National OTC medicines programme
Finnish Medicines Agency Fimea
2015
Julkaisun pysyvä osoite on
https://urn.fi/URN:ISBN:978-952-5624-51-9
Fimea develops, assesses and informs, serial publication : 1/2015
https://urn.fi/URN:ISBN:978-952-5624-51-9
Fimea develops, assesses and informs, serial publication : 1/2015
Kuvaus
Published also in Finnish and Swedish
Tiivistelmä
In 2012, Fimea was entrusted by the Ministry of Social Affairs and Health with the task of
formulating a national OTC medicines programme. The programme delineates the objectives of and prerequisites for Finnish over-the-counter (OTC) medicines and discusses factors influencing the OTC medicine selection. Key stakeholder views have been sought in the preparatory stages.
The national OTC medicines programme lays down the related principles. The programme
does not deal with the entirety of self-care, but focuses on the possibilities offered by medicinal products with a marketing authorisation as a component of self-care. The programme describes the factors guiding the OTC medicine selection and provides pharmaceutical industry stakeholders with assistance in understanding the marketing authorisation process. A survey of OTC medicine users in 2013 served as a backdrop for the programme.
In OTC medicine, some responsibility is transferred to the medicine user. In addition to a
suitable OTC medicine selection, adequate advice and guidance are needed alongside the management of the user's overall medication, in support of successful therapy. The Finnish professional pharmacy system affords an excellent setting for providing counselling, but further work is needed on improving and harmonising such counselling. All stakeholders in the field play a role in providing medicines information, and counselling could be further improved by intensifying co-operation. Not enough research is available on the effects of OTC medicine on people's health behaviour, on the use of health services and on the possible reduction of the load on health care in Finland.
In terms of public health, the availability of OTC medicines in Finland is good in regard to
time, location and selection. To ensure the effectiveness of health care, there may be a
need to broaden the selection of OTC medicines in the market, but this must be effected in a controlled and safe manner. In this connection, it must be ensured that the products proposed for OTC care meet the criteria set for them within the programme. When a product is accepted as an OTC medicine, safety may in some cases be ensured by granting initially an OTC license only for a limited period, or by requiring that additional advice is given when dispensing the product. Harmonisation of the selection of OTC medicines within the EU is not an end in itself, but must take account of the variety of health care systems within the member countries.
As a follow-up to the OTC medicines programme, strong co-operation in developing the implementation of OTC medicine is expected from stakeholders in the Finnish pharmaceutical sector. Fimea can serve as a coordinator of such co-operation, but all stakeholders are expected to play both an active and proactive role.
formulating a national OTC medicines programme. The programme delineates the objectives of and prerequisites for Finnish over-the-counter (OTC) medicines and discusses factors influencing the OTC medicine selection. Key stakeholder views have been sought in the preparatory stages.
The national OTC medicines programme lays down the related principles. The programme
does not deal with the entirety of self-care, but focuses on the possibilities offered by medicinal products with a marketing authorisation as a component of self-care. The programme describes the factors guiding the OTC medicine selection and provides pharmaceutical industry stakeholders with assistance in understanding the marketing authorisation process. A survey of OTC medicine users in 2013 served as a backdrop for the programme.
In OTC medicine, some responsibility is transferred to the medicine user. In addition to a
suitable OTC medicine selection, adequate advice and guidance are needed alongside the management of the user's overall medication, in support of successful therapy. The Finnish professional pharmacy system affords an excellent setting for providing counselling, but further work is needed on improving and harmonising such counselling. All stakeholders in the field play a role in providing medicines information, and counselling could be further improved by intensifying co-operation. Not enough research is available on the effects of OTC medicine on people's health behaviour, on the use of health services and on the possible reduction of the load on health care in Finland.
In terms of public health, the availability of OTC medicines in Finland is good in regard to
time, location and selection. To ensure the effectiveness of health care, there may be a
need to broaden the selection of OTC medicines in the market, but this must be effected in a controlled and safe manner. In this connection, it must be ensured that the products proposed for OTC care meet the criteria set for them within the programme. When a product is accepted as an OTC medicine, safety may in some cases be ensured by granting initially an OTC license only for a limited period, or by requiring that additional advice is given when dispensing the product. Harmonisation of the selection of OTC medicines within the EU is not an end in itself, but must take account of the variety of health care systems within the member countries.
As a follow-up to the OTC medicines programme, strong co-operation in developing the implementation of OTC medicine is expected from stakeholders in the Finnish pharmaceutical sector. Fimea can serve as a coordinator of such co-operation, but all stakeholders are expected to play both an active and proactive role.
Kokoelmat
- Kirjat [162]