A summary of Berlinger’s white paper – Beyond the Cold Chain

“How many drugs are consumed that are outside the official margins for safety?”

This question is posed by Berlinger in a recent white paper concerning the importance of temperature monitoring during transportation and storage of pharmaceuticals. Their study highlights the unique challenges hindering the safe and effective use of pharmaceutical products. The aim is to validate the use of sensitive equipment in the pharmaceutical industry as well as the homes of users.

We have analysed the document, and summarised it for a wider range of readers. Assessing the information provided only served to reinforce our belief in the integrity of Berlinger’s products, and commitment to the vital role temperature monitoring solutions plays in many industries.


Increased regulation

Modern drugs have become increasingly sensitive due to the market trending towards biologic and “patient centric remedies”. Many of these treatments are living cells, the efficacy of which may be impaired by unacceptable temperature exposure. As a result, tight regulatory controls have been implemented particularly to cater to globalised production, new market development and systems of transportation.

Consequently, around 80% of drugs now require temperature-controlled transportation according to World Health Organisation (WHO) standards. In particular, 90% of vaccines must be stored between 2 – 8 degrees Celsius throughout the cold chain system, and when used in an immunisation session. An Effective Vaccine Management assessment by the organisation revealed that only 29% of 70 countries met the minimum standard for temperature control. Many did not transport the vaccinations at the correct temperatures causing the vaccinations to be compromised.


Pharma manufacturer responsibility

Many times, once the product leaves the temperature controlled supply chain environment it is given to parties who do not maintain the correct handling and storage. As the expert, the supplier is responsible not only for delivering the product in the correct form, but also for giving clear instructions as to how it should be stored and used.

We encourage suppliers to take the utmost care with protocol in transporting the medication as well as handing it over with clear guidelines to the following party. If this is not done exactly, innocent people’s lives may be endangered. If you, as the supplier, feels that medication has been compromised in any way, retract the order.

To quote the Centres for Disease Control and Prevention in the US “It is better to not vaccinate than to administer a dose of vaccine that has been mishandled.”


The average consumer

A recent study provided users of a temperature sensitive biologic drug with a data recorder to monitor the temperature their medication was being stored at. The results showed that only 17 of the 255 participants had maintained the recommended temperature range. According to the author of the report, the efficacy of the medication may have been compromised.

Storage at incorrect temperatures can render medications ineffective. This, in turn, can lead to a medical practitioner having to prescribe alternative medication, which would not have been necessary had the original drug been stored appropriately.

A possible solution is introduction of a ‘reliable point-of-use temperature indicator’. This will ensure that that drugs that are consumed away from medical supervision are tested for safety in terms of temperature.

To quote Berlinger’s white paper, “The presence of an accurate temperature indicator means that drugs can be consumed during their ‘safe period’ reducing unnecessary drug wastage and minimising the consumption of potentially dangerous drugs.”

Read the full white paper.