Medicines and the Cold Chain: Four Questions for Annick Demouy
After discussing the main issues faced by pharmaceutical laboratories, Annick Demouy, Quality Assurance Pharmacist at Stradis Laboratories, discusses the transport of temperature-sensitive medicines under cold chain conditions.
Why is it crucial to strictly adhere to +2/+8°C for a temperature-sensitive medicine?
This is a regulatory requirement. The medicine has to meet all the specifications outlined in its Marketing Authorisation (MA) dossier.
For cold products, it is the strict +2/+8 °C range that is most often described.
This temperature range is defined by stability studies conducted during the development of the medicine, which are determined based on:
- – The product itself (molecule, galenic form),
- – The geographical area to which it is intended,
- – The environmental factors to which it may be exposed (temperature, humidity, light).
Stress and accelerated studies help to assess the risk of degradation of a product in case of deviations from ideal storage conditions.
What are the consequences if the cold chain is not respected?
A temperature excursion (hot or cold) can impact the reliability of the medicine and thus public health. A medicine can physically or chemically degrade, or become microbiologically contaminated. It may lose its effectiveness or, worse, become toxic. The degradation of a medicine is rarely visible, so the risk is therefore even higher.
What is the difference between a temperature excursion and a temperature deviation?
These two terms are not synonymous. A temperature excursion is a deviation, but the reverse is not true: a temperature deviation is not always an excursion.
- A temperature deviation is a trend or drift towards an unfavourable situation. There is still time to act with a plan of corrective and preventive actions.
- In the case of a temperature excursion, the product has already fallen outside acceptable norms. This situation requires corrective action.
What should be done in the event of a temperature excursion of the medicine?
An excursion outside the temperature range is a deviation and must be treated as such, regardless of the duration of the excursion.
The potential impact on the quality, efficacy and safety of the medicine must be assessed. This evaluation is based on knowledge of the medicine and its stability studies. It is carried out by the responsible pharmacist, whether industrial, hospital, or retail, who will then need to make a decision.
The correct decision is one that introduces no risk to public health. Patient safety should take precedence over any other consideration.
