The Future of IV Preparation - Canadian Society of …cshpontario.ca/_CMS/files/The Future Of IV Preparation...United States Pharmacopeial Convention (USP). General chapter :

The Future of IV Preparation:

Why technology matters

Jerry Fahrni, Pharm.D.

Disclaimer

I am a consultant, and have provided services to companies in the pharmacy automation and technology space. I am speaking today in my individual capacity. The views and opinions presented here are entirely my own.

PHARMACY IS SIMPLE!

The 5 Rights of Medication Administration:

1. Patient 2. Drug 3. Dose 4. Route 5. Time

Medication Use Process Where Adverse Drug Events (ADEs) and Error Occur

Adopted from: Claussen. (2013) HIT and CPOE Simulator Update. Bates et al., JAMA 1995; Leape et al., JAMA 1995; Classen et al., JAMA 1997

Diagnostic/Therapeutic Decisions

Made

Medication Ordered

Order verified and submitted

Formulary, purchasing decisions

Inventory management

Evaluate order

Select medication

Prepare medication

Dispense/ distribute

medication

Intervene as indicated for

adverse reaction/

error

Assess and document

patient response to

med according to parameters

Document admin and associated

information

Administer according to

order and standards for

drug

Select the correct drug for correct

patient

Educate patient

regarding medication

Educate staff regarding

medications

Ordering

Medication Inventory Management

Pharmacy Management

Administration Management

Monitor/Evaluate Response Document Administer Medication Education

ADEs = 49% Prescribing Errors = 39%

ADEs = 11% Transcription Errors = 12%

ADEs = 14% Dispensing Errors = 11%

ADEs = 26% Admin Errors = 38%

Traditional Storage IV Room

Refrigerated Storage Controlled Storage

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

The scope of this problem is daunting since an estimated 90% of hospitalized patients receive medication via the IV route

“

Husch, M, et al., Quality & Safety in Health Care. 2005; 14:80-86.

”

Risk associated with Injectable Medications

1. Barker KN, et al. Arch Intern Med. 2002;162:1897-1903.

Highest risk for error and most severe harm1

High degree of complexity

High-risk / high-alert

High-risk routes of administration

High-risk populations

1

2

3

4

5

Errors Associated with CSPs

Flynn EA et al. American Journal of Health-System Pharmacy. 1997; 54 (8):904-912 Bateman R et al. Qual Saf Health Care. 2010; 19:1-6

Wrong dose most common error found

9% mean compounding error rate

2% were clinically relevant

25% may have mild to catastrophic impact on patients

CSPs = compounded sterile products

Bateman R et al. Quality and Safety in Health Care. 2010; 19:e29

Image Source: Jerry Fahrni 2017©

Bateman R et al. Quality and Safety in Health Care. 2010; 19:e29

Deng, Y. et al. Am J Health-Syst Pharm. 2016; 73:887-93.

Deng Y et al. Am J Health-Syst Pharm. 2016; 73:887-93.

Sacks, GS. et al. Pharmacotherapy. 2009;29(8): 966–74.

Parshuram CS, et al. CMAJ. 2008; 178:42-48

Profession Total 118 participants

Anesthesia 20

Pharmacy 17

Nursing 81

Years of professional experience

< 5 39

6-10 41

> 10 38

Infusion prepared in previous week

0 27

1-5 50

6-10 23

> 10 18

Adopted from Table 2 in Parshuram CS, Y. et al. CMAJ. 2008; 178:42-48

Overall, 34.7% of the morphine infusions had errors

Parshuram CS, Y. et al. CMAJ. 2008; 178:42-48

3 factors

associated with error of

> 10%

Fewer infusions prepared in the previous week

Increased number of years professional experience

Profession



Our findings challenge the dogma that expertise is synonymous with seniority, and they highlight the distinction between recent practice and cumulative experience.

“

”

4 deaths after exposure to

cardioplegia soln from compounding

pharmacy

2 patients blinded by contaminated

injection from compounding

pharmacy

Death from decimal error in

compounding in a hospital pharmacy

3 deaths from injection made by

compounding pharmacy

9 deaths resulted from contaminated parenteral nutrition

NECC produced and distributed 3 lots of PF

methylprednisolone acetate injection

Death from overly concentrated

injection used in hospital pharmacy

33 fungal eye infections – some with loss of vision –

resulting from contaminated preparations

made by compounding pharmacy

2005 2006 2007 2011 2012

Myers CE. AJHP. 2013;70(16): 1414-1427

2014

St. Charles Hospital in Bend, OR dispenses

rocuronium instead of fosphenytoin. Patient

receives dose and dies.

medication errors have a tremendous impact on

the entire healthcare system

PATIENT CAREGIVER FINANCIAL

PATIENT CAREGIVER FINANCIAL

Preventable ADEs from injectable medications were estimated to occur in 1.2 million inpatient hospitalizations annually in the United States

Example: Eric Cropp. Involved in a compounding error that took the life of 2 year old Emily Jerry 2006. Lost job, lost license, received a fine, and was ultimately sentenced to prison.

According to data from Bates 1997 study, cost can add more than $5000 to the cost of a hospital stay Estimated inpatient preventable ADEs associated with injectable medications increase the annual US payer costs by $2.7 - $5.1 billion

Why?

Image credit: Heather Katsoulis [CC BY-SA 2.0 (http://creativecommons.org/licenses/by-sa/2.0)], via Wikimedia Commons


Basic Tenets of Human Error …......................................................................................................................

Anatomy of an Error. Patient Safety – Quality Improvement. Available at: http://patientsafetyed.duhs.duke.edu/module_e/basic_tenets.html. Accessed March 11, 2017.

Everyone commits errors

Human error is generally the result of circumstances beyond the control of those committing the errors

Systems or processes that depend on perfect human performance are inherently flawed

Classification of Errors

Skill-based errors – slips and lapses

Knowledge-based mistakes

Rule-based mistakes

“strong but wrong”

Reason James (1990). Human error. Cambridge University Press (New York, USA), 1990. ISBN: 9780521314190.

TWO STEPS TO TAKE RIGHT NOW TO MINIMIZE RISK IN THE IV ROOM

Step 1

FOLLOW ESTABLISHED GUIDELINES AND REGULATIONS

1975 NCCLVP published

last recommendations

1998

FDAMA signed into law

1992

ASHP Technical

Assistance Bulletin

“Quality Assurance for

Pharmacy-Prepared

Products”

1997

FDA Modernization Act

1995

USP <1206> “Sterile

Drug Products for Home

Use”

2000

ASHP Guidelines on

Quality Assurance for

Pharmacy-Prepared

Sterile Products

2008

USP <797> revision

official June 1, 2008

2004

USP <797> becomes

official January 1

2001

Section 503A of FDAMA

declared unconstitutional

2006

Proposed Revisions to

USP <797> published

2010

ASHP Guidelines on

Outsourcing Sterile

Compounding Services

2013

Drug Quality and Security

Act (DQSA) becomes law

2014

FDA publishes 503A and

503B guidance

2016

USP publishes chapter

<800>

1970’s 1990’s 2000’s 2010’s

“Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed; and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed.”

United States Pharmacopeial Convention (USP). General chapter <797>: Pharmaceutical Compounding Sterile Preparations – Responsibility of Compounding Personnel

“The use of technologies, techniques, materials, and procedures other than those described in this chapter is not prohibited so long as they have been proven to be equivalent or superior with statistical significance to those described herein.”

United States Pharmacopeial Convention (USP). General chapter <797>: Pharmaceutical Compounding Sterile Preparations

“All compounding personnel…are

responsible for compounding and dispensing sterile products of correct ingredient identity, purity, strength, and sterility and for dispensing them in appropriate containers, labeled accurately and appropriately for the end user.”

ASHP guidelines on quality assurance for pharmacy-prepared sterile products. Am J Health Syst Pharm. 2000 Jun 15;57(12):1150-69.

“Use technology to assist in

the verification process (e.g., barcode scanning verification of ingredients, gravimetric verification, robotics, IV workflow software) to augment the manual processes.”

ISMP 2016-2017 Targeted Medication Safety Best Practices for Hospitals

“Data submitted to the ISMP MERP has repeatedly shown that the manual inspection of IV admixture ingredients by pharmacy technicians and pharmacists is not a totally effective deterrent in preventing preparation and dispensing errors..”



Bottom line

There is nothing in the current USP General Chapters or other U.S. regulatory documentation that directly addresses the use of automation and

technology during the sterile compounding process or their use inside the hood.

Automated compounding device and balance

The automated compounding device (ACD) must be positioned in the C-PEC such that compounding occurs while critical sites are exposed to first air.

The ACD must be calibrated at least once a day, then as needed…

The balance must be calibrated before each use, after it is moved, after disinfecting and as needed…

The results of calibration must be documented

Model Standards for Pharmacy Compounding Sterile Preparations Approved by the NAPRA Board of Directors April 2015, published September 2016


Camera and computer equipment

Audio-visual and computer equipment* used for verification during compounding is allowed in the clean room under certain conditions. Preference must be given to audiovisual and computer equipment that features “hands-free” operation and that is made of smooth, nonporous, cleanable materials with low particulate emission and resistance to damage from cleaning and disinfecting products.

Model Standards for Pharmacy Compounding Sterile Preparations Approved by the NAPRA Board of Directors April 2015, published September 2016 *camera, monitor, pedal system




Step 2

IMPLEMENTATION OF AUTOMATION AND TECHNOLOGY IN THE IV ROOM

One of the advantages of technology is that it can enhance human performance to the extent that the human plus technology is more powerful than either is alone.

Institute of Medicine. (1999). To Err is Human: Building a Safer Health System.

“

”

Dose and volume verification Syringe pull-back method Human visual inspection

CSP ingredients and components Human visual inspection

Final CSP verification Calculation review

Reconciliation

Highly manual process

Dose and volume verification Gravimetrics

Computer vision

CSP ingredients and components Bar-code scanning Computer vision

Final CSP verification Computer vision

Gravimetrics Real-time concentration validation

Highly automated process (Robotics)

http://www.cgpgrey.com [CC BY 2.0 (http://creativecommons.org/licenses/by/2.0)], via Wikimedia Commons

http://www.cgpgrey.com [CC BY 2.0 (http://creativecommons.org/licenses/by/2.0)], via Wikimedia Commons

Step Current Method Future Method Gap

Calculations Manual PhIS/EHR/IVWFMS Error prone (“bad math skills”)

Product/ingredient selection

Visual inspection Bar-code scan Incorrect drug, diluent, carrier

Drug dose/volume Syringe pull-back method “traditional volumetrics”

Image-assisted Volumetrics Gravimetrics

Incorrect volume

Label Produce all and separate Control ("one at a time") Error prone, manual sorting, visual verification

Documentation Manual Automated Error prone("forgot", "too busy")

Tracking Manual Automated Error prone (“missing meds”)

Image source: Jerry Fahrni, Pharm.D. 2014 Image Source: Jerry Fahrni 2014©


IVWFMS

9 Robotic

6 EHR

3

CSP-ASSITANCE TECHNOLOGY FEATURES

Interfaced to PhIS

Web-based UX/UI Remote Access /

Telepharmacy Workflow / Queue

Management

Assistive technologies (Bar-code scanning)

Gravimetrics

Reference and Compounding Aids

Recipe Catalogues ("Master Formulas")

Image Capture/Archive (Documentation)

forcing function

mechanisms built into the

workflow to prevent

specific errors or reduce

their impact

enforcing function

mechanisms built into the

workflow to warn users

when something is outside

safety parameters

Currently only bar-code scanning technology can positively identify an ingredient during the

compounding process.

ASHP Statement on Bar Code Technology

ASHP statement on bar code verification during inventory, preparation, and dispensing of medications. Am J Health‐Syst Pharm. 2011; 68:442‐5.

“The American Society of Health‐System Pharmacists encourages hospital and health‐system pharmacies to incorporate bar‐code scanning into inventory management, dose preparation and packaging, and dispensing of medications.”

ISMP Medication Safety Alert!

“Now is the time for hospital leadership to support the acquisition of IV workflow technologies that utilize barcode scanning of products during pharmacy IV admixture preparation. Systems … that utilize barcode scanning support can assure proper drug selection….”

ISMP. Tragic Error With Neuromuscular Blocker Should Prompt Risk Assessment By All Hospitals. ISMP Medication Safety Alert! 2014.

BAR CODE SCANNING

Galbraith W, et al. Int J Pharm Compd 2012;16 (3)

Targeted Dispensing Errors Pre- and Post-implementation of Preparation Barcode Scanning

PRE-BCAS POST-BCAS

Total Dosages Dispensed 413,085 558,229

Wrong Dosage 29 0

Wrong Drug 14 1

Wrong Volume 3 0

Wrong Procedure 3 0

Wrong Patient 2 0

Total Targeted Dispensing Errors 0.012% 0.002%

BCAS: barcode assistance system Table adopted from Galbraith W, et al. Int J Pharm Compd 16 (3): 253–256 (2012)

ENSURING THE RIGHT DOSE

VOLUMETRIC METHOD

DETERMINING DOSE BY VOLUME

ISO 7886-1 SYRINGE ACCURACY

1156 doses included in study

0.53% mean deviation

64.9% - 94.2% range

Poppe L et al. Journal of Oncology Pharmacy Practice. 2016

Table 3 – Poppe L, et al. Journal of Oncology Pharmacy Practice. 2016;22(1)

Terkola R et al. J Clin Pharm Ther. 2017. [Epub ahead of print]

http://onlinelibrary.wiley.com/doi/10.1111/jcpt.12529/full#jcpt12529-fig-0002

GRAVIMETRIC METHOD

QUANTITATIVE ANALYSIS BY WEIGHT


Reece K et al. AJHP. 2016;73(3)

Reece K et al. AJHP. 2016;73(3) Figure 2

Study period: Nov 2012 to Nov 2013

15,843 doses prepared

1,126 (7.1%) errors detected

292 (26%) detected by barcode scan

797 (71%) deviation and 37 (3%) vial reconstitution errors by gravimetric weighing

Technician production time ↓ by 34%

Pharmacist checking time ↓ by 37%

Labor savings estimated at $158,000 annually

Decreased waste

Pros Utilized in analytical chemistry because it is extremely accurate.

Serves as a forcing function, in that preparers cannot proceed to next steps without scales having confirmed volumes in previous steps

Prevents upstream errors in the preparation process

Cons Volumetrics generally considered as accurate as gravimetrics

Additional time-consuming steps of weighing each item before and after drawing and injecting liquids.

Sensitive to air movement in PECs, requiring time to settle and register weights of products placed on them.

© 2014 Jerry Fahrni, Pharm.D./Mark Neuenschwander

Highly Automated Robotics

Pros and Cons



EHR Integrated BCMP Systems

Pharmacy Products & Purchasing State of Pharmacy Automation. 2016 The Neuenschwander Company (TNC) – data on file

0%

5%

10%

15%

20%

25%

30%

2013 2014 2015 2016

Semi-Automated IVWFMS

PP&P TNC

Diffusion of Innovation

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pe

rce

nt

Pe

net

rati

on

Year/Years Required for Penetration

Penetration Rates of Consumer Technologies (1876 - Present)

Telephone

Electricity

Radio Sets B&W TV

Color TV Cable

CD Player

VCR

Cellular

Adoption of Smartpumps, BCMA, CPOE graphed as percent adoption over time (data source: AJHP - Vol 72 Jul 1, 2015)

"Ninety-nine percent of the failures come from people who have the habit of making excuses." ~ George Washington Carver

Fear of….

Not enough

….

Too slow

Too hard

Too much $$$

RATIONALE FOR NOT ADOPTING

SAFETY

BIAS MULTI-TASKING

DATA

TRANSFORM THE ROLE OF THE TECHNICIAN STANDARDIZE IV ROOM WORKFLOW

COST

EFFICIENCY

REASONS TO ADOPT

Professionals entrusted with the delivery and administrations of pharmaceuticals have a

fundamental responsibility to identify and implement interventions that will improve patient quality outcome measures and also reduce overall health-care costs. These interventions

include timely and judicious use of therapeutic and technological advances.

“

Meyer GE, et al. AJHP. 1991 May 1;48:953-966 Image Source: Jerry Fahrni 2015©

”

Documents

The Future of IV Preparation - Canadian Society of …cshpontario.ca/_CMS/files/The Future Of IV Preparation...United States Pharmacopeial Convention (USP). General chapter :