using aers in postmarketing surveillance of medication errors carol holquist, rph director, division...

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