Using WHI Current Medication Data. Jill Shupe May 6, 2009

Transcription

1 Using WHI Current Medication Data Jill Shupe May 6, 2009

2 Current Medications Presentation Outline Data Collection Medi-Span Data Files Examples

3 Current Medication (Form 44) Data Collection When and on Whom? Visit Study Baseline AV1 AV3 AV6 AV9 (sv1 & sv3)* All CT X X X X X All OS X X * sv = screening visit

4 Baseline Med Use Medications entered at SV1 Newly prescribed/started medications since SV1 entered at SV3 Combine meds at a different baseline visits together to provide picture of baseline medication use. Issues: SV1 and SV3 can be far apart Don t know what medications, if any, a woman stopped, or replaced

5 Current Medication Collection Definition of Current Medication Use Medication: An OTC or prescription medication Not vitamin/mineral supplements Current Use: Using med at the time of data collection interview AND Using med at least once a week AND Using med for at least the last 2 weeks

6 What about Supplements? Supplements collected separately & differently than meds Tums used as antacid entered in medications Tums used as calcium supplement entered in supplements (Form 45 Current Supplements)

7 Current Medication Collection What data was collected? Medication NDC Number - Medi-Span link Medication product and generic name Dosage form (tablet,liquid) Metric strength Therapeutic Class Ingredients (name and strength) Duration of current use If corticosteroid, taken orally and daily?

8 Current Medication Collection What data was NOT collected? Frequency of Use, e.g. # of times per day Dosage, e.g. # of pills Not collected TAKE ONE CAPSULE BY MOUTH TWICE DAILY

9 Medi-Span What is it and How is it used Reference database with data about pharmaceutical and OTC drugs Incorporated into WHI database as look-up list for entering meds Only NDC Number of medication stored in WHI database Link to Medi-Span using NDC number for med details like strength

10 What about Natural or Alternative Medications? Unclear extent of alternative medication entry & reporting Alternative medications were available in Medi-Span Participants prompted specifically for Herbal Estrogens

11 Current Medication Trivia What is the most number of medications recorded for a WHI participant? 43 medications Thyroid, Astralalus, Bilberry, Boron, Butchers Broom, Cats Claw, Cod Liver Oil, COQ10, Cranberry, Dandelion Root, Garlic, Ginkgo Biloba, Ginseng, Hawthorne, Horse Chestnut, Milk Thistle, MSM, Salmon Oil.

12 Medi- Span Form vs Data

13 Medi-Span Relational Structure Therapeutic Class Selective Serotonin Reuptake Inhibitors (SSRIS) Medication Prozac Tab 10 mg Ingredient Fluoxetine HCL 10 mg

14 Medi-Span Therapeutic Classes All medications are assigned to a Therapeutic Class (6-digit code) Drug Group Drug Subclass Drug Class

15 Medi-Span Medications Medication Details Available NDC Number 11-character unique med id Product Name Product name on med package Tylenol Generic Name Ingredient(s), form, strength Acetaminophen tab 500mg Product Description Abbreviation Shortened product description. (product name, dosage form, and strength) TYLENOL TAB 500MG Dosage Form Form in which drug dispensed TABS - Tablet Metric Strength/ Unit of Measure (Dosage Strength) Administration Route Dosage strength for med with single active ingredient. Zero for meds with >1 active ingredient How drug administered 500 MG OR Oral, taken by mouth

16 Medi-Span Medication Ingredients Ingredient Details Available Generic Ingredient Name Metric Strength/ Unit of Measure Generic name of ingredient in drug product. Dosage strength of ingredient Acetaminophen 500 MG

17 Current Medication Trivia What medication did the most WHI women report using? #1: Premarin 0.625mg #2: Aspirin 325 mg

18 Current Medication Data Files Data File Name Data Source Data File Contents F44_ctos_inv WHI Participants F44ref_med_classes Medi-Span WHI participant medication data from baseline & follow-up Therapeutic Class Details F44ref_meds Medi-Span Medication Details F44ref_med ingreds Medi-Span Ingredient Details

19 F44_ctos_inv.dat File WHI Participant Common Id Days Since Randomization/Enrollment Visit Type Visit Year Closest to Visit Flag Expected for Visit Flag NDC Number Adult Duration of Med Use in Days Adult Duration of Med Use in Years Oral/Daily use of Corticosteroid Flag Therapeutic Class Code Common Variables in Most Data Files Link to medi-span medication details Link to medi-span therapeutic class

20 F44_ctos_inv.dat File " " " " " " " " " " " " " " " " " "

21 A word about Duration Duration = Adult Duration = Medication use starting at age 20

22 F44ref_med_classes.dat File Therapeutic Class Code Therapeutic Class Name Links back to f44_ctos_inv.dat file "THYROID" "THYROID HORMONES" "THYROID COMBINATIONS"

23 F44ref_meds.dat File NDC Number Product Name Product Abbreviation Generic Name Metric Strength Strength Unit of Measure Dosage Form Administration Route Therapeutic Class Code Links back to f44_ctos_inv.dat file Links back to f44_ctos_inv.dat file " " "LEVOTHYROXINE SODIUM" "LEVOTHYROXIN TAB 50MCG" "LEVOTHYROXINE SODIUM TAB 50 MCG " 50 " MCG" TABS OR

24 F44ref_med_ingreds.dat File NDC Number Links back to f44_ctos_inv.dat file and F44ref_meds.dat file Ingredient Name Metric Strength Strength Unit of Measure " " "LEVOTHYROXINE SODIUM" 50 "MCG"

25 Current Medication Data File Relationships F44ref_med_classes F44_ctos_inv Therapeutic Class Name Participant med vars F44ref_meds Medication detail vars F44ref_med_ingreds Ingredient 1 details Ingredient 2 details

26 Examples Statin Use Case By Medication Brand name: Mevacor Generic name: Lovastatin By Medication Ingredient Ingredient: Lovastatin By Therapeutic Class Class: HMG COA Reductase Inhibitors

27 By Medication Use F44ref_meds.dat file Look at Medication Product Name (MEDNAME) variable for Mevacor Look at Medication Generic Name (MEDGENER) variable for Lovastatin Note other Brand Names for Lovastatin: Altoprev, Altocor Note combo medication Advicor (Lovastatin and Niacin). You will need to decide to include or exclude in analyses. Use Medication NDC Numbers to get participants in f44_ctos_inv.dat file using Lovastatin: MEDNDC (lovastatin only, no niacin) = , , ,.,

28 What if a ppt taking >1 Lovastatin at a visit? Up to you how to handle it WHI calculates duration as Maximum duration recorded for any Lovastatin.

29 By Medication Ingredient Use F44ref_med_ingreds.dat file Look at Med Ingredient Name (MEDING) variable for Lovastatin Retrieves meds where Lovastatin is only ingredient and where Lovastatin is combined with another ingredient, e.g. Niacin. Use NDC Numbers to get participants in f44_ctos_inv.dat file using Lovastatin or Lovastatin Combo MEDNDC (lovastatin only & lovastatin + niacin) = , , ,,

30 By Therapeutic Class F44ref_med_classes.dat Statins F44ref_therclas.pdf "ANTIHYPERLIPIDEMIC" "BILE SEQUESTRANTS" "FIBRIC ACID DERIVATIVES" "INTESTINAL CHOLESTEROL ABSORPTION INHIBITORS" "HMG COA REDUCTASE INHIBITORS" "HMG COA REDUCTASE INHIBITOR COMBINATIONS" "NICOTINIC ACID DERIVATIVES" "MISC. ANTIHYPERLIPIDEMICS" "ANTIHYPERLIPIDEMIC COMBINATIONS" "FIBRIC ACID DERIVATIVE COMBINATIONS" Statins

31 By Therapeutic Class (cont.) Use Therapeutic Class Code (TCCODE) variable to get participants in f44_ctos_inv.dat file using Statins. TCCODE = or To determine what meds are classified as a Statin look in f44ref_meds.dat file. Find medications with a TCCODE of or You will find meds: Pravachol /Provastatin, Zocor /Simvastatin, Baycol /Cervastatin, Lipitor /Atorvastin, Pravigard /Aspirin+Provastatin etc.

32 Complexity Example Define Aspirin Use Include any med containing Aspirin? Include meds containing only Asprin? Include Other Salicylates, e.g. Sasalate? Low dose versus High dose?

33 Other Medication Data Sources Form 43 Hormone Use (baseline) OS Follow-Up Forms (hormone use) Form 10 HRT Safety Interview (follow-up) Form 17 CaD Safety Interview (follow-up) Form 2 Eligibility Screening (baseline)

34 your brain your brain on medication data Questions?