E-drug: Storage of drugs matters (cont'd)
-------------------------------------------------------------------------
Private sector is an important and neglected sector as Hilbrand
points out. But I am afraid the public sector medical stores in many
places are also in dire need of improvement! Wholesalers in private
sector have probably been paid little attention, in public sector
unfortunately the will seems not to be there. You also find several
levels of stores (national, regional, district..), increasing the chance
of breaks in quality management and storage. Training is definitely
not enough. A person does not become ethically better through a
course if his competitor continues to do business from a cheap
outlet without being 'caught'. It is all about money, not least in
countries with much poverty. You also need laws and regulations in
place and enforce them. A government has to have national laws
and regulations on licensing, good distribution practices as well as
good manufacturing practices. There must be licensing of
wholesalers as there is for manufacturers and pharmacies.
Depending on the requirements in national regulations, the number
of wholesalers would hopefully decrease in those countries which
now have a lot. It cannot be advisable to have up to 300
wholesalers or even more. That does nothing to the price, only
decreases the possibility of regularly inspecting them. No country
can afford such an inspectorate, or? With so many wholesalers,
each probably only handles a few drugs in a dirty basement. And
does it as a side job to being a pharmacy owner, a government
employee, a medical doctor or something else. Often representing
just one company.
In Norway we used to have one state wholesaler and the
government was very much in control. This wholesaler provided
wholesale data on the sale of drugs which has put Norway in a
situation where we have national coverage of the sale of drugs from
wholesaler in retail value and in defined daily doses.
Most countries have only IMS data for a random selection of
wholesalers or pharmacies. The state wholesaler was also
responsible for a certain preparedness of essential drugs. After we
adopted the EU regulations, we had to open up for competition. I
think it was an advantage to go from state to privatisation
gradually. The government provided regulations that ensured it
would be of little interest to start wholesaling because it would be
very expensive. They had to deliver any registered drug within 24
hours and to the whole country. They also have to have a qualified
person (QP), a pharmacist, approved by the authorities. In that way
we prevented wholesalers from covering only densely populated
areas with the most-selling drugs. We now have 3 wholesalers. The
Scandinavian countries with few wholesalers have the lowest
wholesale margins in Europe and may be even worldwide. They are
less than 5 %.
All wholesalers have to deliver sales statistics to the government
and in that way the full data coverage has been maintained. The
problem now is the preparedness because they all want to have as
little stock as possible to save cost. If the government wants to
increase preparedness for disasters as well as for the more and
more common manufacturer-caused drug shortages, they will now
have to pay a high price for using the wholesalers.
These are some points that I think are essential for ensuring good
quality in the distribution chain. Problems such as insulin put in the
freezer could of course be solved by training, but even better by the
QP. If at first things have been allowed to run without much
supervision and with few demands on the wholesaler, I know it will
be diffcicult to change practice. But without it, I am afraid things
will not get better. Please take a look at the WHO or the EU
guidelines for good distribution practices. In particular, the need for
a well qualified QP (qualified person) should be noted.
Kirsten
Kirsten Myhr
Head of Eastern Health Region Drug Information Centre
RELIS Ost
Ulleval University Hospital
0407 Oslo, Norway
Tel.: +47 23 01 64 11(o) Fax: +47 23 01 64 10
+47 22 56 05 85 (h) mobile: +47 416 38 747
kirsten.myhr@relis.ulleval.no
www.relis.no
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Information and archive http://satellife.healthnet.org/programs/edrug.html
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.