Finnish Medicines Agency Fimea

Helsinki, Finland

Finnish Medicines Agency Fimea

Helsinki, Finland
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Kivekas E.,University of Eastern Finland | Enlund H.,Finnish Medicines Agency FIMEA | Borycki E.,University of Victoria | Saranto K.,University of Eastern Finland
Journal of Evaluation in Clinical Practice | Year: 2016

Rationale, aims and objectives: The purpose of this study was to assess general practitioners' (GP) experience of an electronic prescription (e-prescription) system and the use of a national prescription centre. Methods: A web-based survey with 29 structured questions and 8 open-ended questions was used. The technology acceptance model was used to explain first users' use of e-prescribing technology. GPs (n = 269) in two different primary health care organizations, which implemented the e-prescribing module as the first of its kind in Finland. Results: Of the 269 GPs, 69 (26%) completed the survey. E-prescribing had influenced GP work and their management of patients' medication positively. Electronic health records and e-prescribing increased GPs' flexibility at work. There was a notable improvement in the management of prescription of narcotics with the introduction of e-prescribing. Issues with the e-prescribing system software delayed data processing and produced negative experience as users were forced to browse through too many pages to write a prescription. Conclusions: E-prescribing has improved GP's patient medication management, meeting Finland's national objectives. E-prescriptions not only reinforce the process of writing, transmitting and checking the authenticity of prescriptions but also make it mandatory for all key prescription information to be present for transmission. The perceived usefulness of e-prescribing by GPs could lead to more widespread adoption of the technology. Making e-prescribing more user friendly requires reforming work processes, which in turn would enhance the effectiveness of GP work. © 2016 John Wiley & Sons, Ltd.


PubMed | University of Victoria, University of Eastern Finland and Finnish Medicines Agency FIMEA
Type: Journal Article | Journal: Journal of evaluation in clinical practice | Year: 2016

The purpose of this study was to assess general practitioners (GP) experience of an electronic prescription (e-prescription) system and the use of a national prescription centre.A web-based survey with 29 structured questions and 8 open-ended questions was used. The technology acceptance model was used to explain first users use of e-prescribing technology. GPs (n=269) in two different primary health care organizations, which implemented the e-prescribing module as the first of its kind in Finland.Of the 269 GPs, 69 (26%) completed the survey. E-prescribing had influenced GP work and their management of patients medication positively. Electronic health records and e-prescribing increased GPs flexibility at work. There was a notable improvement in the management of prescription of narcotics with the introduction of e-prescribing. Issues with the e-prescribing system software delayed data processing and produced negative experience as users were forced to browse through too many pages to write a prescription.E-prescribing has improved GPs patient medication management, meeting Finlands national objectives. E-prescriptions not only reinforce the process of writing, transmitting and checking the authenticity of prescriptions but also make it mandatory for all key prescription information to be present for transmission. The perceived usefulness of e-prescribing by GPs could lead to more widespread adoption of the technology. Making e-prescribing more user friendly requires reforming work processes, which in turn would enhance the effectiveness of GP work.


Savolainen J.,University of Eastern Finland | Savolainen J.,Kuopio University Hospital | Kautiainen H.,University of Turku | Miettola J.,University of Eastern Finland | And 3 more authors.
Scandinavian Journal of Public Health | Year: 2014

Background: The Lapinlahti 2005 study was carried out to explore cardiovascular disease risk factors, lifestyle and quality of life in Lapinlahti residents in eastern Finland. Our aim was to study the association between lifestyle and health-related quality of life (HRQoL) in the community. Subjects and methods: The present study is based on the baseline data of the followed up (2005-2010) population-based cohort (N = 376, n of males = 184). A trained research nurse measured weight, height, waist circumference and blood pressure. Self-reported HRQoL was measured using a 15D questionnaire. A BDI-21 inventory was used to assess the presence of self-reported depressive symptoms. Lifestyle factors (nutrition, exercise, smoking and alcohol use) were examined with a structured questionnaire. Each lifestyle item was valued as -1, 0 or 1, depending on how well it corresponded to the recommendations. Based on the index the participants were divided into three lifestyle sum tertiles: I = unhealthy, II = neutral and III = healthy. The age- and sex-adjusted linear trend between the tertiles was tested. Results: The 15D score had a positive linear relationship with the lifestyle tertiles (P =.0048 for linearity, age- and sex-adjusted). Respectively, self-reported depressive symptoms were less frequent among subjects with a healthier lifestyle (P =.038). Conclusions: People who are expected to strive most to change their lifestyle have the lowest quality of life and psychological welfare, which should be taken into account in both clinical work and health promotion. © 2013 the Nordic Societies of Public Health.


Peura P.K.,Finnish Medicines Agency Fimea | Peura P.K.,University of Eastern Finland | Martikainen J.A.,University of Eastern Finland | Purmonen T.T.,University of Eastern Finland | Turunen J.H.O.,University of Eastern Finland
Medical Decision Making | Year: 2012

Background. Economic studies funded by the pharmaceutical industry are more likely to report favorable results and recommendations for the sponsor's product than are studies funded by nonindustry establishments. Purpose. To determine whether clinical outcome data obtained from the same meta-analyses are used differently in various economic studies of oral triptans and whether there is an association between the study sponsorship and the choice of clinical outcome measure. Data Sources. Economic studies of triptans were identified by updating a previously published systematic review. Study Selection. Twelve studies that used the same meta-analyses as the source of clinical outcome data were identified. Data Extraction. Two independent reviewers extracted the essential data from the identified studies. Data Synthesis. In the 12 appraised studies, 9 alternative measures of effectiveness were derived from the same meta-analyses. Eleven studies were industry-related, and in these the selected clinical outcome consistently favored the sponsor's product. Also the reported results suggested that the sponsor's product was more cost-effective than the competitors' products. Limitations. The cost-effectiveness of triptans is dependent on both the definition of clinical effectiveness and the treatment-related costs. Only bias related to the selection of the clinical outcome measure has been taken into account in this review. Conclusions. The results of published economic studies of triptans are conflicting and biased. There is a tendency to select clinical outcome measures that support the sponsor's product. This leads to concern about the possible poor applicability of these results in decision making.


Koskela H.O.,Kuopio University Hospital | Koskela H.O.,University of Eastern Finland | Salonen P.H.,Kuopio University Hospital | Romppanen J.,Eastern Finland Laboratory Center | And 2 more authors.
BMJ Open | Year: 2014

Objectives: Community-acquired pneumonia is associated with a significant long-term mortality after initial recovery. It has been acknowledged that additional research is urgently needed to examine the contributors to this long-term mortality. The objective of the present study was to assess whether diabetes or newly discovered hyperglycaemia during pneumonia affects long-term mortality. Design: A prospective, observational cohort study. Setting: A single secondary centre in eastern Finland. Participants: 153 consecutive hospitalised patients who survived at least 30 days after mild-to-moderate community-acquired pneumonia. Interventions: Plasma glucose levels were recorded seven times during the first day on the ward. Several possible confounders were also recorded. The surveillance status and causes of death were recorded after median of 5 years and 11 months. Results: In multivariate Cox regression analysis, a previous diagnosis of diabetes among the whole population (adjusted HR 2.84 (1.35-5.99)) and new postprandial hyperglycaemia among the non-diabetic population (adjusted HR 2.56 (1.04-6.32)) showed independent associations with late mortality. New fasting hyperglycaemia was not an independent predictor. The mortality rates at the end of follow-up were 54%, 37% and 10% among patients with diabetes, patients without diabetes with new postprandial hyperglycaemia and patients without diabetes without postprandial hyperglycaemia, respectively (p<0.001). The underlying causes of death roughly mirrored those in the Finnish general population with a slight excess in mortality due to chronic respiratory diseases. Pneumonia was the immediate cause of death in just 8% of all late deaths. Conclusions: A previous diagnosis of diabetes and newly discovered postprandial hyperglycaemia increase the risk of death for several years after community-acquired pneumonia. As the knowledge about patient subgroups with an increased late mortality risk is gradually gathering, more studies are needed to evaluate the possible postpneumonia interventions to reduce late mortality.


Kastarinen H.,Finnish Medicines Agency Fimea | Oksanen T.,Finnish Medicines Agency Fimea | Okokon E.O.,Finnish Medicines Agency Fimea | Kiviniemi V.V.,Finnish Medicines Agency Fimea | And 5 more authors.
The Cochrane database of systematic reviews | Year: 2014

BACKGROUND: Seborrhoeic dermatitis is a chronic inflammatory skin disorder affecting primarily the skin of the scalp, face, chest, and intertriginous areas, causing scaling and redness of the skin. Current treatment options include antifungal, anti-inflammatory, and keratolytic agents, as well as phototherapy.OBJECTIVES: To assess the effects of topical pharmacological interventions with established anti-inflammatory action for seborrhoeic dermatitis occurring in adolescents and adults.SEARCH METHODS: We searched the following databases up to September 2013: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library (2013, Issue 9), MEDLINE (from 1946), Embase (from 1974), LILACS (from 1982), and the GREAT database. We searched five trials databases and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).SELECTION CRITERIA: We included RCTs in adults or adolescents (> 16 years) with diagnosed seborrhoeic dermatitis of the scalp or face, comparing topical anti-inflammatory treatments (steroids, calcineurin inhibitors, and lithium salts) with other treatments.DATA COLLECTION AND ANALYSIS: Pairs of authors independently assessed eligibility for inclusion, extracted data, and evaluated the risk of bias. We performed meta-analyses if feasible.MAIN RESULTS: We included 36 RCTs (2706 participants), of which 31 examined topical steroids; seven, calcineurin inhibitors; and three, lithium salts. The comparative interventions included placebo, azoles, calcipotriol, a non-steroidal anti-inflammatory compound, and zinc, as well as different anti-inflammatory treatments compared against each other. Our outcomes of interest were total clearance of symptoms, erythema, scaling or pruritus scores, and adverse effects. The risk of bias in studies was most frequently classified as unclear, due to unclear reporting of methods.Steroid treatment resulted in total clearance more often than placebo in short-term trials (four weeks or less) (relative risk (RR) 3.76, 95% confidence interval (CI) 1.22 to 11.56, three RCTs, 313 participants) and in one long-term trial (lasting 12 weeks). Steroids were also more effective in reducing erythema, scaling, and pruritus. Adverse effects were similar in both groups.There may be no difference between steroids and calcineurin inhibitors in total clearance in the short-term (RR 1.08, 95% 0.88 to 1.32, two RCTs, 60 participants, low-quality evidence). Steroids and calcineurin inhibitors were found comparable in all other assessed efficacy outcomes as well (five RCTs, 237 participants). Adverse events were less common in the steroid group compared with the calcineurin group in the short-term (RR 0.22, 95% CI 0.05 to 0.89, two RCTs, 60 participants).There were comparable rates of total clearance in the steroid and azole groups (RR 1.11, 95% CI 0.94 to 1.32, eight RCTs, 464 participants, moderate-quality evidence) as well as of adverse effects in the short-term, but less erythema or scaling with steroids.We found mild (class I and II) and strong (class III and IV) steroids comparable in the assessed outcomes, including adverse events. The only exception was total clearance in long-term use, which occurred more often with a mild steroid (RR 0.79, 95% CI 0.63 to 0.98, one RCT, 117 participants, low-quality evidence).In one study, calcineurin inhibitor was more effective than placebo in reducing erythema and scaling, but there were similar rates in total clearance or adverse events for short-term treatment. In another study, calcineurin inhibitor was comparable with azole when erythema, scaling, or adverse effects were measured for longer-term treatment.Lithium was more effective than placebo with regard to total clearance (RR 8.59, 95% CI 2.08 to 35.52, one RCT, 129 participants) with a comparable safety profile. Compared with azole, lithium resulted in total clearance more often (RR 1.79, 95% CI 1.10 to 2.90 in short-term treatment, one RCT, 288 participants, low-quality evidence).AUTHORS' CONCLUSIONS: Topical steroids are an effective treatment for seborrhoeic dermatitis of the face and scalp in adolescents and adults, with no differences between mild and strong steroids in the short-term. There is some evidence of the benefit of topical calcineurin inhibitor or lithium salt treatment. Treatment with azoles seems as effective as steroids concerning short-term total clearance, but in other outcomes, strong steroids were more effective. Calcineurin inhibitor and azole treatment appeared comparable. Lithium salts were more effective than azoles in producing total clearance.Steroids are similarly effective to calcineurin inhibitors but with less adverse effects.Most of the included studies were small and short, lasting four weeks or less. Future trials should be appropriately blinded; include more than 200 to 300 participants; and compare steroids to calcineurin inhibitors or lithium salts, and calcineurin inhibitors to azoles or lithium salts. The follow-up time should be at least one year, and quality of life should be addressed. There is also a need for the development of well-validated outcome measures.


Asseburg C.,ESiOR Oy | Asseburg C.,University of Eastern Finland | Peura P.,University of Eastern Finland | Peura P.,Finnish Medicines Agency Fimea | And 6 more authors.
International Journal of Technology Assessment in Health Care | Year: 2012

Background: The cost-effectiveness of triptans in the treatment of migraine has not been assessed since generic sumatriptan entered the Finnish market in 2008. Methods: Using systematic review and mixed treatment comparison, the effectiveness of triptans was estimated with regard to 2-hour response, 2-hour pain-free, recurrence, and any adverse event, using published clinical data. Direct and indirect costs (2010 EUR, societal perspective) and quality-adjusted life-years (QALYs) were evaluated over one acute migraine attack using a decision-tree model. Results: The meta-analysis combined data from fifty-six publications. The highest probability of achieving the primary outcome, "sustained pain-free, no adverse event" (SNAE), was estimated for eletriptan 40 mg (20.9 percent). Sumatriptan 100 mg was the treatment with lowest estimated costs (¢20.86), and the incremental cost-effectiveness ratio of eletriptan 40 mg compared with sumatriptan 100 mg was ¢43.65 per SNAE gained (¢19,659 per QALY gained). Conclusion: Depending on the decision-maker's willingness-to-pay threshold, either sumatriptan 100 mg or eletriptan 40 mg is likely to be cost-effective. © Copyright 2012 Cambridge University Press.


Siponen S.,University of Eastern Finland | Ahonen R.,University of Eastern Finland | Kiviniemi V.,Finnish Medicines Agency Fimea | Hameen-Anttila K.,Finnish Medicines Agency Fimea
International Journal of Clinical Pharmacy | Year: 2013

Background The association between parental attitudes and medication administered to their children has been studied mainly regarding specific diseases and ailments, e.g. asthma, fever and pain. Little is known about how parental attitudes toward medicines in general are associated with how they medicate their children using self-medication. Objective The aim of this study was to identify how parental attitudes toward medicines are associated with how they medicate their children with self-medication including the use of over-the-counter (OTC) medicines and complementary and alternative medicines (CAMs). Setting A cross-sectional population-based study was conducted in the spring of 2007. The study sample consisted of a random sample of Finnish children under 12 years of age (n = 6,000). Method A questionnaire was sent to parents, and the parent who usually takes responsibility for the child's medication was instructed to answer the questionnaire. Main outcome measure The responding parent was asked to report the child's use of OTC medicines and CAMs during the preceding 2 days. The parent's attitude toward medicines was measured by 18 statements using a 5-item Likert scale. Results CAM use was least likely among children whose parent had a positive view of prescription medicines. In contrast, a positive attitude toward OTC medicines by a parent was associated with both, OTC medicine and CAM use among children, whereas, parental worry about the risks of medicines predicted the use of CAMs among children. Conclusion This study showed that parental attitudes toward medicines have an impact on how they medicate their children, especially with CAMs. This finding highlights the fact that health care professionals should negotiate a child's treatment, taking into account parental views toward medicines, and previous use of self-medication. © 2012 Springer Science+Business Media Dordrecht.


PubMed | Finnish Medicines Agency Fimea and Finnish Food Safety Authority
Type: Journal Article | Journal: Acta veterinaria Scandinavica | Year: 2016

Oral rabies vaccination of wildlife has effectively reduced the incidence of rabies in wildlife and has led to the elimination of rabies in large areas of Europe. The safety of oral rabies vaccines has been assessed in both target (red fox and raccoon dog) and several non-target species.Since 2011, the competent authority in Finland has received a few reports of dogs experiencing adverse reactions that have been assumed to be caused by the consumption of baits containing oral rabies vaccine. The dogs usually exhibited gastrointestinal symptoms (vomiting, inappetence, constipation or diarrhoea) or behavioral symptoms (restlessness, listlessness and unwillingness to continue hunting).Nevertheless, these adverse reactions are transient and non-life threatening. Even though the adverse reactions are unpleasant to individual dogs and their owners, the benefits of oral rabies vaccination clearly outweigh the risks.


PubMed | Danube University Krems, University of Eastern Finland, Finnish National Institute for Health and Welfare and Finnish Medicines Agency Fimea
Type: Journal Article | Journal: Global heart | Year: 2016

From the very beginning of the North Karelia Project, prevention, detection, and control of hypertension were included as key aims in the project. An intensive hypertension prevention and control program was established in North Karelia in 1972 that included community-based activities to reduce blood pressure levels in the entire population, detect people with hypertension, improve their treatment, establish standard diagnostic and therapeutic methods, and to monitor blood pressure levels, control of hypertension, and the performance of the health care. After the first 5 years of the project, most of these activities were also implemented on the national level. In late 1970s, work to reduce the salt intake was started, and substantial reductions have taken place in salt intake in the Finnish population. Remarkable improvements have been seen both in blood pressure levels and in treatment and control of hypertension in North Karelia and in the whole of Finland. Between 1972 and 2012 in North Karelia, the mean systolic blood pressure among 30- to 59-year-old men has decreased from 149 mm Hg to 135 mm Hg and among women from 153 mm Hg to 129 mm Hg. The decreases in mean diastolic blood pressure have been from 92 mm Hg to 84 mm Hg among men and from 92 mm Hg to 79 mm Hg among women.

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