Information related to medicines under additional monitoring

The promotion and facilitation of the reporting side effects from health care professionals and patients represent one of the requirements of the new pharmacovigilance legislation setting out stricter rules for monitoring the safe use of medicines with the aim to ensure better prevention, signal detection, as well as adverse reaction evaluation, and thus reinforce the contribution to patients' safety.

In accordance with the aforementioned pharmacovigilance legislation, in the beginning of September 2013 the Agency for Medicinal Products and Medical Devices (HALMED) started a public educational campaign with the aim to promote the importance of reading patient information leaflet and ADRs reporting among patients and medicines users. The objective of the campaign is to inform patients, that alongside the information they get from qualified health care providers, additional information may be obtained by reading the package leaflet. By reporting adverse reactions, patients are also encouraged to get actively involved in the treatment and monitoring of the safe use of medicines.

In accordance with the aforementioned approach, the EU introduced a new labelling procedure for medicinal products that are subject to intensive monitoring by competent authorities.

Medicinal products subject to additional monitoring will have in their summary of product characteristics and package leaflet a black symbol in the form of a black inverted equilateral triangle and a short sentence explaining the symbol:

This medicinal product is subject to additional monitoring.

The black triangle will be used in all EU Member States, in order to identify medicinal products subject to additional monitoring. This symbol will start appearing in the summaries of product characteristics and package leaflets concerned from the autumn of 2013. The black triangle will not appear on the outer packaging or labelling of medicinal products.

What does Black Triangle mean?

All medicinal products are carefully monitored after they are placed on the EU market. If a medicinal product carried the Black Triangle, this means that is subject to more intensive monitoring than other medicines. This is generally because there is a less information available as compared to other medicines, i.e. the product is new on the market or there is a relatively limited information about its long term use. Black Triangle does not mean that the medicinal product is unsafe for use and its intention is to actively stimulate healthcare professional and patients to report any suspected adverse reaction to medicinal products labelled with this symbol.

What medicines are under additional monitoring?

The requirement of additional monitoring is always applied to the following categories of medicines:

  • medicinal products containing a new active substance, authorised after 1 January 2011
  • biological medicines, such as vaccine or medicines derived from plasma (blood), authorised after 1 January 2011 (all biological medicines, including biosimilars),medicinal products for which the marketing authorisation holder is required to carry out post-marketing safety studies (PASS), i.e. to provide more data on long-term use of the medicinal product , or on rare adverse reactions seen in clinical trials,
  • medicinal products who have been given a conditional approval (where the company that markets the product must provide more data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data).
  • Other medicinal products can also be placed under additional monitoring, on request from the European Commission, or competent authority from the individual Member State in collaboration with the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC).

Who and how decides what medicines are to be additionally monitored?

In April 2013, the European Medicines Agency (EMA) published for the first time a European list of medicines under additional monitoring. You may read about it here. The list is reviewed every month by the PRAC and the actual version of the list may be found on the EMA's web pages, or here. Here you may find more information about medicines under additional monitoring.

A medicinal product can be included on the list when it is approved for the first time or at any time during its lifecycle. It remains under additional monitoring for five years or until the PRAC decides to remove it from the list.

Why are all medicines monitored after their approval?

European competent authorities authorise medicines after rigorous assessment of their benefit/risk ratio based on clinical trials and non-clinical and pharmaceutical studies. Only medicines with a proof of higher benefit than risk may be placed on the market. This provides patients with necessary treatment without exposing them to inacceptable adverse reactions. Clinical trials involve a relatively small number of patients for a limited period of time under controlled conditions. In a real-life setting, a larger and more diverse group of patients will use the medicines. These patients may have other diseases and may be taking other medicines. Some less common adverse reactions may only be discovered once a medicine has been used for a long time by a large number of people. It is therefore vital that the safety of all medicines continues to be monitored while they are in use.

Why are some medicines additionally monitored?

The additional monitoring and Black Triangle are introduced with the new legislation for monitoring of the safe use of medicines, which is also called new pharmacovigilance legislation, that came in effect in the EU in 2012.

Every medicine approved after 1 September 2013 that is subject to additional monitoring will contain Black Triangle in the package leaflet and summary of product characteristics when placed on the EU market. The requirement of additional monitoring extends to some medicinal products approved in the EU after 1 January 2011. Therefore, a transitional period for medicines approved between January 2011 and August 2013 will exist, until the replacement of old stocks of package leaflets by the renewed ones.

Why is it important to report a suspected adverse reaction?

The adverse reaction reporting contributes to the improvement of the safe use of medicines, more effective patient protection and the advancement of public health.

Health care professionals in the Republic of Croatia are required to report any suspected adverse reaction to HALMED via Form for reporting adverse reactions. Patients/users of medicines suspecting they have developed a side effect to a medicine, may report it directly to HALMED, via Form or on-line application, with a recommendation to consult with their doctor or pharmacist about the continuation of the therapy.

What is HALMED undertaking to promote the adverse reaction reporting?

HALMED continuously promotes the reporting of suspected adverse reactions to medicines from health care professionals and patients/users of medicines. Apart from running a public educational campaign to promote the importance of adverse reaction reporting and package leaflet reading at the national level, HALMED has prepared a guide through ADRs reporting for patients, that may be downloaded here. Also, in August 2012, HALMED was the first in the world to use the on-line application of the Uppsala Monitoring Centre (a collaborating centre of the WHO), that enables an active and simple patient participation in the monitoring of medicinal products safety. After the launch of the on-line application, almost a three-fold increase in suspected adverse reaction from patients /users in 2012 was reported to HALMED as compared to the year 2011, which demonstrates patients recognition of their role and importance in adverse reaction monitoring.

The European Medicines Agency has prepared an informative video about the importance of Black Triangle ane the concept of additional monitoring of medicines. Here you may view the video: