How the safety of medicines is monitored



The Medicines Authority monitors the safety of medicines after they have been placed on the market. Before medicines are given a licence to be placed on the market, their safety is scrutinised through clinical trials. However, the conditions under which patients and medicines are studied in clinical trials do not necessarily reflect the way the medicines are used in the real-life setting. In some cases medicines may cause adverse reactions (side effects) that offset the beneficial effect offered by a medication. Therefore the Medicines Authority, together with patients, healthcare professionals and the manufacturers work together to monitor the benefit of medicines when compared to the side effects of medicines as used by patients and consumers.

Side effects

A side effect (also called an adverse drug reaction, or ADR), is an unwanted effect of medicine or healthcare product that may be unexpected. 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.  In such instances, it might be a while before one realise that the medicines and reaction may be connected. 

Some side effects come about because medicines can interact with other medicines, with some foods, or with existing health conditions like diabetes or heart problems. At times, the symptoms could show up because there is another illness developing at the same time and thus not necessarily due to the use of a specific medicine.

Some side effects are known to occur. Inside every medication package there is a Package Leaflet which tells you how the medicine works and how to use it correctly. The Package also gives you information about side effects that are already known to happen with a medication. The chances of a side effect happening are estimated in this leaflet but sometimes, some side effects that occur may not be in the Package Leaflet at all.  As a patient or consumer one can report side effects independently if the side effects are already mentioned in the leaflet or not, to the Medicines Authority; you can report side effects yourself or ask your doctor, dentist or pharmacist to help you report them. 

Why report a side effect?

The information on side effects helps in enhancing the safety of products as the Medicines Authority and the product's manufacturer will have a more 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 it is recommended that side effects are discussed with the healthcare professional as doctors, pharmacists or dentists can determine whether the side effect means that the treatment needs to be changed.

Reporting side effects may contribute to:

  • the identification of previously unrecognised rare, or serious side effects
  • changes in the Package Leaflet, or other regulatory actions such as a letter to inform doctors to be aware of side effects caused by a particular medicine
  • in some occasions the withdrawal of a medicine from the market
  • international data that healthcare professionals can use regarding benefits, risks and effectiveness of medications
  • having safer medicinal products that benefit the lives of Maltese patients and consumers.


Patients and consumers can report effects on all types of medicines including those bought with/without a prescription and also vaccines.

The form used to send a report is called the Adverse Drug Reaction form (ADR form) and it has four pieces of information that must be filled in (to the best of your knowledge):

  • a way to identify the patient who experienced the side effect
  • a description of the side effect
  • the name of the medicine that you think caused the side effect
  • the name and contact details of the person reporting the side effect.


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 handled by Medicines Authority employees who need it to assess the report, which may require follow-up work. The more information filled on the form, the better. It is very important to report the date the side effect occurred, and the dates the patients started and stopped taking the medicine. All this information is used by the Medicines Authority to look for a possible link between the medicine and the side effect.

What does the Medicines Authority do with the reports people send in?

Reports are first checked to make sure the basic information is complete. The Medicines Authority then sends the reporter a letter, thanking them for submitting a report on side effects. This letter includes a tracking number for the report, which should be used to give any follow-up information at a later stage, or if the Medicines Authority needs to contact the reporter for more information.

All valid reports are entered into an electronic database using a standard terminology, and the information is shared with other European medicines authorities in order to see whether patients in other countries are experiencing the same side effects so manufacturers can take the necessary actions.

The seriousness of the suspected side effect is assessed, by considering different aspects including whether the patient or consumer was admitted to hospital or whether a severe disability resulted.

The information from the reports, along with other information, is used to check for new safety concerns about a product. Safety information is published regularly on the Medicines Authority website and can be accessed on the Safety Information page on this website.

Further Information

More detailed information on a medicine can be found on the Medicines Database or by contacting the Medicines Authority.


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