# Presentation: 658333

## Drug Naming Activities Update

- Mary C. Gross
- Office of Drug Safety
- CDER/FDA

## Drug Naming

- June 26, 2003 Public Meeting
- December 4, 2003 DSaRM Meeting
- Next Steps?

## June 26th Public Meeting

- Co-sponsored by:
- ISMP
- PhRMA
- FDA

## Meeting Purpose

- IOM recommends that FDA require drug companies test (using FDA approved methods) proposed drug names
- HHS recommends that FDA shift the name screening responsibility to industry – FDA will review the data

## Meeting Purpose Continued..

- To encourage an open discussion of current methods and approaches to screen proprietary drug names for similarities

## FDA Looks For..

- Sound alike and look alike properties
- To currently marketed and unapproved names
- To other medicinal products
- To commonly used medical abbreviations, medical procedures and or lab tests
- Promotional and Misleading Claims

## Drug Company Perspective

- No solid evidence that name confusion is causing medication errors
- Some methods are subjective, not reproducible and can not be validated

## Good Naming Practices

- Which methods will pass FDA muster?
- Standardized and predictable methods that yield reproducible results are necessary
- Usefulness of tools need validation

## Practitioner Perspective - Lesar

- Drug name confusion shows clear potential for error
- Out of 32,000 prescriber errors, 20% show link to nomenclature

## Practitioner Perspective

- A growing problem
- 	- Between 1996 and 2000 – 75% due to nomenclature
- 	- contributes to 2 or more significant med errors a day
- 	- commonly contribute to or cause patient harm

## Open Public Hearing (Oral and Written Comments)

- Who commented?
- 	- Pharmaceutical Companies
- 	- Consumer Healthcare Products   	Association
- 	- Health Professional Groups
- 	- Trademark Attorneys

## 1. Are Current Methods Appropriate Screening Tools?

- There are no consistent methods
- Need peer reviewed evidence that the method can reduce the probability for confusion or harm

## Are current methods appropriate screening tools?

- Method must be reproducible, transparent
-     and include objective evidence
- No perceived conflicts of interest or financial gain
- Simulations should mirror true to life hospital situation

## Are current methods appropriate screening tools?

- Medication errors are multifactorial –methods should be developed, including computer tools, to produce reliable, reproducible results

## 2. Study design? Rx study size? Expert panel composition?

- Evaluate names in real practice design with safety as primary measure
- Include controls in research designs
- Use state of art techniques, like linguistics
- Include more info than the drug name (eg indication, route of administration, dose)

## Study Design? Prescription Study Size? Expert Panel Composition?

- Evaluate all written formats while considering the audience
- Do not focus on testing for name similarity, but test the risk that name similarity may lead to med errors
- At a minimum, include doctor, pharmacist, nurse, patient on expert committee

## 3. Information to be included in written or verbal drug studies?

- Assess error potential of the names in the context of the medical order
- Drug name should be the primary variable – strength, quantity, directions for use, abbreviations and name extensions should be examined

## Information to be included in written or verbal drug studies?

- Until a validated, reproducible method is identified, details can not be defined
- Greater weight should be assigned to:
- Differences in strength
- Directions for use
- Patient population
- Patient age and gender differences

## 4. Utility and evaluation of RMP?

- Use RMP as last resort
- Assess health professional experience
- Bring stakeholders in to define the problem
- RMP could be used when the risk of error is established and the intervention can avoid the risk

## 5. Different testing for OTCs and Rx drugs?

- Most felt that OTCs and Rx drugs should be held to same standard
- Methods should be the same – study design, subjects and important outcomes will vary

## Different testing for Rx and OTC drugs?

- Use different methods – consumers self-select, severity and scope of errors are different, pharmacists and doctors aren’t part of process
- According to CHPA, there is no need to change current procedures

## Independent Experts – Mike Cohen (Moderator)

- Strom  - Sampling
- 	- It is qualitative research – no exposed group, no control group, no definable question
- 	- Striking lack of consistency in methods and no evaluation of what works

## Sampling continued

- Need four step process:
- Standardize the procedure providing a description and evaluation
- Test for reliability and reproducibility
- Test for validity – we need a gold standard
- Make changes in procedure

## Questionnaire design - Diamond

- Broad issue of research design and questionnaire construction
- Expert panels are useful – but may not reflect reality

## Questionnaire design

- Focus groups are weak for evaluating individual reactions to specific stimuli
- Computer order entry will bring a new set of problems that will need to be monitored closely

## Handwriting recognition technology - Jaczcak

- Parascript - uses descriptive language that simulates written motions and strokes.
- Compares written graphic patterns of proposed names against already existing names

## Independent experts - Peter Gross, MD (moderator)

- Expert Committees – Shangraw
- 	- Run the committee consistently and without bias
- 	- Do not use an expert committee exclusively; multiple methods work best
- 	- Expert committees should number 8 - 12

## Expert committees

- 	- Include baseline expertise –
- 	- Include physicians, pharmacists, nurses, patients
- 	- Extensive use of computers can diminish returns

## Computer methods – Dorr/Lambert

- ALINE
- Algorithm used to pair up different languages to match up cognates
- String matching –orthographic vs. phonological, distance vs. similarity

## Computer methods cont.

- Similarity has little effect on recognition memory errors to a point.  Later, the more similar the names, the more likely the name will be confused

## Failure mode and effects analysis - Gosbee

- 	Pick a topic
- 	Form a team or expert committee
- 	Flow chart your progress
- 	Determine what is failing and why it’s failing
- 	Assign severity probability and visibility

## Failure mode and effects analysis

- Challenge
- 	- People come with a certain mindset – the idea of similarity or matching is complex and situation dependent

## Risk management programs - Campbell

- Numerous ways to manage risk – but only sparse evidence pointing to what works
- Need measurable quantitative goals to assess baseline risk, acceptable risk, success and targets

## Risk management programs

- Can beg the question:
- 	Is there any level of risk that’s worth taking?  The name affords commercial value – no identifiable public health value

## June 26, 2003 public meeting

- Opened the dialogue with all players
- Demonstrated that there were more questions than answers

## DSaRM – December 4, 2003

- Drug Safety and Risk Management AC
- Issue:  A continued discussion of current screening methods to assess look alike and sound alike potential in proprietary drug names

## Meeting presenters

- Paul Seligman – FDA Opening Remarks
- Bob Lee – PhRMA Perspective
- Jerry Phillips – FDA Review of Names
- Bonnie Dorr – Automatic String Matching
- Richard Shangraw – Expert Committees
- Miriam Bar-Din Kimel – Focus Groups
- Kraig Schell – Laboratory and Simulation Testing
- Sean Hennessy – Mock Pharmacy Practice

## Issues for discussion

- Describe the advantages and disadvantages of evaluating all names for potential confusion versus taking a more selective risk based approach.  Is it possible to triage the drug names into groups that may be handled differently based on risk?

## DSaRM recommendations

- All drug names should be screened, including drug names for OTC switch applications
- Triaging drug names according to level of risk was not recommended

## Issue for discussion

- Based on discussion of the study methods, identify critical design elements of each method that should be included in good naming practices.  Are there any methods that should be discounted as  ineffective screening tools?

## DSaRM recommendations

- No study methods could be validated so they could not assess the credibility and predictability of the methods
- Until more data is available, development of a cohesive set of study methods is premature
- No one method should stand alone

## DSaRM recommendations

- A working group should be established to:
- 	- Identify current screening methods deficiencies
- 	- Define what additional methods are needed
- 	- Propose necessary data to effectively screen names
- 	- and report back to DSaRM within 12 months

## DSaRM discussion

- In addition to the methods discussed today, are there other methods that should be considered?
- 	Drug name pronunciation

## DSaRM discussion

- Describe the circumstances, if any, when a drug name should be approved contingent on a risk management program
-   There are no circumstances – but that RMPs might be a useful postmarket tool

## Possible next steps?

- Engage stakeholders?
- FDA analyses – look back at actual tradename errors and analyze actual contributing factors

## Guidances/MaPPs

- MEPA (Medication Errors Prevention Analysis)
- Good Naming, Labeling and Packaging Practices
- Selecting and Submitting Proprietary Names for Evaluation

- Thank You!