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New Perspectives in Real-World Pharmacoepidemiology and Drug Safety

A special issue of International Journal of Environmental Research and Public Health (ISSN 1660-4601). This special issue belongs to the section "Toxicology and Public Health".

Deadline for manuscript submissions: closed (31 March 2023) | Viewed by 13289

Special Issue Editors


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Guest Editor
Department of Health Policy, Head of Laboratory of Pharmacoepidemiology and Human Nutrition, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy
Interests: pharmacoepidemiology; appropriateness of drug prescription; drug safety; medication adherence; geriatric pharmacology; nutrition; educational randomized controlled trials; polypharmacy

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Co-Guest Editor
Epidemiology and Preventive Pharmacology Service (SEFAP), Department of Pharmacological and Biomolecular Sciences, University of Milan, 20133 Milan, Italy
Interests: epidemiological studies on cardiovascular disease and associated risk factors; Pharmacoutilization; pharmacoepidemiology; drug-drug interactions; off-label use; misprescribing/overprescribing; adherence to therapy

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Co-Guest Editor
Department of Health Policy, Laboratory of Pharmacoepidemiology and Human Nutrition, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156 Milan, Italy
Interests: cancer; gamma distribution; medical computing; optimisation; Polypharmacy; Deprescriptions; Inappropriate Prescribing

Special Issue Information

Dear Colleagues,

Medicines are meant to improve patient health; however, some necessary conditions that require meeting include (i) the choice of therapy having to correspond to patient’s clinical requirements and consider patient’s characteristics, such as age, comorbidities, concomitant therapies, as well as (ii) the patient following the doctor's instructions by taking the recommended drugs at the proper doses for as long as necessary. These two assumptions can represent a challenge in daily clinical practice, especially in particularly critical and frail subpopulations such as the elderly, polytreated patients, or in complex socio-health conditions such as those determined by the recent COVID-19 pandemic. The evaluation of these aspects and the quantification of their consequences in terms of morbidity and mortality are crucial (i) to increase awareness among health decision makers concerning the epidemiological and clinical impact of an inappropriate prescription and low adherence to the own pharmacological therapies, and (ii) to design interventions to improve patients’ clinical outcomes and reduce unnecessary costs for National Health Services.

This Special Issue is dedicated to reviews and original articles addressing the issues surrounding the appropriateness of drug prescriptions, drug adherence, drug safety evaluations in real-life settings and clinical consequences on patients' health.

Dr. Carlotta Franchi
Dr. Manuela Casula
Dr. Ilaria Ardoino
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. International Journal of Environmental Research and Public Health is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2500 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • appropriate prescribing
  • adherence to therapy
  • polypharmacy
  • drug utilization
  • real-world evidence
  • drug safety
  • pharmacovigilance
  • pharmacoepidemiology
  • clinical epidemiology
  • public health
  • patients’ clinical outcomes

Published Papers (8 papers)

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Editorial

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5 pages, 298 KiB  
Editorial
Appropriateness of the Prescription and Use of Medicines: An Old Concept but More Relevant than Ever
by Manuela Casula, Ilaria Ardoino and Carlotta Franchi
Int. J. Environ. Res. Public Health 2023, 20(3), 2700; https://doi.org/10.3390/ijerph20032700 - 02 Feb 2023
Viewed by 1159
Abstract
The availability of drugs to treat diseases, control symptoms, or prevent their onset is one of the most important resources for maintaining health [...] Full article
(This article belongs to the Special Issue New Perspectives in Real-World Pharmacoepidemiology and Drug Safety)

Research

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9 pages, 318 KiB  
Article
Evaluation of Six Years of Appropriateness Level of Blood Transfusion in a Pediatric Ward
by Pier Mario Perrone, Gregorio Paolo Milani, Rosa Maria Dellepiane, Antonella Petaccia, Daniele Prati, Carlo Agostoni, Paola Giovanna Marchisio and Silvana Castaldi
Int. J. Environ. Res. Public Health 2023, 20(3), 1700; https://doi.org/10.3390/ijerph20031700 - 17 Jan 2023
Viewed by 1010
Abstract
Background: Blood transfusion can be considered as a life-saving treatment and is a primary health management topic. This study aims to assess the appropriateness of blood transfusion performed in a large tertiary hospital in Italy. Methods: a multispecialist team composed oof hematologists, public [...] Read more.
Background: Blood transfusion can be considered as a life-saving treatment and is a primary health management topic. This study aims to assess the appropriateness of blood transfusion performed in a large tertiary hospital in Italy. Methods: a multispecialist team composed oof hematologists, public health experts and pediatricians analyzed blood transfusions performed between 2018 and 2022 in the pediatric wards comparing the appropriateness with the available NHS guidelines available. Patients’ characteristics, clinical features and blood component’s data were collected and analyzed. Results: considering 147 blood transfusions performed in 2018–2022, only eight (5.4%) were performed according to guidelines, while 98 (66.7%) were driven by clinicians’ expertise, especially for anemia in genetic syndromes (30) (20.5%) and autoimmune diseases (20) (13.6%). Thirty-nine (26.5%) transfusions could be considered as inappropriate, while two (1.4%) blood packs were never been transfused after being requested. Conclusions: This analysis is one of the first performed to assess the appropriateness of blood component transfusions comparing their compliance to NHS guidelines. The importance of this analysis can be explained first by the clinical point of view and second by the economic one. Full article
(This article belongs to the Special Issue New Perspectives in Real-World Pharmacoepidemiology and Drug Safety)
12 pages, 2077 KiB  
Article
Nationwide Long-Term Evaluation of Polypharmacy Reduction Policies Focusing on Older Adults in Japan
by Takehiro Ishida, Asuka Suzuki and Yoshinori Nakata
Int. J. Environ. Res. Public Health 2022, 19(22), 14684; https://doi.org/10.3390/ijerph192214684 - 09 Nov 2022
Cited by 2 | Viewed by 1590
Abstract
Polypharmacy is a serious health issue for older adults worldwide, including in Japan, which has a rapidly aging society. The “Proper Medication Guideline for Older Adults” was published for healthcare providers in May 2018, and polypharmacy reduction incentives were initiated for medical facilities [...] Read more.
Polypharmacy is a serious health issue for older adults worldwide, including in Japan, which has a rapidly aging society. The “Proper Medication Guideline for Older Adults” was published for healthcare providers in May 2018, and polypharmacy reduction incentives were initiated for medical facilities in April 2016 and April 2018. This study identified the long-term reduction in polypharmacy prescriptions focusing on older adults aged 75 years and above from April 2015 to March 2019. The national health insurance claims database, which covers most reimbursement claims in Japan, was selected as the primary data source. In this study, polypharmacy was defined as the simultaneous prescription of seven or more medications or multi-psychotropic medications. The primary outcome was the polypharmacy reduction ratio, which indicates the decrease in polypharmacy proportion based on the number of medications on an outpatient prescription. A total polypharmacy reduction of 19.3% for the “75–89 years” subgroup and 16.5% for the “90 years and above” subgroup was observed over four years. Based on prefecture analysis, the mean values of polypharmacy proportion showed a statistically significant reduction over four years. This study showed a successful nationwide reduction in polypharmacy prescriptions after implementing the polypharmacy management guidelines for older adults and incentive-based policies. Full article
(This article belongs to the Special Issue New Perspectives in Real-World Pharmacoepidemiology and Drug Safety)
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12 pages, 349 KiB  
Article
Did the New French Regulation of Zolpidem Decrease the Problematic Consumption of Zolpidem? A Field Study among Users
by Edouard-Jules Laforgue, Morgane Rousselet, Antoine Claudon, Aurélie Aquizerate, Pascale Jolliet, Marion Istvan and Caroline Victorri-Vigneau
Int. J. Environ. Res. Public Health 2022, 19(15), 8920; https://doi.org/10.3390/ijerph19158920 - 22 Jul 2022
Viewed by 1109
Abstract
Background: The French national drug regulatory authority stated, in 2017, that a secured prescription pad must be used for zolpidem prescriptions. This study aimed to evaluate the evolution of the problematic consumption of zolpidem at the individual level since the new regulation. Methods: [...] Read more.
Background: The French national drug regulatory authority stated, in 2017, that a secured prescription pad must be used for zolpidem prescriptions. This study aimed to evaluate the evolution of the problematic consumption of zolpidem at the individual level since the new regulation. Methods: Two nationwide populations of at-risk users of zolpidem were recruited: one in general practitioner (GP) offices and one in specialized care centers dedicated to drug dependence (SCDDs). Participants were asked about their zolpidem consumption before and after the regulation change. The primary outcome was the evolution of problematic zolpidem consumption, as defined by at least one of the following criteria: overconsumption, fraudulent ways of obtaining, effects sought other than hypnotic, and modes of administration other than oral. Results: A total of 243 participants were included: 125 from GP offices and 118 from SCDDs. In the GP population, the prevalence of patients who were identified as problematic consumers decreased from 24.8% to 20.8% (p = 0.593), whereas the prevalence decreased from 73.7% to 51.7% in the SCDD population (p < 0.001). The most prevalent criteria for problematic status were overconsumption and fraudulent ways. Conclusions: The new French regulation of zolpidem had different impacts among two different populations of at-risk zolpidem consumers. Full article
(This article belongs to the Special Issue New Perspectives in Real-World Pharmacoepidemiology and Drug Safety)
10 pages, 1049 KiB  
Article
Time-Trends of Drug-Drug Interactions among Elderly Outpatients in the Piedmont Region (Italy): A Population-Based Study
by Elisabetta Galai, Lorenza Scotti, Marco Gilardetti, Andrealuna Ucciero, Daniela Ferrante, Elisabetta Poluzzi, Armando A. Genazzani and Francesco Barone-Adesi
Int. J. Environ. Res. Public Health 2022, 19(12), 7353; https://doi.org/10.3390/ijerph19127353 - 15 Jun 2022
Cited by 2 | Viewed by 1386
Abstract
Adverse drug reactions (ADRs) are a major health problem in the primary care setting, particularly among the elderly population. While the high frequency of ADRs in the elderly has several causes, a major and common determinant is polypharmacy, which can in turn increase [...] Read more.
Adverse drug reactions (ADRs) are a major health problem in the primary care setting, particularly among the elderly population. While the high frequency of ADRs in the elderly has several causes, a major and common determinant is polypharmacy, which can in turn increase the risk of drug-drug interactions (DDIs). In this paper, we analyzed the drugs prescriptions dispensed to elderly outpatients, to assess changes in the prevalence of selected DDIs in the period 2013–2019. Overall, about 15% of the patients aged >65 years were poly-treated. Among them, a decreasing trend in prevalence was observed for the majority of DDIs during the study period. This trend was particularly noticeable for DDIs involving fluoroquinolones and vitamin K antagonists, where a sharp reduction of over 40% was observed. On the opposite, a small increase in prevalence was observed for the association of antidiabetics and beta-blocking agents and for that of clopidogrel and PPIs. While the occurrence of most of the considered DDIs among poly-treated elderly decreased over time, the prevalence of some of them is still worrying. The complexity of the national drug formularies, as well as the increased number of prescribing actors that are involved, further urges the update of DDI lists to be used to monitor drug appropriateness and reduce avoidable ADRs. Full article
(This article belongs to the Special Issue New Perspectives in Real-World Pharmacoepidemiology and Drug Safety)
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13 pages, 2722 KiB  
Article
Use of Biological Drugs for Psoriasis: A Drug-Utilization Study Using Tuscan Administrative Databanks
by Sabrina Giometto, Silvia Tillati, Laura Baglietto, Nicola De Bortoli, Marta Mosca, Marco Conte, Marco Tuccori, Rosa Gini and Ersilia Lucenteforte
Int. J. Environ. Res. Public Health 2022, 19(11), 6799; https://doi.org/10.3390/ijerph19116799 - 02 Jun 2022
Cited by 1 | Viewed by 1570
Abstract
Our study aims at providing evidence on patterns of use of biologic drugs for psoriasis in Tuscany, Italy. We conducted a drug-utilization study based on administrative databanks of Tuscany (EUPAS45365) from 2011 to 2019. We selected new users of etanercept, infliximab, adalimumab, ustekinumab, [...] Read more.
Our study aims at providing evidence on patterns of use of biologic drugs for psoriasis in Tuscany, Italy. We conducted a drug-utilization study based on administrative databanks of Tuscany (EUPAS45365) from 2011 to 2019. We selected new users of etanercept, infliximab, adalimumab, ustekinumab, or secukinumab between 1 January 2011 and 31 December 2016. We considered subjects with psoriasis and followed subjects until the end of the study period (three years after the first dispensation of biologic drug for psoriasis) or the patient’s death, whichever came first. We censored subjects for pregnancy or neoplasia. For each subject, we defined the state as the weekly coverage of one of the biologic drugs of interest. We then defined the switch as the change from a state to another one. A total of 7062 subjects with a first dispensation of a PSObio drug in the inclusion period was identified, and 1839 (52.9% female, 51.6 mean age) patients were included in the analysis. Among new users of adalimumab (N = 770, 41.9%), one third showed a continuous behaviour whereas the others moved to etanercept and ustekinumab. New users of etanercept (N = 758, 41.2%), had the highest proportion of switchers, with adalimumab most often being the second choice. New users of infliximab (N = 159, 8.6%) experienced the highest proportion of treatment discontinuation. The present study suggests that the majority of patients treated with PSObio drugs do not switch from one active ingredient to another. However, patients who started biological therapy with etanercept had the highest frequency of switching to other PSObio drugs, whereas those who started with secukinumab or ustekinumab had the lowest. Full article
(This article belongs to the Special Issue New Perspectives in Real-World Pharmacoepidemiology and Drug Safety)
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12 pages, 783 KiB  
Article
Multiple Medication Adherence and Related Outcomes in Community-Dwelling Older People on Chronic Polypharmacy: A Retrospective Cohort Study on Administrative Claims Data
by Carlotta Franchi, Monica Ludergnani, Luca Merlino, Alessandro Nobili, Ida Fortino, Olivia Leoni and Ilaria Ardoino
Int. J. Environ. Res. Public Health 2022, 19(9), 5692; https://doi.org/10.3390/ijerph19095692 - 07 May 2022
Cited by 11 | Viewed by 2362
Abstract
Poor medication adherence compromises treatment efficacy and adversely affects patients’ clinical outcomes. This study aims to assess (1) multiple medication adherence to the most common drug classes chronically prescribed to older people, (2) the factors associated, and (3) the clinical outcomes. This retrospective [...] Read more.
Poor medication adherence compromises treatment efficacy and adversely affects patients’ clinical outcomes. This study aims to assess (1) multiple medication adherence to the most common drug classes chronically prescribed to older people, (2) the factors associated, and (3) the clinical outcomes. This retrospective cohort study included 122,655 community-dwelling patients aged 65–94 years old, newly exposed to chronic polypharmacy, and recorded in the Lombardy Region (northern Italy) administrative database from 2016 to 2018. Multiple medication adherence was assessed for drugs for diabetes, antithrombotics, antihypertensives, statins, and bisphosphonates, by calculating the daily polypharmacy possession ratio (DPPR). One-year mortality, nursing home, emergency department (ED), and hospital admission rates were calculated for 2019. The most prescribed drugs were antihypertensives (89.0%). The mean (std.dev) DPPR was 82.9% (15.6). Being female (OR = 0.85, 95%CI: 0.84–0.86), age ≥85 years (OR = 0.77, 95%CI: 0.76–0.79), and multimorbidity (≥4 diseases, OR = 0.88, 95%CI: 0.86–0.90) were associated with lower medication adherence. A higher DPPR was associated with clinical outcomes—in particular, improved survival (HR = 0.93 for 10/100-point increase, 95%CI: 0.92–0.94) and lower incidence in nursing home admissions (SDHR = 0.95, 95%CI: 0.93–0.97). Adherence to the most common chronic drugs co-prescribed to the older population was high. Better multiple medication adherence was associated with better clinical outcomes. Full article
(This article belongs to the Special Issue New Perspectives in Real-World Pharmacoepidemiology and Drug Safety)
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Other

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15 pages, 718 KiB  
Systematic Review
Impact of COVID-19 Pandemic on Adherence to Chronic Therapies: A Systematic Review
by Elena Olmastroni, Federica Galimberti, Elena Tragni, Alberico L. Catapano and Manuela Casula
Int. J. Environ. Res. Public Health 2023, 20(5), 3825; https://doi.org/10.3390/ijerph20053825 - 21 Feb 2023
Cited by 10 | Viewed by 1844
Abstract
The spread of the coronavirus disease 2019 (COVID-19) pandemic caused a sudden and significant disruption in healthcare services, especially for patients suffering from chronic diseases. We aimed at evaluating the impact of the pandemic on adherence to chronic therapies through a systematic review [...] Read more.
The spread of the coronavirus disease 2019 (COVID-19) pandemic caused a sudden and significant disruption in healthcare services, especially for patients suffering from chronic diseases. We aimed at evaluating the impact of the pandemic on adherence to chronic therapies through a systematic review of available studies. PubMed, EMBASE, and Web of Science were searched since inception to June 2022. Inclusion criteria were: (1) observational studies or surveys; (2) studies on patients with chronic diseases; (3) reporting the effects of COVID-19 pandemic on adherence to chronic pharmacological treatment, as a comparison of adherence during the pandemic period vs. pre-pandemic period (primary outcome) or as rate of treatment discontinuation/delay specifically due to factors linked to COVID-19 (secondary outcome). Findings from 12 (primary outcome) and 24 (secondary outcome) studies showed that many chronic treatments were interrupted or affected by a reduced adherence in the pandemic period, and that fear of infection, difficulty in reaching physicians or healthcare facilities, and unavailability of medication were often reported as reasons for discontinuation or modification of chronic therapies. For other therapies where the patient was not required to attend the clinic, continuity of treatment was sometimes ensured through the use of telemedicine, and the adherence was guaranteed with drug stockpiling. While the effects of the possible worsening of chronic disease management need to be monitored over time, positive strategies should be acknowledged, such as the implementation of e-health tools and the expanded role of community pharmacists, and may play an important role in preserving continuity of care for people with chronic diseases. Full article
(This article belongs to the Special Issue New Perspectives in Real-World Pharmacoepidemiology and Drug Safety)
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