Medication overuse, healthy lifestyle behaviour and stress in chronic headache: Results from a population-based representative survey.

AIM: This cross-sectional study investigated associations between chronic headache (CH) with and without medication overuse, healthy lifestyle behaviour, and stress. METHODS: Questionnaires were sent to 129,150 adults. Those with headache ≥15 days per month for three months were classified as having CH then further described as having medication-overuse headache (MOH) or CH without medication overuse. Associations between headache and daily smoking, physical inactivity, obesity, excessive drinking, illicit drug use, and high stress were analysed by logistic regression. RESULTS: CH with and without medication overuse (prevalence 1.8% and 1.6%, respectively) had strong, graded associations with stress. Associations with daily smoking, physical inactivity, and obesity were significant only for MOH. Odds for MOH were highest among people who had all three factors compared to those who had none (OR 2.8 in women and 5.1 in men). High stress plus any of these three factors had synergistic effects in MOH but not clearly in those who had CH without overuse. Associations between CH subtypes and excessive drinking or illicit drug use were not statistically significant. CONCLUSION: Results suggest strong links between healthy lifestyle behaviour and stress in MOH. Stress reduction and promoting healthy behaviour are highly relevant in MOH management.

Empirical relations between sense of coherence and self-efficacy, National Danish Survey.

Salutogenic orientation is a health promotion paradigm focusing on the resources of the individual. This study analyzed the relationship between sense of coherence (SOC) and self-efficacy (SE) based on population data. By conducting an empirical analysis of the two models, we wanted to see whether we could make a valid judgement as to whether both SOC and SE could be utilized in health promotion practice, or whether one is preferable to the other. The study population was randomly selected from the Danish Central Population Register and consisted of five birth-year cohorts (1920, 1930, 1940, 1965 and 1975). The study used the 13-item SOC scale and the general SE scale. The main findings were that SOC score increased by age cohort (p = 0.0004), and there is a positive and graded correlation between SOC and SE (r = 0.39; p < 0.0001) and adjusted OR = 10.3 (CI = 6.7-15.4). We found the strongest association at the lowest level of SOC. For health promotion practice, this finding signifies the importance of focusing on improving SOC in people with a low SOC score, as they are most in need and most likely to increase their SOC level. The finding of higher SOC scores in the older age cohorts indicates that SOC changes over lifetime. Public health work focusing on lifestyle change by increasing SOC can be effective throughout life, however early intervention is important. The finding of a positive correlation between SOC and SE indicates that health promotion altering one of the constructs is paralleled in the other.

Sociodemographic and diagnostic characteristics of prescribing a second-line lipid-lowering medication: ezetimibe used as initial medication, switch from statins, or add-on medication.

OBJECTIVE: Ezetimibe is used as a second-line lipid-lowering medication (LLM) if statin therapy is not tolerated or cholesterol targets are not reached by statins alone. We aimed to investigate the impact of sociodemographic factors on ezetimibe initiation as (a) incident LLM therapy, (b) add-on therapy, and (c) switch from statins. METHODS: All individuals aged 30+ who had filled at least one prescription for either statins (N = 581.074) or ezetimibe (N = 7.932) in 2011 were followed in the nationwide Danish registries to explore LLM prescribing patterns from 1 January 2011 to end 2012. Using logistic regression analyses, the odds ratio (OR) with 95% confidence intervals (CIs) was calculated for (a) incident ezetimibe use among LLM initiators (N = 77,472), (b) ezetimibe switching by discontinuing statin users (N = 37,509), and (c) ezetimibe as add-on by non-discontinuing statin users (N = 442,672). RESULTS: Women had higher odds for initiating ezetimibe than men (switch OR = 1.55; 95% CI = 1.32-1.82). While prior use of newer high-potency statins was the strongest predictor (add-on (5.56; 4.95-6.24), income was the strongest socioeconomic predictor for incident LLM use (1.33; 1.14-1.56) and switching (1.64; 1.27-2.13). Both income and education were predictors for add-on therapy, with the educational effect mediated by prior use of high-potency statins. Odds for ezetimibe prescribing were highest in myocardial infarction patients. CONCLUSION: While higher income is a predictor for switching to ezetimibe, both higher education and income are weak predictors for using ezetimibe as add-on therapy. Women and individuals with myocardial infarction are more likely to be prescribed ezetimibe than others, despite lack of evidence of ezetimibe lowering the risk of cardiovascular events.

Prescription pain medications and chronic headache in Denmark: implications for preventing medication overuse.

PURPOSE: The aim of the present paper is to study which prescription pain medications are most commonly dispensed to people with chronic headache (CH), particularly those with medication-overuse headache (MOH). METHODS: This cross-sectional study analysed prescription pain medications dispensed within 1 year to 68,518 respondents of a national health survey. Participants with headache ≥ 15 days per month for 3 months were classified as having CH. Those with CH and over-the-counter analgesic use ≥ 15 days per month or purchase of ≥ 20 or ≥ 30 defined daily doses (DDDs) of prescription pain medication per month (depending on the drug) were classified as having MOH. Associations between CH and other chronic pain conditions were analysed by logistic regression. RESULTS: Among those with CH (adjusted prevalence 3.3%, CI 3.2-3.5%), pain medications most commonly dispensed were paracetamol, tramadol, ibuprofen and codeine. CH was associated with osteoarthritis, back pain, and rheumatoid arthritis. Among those with MOH, 32.4% were dispensed an opioid at least once within 1 year. Only 5.1% of people with CH were dispensed triptans. CONCLUSIONS: High prevalence of opioid use among people with CH may be due to inappropriate headache treatment or development of MOH among those treated for other pain conditions. While there were cases of triptan overuse, triptans remain underutilized among those with CH, suggesting that migraine may be under-recognized and inappropriately treated, leading to overuse of other medications. Education of physicians on appropriate headache management is essential for MOH prevention. There is a need to increase universal awareness about MOH as an adverse effect of long-term analgesic use.

Definitions of medication-overuse headache in population-based studies and their implications on prevalence estimates: a systematic review.

BACKGROUND: Case definitions of medication-overuse headache (MOH) in population-based research have changed over time. This study aims to review MOH prevalence reports with respect to these changes, and to propose a practical case definition for future studies based on the ICHD-3 beta. METHODS: A systematic literature search was conducted to identify MOH prevalence studies. Findings were summarized according to diagnostic criteria. RESULTS: Twenty-seven studies were included. The commonly used case definition for MOH was headache ≥15 days/month with concurrent medication overuse ≥3 months. There were varying definitions for what was considered as overuse. Studies that all used ICHD-2 criteria showed a wide range of prevalence among adults: 0.5%-7.2%. CONCLUSIONS: There are limits to comparing prevalence of MOH across studies and over time. The wide range of reported prevalence might not only be due to changing criteria, but also the diversity of countries now publishing data. The criterion "headache occurring on ≥15 days per month" with concurrent medication overuse can be applied in population-based studies. However, the new requirement that a respondent must have "a preexisting headache disorder" has not been previously validated. Exclusion of other headache diagnoses by expert evaluation and ancillary examinations is not feasible in large population-based studies.

A multistate model and an algorithm for measuring long-term adherence to medication: a case of diabetes mellitus type 2.

OBJECTIVES: To develop a multistate model and an algorithm for calculating long-term adherence to medication among patients with a chronic disease. METHODS: We propose definitions of the different states of waiting, persistence, with sufficient supply to implement the prescribed dosing regimen, gaps, nonpersistence, and nonacceptance and an algorithm for transitions between states to describe long-term adherence to medication treatment. The model and algorithm are operationalized for use in a case with a retrospective cohort of patients with type 2 diabetes mellitus, with access to records of prescribed drugs from a Danish diabetes research hospital and records of filled prescriptions at Danish pharmacies from the Danish Health and Medicines Authority. RESULTS: Calculations of long-term adherence to medication are shown for patients with type 2 diabetes mellitus on metformin and/or simvastatin. The study shows how the prevalence of patients waiting to initiate treatment, patients with supply to implement the prescribed dosing regimen, patients not accepting treatment, and patients discontinuing treatment varies over time. CONCLUSIONS: The proposed multistate model and algorithm can easily be translated and used for the calculation of adherence to medication in any chronic disease. The model and algorithm take time into account, and thus, changes in incidence rates and prevalence of the different states over time can be estimated on several time scales (calendar time, age of the patient, and time since indication for medication).

Ethnic and migrant differences in the use of anti-asthmatic medication for children: the effect of place of residence.

BACKGROUND: Ethnic differences in the use of anti-asthmatic medication have been reported, with ethnic minorities being at a higher risk of suboptimal asthma control. As contextual socioeconomic characteristics may play a role, we analysed whether ethnic differences in the use of anti-asthmatic medication among children residing in the Capital Region of Denmark varied by place of residence. METHODS: Data were obtained from the Danish Civil Registration System, the Central Taxpayers' Register and the Danish National Prescription Register and were linked at the individual level. Population used was the entire child population in the Capital Region from 0 to 17 years old in 2008 (n = 342,403). Use of anti-asthma medicine was defined as at least one prescription having been filled in 2008. The analyses included multiple multilevel logistic regression models. RESULTS: Children living in low-income places of residence had lower odds of being prescribed preventive anti-asthmatics compared with children living in higher-income places of residence [odds ratio (OR) = 0.87, 95% confidence interval (CI) 0.84-0.91]. Immigrant children had the lowest OR of being prescribed anti-asthmatics medication, both relief (OR = 0.50, 95% CI 0.20-0.77) and preventive (OR = 0.47, 95% CI 0.24-0.82) compared with ethnic Danes. Similar associations were found among descendants of immigrant children (OR for preventive medication = 0.70, 95% CI 0.62-0.78). Place of residence contributed to but did not account for the ethnic differences in the use of anti-asthmatic medication. CONCLUSIONS: Ethnic differences in the use of anti-asthmatic medication were documented, and they cannot be explained by socioeconomic characteristics of place of residence. The lower prevalence of anti-asthmatic medication among ethnic minority children suggests poor asthma management control.

Using text-mining techniques in electronic patient records to identify ADRs from medicine use.

This literature review included studies that use text-mining techniques in narrative documents stored in electronic patient records (EPRs) to investigate ADRs. We searched PubMed, Embase, Web of Science and International Pharmaceutical Abstracts without restrictions from origin until July 2011. We included empirically based studies on text mining of electronic patient records (EPRs) that focused on detecting ADRs, excluding those that investigated adverse events not related to medicine use. We extracted information on study populations, EPR data sources, frequencies and types of the identified ADRs, medicines associated with ADRs, text-mining algorithms used and their performance. Seven studies, all from the United States, were eligible for inclusion in the review. Studies were published from 2001, the majority between 2009 and 2010. Text-mining techniques varied over time from simple free text searching of outpatient visit notes and inpatient discharge summaries to more advanced techniques involving natural language processing (NLP) of inpatient discharge summaries. Performance appeared to increase with the use of NLP, although many ADRs were still missed. Due to differences in study design and populations, various types of ADRs were identified and thus we could not make comparisons across studies. The review underscores the feasibility and potential of text mining to investigate narrative documents in EPRs for ADRs. However, more empirical studies are needed to evaluate whether text mining of EPRs can be used systematically to collect new information about ADRs.

Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions.

AIM: To identify adverse drug reactions (ADRs) associated with off-label prescribing of medicines in a paediatric population. METHODS: We analysed spontaneous ADR reports for children from ages 0 to 17 years submitted to the Danish national ADR database from 1998 to 2007. We defined off-label prescribing as prescriptions outside the licensed age group. Off-label ADRs were categorized by therapeutic group, age of child, type and severity. The unit of analysis was one ADR. RESULTS: We analysed 4388 ADRs for children reported in the national database. Approximately 17% of reported ADRs were associated with off-label use, 60% of them serious. More than one half of off-label ADRs were reported in adolescents. Serious ADRs due to off-label prescribing are more likely to be reported for hormonal contraceptives (ATC group G), anti-acne preparations (ATC group D) and allergens (ATC group V). CONCLUSION: One-fifth of all ADRs reported over a decade in Danish children was associated with off-label prescribing, and serious ADRs due to off-label prescribing were primarily present in three therapeutic groups: sex hormones, dermatologicals and allergens. There is a need for more research into the prescribing of these medicines in the teenage population, as well as tighter reporting and monitoring of ADRs for medicines prescribed off-label in the paediatric population.

Adverse events following immunization in children: retrospective analysis of spontaneous reports over a decade.

PURPOSE: There is no doubt that paediatric immunization prevents serious diseases, but the administration of these vaccines to healthy children also involves risks of adverse drug reactions (ADRs), some of which are potentially serious. The current body of evidence on ADRs from immunization therapy at the population level is partly contradictory across countries, time periods and childhood immunization programmes. The objective of our study was to characterize reported adverse events (AEFIs) following immunization in Danish children. METHODS: Adverse events (AEFIs) in 0- to 17-year-old children and adolescents reported to the Danish Medicines Agency (DKMA) between 1998 and 2007 were analysed. The unit of analysis was one AEFI. Data were categorized with respect to time, age, and gender of the children, suspected vaccines, category and seriousness of the AEFIs, and reporting rate. RESULTS: During the study period, the DKMA received 1,365 reports covering 2,600 AEFIs, corresponding to 60% of all adverse events reported for children. One third of the AEFIs were classified as serious, and two deaths were reported. The annual number of serious AEFIs remained constant during the study period. Approximately 80% of AEFIs were reported in children aged 0-2 years. Of all reported AEs, 45% were in the category "general disorders and administration site conditions", followed by the categories "skin and subcutaneous tissue disorders" (20% of total AEFIs) and "nervous system disorders" (16% of total AEFIs). The largest share of serious events was from the category "nervous system disorders" (33% of serious AEFIs). The most frequently reported serious AEs were febrile convulsions, pyrexia, and injection-site reactions. CONCLUSIONS: In Denmark, a large number of AEFIs following paediatric immunization have been reported, but the majority of cases were non-serious.

Stress and medicine use for headache: does sense of coherence modify the association?

BACKGROUND: Medicine use as a strategy for coping with daily stressors is an under-studied issue. Studies show that stress is associated with use of over-the-counter medicine, but the underlying mechanisms are not well understood. The aim of this study was to examine whether sense of coherence (SOC) modifies the association between perceived stress and medicine use for headache. METHODS: National cross-sectional study in Denmark. STUDY POPULATION: men and women aged 25-44 years, n = 990. The survey was conducted by web-based questionnaires and telephone interviews. The outcome measure was medicine use for headache. The independent variable was perceived stress. SOC and gender were investigated as moderators. Social class, headache prevalence and severity, and response method were included as co-variates. RESULTS: Our study showed that SOC modified the association between stress and medicine use for headache (only statistically significant among women). The odds for medicine use among women who felt stressed were 2.30 (1.39-3.79) compared to women who did not feel stressed; among men who felt stressed the equivalent odds were 1.46 (0.80-2.66). In analysis stratified by SOC, the odds for medicine use when stressed were 2.09 (0.71-6.21) among women with high SOC, 2.21 (1.10-4.41) among women with medium SOC and 3.69 (1.09-12.47) among women with low SOC. The equivalent odds for men were 1.29 (0.33-5.04), 1.33 (0.59-3.04) and 2.47 (0.57-10.64), respectively. CONCLUSION: SOC modifies the association between stress and medicine use especially among women. Individuals with fewer coping resources may be more likely to use medicine beyond indication to treat stress.

Information about adverse drug reactions reported in children: a qualitative review of empirical studies.

AIM: To review the literature on adverse drug reactions (ADRs) in children with respect to occurrence, seriousness, type, therapeutic group, age and gender of the child and category of reporter. METHODS: Medline and Embase databases were searched from origin and updated until February 2010. We included empirically based articles on ADRs in populations aged 0 to 17 years. Studies monitoring ADRs in patients with particular conditions or drug exposure were excluded. We extracted information about types and seriousness of ADRs, therapeutic groups, age and gender of the child and category of reporter. ADR occurrence was calculated as incidence rate and prevalence. RESULTS: We included 33 studies monitoring ADRs in general paediatric populations. The highest numbers of ADRs were reported in national ADR databases where data were collected over a longer period than in studies monitoring inpatients and outpatients. However, prevalence and incidence were much lower in the national databases. Types of reported ADRs, seriousness of ADRs and types of medicines differed substantially between studies due to differences in time periods and patient populations. Information about ADRs was mainly provided by health care professionals, although parents also contributed reports. CONCLUSIONS: We found a higher incidence rate of ADRs in hospitalized children and outpatients than in national databases. There seems to be considerable potential for increasing the knowledge of ADRs by advocating the submission of reports to the spontaneous reporting systems. Our study underscores that ADRs in children constitute a significant public health problem.

Use of over-the-counter analgesics and perceived stress among 25-44-year olds.

PURPOSE: To examine the association between perceived stress and use of over-the-counter analgesics in a representative sample of 25-44-year old adults, and to examine the association across various socio-demographic strata. Furthermore, to examine whether an association between perceived stress and use of over-the-counter analgesics attenuates when controlled by potential stress-related pain and discomfort. METHODS: National representative cross-sectional study in Denmark. The study population consisted of men and women aged 25-44 years, n = 4739. The survey was conducted by face-to-face interviews. The outcome measure was use of over-the-counter analgesics (OTCA). The independent variable was perceived stress. Demographic variables and pain and discomfort symptoms were included as covariates. RESULTS: Analyses stratified by socio-demographic factors (gender, education, cohabiting status and whether or not the respondents had children) all showed a significant and graded association between stress and OTCA use. The odds for OTCA use mounted with increasing stress. In analyses adjusted for socio-demographic variables and pain or discomfort the association between stress and OTCA use attenuated somewhat, but remained significant and graded. The crude odds ratio (OR) for OTCA use was 1.36 (1.19-1.55) among participants who sometimes felt stress, and 1.91 (1.58-2.30) among participants who often felt stress, compared to participants without stress. CONCLUSION: There was a significant and graded association between perceived stress and OTCA use. The association was robust across all the examined socio-demographic strata and could not be explained by potential stress-related pain and discomfort. The results indicate that OTCA are used inappropriately to treat feelings of stress.

The effect of health, socio-economic position, and mode of data collection on non-response in health interview surveys.

AIMS: To investigate the relationship between potential explanatory factors (socio-economic factors and health) and non-response in two general population health interview surveys (face-to-face and telephone), and to compare the effects of the two interview modes on non-response patterns. METHODS: Data derives from The Danish Health Interview Survey 2000 (face-to-face interview) and The Funen County Health Survey 2000/2001 (telephone interview). Data on all invited individuals were obtained from administrative registers and linked to survey data at individual level. Multiple logistic regression analyses were used to examine associations between potential explanatory factors and non-response. RESULTS: The overall response rate was higher in the face-to-face interview survey (74.5%) than in the telephone survey (69.2%). Refusal was the most common reason for non-response and the same factors were generally associated with non-response in both modes of interview. The non-response rate was high among persons with low socio-economic position. No significant associations between health and non-response were found. CONCLUSIONS: Health status does not play a systematic role for non-response rates in health interview surveys, but the non-response rate is higher in lower socio-economic groups. Analyses of non-response should be performed to understand the implications of survey findings.

Diagnosing infections: a qualitative view on prescription decisions in general practice over time.

OBJECTIVE: Antibiotics may frequently be prescribed on the basis of vague diagnoses, possibly resulting in unnecessary antimicrobial resistance. Our aim is to map general practitioners' (GPs') decision-making for common infections, exploring their diagnostic basis for antibiotic prescriptions. SETTING: General practice in Iceland. METHOD: Ten in-depth qualitative interviews with, and three observations of, GPs in 1995. Diagnostic issues extracted and analysed. In 2006, eight GPs commented on analysis and updated (email/telephone). MAIN OUTCOME MEASURE: Diagnostic variability and reasons for prescribing antibiotics, consistency or changes over time. RESULTS: Wide variations were uncovered in diagnostic procedures, although each GP remained consistent through time. Some GPs had developed "rules-of-thumb". They often balanced risks against issues like money, time, need for the workforce (perceived importance of the patient's job), client's need for job/earnings (perceived ability to afford a sick day) and doctor-patient relationship (risk of refusal adversely affecting the relationship). Perceptions of risk varied from focusing on resistance development to focusing on possible harm from untreated infections, also ranging between considering both to worrying about neither. Changes over time were not prominent but included increased point-of-care testing and the perception by GPs that patients were increasingly willing to "wait and see". CONCLUSIONS: Large variability and individuality characterized the GPs' diagnostic procedures, contrasted by consistency through time. If modification of diagnostic routines is needed, provision of "scientific facts" and technological aids is insufficient. A prerequisite for changing practice is GPs' acceptance of accuracy of information and of reliability, applicability, and relevance of technology, for physician and/or patient.

Opening the white boxes: the licensing documentation of efficacy and safety of psychotropic medicines for children.

PURPOSE: The objective of the present study was to explore the available evidence in a regulatory agency on the safety and efficacy of two types of psychotropic medicine frequently prescribed to children and adolescents. METHODS: We analysed the documentation in registration files, renewal registration files, summaries of product characteristics and scientific assessment reports in the Danish Medicines Agency for two psychotropic medications prescribed for children: methylphenidate and citalopram to discover what data pertaining to the pediatric population are available to the regulatory agency. RESULTS: The licensing of methylphenidate for treating attention-deficit hyperactivity disorders (ADHD) in children from the age of six was based on a single-dose crossover study and, a 2-week double blind, parallel group clinical trial in 100 patients from ages 6 to 12 and published literature. Citalopram is not licensed for pediatric use in Denmark. Citalopram was being investigated in three ongoing clinical trials lasting 8-24 weeks in 423 patients aged 7-18 years. The registration files contained no data on the long-term efficacy and safety of citalopram in pediatric use. Registration material also contained information on planned clinical trials with methylphenidate and citalopram among children/adolescents. CONCLUSIONS: Evidence on the efficacy and safety of methylphenidate and citalopram for pediatric use in the Danish Medicine Agency is limited and supports the need for further clinical trials. Medicine prescription for the pediatric population should be monitored in order to identify risks that were not identified at the time of licensing. The results of clinical trials already conducted should be made publicly available.

Medicine use for headache in adolescence predicts medicine use for headache in young adulthood.

BACKGROUND: Health risk behaviours such as smoking and binge drinking track from adolescence to adulthood. Medicine use is associated with smoking and binge drinking among adolescents. Whether medicine-use behaviour tracks from adolescence to adulthood is unknown. AIM: To examine tracking of medicine use for headache from age 15 to 19 to 27. METHODS: A national random sample of 15-year-olds (n = 996) was followed up after four and twelve years respectively in a longitudinal study in Denmark; 614 persons completed questionnaires in all three waves. The main outcome measure was medicine use for headache within the past 14 days. RESULTS: Medicine use for headache was common in all age groups and more females than males used medicine in all three age groups: 34.9% vs. 18.0% at age 15, 45.4% vs. 22.1% at age 19 and 44.3% vs. 29.5% at age 27. The risk of using medicine for headache at age 27 increased if medicine was used at age 15 or 19. However, use increased substantially if medicine for headache was used at both age 15 and 19 (OR = 5.83, 95%CI: 1.99-17.14 for males and OR = 4.67, 95%CI: 2.59-8.43 for females). CONCLUSION: Medicine use for headache is a behavioural pattern that may track from adolescence into adulthood.

Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs.

BACKGROUND: Despite surveillance efforts, unexpected and serious adverse drug reactions (ADRs) repeatedly occur after marketing. The aim of this article is to analyse ADRs reported by available ADR signal detection approaches and to explore which information about new and unexpected ADRs these approaches have detected. METHODS: We selected three therapeutic cases for the review: antibiotics for systemic use, non-steroidal anti-inflammatory medicines (NSAID) and selective serotonin re-uptake inhibitors (SSRI). These groups are widely used and represent different therapeutic classes of medicines. The ADR studies were identified through literature search in Medline and Embase. The search was conducted in July 2007. For each therapeutic case, we analysed the time of publication, the strengths of the evidence of safety in the different approaches, reported ADRs and whether the studies have produced new information about ADRs compared to the information available at the time of marketing. RESULTS: 79 studies were eligible for inclusion in the analysis: 23 antibiotics studies, 35 NSAID studies, 20 SSRI studies. Studies were mainly published from the end of the 1990s and onwards. Although the drugs were launched in different decades, both analytical and observational approaches to ADR studies were similar for all three therapeutic cases: antibiotics, NSAIDs and SSRIs. The studies primarily dealt with analyses of ADRs of the type A and B and to a lesser extent C and D, cf. Rawlins' classification system. The therapeutic cases provided similar results with regard to detecting information about new ADRs despite different time periods and organs attacked. Approaches ranging higher in the evidence hierarchy provided information about risks of already known or expected ADRs, while information about new and previously unknown ADRs was only detected by case reports, the lowest ranking approach in the evidence hierarchy. CONCLUSION: Although the medicines were launched in different decades, approaches to the ADR studies were similar for all three therapeutic cases: antibiotics, NSAIDs and SSRIs. Both descriptive and analytical designs were applied. Despite the fact that analytical studies rank higher in the evidence hierarchy, only the lower ranking descriptive case reports/spontaneous reports provided information about new and previously undetected ADRs. This review underscores the importance of systems for spontaneous reporting of ADRs. Therefore, spontaneous reporting should be encouraged further and the information in ADR databases should continuously be subjected to systematic analysis.

Survey of patient and physician assessment of a compliance reminder device in the treatment of hypertension.

Low compliance to therapeutic regimens can have serious impact on patient health. A variety of technologies such as tablet dispensers and reminders has been developed to improve compliance. The aim of this study was to assess the acceptance of patients and physicians with regard to the functions and usefulness of a reminder device. The respondents were participants in a trial evaluating antihypertensive medical treatment. Patients and treating physicians received a self-administered questionnaire to evaluate the device; 1194 patients and their physicians completed the questionnaire. Seventy-three per cent of patients stated that they always or mostly used the device. Overall, 78% of patients and 83% of physicians assessed the device positively. The reminder and feedback functions were assessed similarly. Sixty-four per cent of the patients stated that they would like to continue to use the device, as did 71% of the physicians. The reminder device was well accepted by a majority of patients and physicians in this study. Acceptance is an important factor for such a device to be used in everyday life and a majority of respondents wanted to continue using it. The current device could be a major help for patients on chronic medication therapy in a variety of therapies.

"I'd rather not take it, but . . .": young women's perceptions of medicines.

Little is known about healthy young women's everyday experiences with medicine use and their general perceptions of medicines. In this article, we describe a user-perspective study involving in-depth qualitative interviews with 20 young women between the ages of 16 and 20 in Copenhagen, Denmark. Inspired by Schutz's phenomenology, informants' medicine-taking experiences were considered within the context of their life-worlds. Analysis revealed that the young women possessed predominantly negative perceptions of medicines, which were linked to a preference for complete avoidance of medicines and a desire to maintain a natural body ideal. The essence of participants' experiences was characterized by conflict, as most used medicines at least occasionally, despite the negative perceptions they held. Participants strove to make sense of their medicine-taking practices and provided rationales for their use of medicine, often based on perceptions of need and reduced personal risk.