Transporting Medicine: No Room For Compromise

Not a comforting sight, is it?

It’s a very hot day, everyone wishes they were already there, and the snaking line of brake lights, glass and metal can be seen for miles into the distance. You’re transporting medicines, but you’re not going to arrive any time soon…

Giving in to the sweat…

Unfortunately, your organisations management team deemed temperature-controlled transport or passive packaging an unnecessary expense, and instead insisted on uncontrolled packaging and transport vehicles. We are in the UK after all, and the sun has rarely got its hat on.   

Now, as your customer’s products sit in the uncontrolled van, in their basic cardboard box, the medicine is slowly cooking in a vehicle easily reaching over 45°C inside. What’s worse, you never involved your client at the destination in this decision. The medicines are now likely ruined or at the very least, their efficacy may be compromised. What do you say? How do you explain yourself?  Can you reassure your client of the integrity of the products, given the temperature extremes they may have been subjected to? 

Transporting Medicine | Getting it right

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 its 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.

The team of consultants at Paradigm Shift Consulting always highlight 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, especially if the deviation is regarded as serious enough; particularly so if a patient is 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.

Keep in mind tha the MHRA are not interested in what it costs you to achieve the expected levels of GDP compliance; only that you must.

During a regulatory inspection, if the use of uncontrolled temperature vehicles or packaging has been used to transport medicines and has resulted in the storage requirements compromising the medicinal products, this is considered a risk to patient safety and is highly likely that a major or critical finding will be reported by a regulatory inspector and this may lead to a Compliance Management Team (CMT) or Inspection Action Group (IAG) referral, which can ultimately lead to license suspension or revocation.

Transporting Medicine | Independent / 3rd party hauliers

Independent couriers who advertise pharma haulage services must 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, which 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 he gets 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.

If it’s a seriously hot day and you are concerned about the conditions of transport, undertake transport validation exercises and perform a Risk Assessment (RA) 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 if the vehicle has been tested and suitably risk assessed, along with the planned route.

It is best to try and avoid this scenario when transporting medicine: Even on a moderately clement day and after a Risk Assessment, it is difficult to justify the use of such transport and packaging to a regulatory inspector. 

You must satisfy yourself with the transport validation exercise results and Risk Assessment, and be able to evidence that the consignments will and do 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.

Can you afford to take the risk of not transporting your medicines in packaging and on vehicles that can guarantee your products have not been compromised whilst travelling between your site and that of your customer?

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:

• Contracts For Outsourced Activities
• Outsourced Activities (on our GDP Training Website)
• Managing Outsourced Activities
• What Is A Risk Assessment in GDP?
• Driver Training