Medication Data Collection Training The Study of Womens Health Across the Nation (SWAN)

Training For Medication Data CollectionSheet

The Study of Womens Health Across the Nation (SWAN IV) Samar El Khoudary, PhD, MPHSWAN Coordinating CenterUniversity of PittsburghApril-2010Purpose of the FormTo collect data on prescription (Rx) and selected non-Rx medicationTaken 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 FormTo 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 ProceduresParticipants 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 FormThe 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.

Important DefinitionsRX/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 MedicationsA 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 MedicationWithin 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 ContdOral : by mouthPossible dosage form: tablet, capsule, caplet, pill, liquids (solution, suspension, syrup)

Sublingual: under the tonguePossible dosage form: tablet, lozenge

Parenteral: by injection or infusionPossible 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 ContdIntranasal /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 ContdVaginal: application into the vagina Possible dosage form: ointment, tablet, ring, suppository, liquid

Urethral: into the urethraPossible 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 ContdIf 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 25mg and triamterene 37.5mg)

Strength = 25/37.5Strength UnitIs the unit of a given strength

ExampleStrengthUnitAmoxicillin 500mg capsulesHydrocortisone 1 %Amphetamine-D5 (0.1 mg/ml) Insulin 100-UVicodin 500 MG-5 MG ORVicodin 500-5 MG500mg1%0.1mg/ml100U500/5500/5mg/mgmg

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-QuantityThe time period that best describes the participants actual usageD = DayW= WeekM= MonthY = YearNA= Not applicableOther, ____________

Dose-Quantity/Time UnitExampleDose-QuantityTime unitD W M Y Other, specify:2 Tablets 4 times a day1 Capsule every 12 hours3 Pills every week1 Capsule Every other day

8D2D3W1Other, specify:Every other dayDuration of administration [Dose-duration]The entire length of time the participant will take/took a medicationIt is always followed by a time unit:D = DayW= WeekM= MonthY = YearO= OngoingNA= Not applicable

Dose-Duration/ Time UnitExampleDose-DurationTime unit

D W M Y O NAFor 1 monthAs needed Ongoing1MNANANAOMedications with Tapering DoseIn 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 ContdExample:

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 RX/Selected Non-RX Medication Data Collection Sheet

Section C

Medication NameFor 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 availableRecord the exact name as it appears on the containerYou 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 participantStrengthFor 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 ContdFor selected non-Rx when container is availableRecord the strength and strength unit of only the active ingredients that are listed as one of the selected non-Rx medication/productIf strength was not part of the name you can find it in the drug/product fact box on the containerExample: 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 mgUniflex 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 instructionsWhen 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 InstructionsDosage FormDose-Quantity/appropriate time unitOral liquidsTotal number of ml1teaspoon=5ml1tablespoon=15ml1ounce=30mlInhalantsTotal number of sprays or puffsCreams, lotions, ointmentsTotal number of applicationsPatchesTotal number to be applied to the skin Tablets and capsules Total number of tablets or capsules taken Eye/ear/nasal dropsTotal number of drops usedExample 1Rx-Medication

Name of the medicationStrength and Strength UnitInstructions for Dose-QuantityInformation about ROUTE, FORM, PRN, TAPERFor more information about ROUTE

ALENDRONATE12770MG

1?

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

Example 2Rx-Medication

FLUTICASONE PROP. NASAL ROXANE625-8-8

4?

Example 3Rx-Medication

VAGIFEM82725MCG

2?Full durationExample 4Rx-Medication

PROAIR HFA6138.5GM

8NA

Example 5Rx-Medication

FOSAMAX PLUS D12770/2800MG/U

1?Example 6Rx-Medication

Scenario #1Participant A is using medication 1 since October 20th 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

CHERATUSSIN115-8-8Participant Z

10NAParticipant Z2.5MLEvery 6 hours =4 times a day2.5*4=1062

Participant X

Participant ZExample 7Selected Non-Rx-Medication

TYLENOL EXTRA STRENGTH

12500MGAsk the participant for dose-quantity and duration data

Example 8Selected Non-Rx-Medication

MOVE FREE ADVANCEDVITAMIN D/GLUCOSAMINE HYDROCHLORIDE/CONDROITIN SULFATE

127800/1500/200IU/MG/MGAsk the participant for dose-quantity and duration data

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

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Product NameRecord 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 participantStrengthComplete 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 ContdWhen 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 instructionsAsk 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

Example Over-the-Counter (OTC)/VITAMIN/Dietary SUPPLEMENT (Non Prescription) Products

LORATADINE

12710MG

Ask the participant for dose-quantity and duration data

Questions??