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Although the storage of medicines in community pharmacies falls outside the remit of the Medicines and Healthcare products Regulation Agency (MHRA), current advice is that pharmacies holding MHRA licences should store medicines according to the requirements of Good Distribution Practice and those set out in the Summary of Product Characteristics (SPC).
The Royal Pharmaceutical Society has issued professional guidance around storage and the Care Quality Commission has produced a summary of guidance on vaccines. The General Pharmaceutical Council says it’s up to pharmacy owners and staff to determine the risks and what they need to do to meet the required standards. GPhC media and public affairs manager Claire Haigh says: “Our Guidance for Registered Pharmacies Providing Pharmacy Services at a Distance, Including on the Internet is available.”
Vaccine storage guidelines 2022
In May this year, the UK Health Security Agency published updated guidance about ordering, storing and handling vaccines in Immunisation and Infectious Disease (‘the Green Book’). Being stored outside the recommended temperature range, including during transport, may speed up irreversible loss of potency. Therefore, pharmacy staff should:
- Store according to the SPC (usually between 2˚C and 8˚C) and protect from light. Transfer to a fridge promptly after delivery
- Rotate stock– use the shortest expiry date first.
At least two designated members of staff who have received appropriate training should be responsible for vaccines. However, all members of the team should understand the importance of good vaccine management.
The Green Book also gives detailed guidance on vaccine fridges, including:
- Store vaccines in a validated fridge specifically designed for pharmaceutical products. Do not use a domestic fridge
- Use it to store pharmaceutical products only. Do not store food or clinical specimens alongside vaccines
- Maintain the temperature between 2 and 8˚C. Keep the fridge secure – locked or in a locked room. It should only be accessible to authorised staff
- Reduce the possibility of accidentally interrupting the electricity supply (e.g. install a switchless socket or label the plug with a cautionary notice: ’Do not unplug/switch off’)
- Use a fridge large enough for air to circulate around the vaccine packages
- Keep the fridge clean with no ice build-up. Make sure you follow the manufacturer’s servicing recommendations, calibrate the temperature gauge and include it in portable appliance testing.
Cold chain policy
All providers should have a policy which includes how to handle vaccines to maintain the cold chain, from the point of delivery to administration. The policy should include transport of vaccines, actions to take in the event of a breach in the cold chain and details of how to ensure learning from cold chain incidents. Temperature monitoring should follow the Green Book guidance – ‘the four Rs’. The person making the recording of the fridge temperature should:
- Read the temperature at least once every day during the working week and sign the temperature record sheet
- Record it in a standard fashion and on a standard form to include: current, maximum and minimum readings
- React immediately if the temperature falls outside 2 and 8˚C
- Reset the thermometer after each reading.
Ideally, a second thermometer, independent of the integral thermometer in the fridge, should be used to cross-check the accuracy of readings. It will also monitor the temperature if the electricity supply to the fridge is interrupted. Pharmacies can use a data logger in the vaccine fridge, but must still:
- Read and record temperatures on the integral fridge thermometer (minimum, maximum and current)
- Reset the min/max thermometer.
Digital solutions
Power outages or faults in pharmacy fridges can prove expensive, so Remote Monitoring Ltd has devised a solution. Its wireless refrigerator temperature monitoring system doesn’t need specialist installation, but simply uses sensors placed inside the fridge to keep a constant record that’s sent to the cloud via a base station capable of supporting multiple sensors. In the event of power failure or equipment malfunction resulting in temperature fluctuation, RemoteM generates an immediate SMS, email and/or voice call notification to designated individuals; data can be accessed and analysed remotely. It uses battery-powered wireless communication, so does not rely on local wi-fi or IT systems.
“Hard-pressed staff are still being taken from key duties during an audit to check fridge temperatures”
The system, which can be calibrated to monitor products stored at ambient temperatures, as well as stock in transit, is available on a pay as you go basis based on the number of units monitored.
With regulatory authorities increasing site inspections following the pandemic, pharmacies should be considering automatic monitoring, mapping, calibration and validation solutions to ensure fridges and freezers are fit for purpose, says Marcus Stacey-Bradbury, UK commercial director of the Ellab Group. “Any extra responsibilities can be a headache for pharmacists, who are busy enough dispensing medicines for customers,” he says. “However, there is no hiding place from a visit by an MHRA or CQC inspector looking for a chink in procedures that could put the public at risk.
“Pharmacies may be creaking under the increasing usage of their services, but hard-pressed staff are still being taken from key duties during an audit to check fridge temperatures, often scrambling around for hand-held thermometers and pens to record the data, which cannot guarantee accuracy.”
The latest mapping, calibration, validation and monitoring solutions can relieve pressure on pharmacy teams by making it easier to identify optimum conditions necessary to meet the standards set for drugs storage. Manual checking can be affected by human error, and pharmacy fridge and freezer doors can be left open, resulting in fluctuations in the mean kinetic temperature (MKT) and products being stored outside of temperature parameters.
Mr Stacey-Bradbury says pharmacies should not rely on validated warehouses and shipping in refrigerated vehicles. “When boxes reach the pharmacy, they might be left at the door for hours before a pharmacy dispenses or delivers to people that are housebound, which means drugs cycling through a range of temperatures. It’s essential they are moved as quickly as possible to a properly calibrated and monitored storage area, such as specialist refrigerators.”
Ensuring medicines are fit for purpose
Pharmacies have a responsibility to supply drugs that are fit for purpose and within the parameters that manufacturers have set. This is where new technology comes into its own – by qualifying protocols and executing them. Documenting the process ensures safety and accurate data and can also highlight any weak links.
Niall Balfour, chief executive officer at Tower Cold Chain, says: “Mass vaccination programmes are the public health achievements of the contemporary world and efficient cold chain management is a key part of this success. The Covid-19 vaccine rollout demanded specialist end-to-end supply chain requirements, from manufacture, storage and transportation to healthcare and pharmacy facilities. With community vaccination centres constructed overnight to cope with demand, an efficient and resilient supply chain which assisted with temperature-controlled technologies became imperative.”
Mr Balfour believes the pandemic highlighted the need for preparedness for distribution, with transport corridors and hub networks becoming a focus for logistics providers.
For specialist packaging providers, innovation played a huge role in meeting the growing trend for smaller shipments after the pandemic, such as direct-to-patient, sample shipment, and last-mile deliveries. “It became clear that the pharmacy market would welcome a smaller solution which offers the same robust, reliable, and reusable benefits, but at a size ideal for manual handling,” Mr Balfour says. “Hence, the Tower KTEvolution – with its patent pending design striking the optimum balance between high performance, durability, and optimised weight.”
The KTEvolution is said to be ideal for the transportation of life science products, including vaccines, diagnostic kits, biopharmaceuticals, samples and solutions, clinical trial kits and any other product requiring a stable temperature environment for transportation.
Labcold says it is currently experiencing very high demand for ‘all things pharmacy’. Its Advanced Pharmacy refrigeration range is made from stainless steel. Available in 150, 650 and 1,300 litre capacities, it is designed with a choice of solid or glass doors. All models feature door locks, digital temperature display, high/low and door alarms with min/max recording, interior light and auto defrost, and either fan or ducted air flow to ensure there are no hot or cold spots. Remote alarm contacts and an access port are optional.
Intellicold Pharmacy Refrigeration models range from 36 to 543 litre capacity. All offer the choice of glass or solid doors and use the Labcold-designed IntelliCold touch screen controller.
These refrigerators have fan assisted cooling, off cycle auto defrost, remote alarm contacts, access ports, interior lights, controller battery back-up, mains fail, door open and high and low temperature alarm with min/max recording and 24/7 data recording which can be downloaded to a computer via a micro SD card. They are also fitted with a secondary (wandering) probe which can be placed anywhere within the refrigerator or as a load probe in product packaging. The main probe records the air temperature, giving the user time to react before the load temperature is affected.
The Labcold range also includes two vaccine carriers of 12 and 19 litre capacity that use Peltier cooling so there is
no refrigerant gas used. These can be plugged into a car’s 12 volt socket as well as into the mains, making them ideal for community vaccinators.
Product specifications
- Key refrigeration lines: pharmacy range includes IntelliCold, with 24/7 data recording, and the Advanced Pharmacy Refrigeration range, with stainless steel interiors and a free UKAS calibration certificate.
- Special features: 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 line: cold storage transportation for the pharmacy market is best suited to the KTEvolution container, providing temperature-controlled protection from -80°C (ultracold) to +20°C (controlled room temperature) for small batch, last-mile shipments in 26 and 57 litres capacity.
- Special features: robust, reliable, reusable. Maintains thermal compliance for 120+ hours, using phase change materials, meaning no energy source or manual intervention is required. All units have 24/7 automatic temperature data logging.
- Quality assurance: ISTA 7D summer and winter temperature profiles methodology.
- Key refrigeration lines: solid and glass door medical refrigerators in a range of capacities, from 45 to 544 litres.
- Special features: bespoke models are available.
- Quality assurance: accredited by Alcumus to ISO9001:2015.
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