for the period 2003 / 2004
report for the period March 2002 to March 2003
about Departmental Activities 1999/2000
by the Department Extemporaneous Preparations (Magistralrezepturen) of the Society
for Dermopharmacy for the period 2003 / 2004
There are four new members in the department and it consists
at present of 27 members (see attachment).
Transparency in Quality of Dermatic Bases
occasion of 2nd consensus conference “Dermatological Prescription”
of the GD in Bonn on 1 April 2003 more transparency concerning the quality of
dermatic bases for prescription drugs has been called for in concert with all
members. In this connection, a concept has been elaborated which provides a self-disclosure
by relevant producers regarding the pharmaceutical quality of their products based
on a questionnaire.
Objective of the survey is to furnish a precise overview
of the authorized prescription bases to physicians and pharmacists from which
information as to the qualification of the product for the production of prescription
drugs can be unequivocally gathered. Provision is made for a publication of the
Drug Dossiers as Attachment of the Guideline “Dermatological
A working group inside the department has
been entrusted with the establishing of a drug dossier which may, if so required,
complement the guideline ‘Dermatological Prescription’. It concerns
practice-relevant recommendations concerning a processing of relevant drugs according
to prescription. A first draft provides a table listing drugs with indication
of the pH-levels feasible in formulation as well as an overview of drug dossiers.
of Guideline “Dermatological Prescription”
framework of 2nd consensus conference ‘Dermatological Prescription’
of the GD, the revision of the guideline has been debated and adopted by the body
of experts at the BFArM (Bonn) on 1 April 2003. The revision concerns the following
Labeling of components
The revised version has been considered in the loose-leaf
collection of the NRF 2003.
The announcement of the guideline has been effected in numerous professional pharmaceutical
journals also in Austria and Switzerland. Moreover, the Hygiene Guideline has,
as envisaged, equally been included into the loose-leaf collection of the NRF
Eschborn, 9 March 2004
Report of the GD’s Department for Extemporaneous Preparations for the Period
March 2002 to March 2003
M. Tünnermann, Kerken
Assistant department heads:
Prof. Dr. M.
Pharmacist R. Eifler-Bollen, Eschborn
comprises at present 23 members, see attachment.
members of the department „Hygiene“ met for a conference in Grenzauwird
(Westerwald) on 25 November 2002.
The following essential results from the
department work can be reported:
The revision of the “GD Hygiene Guideline for the Production
of Non-sterile Pharmaceutical Preparations in the Pharmacy” has been the
major subject in the reporting period.
Three years after the initial publication
of the guideline in January 2000, the revision of the Hygiene Guideline has been
debated on 25 November 2002in the working group “Hygiene” involving
further experts. The revised Hygiene Guidelines met with the approval of the GD
board and is meanwhile retrievable on the GD homepage. The GD Hygiene Guideline
– as already the Guideline for Dermatological Prescription will be incorporated
into the NRF 2003. Moreover, the announcement of the guideline in DermoTopics
and the pharmaceutical trade press is envisaged. Further possibilities of publication
are aimed at and analyzed.
Guideline „Dermatological Prescription“
On the occasion of 2nd consensus conference “Dermatological Prescription”
of the GD at the BfArM (Bonn) on 1 March 2003 the revision of the guideline has
been subject to debate in a body of experts.
In particular the following
issues will be revised:
Quality of components
Labeling of components
Assessment of the pharmaceutical quality of branded bases for the dermatics preparation
according to prescription.
Bonn, 1 April 2003
1/2000: First GD Department Meeting in 2000
members of the Department Extemporaneous Preparations will have their 4th meeting
on the occasion of the 4th GD Annual Meeting 2000 in Freiburg: 23 May 2000, 14.30
to 16.30 hours, Konzerthaus Freiburg, Konrad-Adenauer-Platz 1, D-79098 Freiburg.
The conference room will be determined and marked accordingly.
of the minutes of the 3rd meeting on 8 June 1999
of the Department’s Activities
for dermatologic prescription, effects, actualisation
problems with instable individual prescriptions (evaluation of hotline-experiences)
coming about when preparing ready-to-use medicaments in individual prescriptions
of working groups
of individual prescriptions|
in of ready-to-use medicaments into individual prescriptions|
application of cosmetic products into prescription bases|
“rational medicinal agent combinations”|
Preparation of new elections for the department head
Please address questions to the department head, Dr B. Hünerbein or the
GD office at Eschborn.
of the GD’s Department Extemporaneous Preparations for the period 1999/ 2000
(Dr. Bernd Hünerbein, department head, 10 April 2000)
The department consists of 27 members at present. There are working groups
within the department which are formed for current scopes of duties.
Main emphasis of one working group has been the establishing of hygiene
guidelines for the making of non-sterile preparations in pharmacies in the past
reporting period whereas special stress has been given to the dominating dermatologic
preparations. The first-time publication of the guidelines was in the GD Homepage
and in printed version in issue 11 of the Deutsche Apotheker Zeitung (German Pharmacist
Journal), volume 140 (2000). Besides the members of this working group, also experts
from outside the GD could be called on concerning special formulations of questions.
Already in the planning stage ABDA and Bundesapothekerkammer (Federal Pharmacist
Chamber) had the opportunity to give statements.
Thus the guidelines rest on a solid and topic basis. In order to facilitate
the application of the guidelines into operational procedures for pharmacies,
the text coverage has been completed by a tabulated Master Hygiene Plan and a
Master-Check List for self inspection.
The department members take actively part in their respective professional
fields but also beyond these fields in preparation and execution of continuous
training events. Great importance is attached in this context to the cooperation
with chamber and professional associations and as preparation they equally make
use of their logistics. In the frame of the “third study stage” of the pharmaceutic
university education, members of this department have to perform fixed lecture
and seminar events. This continuous training activity is an excellent platform
to explain the GD’s guidelines and standards established so far in a practically
relevant manner. Besides publications come out which serve for their colleagues’
Revision of standardized prescriptions
Additional regulations of standard prescriptions for integration in the
NRF have been prepared in collaboration with members of the departments together
with the pharmacist chambers of Saxony and Saxony-Anhalt as well as the departments
pharmacy of the universities Halle and Leipzig and the Landesuntersuchungsanstalt
of Saxony (Investigation Institution of the land Saxony). Especially for Nystatin
preparations stability analyses could be performed. The results of this working
group activity have been summarized in issue 11 of the Pharmazeutische Zeitung
(Pharmaceutical Journal), volume 145 (2000). For a better handling of the NRF
standardized prescriptions for the medical field, a new paperback edition of the
NRF is being prepared at present.
of cosmetic products and extemporaneous preparations
At the department conference in Berlin on 8 June 1999 the resolution
was passed to establish a sound point of view regarding the in the meantime common,
legally however, not covered preparation of cosmetic products as basis for medicaments.
Starting point should be an expert conversation. Due to the structure of its members,
the GD has the advantage to have the corresponding experts within its own ranks.
Due to various reasons this subject has not been subject to progress so far. However,
this topic remains as current as ever and therefore solutions for this problem
will be strived for within the next reporting period.