Safety of medicines and the production of reliable medicines information

UN Sustainable Development Goal 3:

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.

3.9 By 2030, significantly reduce deaths and diseases caused by hazardous chemicals and air, water and soil contamination and pollution.

Challenge

False information can be easily disseminated in different communication channels unintentionally or intentionally, also regarding medicines, which is why the information should be viewed critically. Fimea distributes reliable information on medicines in various communication channels to both medicine users and social welfare and health care professionals.

An unintentional overdose of a medicine or the administration or taking of an incorrect medicine may cause poisoning and, in the worst case, result in death. The United Nations (UN) has selected mortality associated with unintended poisoning as one of the indicators of healthy life and well-being.

Despite quality assurance measures, 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. In addition, counterfeit medicines are a global problem. In countries where drug safety monitoring (pharmacovigilance) is poor, counterfeit medicines are sold both in markets and pharmacies. The ingredients of counterfeit products might be wrong, ineffective or even dangerous. In Finland, Fimea supervises medicines and the safety of medicines. The risk of receiving counterfeit medicines is particularly related to drugs purchased illegally on the internet or brought home from a trip abroad. In the case of personal imports of veterinary medicines, the most common problems are related to situations where Customs stop products at the border that the traveller has not considered veterinary medicines.

Fimea’s role

Fimea’s operations include the production of reliable, understandable and up-to-date information related to medicines, medical products and pharmacotherapy. Fimea produces unbiased information for citizens, those working in the social welfare and health care sector and others in need of medicines information. Fimea’s tasks also include the long-term planning and coordination of medicines information and the sharing of reliable medicines information. 

The efficacy, safety, risk-benefit balance and quality of medicines are assessed as part of the marketing authorisation process. Fimea also supervises the regulatory compliance of medical devices and the operators in the sector in Finland. The safety of medicines is monitored and assessed throughout their life cycle. The registers of adverse reaction and incident reports for health care professionals and users of medicines and medicinal products are used in benefit-risk assessment and in the detection of potential new adverse reactions. Fimea also acts as part of the European pharmacovigilance network and participates in Europe-wide safety monitoring and division of labour in pharmacovigilance processes.

For its part, Fimea aims to protect public health by monitoring the import, export, manufacture and distribution of narcotics, thus aiming to prevent their misuse. Fimea also assesses the properties of new psychoactive substances used in a similar manner as narcotics. Fimea’s role as the licensing and supervisory authority granting authorisations for narcotics in medicinal and research use and role in the assessment of the properties of new substances are important, but only one factor among measures to reduce the use of narcotics harmful to health and thus the harmful consequences of drug use. 

Goals

Fimea’s goal is to be the primary source of pharmaceutical information in Finland. Achieving the goals requires anticipating, systematic and target group-oriented communication as well as continuous interaction and cooperation with stakeholders. The aim is to promote the well-being of citizens through safe medicines and medicinal products and to reduce the health risks posed to citizens by substances used as narcotics. 

How the achievement of the goals is assessed

Fimea provides reliable information on medicines and medicinal products on its website and in various social media. 

Fimea’s has promoted the achievement of the goals in ways including:

• coordinating the activities of the Medicines Information Network, which includes 65 different organisations. The organisations represent a wide range of public, private and third sector parties. The work of the network is guided by the medicines information strategy. The aim is to promote the goals of the medicines information strategy by increasing multidisciplinary and professional cooperation in the production and communication of reliable medicines information and related materials. In addition, regular theme days and events are organised: In 2022, these included
  • Pharmacotherapy day, whose main event webinar title was “Your pharmacotherapy in the digital age"
  • Medicines Information Forum, which focused on the challenges and solutions of pharmacotherapy for working-age people.

After the 2021–2023 term, the experiences of the medicines information network members on the implementation of the goals of the medicines information strategy will be compiled by means of a survey.  

• maintaining the operation of a patient advisory board, the aim of which is to include the patient perspective in official duties. In 2022–2023 term, 17 patient and disability organisations will participate in the work. In 2022, the meetings discussed:
  • clinical trials and orphan drugs
  • pharmaceutical package labelling and package inserts as well as knowledge-based management.

In 2022, the participants in the meetings of the patient advisory board gave Fimea a grade of 9.15. Feedback from a member of the patient advisory board: “There has been plenty of accurate and reliable information available at the meetings, and it has been a great opportunity to ask the experts, thank you very much for that!

• taking into account pharmaceutical treatments for people of different ages
  • Fimea maintains and develops the Meds75+ database, which supports clinical decision-making on pharmacotherapy for people aged 75 or over and improves medication safety. The database contains a classification and a recommendation for use of almost 500 medicinal substances or combinations thereof in elderly patients. It is primarily intended for use by physicians and other health care professionals, but is also available to everyone on the Fimea website. The database is updated by a working group that is coordinated by Fimea and consists of experts in pharmacotherapy for the elderly.
  • The Regulation on Medicinal Products for Paediatric Use (EC 1901/2006, pdf), which is also applied in Finland, aims to improve the information available on the use of medicines in different groups of the paediatric population. The goal is to facilitate the development and availability of medicines, pharmaceutical forms or routes of administration for children.

• maintaining the National Risk Medicines Classification that lists key high-risk medicines in order to support social welfare and health care personnel in identifying and taking into account their appropriate use.  Experts from Fimea and various stakeholders participated in the classification work launched in 2022. The national risk classification was published digitally on the Fimea website in spring 2023. Future areas of monitoring will include, for example, how well risk medicines have been identified and described in organisations’ pharmacotherapy plans.
• conducting a mystery shopping study aiming to investigate the implementation of OTC medication counselling in the online services and other distance selling services of Finnish pharmacies. The most significant area of development in distance selling services is improving the content and quality of OTC medication counselling and the timeliness of medication counselling. Fimea monitors medication counselling as part of pharmacy supervision, and the results of the mystery shopping studies will be utilised in targeting and developing the monitoring.

• monitoring the safety of medicines and medicinal products. In 2022:
  • Fimea received reports of suspected adverse reactions from health care professionals and users of medicines and medicinal products in the adverse reaction registers it maintains. 
  • Fimea’s pharmacovigilance assessment division participated in the assessment of centralised marketing authorisations, annual reports on various types of marketing authorisation obligations (PASS, LEG, MEA, etc.) and periodic safety reviews of medicinal products (PSUSA).
  • Fimea received six new rapporteurships from the Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for the risk management and post-market surveillance of medicinal products.
  • Fimea participated in the EU Emergency Task Force (ETF), established during the COVID-19 pandemic, which has expanded during 2022 to cover other current vaccines and epidemics related to medicines.
• being on-call on matters concerning product defects in medicines 24/7 every day of the year. For their part, businesses in the pharmaceutical sector are responsible for the appropriateness of the measures required in product defect cases, but Fimea supervises that the measures related to product defects are adequate and appropriate.

• acting as part of a European regulatory network to prevent the distribution of counterfeit medicines and medicinal products. 
• cooperating closely with Customs in cases related to monitoring of imports. In 2022, Fimea issued a total of 1,368 product-specific product assessments to Customs for products that Customs had seized. The number of claims for a revised decision made on the basis of seizure by the Customs has decreased significantly, one of the components of which is the product assessments prepared by Fimea for Customs.

• examining the quality of medicines in Fimea’s laboratory and supervising the release of vaccines and batches of blood and plasma-based medicinal products used in Finland.

In 2022, Fimea released a total of 259 vaccines to the Finnish market, of which 76 were COVID-19 vaccines and 18 were influenza vaccines.

• cooperating with national authorities, such as Customs and the National Bureau of Investigation, by investigating counterfeit medicines, drugs, doping agents etc. 
• granting licences for appropriate use of narcotics, enabling them to be used as medicine, while preventing substances ending up to be misused.
• preventing narcotics and new drugs ending up to be misused by assessing them and proposing that substances causing harm in substance abuse be subjected to stricter supervision. In this case, both health professionals and other authorities will be provided with tools to prevent the overuse or importation of these substances harmful to public health.