Mandatory Drug Risk Information:How much information is too much?

Ruth S. Day / Duke UniversityFDA Public Hearing / Medication Guides

Washington, DC -- June 12, 2007

AccutaneMedication Guide

Ruth Day

Basic Methods

Study Test

time

All MultipleContent Tasks

Ruth Day

--benefits--risks--etc

--attention--comprehension--memory

Basic Methods

Study Test

time

All MultipleContent Tasks

Ruth Day

--benefits--risks--etc

--attention--comprehension--memory

Basic Methods

Study Test

time

All MultipleContent Tasks

Ruth Day

--benefits--risks--etc

--attention--comprehension--memory

Key Educational Message

Ruth Day

Key Educational Message

“What is the most important information I should know about Accutane?”

Ruth Day

0

20

40

60

80

100

Are Preg PlanPreg GetPreg

% C

OR

RE

CT

Pregnancy%

CO

RR

EC

T

Ruth DayRuth Day

96

46

00

20

40

60

80

100

Are Preg PlanPreg GetPreg

% C

OR

RE

CT

% C

OR

RE

CT

Pregnancy

Ruth Day

96

46

00

20

40

60

80

100

Are Preg PlanPreg GetPreg

% C

OR

RE

CT

% C

OR

RE

CT

Pregnancy

Ruth Day

96

46

00

20

40

60

80

100

Are Preg PlanPreg GetPreg

% C

OR

RE

CT

% C

OR

RE

CT

Pregnancy

Ruth Day

96

46

00

20

40

60

80

100

Are Preg PlanPreg GetPreg

% C

OR

RE

CT

% C

OR

RE

CT

Pregnancy

Ruth Day

ACCUTANEMedication

Guide

Ruth Day

Original Version

Become more irritable, angry, or aggressive than usual (for example, temper outbursts,thoughts of violence)

Have a change in your appetite or body weight

Have trouble concentrating

Withdraw from your friends or family

Feel like you have no energy

Have feelings of worthlessness or inappropriate guilt

Start having thoughts about hurting yourself or taking your own life (suicidal thoughts)

What is Accutane?

Accutane is used to treat the most severe form of acne (nodular acne) that cannot be cleared upby any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen,tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated,nodular acne can lead to permanent scars. However, because Accutane can have serious sideeffects, you should talk with your prescriber about all of the possible treatments for your acne,and whether Accutane’s possible benefits outweigh its possible risks.

Who should not take Accutane? Do not take Accutane if you are pregnant, plan to become pregnant, or become

pregnant during Accutane treatment. Accutane causes severe birth defects. All femalesshould read the section "What are the important warnings for females taking Accutane?" formore information and warnings about Accutane and pregnancy.

Do not take Accutane unless you completely understand its possible risks and are willing tofollow all of the instructions in this Medication Guide.

Tell your prescriber if you or someone in your family has had any kind of mental problems,asthma, liver disease, diabetes, heart disease, osteoporosis (bone loss), weak bones, anorexianervosa (an eating disorder where people eat too little), or any other important health problems.Tell your prescriber about any food or drug allergies you have had in the past. These problemsdo not necessarily mean you cannot take Accutane, but your prescriber needs this information todiscuss if Accutane is right for you.

How should I take Accutane? You will get no more than a 30-day supply of Accutane at a time, to be sure you check in

with your prescriber each month to discuss side effects.

Your prescription should have a special yellow self-adhesive sticker attached to it. Thesticker is YELLOW. If your prescription does not have this yellow self-adhesive sticker, callyour prescriber. The pharmacy should not fill your prescription unless it has the yellow self-adhesive sticker. Ruth Day

Original

Who should not take Accutane?

Who should not take Accutane? Do not take Accutane if you are pregnant, plan to become pregnant, or

become pregnant during Accutane treatment. Accutane causes severe birthdefects. All females should read the section "What are the important warnings forfemales taking Accutane?" for more information and warnings about Accutaneand pregnancy.

Do not take Accutane unless you completely understand its possible risks and arewilling to follow all of the instructions in this Medication Guide.

Tell your prescriber if you or someone in your family has had any kind of mentalproblems, asthma, liver disease, diabetes, heart disease, osteoporosis (bone loss), weakbones, anorexia nervosa (an eating disorder where people eat too little), or any otherimportant health problems. Tell your prescriber about any food or drug allergies youhave had in the past. These problems do not necessarily mean you cannot takeAccutane, but your prescriber needs this information to discuss if Accutane is right foryou.

Ruth Day

Original

Enhanced Version

ACCUTANEMedication

Guide

Ruth Day

06/20/02

BEFORE TAKING ACCUTANE

Do NOT start taking Accutane: --Do NOT take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. All females should read the section "Warnings for Females" for more information about Accutane and pregnancy.

--Do NOT take Accutane unless you completely understand its possible risks and are willing to follow all of the instructions in this Medication Guide.

Tell your prescriber about:

Health ProblemsTell your prescriber if you or someone in your family has had any of these health problems

--mental problems--asthma--liver disease--diabetes--heart disease

AllergiesTell your prescriber about any food or drug allergies you have had in the past. These problems do notnecessarily mean you cannot take Accutane, but your prescriber needs this information to discuss ifAccutane is right for you.

WHILE TAKING ACCUTANEGetting your prescriptionYou will get no more than a 30-day supply of Accutane at a time, to be sure you check in with yourprescriber each month to discuss side effects (and get a pregnancy test, if you are female).

Your prescription should have a special self-adhesive sticker attached to it. The sticker is yellow. If yourprescription does not have this yellow sticker, call your prescriber. The pharmacy should not fill yourprescription unless it has the yellow self-adhesive sticker.

How should I take Accutane? --The amount of Accutane you take has been specially chosen for you and may change during treatment.

--You will take Accutane 2 times a day with a meal, unless your prescriber tells you otherwise. Swallow your Accutane capsules with a full glass of liquid. This will help prevent the medication inside the capsule from irritating the lining of your esophagus (connection between mouth and stomach). For the same reason, do not chew or suck on the capsule.

--If you miss a dose, just skip that dose. Do not take 2 doses the next time.

--osteoporosis (bone loss)--weak bones--anorexia nervosa (eating disorder where people eat too little)--any other important health problems

New titles(Time Zones)

Enhanced

Ruth Day

06/20/02

BEFORE TAKING ACCUTANE

Do NOT start taking Accutane: --Do NOT take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. All females should read the section "Warnings for Females" for more information about Accutane and pregnancy.

--Do NOT take Accutane unless you completely understand its possible risks and are willing to follow all of the instructions in this Medication Guide.

Tell your prescriber about:

Health ProblemsTell your prescriber if you or someone in your family has had any of these health problems

--mental problems--asthma--liver disease--diabetes--heart disease

AllergiesTell your prescriber about any food or drug allergies you have had in the past. These problems do notnecessarily mean you cannot take Accutane, but your prescriber needs this information to discuss ifAccutane is right for you.

WHILE TAKING ACCUTANEGetting your prescriptionYou will get no more than a 30-day supply of Accutane at a time, to be sure you check in with yourprescriber each month to discuss side effects (and get a pregnancy test, if you are female).

Your prescription should have a special self-adhesive sticker attached to it. The sticker is yellow. If yourprescription does not have this yellow sticker, call your prescriber. The pharmacy should not fill yourprescription unless it has the yellow self-adhesive sticker.

How should I take Accutane? --The amount of Accutane you take has been specially chosen for you and may change during treatment.

--You will take Accutane 2 times a day with a meal, unless your prescriber tells you otherwise. Swallow your Accutane capsules with a full glass of liquid. This will help prevent the medication inside the capsule from irritating the lining of your esophagus (connection between mouth and stomach). For the same reason, do not chew or suck on the capsule.

--If you miss a dose, just skip that dose. Do not take 2 doses the next time.

--osteoporosis (bone loss)--weak bones--anorexia nervosa (eating disorder where people eat too little)--any other important health problems

Enhanced

Ruth Day

Research Methods

Research Methods

Perceptions

Opinions

Attitudes

Research Methods

Comprehension

Memory

Perceptions

Opinions

Attitudes

Perceptions

Opinions

Attitudes

Research Methods

Comprehension

Memory

Perceptions

Opinions

Attitudes

Research Methods

Comprehension

Memory

Study Test

time

Ruth Day

PreTest PostTest

Metacognition

1

2

3

4

5

PreTest PostTest PreTest PostTest

UNDERSTAND REMEMBER

PreTest PostTest PreTest PostTest

very easy

easy

moderate

hard

very hard

“How easy was it to understand the information in the leaflet?”

Ruth Day

1

2

3

4

5

PreTest PostTest PreTest PostTest

UNDERSTAND REMEMBER

PreTest PostTest PreTest PostTest

very easy

easy

moderate

hard

very hard

“How easy was it to understand the information in the leaflet?”

Ruth Day

1

2

3

4

5

PreTest PostTest PreTest PostTest

UNDERSTAND REMEMBER

PreTest PostTest PreTest PostTest

very easy

easy

moderate

hard

very hard

“How easy would it be to remember the information in the leaflet?”

Ruth Day

ConclusionsFor FDA Advisory Committee (8/1/07)

--People overestimated how much they knew and understood after reading

Ruth Day

ConclusionsFor FDA Advisory Committee (8/1/07)

--People overestimated how much they knew and understood after reading

--After testing, they realized they knew less than they thought

Ruth Day

ConclusionsFor FDA Advisory Committee (8/1/07)

--People overestimated how much they knew and understood after reading

--After testing, they realized they knew less than they thought

--AND they actually knew far less than that.

Ruth Day

ConclusionsFor FDA Advisory Committee (8/1/07)