F:\formsbk\qxqs\md qxq.wpd

Medications (MD) form
Purpose:
To document medication use in last two weeks, and the day of the home visit fordata collection visits without a sleep study, and to document medication use in thelast two weeks, the day of the sleep study, and the night of the sleep study for datacollection visits with a sleep study.
Medication use will be used to better define those reporting prevalentheart disease, hypertension, diabetes and other conditions. For example, aperson taking nitroglycerin will generally have coronary heart disease. Diabetes may be insulin-requiring or not.
Medications may be prescribed for sleep or may have side effects ofsedation.
Medication use may be an essential covariate in the analysis of theprimary effects of sleep apnea on cardiovascular disease.
Initiated the evening of the home visit, and completed the following morning ifthe home visit includes a sleep study Special Instructions
Complete column g by transferring data from the Night Medications (NM) form, whenappropriate. If there is an NM form, Section B of the MD form cannot be fullycompleted until the morning following the visit, as information recorded on the NM formis needed to complete this section.
Note that, unlike all other SHHS forms, the Interviewer/Technician ID is entered at theupper right corner of this form above the key fields A Form Sequence # must be included in the key fields Also unlike other forms, the comments field (item 31) is for field site use only. Comments will not be data entered.
General Information
Definition of “Medication”: Medications are defined as all prescription and non-prescriptionmedications. Included are pills, skin patches, eye drops, creams, salves, and injections, as wellas vitamins, cold or allergy remedies, aspirin, and Tylenol.
Note: Physicians sometimes write prescriptions for medications which can be purchased withouta prescription (over-the-counter medicines). For example, the participant may take one aspirin aday. When the physician wrote a prescription for the aspirin, it is considered a prescriptionmedication. When the physician recommended that the participant take aspirin, but did notwrite a prescription for it, the aspirin is not considered a prescription medication. It is, therefore, Medications (MD) form (cont’d)
possible that drugs such as aspirin may be duplicated in prescription and non-prescriptionsections.
Methods: At the home visit, the participant provides the technician with all medications usedduring the two weeks prior to the visit. The technician transcribes information from the containeronto the data collection form. After the information is transcribed, the interviewer queries theparticipant about each medication.
A Medications Form (MD) must be completed for every participant having a home visit. If aparticipant has not taken any medications, then only Section A of the form needs to becompleted.
Question by Question Specifications
Medication Retrieval (Section A)
The participant is asked to gather all prescription medications taken in theprevious two weeks; this request is made during the pre-visit confirmation call.
During the Home Visit, the interviewer inquires whether all prescriptionmedications taken during the last two weeks are available. The responses arerecorded in Section A.
“As you know, the Sleep Heart Health Study will be describing prescription andnon-prescription medications its participants are using. These include pills, skinpatches, eye drops, creams, salves, and injections, as well as vitamins, cold orallergy remedies, aspirin, and Tylenol. Please show me all of your medications.” (When medications are assembled) “Are these all the medications that you took inthe last two weeks?” When the medications have not been gathered prior to the visit, or all are notavailable, the interviewer requests that the participant proceed with gatheringthem.
When the participant has not taken any prescription medications during theprevious two weeks, check “Took none” on the Medications Form and STOP.
Only medications which where actually taken during the previous two
week period are recorded. Do not record medications prescribed by a
physician, but not taken. This includes instances where a physician wrote
a prescription but it was not filled, or even if filled, no medications were
Medications (MD) form (cont’d)
taken during the previous two weeks.
Medications (MD) form (cont’d)
When the participant refuses, record the reason for refusal on the form and STOP Number of Medications (Section B)
Instructions: If no PSG done, complete items a-d after completing Section C. If PSG is done,
complete items a and b then complete items c and d after NM form information is transferred
to the MD form.
Record the number of prescription and non-prescription medications wheretranscription was possible.
Record the number of medications where complete transcription was not possible. This includes:- Medications with illegible or missing labels- Medications whose containers were not available for transcription Record the number of night medications added. This is to be completed after theNight Medications (NM) form is collected.
Record the total number of medications for data entry. This is to be completedafter information from the Night Medications (NM) form is transferred, whenappropriate.
Transcription Process (Sections C and D)
Medication Name (column a)
Print complete names using block capital letters, one letter per box.
Record all identifying characters and numbers referring to strength.
Combination medicines contain two or more drugs in a single pill or tablet. Somecombination medicines such as Dyazide come in only one fixed combination(hydrochlorothiazide 25 mg and triamterene 50 mg); these combination medicinesdo not generally list a strength. Record DYAZIDE in the space name of medicineand leave the strength prescribed column blank.
Other combination medicines such as Inderide are available in more than onefixed dose combination (propanolol 40 mg and hydrochlorothiazide 25 mg; orpropanolol 80 mg and hydrochlorothiazide 25 mg); these combination medicinesgenerally list the strength as in “Inderide 40/25” or “Inderide 80/25.” For thesemedicines, record INDERIDE, in the space for name, and “40/25” or “80/25” inthe space provided for strength prescribed.
Medications (MD) form (cont’d)
Drugs containing two or more medications:Example: Dyazide (hydrochlorothiazide and triampterene) is recorded as: Inderide 40/25 (40 mg Inderal, 25 mg hydrochlorothiazide) is recorded:Name: “INDERIDE”Strength prescribed: Inderide 80/25 (80 mg Inderal, 25 mg hydrochlorothiazide) is recorded:Name: Do not record flavors of products and whether the preparations are sugar-free orsodium free.
When it is not possible to transcribe the drug name, record the drug name as“CANNOT TRANSCRIBE”.
If participant is part of another study and is on a “study drug” and does not knowwhat the drug is, then code the medication name as “STUDY DRUG.” Structure similar to prescription medications section Only difference is that there is no column for “prescription” data Data acquired is on frequency of actual medication use Record data on dose and frequency use as before Dose (column b)
Dose: Record strength and units ( example: 100mg, 0.125 mg, 1 gm)
Combinations medications contain two or more drugs in a single pill - Example: Dyazide (hydrochlorothiazide 25 mg + triamterene 50 mg Medications (MD) form (cont’d)
Combination medications- record the name and leave the strength blank Some combination medications have more than one “dose” Example: Inderide 40/25 or 80/25 (record in the strength column) Record all characters used to denote units; this includes: % - percent Note: When the abbreviation, “PC” (percent) is used, recordpercent symbol, “%.” When the units are given in grains (gr), convert to milligrams by multiplying by65 milligrams per grain1 grain = 65 milligrams2 grains = 130 milligrams5 grains = 325 milligrams Liquid medicines units are often written in mg/ml (milligrams per milliliter). Forexample, Ampicillin 125 mg / 5 ml, is recorded at the time of the home visit as: NOTE: For data entry the dose will be displayed as 125/5ML Units for some medicines may be written as a percentage.
For example: Alupent 0.6%, is recorded as: Do not record the quantity or number of pills/tablets dispensed as the dose.
If participant is part of another study and is on a “study drug” and does not knowwhat the drug is, then record the dose as N. Number Prescribed (Section C, column c)
Record the total number of pills/times prescribed for the time period.
Circle the appropriate letter to indicate whether the prescribed administration is per Medications (MD) form (cont’d)
“D - day,” “W - week” or “M - month.” When the instructions include a range, record the lowest number of pills/timesadministered recommended. Examples.
- “Take 1-2 pills 3-4 times a day,” record “3” (for 1 pill x 3 times/day) Medications (MD) form (cont’d)
“Take 1-2 pills every 4 hours while awake,” (Example: if participant sleeps 8hours per day, then there are 16 hours awake. Participant would take 5 pills perday, because one is taken upon awakening, 3 during the course of the day, andone at bedtime) “Take 2-4 pills every 4 hours,” record 12, because there are six 4-hour intervals ina 24 hour period and 2 pills are to be taken for each interval (2 x 6 = 12) When instructions indicate “Take as directed,” record “N” in the number of pillsprescribed per day.
COMPLEX INSTRUCTIONS: Example - “take 1 pill every other day, alternatingwith 2 pills every other day” record as an average of 1.5 pills per day.
PILLS, CAPSULES, or TABLETS: record the total number prescribed per day,week or month.
SOLUTIONS: record the total number of milliliters taken per day, week ormonth. NOTE: 1 teaspoon = 5 ml1 tablespoon = 15 ml1 ounce = 30 ml EYE DROPS: record the total numbers of drops prescribed per day, week ormonth. Examples: Two drops in right eye, three times a day = 6One drop in each eye, twice a day = 4 INHALERS: record the total number of sprays or puffs prescribed per day, weekor month.
INSULIN, record the total number of units injected per day, week or month.
CREAMS, LOTIONS, and OINTMENTS: record the total number ofapplications prescribed per day, week, or month.
PATCHES: record the total number to be applied to the skin per day, week, ormonth.
NITROGLYCERIN OINTMENT: record the total number of inches to beapplied to the skin per day, week, or month.
Medications (MD) form (cont’d)
PRN Medication (Section C, column d)
Indicate, using column d, whether the medication is prescribed to be taken on an “asneeded” basis.
Check PRN only when the prescription instructions indicate “as needed,” “whenneeded,” “if needed,” or a synonym. The words, “as directed,” do not mean the sameas “as needed.” Number Used (Section C, column e and Section D, column c)
Record the total number of pills/times used for the previous 2-week time period.
Circle the appropriate letter to indicate whether the use is per “D - day,” “W - week”or “M - month.” Used on Day of Home Visit (Section C, column f and Section D, column d)
Check if the medication was used after awakening on the day of the home visit Used the Night of the PSG (Section C, column g and Section D, column e)
Column g. is to be filled in after the “Night Medications (NM) form” is collected. Check mark should be placed in column g. if a participant took a medication betweenthe time the technician recorded the medications last night and the time theparticipant got up the next morning.
This comment field is for notes for the field site only. Comments cannot be enteredinto the MEDS DB application.

Source: http://jhuccs1.us/shhs/details/manual/forms/formsfu2_qq/md_qq.pdf