Off-label and unlicensed medicine prescribing in university hospital paediatric wards in Finland: A prospective study.

AIMS: The aim of this research is to study the prevalence of prescribing medicines for off-label (OL) use and unlicensed (UL) medicines for children during hospitalization in 2021 and to assess changes compared with 2011. METHODS: The study included all patients aged <18 years who were treated in the neonatal intensive care unit (NICU) or general paediatric ward of Kuopio University Hospital (KUH), Finland, during 4 weeks in April and May 2021. Their background data and daily information on medicine prescriptions were collected from patient records. The prescriptions were classified as OL, UL or on-label/approved. The type of OL category was defined. RESULTS: Altogether, 165 children aged 0-17 years (median 3.2 years) were treated in the paediatric wards (46 in the NICU and 119 in the general ward). In total, 1402 prescriptions were made for 153 children (93%). The proportion of OL and UL prescriptions decreased significantly from 55% in 2011 to 45% (age-adjusted proportion) in 2021 (P < .001). The proportion of patients receiving at least 1 UL medicine prescription decreased from 53% in 2011 to 30% (age-adjusted proportion) in 2021 (P < .001). About 76% of hospitalized children were still prescribed either OL prescription or UL medicine in 2021. CONCLUSION: The prescriptions for OL use and UL medicines were less prevalent in 2021 than 2011, but still a majority of hospitalized children were prescribed either medicine for OL use or UL medicine in 2021. This indicates a persisting need for approved medicines in children suggesting that revision of EU Paediatric Regulation 2007 is necessary.

Medicine use in children aged under 12 years-Population survey in Finland.

PURPOSE: To study the prevalence of prescribed and over-the-counter (OTC) medicine use in children under 12 years of age in Finland and to examine factors associated with the medicine use. METHODS: A nationwide population survey was carried out in Finland in spring 2018 with a random sample of children under 12 years (n = 8000). A response rate of 24% (n = 1921) was attained. The questionnaire was sent to the child's primary guardian. Current use of prescribed medicines and the use of OTC medicines in the preceding 2 days were the main outcome measures. RESULTS: Of all the children 19% had used prescribed medicines, 15% OTC medicines, and 31% either prescription or OTC medicines during the preceding 22 days. Children's health related factors were positively associated with prescribed medicine use including fairly good to poor health status, symptoms experienced, and illnesses diagnosed by a physician. The guardian's healthcare education and use of prescribed medicines were also associated with children's prescribed medicine use. Symptoms of illnesses and fairly good health status were found to be associated with childrens' use of OTC medicines. CONCLUSIONS: The use of medicines in children under 12 years of age is quite common in Finland. As expected, children's health-related factors were associated with medicine use. Also, guardians' healthcare education and the use of prescribed medicines were associated with children's prescription medicine use. Children's medicine use should be continuously monitored and investigated further to identify the reasons leading to appropriate and inappropriate medicine use in children.

Outpatient antibacterial use and costs in children and adolescents: a nationwide register-based study in Finland, 2008-16.

OBJECTIVES: To describe the prevalence of outpatient use and the costs of systemic antibacterials among children and adolescents in Finland during 2008-16 and to examine patterns of use by age and gender. METHODS: Data were retrieved from the Finnish statistical database Kelasto, based on the Finnish Prescription Registry. Data included information on dispensed reimbursed prescriptions of antibacterials for systemic use in children aged 0-17 years during 2008-16. The prevalence of antibacterial prescriptions per 1000 children and costs per prescription were calculated. RESULTS: The overall prevalence of antibacterial prescriptions decreased in the study period and was highest in 2010 (with 708 prescriptions per 1000 children) and lowest in 2016 (with 374 prescriptions per 1000 children). Children aged 1-2 years had the highest prevalence of antibacterial prescriptions. Furthermore, boys had slightly higher prevalences than girls. The 10 most commonly used antibacterial agents covered ∼97% of all prescriptions and broad-spectrum penicillins were the most commonly used antibacterials. The total costs of antibacterials decreased during the study period, but the costs per prescription increased. CONCLUSIONS: This study showed a decreasing trend in the prescribing of antibacterial drugs, regardless of age or gender. Increasing awareness of antimicrobial resistance, reimbursement status changes and pneumococcal and influenza vaccinations are possible reasons for this. Some of the antibacterial oral solutions lost their reimbursement status, but their consumption did not decrease any faster than the consumption of the substances with continuous reimbursability. It is likely that removing the reimbursement status of antibacterials has placed an extra cost burden on families and increased costs per prescription.

Age-related off-label use of nasal corticosteroids for allergies is relatively common in Finnish children with asthma.

AIM: Allergies can worsen asthma symptoms and we used national data to identify allergy medication prescribed for Finnish children and adolescents who used asthma medication. METHODS: Register data were available for 13 435 Finnish children aged 0-17 who were entitled to special reimbursement for asthma medication during 2006-2009. Allergy medication purchases were individually analysed 2 years before and 2 years after the entitlement for asthma medication reimbursement was granted. RESULTS: Two-thirds (66.5%) of the children had used at least one allergy medication during the 4-year follow-up, with an average of five purchases. Most (91%) of the allergy medication purchased was systemic antihistamines and half (50%) was nasal corticosteroids. In all, 8% of the allergy medication and 22% of the nasal corticosteroids were classified as off-label purchases based on the child's age. Paediatric allergologists and paediatricians prescribed 59% of the allergy medication and 76% of the off-label nasal corticoids. CONCLUSION: Most asthmatic children and adolescents used allergy medication. Nasal corticosteroids were the commonly prescribed off-label item and the prescribers were mainly specialists in paediatric allergology or paediatrics. Official dosage instructions and more specific clinical guidelines are needed to support appropriate prescribing of nasal corticosteroids for young children.

Outpatient Antibiotic Use and Costs in Adults: A Nationwide Register-Based Study in Finland 2008-2019.

The objective of this study was to describe the prevalence of outpatient use and costs for systemic antibacterials by age and sex among adults in Finland from 2008-2019. Data from the Finnish statistical database Kelasto, containing information concerning all reimbursed medicines for 18+-year-olds during 2008-2019, were analyzed. In addition to the decreased (26%) use of systemic antibiotics, decreased use was observed in all antibiotic categories, notably including several wide-spectrum antibiotics. The use of quinolones decreased by 49% and of tetracyclines by 39%. The 10 most frequently used antibiotics covered 89% of all adult antibiotic prescriptions. Antibiotic use also decreased in every age group during the study period. Although the overall yearly costs of outpatient antibiotics during the 10-year study period decreased from EUR 36.4 million to EUR 30.7 million, the cost per prescription increased slightly. In conclusion, according to the findings of this study, concerning adults and the results of our previous study concerning children and adolescents (2008-2016), there has been a decreasing trend of outpatient antibacterial use among the whole Finnish outpatient population over the duration of nearly one decade. However, during the same time period, there has been a specific increasing trend for the Gram-negative AMR threat regarding E. coli resistance. Therefore, based on our important findings in Finland, methods other than the restriction of antibiotic use, such as new anti-infective innovations, including antibacterials, are needed as soon as possible to tackle this major global health threat-a silent pandemic.

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.