World Patient Safety Day: Strategies for Transparency and Patient-Centered Care

In an exclusive interview on the eve of World Patient Safety Day, Gurpreet Singh, VP & MD, Integrated Safety at IQVIA, shares his views on the current state of patient safety, the importance of awareness, managing new risks, utilizing technology, and promoting partnerships for improving outcomes in the pharmacovigilance space.

How do you believe the pharmaceutical industry can enhance efforts to ensure patient safety, particularly in developing regions?  

In developed countries especially those with well-established regulated pharmaceutical industries, there is increased efforts towards improving patient safety. However, in the developing countries, there is more to be done. This includes raising awareness through patient safety campaigns, forums, and discussion groups. The aim is to create the environment that would foster patient safety reporting and focus on the outcomes. This awareness needs to be nurtured in the pharmaceutical industry especially in the developing countries in order to ensure that the patient comes first in everything that is being done. Establishing such environment is crucial for enhancing patient safety and making it a core concept in healthcare organizations.

What are the most significant emerging risks in drug development and distribution that could impact patient safety, and how should the industry address them?

New risks in drug development are a major concern in drug safety as the field grows with new technologies, complicated therapies and changing regulations. For instance, innovative technologies like gene therapies, immunotherapies, nanomedicine, and personalized medicine present new and enduring risks that need a change in pharmacovigilance systems. These innovations are also challenging the regulatory frameworks, necessitating changes in the guidelines and development of new risk management strategies. Polypharmacy, drug-drug interactions, and the use of digital health technologies add other layers of complexity that the industry needs to overcome to guarantee safety.

Moreover, the fact that the manufacturing and distribution of drugs has gone global also brings other challenges. Special attention is required in order to address the challenges connected with quality control, counterfeit products, and product availability. Nevertheless, they present the chance for the industry to develop and enhance the patient safety measures, making it a priority.

Therefore, although new risks in the drug development process are apparent threats, they are critical factors that need to be taken into account when it comes to people’s health. As the pharmaceutical industry is constantly changing, the ways in which it addresses these risks will determine the effectiveness of treatments for patients across the globe.

With the rise of personalized medicine, how can the industry ensure that novel therapies maintain the highest safety standards across diverse patient populations?

Personalized medicine, though a novel and important field, has some challenges. It prescribes treatments according to genetic or molecular indicators; this has implications. For instance, if the patient’s genes are misunderstood, precision treatments are likely to have side effects. Also, the abuse or misinterpretation of genetic information may lead to wrong treatment decisions which may be dangerous for the patient. To avoid these risks, personalized medicine has to be accompanied by genetic testing, accurate diagnosis, and constant observation of side effects that may occur. A cautious approach has to be taken in order to avoid complications as the fields of personalized and precision medicine develop.

What role do you see for technological advancements in improving patient safety across the drug lifecycle—from research to post-market surveillance?

Over the last two decades, technology has played a massive role in the changes that have occurred in patient safety. It has improved data handling and safety evaluation so as to facilitate decision-making. In the future, there will be increased enhancement of data collection through technology such as wearable devices that will enhance the real-time data of patient safety, thus enabling timely decision making. Furthermore, artificial intelligence and machine learning are analyzing safety patterns, thus contributing to the prevention of adverse occurrences in a more effective manner. Consequently, technology is moving pharmacovigilance from a post-marketing surveillance model to a pre-marketing risk prevention model, which will further develop and improve patient safety in the future years.  

How important is collaboration between regulatory bodies, healthcare providers, and pharma companies in ensuring patient safety, and what steps can be taken to strengthen these partnerships?

It is crucial to have collaboration in the development of patient safety and pharmacovigilance. The implementation of safety management solutions is based on the cooperation between the regulatory authorities, healthcare organizations, pharma companies, and CROs. This collaboration is important in co-coordinating different activities within organizations and to make sure that real-time safety actions are taken. This is already being done through the channels and platforms in the industry where decisions and discussions concerning enhancing patient safety occur. These collaborative networks and events make it easier for all the parties involved to address safety issues in a coordinated manner. After COVID, there has been a shift to such collaboration with more focus on the improvement of safety measures. In the future, these forums and channels will also keep on promoting the improvement of patient safety since everyone in the industry will be on the same page.

Looking forward, what are the key strategies the pharmaceutical industry should adopt to foster a culture of transparency and patient-centered care in drug development and safety monitoring?   

The main approach to patient safety is to put the patient at the heart of all endeavours, as the patient is the subject of medication use, whether in clinical trials or pharmacovigilance. Besides, the application of human-machine technologies and the use of digital advancements should be scaled up to improve patient safety. Another important aspect is the progress of real-world evidence to guarantee that data changes patient safety to a great extent, moving from reactive to proactive pharmacovigilance. This change will require the current safety practices to be redesigned using analytics, technology and real data to come up with a new patient safety model.