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Biomedical subjects

Ulf Bergman

Publications and source records attributed to Ulf Bergman.

At least 19 recordsLinked to original sources

The new Swedish Prescribed Drug Register--opportunities for pharmacoepidemiological research and experience from the first six months.

PURPOSE: To describe the content and potentials of the new Swedish national register on prescribed and dispensed medicines. METHODS: The Swedish Prescribed Drug Register contains information about age, sex and unique identifier of the patient as well as the prescriber's profession and practice. Information regarding drug utilization and expenditures for prescribed drugs in the entire Swedish population was extracted from the first six months July-December 2005 and compared with total drug sales in the country including OTC and hospital use. RESULTS: The total quantity of drugs sold in Sweden was 2666 million DDDs, corresponding to 1608 DDD/1000 inhabitants daily. The total expenditures were 1.6 billion Euro. The prescribed drugs, included in the register, accounted for 84% of the total utilization and 77% of the total expenditures. About half of all men and two-thirds of all women in the country purchased drugs. The proportion increased by age. The most common drugs for chronic treatment were diuretics among women (8.8% of the population) and antithrombotic agents among men (7.6%). Psychotropic drugs, corticosteroids and analgesics were more common among women, while men used antithrombotic agents, antidiabetic drugs, lipid lowering agents and ACE inhibitors to a greater extent. CONCLUSIONS: The new register provides valuable data on exposure to drugs and is useful to study patterns of drug utilization. The possibilities for record linkage to other health registers gives from an international perspective good opportunities to explore drug and disease associations and the risks, benefits, effectiveness and health economical effects of drug use.

Adolescent↗

Nurses are increasingly involved in pharmacovigilance in Sweden.

INTRODUCTION: In Sweden, voluntary adverse drug reaction (ADR) reporting started over 40 years ago to detect rare, serious, unexpected adverse, mainly type B, reactions. During the period 1965-2004, 92,000 reports were assessed. Since certain nurses are licensed to prescribe a limited number of drugs, nurses also form part of the reporting team. AIM: To analyse the ADR reporting by nurses in Sweden. METHODS: All reports by nurses and other health-care personnel entered into the Swedish ADRs database SWEDIS (Swedish Drug Information System) were retrieved for the 10-year period 1995-2004 (Swedish population: 9 million). The intention was to analyse the nurses' reports from a quantitative and qualitative point of view. RESULTS: The total number of ADR reports has gradually increased during the past 10 years from 3000 to over 4000 in 2004 (465 per million inhabitants), an increase by 28%. All ADR reports originate from health care personnel. The nurses' contribution to the ADR reporting increased from 2-3% in the mid-90s to 12% in 2004. The most common drugs involved in the nurses' reporting were various kinds of vaccines. Skin reactions dominated among the nurses' ADR reports. The ADRs reported by nurses were, as a consequence of many vaccine reports, compared to all reports, not so often classified as serious, but were on the other hand more often assessed with a causal relationship. CONCLUSIONS: Nurses, in their position as drug administrators who record signs and symptoms of the patients, play an increasingly important role for detection of suspected ADRs and are now contributing to a significant amount of the ADR reporting in Sweden.

Adverse Drug Reaction Reporting Systems↗

Drug related problems and off-label drug treatment in children as seen at a drug information centre.

The aim of this work was to analyse the characteristics of Questions and Answers (Q&As) at a drug information centre (DIC) regarding drug related problems and off-label drug treatment in children. All questions concerning children 15 years or younger at a DIC in Stockholm, Sweden during the years 1995-2004 were analysed with respect to the main drug related problem, drug/s and drug group/s, whether the drugs were licensed or not, pediatric labelling of the drug/s and age and sex of the patient. Q&As were classified as whether or not they included evaluated literature information, adding to the labelling of the drugs. We identified 249 Q&As concerning pediatric drug treatment. Each question addressed an average of 1.5 drugs. More than two-thirds of the Q&As concerned adverse drug reactions and pediatric drug choice or dosing. Every second question was classified as off-label, psychotropic drugs being the most common. In half of all off-label Q&As, pediatric documentation on drug efficacy and safety outside the Swedish catalogue of medical products was found. Most Q&As concerned newborns and infants. However, the off-label proportion among questions was highest in adolescence as well as the evaluated literature information, adding to the labelling of the drugs. It was thus found that off-label drug treatment is common among pediatric questions at a DIC. This service can provide additional literature based information contributing to a safer use of drugs in children. There is still, however, a substantial need for clinical documentation of drug use in children.

Adolescent↗

Using aggregate data on dispensed drugs to evaluate the quality of prescribing in urban primary health care in Sweden.

BACKGROUND: Valuable evaluations of the quality of drug prescribing in routine health care are difficult to perform. It is even more difficult to study prescribing in a non-gatekeeping healthcare system with a variety of caregivers involved in patient care. Consequently, there is a need to develop methods for evaluation using data available in routine health care. OBJECTIVES: The aim of this study was to analyse possibilities and limitations for evaluation of the quality of drug prescribing using routinely collected aggregate data on dispensed drugs and health care provision. A secondary aim was to study the effects of allocating more resources to primary health care (PHC) on the quality of drug prescribing. METHODS: The study was performed with routinely collected data from 10 PHC centres in Stockholm, Sweden that were participating in an intervention project that aimed to decrease the number of inhabitants per PHC doctor. Time periods for analysis were October-December 1999, 2000 and 2001. Data on dispensed prescriptions were analysed by age using Anatomical Therapeutic Chemical (ATC) classification/defined daily dose (DDD) methodology. The general quality of prescribing was determined using DU90% methodology (identifying the number of drugs constituting 90% of the volume expressed in DDDs and the adherence to evidence-based recommendations) and ratios between different treatment alternatives. The total volume and cost of drugs prescribed to the population was also analysed. RESULTS: In 2001, PHC centres accounted for, on average, 27% (range 14-36%) of all doctor consultations and 32% (range 22-43%) of all prescriptions to populations in the corresponding primary care districts. There was great variation between the different PHC centres with regard to the prescribing doctors' compliance with guidelines from the regional drug and therapeutics committee, and the utilization of health care and drugs among the population in the corresponding primary care districts. No clear improvement was observed over time. CONCLUSION: Analysis of aggregated prescription and healthcare data at population level was feasible. However, the effects of allocation of increasing resources to PHC on the quality of drug prescribing need to be analysed in a broader context.

Adolescent↗

Adverse drug reactions causing hospitalization can be monitored from computerized medical records and thereby indicate the quality of drug utilization.

PURPOSE: To use computerized medical records to study the frequency of adverse drug reactions (ADR) as a cause for acute admission to a university hospital. METHODS: Computerized medical records in 168 consecutively acutely admitted cases to a short-term internal medicine ward at a university hospital were retrospectively evaluated to see if an ADR could have caused the admission. RESULTS: In 18 cases (11%), an ADR was judged to be the reason for acute admission to the hospital. Augmented pharmacological effects (type A reactions) accounted for 89% of the cases. An additional eight cases (5%) were intentional intoxications with prescription drugs. ADR-associated hospital admissions were age-related (average age 72 compared to 65 in patients admitted for other reasons) and also associated with poly-pharmacy (8.3 drugs compared to 5.2). The ADR was considered to arise from a drug-drug interaction in four cases (22%). Although all ADRs fulfilled the criteria for mandatory reporting, none of them were reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC). CONCLUSIONS: The observed frequency of ADR-related acute hospital admissions in this pilot study is similar to earlier reported data from Sweden and abroad. Almost all of these reactions were known pharmacological (type A) reactions and many therefore theoretically preventable. In contrast to many prospective and costly studies, this retrospective analysis of computerized medical records offered a simple method that can be used in routine health care and also serve as an indicator of the quality of drug use.

Adverse Drug Reaction Reporting Systems↗

The history of the Drug Utilization Research Group in Europe.

Following the recommendations from a World Health Organization (WHO)/Euro symposium Consumption of drugs in 1969, a common classification system for drugs was developed, the Anatomical Therapeutic Chemical (ATC), and a technical unit of comparison, the Defined Daily Dose (DDD), as a comparative unit of drug use. This was found to be robust across therapeutic classifications, dosing forms and diverse populations. To maintain and develop the ATC/DDD system a WHO-Collaborating Centre was established in Oslo. As this was found to be of global interest the centre now reports to the WHO headquarters in Geneva. An informal WHO Drug Utilization Research Group (WHO-DURG), later the EuroDURG, has by now met 28 times in Europe. Since 1994 in Stockholm all these meetings have been with ISPE (International Society for Pharmacoepidemiology) when meeting in Europe. The main focus was initially to improve drug utilization through cross-national drug utilization studies based on the ATC/DDD methodology as they revealed large differences between and within countries that could not easily be explained by morbidity differences alone. These observed differences have led to the expansion of the area to include social, economic and qualitative methods with a more generalized public health focus. One of the most recent contributions was the development of drug use quality indicators.

Benchmarking↗

The use of TDM data to assess the validity of defined daily doses of antiepileptics: a comparison between a Czech and Swedish University Hospital.

Prescribed daily doses (PDDs) of antiepileptic drugs (AED) (N03A ATC group) were recorded for drugs used in monotherapy or in combination therapy in the University Hospitals in Ostrava, Czech Republic and Huddinge, Sweden. Plasma concentrations were used as an indicator of the quality of treatment. PDDs were compared with the defined daily doses (DDDs) suggested by WHO in the ATC/DDD index 2005. Request and reply forms for therapeutic drug monitoring (TDM) were used as a source of mean PDDs. The study included 2,824 adult out- and in-patients in Huddinge treated from 1995 to 1999 and 1,268 out-patients treated in Ostrava from 1993 to 2004. The differences in PDD were tested by Student's t-test. Mean values of PDD were used when patients were examined more than once. Doses given in mono- and polytherapy were compared. Mean PDDs (in mg) in mono-/polytherapy in Huddinge and Ostrava were as follows (DDDs in parenthesis): carbamazepine 588/842 and 618/770 (1,000), clonazepam 3.0/2.5 and 3.4/2.4 (8), phenytoin 278/314 and 291/288 (300), gabapentin -/1,533 and -/921 (1,800), lamotrigine 228/228 and 216/195 (300), phenobarbital 90/75 and 183/117 (100), vigabatrin -/1,794 and -/1,259 (2,000), valproic acid 1,139/1,476 and 814/950 (1,500). The PDDs of most of the AEDs were lower than the DDDs with the exceptions for valproic acid (Huddinge, in polytherapy only), phenytoin, for which PDDs and DDDs were very close, and phenobarbital for which they were similar in Huddinge but higher in Ostrava. PDDs in monotherapy were only slightly lower than in combination therapy. Patients with plasma concentrations within the therapeutic range were usually treated with slightly higher doses than the remainder. In general, plasma concentrations tended to be in the low therapeutic range. The differences in PDDs between hospitals were significant in the case of valproic acid (P < 0.001), phenobarbital (except monotherapy within), vigabatrin, and gabapentin (P < 0.01), and carbamazepine (in monotherapy P < 0.05, polytherapy P < 0.01). Our data suggest that the DDDs of AEDs should be reconsidered as, in the majority of cases, they appear to be too high.

Adolescent↗

Therapeutic monitoring of antiepileptic drugs: a comparison between a Czech and a Swedish University Hospital.

Plasma concentrations obtained during routine therapeutic monitoring of antiepileptic drugs (AED) (N03A ATC group) were compared in patients treated with one or several AED in the University Hospitals in Ostrava, Czech Republic and Huddinge, Sweden. Request and reply forms for therapeutic drug monitoring (TDM) were used as a source of mean plasma concentrations (PC). The study included 2,824 adult out- and inpatients in Huddinge treated from 1995 to 1999 and 1,268 outpatients treated in Ostrava from 1993 to 2004. PC of valproic acid in Huddinge and all AED except clonazepam in Ostrava were analyzed with gas-liquid chromatography. Plasma concentrations of clonazepam in Ostrava and all AED except valproic acid in Huddinge were analyzed by HPLC. The differences in PC were tested by Student's t-test. Chi(2) method was used for the differences in the distribution of PC relative to the therapeutic window. The mean plasma concentrations generally reached the apparent therapeutic ranges but were below the range in the cases of phenytoin monotherapy in both hospitals, and clonazepam, phenobarbital and phenytoin in polytherapy in Ostrava. In monotherapy 33% of the analyses showed sub-therapeutic concentrations in Huddinge, compared to 38% in Ostrava. Eight percent of the analyses showed potentially toxic concentrations in Huddinge, but only 3% in Ostrava. The highest number of sub-therapeutic concentrations was detected for phenytoin in both hospitals: 59% in Huddinge, 78% in Ostrava. In polytherapy only slight differences between the hospitals were found. PC/dose ratios were significantly lower in polytherapy than in monotherapy for carbamazepine and valproic acid in both hospitals. In contrast a higher PC/dose ratio was found in polytherapy for phenytoin in both cohorts and for lamotrigine in Ostrava. Drug treatment of epilepsy in our two hospitals is surprisingly similar in terms of achieved plasma concentrations, in spite of socioeconomic and cultural differences between our two countries. This may be explained by the long experience with TDM in both hospitals, which has the inherent capacity to promote evidence based drug therapy.

Anticonvulsants↗

Antimicrobial prescribing at a university hospital: justified or 'just in case': testing a new scoring system as a key quality indicator.

OBJECTIVE: To evaluate the quality of antimicrobial drug prescribing at a university hospital in the Department of Medicine, by using a new scoring system as a quality indicator. METHODS DESIGN: a prospective, longitudinal survey, during a 21-week period. The necessity of antimicrobial treatment of all in-patients at the Department of Medicine, to whom new antimicrobials were prescribed, was assessed by using a scoring system based on the presence of signs and symptoms of an infection. If the sum's total score was 3 or more, the antimicrobial treatment was deemed justifiable; if the score was less than 3, the antimicrobial treatment was regarded as questionable. SETTING: Department of Medicine (279 hospital-beds) at the University Hospital Center Rijeka, a 1200-patient-bed teaching hospital in Croatia. RESULTS: Antimicrobials were prescribed to 15% of the total patients. They were given as a treatment to 89% of the patients, and in 67% of the cases, this treatment was administered empirically. According to the scoring system, 29% of the patients did not have a justified indication for antimicrobial treatment. CONCLUSION: The proposed quality indicator (scoring system) that we used is a simple method for the quality assessment of antimicrobial use. It has indicated areas that require in-depth analysis.

Adult↗

A study of adherence to drug recommendations by providing feedback of outpatient prescribing patterns to hospital specialists.

PURPOSE: To study the effect of feedback using prescribing profiles combined with interactive group discussions on hospital specialists' adherence to evidence-based guidelines for drug treatment of common diseases issued by a regional Drug and Therapeutics Committee. METHODS: Intervention study performed at 17 clinics at a university hospital in a Swedish metropolitan health region with comparative clinics at a second university hospital as a control. Prescribing profiles based on aggregate pharmacy dispensing data were presented for the physicians in interactive group discussions. Deviations from the guidelines were discussed at each clinic and specific goals of improvement were formulated. The effect was assessed by pre- and post-intervention comparison of the adherence to guidelines for all drugs and within 11 selected therapeutic areas. The credibility and usefulness of the prescribing profiles were evaluated by a questionnaire. RESULTS: The adherence to pharmaceutical products within the pharmacological groups stated in the guideline increased by 2.8%-units at the intervention hospital compared with 0.8%-units at the control hospital. The adherence to drug substance increased by 0.4%-units at the intervention hospital while it decreased by 1.8%-units at the control hospital. For 8 of 11 pre-defined specific goals of improvement, the change in adherence was more positive at the intervention hospital. Most doctors considered the feedback provided clear and relevant. CONCLUSIONS: Interactive group discussions with prescribing profiles were found to be useful in improving hospital specialists' adherence to guidelines. However, the effect on the overall adherence was modest, indicating the importance of clear messages for improvement and relevant guidelines for the prescribing of specialist drugs but also more precise methods for evaluating the effect of real-life-interventions.

Attitude of Health Personnel↗

Quality of prescribing for the elderly in Croatia-computerized pharmacy data can be used to screen for potentially inappropriate prescribing.

OBJECTIVE: The quality of medication use by the elderly is a major safety concern because of an increasing number of people in this segment of the population and the fact that they are major drug consumers. The objective of this study was to test whether administrative computerized pharmacy prescription data could be used to assess the prevalence of potentially inappropriate medication use by the elderly in Rijeka, Croatia, using two sets of explicit criteria data. METHODS: In 2002, the prevalence of potentially inappropriate medication use in the elderly aged 70 years or over was evaluated using Beers' criteria. Inappropriate co-prescribing was evaluated using a list of eight potentially harmful drug combinations. Information on the use of drugs was collected from a computerized pharmacy record of all prescriptions dispensed in the "Jadran Pharmacies" in Rijeka. RESULTS: Five computerized pharmacies dispensed 306,000 (65% of all prescriptions in Rijeka); 78,000 were for those aged 70 years and over. Among these elderly, the prevalence of inappropriate choice of drugs was 2.2% and inadequate co-prescribing 1.9%. The most common inappropriate drug was a long-acting benzodiazepine, diazepam. Mostly used potentially harmful combinations were a non-steroidal anti-inflammatory drug (NSAID) co-prescribed with a diuretic, and two benzodiazepines co-prescribed. CONCLUSION: We found that computerized pharmacy data can be used as a screening tool in efforts to improve the quality of drug prescribing in Rijeka. Explicit criteria for assessing inappropriate prescribing for the elderly can easily be applied to population based surveys. This study suggests a low rate of potentially inappropriate prescribing for the elderly in Rijeka.

Aged↗

Adverse drug reactions and off-label prescribing for paediatric outpatients: a one-year survey of spontaneous reports in Sweden.

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.

Adolescent↗

Use of antibiotics at hospitals in Stockholm: a benchmarking project using internet.

PURPOSE: To evaluate the internet way of feedback to prescribing physicians, providing data on antimicrobial use and to assess the applicability of the DU90% (i.e. Drug Utilisation 90%--the number of drugs accounting for 90% of the volume of usage in defined daily doses, (DDDs)) methodology in the hospital setting. METHODS: Antimicrobial drug use was evaluated in all major departments in seven hospitals in Stockholm in the year 2000. All data were presented anonymously on www.janusinfo.org. Aggregate data on antimicrobial drug use were expressed as the number of DDDs and costs per 100 bed-days. We focused on the number of drugs accounting for 90% of the volume (DDD), including the level of adherence to guidelines. The chief physicians assessed this feedback by a questionnaire. RESULTS: The number of DDDs/100 bed-days varied among different clinics and ranged from 39 to 57 (internal medicine) to 102 to 161 (infectious disease). The cost per 100 bed-days varied more than two-fold. The number of different antibiotics within the DU90% segment ranged from 9 to 13 (orthopaedic clinics) to 16 to 23 (infectious disease). According to the questionnaire, data were considered to be clearly presented and physicians would like to receive this kind of reports in the future, not only for antibiotics but also for other drugs. CONCLUSION: Presenting physicians with aggregate data on drug use via internet could provide a stimulus for prescribing improvement.

Anti-Bacterial Agents↗

Widespread off-label prescribing of topical but not systemic drugs for 350,000 paediatric outpatients in Stockholm.

OBJECTIVES: Many hospital-based studies throughout Europe have shown that a substantial number of children receive off-label prescribed drugs that lack marketing authorisation for paediatric use. Since information about the extent and characteristics of this prescribing pattern in paediatric primary health care is limited, we assessed the proportion of off-label drug prescribing for paediatric outpatients in a reference population of 350,000 children using a computerised prescription database. We also determined the adherence to a treatment guideline provided by the Stockholm county council as a quality of prescribing indicator. METHODS: All drugs prescribed for children younger than 16 years of age in the Stockholm county in the year 2000 were ranked by the number of prescription items. The retrospective, descriptive analysis was restricted to those drugs that accounted for 90% of total prescribing. We calculated the proportion of off-label drug prescribing for different age and therapeutic groups with respect to age, formulation and route of administration using the Swedish Physician's Desk Reference. The quality of prescribing was estimated as the proportion of prescription items corresponding to recommended drugs in the local treatment guideline Kloka Listan (The Wise List). RESULTS: Among the 317 drugs accounting for 90% of total prescribing, 575,526 prescription items were identified with an average proportion of off-label and recommended drug prescribing of 20.7% and 60.5%, respectively. The off-label proportion was similar in various age groups but widely different between therapeutic groups being much higher for topical (70.4%) than for systemic (5.4%) drugs. The extent to which recommended drugs were prescribed also greatly varied between therapeutic groups irrespectively of the off-label proportion. CONCLUSIONS: Off-label drug prescribing for paediatric outpatients is a common phenomenon. However, it mainly applied to topical drugs and was to a substantial extent recommended by the local treatment guideline. Thus, off-label prescribing might represent a more administrative rather than clinical problem in the paediatric outpatient setting.

Administration, Topical↗

Drug utilisation 90% profiles--a useful tool for quality assessment of prescribing in primary health care in Stockholm.

PURPOSE: To analyse strengths and weaknesses of a simple method for assessing the general quality of drug prescribing and to study the acceptance of the method among general practitioners (GPs). METHODS: Prescriptions dispensed during October-December 1999 and 2000, respectively, were analysed for 38 Primary Health Care centres (PHC) in Stockholm participating in an intervention project with the aim of increasing cost-consciousness among GPs. Focus was on quality of prescribing rather than on costs. Prescribing profiles focusing on the number of drugs constituting 90% of the volume (= DU90%) and the adherence to local drug committee guideline within this segment were presented for the prescribers. The credibility and usefulness of the method was evaluated by a questionnaire. RESULT: Among the PHCs, the total number of drugs prescribed varied between 358 and 674. The number of drugs in the DU90%-segment varied between 117 and 194. The adherence to guideline within this segment varied between 56% and 74% and increased over time. The prescribers found the DU90%-profiles clear and relevant and considered the method to be a useful tool for improving the quality of drug prescribing. CONCLUSION: Providing DU90%-profiles with guideline adherence as feedback was shown to be a valuable tool in general practice for assessing the overall quality in prescribing and to form the basis for more disease- or patient-specific analyses.

Age Factors↗

Quality of non-steroidal anti-inflammatory drug prescribing in Croatia (Rijeka) and Sweden (Stockholm).

OBJECTIVE: We compared the utilisation pattern and cost of non-steroidal anti-inflammatory drugs (NSAIDs) in Rijeka, Croatia and in Stockholm, Sweden using a newly introduced method for assessing the quality of drug use, i.e. to determine the number of drugs that account for 90% of the use and the adherence to evidence-based recommendations within this segment (the DU90% methodology). METHODS: We analysed prescription NSAIDs dispensed during the first 6 months of 2000 in Rijeka and in Stockholm and recorded number of prescriptions, number of defined daily doses (DDDs), number of DDDs/1000 inhabitants per day and percentages and determined the DU90% segment by substance and brand name. Within the DU90% segment we determined the proportion of NSAIDs associated with high (ketoprofen, piroxicam) and low (ibuprofen, diclofenac) risk for gastrointestinal (GI) toxicity according to a meta-analysis of controlled epidemiological studies. We also compared the cost for NSAIDs in both regions as well as the cost for each NSAID expressed in Euros. RESULTS: In Stockholm the utilisation of NSAIDs was twofold greater than in Rijeka (28.6 DDDs/1000 inhabitants/day vs 14.2 DDDs/1000 inhabitants/day). Within the DU90% segment we found four NSAIDs (of nine) in Rijeka and 16 (of 37) in Stockholm. In both regions diclofenac was the most commonly prescribed substance (55% in Rijeka and 25% in Stockholm). Diclofenac was also the cheapest drug in Rijeka. In Stockholm, the most commonly prescribed single brand drug was rofecoxib, a cyclooxygenase-2 inhibitor with a price far above the old NSAIDs. A significant proportion of "high GI risk" NSAIDs was found within the DU90% segment both in Rijeka (piroxicam, 23%) and in Stockholm (ketoprofen, 14%). Although the gross national product was five times higher in Sweden than in Croatia during 2000, on average, NSAIDs were three times more expensive in Sweden than in Croatia (0.52 Euros/DDD vs 0.18 Euros/DDD). Ibuprofen (DDD 1200 mg), the safest drug regarding GI toxicity, was not the most prescribed in either region. CONCLUSION: Our study suggests that evidence-based medicine was not the leading impact factor in prescribing NSAIDs during 2000. A proportionally higher use of ibuprofen (at a daily dose of 1200 mg) and a reduced use of either piroxicam or ketoprofen would improve the NSAID GI safety profile in both countries. As previously shown for Sweden and some other countries, the DU90% methodology was found to be a useful method for assessing the general quality of NSAID prescribing in Croatia.

Anti-Inflammatory Agents, Non-Steroidal↗

Non-antiarrhythmic drugs prolonging the QT interval: considerable use in seven countries.

AIMS: Many drugs belonging to different therapeutic classes appear to share a potentially fatal side-effect: ventricular tachyarrhythmias associated with QT prolongation. The aim of this study was to assess the relevance and the magnitude of the problem in seven countries by grouping all nonantiarrhythmic drugs according to the type of evidence on QT prolongation and analysing their sales data. METHODS: We divided all nonantiarrhythmic QT-prolonging agents into the following categories (in increasing order of clinical relevance): group A, drugs with published clinical or preclinical evidence on QT prolongation or with relevant official warnings; group B, drugs with published clinical or preclinical evidence; group C, drugs with published clinical evidence; group D, drug with published clinical evidence on torsades de pointes or ventricular arrhythmias associated with QT prolongation; group E, drugs belonging to group D with official warnings. We retrieved 1998 sales data from community pharmacies in seven countries (Australia, Denmark, England, Germany, Greece, Italy and Sweden). Data for individual agents were expressed as defined daily doses per 1000 inhabitants per day (DDD/1000/day). Overall use in each country was calculated for each drug group. Groups D and E were considered as the most clinically relevant. RESULTS: Among the 102 nonantiarrhythmic agents meeting at least one of the inclusion criteria, 33 drugs had sales data > or =1 DDD/1000/day and 71 drugs had a use > or =0.1 DDD/1000/day in at least one country. Among the 37 nonantiarrhythmic agents with published reports of ventricular arrhythmias associated with QT prolongation, 12 compounds had sales data > or =1 DDD/1000/day. Total consumption in each country ranged: from 51.9 to 94.7 DDD/1000/day for group A; from 51.6 to 92.7 DDD/1000/day for group B; from 37.1 to 76.6 DDD/1000/day for group C; from 12.9 to 29.1 DDD/1000/day for group D; and from 5.8 to 15.3 DDD/1000/day for group E. CONCLUSIONS: In spite of wide variations in the sales of individual agents, the overall extent of use of nonantiarrhythmic QT-prolonging drugs was of the same order of magnitude in all countries. The significant use of drugs belonging to categories D and E should prompt careful risk/benefit assessment of each agent.

Australia↗