The pervasiveness of biopharmaceuticals (biologics) in the 21st century pharmaceutical landscape, means that the presence of ‘heat-labile’ pharmaceuticals even in the ‘corner-store’ pharmacy is almost guaranteed. It is therefore essential that every pharmacist and all dispensary staff have some basic knowledge on how to store, handle and transport Cold Chain Products (CCPs).
Cold Chain Products (CCPs) are those requiring storage under refrigerated conditions (2-8°C).
Cold Chain Products (CCPs) are those requiring storage under refrigerated conditions of 2-8°C. Various pharmaceutical products are heat-labile and the vast majority of those classified as biologics, most of which are protein-based, must be stored and transported under refrigerated conditions (2-8 °C). If these conditions are breached, the quality of the product can be altered possibly compromising product safety, effectiveness or both. Ultimately such breaches place patients at risk and must therefore be minimized, if not eliminated altogether. Where such breaches do occur, clear and extensive record-keeping should be able to provide all the necessary details allowing for assessment of the extent of the breach and the likely damage posed to the product.
The nature of both business and medical care in a globalized society means that pharmaceutical products pass through the control of numerous stakeholders on their way to end-users. These stakeholders may be, but are not limited to, members of the manufacturing organization, those involved in transportation, pharmacists, physicians, nurses and ultimately in some cases, patients.
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Collectively, this ‘chain of custody’ assuring refrigerated conditions and the supporting records confirming it, is referred to as the ‘Cold Chain’
In effect, a ‘chain‘ of stakeholders is involved in handling and hopefully maintaining products at 2-8 °C. More than that, quality assurance systems including temperature monitoring devices, detailed record-keeping and chain of custody documentation must all be put in place to ensure product integrity. Collectively, this ‘chain of custody‘ assuring refrigerated conditions and the supporting records confirming it, is referred to as the ‘Cold Chain‘. In practical use, excursions above 8 °C or below 2 °C will elicit comments like, ‘The cold chain has been broken‘ since above 8 ºC we are approaching the realm of the ‘Cool Chain‘ and below 2 °C we are approaching that of the ‘Frozen Chain‘.
The overall quality assurance plan inclusive of the systems, standards and practices necessary to ensure integrity of the cold chain is called ‘Cold Chain Management (CCM)‘. In much the same way that ‘A chain is as strong as its weakest link’, if any stakeholder mishandles the product or ‘breaks‘ the cold chain, the efforts of everyone else in that chain is likely to be undermined compromising product quality, effectiveness and safety.
The overall quality assurance plan inclusive of the systems, standards and practices necessary to ensure integrity of the cold chain is called ‘Cold Chain Management (CCM)’
Given that availability to the average biopharmaceutical comes at significant cost, loss of these products through improper storage and transportation has serious implications for the financing of national healthcare, particularly in developing countries. Further expenses can accrue from correcting the deleterious effects of administering poorly stored CCPs since macromolecules such as proteins under the best of circumstances, are more prone to elicit immunogenic reactions. As such Cold Chain Management is an area of pharmaceutical science that is rapidly increasing in importance and relevance.
In light of this, CaribbeanBiopharma.com will be making various resources available aimed at enhancement of CCM practices throughout the region.