**LIST OF APPENDICES**

Appendix A: National Panel of Experts, 2001

Appendix B: Commonly Asked Questions and Recommended Answers

Appendix C1: Patient Information Evaluation Form  ATENOLOL

Appendix C2: Patient Information Evaluation Form  GLYBURIDE

Appendix C3: Patient Information Evaluation Form  ATORVASTATIN

Appendix C4: Patient Information Evaluation Form  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  No.
  before?                             

  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            I will pay with cash.
  prescriptions?                      

  Do you have prescription insurance? No.

  Do you have any other medical       No, just some heart disease and
  conditions?                         diabetes.

  Do you take any other prescription  No, I am not taking any other
  medications?                        medications.

  Do you have any allergies to        No, none that I know of.
  medications?                        

  Have you been taking any            No, I havent been taking any
  over-the-counter or                 medications.
  non-prescription medications?       

  Is this the first time you have     Yes, its the first time Ive taken
  taken any of these medications?     any of these.

  What did the doctor tell you about  Just that the directions would be
  the medications?                    on the label.

  When are you talking with the       I will be seeing the doctor in two
  doctor next?                        weeks.

  What will you do if you have any    I will call my doctor.
  problems with the medication?       

  What will you do if your health     I will call my doctor.
  does not improve?                   
  -----------------------------------------------------------------------

  ----------------------------------- -----------------------------------
  For what reason did doctor          My diabetes (If pressed say: the
  prescribe glyburide (or Micronase   doctor said my blood sugar was up)
  or Diabeta)?                        

  For what reason did doctor          I think for cholesterol (If pressed
  prescribe Lipitor (or              say: the doctor said it was too
  atorvastatin)?                      high)

  For what reason did doctor          For chest pain (If pressed say: I
  prescribe nitroglycerin?            had difficulty breathing)

  For what reason did doctor          Doctor said I had some heart
  prescribe the atenolol (Tenormin)?  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      They did stress test (treadmill).
  hospital?                           

  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     No, we didnt discuss that.
  aspirin?                            

  Have you had any other symptoms?    Just chest pain and shortness of
                                      breath

  Atenolol can cause problems with    The doctor mentioned something
  blood sugar. Did your doctor        about that, but said it was
  mention this?                       important for me to take it.

  Did the doctor give you any         No.
  samples of the medication?        

  Would you like pharmacist to        Sure
  counsel you?                        

  Would you like written information  Sure
  about the medication?               
  ----------------------------------- -----------------------------------

**Additional Things to Do and Avoid as a Patient-Observer**

**THINGS TO DO**

-   Make your approach and presentation in each pharmacy as identical as
    possible.

-   Be polite and act interested in what is said to you.

-   Accept whatever information is offered.

-   Answer questions briefly and clearly as directed by your standard
    scenario. If asked for your Social Security number, respond: I
    prefer not to give it.

-   Ask what time your prescription will be ready.

-   Place medication, receipt, and written materials into the pharmacys
    envelope for the project director.

-   Consider yourself a passive patient.

**THINGS TO AVOID**

-   Do not volunteer any information unless you are asked.

-   Do not ask any questions after determining when your prescriptions
    will be ready.

-   Do not initiate any small talk with pharmacy personnel.

-   Do not argue if the legitimacy of your prescriptions or you as a
    patient are questioned. If this happens, politely say, Im sorry to
    inconvenience you. I will fill the prescriptions at home. After
    leaving pharmacy, inform your project director.

-   If no one offers counseling, do not ask for it.

-   If no one offers written information, do not ask for it.

**Appendix C1: Patient Information Evaluation Form  ATENOLOL** Office
Use: Pharmacy ID: \_ \_ \_ Rater ID: \_ \_ Leaflet ID: \_ \_ \_ \_

**Rater:** Check two boxes if sub-criterion is [fully or nearly fully
met.]{.underline} Other wording may be counted if it is equivalent or
similar in meaning.

Check one box  if sub-criterion is [partially]{.underline} 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  | **4. Specific precautions and how |
| for use**                        | to avoid harm while using it**    |
|                                  |                                   |
| 1.1 generic name: atenolol     | 4.1 Tell PR or PH if you take     |
|                                  | [any other                        |
| 1.2 phonetic spelling of generic | medications]{.underline},         |
| name                           | especially:                     |
|                                  |                                   |
| 1.3 brand names: Tenormin      | 4.2 calcium channel blockers such |
| 1.4 drug class :beta-blocker or  | as verapamil and diltiazem      |
| beta-adrenergic blocking agent  |                                   |
|  1.5 treat hypertension (or     | 4.3 other blood pressure          |
| high blood pressure)   1.6     | medicines such as clonidine     |
| treat angina (or chest pain)   |                                   |
|                                  | 4.4 over-the-counter cold         |
| 1.7 treat definite or suspected  | products or decongestants       |
| myocardial infarction (or heart  |                                   |
| attack)                        | 4.5 [Do not stop                  |
|                                  | suddenly]{.underline}; gradual    |
| Comment:                         | dose reduction may be needed#   |
|                                  |                                   |
|                                  | 4.6 May cause serious reaction to |
|                                  | [allergy shots]{.underline}; tell |
|                                  | PR before shots                 |
|                                  |                                   |
|                                  | 4.7 May worsen [allergic          |
|                                  | reaction]{.underline} to foods,   |
|                                  | medicines, or stings; tell        |
|                                  |                                   |
|                                  | PR as soon as possible so it can  |
|                                  | be treated                      |
|                                  |                                   |
|                                  | 4.8 Before [surgery]{.underline}, |
|                                  | tell PR or dentist you are taking |
|                                  | this medicine                   |
|                                  |                                   |
|                                  | 4.9 May affect [blood             |
|                                  | sugar]{.underline} or cover up    |
|                                  | signs of low blood sugar        |
|                                  |                                   |
|                                  | \# information derived from       |
|                                  | black box warning on            |
|                                  | professional labeling             |
|                                  |                                   |
|                                  | Comment:                          |
+----------------------------------+-----------------------------------+
| **2. Contraindications and what  | **5. Symptoms of serious or       |
| to do before using drug**        | frequent adverse reactions and    |
|                                  | what to do**                      |
| Tell PR or PH if you have:       |                                   |
|                                  | Tell PR or PH as soon as possible |
| 2.1 certain heart problems (or:  | if any of these occur:            |
| heart failure, very slow         |                                   |
| heartbeat)                     | 5.1 trouble breathing           |
|                                  |                                   |
| 2.2 asthma or emphysema        | 5.2 cold hands or feet          |
|                                  |                                   |
| 2.3 diabetes                   | 5.3 slow heartbeat or fainting   |
|                                  |                                  |
| 2.4 overactive thyroid         |                                   |
|                                  | 5.4 swelling of legs or           |
| 2.5 poor circulation           | ankles/feet                     |
|                                  |                                   |
| Tell PR or PH if you are:        | Tell PR or PH if any of these do  |
|                                  | not go away or bother you:        |
| 2.6 [pregnant]{.underline} or    |                                   |
| may become pregnant; can cause   | 5.5 feeling dizzy               |
| harm to baby                   |                                   |
|                                  | 5.6 feeling tired               |
| 2.7 [nursing]{.underline} or     |                                   |
| breast-feeding                 | 5.7 feeling depressed           |
|                                  |                                   |
| Comment:                         | 5.7 trouble having sex          |
|                                  |                                   |
|                                  | 5.8 trouble sleeping            |
|                                  |                                   |
|                                  | Comment:                          |
+----------------------------------+-----------------------------------+
| **3. Specific directions about   | **6. General information and      |
| how to use, monitor, and get     | encouragement to ask questions**  |
| most benefit**                   |                                   |
|                                  | 6.1 Keep all medicines [away from |
| 3.1 It is important to take this | children]{.underline}           |
| medicine [regularly]{.underline} |                                   |
| to get the most benefit        | 6.2 Do not give this medicine to  |
|                                  | [others]{.underline}            |
| 3.2 To help you remember, take   |                                   |
| it the [same                     | 6.3 Leaflet states that it [does  |
| time(s)]{.underline} each day   | not include all]{.underline}      |
|                                 | uses, precautions,                |
|                                  |                                   |
| 3.3 If you [miss a               | interactions, adverse reactions,  |
| dose]{.underline}, take it as    | or side effects                 |
| soon as you remember           |                                   |
|                                  | 6.4 Name of                       |
| 3.4 Skip missed dose if next     | [publisher]{.underline}         |
| scheduled dose is less than 8    |                                   |
| hours away                     | 6.5 [Date]{.underline} of         |
|                                  | publication or most recent        |
| 3.5 Do not take two doses at     | revision                        |
| same time (or: do not double up) |                                   |
|                                | 6.6 Ask PR or PH [if any          |
|                                  | questions]{.underline} or         |
| 3.6 May take with or without     | concerns                        |
| [food]{.underline}             |                                   |
|                                  | 6.7 You may ask PH for [longer    |
| 3.7 [Store]{.underline} at room  | leaflet]{.underline} written for  |
| temperature, away from excess    | professionals                   |
| heat and moisture              |                                   |
|                                  | ***\*\*\*\*\*GO TO PAGE           |
| Comment:                         | 2\*\*\*\*\****                    |
|                                  |                                   |
|                                  | Comment:                          |
+----------------------------------+-----------------------------------+

+----------------------------------+-----------------------------------+
| **Criteria 7: Information is     | **Criterion 8: Information is     |
| scientifically accurate,         | readily comprehensible and        |
| unbiased, up-to-date**           | legible**.                        |
+----------------------------------+-----------------------------------+
| 7.1 information is neutral in    | 8.1 black box warning information |
| content and tone               | printed in bold-face type or box  |
|                                  |                                 |
| 7.2 no unapproved uses are       |                                   |
| listed (see 1.0 for approved     | 8.2 minimal use of italics or     |
| uses)                          | ornate typefaces that are hard to |
|                                  | read                            |
| 7.3 no promotional messages      |                                   |
| about a specific brand,          | 8.3 upper and lower case          |
| manufacturer, or                 | lettering                       |
|                                  |                                   |
| distributor (may compare         | 8.4 headings placed on separate   |
| chemical entities)             | lines (not on same line as text)  |
|                                  |                                 |
| 7.4 no inaccurate or outdated    |                                   |
| claims about benefits of product | 8.5 bullets used to enhance       |
|                                | readability                     |
|                                  |                                   |
| 7.5 no inaccurate or outdated    | 8.6 information is well organized |
| claims about risks of product   | and easy to find                |
|                                 |                                   |
|                                  | Comment:                          |
| 7.6 no other inaccurate or       |                                   |
| outdated information was found   | [The following will be assessed   |
| by this rater                  | by office staff  leave boxes     |
|                                  | blank]{.underline}                |
| NOTE: All items should be        |                                   |
| completed even if no information | 8.7 adequate space between lines  |
| is provided about the uses,      | ([\>]{.underline} 2.2 mm; this is |
| benefits, or risks of a product. | approx. 2.2mm)   \*             |
| The purpose is to identify       |                                   |
| inaccurate, biased, and/or       | 8.8 used no smaller than 10-point |
| outdated information             | type (this is 10-point)   \*    |
|                                  |                                   |
| Comment:                         | 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  GLYBURIDE** Office
Use: Pharmacy ID: \_ \_ \_ Rater ID: \_ \_ Leaflet ID: \_\_ \_\_ \_\_
\_\_

**Rater:** Check two boxes if sub-criterion is [fully or nearly fully
met.]{.underline} Other wording may be counted if it is equivalent or
similar in meaning.

Check one box  if sub-criterion is [partially]{.underline} 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   | **4. Specific precautions and    |
| for use**                         | how to avoid harm while using    |
|                                   | it**                             |
| 1.1 generic name: glyburide     |                                  |
|                                   | 4.1 Tell PR or PH before taking  |
| 1.2 phonetic spelling of generic  | [any other                       |
| name                            | medications]{.underline},        |
|                                   | especially:                    |
| 1.3 common brand names: DiaBeta,  |                                  |
| Micronase, Glynase              | 4.2 aspirin products           |
|                                   |                                  |
| 1.4 antidiabetic (or used to      | 4.3 anticoagulants (or blood     |
| treat diabetes)                 | thinners)                      |
|                                   |                                  |
| 1.5 sulfonylurea                | 4.4 azole antifungals (eg,       |
|                                   | fluconazole)                   |
| 1.6 used to lower blood sugar   |                                  |
|                                   | 4.5 beta blockers              |
| 1.7 used in patients whose        |                                  |
| diabetes cannot be controlled by  | 4.6 diuretics (water pills)    |
| diet                            |                                  |
|                                   | 4.7 corticosteriods            |
| 1.8 used for non-insulin          |                                  |
| dependent (or Type 2) diabetes   | 4.8 MAO inhibitors             |
|                                  |                                  |
|                                   | 4.9 May increase [sensitivity to |
| Comment:                          | sun]{.underline}; reduce         |
|                                   | exposure to sun                |
|                                   |                                  |
|                                   | Comment:                         |
+-----------------------------------+----------------------------------+
| **2. Contraindications and what   | **5. Symptoms of serious or      |
| to do if applicable**             | frequent adverse reactions and   |
|                                   | what to do**                     |
| Tell PR or PH if you are:         |                                  |
|                                   | 5.1 May cause [low blood         |
| 2.1 [allergic]{.underline} to     | sugar]{.underline} or            |
| glyburide or other sulfonylureas  | hypoglycemia                   |
|                                 |                                  |
|                                   | 5.2 To help prevent, do not miss |
| 2.2 [pregnant]{.underline} or may | meals or drink alcohol         |
| become pregnant                 |                                  |
|                                   | 5.3 Some symptoms of low blood   |
| 2.3 [nursing]{.underline} or      | sugar: fast heartbeat, sweating, |
| breast-feeding                  |                                  |
|                                   | tremors, headache, confusion,    |
| Other:                            | nervousness \[list 3\]         |
|                                   |                                  |
| 2.4 use of other sulfonylurea     | 5.4 Use quick-acting sugar to    |
| drugs has been associated with    | treat low blood sugar          |
| serious                           |                                  |
|                                   | Tell PR or PH as soon as         |
| heart problems. This risk may     | possible [if any of the          |
| apply to use of glyburide       | following occurs]{.underline}:   |
|                                   |                                  |
| Comment:                          | 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]{.underline}:                |
|                                   |                                  |
|                                   | 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    | **6. General information and     |
| how to use, monitor, and get most | encouragement to ask questions** |
| benefit**                         |                                  |
|                                   | 6.1 Keep all medicines [away     |
| 3.1 It is important to take this  | from children]{.underline}     |
| medicine [regularly]{.underline}  |                                  |
| to get the most benefit         | 6.2 Do not give this medicine to |
|                                   | [others]{.underline}           |
| 3.2 To help you remember, take it |                                  |
| at the [same time(s)]{.underline} | 6.3 Leaflet states that it does  |
| each day                        | [not include all]{.underline}    |
|                                   | uses, precautions,               |
| 3.3 May take with or without      |                                  |
| [food]{.underline}              | interactions, adverse reactions, |
|                                   | or side effects                |
| 3.4 If you [miss a                |                                  |
| dose]{.underline}, take it as     | 6.4 Name of                      |
| soon as possible                | [publisher]{.underline}        |
|                                   |                                  |
| 3.5 Skip missed dose if next      | 6.5 [Date]{.underline} of        |
| scheduled dose is less than 8     | publication or most recent       |
| hours away                      | revision                       |
|                                   |                                  |
| 3.6 Do not double up or take two  | 6.6 Ask PR or PH [if any         |
| doses at the same time          | questions]{.underline} or        |
|                                   | concerns                       |
| 3.7 Regular [testing of blood     |                                  |
| glucose]{.underline} is important | 6.7 You may ask PH for [longer   |
|                                 | leaflet]{.underline} written for |
|                                   | professionals                  |
| 3.8 Important to follow proper    |                                  |
| [diet and exercise]{.underline}   | ***\*\*\*\*\*GO TO PAGE          |
| program                         | 2\*\*\*\*\****                   |
|                                   |                                  |
| 3.9 [Store]{.underline} at room   | Comment:                         |
| temperature, away from excess     |                                  |
| heat and moisture               |                                  |
|                                   |                                  |
| Comment:                          |                                  |
+-----------------------------------+----------------------------------+

+-----------------------------------+----------------------------------+
| **Criterion 7: Information is     | **Criterion 8: Information is    |
| scientifically accurate,          | readily comprehensible and       |
| unbiased, up-to-date**            | legible**.                       |
+-----------------------------------+----------------------------------+
| 7.1 information is neutral in     | 8.1 black box warning            |
| content and tone                | information printed in bold-face |
|                                   | type or box NA **\#**            |
| 7.2 no unapproved uses are listed |                                  |
| (see 1.0 for approved uses)     | 8.2 minimal use of italics or    |
|                                   | ornate typefaces that are hard   |
| 7.3 no promotional messages about | to read                        |
| a specific brand, manufacturer,   |                                  |
| or                                | 8.3 upper and lower case         |
|                                   | lettering                      |
| distributor (may compare chemical |                                  |
| entities)                       | 8.4 headings placed on separate  |
|                                   | lines (not on same line as text) |
| 7.4 no inaccurate or outdated     |                                |
| claims about benefits of product  |                                  |
|                                 | 8.5 bullets used to enhance      |
|                                   | readability                    |
| 7.5 no inaccurate or outdated     |                                  |
| claims about risks of product   | 8.6 information is well          |
|                                   | organized and easy to find     |
| 7.6 no other inaccurate or        |                                  |
| outdated information was found by | Comment:                         |
| this rater                      |                                  |
|                                   | [The following will be assessed  |
| NOTE: All items should be         | by office staff  leave boxes    |
| completed even if no information  | blank]{.underline}               |
| is provided about the uses,       |                                  |
| benefits, or risks of a product.  | 8.7 adequate space between lines |
| The purpose is to identify        | ([\>]{.underline} 2.2 mm; this   |
| inaccurate, biased, and/or        | is approx. 2.2mm)   \*         |
| outdated information              |                                  |
|                                   | 8.8 used no smaller than         |
| Comment:                          | 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  ATORVASTATIN**
Office Use: Pharmacy ID: \_ \_ \_ Rater ID: \_ \_ Leaflet ID: \_ \_ \_
\_

**Rater:** Check two boxes if sub-criterion is [fully or nearly fully
met.]{.underline} Other wording may be counted if it is equivalent or
similar in meaning.

Check one box  if sub-criterion is [partially]{.underline} 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  | **4. Specific precautions and how |
| for use**                        | to avoid harm while using it**    |
|                                  |                                   |
| 1.1 generic name:atorvastatin   | 4.1 Tell PR or PH before taking   |
|                                 | any [other                        |
|                                  | medications]{.underline},         |
| 1.2 phonetic spelling of generic | especially:                     |
| name                           |                                   |
|                                  | 4.2 immunosuppressants,           |
| 1.3 brand name: Lipitor   1.4  | especially cyclosporine           |
| drug class: HMG - CoA reductase  | (Sandimmune)                    |
| inhibitors                     |                                   |
|                                  | 4.3 gemfibrozil (Lopid)         |
| 1.5 used to lower cholesterol    |                                   |
| levels   1.6 used in persons   | 4.4 erythromycin                |
| whose cholesterol levels cannot  |                                   |
| be controlled with               | 4.5 niacin (nicotinic acid)     |
|                                  |                                   |
| proper diet, exercise, and       | 4.6 azole antifungals (eg         |
| weight loss if overweight.     | fluconazole, ketoconazole, or     |
|                                  | itraconazole)                   |
| Comment:                         |                                   |
|                                  | 4.7 Do not eat                    |
|                                  | [grapefruit]{.underline} or drink |
|                                  | grapefruit juice while using this |
|                                  | drug                            |
|                                  |                                   |
|                                  | 4.8 Should have [liver function   |
|                                  | tests]{.underline} before and     |
|                                  | after starting this               |
|                                  |                                   |
|                                  | medicine and on regular basis to  |
|                                  | check for harmful effects.      |
|                                  |                                   |
|                                  | Comment:                          |
+----------------------------------+-----------------------------------+
| **2. Contraindications and what  | **5. Symptoms of serious or       |
| to do if applicable.**           | frequent adverse reactions and    |
|                                  | what to do**                      |
| Do not take this medicine if you |                                   |
| are:                             | Tell PR or PH as soon as possible |
|                                  | if any of these occur:            |
| 2.1 [allergic]{.underline} to    |                                   |
| atorvastatin                   | 5.1 muscle pains or weakness,     |
|                                  | especially with fever           |
| 2.2 [pregnant]{.underline} or    |                                   |
| may become pregnant; can cause   | 5.2 unusual tiredness           |
| harm to baby                   |                                   |
|                                  | 5.3 dark urine or yellowing of    |
| 2.3 [nursing]{.underline} or     | skin or eyes                    |
| breast-feeding                 |                                   |
|                                  | 5.4 skin rash                   |
| Tell PR or PH if you:            |                                   |
|                                  | Tell PR or PH if these do not go  |
| 2.4 drink large amounts of       | away or bother you:               |
| alcohol                        |                                   |
|                                  | 5.5 constipation                |
| 2.5 have had liver disease     |                                   |
|                                  | 5.6 diarrhea                    |
| 2.6 have had kidney disease    |                                   |
|                                  | 5.7 headache                    |
| 2.7 have had recent major        |                                   |
| surgery                        | 5.8 nausea or heartburn         |
|                                  |                                   |
| 2.8 have uncontrolled seizures  | Comment:                          |
|                                 |                                   |
|                                  |                                   |
| Comment:                         |                                   |
+----------------------------------+-----------------------------------+
| **3. Specific directions about   | **6. General information and      |
| how to use, monitor, and get     | encouragement to ask questions**  |
| most benefit**                   |                                   |
|                                  | 6.1 Keep all medicines [away from |
| 3.1 It is important to take this | children]{.underline}           |
| medicine [regularly]{.underline} |                                   |
| to get the most benefit        | 6.2 Do not give this medicine to  |
|                                  | [others]{.underline}            |
| 3.2 To help you remember, take   |                                   |
| it at the [same                  | 6.3 Leaflet states that it does   |
| time(s)]{.underline} each day   | [not include all]{.underline}     |
|                                 | uses, precautions,                |
|                                  |                                   |
| 3.3 May take with or without     | interactions, adverse reactions,  |
| [food]{.underline}             | or side effects                 |
|                                  |                                   |
| 3.4 If you [miss a               | 6.4 Name of                       |
| dose]{.underline}, take it as    | [publisher]{.underline}         |
| soon as possible               |                                   |
|                                  | 6.5 [Date]{.underline} of         |
| 3.5 Skip missed dose if next     | publication or most recent        |
| scheduled dose is less than 8    | revision                        |
| hours away                     |                                   |
|                                  | 6.6 Ask PR or PH [if any          |
| 3.6 Do not take two doses at the | questions]{.underline} or         |
| same time (or: double up)      | concerns                        |
|                                  |                                   |
| 3.7 [Cholesterol                 | 6.7 You may ask PH for [longer    |
| levels]{.underline} should be    | leaflet]{.underline} written for  |
| monitored on a regular basis   | professionals                   |
|                                  |                                   |
| 3.8 Important to continue        | ***\*\*\*\*\*GO TO PAGE           |
| [proper diet and                 | 2\*\*\*\*\****                    |
| exercise]{.underline}          |                                   |
|                                  | Comment:                          |
| 3.9 [Store]{.underline} at room  |                                   |
| temperature, away from excess    |                                   |
| heat and moisture              |                                   |
|                                  |                                   |
| Comment:                         |                                   |
+----------------------------------+-----------------------------------+

+-----------------------------------+-----------------------------------+
| **Criterion 7: Information is     | **Criterion 8: Information is     |
| scientifically accurate,          | readily comprehensible and        |
| unbiased, up-to-date**            | legible**.                        |
+-----------------------------------+-----------------------------------+
| 7.1 information is neutral in     | 8.1 black box warning information |
| content and tone                | printed in bold-face type or box  |
|                                   | NA **\#**                         |
| 7.2 no unapproved uses are listed |                                   |
| (see 1.0 for approved uses)     | 8.2 minimal use of italics or     |
|                                   | ornate typefaces that are hard to |
| 7.3 no promotional messages about | read                            |
| a specific brand, manufacturer,   |                                   |
| or                                | 8.3 upper and lower case          |
|                                   | lettering                       |
| distributor (may compare chemical |                                   |
| entities)                       | 8.4 headings placed on separate   |
|                                   | lines (not on same line as text)  |
| 7.4 no inaccurate or outdated     |                                 |
| claims about benefits of product  |                                   |
|                                 | 8.5 bullets used to enhance       |
|                                   | readability                     |
| 7.5 no inaccurate or outdated     |                                   |
| claims about risks of product   | 8.6 information is well organized |
|                                   | and easy to find                |
| 7.6 no other inaccurate or        |                                   |
| outdated information was found by | Comment:                          |
| this rater                      |                                   |
|                                   | [The following will be assessed   |
| NOTE: All items should be         | by office staff  leave boxes     |
| completed even if no information  | blank]{.underline}                |
| is provided about the uses,       |                                   |
| benefits, or risks of a product.  | 8.7 adequate space between lines  |
| The purpose is to identify        | ([\>]{.underline} 2.2 mm; this is |
| inaccurate, biased, and/or        | approx. 2.2mm)   \*             |
| outdated information              |                                   |
|                                   | 8.8 used no smaller than 10-point |
| Comment:                          | 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  NITROGLYCERIN
(SUBLINGUAL)** Office Use: Pharmacy ID: \_ \_ \_ Rater ID: \_ \_ Leaflet
ID: \_ \_ \_ \_

**Rater:** Check two boxes if sub-criterion is [fully or nearly fully
met.]{.underline} Other wording may be counted if it is equivalent or
similar in meaning.

Check one box  if sub-criterion is [partially]{.underline} 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   | **4. Specific precautions and how |
| for use**                         | to avoid harm while using it**    |
|                                   |                                   |
| 1.1 generic name: nitroglycerin  | 4.1 If possible, [sit down when   |
|                                  | using]{.underline} this medicine. |
|                                   | This may                          |
| 1.2 phonetic spelling of generic  |                                   |
| name                            | prevent falls due to dizziness   |
|                                   |                                  |
| 1.3 common brand names:           |                                   |
| Nitrostat, NitroQuick, or         | 4.2 May cause dizziness when      |
| Nitrotab                        | standing up or getting out of     |
|                                   | bed;                              |
| 1.4 drug class: nitrates        |                                   |
|                                   | [getting up slowly]{.underline}   |
| 1.5 used to relieve or prevent    | may help                        |
| symptoms of angina (chest pain)  |                                   |
|                                  | 4.3 If become dizzy while         |
|                                   | sitting, take several deep        |
| Comment:                          | breaths and bend                  |
|                                   |                                   |
|                                   | forward with your [head between   |
|                                   | your knees]{.underline}         |
|                                   |                                   |
|                                   | 4.4 Dizziness may be more         |
|                                   | frequent if you have had          |
|                                   | [alcohol]{.underline}. Limit      |
|                                   |                                   |
|                                   | amount of alcohol while using     |
|                                   | this medicine                   |
|                                   |                                   |
|                                   | 4.5 Tell PR or PH about any       |
|                                   | [other medications]{.underline},  |
|                                   | 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   | **5. Symptoms of serious or       |
| to do if applicable**             | frequent adverse reactions and    |
|                                   | what to do**                      |
| Do not take this medicine if you: |                                   |
|                                   | Tell PR or PH as soon as possible |
| 2.1 are [allergic]{.underline} to | if any of these occur:            |
| nitroglycerin or other nitrates  |                                   |
|                                  | 5.1 bluish lips or finger nails  |
|                                   |                                  |
| Tell PR or PH if you:             |                                   |
|                                   | 5.2 blurred vision              |
| 2.2 have other heart problems   |                                   |
|                                   | 5.3 drying of the mouth         |
| 2.3 have severe anemia          |                                   |
|                                   | 5.4 severe headache             |
| 2.4 have recent stroke or head    |                                   |
| injury                          | 5.5 shortness of breath,          |
|                                   | weakness, or fainting \[list 1\]  |
| 2.5 have kidney disease         |                                 |
|                                   |                                   |
| 2.6 have liver disease          | Tell PR or PH if any of these do  |
|                                   | not go away or bother you:        |
| 2.7 are [pregnant]{.underline} or |                                   |
| may become pregnant             | 5.6 feeling dizzy or lightheaded  |
|                                   |                                 |
| 2.8 are [nursing]{.underline} or  |                                   |
| breast-feeding                  | 5.7 fast pulse (or heartbeat)   |
|                                   |                                   |
| Comment:                          | 5.8 flushing of face and neck   |
|                                   |                                   |
|                                   | 5.9 nausea or vomiting          |
|                                   |                                   |
|                                   | Comment:                          |
+-----------------------------------+-----------------------------------+
| **3. Specific directions about    | **6. General information and      |
| how to use, monitor, and get most | encouragement to ask questions**  |
| benefit**                         |                                   |
|                                   | 6.1 Keep all medicines [away from |
| 3.1 Use one tablet [at first sign | children]{.underline}           |
| of angina attack]{.underline}     |                                   |
| (chest pain)                    | 6.2 Do not give this medicine to  |
|                                   | [others]{.underline}            |
| 3.2 Put tablet under tongue and   |                                   |
| let it [dissolve]{.underline}   | 6.4 Leaflet states that it [does  |
|                                   | not include all]{.underline}      |
| 3.3 Do not chew, crush, or        | uses, precautions, interactions,  |
| [swallow]{.underline} it        | adverse reactions, or side        |
|                                   | effects                         |
| 3.4 This usually brings [relief   |                                   |
| in 1 to 5 minutes]{.underline}   | 6.5 Name of                       |
|                                  | [publisher]{.underline}         |
|                                   |                                   |
| 3.5 If no relief after 5 minutes, | 6.6 [Date]{.underline} of         |
| use a second tablet. If no relief | publication or most recent        |
| after                             | revision                        |
|                                   |                                   |
| another 5 minutes,use a third     | 6.7 Ask PR or PH [if any          |
| tablet                          | questions]{.underline} or         |
|                                   | concerns                        |
| 3.6 If no relief after three      |                                   |
| tablets in 15 minute period, call | 6.8 You may ask PH for [longer    |
| doctor                            | leaflet]{.underline} written for  |
|                                   | professionals                   |
| and have someone take you to      |                                   |
| hospital emergency room         | ***\*\*\*\*\*\*GO TO PAGE         |
|                                   | 2\*\*\*\*\****                    |
| 3.7 May use one tablet 5 to 10    |                                   |
| minutes [before an expected       | Comment                           |
| attack]{.underline}             |                                   |
|                                   |                                   |
| 3.8 [Store]{.underline} in        |                                   |
| original glass screw-cap bottle,  |                                   |
| tightly capped   3.9            |                                   |
| [Store]{.underline} at room       |                                   |
| temperature, away from excess     |                                   |
| heat and moisture               |                                   |
|                                   |                                   |
| Comment:                          |                                   |
+-----------------------------------+-----------------------------------+

+-----------------------------------+-----------------------------------+
| **Criteria 7: Information is      | **Criterion 8: Information is     |
| scientifically accurate,          | readily comprehensible and        |
| unbiased, up-to-date**            | legible**.                        |
+-----------------------------------+-----------------------------------+
| 7.1 information is neutral in     | 8.1 black box warning information |
| content and tone                | printed in bold-face type or box  |
|                                   | NA **\#**                         |
| 7.2 no unapproved uses are listed |                                   |
| (see 1.0 for approved uses)     | 8.2 minimal use of italics or     |
|                                   | ornate typefaces that are hard to |
| 7.3 no promotional messages about | read                            |
| a specific brand, manufacturer,   |                                   |
| or                                | 8.3 upper and lower case          |
|                                   | lettering                       |
| distributor (may compare chemical |                                   |
| entities)                       | 8.4 headings placed on separate   |
|                                   | lines (not on same line as text)  |
| 7.4 no inaccurate or outdated     |                                 |
| claims about benefits of product  |                                   |
|                                 | 8.5 bullets used to enhance       |
|                                   | readability                     |
| 7.5 no inaccurate or outdated     |                                   |
| claims about risks of product   | 8.6 information is well organized |
|                                   | and easy to find                |
| 7.6 no other inaccurate or        |                                   |
| outdated information was found by | Comment:                          |
| this rater                      |                                   |
|                                   | [The following will be assessed   |
| NOTE: All items should be         | by office staff  leave boxes     |
| completed even if no information  | blank]{.underline}                |
| is provided about the uses,       |                                   |
| benefits, or risks of a product.  | 8.7 adequate space between lines  |
| The purpose is to identify        | ([\>]{.underline} 2.2 mm; this is |
| inaccurate, biased, and/or        | approx. 2.2mm)   \*             |
| outdated information              |                                   |
|                                   | 8.8 used no smaller than 10-point |
| Comment:                          | 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 (). 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 ed or es that make the word have a third
syllable

b\) drug names (brand or generic)

c\) combinations of two simple words (e.g. overdose)

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:
McGrawHill, 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]{.underline}** that best
describes how **[YOU]{.underline}** 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     1   2   3   4   5   good spacing between lines
  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   1   2   3   4   5   easy to find important
  information                                  information

  hard to remember         1   2   3   4   5   easy to remember\*
  ------------------------ --- --- --- --- --- --------------------------

2\. **[Overall,]{.underline}** what is your opinion about this
information sheet. Please **[circle]{.underline}** one number that best
describes how **[you]{.underline}** 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)

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\[\*Item not included in calculation of adherence score\]