Re: E-DRUG: Amateur assessment of GMP

[Kirsten Myhr <myhr@online.no>]

*****************************************
E-DRUG: Amateur assessment of GMP

This is in response to Tim Dodd (end April) and Daniel Vandenbergh (end May).

The quality of drugs should ideally be assessed on a national level as part
of the registration procedure as is done in developed countries. Then, there
would be no need for a daily quality assessment of your purchases. It is not
possible for individual users such as a hospital to evaluate all aspects of
drug quality in a tender procedure, particularly if it is international
tenders. The only amateur assessment, be it in a tender or on a daily bases,
which is possible will be by trial and error, i.e. learning from experience
and if possible from analysis of random samples and documenting to your
hospital administrator why you cannot always choose the cheapest supplier.
By that time some patients may have suffered of course! In my country, when
a couple of years ago, a tender procedure was introduced which cover most of
Norwegian hospitals, the evaluation concerns price, service level and e.g.
what dosage forms a company can offer. You may only tender for drugs already
registered. Because we do not use generic names yet, it is important to
limit the number of different brand names as much as possible to avoid
confusion, and e.g. a company offering both adult and paediatric dosage
forms may be preferred.

Mr Vandenbergh in his reply 25 May discusses tender dossiers. I have
experience from procuring items, both drugs and medical supplies on
international tenders. Although my experience dates back to late 1980's, I
think the problems are the same. From using open tenders we started a
process of prequalifying suppliers and using restricted tenders. Trying to
assess companies from the replies to a questionnaire is not as easy at it
may seem, even if one uses the WHO certification scheme. To visit all
companies is of course impossible and so you have to rely on the information
you get from the manufacturer and the certification given by the relevant
authority which e.g. in India and Germany is not a national FDA, but
regional regulatory authorities. I am afraid the information you get may not
always be reliable.

Firstly, different countries might have different definitions of a
manufacturer (this definition has been discussed earlier on E-drug).
In the country where I worked one of the companies asking to be registered
was Helm pharmaceuticals - a German company which many of you may have seen
mentioned on the network and which was involved in the Haiti scandal and
also has been mentioned in German and American TV documentaries. The company
is in my opinion a wholesaler, but will give you papers from German
authorities (Hamburg region) which tells you the company is a manufacturer
even if it has not produced a single item, only repackaged drugs purchased
from a manufacturer anywhere in the world where they may get it cheap and
whose name they will never disclose. Certificates of analysis are issued by
Helm as if they were the manufacturer. On request they will even give you
forms for some drugs for which they have approval from German authorities
saying they manufacture these drugs. These are simple products from the
Pharmacopeiae. Many years ago you only had to send 50 of these to the German
authorities to say you intended to produce them to get approval as a
manufacturer. You never had to actually make them!

I should now add that we had many problems with them from empty capsules to
false certificates and drugs given an expiry date without being stability
tested.

Another problem we faced was with some medical supplies. We used to buy some
items from a large sort of wholesaler suppling British colonies with all
sorts of goods, not only medical items. They claimed to have inspectors
approving all their suppliers. Once we received some stainless steel items
which rusted and we complained. They of course did not believe us, but being
persistent Norwegians we never gave up! In the end, after investigating,
they had to admit that their supplier in Pakistan which was inspected had,
because of too many orders, subcontracted some items to a place in a small
village which the wholesaler had never inspected or approved! 

These are two examples of problems you face in countries with weak or
non-existing drug regulatory authorities and in my opinion supports the need
for national registration of drugs by suppliers. In addtition, however,
quality control of drugs must still be done.

Regards Kirsten
Ms Kirsten Myhr, MScPharm, MPH
Bygdoy alle 58B
0265 Oslo
Norway

Tel: +47 22 56 05 85 (h)
Fax: +47 22 24 90 17 (w) Tel: +47 22 24 88 55 (w)
E-mail: myhr@online.no



--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to:  `owner-e-drug@usa.healthnet.org'.