Medication Errors: We're Looking Down the Tunnel and ... · – major medication error; –...

Medication ErrorsWe're Looking Down the Tunnel and

Seeing Light

(10+ years since IOM)Michael R. Cohen, RPh, MS, ScD

Institute for Safe Medication Practices

mcohen@ismp.org

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Disclosure Information

Michael R. Cohen, RPh, MS, ScD has no financial relationships to disclose

and will not discuss off label use and/or investigational use in this presentation.

Medication Safety Issues

Culture of safety (blame and shame)Error reporting programsQuality issuesPatient safety technologyProduct related issues

Heparin issuesRecent high-profile reports of injury

Error Reporting Programs and Resulting Improvement Efforts

B+

Patient Safety Act and Quality Improvement Act of 2005

Patient Safety Organizations

ISMP Medication Errors Reporting Program

Pennsylvania Patient Safety Reporting Program

Operated by theInstitute for Safe Medication Practices

www.ismp.org

ISMP is a federally certified patient safety organization (PSO)

Other reporting programs

Maryland Patient Safety Center PSOPennsylvania Patient Safety AuthorityVHA Center for Patient Safety/NASANew York Patient Occurrence and Tracking System (NYPORTS) Oregon Patient Safety CenterMedMARx (medication errors)

Other government funded programs

FDA MedWatch

Web M and M(allows sharing of cases via Internet)

Medication Error Reporting System

Early warning system– Issue nationwide hazard alerts and press

releasesLearning– Dissemination of information and tools

Change– Product nomenclature, labeling, and packaging

changes, device design, practice issuesStandards and Guidelines– Advocates for national standards and guidelines

National Quality Forum Serious Reportable Events (SREs)

Errors in medical care that are clearly identifiable, preventable, and serious in their consequences Examples:– surgery on the wrong body part; – foreign body left in a patient after surgery;– mismatched blood transfusion; – major medication error; – severe “pressure ulcer” acquired in the hospital

National Quality Forum Serious Reportable Events (SREs)

Errors in medical care that are clearly identifiable, preventable, and serious in their consequences Problem in the safety and credibility of a health care facilityExamples:– surgery on the wrong body part; – foreign body left in a patient after surgery;– mismatched blood transfusion; – major medication error; – severe “pressure ulcer” acquired in the hospital

National Patient Safety Goals

The Joint Commission (TJC)Sentinel Event Reporting Program

“You can get much further with a kind word and a gun than you can with a kind word alone.”

Al Capone

JCAHO

NQF Safe Practices

Culture of safety

C+

The single greatest impediment to error prevention in the medical industry is “that we punish people for making mistakes.”

Lucian Leape

Safety Culture “sins”Focus on individualsHindsight biasReacting to emotional component of patient harmFailure to move beyond proximate causesBelieving there is a single root causeResponse confused with proactive risk management when actually reactiveTunnel vision (both causes and actions)Weak error reduction strategies

Culture of Safety

Errors not a measure of competencyManagement style– promote safety and “Just Culture”Value complainersReward patient safety and reportingEncourage story tellingVisible leadership (walk arounds) – medication safety officer

ISMP top things to do to improve safety

Be proactive, not reactive. Learn from experience of other organizations. Medication safety officer/team.Focus on unsafe practices/at risk behaviors (e.g., unlabelled containers, sharing insulin pens, abbreviating drug names, patient weight conversions, etc.)Implement technologies (smart pumps, bedside bar code scanning, follow automated dispensing cabinet guidelines, e-Rx, etc.)Standardize drug concentrations, units of measure, etc.Encourage error reporting – internal and external (see “ISMP Med Safety Alert! Pump up the volume – tips for increasing reporting. Feb 9, 2006 -http://www.ismp.org/Newsletters/acutecare/articles/20060209.asp

Just Culture - The Three Behaviors

Human Error

Product of our current system design

Manage through changes in:

• Processes• Procedures• Training• Design• Environment

Console

At-Risk Behavior

Unintentional Risk-Taking

Manage through:

• Removing incentives for At-Risk Behaviors• Creating incentives for healthy behaviors• Increasing situational awareness

Coach

RecklessBehavior

Intentional Risk-Taking

Manage through:

• Remedial action• Disciplinary action

Punish

Two Disconnected Conversations

No Blame Accountability

Criminal Charges for Medication Errors

ISMP top things to do to improve safety

Be proactive, not reactive. Learn from experience of other organizations. Medication safety officer/team.Focus on unsafe practices/at risk behaviors (e.g., unlabelled containers, sharing insulin pens, abbreviating drug names, patient weight conversions, etc.)Implement technologies (smart pumps, bedside bar code scanning, follow automated dispensing cabinet guidelines, e-Rx, etc.)Standardize drug concentrations, units of measure, etc.Encourage error reporting – internal and external (see “ISMP Med Safety Alert! Pump up the volume – tips for increasing reporting. Feb 9, 2006 -http://www.ismp.org/Newsletters/acutecare/articles/20060209.asp

Quality Issues

B+

Hand WashingTypical hand hygiene rates circa 1999: 20-30%Public reporting of / “no pay” for/?lawsuits for HAIs: tremendous push to improveMany organizations now at 40-70%, and stuck “It’s a Systems Problem”: Education, dispensers every 3 feetA systems problem? Really?

Wachter, Pronovost. NEJM 10/1/09

Patient safety technology

B

Do First Investment

Don’t Bother

Low

High

Impact

HighCost

CPOEBar-coding

Smart pumps

Automated ADE monitoring

Dedicated ICUPharmacist

Pocket drug reference

Preprinted order forms

Medication training

Limiting abbreviations

Drug-food interactions

Constraintson high alert drugs

Intervention database

Unit dose dispensing

(Courtesy David Bates)

Automated dispensing cabinets

Med Safety Officer

Robotic dispensing

Product safety

B

Examples of the Impact Medication Error Reporting

http://www.ismp.org/about/merpimpact.asp

US Food and Drug Administration

PDUFA IV –– Nomenclature testing– Package label requirements– Device safety– Patient safety news– FDA-ISMP Fellowship– Etc.

Division of Medication Error Prevention and Analysis (DMEPA)

Look-alike and Sound-alike Drug Names

Generic Name n %

Insulin* 386 11.3

Morphine* 164 4.8

Heparin* 120 3.5

Fentanyl* 98 2.9

Hydromorphone* 91 2.7

Warfarin* 88 2.6

Potassium Chloride* 69 2.0

Vancomycin 69 2.0

Enoxaparin* 60 1.8

Metoprolol Tartrate 42 1.2

Furosemide 41 1.2

Methylprednisolone 35 1.0

Meperidine* 33 1.0

Leading Products in Harmful Medication Errors

From MedMarx 2007 * = high alert

Problems associated with PCA

Patient selection, assessment and monitoringDrug product mix-upsHuman factors/design flawsStaff training, and competency assessmentOrder communication errorsPCA by proxyDevice-related issues

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Risk Evaluation and Mitigation Strategies (REMS)

Look-alike product labeling

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Current labeling

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TALLman LETTering

Considerations with color on labels

Potential for mix-ups within the class must be considered

Availability of medicines

D-

Drug Shortages

Clinical effects –Adversely affect drug therapy–Compromise or delay medical

treatment/procedures–Result in failure to treat and

progression of disease–Result in medication errors and

adverse patient outcomes

Drug ShortagesFinancial effects of shortages– Costly alternative medications for

provider and patient– Significant time spent on addressing

shortages– Additional costs associated with

treatment of adverse outcomes Emotional effects of shortages– Frustration, anger, mistrust– Strain professional relationships

Adverse patient effects due to drug shortage

Tubing Misconnections

Forthcoming ISO standards for “small bore” connectors

• ISO 80369-1 General Requirements• ISO 80369-2 Breathing Gas Systems• ISO 80369-3 Enteral Feeding• ISO 80369-4 Urological• ISO 80369-5 Limb Cuffs• ISO 80369-6 Neuraxial• ISO 80369-7 Vascular/Luer fittings

(formerly ISO 594)

This is not the end. It is not even the beginning of the end. But it is perhaps, the end of the beginning.