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Browsing by Subject "kasvirohdosvalmiste"

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  • Kasviperäisten valmisteiden lääkevalvonta ja lapsia koskeva lääkeinformaatio Suomessa 1964 - 2012 
    Korkeamäki, Laura (2013)
    The status of herbal products has changed over time and due to changes in medicines legislation in Finland. The study period starts from 1964, when marketing authorisation procedure became obligatory for medicinal products. In 1994 medicines regulation introduced the term "herbal remedy" and in 2005 the terms "herbal medicinal product" and "traditional herbal medicinal product". In recent years there has been an increasing interest in medicines information regarding children. For example in 2007 a new paediatric medicines regulation was given by the EU. In Finland a new medicines information strategy was published in 2012 by the Finnish Medicines Agency. The aim of this study was to find out how the medicines information of herbal products regarding children has changed over time and changes in legislation. The material of this study were the documents of herbal products under medicines regulation in Finland 1964 - 2012. The information was gathered from summary of product characteristics, package leaflets, labellings and their predecessors. In total there were 195 products of which 189 had relevant documents for this study. The method of this study was content analysis. The information was collected from the documents to data sheets. The analysis was based on the legislative periods. Medicines information has become more accurate during the study period 1964 - 2012. Information was less accurate between years 1988 and 1995. The amount of medicines information has increased after the term "herbal remedy" and terms "herbal medicinal product" and "traditional herbal medicinal product" were introduced. Some of the changes in medicines information could be tracked to specific regulatory changes. The study gives historical perspective on the changes in medicines information of herbal products in Finland. It is clear that the legislative changes have limited effect on medicines information, if the amount of paediatric scientific studies is not increased. In the future there is a need to study the prevalence of the use of herbal medicinal products and traditional herbal medicinal products in children and in other population groups. There is also a need to study how the medicine information differs in herbal medicinal products and traditional herbal medicinal products and what are the differences compared to the information on dietary supplements.
  • Lääkeinformaatio osana potilasturvallisuutta : kasviperäisten valmisteiden lainsäädännön ja lääkeinformaation kehitys Suomessa 1964 - 2011 
    Mononen, Anna (2012)
    Herbal preparations are widely used nowadays and the information given has developed a lot during the last decades. Herbal preparations haven`t been acknowledged as medicines and therefore their efficacy and adverse effects are still often underrated. In 2005 along the changes in legislation differently legislated group of herbal preparations was retired. Nowadays herbal preparations are divided to drugs and food products. The aim of the study was to make oneself familiar with the legislation of these products and the evolution of the pharmaceutical information given. The aim also was to compare warnings, prohibitions, contraindications and their evolution to prevalent legislation. The material of the study consisted of product information summaries, patient information leaflets and labeling of herbal medicines, traditional herbal medicines and their predecessors. In addition to this there was also other legislative material. Only herbal medicines and traditional herbal medicines according to directive 2004/24/EY of the European parliament and the council`s definition were taken in to account. According to 2004/24/EY herbal medicinal products is any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. There were all together 194 products included in the study. Documentation of 184 products was found on paper in Fimea`s archives. Of the remaining five out of ten products it was found some basic information in electronic rohdos-register and of one product on an on paper final act. Data of these six products was only used partly because of its deficiencies. The data of four products wasn`t found. Under a more detailed study there was all together 184 products between 1964 and 2011. The material was divided to time periods 1964 - 1983, 1984 - 1987, 1988 - 1995, 1996 - 2005 and 2006 - 2011 by the changes in legislation. The information given of herbal preparations was the most affected by the changes in legislation in 1994 and 2005. The amount of new licenses was increasing until the time period 1988 - 1995. Licenses were granted the most during 1988 - 1955. After 1996 the amount of warnings, prohibitions and contraindications rose and many of the products that got the license in previous time period 1966 - 1955 left the market or transferred under the food legislation. As well many products with less consumption left the market because new studies demanded were expensive and cumbersome. In 2005 along the changes in legislation a clear change in attitudes came true, when a vague group of herbal preparations was removed and herbal preparations were divided into pharmaceuticals and food products. Along this change it has become easier for health care professionals to assess the risks and benefits of herbal preparations and advise the clients while making the decisions.

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