Pharmacovigilance, also known as drug safety surveillance, is the process of monitoring, identifying, and assessing medicinal products’ potential risks and benefits. It is an essential part of ensuring the safety and efficacy of drugs for patients and healthcare providers. If we’re approaching the matter creatively, the history of pharmacovigilance is long and complex, tracing back to ancient civilizations and evolving through centuries of medical discoveries and advancements.
What is Pharmacovigilance in modern day society?
Pharmacovigilance is the process of monitoring the safety of medicines after they have been approved for use, including detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It is an ongoing process that involves collecting, analyzing, and disseminating information about the safety of medicines, aiming to improve patient care and public health. However professional that may sounds, remember we’ve come a long way. Let’s dive into the history of pharmacovigilance.
The history of Pharmacovigilance
The earliest known records of pharmacovigilance date back to ancient civilizations such as Egypt, Greece, and Rome, where doctors and healers recorded the effects of various medicinal plants and substances. These ancient healers used these records to identify which treatments were most effective and which had dangerous side effects.
However, it was not until the 19th century that pharmacovigilance began to take shape as a formalized field of study. The advent of industrialization and the mass production of drugs increased the number of adverse drug reactions (ADRs) reported. In response to this, we established national and international organizations to monitor and study the safety of drugs.
One of the earliest examples of modern pharmacovigilance was the establishment of the Therapeutic Index in the United States in the 1920s. We used this index to evaluate the safety and efficacy of drugs, and it served as the foundation for developing the modern drug safety system.
In the 1960s, the World Health Organization (WHO) established the global ADR monitoring program, the WHO Collaborating Centre for International Drug Monitoring. This program aimed to collect and analyze ADR reports from around the world to identify potential safety concerns and improve the safety of drugs.
The thalidomide crisis of the 1960s. This tragedy, in which thousands of babies were born with congenital disabilities after their mothers took the drug thalidomide during pregnancy, brought the issue of drug safety to the forefront and led to the creation of regulatory systems for ensuring the safety of medicines.
In the 1970s, the United States Food and Drug Administration (FDA) implemented the Adverse Drug Reaction Reporting System (ADRRS), which required pharmaceutical companies to report any adverse reactions associated with their drugs. This system served as a model for other countries and remains an integral part of the modern pharmacovigilance system.
In the 1990s, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established to harmonize the regulatory requirements for the approval of drugs in different countries. One of its key objectives is to ensure the safety and efficacy of drugs, and it has developed several guidelines and standards to support this goal.
In the 1995, the European Medicines Agency (EMA) was established, and it began to play a leading role in regulating drugs in the European Union. One of its essential functions is the monitoring and assessment of the safety of drugs, and it has implemented several systems and programs to accomplish this goal.
In the early 2000s, the FDA and the European Medicines Agency (EMA) introduced the concept of a Risk Management Plan (RMP), which is a document that outlines the measures that pharmaceutical companies will take to ensure the safe use of their products.
The Vioxx scandal. Another tragic event that relates to pharmacovigilance is the case of the anti-inflammatory drug Vioxx (Rofecoxib). In 2004, a study showed an increased risk of heart attack and stroke in patients taking the drug leading to the drug’s withdrawal from the market. It was later estimated that the drug had caused more than 27,000 heart attacks and sudden cardiac deaths.
This event was a significant pharmacovigilance incident as it highlighted the importance of continuous monitoring and risk-benefit evaluation of drugs even after they have been approved and marketed. It led to increased scrutiny of other COX-2 inhibitors and also led to changes in the way clinical trials were conducted and in the way the FDA evaluates the safety of drugs. It also led to the creation of new regulations and guidelines for pharmacovigilance in the US and Europe, emphasizing the need for better post-marketing surveillance.
Professionalization in Pharmacovigilance
A number of different events and developments have accelerated the professionalization of pharmacovigilance. Some of the key factors include:
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The increased use of new technologies:
With the development of new technologies, such as electronic health records and big data analytics, it has become easier to collect, analyze, and share information about the safety of medicines, which has helped to improve the effectiveness of pharmacovigilance.
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The increase in global collaboration
With the globalization of the pharmaceutical industry and the rise of international organizations such as the World Health Organization (WHO), there has been an increase in collaboration among different countries and organizations to share information and best practices about drug safety.
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The increased regulatory requirements
In recent years, regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) implemented stricter guidelines for pharmacovigilance, which has led to greater focus on drug safety and professionalization of the field.
All these events and development have helped to raise awareness of the importance of pharmacovigilance, and to improve the processes and systems in place to monitor the safety of medicines.
How will Pharmacovigilance evolve?
In recent years, advances in technology and data science have greatly improved the ability of pharmacovigilance systems to detect and analyze potential safety issues. For example, electronic systems for reporting ADRs have been implemented in many countries, and data mining techniques are being used to identify patterns and trends in ADR reports. Additionally, the use of big data and artificial intelligence (AI) is expected to further improve pharmacovigilance systems’ ability to detect and analyze potential safety issues.
Overall, the history of pharmacovigilance is a story of evolution and adaptation. From ancient civilizations to modern times, the field has grown and changed to meet the needs of patients and healthcare providers. Today, it continues to play an essential role in ensuring the safety and efficacy of drugs, and we expect it to continue to evolve and improve.
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What do you need to know while preparing RMP for EAEU and CIS region?
Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team’s should be familiar with legislation requirements for RMP preparation in different regions. Within this article, we will concentrate on the Eurasian Economic Union (EAEU) and identify specific conditions of EAEU countries as well as to try to understand the expectations of Competent Authorities in this region.
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Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers, pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder. During the National semi-annual conference „Pharmaceutical News“, State Medicines Control Agency presented the statistics of suspected ADRs reporting in Lithuania.
Biomapas appoints Head of Global Pharmacovigilance
March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, Biomapas continues to strengthen its international team and geographical coverage of its services globally.
What is a Safety Signal?
Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.
Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions
PV legislation introduced by the European Commission in 2012 and GVP guidelines together with local requirements committed each MAH to perform literature review in countries where their products are present. Compliance with mandatory requirements and guidelines is not always a simple task when local requirements and specifics come along. In this article, we will take a closer look at these challenges and specifics for local literature surveillance in different regions as EU, CIS and LATAM.
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On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.
Harmonization of EAEU GVP: CIS is getting more vigilant than ever before
On the 6-7 March, Biomapas Pharmacovigilance Department management and team from the CIS region participated in a meeting in Minsk. It was dedicated to strengthening collaboration between the team members as well as updating knowledge on latest PV trends. We discussed the most recent releases of legislation, such as Eurasian Economic Union Good Pharmacovigilance Practice harmonization and the importance of a teamwork approach with Biomapas’ PV Project Manager CIS, Aliaksandr Bakshtanovich, MD.
