Samar El Khoudary, PhD, MPH SWAN Coordinating Center University of Pittsburgh April-2010

1. Training For Medication Data CollectionSheet The Study of Women’s Health Across the Nation (SWAN IV) Samar El Khoudary, PhD, MPH SWAN Coordinating Center University of Pittsburgh April-2010

2. Purpose of the Form • To collect data on prescription (Rx) and selected non-Rx medication • Taken within the past three months • Administered once or twice yearly since the last study visit (Rx) To be captured on Section C

4. Purpose of the Form • To collect data on over-the-counter (OTC), vitamin and supplement products • Taken within the past three months To be captured on Section D

6. Requirements and Main Procedures • Participants need to bring all Rx/OTC used in the previous three months to their visit • In the instance of medications taken only 1-2 times/year, participant should provide written information when possible • The interviewer will need to review all Rx medications and non-Rx medication/products and transcribe certain data from the container/label to the to the appropriate data collection sheet (section C or D) • If there is no container, the interviewer should record what the participant can provide about each of her medication/OTC

7. Blood Draw and Blood Contact Form • The medication form and blood contact form should be completed at the time of blood draw • To determine if any Rx was taken within 24 hours of the blood draw • If the medication form is NOT completed on the same day as the blood draw, the participant should be asked: • If any of the medications listed were “taken within 24 hours of blood draw?” • If she has taken any medications “within 24 hours of blood draw?” that are NOT listed on the medication form.

8. Important Definitions

9. RX/Prescription Medications: • A medication for which a prescription was written by a physician, dispensed by a pharmacist or physician, and taken by the participant

10. OTC/Non-prescription Medications • A medication, vitamin, or dietary supplement that may be purchased without a physician’s prescription • EXCEPTIONS: • If a prescription is written for a medication, even if it is available without one, it should be considered a prescription medication (Rx) (e.g. Aspirin) • When a physician recommends an over-the-counter product, but does not write a prescription for it, it is considered non-Rx

11. Current Use of Medication • Within the past three months: • Taken at least one time within the two week period (14 days) prior to the current study visit • One or twice/year: • Administered prior to the current visit as well as will be administered after this follow-up visit

12. Route of Administration [ROUTE]Dosage Form[Form] • Route of administration [ROUTE]: • Is the path by which a drug, fluid, or other substance is brought into contact with the body • Dosage form [FORM]: • Is the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption

13. ROUTE/FORM Cont’d • Oral : by mouth • Possible dosage form: tablet, capsule, caplet, pill, liquids (solution, suspension, syrup) • Sublingual: under the tongue • Possible dosage form: tablet, lozenge • Parenteral: by injection or infusion • Possible dosage form: Injection (vial, ampoule)

14. ROA/FORM Cont’d • Epicutaneous: application onto the skin/topical • Possible dosage form: cream, ointment, lotion, powder, liquids, patch, paste • Intraocular/Intraaural: application into eyes/ears • Possible dosage form: eye/ear drops, ointment, cream

15. ROA/FORM Cont’d • Intranasal /Intra-respiratory : into the nose/ into the respiratory system • Possible dosage form: nasal drops, sprays, ointment, cream, inhalant, aerosols • Rectal: application into the rectum • Possible dosage form: enema, suppository ointment, cream

16. ROA/FORM Cont’d • Vaginal: application into the vagina • Possible dosage form: ointment, tablet, ring, suppository, liquid • Urethral: into the urethra • Possible dosage form: liquid, suppository

18. Strength • Is the amount of the main active ingredient in a single dose • It is usually listed as a component of the product name (e.g. Amoxicillin 500mg), but also appears in other data fields • Rx/OTC are available in either single strength or multiple strengths (e.g. Amoxicillin capsules are available with the following strengths 250mg, 500mg)

19. Strength Cont’d • If a medication is available in only single strength. It must likely that strength will not be part of the name • COMBO strength : if the medication included more than one active ingredient (e.g. Dyazide® 25/37.5mg (active ingredients: hydrochlorothiazide 25 mg and triamterene 37.5 mg) Strength = 25/37.5

20. Strength Unit • Is the unit of a given strength mg/mg mg mg/ml mg % U 500 1 0.1 100 500/5 500/5

22. Dose-Quantity (Number Taken) • The total quantity taken for the time period that best describes the participants actual usage. • For a participant who is prescribed to take one capsule of X med. every 6 hours, the dose-quantity refers to the total number of capsules taken per day • In this example it should be 4 capsules

23. Time Unit for Dose-Quantity • The time period that best describes the participants actual usage • D = Day • W= Week • M= Month • Y = Year • NA= Not applicable • Other, ____________

24. Dose-Quantity/Time Unit Other, specify: Every other day 8 2 3 1 D D W

25. Duration of administration [Dose-duration] • The entire length of time the participant will take/took a medication • It is always followed by a time unit: • D = Day • W= Week • M= Month • Y = Year • O= Ongoing • NA= Not applicable

26. Dose-Duration/ Time Unit 1 NA NA M NA O

27. Medications with Tapering Dose • In which the dose was/is gradually reduced (GDR) over time • Because the taper dose is not stable, we will be only collecting the maintenance dose and total duration on the medication • In case the change was for short duration (a dose pack of steriod), strength should be recorded as “Taper”. • Strength unit, dose-quantity will be not applicable “NA” and dose-duration should reflect the total duration on the medication.

28. Tapering Dose Cont’d • Example: • If a participant had been given a steroid taper 4 months prior to the visit with a starting dose of 1 tablet with 50 mg strength of prednisone per day for a month, and was currently taking 1 tablet of 10 mg strength per day for 3 months • The maintenance dose should be recorded (1 tablet of 10mg per day AND NOT 1 tablet of 50mg per day) • The duration should reflect the total duration (4 month)

29. PRN = Pro Re Nata (As Needed) • Indicates whether the medication is taken on an “as needed” basis • PRN is generally used for allergy, pain, or sleep medications • Please note that “As needed” is not the same as “As directed” • When a medication is taken as “PRN” the dose-duration and its time unit should be recorded as “NA”

30. RX/Selected Non-RX Medication Data Collection SheetSection C

34. Medication Name • For Rx medication when container with label is available: • Record the exact name as it appears on the label using CAPITAL LETTERS • For selected non-Rx when container is available • Record the exact name as it appears on the container • You will need also to record only active ingredients that is listed in the selected non-Rx table (e.g. Move Free® contains glucosamine hydrochloride, chondroitin sulfate, Uniflex extract, Joint fluid (hyaluronic acid)) • If there is no container, record the name as provided by the participant

35. Strength • For Rx medication when container with label is available: • Record the strength followed by strength unit exactly as it appears on the container label • For COMBO strength, record strengths of active ingredients separated by a slash. Same for unit

36. Strength Cont’d • For selected non-Rx when container is available • Record the strength and strength unit of only the active ingredients that are listed as one of the selected non-Rx medication/product • If strength was not part of the name you can find it in the drug/product fact box on the container • Example: Move Free® contains glucosamine hydrochloride 1500mg, chondroitin sulfate 200mg, Uniflex extract 250mg, Joint fluid (hyaluronic acid) 3.3mg. • Strength should be “1500/200” and unit should be “mg” • Uniflex extract and Joint fluid (hyaluronic acid) are not included in the non-Rx list • If Strength is not listed on the label or known by the participants (if no container) then strength should be “-8” = unknown

37. Dose-Quantity Special instructions • When medication label indicated take as directed or includes range “take 1-2 tablets 3-4 times a day” • Ask the participant about the usual number taken per unit of time and record that

38. Dose-Quantity Special Instructions

39. Example 1Rx-Medication

40. Instructions for • Dose-Quantity • Information about • ROUTE, FORM, • PRN, TAPER Name of the medication Strength and Strength Unit For more information about ROUTE

41. 27 70 MG ALENDRONATE 1

42. 1 ?

43. Written Rx: prescription medication. This includes non-prescription medications that were obtained with a prescription (e.g. coated aspirin with a prescription) • OTC/self: for all OTC products that were purchased without a physician’s prescription or a physician’s recommendation • OTC/doctor: for all OTC products that were purchased without a prescription but were based on a physician’s recommendation • Unknown = -8: if you were not able to determine the Rx status • Other:if none of the above fit

45. Example 2Rx-Medication

46. FLUTICASONE PROP. NASAL ROXANE -8 25 -8 6

47. 4 ?

49. Example 3Rx-Medication

50. VAGIFEM MCG 27 25 8