E-drug: Survey on labeling of medicines
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SURVEY ON LABELING 1999
The FIP Working Group on Labeling has conducted a survey on labeling.
A summary of the results is following below. The full report is available
on request at sjappe@apotek.no in format Word 2x size about 50 pages.
SURVEY ON LABELING 1999 SUMMARY.
The FIP Working Group on Labeling has conducted a survey on labeling.
Members of the group are: Stein Lyftingsmo, Norway; Oscar Bruce, Ghana;
Leander Fontaine, USA; Avi Moshenson, Israel; Jerome A Reinstein, Great
Britain.
Purpose of survey
The purpose of the survey was to get a better idea of how prescription drug
labeling is done in different parts of the world. The main focus was on
package and immediate (inner) container label, and not on prescribing
information and package leaflets, which is also called labeling in some
countries. It is important to note that we asked how the labeling was, as
seen by the patient, and not as it was when the drug left the manufacturer.
We got 58 answers from 46 countries covering almost half the world
population. Important missing countries are China, Indonesia and Pakistan.
Quality of results
This is a pilot survey, with a very small number of respondents, in a field
with large variation in practice (also within countries), and no common
global vocabulary. Individual answers should not be taken at face value,
but as small elements in a large picture.
Distribution channels and prescription rules
Overall 80% of prescribed medicine is distributed through pharmacies, but
in Taiwan and Thailand the pharmacies have a market share of only 3 and 5%
respectively. Doctors' offices/clinics and hospitals are the other main
distribution channels. In some African countries unlicenced vendors and
chemical sellers' shops are of importance.
In 14 countries with more than half the survey population, it is easy to
obtain prescription medicine without prescription. In seven of these
countries with 45% of the survey population, the market share for
pharmacies was estimated to 90% or higher.
Packaging
There are two basic forms of patient drug packages. One is prepacked in
fixed sizes by the manufacturer (here called prepack) and the other is
dispensed for the patient from large bulk packages (here called bulk).
Extemperanous preparations do not account for an important market share,
except in Japan, Russia and Czech Republic.
Labeling
Prepack and bulk labeling are fairly equal except for batch number and
expiry date, where prepack labeling is better.
In 11 countries with more than half the survey population, the pharmacies
never do any customizing of the prescription drugs. That means they never
write or print the patient's name or individual dosage instructions on the
drug package.
GSD
GSD (Generic name, Strength, individual Dosage instructions) is the
absolute minimum information needed to give meaningful answers to people
asking about their medications. As the table shows, only 19 countries with
592 million inhabitants got Triple A for prepack
Discussion
When it is easy to obtain prescription medicines without prescription, and
pharmacies do not customize drug packages, it is important that also
prescription patient package labeling contain sufficient information. The
important elements of the drug label should be easy to read.
The large market share for pharmacies for prescription medicine could mean
a good starting position in improving global prescription drug labeling.
The survey made us "discover" GSD (Generic name, Strength, individual
Dosage instructions). We believe GSD may become a very central term or tool
in future drug labeling discussions.