As severe ill and incurable patients can be easy victims of misleading advertising activities for dangerous and non-effective healthcare treatments, the marketing of healthcare services are in many ...jurisdictions legislations tightly regulated. This article reviews the Danish regulation on marketing of healthcare services to identify which types of advertising activities that are legal. As the legislation only allows healthcare authorities to control the marketing and not the content and quality of the marketed healthcare services, their ability to intervene in serious cases of misleading advertising is limited. Misleading advertising are statements with the purpose to exaggerate or underestimate the effects and risks of healthcare services or to prevent patients from seeking conventional medical treatments. From a public health perspective, there is a need for a common EU legislation for regulation of the marketing of healthcare services as the increasing use of information technologies makes it possible for the providers to access consumers and patients directly across countries and legal systems.
Poor adherence to medication therapy among type 2 diabetes patients is a clinical challenge. We aimed to determine which factors are associated with the three phases of long-term adherence to ...medication: initiation, implementation and discontinuation in a register-based study.
Adherence to six medicine groups (metformin, sulfonylureas, acetylsalicylic acid, thiazide diuretics, renin angiotensin system inhibitors, and statins) were analysed among 5,232 patients with type 2 diabetes at a tertiary referral hospital during 1998-2009. Rate-ratios of initiation of treatment, recurrent gaps in supply of medication, and discontinuation of treatment were analysed using Poisson regression.
Poor initiation rather than poor implementation or discontinuation was the main contributor to medication nonadherence. Polypharmacy was a risk factor for slower initiation of treatment for all six medicine groups (rate ratio ranging 0.79 95%CI 0.72-0.87 to 0.89 95%CI 0.82-0.96 per already prescribed medicine), but once patients were in treatment, polypharmacy was not associated with recurrence of gaps in supply of medication, and polypharmacy was associated with lower risk of discontinuation (rate ratio ranging 0.93 95%CI 0.86-1.00 to 0.96 95%CI 0.93-0.99 per prescribed medicine). Other identified risk factors for slow initiation, poor implementation, and discontinuation were diabetes duration, younger age, and Turkish/Pakistani origin.
This study showed that a risk factor does not necessarily have the same association with all three elements of adherence (initiation, implementation and discontinuation), and that efforts supporting patients introduced to more complex drug combinations should be prioritized.
Når skolens børn evaluerer sig selv Berg, Mathias Sune; Kaas, Lise Aagaard; Grumløse, Sine Penthin
Studier i læreruddannelse og -profession,
12/2020, Letnik:
5, Številka:
2
Journal Article
Recenzirano
Odprti dostop
I overensstemmelse med ideen om livslang læring forventes skolebørn i stigende grad at vurdere, hvad de har lært. Karakteristisk for disse selvevalueringspraksisser er, at de ikke kun knytter sig til ...børnenes faglige kompetencer. De går ofte også tæt på børnenes mere personlige forhold. Derudover er evaluering en del af den skolepolitiske dagsorden, hvor læreren er forpligtet på at dokumentere elevernes læring.
I denne artikel går vi tæt på undervisningen og præsenterer eksempler på evalueringspraksisser, der skaber vidt forskellige deltagelsesmuligheder for børnene. Der er fokus på aktiviteter, hvor børnene skal vurdere, hvad de har lært, gennem brug af evalueringsværktøjer som portfolio og læringsplatforme. Vi diskuterer den udspændthed, som læreren befinder sig i mellem på den ene side at efterleve politiske krav om evaluering og på den anden side at praktisere evaluering, der kan udvikle undervisningen og styrke børnenes trivsel og læring samtidig med hensynet til børnenes behov og forudsætninger.
Angioedema is a potentially fatal adverse drug reaction of some medications, as swellings of the upper airways can cause death by asphyxiation. Angiotensin converting enzymeinhibitors are widely ...known to cause angioedema but less is known about the association between dipeptidyl peptidase-4 inhibitors (gliptins) and angioedema. Dipeptidyl peptidase-4 inhibitors are antidiabetic drugs used to improve glycaemic control. They, as a class effect, inadvertently affect the degradation of the vasoactive kinins bradykinin and substance P, both of which can cause angioedema due to vasodilatation and increase in vascular permeability in the capillaries.
To assess the risk and pathomechanism of angioedema due to inhibition of dipeptidyl peptidase- 4 inhibitors when used as monotherapy and in combination with angiotensin converting enzymeinhibitors.
PubMed, Embase, the Cochrane Library, PubMed Central, Web of Science, Google Scholar and clinicaltrials.gov were searched using different combinations of keywords "angioedema", "dipeptidyl peptidase 4", "dipeptidyl peptidase 4 inhibitors", "gliptins", "bradykinin", "substance P" and "angiotensin converting enzyme-inhibitors". Original research papers were preferably used as references and their bibliographies were used to further the search for original research results.
Both angiotensin converting enzyme and dipeptidyl peptidase-4 are major enzymes in the degradation pathway of bradykinin and substance P, and when inhibited pharmacologically - especially at the same time - the theoretical risk of angioedema is increased due to accumulation of vasoactive kinins.
Treatment with dipeptidyl peptidase-4 inhibitors must be carefully considered and monitored especially during concurrent treatment with angiotensin converting enzyme-inhibitors or when treating patients with a known predisposition to angioedema.
The aim of this study was to review empirical studies examining associations between candidate genes and adverse events (AEs) from methylphenidate (MPH) use in children and adolescents. The PubMed, ...EMBASE, CINAHL, and Web of Science databases were searched from their inception until March 2017. We included empirically based articles on pharmacogenetic studies in 0–17-year-old patients that investigated associations between specific candidate genes, their polymorphisms, and reported AEs. We extracted information about study design, setting, type of AE reporter, studied genes and their polymorphisms, age and gender, administered doses, method of genotyping, outcome measures, and main findings. A total of nine articles reporting information about four double-blind, placebo-controlled, cross-over studies and five open-label cohort studies were eligible for inclusion. Studies were published from 2006 onward and included a total of 998 patients (3–17-year-olds) diagnosed with attention-deficit hyperactivity disorder (ADHD). Studies predominantly involved males and lasted from 1 to 12 weeks. Studies used polymerase chain reaction and single nucleotide polymorphism genotyping methodology. Reported AEs were significantly associated with the following genes: appetite reduction (CES1*G); buccal-lingual movements (T1065G); diastolic blood pressure (ADRA2A Mspl C/C-GC); emotionality (DAT1*9/9); irritability (SNAP25 T1065G); picking (DRD4*7/DRD4*4); social withdrawal (DRD4*7/DRD4*4); somatic complaints (DAT1*10/10); tics (5-HTTLRP*S/L*L/L; SNAP25 T1065G); sadness (CES1*rsl12443580); and vegetative symptoms (5-HTTLPR). In conclusion, only few MPH pediatric pharmacogenetic studies were located, and large between-study heterogeneity was found. Studies were of naturalistic design and of short duration. They included small patient samples, poorly standardized treatment regimens, and limited outcome assessments. In the future, more pharmacogenomic studies in ADHD are needed, preferably using randomized, controlled study designs and of longer duration (more than 6 months).
Objective: We analyzed prescribing patterns of antipsychotics for children and adolescent affiliated with a Danish Child and Adolescent Mental Health Center) with respect to age, sex, medicine, ...diagnoses, off-label status, and time. Methods: We included all patients below 19 years of age prescribed antipsychotics during 2007-2008 and as of November 1, 2014. Prescription data included all antipsychotic prescriptions and prescriptions of concomitant psychotropic medications. We defined an antipsychotic user as a patient receiving at least one prescription during the study period, irrespective of any previous history of antipsychotic use. We defined off-label prescribing as prescriptions outside the licensed age group and approved indication. Findings: We analyzed 404 antipsychotic prescriptions that were located for 150 patients. The patients were between 7 and 18 years of age. Two-thirds of the prescriptions were for girls and two-thirds of prescriptions for olanzapine and quetiapine. Totally, 92% of all prescribed antipsychotics were used off-label. For typical antipsychotics, this share was 96% and for atypical antipsychotics 90%. As of November 1, 2014, the total share of off-label antipsychotic prescriptions was 96%, and 63% of these were for medications prescribed outside the approved age group, and 26% for nonlicensed indication(s). Conclusion: This study demonstrated a high level of off-label prescribing over time with respect to age and indication. The prescribing patterns underpin the need for further economic incentives for pharmaceutical companies to register pediatric indications, particular for off-patent products.
Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly ...to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications.
ADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR.
We located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types "nervous system disorders" (18% of total ADRs) followed by "psychiatric disorders" (18% of total ADRs) and "general disorders" (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline.
The majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified.
This article reviews the implications of off-label (OL) and unlicensed (UL) medicine use with respect to the legal duty to inform patients and the liability for failure to provide the patient with ...adequate information on benefits and risks. Informed consent is a legal prerequisite to any medical treatment and requires the physician to inform the patient about benefits and risks important for the patient’s decision. Since OL/UL medicine use is common in all fields of medical practice, physicians must be aware of the stricter requirements for information of the patient. The UK High Supreme Court ruled in the case Montgomery v. Lanarkshire Health Board that physicians’ information duty is not limited to the level of information that the physician finds important, but to what the patient deems important. In general, violations of the rule of informed consent does not constitute a physical injury, and patients can only claim compensation for damages, if adequate disclosure had been given, and its likely, that patients would have either rejected or opted for an alternative treatment.
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