Running Your Business
Warming to cold chain management
Tucked away in the dispensary, pharmacy fridges need to provide an optimum environment for storing volatile or high-value medicines and vaccines, including insulin, antibiotic liquids, injections, eye drops and some creams, at a constant temperature of between 2ºC and 8ºC.
The CQC’s guidance around finding out if a product needs to be stored in the fridge is simply to check the packaging, refer to the patient information leaflet, or visit the electronic medicines compendium (medicines.org), but the process doesn’t stop there. It involves a lot more than simply putting these drugs in any old fridge, turning it on and shutting the door. Refrigerated products need to arrive at the right temperature, having travelled in the same conditions in which they need to be stored to ensure their quality and efficacy.
Often referred to as cold chain products or fridge lines, wholesale dealers are expected to store and distribute them in strict accordance with the product labelling requirements, as stated in the EU Good Distribution Practice Guidelines, of which chapters 5.5 (Storage) and 9.2 (Transport) give more information, says the MHRA (Medicines and Healthcare products Regulatory Agency).
On arrival at the pharmacy, the person responsible for receiving the delivery must satisfy themselves that the goods have been transported under appropriate conditions. For example, there should have been no direct contact between the products and gel or ice blocks. If the consignment is warm to the touch, transfer the products to the pharmaceutical refrigerator immediately.
The General Pharmaceutical Council's (GPhC) Standards for Registered Pharmacies (standard 4.3) requires delivery services to have arrangements in place to protect thermolabile (temperature-sensitive) medicines and controlled drugs. Worryingly, however, its latest inspections report highlights that standard 4.3 was the one least likely to be met and the top reason for this was refrigeration issues.
If it appears that the products have not been transported under appropriate conditions and their quality may have been compromised, the MHRA says the delivery should be quarantined in a suitable refrigerator while enquiries of the supplier are made. If there is still doubt as to their quality, the delivery should not be accepted and returned to the supplier.
- Ensure fridges are accessible only to authorised staff
- Site fridge in well-ventilated area away from heat sources
- Do not store large amounts of medicines. This can lead to inadequate airflow and potential freezing
- Regularly check the dates of the contents of your fridge and rotate stock according to your policy
- Clean and defrost fridge regularly and keep dated records
- Service the fridge at least once a year. The maintenance contract must include temperature gauge calibration and portable appliance testing
- Make sure you know how to use and read your thermometer. If in doubt, ask the manufacturer for guidance
- If using a digital thermometer, make sure the probe is in a suitable position, for example inside a box of medicine
- Ensure fridge has space around it for air to circulate
- Delegate the task of taking daily maximum and minimum temperature readings to a trained member of staff
- If temperature is regularly outwith normal range, review the procedure and ensure the fridge is working correctly
- Use a switchless socket or clearly label the plug with a cautionary notice not to switch it off
- Ensure the pharmacy has an emergency power supply if there is a power cut, ideally for a minimum of 24 hours.
The regulator's line
While there are no specific professional regulations governing the use or management of pharmacy fridges, the GPhC standards require the way in which pharmacy services are delivered to safeguard the health, safety and wellbeing of patients and the public. This includes management of medicines and medical devices (standard 4.3), which requires medicines and medical devices to be stored securely, supplied to the patient safely, be obtained from a reputable source and be safe and fit for purpose.
The regulator also requires equipment in a registered pharmacy, including fridges, to be stored securely, be safe to use and fit for purpose, be obtained from a reputable source, be safeguarded from unauthorised access and appropriately maintained.
Even the smallest 45 litre medical fridge can contain up to £30,000 worth of drugs (based on a seven day course of enzyme replacement therapy for patients being treated at home), so the temperature at which medicines are stored is vital to maintain their quality and offer maximum protection to the end user. If the contents are spoilt, the resulting wastage can be very costly.
Pressure to reduce operational expenses may make it tempting to cut costs when it comes to investing in pharmacy refrigeration, but standard domestic refrigerators are not suitable for storing cold chain products because of uneven temperature distribution and a wider normal operating range of between 0ºC and 10ºC.
The MHRA specifies that a pharmaceutical refrigerator is required for the storage of refrigerated medicinal products. The air within this type of refrigerator is circulated by a fan, which provides a uniform temperature profile and a rapid temperature pull-down after the door has been opened. Temperature monitoring is recorded by a calibrated electronic minimum/maximum thermometer, with an accuracy of ±0.5°C, which can be read without opening the refrigerator door.
As with transportation, the MHRA says products stored in a medical refrigerator should be subject to daily temperature monitoring by a minimum and maximum calibrated device that has a supporting appropriate calibration certificate.
Medical fridges are specially designed to maintain an internal temperature between 2ºC and 8ºC and, unlike domestic fridges, they come with a variety of features to ensure they remain at that constant temperature. All have an integral digital controller with an external LED digital temperature display, which makes it easier for pharmacy staff to monitor the internal temperature without having to open the door.
GPhC’s inspection decision-making framework expands on how pharmacy owners can meet standard 4.3, which includes carrying out regular fridge temperature checks and demonstrating that appropriate storage conditions have been maintained.
The MHRA suggests this involves:
- Taking temperature records to identify any temperature deviations and give details of corrective actions taken as a result
- Where there has been a temperature deviation, best practice would be to take a further reading later the same day to ensure that it was a transient deviation and show that the temperature is now back within prescribed parameters
- The responsible person should be informed of any deviations
- The records should be routinely reviewed and signed off by the responsible person.
If the temperature of the fridge strays outside its set parameters, then pharmacy staff need to be alerted instantly. Good quality medical fridges come with a variety of alarms, including audible and visual warnings for high and low temperatures and a simple ‘open door’ alarm, which ensures the contents of the fridge are safe and secure by alerting pharmacy staff if the door has been left open for more than two minutes.
The MHRA also offers some more general guidance about refrigeration best practice.
- Products should be stored in an orderly fashion on shelves – not directly on the floor of the unit – to ensure air circulation and consistent temperatures throughout and facilitate cleaning
- Calibrated temperature monitoring probes should be sited in a central location within the refrigerator and preferably between the products
- Probes should not be placed in the refrigerator door
- The refrigerator should be cleaned regularly (as part of a general cleaning rota) and serviced at least annually
- If the refrigerator is fitted with an audible or visual alarm, this should be routinely tested to confirm correct operation at specified appropriate temperatures
- The stock within the refrigerator should be subject to effective stock rotation based on first expiry, first out
- It should not be assumed that the most recent deliveries will have a longer expiry period
- Refrigerators containing medicinal products must not be used for the storage of food and drink or anything that might contaminate the medicinal products.
In addition, medical fridges should be fully lockable to ensure the contents remain secure and to prevent any illicit entry. Having a sturdy lock with two keys not only limits access to those with responsibility to handle the contents, it helps prevent unauthorised access to potentially dangerous substances. Adequate locks also mean the pharmacy fulfils the requirements of its insurance policy and prevents liability for any damage or harm done by someone opening the fridge and removing the contents.
What happens when the storage conditions are breached?
As with cold chain delivery breaches, the Royal Pharmaceutical Society advice for products that have been stored outside their recommended refrigerator temperature (2-8°C) in the pharmacy – perhaps due to a power cut or the refrigerator door being left open – is that pharmacists contact the relevant manufacturer with details of the batch number, expiry date, storage temperature and the length of time the product has been incorrectly stored.
RPS professional guidance on the safe and secure handling of medicines adds that there must be a policy and procedures in place that outline the actions to be taken if there is a temperature excursion outside the range specified for the medicines being stored. There must also be assurance that the procedure is followed and any decision to store a medicine or use a medicine that has been stored outside the manufacturer’s recommended temperature range should be fully risk assessed.
MHRA advice about handling cold-chain breaches in pharmacies is to:
- Quarantine the products, label them “Do not use” and communicate the incident to staff
- Record the details of the adverse conditions, including the range of temperatures and duration
- Assess each product and dispose of those that have been rendered unsafe (err on the side of caution)
- Document your actions.
Advice to patients
Customers and patients rely on your pharmacy as the final part of the cold chain for their medicines. You have a professional duty to supply medicines that are fit for purpose. Be ready to give information to customers about any special storage conditions for their medicine at the point of sale or dispensing, and explain what improper storage could look like and result in.
Similarly, cold chain breaches can mean delays for patients who need refrigerated medicines and vaccines, so you need to be prepared to communicate and apologise about any incidents of this kind.
Refrigeration round up
Given the importance of medical refrigeration, it pays to source from a reputable manufacturer that supplies quality products and offers a nationwide network of service engineers in the event of breakdown.
When purchasing a new refrigerator, factors to consider might include how long the unit can maintain the required temperature if the power is turned off, and to what extent the temperature is affected by external ambient temperature variation, for example in hot spells. Cost-wise, as with ordinary domestic appliances, prices range from hundreds into the thousands, depending on the size and specifications of the refrigeration unit required.
Details of different systems are included here, but with product development moving fast, readers are advised to check company websites for the most up-to-date specifications and support.
Key refrigeration lines: temperature-controlled light commercial vehicles and Melform Koala top and front opening portable refrigerators from 21 to 1,115 litres capacity. Special features: total compliance with the cold chain at all stages of transport. Can be transported using conventional vehicles. Quality assurance: ISO 9001 accreditation.
Key refrigeration lines: solid and glass door medical refrigerators in a range of sizes. Special features: entire range has 24/7 automatic temperature data logging with minimum/maximum temperature recording and display and R600a environmentally friendly refrigerant. Five year parts and labour warranty.
Key refrigeration lines: Calibrated thermometers and data loggers, pharmacy fridges. Special features: five year warranty (depending on model). Quality assurance: conform to all aspects of BS EN ISO9001:2015 international standard for quality. Electronic controlled drug register, cold chain temperature monitoring solution, new range of original pack MDS trolleys.
Key refrigeration lines: pharmaceutical environmental monitoring systems, medical fridges and freezers and cold chain storage areas. Special features: 24/7 automated alarm and recording tools that meet national regulatory compliance across key statutory requirements and guidelines, such as FDA 21 CFR Part 11.
Key refrigeration lines: pharmacy range includes the new touchscreen IntelliCold with 24/7 data recording and Advanced range with stainless steel interiors and free UKAS calibration certificate.Special features: offers maintenance contracts and calibration in the field. Quality assurance: holds ISO 9001 and ISO 13485 and is an accredited UKAS Temperature Calibration Laboratory No.8898.
Key refrigeration lines: pharmacy refrigeration including freestanding, under-counter and countertop models as well as associated products and services. Special features wifi enabled units with dual temperature monitoring systems for accurate temperature precision. Free two year parts and labour warranty. Quality assurance: ISO 9001, 50001, 13485, among others.
Key refrigeration lines: Solid and glass door medical refrigerators in a range of capacities from 45 to 544 litres. Special features: bespoke models can be accommodated. Quality assurance: accredited by Alcumus to ISO9001:2015. all NPA members can access Shoreline pharmacy refrigerators directly from EMT Healthcare.
White Horse Scientific
Key refrigeration lines: cold storage solutions, including fridges, freezers, ULT freezers and wireless temperature monitoring solutions. Quality assurance: ISO9001. GRAM high performance refrigerator and freezer equipment.
- Visit www.pharmacyregulation.org for GPhC standards for registered pharmacies.
- RPS guidance on the safe and secure handling of medicines can be found at www.rpharms.com. Members can call RPS Support on 0845 257 2570 or 020 7572 2737 (Monday to Friday, 9am to 5pm) for information about individual products.
- Pharmacists can also seek advice on appropriate medicines storage from UKMi, the NHS medicines information service
- CQC guidance on medicines that require fridge storage is available at www.cqc.org.uk.
Feature by Sasa Jankovic
This module highlights a new opportunity to treat heartburn and reflux in the pharmacy with Omeprazole 20mg, which is newly available for customers to purchase OTC.