Focus Action
Pharmaceuticals must be transported in such a way that the temperature range specified 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.
Focus actionsThe starting point forfocus actions are indications from the market. Prior to the most recent action, the BASG / AGES Medical Market Surveillance was informed that medicinal products from other EU member states but also from third countries were repeatedly transported to Austria, the efficacy and safety of which were at risk due to defects during transport. The BASG / AGES Medical Market Inspectorate was also repeatedly informed by the traffic police of tarpaulin trucks transporting medicinal products as well as vaccines in uncooled small trucks without insulating packaging. During inspections of Austrian pharmaceutical wholesalers, the inspectors repeatedly learned that Austrian wholesalers as recipients often had no influence on the transport quality of the delivered pharmaceutical consignments.
Sequence of the focal action
Therefore, the delivery ramps of the largest Austrian central warehouses and pharmaceutical wholesalers were selected as control points for the focus action. At 13 control points, 31 inspectors checked a total of 103 vehicles transporting medicines with a total of 110 individual deliveries of medicines.
Although the quality standards of the individual transports varied considerably, no deliveries of medicines were found to be outside the legal requirements. In detail, 30 individual deliveries of medicines actually showed deviations from the requirements of the relevant laws and standards that needed to be clarified. Examples include the unbuffered transport of pharmaceuticals in a tarpaulin truck (direct influence of the ambient temperature on the transported goods), the use of small trucks without an active refrigeration unit for the cargo area and without temperature measurement in the area of the pharmaceuticals, and the transport of only lightly insulated refrigerated goods in groupage transports by courier services.
Next steps
This information will be clarified in the course of the next months during the periodic inspections with the responsible persons of the pharmaceutical companies concerned in each case, in order to guarantee a validated and thus safe transport of medicinal products for all medicinal products even at critical outside temperatures (less than five and more than 25 degrees Celsius).
Queries:
Institute Inspections, Medical Devices & Hemovigilance.
E-mail: inspektionen@ages.at
