To investigate whether exposure to methadone affects the risk of motor vehicle accident with personal injury.
Cohort study linking three Norwegian administrative registries using unique person identifiers.
Information was retrieved from the Norwegian Prescription Database on any prescriptions ever received by the individuals for methadone and all prescriptions for benzodiazepines. The Norwegian Road Accident Registry provided information about motor vehicle accidents involving personal injuries on Norwegian roads. The Central Population Registry provided demographic information on all residents in Norway.
All Norwegian adults aged 18-69 years were observed for 2.5 years.
Standardized incidence ratio (SIR) was calculated by comparing the incidence of traffic accidents with personal injuries in patients exposed to methadone with the incidence in those not exposed.
During the 4626 person-years observed in patients exposed to methadone, there were 26 motor vehicle accidents. There were very few accidents among the females who received methadone and they had no increased risk of being involved in motor vehicle accidents (SIR 1.1; 95% CI 0.2-3.1). We observed an increased risk of involvement in accidents among males (SIR 2.4; 95% CI 1.5-3.6). This figure did not change significantly when exposure to benzodiazepines was excluded.
Men exposed to methadone appear to have an increased risk of being involved in motor vehicle accidents involving personal injuries. This increased risk could not be explained by exposure of benzodiazepines.
Lack of review of patients' medications in repeat prescribing is common. This and other problems in repeat prescribing need to be addressed. Community pharmacists could be more proactive in the review of chronic medications.
The purpose of this study was to test the feasibility and effects of pharmacists' interventions in repeat prescribing.
The normal repeat prescribing process used at Kuopio University Pharmacy and in Kuopio Health Services was developed by an intervention which included a pharmacist's interview and the annual medication data of the patient that were both transferred to the prescribing physician.
Physicians in the intervention group identified and solved patients' drug-related problems better than was the case in the comparison group with normal repeat prescribing. Over half the patients receiving repeat prescriptions had at least one drug-related problem. The physicians used more information sources to support repeat prescribing in the intervention system.
Community pharmacists are able to improve the quality of physician's repeat prescribing by providing vital information.
To examine associations between gabapentinoids and adverse outcomes related to coordination disturbances (head or body injuries, or both and road traffic incidents or offences), mental health (suicidal behaviour, unintentional overdoses), and criminality.
Population based cohort study.
High quality prescription, patient, death, and crime registers, Sweden.
191?973 people from the Swedish Prescribed Drug Register who collected prescriptions for gabapentinoids (pregabalin or gabapentin) during 2006 to 2013.
Primary outcomes were suicidal behaviour, unintentional overdoses, head/body injuries, road traffic incidents and offences, and arrests for violent crime. Stratified Cox proportional hazards regression was conducted comparing treatment periods with non-treatment periods within an individual. Participants served as their own control, thus accounting for time invariant factors (eg, genetic and historical factors), and reducing confounding by indication. Additional adjustments were made by age, sex, comorbidities, substance use, and use of other antiepileptics.
During the study period, 10?026 (5.2%) participants were treated for suicidal behaviour or died from suicide, 17?144 (8.9%) experienced an unintentional overdose, 12?070 (6.3%) had a road traffic incident or offence, 70?522 (36.7%) presented with head/body injuries, and 7984 (4.1%) were arrested for a violent crime. In within-individual analyses, gabapentinoid treatment was associated with increased hazards of suicidal behaviour and deaths from suicide (age adjusted hazard ratio 1.26, 95% confidence interval 1.20 to 1.32), unintentional overdoses (1.24, 1.19 to 1.28), head/body injuries (1.22, 1.19 to 1.25), and road traffic incidents and offences (1.13, 1.06 to 1.20). Associations with arrests for violent crime were less clear (1.04, 0.98 to 1.11). When the drugs were examined separately, pregabalin was associated with increased hazards of all outcomes, whereas gabapentin was associated with decreased or no statistically significant hazards. When stratifying on age, increased hazards of all outcomes were associated with participants aged 15 to 24 years.
This study suggests that gabapentinoids are associated with an increased risk of suicidal behaviour, unintentional overdoses, head/body injuries, and road traffic incidents and offences. Pregabalin was associated with higher hazards of these outcomes than gabapentin.
CommentIn: BMJ. 2019 Jun 12;365:l4021 PMID 31189536
Drugs predominantly prescribed in general practice should ideally be tested in that setting; however, little is known about drug trials in general practice. Our aim was to describe drug trials in Norwegian general practice over the period of a decade.
The present work concerns a 10-year retrospective study of protocols submitted to the Norwegian national medicines agency (1998 to 2007) identifying all studies involving general practitioners (GPs) as clinical investigator(s). We analyzed the number of trials, drug company involvement, patients, participating doctors, payment, medications tested and main diagnostic criteria for inclusion. We also analyzed one trial in greater detail.
Out of 2,054 clinical drug trials, 196 (9.5%) were undertaken in general practice; 93% were multinational, 96% were industry funded and 77% included patients both from general practice and specialist care. The trials were planned to be completed in the period 1998 to 2012. A total of 23,000 patients in Norway and 340,000 patients internationally were planned to be included in the 196 trials. A median of 5 GPs participated in each trial (range 1 to 402). Only 0.7% of 831 GP investigators had general practice university affiliations. Median payment for participating investigators was €1,900 (range €0 to 13,500) per patient completing the trial. A total of 30 pharmaceutical companies were involved. The drugs most commonly studied were antidiabetics (21%), obstructive airway disease medications (12%), agents acting on the renin-angiotensin system (10%), and lipid modifying agents (10%). One trial, presented in more detail, had several characteristics of a seeding or marketing trial.
Only one in four drug trials involving general practice were solely general practice trials and almost all were industry initiated without input from academic general practice. There was a large variation in the number of patients, participating doctors, and economic compensation for trial investigators, with some investigators receiving substantial payments.
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Children's misuse of harmful legal products (HLPs), including inhaling or ingesting everyday household products, prescription drugs, and over-the-counter drugs, constitutes a serious health problem for American society. This article presents a community prevention model (CPM) focusing on this problem among pre and early adolescents. The model, consisting of a community mobilization strategy and environmental strategies targeting homes, schools, and retail outlets, is designed to increase community readiness and reduce the availability of HLPs, which is hypothesized to reduce HLPs use among children. The CPM is being tested in Alaskan rural communities as part of an inprogress eight-year National Institute on Drug Abuse randomized-controlled trial. This paper presents the CPM conceptual framework, describes the model, and highlights community participation, challenges, and lessons learned from implementation of the model over a 21-month period.
Inappropriate medical treatment of co-morbidities in Alzheimer's disease (AD) is an increasing concern in geriatric medicine. The objective of this study was to compare current drug use related to co-morbidity between individuals with a recent diagnosis of AD and a cognitively healthy control group in a population based clinical trial in Northern Norway.
Nine rural municipalities with 70,000 inhabitants in Northern Norway.
PARTICIPANTS with and without AD recruited in general practice and by population based screening.187 participants with a recent diagnosis of AD were recruited among community dwellers. Of 791 respondents without cognitive symptoms, 500 were randomly selected and invited to further clinical and cognitive testing. The final control group consisted of 200 cognitively healthy individuals from the same municipalities. Demographic characteristics, data on medical history and current medication were included, and a physical and cognitive examination was performed. The statistical analyses were carried out by independent sample t-test, chi-square, ANCOVA and logistic regression.
A co-morbidity score was significantly higher in AD participants compared to controls. The mean number of drugs was higher for AD participants compared to controls (5.1±3.6 and 2.9±2.4 respectively, p
Congenital anomalies of the kidney and the urinary tract (CAKUTs) are relatively common birth defects. The combined prevalence in Europe was 3.3 per 1000 in 2012. The risk factors for these anomalies are not clearly identified. The aims of our study were to calculate the birth prevalences of urinary malformations in Murmansk County during 2006 to 2011 and to investigate related prenatal risk factors.
The Murmansk County Birth Registry was the primary source of information and our study included 50,936 singletons in the examination of structure, prevalence and proportional distribution of CAKUTs. The multivariate analyses of risk factors involved 39,322 newborns.
The prevalence of CAKUTs was 4.0 per 1000 newborns (95% confidence interval [CI], 3.4-4.5) and did not change during the study period. The most prevalent malformation was congenital hydronephrosis (14.2% of all cases). Diabetes mellitus or gestational diabetes (odds ratio [OR]?=?4.77; 95% CI, 1.16-19.65), acute infections while pregnant (OR?=?1.83; 95% CI, 1.14-2.94), the use of medication during pregnancy (OR?=?2.03; 95% CI, 1.44-2.82), and conception during the summer (OR?=?1.75; 95% CI 1.15-2.66) were significantly associated with higher risk of CAKUTs.
The overall fourfold enhancement of the occurrence of urinary malformations in Murmansk County for the 2006 to 2011 period showed little annual dependence. During pregnancy, use of medications, infections, pre-existing diabetes mellitus, or gestational diabetes were associated with increased risk of these anomalies, as was conception during summer. Our findings have direct applications in improving prenatal care in Murmansk County and establishing targets for prenatal screening and women's consultations.
To assess the impact of exposure misclassification on risk associations when using prescription databases as the source for drug exposure in pregnancy by applying results from a validation analysis of exposure classification.
Linkage of data on 27,656 participants in the Norwegian Mother and Child Cohort Study (MoBa) with the Norwegian Prescription Database (NorPD). Exposure to selective serotonin reuptake inhibitors (SSRIs) was defined by dispensed drugs during pregnancy including different time windows before pregnancy. The validity of NorPD data was estimated using self-reported use in MoBa as the reference standard. We applied the results from the validation analysis on data from a Nordic study on SSRI use in pregnancy and risk of persistent pulmonary hypertension in the newborn.
Sensitivity increased and specificity decreased when the time window in NorPD was expanded before pregnancy. Using the same time window as in the Nordic study (+90 days before pregnancy), for use in early pregnancy, the odds ratio (OR) corrected for misclassification was 2.6 compared with the OR of 1.6 in the Nordic study.
Expansion of the time window to include intervals before pregnancy can lead to lower specificity and underestimation of risk associations.
We aimed to explore associations between drugs dispensed to the father prior to conception and pregnancy outcomes, such as pre-term birth, perinatal mortality, foetal growth retardation and birth defects.
In this cohort study, two population-based registries, the Medical Birth Registry of Norway and the Norwegian Prescription Database, were linked. The study cohort consisted of 340?000 pregnancies in 2004-10. The association between specific drugs dispensed to the fathers during the last 3 months prior to conception and pregnancy outcomes was explored by estimating odds ratios (ORs) using multivariate logistic regression.
About one quarter (26%) of the fathers were dispensed at least one drug during the last 3 months prior to conception and 1.3% were dispensed at least one drug requiring special attention. Overall, the odds of different adverse pregnancy outcomes were not increased when the father had been dispensed drugs, i.e. the OR and 95% confidence intervals (CIs) for any birth defect when the fathers had been dispensed any drug were 0.99 (0.94, 1.0). When the fathers had been dispensed diazepam we found increased risk of perinatal mortality and growth retardation, with OR and 95% CIs of 2.2 (1.2, 3.9) and 1.4 (1.2, 1.6), respectively.
Large studies are necessary to reveal increased risk of rare outcomes as specific birth defects. Our study did not indicate that paternal drug exposure is an important risk factor for adverse pregnancy outcomes.
This article presents results from a study of a home environmental strategy (HES) designed to reduce availability of harmful legal products (HLPs) in the home that can be used by youth to get high. HLPs include inhalants, prescription and nonprescription drugs, and household products that can be ingested to get high. Availability is one of the most consistent predictors of substance use among youth. Parents of 5th- to 7th-grade students in four Alaskan communities participated in telephone interviews as part of a larger study of a multicomponent community prevention model (CPM) that included a HES. The strategy was designed to encourage parents to reduce availability of HLPs by removing them from the home, and by locking up and monitoring the supplies of HLPs in the home. Data from 402 parents at Wave 1 and 371 parents at Wave 2 were analyzed using hierarchical non-Linear modeling (HNLM). Results show there was a significant decrease in HLPs in the home from Wave 1 to Wave 2, mostly inhalants and prescription and nonprescription drugs. Parents also reported a significant increase in locking up prescription and nonprescription drugs in the home. Parents' direct exposure to the HES was marginally associated with the change over time in HLP availability in the home. Indirect exposure through others and media was not associated with this change. Study lessons learned and conclusions are highlighted.
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