Good pharmacovigilance practices (GVP) are a set of guidelines established by regulatory authorities to ensure the safety of medicinal products. These guidelines provide a comprehensive framework for monitoring, evaluating, and reporting adverse drug reactions (ADRs). However, there are certain situations where exceptions or modifications to GVP may be necessary.
In the ever-evolving world of pharmaceuticals, ensuring patient safety remains a paramount concern. As new drugs emerge and treatment options expand, the importance of pharmacovigilance, the science of monitoring and evaluating drug safety, has never been greater. To address the growing complexity of pharmacovigilance tasks and enhance the effectiveness of drug safety surveillance, the industry is embracing the transformative power of artificial intelligence (AI) in pharmacovigilance and cutting-edge technology.
According to the World Health Organization (WHO), only 27% of lower-middle-income and low-income economies have national pharmacovigilance systems registered with the WHO program, compared with 96% of the high-income countries in the Organisation for Economic Co-operation and Development. ADRs are estimated to cause 2.6 million deaths each year worldwide, with a disproportionate number of these deaths occurring in developing countries.
In the realm of modern medicine, hope has taken on a new form - Advanced Therapy Medicinal Products (ATMPs). These groundbreaking therapies, utilizing genes, cells, and tissues, hold the potential to cure diseases that were once deemed incurable. Yet, within this potential lies a complexity that challenges the very core of pharmacovigilance. As we venture into this uncharted territory of medical advancement, understanding and addressing these complexities become imperative.
In the pharmaceutical industry, ensuring patient safety is paramount. As new medications are developed and introduced into the market, it becomes crucial to provide accurate and comprehensive information to healthcare professionals and patients. This is where labeling and pharmacovigilance play a pivotal role. Labeling serves as a vital communication tool, providing essential information about a drug's efficacy, dosage, potential side effects, and contraindications.
The COVID-19 pandemic has brought about unprecedented changes in the healthcare industry, including the Pharmacovigilance (PV) process. The pandemic re-emphasized the role of PV in the pharmaceutical industry. As personalized medicine gained popularity, the tactics of pharmaceutical manufacturers and the PV process flow for ensuring the end-user’s safety had to alter. The drug/Medical Devices & Vaccines (MDV) manufacturers faced more challenges as the market transitioned towards personalized medicine, which led to an alignment with new trends and technologies.
In Pharmacovigilance (PV), the examination of safety signals should be a continuous process, and Manufacturing Authorization Holders (MAHs) must have a well-defined mechanism in place to record, evaluate, communicate, and act on possible PV hazards as needed.
COVID-19 caused major disruption in Pharmacovigilance (PV) efforts, particularly post-marketing surveillance. Due to the pandemic's rapidly increasing volume of data and shifting Regulatory and consumer trends, PV leaders were forced to rethink their traditional safety data management processes and PV technology to bring unprecedented levels of scalability, reliability, and agility to their workflow. PV has been on the front lines of this pandemic since its inception, assisting clients in researching COVID treatments and vaccines.
Pharmacovigilance (PV) involves activities for detecting, assessing, understanding, and preventing adverse drug effects/adverse events (AE) of drug products to ensure the safety of the patients. In the post-marketing phase of any pharmaceuticals or biologicals manufacturing company, budgets are mainly allocated to processes such as Adverse Drug Reaction (ADR) reporting and case processing, aggregate reporting, and signal detection.