The pharmaceutical industry plays a fundamental role in the development, production and sale of medicines and other health products, focused on preventing, diagnosing, treating, or curing diseases, thus providing a better quality of life for people. However, these products can have adverse effects, that is, harmful and unintentional reactions that occur after their use, which can cause harm to patients’ health and even lead to death.
For this reason, the pharmaceutical industry must conduct a process called pharmacovigilance. Pharmacovigilance in the pharmaceutical industry involves several stages, from research and development, through production and distribution, to after-sales and post-marketing. At each stage, the pharmaceutical industry must follow national and international standards and regulations, such as those from Anvisa, the FDA and the EMA, among others, which establish the requirements and responsibilities for performing pharmacovigilance.
Have you ever heard of pharmacovigilance? Are you aware of the side effects of medicines and other health products? Do you know how to identify, prevent, monitor, and communicate these effects? If this is a subject that interests you, continue reading our post, as we will explain what pharmacovigilance is, why it is important and how it can be implemented.
What is pharmacovigilance?
Pharmacovigilance is the science that studies the adverse effects of medicines and other health products, with the purpose of identifying, preventing, monitoring, and communicating adverse events related to the use of these products. Pharmacovigilance is an essential activity to ensure the safety, efficacy and quality of medicines and other health products, as well as to assess the benefits and risks of these products, allowing measures to be taken to minimize harm and maximize benefits.
Why is pharmacovigilance important?
Pharmacovigilance is important for several reasons, including:
• Protect public health and patient safety by avoiding or reducing the adverse effects of medicines and other health products, which can cause morbidity, mortality, disability, and additional costs to the health system.
• Promote the rational use of medicines and other health products, educating healthcare professionals and patients about indications, contraindications, interactions, doses, routes of administration, side effects, product warnings and precautions, as well as on the measures to be taken in case of adverse events.
• Contribute to the development and innovation of medicines and other health products, providing information on the effectiveness, safety, and quality of products, as well as on the needs and expectations of users, assisting in research, development, production, regulation, marketing, and post-marketing of products.
• Comply with national and international standards and regulations, such as those established by Anvisa, FDA, and EMA, among others, which establish the requirements and responsibilities for conducting pharmacovigilance, as well as the penalties for non-compliance with these standards and regulations.
How to implement pharmacovigilance?
Pharmacovigilance involves several steps, from collecting, recording, analyzing, and communicating data on adverse events to evaluating, monitoring, and taking actions to prevent or correct identified problems, and requires the participation of several professionals, such as researchers, developers, producers, distributors, pharmacists, doctors, nurses, among others, who must collaborate in the collection, recording, analysis, and communication of data on adverse events related to medicines and other health products.
Furthermore, the pharmaceutical industry must count on the collaboration of patients, consumers, health authorities, regulatory bodies, partners, and customers, who must report adverse events that occur after using the products.
To implement pharmacovigilance, it is necessary to follow some steps, such as:
• Collect data on adverse events, using sources such as spontaneous reports, clinical studies, epidemiological studies, scientific literature, media, and social networks, among others.
• Record data on adverse events, using tools and systems that can store, organize, and manage data, such as SoftExpert Suite, software for the pharmaceutical industry that covers all aspects of pharmacovigilance management.
• Analyze data on adverse events, using statistical, epidemiological, and pharmacological methods, to identify patterns, trends, risk factors, severity, causality, frequency, and impact of adverse events.
• Communicate data on adverse events, using channels such as reports, newsletters, alerts, notifications, and publications, among others, to inform healthcare professionals, patients, consumers, health authorities, regulatory bodies, partners, and customers about adverse events and the measures to be taken.
• Evaluate data on adverse events, using criteria such as benefit/risk, cost/effectiveness, quality of life, among others, to verify whether medicines and other health products are complying with their objectives and whether there is a need for changes or improvements in these products.
• Monitor data on adverse events, using indicators, goals, standards, among other items, to monitor the performance, evolution, and outcomes of medicines and other health products, as well as pharmacovigilance processes and actions.
• Take action based on data on adverse events, using tools and systems that can plan, execute, control, and improve actions, such as SoftExpert Suite, software for the pharmaceutical industry that covers all aspects of pharmacovigilance management. Actions can be corrective, to resolve identified problems, or preventive, to prevent problems from occurring or recurring. Actions may involve changes to medicines and other health products, such as changes in formulation, packaging, labeling, leaflet, dose, route of administration, indication, contraindication, interaction, side effects, precaution, warnings, among others. Actions may also involve changes in pharmacovigilance processes and practices, such as reviewing protocols, methods, tools, systems, channels, criteria, indicators, goals, and standards, among others.
Meet SoftExpert Suite
Pharmacovigilance in the pharmaceutical industry is a challenge that requires planning, organization, management, control and continuous improvement of processes and information related to adverse events. To this end, the pharmaceutical industry must use tools and systems that can streamline and integrate pharmacovigilance activities and information, such as SoftExpert Suite, software for the pharmaceutical industry that covers all aspects of pharmacovigilance management, from collection, registration, storage, analysis, and communication of data on adverse events, to the management of projects, documents, risks, changes, audits, non-conformities, corrective and preventive actions, indicators, training, suppliers, customers, complaints, health surveillance, among others.
SoftExpert Suite is a software solution that allows automation, standardization, traceability, and continuous improvement of pharmacovigilance processes, increasing productivity, quality, safety, and competitiveness in the pharmaceutical industry. Moreover, SoftExpert Suite facilitates communication, collaboration, and integration among different areas and units of the pharmaceutical industry, as well as with regulatory bodies, partners, and customers.
If you want to learn more about SoftExpert Suite, the software for the pharmaceutical industry that will transform your pharmacovigilance management, access the link below and request a free demo.