By Elizabeth Iwuamadi 
During Med Safety Week, we reflect on the importance of reporting adverse events
Reporting adverse events is fundamental in identifying potential safety issues or any associated risk in drug and supports in better characterising the benefit. As per GVP definition, an adverse event (AE) is any untoward occurrence in a subject to whom a medicinal product is administered, and which does not necessarily have a causal relationship with the treatment. On the other hand, an adverse reaction is a response to a medicinal product which is noxious and unintended (response here implies a causal relationship between the event and the treatment).
Typically, people are willing to report adverse drug reactions (ADRs) because they suspect a relationship between a medicine and the event. However, it is important to report all AEs even when it is not certain that the medication has caused it, or if the reaction is expected or if other medications have been given at the same time.
Why do we need to report all AEs? 
Reporting of all AEs, even if they are not perceived as particularly harmful and are not considered to be related to the medicine is crucial for several reasons:
- Patient Safety: Reporting adverse events helps identify potential risks associated with medications, treatments, or medical devices. This can prevent harm to other patients by alerting healthcare providers and regulatory bodies about any emerging complications associated with the product
- Identifying Patterns and Trends: When adverse events are reported, they can help detect patterns or trends that may not be immediately apparent. This can lead to a better understanding of benefit-risk profile.
- Regulatory Oversight: Regulatory agencies like the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency) rely on adverse event data
- to monitor the safety of drugs and medical devices after they are released to the market. The information helps them decide whether further action is needed, such as issuing new warnings, restricting use, usage recommendations or even withdrawing products from the market.
- Improving Medical Research: Reporting AEs could help in adding to the body of knowledge about the safety and efficacy of treatments. It can help improve post-marketing surveillance systems, leading to better future treatments.
- Informed Decision-Making: When healthcare professionals report adverse events, they help ensure that other healthcare providers and patients are aware of potential risks. This enables more informed decision-making when prescribing or using treatments.
In summary, reporting adverse events helps enhance patient safety, contributes to the scientific body of knowledge, helps in early detection of emerging safety issues, ensures regulatory oversight, and improves the overall quality of medical care.
Why are some AEs not reported?
A recent systematic review by Patricia Garcia-Abeijon et. Al (2023) on factors associated with underreporting of adverse drug reactions by health care professionals, identified several key contributing factors, including lack of knowledge to recognize the ADR, its importance and requirements needed to report; procrastination and postponing the notification; ADR resolved, or patient stopped taking the medication.
In another study by Johansen et. Al (2021), only 39.1% of adverse events in obstetric care in Norway were reported. Johansen et al suggested several reasons for under-reporting adverse events including shame and guilt or for fear of punishment. There could also be other reasons such as the feeling that AE reporting is less of a priority than all the other urgent tasks for busy healthcare professionals, the difficulty or ease of reporting in that region, or reluctance borne out of the belief that the report will not make a difference overall. There could also be a belief that reporting an AE will somehow lead to legal action. The ‘reporting culture’ differs between clinical environments and different countries.
What happens to the AE reports?
When an AE or ADR report is received by a regulatory agency or manufacturer of the medicine, it is entered into a safety database. The name and contact details of the patient are not entered so that only the details of the event and any other information that is relevant to the assessment of the event will be stored.
There are sophisticated algorithms used by global pharmaceutical companies and regulatory agencies around the world to detect “signals” (suggestions of new ADRs or new information on existing ADRs). If a signal is detected this is reviewed by specialists called pharmacovigilance scientists and medics to understand it further. If they find sufficient information to support a causal relationship they will update the product information leaflet to inform future patients of the possible risks. If there is adequate information in those reports it may even be possible to suggest ways to minimise the risk of developing that AE or ways to treat it. This is vital information to help improve patient safety.
How to report an AE:
In some countries there is an established reporting system to send the AE directly to the regulatory agency. However, all manufacturers must have a medical information department who will provide a telephone number for you to call and report AEs directly to them any time of the day. If you search online, you can find this number and let the medical information team know the details of the event. If you don’t wish to do this you can report the AE to your pharmacist or to any healthcare professional you are seen by and ask them to report it for you, but this is not guaranteed.
There are only four requirements needed for a valid adverse drug reaction report (you could call them the “fantastic four”):
- An identifiable patient (e.g. date of birth, age, gender)
- Suspect medicine
- Identifiable event
- Identifiable reporter
This is not much information. Therefore, you can imagine many reports on the safety database may not be very helpful.
What information should I report?
There are some pieces of information that will make AE reports much more useful for those assessing the event. These include:Medication: name, dose and any other details of the medication (e.g. formulation such as tablet/syrup etc).
Timing: when did you start and stop the medicine and when did the AE begin and end?
Medical conditions: why did you take the medicine? Any other conditions you suffer from.
Concomitant medications: any other medicines or herbal remedies that you were taking at the time of the event (including those you bought over the counter). If you stopped taking a regular medication just before the event began it is important to mention this.
Event: what happened? Providing as much detail as possible will really help in assessing the report, particularly any hospitalisation or treatments.
Dechallenge: what happened when you stopped taking the medicine? Did the AE resolve?
Rechallenge: did you start taking the medicine again? If so, did the AE recur?
If you think there is something relevant that is not in the above list (e.g. the event happened just after working in the garden or painting the fence) it is important to state it.
Every AE report can make a difference. If you have an AE to report in the UK, you can report it directly to the regulatory agency here.
In countries outside the UK you may also have a local regulatory reporting system, but even if not, you can call the manufacturer to report the event at any time.
