Individualized versus Standardized Risk Assessment in Patients at High Risk for Adverse Drug Reactions (The IDrug Randomized Controlled Trial)-Never Change a Running System?

The aim of this study was to compare effects of an individualized with a standardized risk assessment for adverse drug reactions to improve drug treatment with antithrombotic drugs in older adults. A randomized controlled trial was conducted in general practitioner (GP) offices. Patients aged 60 years and older, multi-morbid, taking antithrombotic drugs and at least one additional drug continuously were randomized to individualized and standardized risk assessment groups. Patients were followed up for nine months. A composite endpoint defined as at least one bleeding, thromboembolic event or death reported via a trigger list was used. Odds ratios (OR) and 95% confidence intervals (CI) were calculated. In total, N = 340 patients were enrolled from 43 GP offices. Patients in the individualized risk assessment group met the composite endpoint more often than in the standardized group (OR 1.63 [95%CI 1.02-2.63]) with multiple adjustments. The OR was higher in patients on phenprocoumon treatment (OR 1.99 [95%CI 1.05-3.76]), and not significant on DOAC treatment (OR 1.52 [95%CI 0.63-3.69]). Pharmacogenenetic variants of CYP2C9, 2C19 and VKORC1 were not observed to be associated with the composite endpoint. The results of this study may indicate that the time point for implementing individualized risk assessments is of importance.

Correction: Rate of opioid use disorder in adults who received prescription opioid pain therapy-A secondary data analysis.

[This corrects the article DOI: 10.1371/journal.pone.0236268.].

Rate of opioid use disorder in adults who received prescription opioid pain therapy-A secondary data analysis.

BACKGROUND AND AIMS: Data on rates of prescription opioid use disorder (pOUD) in European countries is limited. The aim of this investigation was to analyze a representative population sample regarding the 1-year prevalence of opioid use disorder in patients who received prescription opioid pain therapy and to identify related risk factors. DESIGN: Cross-sectional secondary data analysis. SETTING: Secondary data analysis based on data from the 2015 Epidemiological Survey of Substance Abuse (ESA 2015) in Germany. PARTICIPANTS: German-speaking individuals living in private households aged 18 to 64 years were investigated. A total of 9204 individuals participated in the survey, resulting in a response rate of 52.2%. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome measure was the weighted prevalence of pOUD in the subgroup of study participants who had received prescription opioids. Secondary outcome measure was an analysis of risk factors connected with pOUD in the same subgroup. FINDINGS: A total of n = 9204 participants were included in the study of which n = 275 had received an opioid prescription in the last 12 months of which n = 54 were diagnosed with pOUD. The weighted 1-year prevalence of pOUD was 21.2% (mild: 14.7% | moderate: 3.5% | severe: 2.9%). Participants who had received opioid pain therapy had significantly higher odds of pOUD if they reported signs of depression (OR: 2.69; CI 95%: 1.13-6.38), inexplicable physical complaints (OR: 2.68; CI 95%: 1.14-6.31) or a psychiatric diagnosis (OR: 4.12; CI 95%: 1.36-12.43), and significantly lower odds of pOUD if they reported the use of non-opioid painkillers (OR: 0.27; CI 95%: 0.09-0.81). CONCLUSIONS: pOUD is a common phenomenon in working-age patients who receive prescription opioid pain therapy in Germany and may be related to the co-existence of psychosomatic and psychiatric disorders such as depression.

More counselling for end-of-life decisions by GPs with own advance directives: A postal survey among German general practitioners.

BACKGROUND: Although general practitioners (GPs) are among the preferred contact persons for discussing end-of-life issues including advance directives (ADs), there is little data on how GPs manage such consultations. OBJECTIVES: This postal survey asked German GPs about their counselling for end-of-life decisions. METHODS: In 2015, a two-sided questionnaire was mailed to 959 GPs. GPs were asked for details of their consultations on ADs: frequency, duration, template use, and whether they have own ADs. Statistical analysis evaluated physician characteristics associated with an above-average number of consultations on AD. RESULTS: The participation rate was 50.3% (n = 482), 70.5% of the GPs were male; the average age was 54 years. GPs had an average of 18 years of professional experience, and 61.4% serve more than 900 patients per three months. Most (96.9%) GPs perform consultations on living wills (LW) and/or powers of attorney (PA), mainly in selected patients (72.3%). More than 20 consultations each on LWs and PAs are performed by 60% and 50% of GPs, respectively. The estimated mean duration of consultations was 21 min for LWs and 16 min for PAs. Predefined templates were used in 72% of the GPs, 50% of GPs had their ADs. A statistical model showed that GPs with ADs and/or a qualification in palliative medicine were more likely to counsel ≥20 patients per year for each document. CONCLUSION: The study confirmed that nearly all German GPs surveyed provide counselling on ADs. Physicians with ADs counsel more frequently than those without such documents.

Drug-related celebrity deaths: A cross-sectional study.

BACKGROUND: Celebrities are at risk for premature mortality as well as drug-related death. Despite being a vulnerable patient group, celebrities influence people's health behaviours through biological, psychological and social processes. Therefore, celebrity endorsement of the topic could be one way to challenge the current "opioid endemic". Our aim was to better understand the factors surrounding drug-related celebrity deaths by investigating the incidence as well as substances used between 1970 and 2015 using a cross-sectional study design. METHOD: We searched public databases for drug-related celebrity deaths between 1970 and 2015. They were categorized for sex, profession, age at death, year of death and substances involved. The main outcome measures are descriptive values including number of drug deaths per year and substances involved. Secondary outcome measures are analytical questions to examine whether and which factors influence age at death and year of death (e.g. type of substance use disorder). RESULTS: We identified 220 celebrities who died a drug-related death with a clear indication of involved substances between 1970 and 2015. The average age at death was 38.6 years; 75% were male. Most celebrities died between the age of 25 and 40. The number of drug-related deaths increased in the 21st century, with a significant increase in the use of prescription opioids. Deaths involving prescription opioids and heroin were associated with a significantly lower mean age at death compared to deaths where these substances were not involved. CONCLUSIONS: Compared to the 20th century, the total number of celebrities who died from a drug-related death in the 21st century increased, possibly due to an increased involvement of prescription opioids. Negative effects on individual health decisions of celebrity's followers could be the result.

Quinine induced simvastatin toxicity through cytochrome inhibition - a case report.

BACKGROUND: Nocturnal leg cramps are painful, involuntary muscle contractions commonly seen in elderly. While mostly harmless, they can severely impair quality of life and often disrupt sleep. Adverse drug effects may be responsible for a fraction of nocturnal leg cramps but often go unrecognized, resulting in additional prescribing intended to deal with adverse effects that might be better addressed by reduction, substitution, or discontinuation of the offending agent. CASE PRESENTATION: An 87 year old female presented as outpatient in family medicine with nocturnal leg cramps which had been present for five years and increasingly burdened her quality of life. She had been using quinine 200 mg once daily for symptomatic relief but the cramps kept returning with increasing intensity. During clinical examination we found neither structural nor neurological or metabolic disorders that explained her symptoms. When doing a medication analysis, we found that she was taking a statin together with quinine. Quinine is a cytochrome P450 isoenzyme 3A4 inhibitor, the very enzyme which is involved in the metabolism of most statins. Therefore the use of both substances simultaneously increases blood levels of the statin thereby increasing the risk of side effects including symptomatic myopathy and myalgia. After discontinuing both medications, the patient was, and remained, symptom free. CONCLUSION: This case report describes a possible medication interaction that has rarely been noted in literature.

Palliative care for the elderly--developing a curriculum for nursing and medical students.

BACKGROUND: Delivering palliative care to elderly, dying patients is a present and future challenge. In Germany, this has been underlined by a 2009 legislation implementing palliative care as compulsory in the medical curriculum. While the number of elderly patients is increasing in many western countries multimorbidity, dementia and frailty complicate care. Teaching palliative care of the elderly to an interprofessional group of medical and nursing students can help to provide better care as acknowledged by the ministry of health and its expert panels. In this study we researched and created an interdisciplinary curriculum focussing on the palliative care needs of the elderly which will be presented in this paper. METHODS: In order to identify relevant learning goals and objectives for the curriculum, we proceeded in four subsequent stages. We searched international literature for existing undergraduate palliative care curricula focussing on the palliative care situation of elderly patients; we searched international literature for palliative care needs of the elderly. The searches were sensitive and limited in nature. Mesh terms were used where applicable. We then presented the results to a group of geriatrics and palliative care experts for critical appraisal. Finally, the findings were transformed into a curriculum, focussing on learning goals, using the literature found. RESULTS: The literature searches and expert feedback produced a primary body of results. The following deduction domains emerged: Geriatrics, Palliative Care, Communication & Patient Autonomy and Organisation & Social Networks. Based on these domains we developed our curriculum. CONCLUSIONS: The curriculum was successfully implemented following the Kern approach for medical curricula. The process is documented in this paper. The information given may support curriculum developers in their search for learning goals and objectives.