Medicines storage: do care homes really need to monitor room temperature?

Medicines storage: do care homes really need to monitor room temperature?

Summary

NICE guidelines fail to give clear advice on whether room temperatures need monitoring for medicines stored in care homes. We recommend that care homes in England should follow the same advice that applies to pharmacies in England and care homes in Scotland, namely:

If it is felt that the room(s) where medicines are stored appear to be “warm”, then take daily temperature readings for 2-3 months (e.g. over the summer months) to see if the temperature is consistently above 25 degrees centigrade.

If so, address the problem by the use of an air conditioner or storage in a cooler place. Take more sample temperatures to confirm the problem is solved. Keep the temperature logs as evidence, then stop recording room temperatures.

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In detail

Some care homes keep a daily log of room temperatures where medicines are stored. They might have been told to do this by their supplying pharmacy or a care inspector.

This might not seem like much work when medicines are stored centrally in one room, as you can just check and record the room temperature when you check the fridge temperature (we definitely advise you record the daily minimum and maximum temperature in the fridge).

However, increasingly care settings are storing each person’s medicines in their bedrooms. So with a 90-bed care home, that would mean checking and recording 90 thermometers each day. Is this really necessary?

Expiry dates, and storage conditions

Most medicines come with directions from the manufacturer to store below 25C. Some state store below 30C. When you look at temperature logs in those care homes that have been recording room temperatures, they are mostly below 25C, but they may spend the odd day at 26, 27 or maybe 28C during the summer months. Is this a problem? Let’s look at some background here.

Medicines slowly start to break down and degrade after they are manufactured. For most medicines it takes years for them to break down and become less active. When they reach a certain percentage of their initial activity (say, 90%) that’s when the expiry date is set.

So (for example) if aspirin is manufactured in Jan 2010, and 5 years and 3 months later, it degrades to 90% activity, then the expiry date is set at April 2015. If you were to take this aspirin in December 2015, it might only be 89% active. By the way, these aren’t exact figures, they are just used to illustrate the principle. The key point here is that the aspirin doesn’t go from 100% active to 0% active at midnight on the expiry date!

The rate of breakdown of the medicine is usually affected by heat and humidity. Basically, the hotter and wetter it is, the quicker the medicine breaks down. Going back to the aspirin example, if aspirin was stored at say, 32C for 5 years and 3 months it might be only 75% active at its expiry date. Again, these aren’t actual figures, they just illustrate the point.

What’s important is the length of time that the medicine is stored at these higher temperatures. Spending just a few days of the year at these higher temperatures is unlikely to affect the medicine in any clinically significant way.

Pharmacies don’t routinely record room temperatures

Pharmacies do not record daily room temperatures, and the medicines can sit on a pharmacy shelf for years. This point has been recently checked with the pharmaceutical inspectors from the General Pharmaceutical Council. The only settings that requires a daily log of room temperature are pharmaceutical wholesalers.

So if pharmacies don’t do this, why do care homes record room temperatures for medicines that are usually just stored for a month (or a few months for when required medicines or homely remedies)? It makes no sense.

What do NICE guidelines and CQC say?

NICE guidelines don’t really help. On pages 23-24 of the full 223-page care guidelines [1], we have:

Recommendation 1.12.2:

“Care home providers should include the following information in their process for storing medicines safely:”

3rd bullet point:

“- the temperatures for storing medicines and how the storage conditions should be monitored”

Then later on page 130, we have:

“storage temperatures and monitoring (fridge 2–8°C, room usually no more than 25°C)”

Note the use of the word “usually”.

CQC have not issued any advice on this and they should follow NICE guidelines.

So what is our advice?

Our advice is to follow the same rules as pharmacies. Interestingly, this is what the Care Inspectorate in Scotland advise their care homes do [2]. They state:

“The requirement to monitor room temperatures is only an issue if the room appears to be “warm”. This might be the case, for example, if the room was next to the kitchen, contained a cupboard with a hot water tank, was consistently warmed by sunshine through a window etc.

If the main medicines room falls into this sort of situation, or if there is any doubt about the temperature of the room, it would be recommended that daily temperature readings are recorded for a sustained period (e.g. 2-3 months) to ascertain if the temperature is consistently above 25 degrees.

If the main storage area is found to be consistently above 25°C measures such as the introduction of an air conditioner should be implemented by the service in an attempt to control the problem.

While some medicines will be unaffected at temperatures consistently above 25°C, others, however, will not. If the service is in any doubt about which medicines may be affected they should contact their supplying pharmacist for advice.”

The question of course will then come, what is meant by consistently? Let me give you my opinion as an experienced pharmacist and say (for the sake of clarity) more than 5 days a month above 25°C.

We then advise that you keep these temperature records to show and inspectors that the problem has been checked, monitored and (if needs be) addressed. You are then satisfying NICE guidelines.

Then, stop taking the room temperatures and focus on caring for your clients.

If you want more information or want to discuss how this might affect you, call us (01273 917210), email us or click here to find out about our open workshops running this month.

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References:

[1]          Managing medicines in care homes. Published 14 March 2014. http://www.nice.org.uk/guidance/sc/SC1.jsp.

[2]          The temperature requirements for medicines storage. Health Guidance. The Care Inspectorate. Publication date: March 2016. http://www.careinspectorate.com/images/documents/1915/Temperature%20Reqs%20for%20Medicine%20Storage_HCR0316099.pdf