The UK’s National Patients Safety Agency issued a Rapid Response Report earlier this year stating that all NHS departments and independent contractors must ensure that vaccines are continually stored at a safe temperature. Temperature data loggers can make a significant contribution toward meeting those requirements.

The need to maintain a stable ambient temperature in the cold chain has serious implications for the pharmaceutical industry, which has the welfare of the consumer to consider and, in the UK, the stringent requirements of the Medicines and Healthcare Produces Regulatory Agency (MHRA) to fulfil. It is only in January that the NPSA (National Patients Safety Agency) issued a Rapid Response Report stating that all NHS departments and independent contractors must comply with the need to have vaccines continually stored at a safe temperature. This followed the published results of a primary care trust (PCT) audit and NPSA’s own assessment.

The issue

The single biggest issue for those with responsibility for storing pharmaceutical products had always been temperature increases above +25°C, according to MHRA statistics. The situation regarding vaccines is even more critical as their safe storage temperature in order to retain potency is +2°C to +8°C, depending on the manufacturer’s recommendations. It is this latter case that has the been the subject of current debate, following an audit carried out by the Nottinghamshire Primary Care Trust, which was subsequently shared with the NPSA in June 2009. The two-year audit of 96 practices revealed that 40% of vaccines had been stored outside the recommended temperature range.

The NPSA searched its database for all clinical incidents and near misses and found 260 reported problems with vaccine storage between January 2005 and April 2009. During this time, 50 million doses of childhood vaccines were distributed across Britain. Several common themes were identified from these reports, which included delays in the storage of vaccines especially after delivery; storage at the wrong temperature; a fridge being switched off or broken; a power cut or a fridge door left open; no temperature monitoring controls at all; inadequate or missing equipment and, finally, inappropriate use of domestic fridges.

The PCT did a further risk assessment to identify which of the vaccines concerned had the greatest potential for harm. Vaccines known to have been stored below -2°C were considered to be the highest risk and resulted in recall from two practices. The first recall involved approximately 200 children, the second included 360 adults and children. These local findings, together with incidents reported to the NPSA, has made it necessary to highlight the continuing problem and to emphasise how too cold an environment can pose a worse threat. Freezing, for example, can cause hairline cracks in the container, leading to contamination of the contents. The Rapid Response Report calls for immediate action by all NHS organisations whose departments and providers, including independent contractors, hold vaccines requiring cold storage. The deadline for action is 21 July 2010.

Requirements are re-emphasised

The alert calls for all NHS organisations and independent contractors holding vaccines to:

  • Be issued with guidance relating to vaccine cold chain storage. A document called ‘supporting information’ should be consulted. Local policies should include having a designated person and deputy or deputies responsible for receipt and storage of vaccines.
  • Have procedures are in place to ensure correct working practices are being followed, such as reviewing refrigerator temperature regularly to identify if vaccines have been stored outside manufacturers’ recommended temperature ranges before they are administered to patients.
  • Have procedures in place for remedial action where vaccines are stored outside manufacturers’ recommended temperature ranges, and ensure departments and providers are aware of these. Actions may include initial reference to the UKMi fridge database (www. ukmi.nhs.uk/applications/fridge) with subsequent advice sought from NHS medicines information services or the vaccine manufacturer.

There are penalties for failure to recognise your responsibility as a handler of vaccines. The MHRA’s Orange Guide collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It also makes it clear that distributors must comply with the regulations or face penalties if their storage or transportation environment contravenes the requirements in any way. Adverse inspections will result in recommendations for correction and if it is not taken the MHRA can take regulatory action. This may include suspension or even loss, if the offence is serious enough, of a manufacturer’s or wholesale distribution licence.

How data loggers can help

Many errors identified in the report can be avoided using data loggers. Data logging will directly address that part of the Rapid Response Report that states that procedures are "in place to ensure correct working practices are being followed… such as reviewing refrigerator temperature". Data loggers are small, battery-operated, inexpensive units that monitor the ambient temperature surrounding a vaccine or any other pharmaceutical product. Although a thermometer may already be used in a fridge for spot readings, data logging formalises the procedure by being able to record temperatures over a set period of time.

A data logger encourages good habits and highlights the importance of maintaining a stable temperature, pushing it to the forefront of a staff’s mind at all times. It can be set to record at a suitable time interval, for example hourly, and then the information can be easily downloaded and documented when required. Some loggers have an alarm, such as a red flashing light, so that if, for example, a refrigerator’s door is left open and the temperature goes out of range, the alarm will be triggered, alerting the person responsible, who can then download the data to see the fluctuations in temperature and to make a decision on what should happen to the pharmaceuticals or vaccines stored there.

When looking for the right data logger, it is important to look for a specialist logger for use in refrigerators. It is useful to be aware of World Health Organisation (WHO) recommendations in order to maximise the potential of the data logger. Being aware of such recommendations will also help comply with the latest Rapid Response Alert on Cold Storage of Vaccines.

Care should be taken when positioning it in a refrigerator. For example, data loggers that are positioned in the fridge door or near the front of a shelf are more likely to show higher readings and more variations in temperature than one placed at the back of a shelf or at the bottom of the fridge where it is colder. A data logger is best positioned in the middle of a shelf, in among the product being monitored, as this more closely reflects the temperatures they are exposed to.

Ice build-up should not be allowed as this reduces the effectiveness of the vaccine. During defrosting, an alternative refrigerator or approved cool box with a data logger should be used to store vaccines. Temperatures in the refrigerator must be monitored and recorded at least once each working day using a data logger. For no extra effort this can be done more often, for instance every hour, and the data automatically documented on a chart for recording temperatures. Downloading data, in the form of tables or a graph, requires just a few simple steps. Annual calibration checks are recommended, too, so be sure to choose a supplier who will re-certify or advise on a replacement if necessary.

There may be a need to package and transport vaccines to outlying clinics. In this situation, WHO recommends the use of validated cool boxes and ice packs from a recognised medical company. While the vaccine is in transit, the temperature will need to be monitored and a data logger can be packaged close to the packages of vaccines in order to keep a record of any fluctuations. Vaccines must be kept in the original packaging, wrapped in bubble wrap or other insulation material and placed in a cool box with cool packs as recommended by the manufacturers’ instructions. This prevents contact between the vaccine and the cool packs.

In the workplace

Many companies have made it their business to satisfy this important need in the pharmaceutical chain. Logistics companies, specialists in temperature-controlled storage and transportation of pharmaceuticals, have the temperature requirement first and foremost in their minds. In this situation, Tinytag data loggers are used to track temperatures when the goods are in the refrigerated vehicles. Data is then downloaded at the next convenient point and used to verify the temperatures for that period.

Tinytag data loggers have also been used by pharmaceutical manufacturers in warehouses and large walk-in fridges, where temperature-critical vaccines need to be stored at an even temperature. Data loggers are positioned within the warehouse and walk-in fridges and it is part of the staff’s responsibilities to download the data from each logger to identify any fluctuations and what may have contributed to this. Some companies go one stage further and undertake temperature mapping exercises. This is where multiple loggers are placed around a building and set to record over a period of time. This data is then downloaded and documented to report on the thermal characteristics of the building or to determine temperature hotspots within the warehouse and fridges. Such hotspots can occur at a change of shift, for example, or when a delivery is made. Knowing the effect of such changes helps make staff much more vigilant as the data is visible for all to see.

Conclusion

The Rapid Response Alert has simply re-stressed existing requirements and acts as a warning. The MHRA had previously been concerned about temperatures creeping up. The recent audit and subsequent Rapid Response Alert highlights the danger of temperatures becoming too low. Automatic temperature monitoring, using Tinytag data loggers, helps formalise a procedure and provides physical evidence of pharmaceuticals being monitored.