Supporting Seafarer Health: Temperature Controlled Medications

Have you ever wondered why some medications need to be temperature controlled during transit? Does it even matter really? What are the consequences of getting it wrong?

In this month’s Supporting Seafarer Health blog, we explore the topic, why it’s needed, when it can go wrong, how you can check that your delivery of medication has remained within its temperature controlled parameters during transit and how we can manage it more efficiently.

Managing temperature controlled resupplies at sea

For any pharmaceutical supplier, medical team onboard, or medical operations ashore, managing temperature controlled resupplies, and storage onboard, can be tricky at best. 

A typical situation could be supplying medication from the UK (not exactly known for its warm climate!) to the Antarctic, where let's face it, it’s pretty cold. But the delivery will involve several flights and cross the Equator, spending plenty of time in warehouses on the ground as well as in the air. This means transiting multiple temperature zones from tropical to polar and everything in between. 

Medications containing proteins, living components, or sensitive molecules, such as insulin, many vaccines, hormones and biological drugs, must be kept within a specific range, as heat can break down the active ingredients and cold can cause them to freeze and become damaged.

Extreme temperatures can also alter the physical properties of medications. Freezing can cause liquid solutions to crystallise or separate, while high heat can melt capsules or dry out creams. These physical changes can make the medication unusable, even if the active ingredient itself is not immediately destroyed.

Temperature-controlled medications must be stored, including during transit, within specific ranges, depending on their classification:

• Chilled: 2–8°C

• Ambient (below 25°C)

• Ambient (below 30°C)

  
  

These ranges must be maintained throughout the supply chain to ensure product integrity and compliance with manufacturer requirements. If that can be achieved, the medications are guaranteed to retain at least 90% of their potency throughout their shelf life. 

With regard to storage, the majority of medications are required to be stored within a specific temperature range, but there are also products that do not have any storage requirements (NSR). Generally, there is no tolerance for deviations. Medications are only licensed for use if stored strictly in accordance with the manufacturer’s specified temperature conditions.

We also need to consider the regulatory compliance side of things. The pharmaceutical industry is heavily regulated by bodies like the WHO, FDA, and MHRA. Regulations such as Good Distribution Practice (GDP) require strict temperature control and monitoring throughout the entire supply chain, from manufacturing to patient delivery, in order to ensure product quality and safety.

Storing medications correctly is vital

Specialised cold chain logistics are used to transport medications, including insulated containers, refrigerating systems, and real-time temperature monitoring (dataloggers), which record the temperature through the journey and can be downloaded for checking at the final destination. Only the temperature controlled items in a resupply need to be packaged with dataloggers, any NSR items stay outside the temperature controlled packaging.

On arrival at their destination, if data logs indicate that temperature limits have been breached, the affected medications must be destroyed. If it’s not feasible to return the stock involved to the sender and destruction is arranged by the vessel, a valid certificate of destruction must be provided as evidence. 

Frustrating as it can be if your resupply is affected, it’s so important to understand that the storage and temperature management of pharmaceuticals are critical components of the supply chain. Failure to maintain the required conditions may render products unfit for use or compromise their stability. 

It’s a good reminder to consider: Would you choose to take medication if you were unsure about whether it had been stored correctly?

In summary, maintaining proper storage conditions should be no different for medical stores on their way to, or onboard a vessel, than it would be on land. It is a vital element of compliance and ensures the safety and efficacy of all pharmaceutical products for our patients.