Pharmaceutical companies contend with various stringent regulations put in place by governments to protect patients and consumers. As a result, major pharmaceutical companies have compliance divisions whose job is to ensure the business is following all the relevant requirements put in place by government regulatory agencies. The cost of pharma compliance is high, often requiring large, dedicated teams of compliance workers.
It’s, therefore, no surprise that pharmaceutical companies are looking for ways to reduce the costs associated with regulatory compliance. However, while cutting costs is a priority, these companies need also to make sure that cuts in compliance spending don’t result in regulatory violations that lead to future civil and criminal liability. The pharmaceutical industry must walk a fine line between minimizing compliance spending and limiting regulatory infringement risk.
Some of the essential tools that pharmaceutical companies use today to accomplish these goals are risk monitoring software and procedures. Risk management systems allow managers to understand the statistical significance of specific threats to the business and compare them. Comparing the relative importance and probability of various risks will enable managers to allocate resources and personnel efficiently.
How Risk Management Systems Work for Compliance
Risk management software takes many different data points as inputs, analyzes that data, and uses programmable algorithms to predict relative risks to the company based on varying conditions or regulatory violations. The idea behind quantifying relative risk is that some level of risk will always be present and that ensuring 100 percent compliance at all times is unrealistic. Therefore, risk management professionals advise taking a sober, analytical approach to risk and minimizing the most harmful outcomes faced while spending the least possible.
To use risk management systems, managers must look at all of the specific interactions that each healthcare professional has and input those interactions into software that analyzes the risk of each incidence. It’s also essential to ensure that every healthcare professional involved in this process is qualified, appropriately licensed, and professional while weeding out those that aren’t.
Risk management software can then use a programmable algorithm to parse out which specific interactions represent the greatest risks to the organization. You can even have the algorithms configured to recommend potential risk mitigation strategies. You can program particular risk thresholds for different interactions to tailor how the algorithm operates.
Risk management software allows managers to separate signal from noise to determine which risks they should focus on mitigating even after analyzing thousands of different interactions and data points. Managers can also customize the software to reflect their niche’s specific policies and regulations. That includes regulations that pertain to fraud and PhRMA codes, a voluntary code of ethics that applies to pharmaceutical company interactions with U.S. healthcare professionals.
After identifying high-risk interactions, managers can create a specific category in their risk management software related to interactions on which the company needs to act. That’s important since a crucial part of pharma compliance is to take action to reduce the potential liabilities of business practices and procedures. Facilitating a transparent exchange of ideas and communication among medical professionals is also a vital part of this process.
Pharmaceutical companies can use the software to coordinate actions and responses to high-risk interactions that mitigate those risks cost-effectively.
How Data Monitoring is Used in Risk Management
Deciding to use risk management software is just the first step to facilitating compliance. Pharmaceutical companies must gather data and then input it into the software. This data must include important information related to each healthcare professional’s interactions, but it is often necessary to include environmental data.
Companies will gather environmental data such as temperature, humidity, and differential pressure. Pharmaceutical manufacturers can automate this process by using data loggers. Data loggers are small electronic devices that collect environmental data regularly.
That data is then either stored internally to be exported later or transferred to external computer systems and software through the internet. The collecting of environmental data has become increasingly important today due to various environmental concerns.
Pharmaceutical companies are no strangers to data loggers since many regulators require temperature and environmental data to be reported, particularly for temperature-sensitive medical products. These data loggers are crucial to ensuring public health and consumer safety in many different sectors, including the food, beverage, and aerospace industries. Indeed, collecting and reporting environmental data at regular time intervals can help prevent food-borne illness outbreaks and hazardous medical products from being administered to patients.
As a result, data loggers help pharmaceutical companies mitigate the risk of bad outcomes for patients, regulatory fines, and expired medical products. However, Dickson notes that those are just a few ways that data loggers can reduce risk and facilitate pharma compliance.
Data loggers can also be used extensively in supply chain management to minimize inefficiencies and time delays. That’s important since pharmaceutical companies must often get products to healthcare facilities within specific timelines.
For example, we could set up data loggers to monitor the exact location of shipments to uncover which parts of the supply chain are most prone to delays. The manufacturer can take investigative action to better understand the cause of unexpected delays and reduce the probability of them occurring in the future.
Data loggers can be programmed to automate the FDA standards for environmental monitoring and pharma compliance. Specifically, the FDA uses the ALCOA rule, which requires collected data to be Attributable, Legible, Contemporaneously recorded, an Original copy, and Accurate. Data loggers can be programmed to meet all of these criteria.
Once collected, management can view data collected throughout different geographical areas through cloud-based software or risk management tools with compliance in mind. For companies wishing to abide by the Drug Distributor Accreditation program and pursue accreditation, this is particularly important. Pharmaceutical executives instituting any compliance program must always be wary of potential conflicts of interest.
To sum up, a comprehensive risk monitoring strategy can help reduce the cost and increase the effectiveness of pharma compliance efforts. Manufacturers find this especially true when they pair risk management systems with accurate and substantial data collection, making data loggers a vital part of the risk management process.
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