How we monitor the safety of medicinal products



Pharmacovigilance is an ongoing practice that provides information on newly identified risks with medicines, which did not appear during the medication's authorisation process. Before a product is marketed, safety and efficacy experience is is mostly known from research in animals and from use in humans during clinical trials. Clinical trials detect many common and frequent Adverse Drug Reactions (ADRs) to medicines. However some important reactions may take an extended time to develop or occur infrequently. In addition, the controlled conditions under which patients use medicinal products in clinical trials do not necessarily reflect the way the product will be used in hospitals and general practice once it is marketed since clinical trials may have limitations such as;  

  • a low number of subjects participating in the trial
  • exclusion of some age groups
  • other diseases not being present in the subjects
  • other medicines not being taken by the subjects
  • the clinical trial not being long enough to reveal any long term adverse events


Therefore, it is recognized that once medicines are placed on the market they need to be continuously monitored throughout their time on the market. This process of surveillance is known as Pharmacovigilance.

Pharmacovigilance data originates from different sources:

  • spontaneous reports by vigilant healthcare professionals and patients of suspected adverse drug reactions (ADRs)
  • post-authorisation safety and efficacy studies and
  • scientific literature amongst others


Spontaneous reporting by vigilant healthcare professionals and patients/consumers of suspected ADRs is the most common way to monitor the safety and effectiveness of marketed medicinal products. The Medicines Authority works together with health care professionals, pharmaceutical manufacturers and patients to monitor adverse drug reactions.

Adverse Drug Reactions

Adverse drug reactions are noxious and unintended effects to medications. Reactions may occur under normal use conditions of the product or due to other causative factors such as medication errors, occupational exposure and abuse. Reactions may be evident within minutes or sometimes years after exposure to the product and may range from minor reactions like a skin rash to serious and life-threatening events such as a cardiac arrest or hepatic damage.

Adverse Events can also be caused from drug-drug interactions. Due to the large number of drugs present in the market, new interactions between medications have been increasingly reported. Therefore it is becoming very difficult also for healthcare professionals to rely on memory alone to avoid potential drug interactions. Refer always to the Summary of Product Characteristics for information on drug-drug interactions. Online tools found reputable websites may also be useful.

Healthcare professionals need not be certain that a medicinal product caused the reaction in order to report it. Adverse drug reaction reports are, for the most part, only suspected associations.

In Malta all ADRs are collected and collated within a national pharmacovigilance database. The national pharmacovigilance database also operates in connection with the European network for pharmacovigilance that collects in a single database all data provided at national level by each of the European Union countries.

The national ADR database supports the Medicines Authority as a tool for storing and analysing safety reports. These reports are evaluated by post-licensing staff to monitor medication safety. They are examined individually and in the aggregate for a product in order to identify clusters of reports that could represent a signal of a previously unknown adverse reaction or drug interaction or some change in the frequency of a known adverse reaction. It may also be possible to recognise a new risk factor for a reaction to a product, such as a sub-group of patients at particular risk.

Based on pharmacovigilance findings, the Medicines Authority may then take regulatory actions to improve product safety and protect public health, such as:

  • Updating a product's information, such as by restricting its conditions of use or increasing its surveillance when new issues appear.
  • In some cases re-evaluating a medicines marketing authorisation decision, takes place which can result in a products withdrawal.
  • Overseeing the implementation of Risk Minimisation Plans that are undertaken by pharmaceutical companies in order to mitigate identified risks.


Why report an Adverse Drug Reaction?

The information on adverse drug reactions to 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.

Your report may contribute to:

  • the identification of previously unrecognized rare, or serious side effects
  • changes in the products' information leaflet, or other regulatory actions such as a letter to inform healthcare professionals to be aware of the adverse drug reactions caused by a particular product
  • in some occasions the withdrawal of a product from the Maltese 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.


Reporting an Adverse Drug Reaction: what you need to know

Adverse Drug Reaction(ADR) reports may be reported directly to the marketing authorisation holders, or to the Medicines Authority. To report to the Medicines Authority an ADR may be submitted using the online ADR form or by post to 203, Medicines Authority, Rue D'Argens, Gzira, 1368.

Adverse drug reaction (ADR) reports require four information items in order to be properly assessed by the Medicines Authority. The minimum requirements are:

  1. patient information - for reasons of confidentiality the patient name should not be used
  2. description of the adverse reaction the patient experienced
  3. name of the medicinal product you suspect caused the adverse reaction
  4. contact information in case the Medicines Authority requires additional information


The information about a reporter's identity, is kept confidential. It's use is covered by the Data Protection Act and is only looked at by Medicines Authority employees who need it to assess the report, which may require follow up work. Other useful information for the assessment of an ADR includes: patient characteristics (age, gender, height and weight); therapy dates (date the adverse reaction occurred and resolved if applicable; and date the health product was started and stopped); relevant tests/lab data; and concomitant products. Healthcare professionals are reminded that the reporting of ADRs is a duty in accordance with regulation 3 (4) of the Pharmacovigilance Regulations of 2012.  

All the information provided in the ADR report 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 Healthcare Professionals send in?

Reports are first checked to make sure the basic information is complete. The Medicines Authority then sends an acknowledgment letter to the reporter, thanking them for submitting an adverse drug reaction report. The letter also gives a tracking number for your report. This number should be used if you have follow-up information to give later, or if the Medicines Authority needs to contact you for more information.

The Medicines Authroity uses a variety of mechanisms to share information that arises from adverse drug reaction reporting which can help healthcare professionals stay informed about safety alerts and recalls that are ongoing. Communication of safety information and regulatory action in a timely manner enables health professionals and patients make informed decisions about the safe use of medicinal products. The Medicines Authority communicates risks and benefits on medicines through:

  • Safety Circulars, distributed amongst healthcare professionals and uploaded regularly on our website. An SMS notification service to alert you of new safety information can be applied for, free of charge.  
  • Direct Healthcare Professional Communications that can be found on our website are reviewed by the Medicines Authority and sent by pharmaceutical companies to healthcare professionals by post or electronic means to highlight warnings about drug hazards.


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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