The prevalence of contact allergy in the general population has traditionally been investigated through population-based epidemiological studies. A different approach is the combination of clinical epidemiological (CE) data and the World Health Organization-defined drug utilization research (DUR) method. The CE-DUR method was applied in Denmark to estimate the prevalence of contact allergy in the general population and compare it with the prevalence estimates from the Glostrup allergy studies. Contact allergy prevalence estimates ranging from very liberal ('worst case') to conservative ('best case') assumptions were based on patch test reading data in combination with an estimate of the number of persons eligible for patch testing each year based on sales data of the 'standard series'. The estimated 10-year prevalence of contact allergy ranged between 7.3% and 12.9% for adult Danes older than 18 years. The 10-year prevalence of contact allergy measured by CE-DUR was slightly lower than previous prevalence estimates from the Glostrup allergy studies. This could probably be explained by a decrease in nickel allergy. The CE-DUR approach holds the potential of being an efficient and easy monitoring method of contact allergy prevalence.
Cyclooxygenase 2-selective non-steroidal anti-inflammatory drugs (NSAIDs, coxibs) are recommended primarily for patients at high risk of gastrointestinal bleeding, most of them being elderly. Our objective was to describe and analyse patient- and physician-related factors affecting the adoption of celecoxib and rofecoxib 2 years after their launch in Finland.
Retrospective analysis of the nationwide Prescription Register. Physicians who had issued at least 200 reimbursed prescriptions in 2002 (n = 12 033, 80% of working-age Finnish physicians) were involved in the analysis.
Excluding patients with rheumatoid arthritis (RA), almost one-fifth (18%) of NSAIDs prescriptions were for coxibs. In patients with RA the share was 25%. The share of coxib prescriptions of all NSAIDs increased with age of the patient. Over one half (58%) of coxib prescriptions were issued for patients under 65 years of age. Specialists in physical and rehabilitation medicine were the fastest adopters of coxibs: one-third of their NSAID prescriptions in 2002 were for coxibs. Primary care physicians were the most conservative both in adopting and favouring coxibs.
Coxibs have gained the status of standard prescription NSAIDs within a few years. Their use should be restricted to patients who could benefit most from the use. Routine prescribing of expensive new drugs increases the drug bill without additional health gain.
Older adults take almost one-third of the drugs prescribed today yet represent only about 12 percent of the population. Adverse drug events are common in this population, but often these events appear to be preventable. Interest in adverse events related to the use of prescription drugs has rarely been higher or broader. The research community continues to develop new tools to study adverse effects of drugs in individuals and populations. However, the published literature on drug-related adverse events is fraught with problems, starting with the original reports and extending to systematic reviews. Prospective data are missing, adverse drug events are poorly described, and analytical methods are questionable. This leads to problems with imprecise estimates and generalizability of results.
Spontaneous reporting of adverse drug reactions (ADRs) is a cornerstone in pharmacovigilance. However, information about the underlying consumption of drugs is rarely used when analysing spontaneous reports. The purpose of this study was to combine ADR reports with drug consumption data to demonstrate the additional information this gives in various scenarios, comparing different drugs, gender-stratified sub-populations and changes in reporting over time.
We combined all Norwegian ADR reports in 2004-2013 from the EudraVigilance database (n?=?14.028) with dispensing data from the Norwegian Prescription Database (more than 800 million dispensed prescriptions during 2004-2013). This was done in order to calculate drug-specific consumption-adjusted adverse drug reaction reporting rates (CADRRs) by dividing the number of reports for each drug with the number of users of the drug during the same time period.
Among the ten drugs with the highest number of ADR reports and the ten drugs with the highest CADRR, only four drugs were in both categories. This indicates that drugs with a high number of reports often also have a high number of users and that CADRR captures drugs with potentially relevant safety issues but a smaller number of users. Comparing reported ADRs in females and males using methylphenidate, we found that the two groups report different ADRs. Finally, we showed that changes in ADR reporting for simvastatin and atorvastatin during 2004-2013 were due to changes in consumption and that atorvastatin had a higher CADRR but fewer reports than simvastatin.
CADRR provides additional information compared with number of reports alone in studies using spontaneous reports. It is important for researchers to adjust for consumption whenever possible in pharmacovigilance studies.
Cites: JAMA. 2002 May 1;287(17):2215-20 PMID 11980521
PURPOSE: To investigate the extent and characteristics of off-label prescribing for paediatric outpatients among drugs reported to have caused an adverse reaction. METHODS: A retrospective, cross-sectional, observational analysis of spontaneous adverse drug reaction (ADR) reports in Sweden in the year 2000. We included all reports concerning drugs prescribed for outpatients younger than 16 years. Each ADR was classified with respect to its causality, seriousness and type of reaction. Off-label prescribing was evaluated with respect to age, dose, indication, formulation and route and frequency of administration. RESULTS: We identified 112 patient-linked reports corresponding to 158 ADRs of which 31% were serious. Antiasthmatic drugs were most frequently suspected as a cause of almost every third adverse reaction. The average proportion of off-label drug prescribing amounted to 42.4%. It was more frequently associated with serious than non-serious ADRs and mostly due to a non-approved age or dose. The most common clinical manifestations were psychiatric disorders and mucocutaneous inflammatory reactions. CONCLUSIONS: Off-label prescribing for paediatric outpatients is common among drugs reported to have caused an ADR. It is suggested to further identify unlabelled drugs frequently contributing to, in particular serious ADRs in children for a proper benefit-risk assessment of off-label drug use.
the analgesic drug use has been reported to increase in general in nursing home patients. However, there is insufficient evidence in terms of what agents are used, variations of use over time and to whom these drugs are prescribed.
we investigated the prescribing patterns of scheduled analgesic drugs in Norwegian nursing home patients from 2000 to 2011, with the association to age, gender, cognitive function and type of nursing home unit.
secondary analyses of four study samples (three observational studies and one randomised controlled trial).
nursing home patients included in study samples from 2000 (n = 1,926), 2004 (n = 1,163), 2009 (n = 850) and 2011 (n = 1,858) located in 14 Norwegian counties.
trend analyses of analgesic drug prescriptions. Percentages were described using t-test, ?(2) and Mann-Whitney U test and multivariate logistic regression.
the odds ratio for receiving any pain medication in 2011 compared with 2000 was 2.6 (95% CI 2.23-2.91), this is corresponding to a 65% increase from 34.9 to 57.6%. The paracetamol prescription increased by 113%, from 22.7% in 2000 to 48.4% in 2011. Strong opioids (fentanyl, buprenorphine, morphine, oxycodone) increased from 1.9% in 2000 to 17.9% in 2011 (P
Comment In: Age Ageing. 2016 Jan;45(1):7-826764389
Erratum In: Age Ageing. 2016 Mar;45(2):32326941355
Hospitalization can significantly disrupt sleeping patterns. In consideration of the previous reports of insomnia and apparent widespread use of benzodiazepines and other hypnotics in hospitalized patients, we conducted a study to assess quality of sleep and hypnotic drug use in our acute care adult patient population. The primary objectives of this study were to assess sleep disturbance and its determinants including the use of drugs with sedating properties.
This single-centre prospective study involved an assessment of sleep quality for consenting patients admitted to the general medicine and family practice units of an acute care Canadian hospital. A validated Verran and Snyder-Halpern (VSH) Sleep Scale measuring sleep disturbance, sleep effectiveness, and sleep supplementation was completed daily by patients and scores were compared to population statistics. Patients were also asked to identify factors influencing sleep while in hospital, and sedating drug use prior to and during hospitalization was also assessed.
During the 70-day study period, 100 patients completed at least one sleep questionnaire. There was a relatively even distribution of males versus females, most patients were in their 8th decade of life, retired, and suffered from multiple chronic diseases. The median self-reported pre-admission sleep duration for participants was 8 hours and our review of PharmaNet profiles revealed that 35 (35%) patients had received a dispensed prescription for a hypnotic or antidepressant drug in the 3-month period prior to admission. Benzodiazepines were the most common sedating drugs prescribed. Over 300 sleep disturbance, effective and supplementation scores were completed. Sleep disturbance scores across all study days ranged 16-681, sleep effectiveness scores ranged 54-402, while sleep supplementation scores ranged between 0-358. Patients tended to have worse sleep scores as compared to healthy non-hospitalized US adults in all three scales. When compared to US non-hospitalized adults with insomnia, our patients demonstrated sleep disturbance and supplementation scores that were similar on Day 1, but lower (i.e. improved) on Day 3, while sleep effectiveness were higher (i.e. better) on both days. There was an association between sleep disturbance scores and the number of chronic diseases, the presence of pain, the use of bedtime tricyclic antidepressants, and the number of chronic diseases without pain. There was also an association between sleep effectiveness scores and the length of hospitalization, the in hospital use of bedtime sedatives and the presence of pain. Finally, an association was identified between sleep supplementation scores and the in hospital use of bedtime sedatives (tricyclic antidepressants and loxapine), and age. Twenty-nine (29%) patients received a prescription for a hypnotic drug while in hospital, with no evidence of pre-admission hypnotic use. The majority of these patients were prescribed zopiclone, lorazepam or another benzodiazepine.
The results of this study reveal that quality of sleep is a problem that affects hospitalized adult medical service patients and a relatively high percentage of these patients are being prescribed a hypnotic prior to and during hospitalization.
Cites: Med Lett Drugs Ther. 2000 Aug 7;42(1084):71-210932303
The Canadian Cardiovascular Atlas project, an initiative of the Canadian Cardiovascular Outcomes Research Team (CCORT), will be published as a series of 20 articles in future issues of the Canadian Journal of Cardiology. Through a wide range of data sources and analyses from a number of collaborators across Canada, the CCORT Atlas will provide a comprehensive overview of the current state of cardiac care and disease in Canada. Administrative data, clinical registries and community survey data will be analyzed at the provincial and health region levels. The purposes of this article are to 1) provide an overview of the data types and sources used in the Atlas project, 2) give a general description of the methods and analyses used to report Atlas data and 3) describe how Atlas maps were created and how they can be interpreted.
The aim of this paper was to describe and analyze the effect of antibiotic policy changes on antibiotic consumption in Swedish hospitals and to review antibiotic stewardship in Swedish hospitals.
The main findings were: 1) Antibiotic consumption has significantly increased in Swedish hospitals over the last decade. The consumption of cephalosporins has decreased, whereas that of most other drugs including piperacillin-tazobactam, carbapenems, and penicillinase-sensitive and -resistant penicillins has increased and replaced cephalosporins. 2) Invasive infections caused by ESBL-producing Escherichia coli and Klebsiella pneumoniae have increased, but the proportion of pathogens resistant to third-generation cephalosporins causing invasive infections is still very low in a European and international perspective. Furthermore, the following gaps in knowledge were identified: 1) lack of national, regional, and local data on the incidence of antibiotic resistance among bacteria causing hospital-acquired infections e.g. bloodstream infections and hospital-acquired pneumonia-data on which standard treatment guidelines should be based; 2) lack of data on the incidence of Clostridium difficile infections and the effect of change of antibiotic policies on the incidence of C. difficile infections and infections caused by antibiotic-resistant pathogens; and 3) lack of prospective surveillance programs regarding appropriate antibiotic treatment, including selection of optimal antimicrobial drug regimens, dosage, duration of therapy, and adverse ecological effects such as increases in C. difficile infections and emergence of antibiotic-resistant pathogens.
Evidence-based actions to improve antibiotic use and to slow down the problem of antibiotic resistance need to be strengthened. The effect of such actions should be analyzed, and standard treatment guidelines should be continuously updated at national, regional, and local levels.
Comprehensive information on prescription patterns of antibiotics in Italy is scarce. This study describes the use of systemic antibiotics in children according to age and sex in Friuli Venezia Giulia, north-east Italy. A pharmacological prescription database was used to identify individual prescriptions provided to all 0-15-y-old resident children (n = 140,630) during 1998. Overall, 124,383 prescriptions were identified. The prescription rate was highest in the 3-6 y olds, with 1491 antibiotic prescriptions per 1,000 children per year. Antibiotics were prescribed for 52% of infants, 57.2% of toddlers and 62% of preschool children. Twenty-nine percent of the prescriptions were for cephalosporins, 27% for macrolides and 24% for broad-spectrum penicillins. Prescription rates were much higher than in other countries such as Denmark, with more antibiotic courses prescribed for more children at all ages. Prescriptions from general practitioners and family paediatricians often included second-line antibiotics (e.g. cephalosporins and macrolides) or antibiotics that have not been approved for community-acquired paediatric infections (e.g. quinolones). CONCLUSION: The development of regional guidelines for antibiotic use in children should be urgently recommended.