Vaccines
Adverse Events / Drug Reactions Reporting
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VigiAccess
- VigiAccess - by WHO Collaborating Centre for International Drug Monitoring / Uppsala Monitoring Cetnre
What is pharmacovigilance?
Pharmacovigilance is the science and practice of detecting, assessing, understanding, and preventing the side effects and other problems related to medicinal products, which includes medicines and vaccines. Pharmacovigilance focuses on science and methodology but also on supporting good therapeutic decision-making about the benefits and risks of treatment options for people taking medicinal products. All medicinal products need to be monitored as long as they are on the market, since it is unlikely that less frequent side effect will be observed while the products are being developed. When a medicinal product becomes available and more people receive it, previously unknown effects are more likely to emerge. Medication errors, bad quality drugs, and inappropriate use of medicinal products are also part of pharmacovigilance.
What is VigiAccess?
VigiAccess is a web-based tool for searching VigiBase (see below) to retrieve summarised statistical representations of the data available on potential side effects that have been reported to the World Health Organization Programme for International Drug Monitoring (WHO PIDM). VigiAccess was designed to deliver greater transparency to the medical safety system by providing a basic overview of the potential side effects reported in association with any particular medicinal product. Please note, in VigiAccess, potential side effects are listed under the heading “Adverse drug reactions (ADRs)”, but this listing includes suspected adverse drug reactions (in relation to medicines) and adverse events following immunization (in relation to vaccines).
What is VigiBase?
VigiBase is the unique WHO global database of reported potential side effects of medicinal products. It contains more than 26 million reports dating back to 1968. The data in VigiBase are provided by the more than 140 members of the WHO PIDM, who share their data to support global pharmacovigilance. All Programme members that share data have their own rules and guidelines for when and how to report information about side effects and what to share with the programme through VigiBase. For example, one member may require that there is at least a probable link between the product and the reaction to warrant reporting to VigiBase, while another may share all events that have been observed within a certain period after the product was administered, whether a link is suspected or not. Understanding the variety of reporting practices used throughout the programme is vital when interpreting the data in VigiBase.
What is Uppsala Monitoring Centre (UMC)?
Since 1978, Uppsala Monitoring Centre (UMC) has advanced the science of pharmacovigilance and inspired patient safety initiatives all over the world. As an independent, non-profit foundation, UMC engages stakeholders who share a common vision of a world where patients and healthcare providers make wise therapeutic decisions in their use of medicinal products. As a leader in the research and development of new scientific methods, UMC explores the benefits and risks of medicinal products, and offers products and services used by health authorities and the pharmaceutical industry worldwide. For more than 40 years, UMC has provided scientific leadership and operational support to the WHO PIDM. As the WHO Collaborating Centre for International Drug Monitoring, one of UMC’s key roles is to maintain VigiBase and its related systems and tools.
What is the WHO Programme for International Drug Monitoring?
In 1968, WHO set up a pilot project in Geneva, collaborating with a small group of governments with the goal of ensuring that early signs of previously unknown medicinal product-related safety problems would be identified and information about them shared and acted upon. This project was later made permanent as the WHO Programme for International Drug Monitoring (PIDM) and, in 1978, the operational activities were transferred to the foundation, WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre (UMC).
Why is it important to report a potential side effect?
When medicinal products are being developed, those products are tested on a limited number of participants selected for clinical trials. While this allows researchers to observe the most common side effects, rare side effects are statistically less likely to be observed at this stage. However, once a medicine is launched on the market, a much bigger and more diverse population is exposed to it, and the rare side effects become more likely to occur. It is vital to identify and investigate unknown or poorly understood side effects to help ensure the safe use of medicinal products, and this can only be done if potential side effects are reported.
How can I report a suspected side effect?
It is important to talk to your healthcare provider about any side effects – they are responsible for reporting that. In many countries, patients are also encouraged to report side effects themselves. Further information may be found on the website of your national regulatory authority for medicinal products or national centre for pharmacovigilance. A current list of members of the WHO PIDM is available here.
What do I do if I suspect I am experiencing a side effect?
Please contact your healthcare provider (such as your doctor, pharmacist, or other qualified medical professional) if you suspect you are experiencing a side effect from any medicinal product. Never stop any medication or change the dose without seeking the advice of your healthcare provider. Your healthcare provider will give the advice you need, and it is very important that you make decisions together about what is right for you. Communication with your healthcare provider is essential as VigiBase is only intended to be used as a reference source. The reports in VigiBase result from suspicions of a relationship between a medicinal product and a reaction. No causal relation has been confirmed. The balance between benefit and harm of a medicinal product is not the same for all patients, and individual decisions must be taken between patients and their healthcare providers.
What happens once a potential side effect has been reported?
The national centre for pharmacovigilance that receives the report will evaluate it and identify unknown or poorly addressed potential risks. The WHO PIDM members anonymise their reports – so that the patients, healthcare professionals, or institutions involved cannot be identified – and forward them to UMC to be uploaded into VigiBase. UMC regularly screens the data to identify, better characterise, and understand potential risks of medicinal products. UMC shares the results of its analyses with the national centres, WHO, and the general public through various channels. For more information, please visit the UMC website.
How is the information on potential side effects presented?
The potential side effects extracted from the reports in VigiBase are structured by mapping the originally reported symptoms to a standardised medical terminology, enabling statistical analyses of the data. One of the benefits of this process is that this makes it possible to group terms that are similar to each other and present them in a hierarchical structure. The standard terminology used in VigiAccess is MedDRA (Medical Dictionary for Regulatory Activities). Please note, VigiAccess only displays the terms actually reported, and the structure of the search result does not represent the complete MedDRA terminology.
What is a safety profile of a medicinal product?
The safety profile provides information about the possible risks associated with a medicinal product. Patients and healthcare providers need to make a benefit-harm assessment to make the decision that best responds to the patient's specific needs and conditions.
Can I compare the safety profile of different medicinal products based on data from VigiBase?
No, it is not possible to compare different substances based on this information and conclude that one is safer than another. VigiBase reports refer to a suspected causal relationship between a medicinal product and an outcome, not a confirmed relation. There might be other reasons for a patient to develop the condition reported. Also, VigiBase does not contain any data about the relative prevalence of use of any drugs. Spontaneous reporting is influenced by many factors and only a small percentage of the occurring adverse drug reactions are notified.
What can we learn from the information in a reporting system?
A spontaneous reporting system provides very important information on potential risks and helps to identify groups of patients or situations in which particular attention or special monitoring might be needed. The information gathered from a spontaneous reporting system is unique, as it covers all populations treated as long as a medicinal product is available on the market. It is also very cost effective.
What does a national centre for pharmacovigilance do?
National centres for pharmacovigilance work either within their respective national regulatory authority or ministry of health, or on their behalf. They collect and evaluate spontaneous reports on potential side effects to medicinal products, advise the relevant authorities, and act as drug information centres for healthcare professionals and the public. Some also operate as poison information centres. The range of activities of national centres varies greatly depending on local needs and resources.
What is a regulatory authority?
Most WHO PIDM members have an authority in charge of approving or licensing medicinal products for use and ensuring that all medicinal products available on the market are effective, of good quality, and have a positive benefit-harm balance (that is, their effectiveness outweighs their risk). Some regulatory authorities are part of a ministry of health, and some are not. Well-known regulatory authorities include the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA).
Why can I only see information on the active ingredient?
When you search for a specific medicinal product – a brand name or trade name – the result will be presented for that particular product’s active ingredients. This one of several necessary measures taken to guarantee that patients, reporters, or treating institutions cannot be identified.
Why can I retrieve data only at continental, not at national level?
Displaying data for a single WHO PIDM member has the potential to enable privacy breaches, especially in the case of members which have only a small number of reports. Therefore, VigiAccess displays data that is grouped according to the United Nations continental definitions.
What can I do if I need more information about data in my nation?
Your national centre for pharmacovigilance may provide you with more information, in compliance with local data protection laws.
Report duplicates
An automatic algorithm, vigiMatch, is used to detect and remove suspected duplicate reports from the dataset. For suspected duplicate reports, only the most complete report is used in the statistics. It is important to note that suspected duplicates may be “false positives”, that is, reports that are not true duplicates, but have been marked as such by vigiMatch. Conversely, there can be “false negatives”, where true duplicates have not been highlighted by the algorithm.
Why are reports duplicated?
There are several reasons why a report could be duplicated. Reports could be sent by multiple caregivers of the same patient, as well as by the patient themselves. Often, pharmaceutical companies are required to submit a report to the appropriate regulatory agency for any potential side effect they gain knowledge of, and reports often contain drugs from different companies, which can result in many duplicates of a single underlying case. Duplication can also arise due to errors when transferring the reports between different systems and databases. Since reports of the same underlying case can come from multiple different sources, it means that the reports are usually not identical. Differences can arise from typographical errors, variability when coding drugs and side effects, and uncertainty in the available case information. This makes it harder to detect if two reports actually describe the same underlying case.
Flu Vaccines
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Quadrivalent recombinant influenza vaccines
- Postmarketing safety surveillance of quadrivalent recombinant influenza vaccine: Reports to the vaccine adverse event reporting system - ScienceDirect
- Quadrivalent Influenza vaccine (Split virion, inactivated) - emc (electronic medicines compendium) on https://www.medicines.org.uk
- Datapharm - Datapharm runs emc (electronic medicines compendium), the UK’s leading provider of trusted medical information, and provides regulatory and compliance software solutions to the pharmaceutical industry.
- Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled syringe Quadrivalent influenza vaccine (split virion, inactivated) - Package leaflet: Information for the user (.PDF)
- Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled syringe - emc - Note in the URL the product # is '666'
