# Presentation: 315342

## Behavioral Studies Supporting Rx-to-OTC Switches

- Saul Shiffman, Ph.D.
- Professor, Psychology, Psychiatry & Pharmaceutical Sciences, University of Pittsburgh
- Senior Scientific Advisor, Pinney Associates
- Partner, JSR LLC
- Chief Science Officer, invivodata, inc.

## Agenda

- Predict/evaluate consumer behavior in the OTC environment
- Consider more information on likely OTC use
- Leverage a wider array of influences on OTC use
- Expand scientific foundations of OTC switch

- NDAC 9/25/06

## The New OTC Paradigm

- OTC switches increasingly complex
- From acute treatment of symptomatic conditions to
- Support of preventive lifestyle changes
- Chronic treatment of asymptomatic conditions
- Challenges ahead

- NDAC 9/25/06

## Behavioral End-Points in OTC Switch

- Drug pharmacology typically well-understood
- Considered safe & effective if used properly
- Questions in OTC switch are behavioral
- Critical question:
*Will consumer behavior lead to safe and effective use?*

- NDAC 9/25/06

## Key Elements of OTC Simulation in Actual Use Studies

- No learned intermediary
- Sample consumers with interest in treatment
- Consumer makes decisions regarding drug purchase / use / repurchase / discontinuation
- Data-gathering may cause “reactivity”

- NDAC 9/25/06

## Strategies to Limit Reactivity:Reactivity vs. Insight

| Strategy | Pros | Cons |
| --- | --- | --- |
| Limit frequency of data collection contacts | Reduce potential influence | Reduce detail in data
Maximize use of recall |

- NDAC 9/25/06

## Strategies to Limit Reactivity:Reactivity vs. Insight

| Strategy | Pros | Cons |
| --- | --- | --- |
| Limit frequency of data collection contacts | Reduce potential influence | Reduce detail in data
Maximize use of recall |
| Ask very open questions  | Reduce information to subjects  | Reduce detail in data
Introduce ambiguity |

- NDAC 9/25/06

## Strategies to Limit Reactivity:Reactivity vs. Insight

| Strategy | Pros | Cons |
| --- | --- | --- |
| Limit frequency of data collection contacts | Reduce potential influence | Reduce detail in data
Maximize use of recall |
| Ask very open questions  | Reduce information to subjects  | Reduce detail in data
Introduce ambiguity |
| Conduct Self-selection tests separate from AUS | Allow detailed debriefing of self-selection, without contaminating AUS | Additional research burden
Do not observe purchase |

- NDAC 9/25/06

## Evaluating Study Outcomes:Focus on What’s Critical to Risk / Benefit

- Focus on issues that matter most for consumer health
- Identify and agree on core issues for particular switch
- _Design:_ Study & end-points to address key questions
- _Evaluation:_ Focus on key end-points for risk

- NDAC 9/25/06

## Total Compliance Measures Highly Sensitive to Number of Warnings + Directions

- NDAC 9/25/06

## Total Compliance Measures Highly Sensitive to Number of Warnings + Directions

- NDAC 9/25/06

## Interpreting Outcomes: How Good is Good Enough?

- No single standard; weigh by risk
- Benchmarks:
- Compliance with warnings in other domains
- Behavior under Rx

- NDAC 9/25/06

## Realistic Expectations of Warning Compliance

- _Experimental example_: Warning to wear gloves/mask
- Randomized to:
- Range of different warnings
- Cluttered vs. uncluttered setting
- Evaluate compliance

- Wogalter et al (1993)

- NDAC 9/25/06

## Compliance with Warning/Direction for Chemical Protection

- Wogalter et al (1993)

- +

- NDAC 9/25/06

## Compliance with Warning/Direction for Chemical Protection

- Wogalter et al (1993)

- +

- +

- NDAC 9/25/06

## Compliance with Warning/Direction for Chemical Protection

- Wogalter et al (1993)

- +

- +

- +

- NDAC 9/25/06

## Context for OTC Switch:Rx Use Patterns

- Evaluate change: existing Rx context vs. OTC
- Real-world Rx use as benchmark
- Example: OTC Switch of Nicotine Replacement Therapy (NRT): Nicotine gum and patch

- NDAC 9/25/06

## Prescribing Practices for NRT(Pre-OTC Switch, Patient Reports)

- Shiffman et al (in press)

- NDAC 9/25/06

## Prescribing Practices for NRT(Pre-OTC Switch, Patient Reports)

- Shiffman et al (in press)

- NDAC 9/25/06

## Expanding Sources of Information for Predicting OTC Behavior

- Actual patterns of Rx use
- Actual patterns of OTC (BTC) use ex-US
- Actual patterns of use of similar OTCs
- Post-marketing surveillance

- NDAC 9/25/06

## Expand Sources of Influence on OTC Behavior

- Label is primary source of OTC information
- Expand other points of influence
- In-pack materials: Print, CDs (still considered ‘labeling’)
- Consumer educational materials/programs
- Behavioral programs
- Outreach to physicians and other influencers
- Risk Management Programs
- Especially important for small at-risk populations

- NDAC 9/25/06

## Evaluating Supplementary Programs

- Evaluation based on importance for safe OTC use
- Demonstrate the drug is OTC-able **with** the program
- Some programs can’t be implemented/evaluated before approval

- NDAC 9/25/06

## More Research Is Needed

- e.g.,
-  How do wording, format, order of warnings affect attention,    priority, & compliance?
-  How much does assessment lead to reactivity?  How best to minimize reactivity?

## Advancing the Scientific Foundations of OTC Switch

- Assess “State of the Science”
- Analyze past switches
- Review behavioral research relevant to OTC
- Collect new data on key OTC issues
- Develop behavioral science of OTC Switch

- NDAC 9/25/06

## Questions?

- NDAC 9/25/06