Pharmacovigilance and Adverse Drug Reactions (ADR)
Pharmacovigilance activities (collection, collation and evaluation of adverse drug reactions occurring within Estonia and reported by healthcare professionals) are carried out by the Pharmacovigilance Centre which is functioning under State Agency of Medicines.
State Agency of Medicines is working in close cooperation with WHO Collaborating Centre for International Drug Monitoring Centre in Uppsala. Since 1998 Estonia is a full member of WHO Drug Monitoring Programm as member country.
The programme for collection of spontaneous adverse drug reaction reports is functioning since 1993.
The activities of the pharmacovigilance centre cover the whole country. Reporting of adverse drug reactions in Estonia is voluntary for healthcare professionals.
For reporting of ADRs occurring within Estonia the reporting form is available ("yellow card") which is distributed with Drug Information Bulletin, by mail to doctors and with data sheet compendium Pharmaca Estica
- The electronic reporting form is available at Agencys homepage
- Information to Marketing Authorisation Holders and Sponsors of Clinical Trials - Eudravigilance for Human Medicines
- Minister of Social Affairs Regulation No. 26 “Procedure for providing safety information about a medicinal product and the calculation of fee payable for safety and quality surveillance of a medicinal product"
Drug Information Bulletin
"Ravimiinfo Bülletään" has been published since April 1995. The official publisher is the State Agency of Medicines. The articles are directed mostly to general practitioners. Each issue (four A4 pages) contains one review article and some news, usually official drug regulatory information, an analysis of Estonian Statistics on Medicines. It gives updates on side effects and assessments of groups of drugs (including their benefits and risks), helps to consider the price of alternative medicinal products. The basic aim is to promote rational drug use. The bulletin helps to communicate between Regulatory Authority and prescribers.
"Ravimiinfo Bülletään" is published bimonthly. Up to now 24 bulletins have been published. "Ravimiinfo Bülletään" is available in Estonian only. For further information see the content of bulletins enclosed below.
Feeback and questions to editors by e-mail: firstname.lastname@example.org
"Ravimiinfo Bülletään" has 4300 subscribers (The population of Estonia 1,4 million, the number of physicians is 5000, the number of pharmacists is 860). The subscribers get the bulletin free of charge. The expenses are covered by the government.
1. Antifungal therapy.
Nicotine substitution therapy.
ACE inhibitors available in Estonia.
2. ACE inhibitors.
Acute bronchitis - why antibiotics?
Caution - hepatotoxicity of cyproterone.
Herpes zoster and aciclovir.
OTC drugs - used but unknown.
Adverse drug reactions reporting system in Estonia.
Problems with the use of metamizole.
4. Morphine and other opioid analgesics in cancer pain.
Drugs for rhinitis.
Problems with the use of barbiturates as hypnotics.
5. The treatment of osteoporosis in postmenopausal period.
Lipid-lowering drugs rhabdomyolysis.
6. Topical corticosteroids.
Serevent® is not suitable for the treatment of severe acute asthma.
7. The pharmacotherapy of headache.
The use of nifedipine in the treatment of angina pectoris and hypertension.
8/9. The obstipation.
10. The Treatment of Epilepsy.
11. How to arrange humanitarian aid of medicines.
12. Treatment of Chlamydiosis (Chlamydia trachomatis)
13. Treatment of Acne vulgaris.
14. Treatment of Lyme' disease.
15. Anticoagulants and their clinical use.
16. The new and older NSAIDs.
17. The use of melatonine.
Incontinence in adults.
18. The use of atypical antipsychotics.
The treatment of open-angle glaucoma.
19. Hypertension during pregnancy.
20. The infection of Helicobacter pylori and treatment.
Treatment of atrial fibrillation.
22. Antiviral drugs.
Metamizole - for prescription only.
23. The treatment of chronic hepatitis type C and B.
Treatment of hepatic cirrhosis.
24. The treatment of chronic heart failure with spironolactone and ß-adrenoblocators.
The antagonist of AT II receptors and chronic heart failure.
25. Guidline for treatment of tuberculosis
Antibacterial treatment of pneumonia
Cisapride - drug interactions and side effects
Last updated: 09.03.2022