12/4/031 Drug Safety and Risk Management Advisory Committee Advancing the Science of Proprietary Drug Name Review Paul J. Seligman, MD

12/4/032 Description of Problem Substantial Numbers of Medication Errors are resulting from: –Look and Sound Alike Names –Confusing packaging and drug labeling

12/4/033 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

12/4/034 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

12/4/035 What did we hear? Current approach is qualitative and isn’t consistent nor can most approaches be validated or reproduced.

12/4/036 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

12/4/037 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

12/4/038 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 what’s not working, why something’s not working Assign a level based on severity and visibility

12/4/039 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

12/4/0310 Computation Linguistic Techniques String Matching –Orthographic vs. phonological –Phonological matching approaches –ALIGN

12/4/0311 Sampling Qualitative, not quantifiable Lack of specific, definable question Needs quantitative approach 1.Standardize the procedure 2.Test for reliability or reproducibility 3.Test for validity (does measure compare w/gold standard)? 4.Make appropriate changes to procedure

12/4/0312 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

12/4/0313 Risk Management Programs What role should they play? –Is there ever a situation where there’s 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?

12/4/0314 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

12/4/0315 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

12/4/0316 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.

12/4/0317 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.

12/4/0318 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

12/4/0319 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.

12/4/0320 Today’s 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

12/4/0321 Today’s 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

12/4/0322 At Today’s 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;

12/4/0323 Today’s Discussion c. describe circumstances when a field test should be required and to indicate whether any one method could stand alone, and

12/4/0324 Today’s Discussion d. Describe circumstances when it would be appropriate to approve a proprietary drug name contingent on a risk management program.

12/4/0325 Thanks!