How Pharmacovigilance Impacts Patient Safety

November 21, 2022

IPharmacovigilance (PV) is defined as the process and science of monitoring safety and taking action to reduce the risks and increase the benefits of medicines. Chemicals other than food that can alter biological systems are called drugs. A chemical which shows beneficial therapeutic effect on the body is called a medicine. The PV industry aims to monitor the risk/benefit ratio of drugs as well as improve patients’ safety and their quality of life. PV activities includes collecting and managing data on the safety of medicines, reviewing individual case reports to detect signals, risk management to minimize any potential risk associated with the use of medicines, as well as communicating and informing stakeholders and patients. (Claudia Giardina, 2018) (PRAC, 2022)

Why is PV more important than ever in our industry? Simply stated, because it can provide new insights into disease processes and technologically advanced environments, enabling a PV team to collect information that supports prediction, detection and prevention of drug related adverse events. The data, whether real time or artificial intelligence (AI) is the “crown jewel,” and understanding the trends scientifically is paramount. The future of the PV industry is built around technologies, trends, and differentiators driven with artificial Intelligence, automatic intake, text recognition for auto population of case narrative, automatic case entry, and automated translation. Additionally, there will be multiple types of case reports to satisfy country RA (regulatory authority) requirements (MedWatch 3500A, CIOMS, Health Canada, China ADR or SAE, EU Vigilance, etc,) and automated metric reporting.

It is key to understand the adverse reactions to medicines that are captured in both the clinical and post-market settings. In the pre-approval clinical setting with a medicinal product: all noxious and unintended response to a medicinal product related to any dose are considered as Adverse Drug Reactions (ADRs). However, Adverse Events (AEs) are any untoward events that occurred during drug therapy administration and having no relation with its use or any untoward medical occurrence in a patient or clinical subject. The difference between an ADR and an Adverse Event (AE) is the harm caused by appropriate or inappropriate use of a drug whereas adverse drug reactions are a subset of these events, where harm is directly caused by a drug under appropriate use (i.e. at normal doses) which defines the causal relationship. ADRs account for 5–10% of all hospital admissions (Beijer, 2002) (Baker, 2004) (Kongkaew, 2008) (Al Hamid, 2014). Based on a survey ordered by the European Commission, it has been estimated that 5% of hospital admissions in Europe are due to ADRs, 5% of all hospitalized patients experience an ADR during hospital stay and ADRs represent the fifth most common cause of death in hospital setting. A meta-analysis conducted by Lazarou et al (Lazarou, 1998) found that ADRs were the fourth to six highest cause of death in the United States, following ischemic cardiopathy, cancer, and stroke. In relation to mortality Davies et al (Davies, 2009) found an increased risk in patients who experienced an ADR compared to those who did not.

Any medicine is said to be safe only when its benefits are greater than the associated risk. With the assistance of PV, the complete safety profile of a marketed medicine/drug is possible with a constant and continuous monitoring in a diverse population. During the research and development of a medicine/drug, PV collects data which reflects the safety and effectiveness of a drug prior to submission for marketing. The data is collected using various databases like VigiBase, EudraVigilance and FAERS. Approximately 50% of ADRs are preventable (Davies, 2009) (Pourseyed, 2009) (Farcas, 2010) (Hakkarainen, 2012), providing strong evidence that post-marketing drug surveillance plays an increasingly important and essential role, mainly in assessing benefit/risk ratios, health economics, and public health. Once a medicinal product is marketed and in use by patients, the Marketing Authorization Holder (MAH) continues to be responsible for monitoring its safety. PV keeps a constant watch on the drug throughout its life cycle, recording drug related adverse effects and other problems. This drug surveillance, which is aimed at protecting the public, allows Regulatory Authorities to modify the Summary Product Characteristics (SPC), released by the MAH for any new medicinal product. Post-marketed drug reports can include AEs reported from Health Care Professional (HCPs), consumers, regulatory bodies, and other sources like literature and social media. Depending on how widely used the drug is, there can be thousands and thousands of AEs a year which are reviewed individually and in aggregate to determine whether there is a new signal, which would then be further assessed. Every drug is monitored in this fashion from approval until the drug is no longer marketed.

Some Important Safety Databases

  • VigiBase: VigiBase is the single largest drug safety data repository in the world Since 1978 the Uppsala Monitoring Centre (UMC; established in Uppsala, Sweden) on behalf of WHO, have been maintaining VigiBase. Vigibase is used to obtain the information about a safety profile of a medicinal product These data are used by pharmaceutical industries, academic institutions and regulatory authorities for statistical signal detection, updating periodic reports, ICSR comparisons with company databases and studying the reporting patterns. The data is collected from each of its 110 member states. About a hundred thousand ICSRs are added each year.
  • EudraVigilance: A centralized European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
  • FAERS: FDA Adverse Event Reporting System: This is a database that contains information on adverse event and medication error reports submitted to FDA.

What makes Linical’s Global PV team/service different is that we have Project Managers (PMs) in the US, Canada, India, Japan, and EU that are English speaking with an additional 5 languages represented (Hindi, German, Spanish, Japanese, Chinese).

PV services are different than the clinical research services in that the information collected from Safety Data monitoring ultimately improves patient safety, which achieves Pharmaceutical and Biotechnology goals and endpoints. Continuous monitoring of Adverse Events contributes to the assessment of benefit, harm, effectiveness, and risk of medicines.

Are you qualified to be a pharmacovigilance professional at Linical? Our global and regionally based professionals all agree that you must be a team player, have strong organizational and medical writing skills, hold a solid understanding of medical terminology, expert knowledge of regulatory safety reporting guidelines and/or regulations, experience entering data into a safety database, good communication skills, and have proficiency in Microsoft Office suite.

PV is an important service and role within the Biopharma industry and will continue to evolve. As leaders in PV services, Linical ensures that not only are we dedicated to improving patient safety but that we also build customized solutions with our clients to achieve their objectives.


Abhay Thaker
PVA-II - Linical Americas


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