Drug Safety and Risk Management Advisory Committee

1
Drug Safety and Risk Management Advisory
Committee

• Advancing the Science of
• Proprietary Drug Name Review
• Paul J. Seligman, MD

2
Description of Problem

• Substantial Numbers of Medication Errors are
  resulting from
• Look and Sound Alike Names
• Confusing packaging and drug labeling

3
IOM Report

• 12/99 To Err is Human IOM Report proposed that
  FDA require drug companies to test proposed drug
  names for confusion
• 11/02 HHS Committee on Regulatory Reform called
  for FDA to shift responsibility to industry

4
June 26, 2003 Public Meeting

• Held in cooperation with PhRMA and ISMP
• The first attempt at a public discussion of
  current methods to screen proprietary drug names
  for similarities.
• Well attended by industry and others

5
What did we hear?

• Current approach is qualitative and isnt
  consistent nor can most approaches be validated
  or reproduced.

6
Proprietary Drug Name Testing Methods

• Expert Committees
• not much research in area
• Expert panels need to be run consistently to be
  useful.
• Keep the group between 8 12 participants
• Establish a baseline level of expertise
• Avoid group think

7
Questionnaire Design

• Huge challenges in designing surveys for
  unmarketed products
• Limits on experts ability to predict errors
• Need to consider simulated circumstances that
  accurately reflect pharmacy environment
• Focus groups good for generating ideas, weak
  for evaluating individual reactions to stimuli

8
Failure Mode and Effect Analysis

• Pick an expert committee or team
• Flow chart your process to determine root cause
  analysis
• Using all tools, systematically go through each
  step to determine whats not working, why
  somethings not working
• Assign a level based on severity and visibility

9
Handwriting Recognition Techniques

• Basic combination of certain handwriting elements
  that are similar in all handwriting techniques
• Pattern of writing a proposed name
• A database of graphic patterns for all existing
  drug names to make comparisons

10
Computation Linguistic Techniques

• String Matching
• Orthographic vs. phonological
• Phonological matching approaches
• ALIGN

11
Sampling

• Qualitative, not quantifiable
• Lack of specific, definable question
• Needs quantitative approach
• Standardize the procedure
• Test for reliability or reproducibility
• Test for validity (does measure compare w/gold
  standard)?
• Make appropriate changes to procedure

12
Computer Assisted Decision Analysis

• Prescribing Frequency - a powerful driver of
  errors
• Focus on harm reduction
• Objective measures demonstrate perfect
  reliability
• Predict probability of human error

13
Risk Management Programs

• What role should they play?
• Is there ever a situation where theres a
  substantial therapeutic benefit for a new name?
• Elements of risk management plans unproven
• Need measurable goals
• determination of baseline of error,
• minimal risk of error,
• measure of success in RMP and
• what are the quantitative goals of the program?

14
What did we hear at the public hearing?

• Need to adopt a more systematic process with
  standardized tools.
• OTC and Prescription drugs should be held to the
  same testing standard.
• Simulation should reflect real life drug order
  situations

15
Open Public Hearing cont.

• Study design should replicate medication order
  situations with known error vulnerabilities
• How medication orders are communicated either
  contribute or reduce the potential for errors

16
Open Public Hearing cont.

• Drug name, strength, quantity and directions for
  use, patient age and weight for pediatric
  patients should be included in studies.
• Study methods must be scientifically validated,
  reproducible, objective and transparent.

17
Issues for Later Discussion

• Prefixes and Suffixes - May contribute to the
  problem of medication errors.
• OTC Family Names Drug product names marketed
  based on consumer recognition. The practice
  leads to consumer confusion.

18
Major Themes

• That there is inconsistency in how name testing
  is currently conducted.
• Validation and reproducibility of findings is
  important.
• All methods discussed offered value - and should
  be used complimentarily

19
Next Steps

• Summarize Public Meeting Proceedings
• Consider public meeting discussion/written
  comments and DSaRM recommendations
• We may ask industry to provide pre-marketing
  testing results/data to FDA a guidance document
  is likely.

20
Todays Independent Experts

• Five Speakers
• Phonological String Matching - Dorr
• Use of Expert Panels - Shangraw
• Use of Focus Groups - Kimel
• Laboratory, other Simulated Approaches - Schell
• Simulated Pharmacy Practice - Hennessey

21
Todays independent experts will present

• An overview of each method
• How method should be validated
• Proposed study design to determine potential for
  drug name to lead to medication errors
• Strengths and weaknesses of each method

22
At Todays Meeting

• We will consider the pros and cons of
• a. taking a risk based approach to testing
  proprietary drug names
• b. identifying critical design elements of each
  method to be included in good naming practices

23
Todays Discussion

• c. describe circumstances when a field test
  should be required and to indicate whether any
  one method could stand alone, and

24
Todays Discussion

• d. Describe circumstances when it would be
  appropriate to approve a proprietary drug name
  contingent on a risk management program.

25

• Thanks!