Search



You are viewing an old version of this page. View the current version.

Compare with Current View Page History

Version 1 Next »

To correctly interpret "one countable instance of a whole of medicinal product", it is important that this is seen in the context of the overall description of a medicinal product, which is always presented from the manufacturer in as a "packaged medicinal product".  Note that description of packaged medicinal products is outside the scope of the international release but may be included within a national extension.  The IDMP Medicinal Product model describes this, showing how the Manufactured Item is related to the Packaged Medicinal Product via the Package Item (Container); this is a recursive class that represents both the package as supplied by the manufacturer (and, for example, labelled with the GTIN, the batch number and the expiry), and through a recursive relationship, with any sub-packages inside the outer pack.

By describing the various standard patterns of products with their basic dose forms and intimate containers, consistent representation of strength based on unit of presentation can be maintained.Note: in all the patterns described below, although pack size may be mentioned, this is to show how information is sourced from "what is".  Description of pack size is out of scope for the international release, although it will be in scope for the national extension model, as some nations may require medicinal products that include description of pack size for their national terminology; therefore it is useful to have it shown here for informational purposes only.

Discrete manufactured dose form; similar unit of presentation

Examples: various tablets, capsules, cachets, pessaries, suppositories, tampons
The unit of presentation is usually a less granular term than the manufactured dose form, and often corresponds to the basic dose form.  
Strength is expressed as "per one unit of presentation" and the presentation strength and the concentration are exactly the same.

Example 1: A bottle of 56 simvastatin 40mg oral tablets

Manufactured dose formOral tablet
Unit of presentationTablet
[Pack size]56 tablets in the container

Precise active ingredientsimvastatin
Basis of strength substancesimvastatin
Presentation strength (logical)40 mg per 1 unit of presentation
Presentation strength

40 mg [per 1 tablet]

UCUM: 40 mg [per 1 each]
Concentration strength
The weight of the tablet is not usually known so concentration strength is not usually available and is not deemed clinically significant


Example 2: A pack of 28 bisoprolol 5 mg oral tablets contains two blister strips each with 14 tablets

Manufactured dose formOral tablet
Unit of presentationTablet
[Pack size]14 tablets in the blister strip2 blister strips in the box28 tablets in the outer container
Precise active ingredientbisoprolol fumarate
Basis of strength substancebisoprolol fumarate
Presentation strength (logical)5 mg per 1 unit of presentation
Presentation strength5 mg [per 1 tablet]UCUM: 5 mg [per 1 each]
Concentration strength
The weight of the tablet is not usually known so concentration strength is not usually available and is not deemed clinically significant


Continuous presentation: Metered dose unit of presentation

Examples: various inhalers, nasal sprays, some cutaneous sprays/foamsThe unit of presentation is the actuation, the “single operation of a metered-dose pump, valve or other equivalent dosing mechanism” [EDQM].Strength is expressed as “per one unit of presentation” and the presentation strength and the concentration are exactly the same.

Example: A single inhaler containing a total of 200 actuations worth of salbutamol, 100 micrograms per actuation, packaged in a box

Manufactured dose formSolution for aerosolisation
Unit of presentationActuation
[Pack size]200 actuations in the inhaler
Precise active ingredientsalbutamol sulphate
Basis of strength substancesalbutamol
Presentation strength (logical)100 mcg per 1 unit of presentation
Presentation strength100 mcg per 1 actuationUCUM: 100 mcg per 1 each
Concentration strength
The concentration of salbutamol sulphate in the inhalant solution inside the inhaler container is probably known to the regulatory agency but is not deemed clinically significant

Continuous presentation: Oral liquids designed for administration by "metered" medicine spoon

Examples: oral solutions, suspensions, emulsions, syrups.  This is a variation on the metered dose presentation; the unit of presentation supplied by the manufacturer to provide the “metered dose” is the 5mL spoonful, since this represents “the quantity of product that is administered by filling a single spoon administration device” [EDQM]. Strength is expressed as “per one unit of presentation” (per 5 mL [spoonful]) BUT the presentation strength and the concentration are NOT the same, since these are continuous liquids, so the concentration strength of “per 1 mL” will usually be a different value.  Note that explicit representation of the medicine spoon would be as an administration device, and is therefore out of scope of the international Medicinal Product hierarchy.   National extensions may wish to represent the inclusion of a medicine spoon (or indeed any other administration device such as an applicator) in the package description (as in IDMP, for example) should the use case(s) require.

Example: A bottle of 125 mL of aciclovir oral suspension 200mg/5mL



Manufactured dose formOral suspension
Unit of presentation5 mL [spoonful]
[Pack size]125 mL in the bottleNot usually expressed as 25 spoonfuls!
Precise active ingredientaciclovir
Basis of strength substanceaciclovir
Presentation strength (logical)200 mg per 1 unit of presentation
Presentation strength200 mg per 5 mL
Concentration strength40 mg per 1 mL

Continuous presentation: bounded by unit of presentation; solid dose forms

Examples: vials, ampoules, sachets, containing solid dose forms such as powders or granules which may or may not be dissolved before administration
The unit of presentation usually either uses the same word (even though it is a different concept) as the (package item) container, or the (package item) container is a more granular concept and the unit of presentation uses a less granular term.
Strength is expressed as "per one unit of presentation" and the presentation strength and the concentration are exactly the same.

Example 1: A pack of 10 vials each containing 2g cefotaxime powder for solution for injection

Manufactured dose formPowder for solution for injection
Unit of presentationvialThe vial "bounds" the 2g of the dose form
[Pack size]10 vials in the carton
Precise active ingredientcefotaxime sodium
Basis of strength substancecefotaxime
Presentation strength (logical)2 g per 1 unit of presentation
Presentation strength2 g [per 1 vial]UCUM: 2 g per 1 each
Concentration strength
The concentration of cefotaxime in the powder inside the vial is known to the regulatory agency but is not deemed clinically significant
Example 2: A pack of 50 sachets containing 4g of colestyramine powder for oral solution

Manufactured dose formPowder for oral suspension
Unit of presentationSachetThe sachet "bounds" the 4g of the dose form
[Pack size]50 sachets in the box
Precise active ingredientcolestyramine
Basis of strength substancecolestyramine
Presentation strength (logical)4 g per 1 unit of presentation
Presentation strength4 g per 1 sachetUCUM: 4 g per 1 each
Concentration strength
The concentration of colestyramine in the powder inside the sachet is known to the regulatory agency but not deemed clinically significant

Continuous presentation: bounded by container; liquid dose forms

Examples: parenteral solutions, unit dose nebuliser solutions
The unit of presentation usually either uses the same word (even though it is a different concept) as the (package item) container, or the (package item) container is a more granular concept and the unit of presentation uses a less granular term.
Presentation strength is expressed as "per the amount of liquid bounded by the unit of presentation" but concentration strength is per mL (and therefore is often different).

Example 1: A pack of 10 ampoules each containing 20mL of metoclopramide hydrochloride for solution for injection



Manufactured dose formSolution for injection
Unit of presentationAmpouleThe ampoule "bounds" the liquid
[Pack size]10 ampoules in the box
Precise active ingredientmetoclopramide hydrochloride
Basis of strength substancemetoclopramide hydrochloride
Presentation strength (logical)100 mg per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength100 mg per 20 mL
Concentration strength5 mg per 1 mL
Example 2: A pack of 20 UDVs each containing 2mL of ipratropium bromide for solution for nebulisation

Manufactured dose formSolution for nebulisation
Unit of presentationUnit dose vialThe vial "bounds" the liquid
[Pack size]5 vials in a sleeve, 4 sleeves in the box
Precise active ingredientipratropium bromide
Basis of strength substanceipratropium bromide
Presentation strength (logical)500 mcg per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength500 mcg per 2 mL
Concentration strength250 mcg per 1 mL

Continuous presentation: bounded by container; liquid/semi-solid dose forms; concentration strength required

Examples: bulk parenteral solutions, insulins, patches
The unit of presentation usually either uses the same word (even though it is a different concept) as the (package item) container, or the (package item) container is a more granular concept and the unit of presentation uses a less granular term.
However, although presentation strength is expressed as "per one unit of presentation" the clinically relevant strength is the concentration strength as almost all are used in individually calculated and variable amounts.
Note that the unit of presentation is likely to be useful in description of the medicinal product concept at some level; insulin presented in a multi-dose vial will be used/administered differently from insulin presented in a cartridge for use within a "pen device".

Example 1: A pack of 5 cartridges each containing 1.5mL soluble human insulin 100 units/mL solution for injection

Manufactured dose formSolution for injection
Unit of presentationCartridgeThe vial "bounds" the liquid
[Pack size]5 cartridges in a sleeve,1 sleeve in the box
Precise active ingredientinsulin soluble human
Basis of strength substanceinsulin soluble human
Presentation strength (logical)150 units per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength150 units per 1.5 mLNot a clinically safe expression of strength
Concentration strength100 units per 1 mL
Example 2: A box of 10 bags of Sodium chloride 0.9% solution for infusion 500mL

Manufactured dose formSolution for injection
Unit of presentationBagThe bag "bounds" the liquid
[Pack size]1 bag in a sterile pouch,10 pouches in the box
Precise active ingredientsodium chloride
Basis of strength substancesodium chloride
Presentation strength (logical)450 mg per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength450 mg per 500 mLNot a clinically safe expression of strength
Concentration strength9 mg per 1 mLSynonym: 0.9% w/v
Example 3: A pack of 30 sachets each containing a transdermal patch delivering 4.6mg per 24 hours of rivastigmine



Manufactured dose formTransdermal patch
Unit of presentationPatchThe patch "bounds" the dose form that delivers the medication
[Pack size]1 patch in sachet, 30 sachets in the box
Precise active ingredientrivastigmine
Basis of strength substancerivastigmine
Presentation strength (logical)9 g per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength9 g per (5cm) patchNot a clinically safe expression of strength
Concentration strength4.6 mg per 24 hoursThis is a "rate" strength

Continuous presentation: unbounded by container

Examples: bulk powders and granules, bulk liquids, semi-solids
These presentations are not particularly bound by their container in any way that is meaningful in terms of their use or administration; the Manufactured Item is a continuous presentation and almost all are used in individually calculated and variable amounts. For example, hydrocortisone cream for cutaneous use is contained in a tube, but its use is based on how much is squeezed out and applied to the skin; chloramphenicol eye drops are presented in a dropper bottle, but they are administered drop by drop and although the dropper bottle aims to deliver a roughly uniform sized drop to the eye, they are not "metered dose containers" in the way that containers with valves are.
A unit of presentation is not usually given for these products. The pack size (not relevant for SNOMED international model) is given as the Manufactured Item quantity.
Strength is expressed as a concentration and as such the presentation strength and the concentration are exactly the same.

Example 1: A 30g tube of hydrocortisone 1% cutaneous cream w/w in an outer box

Manufactured dose formCutaneous cream
Unit of presentationNOT VALUEDThere is nothing that really "bounds" the dose form that delivers the medication "per dose"
[Pack size]30 g in the tube,1 tube in the box
Precise active ingredienthydrocortisone
Basis of strength substancehydrocortisone
Presentation strength (logical)300 mg per 30 gNot a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength10 mg per 1 gSynonym: 1.0 % w/w
Example 2: A bottle of 5 mL of chloramphenicol eye drops 0.5% w/v in an outer box



Manufactured dose formEye drops, solution
Unit of presentationNOT VALUEDThere is nothing that really "bounds" the dose form that delivers the medication "per dose"
[Pack size]5 ml in the dropper bottle,1 bottle in the box
Precise active ingredientchloramphenicol
Basis of strength substancechloramphenicol
Presentation strength (logical)25 mg per 5 mLNot a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength5 mg per 1 mLSynonym: 0.5 % w/v
Example 3: A pack of 500g of sterculia 62% w/w granules (EDQM –"granules" = "oral granules")

Manufactured dose formOral granules
Unit of presentationNOT VALUEDThere is nothing that really "bounds" the dose form that delivers the medication "per dose"
[Pack size]500 g in the box
Precise active ingredientsterculia
Basis of strength substancesterculia
Presentation strength (logical)310 g per 500 gNot a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength620 mg per 1 gSynonym: 62 % w/w


Example 4: A bottle of 60 mL of digoxin oral solution 50mcg/mL in an outer box (which has an oral syringe in it)

Manufactured dose formOral solution
Unit of presentationNOT VALUEDThere is nothing that really "bounds" the dose form that delivers the medication "per dose"
[Pack size]60 ml in the bottle,1 bottle in the box

Precise active ingredientdigoxin
Basis of strength substancedigoxin
Presentation strength (logical)3 mg per 60 mLNot a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength50 mcg per 1 mLSynonym: 0.5 % w/v



Feedback
  • No labels