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Responsible Pharmacist regulations and the pharmacy refrigerator


13 May 2010

Many pharmacists had already developed standard operating procedures long before this legislation, covering topics such as stock rotation and the prompt refrigeration of temperature sensitive products in line with MHRA guidelines. However, with the new legislation, all this now has to be available for inspection by law. This is where having a refrigerator specifically designed for the pharmacy can make life much easier for both the responsible pharmacist and the rest of the team.

Unlike domestic refrigerators, purpose designed pharmacy fridges are carefully designed to meet both the needs of pharmacists and the safe storage of medicines in line with manufacturers’ instructions. They have many time saving accessories that help to make it easier to adopt standard operating procedures that everyone can work with.

The advantages of a professional pharmacy fridge

The first difference between a fridge designed from the ground up for the pharmacy and a domestic refrigerator is that a pharmacy fridge will have a digital controller. Domestic units usually only have a number between one and five, the highest number being the coldest. When a manufacturer states that a product has to be stored between 2-8C the only way to be sure that you are storing a product at this temperature using a domestic fridge is to get a calibrated thermometer and manually take the temperature. However, how can you be sure that when you’re not taking the temperature it remains constant?

Most professional pharmacy fridges have an internal digital temperature controller that maintains the inside of the chamber at a constant set point – usually around 5C. This will be displayed on the front of the unit giving a busy team the reassurance that all the expensive contents of the refrigerator are well within the manufacturers’ (and the MHRA’s) guidelines and are, therefore, safe for patients. Usually included with the temperature display is an audio visual alarm to alert you if, for example, the door is left open, giving you ample time to restore the inside of the fridge to the correct temperature without losing products or endangering health. If the unthinkable happens, such as a power cut when the pharmacy is not staffed, the fridge will also alarm when the power resumes, alerting you to a potential danger so all the safety procedures regarding the storage of medicines in adverse temperatures can swing into action. 

Storing medicines correctly

The NPA recommends that to be sure that pharmaceuticals are stored correctly the temperature of the fridge should be taken twice daily and records kept for the life of the product stored therein. With a purpose built fridge there will be an integral minimum and maximum recorder. As a result, instead of having to apply a calibrated probe or thermometer to the unit twice a day (which may give an inaccurate reading because by necessity the door would have to be open in order to obtain such a reading) these temperatures will display at the touch of a button and without opening the door, and consequently can be easily recorded. Not only does this lead to easier, more accurate record keeping which requires minimal training, but also constant reassurance that the contents are safe.

But it is not just the controller that can save time and money. The fact that a professional fridge can keep its contents at such a constant temperature, whereas a domestic would be unlikely to maintain such tight temperature control, is something else that separates equipment for professional use from domestic units. Pharmacy fridges usually have fan air circulation which is vital if the temperature is to be quickly restored after frequent or extended door openings.

Opening the door introduces warm air in to the refrigerator, causing the internal temperature to rise. In a professional pharmacy fridge with fan assisted cooling the warm air is cooled very rapidly by the fan which also distributes the cool air throughout the cabinet. There are no hot or cold spots, meaning temperature tolerances throughout the chamber are kept very close to the set point displayed on the front of the refrigerator. Also, as specialist pharmacy fridges do not have door pockets, there is no risk that product can inadvertently be stored in the warmest part of the fridge.

When it comes to stock rotation, a vital part of the safe storage of medicines, most manufacturers can provide divided drawer systems for the fridge. These metal drawers contain dividers so boxes can be separated and kept neatly, making it quick and easy to put the newest items at the back. They will be specially designed to maximise air circulation so that contents loose none of the benefits from the advanced cooling systems within the fridge. In addition, the drawers for pharmacy fridges work on an ‘easy glide’ mechanism so there is no chance that contents once arranged will be disturbed during use. Once the items are stored existing stock can just be moved forward and new stock placed behind it.

When it comes to the neat and documented storage of stock, most manufacturers will offer the option of glass door refrigerators. Obviously, if a unit is to be sited in direct sunlight a solid door model would be recommended but if not, a glass door refrigerator will allow a quick visual assessment of stock whilst minimising door openings They also have the added bonus of turning the necessity of storing stock in to an attractive point of sale feature.

The last time saving feature you will find on a professional pharmacy fridge is an integral lock. This negates the need to keep the refrigerator behind a locked door allowing the contents to be easily accessed during opening hours. In addition, it means that you can be sure who has access to the fridge making it easier to keep the relevant records.

The cost effective option

A recent survey by a specialist manufacturer revealed that almost half of all pharmacies were still not using professional pharmacy refrigerators for temperature controlled storage of medicines. There are many reasons for this, not least the cost of buying a professional model which will be more expensive than a domestic fridge. However, with the need to develop and demonstrate SOPs regarding the safe storage of medicines, a purpose built refrigerator from a dedicated manufacturer will pay for itself in terms of time saved and ease of operation.

The Responsible Pharmacist regulations have made the issue of the safe storage of medicines more important and SOPs and other documentation may also be inspected at some point in the future. A purpose designed pharmacy fridge can take some of the time and effort out of this, freeing up team members for other duties while effectively storing costly stock in a safe, secure and recordable way. So, when it comes to this aspect of the new legislation, a professional pharmacy fridge may be the best part of any storage SOP you can introduce. Available in a range of sizes and configurations, designed to be suitable for all types of pharmacies, these purpose designed models also offer safety, security and temperature conformity levels which no domestic model can match.

The medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 SI 2008/2789

The matters which must be covered by pharmacy procedures included the arrangements for medicinal products to be:

  • Ordered;
  • Stored;
  • Prepared;
  • Sold by retail;
  • Supplied in circumstances corresponding to retail sales;
  • Delivered outside the pharmacy;
  • Disposed of in a safe, effective manner.

NPA SOP – The safe and effective storage of medicines

On a daily basis:

    • Check the fridge temperature and record the maximum and minimum temperature into the fridge temperature chart.
    • Fridge temperature record charts should be retained for the life of any product which has been stored within.
    • Reset the thermometer following the manufacturer’s instruction
    • Where the temperature falls outside of the 2-8C range then assess the maximum length of time the medicines have been exposed to temperatures outside of the recommended range.
    • If the temperature has gone below freezing then stock must be written off and disposed of following NPA SOP: The safe and effective disposal of medicines.

Michelle Rogers, Marketing and Sales Director of Labcold Clinical Services


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