Notfallmäßige Herstellung von Arzneimitteln in öffentlichen Apotheken
Untersuchung in wie weit öffentliche Apotheken in der Lage sind die pharmazeutische Versorgung der Bevölkerung in einem Katastrophen- oder Zivilschutzszenario sicherzustellen. Betrachtet wurde hierbei die Fähigkeit zur Synthese von Arzneistoffen, sowie die Fähigkeit zur technologischen Herstellung v...
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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.