| Abgabe von Fertigarzneimittel als Ärztemuster Ein Audit-Bericht Dr. Heinrich Prinza, Dr. Manfred Rummelb und Dr. Harald Wiednerb Consulting in Quality Systems for Medical Devices, In Vitro Diagnostics and Pharmaceutical Products, Groß-Zimmerna, und QuaSyCon, Bernriedb
In order to obtain information from the appropriate scientific community concerning their prod-ucts pharmaceutical companies distribute samples of medicines via qualified consultants for phar-maceuticals. This is allowed as long as some legal requirements are observed. The regulations concerning the distribution of medicines are to be found in AMG, [1] in § 47, 3 ff. These regulations found in the AMG contain specific statements concerning the persons to whom the distribution of medicines is allowed, the amount and the form of the medicine to be distributed. Furthermore, the aforementioned paragraphs state which forms the documentation concerning the distribution has to take. The samples for the distribution to medicines cannot normally be stored by the pharmaceutical company. The individual pharmaceutical consultants are responsible for the storage and transport to the recipient. Therefore the re-sponsibility of the head of production is for the storage of the medicine to the stage where it reaches the pharmaceutical consultant.
The head of sales and distribution is responsible for ensuring that the distribution of the medi-cine is in accordance with § 47, 3 and 4 AMG. Furthermore, he must ensure that the regulations con-cerning the documentation for the distribution of the medicine are complete. This penultimate responsibility is shared with the qualified person responsible for pharma-covigilance (Stufenplanbeauftragten). The period of storage for the documentation is also regulated by the above law.
In order to investigate the correct legal storage of medicines (according to §19 AMG Responsibilities of the Head of Production) 59 pharmaceutical consultants were investigated. A further goal was to investigate the conformity of the distribution of the medicines, which must also be in accordance with the AMG. The 59 pharmaceutical consultants were distributed throughout the whole of the Federal Republic of Germany. The observations of this investigative audit were listed together with recommendations for corrective action and mitigation. |
