There are several temperature-related problems in the delivery and storage of drugs once they leave the main supply chain management system at various facilities. In fact, the last mile of transportation and subsequent storage conditions present unique challenges to ensuring that pharmaceutical products remain safe and effective.

According to the World Health Organisation, more than 90% of all vaccines require a temperature-controlled supply chain. Modern drugs are increasingly sensitive, and so the ability to control the environments we transport and store them in is more and more important. This requirement is underpinned by tight regulatory controls and compounded by factors such as globalised production, new market development and new systems of transportation.

The problem of maintaining drug safety and efficacy is neither new nor insignificant. It’s not just that the drugs are becoming more intricate; the supply chain is also becoming increasingly complex due to changes to shipping modes, climate zones, storage facilities and patient health facilities.

The market effect

One of the biggest market trends in pharmaceuticals at the moment is the move towards biologic medicines and personalised, patient-centric remedies. The basis for many of these treatments is living cells or complex chemical molecules, so there is a significant risk of therapeutic loss or impairment in the event of unacceptable temperature exposures. In some cases, such temperature deviation can even result in the product becoming dangerous due to the production of toxic degradation compounds.

Regulation requirements

Regulatory authorities require that a manufacturer ensures product quality right up until the drug concerned is used for patient treatment. These regulations go further than the professional monitoring of vaccines. In fact, they go so far that pharmacists have to think about a myriad of things when creating medicines in the first place. They must consider how the drug will be transferred to and stored in pharmacies, retailers, hospitals and community doctors. They also have a duty to contemplate the journey of the drug with a consumer – how they will get it home and store it there. The fact that medicine is rarely temperature monitored in people’s homes is a huge factor.

Help at home

Despite instructions in fine print, a recent study showed that only 6.7% of patients store their medicine at the correct temperature. Of those who did not, 24.3% had stored their medication for more than 2 hours outside of the recommended range.

The impact overall

The problem of temperature control is not confined to high temperatures. Medicines, especially vaccines, can also be very sensitive to cold conditions. According to the World Health Organisation, “protecting vaccines from freeze damage remains one of the most poorly addressed problems in vaccine management. Although many sensitive drugs fall into the nominal 2-8 degrees temperature band, others require very specific storage conditions and these conditions must be maintained until the point of administration.”

At TMSA, we pride ourselves in distributing products that combat these problems – including devices from the Berlinger range. To find out more about the services and products we offer to help your business stay on top of their temperature monitoring game, call Samantha on 083 415 6815 or send an email to samantha@tempmonitor.co.za.