Study of Women’s Health Across the Nation



Date Data Entered / Initials _____________________ Date Verified / Initials _____________________

RX/OTC/VITAMIN/SUPPLEMENT MEDICATION FORM

INTERVIEWER-ADMINISTERED ANNUAL FOLLOW-UP FORM

Study of Women’s Health Across the Nation

SECTION A. GENERAL INFORMATION

AFFIX ID LABEL HERE

A1. RESPONDENT ID:

A2. SWAN STUDY VISIT # 12

A3. FORM VERSION: 11/01/2009

A4. DATE FORM COMPLETED: ___ ___ / ___ ___ / ___ ___ ___ ___

M M D D Y Y Y Y

A5. INTERVIEWER’S INITIALS: ___ ___ ___

A6. RESPONDENT’S DOB: ___ ___ / ___ ___ / 1 9 ___ ___

M M D D Y Y Y Y

VERIFY WITH RESPONDENT

A7. INTERVIEW COMPLETED IN:

RESPONDENT’S HOME/OFFICE 1

CLINIC/OFFICE 2

RESPONDENT’S HOME W/ PROXY 3

CLINIC/OFFICE W/ PROXY 4

TELEPHONE 5

TELEPHONE BY PROXY 6

A8. INTERVIEW LANGUAGE:

ENGLISH 1

SPANISH 2

CANTONESE 3

JAPANESE 4

SECTION B. RX/OTC MEDICATIONS SINCE LAST STUDY VISIT

We last interviewed you on [DATE]. We would like to ask you questions about what’s happened to you since then.

I would like to begin the interview by asking you some questions about prescribed and over - the - counter (OTC) medications.

I will start by asking about any pills or medicines, including patches, suppositories, injections, creams and ointments which are prescribed by your doctor or other health care provider that you have taken since your last study visit.

| |Since your last study visit… |NO |YES |DON’T KNOW |

|B1. |Have you taken any medication, pills or other medicine to thin your blood (anticoagulants)? |1 |2 |-8 |

|B2. |Anything for your heart or heart beat, including pills or patches? |1 |2 |-8 |

|B3. |Any medications for cholesterol or fats in your blood? |1 |2 |-8 |

|B4. |Blood pressure pills? |1 |2 |-8 |

|B5. |Diuretics for water retention? |1 |2 |-8 |

|B6. |Thyroid pills? |1 |2 |-8 |

|B7. |Insulin or pills for sugar in your blood? |1 |2 |-8 |

|B8. |Any medications for a nervous condition such as tranquilizers, sedatives, sleeping pills, or anti- |1 |2 |-8 |

| |depression medication? | | | |

|B9. |Steroid pills such as Prednisone or Cortisone? |1 |2 |-8 |

|B10. |Prescribed medication for arthritis? |1 |2 |-8 |

|B11. |Fertility medications to help you get pregnant? |1 |2 |-8 |

|B12. |IV (into the vein) medication to prevent or treat osteoporosis (brittle or thinning bones)? |1 |2 |-8 |

|B13. |Non IV medications to prevent or treat osteoporosis (brittle or thinning bones)? |1 |2 |-8 |

|B14. |Birth Control pills? |1 |2 |-8 |

|B15. |Estrogen pills (such as Premarin, Estrace, Ogen, etc)? |1 |2 |-8 |

|B16. |Estrogen by injection or patch (such as Estraderm)? |1 |2 |-8 |

|B17. |Combination estrogen/progestin (such as Premphase or Prempro)? |1 |2 |-8 |

|B18. |Progestin pills (such as Provera)? |1 |2 |-8 |

|B19. |Any other prescription hormones that I haven’t asked you about, for example vaginal rings (such as |1 |2 |-8 |

| |Femring), progestin injections (such as Depo-Provera), estrogen/testosterone combinations (such as | | | |

| |Estratest), or vaginal creams? | | | |

IF RESPONDENT HAS TAKEN ANY HORMONES (IF YES TO ANY OF B15 - 19) ASK B20,

OTHERWISE GO TO Q B22.

B20. Were you using any prescription medications containing estrogen or progestin at the time of your last study visit?

NO 1 (B21)

YES 2 (B22)

DON’T KNOW -8 (B21)

|B21. |I am going to read a list of some reasons why women start taking hormones, not including birth control pills. For each one, please tell me if it is a |

| |reason why you started taking hormones. (READ LIST a THROUGH i.) |

| | | | | | |

| | | |NO |YES | |

| | | | | | |

| |a. |To reduce the risk of heart disease |1 |2 | |

| | | | | | |

| |b. |To reduce the risk of osteoporosis (brittle or thinning bones) |1 |2 | |

| | | | | | |

| |c. |To relieve menopausal symptoms |1 |2 | |

| | | | | | |

| |d. |To stay young-looking |1 |2 | |

| | | | | | |

| |e. |A health care provider advised me to take them |1 |2 | |

| | | | | | |

| |f. |A friend or relative advised me to take them |1 |2 | |

| | | | | | |

| |g. |To improve my memory |1 |2 | |

| | | | | | |

| |h. |To regulate periods |1 |2 | |

| | | | | | |

| |i. |Any other? SPECIFY |1 |2 | |

| | | | | | |

| | | | | | |

| | | | | | |

| |j. |DON’T KNOW/REMEMBER |1 |2 | |

IF PARTICIPANT REPORTED TAKING ANY HORMONES SINCE HER LAST STUDY VISIT (THAT IS, “YES” TO ANY OF B15 - 19), ASK B22, OTHERWISE GO TO Q B23 ON PAGE 4.)

|B22. |Since your last study visit, were you taking some hormones and then stopped taking them? |

| | |

| |NO 1 (B23, PAGE 4) |

| |YES 2 |

| | | |

| |B22.1 In what month and year did you last take hormones? |

| | |

| | |

| |___ ___ |

| |M M |

| | |

| |/ |

| | |

| |___ ___ ___ ___ Y Y Y Y |

| | |

| |[PROMPT FOR YEAR EVEN IF MONTH IS UNKNOWN. ENTER –8 IF MONTH IS UNKNOWN.] |

| | |

| |B22.2. What were your reasons for stopping? PROBE: Any others? |

| |[DO NOT READ THE LIST. CODE 1(NO) OR 2 (YES) FOR EACH ITEM.] |

| | | |NO |YES | |

| | | | | | |

| | | | | | |

| |a. |PROBLEMS WITH BLEEDING |1 |2 | |

| | | | | | |

| |b. |DIDN’T LIKE HAVING PERIODS |1 |2 | |

| | | | | | |

| |c. |DIDN’T LIKE HOW I FELT ON THEM |1 |2 | |

| | | | | | |

| |d. |WORRIED ABOUT POSSIBLE SIDE EFFECTS |1 |2 | |

| | | | | | |

| |e. |WORRIED ABOUT CANCER |1 |2 | |

| | | | | | |

| |f. |MY HEALTH CARE PROVIDER ADVISED ME TO STOP (FOR MEDICAL REASONS) |1 |2 | |

| | | | | | |

| |g. |TOO EXPENSIVE |1 |2 | |

| | | | | | |

| |h. |DON’T LIKE TO TAKE ANY MEDICATIONS |1 |2 | |

| | | | | | |

| |i. |COULDN’T REMEMBER TO TAKE THEM |1 |2 | |

| | | | | | |

| |j. |DON’T KNOW |1 |2 | |

| | | | | | |

| |k. |OTHER, SPECIFY: | |1 |2 | |

| | | | | | |

| | | | | | |

| | | | | | |

| |l. |NO REASON GIVEN |1 |2 | |

| | | | | | |

| |m. |NEWS / MEDIA REPORTS ABOUT WOMEN WHO TOOK HORMONES AS PART OF A RESEARCH STUDY (E.G. RESULTS OF WHI) |1 |2 | |

B23. Since your last study visit, did you take any medications that are administered only once or twice per year? (CIRCLE ONE.)

NO 1

YES 2

B24. In the past three months, have you used any prescription or over the counter medications including supplements, vitamins, pain medications, laxatives, cold medications, cough medications, stomach medications, and ointments or salves? (CIRCLE ONE.)

NO 1

YES 2

IF PARTICIPANT REPORTED “YES” to B23 or B24,

• RECORD ALL RX and SELECTED NON-RX MEDICATIONS (Page 8) ON “RX/SELECTED Non-Rx Medication Data Collection Sheet” (SECTION C)

• RECORD ALL OTHER OTC/VITAMINS/SUPPLEMENTS PRODUCTS ON “Over-the-Counter (OTC) / VITAMIN/Dietary SUPPLEMENT (Non Prescription) Products Data Collection Sheet” (SECTION D)

•

DETACH PAGE 7 TO ASSIST WITH ROUTE/FORM CODES AND PAGE 8 FOR A LIST OF SELECTED NON-RX MEDICATIONS

C. Record all prescription and selected non-Rx medications (including pills, dermal patches, eye drops, creams, salves, and injections) that were a)  administered only once or twice a year and used since your last study visit (“YES” to B23) or b) used in the previous three months (“YES” to B24). Record the complete medication name exactly as written on the container label.

| | | |

|#___ Medication Details |Dose – Quantity |Dose – Duration |

| |(how many taken total/time unit) |(for how long) |

|Medication Name |Route* |Dosage |Strength |Strength Unit |# |Time Unit |# |

| | |Form** | | | | | |

|Rx Status: |PRN? |Verified by container? |Currently using medication? |Taken within 24 hours of blood draw? |

| | | | |No 1 | |

|1 Written Rx 2 OTC/self -8 Unknown |No 1 |No 1 |No 1 |Yes 2 | |

|3 OTC/doctor 4 Other |Yes 2 |Yes 2 |Yes 2 |No Blood Draw 3 | |

| | | |

|Medication Name |

|Product Name |Route* |Dosage |Strength† |Strength Unit† |Number taken in previous 24 |Verified by container? |

| | |Form** | | |hours? | |

| | | | | | | |

| | | | | | |No 1 |

|__________________________________ |_______ |_____ |________ |______ |________ |Yes 2 |

| |

| |

|#____ OTC/Vitamin/Supplement |

|Product Name |

| |

|#____ OTC/Vitamin/Supplement |

| |

|Product Name |Route* |Dosage |Strength† |Strength Unit† |Number taken in previous 24 |Verified by container? |

| | |Form** | | |hours? | |

| | | | | | | |

| | | | | | |No 1 |

|___________________________________ |_______ |_____ |________ |______ |________ |Yes 2 |

| |

†Complete strength and strength unit if only 1 or 2 active ingredients for oral route

USE ADDITIONAL OTC/VITAMIN/Dietary SUPPLEMENT (NON-RX) PRODUCTS DATA COLLECTION SHEETS AS NECESSARY

|# |*Route of Administration [ROA] |**Primary Dosage Form |

|1 |ORAL (by mouth) |Caplet/ Gel tab - 2 |

| | |Capsules – 3 |

| | |Gels - 11 |

| | |Granules – 12 |

| | |Liquids - 15 |

| | |Powder - 22 |

| | |Tablets - 27 |

|2 |SUBLINGUAL (under the tongue) |Lozenges - 17 |

| | |Tablets - 27 |

|3 |PARENTERAL (by injection. E.g. Subcutaneous (SC) , Intravenous (IV) , |Injections (vial, ampoule) - 14 |

| |Intramuscular (IM) , Intraosseous , Intraperitoneal (IP) , Intrathecal ) | |

|4 |EPICUTANEOUS (Topical, on the skin) |Aerosols - 1 |

| | |Creams - 4 |

| | |Discs - 5 |

| | |Gels – 11 |

| | |Liquids - 15 |

| | |Lotions – 16 |

| | |Ointments - 19 |

| | |Pastes - 20 |

| | |Plasters - 21 |

| | |Powders - 22 |

| | |Transdermal Patches – 28 |

|5 |INTRAOCULAR (into the eye) /INTRAAURAL (into the ear) |Creams – 4 |

| | |Ear drops-6 |

| | |Eye drops -9 |

| | |Ointments - 19 |

|6 |INTRANASAL (into the nose)/ INTRARESPIRATORY (into the lungs) |Aerosols -1 |

| | |Gasses - 10 |

| | |Inhalants – 13 |

| | |Nasal drops -18 |

| | |Ointments - 19 |

| | |Sprays - 25 |

|7 |RECTAL (into the rectum) |Creams – 4 |

| | |Enemas - 7 |

| | |Ointments - 19 |

| | |Powders - 22 |

| | |Suppositories - 26 |

|8 |VAGINAL (into the vagina) |Emulsion foams (foams)– 8 |

| | |Liquids - 15 |

| | |Ointments – 19 |

| | |Rings-23 |

| | |Sponge - 24 |

| | |Suppositories - 26 |

| | |Tablets – 27 |

|9 |URETHRAL (into the urethra) |Liquids - 15 |

| | |Suppositories - 26 |

1. IF PRIMARY DOSAGE FORM IS NOT LISTED, PLEASE CODE DOSAGE FORM AS “29” OTHER

2. FOR UNKNOWN DOSAGE FORM, PLEASE RECORD (-8)

SELECTED Non-Rx (OTC, Supplements, Vitamins) Medications to Collect on Rx Form (Section C)

|# |Generic Name |Common Brand Name |

|1 |Acetaminophen |Tylenol, Anacin-3 |

|2 |Aspirin |Bufferin, Ecotrin, Ascriptin, Aspir-Low, |

| | |Anacin |

|3 |Calcium |Citracal, Caltrate, Tums |

|4 |Chondroitin | |

|5 |Cimetidine |Tagamet |

|6 |Co-enzyme Q, Co-Q10, Q10 | |

|7 |Famotidine |Pepcid AC, Fluxid, Mylanta |

|8 |Glucosamine | |

|9 |Ibuprofen |Advil, Nuprin, Motrin |

|10 |Insulin |Novolin, Humulin |

|11 |Naproxen |Aleve, Naprosyn, Anaprox |

|12 |Nizatidine |Axid AR |

|13 |Omeprazole |Prilosec |

|14 |Ranitidine |Zantac |

|15 |Vitamin D |Calcitriol |

-----------------------

SECTION D. Over-the-Counter (OTC)/VITAMIN/Dietary SUPPLEMENT (Non Prescription) Products Data Collection Sheet

SECTION C. SWAN RX/SELECTED Non-Rx Medication Data Collection Sheet

1. D=day, W=week, M=month, Y=year, O=ongoing, NA= not applicable 2. For ongoing and PRN medications: dose- duration # is “NA” and Time unit is “O” for ongoing medications and “NA” for PRN medications

USE ADDITIONAL RX/SELECTED Non-RX MEDICATION DATA COLLECTION SHEETS AS NECESSARY

List of All Possible Routes of Administrations and Corresponding Dosage Forms

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