These conventions have been curated to show how to consider calculating cumulative and daily drug dose for a given exposure record. These are high-level examples meant to demonstrate how one might use the DRUG_STRENGTH table and they do not take into account switching or stockpiling.
1. Tablets and other fixed amount
formulations
Example: Acetaminophen
(Paracetamol) 500 mg, 20 tablets.
DRUG_STRENGTH The
denominator_unit is empty
DRUG_EXPOSURE The
quantity refers to number of pieces, e.g. tablets.
In the
example: 20
Ingredient dose= quantity x amount_value [amount_unit_concept_id]
Acetaminophen dose = 20 x 500mg = 10,000mg
Daily dose =
Acetaminophen dose/drug duration
2. Puffs of an inhaler
Note: There is no difference to use case 1 above
besides that the DRUG_STRENGTH table may put {actuat} in the denominator
unit. In this case the strength is provided in the numerator.
DRUG_STRENGTH The denominator_unit is {actuat}
DRUG_EXPOSURE The quantity refers to the number of
pieces, e.g. puffs
Ingredient dose= quantity x numerator_value [numerator_unit_concept_id]
Daily dose = Ingredient dose/drug duration
3. Quantified
Drugs which are formulated as a concentration
Example: The Clinical Drug is Acetaminophen 250 mg/mL
in a 5mL oral suspension. The Quantified Clinical Drug would have 1250
mg / 5 ml in the DRUG_STRENGTH table. Two suspensions are dispensed.
DRUG_STRENGTH The denominator_unit is either mg or mL.
The denominator_value might be different from 1.
DRUG_EXPOSURE The quantity refers to a fraction or
multiple of the pack.
In the example: 2
Ingredient dose= quantity x numerator_value [numerator_unit_concept_id]
Acetaminophen dose = 2 x 1250mg = 2500mg
Daily dose =
Acetaminophen dose/drug duration
4. Drugs with the total
amount provided in quantity, e.g. chemotherapeutics
Example: 42799258 “Benzyl Alcohol 0.1 ML/ML / Pramoxine
hydrochloride 0.01 MG/MG Topical Gel” dispensed in a 1.25oz pack.
DRUG_STRENGTH The denominator_unit is either mg or
mL.
Example: Benzyl Alcohol in mL and Pramoxine
hydrochloride in mg
DRUG_EXPOSURE The quantity
refers to mL or g.
Example: 1.25 x 30
(conversion factor oz -> mL) = 37
Ingredient dose= quantity x numerator_value [numerator_unit_concept_id]
Benzyl Alcohol dose = 37 x 0.1mL = 3.7mL
Daily dose =
Benzyl Alcohol dose/drug duration
Pramoxine hydrochloride
dose = 37 x 0.01mg x 1000 = 370mg
Daily dose = Pramoxine
hydrochloride dose/drug duration
Note: The
analytical side should check the denominator in the DRUG_STRENGTH table.
As mg is used for the second ingredient the factor 1000 will be applied
to convert between g and mg.
5. Compounded
drugs
Example: Ibuprofen 20%/Piroxicam
1% Cream, 30ml in 5ml tubes.
DRUG_STRENGTH We need
entries for the ingredients of Ibuprofen and Piroxicam, probably with an
amount_value of 1 and a unit of mg.
DRUG_EXPOSURE
The quantity refers to the total amount of the compound. Use one record
in the DRUG_EXPOSURE table for each compound.
Example: 20% Ibuprofen of 30ml = 6mL, 1% Piroxicam of
30ml = 0.3mL
Ingredient dose= Depends on the drugs involved: One of the use cases above.
Ibuprofen dose = 6 x 1mg x 1000 = 6000mg
Daily dose =
Ibuprofen dose/drug duration
Piroxicam dose = 0.3 x 1mg x
1000 = 300mg
Daily dose = Piroxicam dose/drug duration
Note: The analytical side determines that the
denominator for both ingredients in the DRUG_STRENGTH table is mg and
applies the factor 1000 to convert between mL/g and mg.
6. Drugs with the active ingredient released over time,
e.g. patches
Example: Ethinyl
Estradiol 0.000833 MG/HR / norelgestromin 0.00625 MG/HR Weekly
Transdermal Patch
DRUG_STRENGTH The denominator
units refer to hour.
Example: Ethinyl Estradiol
0.000833 mg/h / norelgestromin 0.00625 mg/h
DRUG_EXPOSURE The quantity refers to the number of
pieces.
Example: 1 patch
Ingredient rate= numerator_value [numerator_unit_concept_id]
Ethinyl Estradiol rate = 0.000833 mg/h
norelgestromin
rate 0.00625 mg/h
Note: This can be converted
to a daily dosage by multiplying it with 24. (Assuming 1 patch at a time
for at least 24 hours)