Eurordis - Rare Disease Europe

Medicines go through strict testing before they are available to the public. However, sometimes unexpected side effects can occur when patients use them. Pharmacovigilance is the science of detecting and reporting these side effects of medicines. It also involves taking measures to reduce these risks.

Your experiences with the medicines you or your child take are valuable. By sharing your experiences with others and reporting them to authorities, we can learn more about these medicines and how different people react to them.

Patients play an active role in this process. You’re not just taking prescribed treatments; you can help generate knowledge about these products. Being vigilant when trying a new medicine, staying informed about its properties, positive and negative effects, and sharing your experience are essential. The information below explains how you can report any side effects or adverse events related to a medicine.

Understanding side effects and adverse drug reactions

Medicines can have both positive and negative effects on our bodies. The desired effects aim to prevent, treat, or cure diseases, while the undesired effects are known as side effects or adverse events.

• Side Effect: Sometimes, when you take a medicine, you might experience effects that you didn’t expect or want. These are called side effects or undesired effects. They can be mild or more severe and can happen with any medicine.
• Adverse Drug Reaction: When a side effect is confirmed to be directly caused by the medicine, it becomes an adverse drug reaction. Healthcare professionals carefully investigate and confirm this connection.

It’s important to know that no medicine is entirely risk-free, even if it’s beneficial for many people. Before a medicine is approved for use, experts assess its benefits and risks. However, some risks may only become known after it enters the market, as more patients use it and report their experiences.

The term “toxicity profile” is used instead of “safety profile” because all drugs carry some level of risk. If a medicine shows more unexpected or severe adverse reactions than expected, experts may re-evaluate their decision, take measures to reduce risks, or withdraw the drug from the market if necessary. This ongoing monitoring helps ensure the best possible use and understanding of medicines.

What to do if you suspect an adverse drug reaction?

If you experience a reaction to a medicine that is severe or concerning, or if you notice any possible severe reactions mentioned in the medicine’s notice, it’s essential to get in touch with your doctor or another healthcare professional right away. If the situation is urgent, or you believe it requires immediate attention, don’t hesitate to contact emergency services or visit the nearest emergency unit.

Understanding the inverted black triangle:

After a medicine is introduced to the European Union (EU) market, all medicines are carefully monitored. Some medicines are labelled with an inverted black triangle (▼) to indicate that they are under even closer observation than other medicines. This is because there might be less information available about them compared to other medicines. Possible reasons for this include being new to the market or having limited data on long-term use. It’s important to note that the presence of the black triangle does not mean that the medicine is dangerous.

The European Medicines Agency (EMA) and Member States maintain a list of medicines under additional monitoring in the EU, updating it every month. This ongoing monitoring ensures a comprehensive understanding of medicines and helps identify any potential risks or adverse reactions more promptly.

How to report an adverse event or side effect:

Reporting an adverse event or side effect is crucial for your own well-being and for helping others who might use the same medication in the future. Here’s what you can do:

Speak to your doctor: If you experience a side effect, talk to your doctor first. They will address the reaction and decide whether it should be reported to a pharmacovigilance expert. In serious cases, reporting is mandatory.

Reporting process: If your doctor decides to report the side effect, they will submit a report to EudraVigilance. This is a European database designed to collect suspected side effect reports, managed by the European Medicines Agency (EMA). 

Patient reporting: You can also report the side effect directly if you prefer. Several reporting options are available, including online forms, mobile applications, printed materials from your doctor, pharmacist, or patient organisations, or reporting by telephone. It’s essential to provide all the requested information on the reporting form, as every detail is valuable.

Healthcare professionals’ role: Sometimes, healthcare professionals may not report adverse reactions due to time constraints or lack of awareness about the importance of reporting. In such cases, your report becomes even more crucial.

National rare disease helpline: If you need assistance in reporting a side effect related to a rare disease, you can reach out to the national rare disease helpline in your country for guidance.

Remember, reporting side effects helps experts analyse what happened, determine if it was caused by the medication, and develop measures to reduce the risk of similar reactions in other patients. Your contribution can lead to safer medication use for everyone. Below, you can find information on how to report an adverse event in your specific country.

Should I report my error If I make a mistake when taking a medicine?

We all can make mistakes when taking medicines, especially if the package information is unclear or confusing. If such unclear instructions lead to errors, like taking the wrong amount or the wrong medication, it’s important to report them. By doing so, you help inform the authorities in charge, who can compare different packages and suggest improvements.

You have two options for reporting medication errors:

• Inform your doctor: If you make a mistake with your medication, let your doctor know. They can provide guidance and may report the incident on your behalf.
• Report to the national competent authority: You can also directly report the error to your country’s national competent authority. These organisations oversee medicine safety and effectiveness.

Where can I find information on other reports made by patients?

To find information on other reports made by patients, you can access the EudraVigilance database, which is managed by the European Medicines Agency (EMA). This database stores reports from both doctors and patients, and it contains millions of suspected adverse drug reactions and other related data. Before April 2012, this information was only accessible to pharmacovigilance experts and the pharmaceutical industry.

Now, you have access to this valuable data through the website www.adrreports.eu. By visiting this site and searching for a specific medicine, you can explore the reports made by both healthcare professionals and patients.

The EudraVigilance database contained 53,130 patient reports in the three years preceding the legislation’s operational period and 113,371 reports in the three years after. 

Some countries, such as the Netherlands, Sweden, Belgium, Austria, and Great Britain, had more frequent patient reporting compared to other Member States, with the number of reports per million inhabitants being higher in these countries.

If you need assistance in navigating the database or have any questions related to patient reporting, you can contact francois.houyez@eurordis.org for support.

What happens after I report an adverse drug effect?

After you report an adverse drug effect, here’s what typically happens:

• Resources
  • The European Medicine Agency’s information on:
    • Pharmacovigilance
    • Its Pharmacovigilance Risk Assessment Committee (PRAC).
    • EudraVigilance.
  • EudraVigilance, the European database of suspected adverse drug reaction reports.
  • Safety alerts on medicines will be published by the EMA via their news page and their RSS news feeds.
  • List of national competent authorities for reporting adverse events.
• Pharmacovigilance glossary

  A glossary of terms covering topics including adverse reactions and pharmacovigilance.

  Adverse event (AE); synonym: Adverse experience

  Any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product

  Adverse reaction; synonyms: Adverse drug reaction (ADR), Suspected adverse (drug) reaction

  A response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.
  Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include overdose, misuse, abuse and medication errors.

  Consumer

  A person who is not a healthcare professional – such as a patient, lawyer, friend or relative/parent/child of a patient.

  Healthcare professional

  For the purposes of reporting suspected adverse reactions, healthcare professionals are defined as medically qualified persons, such as physicians, dentists, pharmacists, nurses and coroners.

  Medication Error

  Any unintentional error in the prescribing, dispensing, or administration of a medicinal product while in the control of the healthcare professional, patient or consumer.

  Name of the medicinal product

  The name which may be either an invented name not liable to cause confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.
  The common name is the international non-proprietary name (INN) recommended by the World Health Organization, or, if one does not exist, the usual common name.
  The complete name of the medicinal product is the name of the medicinal product followed by the strength and pharmaceutical form e.g. Elaprase 2 mg/ml concentrate for solution for infusion.

  Pharmacovigilance

  Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
  In line with this general definition, underlying objectives of the applicable EU legislation for pharmacovigilance are:
  • preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure; and
  • promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.
  Pharmacovigilance is therefore an activity contributing to the protection of patients’ and public health.

  Serious adverse reaction

  Serious adverse reaction means an adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
  Life-threatening in this context refers to a reaction in which the patient was at risk of death at the time of the reaction; it does not refer to a reaction that hypothetically might have caused death if more severe.
  Medical and scientific judgement should be exercised in deciding whether other situations should be considered serious reactions, such as important medical events that might not be immediately life threatening or result in death or hospitalisation but might jeopardise the patient or might require intervention to prevent one of the other outcomes listed above. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or the development of dependency or abuse.
  Any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction.

  Spontaneous report, synonym: Spontaneous notification

  An unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organisation (e.g. the World Health Organization, a regional centre, a poison control centre) that describes one or more adverse reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organised data collection scheme.
  Stimulated reporting can occur in certain situations, such as direct healthcare professional communication (DHPC), a publication in the press or questioning of healthcare professionals by company representatives, and adverse reaction reports arising from these situations are considered spontaneous reports, provided the report meets the definition above.