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Skewed information about medicines in social media influence the healthcare-patient contact. Healthcare staff need situation adapted evidence that can be linked to patient data. For 20 years Sweden has provided praised Pharmacological Knowledge Bases (PKB). They include »Janusmed drug-drug interactions«, »Janusmed drugs and birth defects« and »e-Ped (electronic pediatric) instructions and drug dosage control«. PKBs need to be better integrated into digital tools adhering to a national guide for optimal interface presentation of information. They should be produced by medical editors and delivered through a national digital highway. Experts need to adhere to a policy for handling conflicts of interest and evaluate that information is appreciated and used. PKBs should be accessible as a public good for healthcare staff, students and the public to support personalized medical care.

Adverse drug reactions (ADRs) for all drugs in Europe are described in the legally approved Summary of Product Characteristics (SmPC). An overview of all ADRs of the patients' drug list can support healthcare staff to link patient symptoms to possible ADRs. We review the possibilities and challenges to extract ADR information from SmPCs and present the development of our semi-automated procedure for extraction of ADRs from the tabulated section of the SmPCs to create a database, named Bikt, which is regularly updated and used at point of care in Sweden. The existence of five major table formats for ADRs used in the SmPCs required the development of different parsing scripts. Manual checks for correctness for all content has to be performed. The quality of extraction was investigated for all SmPCs by measuring precision, recall and F1 scores (i.e. the weighted harmonic mean of precision and recall) and compared with other methods published. We conclude that it is possible to semi-automatically extract ADR information from SmPCs. However, clear technical and content guidelines and standards for ADR tables and terms from drug registration authorities would lead to improved extraction and usability of ADR information at point of care.

Adverse drug reactions (ADRs) for all drugs in Europe are described in the legally approved Summary of Product Characteristics (SmPC). An overview of all ADRs of the patients’ drug list can support healthcare staff to link patient symptoms to possible ADRs. We review the possibilities and challenges to extract ADR information from SmPCs and present the development of our semi-automated procedure for extraction of ADRs from the tabulated section of the SmPCs to create a database, named Bikt, which is regularly updated and used at point of care in Sweden. The existence of five major table formats for ADRs used in the SmPCs required the development of different parsing scripts. Manual checks for correctness for all content has to be performed. The quality of extraction was investigated for all SmPCs by measuring precision, recall and F1 scores (i.e. the weighted harmonic mean of precision and recall) and compared with other methods published. We conclude that it is possible to semi-automatically extract ADR information from SmPCs. However, clear technical and content guidelines and standards for ADR tables and terms from drug registration authorities would lead to improved extraction and usability of ADR information at point of care.

Adverse drug reactions (ADRs) for all drugs in Europe are described in the legally approved Summary of Product Characteristics (SmPC). An overview of all ADRs of the patients' drug list can support healthcare staff to link patient symptoms to possible ADRs. We review the possibilities and challenges to extract ADR information from SmPCs or American Structured Product Labels and present the development of our semi-automated procedure for extraction of ADRs from the tabulated section in the SmPCs to create a database, named Bikt, which is regularly updated and used at point of care in Sweden. The existence of five major table formats for ADRs used in the SmPCs required the development of different parsing scripts. Manual checks for correctness for all content have to be performed. The quality of extraction was investigated for all SmPCs by measuring precision, recall and F1 scores and compared with other methods published. We conclude that it is possible to semi-automatically extract ADR information from SmPCs. However, clear technical and content guidelines and standards for ADR tables and terms from drug registration authorities would lead to improved extraction and usability of ADR information at point of care.

Drug-drug interactions are increasingly common, as patients are getting older and the number of drugs per patient is increasing. In this study, we investigated to which extent potential drug-drug interactions originated from single or multiple prescribers. All patients attending any of 20 primary healthcare centres were included in a retrospective observational cohort study. Data on all prescriptions to these patients, irrespectively of the prescriber, were collected for two 4-month periods. Potential drug interactions were identified using the drug-drug interaction database SFINX. Interactions were classified with respect to the workplace of the prescriber, and the prevalence of interactions according to origin was analysed. We found that the drug interactions were significantly more common when the drugs were prescribed from different healthcare centres, compared with drugs prescribed from the patients' primary healthcare centre only. One explanation for this increased risk of drug interactions could be that the prescribers at different primary healthcare centres do not share the same information concerning the total medication list of the patient.

AIMS Relevant and easily accessible drug information at point-of-care is essential for physicians' decision making when prescribing. However, the information available by using Clinical Decision Support Systems (CDSSs) often does not meet physicians' requirements. The Summary of Product Characteristics (SmPC) is statutory information about drugs. However, the current structure, content and format of SmPCs make it difficult to incorporate them into CDSSs and link them to relevant patient information from the Electronic Health Records. The aim of the study was to evaluate the perceived needs for drug information among physicians in Sweden. METHODS We recruited three focus group discussions with 18 physicians covering different specialities. The information from the groups was combined with a questionnaire administered at the beginning of the group discussions. RESULTS Physicians reported their needs for knowledge databases at the point of drug prescribing. This included more consistent information about existing and new drugs. They also wished to receive automatically generated alerts for severe drug-drug interactions and adverse effects, and to have functions for calculating glomerular filtration rate to enable appropriate dose adjustments to be made for elderly patients and those with impaired renal function. Additionally, features enhancing electronic communication with colleagues and making drug information more searchable were suggested. CONCLUSIONS The results from the current study showed the need for knowledge databases which provide consistent information about new and existing drugs. Most of the required information from physicians appeared to be possible to transfer from current SmPCs to CDSSs. However, inconsistencies in the SmPC information have to be reduced to enhance their utility.

Introduction Stockholm County Council is the largest health care provider in Sweden with an annual budget of US$ 5 billion and catering the needs of a metropolitan population of 2 million people. About 10% of health care costs are used on drugs. In 1996 Stockholm County Council decided to address the main problems associated with the process and the quality of drug prescribing. Methods A multiyear strategy was designed, including the establishment of a strong evidence-based organisation, Drug and Therapeutics Committees and editorial resources to adapt information to the IT-media and the development of the IT-architecture. The development and implementation of computerized tools such as a physician drug order entry system including decision support, a drug information website and electronic transmission of prescriptions were started in 1996. Results The implementation was slow at the point-of-care units. It took about 6 years before the implementation process gained speed. In September 2005 almost 1000 doctors could use the decision support system for prescribing drugs and more than 70% of all prescriptions were transmitted electronically in our region. Conclusions The work with the strategy has shown that improvements in drug use can be accomplished by providing access to simple, rapid and safe electronic tools, but the information provided has to be associated with well-recognized regional and national expert organisations.

In a recent Swedish register study, a limited number of specific drugs explained a large part of clinically relevant, potential drug-drug interactions (DDI), as defined and detected by the DDI database SFINX. Regarding interactions that should be avoided according to the definition in the database (class D), 15 drug combinations accounted for as much as 80 % of the prevalence in the Swedish population. Ten specific drugs were involved in 94 % of all detected class D interactions. About half of the clinically relevant interactions detected during the four-month study period were associated with an increased risk of adverse drug reactions, whereas the other half has a potential to cause therapeutic failure. An increased awareness among prescribers of these interacting drugs could contribute to safer and more effective drug use.

Background Drug-related problems cause suffering for patients and substantial costs. Multi-dose drug dispensing is a service in which patients receive their medication packed in bags with one unit for each dose occasion. The electronic expert support system (EES) is a clinical decision support system that provides alerts if potential drug-related problems are detected among a patients’ current prescriptions, including drug–drug interactions, therapy duplications, high doses, drug-disease interactions, drug gender warnings, and inappropriate drugs and doses for geriatric or pediatric patients. Objective The aim of the study was to explore physicians’ views on the clinical relevance of alerts provided by EES. Furthermore we investigated if physicians performed any changes in drug treatment following the alerts and if there were any differences in perceived relevance and performed changes between different types of alerts and drugs. Setting Two geriatric clinics and three primary care units in Sweden. Method Prescribed medications for patients (n = 254) with multi-dose drug dispensing were analyzed for potential drug-related problems using EES. For each alert, a physician assessed clinical relevance and indicated any intended action. A total of 15 physicians took part in the study. Changes in drug treatment following the alerts were later measured. The relationship between variables was analyzed using Chi square test. Main outcome measure Physicians’ perceived clinical relevance of each alert, and changes in drug treatment following the alerts. Results Physicians perceived 68 % (502/740) of EES alerts as clinically relevant and 11 % of all alerts were followed by a change in drug treatment. Clinical relevance and likelihood to make changes in drug treatment was related to the alert category and substances involved in the alert. Conclusion In most patients with multi-dose drug dispensing, EES detected potential drug-related problems, with the majority of the alerts regarded as clinically relevant and some followed by measurable changes in drug treatment.

Clozapine (CLZ), an atypical neuroleptic with a high risk of causing agranulocytosis, is metabolized in the liver to desmethylclozapine (DCLZ) and clozapine N-oxide (CLZ-NO). This study investigated the involvement of different CYP isoforms in the formation of these two metabolites.Human liver microsomal incubations, chemical inhibitors, specific antibodies, and different cytochrome P450 expression systems were used.Km and Vmax values determined in human liver microsomes were lower for the demethylation (61 +/- 21 microM, 159 +/- 42 pmol min(-1) mg protein(-1) mean +/- s.d.; n = 4), than for the N-oxidation of CLZ (308 +/- 1.5 microM, 456 +/- 167 pmol min(-1) mg protein(-1); n = 3). Formation of DCLZ was inhibited by fluvoxamine (53 +/- 28% at 10 microM), triacetyloleandomycin (33 +/- 15% at 10 microM), and ketoconazole (51 +/- 28% at 2 microM) and by antibodies against CYP1A2 and CYP3A4. CLZ-NO formation was inhibited by triacetyloleandomycin (34 +/- 16% at 10 microM) and ketoconazole (51 +/- 13% at 2 microM), and by antibodies against CYP3A4. There was a significant correlation between CYP3A content and DCLZ formation in microsomes from 15 human livers (r=0.67; P=0.04). A high but not significant correlation coefficient was found for CYP3A content and CLZ-NO formation (r=0.59; P=0.09). Using expression systems it was shown that CYP1A2 and CYP3A4 formed DCLZ and CLZ-NO. Km and Vmax values were lower in the CYP1A2 expression system compared to CYP3A4 for both metabolic reactions.It is concluded that CYP1A2 and CYP3A4 are involved in the demethylation of CLZ and CYP3A4 in the N-oxidation of CLZ. Close monitoring of CLZ plasma levels is recommended in patients treated at the same time with other drugs affecting these two enzymes.

To investigate the impact of the integration of the drug-drug interaction database SFINX into primary health care records on the prevalence of potentially serious drug-drug interactions.The study was a controlled before-and-after study on the prevalence of potential drug-drug interactions before and after the implementation of SFINX at 15 primary healthcare centres compared with 5 centres not receiving the intervention. Data on dispensed prescriptions from health care centres were retrieved from the Swedish prescribed drug register and analysed for September-December 2006 (pre-intervention) and September-December 2007 (post-intervention). All drugs dispensed during each 4 month period were regarded as potentially interacting.Use of SFINX was associated with a 17% decrease, to 1.81 × 10(-3) from 2.15 × 10(-3) interactions per prescribed drug-drug pair, in the prevalence of potentially serious drug-drug interactions (p = 0.042), whereas no significant effect was observed in the control group. The change in prevalence of potentially serious drug-drug interactions did not differ significantly between the two study groups. The majority of drug-drug interactions identified were related to chelate formation.Prescriptions resulting in potentially serious drug-drug interactions were significantly reduced after integration of the drug-drug interaction database SFINX into electronic health records in primary care. Further studies are needed to demonstrate the effectiveness of drug-drug interaction warning systems.

Knowledge databases for clinical decision support in drug prescribing-development, quality assurance, management, integration, implementation and evaluation of clinical value

Objective The aim was to develop a drug-drug interaction database (SFINX) to be integrated into decision support systems or to be used in website solutions for clinical evaluation of interactions. Methods Key elements such as substance properties and names, drug formulations, text structures and references were defined before development of the database. Standard operating procedures for literature searches, text writing rules and a classification system for clinical relevance and documentation level were determined. ATC codes, CAS numbers and country-specific codes for substances were identified and quality assured to ensure safe integration of SFINX into other data systems. Much effort was put into giving short and practical advice regarding clinically relevant drug-drug interactions. Results SFINX includes over 8,000 interaction pairs and is integrated into Swedish and Finnish computerised decision support systems. Over 31,000 physicians and pharmacists are receiving interaction alerts through SFINX. User feedback is collected for continuous improvement of the content. Conclusion SFINX is a potentially valuable tool delivering instant information on drug interactions during prescribing and dispensing.