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Philipps-Universität Marburg
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Abstract
According to the professional code of conduct for pharmacists, pharmacists
and public pharmacies are obliged to ensure that the population is
supplied with medicines. This includes disaster and civil defense
scenarios. However, since supply bottlenecks can arise very quickly in the
context of catastrophes and wars, in-house production in public pharmacies
is mentioned as a way of compensating, for example, in the event of a
pandemic.1
So far, the possibilities/capacities of the public pharmacy for in-house
production have not been determined and there are therefore plans for the
integration of public pharmacies in civil protection and disaster control
that are not based on a valid database. Within the scope of this work, the
ability of the public pharmacy with regard to the synthesis of medicinal
substances and the technological production of dosage forms was examined
with regard to various civil defense and disaster control scenarios.
During the synthesis, certain limitations in the laboratory equipment had
to be taken into account, since public pharmacies usually only have basic
laboratory equipment. Syntheses under protective gas, working with metal
hydrides and under vacuum were therefore not possible and are not included
in the data collection. Despite these limitations, it was possible to
synthesize drugs that met the quality requirements of the pharmacopoeia.
In addition to the pharmacopoeia analysis, elemental analysis,
mass-spectrometry and IR-spectroscopic methods have been used to qualify
the products. However, it has not been possible to produce pharmaceutical
substances in a quantitative amount that would be sufficient to supply the
population through self-synthesis.
In the context of technological production, solid (capsules) and liquid
(solutions, suspensions) preparations were considered. In terms of
quality, both the solid and liquid dosage forms met the requirements of
the Pharmacopoeia. The production of liquid dosage forms was superior to
the production of solid dosage forms in terms of quantity. In the case of
the liquid dosage forms, it was possible to achieve production quantities
which, in relation to the scenarios described, are sufficient to supply
the population.
The preparation of sterile dosage forms was also examined as a special
form of technological production. These put higher demands on the
implementation than the aseptic production of solutions and capsules.
Although it was possible to achieve a quality that corresponded to the
pharmacopoeia, it could only be achieved by means of a disproportionately
high amount of work compared to the yield. The production of sterile
preparations is therefore not an option for public pharmacies, even in the
event of a disaster.
However, since a self-synthesis of drugs and other pharmaceutical
substances has to be assessed as insufficient for the, the stocking of
drugs and auxiliaries is an imperative for technological production. This
stockpiling should be organized by the state and federal authorities,
since the necessary costs as well as the storage and quality control of
the material represent an unattainable burden for public pharmacies.
A civil defenses scenario, a pandemic and a mass-casualty incident in the
context of a natural disaster were chosen as scenarios for emergency
production. The basis of these scenarios are the risk analyzes of the
Federal Office for Civil Protection and Disaster Relief, as well as the
conception of civil defense and the concepts for national and alliance
defense.
Overall, the pharmaceutical supply of the population from public
pharmacies can be viewed as potentially robust. The public pharmacies have
the capacities for the technological in-house production of drugs, while
the ability to synthesize drugs themselves is insufficient. A mandatory
requirement for in-house production however is that the authorities have
stocks of pharmaceuticals and auxiliary materials.
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Dates
Created: 2022Issued: 2022-07-04Updated: 2022-07-04
Faculty
Fachbereich Pharmazie
Publisher
Philipps-Universität Marburg
Language
ger
Data types
DoctoralThesis
DDC-Numbers
610
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Haarnagel, Falco: Notfallmäßige Herstellung von Arzneimitteln in öffentlichen Apotheken. : Philipps-Universität Marburg 2022-07-04. DOI: https://doi.org/10.17192/z2022.0215.