TempMark8 shows importance of temperature monitoring
Written by Derek Richardson, Group Sales Director, The IMC Group
The need to store certain drugs in refrigerated conditions is widely accepted and while many drugs are unaffected by fluctuations in temperature, there are several categories of medicine that must be maintained at between 2°C and 8°C in order to safeguard their quality and effectiveness.
The problem is that pharmaceuticals rarely stay in one place, so although the hospital refrigerator might be ideally configured, the conditions encountered during transit can vary wildly.
Exposure to inappropriate storage and handling conditions, depending on the extent of temperature levels and the period of time involved, may not just impinge on the effectiveness of certain drugs, but in some cases can even have negative health consequences for patients.
It’s an issue that is now being addressed by rapid advances in technology. The risks of deterioration can be dramatically reduced with the deployment of inexpensive monitoring devices such as Lamerholm’s specially designed TempMark8, which records instances where preset temperature limits have been exceeded.
Vaccines are a prime example of the importance of such developments. It was when major immunisation programmes were underway in developing countries that concerns about vaccine instability were first raised.
The fact that large proportions of the population were not benefitting from vaccinations turned the spotlight on the supply chain as a possible cause. In the journey from manufacturer to end user, the vaccines were handled by a number of transport and storage companies, which is where inconsistencies in temperature conditions arose. These came to be known as breaks in the cold chain.
Research prompted the intervention of the World Health Organisation(WHO), which introduced new rules on the transportation and storage of vaccines and encouraged the use of temperature indicators.
However, the adoption of such technology across the wider pharmaceutical sector has been slower. One reason could be that the problems caused by breaks in the cold chain are not as immediately apparent as in the mass immunisation programme mentioned previously, where higher temperatures and extended journey times were more common.
But this should not detract from the risk of deterioration that can result from fluctuating temperatures in other situations.
In the UK, for example, failure to comply with the guidelines imposed by the Medicines and Healthcare Produces Regulatory Agency (MHRA) can result in the wastage of affected drugs, the high costs of product recall and most importantly, a risk to patients’ health.
A significant factor is that while manufacturers are acutely aware of the ideal conditions in which their drugs should be stored, this information is not always relayed fully to the health workers and transport staff who are moving them from place to place. Therefore,an additional issue arises around who should be responsible for ensuring correct storage.
Not only should measures be taken when packing and storing pharmaceutical drugs but when transporting products to suppliers.
For distributors, a failure to keep substances at the correct temperature can be detrimental to their reputation, often costing them vital customers.
This is not something that should be left to chance. Lamerholm has revolutionised the packaging industry by creating a device designed to record up to eight conditions of temperature during packing, storage and transportation. The TempMark8, the first device of its kind to go on the market, allows pharmacists to determine whether packages have been exposed to dangerous temperatures and the safety of the product has been compromised.
The small, single-use device has an adhesive back cover for easy fixing onto packages. The review button allows the user to cycle through alarm level, number of times the predetermined limit was exceeded, consecutive samples over the limit and cumulative samples over the limit. The eight alarm triggers combine three descending (-1°C, 0°C and 2°C) and five ascending (8°C, 10°C, 15°C, 20°C and 25°C).
To help allow for international logistics and extended periods of storage, the device has a battery life of 90 days and then switches into low-battery mode in order to retain the data until the battery is completely depleted.
For pharmaceutical manufacturers, and the packaging and logistics suppliers who serve them, the TempMark8 is a highly cost-effective assurance that the items being delivered have been stored at an appropriate temperature throughout.
The attachment of such a device to a pharmaceutical package not only provides assurance but can also act as a visual deterrent against improper handling, thereby making logistics staff aware of the need to maintain appropriate temperatures.
As a result of technology like this, there is no longer any excuse for manufacturers and carriers to take risks with adverse temperatures.
The IMC Group was formed in 2007 by the amalgamation of Lamerholm Electronics, Hanwell Instruments and Jekyll Electronic Technology. The IMC Group has recently announced the acquisition of Silvertree Engineering Ltd. The group has over 100 years of experience and offers a comprehensive range of instrumentation and communication systems.
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Getting ready for cloud data-driven healthcare
As healthcare continues to recognise the value of data and digital transformation, many organisations are relying on the cloud to make their future-forward and data-centric thinking a reality. In fact, the global healthcare cloud computing market was valued at approximately $18 billion and is expected to generate around $61 billion USD by 2025.
At the forefront of these changes is the rapid adoption of cloud-based, or software-as-a-service (SaaS), applications. These apps can be used to handle patient interactions, track prescriptions, care, billing and more, and the insights derived from this important data can vastly improve operations, procurement and courses of treatment. However, before healthcare organisations can begin to dream about a true data-driven future, they have to deal with a data-driven dilemma: compliance.
Meeting regulation requirements
It’s no secret that healthcare is a highly regulated industry when it comes to data and privacy – and rightfully so. Patient records contain extremely sensitive data that, if changed or erased, could cost someone their life. This is why healthcare systems rely on legacy technologies, like Cerner and Epic EHRs, to manage patient information – the industry knows the vendors put an emphasis on making them as secure as possible.
Yet when SaaS applications are introduced and data starts being moved into them, compliance gets complicated. For example, every time a new application is introduced into an organisation, that organisation must have the vendor complete a BAA (Business Associate Agreement). This agreement essentially puts the responsibility for the safety of patients’ information — maintaining appropriate safeguards and complying with regulations — on the vendor.
However, even with these agreements in place, healthcare systems still are at risk of failing to meet compliance requirements. To comply with HIPAA, U.S. Food and Drug Administration 21 CFR Part 11 and other regulations that stipulate the need to exercise best practices to keep electronic patient data safe, healthcare organisations must maintain comprehensive audit trails – something that gets increasingly difficult when data sits in an application that resides in the vendor’s infrastructure.
Additionally, data often does not stay in the applications – instead healthcare users download, save and copy it into other business intelligence tools, creating data sprawl across the organisation and exposing patient privacy to greater risk.
With so many of these tools that are meant to spur growth and more effective care creating compliance challenges, it begs the question: how can healthcare organisations take advantage of the data they have without risking non-compliance?
Yes, healthcare organisations can adhere to regulations while also getting valuable insights from the wealth of data they have available. However, to help do this, organisations must own their data. This means data must be backed up and stored in an environment that they have control over, rather than in the SaaS vendors’ applications.
Backing up historical SaaS application data directly from an app into an organisation’s own secure cloud infrastructure, such as AWS or Microsoft Azure, makes it easier, and less costly, to maintain a digital chain of custody – or a trail of the different touchpoints of data. This not only increases the visibility and auditability of that data, but organisations can then set appropriate controls around who can access the data.
Likewise, having data from these apps located in one central, easily accessible location can decrease the number of copies floating around an organisation, reducing the surface area of exposure while also making it easier for organisations to securely pull data into business intelligence tools.
When healthcare providers have unfettered access to all their historical data, the possibilities for growth and insights are endless. For example, having ownership and ready access to authorised data can help organisations further implement and support outcome-based care. Insights enabled by this data will help inform diagnoses, prescriptions, treatment plans and more, which benefits not only the patient, but the healthcare ecosystem as a whole.
To keep optimising and improving care, healthcare systems must take advantage of new tools like SaaS applications. By backing up and owning their historical SaaS application data, they can do so while minimising the risk to patient privacy or compliance requirements. Having this ownership and access can propel healthcare organisations to be more data-driven – creating better outcomes for everyone.