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European Pharmaceutical Contractor

Rapid Responses

Ana Carmona-Rodriguez at Gemini Data Loggers (UK) Ltd and Dawn Brown, freelance Consultant, examine the importance of automatic temperature monitoring of pharmaceuticals in storage and transit

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 was only in January 2010 that the UK National Patients Safety Agency (NPSA) 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. This article discusses the implications of the Rapid Response Report and how temperature data loggers can make a significant contribution to meeting the requirements.

THE ISSUE

The single biggest issue for those responsibile for storing pharmaceutical products has always been temperature increases above +25°C. This has been highlighted in MHRA statistics since the start of the decade (1). 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 which has 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 per cent of vaccines had been stored outside of the recommended temperature range (3).

The NPSA searched their database of 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 (3).

THE LATEST TWIST IN THE TALE

The PCT performed 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 recall included 360 adults and children. These local findings, together with incidents reported to the NPSA, have made it necessary to highlight the continuing problem and to emphasise that an environment which is too cold can pose an even greater threat than an environment that is too warm (3). Freezing can cause hairline cracks in the container, leading to contamination of the contents. The Rapid Response Report is for immediate action by all NHS organisations whose departments and providers, including independent contractors, hold vaccines requiring cold storage – the deadline for action is 21st July 2010.

REQUIREMENTS ARE RE-EMPHASISED

The Alert calls for all NHS organisations and independent contractors holding vaccines to (2):

  • 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 the receipt and storage of vaccines.
  • Have procedures in place to ensure correct working practices are being followed, such as reviewing refrigerator temperature regularly to identify if vaccines have been stored outside of the 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 any of the requirements. Adverse inspections will result in recommendations for corrective action 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 (1).

HOW USING DATA LOGGERS HELPS YOU COMPLY

Many ‘avoidable’ mistakes or errors identified in the report can be avoided using data loggers. Data logging will directly address the part of the Rapid Response Report that demands companies to “have procedures in place to ensure correct working practices are being followed ... such as reviewing refrigerator temperature”. Data loggers are small, inexpensive, battery-operated units which 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 the staff member’s mind at all times. The logger can be set to record at a suitable time interval, such as 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 responsible person who can then download the data to see the fluctuations on temperature, and 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 find a specialist logger that can be used in refrigerators. It is useful to be aware of World Health Organisation (WHO) recommendations in order to maximise the potential of your 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 door of the fridge or positioned near the front of a shelf are more likely to show higher readings and more variations in temperature than a logger place 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 amongst the product being monitored, as this more closely reflects the temperatures they are exposed to (4).

Ice build-up should not be allowed, as this reduces the effectiveness of the vaccine (4). During defrosting, an alternative refrigerator or an 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 (4). 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. Getting data from a data logger is easy and requires just a few simple steps. Downloads can be in a table format or a graph. Annual calibration checks of the data logger are recommended, 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, the 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 (4).

EXAMPLES OF LOGGERS’ USE IN THE PHARMACEUTICAL CHAIN

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, 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. It provides an easy and convenient solution for the demands of their customers, and ensure that responsibilities are met all round.

Data loggers have also successfully 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 within the walk-in fridges and it is part of the staff ’s responsibilities to download the data from each logger to identify any fluctuations and their causes. 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 to 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 highlight the danger of temperatures becoming too low. Automatic temperature monitoring, using data loggers, helps formalise a procedure and provides physical evidence of pharmaceuticals being monitored.

References

  1. MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 – the ‘Orange Guide’
  2. NHS Rapid Response Report, January 2010
  3. NPSA Vaccine Cold Storage, supporting information, January 2010, http://www.nrls.npsa.nhs.uk/
  4. World Health Organization, Temperature Sensitivity of Vaccines, www.who.int/vaccinesdocuments/ DocsPDF06/847.pdf, 2006

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Ana Carmona-Rodriguez has worked in the data logging industry for over five years, in the role of Marketing Manager at Gemini Data Loggers. In this role, she has spearheaded many initiatives and implemented the company’s strategic marketing and tactical plan. She graduated from CESMA University, Madrid, with a joint honours BA in Marketing and Advertising. Throughout her career, Ana has developed extensive knowledge in the instrumentation industry, focused on areas such as test and measurement and data logging.

Dawn Brown works as a freelance business to business marketing and communications consultant, with over 20 years of experience in the field. She specialises in the technical sector and her work is particularly focussed on the areas of electronics and instrumentation. Dawn writes for a wide array of media, both online and offline, and covers all the communication channels, from working for traditional trade press and business newsletters, to online information portals and newswires.

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Dawn Brown
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