ARE YOU STORING YOUR TOXINS CORRECTLY?

Lec Medical’s senior technical manager Colin Burgess explains best practice for storage of botulinum toxin

As a neurotoxin, botulinum toxin should be stored like other medical product, such as vaccines. The need to refrigerate cosmetic injectables is printed on product packaging by manufacturers and supported by major distributors. What this means in practice is set out in the Code of Practice and Guidance for Practitioners Who Provide Cosmetic Interventions, drawn up by the Joint Council for Cosmetic Practitioners (JCCP) in partnership with the Cosmetic Practice Standards Authority (CPSA). Its guidelines, which every reputable practitioner should follow, echo those set out in the ‘bible’ for medicine storage, the NHS Green Book.

They state that botulinum toxin should be stored in a wellmaintained medical fridge, with a temperature gauge and a lockable door, and that the fridge temperature must be audited and recorded. Additionally, all storage, prescription and dispensing of botulinum toxin must be recorded by an accountable officer. The crucial factor is the stipulation of a medical fridge. It is the only product that can deliver the controlled conditions, monitoring options and safety mechanisms required to ensure secure and safe storage of cosmetic toxins.

There is some debate around the need to refrigerate botulinum toxin, with research by L. Parraga et al indicating that it could remain stable for 14 days at 25°C and seven days at 30 °C.

This is good news in the event of a transportation breakdown or other unforeseen one-off incident that leaves toxin stores exposed to higher temperatures. However, it should not be the overriding factor which informs your everyday storage processes.

The long-term impact of inadequate storage of botulinum toxins remains unknown, so the risk of an inadequately stored product becoming unstable could increase over time. It is this unknown risk which should guide your storage practices if you want to deliver a best-practice service to your customers.

Best practice guidance is universal in stating that you should store your botulinum toxin in line with other cold-chain products, meaning it must be stored within a controlled temperature of between 2°C and 8°C, and never frozen.

This temperature range is guaranteed to keep the molecular structure of the toxin stable and prevent the development of harmful bacteria. A temperature which is too high (or too low) runs the risk of degrading the toxin over time, reducing its effectiveness as a muscle relaxant.

It is a common misconception that a standard domestic fridge is suitable for storing these highly sensitive – and expensive – products. This is not the case.

Use anything other than a medical fridge and you run a similar risk of reducing the efficacy of your botulinum toxin as leaving it out and so delivering a sub-standard service to the people who have paid for cosmetic treatments.

This is in direct conflict with the first key responsibility listed in the JCCP/CPSA code, that practitioners must ‘promote the safety and wellbeing of patients/clients and promote public trust and confidence and not to bring the profession into disrepute’.

Wasted toxins can be costly, so the fact that botulinum toxin should remain stable in the event of cold chain failure is good news. However, the potential legal costs and reputational damage that could be caused in the event of a treatment being flawed due to the use of an ineffective product are equall if not more.

The Save Face industry organisation reports a record number of complaints being made about non-surgical cosmetic procedures – so any perceived failure of service is unlikely to go unnoticed or unchallenged by patients or clients.

The only way to ensure the efficacy of the toxin and mitigate any risk is to store it within the accepted guidance.

STORING TOXINS FOR SAFETY AND EFFICACY

The NHS Green Book provides the foundation for the accurate storage of cold chain products.

The golden rule is that a medical fridge must be reserved exclusively for the storage of botulinum toxin and other cold chain products – so as not to be used to store anything that might present a contamination risk, such as food or drink. It should be sited in a well-ventilated room which is maintained between 10°C and 25 ̊C, away from external windows and all heat sources such as radiators or direct sunlight, and at least 5-10 cm from walls and other units.

The fridge should be filled to no more than 75% capacity to allow adequate air circulation, and stock should be stored according to first expiry. It must be kept clean and serviced regularly, according to the manufacturer’s instructions.

Finally, fridge temperatures should be recorded twice per day by a named and accountable staff member.

When checking the fridge temperature, the NHS Green Book states that the four ‘R’s should be observed:

• Read – Check temperature at the same time daily and sign the sheet when completed.

• Record – Record temperature in standard fashion on a temperature monitoring chart.

• Reset – Reset the temperature after each reading.

• React – React if the temperature falls outside +2°C to +8°C

Stored correctly, refrigerated, and unopened, 100U vials of toxin will last for up to 36 months and 200U vials for up to 24 months. Reconstituted botulinum toxin is generally considered to be safe for use in refrigerated conditions for four weeks, though it is important to note that multiple withdrawals of the toxin could result in contamination and risk to patients.

Azzalure’s shelf life in temperatures of 2° to 8°C is two years. Once reconstituted the recommended storage time before use is 24 hours maximum, though the advice is that any unused toxin should be destroyed after use.

CHOOSING THE RIGHT REFRIGERATOR

A medical refrigerator will take the pressure off a busy practice wanting to achieve the highest professional standards.

Products, such as Lec Medical’s Pharmacy Plus range, employ Bluetooth technology to enable completely contactless temperature readings, using air and load probes for accurate measurement.

An intelligent fan management system prevents warm air being sucked in when the door is open and automatically restarts when it closes, ensuring temperatures remain stable, while a power failure alarm with battery backup and rechargeable battery offers peace of mind.

Advanced medical refrigerators allow reports to be scheduled remotely and downloaded directly to a mobile device, allowing for remote diagnostics by engineers and reducing the potential for appliance failure.

The cost of a medical refrigerator does not need to be prohibitive – there is a wide choice of size and capacity levels, from as little as 47 litres up to 400 litres.

The CPSA/JCCP Code of Practice was created to bridge the gap until the proposed regulation of the aesthetics industry comes into force when using a medical refrigerator to store toxins is likely to become a requirement rather than a choice.

When you also consider the potential cost of wasted products and, worse, delivering a sub-standard treatment that could damage patients’ health and your professional reputation – the time is right to ensure your botulinum toxins are stored safely. www.lec-medical.co.uk