samar el khoudary, phd, mph swan coordinating center university of pittsburgh april-2010

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

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

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

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

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.

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

OTC/Non-prescription Medications A medication, vitamin, or dietary supplement that may be purchased without a physicians 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

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

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

ROUTE/FORM Contd 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)

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 ROA/FORM Contd

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 ROA/FORM Contd

Vaginal: application into the vagina Possible dosage form: ointment, tablet, ring, suppository, liquid Urethral: into the urethra Possible dosage form: liquid, suppository ROA/FORM Contd

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)

Strength Contd 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

Strength Unit Is the unit of a given strength ExampleStrengthUnit Amoxicillin 500mg capsules Hydrocortisone 1 % Amphetamine-D5 (0.1 mg/ml) Insulin 100-U Vicodin 500 MG-5 MG OR Vicodin 500-5 MG 500 mg 1 % 0.1 mg/ml 100 U 500/5 mg/mg mg

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

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, ____________

Dose-Quantity/Time Unit ExampleDose-QuantityTime unit D W M Y Other, specify: 2 Tablets 4 times a day 1 Capsule every 12 hours 3 Pills every week 1 Capsule Every other day 8 D 2 D 3 W 1 Other, specify: Every other day

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

Dose-Duration/ Time Unit ExampleDose-DurationTime unit D W M Y O NA For 1 month As needed Ongoing 1 M NA O

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.

Tapering Dose Contd 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)

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

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

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

Strength Contd 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

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

Dose-Quantity Special Instructions Dosage FormDose-Quantity/appropriate time unit Oral liquidsTotal number of ml 1teaspoon=5ml 1tablespoon=15ml 1ounce=30ml InhalantsTotal number of sprays or puffs Creams, lotions, ointmentsTotal number of applications PatchesTotal number to be applied to the skin Tablets and capsulesTotal number of tablets or capsules taken Eye/ear/nasal dropsTotal number of drops used

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

ALENDRONATE 1 27 70MG

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 physicians prescription or a physicians recommendation OTC/doctor: for all OTC products that were purchased without a prescription but were based on a physicians recommendation Unknown = -8: if you were not able to determine the Rx status Other: if none of the above fit

FLUTICASONE PROP. NASAL ROXANE 6 25 -8

VAGIFEM 8 27 25 MCG

2 ? Full duration

PROAIR HFA 6 13 8.5 GM

FOSAMAX PLUS D 1 27 70/2800 MG/U

Scenario #1 Participant A is using medication 1 since October 20 th 2009. She brought the following container to her visit on 11/2/2009. She indicated that she usually took the teaspoonful every 6 hours as needed. Using the information on the label for medication 1 and the information above, please complete the appropriate data collection sheet (Section C or D). Participant A

CHERATUSSIN 1 15 -8 Participant Z

10 NA Participant Z 2.5ML Every 6 hours =4 times a day 2.5*4=10

Participant X Participant Z

TYLENOL EXTRA STRENGTH 1 2 500 MG

Ask the participant for dose-quantity and duration data

MOVE FREE ADVANCED VITAMIN D/GLUCOSAMINE HYDROCHLORIDE/ CONDROITIN SULFATE 1 27 800/1500/200 IU/MG/MG

Product Name Record the exact name as it appears on the container using CAPITAL LETTERS Also record components (active ingredients) separated by a slash for products: Taken orally Contain one or two active ingredients If there is no container, record the name as provided by the participant

Strength Complete strength and strength unit if ONLY 1 or 2 active ingredients for oral route of administration For all other route of administrations and oral products that contain more than 2 active ingredients, strength and strength unit should be recorded as NA Record the strength followed by strength unit exactly as it appears on the container (product fact box)

Strength Contd When the oral product contain 2 active ingredients, the strength of each ingredient should be recorded separated by a slash in the same order as the active ingredients were listed under the product name box For multivitamins, the strength and the strength unit should be recorded as NA

Dose-Quantity Special instructions Ask the participants about the total quantity she took or used in previous 24 hours Follow specific instructions by dosage form as given for section c for quantity-use however record that for only the previous 24 hours

LORATADINE 1 27 10 MG

samar el khoudary, phd, mph swan coordinating center university of pittsburgh april-2010

Documents

medication form

participant slide

body dosage form form

blood contact form

nonrx slide

prescription medication

physical form

ampoule slide