Using AERS in Postmarketing Surveillance of Medication Errors

Carol Holquist, RPh Director, Division of Medication Errors and Technical Support

Office of Drug Safety

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Outline

• Definition of medication error

• Description of medication error surveillance – Signal identification – Evaluation of cases

• Postmarketing examples

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What is a Medication Error?

• Any PREVENTABLE event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.

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Medication Error Events

• Professional practice• Health care products• Procedures• Systems

– including prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use

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NCC MERP Index for Categorizing Medication Errors

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Medication Error Surveillance

• 1999 – Reports to AERS

• Source of reports– Health care providers and consumers– Sponsors– USP/ISMP MERP– Manufacturer

• Approximately 300 reports/month

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DMETS Safety Evaluator

• Dual mission– Identify and monitor medication error postmarketing

“safety signals”– Premarketing safety review of proprietary names,

product labels, labeling and packaging

• Collaborate with OND (medical officer/chemist), Office of Generic Drugs, and Office of Compliance

• NO daily “in-box”• Monthly review of all medication error reports

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Medication Error Safety Signals

• Confusion with product names – proprietary and established

• Error prone product labels/labeling

• Error prone product packaging or device

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Exploring Possible Medication Error Signals in AERS

• A safety question is raised:– MedWatch/ISMP/USP report– Medical literature– Outside inquiry – Etc.

• Search AERS

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Case Search Strategy

• Limited MedDRA terminology – Single PT (Medication Error)– Difficult to retrieve all cases (many miscoded)– Search narrow then broad

• MedDRA 8.0 expands terminology– SADR rule creates additional need for more medication

error terms – Inefficient use of time recoding reports

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Good Quality Medication Error Report

• Products involved – Manufacturer, trade/established names, dosage form,

strength, concentration, type and size of container, etc.

• Sequence of events leading up to the error• Type of error and contributing factors• Work environment• Types of personnel involved in error

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Investigating Causes of Error

• Evaluate AERS/medical literature cases

• Attempt follow-up with reporters

• Categorize cases by type and cause– NCCMERP taxonomy

• Identify risk/contributing factors– Dependent on drug and type of error– Overlapping product characteristics

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Investigating Causes of Error

• Answer “why” & “how”

• Look for trends & patterns of errors– Postmarketing experience (other product lines)

• Evaluate strength of evidence for causal relationship

• Evaluate current labels/labeling/device described in report

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Challenges in Evaluating Case Reports

• Absence of complete description of events • Specific manufacturer not identified• Limited number of cases• Cases can be confounded by other possible

etiologies• Difficulty in acquiring labels/labeling

– Grandfather products (pre-1938), OTC monograph and distributor

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Medication Error Examples

• Poor Label Design

• Poor Packaging Design

• Dual Tradename Confusion

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Dual Tradename

• Approved – Wellbutrin – October 1996– Zyban – May 1997

• Concomitant administration– Dose related seizures

• Limited number of case reports

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Summary

• Useful in detecting product label/labeling problems, packaging problems, and some name confusion

• Reflects use of products in clinical practice

• Not reflective of the magnitude of problem

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DMETS Safety Evaluators

• Linda Kim-Jung• Kristina Arnwine• Todd Bridges• Tselaine Jones-Smith• Laura Pincock• Maria Thomas• Linda Wisniewski• Loretta Holmes

• Alina Mahmud• Kimberly Culley• Felicia Duffy• Shakira Gbadamosi• Charles Hoppes• Jinhee Jahng• Nora Roselle• Tina Tezky