Ulf Bergman - Academia.edu (original) (raw)
Papers by Ulf Bergman
British Journal of Psychiatry, Mar 1, 1999
Authorea (Authorea), Jun 19, 2023
Eurosurveillance, Jul 1, 2006
La vigilancia de las infecciones nosocomiales es un parametro de buenas practicas clinicas demasi... more La vigilancia de las infecciones nosocomiales es un parametro de buenas practicas clinicas demasiado descuidado en las instituciones sanitarias, debido al trabajo que implica cuando no existe un sistema informatico adecuado. El objetivo de este estudio fue evaluar si se podia utilizar un protocolo sencillo para estimar la carga de las infecciones nosocomiales y si dicho protocolo pudiera ser la base de un sistema de vigilancia a largo plazo. Esa evaluacion se llevo a cabo en tres centros hospitalarios universitarios, en Huddinge en Suecia, Riga en Letonia y Vilnius en Lituania. Se analizaron los registros medicos de todos los pacientes tratados con antibioticos de acuerdo a un protocolo estandardizado, segun las indicaciones para el tratamiento y la frecuencia de las infecciones nosocomiales obtenidas de una encuesta de prevalencia. Solamente se incluyeron las especialidades comparables. La proporcion de pacientes tratados por antibioticos (excepto las profilaxis) fue de 63/280 (22 %) en Huddinge, 73/649 (11 %) en Riga y de 99/682 (15 %) en Vilnius. La proporcion de pacientes hospitalizados tratados por una infeccion nosocomial fue del 15%, 3% y 4%, respectivamente (en los dos casos, Huddinge comparado con los otros centros, pl0,001). Las infecciones en la herida quirurgica fueron las mas frecuentes, seguidas por las infecciones sucedidas mas de dos dias despues de la hospitalizacion, en ausencia de otro factor de riesgo. Nuestro metodo sencillo y barato mostro que las infecciones nosocomiales son un problema importante en los pacientes hospitalizados en Huddinge. Los resultados obtenidos pueden servir para una discusion posterior y para un seguimiento a nivel local. La comparacion de los resultados entre los centros es mucho menos relevante que todo el proceso que acompano a este estudio.
Pharmacoepidemiology and Drug Safety, 2008
Pharmacoepidemiology and Drug Safety, May 23, 2013
Purpose All five Nordic countries have nationwide prescription databases covering all dispensed d... more Purpose All five Nordic countries have nationwide prescription databases covering all dispensed drugs, with potential for linkage to outcomes. The aim of this review is to present an overview of therapeutic areas studied and methods applied in pharmacoepidemiologic studies using data from these databases. Methods The study consists of a Medline-based structured literature review of scientific papers published during 2005-2010 using data from the prescription databases in Denmark, Finland, Iceland, Norway, and Sweden, covering 25 million inhabitants. Relevant studies were analyzed in terms of pharmacological group, study population, outcomes examined, type of study (drug utilization vs. effect of drug therapy), country of origin, and extent of cross-national collaboration. Results A total of 515 studies were identified. Of these, 262 were conducted in Denmark, 97 in Finland, 4 in Iceland, 87 in Norway, and 61 in Sweden. Four studies used data from more than one Nordic country. The most commonly studied drugs were those acting on the nervous system, followed by cardiovascular drugs and gastrointestinal/endocrine drugs. A total of 228 studies examined drug utilization and 263 focused on the effects and safety of drug therapy. Pregnant women were the most commonly studied population in safety studies, whereas prescribers' adherence to guidelines was the most frequent topic of drug utilization studies. Conclusions The Nordic prescription databases, with their possibility of record-linkage, represent an outstanding resource for assessing the beneficial and adverse effects of drug use in large populations, under routine care conditions, and with the potential for long-term follow-up.
Therapie, Jul 1, 2009
medical products that include herbal and complementary medicines, vaccines, and other biologicals... more medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always
The Journal of Pediatrics, Mar 1, 1990
Pharmacoepidemiology and Drug Safety, 2020
This is the first manuscript, and it is related to the challenges identified in the DUR area in t... more This is the first manuscript, and it is related to the challenges identified in the DUR area in the LatAm region. Drug utilization researchers in LatAm voluntarily participated in multiple discussions contributed with local data and reviewed successive drafts and the final document.
Drug Safety, 2020
Introduction The increased access to medicinal products in Africa is not well-matched with the ph... more Introduction The increased access to medicinal products in Africa is not well-matched with the pharmacovigilance capacity to monitor drug safety. The objective of this study was to assess the functionality and identify the strengths and limitations of the national pharmacovigilance systems in Ethiopia, Kenya, Rwanda, and Tanzania, and compare these systems. Methods Legal and statutory documents governing the pharmacovigilance systems of each participating country were examined by assessors prior to on-site review. The staff of the pharmacovigilance unit of the National Medicines Regulatory Authorities (NMRAs) were interviewed using the East African Community Harmonized Pharmacovigilance Indicators tool, supplemented with indicators from the World Health Organization (WHO) Global Benchmarking Tool. Responses were recorded, and data were analyzed. Results The pharmacovigilance systems were supported by law and regulations in line with international standards. Standard operating procedures for receiving, processing, and communicating suspected adverse event reports were in place, but reporting of suspected medicine-related harm from stakeholders was inadequate in all countries. The number of Individual Case Safety Reports (ICSRs) received by NMRAs in Kenya, Ethiopia, and Tanzania (mainland) were 35.0, 6.7, and 4.1 per million inhabitants, respectively, in the last calendar year. At the time of assessment, Rwanda did not have an operational system. Overall, ≤ 1% of the total number of health facilities per country submitted ICSRs. Only Kenya and Tanzania had a designated budget for pharmacovigilance activities and an electronic ICSR reporting system. The national pharmacovigilance systems in all four countries did not have access to data on drug utilization. Conclusions The national pharmacovigilance systems in the four East African countries have policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the four national pharmacovigilance systems are at different levels of capacity and performance with respect to conducting pharmacovigilance activities. Targeted interventions are needed to strengthen the pharmacovigilance systems to enable evidence-based decision making for patient safety.
Vaccine, 2017
In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Workin... more In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety concerns is becoming a priority due to recent progress in the development and deployment of new vaccines of global importance, as well as novel vaccines targeting diseases specifically endemic to many resource-limited countries (RLCs), e.g. malaria, dengue. The WG created a Guide to Active Vaccine Safety Surveillance (AVSS) to assist national regulatory authorities and national immunization program officers in RLCs in determining the best course of action with regards to non-routine pharmacovigilance activities, when confronted with a launch of a new vaccine or a vaccine that is new to their country. Here we summarize the results of the WG, further detailed in the Guide, which for the first time provides a structured approach to identifying and analyzing specific vaccines safety knowledge gaps, while considering all available sources of information, in order to determine whether AVSS is an appropriate solution. If AVSS is confirmed as being the appropriate tool, the Guide provides additional essential information on AVSS, a detailed overview of common types of AVSS and practical implementation considerations. It also provides a framework for a well-constructed and informative AVSS when needed, thus aiming to ensure the best possible safety of immunization in this new landscape.
Clinical Therapeutics, 2017
The participant understands differences and similarities between Korea and one's own country on t... more The participant understands differences and similarities between Korea and one's own country on the education and training of clinical pharmacology and can suggest improved curriculum for education and training. Purpose: Status of clinical pharmacology education and training in Korea will be introduced. Methods: Author surveyed major hospitals and universities in Korea about the current situation of clinical pharmacology education and training. Results: Professor Sang-Goo Shin founded Clinical Pharmacology Team at Seoul National University Hospital in 1988. Korean Society for Clinical Pharmacology and Therapeutics(KSCPT) was established in 1992. 1 KSCPT standardized training curriculum and tests for 4 years of medical residents in 2008 and started certification examination in 2011. Currently 25 major hospitals in Korea have units or departments of clinical pharmacology. As of 2017, there are 136 certified clinical pharmacologists in Korea. KSCPT accredited 7 teaching hospitals for training clinical pharmacology residents. Their curricula were similar with one suggested in the position paper 'Clinical Pharmacology in Health Care, Teaching and Research' by WHO, IUPHAR, and CIOMS, 2 which was translated into Korean in 2015. Common curriculum includes clinical pharmacokinetics, therapeutic drug monitoring, phase 1 clinical trial, pharmacogenomics, pharmacometrics, and necessary skills and subjects (such as statistics, software, communication, project management, leadership) for new drug development science. Conclusions: Although education and training of medical residents in Korea is similar with one proposed by WHO, IUPHAR, and CIOMS, undergraduate education is limited and many hospitals do not have clinical pharmacology team. Author's impression is that new drug development is more emphasized than the therapeutic use of approved drugs.
Inflammation and Drug Therapy Series, 1987
Although the importance of estimating the incidence of renal toxicity associated with NSAID usage... more Although the importance of estimating the incidence of renal toxicity associated with NSAID usage has been recognized, few epidemiological studies have been conducted. Several early studies examined the relationship between analgesic use and various measures of renal impairment, with largely negative results1–4 The one positive study of Dubach et al. 2 focused on users of phenacetin-containing analgesics. In the only epidemiological study specifically addressing prescription NSAIDs, Fox and Jick found no hospitalizations for acute renal parenchymal disease related to NSAID use among more than 50,000 outpatient NSAID users in a large health maintenance organization5.
Läkartidningen, Jan 12, 2001
Quality assurance of drug prescription is a pre-requisite for rational drug use. From 22 health-c... more Quality assurance of drug prescription is a pre-requisite for rational drug use. From 22 health-care centres in the south-western area of the Stockholm County Council region, drug-prescription data were obtained from the patients' computerised medical recordings. This could be done with the aid of a specially designed database program. The drug-prescription data from the 22 health-care centres were collected and compiled in a central unit. Thereafter the results were brought back to the health-care centres, in which the quality assurance of drug prescription could be started.
The concept of Essential Medicines is one of the most important tools available for improving pub... more The concept of Essential Medicines is one of the most important tools available for improving public health in developing countries and key elements include the WHO Model List of Essential Medicines (1, 2). It has been proposed that developed countries could also make use of the Model List to a greater extent, in particular to promote better quality of care and control drug expenditure (2). However, the applicability of the Essential Medicines concept for industrialized countries has been questioned and there is a lack of studies analysing the use of the Model List in this context (3). In this article, adherence to the 2003 WHO Model List of Essential Medicines (EML) was analysed through an observational study of medicines use in outpatient care in two European countries — Croatia and Sweden. Data on dispensed prescriptions and over-the-counter (OTC) drugs were collected from wholesalers in Croatia and pharmacies in Sweden. WHO Collaborating Centres in Norway and Sweden have developed and apply several methodologies to evaluate drug use and quality of drug utilization patterns. In the study, analyses focused on medicines accounting for 90% of use in Defined Daily Doses (DU90%). DU90% profiles provide a quick method to overview and evaluate potential for improvement while offering a reflection on the relevance and appropriateness of the WHO Model List of Essential Medicines.
Läkartidningen, Jun 13, 2007
European Journal of Clinical Pharmacology, Apr 20, 2010
British Journal of Psychiatry, Mar 1, 1999
Authorea (Authorea), Jun 19, 2023
Eurosurveillance, Jul 1, 2006
La vigilancia de las infecciones nosocomiales es un parametro de buenas practicas clinicas demasi... more La vigilancia de las infecciones nosocomiales es un parametro de buenas practicas clinicas demasiado descuidado en las instituciones sanitarias, debido al trabajo que implica cuando no existe un sistema informatico adecuado. El objetivo de este estudio fue evaluar si se podia utilizar un protocolo sencillo para estimar la carga de las infecciones nosocomiales y si dicho protocolo pudiera ser la base de un sistema de vigilancia a largo plazo. Esa evaluacion se llevo a cabo en tres centros hospitalarios universitarios, en Huddinge en Suecia, Riga en Letonia y Vilnius en Lituania. Se analizaron los registros medicos de todos los pacientes tratados con antibioticos de acuerdo a un protocolo estandardizado, segun las indicaciones para el tratamiento y la frecuencia de las infecciones nosocomiales obtenidas de una encuesta de prevalencia. Solamente se incluyeron las especialidades comparables. La proporcion de pacientes tratados por antibioticos (excepto las profilaxis) fue de 63/280 (22 %) en Huddinge, 73/649 (11 %) en Riga y de 99/682 (15 %) en Vilnius. La proporcion de pacientes hospitalizados tratados por una infeccion nosocomial fue del 15%, 3% y 4%, respectivamente (en los dos casos, Huddinge comparado con los otros centros, pl0,001). Las infecciones en la herida quirurgica fueron las mas frecuentes, seguidas por las infecciones sucedidas mas de dos dias despues de la hospitalizacion, en ausencia de otro factor de riesgo. Nuestro metodo sencillo y barato mostro que las infecciones nosocomiales son un problema importante en los pacientes hospitalizados en Huddinge. Los resultados obtenidos pueden servir para una discusion posterior y para un seguimiento a nivel local. La comparacion de los resultados entre los centros es mucho menos relevante que todo el proceso que acompano a este estudio.
Pharmacoepidemiology and Drug Safety, 2008
Pharmacoepidemiology and Drug Safety, May 23, 2013
Purpose All five Nordic countries have nationwide prescription databases covering all dispensed d... more Purpose All five Nordic countries have nationwide prescription databases covering all dispensed drugs, with potential for linkage to outcomes. The aim of this review is to present an overview of therapeutic areas studied and methods applied in pharmacoepidemiologic studies using data from these databases. Methods The study consists of a Medline-based structured literature review of scientific papers published during 2005-2010 using data from the prescription databases in Denmark, Finland, Iceland, Norway, and Sweden, covering 25 million inhabitants. Relevant studies were analyzed in terms of pharmacological group, study population, outcomes examined, type of study (drug utilization vs. effect of drug therapy), country of origin, and extent of cross-national collaboration. Results A total of 515 studies were identified. Of these, 262 were conducted in Denmark, 97 in Finland, 4 in Iceland, 87 in Norway, and 61 in Sweden. Four studies used data from more than one Nordic country. The most commonly studied drugs were those acting on the nervous system, followed by cardiovascular drugs and gastrointestinal/endocrine drugs. A total of 228 studies examined drug utilization and 263 focused on the effects and safety of drug therapy. Pregnant women were the most commonly studied population in safety studies, whereas prescribers' adherence to guidelines was the most frequent topic of drug utilization studies. Conclusions The Nordic prescription databases, with their possibility of record-linkage, represent an outstanding resource for assessing the beneficial and adverse effects of drug use in large populations, under routine care conditions, and with the potential for long-term follow-up.
Therapie, Jul 1, 2009
medical products that include herbal and complementary medicines, vaccines, and other biologicals... more medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always
The Journal of Pediatrics, Mar 1, 1990
Pharmacoepidemiology and Drug Safety, 2020
This is the first manuscript, and it is related to the challenges identified in the DUR area in t... more This is the first manuscript, and it is related to the challenges identified in the DUR area in the LatAm region. Drug utilization researchers in LatAm voluntarily participated in multiple discussions contributed with local data and reviewed successive drafts and the final document.
Drug Safety, 2020
Introduction The increased access to medicinal products in Africa is not well-matched with the ph... more Introduction The increased access to medicinal products in Africa is not well-matched with the pharmacovigilance capacity to monitor drug safety. The objective of this study was to assess the functionality and identify the strengths and limitations of the national pharmacovigilance systems in Ethiopia, Kenya, Rwanda, and Tanzania, and compare these systems. Methods Legal and statutory documents governing the pharmacovigilance systems of each participating country were examined by assessors prior to on-site review. The staff of the pharmacovigilance unit of the National Medicines Regulatory Authorities (NMRAs) were interviewed using the East African Community Harmonized Pharmacovigilance Indicators tool, supplemented with indicators from the World Health Organization (WHO) Global Benchmarking Tool. Responses were recorded, and data were analyzed. Results The pharmacovigilance systems were supported by law and regulations in line with international standards. Standard operating procedures for receiving, processing, and communicating suspected adverse event reports were in place, but reporting of suspected medicine-related harm from stakeholders was inadequate in all countries. The number of Individual Case Safety Reports (ICSRs) received by NMRAs in Kenya, Ethiopia, and Tanzania (mainland) were 35.0, 6.7, and 4.1 per million inhabitants, respectively, in the last calendar year. At the time of assessment, Rwanda did not have an operational system. Overall, ≤ 1% of the total number of health facilities per country submitted ICSRs. Only Kenya and Tanzania had a designated budget for pharmacovigilance activities and an electronic ICSR reporting system. The national pharmacovigilance systems in all four countries did not have access to data on drug utilization. Conclusions The national pharmacovigilance systems in the four East African countries have policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the four national pharmacovigilance systems are at different levels of capacity and performance with respect to conducting pharmacovigilance activities. Targeted interventions are needed to strengthen the pharmacovigilance systems to enable evidence-based decision making for patient safety.
Vaccine, 2017
In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Workin... more In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety concerns is becoming a priority due to recent progress in the development and deployment of new vaccines of global importance, as well as novel vaccines targeting diseases specifically endemic to many resource-limited countries (RLCs), e.g. malaria, dengue. The WG created a Guide to Active Vaccine Safety Surveillance (AVSS) to assist national regulatory authorities and national immunization program officers in RLCs in determining the best course of action with regards to non-routine pharmacovigilance activities, when confronted with a launch of a new vaccine or a vaccine that is new to their country. Here we summarize the results of the WG, further detailed in the Guide, which for the first time provides a structured approach to identifying and analyzing specific vaccines safety knowledge gaps, while considering all available sources of information, in order to determine whether AVSS is an appropriate solution. If AVSS is confirmed as being the appropriate tool, the Guide provides additional essential information on AVSS, a detailed overview of common types of AVSS and practical implementation considerations. It also provides a framework for a well-constructed and informative AVSS when needed, thus aiming to ensure the best possible safety of immunization in this new landscape.
Clinical Therapeutics, 2017
The participant understands differences and similarities between Korea and one's own country on t... more The participant understands differences and similarities between Korea and one's own country on the education and training of clinical pharmacology and can suggest improved curriculum for education and training. Purpose: Status of clinical pharmacology education and training in Korea will be introduced. Methods: Author surveyed major hospitals and universities in Korea about the current situation of clinical pharmacology education and training. Results: Professor Sang-Goo Shin founded Clinical Pharmacology Team at Seoul National University Hospital in 1988. Korean Society for Clinical Pharmacology and Therapeutics(KSCPT) was established in 1992. 1 KSCPT standardized training curriculum and tests for 4 years of medical residents in 2008 and started certification examination in 2011. Currently 25 major hospitals in Korea have units or departments of clinical pharmacology. As of 2017, there are 136 certified clinical pharmacologists in Korea. KSCPT accredited 7 teaching hospitals for training clinical pharmacology residents. Their curricula were similar with one suggested in the position paper 'Clinical Pharmacology in Health Care, Teaching and Research' by WHO, IUPHAR, and CIOMS, 2 which was translated into Korean in 2015. Common curriculum includes clinical pharmacokinetics, therapeutic drug monitoring, phase 1 clinical trial, pharmacogenomics, pharmacometrics, and necessary skills and subjects (such as statistics, software, communication, project management, leadership) for new drug development science. Conclusions: Although education and training of medical residents in Korea is similar with one proposed by WHO, IUPHAR, and CIOMS, undergraduate education is limited and many hospitals do not have clinical pharmacology team. Author's impression is that new drug development is more emphasized than the therapeutic use of approved drugs.
Inflammation and Drug Therapy Series, 1987
Although the importance of estimating the incidence of renal toxicity associated with NSAID usage... more Although the importance of estimating the incidence of renal toxicity associated with NSAID usage has been recognized, few epidemiological studies have been conducted. Several early studies examined the relationship between analgesic use and various measures of renal impairment, with largely negative results1–4 The one positive study of Dubach et al. 2 focused on users of phenacetin-containing analgesics. In the only epidemiological study specifically addressing prescription NSAIDs, Fox and Jick found no hospitalizations for acute renal parenchymal disease related to NSAID use among more than 50,000 outpatient NSAID users in a large health maintenance organization5.
Läkartidningen, Jan 12, 2001
Quality assurance of drug prescription is a pre-requisite for rational drug use. From 22 health-c... more Quality assurance of drug prescription is a pre-requisite for rational drug use. From 22 health-care centres in the south-western area of the Stockholm County Council region, drug-prescription data were obtained from the patients' computerised medical recordings. This could be done with the aid of a specially designed database program. The drug-prescription data from the 22 health-care centres were collected and compiled in a central unit. Thereafter the results were brought back to the health-care centres, in which the quality assurance of drug prescription could be started.
The concept of Essential Medicines is one of the most important tools available for improving pub... more The concept of Essential Medicines is one of the most important tools available for improving public health in developing countries and key elements include the WHO Model List of Essential Medicines (1, 2). It has been proposed that developed countries could also make use of the Model List to a greater extent, in particular to promote better quality of care and control drug expenditure (2). However, the applicability of the Essential Medicines concept for industrialized countries has been questioned and there is a lack of studies analysing the use of the Model List in this context (3). In this article, adherence to the 2003 WHO Model List of Essential Medicines (EML) was analysed through an observational study of medicines use in outpatient care in two European countries — Croatia and Sweden. Data on dispensed prescriptions and over-the-counter (OTC) drugs were collected from wholesalers in Croatia and pharmacies in Sweden. WHO Collaborating Centres in Norway and Sweden have developed and apply several methodologies to evaluate drug use and quality of drug utilization patterns. In the study, analyses focused on medicines accounting for 90% of use in Defined Daily Doses (DU90%). DU90% profiles provide a quick method to overview and evaluate potential for improvement while offering a reflection on the relevance and appropriateness of the WHO Model List of Essential Medicines.
Läkartidningen, Jun 13, 2007
European Journal of Clinical Pharmacology, Apr 20, 2010