Evaluating Drug Names for Similarities: Methods and Approaches Public Meeting

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Evaluating Drug Names for Similarities Methods
and Approaches Public Meeting

• June 26, 2003
• Bill Campbell, PhD
• Dean, UNC School of Pharmacy
• Director, UNC Center for Education and Research
  on Therapeutics (CERTs)

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Sometimes similar drug names are
approved contingent on a
pre-marketing agreement for a risk
management program. 1. What role should a
pre-marketing commitment for a risk
management plan play in the approval of a
proprietary name that has some potential for
sound- alike or look-alike confusion with
other marketed products? 2. What
components of a risk management plan should
be considered in order to minimize the risk
associated with proprietary name
confusion? 3. What should be the measurable
goal(s) of such a risk management plan?
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Risk Management Program (RMP) a strategic
safety program designed to decrease product
risk by using one or more interventions or
tools beyond the package insert 1 i.e., a
safety net General categories of RMP
Specialized educational materials for health
practitioners or patients Processes or
forms to increase compliance with
reduced-risk prescribing and use, Systems
that modify conventional prescribing,
dispensing, and use of the product to minimize
specific risks 1 FDA Concept Paper Risk
Management Programs
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What role should a pre-marketing commitment for
a risk management plan (RMP) play in the approval
of a proprietary name that has some potential
for sound-alike or look-alike confusion with
other marketed products? a. CERTs Theme
Manage the Risk, Benefit the Patient
b. Analogous to premarketing clinical
assessment Efficacy vs.
Effectiveness c. Can an approved RMP reduce
the time to market?
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a. CERTs Theme Manage the
Risk, Benefit the Patient There
will always be risk, it cannot be totally
eliminated. Welcome the opportunity to manage
risk, since this is the only way to deliver
benefit. The challenge is to identify the
maximum acceptable risk, manage it, and maximize
the benefits.
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What components of a risk management program
should be considered in order to minimize
the risk associated with proprietary name
confusion? Components of a RM
Program Dear Provider Letters Active
Surveillance Passive Surveillance Sticker
(attestation) Patient Registration Prescriber
Registration Restricted Distribution Restrict
ed Prescribing Mandatory Education
Program Card System 800 number Pharmacovigil
ance Analysis CME
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What components of a risk
management plan should be considered in
order to minimize the risk associated with
proprietary name confusion? Components
of a RM Program (continued) Educational
Programs (journal ads, direct mailing) Usual
Promotional Activities Prescriber
Credentialing Patient Monitoring Pharmacist
Registration Pharmacist Monitoring No-refill
Policy Restricted Distribution Information
Technology Solutions CPOE Internet Person
al Electronic Medical Record (Permutations and
Combinations)
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What components of a risk
management plan should be considered in
order to minimize the risk associated with
proprietary name confusion? Suggested
Components of a RM Program (tailored to
Proprietary Name Confusion) Written
prescription only (no verbal prescription) Attes
tation of Potential for Confusion RMP using two
names Prescriber Validation by
Feedback etc. There are no gold standards,
only hypotheses to be tested Systems Approach
preferred to One-up Approach
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b. Efficacy vs. Effectiveness Similarities
to predicting real world practice from RCT
data Cognitive medical psychology
Application Software Behavioral
laboratory Focus groups Case
studies Modeling and Mapping Expert
Committees Surveys etc. but without
the RCT as reference
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Role of drug name efficacy studies for
RMP Describe expected risks Identify
risks not previously suspected Provide
estimate of risk (rate measure) Identify
benefits not previously suspected Provide
estimate of benefit (rate and measure) Inform
RMP and evaluation
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c. Can an approved RMP reduce time to
market? Hypothetical
Case Proposed drug name Appesate Existing
drug name Apresolate Scenario A Approve
with required RMP to define and reduce unknown
risk of substitution/confusion (reduced time to
market) Scenario B Defer approval until
premarketing studies eliminate potential for
error (no effect on time to market)
(Should it reduce time to market?
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Should a RMP ever be used to reduce time to
market? Criteria for
approving a drug contingent on RM Plan When
no alternative therapy is available When
substantial therapeutic advantage exists for new
product When therapy is for serious and/or
life threatening When Risk/Benefit of therapy
can be effectively communicated to provider
and patient
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When no alternative therapy is available When
substantial therapeutic advantage exists When
therapy is for serious or life threatening When
Risk/Benefit of therapy can be effectively
communicated to provider and
patient Do any of these conditions apply
for choosing a confusing name? No alternative
name? (17,000 current proprietary
names) Substantial therapeutic advantage for a
new name? (Ziagra) Treated condition made less
serious by name? Risk/Benefit of name can be
communicated? CONCLUSION Reduction of time
to market is not a rational goal
for a name-based RMP
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What components of a risk
management plan have been shown to be
effective in minimizing risk associated with
proprietary name confusion? Face
Validity Restricted Distribution Restricted
Prescribing Unproven All others
Hypotheses Effectiveness of individual
elements not known Effectiveness of
combinations not known (a large, and
unfunded, research agenda)
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What should be the measurable
goal(s) of such a risk management
program? 1. What is the baseline? 2. What
is the maximum acceptable risk? 3. What is
the measure of success? 4. What is the
target?
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What is the baseline? Baseline
the error rate for a proprietary name with no
projected look-alike, sound-alike confusion.
(Baseline a, where a gt 0) requires
knowledge of risk requires data on current
practice (prescribing, dispensing, use)
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What is maximum acceptable
risk? Maximum Acceptable Risk acceptable
error rate for a proprietary name with a
potential look-alike, sound-alike comparitor
Maximum Acceptable Risk ß, where ß gt a gt
0 requires knowledge of R/B of proposed
name requires knowledge of R/B of
distracter names
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What is the measure of
success? Measure of Success (?) A
range of error rates ETLT maximum acceptable
risk (ß), but ETGT baseline risk
(a) (Measure of Success ?, where 0 lt a lt ? ltß
)
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What are the targets for a
RMP? A target is a specific, quantitative
goal for error rate established a priori by a
RMP i.e., an expected rate (e) e
?1?n, where ?1 lt e lt ?n
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OPTIONS

• Hurricanes and Tropical Storms
• 1. Gender specific names
• 2. Alternating genders
• 3. Name acquires attributes
• of the drug (e.g., Floyd)
• Thoroughbred Horses
• 1. Initially an alphanumeric designator (CF321)
• 2. Secondarily a name (Secretariat)

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OPTION B Status Quo

• 17,000 Proprietary Drug Names
• 1. First come driven names
• 2. Class naming by competition
• 3. Drug acquires attributes of
• the name (e.g., Viagra)

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Conclusions and Recommendations

• 1. RMP can improve Risk/Benefit
• Ratio,but the choice of individual
• elements or an optimum
• combination requires primary
• research.

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Conclusions and Recommendations

• 2. In order to have an effective RMP
• there must be measurable
• quantitative goals for baseline risk,
• acceptable risk, success, and
• targets.

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Conclusions and Recommendations

• 3. Given the state-of-the-art of research in
  proprietary name-
• related RMP, this is not a
• mechanism for reducing time
• to market.

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