As a pharmacist, you bear responsibility for the safe storage and dispensing of medicines and vaccines. Although guidelines for temperature monitoring in pharmacies are not always explicit, it is still essential to comply with applicable standards such as the Dutch Pharmacy Standard (NAN). In this blog, we explain what is expected of you and how you can easily regulate temperature monitoring without it having to be a complicated process.
Guidelines for temperature monitoring in pharmacies
What you need to know about the requirements and solutions for reliable temperature monitoring in your pharmacy
Pharmacy guidelines for temperature monitoring
As a pharmacist, you have to comply with standards and guidelines. Nothing complicated about that you might say. But the interesting thing is that there is precisely nothing concrete anywhere about temperature monitoring. There are literally no pharmacy guidelines for temperature monitoring. This is quite strange since a pharmacy is after all the last in line before drugs reach the patient. The fact that the use of temperature monitoring for pharmacists is not well described in the standard means that pharmacies have something of an exception. This is what the RIVM says about it:
“It was not legally possible at EU level for the GDP Guideline to apply to the entire distribution chain, from manufacturer to patient. It is obviously important to ensure the quality of medicines throughout the distribution chain. For example, hospital pharmacists and community pharmacists have professional standards containing GDP requirements, such as the Dutch Pharmacy Standard (NAN) and Hospital Pharmacy Standard (ZAS).”
If you are in the business of manufacturing, storing or distributing drugs or medical devices, you must have a license. This is a manufacturer’s or wholesale license. In both cases, there are strict requirements for obtaining and maintaining this license. There are also additional guidelines you must meet, such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Automated Manufacturing Practice (GAMP).
In practice, this means that as a pharmacist you have to comply with a standard that does not clearly describe exactly what you have to comply with. Pharmacists also say they comply, but they cannot always demonstrate this. And if you also refer to a standard that is not clear, it becomes difficult!
Always demonstrably comply with Dyzle
Part of these guidelines is that systems, objects and tools you use for business operations must also meet all these requirements. Whereas before 2013 one had to pay attention to this on the basis of a “risk-based approach,” today this is done on a “compliance-based approach. In short, this means that you must be able to demonstrate at all times that the resources used are suitable for the purpose for which they are intended. But also that you have tested the operation and can demonstrate this.
Choose security
Dyzle’s temperature monitoring meets GxP guidelines as standard. As a pharmacist, you do not have to do anything extra for this. If the requirements change in the future, validating our solution is easy. Do you have questions about temperature monitoring in your pharmacy or chain? Contact us for no-obligation advice.
