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.

Health professionals' perceptions of the development needs of incident reporting software: A qualitative systematic review.

AIM: To systemically identify and synthesize information on health professionals' and students' perceptions regarding the development needs of incident reporting software. DESIGN: A systematic review of qualitative studies. DATA SOURCES: A database search was conducted using Medline, CINAHL, Scopus, Web of Science and Medic without time or language limits in February 2023. REVIEW METHODS: A total of 4359 studies were identified. Qualitative studies concerning the perceptions of health professionals and students regarding the development needs of incident reporting software were included, based on screening and critical appraisal by two independent reviewers. A thematic synthesis was conducted. RESULTS: From 10 included studies, five analytical themes were analysed. Health professionals and students desired the following improvements or changes to incident reporting software: (1) the design of reporting software, (2) the anonymity of reporting, (3) the accessibility of reporting software, (4) the classification of fields and answer options and (5) feedback and tracking of reports. Wanted features included suitable reporting forms for various specialized fields that could be integrated into existing hospital information systems. Rapid, user-friendly reporting software using multiple reporting platforms and with flexible fields and predefined answer options was preferred. While anonymous reporting was favoured, the idea of reporting serious incidents with both patient and reporter names was also suggested. CONCLUSION: Health professionals and students provided concrete insights into the development needs for reporting software. Considering the underreporting of healthcare cases, the perspectives of healthcare professionals must be considered while developing user-friendly reporting tools. Reporting software that facilitates the reporting process could reduce underreporting. REPORTING METHOD: The ENTREQ reporting guideline was used to support the reporting of this systematic review. PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public contribution. PROTOCOL REGISTRATION: The protocol is registered in the International Prospective Register of Systematic Reviews with register number CRD42023393804.

An audit on parental attitudes towards medicines used in children.

INTRODUCTION: There is growing concerns regarding the use of medicines in children. Therefore, many strategies were implemented to improve such use and make safe and effective medicines more available for children. Enhancing interaction between parents and health care providers plays an important role in insuring the proper use of medicines. In order to optimize such interaction, the attitudes, beliefs and practices of parents toward medicine use in children need to be explored. METHODS: A validated questionnaire was administered via face to face interviews to 1000 parents attending pediatric outpatient clinics with their children in order to investigate their attitudes toward children's medicines. RESULTS: The majority of respondents (83.2%) were mothers. The majority participants (84.4%) agreed that medicines are necessary in treating illnesses, 80% of the parents had worries about the side effects and interactions of medicines, and 60% of the parents said they try to avoid giving medicines to their children. Moreover, parents in this study varied considerably in their views toward prescription and over-the- counter medicines. More than half of the participants (55.2%) declared that doctors in Jordan prescribe antibiotics to children too easily. CONCLUSION: Participants had positive attitudes toward the necessity of medicines for ill children. However, a considerable proportion of the parents had negative attitudes toward children's medicines with respect to their side effects and interactions, their capability of disturbing the body's own capability of healing illnesses, their unnatural characteristic and other aspects related to medicines.

Patterns and factors associated with low adherence to psychotropic medications during pregnancy--a cross-sectional, multinational web-based study.

BACKGROUND: No previous studies have explored how closely women follow their psychotropic drug regimens during pregnancy. This study aimed to explore patterns of and factors associated with low adherence to psychotropic medication during pregnancy. METHODS: Multinational web-based study was performed in 18 countries in Europe, North America, and Australia. Uniform data collection was ensured via an electronic questionnaire. Pregnant women were eligible to participate. Adherence was measured via the 8-item Morisky Medication Adherence Scale (MMAS-8). The Beliefs about Prescribed Medicines Questionnaire (BMQ-specific), the Edinburgh Postnatal Depression Scale (EPDS), and a numeric rating scale were utilized to measure women's beliefs, depressive symptoms, and antidepressant risk perception, respectively. Participants reporting use of psychotropic medication during pregnancy (n = 160) were included in the analysis. RESULTS: On the basis of the MMAS-8, 78 of 160 women (48.8%, 95% CI: 41.1-56.4%) demonstrated low adherence during pregnancy. The rates of low adherence were 51.3% for medication for anxiety, 47.2% for depression, and 42.9% for other psychiatric disorders. Smoking during pregnancy, elevated antidepressant risk perception (risk≥6), and depressive symptoms were associated with a significant 3.9-, 2.3-, and 2.5-fold increased likelihood of low medication adherence, respectively. Women on psychotropic polytherapy were less likely to demonstrate low adherence. The belief that the benefit of pharmacotherapy outweighed the risks positively correlated (r = .282) with higher medication adherence. CONCLUSIONS: Approximately one of two pregnant women using psychotropic medication demonstrated low adherence in pregnancy. Life-style factors, risk perception, depressive symptoms, and individual beliefs are important factors related to adherence to psychotropic medication in pregnancy.

Patient perspective in health technology assessment of pharmaceuticals in Finland.

OBJECTIVES: The need to consider the patient perspective in health technology assessments (HTA) has been widely recognized. In July 2012, the Finnish Medicines Agency (Fimea) published a national recommendation for integrating the patient perspective into the HTAs of pharmaceuticals. The aim of this study is to describe the development of the recommendation for integrating the patient perspective into the HTA process of pharmaceuticals in Finland. METHODS: The development of the recommendation was based on a review of international recommendations and experiences of patient and public involvement in HTA. The draft recommendation was tested in two focus group discussions (n = 7 patients) and three individual interviews among diabetes patients (type 1 or 2) using long-acting insulin treatment. The recommendation was open for public consultation in April 2012 and revised according to the comments received. RESULTS: Patients will be involved in multiple stages of Fimea's HTA process. The recommendation includes step-by-step instructions on how to assess the patient perspective. The main focus is on qualitative interviews, which will be conducted at the beginning of the assessments to gain information, particularly on patient preferences and values, including positive and negative outcomes important to patients and ethical and social aspects of the medicine's use. CONCLUSIONS: The recommendation will act as a tool to integrate patients' experiences, needs and preferences into Fimea's HTAs of pharmaceuticals.

Multiple information sources and consequences of conflicting information about medicine use during pregnancy: a multinational Internet-based survey.

BACKGROUND: A wide variety of information sources on medicines is available for pregnant women. When using multiple information sources, there is the risk that information will vary or even conflict. OBJECTIVE: The objective of this multinational study was to analyze the extent to which pregnant women use multiple information sources and the consequences of conflicting information, and to investigate which maternal sociodemographic, lifestyle, and medical factors were associated with these objectives. METHODS: An anonymous Internet-based questionnaire was made accessible during a period of 2 months, on 1 to 4 Internet websites used by pregnant women in 5 regions (Eastern Europe, Western Europe, Northern Europe, Americas, Australia). A total of 7092 responses were obtained (n=5090 pregnant women; n=2002 women with a child younger than 25 weeks). Descriptive statistics and logistic regression analysis were used. RESULTS: Of the respondents who stated that they needed information, 16.16% (655/4054) used one information source and 83.69% (3393/4054) used multiple information sources. Of respondents who used more than one information source, 22.62% (759/3355) stated that the information was conflicted. According to multivariate logistic regression analysis, factors significantly associated with experiencing conflict in medicine information included being a mother (OR 1.32, 95% CI 1.11-1.58), having university (OR 1.33, 95% CI 1.09-1.63) or other education (OR 1.49, 95% CI 1.09-2.03), residing in Eastern Europe (OR 1.52, 95% CI 1.22-1.89) or Australia (OR 2.28, 95% CI 1.42-3.67), use of 3 (OR 1.29, 95% CI 1.04-1.60) or >4 information sources (OR 1.82, 95% CI 1.49-2.23), and having ≥2 chronic diseases (OR 1.49, 95% CI 1.18-1.89). Because of conflicting information, 43.61% (331/759) decided not to use medication during pregnancy, 30.30% (230/759) sought a new information source, 32.67% (248/759) chose to rely on one source and ignore the conflicting one, 25.03% (190/759) became anxious, and 2.64% (20/759) did nothing. Factors significantly associated with not using medication as a consequence of conflicting information were being pregnant (OR 1.75, 95% CI 1.28-2.41) or experiencing 3-4 health disorders (OR 1.99, 95% CI 1.10-3.58). Women with no chronic diseases were more likely not to take medicines than women with ≥2 chronic diseases (OR 2.22, 95% CI 1.47-3.45). Factors significantly associated with becoming anxious were >4 information sources (OR 2.67, 95% CI 1.70-4.18) and residing in Eastern Europe (OR 0.57, 95% CI 0.36-0.90). CONCLUSIONS: Almost all the pregnant women used multiple information sources when seeking information on taking medicines during pregnancy and one-fifth obtained conflicting information, leading to anxiety and the decision not to use the medication. Regional, educational, and chronic disease characteristics were associated with experiencing conflicting information and influenced the decision not to use medication or increased anxiety. Accurate and uniform teratology information should be made more available to the public.

Is there a need for standardization of medication counseling in community pharmacies?

Medication counseling is one of the most important duties in community pharmacies aiming to ensure rational pharmacotherapy and medication safety. However, based on research evidence, the quality of medication counseling in pharmacies is often low and shown to vary between different patient groups. This Commentary raises a question whether there is a need to standardize medication counseling in community pharmacies to ensure quality of care for every customer? The law obligates to counsel about medications when dispensing medicines in many countries, however, on a very general level. It seems clear that the general level in which medication counseling is required in law is not enough to ensure the quality of medication counseling, and thus, some standards are needed. However, these standards should take into account the multidisciplinary nature of the pharmacotherapy process as well as the different patient groups and situations that patients face. Most importantly, such standards should not inhibit interaction between the patient and the pharmacist, and they should encourage tailored medication counseling that is based on the individual needs of the patient.

Empowering patients as co-researchers in social pharmacy: Lessons learned and practical tips for meaningful partnership and impact.

Engaging patients as co-researchers in health service research, involving them in the design, planning, and implementation rather than treating them as mere participants, can yield positive outcomes and generate value for patients' health. It also increases patients' health literacy and empowerment, leading to more meaningful studies and substantial research impact. However, deeper levels of engagement as partners throughout the research lifecycle come with ethical and methodological challenges. This commentary provides actionable advice for Patient Engagement and Involvement (PEI) in social pharmacy research through a rapid review of models, frameworks, and guidelines and by gathering lessons from four recent social pharmacy research initiatives conducted in Nordic settings. It also identifies and discusses ethical and methodological challenges to conducting authentic and sustained patient-driven research. Deeper levels of engagement where patients take the lead in shaping the social pharmacy research question(s) are rare due to the intensity of resources required. With these 24 tips and the lessons learned, we aim to make this approach more accessible to social pharmacy researchers interested in PEI.

[Focusing on the patient perspective in the use of medicines]. / Potilas päättää lääkkeen otosta.

Patients' own views on medicines will grow in importance when trying to improve the quality of medicines use. Today, there is a general trend from paternalism towards concordance. Clarifying the patient's expectations and fears/worries is the first step in establishing a patient centered approach. A reserved attitude towards medicines is common, and therefore two-way communication is essential in ensuring a rational use of medicines. Patients use several information sources, which may cause unnecessary worries and discontinuation of treatment. Improving physicians' communication skills and use of techniques like motivational interviewing may be helpful in managing the situation.

The quality of non-prescription medicine counselling in Finnish pharmacies - a simulated patient study.

Background: Medication counselling provided by pharmacists is important for ensuring the safe use of medicines. Objective: To assess the quality of non-prescription medicines counselling in Finnish pharmacies. Methods: Three scenarios using simulated patient methodology were conducted: the patient requesting a specific brand name Burana® (ibuprofen, OTC medicine), Pronaxen® (naproxen, behind-the-counter (BTC) medicine) and a nasal spray. The visits were conducted in 146 pharmacies by trained simulated patients. Each pharmacy was visited twice. The quality of counselling was defined as poor (1-2 points), moderate (3-4 points), or high (5-6 points) based on developed scenario-based scoring criteria. Results: The total number of conducted visits was 292, of which only 29 received high quality counselling. The quality was high in 20% of the cases for Pronaxen® and in 7% of the cases for Nasal spray scenarios. In the Burana® scenario, counselling quality was high only in 2% of the cases. Patients who requested a nasal spray were often asked questions about their symptoms (93%). In the Pronaxen®-scenario, the most frequently asked questions were related to contraindications and drug interactions (56%). The most often given instructions varied between the scenarios, being follow-up in the Burana® and Nasal spray scenarios (17% and 70%, respectively) and how to use the medicine in the Pronaxen®-scenario (63%). Conclusions: Non-prescription medicine counselling is rarely performed with high quality. However, the quality of counselling depends on the medication in question. There is room to improve medication counselling and the assessment of the necessity and suitability of treatment, especially when a patient requests an OTC pain medicine by its brand name.

Understanding medication-related burden from patient perspectives: a qualitative study testing the applicability of the conceptual model among chronically ill outpatients in Finland.

OBJECTIVES: Disease self-management and medication therapy can cause burden to patients that can influence adherence. The conceptual model 'patients' lived experience with medicine' (PLEM) brings new insights into medication-related burden (MRB) from patient perspective. This study aimed to test the applicability of the PLEM model by interviewing chronically ill patients in Finland and to investigate the MRB experienced by the Finnish patients. DESIGN: Focus group discussion study conducted online via Zoom. Directed qualitative content analysis guided by the PLEM model. SETTING: Outpatient primary care in Finland. PARTICIPANTS: Chronically ill outpatients (n=14) divided into five focus groups according to their chronic condition: asthma (n=3), heart disease (n=3), diabetes (n=6), intestinal disease (n=2). RESULTS: Our findings were mainly in line with the PLEM model although some new contributing factors to MRB emerged. In general, the participants were satisfied with their medication, and that it enabled them to live normal lives. The most common causes of MRB were medication routines and the healthcare system. The participants introduced two new aspects contributing to MRB: medication-related environmental anxiety associated with the waste resulting from medicine use, and the effect of medication use on their working life. Our findings are consistent with previous findings that a higher level of MRB may lead to independently modifying the medication regimen or not taking the medicine. CONCLUSIONS: Our findings provide further evidence that the PLEM model is an applicable tool also in the Finnish context for gaining better understanding of MRB in chronically ill patients self-managing their long-term medications. The model provides a promising tool to understand the connection between MRB and the rationale for not always taking medicines as prescribed. Further research is needed to explore the potential of the model in extending patient perspectives in chronic disease management.

Complementary or alternative? Patterns of complementary and alternative medicine (CAM) use among Finnish children.

PURPOSE: The aim of this study was to measure patterns of complementary and alternative medicine (CAM) use among Finnish children and to explore whether CAM use among children is mainly complementary or alternative. METHODS: We carried out a cross-sectional population-based survey in spring 2007. The study population consisted of a representative sample (n = 6,000) of Finnish children under 12 years of age. A questionnaire was sent to their parents, and 4,032 questionnaires were returned (response rate 67 %). Pearson's chi-square test and logistic regression analysis were conducted to measure factors associated with CAM use. RESULTS: The prevalence of CAM use among children was 11 %. Fish oils and fatty acids (6 %) followed by probiotics (4 %) were the most commonly reported CAMs used. Being the first born, using vitamins and having at least one symptom predicted the use of CAMs. Parental use of vitamins and CAMs were also associated with CAM use among children. In the preceding 2 days, 3 % of children in the study had used only CAMs, and 7 % had used a CAM concomitantly with prescribed and/or over-the-counter medicines. CONCLUSIONS: Our results indicate that the use of CAMs among Finnish children is mainly for improving health and alleviating symptoms, especially in families where at least one parent also uses these modalities. CAMs were mainly used as complementary rather than as an alternative to conventional care. Healthcare professionals should be aware of this complementary use of CAMs and medicines in patients to avoid risks of potential interactions.

The perceived development needs for medicines information services in university hospital pharmacies: A mixed methods study.

Background: Reliable and evidence-based medicines information (MI) is critical for patient care. To guarantee this, in many countries, there are medicines information centers (MICs) which offer medicines information services (MISs). While there are no MICs in Finland, pharmacists in all five university hospital pharmacies provide MISs. A proposal for establishing five MICs has been made by the National Medicines Information Network. Objectives: The aim was to explore the current MISs and the perceptions of current and potential MI service providers of the need for the proposed national MICs. Barriers and facilitators for potential transition from the current MISs provided by the university hospital pharmacies to establishing national MICs, were examined. Methods: This sequential explanatory mixed methods study was conducted nationally during September 2019-April 2020 as an online survey and semi-structured individual, pair and group theme interviews with hospital representatives. The survey questionnaire was sent to chief pharmacists and MI pharmacists in all five Finnish university hospital pharmacies (n = 5, census). The interviews (n = 13) were carried out with chief pharmacists, MI pharmacists, medication safety officers (pharmacists), chairs of the Medicines Advisory Board (physicians) and clinical pharmacologists (physicians) (participants n = 19). The data was analyzed using descriptive quantitative analysis and qualitative content analysis. Results: All invited representatives participated in the study. Offered MISs are quite similar but the human resources vary among the organizations. Answering MI questions was one of the core MISs. Most representatives considered a proposal of establishing five MICs to Finland positively. The expected benefits were related to achieving an official status to enhance MI, establishing the MICs within the university hospitals and close to where the MISs are needed, and fostering multiprofessional collaboration and collaboration between the MICs. Limited financial and human resources were seen the most critical challenges. Conclusion: The existing expertise of the pharmacists and the similarities in MISs provided by the university hospital pharmacies seem to provide a good basis and preconditions for expanding MI operations and forming MICs at the national level. By pooling current limited resources, synergies could be achieved and MISs, and potentially MICs developed. The establishment of MICs may enhance utilization of networking and multiprofessional collaboration in producing MISs at the national level.

Children's health and parental socioeconomic factors: a population-based survey in Finland.

BACKGROUND: Socioeconomic inequalities in health are a global problem, not only among the adult population but also among children. However, studies concerning young children especially are rare. The aim of this study was to describe the health of Finnish children under 12 years of age, and the socioeconomic factors associated with health. The socioeconomic factors were parental education level, household net income, and working status. METHODS: A population-based survey among Finnish children aged under 12 years (n = 6,000) was conducted in spring 2007. A questionnaire was sent to parents, and a response rate of 67% was achieved. Each child's health was explored by asking a parent to report the child's health status on a 5-point Likert scale, current symptoms from a symptoms list, and current disease(s) diagnosed by a physician. The final three outcome measures were poor health, the prevalences of psychosomatic symptoms, and long-term diseases. Data were analysed using Pearson's Chi-Square tests, and logistic regression analysis with 95% confidence intervals (CIs). P-values ≤ 0.05 were considered as statistically significant. RESULTS: In total, 3% of parents reported that their child's health status was poor. The prevalences of psychosomatic symptoms and long-term diseases were both 11%. The probability for poor health status was lowest among children aged 3-6 and 7-11 years, and for psychosomatic symptoms among 3-6-year-old children, whereas the odds ratios for long-term diseases was highest among children aged 7-11 years. Parental socioeconomic factors were not associated with the children's health. CONCLUSIONS: Most of the children were reported by their parent to have good health status, and approximately one tenth had experienced some psychosomatic symptoms or long-term diseases. Our study suggests that parental socioeconomic factors are not associated with the health of children aged under 12 years in Finland.

The use of complementary and alternative medicine products in preceding two days among Finnish parents - a population survey.

BACKGROUND: The use of complementary and alternative medicines (CAM) has been extensively studied globally among adult and paediatric populations. Parents, as a group, had not been studied to assess their knowledge and attitude to CAM and general medicine use. This study is necessary since parents' attitude to medicine use is known to influence their child's attitude to medicine use later in life. We therefore aim to assess the extent and types of CAM use among Finnish parents, and to determine the factors that promote the CAM use. Also, we aim to determine parents' attitude to general medicine use. METHODS: Children less than 12 years old, as of spring 2007, were identified from the database of the Finnish Population Register Centre and were selected by random sampling. The parents of these children were identified and a questionnaire was sent to them. Only the parent who regularly takes care of the child's medicine was requested to fill the questionnaire. Cross-tabulations and Chi-square test were used to determine the associations between categorical variables. CAMs were defined as natural products that are not registered as medicines, such as homeopathic preparations, dietary food supplements, and traditional medicinal products. RESULTS: The response rate of the survey was 67% (n = 4032). The use of CAM was 31% in the preceding two days. The most commonly used CAM products were vitamins and minerals, followed by fish oils and fatty acids. Prescription and OTC medicines were used concomitantly with CAM by one-third of the parents. CAM was frequently used by parents over 30 years (33%), female parents (32%), highly educated parents (35%), and parents with high monthly net income (3000-3999 euros, 34%). The users of CAM had more negative attitudes towards medicines than non-users of CAM. CONCLUSIONS: Our findings are in accordance with those of previous studies that women over 30 years of age with a high education and income typically use CAMs. Finnish parents seem to use CAMs as complementary rather than alternative to medicines. Health care professionals should take into consideration both the concomitant use as well as the negative attitudes among CAM users in encounters with the parents.

Point prevalence survey of antibiotic consumption across three hospitals in Ghana.

BACKGROUND: Actionable data on antimicrobial use is important when planning strategic interventions such as antimicrobial stewardship to address the challenge of drug resistance, particularly in resource-constrained settings. OBJECTIVES: To assess the prevalence of antibiotic use, the pattern of commonly used antibiotics and patient factors that may be associated with the increased use of antibiotics in the study hospitals. METHODS: This was a cross-sectional study conducted using the WHO Methodology for Point Prevalence Surveys in hospitals. Chi-squared analysis, Fisher's exact test and logistic regression were employed to analyse statistically the data obtained. RESULTS: The overall prevalence of antibiotic use in the hospitals was 60.5%. The commonest indications for antibiotic recommendations were community-acquired infections (36.5%), surgical prophylaxis (26.1%) and hospital-acquired infections (15.7%), among others. Very few (2.7%) of the patients had their samples taken for culture and susceptibility testing to guide therapy. Penicillins (48.7%), cephalosporins (23.5%) and fluoroquinolones (17.4%) were the most commonly prescribed antibiotics. Concurrent malaria infection [adjusted OR (AOR) 0.33, 95% CI 0.11-0.94, P = 0.04] and increasing age (AOR 0.98, 95% CI 0.96-1.00, P = 0.02) were associated with lower risk of antibiotic use. CONCLUSIONS: The prevalence of antibiotic consumption in the hospitals was lower than that reported in similar studies in Ghana, but high relative to some reports from high-income countries. Most antibiotic therapy was empirical and not guided by culture and susceptibility testing. There is the need for application of the WHO AWaRe classification for the selection of antibiotics and increased use of culture and susceptibility data to guide infectious disease therapy.

Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review.

BACKGROUND: Biosimilars are expected to decrease growing health care expenditures. Given that uptake of biosimilars has been modest, automatic substitution has been suggested to increase their use, but the practice is not yet allowed or implemented in many jurisdictions. METHODS: A systematic review was performed by searching databases Scopus, Medline (Ovid), CINAHL, and Web of Science. Peer-reviewed, original studies written in English and published during the period January 1, 2006 to April 24, 2021 reporting any interventions, pilots or any other studies including experiences or perceptions of any relevant stakeholders on automatic substitution of biologics were included without limitation by setting or geography. The quality of the included studies were evaluated by pre-determined criteria. RESULTS: Altogether, 27 studies fulfilled the inclusion criteria, of which 23 were surveys, and four semi-structured interviews reporting mainly stakeholders' perceptions on automatic substitution. Most of the studies (56%, 15/27) were from Europe. Studies were conducted among prescribers (n = 12), pharmacists (n = 5), patients (n = 4), payers (n = 1), and mixed stakeholders (n = 5). The primary objective of the majority (81%, 22/27) of the studies was to investigate some other biosimilar topic than automatic substitution. The reported perceptions of substitution were mainly negative. Studies evaluating risks, safety or effectiveness, or reporting real-life experiences of biologic substitution were lacking except one intervention and two prospective risk management studies. The overall quality of the studies was low to moderate, and the results were not generalizable due to convenience sampling not representing the populations of interest, and low response rates. CONCLUSIONS: The current research evidence on the automatic substitution of biologics is scarce and of low to moderate quality, reflecting low stakeholder knowledge and their cautious attitude towards biosimilars. The safe and efficient implementation of automatic substitution requires well-designed practices, pilot studies, and evolving legislation.

The use of prescription medicines and self-medication among children--a population-based study in Finland.

PURPOSE: The aim of this study was to investigate the prevalence and concomitant use of prescription medicines and self-medication, including over-the-counter (OTC) medicines, vitamins, and complementary and alternative medicines (CAMs) among Finnish children aged under 12 years. METHODS: We carried out a nationwide postal survey of the use of medicines by a representative sample (n = 6000) of Finnish children aged under 12 years in spring 2007. A response rate of 67% (n = 4032) was achieved. The current use of prescription medicines and the use of OTC medicines, vitamins, and CAMs in the preceding 2 days were the main outcome measures. RESULTS: In total, 17% of children had used prescription medicines and 50% some self-medication. The corresponding figures for OTC medicines, vitamins, and CAMs use were 17, 37, and 11%, respectively. Drugs for obstructive airway diseases were the most common prescription medicines, whereas analgesics and antipyretics, including non-steroidal-anti-inflammatory-medicines (NSAID), were the most common OTC medicines reported. Vitamin D was the most common vitamin, while fish oils and fatty acids were the most common CAMs used. Ten percent of the children had used prescription medicines and self-medication concomitantly. CONCLUSIONS: Most of the children's medication consists of self-medication, and especially of vitamin use. However, also a considerable proportion had used prescription medicines, and a minority prescription medicines and self-medication concomitantly. In three of the cases, a combination of prescription and OTC medicine with a potential risk for interactions were found. Physicians should be aware of this wide use of self-medication when prescribing medicines.

Factors associated with medicine use among children aged under 12 years--a population survey in Finland.

PURPOSE: The goal was to determine the prevalence of medicine use and to provide population-based information on factors associated with medicine use, including prescribed and over-the-counter (OTC) medicines, in children aged under 12 years. METHODS: A cross-sectional population survey of a random sample of children aged under 12 years (n = 6000) was carried out in Finland in spring 2007, with a response rate of 67%. A questionnaire was sent to their parents. Current use of medicines prescribed by a physician and use of OTC medicines during the preceding two days were the main outcome measures. RESULTS: The prevalence of current prescribed medicine use was 17%, and the 2-day prevalence of OTC medicine use 17% (vitamins excluded). The use of prescribed medicines was higher among children with illnesses diagnosed by a physician. Additionally, predictors for the use of prescribed medicines were young age among boys, health status worse than good, and the use of any prescribed medicines by a parent. The predictors for the use of OTC medicines by the child were young age and fairly good to poor health status, and the use of OTC medicines by a parent. However, children with any illnesses diagnosed by a physician were less likely to use OTC medicines. CONCLUSIONS: A considerable proportion of children use prescription and OTC medicines in Finland. Young age and health-related factors, morbidity and health status, and parental medicine use predicted children's medicine use. Further studies are needed to examine the association between parents' and children's medicine use.

Validating the children's medicines use questionnaire (CMUQ) in Australia.

OBJECTIVE: To pilot test the validity and reliability of the English version of the Children's Medicines Questionnaire (CMUQ) and to explore the attitudes of Australian caregivers towards the use of medicines in children. SETTING: Survey of Australian parents and primary care givers of children 0-15 years. METHODS: The questionnaire was translated from Finnish to English then back-translated to ensure semantic equivalence. A total of 153 parents/main caregiver of a child aged 0-15 years were recruited via convenience sampling. Construct validity of the attitudinal section of the CMUQ was performed using exploratory factor analysis. Reliability was assessed using the Cronbach's alpha coefficient as a marker of internal consistency. Three focus groups were conducted to explore participants' attitudes towards medicating children and to triangulate quantitative data. MAIN OUTCOME MEASURE: Construct validity and internal reliability of the CMUQ. RESULTS: Factor analysis generated a parsimonious four factor solution explaining 50% of variance in the data. The four subscales representing the four factor solution each returned a Cronbach's Alpha coefficient >0.6, indicating good internal consistency. Participants in focus groups were satisfied with the structure and content of the questionnaire. There were 5 emergent themes through focus group discussions with parents and primary care givers of children, regarding the perception of medicines use in children. These included, 'concerns about the negative effects of medicines', 'medicines are useful, necessary and safe in treating illnesses in children', 'the body's natural processes are sufficient in fighting illness', 'over the counter medicines are effective and useful in treating illness', 'perception of alternative medicines use in children'. CONCLUSIONS: The CMUQ is a valid and reliable tool to measure parents' medicine use for their children in an Australian sample. Although small modifications should be made, this instrument will be valuable in informing the development of medicines information for this cohort in the future.