A side effect, also called an adverse drug reaction, is an unwanted effect of your medicine or healthcare product that may be unexpected and shows up while you are taking a medicine or after you stop the medicine.
A side effect could be something that is felt immediately such as a rash or an upset stomach or it could take a long time to develop such as effects on the heart, liver and kidney.
Side effects show up in different ways. A side effect could appear soon after you start a medicine, and you might suspect a connection right away. On the other hand, a side effect might take time to develop, and it might be a while before you or your healthcare professional start to realise that the medicines and reaction may be connected.
Some side effects come about because medicines can interact with other medicines, or with some foods. Having pre-existing medical conditions such as diabetes or heart problems may also predispose you to experience an adverse event. The Product Information Leaflet found in every medicine package gives more information about these interactions. Patients who have any concerns about interactions are encouraged to speak with their heathcare professional. Sometimes there isn't really a side effect at all; the symptoms could show up because you're developing another illness at the same time, and mistakenly think the medicine was the cause.
Some side effects are known to occur while some others are not expected. The Product Information Leaflet which may be found inside every medicine package tells you how the medicine works and how to use it correctly. This leaflet also gives you information about side effects which you may expect since they are already known to happen with a given medication. Unexpected side effects may on the other hand not be found in the Product Leaflet at all. The chances of of occurrence a side effect may also be described in this leaflet eg. a common side effect is expected to affect between 1 in 10 or 1 in 100 people while a very rare side effect means that fewer than one in 10,000 people are affected.
Benefits and Risks of Medicines
Most people take medicines without suffering any unwanted side effects, however all medicines may give rise to unexpected issues which are also termed adverse events. For a medicine to be considered safe, its expected benefits should be greater than the risk of harmful reactions (side effects). This is known as a positive Benefit-Risk balance. Information on the risks and safety of medicines often becomes known after the product is placed on the market (for more information visit our page on "How the safety of medicines is monitored") and therefore the Benefit-Risk balance may change throughout a products marketed life.
The package leaflet accompanying a medicine will list all of its treatment benefits and also its known associated side effects. Healthcare professionals such as doctors and pharmacists can also provide this information.
Patients and consumers as well as healthcare professionals can report side effects that are experienced while taking a medicine, irrespective of whether the side effects is already mentioned in the leaflet or not.
For HCPs:
Kindly use the archived Adverse Drug Reactions reporting form (for Healthcare Professionals) which may be found here.
HCPs may fill in the ADR form electronically using MS Word and send via email to postlicensing.medicinesauthority@gov.mt
OR
HCPs may fill in the ADR form in ink, scan and then send via email to postlicensing.medicinesauthority@gov.mt
Send to the Marketing Authorisation Holder on the address that can be found on the medicine's package.
HCPs may refer to the Adverse Drug Reaction Reporting & Pharmacovigilance Guidance Notes for Healthcare Professionals for further background and instruction on how to report ADRs. The ADR form for HCPs also contains an instruct sheet overleaf
For Patients:
Patient may choose to report a side effect themselves or may ask a trusted HCP to report on their behalf.
Patients can use the below forms to report directly to the Medicines Authority
Patient / Consumer Side Effect Reporting form - Word Version
Patient / Consumer Side Effect Reporting form - PDF Version
The form can by sent free post [no stamp required] to the Medicines Authority. Fold, staple and post this form.
Alternatively, the form can be submitted electronically to Post Licensing at Medicines Authority: postlicensing.medicinesauthority@gov.mt, after filling in the form using ink and scanning or filled in MS Word.
In case of difficulty write to postlicensing.medicinesauthority@gov.mt
You can report effects on all types of medicines including those bought with a prescription, those bought without a prescription and also on vaccines.
The form on which to report is called the Side Effect Form or Adverse Drug Reaction form (ADR) form and it requires four criteria which must be filled in. Without this information, reports cannot be processed:
The information about a person's identity is kept confidential. Its use is covered by the Data Protection Act and is only looked at by Medicines Authority employees who need it to assess reports which may require follow up work. The more information you can fill in on the report form, the better. Time-lines are very important especially the date the side effect happened, and the dates you started and stopped taking the medicine. This information is used by the Medicines Authority to look for a possible link between the medicine and the side effect. Therefore it is ideal that these dates are filled in to the best of your knowledge.
Patients can ask their doctor or pharmacist to help them fill in the adverse event report form if they have have any problems.
Reports are first checked to make sure the basic information is complete. The Medicines Authority then confirms the receipt of the report and provides the reporter with a tracking number. This number will be referenced in case the Medicines Authority needs to contact you for more information or if you have follow-up information becomes available after the report was submitted.
All valid reports are saved in an electronic database. The information is then shared with other European medicine authorities allowing a comparison with side effects experienced by patients taking the same drug in other countries. This monitoring of side effects prompts actions to be taken by authorities and manufacturers as necessary.
Side effects are also assess, and their seriousness level is graded based on a number of criteria such as hospitalisation, severe disability, and so on. Standard medical terminology is used when classifying the information related to the adverse event. This ensures standardisation which is important when collecting and analysing data from these side effects. This pool of information is then used to check for any new / emerging safety concerns about a medicinal product.
Safety information is published regularly on the Medicines Authority website and can be accessed on the Safety Information page.
The information on side-effects from medicines helps the Medicines Authority and the product's manufacturer build a complete and accurate picture of the experience patients/consumers are having with their medicines. Medicine users or their relatives can report side effects directly to the Medicines Authority. However you should still inform a healthcare professional if you have side effects since only your doctor, pharmacist or dentist can determine whether the side effect means that your treatment needs to be changed.
Your report may contribute to:
The European Medicines Agency has made available to the public its Adverse Drug Reactions (side-effect) database, at the following website www.adrreports.eu
Suspected side effects are reported by patients, consumers and healthcare professionals. These reports are suspected but not necessarily established side effects. They may not be related to or caused by the medicine as only a reasonable suspicion is necessary for a report to be lodged.
Throughout a medicinal product's life cycle, the data compiled from any reports that are received and the data which is already available, is analysed regularly by regulatory authorities The result of such analysis is carried out to ensure that any particular medicinal product's benefits remain greater than their risks and to optimise their use. Each report available on the public website contributes towards the total number of suspected side effects reports submitted to the EU-wide database on side-effects (EudraVigilance). These aggregated data can be viewed by age group, sex, type of suspected side effect and outcome.
The European Medicines Agency has also published a leaflet to encourage European citizens to report side effects. These reports help to gather more information on medicines on the market. In a real-life setting, where a larger and more diverse group of patients use the medicines, less common side effects may be identified through this reporting after they are placed on the market.
Patients can report side effects directly to the authorities in all EU Member States, including the Medicines Authority. The leaflet explains how patients can report side effects and includes contact details for all Member States. In Malta patients can use the patient side-effect online form. A patient should always report a side-effect to the authority of the member state in which he/she resides. The leaflet is available here.
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