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Cold and temperate chain compliance – who’s ‘responsible’?


13 Oct 2011

There are two critical temperature ranges:

  • 2-8 °C is known as the cold chain and these products require refrigerated storage and transportation
  • the temperate chain, which applies to all pharmaceuticals that require storage at 25-30 °C.

Studies have shown that many medicines degrade when stored above this range. For every 10°C increase in temperature it has been shown there is generally an exponential increase in the rate of oxidation or hydrolysis. This is especially true for antibiotics like cefalexin, but even substances like aspirin are similarly affected. It is therefore no surprise that the safe storage of medicines is such an important issue.

The MHRA has reported that in the month of October 2010 in the fifty inspections it carried out in wholesale pharmacies, 24 per cent had temperature control and monitoring deficiencies, 50 per cent of which were considered major deficiencies. This is really no surprise, since temperature controlled storage has topped the MHRA league of deficiencies seen in wholesale pharmacies since 2001. The question is, what can pharmacists do to solve this problem?

Using refrigeration properly
As with retail pharmacists, the sensible thing is to use refrigeration properly. There are purpose built pharmacy refrigerators, so why use a domestic? Domestic refrigerators are very good at storing food and are designed to efficiently store their contents at between 0-5°C. However, this means that most of the chamber inside the refrigerator is 2°C below that recommended for cold chain pharmaceuticals. This two degrees variance can result in freezing, which renders most of the active ingredients in a medicine inert. The effect of freezing on the potency of vaccines is well documented. This is why, unlike a domestic counterpart, a professional pharmacy refrigerator is designed to operate at 5°C in order to protect expensive contents from freezing. In addition, they should have an internal fan to ensure an even distribution throughout the fridge and rapid temperature recovery after any door openings. The temperature is also very tightly controlled by a microprocessor programmed to maintain the temperature between 2-8°C, but usually around a set point of 5°C.

But it is not just the temperature range that makes the purpose built pharmacy fridge such an asset to both retail and wholesale pharmacists. Responsible pharmacist regulations and the MHRA require proof that pharmaceuticals are stored correctly and ‘action’ taken should a temperature deviation be experienced4. Most pharmacy refrigerators will alarm in the event of a temperature incursion and have built-in thermometers which will display the minimum and maximum temperature inside the fridge since the last reset.

 Minimum/maximum displays allow records to taken and kept as proof that products have been stored as per their marketing authorisation. However, it is even more helpful if the fridge has a built in temperature logger. Then, if for any reason records are not taken on a particular day or you want to establish the performance of the fridge prior to temperature mapping or after an incursion, you can secure objective, accurate evidence of the temperatures quickly and with the minimum of disruption. It can also act as proof of action taken to resolve a temperature issue. This lack of ‘action’ was something which concerned the MHRA when inspecting wholesale premises, but with an integral data logger built in to the refrigerator, the maximum/ minimum issue ceases to be a time consuming problem. In addition, the responsible person is never in the position where they have no evidence of at least attempted compliance. However, with some pharmacy refrigerators the temperature cannot be taken if the refrigerator is mains powered and a disruption in the electricity supply occurs. Unlike the majority of domestic refrigerators, good pharmacy refrigerators come complete with an alarm battery back up. This allows the alarm to sound and the temperature to be recorded despite the lack of power. It can even be argued that without this feature you may not notice that a problem has occurred until you next come to reset the refrigerator. By then, stock will have been sold and used in good faith. Used in conjunction with integral data logging, you can track the power cut and see exactly how long the fridge was without electricity and what temperatures were experienced within the chamber. This also has the advantage that you can tell the manufacturer all the details and maybe salvage valuable stock.

The temperate chain
When it comes to the temperate chain it could be claimed that other than precise climate control, nothing can really assist the pharmacist. But, this would mean that the whole premises would have to be temperature mapped to be completely compliant for MHRA purposes. This is not a problem if your operation is large enough, however, for the smaller wholesaler or retailer an easier solution may be a refrigerated cooled incubator. Designed to store contents at or above room temperature at a constant temperature, an incubator can be easily mapped, calibrated and have an integral minimum/maximum temperature recorder and alarm.

Whether a retail or wholesale pharmacist, it is clear that controlled temperature storage is of increasing importance and regulators are looking for a ‘responsible’ person to ensure that safeguards and SOPs are in place and followed correctly. This can be daunting, but the use of purpose built specialist refrigeration can save both time and money. Time, because all the records you need are either stored in the fridge or can be seen at the touch of a button. Money because not only do insurers often refuse to pay if a domestic fridge is used for commercial purposes, but because these units are built for the pharmacy they are extremely robust and designed to alarm immediately if the temperature goes out of range. This provides you with valuable time in which to save stock. In addition, annual maintenance and calibration contracts are usually available for extra peace of mind and MHRA compliance.

When considering the issue of controlled temperature storage of both cold and temperate chain pharmaceuticals, pharmacists need to be aware of the regulations surrounding their particular circumstances. However, they can be confident that if they purchase purpose built refrigeration for this controlled temperature storage the bulk of the record keeping can be performed by the unit itself, allowing the team to record relevant data by just looking at the refrigerator or incubator, freeing the responsible person or pharmacist to be responsible.

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 n Reset the thermometer following the manufacturer’s instruction
  • Where the temperature falls outside of the 2 to 8 degrees 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,
Sales and marketing director
of Labcold

References
1. Crichton. B, Keep in a cool place: exposure of medicines to high temperatures in general practice during a British heatwave. Journal of the Royal Society of medicine, July 2004. www.ncbi.nlm.nih.gov/pmc/articles/PMC1079525
2. MHRA, Good Distribution Practice: Frequently asked Questions, www.mhra.gov.uk, 2010
3. MHRA, op cit
4. MHRA, Review of GDP Deficiencies, www.mhra.gov.uk
5. MHRA Appendix 1 Control and Monitoring of Storage and Transportation temperatures p30, www.mhra.gov.uk

Further reading

  • Todd, S. Refrigerated medicinal products: what pharmacists need to know, The Pharmaceutical Journal volume 281, 2008.
  • MHRA, Good Distribution Practice: Frequently asked Questions, www.mhra.gov.uk.
  • Taylor, J. Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products, The Pharmaceutical Journal volume 267, 2001.
  • European Commission guidelines on good distribution practice of medicinal products for human use (94/c63/03).

Further information
For full information on the Labcold range of pharmacy fridges, all fully conforming to relevant regulations and guidelines including the DH Green Book and the RPSGB/GPhC recommendations, please visit www.labcold.com, or contact sales@labcold.com, telephone 0870 300 1001.


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