Department Extemporaneous Preparations

Report for the period 2003 / 2004
Activity report for the period March 2002 to March 2003
News 1/2000
Report about Departmental Activities 1999/2000

Number of Members:
There are four new members in the department and it consists at present of 27 members (see attachment).

Activity Report

Transparency in Quality of Dermatic Bases

On the 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 survey.

Drug Dossiers as Attachment of the Guideline “Dermatological Prescription”

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.

Revision of Guideline “Dermatological Prescription”

In the 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 issues:

Quality of components
Industrial hygiene
Labeling of components

The revised version has been considered in the loose-leaf collection of the NRF 2003.

Hygiene Guideline

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 2003.

Rosemarie Eifler-Bollen
Eschborn, 9 March 2004

Activity Report of the GD’s Department for Extemporaneous Preparations for the Period March 2002 to March 2003

Department head:
Pharmacist M. Tünnermann, Kerken

Assistant department heads:
Prof. Dr. M. Gloor, Karlsruhe
Pharmacist R. Eifler-Bollen, Eschborn

The department comprises at present 23 members, see attachment.

Activity Report

The 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:

Guidelines

Hygiene Guideline
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
Industrial hygiene
Labeling of components

Planned projects

Assessment of the pharmaceutical quality of branded bases for the dermatics preparation according to prescription.

Michaela Tünnermann
Bonn, 1 April 2003

News 1/2000: First GD Department Meeting in 2000

The 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.

Preliminary Agenda

1.    Opening and welcome
2.    Approval of agenda
3.    Approval of the minutes of the 3rd meeting on 8 June 1999
4.    Report of the Department’s Activities
5.    Guidelines for dermatologic prescription, effects, actualisation
6.    Current problems with instable individual prescriptions (evaluation of hotline-experiences)
7.    Problems coming about when preparing ready-to-use medicaments in individual prescriptions
8.    Formation of working groups

	instabilities of individual prescriptions
	working in of ready-to-use medicaments into individual prescriptions
	application of cosmetic products into prescription bases
	recommendations “rational medicinal agent combinations”

9.  Preparation of new elections for the department head
10. Miscellaneous

Please address questions to the department head, Dr B. Hünerbein or the GD office at Eschborn.

Report 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.

Emphasis Hygiene Guidelines

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.

Emphasis Continuous Training

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’ personal training.

Emphasis 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.

Emphasis 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.

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