Pharmacotherapies cure and prevent diseases and alleviate symptoms. When a medicine is efficient, it may also cause adverse reactions. However, it is still of high quality, correctly manufactured and safe to use. The underpinning concept is medicine safety.
Verifying safety takes time
The development of a new medicine starts at the laboratory. When there is sufficient information on the medicine properties, its safety and efficacy must be proved on humans.
Individual trials go on for months or even years – it takes over 10 years to complete the whole package of documentary evidence on safety. The process cannot be hurried without risking safety.
Safety is not compromised even when the authorities find that expediting development would be a smaller risk than leaving the patient without therapy. This is the case, for example, when the population faces the threat of an infectious disease or other illness with no known cure.
Same medicine can bring benefits and cause adverse reactions
Medicines impact each human body individually. The product bringing the desired cure to one person may cause such intense adverse reactions in another that the change of medication is indispensable in order to prevent any permanent consequences.
There is no such thing as a medicine totally free from any adverse reactions in all persons.
Reporting on adverse reactions is mandatory
Any observations on unexpected adverse reactions of medicines must be reported to the authorities.
- Doctors and pharmacy personnel inform the Finnish Medicines Agency FIMEA about any medicine-related adverse reactions.
- All healthcare professionals must inform the Institute for Health and Welfare THL of any vaccine-related adverse reactions.
If you suspect that your medicine is causing adverse reactions, you should tell about it to your attending doctor or report it to Fimea directly or through the pharmacy.
Follow-up throughout medicine life
Pharmaceutical companies are responsible for their products and follow the safety of their medicines throughout their life. Pharmacovigilance within the pharmaceutical companies includes the gathering of information on the adverse reactions of medicines.
Clinical trials always involve a limited number of people, and the rarest adverse reactions do not necessarily come up in the samples. Adverse reactions may emerge even decades after the introduction of the medicine.
If necessary, the summary of product characteristics of medicinal products will be complemented with warnings or restrictions of use.
Pharmaceutical insurance exceeds scope of product liability
Product liability insurance covers any damage caused by a faulty product. In many countries, this is a common insurance form. Product liability insurance is specific to the company in question, and the claims are made directly to the company.
Pharmaceutical insurance is a voluntary insurance cover taken jointly by the pharmaceutical branch. In Finland, it has been in place for a long time to safeguard the users of medicines. The cover of the pharmaceutical insurance is significantly more extensive than the cover provided by product liability insurance.
The Finnish pharmaceutical insurance covers adverse reactions caused by medicines used in consumption or in pharmaceutical research. In these situations, the medicine has no fault as such but the adverse reactions are unexpected in the therapy situation.