EU transportation loophole could compromise drug quality
Online pharmacies in many parts of Europe are not bound by EU GDP rules, allowing them to bypass manufacturers’ temperature guidelines which could put patients’ health at risk
If the storage and transportation of drugs is not maintained at the right temperatures – as defined by drug manufacturers – then medical products may not reach the patient in peak condition and patients’ heath could be put at risk.
Good Distribution Practices (GDP)
Such practices fall under EU Good Distribution Practice guidelines (GDPs) – which cover parties involved in the supply chain, including manufacturers, wholesale distributors and transport service providers.
However, online pharmacies in many parts of Europe are not bound by EU GDP guidelines and this legislative loophole could compromise the quality of medicinal products.
In a study earlier this year, the European Institute for Pharma Logistics (EIPL) shipped 100 test parcels, fitted with temperature sensors, with five different parcel services used regularly by seven online pharmacies to compare the measures taken to protect temperature sensitive goods on the transport route.
The medical products shipped included:
- Paracetamol oral suspension for children (where the manufacturers’ instructions were "do not store at less than 8°C. Do not refrigerate or freeze");
- Bromelain hysan tablets ("May be kept outside of the fridge for up to 4 weeks, but not above 25°C.";
- Mutaflor suspension ("refrigerate at 2°C to 8°C");
- and Lamisil spray ("do not store at over 30°C. Do not refrigerate or freeze.")
The results of the temperature study were “alarming,” the Good Distribution Practice Group said. Medicinal products requiring tempered transport were often transported in regular vehicles without active temperature control, while cold-sensitive drugs were often packed up and delivered together with refrigerated drugs.
Medicinal products requiring tempered transport were often transported in regular vehicles without active temperature control, while cold-sensitive drugs were often packed up and delivered together with refrigerated drugs.
“Due to the addition of cold packs by the online pharmacies, the medicinal products had, on top of the cold outer temperatures, been carelessly exposed to additionally extreme temperature conditions inside the parcel”, according to the Good Distribution Practice Group.
One medicine, which should not be stored or transported at less than +8°C, had been put directly on a frozen cold pack for shipment.
In addition, some deliveries that were in standard shipping cartons had been placed on the cold ground at outdoor temperatures.
Temperature sensitive medicinal products had often been shipped in standard shipping cartons and therefore insufficiently protected from too low or too high temperatures.
The evaluation of the parcels that were fitted with sensors showed that the temperature requirements were not complied with in many cases.
The highest temperature recorded was 35.9°C; the lowest was -12.5°C. The parcels were understood to be outside the temperature range of 2-8°C for more than half of the transportation time.
"From our point of view, the field test shows that the concept of online pharmacies doesn't work out,” said EIPL CEO Christian Specht in a recent press statement. “With the current transport methods via the usual parcel services, transport quality and hence patient safety is clearly neglected.”
"The transport route of online pharmacies has to meet GDP requirements. We ask the legislator to fix this loophole and issue a clear regulation in regards to the distribution by online pharmacies."