The safety and quality of medicines and vaccines is also studied after they have been implemented for widespread. It is organized with the safety and quality monitoring of medicines. The purpose of the monitoring is to ensure that all preparations used meet current quality and safety requirements. The Agency of Medicines conducts safety and quality monitoring following the issuing of marketing authorisation of medicines in Estonia.
In practice, monitoring is provided by side effect notifications submitted by healthcare professionals (contain information from the patient), by marketing authorisation holders or through communications received through international notification systems. A side effect notification can be submitted as a form of the State Agency of Medicines. Healthcare workers carrying out vaccinations are required to provide information to the State Agency of Medicines regarding the serious side effects reported to them. Non-serious side effects are reported to the marketing authorisation holder of the medicine.
Marketing authorization holders are obliged to submit the safety reports of medicines imported by them to the State Agency of Medicines on a regular basis. If necessary, the State Agency of Medicines may request additional reports.
The issuer of the marketing authorisation (e.g. the Estonian Agency of Medicines) has the right to suspend or revoke the authorisation, if necessary. This could be due, for example, new information that confirms the lower efficacy or increased risk of the medicine.
Supervision of medical staff
The Health Board carries out supervision of healthcare providers that conduct vaccination. It aims to ensure:
- ensuring the quality, efficiency and safety of vaccines at all stages of their handling;
- adherence to vaccination (safety) requirements;
- completion of the immunization schedule.
Behaviour in case of side effects
In case of a suspected side effect of vaccination, contact your family physician or call the family physician helpline 1220. If emergency medical assistance is needed, call 112.
After vaccination, a fever (above 38.0°C) may be reduced with paracetamol. Information on the recommended dose can be found on the package and information leaflet of the medicine. If necessary, consult a pharmacist, family physician or nurse.
A cool compress may be applied to the swollen and red injection site, by using 20% alcohol solution, chamomile tea or just cold water.
If the child is restless and crying, the cause for this may be pain at the injection site, which can also be relieved with paracetamol.
On very rare occasions, a severe allergic reaction may occur in the form of an extensive itchy rash, swelling of the eyes and face, difficulty in breathing or swallowing. In this case, seek immediate medical attention. To mitigate this risk, it is recommended that you wait for at least a quarter to half an hour in the doctor's office or in the waiting room after being vaccinated.
In the course of supervision, the Health Board checks the storage, distribution and transport of vaccines following cold chain requirements. The cold chain is a system that ensures proper storage and transport of the immunological preparations.
from production to administration. Compliance with cold chain requirements ensures the quality, efficacy, stability and safety of the vaccine.
Experts of the Health Board also pay attention to the knowledge and capabilities of healthcare professionals. In the course of monitoring, it is checked whether the people who carried out the vaccinations have received adequate training and that all vaccinations have been made, registered and documented in a timely manner.