Chaos at the Agency for Medicines: Still no information on what happened with the tetanus vaccine!

The public in Bosnia and Herzegovina is still upset after several students experienced adverse effects after receiving the tetanus vaccine at the Sarajevo Health Center Vrazova, writes the Patria news agency.

To this day, we have no adequate answer as to what actually happened, and there is clearly a kind of chaos at the Agency for Medicines and Medical Devices, with conflicting information coming from this institution. Nataša Grubiša, director of the Agency for Medicines, persistently pushes the narrative that citizens have no reason to panic, but there are reasons, because it now turns out that the system the Agency was supposed to establish exists only on paper, and the regulation has not been implemented.

Namely, the Agency's website still displays a news item published on December 19, stating that "to date, we have not received any reports of suspected adverse reactions mentioned in the media, related to the tetanus vaccine. Upon receiving a report of suspected adverse reaction/reactions, we will immediately react by assessing the causal relationship between the reported adverse reaction and the suspected drug, and take appropriate regulatory measures in accordance with the assessment made".

However, in response to a query sent by Patria to the Agency requesting information on which side effects were reported and by whom, we received the following answer:

- We received a report on adverse effects from the Public Health Institute of the Federation of Bosnia and Herzegovina (from Dr. Jelena Ravlija), which clearly describes the recorded side effects (adverse effects) of the vaccine. The evaluation of the reported adverse reactions is underway, i.e., the investigation of the causal relationship with the administered vaccine. We are in constant contact and exchange of information with the Public Health Institute regarding the issue in question - the message sent to our editorial office, signed by Grubiša, whose mandate expired two years ago, states!

Furthermore, as we learn, doctors are in a panic because at the given moment it was not known at all who to report adverse effects to, while KCUS refuses to report side effects to the Agency, forwarding this data to the Institute for Pharmacy.

Although we are awaiting an official response from the distributor of the tetanus vaccine, the company "Melcom", we learn that they also found out about the events from the media (!?), meaning no one officially informed them about the problem that arose.

Earlier, in media appearances, Grubiša stated that citizens should report suspected adverse drug reactions to a healthcare professional for recording through the so-called official pharmacovigilance system and assessment of its causal relationship with the administered drug as soon as possible. However, how things are done in our country at the Main Pharmacovigilance Office in Mostar is best illustrated by the fact that the head of two referents from Mostar does not sit with them in the office, but in Banja Luka. Otherwise, someone from the Croat people should be appointed to this position, and Grubiša has been delaying this since 2008!

Finally, how pharmacovigilance is done can be seen at our neighboring Croatian Agency for Medicines and Medical Devices, which is full of PDF documents and data. Our department is very poor, and yet Grubiša stated that "this year the Agency had about 150 reports of suspected adverse drug reactions, of which about ten reports related to adverse reactions to vaccines".

In today's letter to Patria, it is stated that "so far we have not had reports of serious adverse effects from the vaccine in question, all reports of adverse effects were expected and described in the Patient Information Leaflet and the Summary of Product Characteristics".

Otherwise, as Grubiša confirmed to us, the vaccines have not yet been delivered to the Control Laboratory in Sarajevo for extraordinary control.

- As soon as they arrive, they will be processed - says Grubiša.