3.5 Enhance the prevention and treatment of substance abuse, including drugs and alcohol.
3.8 Achieve universal health care coverage, including financial risk protection, access to high-quality and essential health-care services, and safe, effective, high-quality and affordable essential medicines and vaccines for all.
Challenge
The safety of medicines or medical products is vital, as is access to reliable information on them. The spread of misinformation about medicines in various communication channels is a growing concern, which may lead to issues such as using medicines contrary to their intended use. Abuse of medicines, such as unintended overdose of medicines or taking the wrong medicine, can have harmful or even fatal consequences. The United Nations (UN) has selected mortality associated with unintended poisoning as one of the indicators of healthy life and well-being.
Accidents involving poisoning and exposure to harmful substances:
Accidental overdose or accidental administration or taking of an incorrect medicine.
Accidents involving the use of medicinal substances, medicines or biological substances in connection with surgical or other medical treatment.
Poisoning where it has not been determined whether it was accidental or with the intention of harm.
Source: Statistics Finland (Finland).
Despite quality assurance, errors may occur in the manufacture of medicines, resulting in the sale of medicines which do not meet quality requirements or might be hazardous to users. Furthermore, counterfeit medicines are a global problem, especially in countries with poor pharmacovigilance. Counterfeit products may contain ineffective or even life-threatening substances.
Fimea’s role
Fimea produces reliable, clear and up-to-date information on medicines, medical products and matters related to medicinal treatments for citizens, social welfare and health care professionals and others who need information on medicines. Fimea plans and coordinates medicines information and shares reliable information.
In Finland, Fimea supervises medicines and medical products and their safety. The efficacy, safety, risk-benefit balance and quality of medicines are assessed as part of the marketing authorisation process. A marketing authorisation is granted if the risk-benefit balance of the medicine has been assessed to be positive. The safety of medicines is monitored and assessed throughout their lifecycle, and a marketing authorisation can be withdrawn if the risk-benefit balance becomes unfavourable. Fimea also supervises the regulatory compliance of medical devices and the operators in the sector in Finland.
Fimea grants permits for the import, export, manufacture and processing of narcotics for medical and research purposes and strives to prevent their misuse. Fimea also assesses the properties of new psychoactive substances used in a similar manner as narcotics. Fimea’s role in the supervision of narcotics is an important part of broader measures aimed at reducing the negative impacts to health caused by the abuse of narcotics.
Objective
Fimea’s objective is to be the primary source of pharmaceutical information in Finland. This requires proactive, systematic and target group-oriented communication and research as well as continuous cooperation with stakeholders. The aim is to promote the well-being of citizens through safe medicines and medical products and to reduce the health risks posed by substances used as narcotics.
Case study: Ensuring the safe management of local scabies epidemics in Finland
Local scabies epidemics were found in people in Finland in early 2024. Some of the affected persons started treating their infection with the BioNix product intended for equine skin care, sold as a free-trade product. Using veterinary products on humans is always a health risk. Fimea examined the composition of the product and found that it contains benzyl benzoate, which is an active substance in medicines intended for external parasite treatment (e.g. scabies) in many countries. To ensure consumer safety, BioNix was classified as a veterinary medicine, which meant that it could no longer be sold as a free-trade product.
During the spring, Fimea engaged in the discourse on scabies medication by participating in events such as a joint press conference on the scabies situation organised by the authorities and a chat evening organised by Yle. Fimea also informed pharmacies and citizens about the possible adverse effects of human scabies medication on pets.
To ensure the availability of scabies medicines, Fimea granted exemptions for products subject to marketing authorisation. In addition, Fimea did an expedited procedure to process the marketing authorisation application of a scabies medicine product that had not been previously sold in Finland. Fimea also investigated pharmacies’ possibilities for the ex tempore preparation of sulphur cream used as local treatment. When necessary, ex tempore preparation can be used to ensure the availability of pharmaceutical treatments for some patients, for example in the absence of a suitable medicine with a marketing authorisation.
How Fimea has promoted the attainment of the objectives
Participating in the reform of the EU’s general pharmaceutical legislation in cooperation with the Ministry of Social Affairs and Health. In April 2023, the European Commission adopted proposals to reform the EU’s general pharmaceutical legislation. This legislation has not been reformed in 20 years. In 2024, Fimea participated actively in commenting on the proposed legislation and supporting the Ministry of Social Affairs and Health in the legislative reform process. Fimea actively highlighted and promoted national special features in the changes to the EU legislation.
Initiating a pharmacovigilance referral due to serious adverse reactions caused by a medicine. In summer 2024, despite the risk minimisation measures previously imposed on Litalgin (used to e.g. treat abdominal pain), its use was still found to cause serious adverse effects to white blood cells. Despite its rarity, the adverse reaction was serious, even fatal. In the latest safety assessment, the risk-benefit balance of Litalgin was found to be unfavourable; the risk of possible adverse effects was found to be greater than the benefit of the medicinal treatment. As agreed with Fimea, the marketing authorisation holder decided to cancel the marketing authorisations for Litalgin products. As a result, Fimea notified the European Medicines Agency, which launched a pharmacovigilance referral, meaning a safety assessment, in accordance with Article 107i of the Medicines Directive.
Examining the media visibility of medicines and the quality of pharmacy services and medicines.
In 2024, Fimea and the University of Eastern Finland launched a study on the media visibility of medicines (UEFConnect). Besides increasing awareness, media visibility can also influence political decision-making in health care and shape opinions on medicines and their benefits. The aim of the study funded by Kela is to determine the visibility of new medicines in journalistic media and social media and to investigate what information is shared about the medicines during their lifecycle. The study will increase understanding of the importance of media visibility in the introduction and substitutability processes of medicines and help to anticipate the impacts of media visibility on the use of medicines and the costs incurred by society.
In spring 2024, Fimea published the results of its fourth mystery shopping study (Julkari). Pharmacies have a statutory obligation to provide pharmaceutical advice, and mystery shopping studies targeted at their over-the-counter advice are used to collect information on genuine medication advice situations in order to assess the quality of pharmacy services. This time, the mystery shoppers bought medicine at pharmacies either for heartburn or for managing fever in a small child. Nearly all of the mystery shoppers received at least one piece of advice on using the OTC medicines. The need for the medicinal treatment and its appropriateness for the customer was also assessed well in pharmacies. However, a significant number of the shoppers would have liked more advice from a pharmaceutical professional, especially regarding adverse drug reactions.
The Fimea Laboratory carried out two nationwide control campaigns to test the quality of medicines. The Laboratory tested all film-coated tablets containing different strengths of teriflunomide (MS) and all injection fluids containing fulvestrant (for breast cancer treatment) on the Finnish market. Such control campaigns provide a good situational picture of the quality of the products in the group in question in Finland. There were no issues with the quality of the products tested.
Producing materials for medicines education. The goal of medicines education at schools is to increase information on medicines and their safe use, to influence attitudes and to promote the development of positive health behaviour. Teaching the correct and safe use of medicines also prevents the misuse of medicines. The medicines education materials (Healthy Pupil) contain an extensive information package on the correct use of medicines and reliable sources of medicines information, and assignments and lesson plans for teachers of different grades. Fimea and the UKK Institute renewed their cooperation agreement on maintaining medicines education materials on the Healthy Pupil website in 2024.
Participating in the working group on expanding the sales channel of OTC medicines. In December 2023, the Ministry of Social Affairs and Health appointed a working group to prepare for releasing the sales of some of the most common OTC medicines outside pharmacies. Fimea participated in a working group whose final report (Ministry of Social Affairs and Health press release 3 October 2024) was published in October 2024. According to the report, the sale of OTC medicines outside pharmacies should be based on an application submitted by the pharmaceutical company to Fimea, who should also be responsible for supervising potential new points of sale. The working group considered that medication safety and the success of pharmacotherapies should be ensured, which means that realisation of medication counselling is an important factor. In addition, regardless of the pricing model for OTC medicines, it is essential to ensure that the inappropriate use of medicines does not increase.
Continuing the development of the updated medicines wholesale register by publishing a reporting package for its personnel and producing the materials for the Finnish Statistics on Medicines. The new reporting tool can be used to create up-to-date, visualised and informative reports. Fimea uses the wholesale register to monitor and compile statistics on the sales and consumption of medicines in Finland and in different regions to compile a knowledge base on medicines consumption in Finland. The new register and reporting enable knowledge-based management and meet the information needs of supervision, guidance, scientific research and official duties.
Publishing information on registered operators of medical devices. In Finland, operators in the medical devices sector subject to the registration obligation must register either in the European EUDAMED database or the national CERE register. In June 2024, Fimea started publishing a list of CERE registered operators. These operators include manufacturers of custom-made devices, distributors subject to the registration obligation, and health care units that manufacture devices. The publication of operator data increases transparency, supports market surveillance and makes it possible for procurement units to ensure that devices are procured from responsible operators. Moreover, publishing the details of CERE operators puts all operators in an equal position since operator details are also publicly available in EUDAMED.
Assessing and controlling new psychoactive substances (so-called modified drugs) in cooperation with other authorities. In 2024, control measures were extended to 32 new psychoactive substances that are prohibited from the consumer market. In addition, six new synthetic opioids with no medical use were added to the list of controlled narcotics. Control was also extended to a total of nine new synthetic nitazene-type opioids that cause a serious hazard to life and health at very low doses. Rapid additions to the scope of control aim to prevent the introduction of these substances to Finland, to raise awareness of their dangers, improve health care preparedness and curb demand.
Participating in the EU project on product safety of injectable fillers. Together with eight other countries, Fimea has participated in the Joint Actions on Compliance of Products in the EU and EFTA countries (JACOP), a project testing injectable fillers. As part of the project, Fimea has taken samples of hyaluronic acid-based fillers sold in Finland. The samples have been sent for analysis to a joint European laboratory where the samples have been examined for harmful ingredients and microbiological quality. The samples have also been examined in the Fimea Laboratory. The results of the project will be reported in spring 2025. The JACOP project helps Fimea prepare for more extensive supervision of fillers.
Maintaining the Meds75+ information product, which indicates the suitability of medicines for people aged 75 or over. The information content is available free of charge on the Fimea website for the needs of application developers. In 2024, the Meds75+ information production underwent development, which is reflected in improved quality of information. Meds75+ has been integrated into several national systems supporting decision-making and patient information systems. Internationally, Meds75+ is now used by at least the Latvian pharmaceutical authority and the Central Norway patient information system.
Indicators describing safe pharmacotherapy for older people in 2020-2024
More than one third of those aged 75 or over use medicines the use of which should be avoided by older people. The total number of people using medicines that should be avoided in accordance with recommendations has increased annually due to the increase in the number of older people. During the review period, the share of older people using multiple medications, i.e. at least 10 different medicines, has been one fifth of all those aged 75 or over, and the share of those using multiple medications has increased annually. At the same time, the total costs of medicines dispensed by prescription for patients aged 75 or over have increased throughout Finland. Source: sotekuva.fi/en
Producing medication monitoring data on the population aged 75 or over.
The monitoring data can for example be used in wellbeing services counties when assessing the use and costs of medicines. In 2024, the relative number of people aged 75 or over who were using medicines recommended to be avoided decreased, but the relative number of people using a high number of medications (10 or more medicines) increased. The average total cost of medicines delivered with a prescription also increased slightly among the population aged 75 or over. Fimea pharmacotherapy indicators for older people.
Fimea monitors the savings potential of medicine deliveries reimbursed from health insurance on an annual basis. The state could save up to tens of millions of euros annually in pharmaceutical costs if the cheapest interchangeable products were always used in generic substitution.
Producing the National High-Risk Medicines Classification as open data. The High-Risk Medicines Classification is Fimea’s information product supporting medication safety, which was added to Fimea’s Medicine search and the Duodecim pharmaceutical database in 2024. The classification lists high-risk medicines whose use requires special attention. The classification is intended for use by health care professionals and helps to identify key high-risk medicines in different social welfare and health care environments.
