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[e-drug] Generic quality (cont)

E-drug: Generic quality (cont)
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Patrice took some of the points I had planned to comment on. Which is good
and shows that at least two of us are sceptical to black and white lists!
As Patrice mentioned such lists were discussed extensively 1-2 years ago.

I wish there was an easy solution to assuring the quality of any product on
the world market, but this is a difficult issue, cf. WHO's list of
manufacturers of raw materials which is now and again being criticised. Who
should qualify and monitor? International team of inspectors? How often
would they inspect etc. Strengthening national regulatory authorities and
procurement agencies would be a better more sustainable way to go and would
give more knowledge transfer, but alas not so easy either. Lack of
qualified staff and government salaries that are not attractive means
people often have more than one job, and how do you then find independent
inspectors?

Quality is not only bioequivalence as some people tend to believe, but
products should comply with pharmacopoeial standards for e.g. content,
dissolution and amount of impurities. What should be requirements for GMP?
As Linda Horton mentions in her message 25 February on FDA and drug
quality: 'FDA's experience is  that there is no way to assure drug quality
without attention to current GMP regulations and the drug quality testing
and other checks associated with GMPs We have WHO GMP documents and 
the EU directives on GMP which you will find on
http://dg3.eudra.org/eudralex/vol-4/home.htm. Important points are e.g.
- quality of raw materials. How do companies check the starting material,
cf. recent E-drug messages on the blood scandal. Here the problem was that
the finished product contained pyrogens.
- recall procedures. How do companies handle complaints and quality
problems? Part of GMP requirements is to have a system of how to recall a
product from the whole market. In my previous mail, I mentioned a problem
in the US with contaminated tablets which were recalled. There it 
functions. When we discovered that Helm pharmaceuticals had sent us 
approx.
10% empty rifampicin capsules to Botswana, what did they do? 
Volunteered to send us for free an additional 10% of the initial 
order. How would that
help patients who were being treated with empty capsules? Such conduct is
of course unacceptable.
- quality assurance procedures, staff qualifications, responsible persons,
job descriptions, site master file, all important parts of GMP.

Lastly, I am still worried that people are upset by quality of generics
only. We have at present a problem in Norway with people being scared of
wolves because a few anti-wolves activists keep repeating without any
scientific evidence that wolves attack humans. When it comes to the issue
of quality of generics, it seems like the anti-generics people have
succeeded in planting that scare in us that generics are problematic. Larry
Sasich posted last week on E-drug a reference to a letter Public Citizen
wrote about Schering-Plough's possibly exporting recalled metered inhalers,
some of which they knew were without active ingredients. Yes there is bad
conduct in the generics industry. Yes there is bad conduct amongst the
multinationals. Is it not time to at least 'treat' any product with the
same suspicion be it generic or from a multinational? So if there ever
would be a white list, it should be for all manufacturers! In the meantime,
DRAs must be strengthened and must not register all products that are
offered. For public sector we must prequalify suppliers, convince central
tender boards and others that invitations to tenders should only be to
registered suppliers, that cheapest product might not be the best choice
etc. (I know it is not always so easy....)

Regards

Kirsten

Kirsten Myhr, MScPharm, MPH
Bygdoy alle 58B
0265 Oslo, Norway
Tel.: +47 22 56 05 85
myhr@online.no
[The idea of the Pacific Islands network was that people working in 
the essential drugs procurement area share any information they 
thought might be helpful, with their colleagues in other Pacific 
Island countries. Experiences could  include good and bad experience 
of all aspects of drug program management: quality of drugs, 
efficiency of suppliers, means of transport, source of resources etc 
etc.  Those countries share unique and enormous problems associated 
with lack of economy of scale, huge distances and expenses related to 
transport, communication difficulties and so on.  They decided that 
sharing any information they thought might be important could be 
helpful.  Perhaps other groups of programs?, countries? could look at 
a similar approach.  BS]
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