E-DRUG: Expression of Strength in the Name of Medicines
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dear E-druggers,
EMEA, the European Medicine Agency, has asked for comments on a draft document on the expression of strength in the name of medicines.
The document is available here:
http://www.emea.europa.eu/htms/human/qrd/docs/20830409en.pdf
Template for submitting comments can be found here:
http://www.emea.europa.eu/pdfs/human/regaffair/submitcomment.doc
In a time when the pharmaceutical market is increasingly global, this is an important document.
Very bad: The document does not say one word about medicines with more than one active ingredient (Fixed Drug Combinations, or FDCs).
Very good: The rest of the documents, except for a few details.
The document points out that the name of a medicine has practical, daily use, and should have properties that reduce medication errors, whereas more detailed information should be found elsewhere.
Especially for liquid preparations there are very many different traditions. Percentage per weight or volume, amount per ml or per 5ml or in the whole container.
One minor bad thing:
The document recommends the use of IU, International units. IU is included in a list from Institute for Safe Medication Practices over abbreviations that should be avoided because they increase the risk for medication errors.
IU can be mistaken as IV (intravenous) or 10 (ten). International is an impressive, but meaningless word regarding measuring of activity.
Only the full word unit should be used in the name, more specific information should be found elsewhere.
http://www.ismp.org/Tools/errorproneabbreviations.pdf
The big bad thing:
No medicinal authority has issued regulations or recommendations for the expression of strength in medicines with more than one active ingredient.
(I have written more about this problem on my website www.lyftingsmo.no)
The result is a dangerous mess. Especially when there are several strengths of a combination, and when there is parallel import or generic competition for the product.
It is very common with no numerical strength at all in the names of FDCs.
This is double dangerous. Not only is the strength hidden, but also the signal that this is a more complicated product than a single substance medicine.
Another not uncommonly used method is to summarize the milligrams of the two substances. This is like adding mice to elephants, hoping that the number of animals could be relevant information. It is no better to mention only the mice, but I have also seen that been done on several FDCs.
When the strength of a FDC is increased, what is increased? Substance A or B, or both? In Norway we have three strengths of losartan / hydrochlorthiazide. Words like forte or mite have no meaning to most people, even for pharmacists and physicians they are only vague pointers.
Precise strength indication of FDCs can be very lengthy, especially for liquid products. Remember then that the product name is for practical daily use, and should not include all the details.
I very strongly hope that EMEA recognizes the problem of strength indication in FDCs, and includes a recommendation in its document.
My recommendation is:
For FDCs with two or three active ingredients, as a minimum the numerical strength should be indicated in the product name.
If denotations (mg, Units) are omitted, the values should be separated by a dash (solidus) or '+'.
For FDCs with four or more active ingredients the term 'multi ingredient' should be printed directly beneath the product name.
Examples:
Paralgin Forte 30/400 or Paralgin Forte 30+400 or Paralgin Forte 30mg + 400mg (codeine phosphate 30mg, paracetamol 400mg)
Paralgin Major 60/800
Rifater 50/120/300
Regards
Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
www.lyftingsmo.no
stein@lyftingsmo.no