A framework for monitoring of new drugs in Sweden.

In order to monitor the net public health benefit of new drugs, especially in the light of recent stepwise approval approaches, there is a need to optimize real-time post-marketing evaluation of new drugs using data collected in routine care. Sweden, with its unique possibilities for observational research, can provide these data. We herein propose a framework for continuous monitoring of the effectiveness, safety, and cost-effectiveness of new drugs, using prospectively determined protocols designed in collaboration between all relevant stakeholders. We believe that this framework can be a useful tool for healthcare authorities and reimbursement agencies in the introduction of new drugs.

Most common diseases diagnosed in primary care in Stockholm, Sweden, in 2011.

BACKGROUND: The most commonly reported diagnoses in primary care are useful to identify and meet health care needs in society. We estimated the rates of the most common diagnoses in primary health care in total and also by gender. METHODS: This was a cross-sectional study including all 2.0 million inhabitants living in Stockholm County, Sweden, on 1 January 2009. Data on all health care appointments made in primary care in 2011 and during 2009-11 were extracted from the Stockholm County Council data warehouse VAL (Vårdanalysdatabasen; Stockholm regional health care data warehouse). Primary care data were analysed by underlying population and age. Appropriate specialist open care and inpatient data were used for comparison. RESULTS: The five most common diagnoses in primary care (in 2011) were acute upper respiratory tract infections (6.0% of the population), essential hypertension (5.6%), coughing (2.6%), dorsalgia (2.6%) and acute tonsillitis (2.4%). Female-to-male ratios were higher for 27 of the 30 most common diagnoses, the exceptions being type 2 diabetes, unspecified types of diabetes and multiple wounds. CONCLUSIONS: The 30 most common diagnoses in primary care reflect the complexity of disorders cared for in the first line of health care. Knowledge of these patterns is important when aiming at using primary health care resources in a proper way.

Trends in antiarrhythmic drug use after marketing authorization of dronedarone: comparison between Emilia Romagna (Italy) and Sweden.

PURPOSE: Our aim was to evaluate whether dronedarone authorization impacts antiarrhythmic drug prescribing in Sweden and Emilia Romagna (Italy). METHODS: Prescriptions of classes I and III antiarrhythmics, expressed as defined daily doses per thousand inhabitants per day (DDD/TID) were monthly using information collected from pharmacy-reimbursed databases. Interrupted time series analysis was applied to compare prescription data over the 2009-2011 period. RESULTS: In Emilia Romagna, the overall consumption of antiarrhythmics was six times as high as in Sweden (7.6 vs. 1.2 DDD/TID). In the first year on the market, dronedarone represented 1.0 % in Italy and 10.7 % in Sweden of the overall antiarrhythmic prescriptions. In Sweden, dronedarone authorization generated an increase in the prescription trend of antiarrhythmics (trend change +0.02; p < 0.001) without variation in amiodarone use In Emilia Romagna, dronedarone marketing did not influence the prescription pattern of either overall antiarrhythmics or amiodarone. CONCLUSIONS: Emilia Romagna and Sweden substantially differ in terms of overall antiarrhythmic use. Although clinical guidelines place dronedarone among first-choice treatments for atrial fibrillation, amiodarone prescribing was not affected in either country by the entry of dronedarone, probably due to a cautious approach by clinicians in line with regulatory recommendations and safety warnings.

A MiniReview of the use of hospital-based databases in observational inpatient studies of drugs.

The majority of pharmacoepidemiological data resources are based on data generated in primary health care. Although inpatient data resources have existed since the 1960s, inpatient pharmacoepidemiological studies are relatively scarce. The objectives of this MiniReview were to describe pharmacoepidemiological studies in hospital settings and the underlying databases to provide an overview of research questions addressed by such databases. The studies were retrieved by chain searching. We included pharmacoepidemiological studies in hospital settings containing data on inpatient drug use. Twelve inpatient databases in Asia, the United States and Europe were found. Most databases were automatically collected from claims data or generated from electronic medical records. The contents of the databases varied as well as the potential for linkage with other data sources such as laboratory and outpatient data. Twenty studies were selected and discussed to illustrate the diversity of inpatient pharmacoepidemiological studies. Hospital-based databases had mainly been used for drug utilization studies and research in adverse drug reactions. Five studies within comparative effectiveness were found. The number of pharmacoepidemiological studies in inpatient settings was low compared with studies from primary healthcare settings. These resources may be under-utilized.