Article

Pharmaceuticals

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. In January, 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 article discusses how temperature data loggers can make a significant contribution to meeting the requirements of the Rapid Response Report.

The issue

The biggest issue for those storing pharmaceutical products has always been temperature increases above 25°C, according to MHRA statistics (1). Vaccine storage is even more critical as their safe storage temperature in order to retain potency is usually 2°C to 8°C. This issue has been the subject of debate following an audit carried out by the Nottinghamshire Primary Care Trust. The two-year audit of 96 practices revealed that 40% of vaccines had been stored outside the recommended temperature range (3).

The NPSA searched their database of all clinical incidents 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 fridge door left open; no temperature monitoring controls at all; inadequate or missing equipment and inappropriate use of domestic fridges(3).

The latest twist in the tail

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 recall included 360 adults and children. These findings, together with incidents reported to the NPSA, have made it necessary to highlight the continuing problem. Freezing 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 that hold vaccines requiring cold storage, and 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 (2):

• Be issued with guidance relating to Vaccine Cold Chain Storage. Local policies should include having a designated person and deputy or deputies responsible for 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 manufacturers' recommended temperature ranges.

• Have procedures in place for remedial action where vaccines are stored outside manufacturers' recommended temperature ranges.

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 relating to the manufacture and distribution of medicines for human use. It also states 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 corrective action and if it is not taken the MHRA can take regulatory action. This may include suspension or even loss, of a manufacturer's or wholesale distribution licence (1).

How using Tinytag data loggers helps you comply

Many errors identified in the report can be avoided using data loggers. Data logging will directly address part of the Rapid Response Report stated as "have procedures in place to ensure correct working practices are being followed.., such as reviewing refrigerator temperature". Data loggers are small battery operated, inexpensive units which monitor the ambient temperature surrounding a vaccine or any other pharmaceutical product. Although a thermometer may already be used in a fridge, data logging formalizes the procedure by being able to record temperature over a set period of time. A data logger highlights the importance of maintaining a stable temperature, pushing it to the forefront of a staff's mind. The logger can be set to record at a suitable time interval, e.g hourly, and the information can be easily downloaded. Some loggers have an alarm, so that if, for example, a refrigerator's door is left open and temperature goes out of range, the alarm will be triggered, alerting the responsible person who can download the data and make a decision on what should happen to the pharmaceuticals or vaccines stored there.

When looking for a data logger, it is important to look for a specialist logger for use in refrigerators. It is useful to be aware of World Health Organization (WHO) recommendations in order to maximize the potential of your data logger. This 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. A data logger is best positioned in the middle of a shelf, in amongst the product being monitored (4), as this more closely reflects the temperatures they are exposed to.

Ice build up reduces the effectiveness of a vaccine (4). During defrosting, alternative refrigerators or approved cool boxes with a data logger should be used to store vaccines. Temperatures in the refrigerator must be recorded at least once each working day (4) using a data logger. For no extra effort this can be done more often, and the data automatically documented on a chart for recording temperatures. Getting data from a data logger is easy and 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 provide this.

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 recognized medical company. While the vaccine is in transit, a data logger can be packaged close to the vaccines in order to record any fluctuations. Vaccines must be kept in the orginal packaging, wrapped in bubble wrap or other insulation material  and placed in a cool box with cool packs as recommended by the manufacturer. This prevents contact between the vaccine and the cool packs (4).

Examples of Tinytag data logger's 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, 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. It provides an easy and convenient solution for the demands of their customers, and to ensure responsibilities all round are met.

Tinytag Data loggers have also been used by pharmaceutical's 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 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 within the fridges. Such hotspots can occur at 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 re-stressed existing requirements and acts as a warning. 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.