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Re: [Gnumed-devel] gmdrugs structure


From: Hilmar Berger
Subject: Re: [Gnumed-devel] gmdrugs structure
Date: Mon, 25 Nov 2002 17:22:28 +0100 (CET)

Hallo,

On Wed, 20 Nov 2002, Ian Haywood wrote:

> > It's not like there was no prescribing conditions in Germany - they are
> ...
> Or, is there extra meta-data about the subsidy? In Australia we have
> maximum repeats, maximum units at single dispensing, etc.  What would
> these extra fields be?
There is other meta-data, basically because the whole system of subsidies
is quite different. In Germany, patients usually pay only a fixed amount
of money per package (that amount depends on package size) if they have a
prescription. The only exception to this rule is patients that have a
so-called private health insurance - those pay the whole price and than
the insurance company returns the money paid. So we would need at least a
field for the fixed price on a particular package (or the standardized
package size N1-N3). 
Furthermore there are regulations which drugs are available
over-the-counter, which need an prescription and so on (one field for all
possible cases).  
There are drugs ('narcotics') you have to follow special rules of
prescription (one boolean field).
There are some more cases we might have to cover. I will try to find out
which fields we will need and if we can share some of the entries allready
available. 
 
> I am keen to avoid filling the schema with "foo_au" and "foo_de"
> (although I admit sometimes it may be the only solution) If it only
> needs a couple of extra fields I would put them in subsidized_product:
> other jurisdictions can just have NULLs on these columns.
I will send you a more definite answer within the next days. 

> > Which means that we will in any case need some way to define what is the
> > unit the amount in link_product_component refers to (ml, tablet, bottle,
> > bag, etc.)
> Not sure I understand here. If we link (penicillin, 1, gram) to (bottle,
> 10, ml) then it is 1g of penicillin in a 10ml bottle, there is no need
> for a separate link.

Maybe I'm wrong here, and probably I didn't say what I meant, but I
thought that it will be difficult to cover the case of for instance a
package containing 10 bottles of 10ml each that contain a solution of 1g
penicillin.

> > 'Rote Liste', there are class specific entries with subentries (e.g.
> > adverse effects numbered a through f for a given substance where one drug
> > could include effect a-c and another one a-d,f). Same is possible for
> > indications, hints etc.
> I am not sure I fully understand. Could you post a couple of pages from
> Rote Liste to demonstrate?

Just one example:
Entry for class "Cephalosporins" (excerpt) (id= C20 )
 KI : allergic reaction on cephalosporins or other betalactam-antibiotics
 Pregnancy: c. pass the placenta
 Lactation: possibility of diarrhoea
 AE: a) exanthema, pruritus
     b) angioneurotic edema
     c) Erythema exsudativum multiforme
     d) gastrointestinal problems (diarrhea, anorexia, vomitus etc.)
     e) possibility of pseudomembranaceus colitis
     f) elevated liver encymes
     g) hepatitis
     h) i.v. administration: thrombophlebitis
     i) toxic and/or allergic anemia
     j) koagulation abnormalities
     ... 

 Interactions: 
     a) aminoglycoside antibiotics
     b) Polymyxine B
     c) diuretics (high-dose)
     d) anticoagulants
     e) tetracyclin, 
     f) changes in intestinal flora leading to changes in enterhepatic
circulation of contraceptives

 ...
     
An i.v. cephalosporin like Cefuroxim has an entry 
AE: C20 (all subentries)
Interactions: C20 a-c,e,f

Cefalexin has
AE: C20 a-g,i-q
Interactions: C20 e,f

> What I *think* you are talking about is class<->substance inheritance.
Yes. I know that there is no easy solution to this problem, and I guess we
will have to wait and see what solution will work best.

> The other issue is the next level: ascribing drug attributes to the
> drug-dose-route tuple. I agree indication can be drug-dose-route
> dependent, but the other attributes? Can a drug change it's
> side-effects, receptor-binding, etc. by a different route? NSAIDs for
> example, still cause ulcers when given rectally.
IMHO drug route is as important for main and side effects of a drug as is
dose and adjuvants. Pharmacokinetics depend heavily on resorption,
metabolism, degradation, elimination and so on - and those are not only
dependant on the active substance. You might have a first-pass effect and
intestinal interactions in drugs administered orally and you won't see
vascular/tissue adverse effects until you inject the drug directly i.v. or
i.m. 
To me, *substances* are just abstractions of a broad range of drugs
containing this substance. The single drug might or might not possess all
characteristics of the drug - and that's (IMHO) not only an exception, but
a feature used heavily for adjustion drug effects to particular needs. 
 
Regards, Hilmar





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