Introduction: Given the increasing adult use of amphetamine and methylphenidate and their high misuse potential, we examined suspected suicide attempts and other intentional misuse and medical outcomes and their associations with co-used other substances among amphetamine and methylphenidate exposure cases aged 50+. Methods: Using the 2015–2021 U.S. National Poison Data System (N = 7701 amphetamine and/or methylphenidate cases), we fit two generalized linear models for a Poisson distribution with a log link function, with suspected suicide attempt versus intentional misuse and major medical effect/death versus other outcomes as the dependent variables. Results: Of all amphetamine/methylphenidate exposure cases, suspected suicide attempts and intentional misuse were 28.4% and 13.2%, respectively. Benzodiazepine use was associated with a higher likelihood, but any illicit drug use was associated with a lower likelihood of suspected suicide attempts compared to intentional misuse. The type of stimulant involved (amphetamine or methylphenidate) was not significant. The co-use of antidepressants (IRR = 1.43, 95% CI = 1.16–1.76), prescription opioids (IRR = 1.48, 95% CI = 1.21–1.81), drugs for cardiovascular disease (IRR = 1.51, 95% CI = 1.20–1.90), antipsychotics (IRR = 1.26, 95% CI = 1.02–1.55), or illicit drugs (IRR = 2.40, 95% CI = 1.82–3.15) was associated with a higher likelihood of major effect/death. Conclusions: Suspected suicide attempts or intentional misuse accounted for more than 40% of amphetamine or methylphenidate exposure cases aged 50+. The higher likelihood of major effect/death in cases involving antidepressants, antipsychotics, and cardiovascular disease drugs also suggests the confounding effects of comorbid mental and physical health problems. Careful monitoring of those who were prescribed amphetamine or methylphenidate and use other substances is needed.
引言:鉴于成人对安非他明和哌甲酯的使用越来越多，滥用的可能性也越来越大，我们研究了50岁以上安非他明和哌甲酯暴露病例中疑似自杀企图、其他故意滥用和医疗结果，以及它们与共同使用其他物质的关系。方法:使用2015-2021年美国国家毒物数据系统(N = 7701安非他明和/或哌甲酯病例)，我们拟合了两个广义线性泊松分布的对数链接函数模型，以可疑自杀企图与故意滥用和主要医疗效果/死亡与其他结果作为因变量。结果:在所有苯丙胺/哌甲酯暴露病例中，有自杀企图和故意滥用的比例分别为28.4%和13.2%。苯二氮卓类药物的使用与较高的可能性相关，但与故意滥用相比，任何非法药物的使用与疑似自杀企图的可能性较低相关。所涉及的兴奋剂类型(安非他明或哌甲酯)无显著性。抗抑郁药(IRR = 1.43, 95% CI = 1.16-1.76)、处方阿片类药物(IRR = 1.48, 95% CI = 1.21-1.81)、心血管疾病药物(IRR = 1.51, 95% CI = 1.20-1.90)、抗精神病药物(IRR = 1.26, 95% CI = 1.02-1.55)或非法药物(IRR = 2.40, 95% CI = 1.82-3.15)的共同使用与主要效应/死亡的可能性较高相关。结论:在50岁以上的安非他明或哌甲酯暴露病例中，疑似自杀企图或故意滥用占40%以上。在涉及抗抑郁药、抗精神病药和心血管疾病药物的病例中，更有可能产生重大影响/死亡，这也表明，精神和身体健康问题的合并症存在混淆效应。需要对服用安非他明或哌甲酯并使用其他药物的患者进行仔细监测。
{"title":"Suspected Suicide Attempt and Intentional Misuse Cases Aged 50+ Involving Amphetamine or Methylphenidate and Medical Outcomes: Associations with Co-Used Other Substances","authors":"N. Choi, Bryan Y. Choi, S. D. Baker","doi":"10.3390/pharma2030020","DOIUrl":"https://doi.org/10.3390/pharma2030020","url":null,"abstract":"Introduction: Given the increasing adult use of amphetamine and methylphenidate and their high misuse potential, we examined suspected suicide attempts and other intentional misuse and medical outcomes and their associations with co-used other substances among amphetamine and methylphenidate exposure cases aged 50+. Methods: Using the 2015–2021 U.S. National Poison Data System (N = 7701 amphetamine and/or methylphenidate cases), we fit two generalized linear models for a Poisson distribution with a log link function, with suspected suicide attempt versus intentional misuse and major medical effect/death versus other outcomes as the dependent variables. Results: Of all amphetamine/methylphenidate exposure cases, suspected suicide attempts and intentional misuse were 28.4% and 13.2%, respectively. Benzodiazepine use was associated with a higher likelihood, but any illicit drug use was associated with a lower likelihood of suspected suicide attempts compared to intentional misuse. The type of stimulant involved (amphetamine or methylphenidate) was not significant. The co-use of antidepressants (IRR = 1.43, 95% CI = 1.16–1.76), prescription opioids (IRR = 1.48, 95% CI = 1.21–1.81), drugs for cardiovascular disease (IRR = 1.51, 95% CI = 1.20–1.90), antipsychotics (IRR = 1.26, 95% CI = 1.02–1.55), or illicit drugs (IRR = 2.40, 95% CI = 1.82–3.15) was associated with a higher likelihood of major effect/death. Conclusions: Suspected suicide attempts or intentional misuse accounted for more than 40% of amphetamine or methylphenidate exposure cases aged 50+. The higher likelihood of major effect/death in cases involving antidepressants, antipsychotics, and cardiovascular disease drugs also suggests the confounding effects of comorbid mental and physical health problems. Careful monitoring of those who were prescribed amphetamine or methylphenidate and use other substances is needed.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43375319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hui Xing Tan, R. Lim, Pei San Ang, Belinda P. Q. Foo, Yen Ling Koon, Jing Wei Neo, Amelia Jing Jing Ng, S. Tan, D. Teo, Mun Yee Tham, Aaron Jun Yi Yap, Nicholas Kai Ming Ng, C. Loke, Li Fung Peck, Huilin Huang, S. Dorajoo
Background: Identifying patients with diabetes mellitus (DM) is often performed in epidemiological studies using electronic health records (EHR), but currently available algorithms have features that limit their generalizability. Methods: We developed a rule-based algorithm to determine DM status using the nationally aggregated EHR database. The algorithm was validated on two chart-reviewed samples (n = 2813) of (a) patients with atrial fibrillation (AF, n = 1194) and (b) randomly sampled hospitalized patients (n = 1619). Results: DM diagnosis codes alone resulted in a sensitivity of 77.0% and 83.4% in the AF and random hospitalized samples, respectively. The proposed algorithm combines blood glucose values and DM medication usage with diagnostic codes and exhibits sensitivities between 96.9% and 98.0%, while positive predictive values (PPV) ranged between 61.1% and 75.6%. Performances were comparable across sexes, but a lower specificity was observed in younger patients (below 65 versus 65 and above) in both validation samples (75.8% vs. 90.8% and 60.6% vs. 88.8%). The algorithm was robust for missing laboratory data but not for missing medication data. Conclusions: In this nationwide EHR database analysis, an algorithm for identifying patients with DM has been developed and validated. The algorithm supports quantitative bias analyses in future studies involving EHR-based DM studies.
{"title":"Phenotyping Diabetes Mellitus on Aggregated Electronic Health Records from Disparate Health Systems","authors":"Hui Xing Tan, R. Lim, Pei San Ang, Belinda P. Q. Foo, Yen Ling Koon, Jing Wei Neo, Amelia Jing Jing Ng, S. Tan, D. Teo, Mun Yee Tham, Aaron Jun Yi Yap, Nicholas Kai Ming Ng, C. Loke, Li Fung Peck, Huilin Huang, S. Dorajoo","doi":"10.3390/pharma2030019","DOIUrl":"https://doi.org/10.3390/pharma2030019","url":null,"abstract":"Background: Identifying patients with diabetes mellitus (DM) is often performed in epidemiological studies using electronic health records (EHR), but currently available algorithms have features that limit their generalizability. Methods: We developed a rule-based algorithm to determine DM status using the nationally aggregated EHR database. The algorithm was validated on two chart-reviewed samples (n = 2813) of (a) patients with atrial fibrillation (AF, n = 1194) and (b) randomly sampled hospitalized patients (n = 1619). Results: DM diagnosis codes alone resulted in a sensitivity of 77.0% and 83.4% in the AF and random hospitalized samples, respectively. The proposed algorithm combines blood glucose values and DM medication usage with diagnostic codes and exhibits sensitivities between 96.9% and 98.0%, while positive predictive values (PPV) ranged between 61.1% and 75.6%. Performances were comparable across sexes, but a lower specificity was observed in younger patients (below 65 versus 65 and above) in both validation samples (75.8% vs. 90.8% and 60.6% vs. 88.8%). The algorithm was robust for missing laboratory data but not for missing medication data. Conclusions: In this nationwide EHR database analysis, an algorithm for identifying patients with DM has been developed and validated. The algorithm supports quantitative bias analyses in future studies involving EHR-based DM studies.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47862201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Though it is well documented that antidepressants are associated with an increased risk of falls in older adults at the drug class level, the comparative risk between individual antidepressants for fall injury in older adults with depression is unknown. Currently, clinicians are making decisions at the drug class level without consideration of the potential that there could be safer choices within classes. We compared the risk of fall injury among initiators of bupropion, duloxetine, fluoxetine, paroxetine, and venlafaxine to those of (es)citalopram and, separately, sertraline. We performed a retrospective cohort study using the MarketScan® Medicare Supplemental claims from 2007 to 2019. Individuals had incident depression (washout in previous continually enrolled year) with a first antidepressant claim up to three months after depression diagnosis. Individuals were followed for the first three months of antidepressant use until the first occurrence of fall injury, change/discontinuation of antidepressant, discontinued insurance coverage, or end of study. Propensity score inverse probability of treatment-weighted Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals for each antidepressant comparison and fall injury. We identified 114,505 individuals (mean age 76.6 years, 68% female, 97% without prior fall). A higher risk of fall injury was associated with initiating bupropion (HR 1.20 to 1.61), duloxetine (HR 1.27 to 1.36), paroxetine (HR 1.14 to 1.22), and venlafaxine (HR 1.22 to 1.34) when compared to (es)citalopram or sertraline. New use of duloxetine, bupropion, paroxetine, and venlafaxine was associated with a higher risk of fall injury compared to (es)citalopram and sertraline.
{"title":"Antidepressants and the Risk of Fall-Related Injury in Older Adults with Incident Depression in the United States: A Comparative Safety Analysis","authors":"A. Tabah, L. Gold, Z. Marcum, R. Hansen","doi":"10.3390/pharma2030018","DOIUrl":"https://doi.org/10.3390/pharma2030018","url":null,"abstract":"Though it is well documented that antidepressants are associated with an increased risk of falls in older adults at the drug class level, the comparative risk between individual antidepressants for fall injury in older adults with depression is unknown. Currently, clinicians are making decisions at the drug class level without consideration of the potential that there could be safer choices within classes. We compared the risk of fall injury among initiators of bupropion, duloxetine, fluoxetine, paroxetine, and venlafaxine to those of (es)citalopram and, separately, sertraline. We performed a retrospective cohort study using the MarketScan® Medicare Supplemental claims from 2007 to 2019. Individuals had incident depression (washout in previous continually enrolled year) with a first antidepressant claim up to three months after depression diagnosis. Individuals were followed for the first three months of antidepressant use until the first occurrence of fall injury, change/discontinuation of antidepressant, discontinued insurance coverage, or end of study. Propensity score inverse probability of treatment-weighted Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals for each antidepressant comparison and fall injury. We identified 114,505 individuals (mean age 76.6 years, 68% female, 97% without prior fall). A higher risk of fall injury was associated with initiating bupropion (HR 1.20 to 1.61), duloxetine (HR 1.27 to 1.36), paroxetine (HR 1.14 to 1.22), and venlafaxine (HR 1.22 to 1.34) when compared to (es)citalopram or sertraline. New use of duloxetine, bupropion, paroxetine, and venlafaxine was associated with a higher risk of fall injury compared to (es)citalopram and sertraline.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42767704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
More than 3 years have passed since the emergence of COVID-19. On 8 May 2023, COVID-19 in Japan was downgraded to Category 5 by the Infectious Disease Control Law. In Japan, at the beginning of the COVID-19 pandemic in 2020, cases of infection and deaths from severe disease were few compared with those in Western countries. However, in the medical field, screening for COVID-19 was given top priority, resulting in confusion and proving disadvantageous for many patients. The overreaction to COVID-19 as the most important issue in society can be attributed largely to statements by infectious disease experts. In addition, the mRNA vaccine emerged in 2021, and most of the population was vaccinated up to two times within a short period of less than 1 year because infectious disease experts strongly promoted vaccination. After 2022, when vaccination progressed and the Omicron strain, which is an attenuated strain, became the mainstay of SARS-CoV-2, the number of severe cases of COVID-19 decreased significantly; however, the number of infected people increased dramatically instead. A significant portion of the population is thought to have hybrid immunity due to vaccination plus natural infection and maintains high antibody titer levels. Henceforth, additional vaccination should be given preferentially to those who will benefit most from it. Conversely, measures against COVID-19 caused serious damage to the economy and society. Policies that not only address countermeasures against infection, but also those that encompass the economy and society as a whole, are necessary.
{"title":"COVID-19 and the COVID-19 Vaccine in Japan—A Review from a General Physician’s Perspective","authors":"H. Kusunoki","doi":"10.3390/pharma2030017","DOIUrl":"https://doi.org/10.3390/pharma2030017","url":null,"abstract":"More than 3 years have passed since the emergence of COVID-19. On 8 May 2023, COVID-19 in Japan was downgraded to Category 5 by the Infectious Disease Control Law. In Japan, at the beginning of the COVID-19 pandemic in 2020, cases of infection and deaths from severe disease were few compared with those in Western countries. However, in the medical field, screening for COVID-19 was given top priority, resulting in confusion and proving disadvantageous for many patients. The overreaction to COVID-19 as the most important issue in society can be attributed largely to statements by infectious disease experts. In addition, the mRNA vaccine emerged in 2021, and most of the population was vaccinated up to two times within a short period of less than 1 year because infectious disease experts strongly promoted vaccination. After 2022, when vaccination progressed and the Omicron strain, which is an attenuated strain, became the mainstay of SARS-CoV-2, the number of severe cases of COVID-19 decreased significantly; however, the number of infected people increased dramatically instead. A significant portion of the population is thought to have hybrid immunity due to vaccination plus natural infection and maintains high antibody titer levels. Henceforth, additional vaccination should be given preferentially to those who will benefit most from it. Conversely, measures against COVID-19 caused serious damage to the economy and society. Policies that not only address countermeasures against infection, but also those that encompass the economy and society as a whole, are necessary.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42657847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Orlek, E. Harvey, Louis Fisher, A. Mehrkar, S. Bacon, B. Goldacre, B. Mackenna, D. Ashiru-Oredope
COVID-19 pandemic-related pressures on primary care may have driven the inappropriate continuation of antibiotic prescriptions. Yet, prescribing modality (repeat/non-repeat) has not previously been investigated in a pandemic context. With the approval of NHS England, we conducted a retrospective cohort study of >19 million English primary care patient records using the OpenSAFELY-TPP analytics platform. We analysed repeat/non-repeat prescribing frequency in monthly patient cohorts between January 2020 and 2022. In-depth analysis was conducted on January 2020 (“pre-pandemic”) and January 2021 (“pandemic”) cohorts (with a particular focus on repeat prescribing). Per-patient prescribing and clinical conditions were determined by searching primary care records using clinical codelists. Prescriptions in a 6-month lookback period were used to delineate repeat prescribing (≥3 prescriptions) and non-repeat prescribing (1–2 prescriptions). Associations between demographics (e.g., age, sex, ethnicity) and prescribing were explored using unadjusted risk ratios. The frequency of clinical conditions among prescribed patients was examined. Antibiotic prescribing declined from May 2020; non-repeat prescribing declined more strongly than repeat prescribing (maximum declines −26% vs. −11%, respectively). Older patients were at a higher risk of prescribing (especially repeat prescribing). Comorbidities were more common among repeat- vs. non-repeat-prescribed patients. In the pandemic cohort, the most common clinical conditions linked to repeat prescribing were COPD comorbidity and urinary tract infection. Our findings inform the ongoing development of stewardship interventions in England, targeting patient groups wherein there is a high prevalence of repeat prescribing.
{"title":"Patient Characteristics Associated with Repeat Antibiotic Prescribing Pre- and during the COVID-19 Pandemic: A Retrospective Nationwide Cohort Study of >19 Million Primary Care Records Using the OpenSAFELY Platform","authors":"A. Orlek, E. Harvey, Louis Fisher, A. Mehrkar, S. Bacon, B. Goldacre, B. Mackenna, D. Ashiru-Oredope","doi":"10.3390/pharma2020016","DOIUrl":"https://doi.org/10.3390/pharma2020016","url":null,"abstract":"COVID-19 pandemic-related pressures on primary care may have driven the inappropriate continuation of antibiotic prescriptions. Yet, prescribing modality (repeat/non-repeat) has not previously been investigated in a pandemic context. With the approval of NHS England, we conducted a retrospective cohort study of >19 million English primary care patient records using the OpenSAFELY-TPP analytics platform. We analysed repeat/non-repeat prescribing frequency in monthly patient cohorts between January 2020 and 2022. In-depth analysis was conducted on January 2020 (“pre-pandemic”) and January 2021 (“pandemic”) cohorts (with a particular focus on repeat prescribing). Per-patient prescribing and clinical conditions were determined by searching primary care records using clinical codelists. Prescriptions in a 6-month lookback period were used to delineate repeat prescribing (≥3 prescriptions) and non-repeat prescribing (1–2 prescriptions). Associations between demographics (e.g., age, sex, ethnicity) and prescribing were explored using unadjusted risk ratios. The frequency of clinical conditions among prescribed patients was examined. Antibiotic prescribing declined from May 2020; non-repeat prescribing declined more strongly than repeat prescribing (maximum declines −26% vs. −11%, respectively). Older patients were at a higher risk of prescribing (especially repeat prescribing). Comorbidities were more common among repeat- vs. non-repeat-prescribed patients. In the pandemic cohort, the most common clinical conditions linked to repeat prescribing were COPD comorbidity and urinary tract infection. Our findings inform the ongoing development of stewardship interventions in England, targeting patient groups wherein there is a high prevalence of repeat prescribing.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47129003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-05DOI: 10.1101/2023.06.03.23290931
Tigran Makunts, Haroutyun Joulfayan, Kenneth Ta, R. Abagyan
Proton-pump inhibitors, PPIs, are widely prescribed and are available over the counter for prolonged reduction of stomach acid production and related disorders. PPIs irreversibly inhibit the hydrogen/potassium ATPase in gastric parietal cells. Recent retrospective studies have described an association between PPI use and depression. However, there is conflicting evidence that PPI therapy improves depressive symptoms. Considering the widespread use and over the counter availability of these drugs, further investigation into depression adverse event was warranted with a larger scale postmarketing set of reports. Here we analyzed over 68,178 reports from the FDA Adverse Event Reporting System consisting of PPI and histamine-2 receptor antagonist monotherapy records and found a statistically significant association between use of PPIs and depression. Additionally, we analyzed each of the six currently marketed PPIs individually and observed the association with the depression adverse reaction for all of them.
{"title":"Depression events associated with proton-pump inhibitors in postmarketing drug surveillance data","authors":"Tigran Makunts, Haroutyun Joulfayan, Kenneth Ta, R. Abagyan","doi":"10.1101/2023.06.03.23290931","DOIUrl":"https://doi.org/10.1101/2023.06.03.23290931","url":null,"abstract":"Proton-pump inhibitors, PPIs, are widely prescribed and are available over the counter for prolonged reduction of stomach acid production and related disorders. PPIs irreversibly inhibit the hydrogen/potassium ATPase in gastric parietal cells. Recent retrospective studies have described an association between PPI use and depression. However, there is conflicting evidence that PPI therapy improves depressive symptoms. Considering the widespread use and over the counter availability of these drugs, further investigation into depression adverse event was warranted with a larger scale postmarketing set of reports. Here we analyzed over 68,178 reports from the FDA Adverse Event Reporting System consisting of PPI and histamine-2 receptor antagonist monotherapy records and found a statistically significant association between use of PPIs and depression. Additionally, we analyzed each of the six currently marketed PPIs individually and observed the association with the depression adverse reaction for all of them.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42127982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
José Fernando Pérez-Franco, G. Hernández-Pliego, Jocelyn Jacobo-Mendoza, Vanessa Karina Martínez-Lara, L. Juárez-Villegas, P. Clark, J. L. Vargas-Neri
Late adverse events (LAEs) are an important cause of illness and disability in childhood cancer survivors (CCSs) and increase the risk of mortality. The aim of this cross-sectional study was to describe the frequency and severity of treatment-related LAEs in Mexican CCSs. The study period was between September 2018 and April 2019. We tested a sample of 82 CCSs at the Hospital Infantil de México Federico Gómez. We considered an LAE to be any medical effect related to treatment after ending cancer therapy. All LAEs were classified according to severity (using the grades of Common Terminology Criteria for Adverse Events v.5.0), diagnosis and time of occurrence after treatment. The treatment-related LAE frequency was 11.0% (95% CI; 4.2–17.8%). A total of 11 LAEs were identified in nine patients. Slightly over half of the patients were male (54.9%). The most frequent diagnosis was acute lymphoblastic leukemia (45.1%). The body systems involved in LAEs were the endocrine (55.6%), neurological (22.2%), auditory (11.1%) and renal (11.1%) systems. Obesity was the most frequent LAE (45.4%). Most LAEs were classified as grade 1 and 2 (60%). The median follow-up was 6.5 years. The odds ratio was used as a measure of association to identify characteristics associated with the LAEs. We identified that the age at diagnosis (OR = 0.71, 95% CI, 0.51–0.99; p = 0.046) and chemotherapy-only group (OR = 0.03, 95% CI, 0.00–0.86, p = 0.040) were associated with LAEs. This is the first study that describes the frequency and severity of LAEs in Mexican childhood cancer survivors.
{"title":"Treatment-Related Late Adverse Events in Childhood Cancer Survivors of Mexico: A Cross-Sectional Study","authors":"José Fernando Pérez-Franco, G. Hernández-Pliego, Jocelyn Jacobo-Mendoza, Vanessa Karina Martínez-Lara, L. Juárez-Villegas, P. Clark, J. L. Vargas-Neri","doi":"10.3390/pharma2020015","DOIUrl":"https://doi.org/10.3390/pharma2020015","url":null,"abstract":"Late adverse events (LAEs) are an important cause of illness and disability in childhood cancer survivors (CCSs) and increase the risk of mortality. The aim of this cross-sectional study was to describe the frequency and severity of treatment-related LAEs in Mexican CCSs. The study period was between September 2018 and April 2019. We tested a sample of 82 CCSs at the Hospital Infantil de México Federico Gómez. We considered an LAE to be any medical effect related to treatment after ending cancer therapy. All LAEs were classified according to severity (using the grades of Common Terminology Criteria for Adverse Events v.5.0), diagnosis and time of occurrence after treatment. The treatment-related LAE frequency was 11.0% (95% CI; 4.2–17.8%). A total of 11 LAEs were identified in nine patients. Slightly over half of the patients were male (54.9%). The most frequent diagnosis was acute lymphoblastic leukemia (45.1%). The body systems involved in LAEs were the endocrine (55.6%), neurological (22.2%), auditory (11.1%) and renal (11.1%) systems. Obesity was the most frequent LAE (45.4%). Most LAEs were classified as grade 1 and 2 (60%). The median follow-up was 6.5 years. The odds ratio was used as a measure of association to identify characteristics associated with the LAEs. We identified that the age at diagnosis (OR = 0.71, 95% CI, 0.51–0.99; p = 0.046) and chemotherapy-only group (OR = 0.03, 95% CI, 0.00–0.86, p = 0.040) were associated with LAEs. This is the first study that describes the frequency and severity of LAEs in Mexican childhood cancer survivors.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48052593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Mandelli, I. Ardoino, A. Nobili, I. Fortino, C. Franchi
Background: The extensive use of antibiotics has contributed to the development of antibiotic resistance. Understanding the factors behind the attitude of physicians in prescribing antibiotics may be useful to address educational interventions to sensitize them to a more rational use of these drugs. This study aimed to evaluate the general practitioners’ (GPs) characteristics potentially associated with antibiotic prescription in community-dwelling adults from 2000 to 2019. Method: Multivariable linear regression models were performed to evaluate the association of GPs’ characteristics with the mean number of different antibiotics prescribed and the mean number of Defined Daily Doses (DDD) prescribed per patient. Results: We found that GPs older than 60 years prescribed a smaller number of different antibiotics per patient compared to 30–40 years old GPs (mean (standard error) 1.4 (0.5) vs. 1.8 (0.4)). In contrast older GPs prescribed more DDD compared to younger ones (28.9 (0.1) vs. 27.3 (0.3)). GPs prescribed 29 (0.1) DDD for >200 patients on polypharmacy vs. 28 (0.1) DDD for <100 patients on polypharmacy. The mean number of DDD prescribed increased by 5 units and by 16 units for each refill and switch, respectively. Conclusions: Age and number of patients in polypharmacy in charge were found to be associated with higher antibiotic prescriptions. The knowledge of the GPs-related factors could allow the stakeholders to design interventions to sensitize them to a more appropriate use of antibiotics in view of the increasing issue of antibiotic resistance.
{"title":"General Practitioner-Related Factors Associated with Antibiotic Prescription in Community-Dwelling Adult Population","authors":"S. Mandelli, I. Ardoino, A. Nobili, I. Fortino, C. Franchi","doi":"10.3390/pharma2020014","DOIUrl":"https://doi.org/10.3390/pharma2020014","url":null,"abstract":"Background: The extensive use of antibiotics has contributed to the development of antibiotic resistance. Understanding the factors behind the attitude of physicians in prescribing antibiotics may be useful to address educational interventions to sensitize them to a more rational use of these drugs. This study aimed to evaluate the general practitioners’ (GPs) characteristics potentially associated with antibiotic prescription in community-dwelling adults from 2000 to 2019. Method: Multivariable linear regression models were performed to evaluate the association of GPs’ characteristics with the mean number of different antibiotics prescribed and the mean number of Defined Daily Doses (DDD) prescribed per patient. Results: We found that GPs older than 60 years prescribed a smaller number of different antibiotics per patient compared to 30–40 years old GPs (mean (standard error) 1.4 (0.5) vs. 1.8 (0.4)). In contrast older GPs prescribed more DDD compared to younger ones (28.9 (0.1) vs. 27.3 (0.3)). GPs prescribed 29 (0.1) DDD for >200 patients on polypharmacy vs. 28 (0.1) DDD for <100 patients on polypharmacy. The mean number of DDD prescribed increased by 5 units and by 16 units for each refill and switch, respectively. Conclusions: Age and number of patients in polypharmacy in charge were found to be associated with higher antibiotic prescriptions. The knowledge of the GPs-related factors could allow the stakeholders to design interventions to sensitize them to a more appropriate use of antibiotics in view of the increasing issue of antibiotic resistance.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45055501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thomas W. Wilson, Joseph T. Dye, Sarah Spark, N. Robert, J. Espirito, E. Amirian
We examined eligibility criteria from recent oncology clinical trials to see whether real-world data (RWD) from electronic health records (EHRs) could be used to create external control groups for clinical trials. Trials were identified from the Aggregate Analysis of ClinicalTrials.gov database; the selected trials were for oncology drugs approved by the FDA in 2020. Verbatim text from trial inclusion and exclusion criteria was qualitatively assessed by an expert panel to determine if criteria could be ascertained from structured and unstructured EHR data. Identified criteria were categorized (cancer-related, comorbidity-related, demographic, functional status, and trial operations) and subcategorized. Among 53 identified trials, 20 met the requirements for study inclusion, which included 463 eligibility criteria. Percentages of criteria by category were as follows: cancer-related factors (46%), comorbidities (20%), functional status (18%), trial operations (14%), and demographics (2%). For 18 of the 20 trials, 80% of the eligibility criteria could be ascertained with RWD; for 4 of the 20, it was 100%. When trial operation-specific criteria were excluded, all 20 met the 100% threshold. Our study indicates that both structured and unstructured data from community-based oncology-specific EHRs can be used for determining patient eligibility for external control arms for clinical trials.
我们检查了近期肿瘤临床试验的资格标准，以了解电子健康记录(EHRs)的真实世界数据(RWD)是否可用于创建临床试验的外部对照组。试验从ClinicalTrials.gov数据库的汇总分析(Aggregate Analysis of ClinicalTrials.gov)中确定;所选试验是针对FDA于2020年批准的肿瘤药物。专家小组对试验纳入标准和排除标准的逐字文本进行定性评估，以确定是否可以从结构化和非结构化电子病历数据中确定标准。确定的标准被分类(癌症相关、合并症相关、人口统计学、功能状态和试验手术)和亚分类。在纳入的53项试验中，有20项符合纳入研究的要求，其中包括463项入选标准。分类标准的百分比如下:癌症相关因素(46%)、合并症(20%)、功能状态(18%)、试验手术(14%)和人口统计学(2%)。在20项试验中的18项中，80%的合格标准可以用RWD确定;20个中有4个是100%。当排除试验手术特定标准时，所有20例均达到100%阈值。我们的研究表明，来自社区肿瘤特异性电子病历的结构化和非结构化数据均可用于确定患者是否适合临床试验的外部对照组。
{"title":"Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria","authors":"Thomas W. Wilson, Joseph T. Dye, Sarah Spark, N. Robert, J. Espirito, E. Amirian","doi":"10.3390/pharma2020013","DOIUrl":"https://doi.org/10.3390/pharma2020013","url":null,"abstract":"We examined eligibility criteria from recent oncology clinical trials to see whether real-world data (RWD) from electronic health records (EHRs) could be used to create external control groups for clinical trials. Trials were identified from the Aggregate Analysis of ClinicalTrials.gov database; the selected trials were for oncology drugs approved by the FDA in 2020. Verbatim text from trial inclusion and exclusion criteria was qualitatively assessed by an expert panel to determine if criteria could be ascertained from structured and unstructured EHR data. Identified criteria were categorized (cancer-related, comorbidity-related, demographic, functional status, and trial operations) and subcategorized. Among 53 identified trials, 20 met the requirements for study inclusion, which included 463 eligibility criteria. Percentages of criteria by category were as follows: cancer-related factors (46%), comorbidities (20%), functional status (18%), trial operations (14%), and demographics (2%). For 18 of the 20 trials, 80% of the eligibility criteria could be ascertained with RWD; for 4 of the 20, it was 100%. When trial operation-specific criteria were excluded, all 20 met the 100% threshold. Our study indicates that both structured and unstructured data from community-based oncology-specific EHRs can be used for determining patient eligibility for external control arms for clinical trials.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45108781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This study aimed to systematically review and explore the impact of study methods on the cost of managing adverse drug reactions (ADRs) among hospitalized patients to guide policymakers and researchers. A literature search was conducted in MEDLINE, EMBASE, CINAHL, Cochrane Library, and Google Scholar. The search was restricted to studies from 2000 to 2017. Two authors independently reviewed the studies, assessed their risk of bias, and extracted information for analysis. Data abstraction was based on the study design, ADR reporting, and costing approaches. Of 677 studies identified, 12 were included for analysis. All studies defined ADR according to WHO classifications. The percentage of admission due to ADR ranged from 0.03% to 17.11%. All studies adopted a healthcare provider perspective, using either a micro-costing (n = 7), case-mix group costing (n = 3), or average-per-diem costing (n = 2) approach. The cost per ADR widely fluctuated from USD 65.00 to USD 12,129.90 based on various factors. The micro-costing approach generally had a lower cost compared to other approaches. The cost per ADR in high-income countries was also 10 times higher than in lower- or middle-income countries. This study evidenced that the methodological heterogeneity across studies has resulted in a wide range of cost estimations for ADR management.
{"title":"Cost Estimations of Managing Adverse Drug Reactions in Hospitalized Patients: A Systematic Review of Study Methods and Their Influences","authors":"Siti Fauziah Abu, A. Shafie, H. Chandriah","doi":"10.3390/pharma2020012","DOIUrl":"https://doi.org/10.3390/pharma2020012","url":null,"abstract":"This study aimed to systematically review and explore the impact of study methods on the cost of managing adverse drug reactions (ADRs) among hospitalized patients to guide policymakers and researchers. A literature search was conducted in MEDLINE, EMBASE, CINAHL, Cochrane Library, and Google Scholar. The search was restricted to studies from 2000 to 2017. Two authors independently reviewed the studies, assessed their risk of bias, and extracted information for analysis. Data abstraction was based on the study design, ADR reporting, and costing approaches. Of 677 studies identified, 12 were included for analysis. All studies defined ADR according to WHO classifications. The percentage of admission due to ADR ranged from 0.03% to 17.11%. All studies adopted a healthcare provider perspective, using either a micro-costing (n = 7), case-mix group costing (n = 3), or average-per-diem costing (n = 2) approach. The cost per ADR widely fluctuated from USD 65.00 to USD 12,129.90 based on various factors. The micro-costing approach generally had a lower cost compared to other approaches. The cost per ADR in high-income countries was also 10 times higher than in lower- or middle-income countries. This study evidenced that the methodological heterogeneity across studies has resulted in a wide range of cost estimations for ADR management.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47491686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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