September 17 is World Patient Safety Day, a time designated to think about the progress pharmaceutical companies, healthcare providers and patients themselves have made on the safe use of medicines – and what more we can do in this vital area of pharmacovigilance (PV). Klaudija Marijanovic Barac, MD, Head of Teva’s Periodic Reports & Risk Management Center and Europe & UK Deputy Qualified Person Responsible For Pharmacovigilance (QPPV), shares prominent trends in patient safety.

1. Artificial intelligence (AI) and machine learning (ML) are revolutionizing how we process safety data, detect adverse events and communicate risks – and we are proceeding with caution.

AI and ML are used in many fields to accelerate traditionally time-consuming processes. As applied to PV, these technologies analyze large amounts of safety data from multiple sources – such as adverse event reports, social media, real-world data including electronic health records and wearable devices – and identify potential safety signals and adverse events in real time.

Natural language processing (NLP) – which allows computers to understand and process human language – is used to dramatically improve the intake process of adverse events received globally in various languages. Our Pregnancy Cases Quality Mining Project, for example, employs text mining – an AI technology that uses NLP – to accurately identify pregnancy-related cases in our global database. Many other exciting applications that improve data analysis and safety communication are under development.

The time savings AI and ML help us achieve in PV are in the interest of patients’ well-being. The earlier Teva and our peer companies know about medicine-related safety issues, the quicker we can analyze them, address the situation and notify regulatory bodies, healthcare professionals (HCPs) and patients. Once aware of important safety updates, HCPs can make informed decisions about medicines with individual patients, with the goal of achieving the best possible health outcomes.

In the future, by analyzing historical data and identifying certain patterns, ML algorithms could possibly help predict the likelihood of adverse events from medicines or how a patient might respond to specific treatments. With applications of predictive modeling, we could one day potentially have the information needed to prevent some AEs from happening altogether.

While AI and ML have tremendous benefits, PV experts and regulatory authorities are proceeding with caution to avoid any risk of sacrificing data quality for the sake of speed or efficiency. Low-quality or incomplete data applied to AI/ML can lead to inaccurate or misleading information, which in turn could have serious consequences for patient safety. Through careful data collection and regular validation of AI/ML, industry and health authorities can ensure more accurate data assessments. PV is a highly regulated area where validation is required prior to implementation, and AI/ML is no exception.

2. Patients are taking a bigger role in drug safety than ever before.

Historically, patient care models heavily relied on HCPs and pharmaceutical companies. Today, however, it's more common for patient care to be a shared responsibility among all stakeholders involved – HCPs and pharmaceutical companies as well as regulators, national health authorities, and, most importantly, patients and caregivers.

We know that patients who actively engage in their own health care – such as reporting adverse events, participating in patient support programs and using technology to track appropriate medication use – feel more empowered managing their conditions. Individually, they have a greater sense of control over their own health, and collectively, they take pride in contributing to a shared pool of knowledge. Adding to this empowerment are patient groups where patients and caregivers share experiences and learn from others with the same condition. The drug safety connection here is that these communities help patients better understand how to take or administer their medicine, which potentially could decrease side effects.

Patient safety is expanding by implementing supplementary risk minimization/mitigation activities (required to assure additional patient safety for certain drugs with severe risks). In the United States, Risk Evaluation and Mitigation Strategy (REMS) programs have digital components. In Europe, Teva was among the first companies to develop a digitally controlled drug distribution program. Our company wanted to help promote patient safety through real-time support of HCPs, who use the platform to access training resources, register patients, and complete and approve prescription information after doing safety checks.

In one of the newer technology advancements, patients who are prescribed a combination drug-device for certain respiratory conditions and diabetes, for example, can download a mobile app that allows them to send data to their doctor's office and communicate with their HCP about treatment and disease control. Patients today can also scan QR codes on medication packaging to access product information or educational materials. As digital technologies continue to evolve, we must ensure they are highly interactive and user-friendly enough so everyone benefits.

3. Eco-pharmacovigilance is becoming extremely important for our planet's future.

One of the primary aims of Teva's PV program is to decrease the number of adverse events that may occur – those that affect humans and the environment. Eco-pharmacovigilance refers to adverse events linked to pharmaceuticals in the environment, which could affect humans and other living things.

Antimicrobial resistance (AMR), for example, can occur when bacteria, viruses, fungi, and parasites change over time and no longer respond to medicines. This makes infections harder to treat and potentially increases the risk of disease spread. Misuse and overuse of antimicrobials are the main drivers in the development of drug-resistant pathogens. AMR is a global health threat that requires urgent multisectoral action to achieve the United Nation’s Sustainable Development Goals.

At Teva, we are committed to the responsible production of antimicrobial compounds and minimizing their discharge, which can result in AMR, from our manufacturing facilities and extended supply chain. Also, we serve on the board of the AMR Industry Alliance, which brings together more than 100 biotech, diagnostics, generics and research-based pharmaceutical companies to drive progress. In addition, we are working with the alliance to develop a third-party certification program for independent experts to confirm when an antibiotic product meets standards. Like companies, patients can also play a role in eco-pharmacovigilance by properly disposing leftover or expired medicines at drop-off sites instead of emptying containers down the drain or throwing them into the trash, which over time can harm water supplies or soil. It's small, but appropriate actions such as these that can make a difference in patient safety for all of us and our planet.

NPS-ALL-NP-01083 AUGUST 2023

Find out more

• Read how our Patient Safety team learns more about the medicines we make from the people who take them.
• Explore “A journey into patient safety”, a book by 14 Teva colleagues that explains how pharmacovigilance works to keep patients safe.
• Learn about our winning Formula for patient safety at Teva.
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