Brent I. Fox, PharmD, PhDHarrison School of PharmacyAuburn Universityfoxbren@auburn.edu

The current state: focus on medication use safety

Connecting providers and patients Unavoidable patient safety technologies Portable technology The e-Society Conclusions

Safe- patient’s safety comes first

Timely- care delivered in a timely manner

Effective- based on the best science available

Efficient- avoids waste of time, money, resources

Equitable- care provided to all in an equitable manner

Patient-centered- patients participate fully in care decisions

IOM Workshop

Ordering

49%(48%)

Transcribing

11%(23%)

Dispensing

14%(37%)

Administering

26% (0%)

Bates DW et al. Incidence of adverse drug events and potential adverse drug events: Implications for prevention. JAMA 1995. 274(1):29-34

6.5% of patients experience ADE 28% of ADEs are preventable

Preventable ADEs LOS increased 4.6 days Total costs increased $5857

Bates DW et al. Incidence of adverse drug events and potential adverse drug events: Implications for prevention. JAMA 1995. 274(1):29-34

Bates DW et al. The cost of adverse drug events in hospitalized patients. JAMA 1995. 277(4):307-311

Migrating from Paper to ElectronicData

“the way I do it now”

Paper

“feels like typing or dictating”

Electronicfree text

“feels like filling in a form”

Partiallystructured

“feels like picking everything from a huge menu”

Rigidly structured

Starting Point

8

Isordil ?

Plendil?

ZestrilJury blames doctor's bad penmanship for patient death; awards

$450,000

Responsible?Responsible?

http://www.ama-assn.org/amednews/1999/pick_99/prl21122.htm

9

Copyright ©1997 BMJ Publishing Group Ltd.

Smith, R. BMJ 1997;314:1495

How "industrial age medicine" will invert to become "information age healthcare”

Inverting the Pyramid

Can be exceedingly expensive

Technology seen as “fix” for more fundamental problems

Suboptimal or poor design

Response time, downtime, crashes, viruses, and hardware failures

Deferred improvement, waiting for the new to be developed

Losses in clinician time, efficiency and redistribution of tasks

Poor interconnectivity and integration

Volatile, vendor-driven marketplace

Poor marketplace memory of failed implementations

Underdeveloped mechanism for continuous learning

CDSS often not standardized, untested, poor signal to noise ratio

Can cause errors, and these can be large scale

Tendency to over-rely on info from computer rather than the patient

Lack of integration for medication reconciliation across the continuum

Increasing information overload from sheer volume without reliable filters

1515

www.cchit.org 15

16

EHREHRPharmacyPharmacy

PBMPBMPharmacyPharmacy

PBMPBM

PayerPayerPayerPayer

ElectronicElectronicMedicalMedicalRecordRecord

ElectronicElectronicMedicalMedicalRecordRecord

PersonalPersonalHealthHealthRecordRecord

PersonalPersonalHealthHealthRecordRecord

HospitalHospitalInformationInformation

SystemSystem

HospitalHospitalInformationInformation

SystemSystem

Managed CareManaged CareInformationInformation

SystemSystem

Managed CareManaged CareInformationInformation

SystemSystem

PharmacyPharmacyPharmacyPharmacy

PhysicianPhysicianPracticePractice

PhysicianPhysicianPracticePractice

PatientPatientPatientPatient

HospitalHospitalOr IDNOr IDN

HospitalHospitalOr IDNOr IDN

PharmacyPharmacyManagementManagement

SystemSystem

PharmacyPharmacyManagementManagement

SystemSystem

LabLabLabLab

Clinical LabClinical LabInformationInformation

SystemSystem

Clinical LabClinical LabInformationInformation

SystemSystem

Inpatient EMRClinical Data Repository

Payer EMRMember Clinical SummaryRx Claims History

Patient Lab HistoryBlood Donor RepositoryGenetic Profiles

ImagingImagingImagingImaging

ImageImageManagementManagement

SystemSystem

ImageImageManagementManagement

SystemSystem

PACS ArchiveDiagnostic Image Repository

Prescription History

PHRClipboardPMR: Current Meds

Ambulatory EMR

Digital scale

Sphygmomanometer

Glucometer

Pulse oximeter

Electrocardiogram/ Respiration

Thermometer

The PHR contains an “ongoing, longitudinal and life-long record of information that bridges both wellness and illness” [Markle Personal Health Working Group]

Each person controls their own PHR: individuals decide which parts of their PHR can be accessed, by whom and for how long

Slightly different than allowing a patient view of an EHR (it which case ‘the system’ owns and controls the record)PHR requires more initiative from the consumerEHR may have stronger advantage with respect to patient

observing errors (or verifying a lack of errors for ‘buy in’)

iMetrikus MediCompass: Biometric Device Interfaces

Blood Glucose Monitors:•Accu-Chek ™ Active •Accu-Chek™ Advantage•Accu-Chek ™ Compact •Accu-Chek ™ Complete•Ascensia® Breeze™•Ascensia® Contour™•Ascensia Elite XL®•Bayer Glucometer ® DEX•Bayer Glucometer ® DEX2•Bayer Glucometer ® Elite XL•BD Logic ™•BD Paradigm Link ™•In Duo ™•One Touch® Basic•One Touch ® II•One Touch ® Profile•One Touch ® Ultra•One Touch ® UltraSmart•One Touch ® Sure Step•Precision Q-I-D ®•Precision XTRA™•Prestige Smart System™•TrueTrack Smart System ™•TheraSense FreeStyle ®

Diabetes Management

Cardiac Management

Respiratory Management

Insulin Pumps:

D-TRON PlusBlood Pressure Cuffs:A&D LifeSource UA-767PC (Arm)OMRON HEM-637 (Wrist)OMRON HEM-705CP (Arm)

Digital Scales:A&D LifeSource UC-321PL*

Digital Spirometry:

AirWatch Lipid Testing:

CardioChek PA*(cholesterol, triglycerides, glucose, & ketones)

Reminds patients of their

scheduled activities, such as taking medications and physiologic measurements.

Provides patients with health education tailored to their clinical situation based on orders.

Collects information from patients about compliance with the orders, their comprehension of the educational information, and their clinical status.

Contains a system of "clinical alerts" allowing the agency to identify specific events that need to be brought to a clinician's attention.

Pharmacy/medication mistakes due to negative drug interactions, misread handwriting, and dosage misinterpretation

Repeat laboratory procedures Increase defensive medicine costs Repeat imaging Increased capacity for fraud Paperwork costs of faxing records Increased capacity for medical overuse Increased number of medical visits Increased cost of chronic disease management

Pricing/PerformancePricing/PerformanceTransparencyTransparency

Providers (By Specialty/Service)Providers (By Specialty/Service)

Payers (By Health Plan Class)Payers (By Health Plan Class)

Drugs, Devices, Equipment, SuppliesDrugs, Devices, Equipment, Supplies

Treatments/InterventionsTreatments/Interventions

Pricing/performance transparencywill clarify the value propositions acrossproviders, payers, drugs, etc.

ID Patients at Risk

ID Best Practice

A Broad Vision of Web/Health 2.0A Broad Vision of Web/Health 2.0Reformulating Data for Transparency, Decision Support Reformulating Data for Transparency, Decision Support

& Revitalized Health Care Markets& Revitalized Health Care Markets

Brian Klepper andBrian Klepper andJane Sarasohn-Kahn, Jane Sarasohn-Kahn, October, 2007October, 2007

EMREMREMREMR

PHRPHRPHRPHR

Data sources Data sources mapped to a mapped to a common common format format (e.g., CCR).(e.g., CCR).

ClaimsClaims

ClinicalClinical

DrugDrug

LabLab

ImageImage

Health MgmtHealth MgmtHealth MgmtHealth Mgmt

Expert-Expert-GeneratedGenerated

ContentContent& Search& Search

AnalyticsAnalyticsAlgorithms for achieving transparency (e.g., ETGs, DxCGs, CRGs, APR-DRGs) should be well-accepted and their approaches transparent.

User-GeneratedContent

Patients and caregivers advising others, sharing family histories, and more.

Vendor MgmtVendor MgmtVendor MgmtVendor MgmtTools

DecisionDecisionSupportSupport

Expert content, data-based evidence and artificial intelligence algorithms can drive better decision making for patients, clinicians, health managers and purchasers.

CentralizedCentralizedDataData

RepositoryRepository

If open about their analytical approaches, public & private groups can credibly report comparative pricing and performance information.

PublicPublicReportingReporting

Count only White Shirt to White Shirt Direct Passes that are Flat or Arched

Bounced passes do NOT count.

Black Shirt passes do NOT count.

Nurse barcode scans name tag

Nurse barcode scans patient identification bracelet

Patient MAR appears on bedside laptop

Scheduled and prn meds are scanned

Warnings/alerts are issued when indicated

Barcode Technology

Manufacturer bar codes

Repackaging

Adding barcodes to existing package

Quality control

How will this be managed? Resource requirements (FTE’s)Chris Fortier & Mike Sura

Dispensing Errors Alert fatigue

Intentional System Bypass Process resistance → easier workaround Medication Held/Discontinued Medication not bar-coded Emergency situation Patient’s own medication

Unintentional System Bypass Alert fatigue Workflow Hardware issues

Chris Fortier & Mike Sura

Often a low therapeutic index All patient populations Responsible for >50% of all serious and

potentially life threatening ADEs

Misuse of infusion pumps & other parenteral systems proximal cause of 13% of administration errors

Williams & Maddox. Implementation of an IV medication safety system. AJHP. 2005;62:530-536.

Leape LL et al. Systems analysis of adverse drug events. JAMA. 1995;274:35-43.

Assess impact of smart pumps on rate of serious medication errors

Four 8-week data collection periods 1st & 3rd: control 2nd & 4th: intervention (real time DS)

DS – drug library, dose & rate limit alerts

Hard limits were not used Nonspecific generic infusions

Rothschild JM et al. A controlled trial of smart infusion pumps to improve medication safety in critically ill patients. Crit Care Med. 2005;33:533-540.

4276 patient pump days control; 3869 patient pump days intervention 5364 & 5295 IV meds ordered, respectively

ControControll

InterventioInterventionn

p-valuep-value

Preventable ADEsPreventable ADEs 1414 1111 0.80.8

Nonintercepted Nonintercepted potential ADEspotential ADEs

7373 8282 0.0860.086

Serious med errorsSerious med errors 8787 9393 0.1240.124Rothschild JM et al. A controlled trial of smart infusion pumps to improve medication safety in critically ill patients. Crit Care Med. 2005;33:533-540.

Robotic IV automation removes the largest source of contamination from the compounding environment: the human operator

Robots provide consistent operational support

Improved accuracy and documentation

Mike Culligan and Luci Power

44Mike Culligan and Luci Power

Mike Culligan and Luci Power

ISO 5 compounding area Contained air handling system –

designed for hazardous drugs No human access to compounding area

during compounding process Flexible selection of syringes, IV bags,

elastomeric infusers and bottles

Mike Culligan and Luci Power

ISO 5 compounding area ISO 5 vestibules for loading inventory into

the storage carousels Contained air handling system – designed

for standard sterile compounding but may be used for hazardous drugs

No human access to compounding area during compounding process

Mike Culligan and Luci Power

IntelliFill IV automates the preparation of small-volume IV medications in 12 ml syringes for doses as small as 0.5mls to as large as 11.5mls.

Can hold up to ~40 different medications in drug cabinet

First Introduced in 2002

Mike Culligan and Luci Power

52

RFID’s Impact on Pharmacy Settings

The advantage of RFID is that it does not require direct contact or line-of-sight scanning.

RF signals communicate through many materials including clothing

RFID can store much more data than a typical barcode.

Some RFID tags can both transmit and record data.

Sackett and his colleagues define evidence-based medicine as, "The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients."

Other types of Decision Support Systems are: Algorithms Guidelines Order sets/standing orders Trend monitors Co-sign enforcers

Patricia L. Hale, Ph.D., M.D. Patricia L. Hale, Ph.D., M.D. Medical Informatics Subcommittee ACP-ASIM

Results - Frequency Recommendations (Ondansetron)

020406080

100120

-4 -3 -2 -1 0 1 2 3 4 5 6 7 8

Week

% o

f O

rders

TIDQID

p value <0.001 at –4 and 4 weeks

(Teich, 2000)

1. Speed is everything

2. Anticipate needs and deliver in real time

3. Fit into the user’s workflow

4. Little things can make a big difference.

5. Physicians resist stopping

6. Changing direction is fine

7. Simple interventions work best

8. Asking for information is OK--but be sure you really need it

9. Monitor impact, get feedback, and respond

10.Knowledge-based systems must be managed and maintained

Bates DW Kuperman GJ et al J Am Med Inform Assoc 2003; 10:523

Evanston Northwestern Healthcare implemented an EMR (Epic) with CPOE capability at three hospitals and 50 outpatient clinics and medical offices. The number of system users is 6,200. Number of delays in administering medication has fallen

by 70% Omitted administration of drugs has dropped 20% Test results for mammograms now take one day, down

from as long as three weeks Cardiographics reports also take one day, down from as

many as 10 days Spent $7.5 million on training and $35 million capital on

hardware, software, and implementation Won the Davies Award for 2004

Source: HIMSS 2007 HIMSS AnalyticsSource: Gregory S. Walton, FHIMSS, Oct 2007

► Perspective► Rate of prescriber order entry► Reduction in medication errors► Legibility► Efficiencies► The Leapfrog Group hospital quality ratings Leap 1 = CPOE

In order to fully meet Leapfrog’s CPOE Standard, hospitalsmust:1. Assure that physicians enter at least 75% of medication orders via a computer system

that includes prescribing-error prevention software;2. Demonstrate that their inpatient CPOE system can alert physicians of at least 50% of

common, serious prescribing errors, using a testing protocol now under development by First Consulting Group and the Institute for Safe Medication Practices (this criterion for the Leap will not count towards the hospital’s publicly reported status on this Leap until the test is available); and,

3. Require that physicians electronically document a reason for overriding an interception prior to doing so. (www.leapfroggroup.org accessed 3/11/08)

Anne Bobb & Lynn Boecler

“If I had one thing to ‘do over’ in our CPOE implementation, it would be to

have devoted more resources to track errors and problems that were created---it is just impossible to ‘get

it all right’ at the outset, because the processes involved are so

complex.”

David Bates, June 2005

Anne Bobb & Lynn Boecler

5. Expert Opinion

4. Case Series*

3. Case Control

2. Cohort*

1b. Single RCT

1a. Multiple RCTs

Centre for Evidence-based Medicine. Levels of evidence and grades of recommendation. November 1998; Available at: http://www.cebm.net/levels_of_evidence.asp. Accessed October 1, 2006.

Error Rate in %

Hospital Before After Installation

1mo. 2mo. 3mo. 2 Yrs

X - Unit A 14 10 12 8 7

Unit B 17 6 20 12 5

Y - Unit A 14 12 21 13 9

Unit B 4 6 12 12 5

Source: Barker, Flynn and Bunnell, 2000

85.5

93.494.6

93.194.9

89.3

95

89.2

97

91

96.897.8

9191.7 92.6

9795.7

84

86

88

90

92

94

96

98

100

Jul F

Y01

Au

g

Sep

t

Oct

Nov

Dec

Jan

Feb

Mar

Ap

r

May

-Ju

n

Jul F

Y02

Au

g

Sep

t

Oct

Nov

Dec

#6. Cubie Installation Complete

#5. New Units Added/ TS Drug List Revised

#4. Pharmacy Nursg Reviewed Video

#3. Education per Video

#2. Connect Complete

#1. LPN Role Change

CONFIDENTIAL QUALITY ASSURANCE INFORMATION PROTECTED FROM DISCOVERY BY ALABAMA CODE 22-21-8

Effect of Interventions on Accuracy, Hospital X, FY 01-02

456

341

050

100150200250300350400450500

Errors detected on 2557 doses

Observation(RPh)

Chart review(RPh)

Incident reports

Observer selection and training program Manual Interactive video Training Practice observations Tests

Software for data analysis, PowerPoint slide generation

Observer certification Service and Support

86.7

89.4

91.5 91.2

94.495.2

81.9

86

91.792.9 93

94.4

747678808284868890929496

Y X

BaselineFY 97FY 98FY 99FY 2000FY2001

Palm OS, Pocket PC, Blackberry, iPhone Color Quality (Monochrome - RIP) At least 32 (>200 to 4000) MB RAM Expandable Memory (8+ GB) Wireless (IR – Bluetooth – Cellular WAN –

WiFi) Telephone Combination (SmartPhone) Peripherals Multimedia

• Mini-Laptop• PDA• WiFi• Bluetooth• WAN• Camera• Speech

Emano Tec Inc., has designed a wafer-thin, wireless hand-held computer that can be washed thousands of times.

5.5” X 7.5” X 0.5”

1. Lexi-Drugs 2. Lexi-Interact3. Lexi-Natural Products4. Pediatric Lexi-Drugs5. Lexi Poisoning and

Toxicology6. Lexi-Lab and

Diagnostic Procedures7. Lexi-Infectious

Diseases8. Lexi-

Pharmacogenomics9. Lexi-Calc10. Dental Lexi-Drugs

11. Nursing Lexi-Drugs12. Lexi-PALS 13. Nuclear, Biological, and

Chemical Agent Exposures14. Lexi-Companion Guides15. Perioperative Nursing Lexi-

Drugs16. Lexi-I.V. Compatibility17. Medical Abbreviations18. Griffith’s 5 Minute Clinical

Consult19. Stedman’s Medical Dictionary20. Pharmacotherapy Handbook

(from McGraw Hill)21. Harrison’s Practice

E-mail E-commerce E-learning E-government

And now e-health, e-patientsAnd now e-health, e-patients

Terms first came into use in 2000

Blogs Wikis RSS Podcast CE Twitters Jaiku Pownce Widgets Del.icio.us/Connotea

YouTube Flickr Second Life Mobile Apps Skype/VOIP Twine Semantic Web Facebook/MySpace Mashups Ingenta

13 Main Communities, 23 Bloggers, Ratings

Isn’t this Just eMail?

eMail

Not HIPAA compliant– Not secure– Limited audit trail

Free-form

Non-chargeable

One-to-one exchange without workflow support

Limited feature set

HIPAA ready– Secure servers, 2 firewalls, 128-bit, SSL

encryption– Full audit trail

Clinically structured

Reimbursable

Advanced workflow support– Message routing by type– Distinct roles/proxy rights

Comprehensive feature set– e-Prescribing, e-Referrals– Clinical content and forms

How do webVisits Work?Patients select from 140+ Common Symptoms or Chronic Conditions

How do webVisits Work?Patient Completes an MD-Authored Interactive Online Interview

How do webVisits Work?Physician Receives Concise, Structured Message with Summary Health Record

How do webVisits Work?Physician Replies using Customizable Templates and Time-saving Attachments

Results: Reduced Absenteeism

Patients who messaged their doctor using RelayHealth were…

50% less likely to report missing work# due to illness

40% less likely to report having limited work capacity† due to illness

#p < .01†p < .05

IPv4 = 4.3 billion 2/3rd usedIPv6 = 3.4 X 1038

6.5B = 5 X 1028

Google video sites reach over 37% of all internet users!

Health Information Exchange (HIE) Federal NHIN/EHR efforts Health Information Technology

Electronic Medical/Health Record (EMR vs EHR) CPOE/eRx Bar Codes and RFID Automated dispensing machines, robots, smart pumps Electronic Medication Administration Record (eMAR) Medication Reconciliation Automation

Transparency to consumers PHRs and connectivity with patients and other

providers

Brent I. Fox, PharmD, PhDHarrison School of PharmacyAuburn Universityfoxbren@auburn.edu