (DERS)• Drug library limits (min/max)

– Dose– Rate– Duration– Concentration– Patient weight

• Hard limit cannot override• Soft limit able to override• Alerts• Alarms

Shah PK. Pharmacotherapy. 2018;38:842‐50.

Smart Pump “Lingo”


63


• Searched PubMed, Scopus, and CINAHL for peer‐reviewed literature on managing smart pump alerts, alarms, and related fatigue

• 29 articles met inclusion criteria (1/1/04 – 8/31/17)• Two main categories of alerts:

– Mechanical alarms (occur more frequently)– Clinical alerts (several causes are actionable)

• Proposed strategies: – Development of interdisciplinary teams to oversee continuous quality

improvement (CQI) involving end users– Standardization of medication administration practices– Widening of drug limits when clinically appropriate– Maintaining up‐to‐date drug limit libraries– Interoperability


Strategies for Managing Smart Pump Alarm & Alert Fatigue

Continuous Quality Improvement Using Data Analysis

Breland BD. Am J Health‐Syst Pharm. 2010;67:1446‐55.

ObjectiveDescribe the use of CQI process in the implementation of smart pumps in a community teaching hospital

Summary

• 413‐bed, community teaching hospital• Post‐implementation CQI allowed refinement of clinically important safety limits• Minimization of inappropriate, meaningless soft limit alerts on select agents• Assigning individual clinical profiles to specific patient care areas allowed

customization of libraries and identification of specific compliance concerns• Seven library updates over the first 12 months• Compliance with safety software improved from 33% to 98% over a 3‐year period• 4‐6% of soft limit alerts prompted edits to drug library limits

Conclusion• Compliance rates improved over time• Education, auditing, and refinement of drug libraries led to improved compliance in

most clinical profiles


64


Quality‐Improvement Analytics & Metrics

Skledar SJ. Am J Health‐Syst Pharm. 2013;70:680‐6.

ObjectiveDescribe implementation of a smart pump CQI program across a large health‐system, with an emphasis on key metrics for outcomes analysis and program refinement

Summary

• 6000 pumps across 14 inpatient facilities • Centralized team responsible for retrieval and interpretation of smart pump data • Metrics:

• Compliance with programmed limits• Top 20 Drugs involved in alerts• Drugs with alert‐override rates > 90%• Alerts by infusion type• Nurse response to alerts• Alert rate per drug library update• Four system‐wide updates over 18 months

Conclusion

• Reduction in “nuisance alerts” by about 10%• Targeted interventions to reduce adverse drug events (ADEs), rapid‐infusion errors,

and workarounds• Nurses reprogrammed or canceled infusion average of 400 times/month• Smart pump CQI program effective tool for enhancing IV medication safety

• Total number of alerts or alarms• Number of clinically irrelevant alerts• Alerts overridden• Low drug library limits compliance• Nurse perceptions through survey• Time to override• Workarounds


Additional Metrics for Smart Pump Alert and Alarm Fatigue


65


• Minimum

• Maximum

• Standard concentrations

• Wildcards

• Adults vs. Pediatrics

Types of Clinical Alerts

• Deviation from standards

• Bolus doses

• Concentration limits

• Soft min

• Soft max

• Hard max

Dosing Duration

Rate Concentration

General Problem Solving

Question Example

Correct profile? Med/Surg vs. ICUCorrect medication name? Piperacillin vs. piperacillin/tazobactam

Intermittent vs. continuous dosing? Nafcillin, cefepime, etc.Bolus vs. continuous dosing? Pantoprazole

Correct therapy? Argatroban, alteplase, etc.Correct weight? Kg vs. lbs

Correct dosing units? Gram vs. mg


66


ICPS Smart Pump Alert Fatigue Workgroup

TJC NPSG 06.01.01: “Improve the safety of clinical alarm systems”

Dulling effect causes end users to ignore potential safety issues

False Alert = “Clinically Insignificant Alert”

Alert Fatigue

Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900. Joint Commission. https://www.jointcommission.org/assets/1/6/2018_HAP_NPSG_goals_final.pdf (accessed 2018 Nov 9).

GOAL: Shared vision and challenge of making Indianapolis the safest city for healthcare

Used with permission from ICPS (J. Fuller).

Indianapolis Coalition for Patient Safety, Inc. (ICPS)

Community Health Network

Eskenazi HealthFranciscan Health

Indianapolis

Indiana University Health

Richard L. RoudebushVA Medical Center

St. Vincent


67


• 315 bed academic medical center• Safety‐net health system in Indianapolis, IN• Level I Trauma Center (>100,000 ED visits/year)• 21,680 inpatient admissions• 217,924 Primary Care visits• 100,644 Specialty Care visits• 603,340 Mental Health visits

Image used with permission from Eskenazi Health

Eskenazi Health

ProblemVariability within and lack of consistent process for managing smart pump drug libraries across institutions

GoalTo minimize the number of clinically insignificant alerts presented to end users through development of a Consensus Statement

Methods• Interdisciplinary group (i.e., pharmacists, nurses, engineers)• Lean/Six Sigma methodologies to achieve process standardization• Prioritized current state needs and barriers

Results

• ICPS Consensus Statement• Crosswalk of terminology between manufacturers• Clinical Advisories guidelines• Policy template• Culture of shared learning

ICPS Smart Pump Workgroup

Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.


68


Targets for Optimization


Drug Limits & Libraries

Types of Alerts

PoliciesSafety Items

Learning Activity: Think/Pair/Share

• Consider current state practices at your institution for reviewing alerts and managing drug libraries

• Collaborate with a partner• Share processes for

reviewing each of these targeted areas

• Discuss gaps and areas for improvement

Drug Limits & Libraries

Types of Alerts

PoliciesSafety Items


69


• Standardized, city‐wide process for managing smart pump drug libraries

• Clinical advisories • Visual cue project/data set updates• Overfill/flush bag project • Top ten lists• Pump integration subgroup • Interoperability metrics and reports

ICPS Smart Pump Safety Workgroup

• Identify best practices to establish specific, actionable safety items related to smart pump drug library optimization

Project Objective


70



• Multi‐site project

• Interdisciplinary approach

• All six ICPS health‐systems represented

• June 15, 2018

ICPS Final Consensus Statement – Drug Dosing Libraries Review Process


Individuals Involved

Timeline/Schedule

Content for Review

Approval Process

Communication & Education

Follow‐up

1.

2.

3.

4.

5.

6.


71


Recommendation 1: Individuals involved in the review process


Pharmacy NursingMedication

Safety

Recommendation 2: Timeline/schedule for review


• All profiles reviewed at least once per yearAnnuallyAnnually• Individual/grouped profiles facility‐specific• Not every profile reviewed each quarterQuarterlyQuarterly• Additional reviews as needed• Follow‐up on medication incidents, etc.MonthlyMonthly


72


•• Top Ten Drugs• Formulary updates

• Bedside audits• Compliance with dosing limits

• Compliance per profile

At aminimum

Recommendation 3:Content for review


••Good‐catches•Patient outliers•ISMP Action Alerts

•Medication errors

When available

Recommendation 4: Approval process for recommended changes


Interdisciplinary Committee Approval

Medication SafetyPatient Safety

Smart Pump Committee


73


Safety Huddle

One Page Sheet

Audits EMS

Supply ChainEmails

CPOE Alerts

Central Supply

Pump Safety Day

BioMed

Morning ReportFacilities

Recommendation 5: Communication & Education


Safety Huddle

One Page Sheet

Audits EMS

Supply ChainEmails

CPOE Alerts

Central Supply

Pump Safety Day

BioMed





74


Safety Huddle

One Page Sheet

Audits EMS

Supply ChainEmails

CPOE Alerts

Central Supply

Pump Safety Day

BioMed




Recommendation 6: Follow‐up and continued review


Previous Top Ten Drugs

Changes from previous quarter

Assess for improvements


75


Alert Review: Lorazepam

Override (n = 203)Reprogram (n = 14)Cancel (n = 7)Other (n = 8)

Alert Review: Lorazepam


76


Total Lorazepam Alerts (Critical Care/Emergency Department)

232

60

50

100

150

200

250

3Q2011 1Q2012

Zero alerts remaining after two revisions



77


50% decrease in alerts per device per month over 5 years

7.2

3.6






78


CLINICAL ADVISORIES

Rules for Creating Advisories1. Operations focused (not clinically focused)2. Descriptive – make sure it includes quantitative or objective values (actual cutoffs,

values, etc.) not open for interpretation3. Must be actionable at the time of programming the pump, or focus on special

techniques4. Contain a specific strategy to alert a different user (volume to be infused for

amiodarone)5. In general, monitoring, vitals, etc. should be general knowledge for the drug and

should not be included as an advisory6. Remove any lab related alerts7. Error prevention, ISMP recommendations, or response to multiple drug

errors/sentinel event reviews may warrant a specific advisory8. If independent nursing double‐check required, indicate that upon programming9. Any new advisories should be approved through Med Safety, Smart Pump

Committee, or equivalent


79


VISUAL CUE PROJECT/DATA SET UPDATES

Drug Library Wireless Update Delays

DeLaurentis P. Am J Health Syst Pharm. 2018;75:1140‐4.

PurposeTo estimate the prevalence and severity of delays in wireless updates of smart pump drug libraries across a large group of US hospitals

Methods

• Retrospective study using REMEDI database• 49 hospitals, 12 health‐systems, across 5 states• Update delay defined as interval from time of drug library versions

replaced to time of last infusion alert triggered by previous version during the study

Results• 11 of 12 health‐systems were found to have drug library update delays• Update delay medians ranged from 22 to 192 days • Overall delay min and max durations were 0 and 661 days

ConclusionSubstantial delays in completion of wireless updates of smart pump drug libraries were common across a large group of hospitals over various sizes


80


• Two‐phase study:– End user perceptions– Implementing visual cues for pump updates

• Project Partners:– ICPS – RCHE/Purdue University – Eskenazi Health

Visual Cues Project

Preliminary Data

Used with permission from P. DeLaurentis.

Study Unit shows ~30%

higher update rate

than Control Unit


81


FLUSH BAG PROJECT

• Goal to minimize amount of drug remaining in the bag at the end of the infusion due to: – Manufacturer overfill– Pharmacy overfill/drug additives

• Developed standardized approach to addressing the infusion of intermittent IV medications in adults– ICPS Consensus Statement for Flushing Intermittent IV Medications – Policy template– Standardized education/competencies

• ↓ workarounds required = ↓ clinically insignificant alerts

Flush Bag Project


82


Protocol Recommendations

• Ordering instructions• Size of bag• Product• Administration• Volume to be infused• Rate of infusion• Out of scope meds

Used with permission from ICPS (J. Fuller).





83


TOP TEN LISTS

NS‐normal saline

• One site reviewed workflow, drug library limits, screen shots of electronic health record (EHR), and alerts fired

• Group discussion, comments, and questions• Focus points for follow‐up:

– Workflow– Bolus doses– Therapies

Deeper Dive Into Insulin


84


• When (and why) in practice do you allow insulin bolus doses for patients (excluding hyperkalemia)?

• How are insulin bolus doses ordered (e.g., within an order set, part of a protocol, one time doses when needed)?

• Does every site have a bolus option built in the pump? If so, how much?

• Is this limited to certain therapies and/or areas? • Are nurses bolus dosing from the bag/pump? • Are nurses using 999 mL/hr to bolus insulin?• Do you have a hard max for your insulin infusion rates?

Insulin Follow‐up Questions

• BB/CCB order set recommend including bolus doses• All other current state bolus dose orders are one time orders

(no bolus option in the Hyperglycemia or DKA order sets)• Change bolus admin rate soft min to 1 unit/min and soft max

to 20 unit/min• Consider having a hard max on bolus doses• Recommend therapies for high dose insulin usage (i.e., BB/CCB

overdose) • Add hard max infusion rate for Toxicology therapies

BB‐beta blocker; CCB‐calcium channel blocker

Insulin Recommendations


85


• Most alerts are primary intermittent duration• Well known issue (overfill/volume in bag)• No changes needed in general at this time• Recommended to review ICPS IV Flush Bag

Protocol

Deeper Dive into Vancomycin

Upcoming Reviews of Top Ten Drugs

• Oxytocin• Heparin• Rituximab• Propofol• Potassium• Piperacillin/

tazobactam

NS‐normal saline


86





• Four ICPS health‐systems represented• Pump integration projects – sharing & brainstorming• Alert standardization• Gap analysis of reporting:

– EHR– Vendors – Online database

• Crosswalk of appropriate reports based on need and discipline• Goal is to identify standard metrics and associated benchmarks

Pump Integration & Interoperability


87


• Implementing and optimizing interoperability • Standardized approach to managing occlusion and air‐in‐

line alarms• Evaluation of specific, replicable alert and alarm reduction

strategies • Aligning and leveraging reports (EHR vs. vendors vs. online

databases)• Greater emphasis on benchmarking quantitative metrics

Future Directions

• Key Takeaway #1– A standardized, consensus‐driven process should be used for smart

pump drug library data review and optimization • Key Takeaway #2

– The ICPS approach can help other health‐systems to reduce the number of clinically insignificant alerts presented to end users

• Key Takeaway #3– Interdisciplinary idea‐sharing can yield additional projects aimed at

reducing alert fatigue and opportunities to leverage smart pump data

Key Takeaways


88


• Implement a standardized process for drug library data review and optimization

• Use an interdisciplinary approach to reviewing smart pump data• Review Top Ten Drug lists on a regular basis to identify

opportunities for improvement• Consider addressing additional projects that can result in

decreased smart pump alerts (e.g., PCA, wireless drug library updates lag times, flush bag/overfill standardization, interoperability, identifying and reporting key metrics, etc.)

Which of these practice changes will you consider making?

Audience Reflection

ASHP CE Processing Deadline: January 31 elearning.ashp.org Code: ____________ Complete evaluation Additional instructions in

handout

• Archive of today’s symposium will be released March 2018

Thank You for Joining Us

www.ashpadvantagemedia.com/ivsafety


89


Top 10 Reports Used in Smart Pump Data Analysis

Presented as a supplement to the ASHP Advantage Pre-Meeting Symposium, Current Issues in I.V. Injectable Safety: Continuing the Conversation, Sunday, December 2, 2018.

Rich Zink, MBA Managing Director, REMEDI Operations

Regenstrief Center for Healthcare Engineering Purdue University

West Lafayette, Indiana This document contains sample reports used in the analysis of smart infusion pump data. These reports are limited to alert data (warnings generated while the clinician is programming the pump) and compliance data (measurement of the frequency of use of smart pump features). Reports and analyses of other smart infusion pump data (e.g., operational alarms, pump update status, variation in concentrations and doses, etc.) are out of scope for this document.

Current Issues in Injectable Safety: Continuing the Conversation


90

Report title: Alert Details

Critical question answered: What are the details for each alert?

Suggested attributes: Drug, Profile, Therapy, Dataset, Facility, Hard/Soft, Type, Above/Below Limit, Drug Limit, Programmed Value, Amount Exceeded, Units,% Exceeded, Times Limit, Field Limit Type, Date, Device ID, Action Taken, Drug Amount, Diluent Vol, Concentration, Infusion Rate, Volume to be infused (VTBI), Infusion Duration.

Comment(s):

• If desired, export from vendor software to Excel and leverage pivot tables

• Sorting by Times Limit is often helpful

Example report(s):

Current Issues in IV Injectable Safety: Continuing the Conversatin


92

Report title: Compliance Trend

Critical question answered: How well are we using our smart infusion pump features?

Suggested attribute: Compliance percentage (as defined by the vendor)

Comment(s):

• Line graphs or histograms make it easier to detect trends

Example report(s):



93

Report title: Compliance by Profile

Critical question answered: What percentage of infusions use the smart pump features and what percentage do not use the features (often called BASIC)?

Suggested attributes: Compliance percentage (as defined by the vendor)

Comment(s):

• Blue bar indicates infusion percentage using smart pump features

Example report(s):



94

Report title: Compliance by Number of Infusions

Critical question answered: Number of compliant and non-compliant (BASIC) infusions delivered by unit.

Suggested attributes: Compliance percentage (as defined by the vendor)

Comment(s):

• Compliments percentage by profile reports

Example report(s):



95

Report title: Alert trends (by month)

Critical question answered by the report: What is the total volume of alerts and how are they trending?

Comment(s):


Example report(s):



96

Report title: Top 10 Alerts

Critical question answered: Which drugs or fluids get the most alerts?

Suggested attributes: Number of alerts by drug

Comment(s):

• The top 10 list provides a list of candidate drugs or fluids for addressing alertfatigue

Example report(s):



97

Report title: Alerts by Profile

Critical question answered: What is the profile breakdown of all alerts by month?

Suggested attributes: Number of alerts by profile

Comment(s):


• Identifies which care areas have more issues with alerts

Example report(s):



98

Report title: Alerts by Infusion Type

Critical question answered: Which methods of infusing medications are generating the most alerts?

Suggested attributes: Number of alerts by infusion type

Comment(s):

• Vendor terminology differs in naming the infusion types

Example report(s):



99

Report title: Alerts by Type

Critical question answered: What type of alerts are generated when programming the pump?

Suggested attributes: Number of alerts by type

Comment(s):

• Different vendors have different types of programming alerts

Example report(s):



100

Report title: Alerts by Action Taken

Critical question answered: How do clinicians respond to alerts?

Suggested attributes: Number of alerts

Comment(s):

• Can be run on all drugs, high alert medications, or selected drugs

Example report(s):



101

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email address and password that you used when registering for the Midyear.The system validates your meeting registration to grant you access to claim credit.

2. Click on Process CE for the Midyear Clinical Meeting and Exhibition.3. Enter the Attendance Codes that were announced during the sessions and click Submit.4. Click Claim for any session.5. Complete the Evaluation.6. Once all requirements are complete, click Claim Credit for the appropriate profession.

Pharmacists and Pharmacy Technicians: Be prepared to provide your NABP eProfile ID, birthmonth and date (required in order for ASHP to submit your credits to CPE Monitor).Others (International, students, etc.). Select ASHP Statement of Completion.

All continuing pharmacy education credits must be claimed within 60 days of the live session you attend. To be sure your CE is accepted inside of ACPE's 60-day

window, plan to process your CE before January 31, 2019.

Exhibitors Exhibitors should complete the steps below first. If you encounter any issues with the process, please stop by the Meeting Info Desk onsite or email [email protected].

1. Log in to www.ashp.org/ExhibitorCE with your ASHP username and password.2. Click on the Get Started button.3. Select the 2018 Midyear Clinical Meeting and Exhibition from the dropdown menu.4. Select your Exhibiting Company from the list of exhibitors. Your screen will change and you will

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About the Faculty

www.ashpadvantagemedia.com/ivsafety

Accreditation

The American Society of Health-System Pharmacists (ASHP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

n ACPE #0204-0000-18-445-L05-P

n 3.0 contact hours I Application-based

n Qualifies for Patient Safety CE

Kevin Hansen, Pharm.D., M.S., BCPS, Activity ChairAssistant Director of Pharmacy Sterile Products, Special Formulations, Perioperative ServicesMoses H. Cone Memorial Hospital Greensboro, North Carolina

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Richard J. Zink, MBAManaging Director, REMEDI Operations Purdue University West Lafayette, Indiana

Erin Fox, Pharm.D., BCPS, FASHPSenior Director, Drug Information Service University of Utah Health Salt Lake City, Utah

Todd Walroth, Pharm.D., BCPS, BCCCPPharmacy Manager, Clinical ServicesClinical Pharmacy Specialist Burn/Critical Care, Eskenazi Health Indianapolis, Indiana