LIST OF APPENDICES

 

 

 

Appendix A: National Panel of Experts, 2001

 

Appendix B: Commonly Asked Questions and Recommended Answers

 

Appendix C1: Patient Information Evaluation Form B ATENOLOL

 

Appendix C2: Patient Information Evaluation Form B GLYBURIDE

 

Appendix C3: Patient Information Evaluation Form B ATORVASTATIN

 

Appendix C4: Patient Information Evaluation Form B NITROGLYCERIN (SUBLINGUAL)

 

Appendix D: Readability Assessment Procedures

 

Appendix E: Consumer Evaluation Form, 2001

Appendix A: National Panel of Experts, 2001

Mary G. Amato, M.P.H., Pharm.D.

Massachusetts College of Pharmacy & Health Sciences

179 Longwood Ave.

Boston, MA 02115-5896

Heidi M. Anderson-Harper, Ph.D., R.Ph.

School of Pharmacy

Auburn University

Auburn, AL 36849-5501

Robert S. Beardsley, Ph.D., R.Ph.

School of Pharmacy

University of Maryland

20 North Pine Street

Baltimore, MD 21201-1180

C. A. Bond, Pharm.D.

School of Pharmacy

Texas Tech University HSC

1300 South Coulter Street

Amarillo, TX 79106

Marie E. Gardner, Pharm.D.

College of Pharmacy

The University of Arizona

PO Box 210207

Tucson, AZ 85721-0207

Betty J. Dong, Pharm D.

Department of Clinical Pharmacy

School of Pharmacy

University of California, San Francisco

San Francisco, CA 94143

Carole L. Kimberlin, Ph.D.

College of Pharmacy

University of Florida

Box 100484

Health Science Center

Gainesville, FL 32610-0484

Duane M. Kirking, Ph.D., Pharm.D.

College of Pharmacy

The University of Michigan

Ann Arbor, MI 48109-1065

Sharlea Leatherwood, R.Ph.

PO 34655

North Oak Pharmacy

Kansas City, MO 64116

Matthew C. Osterhaus, R.Ph.

Osterhaus Pharmacy

124 S. Main Street

Maquoketa, IA 52060

Anthony Provenzano, Pharm.D.

Albertson=s, Inc.

9422 Windsor Parkway

Tinley Park, IL 60477

Mary J. Pubentz, Pharm.D.

Anticoagulation Center

Lutheran General Hospital - Advocate HealthCare

8816 Dempster Street

Niles, IL 60714

Betsy Sleath, PhD, R.Ph.

School of Pharmacy

University of North Carolina

Beard Hall CB#7360

Chapel Hill, NC 27599-7360

Jenene Robin Spencer, Pharm.D.

Residency Preceptor

Fry=s Food and Drug Stores/University of Arizona Community Pharmacy Residency Program

7870 N. Silverbell Rd.

Tucson, AZ 85743

Judith B. Sommers Hanson, Pharm.D.

10011 Marvin Drive

Huntley, IL 60142

Gayle Dichter, R.Ph., M.B.A.

Consultant

The Pharmacy Group

P.O. Box 129

Glastonbury, CT 06025

Bonnie L. Svarstad, Ph.D. (chair)

University of Wisconsin

School of Pharmacy

777 Highland Ave

Madison, WI 53705

 

 

 

Appendix B: Commonly Asked Questions and Recommended Answers

 

Question by Pharmacy Staff

Answer by Patient-Observer

Hello, can I help you?

Yes, would you fill these prescriptions for me.

Have you filled prescriptions here before?

No.

What is your name?

(assigned name)

What is your birth date?

(your modified birth date)

What is your address?

(your modified address)

Are you visiting?

Yes, I am.

What is your telephone number?

(your modified telephone number)

How will you pay for the prescriptions?

I will pay with cash.

Do you have prescription insurance?

No.

Do you have any other medical conditions?

No, just some heart disease and diabetes.

Do you take any other prescription medications?

No, I am not taking any other medications.

Do you have any allergies to medications?

No, none that I know of.

Have you been taking any over-the-counter or non-prescription medications?

No, I haven=t been taking any medications.

Is this the first time you have taken any of these medications?

Yes, it=s the first time I=ve taken any of these.

What did the doctor tell you about the medications?

Just that the directions would be on the label.

When are you talking with the doctor next?

I will be seeing the doctor in two weeks.

What will you do if you have any problems with the medication?

I will call my doctor.

What will you do if your health does not improve?

I will call my doctor.

 

For what reason did doctor prescribe glyburide (or Micronase or Diabeta)?

My diabetes (If pressed say: the doctor said my blood sugar was up)

For what reason did doctor prescribe Lipitor7 (or atorvastatin)?

I think for cholesterol (If pressed say: the doctor said it was too high)

For what reason did doctor prescribe nitroglycerin?

For chest pain (If pressed say: I had difficulty breathing)

For what reason did doctor prescribe the atenolol (Tenormin)?

Doctor said I had some heart disease (If pressed say: That=s about all I know)

Appendix B: Commonly Asked Questions and Recommended Answers

 

Question by Pharmacy Staff

Answer by Patient-Observer

What tests did you have at the hospital?

They did stress test (treadmill).

Do you monitor your diabetes?

No.

Do you follow any special diet?

Yes, for my diabetes.

Do you exercise?

Yes, I walk 20-30 minutes a day.

Did the doctor tell you to take aspirin?

No, we didn=t discuss that.

Have you had any other symptoms?

Just chest pain and shortness of breath

Atenolol can cause problems with blood sugar. Did your doctor mention this?

The doctor mentioned something about that, but said it was important for me to take it.

Did the doctor give you any Asamples@ of the medication?

No.

Would you like pharmacist to counsel you?

Sure

Would you like written information about the medication?

Sure

 

Additional Things to Do and Avoid as a Patient-Observer

THINGS TO DO

THINGS TO AVOID

Appendix C1: Patient Information Evaluation Form B ATENOLOL Office Use: Pharmacy ID: _ _ _ Rater ID: _ _ Leaflet ID: _ _ _ _

Rater: Check two boxes UUif sub-criterion is fully or nearly fully met. Other wording may be counted if it is equivalent or similar in meaning.

Check one box U if sub-criterion is partially met. Leave both boxes blank if no information is provided. PR= doctor or other prescriber; PH= pharmacist

Criteria 1-6: Information is sufficiently specific and comprehensive.

1. Drug names and indications for use

1.1 generic name: atenolol

1.2 phonetic spelling of generic name

1.3 brand names: Tenormin 1.4 drug class :beta-blocker or beta-adrenergic blocking agent 1.5 treat hypertension (or high blood pressure) 1.6 treat angina (or chest pain)

1.7 treat definite or suspected myocardial infarction (or heart attack)

 

 

Comment:

4. Specific precautions and how to avoid harm while using it

4.1 Tell PR or PH if you take any other medications, especially:

4.2 calcium channel blockers such as verapamil and diltiazem

4.3 other blood pressure medicines such as clonidine

4.4 over-the-counter cold products or decongestants

4.5 Do not stop suddenly; gradual dose reduction may be needed#

4.6 May cause serious reaction to allergy shots; tell PR before shots

4.7 May worsen allergic reaction to foods, medicines, or stings; tell

PR as soon as possible so it can be treated

4.8 Before surgery, tell PR or dentist you are taking this medicine

4.9 May affect blood sugar or cover up signs of low blood sugar

# information derived from Ablack box@ warning on professional labeling

Comment:

2. Contraindications and what to do before using drug

Tell PR or PH if you have:

2.1 certain heart problems (or: heart failure, very slow heartbeat) "

2.2 asthma or emphysema "

2.3 diabetes "

2.4 overactive thyroid "

2.5 poor circulation

Tell PR or PH if you are:

2.6 pregnant or may become pregnant; can cause harm to baby "

2.7 nursing or breast-feeding

 

Comment:

5. Symptoms of serious or frequent adverse reactions and what to do

Tell PR or PH as soon as possible if any of these occur:

5.1 trouble breathing

5.2 cold hands or feet

5.3 slow heartbeat or fainting

5.4 swelling of legs or ankles/feet

Tell PR or PH if any of these do not go away or bother you:

5.5 feeling dizzy

5.6 feeling tired

5.7 feeling depressed

5.7 trouble having sex

5.8 trouble sleeping

Comment:

3. Specific directions about how to use, monitor, and get most benefit

3.1 It is important to take this medicine regularly to get the most benefit

3.2 To help you remember, take it the same time(s) each day

3.3 If you miss a dose, take it as soon as you remember

3.4 Skip missed dose if next scheduled dose is less than 8 hours away

3.5 Do not take two doses at same time (or: do not double up)

3.6 May take with or without food

3.7 Store at room temperature, away from excess heat and moisture

 

Comment:

6. General information and encouragement to ask questions

6.1 Keep all medicines away from children

6.2 Do not give this medicine to others

6.3 Leaflet states that it does not include all uses, precautions,

interactions, adverse reactions, or side effects

6.4 Name of publisher

6.5 Date of publication or most recent revision

6.6 Ask PR or PH if any questions or concerns

6.7 You may ask PH for longer leaflet written for professionals

*****GO TO PAGE 2*****

Comment:

 

 

Criteria 7: Information is scientifically accurate, unbiased, up-to-date

Criterion 8: Information is readily comprehensible and legible.

7.1 information is neutral in content and tone

7.2 no unapproved uses are listed (see 1.0 for approved uses)

7.3 no promotional messages about a specific brand, manufacturer, or

distributor (may compare chemical entities)

7.4 no inaccurate or outdated claims about benefits of product

7.5 no inaccurate or outdated claims about risks of product

7.6 no other inaccurate or outdated information was found by this rater

NOTE: All items should be completed even if no information is provided about the uses, benefits, or risks of a product. The purpose is to identify inaccurate, biased, and/or outdated information

 

 

Comment:

8.1 black box warning information printed in bold-face type or box

8.2 minimal use of italics or ornate typefaces that are hard to read

8.3 upper and lower case lettering

8.4 headings placed on separate lines (not on same line as text)

8.5 bullets used to enhance readability

8.6 information is well organized and easy to find

Comment:

The following will be assessed by office staff B leave boxes blank

8.7 adequate space between lines (> 2.2 mm; this is approx. 2.2mm) *

8.8 used no smaller than 10-point type (this is 10-point) *

8.9 good ink-paper contrast *

8.10 written at 6-8th grade level (excluding drug names) *

# none applicable for this drug

* will be assessed by office staff, leave blank

 

 

 

 

atenelol

Appendix C2: Patient Information Evaluation Form B GLYBURIDE Office Use: Pharmacy ID: _ _ _ Rater ID: _ _ Leaflet ID: __ __ __ __

Rater: Check two boxes UUif sub-criterion is fully or nearly fully met. Other wording may be counted if it is equivalent or similar in meaning.

Check one box U if sub-criterion is partially met. Leave both boxes blank if no information is provided. PR= doctor or other prescriber; PH= pharmacist

 

Criteria 1-6: Information is sufficiently specific and comprehensive.

1. Drug names and indications for use

1.1 generic name: glyburide

1.2 phonetic spelling of generic name

1.3 common brand names: DiaBeta, Micronase, Glynase

1.4 antidiabetic (or used to treat diabetes)

1.5 sulfonylurea

1.6 used to lower blood sugar

1.7 used in patients whose diabetes cannot be controlled by diet

1.8 used for non-insulin dependent (or Type 2) diabetes

Comment:

4. Specific precautions and how to avoid harm while using it

4.1 Tell PR or PH before taking any other medications, especially:

4.2 aspirin products

4.3 anticoagulants (or blood thinners)

4.4 azole antifungals (eg, fluconazole)

4.5 beta blockers

4.6 diuretics (water pills)

4.7 corticosteriods

4.8 MAO inhibitors

4.9 May increase sensitivity to sun; reduce exposure to sun

Comment:

2. Contraindications and what to do if applicable

Tell PR or PH if you are:

2.1 allergic to glyburide or other sulfonylureas "

2.2 pregnant or may become pregnant "

2.3 nursing or breast-feeding "

Other:

2.4 use of other sulfonylurea drugs has been associated with serious

heart problems. This risk may apply to use of glyburide

 

 

 

 

Comment:

5. Symptoms of serious or frequent adverse reactions and what to do

5.1 May cause low blood sugar or hypoglycemia

5.2 To help prevent, do not miss meals or drink alcohol

5.3 Some symptoms of low blood sugar: fast heartbeat, sweating,

tremors, headache, confusion, nervousness [list 3]

5.4 Use quick-acting sugar to treat low blood sugar

Tell PR or PH as soon as possible if any of the following occurs:

5.5 allergic reaction: fever, chills, rash, trouble breathing [list 2]

5.6 dark urine, unusual bleeding/bruising, yellowing of eyes [list 2]

Tell PR or PH if any of these do not go away or bother you:

5.7 stomach discomfort, pain, fullness [list 1]

5.8 diarrhea

5.9 more frequent urination

[Number in brackets shows number of symptoms to be listed for full credit]

Comment:

 

3. Specific directions about how to use, monitor, and get most benefit

3.1 It is important to take this medicine regularly to get the most benefit

3.2 To help you remember, take it at the same time(s) each day

3.3 May take with or without food

3.4 If you miss a dose, take it as soon as possible

3.5 Skip missed dose if next scheduled dose is less than 8 hours away

3.6 Do not double up or take two doses at the same time

3.7 Regular testing of blood glucose is important

3.8 Important to follow proper diet and exercise program

3.9 Store at room temperature, away from excess heat and moisture

Comment:

6. General information and encouragement to ask questions

6.1 Keep all medicines away from children

6.2 Do not give this medicine to others

6.3 Leaflet states that it does not include all uses, precautions,

interactions, adverse reactions, or side effects

6.4 Name of publisher

6.5 Date of publication or most recent revision

6.6 Ask PR or PH if any questions or concerns

6.7 You may ask PH for longer leaflet written for professionals

*****GO TO PAGE 2*****

Comment:

 

Criterion 7: Information is scientifically accurate, unbiased, up-to-date

Criterion 8: Information is readily comprehensible and legible.

7.1 information is neutral in content and tone

7.2 no unapproved uses are listed (see 1.0 for approved uses)

7.3 no promotional messages about a specific brand, manufacturer, or

distributor (may compare chemical entities)

7.4 no inaccurate or outdated claims about benefits of product

7.5 no inaccurate or outdated claims about risks of product

7.6 no other inaccurate or outdated information was found by this rater

NOTE: All items should be completed even if no information is provided about the uses, benefits, or risks of a product. The purpose is to identify inaccurate, biased, and/or outdated information

 

 

Comment:

8.1 black box warning information printed in bold-face type or box NA #

8.2 minimal use of italics or ornate typefaces that are hard to read

8.3 upper and lower case lettering

8.4 headings placed on separate lines (not on same line as text)

8.5 bullets used to enhance readability

8.6 information is well organized and easy to find

Comment:

The following will be assessed by office staff B leave boxes blank

8.7 adequate space between lines (> 2.2 mm; this is approx. 2.2mm) *

8.8 used no smaller than 10-point type (this is 10-point) *

8.9 good ink-paper contrast *

8.10 written at 6-8th grade level (excluding drug names) *

# none applicable for this drug

* will be assessed by office staff, leave blank

 

 

 

 

 

 

glyburide

Appendix C3: Patient Information Evaluation Form B ATORVASTATIN Office Use: Pharmacy ID: _ _ _ Rater ID: _ _ Leaflet ID: _ _ _ _

Rater: Check two boxes UUif sub-criterion is fully or nearly fully met. Other wording may be counted if it is equivalent or similar in meaning.

Check one box U if sub-criterion is partially met. Leave both boxes blank if no information is provided. PR= doctor or other prescriber; PH= pharmacist

 

Criteria 1-6: Information is sufficiently specific and comprehensive.

1. Drug names and indications for use

1.1 generic name:atorvastatin

1.2 phonetic spelling of generic name

1.3 brand name: Lipitor 1.4 drug class: HMG - CoA reductase inhibitors

1.5 used to lower cholesterol levels 1.6 used in persons whose cholesterol levels cannot be controlled with

proper diet, exercise, and weight loss if overweight.

 

Comment:

4. Specific precautions and how to avoid harm while using it

4.1 Tell PR or PH before taking any other medications, especially:

4.2 immunosuppressants, especially cyclosporine (Sandimmune)

4.3 gemfibrozil (Lopid)

4.4 erythromycin

4.5 niacin (nicotinic acid)

4.6 azole antifungals (eg fluconazole, ketoconazole, or itraconazole)

4.7 Do not eat grapefruit or drink grapefruit juice while using this drug "

4.8 Should have liver function tests before and after starting this

medicine and on regular basis to check for harmful effects.

Comment:

2. Contraindications and what to do if applicable.

Do not take this medicine if you are:

2.1 allergic to atorvastatin

2.2 pregnant or may become pregnant; can cause harm to baby

2.3 nursing or breast-feeding

Tell PR or PH if you:

2.4 drink large amounts of alcohol "

2.5 have had liver disease

2.6 have had kidney disease "

2.7 have had recent major surgery

2.8 have uncontrolled seizures

Comment:

5. Symptoms of serious or frequent adverse reactions and what to do

Tell PR or PH as soon as possible if any of these occur:

5.1 muscle pains or weakness, especially with fever

5.2 unusual tiredness

5.3 dark urine or yellowing of skin or eyes

5.4 skin rash

Tell PR or PH if these do not go away or bother you:

5.5 constipation

5.6 diarrhea

5.7 headache

5.8 nausea or heartburn

Comment:

3. Specific directions about how to use, monitor, and get most benefit

3.1 It is important to take this medicine regularly to get the most benefit

3.2 To help you remember, take it at the same time(s) each day

3.3 May take with or without food

3.4 If you miss a dose, take it as soon as possible

3.5 Skip missed dose if next scheduled dose is less than 8 hours away

3.6 Do not take two doses at the same time (or: double up)

3.7 Cholesterol levels should be monitored on a regular basis

3.8 Important to continue proper diet and exercise

3.9 Store at room temperature, away from excess heat and moisture

Comment:

6. General information and encouragement to ask questions

6.1 Keep all medicines away from children

6.2 Do not give this medicine to others

6.3 Leaflet states that it does not include all uses, precautions,

interactions, adverse reactions, or side effects

6.4 Name of publisher

6.5 Date of publication or most recent revision

6.6 Ask PR or PH if any questions or concerns

6.7 You may ask PH for longer leaflet written for professionals

*****GO TO PAGE 2*****

Comment:

 

 

Criterion 7: Information is scientifically accurate, unbiased, up-to-date

Criterion 8: Information is readily comprehensible and legible.

7.1 information is neutral in content and tone

7.2 no unapproved uses are listed (see 1.0 for approved uses)

7.3 no promotional messages about a specific brand, manufacturer, or

distributor (may compare chemical entities)

7.4 no inaccurate or outdated claims about benefits of product

7.5 no inaccurate or outdated claims about risks of product

7.6 no other inaccurate or outdated information was found by this rater

NOTE: All items should be completed even if no information is provided about the uses, benefits, or risks of a product. The purpose is to identify inaccurate, biased, and/or outdated information

 

 

Comment:

8.1 black box warning information printed in bold-face type or box NA #

8.2 minimal use of italics or ornate typefaces that are hard to read

8.3 upper and lower case lettering

8.4 headings placed on separate lines (not on same line as text)

8.5 bullets used to enhance readability

8.6 information is well organized and easy to find

Comment:

The following will be assessed by office staff B leave boxes blank

8.7 adequate space between lines (> 2.2 mm; this is approx. 2.2mm) *

8.8 used no smaller than 10-point type (this is 10-point) *

8.9 good ink-paper contrast *

8.10 written at 6-8th grade level (excluding drug names) *

# none applicable for this drug

* will be assessed by office staff, leave blank

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

atorvastatin

Appendix C4: Patient Information Evaluation Form B NITROGLYCERIN (SUBLINGUAL) Office Use: Pharmacy ID: _ _ _ Rater ID: _ _ Leaflet ID: _ _ _ _

Rater: Check two boxes UUif sub-criterion is fully or nearly fully met. Other wording may be counted if it is equivalent or similar in meaning.

Check one box U if sub-criterion is partially met. Leave both boxes blank if no information is provided. PR= doctor or other prescriber; PH= pharmacist

 

Criteria 1-6: Information is sufficiently specific and comprehensive.

1. Drug names and indications for use

1.1 generic name: nitroglycerin

1.2 phonetic spelling of generic name

1.3 common brand names: Nitrostat, NitroQuick, or Nitrotab

1.4 drug class: nitrates

1.5 used to relieve or prevent symptoms of angina (chest pain)

 

 

 

 

 

Comment:

4. Specific precautions and how to avoid harm while using it

4.1 If possible, sit down when using this medicine. This may

prevent falls due to dizziness

4.2 May cause dizziness when standing up or getting out of bed;

getting up slowly may help

4.3 If become dizzy while sitting, take several deep breaths and bend

forward with your head between your knees

4.4 Dizziness may be more frequent if you have had alcohol. Limit

amount of alcohol while using this medicine

4.5 Tell PR or PH about any other medications, especially:

4.6 high blood pressure medicines

4.7 other heart medicines

4.8 sildenafil (Viagra); death can occur with combined use

Comment:

2. Contraindications and what to do if applicable

Do not take this medicine if you:

2.1 are allergic to nitroglycerin or other nitrates "

Tell PR or PH if you:

2.2 have other heart problems

2.3 have severe anemia "

2.4 have recent stroke or head injury "

2.5 have kidney disease "

2.6 have liver disease "

2.7 are pregnant or may become pregnant "

2.8 are nursing or breast-feeding "

Comment:

5. Symptoms of serious or frequent adverse reactions and what to do

Tell PR or PH as soon as possible if any of these occur:

5.1 bluish lips or finger nails

5.2 blurred vision

5.3 drying of the mouth

5.4 severe headache

5.5 shortness of breath, weakness, or fainting [list 1]

Tell PR or PH if any of these do not go away or bother you:

5.6 feeling dizzy or lightheaded

5.7 fast pulse (or heartbeat)

5.8 flushing of face and neck

5.9 nausea or vomiting

Comment:

3. Specific directions about how to use, monitor, and get most benefit

3.1 Use one tablet at first sign of angina attack (chest pain)

3.2 Put tablet under tongue and let it dissolve

3.3 Do not chew, crush, or swallow it

3.4 This usually brings relief in 1 to 5 minutes

3.5 If no relief after 5 minutes, use a second tablet. If no relief after

another 5 minutes,use a third tablet

3.6 If no relief after three tablets in 15 minute period, call doctor

and have someone take you to hospital emergency room

3.7 May use one tablet 5 to 10 minutes before an expected attack

3.8 Store in original glass screw-cap bottle, tightly capped 3.9 Store at room temperature, away from excess heat and moisture

Comment:

6. General information and encouragement to ask questions

6.1 Keep all medicines away from children

6.2 Do not give this medicine to others

6.4 Leaflet states that it does not include all uses, precautions, interactions, adverse reactions, or side effects

6.5 Name of publisher

6.6 Date of publication or most recent revision

6.7 Ask PR or PH if any questions or concerns

6.8 You may ask PH for longer leaflet written for professionals

******GO TO PAGE 2*****

Comment

 

Criteria 7: Information is scientifically accurate, unbiased, up-to-date

Criterion 8: Information is readily comprehensible and legible.

7.1 information is neutral in content and tone

7.2 no unapproved uses are listed (see 1.0 for approved uses)

7.3 no promotional messages about a specific brand, manufacturer, or

distributor (may compare chemical entities)

7.4 no inaccurate or outdated claims about benefits of product

7.5 no inaccurate or outdated claims about risks of product

7.6 no other inaccurate or outdated information was found by this rater

NOTE: All items should be completed even if no information is provided about the uses, benefits, or risks of a product. The purpose is to identify inaccurate, biased, and/or outdated information

 

 

Comment:

8.1 black box warning information printed in bold-face type or box NA #

8.2 minimal use of italics or ornate typefaces that are hard to read

8.3 upper and lower case lettering

8.4 headings placed on separate lines (not on same line as text)

8.5 bullets used to enhance readability

8.6 information is well organized and easy to find

Comment:

The following will be assessed by office staff B leave boxes blank

8.7 adequate space between lines (> 2.2 mm; this is approx. 2.2mm) *

8.8 used no smaller than 10-point type (this is 10-point) *

8.9 good ink-paper contrast *

8.10 written at 6-8th grade level (excluding drug names) *

# none applicable for this drug

* will be assessed by office staff, leave blank

 

 

 

 

nitroglycerin (sublingual)

Appendix D: Readability Assessment Procedures

 

1. Count off 100 words in succession (W), beginning with paragraph on how to use or take the medicine. Mark the beginning and the end of 100 word sample with brackets [ ]. If leaflet is shorter than 100 words, begin with first instructional or informational statement. Do not count patient or provider names or label directions. Count hyphenated words as a word. Count Roman or Arabic numbers as words. Abbreviated words also are counted as words.

2. Mark the end of each sentence with a check (U). Count the number of sentences (S). If the 100-word mark falls past the middle of a sentence, include this sentence in the count. A sentence includes any grammatically independent unit ending with a period (.), question mark (?), exclamation point (!), semicolon (;), or colon (:).

3. Underline or circle all words having three or more syllables (T). Count the number of words having three or more syllables, BUT DO NOT COUNT:

a) verbs ending in Aed@ or Aes@ that make the word have a third syllable

b) drug names (brand or generic)

c) combinations of two simple words (e.g. Aoverdose@)

4. Write # words, # sentences, and # of three or more syllable words in pencil on the copy of information sheet. These data will be entered into the computer.

5. Use computer to calculate grade level using the Gunning Fog equation:

GL= (W/S + T) x 0.4

where GL is grade level, W is number of words in the sample (usually 100), S is number of sentences in the sample, and T is the number of words having three or more syllables in the sample.

 

Reference: R. Gunning, The Technique of Clear Writing. Rev Ed. New York: McGrawBHill, 1968, pp.38-39.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

readability\modifiedfog-instructions

Appendix E: Consumer Evaluation Form, 2001 Consumer ID: __ __ __

Sheet #: __ __ __ __

Thank you for reading and answering some questions about the attached patient information sheet. Only a few people are being asked to help evaluate this material so your opinions are important. All answers will be kept confidential.

1. Below is a list of words describing the attached information sheet. For each item, please circle one number that best describes how YOU would feel if you were taking this medicine for the first time and received this information sheet from the pharmacy.

 

poor print size

1

2

3

4

5

good print size

poor print quality

1

2

3

4

5

good print quality

poor spacing between lines

1

2

3

4

5

good spacing between lines

poorly organized

1

2

3

4

5

well organized

poor length

1

2

3

4

5

good length

unattractive

1

2

3

4

5

attractive*

unclear

1

2

3

4

5

clear

unhelpful

1

2

3

4

5

helpful

incomplete

1

2

3

4

5

complete

scary

1

2

3

4

5

reassuring*

hard to find important information

1

2

3

4

5

easy to find important information

hard to remember

1

2

3

4

5

easy to remember*

 

2. Overall, what is your opinion about this information sheet. Please circle one number that best describes how you would feel if you received this information sheet.

hard to read

1

2

3

4

5

easy to read

hard to understand

1

2

3

4

5

easy to understand

not useful

1

2

3

4

5

useful

 

3. Do you have any other comments about this information sheet? (Write on back of page if you wish)

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[*Item not included in calculation of adherence score]