Control of the distribution network
In order to achieve the highest possible level of health protection, very high quality requirements are placed on the manufacture of medicinal products. As a result, only drugs whose quality, efficacy and safety are guaranteed are released for distribution.
This level of quality must be maintained throughout the entire distribution network, which can be very complex. This distribution network includes manufacturers as well as wholesalers, transporters and pharmacies.
Regulations in this regard can be found at the national level in the Medicines Act, in the Medicines Operations Ordinance 2009 and in the Pharmacy Operations Ordinance 2005. At the European level, regulations can be found in the so-called "GDP Guideline" of the European Commission, which is of course also valid in Austria.
The task of the Federal Office for Safety in Health Care (BASG) is to review and control the supply chain with regard to compliance with the relevant transport and storage regulations to ensure that only high-quality medicinal products are dispensed to patients.
BASG bodies or AGES Medical Market Surveillance experts are authorized to enter, visit and inspect pharmacies, pharmaceutical companies and transporters of medicinal products, as well as to take samples in the quantities required for an investigation and to inspect the company's records, which are to be kept in accordance with the provisions of pharmaceutical law, and to make copies thereof as well as photographs and video recordings in the company, insofar as this is necessary for the preservation of evidence.
This is done on the one hand routinely by regular spot checks according to an annually defined "sample plan" and on the other hand by coordinated, large-scale focus actions.
A distinction must be made between these activities and those aimed at combating the sale of illegal medicines outside the legal distribution channels.
A. Sample plan
In order to achieve the greatest possible effect at a reasonable cost, a risk-based European sample plan is drawn up annually. The random sampling is carried out by experts of the AGES Medical Market Surveillance or by organs of the BASG.
In addition, samples are taken when necessary due to reported quality deficiencies, in the context of company inspections or by public health officers.
If possible, the sample taken is split and a sealed counter sample is left behind.
For each drug withdrawn from the legal distribution chain, a withdrawal slip is issued at the place of withdrawal. No compensation is due for samples taken.
The samples are then submitted for laboratory analysis and assessment in the drug control laboratory of AGES Medizinmarktaufsicht.
B. Priority actions
In order to achieve the aforementioned objectives, the distribution network has been and is being reviewed with regard to the proper transport of medicinal products, particularly with regard to the temperature range required by law. For this purpose, the so-called SOKO "Temp" was established.
Pharmaceuticals must be transported in such a way that the temperature range required on the packaging and in the instructions for use is always maintained. Deviations from this can lead to a reduced shelf life, increased chemical degradation of the active ingredients and, in the case of certain products (e.g. vaccines), to complete ineffectiveness.
Two priority actions have been carried out so far:
- SOKO Temp I (2009)
As part of SOKO Temp I, inspectors checked 16 transfer points of pharmaceuticals to pharmacies and verified the outside temperature, the type of pharmaceuticals, and the quality of temperature regulation in the cargo area of the transport vehicle. Information
- SOKO Temp II (2012)
The delivery ramps of Austria's largest central warehouses and pharmaceutical wholesalers were selected as inspection points for the focus action. 31 inspectors checked a total of 103 vehicles transporting medicines with a total of 110 individual deliveries of medicines at 13 control points. Information
C. Combating the illegal pharmaceutical market
As a rule, the starting point for priority actions are tips from the market. Increasingly, however, samples are taken or anonymous test purchases are carried out in cooperation with other authorities (police, customs, food inspectorate, judiciary) on suspicion of illegal or counterfeit medicines. This cooperation often takes place in long-term planned, joint purely national or international actions.
This also includes the international action "PANGEA". PANGEA is a worldwide priority action that takes place annually. In this action, pharmaceutical authorities, Interpol and health ministries or customs and police work together. The task is to access the websites of dubious Internet suppliers of medicines at a specific time and in a coordinated manner. The aim is to combat the illegal sale of counterfeit medicines on the Internet.
Queries:
MMMag. Bernd Unterkofler, MBA
Tel.: +43 (0) 50 555-36650
E-mail: bernd.unterkofler@ages.at
