[Image courtesy of LeoWolfert via iStock]
Unified regulatory standards and pharmacovigilance harmonization are critical to enabling global pharmaceutical firms to operate more safely and efficiently. By normalizing the reporting of clinical data, stakeholders can minimize risks, improve market conditions, support early access to products, promote competition and efficiency, and reduce the unnecessary duplication of clinical testing.
Multiple regulatory agencies, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pan American Network for Drug Regulatory Harmonization, are looking for ways to achieve this. Through the use of technology, stakeholders can deploy tools such as artificial intelligence (AI), machine learning (ML), and natural language processing (NLP) to improve safety monitoring and shift the industry from reactive to proactive adverse event (AE) management.
The present position
The current state of pharmacovigilance harmonization varies between countries and governments. The existing reactive PV model collects and reports individual and aggregated adverse events (AEs). The circuitous processes these reports follow from the patient to the manufacturer or regulator often culminate in lengthy delays. These interruptions allow for potentially severe impacts on patient health, higher treatment costs, and product waste.
Harmonization offers a proactive solution based on faster safety monitoring and signal evaluation that reduces risk and improves overall management. However, this process also faces multiple barriers.
Challenges facing pharmacovigilance harmonization
Local authorities’ preferences often obstruct harmonization efforts, resulting in political changes at national and regional levels. This turmoil often results in a higher-than-expected staff turnover at regulatory agencies, which can delay progress. In addition, regulations are often rooted in a region’s legal practices and precedents, making harmonization initiatives far more difficult to achieve.
Lack of technical expertise in some countries disrupts the transformation process, while economic factors hinder implementation in others. The list goes on. Nevertheless, technology can play a vital role in selecting the right tools to ensure harmonization and compliance during this move to proactive pharmacovigilance.
Technology’s role in harmonization
Regulatory harmonization requires all the relevant authorities to adopt the same technical processes, standards, and guidelines for quality, safety, and efficacy. Purpose-built software can help manage oversight and reporting of adverse events over thousands of platforms and across more medications than was previously imaginable. Technology’s role in achieving harmonization includes:
1. Managing the data
Organizations need the right technological tools to manage the growing volumes of case data, which is currently increasing at a 15% annual rate. Admittedly, these numbers are partly caused by the pandemic, giving rise to an anomalous situation. However, data volumes continue to grow due to shifting regulatory and consumer trends. Sophisticated technology is necessary to manage these volumes, and that situation is unlikely to change in the pandemic’s aftermath.
According to McKinsey Global Institute, applying big-data management strategies in healthcare can optimize innovation while improving the efficiency of pharmaceutical research and trials. Such strategies also provide new tools for physicians, consumers, insurers, and regulators that allow for more individualized approaches. To harmonize pharmacovigilance effectively, organizations must capitalize on these strategies and utilize AE data to its full potential to optimize its value.
2. Accelerating insight delivery
The pandemic also spurred a requirement for faster results. This “need for speed” could continue impacting COVID-19 vaccine- and treatment-related trends and potential side effects for the foreseeable future.
By implementing AI, ML, and NLP tools, companies can enable real-time data collection, processing, and standardization. They can expand the use of auto-narratives and translation to all types of reports.
Systems can use algorithms to read databases, scan the internet for safety information and adverse event accounts, and deliver insights in a fraction of the time it takes to do it manually.
3. Improving resource deployment
By leveraging automated chatbots to handle basic inquiries, which account for up to 20% of all queries, companies can minimize the need for human and financial resources. In addition, with increased levels of harmonized automation, functions such as case processing and translation can happen much faster and with a decreased risk of human error, regardless of the report’s country of origin.
Harmonizing systems across regulators will also eliminate delays caused by incompatibility. Organizations can follow up and respond faster by proactively reducing the number of touchpoints involved in AE reporting. They can also draw out specific information about AEs to implement more proactive safety measures, manage the risks better and achieve better outcomes.
Benefits of pharmacovigilance harmonization
Pharmaceutical regulatory harmonization promises multiple benefits. The financial savings could total billions in value for global healthcare, from less duplication of clinical trials to lower drug development and regulatory costs. In addition, the increased speed of new approvals and responses to AEs could save lives and improve population health.
Countries are already reaping the benefits of harmonization at bilateral, regional, and global levels, with examples like acceptance of the Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD). The World Health Organization drove this drug classification system after recognizing the need for an international standard for drug utilization studies.
Getting the ball rolling
Despite the progress, we still have a long way to evolve from reactive to proactive PV. Success demands sweeping harmonization that supports global health by applying common high standards. Organizations need expert guidance in choosing appropriate technology to manage and overcome the challenges of harmonizing processes. Let’s get the ball rolling on this critical matter without further delay.
Sreeganesh Jaishankar is a director and head of lifecycle safety systems, data sciences, safety and medical at IQVIA.