Pharmaceutical companies create many of the products that patients and healthcare providers rely on every day for essential treatments and medical interventions. Despite being crucial for patients’ health and our healthcare system at large, pharmaceutical companies are not without their share of past missteps.
The false advertising or misbranding of Oxycontin as non-addictive gave rise to the opioid crisis in the U.S. and resulted in billions of dollars of criminal and civil fines for its inventor, Purdue Pharma, and its leadership, the Sackler family. Despite no Purdue company executive facing jail time, the opioid crisis has caused an immense amount of pain and suffering in communities around the country and eventually led Purdue to file for bankruptcy and restructure. Stories like these act as cautionary tales that demonstrate the importance of pharma compliance with regulations designed to protect patients.
Pharmaceutical companies would do well to make sure that they are following regulations to the letter of the law to avoid harming patients and facing criminal and civil lawsuits. Because it’s so important for pharmaceutical companies to carefully follow regulatory guidelines, most companies boast robust compliance divisions that are dedicated to ensuring lawful behavior.
However, these compliance divisions don’t merely operate in a vacuum. To be effective, compliance teams must engineer bold pillars of support and infrastructure. This includes everything from technical tools, to customer service, to supply chain management.
Since compliance is so important for the pharmaceutical industry, let’s explore some of the core procedures, policies, and technologies needed for a successful compliance strategy.
Cold Chain Management
Many pharmaceutical companies must store and transfer medical products in very specific conditions. Many medications degrade, become unstable, or lose efficacy if stored in inappropriate conditions.
One of the most important environmental variables that can impact many medications is the temperature of storage facilities. Medical products that are stored in temperatures that exceed specific ranges can be at risk of becoming ineffective. As a result, healthcare workers must ensure that these medications are stored in controlled conditions, even while they are being transferred to healthcare facilities and patients.
This has given rise to the need for different kinds of supply chain procedures such as temperature-controlled supply chains, also known as cold chain management. Setting up reliable cold chains requires the use of a number of technologies, tools, and infrastructures. It also entails recruiting healthcare professionals with specific skill sets.
Data Loggers for Cold Chain Management
Aside from merely setting up cooling systems to keep temperatures low such as freezers or refrigerated trucks, companies must also utilize tech that allows them to monitor temperatures within storage facilities. For this purpose, pharmaceutical executives make use of temperature recorders, ambient temperature monitors, and data loggers.
Data loggers are small, electronic devices that collect environmental data from their surroundings such as temperature, humidity, or differential pressure. Data loggers offer a number of benefits for cold chain storage professionals.
Firstly, data loggers can be programmed to automatically collect temperature data at set intervals, mitigating human and instrumental error. They are also more accurate than traditional temperature monitoring tools such as thermometers. Data loggers also boast internal storage capability so that temperature data can be held on the device and later transferred to external computers or hard drive systems.
After data migration, temperature data can then be analyzed and formatted before being submitted to regulators. Given the reliability and benefits of data loggers, it should be no surprise that many regulators mandate their use for pharmaceutical companies. Some regulators even specify the models or specifications of data loggers that should be used.
While these regulations can be costly for pharmaceutical companies, it is extremely important that temperature data be continuously stored and reviewed in order to ensure pharmaceutical products will be helpful for patients.
Different Capabilities of Data Loggers
Part of setting up a cold chain management process is organizing reliably scheduled maintenance in which data is extracted from data loggers and transferred to computer systems. Since this represents a significant time commitment and source of liability for companies, some are exploring data loggers that can transfer data using a Bluetooth or WiFi connection, as well as other high-tech healthcare solutions.
Bluetooth data loggers can transfer data to a gateway device, often a phone or laptop, which can then connect to the internet to transfer that data into cloud storage systems. On the other hand, internet-enabled data loggers can connect to the internet themselves and send data to cloud storage systems directly.
Cloud storage offers pharmaceutical companies a number of advantages. By renting out hardware infrastructure, some companies can reduce their data storage costs and scale more quickly. Cloud-based cold data storage also allows companies to avoid having to continually buy, replace, and upgrade their own hardware, according to Dickson.
Despite these many benefits, pharmaceutical companies should be aware of some of the cybersecurity risks of cloud storage and be sure to work with a cloud service provider with integrity. As data becomes a bigger part of our lives and our economy, more cybersecurity and privacy issues are likely to come to the forefront when considering pharma compliance strategies.
One of the key benefits of using internet-enabled data loggers is that it can enable companies to view data in real time. That means that managers can become immediately aware of deviations in temperatures that could harm products. Many of these data loggers can even be programmed to send automatic alerts to management in response to certain environmental conditions such as increased temperatures or when doors to a storage facility are left open.
Temperature Mapping and Organizing Compliance Teams
Pharmaceutical companies can use data loggers to execute temperature mapping strategies. Temperature mapping is important because temperatures within different areas of a storage facility can vary significantly. That means that data loggers placed in one part of a storage facility could indicate optimal temperatures, while temperatures in another part of the facility are, in fact, too high.
In response to this problem, pharmaceutical companies attach data loggers in different parts of storage units, and this data can be used to develop a temperature map of the facility at large. In some cases, this temperature map can be updated in real time to ensure that all products in the facility are within safe temperature ranges.
Temperature mapping should be part of a larger strategy to build a system of procedures and compliance team members that are invested in making sure companies closely follow regulatory guidelines. This can include recruiting or working with healthcare professionals like Medical Science Liaisons that work in-house or externally.
Some pharmaceutical companies might consider pursuing Medical Affairs accreditation, a step that a majority of pharma compliance officers recommend. A Medical Affairs Board certification can help to minimize a company’s risk of running afoul of regulations in the future.
To sum up, some of the most important pillars of support in pharma compliance include establishing a supply chain that uses technological tools like data loggers to carefully manage storage conditions for medical products. Temperature data must be organized, formatted, and submitted to regulators to comply with regulatory guidelines. Exploring cloud computing and temperature mapping options is also worthwhile for pharmaceutical companies, as is working with Medical Science Liaisons and Medical Affairs Board certification.
