Drawing up the public national Rational Pharmacotherapy Action Plan as part of social and health services reform in Finland: a bottom-up approach involving stakeholders.

BACKGROUND: Ensuring equal access to medicines and their appropriate and safe use at reasonable costs are core functions of health systems. Despite that, few descriptions of national medicines policies' development processes and implementation strategies have been published. This study aimed to describe the government program-based development of the Rational Pharmacotherapy Action Plan in Finland as a part of the undergoing major health and social service system reform, also covering the implementation of rational pharmacotherapy in the reformed system and processes. METHODS: The data of this qualitative study consisted of public reports and Steering Group meeting memos related to the development of the national Rational Pharmacotherapy Action Plan that the Ministry of Social Affairs and Health coordinated. Qualitative content analysis applying systems theory and the conceptual framework of integrated services as theoretical frameworks was used as an analysis method. RESULTS: The national Rational Pharmacotherapy Action Plan covering 2018-2022 was created in a bottom-up development process involving a wide range of stakeholders. Rational pharmacotherapy was redefined by adding equality as the fifth pillar to complement the previously defined pillars of being effective, safe, high-quality, and cost-effective. The Action Plan formed a normative framework for long-term development, with a vision and principles focusing on people-centeredness, better coordination and management of the medication use processes, the continuity of treatment paths and the flow of patient and medicines information through partnerships, and evidence-informed policies and practices. CONCLUSION: Through intensive stakeholder participation, the bottom-up approach created a national vision and principles of rational pharmacotherapy along with strong commitment to implementing the goals and measures. The concern lies in ensuring the continuity of the Action Plan implementation and achieving a balanced long-term development aligned with the integrated and reformed national social and health services system. The development of the pharmaceutical system has several national and EU-level dependencies requiring political long-term commitment. While the Action Plan differs from the national medicines policy, it forms a good basis for long-term development covering important parts of medicine policy at the micro, meso, and macro levels of the service system.

Preliminary appraisal of clinical drug trials is changing.

The EU Clinical Trials Regulation will change the preliminary appraisal of trials and lighten the bureaucracy. Routines of the member states will be standardized, processing of applications provided with tighter time limits, and the licensing procedure made more flexible by using a common European portal. At the same time, definitions will be provided for low intervention trials subject to more flexible rules of follow-up, requirements of master file content, and traceability of test drugs. Implementation of the regulation depends on the completion of the EU portal, currently estimated to take place in the autumn of 2018. Preparations for execution in Finland are carried out by a working group appointed by the Ministry of Social Affairs and Health. On the national level, preparations are in progress to e.g. reorganize ethical evaluation, because the deadlines of evaluation of applications cannot be met with the current structure. Furthermore, regulations concerning insurances and collaterals, language requirements and possibilities of petitioning relating to the applications will also be decided on a national basis.

Is the Internet replacing health professionals? A population survey on sources of medicines information among people with mental disorders.

BACKGROUND: People with mental disorders often report unmet medicine information needs and may search for information on medicines from sources including the Internet, telephone services, books and other written materials. OBJECTIVE: This study aimed to identify and describe the sources of medicines information used by people with and without mental disorders. METHODS: A cross sectional postal survey was mailed to a nationally representative sample (n = 5,000) of Finns aged 15-64 years in spring 2005. Completed responses were received from 3,287 people (response rate 66%), of whom 2,348 reported using one or more sources of medicines information during the past 12 months. Of those who reported one or more sources of medicines information, 10% (n = 228) reported being diagnosed with or treated for a mental disorder. The main outcome measures were the sources of medicines information used by people who did and did not report being diagnosed with or treated for a mental disorder. RESULTS: Among respondents with and without a mental disorder, physicians (83 vs. 59%), pharmacists (56 vs. 49%) and patient information leaflets (53 vs. 43%) were the most common sources of medicines information. After adjusting for age, gender, level of education, working status and number of chronic diseases, respondents with mental disorders were more likely to use patient information leaflets (OR 1.47, 95% CI 1.06-1.98) and the Internet (OR 1.64, 95% CI 1.02-2.64) as sources of medicines information than respondents without mental disorders. CONCLUSIONS: The results indicate that physicians and pharmacists are the most common sources of medicines information among people both with and without mental disorders. However, patient information leaflets and the Internet were more commonly used by people with mental disorders. There may be an opportunity for clinicians to better exploit these sources of medicines information when developing medicines information services for people with mental disorders.

How and why do people with depression access and utilize online drug information: a qualitative study.

BACKGROUND: People with depression commonly use the Internet to access antidepressant information, but the quality of this information is highly variable. The objective of this study was to assess how and why people use the Internet to access antidepressant information, and the self-reported impact of information obtained online. METHODS: Six focus groups were conducted with a cross-section of Internet users (n=29) with depression. Focus group transcripts were thematically content analyzed using a constant comparison approach. RESULTS: Reasons cited for seeking online information included to obtain a second opinion, to verify information provided in the Package Information Leaflet, to prepare to visit to a physician, and to learn about peer experiences. The Internet was used to complement rather than replace information provided by health professionals. The self-reported impacts of utilizing online drug information included increased autonomy, improved knowledge, being reassured, deciding to change a dose, to discontinue a drug and to suggest a new drug to a physician. LIMITATIONS: Additional quantitative research and a random sampling technique would be required to obtain generalizable results and to assess the relative importance of the various reasons cited by the focus group participants. CONCLUSIONS: The Internet was perceived as an important source of additional drug information, particularly when fear of stigmatization or depression related symptoms limited information seeking from other sources. Health professionals should design online services and direct their clients to accurate and reliable sources of online drug information.

The DARTS tool for assessing online medicines information.

OBJECTIVE: The use of the Internet as a source of medicines information is increasing. However, the quality of online information is highly variable. Equipping Internet users to distinguish good quality information is the aim of a new five-item quality assessment tool (DARTS) that was developed by the Working Group on Information to Patients under the Pharmaceutical Forum established by the European Commission. The objective of this study was to investigate how people with depression assess the quality of online medicines information and to study their opinions about the DARTS tool in assisting in this process. SETTING: Focus group discussions with Internet users were conducted in metropolitan Helsinki, Finland. METHOD: Six focus group discussions (67-109 min duration) were conducted with people with depression (n = 29). The DARTS tool was used as a stimulus after open discussion in relation to the evaluation of the quality of Internet-based medicines information. The focus groups were digitally audiotaped and transcribed verbatim. The transcripts were thematically content analysed by two researchers. RESULTS: Focus group participants were generally critical of the information they retrieved. However, few participants systematically applied quality assessment criteria when retrieving online information. No participants had knowledge or experience of any quality assessment tools. The DARTS tool was perceived as being concise and easy to use and understand. Many participants indicated it would allay some of their concerns related to information quality and act as a reminder. While several participants felt the tool should not be any more extensive, some of them believed it should include a more in-depth explanation to accompany each of the quality criteria. CONCLUSIONS: The DARTS tool may act as a prompt for people with depression to assess the quality of online information they obtain. The five DARTS criteria may form the basis of a systematic approach to quality assessment and the tool may also act as a reminder of quality issues in general. Further studies are needed to assess the actual value of the DARTS tool as well as its value in relation to other quality assessment instruments.

Sources of medicine information in Finland.

OBJECTIVES: To identify differences in reported sources of medicine information between age groups and genders in one European country (Finland). METHODS: A questionnaire on health behaviour was sent by mail to a random sample of 5000 Finns aged 15-64 years in the spring of 2005. The respondents (n=3287) were asked to report the sources from which they had received information about their medicines (both prescription medicines and self-medication) used over the past year (12 months). Number of respondents who had used medicines during the past year and reported at least one source of medicine information was 2348. RESULTS: Women used PILs, newspapers, magazines, books, Health Food Stores (p<0.001) and advertisements (p<0.01) more than men as their medicine information sources. The oldest (50-64-year-olds) men and women reported doctors as sources of medicine information more commonly (p<0.001) and the Internet less commonly (p<0.001) than respondents in other age groups. The 15-29-year-old women received more information from PILs, nurses, relatives and friends (p<0.001) and from radio and television (p<0.05) than women in other age groups. The 15-29-year-old men found more information from relatives, friends, radio and television (p<0.001) than men in other age groups. CONCLUSIONS: There are differences in the reported sources of medicine information between genders and age groups. Older persons seem mostly to use health professionals as their source, while younger persons seem to prefer the Internet or other sources which they can use by themselves. Women seem to be more active than men in searching for medicine information and, like younger persons, on their own initiative.

Providing patient care in community pharmacies: practice and research in Finland.

OBJECTIVE: To describe the provision of patient care in community pharmacies in Finland. FINDINGS: The network of 799 community pharmacies across Finland dispensed 42.1 million prescriptions in 2005. Medication counseling has been mandated by law since 1983 and only pharmacists are permitted to provide therapeutic advice in pharmacies. Measurable improvements in the rates of pharmacists' medication counseling have been observed since 2000. Long-term national pharmacy practice initiatives commenced with the World Health Organization EuroPharm Forum's Questions to Ask About Your Medicines campaign from 1993 to 1996. This was followed by the larger Customized Information for the Benefit of Community Pharmacy Patients project. Since the late 1990s, Finnish pharmacies have actively participated in ongoing national public health programs, initially in the areas of asthma and diabetes, and more recently in the treatment and prevention of heart disease. Automated dose dispensing and electronic prescribing are in the process of wider uptake and implementation. A nationwide multidisciplinary project to improve the use of drugs in older people has recently been announced and research in this area is underway. DISCUSSION: Research has focused on improving the quality of patient care as a strategic priority in community pharmacies. The development of community pharmacy services in Finland has been characterized by strong collaboration among the professional associations, university departments of social pharmacy, continuing education centers, and practicing pharmacists. CONCLUSIONS: Implementation of new patient care services has required long-term, systematic, and well coordinated actions at the local and national levels. Future services will seek to promote the quality use of medications and to ensure that rising costs do not limit uniform access to drugs by all Finnish residents.

Sources of medicine information and their reliability evaluated by medicine users.

OBJECTIVE: To study the medicine users' sources of medicine information and the perceived reliability of these sources in different age groups. SETTING: A computer-aided telephone interview (CATI) to Finnish consumers (n = 1,004). Those respondents (n = 714) who reported using any prescription or self-medication medicines more than once a month were included in the study. METHOD: The respondents were interviewed about their use of sources of medicine information during the previous 6 months. The reliability of sources in different age groups was estimated using a 4-point scale: very reliable, somewhat reliable, somewhat unreliable and very unreliable. The respondents also had the option of being unable to make an appraisal. MAIN OUTCOME MEASURE: A proportion of respondents reporting using the source, number of mentioned sources and their reliability evaluated by respondents. RESULTS: About half of the respondents in each age group mentioned two to four sources. The most common sources of information were Patient Information Leaflets (PILs) (74%), doctors (68%) and pharmacists (60%). Next came television (40%), newspapers and magazines (40%), drug advertisements (32%), nurses (28%), drug information leaflets (27%), relatives and friends (24%), medicine guides and books (22%) and the Internet (20%). There was a significant difference between age groups in reporting the Internet as a source of medicine information (15-34-year-old respondents reported the greatest Internet use). The three most reliable sources in every age group were reported to be PILs, doctors and pharmacists. Nurses, drug regulatory authorities, drug information leaflets and medicine guides and books were considered next most reliable. Relatives and friends, television, newspapers and magazines were considered the least reliable. The respondents were most uncertain about the reliability of the Internet, patient organisations and telephone services. There was a significant difference between age groups in evaluating the reliability of telephone services (15-34-year-olds found them more reliable). CONCLUSION: Medicine users reported receiving medicine information from many sources. The most commonly used sources were perceived as the most reliable, but their reliability did not seem to depend on age. The counsellors should take into account that patients have many sources of medicine information, with varying validity.

Switching of H(2)-Receptor Antagonists to Over-the-Counter Status in Finland : Implications for Consumption and Adverse Effects.

OBJECTIVE: To evaluate the consumption and safety of H(2)-receptor antagonists after switching ranitidine and famotidine to over-the-counter (OTC) status. METHODS: The Finnish drug consumption data, based on the sales of medicines, and the national register for adverse drug reactions (ADRs) from 1990 to 2003 were used. We studied the consumption of H(2)-receptor antagonists, proton pump inhibitors, sucralfate and antacids (A02BA, A02BC, A02BX02 and A02A, respectively, according to the Anatomical Therapeutic Chemical [ATC] classification). We compared the ADRs of H(2)-receptor antagonists with proton pump inhibitors. RESULTS: The total consumption of medicines for the treatment of peptic ulcer disease and gastro-oesophageal reflux disease increased more than 2-fold from 1990 to 2003 (from 12.8 daily defined doses [DDD]/1000 inhabitants/day to 29.6 DDD/1000 inhabitants/day). Initially, switching ranitidine and famotidine to OTC status in 1996 increased their consumption. Since 1998, proton pump inhibitors have been the most commonly used drug group for the treatment of peptic ulcer and gastro-oesophageal reflux disease in Finland. In 2003, the consumption of proton pump inhibitors was 75% (22.2 DDD/1000 inhabitants/day) of the total consumption of drugs for the treatment of peptic ulcer and gastro-oesophageal reflux disease. Switching ranitidine and famotidine to OTC status did not affect the number of reported adverse reactions to these drugs. CONCLUSIONS: According to information collected from the Finnish consumption and ADR databases, H(2)-receptor antagonists are very often used in self-medication and they do not have serious adverse effects. However, the total number of reports concerning these ATC groups in the national ADR database is not very high, and therefore patient-based surveys are needed to verify this finding.

Consumption and distribution of propofol in anaesthesia and intensive care use in Finland.

BACKGROUND: Propofol is approved both for anaesthesia and sedation during intensive care. Serious adverse reactions with propofol have recently been reported, but patient exposure to the drug is unknown. OBJECTIVE: To investigate the consumption of propofol in Finnish hospitals and to develop a denominator to estimate patient exposure. METHODS: The consumption of propofol was investigated using the drug consumption database for 1990-2001. Distribution between anaesthesia and intensive care use in Finnish hospitals was investigated by a survey covering the period 2000-2001. We based the estimate of patient exposure on doses commonly described in the literature on propofol use in different indications. RESULTS: Total consumption of propofol increased more than 4-fold from 1990-2001. Most of the propofol consumed was the 10 mg/mL strength. In 2001, one-third of the total sales consisted of the 20 mg/mL strength. In 2000 and 2001, a little more than half of the total consumption of propofol was used for sedation in intensive care. CONCLUSION: The use of propofol is increasing in Finland. Half of the propofol was used in anaesthesia units and half in intensive care units. We propose the following defined daily doses: 175mg for anaesthesia induction; 750 mg/patient-hour for anaesthesia maintenance; and 4200 mg/patient-day for sedation in intensive care.M.