Proactive Pharmacovigilance

It may be years before a national – or international – system of pharmacovigilance is in place. So how can we ensure patient safety today?

by Barbara J. Yorke & Daniel C. Utzinger

Imagine an environment in which pharmaceutical manufacturers, regulators, healthcare providers and payers serve patients who do not worry about the safety of approved drugs, vaccines or devices. Imagine those same stakeholders working together to establish proactive pharmacovigilance practices that ensure confidence in a system to which patients entrust their lives. In this environment, industry specialists can detect safety signals early, understand safety and efficacy across patient populations, make better and quicker decisions on behalf of patients, and provide safer, more effective products.

In fact, the industry must look beyond today's pharmacovigilance model, where each step triggers a stakeholder reaction that can lead to a product's withdrawal or a negative impact to the company or the brand. Everyone loses in this scenario, particularly the patient. But it may be years before a national – or international – system of pharmacovigilance is in place. So how can stakeholders invest in patient safety today, thus providing value to their organizations while building a foundation for the future?

The answer, at the company level, has three components:
Know sooner when there may be an issue with a product.
Understand faster what is really happening.
Respond better to whatever the situation might be.

The old model
Let's start by understanding basic product safety. Typically, physicians report adverse events (AEs) or unintended results – regardless of cause, severity or unexpectedness – to pharmaceutical or medical device manufacturers or, in some cases, directly to health authorities. The manufacturer must then report all AEs to the appropriate regulators within a predetermined timetable. Unfortunately, recent product withdrawals stemming from safety concerns have shown that this process doesn't ensure patient safety.

Why? First, the data collected is often incomplete and unreliable, since physicians lack a common, efficient process for reporting AEs and rarely receive feedback on the actions the company or regulator takes in response to the report. Second, it is difficult to analyze data across a therapeutic area or class within a manufacturer, so safety scientists typically analyze smaller sets of data. Broad discovery efforts generally occur only when manufacturers face issues with individual products. Finally, most manufacturers are unable to analyze AEs against supporting epidemiological data sources, so they cannot truly understand an event's potential impact in the general population or the medicine's target population. In fact, the inability to access reliable and timely data may be the most significant challenge to the current system.

Existing product analyses based on AEs alone are reactive – rather than proactive – attempts to find a product's optimal application. When companies launch those analyses, the search for the right information invariably gets delayed.

The result: a costly process that the public does not trust. If this process remains unchanged, manufacturers might face more restrictive regulations, requiring larger and longer clinical trials to prove safety prior to commercial availability. Ultimately, they will have to invest more in drug safety – with funds that will likely take a larger portion of R&D budgets. Given the shrinking pipelines and rising costs in recent years, this is hardly the way to increase shareholder value. 

The new model
Pharmacovigilance, on the other hand, is a natural extension of current data capture and reporting processes. At its core is an advanced analytical engine that allows healthcare stakeholders to monitor product safety data. Based on data warehousing and statistical analysis techniques, this "engine" provides various algorithms to identify trends or clusters of events to help organizations make better decisions over time.

There are two components of this capability: access to the right kind of information in the right format and the use of more advanced statistical methods to see and understand potential signals in earlier stages of the process.

Here, manufacturers' product safety information "lives" in an analysis-friendly structure with real-time access to a combination of data sources. An established library of algorithms helps detect potential signals so that users can analyze what is really happening. Moreover, with appropriate security and firewalls, companies can share the cost of development, rather than shoulder the costs individually.

The good news is that every stakeholder benefits. Manufacturers can increase compliance with regulatory timelines (100 percent is achievable), deliver higher-quality data, reduce time spent in physician follow-up, increase brand protection with earlier safety warnings, provide competitor product intelligence and potentially open new revenue streams through product line extensions. Healthcare providers gain standard tools and processes for reporting AEs that save time and offer a higher level of protection for their patients. Healthcare payers can access standardized data to make more informed coverage decisions. With standardization, regulators' safety reviews will be faster and more accurate. Ultimately, patients win with an efficient system that protects them, and, as a result, their perception of the industry will improve.

Basic components already exist for leading companies to begin the process of storing and analyzing data for pharmacovigilance. Virtually all pharmaceutical companies use SAS for analytic processing, particularly to create complex analyses and reports. Complemented by a suite of other SAS solutions – including SAS Data Integration, which allows companies to consistently integrate disparate data sources into industry-standard data structures (e.g., E2B, CDISC and HL7), and SAS Drug Development, which provides a standard, compliant environment to store, retrieve, analyze and report data that unlocks the power of signal detection – companies can enable proactive pharmacovigilance.

The bottom line? Pharmacovigilance allows the industry to identify issues sooner, understand cause and effect faster, and respond better to protect patients. Forward-thinking companies that choose to use existing technologies to ensure pharmacovigilance can leap-frog the competition to make reactionary product safety a thing of the past.