Package size labeling
The packaging size labeling for medication is a standardization of the quantity to be dispensed in the pharmacy (number of pieces for tablets , capsules , suppositories and other single-dose forms, milliliters or grams for semi-solid and liquid agents) of a finished medicinal product within the framework of statutory medical care.
Basics
| Package size labeling |
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| With the same number of items, different standard sizes can result depending on the duration of therapy: |
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The legal basis for standardization was the Packing Size Ordinance (PackungsV) until 2010 . She assigned the following three pack sizes - the N stands for standard size:
- N1 - small pack
- N2 - medium packing
- N3 - large pack
Which pack size is to be described as “small”, “medium” and “large” is regulated differently for medicinal products in different areas of application, see below. There is also the label as “clinic pack”.
As a result of the Medicines Market Reform Act (AMNOG) of December 22, 2010 ( Federal Law Gazette I p. 2262, 2275 ), the pack size designations N1, N2 and N3 changed and were coordinated with the duration of the typical treatment cycles. This change in the amount of the formulation is intended to avoid the need for a new drug prescription during a treatment cycle or the prescribed number of items significantly exceeding the therapeutic need.
Because the duration of the respective treatment cycles first had to be defined, the AMNOG provided for a transition period until July 1, 2013 in order to make the necessary change. Since then, the pack sizes refer to the duration of the therapy.
That means:
- N1: Packs for acute therapy or for setting therapy for a treatment duration of ten days with a deviation of up to 20 percent.
- N2: Packs for long-term therapy that require special medical supervision for a treatment duration of 30 days with a deviation of up to ten percent.
- N3: packs for long-term therapy for a treatment duration of 100 days with a deviation of up to five percent (only downwards).
Until the AMNOG, the size specifications did not correspond to a specific number of tablets, capsules or a defined amount in milliliters. As a result of this change in the definition in the AMNOG, the measurement numbers on the pack size labeling change. So apply z. B. as N1 all pack sizes with "quantity" = "measurement number for N1" ± 20%
| size | Example measurement number | possible deviation | amount |
|---|---|---|---|
| N1 | 20th | ± 20% | 16-24 |
| N2 | 50 | ± 10% | 45-55 |
| N3 | 100 | - 5% | 95-100 |
history
In February 1980, health insurance companies , contract doctors, pharmacists and the pharmaceutical industry agreed to reduce the packaging sizes from the original eight to three and this was implemented by the end of 1982.
Until 2003, the statutory co-payment was based on the standard size (most recently N1 EUR 4, N2 EUR 4.50, N3 EUR 5). However, since 2004 the co-payment has been based on the price of the drug.
meaning
The purpose of the standard sizes is to avoid dispensing unnecessarily large or disadvantageously small packages at the expense of the statutory health insurance companies. The aim is to ensure that drugs only burden the solidarity community to the extent of the necessary therapy and at the same time in an economically justifiable manner .
The specification of a standard size designation is not clearly assigned to a specific pack size. For example, most insulins are available in packs of 5 or 10 cartridges (both N2); the pack sizes N1 and N3 do not exist here. While for certain migraine drugs the smallest N1 contains two and the N3 a maximum of 18 tablets, there are AIDS drugs with 540 tablets in one N3; the N1 already contains 180 tablets. The standard sizes differ depending on the type of drug and set a range for drug quantities that - as a rule - should be prescribed for a short, medium or long-term treatment period (e.g. for chronic diseases) while maintaining economic efficiency.
Even packs with a content between two standard sizes can be billed to the health insurance companies, unless there are other reasons to the contrary. However, packs whose content exceeds the largest defined standard size (mostly N3) are not covered by the health insurance as so-called jumbo packs (see Section 2, Paragraph (5) of the Pack Size Ordinance). Medicines that are not reimbursable must not be labeled with a standard size.
Examples of standard sizes
Package sizes of drugs are set by the Federal Institute for Drugs and Medical Devices (BfArM) in coordination with the BMG . An administrative regulation regulates the procedure in a specific case. The standard size (N1, N2 or N3) is based on measurement numbers that are assigned based on the active ingredient and dosage form. The measurement numbers are determined based on the frequency and amount of application.
The table shows some examples (as of July 2020) for different dosage forms and areas of application: The measurement numbers given in columns N1, N2 or N3 of the table determine how the standard sizes are to be assigned to the respective product group. Example of antihypertensive drugs: packs of up to 30 pieces (tablets, capsules, etc.) count as standard size N1, 31 to 60 pieces as standard size N2 and 61 to 100 pieces as standard size N3.
| Divided oral dosage forms (tablets, capsules, etc.) | |||
| Number of pieces as a measurement number | N1 | N2 | N3 |
| Antihypertensive drugs | 30th | 60 | 100 |
| Anti-diabetic agents | 30th | 120 | 200 |
| Sleeping pills / sedatives | 10 | 20th | 50 |
| Triptans ( moderate migraines ) | 3 | 6th | 12 |
| Divided rectal and vaginal dosage forms (e.g. suppositories) | |||
| Number of pieces as a measurement number | N1 | N2 | N3 |
| Sleeping pills / sedatives | 5 | - | - |
| laxative | 6th | 12 | 30th |
| Peroral dosage forms (drops, juices, etc.) that have not been divided | |||
| Grams or milliliters as a measure | N1 | N2 | N3 |
| Sedatives , single dose up to 3 g or ml | 30th | 50 | 100 |
| Sedatives, single dose up to 5 g or ml | 100 | 250 | - |
For other dosage forms such as divided dosage forms for injection or infusion, dermal and topical preparations, implants , inhalants and others, measurement numbers and standard sizes are defined, and there are also regulations for combination drugs .
An annex to the administrative regulation provides a complete overview of the measurement figures.
Individual evidence
- ↑ General administrative regulation for the determination of pack sizes according to § 5 PackungsV , available on the BfArM's "Pack sizes" page . Retrieved July 19, 2020.
- ↑ General administrative regulation for the determination of pack sizes according to § 5 PackungsV, Annex 2: Rules for the calculation of measurement numbers , available on the BfArM's “Pack sizes” page . Retrieved July 19, 2020.
- ↑ General administrative regulation for the determination of pack sizes according to § 5 PackungsV, Annex 1: Overview of the measurement figures , available on the BfArM's "Pack sizes" page . Retrieved July 19, 2020.
