Pharmacoepidemiology最新文献

{"title":"Literature Review of Safety Event Reporting in Observational Studies: Challenges Extrapolating across Comparable Products","authors":"Heather A. Ward, B. Nguyen-khoa, Robert Massouh","doi":"10.3390/pharma2040029","DOIUrl":"https://doi.org/10.3390/pharma2040029","url":null,"abstract":"Nirmatrelvir/ritonavir (PAXLOVIDTM, Pfizer) is an anti-infective inhibiting CYP3A4 indicated for the treatment of COVID-19 in adults at increased risk of severe COVID-19. As a newly approved product, PAXLOVID has limited safety information regarding rare events and serious adverse events (SAEs). This review describes the characterization of the real-world safety profile of products with similar pharmacological properties to PAXLOVID and aims to understand the impact of any drug interaction on the concomitantly prescribed products. A literature search of articles in PubMed published between 2018 and 2023 was conducted to assess the real-world frequency of safety outcomes of interest, specifically those meeting the criteria of serious adverse reaction. The review was restricted to observational, noninterventional studies and included CYP3A4 inhibitors prescribed for short-term treatment of infections in the outpatient setting. Twenty-one articles were included in the review. Most focused on a small, predefined list of safety outcomes and did not provide insight into the broader range of safety outcomes that might occur for the evaluated products with similar pharmacological properties to PAXLOVID or the impact of any interaction on the concomitant product. The findings highlight the challenges in obtaining proxy safety outcomes characteristics via a review of products with comparable pharmacological properties and underscore the need to have large, rapidly accessible data sources that can contribute to the safety profile of newly authorized products in the real world.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":"128 35","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138599305","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}

{"title":"A Retrospective Review of COVID-19 Medicines Information Queries in a Quaternary Hospital with Unique COVID-19 Border Controls","authors":"Jeanie Misko, Matthew D. M. Rawlins","doi":"10.3390/pharma2040028","DOIUrl":"https://doi.org/10.3390/pharma2040028","url":null,"abstract":"Background: Medicines information (MI) is a specialist area of pharmacy that provides evidence-based answers to often complex medication queries, utilising resources such as textbooks and databases. With the advent of the COVID-19 pandemic, there was a need to change the way COVID-19-related queries were answered due to the rapid evolution of information on vaccination, treatment and prevention. Methods: Medicines information queries were retrospectively reviewed utilising the centre’s medicines information database from January 2020 through December 2022 using the COVID-19 keyword to retrieve relevant queries. Information was collected on the enquirer’s role, query category, time taken to complete the query, relevant keywords and references accessed. Keywords and references were analysed further to determine the types of queries asked and which references were helpful. Results: The centre received 214 COVID-19-related queries, predominantly in 2022. Most queries were from pharmacy staff (95.8%) and related to vaccination (n = 95, 44.4%) or treatment (n = 87, 40.7%). Government and specialist organisation websites were used most commonly as reference sources (24.6% and 16.5%, respectively) for their currency with COVID-19-specific resources (such as national guidelines, COVID-19 treatment interaction checkers) and textbooks/databases used less commonly. Conclusions: MI pharmacists have demonstrated their ability to obtain reliable COVID-19-related information, utilising and interpreting information from less traditional sources.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" July","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135186261","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}

{"title":"Analyzing Black Market Sales of the Second-Line ADHD Medication Atomoxetine","authors":"Sophie A. Roe, Dayna S. DeSalve, Brian J. Piper","doi":"10.3390/pharma2040027","DOIUrl":"https://doi.org/10.3390/pharma2040027","url":null,"abstract":"Research Question and Objective: While the number of pharmacoepidemiological studies on stimulant-based ADHD medications has expanded rapidly in recent years, likely due to the stimulant shortage, few studies have analyzed non-stimulant ADHD medications from a pharmacoepidemiological perspective. Such research is important because a significant number of individuals with ADHD have medical or psychiatric conditions that preclude stimulant use. Furthermore, no studies, to our knowledge, have analyzed atomoxetine exchanges on the black market. In this report, we seek to fill both these gaps in the research by analyzing black market diversions of atomoxetine, a non-stimulant medication for ADHD. As ADHD medication diversion is a growing issue, we also hypothesize the pharmacoepidemiologic contributors to and implications of such diversion. Method: This study analyzed black market atomoxetine purchases entered on the web-based platform StreetRx between January 2015 and July 2019. Data included the generic drug name, dosage, purchase price, date, and location in the United States. The mean price per milligram was determined and a heatmap was generated. Results: The average price per milligram of 113 diverted atomoxetine submissions was USD 1.35 (±USD 2.76 SD) (Median = USD 0.05, Min = USD 0.01, Max = USD 20.00). The states with the most submissions included Michigan (11), Pennsylvania (9), Indiana (8), and Ohio (8). Conclusion: The cost per milligram of atomoxetine on the black market is over 50 times the cost per milligram of the generic prescribed form. Future qualitative studies should investigate reasons why individuals are motivated to purchase atomoxetine, a non-stimulant medication, on the black market (recreational vs. nootropic vs. other clinical uses).","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":"2 4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135432963","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}

{"title":"Blood Pressure Control in the DIAbetes and LifEstyle Cohort Twente (DIALECT): The Role of Patient Adherence and Physician’s Follow-Up Action","authors":"Simone L. Dam, Heleen M. Masselink-Haverkate, Christina M. Gant, Stephan J. L. Bakker, Roos M. Nijboer, Willemien J. Kruik-Kollöffel, Gozewijn D. Laverman","doi":"10.3390/pharma2040026","DOIUrl":"https://doi.org/10.3390/pharma2040026","url":null,"abstract":"We studied the role of adherence to antihypertensive drug therapy (AHT) in blood pressure (BP) control in a type 2 diabetes (T2D) population treated in secondary care in the DIAbetes and LifEstyle Cohort Twente-1 (DIALECT-1). In addition, intensification of AHT was assessed. Adherence was determined by using the medication possession ratio (MPR), calculated with pharmacy dispensing data for a period of two years following baseline. Adherence was defined as an MPR ≥ 80%. The proportion of adherent patients was compared between patients who had BP-on target (BP-OT) and BP-not on target (BP-NOT). Of the 385 patients included, 56% achieved their BP target. The proportion of adherent patients did not differ between BP-OT and BP-NOT (96% vs. 96%; p = 0.91). Intensification of AHT, including ‘increase in dosage’ and ‘start of a new drug’, was assessed in the two years following baseline. In only 37% of patients with uncontrolled BP during follow-up was AHT intensified. To conclude, adherence to AHT was high and there does not seem to be a relationship between adherence and BP control. There is an opportunity to improve AHT in patients who do not reach their BP target.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":"44 5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136022659","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}

{"title":"Impact of Antibiotic De-Escalation on Antibiotic Consumption, Length of Hospitalization, Mortality, and Cost: A Systematic Review and Meta-Analysis","authors":"Abeer Alanazi, Reem Almuhaya, Mohammad Almohaimeed, Nada Alahmari, Noor Abdulrahim, Marouj Basyouni, Farah Althikrallah, Jumanah Al Badwyi, Abdulrahman Khallaf, Khalid Albalawi, Amal Almalki, Khalid Alsaedi, Fatima Bakarman, Fatimah Alotaibi, Mohammed Kanan","doi":"10.3390/pharma2040025","DOIUrl":"https://doi.org/10.3390/pharma2040025","url":null,"abstract":"Overuse and misuse of antibiotics have led to the emergence of antibiotic-resistant bacteria and pose a significant threat due to adverse drug reactions, increased healthcare costs, and poor patient outcomes. Antibiotic stewardship programs, including antibiotic de-escalation, aim to optimize antibiotic use and to reduce the development of antibiotic resistance. This systematic review and meta-analysis aim to fill the gap by analyzing the current literature on the implications of antibiotic de-escalation in patients on antibiotic use, duration of hospital stay, mortality, and cost; to update clinical practice recommendations for the proper use of antibiotics; and to offer insightful information about the efficacy of antibiotic de-escalation. Based on the PRISMA 2020 recommendations, a comprehensive literature search was conducted using electronic databases and reference lists of identified studies. Eligible studies were published in English, conducted in humans, and evaluated the impact of antibiotic de-escalation on antibiotic consumption, length of hospitalization, mortality, or cost in hospitalized adult patients. Data were extracted using a standardized form, and the quality of included studies was assessed using the Newcastle–Ottawa Scale. The data from 25 studies were pooled and analyzed using the Revman-5 software, and statistical heterogeneity was evaluated using a chi-square test and I2 statistics. Among the total studies, seven studies were conducted in pediatric patients and the remaining studies were conducted in adults. The studies showed a wide range of de-escalation rates, with most studies reporting a rate above 50%. In some studies, de-escalation was associated with a decrease in antimicrobial utilization and mean length of stay, but the impact on overall cost was mixed. Our pooled analysis for mortality reported that a significant difference was observed between the de-escalation group and the non-de-escalation group in a random effect model (RR = 0.67, 95% CI 0.52–0.86, p = 0.001). The results suggest that de-escalation therapy can be applied in different healthcare settings and patient populations. However, the de-escalation rate varied depending on the study population and definition of de-escalation. Despite this variation, the results of this systematic review support the importance of de-escalation as a strategy to optimize antibiotic therapy and to reduce the development of subsequent antibiotic resistance. Further studies are needed to evaluate the impact of de-escalation on patient outcomes and to standardize the definition of de-escalation to allow for better comparison of studies.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":"2012 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135855861","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}

{"title":"Detectable Vancomycin Stool Concentrations in Hospitalized Patients with Diarrhea Given Intravenous Vancomycin","authors":"Taryn A. Eubank, Chenlin Hu, Anne J. Gonzales-Luna, Kevin W. Garey","doi":"10.3390/pharma2040024","DOIUrl":"https://doi.org/10.3390/pharma2040024","url":null,"abstract":"Vancomycin is not appreciably passaged via the colonic membrane to the gastrointestinal (GI) tract in persons with an intact gut epithelium due to its large chemical structure. However; hospitalized patients with diarrhea often have a disrupted GI tract. The aim of this study was to determine the frequency of detectable vancomycin concentrations in the stool of patients with antibiotic-associated diarrhea receiving IV vancomycin. This was a multicenter cohort study of hospitalized patients with stool samples collected for Clostridioides difficile testing. Leftover stool samples were collected from patients who had received at least 3 days of IV vancomycin. Fecal vancomycin was quantified by high-performance liquid chromatography. The study cohort included 33 unique patients, majority female (54.5%) aged 60 years (range 23–84). Eighteen of thirty-three patients (54.5%) tested positive for C. difficile toxins. The average duration of systemic vancomycin administration prior to stool collection was 3.5 (range 2–15) days. Three of 33 (9%) stool samples had a detectable vancomycin concentration (range 1.2–13.2 mcg/mL). These concentrations may promote the development of vancomycin-resistant Enterococcus or van mutations in C. difficile, leading to vancomycin resistance. Further studies on implications are warranted.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135386888","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}

{"title":"Depression Events Associated with Proton-Pump Inhibitors in Postmarketing Drug Surveillance Data","authors":"Tigran Makunts, Haroutyun Joulfayan, Kenneth Ta, Ruben Abagyan","doi":"10.3390/pharma2030023","DOIUrl":"https://doi.org/10.3390/pharma2030023","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 125,923 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":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136143219","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}

{"title":"Use of Hand Sanitizers in COVID-19 Prevention: A Comprehensive Overview","authors":"Suneetha Vuppu, Toshika Mishra, Arjun Chinamgari","doi":"10.3390/pharma2030022","DOIUrl":"https://doi.org/10.3390/pharma2030022","url":null,"abstract":"The pandemic outbreak of Coronavirus disease 2019 (COVID-19) has drastically changed the picture of global healthcare. With the rapid emergence of novel variants of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) that rendered the currently available therapeutic and diagnostic approaches inefficient in containing the transmission of infection, it becomes important to focus on strategies to break the transmission chain. The major approach to contain the spread of infection is the promotion of adequate hand hygiene practices in public as hands are an important source of pathogenic microbes. Hand hygiene is an important part of everyday life for maintaining a healthy and disease-free lifestyle. With the outbreak of the pandemic, people are now understanding the importance of hand hygiene practices. The global market of hand sanitizers has experienced rapid growth and high demand. This review aims to discuss the use of sanitizers during the period of COVID-19 and their role in controlling the transmission of infection. It also focuses on global market trends, the advancements in the development of sanitizer formulations, and the limitations of commercial sanitizers. Therefore, the formulation of an effective hand disinfectant is crucial for preventing future pandemic outbreaks.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44688630","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}

{"title":"Drug Prescriptions during Pregnancy in Lombardy: Temporal Trends and the Impact of the Onset of the COVID-19 Pandemic","authors":"G. Esposito, A. Cantarutti, M. Franchi, G. Corrao, F. Parazzini","doi":"10.3390/pharma2030021","DOIUrl":"https://doi.org/10.3390/pharma2030021","url":null,"abstract":"This population-based study aimed at providing an overview of drug prescription patterns during pregnancy in the Italian region of Lombardy from 2010 to 2020. The cohort consisted of 780,075 deliveries identified from the regional healthcare utilization databases. The prevalence of drugs’ dispensed prescriptions was estimated as the proportion of pregnant women with at least one prescription out of the total deliveries over the entire pregnancy and by trimester. Drugs were classified according to the Anatomical Therapeutic Chemical code. In addition, interrupted time series analysis was conducted to investigate temporal trends of antibiotics’ use during the onset of the COVID-19 pandemic. A total of 497,515 women (63.8%) used at least a drug, including vitamins and minerals, at some point during pregnancy. Vitamins, minerals, and anti-anaemic preparations were prescribed in 20.8%, 13.3%, and 18.3% of deliveries over the trimesters of pregnancy. Folic acid was the most prescribed drug, with about one woman out of four, followed by iron preparations, progestogen, and antibiotics (prescription rate, respectively: 15.9%, 10.2%, and 9.8%). A decreasing trend in the dispensing of antibiotics emerged during the entire study period; however, a significant further decrease following the spread of the pandemic was observed. Further evidence is needed to monitor the use of drugs during pregnancy, determinants, and implications.","PeriodicalId":74431,"journal":{"name":"Pharmacoepidemiology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42516566","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}

{"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}