Statin prescribing according to gender, age and indication: what about the benefit-risk balance?

RATIONALES, AIMS AND OBJECTIVES: The increasing dispensing of statins has raised concern about the appropriateness of prescribing to various population groups. We aimed to (1) investigate incident and prevalent statin prescribing according to indication, gender and age and (2) relate prescribing patterns to evidence on beneficial and adverse effects. METHODS: A cohort of Danish inhabitants (n = 4 424 818) was followed in nationwide registries for dispensed statin prescriptions and hospital discharge information. We calculated incidence rates (2005-2009), prevalence trends (2000-2010) and absolute numbers of statin users according to register proxies for indication, gender and age. RESULTS: In 2010, the prevalence became highest for ages 75-84 and was higher in men than women (37% and 33%, respectively). Indication-specific incidences and prevalences peaked at ages around 65-70, but in myocardial infarction, the prevalence was about 80% at ages 45-80. Particularly, incidences tended to be lower in women until ages of about 60 where after gender differences were negligible. In asymptomatic individuals (hypercholesterolaemia, presumably only indication) aged 50+, dispensing was highest in women. The fraction of statin dispensing for primary prevention decreased with age: higher for incident than prevalent prescribing. Independent of age, this fraction was highest among women, e.g. 60% versus 45% at ages 55-64. The fraction for potential atherosclerotic condition (PAC, e.g. heart failure) increased with age. CONCLUSION: Prevalence of statin utilization was highest for ages 75-84, although indication-specific measures were relatively low. Despite inconclusive evidence for a favourable risk-benefit balance, statin prescribing was high among people aged 80+, asymptomatic women and PAC patients.

The "child size medicines" concept: policy provisions in Uganda.

BACKGROUND: In 2007, the World Health Organization (WHO) launched the 'make medicines child size' (MMCS) campaign by urging countries to prioritize procurement of medicines with appropriate strengths for children's age and weight and, in child-friendly formulations of rectal and flexible oral solid formulations. This study examined policy provisions for MMCS recommendations in Uganda. METHODS: This was an in-depth case study of the Ugandan health policy documents to assess provisions for MMCS recommendations in respect to oral and rectal medicine formulations for malaria, pneumonia and diarrhea, the major causes of morbidity and mortality among children in Uganda- diseases that were also emphasized in the MMCS campaign. Asthma and epilepsy were included as conditions that require long term care. Schistomiasis was included as a neglected tropical disease. Content analysis was used to assess evidence of policy provisions for the MMCS recommendations. RESULTS: For most medicines for the selected diseases, appropriate strength for children's age and weight was addressed especially in the EMHSLU 2012. However, policy documents neither referred to 'child size medicines' concept nor provided for flexible oral solid dosage formulations like dispersible tablets, pellets and granules- indicating limited adherence to MMCS recommendations. Some of the medicines recommended in the clinical guidelines as first line treatment for malaria and pneumonia among children were not evidence-based. CONCLUSION: The Ugandan health policy documents reflected limited adherence to the MMCS recommendations. This and failure to use evidence based medicines may result into treatment failure and or death. A revision of the current policies and guidelines to better reflect 'child size', child appropriate and evidence based medicines for children is recommended.

Adolescents' medicine use for headache: secular trends in 20 countries from 1986 to 2010.

BACKGROUND: This study reports secular trends in medicine use for headache among adolescents in 20 countries from 1986 to 2010. METHODS: The international Health Behaviour in School-aged Children (HBSC) survey includes self-reported data about medicine use for headaches among nationally representative samples of 11-, 13- and 15-year-olds. We included 20 countries with data from at least three data collection waves, with a total of 380 129 participants. RESULTS: The prevalence of medicine use for headaches varied from 16.5% among Hungarian boys in 1994 to 62.9% among girls in Wales in 1998. The prevalence was higher among girls than boys in every country and data collection year. The prevalence of medicine use for headaches increased in 12 of 20 countries, most notably in the Czech Republic, Poland, Russia, Sweden and Wales. CONCLUSION: The prevalence of medicine use for headaches among adolescents is high and increasing in many countries. As some medicines are toxic this may constitute a public health problem.

Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase™.

BACKGROUND: Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income. OBJECTIVE: The aim of the study was to characterize ADRs reported to the WHO-ADR database, VigiBase™, and to relate data to national income. METHODS: We analysed ADR reports submitted to VigiBase™ from 2000 to 2009 with respect to reporting rate, age and sex of patient, type, seriousness and medications. Reports were also analysed with respect to national income level, classified in accordance with the World Bank definition: low, lower-middle, upper-middle and high. RESULTS: We analysed 1,359,067 ADR reports including 3,013,074 ADRs. Overall, 16% of reports were serious and 60% were reported for females. High-income countries had the highest ADR reporting rates (range 3-613 reports/million inhabitants/year) and low-income countries the lowest (range 0-21). Distribution of ADRs across income groups with respect to age group, seriousness and sex was non-significant. Overall, the majority of ADRs were reported for nervous system medications, followed by cardiovascular medicines. Low-income countries reported relatively more ADRs for antiinfectives for systemic use than high-income countries, and high-income countries reported more ADRs for antineoplastic and immunomodulating agents than lower-income groups. CONCLUSION: This study showed that high-income countries had the highest ADR reporting rates and low-income countries the lowest, with large variations across countries in each group. Significant differences in ADR reporting rates were only found for ADRs of the type 'skin and subcutaneous tissue disorders' and for the therapeutic groups 'antiinfectives for systemic use' and 'antineoplastic and immunomodulation agents'. To strengthen ADR reporting rates, especially in low-income countries, more research is needed about the impact of organizational structures and economic resources of national pharmacovigilance centres and ADR reporting practices on the large variations in ADR reporting rates within income groups.

Pharmacoeconomic assessment of oseltamivir in treating influenza--the case of otherwise healthy Danish adolescents and adults.

OBJECTIVE: To assess the pharmacoeconomics of treating influenza with oseltamivir in healthy Danish adolescents and adults. METHOD: Cost-effectiveness and cost-utility analyses were used to compare oseltamivir to usual care (symptomatic treatment with over the counter (OTC) medicine), considering both the societal and health care payer's perspectives. The population group studied was otherwise healthy adolescents and adults, aged 13 to 64. Danish data were collected to simulate results that are specific to Denmark. The economic model included first- and second-order Monte Carlo simulations. Sensitivity analyses were conducted to test the robustness of the analyses. MAIN OUTCOME MEASURE: The cost-effectiveness study was expressed as gain in cost per day to return to normal activity, and the cost-utility study as cost per QALY (quality adjusted life years) gained. RESULTS: From a societal perspective, oseltamivir was a dominant treatment compared to usual care. From a health care payer's perspective, the cost-effectiveness ratio was 12.3 euros per gain in day to return to normal activity and 5,063 euros/QALY gained. A sensitivity analysis leaving out hospitalisation, complications, and mortality showed increased cost-effectiveness and cost-utility ratios. However, treatment with oseltamivir remained cost-effective, assuming a willingness to pay for health benefits at 26,174 euros/QALY. CONCLUSION: Pharmacoeconomic analyses of influenza treatment with oseltamivir in an otherwise healthy Danish adolescent/adult population show that this treatment saves money for society and is associated with a relatively low cost from a health care payer's perspective. Treatment of influenza with oseltamivir would be cost-effective for healthy adolescents/adults in Denmark.

Self-reported medicine use among 11- to 15-year-old girls and boys in Denmark 1988-1998.

AIMS: To describe the self-reported medicine use for common health complaints among 11-15-year-olds in Denmark during a ten year period, 1988-1998. The paper focuses on medicine for headache, stomach ache, cough, cold, nervousness, and difficulties in getting to sleep. METHODS: Four cross-sectional surveys of 11-15-year-old students in random samples of schools in Denmark, conducted in 1988 (n=1671), 1991 (n=1860), 1994 (n=4046) and 1998 (n=5205). The surveys were similar with regard to sampling and data collection. Data were collected by self-administered questionnaires in the classroom. RESULTS: A large proportion of 11-15-year-olds reported medicine use during the past month. It was most common to take medicines for headache (used by 55% of 15-year-old girls and 36% of 15-year-old boys in 1998) and stomach ache (33% among 15-year-old girls in 1998). Pain reliever use was higher among girls than boys and this sex difference increased with age. There was an upward trend in reported medicine use from 1988 to 1998, in particular regarding medicine for stomach-ache among 13- and 15-year-old girls. A large proportion of girls were frequent users of medicine for headache, stomach-ache, and sleeping difficulties. CONCLUSION: A high proportion of 11-15-year-old girls and boys reported medicine use in relation to common health complaints. The proportion of users increased during the past decade. It is suggested that more information about medicine be built into health education programs in the future.