Community pharmacies manage on a daily basis the receipt of cold chain medicines from wholesalers, storage and subsequent dispensing to patients. Elevated temperatures can affect both chemical and physical stability of many medicines. With increasingly more expensive thermolabile products being dispensed, and with more community pharmacists involved in vaccination campaigns, it is important to have robust and cost-efficient procedures to ensure maintenance of the cold chain.
Cold chain breaches (CCBs) can lead to considerable non-recoverable financial losses due to spoilage. For pharmacists what can be of even more concern is that CCBs can also lead to inconvenience to the patient, and failure to get a much-needed treatment on time could potentially have an impact on the patient’s health.
CCBs can, and will, happen. Power outages do occur. Mistakes can happen. Staff can accidentally forget to close the door. Deliveries from suppliers can go unnoticed and unopened for too long. While a quick search for the purposes of this article did not find any local specific research, I easily found the following two studies that demonstrate this: A 2019 study in Germany looked at data from 75 refrigerators in General Practices and found that two-thirds exhibited cold chain breaches and 15% reached critically low temperatures threatening vaccine potency. A 2018 Australian survey found that 39% of community pharmacies had experienced one or two power outages, and 11% had experienced two to four outages during the previous 12 months.
So let us look at refrigeration temperature control monitoring and what’s available.
Section 3.2.2 of the PSI’s Guidelines on the Storage of Medicinal Products within a Retail Pharmacy Business states that, “Extra care and precaution should be taken with medicinal products that require refrigeration, i.e. storage between the ranges of 2°C-8°C. It is necessary to ensure that the narrow temperature range required for the storage of such products has been maintained and that appropriate records are in place to demonstrate this.”
Furthermore, Section 3.2.2 states that, “The maximum and minimum temperatures of the pharmacy refrigerator, i.e. the maximum and minimum internal temperatures reached since the previous measurement, should be recorded, at a minimum, on a daily basis, at a specified time, by a designated member of staff and the results should be entered in a log which should be retained in the pharmacy. Readings should be taken in accordance with the manufacturer’s instructions. The temperature recording equipment should be calibrated as recommended by the manufacturer or, at a minimum, annually and appropriate records maintained. Temperature monitoring records should be reviewed and approved regularly by the supervising pharmacist to ensure compliance with the required conditions.”
So, at a minimum, a once-a-day a check on the maximum and minimum thermometer in the refrigerator by a designated member of staff is sufficient, from a regulatory point of view. However, I would suggest it’s not that efficient. Under this method data can be missed, temperatures fluctuate unnoticed, and power failures are left undiscovered for long periods. There are now other options to maintain pharmacy refrigerators temperatures that are more efficient, and I would suggest more cost effective.
Wireless temperature USB data loggers
The simplest and cheapest option is to use a USB data logger. These are portable, lithium battery operated measurement instruments that continuously and autonomously record temperature. They are independent of the fridge and continue to record the temperatures even when there is no power supply. They therefore give an accurate record of the temperatures reached and the duration of any temperature breach.
They are usually the same size as a USB stick and, as their name implies, have a USB port. They can be plugged in to a computer and digital data can be retrieved, viewed, and evaluated after it has been recorded. Data can then be printed and exported to other applications.
When considering using this option, some things to consider are:
While wireless temperature USB data loggers are a big improvement on a max/min thermometer and pen and paper, they do have limitations. Primarily, they do not alert the pharmacy staff to a CCB at the time it occurs. So, should there be a power outage when the pharmacy is closed you may not know about it until you open again. And indeed, even if the power outage occurs when you are open and staffed, you may not know the temperature in the fridge unless you open it and take out the probe — and in so doing increase the temperature. For these and other reasons I invite you to consider a remote wireless cloud-based temperature monitoring system.
Cloud-based wireless temperature sensors and systems
Battery operated sensors are placed in the fridge and transmit to a local network controller or gateway box. The gateway box is not in the fridge. It is placed on a desktop or wall-mounted. It is connected directly to the internet via a cable or WiFi. You only need one gateway box even if you have more than one fridge. The sensors in each will transmit to this single box. Should you have a CCB the alarms and flashing lights on the gateway box can notify you straight away. However, the real advantage of this system is in the email and texting alerts.
Cold chain breaches can also lead to inconvenience to the patient, and failure to get a much-needed treatment on time could potentially have an impact on the patient’s health.
Prior to a CCB, if the temperature is getting close to causing a CCB you will get a warning email and SMS text. These ‘alert’ temperatures are predetermined and preset by the pharmacy. This will allow you to correct the problem before the CCB happens — day or night, whether you are on the premises or not. If there is a power cut during the night, you will be notified if the temperature starts to rise. However, even if there is a power cut, if the temperature in the fridge is still maintained within the minimum and maximum levels, you will be able to sleep easy.
If a CCB occurs you will know how long and to what extent that happened. This is important as each refrigerated product will have its own stability guidelines. By knowing the details of the CCB you may or may not have to destroy the product; at the very least you will have accurate data to talk to the manufacturer with.
These systems are usually offered as a complete ‘package’ with sensors, gateway boxes, cloud-based interfaces and alerts all combined in the cost. In addition, there is usually the option for annual calibration — something that you should also undertake if using a wireless temperature USB data logger but may be more difficult.
The continuous stream of temperature data is usually accessible via the cloud-based portal, and can be viewed at any stage, from anywhere. This can be printed in various formats. Some providers also offer to email the data as a document at set intervals.
The ‘packages’ often contain sensors that can record not only temperature, but also humidity — something that we also need to monitor. There are usually also options to link room temperature and room humidity sensors to the same gateway box. So, you will have complete data.
The current PSI Guidelines state that; “It is important to consider additionally equipping the unit with an independent temperature monitoring probe, particularly where the unit is being used to store high-risk products, for example, vaccines. Temperature monitoring probes should be placed between medicinal products in a location which has been assessed to be the ‘worst case’, and the temperature should be measured continuously. The location of the temperature monitoring probes should be recorded. Such monitoring equipment should be calibrated in accordance with the manufacturer’s instructions or, at a minimum annually, and records of the calibration maintained.”
For the purpose of this article, I asked the PSI their opinion on the use of remote wireless cloud-based temperature monitoring, and specifically the fact that other health care facilities do not log daily checks. The Acting Community Pharmacy Quality and Safety Manager, replied on behalf of the PSI as follows:
“Under Section 3.2.2, ‘Temperature Monitoring’, it states: ‘The maximum and minimum temperatures of the pharmacy refrigerator, i.e. the maximum and minimum internal temperatures reached since the previous measurement, should be recorded, at a minimum, on a daily basis, at a specified time, by a designated member of staff and the results should be entered in a log which should be retained in the pharmacy. Readings should be taken in accordance with the manufacturer’s instructions. The temperature recording equipment should be calibrated as recommended by the manufacturer or, at a minimum, annually and appropriate records maintained. Temperature monitoring records should be reviewed and approved regularly by the supervising pharmacist to ensure compliance with the required conditions.’”
“The use of automated devices to record fridge and environmental temperatures has been noted at inspections. The advice given in such circumstances is that the pharmacist must be in a position to assure themselves on a daily basis that temperature recording devices are fully operational and that storage conditions for all medicines are maintained within the required temperature range. It is also recommended that, where temperatures are logged only by the automated device, the electronic records are reviewed on a weekly basis by the supervising pharmacist, and that this review is documented.”
I personally am in a ‘more assured position’ by using remote wireless cloud-based temperature monitoring that storage conditions for all medicines are maintained. However, I leave it with individual superintendent pharmacists to explore the options and assure themselves both on the suitability, efficiency, and costs of their system.
References available on request.Colin Deeny
Superintendent Pharmacist of Inish Pharmacy group, and PPWG member
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