Understanding Pharmacovigilance: Its Significance and Role

What is pharmacovigilance?

It costs around £170 million to research and develop a new pharmaceutical product such as a medicine or vaccine, and it can take, on average, 12-13 years for it to reach the market thanks to the rigorous and strenuous testing process it undergoes. Pharmacovigilance ensures that when it does reach the people who it is intended for it has been through a process of assessment to ensure that it is, firstly, effective and, secondly, it will have no adverse effects. 

Ensuring patient safety through vigilance

The term pharmacovigilance was first used in the 1970s and is used to describe the safety and monitoring of medicines. All drugs have to undergo a process of pharmacovigilance, meaning that the patients who need them have safe access to them, that the risks they face when taking them are minimised, and that they are used effectively.

Importance of Pharmacovigilance

Pharmacovigilance is important to ensure that medicines and drugs are both effective and safe for patients. It highlights any potential issues such as the safety of drugs and the protection of patients and it enables the production of safe and effective treatments. 

It also allows pharmacovigilance scientists to learn about a medicine’s safety profile to understand how and why it should be prescribed, identify any concerns regarding potential abuse, and discover problems that may lead to injury or death, to avoid potential prosecution. 

Role in Research & Medicine

The role of pharmacovigilance in research and medicine is vital to ensure that any new products do not have adverse effects on patients, even after the product has gone to market. The European Medicines Agency (EMA) is responsible for the ‘evaluation and supervision’ of medicines within the EU and requires that medicine is subject to clinical trials before its safety and efficacy are confirmed. 

Detecting Emerging Safety Concerns 

Sometimes a product is authorised for use but then presents an adverse reaction in some patients. According to the European Commission, there are in excess of 190,000 deaths every year in the EU caused by adverse drug reactions. Its pharmacovigilance system is in place to ensure that should a product make it to market and then present an unacceptable risk to public health, it can be quickly and safely withdrawn. 

Pharmacovigilance Process

There are three stages to the pharmacovigilance process: 

1. Preclinical – using animal testing and clinical trials to identify any potential risks that a new medicine may pose before it is approved by the regulatory authorities for use. 

2. Clinical – testing the drug in a controlled setting in order to assess its safety and efficacy before the approval stage.

3. Post-marketing – after the drug has been approved and is available on the market its long-term safety is monitored through adverse event reporting by doctors, pharmacists and patients themselves.

Signal Detection and Analysis

The pharmacovigilance definition of signal detection and analysis is the process of evaluating further risks and safety signals from a wide variety of sources. These can be biopharmaceutical companies themselves, or the bodies which regulate them. The databases on which the data are stored are periodically monitored and added to other databases to identify potential harmful events. 

Global Pharmacovigilance Efforts

In order to maintain worldwide safety for the maximum number of people global pharmacovigilance efforts are made and reinforced. The World Health Organisation (WHO) maintains a database in which all pharmaceutical companies are invited to participate in order to standardise regulation and to eliminate dubious replica medicines which may be detrimental to people’s health.

International Collaboration in Drug Safety

A vital factor in creating greater transparency and accountability, international efforts to assess compliance with legislation and standards of safety are essential to ensuring the safety and quality of medicines. Regulators throughout the world cooperate so that supply chains can be maintained, duplication can be avoided and limited resources can be maximised. 

Future trends in pharmacovigilance

Technology is leading the way into the future of pharmacovigilance and providing opportunities to further develop the sector. Tech-based solutions such as mobile health apps and digital technology, access to electronic health records, and ‘wearables’ all allow medical practitioners to more easily identify potential problems and deal with them in real-time. 

In addition, personalised medicine, which allows medication to be personally adjusted to the patient’s physiology, genetic traits, environment and lifestyle, will enable more effective monitoring of adverse reactions.

Utilisation of Big Data and AI

The rapid progression of Big Data and Artificial Intelligence (AI) is also advancing pharmacovigilance. The massive, and increasing, amount of healthcare data will enable more efficient and effective insights into pharmacovigilance, improving patient safety even further.

AI is already being used to improve the assessment of drug safety, and techniques such as Natural Language Processing (NPL), and ‘text mining’ allows scientists to gather information on ADRs and drug/drug interactions from a wide range of sources which would have been previously impossible.

Conclusion

In a dynamic and constantly evolving pharmaceutical industry, and as new drugs and therapies are developed, pharmacovigilance is essential to the continuing safety and efficacy of medication which enables people to live longer and healthier lives. If you’re looking for your first or next role in this vital sector, or if you have a position you need to fill, talk to us about the range of pharmacovigilance jobs we have available. Call us on +31 (0)20 2044 502, email us at partner@panda-int.com, or fill in the contact form here.