Pharmacoepidemiology, Volume 2, Issue 3 (September 2023) – 7 articles

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. Full article

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. Full article

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. Full article

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. Full article

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. Full article

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. Full article

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. Full article