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December 20, 2012

Monitoring Devices And Vaccine Storage: A Global Concern

Written by SmartSense | Pharmacy Safety

We recently spoke with an individual from a reputable hospital who outlined a recent failure in one of their systems. According to the source, over 900 monitoring points were inactive as result of a faulty monitoring system. The question of "who's monitoring your monitoring device?" was part of our discussion on refrigerators and is an extremely important issue. The upkeep of monitoring systems is an important piece of any "best practice" storage strategy. Unfortunately, this mishap at the U.S. based hospital is part of a larger theme around the world; that inadequate monitoring and storage of vaccines (and medicine) is still a significant problem.

As we can see, Chad has environmental roadblocks to best storage practices for vaccines. This is only one of many major concerns in vaccine storage and will continue to be a struggle for Africa as a whole. In recent news, a bill “to provide for the establishment of a Drug Regulatory Authority of Pakistan” was passed. This bill came nearly a full year after an estimated 40,000 cardiac patients in Lahore were given faulty drugs, leading to the deaths of nearly 100 people. Despite legal complications, this authority is absolutely necessary for the quality control and safety of Pakistan-based hospitals, clinics and laboratories. Unfortunately, the 100 deaths constitute part of the basis for this bill. As quoted from the article, “In retrospect the lesson learnt from this experience is that decision-making should be guided by evidence, earlier on without the need for a catastrophic event to underscore its salience”. This speaks to the deterrence question that we discussed last week with Hurricane Sandy and flooding;  preparation and prevention should not be based on a sole event or glaring weakness in any system. Preventative methods in medicine should be proactive and progressive; weaknesses should be exploited before they can develop into larger problems. Whether the issue is environmental (like in Chad), financial or legislative, the issue must be addressed sooner rather than later.

There are obvious signs that the ‘authority’ is not the sole answer to the problem. The bill is referenced by statistics that estimate a presence of only 250 inspectors to monitor a variety of manufacturing facilities in one city. In terms of pharmacies in Pakistan, a 2005 survey from the International Journal for Health Care in Rawalpindi (3rd largest city) showed that only 22% had qualified pharmacists on site, only 10% had temperature monitoring, and 4% alternative supply of electricity for refrigerators. These numbers are shocking, given the Meningitis issue that we also discussed last week. It's also troubling that this authority has been established nearly seven years after that survey was conducted; it's obvious to any reader that immediate action must be taken to improve the system. Still, the legal complications have made this "no-brainer" into a lengthy process.

If we know that a single, isolated laboratory in Massachusetts can cause 300+ breakouts and 30+ deaths from one tainted batch of steroids, an entire city with less-than-adequate quality control in Pharmacies could be potentially disastrous. Quoted from the 'conclusions' of the 2005 survey, "Most drug sellers had fragmentary knowledge regarding drug dispensing and storage and improper dispensing practices." Given the percentages listed, this ‘new’ authority will hopefully breathe a fresh breath into the Pharmaceutical industry of Pakistan.

Since our induction, the Bio-Pharamceutical industry has been a primary (and sensitive) target for SmartSense. Temperature monitoring devices should be part of a larger prevention strategy for medicine (black matter in Steroids), and devices need to be regularly monitored and tested. Here at SmartSense, we have an excellent understanding of health guidelines and the necessary certifications that are needed for device application in the pharmaceutical industry. Unlike Property Management, in which consequences of inadequate temperature monitoring can translate into flooding  (bursted pipes) and overheating, the biopharmaceutical industry can house extremely sensitive (and valuable) research data and vaccines. Particularly for vaccine storage, the cost of inadequate monitoring can be measured in lives lost, as seen in both the U.S. and in Pakistan.

SmartSense uses a National Institutes of Standards and Technology (NIST) certification process for clients who request official documentation of our accuracy. With this certification, our SmartSense monitoring devices can be used in the most sensitive of circumstances, including storage of vaccines. The automated alerts are designed to help avert vaccine contamination or irregular temperature fluctuation, and can be configured in a number of ways. Our SensorCloud portal allows alert setting in five or 15 minute intervals. This is particularly important for Pharmaceutical companies, where best storage "practices" must be used for the mission-critical storage units.

Topics: Pharmacy Safety

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