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Bio-pharmaceutical companies are continually tasked with gathering more safety information and responding to requirements more quickly. Recent examples of significant changes in reporting requirements include 2010/84/EU and Regulation Number 1235/2010 on pharmacovigilance, and the 2012 European Medicines Agency (EMA) new guidelines on good pharmacovigilance practices.
Bio-pharmaceutical companies are continually tasked with gathering more safety information and responding to requirements more quickly. Recent examples of significant changes in reporting requirements include 2010/84/EU and Regulation Number 1235/2010 on pharmacovigilance, and the 2012 European Medicines Agency (EMA) new guidelines on good pharmacovigilance practices. These new requirements have significant implications for pharmaceutical companies with marketing authorization in the EU. As health authorities look to reduce treatment-related health risks to patients, pharmacovigilance (PV) or drug safety has stepped into the spotlight.
To minimize risks associated with approved medical products, PV professionals must decide whether their current systems for detecting and adjudicating signal-safety information rely too much on manual methods. Too often data in these systems is siloed. Managing signal-safety information tracking often requires manual entry, leading to duplication of effort and errors.
To make matters worse, there are often too many non-value-added activities across the PV platform. These non-added value activities include manual operations for contributing to the label update, clinical overview, risk minimization and risk management planning, and generating reports. What’s more, there is limited systems integration within existing processes. Consequently, signal detection/adjudication cycle times are longer, productivity is decreased, and business agility is compromised.
Given the importance of product safety and the corresponding regulatory requirements, it is becoming increasingly clear maintaining data required for regulatory purposes in spreadsheets is not the ideal future state for pharmacovigilance. The primary collaboration tool becomes email, and there is almost no visibility into the process. Determining who did what and when, or even tracking versions of these files, is a time-consuming activity. It can take an objectionable 6 to 8 weeks to generate required regulatory documents such as the Periodic Safety Update Report.
As far back as 2010, in a Nature Review Drug Discovery analysis by Steven Paul and other researchers, declining productivity was reported in the pharmaceutical research and development (R & D) processes, putting the entire industry at risk. In the context of PV, productivity and quick completion of work assignments can be hampered by something as simple as unnecessary time spent finding key documents to complete basic tasks. The result is increased risk of errors, lack of transparency and insight into the process, process inefficiency, lower productivity, control, business agility, and limited predictive analytic capabilities. This type of scenario exposes bio-pharmaceutical companies to fines, penalties or even withdrawal of drugs from the market. The regulatory requirements for timely reporting product safety are very serious – as evidenced by the recent $3 billion fine imposed on GlaxoSmithKline, which pled guilty to failing to disclose safety information about the diabetes drug Avadia to the FDA.
Automation could solve much of the difficulty faced by PV professionals.
Modern work platforms are emerging on the market to enable PV teams to do away with problems in regulatory compliance and reporting – and reduce risks to patients using approved medical products.
Let’s look at four areas where automation can improve PV effectiveness:
Faster Signal Adjudication and Reporting – To minimize risks, PV should reduce the time from signal detection to characterization to adjudication. Automating non-value-added processes allows companies to reduce manual data entry – cutting down on duplication of entries or errors, and allowing workers to focus on value-added activities. Automation offers companies a 360-degree view into the safety information management process across the PV platform, from signal detection to decisions about labeling.
Automated PV Task Management – PV IT systems often suffer from process gaps that create delays and force teams to develop manual workarounds. To ensure timely follow-up on safety-related activities, companies should customize work automation tools to import signal information from various sources, and assign tasks and alerts to individuals based on role. This allows organizations to effectively track productivity and efficiency measures with a complete audit trail of who did what and when.
Increased PV Activity Visibility – With all work processes tracked and managed, it’s important to have a 360-degree view of drug safety-related processes PV activity in a simple report. Ideally, this report should be viewable from any mobile device or computer screen. Executives can have insight into process inefficiencies and bottlenecks at the click of a button. Users with the appropriate access/security can obtain information needed to do their jobs with ease, with the necessary awareness to act on the spot.
Standardized PV Processes with Local Variations – PV organizations need a consistent/centralized system to track signals, to ensure all safety actions are reconciled in a standardized manner independent of geography and/or therapeutic category. Having the ability to customize a work automation solution based on specific processes and procedures will allow organizations to have the flexibility and agility required to make global safety decisions. (To achieve the best results, the system has to be secure and strict business rules need to be put in place.)
The risks and cost associated with an inefficient and highly siloed PV infrastructure are enormous. Companies need to examine their safety signal information systems and question whether these systems provide needed information in a timely manner, to avoid the chance of a failed audit or worse.
Automation can dramatically improve drug safety and risk management information tracking across pharmacovigilance activities. PV teams can rapidly detect and resolve safety signals, and provide regular updates to regulatory authorities on the safety of approved products. Process managers and executives can spot trends and raise alerts quickly. Companies can produce accurate safety reports that stand up to intense scrutiny from regulatory bodies.
By meeting the four considerations outlined here, automating PV processes can enable the proper, rapid movement of information while maximizing collaboration across the entire bio-pharmaceutical enterprise.
James Pierce is the Global Pharmaceutical Practice Leader for Appian. He can be reached at [email protected]