The Role of Medication Safety Research in Evidence-Informed

Practice Development

Matthew Grissinger, FISMP, FASCP

Director, Error Reporting Programs

Institute for Safe Medication Practices

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Pidetty Potilasturvallisuuspäivillä Helsingissä 18.3.2013

ISMP Medication Errors

Reporting Programs

Pennsylvania Patient Safety Reporting Program

Operated by

The Institute for Safe Medication Practices A federally-certified Patient Safety Organization

(PSO)

www.ismp.org

MERP Process

• Report sent to ISMP

– Follow-up with reporters for causality

and validation for select cases

– Receive supporting material

• Scanned orders

• Pictures of products

– Entered into database

– Forward to FDA and manufacturer

http://patientsafetyauthority.org/ PA-PSRS (Pennsylvania Patient Safety Reporting System)

Patient Safety Provisions

• Establishment of Patient Safety Authority

– Non-regulatory

• Mandates medical facility patient safety

plans

• Provides for confidentiality of information

• Identifies procedures for reporting medical

errors and written notification to patients

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www.patientsafetyauthority.org

Recent Advisory Topics

• Adverse Drug Events with HYDROmorphone:

How Preventable are They?

• Medication Errors with the Dosing of Insulin:

Problems across the Continuum

• Medication Errors in Labor and Delivery:

Reducing Maternal and Fetal Harm

• Neuromuscular Blocking Agents: Reducing

Associated Wrong-Drug Errors

• Medication Monitoring Errors: Inappropriate

Levofloxacin Doses

High Alert Medications

• 25% of all medication error reports

involved a high-alert drug

– 44% involved pain management medications

including morphine, hydromorphone,

meperidine and fentanyl.

– 16.3% involved insulin products.

– 14.2% involved heparin.

– 9.4% involved warfarin (COUMADIN®).

32% of all wrong drug errors did not list

the second drug in the report

9.7% of Medication Error reports

are classified as “other”

Other?

What else we’ve seen….

• Of the 15,511 reports submitted in December

2006,

– 72.4% of the reports had no contributing factor

selected

– The event detail in 24% reports contained 20 or

fewer characters

• Of the 6,937 serious event reports in 2006, 13%

contained 116 characters or less in the event

detail (this bullet contains 117 characters)

www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Mar6(1)/Pages/10.aspx

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www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Mar6(1)/Pages/10.aspx

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www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Mar6(1)/Pages/10.aspx

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www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Mar6(1)/Pages/10.aspx

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Using Adverse Drug Reaction (ADR)

Reports to Identify Medication Errors

• PSA analysts reviewed ADR reports submitted to

the Authority to determine if there were cases

that may have been preventable

• Greater than a 1 mg dose for the general adult

population for an opioid-naïve patient

• 1 mg or greater for an elderly patient who was opioid-

naïve

• Multiple opioids

• There were 937 ADR reports submitted to the

Authority between June 2004 and October 2009

www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Sep7(3)/Pages/69.aspx 25

www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Sep7(3)/Pages/69.aspx

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Adverse Drug Reaction (ADR) Reports

Mentioning HYDROmorphone

• Of the reported CNS and respiratory adverse

reactions, (65%, n=292) appear to have been

preventable events, in which

– Opiate naive patients received a dose in excess of what

would be needed to resolve pain symptoms

– HYDROmorphone was prescribed and administered

with other medications that would lead to additive

sedative effects

www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Sep7(3)/Pages/69.aspx

• Nurses reported more ADEs through voluntary

IRs than pharmacists, parents/patients, medical

staff combined.

Kunac DL, Reith DM. Preventable medication-related events in hospitalized children in New

Zealand. N Z Med J. 2008; 121:17-32.

Figure 1 from Kunac et al.6

Who Reports Medication Errors?

Voluntary Reporting

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Studies of medical services suggest that only

1.5% of all adverse events result in an

incident report.

O'Neil A,. Ann Intern Med 1993;119:370-376

“We found that less than 4% of all adverse

drug events involving use of rescue drugs

were reported.”

Schade, Am J Med Qual. 2006 Sep-Oct;21(5):335-41

Problems with Quantitative Reporting

• Quality of reports

• Competing programs

• Fear of punitive action

• Follow-up

• A reporting program alone does not

improve patient safety

Factors that Inhibit Reporting

• Lack of a clear definition of a medication

error

• Insufficient information collected

• Failure to improve the medication system

or address reported issues

• Lack of feedback to staff

• Complex reporting process

• Fear of punishment or ridicule

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Medication Error Reporting Forms

• Too much emphasis on front line staff to

fill out the entire form

• Unrealistic expectations of what staff will

know

• Who is going to follow-up?

• Which reports do we put time into further

investigation?

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Ineffective Error Measurement

• Total reliance only on spontaneous reporting

• Analysis

– Lack of identifying root causes of errors

• Internal aggregate data – Focus on error rates

0

5

10

15

20

25

30

35

January February March April May June

Wrong Drug Wrong Dose Wrong Patient

“Trending” of Error Reports

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Aggregated Data

• Shows interesting trends

• Better for global evaluation

• No detail to work with

• Cause unclear at the macro level

• Potential false conclusions

• What really happened?

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Risk Identification in Healthcare

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The detection of a potential or actual

problem associated with patient care

Recognizing variations in process or

expected outcomes which may or may not

involve patient harm

Methods of Data Collection • Proactive Risk Assessment

– Self Assessments

– Failure Mode and Effects Analysis (FMEA)

– External Sources of Data

– Walkrounds™

– Staff Meetings, Safety Briefs

• Concurrent Risk Assessment

– Pharmacy Interventions (clinical or dispensing staff)

– Nursing Interventions

– Triggers and Markers

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Methods of Data Collection

• Retrospective Risk Assessment

– Observational methodology

– Data from technology

– Chart reviews

– Internal, voluntary reporting

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PA HEN Opioid

Knowledge Assessment

• Types of questions

– Opioid-naïve vs. opioid-tolerant patients

– Long-acting opioids

– Equianalgesic dosing

• HYDROmorphone dosing

– Patient-specific conditions requiring a lower

starting dose of opioids

– Concomitant medications

– Monitoring the effects of opioids

Opioid Tolerant

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0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Overall

Doctors

Residents

PA/NP

Nurses

Pharmacists

% Answering Correctly

Pharmacist Interventions

• Order interventions

– Dose adjustment for antibiotic therapy

based on current laboratory values

• Computer screening and alerts

– Patient information

– Lab information

– Drug database

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Process Measures

• Are you hospitals performing processes

as expected?

• Measuring the rate of compliance

• Does not tell you “why” they didn’t follow

process

– “Didn’t follow policy and procedure”

Process Measures

• Phone calls to obtain weights / Patients

on IV heparin/enoxaparin

• Phone calls to clarify aminoglycoside

dosing / New orders for

aminoglycosides

• Patients assessed for opioid status /

Patients prescribed opioids

Triggers • An easily identifiable, focused item

representing an opportunity (or clue)

that may lead to an adverse event

• Medications, laboratory tests, patient

conditions

• “Something went wrong”

• Effective method for measuring the

overall level of harm

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Medication “Triggers”

Triggers

• Antihistamines

• Epinephrine

• Dextrose 50%

• Glucagon

• Naloxone

• Vitamin K

• Protamine

Possible ADE

• Allergic reactions

• Allergic reactions

• Hypoglycemia

• Hypoglycemia

• Narcotic overdose

• Warfarin misuse

• Heparin misuse

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Triggers

• INR more than 6

• PTT greater than 100 seconds

• Blood glucose more than 300 or

less than 50

• STAT medications or labs

• Oversedation events (RST calls)

• Patient falls

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Outcome Measures

• Measuring the rate of harm

– Naloxone use / Patients administered

opioids

– Patients with BG <70 / Patients on insulin

– Patients with INR >6 / Patients on warfarin

Alternatives to Error Reporting for

Research Purposes

• Triggers

• Tracking of pharmacist interventions

• Focused audits/checks

• Errors detected and averted by automation

• Preparation variances

• Direct observational methods

• Must be a consistent process over time to be

useful as a measure

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Questions?