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Issue 2 (2004)

GD News
GD-guideline „Dermatological Prescriptions“ updated
Topical dermatological prescriptions –
a quality feature of dermatologists and pharmacists

Pharmacists, dermatologists from clinic and practice, industry representatives and other experts center their efforts in the department Extemporaneous Preparations of the Gesellschaft für Dermopharmazie to establish interdisciplinary concepts appropriate to reach a consensus regarding current dermatological prescriptions. On initiative of the department, a second consensus conference of the GD concerning dermatological prescription took place at the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (Federal Institute for Drugs and Medicinal Products) in Bonn on 1 April 2003. The GD guideline „Dermatological Prescriptions“, in first version published in 1999, was deliberated and updated on the occasion of this conference.

Experts from the fields administration, official surveillance, dermatological practice, pharmacy, university, clinic, specialized societies, professional associations and industry took part in the conference. The focus of discussions was on the quality proof of raw materials and their prescription bases, hygiene conditions for preparation of the product in the pharmacy and the labelling of the preparations.

According to the conference participants’ opinion, the circles of experts involved should consider certain recommendations for implementation of a topical dermatological prescription. Partly justified criticism on the quality of medical prescription and the quality of preparation in pharmacies should form the basis for permanent structural improvement. In this context for example belong regular tests of „clandestinely” ordered samples.

Documentation of
quality ineluctable

The conference participants agreed on the fact that the quality documentation of the prescription raw materials which also comprise pre-manufactured bases according to Apothekenbetriebsordnung (ApBetrO) (Pharmacies Rules and Regulations) is an absolute must. It has to be performed in the first place by means of a valid test certificate. In most cases the pharmacist receives this proof from the manufacturer along with the product ordered. Further possibilities as making use of the internet and fax inquiry directly from the manufacturer are envisaged as alternatives in the future.

In conjunction with the test certificate also test instructions for the identity test in pharmacies are to be made available for non-officinal raw materials and bases. Uncertainty remains if cosmetic bases are ordered for the preparation of prescriptions and the quality status is neither transparent to the physician nor the pharmacist. The participants deem a legally binding clarification in written form by the manufacturer about the permissibility of the prescription base to be indispensable. A list to be established about approved brand bases is to facilitate decision-making.

The revised version of the GD-guideline „Dermatological Prescriptions“ has been elaborated by members of the GD-department Extemporaneous Preparation and further experts and released for publication by the GD committee. It is published on the GD homepage ( and furthermore printed on pages 27 to 39 of DermoTopics as well as in this online-version.

Consensus regarding
labelling of prescriptions

The pharmacist has to adhere to the regulations of Apothekenbetriebsordnung (§ 14 ApBetrO) (Pharmacies Rules and Regulations) for the labelling of prescriptions. It stipulates as minimal requirement the labelling for medicinal agents according to type and quantity as well as additional ingredients according to the type. A focus is set in this context on the comprehensibility and reproducibility of the composition also in order to render follow-up prescription and repeated preparation possible.

The INCI declaration in English for cosmetic products in the context of labelling of dermatological prescriptions has proven problematic. The derivation of pharmaceutical-scientific designations of substances merely via this declaration is often difficult and partly not definite. Therefore, a decision on the occasion of the consensus conference has been taken to no longer accept INCI designations for the characterization of prescription components. Instead, exclusively pharmacopoeia designations in German should be used for this purpose.

Standardized prescriptions
ensure safety

In order to allow a trouble-free preparation in the pharmacy and minimize the risk of a poor galenical quality, the physician should preferably prescribe standardized extemporaneous preparations – as for example included in the „Neue Rezeptur-Formularium (NRF)“ (New Prescription Formulatory).

Wanted measures for implementation of an up-to-date dermatological prescription


In favour of ordering standardized prescription, adherence to guidelines


Transparent test certificates at prescription bases, improved quality documentation for prescription suggestions


Adherence to guidelines, improved information for physicians


Concretion of detailed requirement for labelling

The NRF formulas are however still not sufficiently known to physicians. Against this background, it has again been emphasized by the conference participants that besides the comprehensive two-volume NRF loose-leaf-collection for pharmacists there is also a compact version of the prescription collection designated as „ Ärzte-NRF” (Physicians’ NRF) available which has been recently published in third completely revised edition (please refer to book reference on this page).

At present the NRF comprises 239 predominantly dermatological prescriptions. In the third issue of „Ärzte-NRF“ (Physicians’ NRF), by recommendation from the practice, all those prescriptions are characterized which are available on prescription only and thus further on refunded by public health funds. Overviews of the composition of officinal dermatic bases and basic therapeutics as well as a table on prescription therapeutics considered to be questionable by the Arzneimittelkommission der Deutschen Apotheker (Medicinal Agent Commission of German Pharmacists) represent an additional major complementation for the dermatological practice. (eb/hr/jk)

Subject reference

Pharmazeutisches Laboratorium of the NRF (Pharmaceutical Laboratory) (Publisher): Standardisierte Rezepturen (Standardized Prescriptions) NRF/SR, 3rd edition, Govi-Verlag , Pharmazeutischer Verlag GmbH (Pharmaceutical publishing house), Eschborn 2004. 164 pages, paper-bound, € 9,80. ISBN 3-7741-1023-9


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