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Refrigeration Guidelines

Are you storing your vaccines correctly?

The Royal Pharmaceutical Society's Code of Ethics sets the industry guideline that all medicines that require refrigeration are stored between +2°C and +8°C. However, thousands of community pharmacists as well as doctors, vets, dentists and others within this area of medical expertise have not invested in a professional pharmacy refrigerator, which can achieve this specified temperature range.

The NPA cite reluctance to pay the high price and the fact that refrigerated storage is a low priority, as the main reasons for these pharmacists not investing. In doing so these pharmacists, doctors, vets, dentists and medical professionals are risking the quality of their stock and are failing to provide good quality healthcare for their customers.

Domestic vs Pharmaceutical Refrigerators

Many pharmacists, doctors, dentists, vets and other medical professionals are storing medicines in standard domestic fridges. Whilst these units are cheaper to purchase and can store household and basic goods at a suitable temperature, they are not built for the storage of vaccines and other medicines. Domestic refrigerators are designed to sustain a temperature between 0°C and +10°C. The difference is slight, but the few degrees can have drastic effects on your stock. At 0°C vaccines freeze and become deactivated, whilst at temperatures in excess of 8°C their potency may be compromised.

The main reasons for this variation in temperature is that standard domestic fridges have static air - the temperature at the bottom of the refrigerator is always cooler than the air at the top - so monitoring the internal temperature of the cabinet is difficult. There are numerous features on professional, specially designed, pharmacy refrigerators that overcome these problems. They are calibrated and factory set in order to ensure the internal temperature is between +2°C and +8°C. Their design also ensures a uniform temperature range across the cabinet as well as giving rapid temperature pull-down after the door has been opened.

Additionally, they are fitted with a digital minimum/maximum memory display, which assists continuous temperature monitoring. As an added safety option these refrigerators have an audio and visual alarm system to monitor temperature fluctuation should it stray outside of normal operating parameters.

Recommendations for Good Practice

Recent research has shown an alarming level of use of domestic refrigerators to store vaccines. Did you know that not only can this damage the efficacy of the vaccines it also poses a security risk for medicines which should be locked away.

The storage of vaccines and other refrigerated medicines has never been more topical. A recent newspaper investigation revealed that drug thefts in the National Health Service are at epidemic proportions. Security is not the only important issue as insufficient maintenance and poor quality storage mean that delicate materials are stored at incorrect temperatures and are being damaged as a result.

A recent investigation by the Sunday Epress revealed that more than £10 million worth of Class A and prescription strength narcotics are ending up in the hands of street dealers. The article went on to reveal that a typical inner city hospital "losses" are in excess of £100,000 worth of pills, tablets and vials every year. Obviously, not all of these narcotics are stored in refrigerated units, but the installation of a professional unit, from a recognised supplier, would help reduce theft as all units are fitted with secure key locks.

The NPA represents over 90% of community pharmacies and recommends that fridges for the storage of vaccines must meet the following criteria:

Should only be used for the storage of pharmaceutical products and medicines, which require refrigeration.
Maintain the stored pharmaceuticals within the temperature range +2°C and +8°C.
Have a means of indicating the temperature of the products stored in the refrigerator.
Have the means of recording the maximum and minimum temperature in the refrigerator.
Must be capable of automatic defrosting.

In addition to the above points, the NPA recommend the following guidelines with regard to the use of the refrigerator:

The refrigerator must be regularly cleaned. It must be filled in accordance with the manufacturer's gudelines. The operating temperature range of the refrigerator must be monitored at regular intervals. Good practice would be to check and record the maximum/minimum temperatures of the refrigerator on a daily basis, on each day that the premises are open. The units should also be secure and fitted with a key lock.

Obviously, we're all aware that there is no governmental or legal requirement for pharmacists, doctors, vets, dentists and other medical professionals to use a professional refrigerator. However, if faulty or damaged goods were issued and the customer were to complain, or worse still, fall ill as a result then the drug company who supplied the product would be able to protect themselves. They could easily show evidence that they provided adequate chilled storage from the drug's initial creation to its delivery to your store - they would have sustained the 'cold chain'. Could you be so sure that you had stored the products correctly?

Refrigerators should be located in areas that are well ventilated and do not exceed 38°C ambient air temperature.

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