Análisis final: la recta final
“Inappropriate drug storage can reduce the quality of the product, so patients and investigators must be aware of the risks. Clinical trials insight will take a look at the importance of ‘last mile distribution’ to understand the effects it has on patient safety as well as cost for pharmaceutical companies”.
The global pharmaceutical industry will have spent more than $8 billion on cold chain logistics in 2014, getting their products and clinical trial supplies into pharmacies and hospitals all over the world. Millions of miles will be travelled under the GxP regulations with every consignment controlled for the correct storage conditions, including temperature, and sometimes light levels and humidity. Then the drug arrives at the last mile, a phrase that can bring fear into the hearts of project managers and supply chain professionals around the word. This is the point from which it arrives with the ultimate users, which may be the investigator site, the patient’s bedside, or right to the patient at a home address.
There is not just one last mile, it depends on who you speak to, and whereabouts in the world they are, the developed world has sophisticated distribution systems, but getting a vaccine or other temperature controlled materials into a site in the developing world is a much more difficult proposition requiring control and excellent communications to make necessary arrangements.
There is often a time element involved and usually technology with temperature monitors and IxRS registration. There are plenty of tools to help, and cloud based technology for uploading data directly at the consignee can make all the difference. This is where being able to understand and which between the macro and micro levels is crucial. Monitoring a whole pallet is easy; GPS equipment that can be used during air transport is one of the newest technologies in the temperature-control market. This technology is switched off and on during takeoff and landing, but is actively reading at all times, and sending the location of the package. While geo-temp technology has a long way to go beyond its function as an alarm system this is an innovation the transport world is excited about. When we get to the final delivery these are simply not practical or cost effective for most shipments and using a simple TempTale or Elpro device is usually a better option even if the location visibility is no longer available.
Successful deliveries require systems to be in place so that the critical control points and handovers are monitored. Ensuring that the ultimate consignee understands their responsibilities in downloading temperature monitors and dealing with the materials when they arrive is crucial for the success of the shipment, having spent time and budget delivering into the site all can be lost if the material is left out at room temperature in an office, or is placed into the wrong storage area. Preplanning and communication are key for success. Even the best laid plans can go wrong, due to circumstances beyond your control, requiring flexibility from all parties involved in the supply chain. We had some vaccine deliveries into Poland which were very delayed due to bad weather in the middle of the winter. With sub zero temperatures forecast, rather than leaving the boxes in a cold warehouse overnight, our office arranged to collect the investigators and take them with the shipment to their offices late that night so that the materials could be accessioned into their fridges without a single temperature excursion.
The last mile makes all the difference to the consumer and it’s the only thing that they will see, as the rest of the supply chain is (and should be) hidden to them. The world’s best-designed supply chain is worth little if it all goes wrong at the hand-off at delivery.