Samar El Khoudary, PhD, MPH SWAN Coordinating Center University of Pittsburgh April-2010
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Training For Medication Data Collection Sheet The Study of Women’s Health Across the Nation (SWAN IV) 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
Samar El Khoudary, PhD, MPH SWAN Coordinating Center University
of Pittsburgh April-2010
Slide 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
Slide 3
Slide 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
Slide 5
Slide 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
Slide 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.
Slide 8
Slide 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
Slide 10
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
Slide 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
Slide 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
Slide 13
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)
Slide 14
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
Slide 15
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
Slide 16
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
Slide 17
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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)
Slide 19
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
Slide 20
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
Slide 21
Slide 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
Slide 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, ____________
Slide 24
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
Slide 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
Slide 26
Dose-Duration/ Time Unit ExampleDose-DurationTime unit D W M Y
O NA For 1 month As needed Ongoing 1 M NA O
Slide 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.
Slide 28
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)
Slide 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
Slide 30
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Slide 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
Slide 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
Slide 36
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
Slide 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
Slide 38
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
Slide 39
Slide 40
Name of the medication Strength and Strength Unit Instructions
for Dose-Quantity Information about ROUTE, FORM, PRN, TAPER For
more information about ROUTE
Slide 41
ALENDRONATE 1 27 70MG
Slide 42
1 ?
Slide 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 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
Slide 44
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Slide 46
FLUTICASONE PROP. NASAL ROXANE 6 25 -8
Slide 47
4 ?
Slide 48
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Slide 50
VAGIFEM 8 27 25 MCG
Slide 51
2 ? Full duration
Slide 52
Slide 53
PROAIR HFA 6 13 8.5 GM
Slide 54
8 NA
Slide 55
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Slide 57
FOSAMAX PLUS D 1 27 70/2800 MG/U
Slide 58
1 ?
Slide 59
Slide 60
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
Slide 61
CHERATUSSIN 1 15 -8 Participant Z
Slide 62
10 NA Participant Z 2.5ML Every 6 hours =4 times a day
2.5*4=10
Slide 63
Participant X Participant Z
Slide 64
Slide 65
TYLENOL EXTRA STRENGTH 1 2 500 MG
Slide 66
Ask the participant for dose-quantity and duration data
Ask the participant for dose-quantity and duration data
Slide 70
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Slide 74
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
Slide 75
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)
Slide 76
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
Slide 77
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
Slide 78
Slide 79
LORATADINE 1 27 10 MG
Slide 80
Ask the participant for dose-quantity and duration data