Knowledge of adverse drug reactions (ADRs) from medicine use in children is limited. We analyzed ... more Knowledge of adverse drug reactions (ADRs) from medicine use in children is limited. We analyzed 4,500 ADRs submitted for children from ages 0 to 17 years to the Danish National ADR Database in the period from 1998 to 2007 with respect to occurrence, seriousness and type of reported ADRs, therapeutic group, age, gender and reporter. 40 per cent of the reported ADRs were serious, and fatal cases were found. Half of the ADRs were reported in children from 0 up to 2 years of age. The majority of the ADRs were reported for immunization therapies, antibiotics and psychotropic medicine. Physicians reported 90% of all ADRs.
Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Da... more Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood-glucose lowering medicines" (A10BD), "dipeptidyl peptidase-4 (DDP-4) inhibitors" (A10BH), and "other blood glucose lowering medicines" (A10BX). Specifically, we aimed to describe the potential of clinical notes to identify new ADRs and to evaluate if sufficient information can be obtained for causality assessment. For observed adverse events (AEs) we extracted time to onset, outcome, and suspected medicine(s). AEs were assessed according to World Health Organization-Uppsala Monitoring Centre causality criteria and analyzed with respect to suspected medicines, type of ADR (system organ class), seriousness and labeling status. A total of 207 patients were included in the study leading ...
To characterise consumer adverse drug reaction (ADR) reports for phosphodiesterase type 5 (PDE5) ... more To characterise consumer adverse drug reaction (ADR) reports for phosphodiesterase type 5 (PDE5) inhibitors. We included ADR reports submitted by adults to the European ADR database (EudraVigialnce) from 2007 to 2011. ADRs were classified according to type, seriousness and age and sex of consumers. The unit of analysis was one ADR. Totally, 328 ADRs were reported for sildenafil and vardenafil, and only 5% of these were serious. The largest number of reported ADRs was found for sildenafil, i.e., "lack of efficacy" and/or "drug efficacy decreased" (n = 134) and "headache" (n = 21). ADRs reported by consumers for PDE5 inhibitors were relatively low, and only few ADRs were serious.
To characterize adverse drug reactions (ADRs) reported by European (EU) consumer for antineoplast... more To characterize adverse drug reactions (ADRs) reported by European (EU) consumer for antineoplastic and immunomodulating medications. ADRs reported by consumers of antineoplastic and immunomodulating medications (anatomical therapeutic chemical [ATC]) group L from 2007 to 2011 and located in the EU ADR database, EudraVigilance, were analyzed. Data were categorized with respect to age and sex, category, and seriousness of reported ADRs and medications. The unit of analysis was one ADR. We located 9649 ADRs reported for antineoplastic and immunomodulating medications, which approximately 15% of were serious, including 26 deaths. Less than 5% of ADRs were reported in children. Totally 73% of ADRs were reported for women and 27% for men. The majority of ADRs were of the type "general disorders and administration site conditions" (54% of total ADRs), followed by "skin and subcutaneous disorders" (7% of total ADRs), and "infections and infestations" (6% of to...
Respiratory medications are frequently prescribed for use in children. Several studies have repor... more Respiratory medications are frequently prescribed for use in children. Several studies have reported information on the safety of asthma medications in clinical studies in adults, but information about safety in children is scarce. To review published clinical trials on the occurrence and characteristics of adverse drug reactions (ADRs) in children, reported for asthma medications licensed for paediatric use. We systematically reviewed the literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed, Embase, Cochrane Library, PsycINFO, IPA, and CINAHLs databases were searched from origin until July 2013 for studies reporting ADRs for beta2-receptor agonists, inhaled corticosteroids, leukotriene receptor antagonists and combination products in children from birth to age 17. Information on ADR reporting rates, age and gender, type and seriousness of ADRs, design, setting, observation period, type of assessors, and funding sou...
Knowledge of adverse drug reactions (ADRs) from medicine use in children is limited. We analyzed ... more Knowledge of adverse drug reactions (ADRs) from medicine use in children is limited. We analyzed 4,500 ADRs submitted for children from ages 0 to 17 years to the Danish National ADR Database in the period from 1998 to 2007 with respect to occurrence, seriousness and type of reported ADRs, therapeutic group, age, gender and reporter. 40 per cent of the reported ADRs were serious, and fatal cases were found. Half of the ADRs were reported in children from 0 up to 2 years of age. The majority of the ADRs were reported for immunization therapies, antibiotics and psychotropic medicine. Physicians reported 90% of all ADRs.
Among health professionals, a national drug interactions database including all relevant informat... more Among health professionals, a national drug interactions database including all relevant information, conclusions and recommendations has been in demand for a long time. A project group was established in 2001, and the database became a reality at the end of 2003. It contains about 2,000 descriptions of drug interactions for pharmaceuticals, herbal drugs and vitamins/minerals. The Danish Medicines Agency is responsible for the updating of the database in cooperation with a scientific board.
Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source... more Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs lis...
Objectives To describe the development of acronym use across five major medical specialties and t... more Objectives To describe the development of acronym use across five major medical specialties and to evaluate the technical and aesthetic quality of the acronyms. Design Acronyms obtained through a literature search of Pubmed.gov followed by a standardised assessment of acronym quality (BEAUTY and CHEATING criteria). Participants Randomised controlled trials within psychiatry, rheumatology, pulmonary medicine, endocrinology, and cardiology published between 2000 and 2012. Main outcome measures Prevalence proportion of acronyms and composite quality score for acronyms over time. Results 14 965 publications were identified, of which 18.3% (n=2737) contained an acronym in the title. Acronym use was more common among cardiological studies than among the other four medical specialties (40% v 8-15% in 2012, P<0.001). Except for within cardiology, the prevalence of acronyms increased over time, with the average prevalence proportion among the remaining four specialties increasing from 4.0% to 12.4% from 2000 to 2012 (P<0.001). The median combined acronym quality score decreased significantly over the study period (P<0.001), from a median 9.25 in 2000 to 5.50 in 2012. Conclusion From 2000 to 2012 the prevalence of acronyms in trial reports increased, coinciding with a substantial decrease in the technical and aesthetic quality of the acronyms. Strict enforcement of current guidelines on acronym construction by journal editors is necessary to ensure the proper use of acronyms in the future.
Purpose There is no doubt that paediatric immunization prevents serious diseases, but the adminis... more Purpose There is no doubt that paediatric immunization prevents serious diseases, but the administration of these vaccines to healthy children also involves risks of adverse drug reactions (ADRs), some of which are potentially serious. The current body of evidence on ADRs from immunization therapy at the population level is partly contradictory across countries, time periods and childhood immunization programmes. The objective of our study was to characterize reported adverse events (AEFIs) following immunization in Danish children. Methods Adverse events (AEFIs) in 0- to 17-year-old children and adolescents reported to the Danish Medicines Agency (DKMA) between 1998 and 2007 were analysed. The unit of analysis was one AEFI. Data were categorized with respect to time, age, and gender of the children, suspected vaccines, category and seriousness of the AEFIs, and reporting rate. Results During the study period, the DKMA received 1,365 reports covering 2,600 AEFIs, corresponding to 60% of all adverse events reported for children. One third of the AEFIs were classified as serious, and two deaths were reported. The annual number of serious AEFIs remained constant during the study period. Approximately 80% of AEFIs were reported in children aged 0–2 years. Of all reported AEs, 45% were in the category “general disorders and administration site conditions”, followed by the categories “skin and subcutaneous tissue disorders” (20% of total AEFIs) and “nervous system disorders” (16% of total AEFIs). The largest share of serious events was from the category “nervous system disorders” (33% of serious AEFIs). The most frequently reported serious AEs were febrile convulsions, pyrexia, and injection-site reactions. Conclusions In Denmark, a large number of AEFIs following paediatric immunization have been reported, but the majority of cases were non-serious.
Knowledge of adverse drug reactions (ADRs) from medicine use in children is limited. We analyzed ... more Knowledge of adverse drug reactions (ADRs) from medicine use in children is limited. We analyzed 4,500 ADRs submitted for children from ages 0 to 17 years to the Danish National ADR Database in the period from 1998 to 2007 with respect to occurrence, seriousness and type of reported ADRs, therapeutic group, age, gender and reporter. 40 per cent of the reported ADRs were serious, and fatal cases were found. Half of the ADRs were reported in children from 0 up to 2 years of age. The majority of the ADRs were reported for immunization therapies, antibiotics and psychotropic medicine. Physicians reported 90% of all ADRs.
Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Da... more Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood-glucose lowering medicines" (A10BD), "dipeptidyl peptidase-4 (DDP-4) inhibitors" (A10BH), and "other blood glucose lowering medicines" (A10BX). Specifically, we aimed to describe the potential of clinical notes to identify new ADRs and to evaluate if sufficient information can be obtained for causality assessment. For observed adverse events (AEs) we extracted time to onset, outcome, and suspected medicine(s). AEs were assessed according to World Health Organization-Uppsala Monitoring Centre causality criteria and analyzed with respect to suspected medicines, type of ADR (system organ class), seriousness and labeling status. A total of 207 patients were included in the study leading ...
To characterise consumer adverse drug reaction (ADR) reports for phosphodiesterase type 5 (PDE5) ... more To characterise consumer adverse drug reaction (ADR) reports for phosphodiesterase type 5 (PDE5) inhibitors. We included ADR reports submitted by adults to the European ADR database (EudraVigialnce) from 2007 to 2011. ADRs were classified according to type, seriousness and age and sex of consumers. The unit of analysis was one ADR. Totally, 328 ADRs were reported for sildenafil and vardenafil, and only 5% of these were serious. The largest number of reported ADRs was found for sildenafil, i.e., "lack of efficacy" and/or "drug efficacy decreased" (n = 134) and "headache" (n = 21). ADRs reported by consumers for PDE5 inhibitors were relatively low, and only few ADRs were serious.
To characterize adverse drug reactions (ADRs) reported by European (EU) consumer for antineoplast... more To characterize adverse drug reactions (ADRs) reported by European (EU) consumer for antineoplastic and immunomodulating medications. ADRs reported by consumers of antineoplastic and immunomodulating medications (anatomical therapeutic chemical [ATC]) group L from 2007 to 2011 and located in the EU ADR database, EudraVigilance, were analyzed. Data were categorized with respect to age and sex, category, and seriousness of reported ADRs and medications. The unit of analysis was one ADR. We located 9649 ADRs reported for antineoplastic and immunomodulating medications, which approximately 15% of were serious, including 26 deaths. Less than 5% of ADRs were reported in children. Totally 73% of ADRs were reported for women and 27% for men. The majority of ADRs were of the type "general disorders and administration site conditions" (54% of total ADRs), followed by "skin and subcutaneous disorders" (7% of total ADRs), and "infections and infestations" (6% of to...
Respiratory medications are frequently prescribed for use in children. Several studies have repor... more Respiratory medications are frequently prescribed for use in children. Several studies have reported information on the safety of asthma medications in clinical studies in adults, but information about safety in children is scarce. To review published clinical trials on the occurrence and characteristics of adverse drug reactions (ADRs) in children, reported for asthma medications licensed for paediatric use. We systematically reviewed the literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed, Embase, Cochrane Library, PsycINFO, IPA, and CINAHLs databases were searched from origin until July 2013 for studies reporting ADRs for beta2-receptor agonists, inhaled corticosteroids, leukotriene receptor antagonists and combination products in children from birth to age 17. Information on ADR reporting rates, age and gender, type and seriousness of ADRs, design, setting, observation period, type of assessors, and funding sou...
Knowledge of adverse drug reactions (ADRs) from medicine use in children is limited. We analyzed ... more Knowledge of adverse drug reactions (ADRs) from medicine use in children is limited. We analyzed 4,500 ADRs submitted for children from ages 0 to 17 years to the Danish National ADR Database in the period from 1998 to 2007 with respect to occurrence, seriousness and type of reported ADRs, therapeutic group, age, gender and reporter. 40 per cent of the reported ADRs were serious, and fatal cases were found. Half of the ADRs were reported in children from 0 up to 2 years of age. The majority of the ADRs were reported for immunization therapies, antibiotics and psychotropic medicine. Physicians reported 90% of all ADRs.
Among health professionals, a national drug interactions database including all relevant informat... more Among health professionals, a national drug interactions database including all relevant information, conclusions and recommendations has been in demand for a long time. A project group was established in 2001, and the database became a reality at the end of 2003. It contains about 2,000 descriptions of drug interactions for pharmaceuticals, herbal drugs and vitamins/minerals. The Danish Medicines Agency is responsible for the updating of the database in cooperation with a scientific board.
Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source... more Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs lis...
Objectives To describe the development of acronym use across five major medical specialties and t... more Objectives To describe the development of acronym use across five major medical specialties and to evaluate the technical and aesthetic quality of the acronyms. Design Acronyms obtained through a literature search of Pubmed.gov followed by a standardised assessment of acronym quality (BEAUTY and CHEATING criteria). Participants Randomised controlled trials within psychiatry, rheumatology, pulmonary medicine, endocrinology, and cardiology published between 2000 and 2012. Main outcome measures Prevalence proportion of acronyms and composite quality score for acronyms over time. Results 14 965 publications were identified, of which 18.3% (n=2737) contained an acronym in the title. Acronym use was more common among cardiological studies than among the other four medical specialties (40% v 8-15% in 2012, P<0.001). Except for within cardiology, the prevalence of acronyms increased over time, with the average prevalence proportion among the remaining four specialties increasing from 4.0% to 12.4% from 2000 to 2012 (P<0.001). The median combined acronym quality score decreased significantly over the study period (P<0.001), from a median 9.25 in 2000 to 5.50 in 2012. Conclusion From 2000 to 2012 the prevalence of acronyms in trial reports increased, coinciding with a substantial decrease in the technical and aesthetic quality of the acronyms. Strict enforcement of current guidelines on acronym construction by journal editors is necessary to ensure the proper use of acronyms in the future.
Purpose There is no doubt that paediatric immunization prevents serious diseases, but the adminis... more Purpose There is no doubt that paediatric immunization prevents serious diseases, but the administration of these vaccines to healthy children also involves risks of adverse drug reactions (ADRs), some of which are potentially serious. The current body of evidence on ADRs from immunization therapy at the population level is partly contradictory across countries, time periods and childhood immunization programmes. The objective of our study was to characterize reported adverse events (AEFIs) following immunization in Danish children. Methods Adverse events (AEFIs) in 0- to 17-year-old children and adolescents reported to the Danish Medicines Agency (DKMA) between 1998 and 2007 were analysed. The unit of analysis was one AEFI. Data were categorized with respect to time, age, and gender of the children, suspected vaccines, category and seriousness of the AEFIs, and reporting rate. Results During the study period, the DKMA received 1,365 reports covering 2,600 AEFIs, corresponding to 60% of all adverse events reported for children. One third of the AEFIs were classified as serious, and two deaths were reported. The annual number of serious AEFIs remained constant during the study period. Approximately 80% of AEFIs were reported in children aged 0–2 years. Of all reported AEs, 45% were in the category “general disorders and administration site conditions”, followed by the categories “skin and subcutaneous tissue disorders” (20% of total AEFIs) and “nervous system disorders” (16% of total AEFIs). The largest share of serious events was from the category “nervous system disorders” (33% of serious AEFIs). The most frequently reported serious AEs were febrile convulsions, pyrexia, and injection-site reactions. Conclusions In Denmark, a large number of AEFIs following paediatric immunization have been reported, but the majority of cases were non-serious.
Uploads
Papers by Lise Aagaard
Design Acronyms obtained through a literature search of Pubmed.gov followed by a standardised assessment of acronym quality (BEAUTY and CHEATING criteria).
Participants Randomised controlled trials within psychiatry, rheumatology, pulmonary medicine, endocrinology, and cardiology published between 2000 and 2012.
Main outcome measures Prevalence proportion of acronyms and composite quality score for acronyms over time.
Results 14 965 publications were identified, of which 18.3% (n=2737) contained an acronym in the title. Acronym use was more common among cardiological studies than among the other four medical specialties (40% v 8-15% in 2012, P<0.001). Except for within cardiology, the prevalence of acronyms increased over time, with the average prevalence proportion among the remaining four specialties increasing from 4.0% to 12.4% from 2000 to 2012 (P<0.001). The median combined acronym quality score decreased significantly over the study period (P<0.001), from a median 9.25 in 2000 to 5.50 in 2012.
Conclusion From 2000 to 2012 the prevalence of acronyms in trial reports increased, coinciding with a substantial decrease in the technical and aesthetic quality of the acronyms. Strict enforcement of current guidelines on acronym construction by journal editors is necessary to ensure the proper use of acronyms in the future.
Design Acronyms obtained through a literature search of Pubmed.gov followed by a standardised assessment of acronym quality (BEAUTY and CHEATING criteria).
Participants Randomised controlled trials within psychiatry, rheumatology, pulmonary medicine, endocrinology, and cardiology published between 2000 and 2012.
Main outcome measures Prevalence proportion of acronyms and composite quality score for acronyms over time.
Results 14 965 publications were identified, of which 18.3% (n=2737) contained an acronym in the title. Acronym use was more common among cardiological studies than among the other four medical specialties (40% v 8-15% in 2012, P<0.001). Except for within cardiology, the prevalence of acronyms increased over time, with the average prevalence proportion among the remaining four specialties increasing from 4.0% to 12.4% from 2000 to 2012 (P<0.001). The median combined acronym quality score decreased significantly over the study period (P<0.001), from a median 9.25 in 2000 to 5.50 in 2012.
Conclusion From 2000 to 2012 the prevalence of acronyms in trial reports increased, coinciding with a substantial decrease in the technical and aesthetic quality of the acronyms. Strict enforcement of current guidelines on acronym construction by journal editors is necessary to ensure the proper use of acronyms in the future.