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Issue October 2000

Extemporaneous Preparations
Discussion about Dermatologists' Domain going on

In spite of the wide offer of industrially manufactured preparations, the dermatologic prescription is still considered to be an indispensable part of the external dermatotherapy. Lately, however, there has been rise to criticism: the dermatologic oriented pharmaceutical industry complains about - in their opinion by far too high part among the dermatological prescriptions and speculates that the prescription is employed less because of reasons of a better therapeutical care but rather because of cost considerations and other secondary reasons. Furthermore, editions pile up reporting about quality problems of dermatologic prescriptions both at the side of the prescriber and the preparing pharmacies.

The Gesellschaft für Dermopharmazie e.V. (Society for Dermopharmacy) has taken up this problematic subject by elaborating general conditions regarding quality assurance of dermatological prescriptions in its interdisciplinary composed department Extemporaneous Preparations. A first working result were the guidelines containing principles for prescription, preparation and sale of dermatological prescriptions adopted on the occasion of a consensus conference at the end of 1998. In the beginning of this year, hygiene guidelines for the preparation of non-sterile preparations in pharmacies has been published. Both papers can be looked up in the internet at the GD website ( Guidelines for dermatological prescription und GD Hygiene Guidelines.

If the dermatological prescription is to remain in the long-run, measures regarding quality assurance have to be implemented in practice as quickly as possible. DermoTopics will accompany this process and report about the progress on a regular basis. In this context both opinions - of advocates and critics of the dermatological prescription will be heard. Professor Dr. med. Max Gloor, medical superintendent of the Hautklinik of the Klinikum Karlsruhe (Dermatological Clinic of the Clinical Center) for whom the prescription represents a quality criterion of the dermatologist. DermoTopics had the following conversation with him.

Professor Gloor, where lies in your opinion the necessity for extemporaneous preparations?

Prof. Gloor:
Extemporaneous preparations should be reserved to therapeutical requirements and employed in those cases for which no alternative exists. The prescription of an extemporaneous preparation requires in my opinion an objective therapeutical explanation.

What exactly do you understand by extemporaneous preparations?

Prof. Gloor:
We have to distinguish between standardized and individual extemporaneous preparations. Standardized extemporaneous preparations fall back on rationally justifiable recommendations in relevant publications, especially collections of corresponding recommendations. In Germany these are for instance the pharmacopoeia, the Deutsche Arzneimittel-Codex (DAC) [German Drug Code] and the Neue Rezeptur-Formularium (NRF) [New Prescription Formulatory]. In case it is not possible to make use of such given data then we speak of extemporaneous preparations.

„The prescription
of an
extemporaneous preparation
requires an
therapeutical explanation.“

The standardized extemporaneous preparations can as a rule be prepared in pharmacies without any difficulties and there is a minor risk of a poor galenic quality. The state of affairs is different for individual extemporaneous preparations: they require detailed galenic and pharmacological knowledge by the prescribing pharmacist and make it furthermore necessary that physician and pharmacist get in contact in case of difficulties. As long as the physician orients himself on published empirical values, the risk of incompatibility is here equally low. Whereas the pharmacists' own compositions not falling back on corresponding recommendations should be handled with special caution. They might possibly be indicated if the treatment objective cannot be achieved in a different manner.

„Extemporaneous preparations
are a
quality characteristic
of the

In which cases are extemporaneous preparations really useful despite the large offer of ready-to-use medicaments?

Prof. Gloor:
There is a series of reasons for this way of proceedings. For example active substances as Metronidazol can be processed which are not contained in specialties. Furthermore, there are numerous active substances which are necessary in a specific base for the treatment of the neurodermatitis. By means of an optimal base much can be achieved in the treatment of neurodermatitis. Quite often corticoids are not necessary or a change from a more to a less potent corticoid is possible.

Does in your opinion the extemporaneous preparation represent a quality characteristic of the dermatologist?

Prof. Gloor:
Yes, absolutely. If a dermatologist does not have complete command of the basic treatment then he does not know his trade. It has to be realized that concerning the specialties the exact ingredients are generally not known. The respective basic elements are in general only qualitatively but not quantitatively declared. Often the galenic system is only described in an insufficient manner, i.e. for example information regarding the emulsion type, the share of water or the content of moisturizers is lacking.

In my opinion this is completely out of the question concerning the therapy of the neurodermatitis and in addition unworthy for dermatologists. There is no optimal possibility of treatment for the neurodermatitis without applying extemporaneous preparations as can be expected by a dermatologist. Altogether extemporaneous preparations offer the dermatologist an immense therapeutical scope of action. A restriction in this field would entail a loss of the right for existence. Differently from England with only approximately 300 dermatologists, skin diseases can be treated by specialists in Germany. A specialized system of the kind only holds its authorization if it is more efficient than the treatment by a general practitioner. This, however, is only possible if the dermatologist makes use of all therapeutical possibilities of his special field - this includes the extemporaneous preparation.

What is in your opinion an optimal topical preparation for the treatment of neurodermatitis like?

Prof. Gloor:
The neurodermatitis is a domain of the individual extemporaneous preparation. Neither ready-to-use preparations nor the standardized extemporaneous preparations at the NRF supply all what is required for the treatment of the neurodermatitis. There are recommendations as well as adequate prescription bases for the individual therapeutical objective which allow an optimal implementation. W/o emulsions containing the moisturizers glycerine and urea are proven remedies in a certain mixing ratio. In addition, oenothera biennis and an antiseptic as Triclosan in an antiseptically effective concentration should be contained (for prescription examples please refer to the table below).

There is
no optimal possibility
of treatment
for the neurodermatitis
without applying
extemporaneous preparations
as can be expected
by a

Prof. Gloor, thank you very much for this conversation.

Individual extemporaneous preparations for the treatment of neurodermatitis (examples from a lecture script by professor Gloor)

Example 1
Example 2
Glycerine 85 %
Glycerine 85 %
Oenothera biennis
Oenothera biennis
w/o base
ad 100,0
Pionier KHW Pharm
Acid. citr. anhydricum
Aqua dest.
ad 100,0



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