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Browsing by Subject "pakkausselosteet"

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  • Bentsodiatsepiinivalmisteiden pakkausselosteet ikääntyneiden lääketiedon lähteenä 
    Saarenpää, Maija (2014)
    The body changes its response to medicine by age. Thus, medicines information for the elderly needs to differ from information targeted to younger adults. Package leaflets (PLs) are among the key sources of medicines information among general public. Although not generally recommended, benzodiazepines are commonly used by the elderly. The aim of this study was to evaluate the usability of benzodiazepine PLs and their information content from the elderly perspective. Additionally, the study aimed to explore how medicines information targeted to elderly in PLs aligns with the information targeted to health care professionals (HCPs). The study focused on PLs of benzodiazepines and their derivatives (diazepam, alprazolam, oxazepam, zopiclone and temazepam) that are commonly used but not recommended for the elderly. The usability of PLs was evaluated by using the Medication Information Design Assessment Scale (MIDAS). The informational content of PLs was studied by identifying all references for the elderly and comparing them to information targeted to HCPs in Database of medication for the elderly, Beer's criteria, Kapseli 35 publication, Martindale, Current Care Guideline for insomnia and the Summaries of Product Characteristics. The usability of the PLs in this study required several improvements. The mean of MIDAS-credits was 6,22 (n = 27; range 5,00-7,00), the scale maximum being 13. Sufficient line spacing and highlighting of important information were among the poorly represented elements. The occurrence of different font-sizes also varied. The most proficiently represented features included headings, contrast and the usage of upper and lower case in text. The PLs included in the content-analysis contained references to the elderly in all cases except one (n = 35). The references were categorized to general warnings, side effects and dose recommendations. They were in line with the information targeted to HCPs, but relatively short and often inadequate. Most PLs did not give an adequate overall picture of the medicine use among the elderly. The PLs for benzodiazepines need to be improved from the elderly perspective both in terms of information content and usability. Attention both from the medicine authorities and the pharmaceutical industry is required. Alternatively, separate drug-specific information leaflets for the elderly may be developed.
  • Toisen polven antipsykoottivalmisteiden pakkausselosteet ikääntyneiden näkökulmasta 
    Aalto, Hanna (2016)
    Atypical antipsychotics (AAPs) can be used to treat severe behavioural symptoms of dementia when certain conditions are fulfilled. They are not considered as primary treatment for these symptoms due to their possible serious side effects that are found to be more common in elderly dementia patients. Package leaflets (PLs) are one of the most important sources of medicine information for elderly patients. Evidence-based medicines information is the prerequisite for decision-making and success of pharmacotherapy. The aim of this study was to evaluate the usability and informational content of atypical antipsychotic PLs from the perspective of the elderly. Additionally, the content of medicines information for the elderly found in PLs was compared to similar medicines information targeted to health care professionals (HCPs). Medication Information Design Assessment Scale (MIDAS) was used to evaluate the usability of the most commonly used AAPs (olanzapine, quetiapine and risperidone) among the elderly in Finland. To evaluate the informational content of the PLs and summaries of product characteristics (SmPCs) all the references for the elderly were identified using certain keywords. The informational content concerning elderly from the PLs was compared to information targeted to HCPs in Beer's criteria, Current Care Guideline for memory disorders, Database of medication for the elderly, Martindale and SmPCs. The usability of the PLs in this study was found to be insufficient. The mean MIDAS-credit was 6,4 (n=61; range 5,0-8,0), the maximum credit being 13. Sufficient line spacing and limiting the length of line were among the poorly represented features in the PLs in this study. The occurrence of sufficient font-size varied. Good contrast, headings, usage of upper and lower case in text and bullet points were among the well-represented features. All the PLs included in the content-analysis (n=106) contained at least three references to the elderly. The way the information was presented and how well it stood out from the leaflet varied. The SmPCs contained useful information targeted to elderly that was not found in corresponding PLs. Actions need to be taken to improve the usability and content of product specific medicines information from the perspective of the elderly. Medicine authorities and the pharmaceutical industry have the authority to make these improvements possible. Scientific data and concrete tools are needed to facilitate the change.

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