FOCUS - ashpadvantagemedia.comashpadvantagemedia.com/safety/files/FocusSafety_Handout._Web.pdf · Focus on Safety: Compliance Pearls and Priority Issues to Address Learning Objectives

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Supported by an educational grant from Baxter Healthcare Corporation

Compliance Pearls and Priority Issues to Address

F O C U SO N S A F E T Y

AGENDA2:00 p.m. Introductions and Announcements

Deborah Pasko, Pharm.D., M.H.A., Moderator

2:10 p.m. ASHP and Safety: The Standardize 4 Safety Initiative

Rhonda Liberto, Pharm.D., CPPS

2:50 p.m. Transitioning to ENFit Devices: An Update

Sarah Bledsoe, Pharm.D., CPHIMS

3:10 p.m. Break

3:25 p.m. Ready or Not: Safety First-USP Chapter <800> Is Going to Be Enforceable

Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP

4:00 p.m. Real World Experience with USP Chapters <797> and <800>: Compliance Pearls

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

4:40 p.m. Roundtable Discussion

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

A Sunday Symposium conducted at the 52nd ASHP Midyear Cinical Meeting and Exhibition

Sunday, December 3, 2017 2:00 p.m. – 5:00 p.m. Orlando, Florida

Focus on Safety: Compliance Pearls and Priority Issues to Address

Deborah Pasko, Pharm.D., M.H.A., Moderator





Provided by ASHPSupported by an educational grant from Baxter Healthcare Corporation

3 hrs

Disclosure

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 relevant financial relationships. In this activity, only the individual/s below has disclosed a relevant financial relationship. No other persons associated with this presentation have disclosed any relevant financial relationships.• Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP

– Cardinal Health: employee– CriticalPoint, LLC: consultant, speaker

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


Learning Objectives

• Explain the Standardize 4 Safety Initiative and its anticipated potential to improve patient safety.

• Review the current status of the transition to ENFit devices.• Review key components of USP Chapter <800> that

pharmacies will need to employ to be fully in compliance with the standards.

• Illustrate using real‐world experiences, how to overcome common challenges and barriers to complying with USP Chapters <797> and <800>.

Standardize 4 Safety: Standardized Concentrations for Intravenous (IV) and Oral Liquids


System Medication Safety Officer

Ochsner Health System

New Orleans, Louisiana

Copyright © 2017 American Society of Health-System Pharmacists, Inc. All rights reserved.

2


Disclaimer

• The opinions expressed are those of myself and not Ochsner Health System.

Section Objectives

• Describe the national Standardize 4 Safety Initiative• Discuss opportunities related to medication safety

associated with this initiative• Describe the utilization of data to drive

implementation of these standards• Identify three process improvement opportunities

around medication safety


3


How

• FDA awarded ASHP a 3‐year contract to develop and implement national standardized concentrations for IV and oral liquid medications

• First national, interprofessional effort to standardize medication concentrations to reduce errors and improve transitions of care

Who – Organizations

• Pediatric Pharmacy Association• Institute for Safe Medication Practices (ISMP)• Association for the Advancement of Medical

Instrumentation (AAMI)• Other regional and local healthcare organizations


4


Who – Expert Panel

• Interprofessional panel of physicians, nurses, and pharmacists

• Disciplines – critical care, anesthesia, operating room (OR) & procedural areas, emergency department (ED), medication safety, clinical engineering, infusion safety, informatics

• Society recommendations ‐ American Society of Anesthesiologists (ASA), Society of Critical Care Medicine (SCCM), American Association of Critical‐Care Nurses (AACN)

Why

• Resulted from the identification of barriers & recommendations from an IV Summit in 2008 around IV medication errors and preventing harm– Lack of standardization and good process design– Lack of shared safety accountability among

disciplines– High volume, high‐demand environments where

priorities may sacrifice safety


5


Why

• Resulted from the identification of barriers & recommendations from an IV Summit in 2008 around IV medication errors and preventing harm– National standards for IV medications

• Concentrations, dosing units, & dosing– Partner with FDA and pharmaceutical industry, to

help alleviate shortage & compounding quality issues

Why

• End goals– Zero harm around IV medications

•Integrated electronic medical records (EMRs), smart infusion devices & barcode scanning, with standard information and medication safety initiatives

•Interoperability – ‘Perfect’, but… don’t wait


6


What

Standardized concentrations and dosing units for IV continuous medications – adults and pediatrics

Standardized concentrations and doses for compounded oral liquids (just released in July)

• Concentrations for intermittent medications• Concentrations for patient‐controlled analgesia

(PCA) & epidurals

What – Phases of the Infusion Standards

I. Adult (>50 kg) continuous infusionsa. Released in October 2016

II. Pediatric (<50 kg) continuous infusionsIII. IV intermittentIV. PCA/epidural medications


7


How – Methodology

• State standards – ME, IN, NC, San Diego• Utah DI• Panel lists• 503B lists• Random offers of list• Public comment

How – Excluded

• Extracorporeal modalities (e.g., continuous renal replacement therapy [CRRT])

• Non‐treatment modalities (e.g., heparin for line patency)

• Chemotherapy medications• Diluents (e.g., Dextrose, NS) & final volumes• Library & profile nomenclature


8


How – Guiding Principles

• Patients first• Commercial products• One concentration, but may need 2‐3 for tenuous

patients• Fluid status• Operational issues related compounding

– Op. mize vials, ↓ $, and ↓ waste

Why? We’ve already done this…Who Cares?

?


9


Who Cares

Over a five year period, more than 56,000 adverse events and 710 deaths associated with infusion devices were reported to FDA—more than any other medical technology

www.aami.org/thefoundation/content.aspx?ItemNumber=1523&navItemNumber=672 (accessed 17 Mar 2016).

Who Cares

Medication errors that took place in a hospital added about $8,750 (2006 dollars) to the cost of the hospital stay…

~ $490,000,000

Institute of Medicine Report Brief. Advising the nation, Improving health. Preventing medication errors. National Academy of Science 2007. p. 22.


10


Who Cares

Why? We’ve already done this…Who Cares

Medication Safety Principles ‐ Integration & Maintenance

Infusion Therapy Safety Principles ‐ Systems Approach

Growth ‐ System vs. Hospital; Practice areas


11


Why/ ‘Where’ Do Medication Events Happen?

Adapted from Dr. James Reason, Managing the Risks of Organizational Accidents, 1997.

Significantevents orinjuries

Order entry

Administration

Dispensing

Monitoring

“Safety is a Dynamic Non‐Event”

Medication Safety Principles

• Standard concentrations– Validated purchasing/ordering & utilization– EMR and smart infusion device libraries match– Clinical practice match above– Implemented and maintained as planned


12


Medication Safety Principles

• TALLman lettering• Compounding practices

– Shortage maintenance• Storing practices

– In the pharmacy, automated dispensing cabinets (ADCs), central supply

Infusion Therapy Safety Principles

• Integrating the infusion device, EMR, and practice to minimize variation, reduce alert fatigue and mitigate infusion medication errors


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• Robust library– Concentrations vs. wild cards/toggles– Match EMR– Indications of use– Appropriateness of use– Areas of use– Advisories/alerts

Infusion Therapy Safety PrinciplesRobust library • Dose modes

– Heparin – unit/hr to units/kg/hr, therapies– Vasopressin dose modes – prescribing, device, MAR (unit/hr vs.

units/min)– Nitroglycerin – mcg/kg/min to mcg/min

• Hard/soft minimum/maximums/defaults– Dosing– Concentrations– Durations– Bolus functionality

• Other med safety principles incorporatedMAR=medication administration record


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• Systems Approach – standardization vs. variability– One library

•Safer intrasystem/hospital patient transfers•Spreadability•Already one EMR

Standard ConcentrationMeasurement Opportunities

• Policies & Procedures• EMR • Gap analysis of standard concentrations, dose

modes– Assessment of cost effective and safe time for

conversion, if necessary


15


Drug ASHP

common table

and table 5 if

different

First

concentration

80%

Second

concentration

Policy

attachment

033 ‐ Aug

2017

Policy M02

010917 Dosing units

X ‐ conc, dose

mode match(yes

or no) ‐ many wild

cards‐ Why?

Y ‐ conc, dose

mode match(yes

or no) ‐ many wild

cards‐ why?

Alteplase 1 mg/mL 1mg/mLno @ 0.01 mg/mL mg/hour

no‐wild card & arterial, yes

yes, yes; but arterial

Amiodarone 1.5‐bolus 1.8‐inf 1.5 mg/mL 3.6 mg/mL

1.5 & 1.8 mg/mL yes & no mg/min no 1.8mg,yes; no 1.8mg,yes;

Argatroban 1 mg/mL 1mg/mL yes mcg/kg/min yes, yes yes,yesBumetanide 0.25 mg/mL 0.025mg/mL no mg/hour not in library not in library

Alaris or other infusion device libraryPolicyASHP recommendations

implementation i

Dashboard Examples

Dashboard Examples

Medication Safety Data Source X Y Z System

Goal 2017

ISMP Natl Best practices 2016‐2017 (%)

High Alert Medications (HAMs) best

practices implemented (%) *assessment not fully completed 80% 77% 77% 68* 75.00%

Standardize Adult Chemo Preparation ‐

from May 2016 document 19% 19% 19% 19% 40.00%Pump DERS use 2017 (%) 97.66 97.19 98.34 93.53 95.00Med Barcode Scanning 2017 (%) 98.87 98.75 99.59 98.51 98.50%ASHP standard concentrations ‐ library &

EMR 75% 69% 69% 66% 75%


16


Standard Concentration Measurement Opportunities

• Utilization data from EMR for standard concentrations and nonstandard concentrations

• Utilization of medication drug error reduction software (DERS)– Implementation of system goals regarding – Robust library allows confidence in the data

DERS vs. Basic Infusion?

84.42% 90.05% 82.69%

62.26% 68.91%81.98%

0.00%

15.58% 9.95% 17.31%

37.74% 31.09%18.02%

100.00%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Type of Infusion

Care Area Profile


17



• Practice assessmentsProfile Alert Value Drug NamProgrammed Dose Rate.Med Surg 11.0029 unit/kg/h heparin, . 11.0029 unit/kg/h 11.3 mL/h.Med Surg 11.0029 unit/kg/h heparin, . 11.0029 unit/kg/h 11.3 mL/h.Stepdown 11.2113 unit/kg/h heparin, . 11.2113 unit/kg/h 8.7 mL/h.Critical Care Adult 11 unit/kg/h heparin, . 11 unit/kg/h 8.635 mL/h.Critical Care Adult 11 unit/kg/h heparin, . 11 unit/kg/h 8.635 mL/h.Critical Care Adult 11 unit/kg/h heparin, . 11 unit/kg/h 8.635 mL/h


• Practice assessments– Physician ordering method?

• units/hr vs. units/kg/hr


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Infrastructure• Developing a process to evaluate medication utilization outside of DERS

&/or predetermined dose limits– Clinical leadership group

• Nursing and pharmacy• Physicians adhoc – mostly exposure of practice variance with

protocol/order set involvement• Focused working groups

– Medication safety committee• Multidisciplinary• All practice areas • All hospitals (if system)

– Pharmacy and Therapeutics (P&T) Committee

Indirect Opportunities

• Habit– Use needs to be part of the process, not an

addition– HRO Journey

• Streamlining infusion error or event investigations

HRO=high reliability organization


19


Direct Opportunities

• Error mitigation around standard concentrations– Less transcription errors– Pick risk

• Both pump programming choices• EMR lists

– Calculation errors• Shortage management

?Which of these medication safety opportunities will you assess for?

a. Standard concentration utilizationb. TALLman lettering c. Pump dataset/library review


20


?What are some direct opportunities?

a. Transcription riskb. Pick riskc. Calculation errors

?What are some indirect opportunities?

a. Practice alignmentb. HROc. Multidisciplinary involvement


21


Key Takeaways• Key Takeaway #1

– When was your last standard concentration policy assessment?

• Key Takeaway #2– Are you as standardized and systemized as you think?

• Practice• Technology – EMR or smart pump infusion devices

• Key Takeaway #3– Integration can happen now, don’t wait

Selected Resources

• AAMI Foundation Quick Guides– Optimizing Patient Outcomes: Questions Senior Leaders

should ask about Infusion Therapy Safety. 2016.– Improving the Safe Use of Multiple IV Infusions. 2016.

• Infusing Patients Safely – Priority Issues from AAMI/FDA Infusion Device Summit

• ASHP Standards 4 Safety Document– www.ashp.org/Pharmacy‐Practice/Standardize‐4‐Safety‐

Initiative.


22


Transitioning to ENFit Devices: An Update


Assistant Director

Children’s Mercy

Kansas City, Missouri

Together We’re Working Wonders and Transforming Outcomes

* All numbers Fiscal 2015


23


Disclaimer

• This presentation represents my views and not the views of my institution.

GEDSA=Global Enteral Device Supplier Association

Visit: www.stayconnected.orgto learn more


24


Section Objectives

• Describe a successful interprofessional team process, for mobilization of an organizational wide product and practice conversion

• Discuss lessons learned while implementing the enteral tubing standardization (ENFit)

• Provide updates on the enteral tubing standardization (ENFit)

?Where are you at with ENFit?

a. Already liveb. Going live in the next 6 monthsc. Going live in the next yeard. What is this ENFit thing?


25


Data from GEDSA.

ENFit Hospital Survey Results

Yes28%No

72%

Has your facility transitioned to ENFit?

0%

10%

20%

30%

40%

50%

60%Obstacles from Transitioning

*Adoption rates are only rough estimates based on feedback from manufacturers, GPOs, hospitals and other stakeholders throughout the world Data from GEDSA.

ENFit Global Adoption StatusGlobal Adoption is Well Underway with Europe Leading*

North America• < 30%• Primary concern

over adequate supply

• Law (AB444) in CA effective July 1, 2016

South America• < 5%• Transition

anticipated to commence in 2018

Europe• > 50% depending on

market • UK, Netherlands,

France, Italy, Belgium > 90% transitioned

ANZ• > 50%

adoption

Asia• <5% adoption• Transition anticipated

to commence in ‘18• 2019 for China & Japan

Eastern Europe, Middle East & Africa• < 30%


26


Identify Stakeholders Processes

Plan Products

Risk Assessments and Develop New Practices

Act Education Implementation

Who do you need on your team?

Patients and

Families

Home Care /

Discharge Planners

NursingPharmacyMedical staff

Quality / Safety

Supply Chain


27


GEDSA Stay Connected. http://stayconnected.org/enfit‐transition‐checklists/

Transition Checklists

Practices

• Failure modes effect analysis (FMEA)– Supplies– Procedures– Risk points– Data collection– Implementing strategy

11 22

3344

55


28


ENFit Pharmacy Products

• Bottle adapters– ENFit compatible– Alternative ‐ Medication straw

• Syringe caps– Tamper evident

Nurses Preparing Medications


29


Oral Administration

Transition Pieces

• Necessary for early days in implementation


30


Transition Adapters Are Problematic

• Nearly half are having problems with transition adapters at least once a week. This is consistent with what we hear and experience as users.

Q: If you are using ENFittransition adapters, how often have you had problems with them? (n=291)

Data from GEDSA in partnership with Feeding Tube Awareness Foundation.

14%

26%

11%

7%

22%

19%

Never

Hardly ever

Every few…

Once a…

Few…

Every day

New Alerts on Transition Pieces

• Compatible with non‐ENFit devices• Not a long term solution

ISMP. http://www.ismp.org/newsletters/acutecare/issues/20170921.pdf. Vol 22. Issue 19. September 2017.


31


ENFit to ENFit is More Favorable

• More than two‐thirds report a favorable experience with their ENFit to ENFitconnections. 59% of these responses are from outside the U.S. where the transition is more complete.

Q: If you are using ENFit to ENFitconnections, what has your experience been? (n=106)


4%

13%

14%

25%

44%

N/A

VeryNegative

SomewhatNegative

SomewhatPositive

VeryPositive

Taking Care of Patients at Home

• Syringes and tubes require a PRESCRIPTION

• Working with homecare companies and retail pharmacies to meet patient needs

• Creating patient and family brochure focused on medication issues


32


Most Patients at Home Familiar with ENFit

• Educating about ENFit has been challenging with the delays in the transition. More than three‐quarters are at least somewhat familiar with ENFit.

Q: How familiar are you with ENFit? (n=534)


Very familiar43%

Somewhat familiar 35%

Not very familiar11%

Haven't heard of it

11%

Solving the ENFit Tip Syringe Access Issues

Rx to Over the Counter (OTC)• Requires FDA clearance for each companies set of devices• Establish Instructions for Use (IFU) for average user• Usability studies demonstrating IFU can be followed without supervision of

a physician

Timing (anticipate 6‐12 months)• Usability testing• FDA review and manufacturer 510k pre‐market clearance (TBD)• Manufacturing and product availability (check with supplier rep)


33


ENFit® Interactive Demonstration Station

• Available to Order• Send email to:

– [email protected]– Contact Information– Ship to address– Order Quantity

• Dimensions:– Closed: 18.5” x 6” x 13”– Set Up: 31” x 23” x 13”

Conclusion

• Tubing misconnections are a real risk in healthcare, we must do our part to prevent these

• An interdisciplinary team is needed for a successful implementation

• Risk analysis and work flow planning can play a vital role in facilitating system level changes that impact patient care

• Education is key – healthcare staff, patients, and families!


34


Break

Ready or Not: Safety First‐USP Chapter <800> is Going to Be

Enforceable


Director, Accreditation and Medication Safety

Cardinal Health Innovative Delivery Solutions

Wilkes‐Barre, Pennsylvania


35


Related affiliations

• Member of the USP Compounding Expert Committee but this talk is not affiliated with or endorsed by USP

• Author of The Chapter <800> Answer Book, and Assuring Continuous Compliance with Joint Commission Standards, 8th Edition

?What is your biggest angst point concerning USP Chapter <800>?

a. My facility still isn’t compliantb. We are struggling with doing an Assessment of Riskc. I don’t know what solutions to use to

decontaminate the hazardous drug aread. Something else


36


Timeline for USP Chapter <800>

19851985 20042004 20082008

Timeline for USP Chapter <800>

2014

March & December

2014

March & December

20162016 20192019


37


Safety First

• Designed to protect– Patients– Personnel– Environment

Key Elements

• Required– Assessment of risk– Facilities– Work practices

• Recommended– Wipe sampling– Medical surveillance


38


Assessment of Risk

• Establish your list of hazardous drugs (HD) to the dosage form level

• Determine if some can be safely handled without meeting all the requirements of <800>

www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous‐drugs‐list_2016‐161.pdf

NIOSH=National Institute for Occupational Safety and Health

Decision Tree

Must follow all elements of <800>

Can be considered for your Assessment of Risk

Active Pharmaceutical Ingredient of any drug on the NIOSH list

Table 1 antineoplastics that only need to be counted or packaged

Table 1 antineoplastics, except those that only need to be counted orpackaged

Table 2 non‐antineoplastics

Drugs and/or dosage forms that are not entity‐exempt

Table 3 reproductive‐only hazards


39


Entity Exemptions

• If you entity‐exempt any dosage forms of any drugs on the HD list, you must identify and implement alternative containment strategies and/or work practices

?Can RNs mix fosphenytoin for stat doses?

a. Yes, since it’s not hazardousb. Yes, if it’s described in your Assessment of Riskc. No, it must be mixed in pharmacyd. No, it must be mixed in a BSC or CACI

BSC=biological safety cabinet , CACI= compounding aseptic containment isolator


40


Containment Engineering Controls

• Primary (C‐PEC)– For nonsterile: Containment Ventilated Enclosure– For sterile: Biological Safety Cabinet or Containment

Aseptic Compounding Isolator• Secondary (C‐SEC)

– The room in which the PEC is located• Supplemental

– Closed system transfer device (CSTD)

C‐PEC= containment primary engineering controlsC‐SEC= containment secondary engineering controls

Facilities

• Unless entity‐exempt, all hazardous drugs must be stored and compounded in a room with air pressure that is negative relative to that in the adjacent space, vented to the outside, and has an appropriate number of air changes per hour.


41


?What is the pressure of your chemo buffer room?

a. Positiveb. More than 0.01” negativec. Between 0.01” and 0.03” negatived. I have no idea

Minimum Room Requirements in <800>

Room with fixed walls that is separate from non‐hazardous

storage and compounding

Vented outside the building

Negative pressure of 0.01 to 0.03” to adjacent space

At least 12 air changes per hourC

ontains hazard

Removes h

azard


42


Facilities for Hazardous DrugsConfiguration Allowed in <797> Allowed in <800>

Cleanroom suite (ISO positive anteroom opening into ISO 7 negative buffer room)

Yes, with negative pressure of at least 0.01” negative to adjacent space

Yes, with pressure range of 0.01 to 0.03” negative to adjacent space

Low Use Exemption Yes No

Containment SegregatedCompounding Area

Not addressed in <797> Yes, if externally vented and pressure range of 0.01 to 0.03” negative to adjacent space, but limited to 12 hour beyond use date (BUD)

CACI in negative room with 12 air changes per hour

Yes, optimally vented

BSC outside of cleanroom No

Work Practices

• Personal Protective Equipment (PPE)• Use of CSTDs• Decontamination of surfaces


43


Personal Protective Equipment

• Garb protects the preparation• PPE protects you wear it!• Gloves that meet ASTM standard D6978• Gowns that are designed for chemo• Other garb as required

CSTDs

• Recommended for compounding• Required for administration when the dosage form

allows


44


?What do you use to remove hazardous drugs from your chemo hood?

a. Sterile alcoholb. Germicidal detergentc. Bleachd. Commercial product designed for use with

hazardous drugs

Decontaminating Surfaces

Decontaminate

with an oxidizer

Decontaminate

with an oxidizer

Clean

with a germicidal detergent

Clean

with a germicidal detergent

Disinfect

with sterile isopropyl alcohol

Disinfect

with sterile isopropyl alcohol


45


Key Takeaways

• Complete your Assessment of Risk– Determine which dosage forms of specific hazardous

drugs can be handled with alternative protection• Understand your certification report

– What components pass, fail, or need attention• Review and revise work practice procedures

– PPE, decontamination, and others

Selected Resources

• USP <800> Hazardous Drugs – Handling in Healthcare Settings, www.usp.org, document and FAQs

• Perform an Assessment of Risk to Comply with USP <800>, K Douglass and P Kienle, www.pppmag.com, March 2017


46


Resources for USP Chapter <800>

ASHPwww.ashp.org

The Joint Commissionwww.hazmedsafety.com

Real World Experience withUSP Chapters <797> and <800>:

Compliance Pearls


Assistant Director of Pharmacy

Moses H. Cone Memorial Hospital | Cone Health

Greensboro, North Carolina


47


Disclaimer

• The views and opinions expressed are my own and not of my institution.

Abbreviations

• CSP: compounded sterile product• CAI: compounding aseptic

isolator• ED: emergency department• HEPA: high efficiency particulate

air• HVAC: heating, ventilation, and

air conditioning• ICRA: infection control risk

assessment

• ISO: International Organization for Standardization

• LET: lidocaine‐epinephrine‐tetracaine

• PEC: primary engineering control• POC: point‐of‐care• USP: United States Pharmacopeia• WFMS: workflow management

system


48


Cone Health

• 6 hospital integrated health‐system

• 1271 acute care beds • 6 cancer centers• 4 outpatient pharmacies• Stand alone emergency center• Urgent care facilities• Specialty clinics

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

Moses H. Cone Memorial Hospital

• 536 licensed beds (private, not‐for‐profit)• Level 2 trauma center; 81 ED Beds• Annual ED visits: 110,000• Annual drug dispenses: 3.1 Million

• Annual CSP dispenses: 352,000


49


Section Objectives• Objective: Illustrate using real‐world experiences, how to overcome

common challenges and barriers to complying with USP Chapters <797> and <800>– Outline alternative compounding strategies to mitigate drug shortages

and provide safe compounding practices– Explain the importance of maintaining a cleanroom environment– Identify non‐compliant cleanroom practices requiring remediation– List mechanisms to operationalize handling hazardous drug strategies

• Intent: Provide anecdotal successes/challenges in my journey to achieve pharmaceutical compounding compliance

• Goal: Apply pearls to practice setting to incrementally improve compounding compliance

Overview

• Compounding strategies• Compounding personnel & environment• Cleanroom construction planning• Operationalizing hazardous drug handling


50


?Does your compounding strategy contain contingency plans for natural disasters?

a. Yes, we have contingency plansb. We have begun planningc. We are not preparedd. Help!

Preparing for Natural Disasters

• Puerto Rico is the fifth largest area in the world for pharmaceutical manufacturing

• 162nd largest country in the world (195 total)

• Puerto Rico produces sixteen of the top twenty selling drugs in the mainland United States

• Exports– Pharmaceuticals: 72% ($14.9 B)– Medical Supplies: 8% ($1.6 B)

U.S. Bureau of Labor Statistics; 2014.

Puerto Rico Pharmaceutical Manufacturing Companies

AbbottAmgenAstraZenecaBaxterBDBiovailBristol Myers SquibbCardinal Health

Eli LillyGlaxoSmithKlineIvaxJohnson & JohnsonMerck Sharp & DohmeMylanNovartisPatheon

PfizerProcter & GambleSchering PloughWarner ChilcottWatsonWyeth

Others…

Puerto Rico


51


Compounding Strategy

• Choose a compounding strategy that fits your resources, environment, staffing, etc.

• Consider mission/vision of compounding division• Have contingency planning for each strategy

Risk: regulatory, patient safety | Effort: Training, Multidisciplinary

Compounding StrategyStrategy Cost Risk Effort

Admixing CSPs at bedside $ *** ++

IV Push $ *** ++

Admixing in cleanroom $$ ** +++

POC devices $ * +

Premix/Frozen $$$ * +

Outsource to 503B $$$$ * +

USP 797 medium‐risk batching $$ *** ++

USP 797 high‐risk compounding $$ **** +++

Extended BUD $$$$ **** ++++

Drug specific considerations: cardioplegia, total parenteral nutrition (TPN)


52


Top 10 CSP Dispenses at Moses Cone

Dates: 07.01.2016 – 06.30.2017

Dispense Code Medication Name Total Avg/day % OF TOTALIVPB Premix PIPERACILLIN‐TAZOBACTAM 3.375 G IVPB 28,996 80 8.23%Syringe INSULIN GLARGINE 100 UNIT/ML SC SOLN 23,144 64 6.57%IVPB Premix VANCOMYCIN HCL IN DEXTROSE 1‐5 GM/200ML‐% IV SOLN 13,046 36 3.70%Syringe INSULIN DETEMIR 100 UNIT/ML SC SOLN 9,044 25 2.57%IVPB VANCOMYCIN HCL IN DEXTROSE 750‐5 MG/150ML‐% IV SOLN 8,055 23 2.29%IVPB CEFTRIAXONE 1 GM IVPB MIXTURE 7,849 22 2.23%IVPB CEFAZOLIN SODIUM‐DEXTROSE 2‐3 GM‐% IV SOLR 7,809 22 2.22%Continuous Mixture PRISMASATE (DIALYSATE) 7,747 22 2.20%IVPB Premix CEFAZOLIN SODIUM 1‐5 GM‐% IV SOLN 7,479 21 2.12%IVPB LEVETIRACETAM IVPB 7,167 20 2.03%

Unavailability of premix/POC CSPs in top 10 could lead to more than 200 additional manually admixed compounds per day.• Staffing? Facility?• Safe?• Availability of fluids?

Adult IV Push Medications

ISMP Guidelines; 2015.

Safe Practice Guidelines1. Acquisition and distribution2. Aseptic technique3. Clinician preparation4. Labeling5. Clinician administration6. Drug information resources7. Competency assessment8. Error reporting ISMP Safe Practice Guidelines

for Adult IV Push Medications

May help to minimize fluid use for IVPB CSPs


53


Risk of CSPs

• Significant patient harm

• Compounding errors• Employee exposure• Employee safety• Regulatory compliance

Lynn E et al. Am J Health‐Syst Pharm. 1997; 54:904‐12.

Study: Accuracy of compounding IV admixtures• Admixed

• 9% error (2% clinically significant)

• ‘ready‐to‐use’• 0.3% error

(0% clinically significant)

Reduce Risk of CSPs

• Reduce/eliminate high‐risk compounding

• Maximize use of premix/frozen• Outsource high‐volume CSPs to 503B

facilities• Utilize workflow management

systems• Utilize automation/robotics• Robust training with continual

evaluation• Quality assurance program• Error documentation and tracking

Low High

RISK

• Compounding errors• Sterility• Stability• Regulatory requirements


54


Identification of High‐Risk Compounding

• Recognize true high‐risk compounding practices

• Interview staff regarding practices

• Action plan to address with monitoring

• If wanting to pursue, ensure adequate staff training, quality assurance, monitoring, and notify Board of Pharmacy

High‐Risk Compounding Criteria:• Non‐sterile ingredients• Exposure to worse than ISO Class 5

air for more than 1‐hour• Personnel improperly garbed

Examples:• Aluminum bladder irrigation• Formalin bladder irrigation• Phenol injections• LET solution being used as injection

The ‘invisible errors’“If you can’t measure it, you can’t manage it” – Peter Drucker

Lynn E et al. Am J Health‐Syst Pharm. 1997; 54:904‐12.

Error Potential Strategies

Wrong drug/solution BarcodingWrong dose Gravimetric verificationWrong volume Volumetric photo verificationOmission Barcoding, gravimetric, volumetricWrong preparation technique Training and continual evaluation, videoWrong form of delivery LabelingWrong reconstitution process Double check prior to admixing


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Compounding Compendium

• Develop robust, evidence‐based compounding compendium

• Standardization, safety, waste reduction• Consider separate sections for: adult, pediatric, factor

products, chemotherapy, non‐sterile compounds, etc.• Ensure access to adequate resources to provide

evidence based stability data (i.e. Trissel, King’s Guide, etc.)

LABEL INFORMATION STORAGEDO NOT

TUBE

PROTECT

FROM

LIGHT

FILTER REFERENCESLAST

UPDATED

• Do not tube• Do not s hake• The Orencia powder in each via l mus t be reconsti tuted us ing only the s i l i cone‐free disposable s yringe provided with each via l

RT X

1.2 micron

low protein binding

fi l ter

PI (BMS)5/2/2017 LPJ

INFUSION

SOLUTION

DILUTION

SPECIFICS

STANDARD

CONCENTRATION

BEYOND

USE DATEINFUSION ADMINISTRATION

NS Total Volume

100 mL max 10 mg/mL24 hours RT

30 minutes

Infus e with a 0.2 to 1.2 micron low protein‐binding fi l ter

DRUG COST VIAL SIZE DILUENT CONCENTRATIONBEYOND

USE DATEPREPARATION

Abatacept

(Orencia )$$$$

250 mg (SDV)

10 mL SWFI

25 mg/mLUs e

immediately

• Fol low ins tructions in package ins ert careful ly• Use only s uppl ied s i l i cone‐free syringe• Make bag tota l volume

Vial/ Preparation

Admixture/ Administration

Label/Storage/ Transport


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Practice Considerations

• Perform GAP analysis to determine areas of compliance gaps

• Utilize state board of pharmacy inspection reports to aide in review (if available)

• Prioritize gaps based on risks to the patient• Be in continual state of readiness

?How compliant are your compounding practices according to current USP <797>?

a. Exceeds standards, focus on best practicesb. Compliant with standardsc. Mostly compliant, few gapsd. Significant compliance gapse. Not required to follow standards in my state


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Am I required to follow USP <797>?Centers for Medicare and Medicaid Services (CMS)

Conditions of participation (CoP) require compliance:• Hospital Pharmaceutical Services (42 CFR 482.25)• Nursing Services (42 CRF 482.23)

The Joint Commission (TJC) • Pharmacist surveyors have undergone specific training in evaluating USP compliance

• Offers ‘Medication Compounding Certification Program’

Food and Drug Administration (FDA)

• FDA has the authority to inspect pharmacies and enforce USP standards in the interest of public health

National Association of Boards of Pharmacy (NABP)

• Shown support of USP <797> by incorporating the requirements into its Model State Pharmacy Act and Model Rules

Accepted standards of practice, guidelines, etc.

• American Society of Health‐System Pharmacy (ASHP)• Institute for Safe Medication Practices (ISMP)• Infusion Nurses Society (INS)• National Coordinating Council for Medication Error Reporting

and Prevention

Cleansing and Garbing

• Compliant practices start with proper anteroom setup

• Include physical line of demarcation

• Strict compliance

ANTEROOM, ISO 7, (+) Pressure

Door

Bench Bench

Supplies

Supplies

“Dirty Side”

“Clean Side”

Sink Sink

Garb and Rack

Door D

oor

Line of Demarcation

DIRTIEST

CLEA

NEST


58


Cleanroom Design

Dirty

• Be creative if design of rooms are not optimal

Clean

Cleansing and Garbing1. Remove all jewelry and cosmetic products2. Put on hair cover and face mask3. Put on shoe covers, while stepping over line of demarcation,

one foot at a time4. Clean under fingernails5. Wash hands and forearms to elbows for at least 30 seconds

with soap and warm water6. Dry hands and forearms completely with lint‐free disposable

towel7. Use disposable towel to turn off faucet 8. Put on gown9. Apply alcohol based surgical hand rub (with persistent killing

activity) and allow to dry10. Place thumbs in loops in sleeves 11. Put on sterile gloves and pull cuffs over gown sleeves

DIRTIEST

CLEANEST


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• The biggest threat to cleanrooms are: people

• Control, Contain, Cleansing, Cleaning, Continuous Monitoring

Maintaining Cleanroom EnvironmentScalp: 1 Million/cm3

Saliva/nasal fluid: 10 million/g

Back: 100/cm3

Groin: 1 – 20 Million/cm3

Forehead: 100 – 1000/cm3

Armpit: 1 – 10 Million/cm3

Feet: 1 Million/cm3

?Which of the following contains the most bacteria?

a. Toilet seatb. Toilet handlec. Door Knobd. Cell Phone


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Maintaining Cleanroom Environment

• Items that do NOT belong in a cleanroom:– Outer garments– Cellphones and other

personal electronics– Cosmetics– Visible jewelry– Artificial nails or nail polish– Natural nails longer than ¼”– Cardboard / particle board

Garments and Garbing

• Contain particles• Minimize staff motion• Understand garment design• Scrubs are not ‘lint‐free’

Austin P. Acorn Industries; 2000.

Personnel Activity Snap Smock

Standard Coverall

Membrane Coverall

No movement 100,000 10,000 10

Light movement 500,000 50,000 50

Heavy movement 1,000,000 100,000 100

Change position 2,500,000 250,000 250

Slow walk 5,000,000 500,000 500

Fast walk 10,000,000 1,000,000 1,000

Particles ≥0.3 micrometer emitted per minute

Area Standard Particle Limit (ft3)

Anteroom ISO 7 10,000

Cleanroom ISO 7 10,000

Hazardousroom

ISO 7 10,000

Inside IV hood ISO 5 100


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FDA 483

• FDA 483: form that notifies the compounding pharmacies management of objectionable conditions discovered after an FDA inspection

• Review FDA 483s and warning letters on FDA’s website

• Utilize ‘Vendor Assessment Tools’ for outsourcing sterile products

Link: http://outsourcingassessment.org/

Sample FDA 483

Isolators

• CAIs and CACIs (gloveboxes) are not closed‐systems• System may be compromised when door is open for

drug/material transferring, cleaning, etc.• A true ‘closed‐system’ is a Restricted Access Barrier

System (RABS)• Proposed USP <797> further defines the minimum

garbing requirements for each PEC type


62


Isolators

Image Source: LABRepCo

• For PECs (CAI, CACI) that are not located within an ISO Class 7 buffer area

• ‘Low‐Risk Level CSPs with 12‐Hour or Less BUD’

• “Personnel shall follow the procedures described in Personnel Cleansing and Garbing…”

• Is this being followed at your facility?

Hands‐Free Considerations

• Personnel pose the highest risk of introducing microbial contaminants into a cleanroom and CSPs

• Touch contamination is most common cause of CSP contamination

• Identify all touch‐contamination points and introduce technology/practices to eliminate


63


Door Entry Sink

Hand‐Rub Dispenser Remote Activated Intercom System

• Others:– Computer– WFMS– Pass‐thru– Pens

Drying Hands

• Eliminate use of jet air hand dryers• Dry hands/forearms with low‐lint disposable

towel• Mechanism:

– Towel: absorption– Warm air: evaporation– Jet air: force

• Jet air dryers produce more than 1300x virus dispersal compared to paper towels

Kimmitt P et al. J Appl Microbiol. 2016; 120:478‐86.


64


Cleanroom Validation

• Read the report in detail• Understand the requirements• Know what is/isn’t being performed• Create and document action plans• Modify environment, terminally clean, re‐train, re‐

test, monitor

Cleanroom Validation Reports

• What story do the reports tell?

• Review work practices and environment to locate cause

• Provide immediate action planning and documentation


65


HEPA Filter Integrity Testing

• Room HEPA filters must be leak tested• At factory, after installation, and as part of

recertification (every 6 months)• CETA CAG 003 guidelines (not mentioned in USP

<797> revision)

HEPA Filter Integrity Testing

• How are your re‐certifiers leak testing room HEPA filters?– Are they moving ceiling tiles?– Are your ceiling tiles caulked?

• Some facilities are built without any means for testing appropriately

• Recommendation: install aerosol injection ports into ceiling


66


Safety Walk

• Develop technician led safety walk of cleanroom spaces each shift with checklist

• Consider ‘insanitary conditions at compounding facilities’ FDA guidance document

FDA Draft Guidance; Aug 2016.

Insanitary Conditions• Unsealed, loose ceiling tiles• Vermin in production areas• Visible contamination (bacteria, mold)• Non‐microbial contamination (rust, hair,

etc.)• Improper gowning• Failure to disinfect gloves• Exposed wrists during aseptic

manipulations• Etc.

Examples


67


?For pharmacy construction/renovations have you been involved in an ICRA process?

a. Yes, active participationb. Yes, limited participationc. No, not involvedd. What’s an ICRA?

Infection Control Risk Assessment

• Infection Control Risk Assessment (ICRA)

– Multidisciplinary, organizational, documented process

– Reduction of risk from infection

– Processes related to facility planning, design, construction, renovation, facility maintenance, etc.

– Processes for design, construction, mitigation

Bartley J. APIC Guidelines; 2000.


68


ICRA Matrix of Precautions

Kennedy V. ESCI Inc; 2002.

Type A Inspection of non‐invasive activates

Type B Small scale, short duration activities, minimal dust

Type C Work that generates moderate to high level of dust or requires demolition or removal of any fixed building components or assemblies

Type D Major demolition and construction projects

Type of Construction Project/ActivityLow Risk Office areas

Medium Risk Echocardiography, endoscopy, nuclearmedicine, radiology, etc.

High Risk Emergency room, labor & delivery, newborn nursery, pharmacy, surgical units, etc.

Highest Risk Areas with immunocompromised patients, burn unit, cath lab, central sterile supply, ICUs, operating rooms, etc.

Identify the Risk

ICRA Process

1. Identify type of construction project/activity

2. Identify the patient risk groups3. Use IC matrix to determine

class4. Assess areas surrounding

project area5. Identify specific site of activity6. Identify issues related to outages

(i.e., HVAC)7. Identify containment measures

8. Consider water damage, structural integrity, etc.

9. Consider work hours10. Adequate isolation/negative

airflow11. Plan traffic flow, housekeeping,

debris removal, etc.12. Plan DURING construction13. Plan AFTER construction

Kennedy V. ESCI Inc; 2002.


69


Major construction/renovations

• For each key decision maker: have they read the applicable standards?

• Differentiate standards vs. best practice

• Have multidisciplinary discussions prior to decision making

• Consider the future (i.e., automation)• Consider the workflow (how does

product get in/out, etc.)

Multidisciplinary Discussion

• Include appropriate individuals for each project

• Each adds element of safety to the project

• Do it right the first time• Build relationships with

key stakeholders

• Consider:– Pharmacy– Infection control– Workplace safety– Facilities– Electrician– Plumber– Construction– HVAC technician– Cleanroom validation


70


Cleanroom Design PearlsAnteroom:

• Door and sink placement to allow proper ‘clean’ and ‘dirty’ side

• Minimize all activities in this room

Cleanroom

• Minimize storage• Maximize use of pass‐thru storage

Hazardous Room

• Ensure adequate space for drug storage

Inventory inside the cleanroom

• If pharmacy/cleanroom design allows…get all of your inventory out of your cleanroom

• Consider risks of introducing particles/contaminants

• If having to store, keep like items sealed in ziploc bags

• Before storing anything in cleanroom, consider how easy it is to clean


71


Servicing room HEPA filters

• Consider installing ‘room‐side serviceable’ HEPA filters

• Cleanroom design should include contingency plan for ‘down‐time’ for repairs

• If possible, design cleanroom so portion can be shut down while other is serviced

?Have you operationalized your hazardous drug assessment of risk?

a. Yes, implementedb. No, but have plansc. No, do not currently have plansd. Have not completed assessment of risk


72


Hierarchy of Controls

CDC; NIOSH; 2016.

‐ Design it out

‐ Use something else

‐ Isolation and guarding

‐ Training and work scheduling

‐ Last resort


73


How to operationalize handling

• Color coded bins• Labels (EHR); separate printer?• Accessory labels• ADC prompts• EHR/MAR Prompts• Consider areas outside of normal

dispensing processes (i.e., operating rooms, etc.)

• Create ‘Hazardous Drug Safety Manual’ and make available to all employees

NIOSH HAZARDOUS DRUG

CISplatin (PLATINOL) 50 mg in sodium chloride 0.9%, 250 mL chemo infusionRate: 300 mL/hr Volume: 300 mLRoute: Intravenous Frequency: OnceDuration: 60 minutes

Expiration Date:_____ Time: _______

CAUTION: NIOSH Hazardous Drug (Antineoplastic); Exposure Risk: HIGH; Refer to Safety Manual for safe handling

Sample Label

USP <800> Gap AnalysisSample Gap Analysis


74


Impact‐Effort Grid

Key Takeaways: Checklist

Create contingency plan for natural disasters

Develop strategy to reduce risk of CSPs Identify high‐risk compounding practices Implement strategies to identify ‘invisible

errors’ Develop evidence based compounding

compendium Perform USP 797 GAP analysis Utilize State Board of Pharmacy inspection

report (if available) Ensure adequate environment and materials

to properly cleanse/garb Ban insanitary items from the cleanroom

Choose garments and garb that contain particles

Apply cleansing/garbing practices to personnel using ‘glove‐boxes’

Implement ‘hands‐free’ options in cleanroom spaces

Use low‐lint disposable towels to dry hands Ban use of jet air dryers Review your cleanroom validation reports

and testing procedures Install mechanism to leak test HEPA filters

without moving ceiling tiles Institute a ‘safety walk’ to identify insanitary

conditions


75


Key Takeaways: Checklist

Utilize ICRA’s for all pharmacyconstruction/renovation projects

Ensure all key stakeholders involved inconstruction/planning know the standards

Strengthen relationships with keystakeholders outside of pharmacy

Design cleanroom spaces that promotes aclean environment and considers workflow

Utilize ziploc bags to contain all druginventory inside cleanroom spaces

Utilize ‘room‐side serviceable’ HEPA filters(if able)

Consider most effective containmentmeasures during assessment of risk

Develop operational plan to support properhandling procedures of hazardous drugs

Create a ‘hazardous drug safety manual’ andmake available to all employees

Develop a multi‐disciplinary ‘hazardous drugcommittee’

Perform a USP <800> gap analysis andprioritize gaps

Roundtable Discussion

• What is the biggest challenge for which you don't yet have an answer?


76


Faculty Discussion

Consider these practice changes. Which will you make?

• Review ASHP’s Standardize 4 Safety Initiative www.ashp.org/Pharmacy‐Practice/Standardize‐4‐Safety‐Initiative.

• Review the standardized concentrations used at my institution.

• Review ENFit resources at StayConnected.org.

• Investigate the status of my organization’s transition to ENFit devices.

• Work to complete our Assessment of Risk.

• Revise PPE procedures.

• Revise cleaning and decontamination procedures.

• Review my Board of Pharmacy’s standard compounding inspection report to determine areas where my institution is in compliance and areas where improvement is needed.

• Join, or start, a Hazardous Drug Committee at my institution.

• Strengthen relationships with key stakeholders outside of pharmacy for USP Chapter <800> planning (e.g., infection control, architects).


77


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

handout

Thank You for Joining Us!

• Coming March 2018– Archive version of

today’s activity


78

Claiming CE Credit 1. Log in to the ASHP eLearning Portal at elearning.ashp.org with the

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, 2018!

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 2017 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

then be logged into the ASHP eLearning Portal.5. Follow the instructions in the section above this, starting with Step Two.

For Offsite Webinar Attendees 1. Log in to the ASHP eLearning Portal at elearning.ashp.org/my-activities. If you have never

registered with ASHP, use the Register link to set up a free account.2. Enter the Enrollment Code announced during the webinar in the Enrollment Code box and click

Redeem. The title of this activity will appear in a pop-up box on your screen. Click on Go or theactivity title.

3. Complete all required elements. Go to Step Six above.

Questions? Contact [email protected]!

Patricia C. Kienle, B.S.Pharm., M.P.A., FASHPDirector, Accreditation and Medication Safety Cardinal Health Innovative Delivery Systems Wilkes-Barre, Pennsylvania

Deborah Pasko, Pharm.D., M.H.A., ModeratorDirector, Medication Safety & Quality Center on Medication Safety and Quality ASHP Bethesda, Maryland

Faculty

On-demand activity of today’s live symposium coming in March 2018

www.ashpadvantage.com/go/safety

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 #0204-0000-17-444-L05-P n 3 contact hours, application-based

Sarah Bledsoe, Pharm.D., CPHIMSAssistant Director, Department of Pharmacy Children’s Mercy Kansas City Kansas City, Missouri

Kevin Hansen, Pharm.D., M.S., BCPSAssistant Director of Pharmacy Sterile Products, Special Formulations, Perioperative Services Moses H. Cone Memorial Hospital Greensboro, North Carolina

Rhonda Liberto, Pharm.D., CPPSSystem Medication Safety Officer Ochsner Health System New Orleans, Louisiana

QUALIFIES AS PATIENT SAFETY CE

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FOCUS - ashpadvantagemedia.comashpadvantagemedia.com/safety/files/FocusSafety_Handout._Web.pdf · Focus on Safety: Compliance Pearls and Priority Issues to Address Learning Objectives