It’s a very hot day, everyone wishes they were already there, and the snaking line of glass and metal winds its way off into the distance. You're transporting medicine, but it’s going to be quite a while yet…
Unfortunately, this is the day you decided to cut corners, save time and money, and try to beat the deadline. You had no temperature-controlled vehicles available, so you took a chance. You may even ask the driver to turn a blind eye and say nothing.
And now, the medicine is slowly cooking in a vehicle easily reaching over 45 degrees Centigrade inside. What’s worse, you never involved your client at the destination in this decision. The medicines are now likely ruined or at least, their efficacy is compromised. What do you say? How do you explain yourself?
No matter how the medicine is being transported, you must be able to demonstrate that they have not been unnecessarily exposed to conditions that will compromise it’s integrity and quality, and that the medicinal products have been kept within label conditions for the length of the journey. Prolonged exposure to high temperatures can render medicines either useless at one extreme, or potentially harmful in the other.
UK GDP Association will always point out that the cost of cutting corners, economising, compromising or ignoring the guidelines - including when transporting medicine - will almost always outweigh the cost of following them.
The above scenario can wipe out a licensed wholesaler or transport company at a stroke, if the deviation is regarded as serious enough; particularly so if there are major or critical deviations that result in license suspension or revocation, possibly due to a patient being hurt by prescribed medicines that have been damaged during transport and have got through the supply chain undetected.
The WDA requires the wholesaler to ensure that when transporting medicine, this does not happen ever. If it does, they are expected to have procedures in place to report, investigate, document and resolve it; ultimately making sure it does not happen again.
The MHRA are not interested in what it costs you to achieve the expected levels of GDP compliance; only that you must.
Independent couriers who advertise their services must also be able to demonstrate that their vehicles meet GDP requirements to a satisfactory level of compliance. This means proving that the vehicle payload compartment is proofed against extremes of weather conditions with properly installed and validated temperature control equipment that can supply up-to-date data on demand to the receiving party and/or the supplying wholesaler. This also means not leaving the consignment at an alternative address, or with people who are not authorised to receive it. The phrase “I’ll make sure they get it”, does not qualify you or anybody to handle the consignment any differently, and any shipment of medicinal products must always be left at the licensed site only.
NOTE: If you're a private courier, it's usually adviseable to not advertise what you are carrying, or if you're exclusively transporting medicines. Criminals will know immediately what you may be carrying and could target you for a potential highway robbery.
If it’s a seriously hot day and you are concerned about the conditions of transport, make an RA (Risk Assessment) of the route.
If you are considering transporting medicine in an uninsulated and uncontrolled vehicle, it should travel with a data logger that records the full length of the journey, which is calibrated to cover the temperature range of the products shipped, and/or the vehicle has been tested and suitably risk assessed, along with the planned route.
It would also be adviseable to pay additional attention to packaging. Do what you can to mitigate temperature excursions as much as possible.
It is best to try and avoid this scenario when transporting medicine: Even on a moderately clement day and after a Risk Assessment, it must be engaged only as a last resort in an emergency and with the customer's full cooperation.
You must satisfy yourself with the Risk Assessment and be able to evidence that the consignments will arrive in good order, safely and uncompromised. Communicate! It is better to agree that there’s a potential risk and avoid it, than it is to take the chance and risk hurting the patient.
You will find a comprehensive overview of what is required for GDP compliance when transporting medicines in Chapter 9 of the European EU GDP Guidelines (2013/C 343/01).
There are also useful informative blogs on this site you can read including:
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