Submit to Special Issue Submit Abstract to Special Issue Review for Pharmaceuticals Edit a Special Issue

Journal Menu

Journal Browser

► Journal Browser

Special Issue "Drug Safety and Relevant Issues in the Real-World"

Print Special Issue Flyer
Special Issue Editors
Special Issue Information
Keywords
Published Papers

A special issue of Pharmaceuticals (ISSN 1424-8247).

Deadline for manuscript submissions: 31 July 2023 | Viewed by 4182

Share This Special Issue

Special Issue Editors

Dr. Maria Antonietta Barbieri

E-Mail Website
Guest Editor

Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy
Interests: pharmacovigilance; pharmacoepidemiology; real-world data; adverse drug reactions; post-marketing surveillance

Dr. Natasha Irrera

E-Mail Website
Guest Editor

Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy
Interests: mechanism of action of drugs; tissue remodeling; nutraceuticals; pharmacovigilance
Special Issues, Collections and Topics in MDPI journals

Dr. Irma Convertino

E-Mail Website
Guest Editor

Unit of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
Interests: pharmacology; pharmacovigilance; pharmacoepidemiology; real world

Special Issue Information

Dear Colleagues,

The COVID-19 pandemic showed, once again, how drug safety and proper communication in the field of pharmacovigilance play key roles in public health, especially in times of emergency. Although randomized clinical trials aim to assess drug efficacy and safety before its approval, some intrinsic limitations may be detected, such as the limited number of eligible patients and short follow-up periods, which consequently, do not reflect the real-world population. Real-world data collection from electronic health databases and the adoption of automated tools with the integration of advanced methodologies have radically changed scientific evidence by improving drug benefit–risk profile assessment in real-world setting. For this reason, pharmacovigilance and pharmacoepidemiology studies are essential to further establish the appropriate prescribing, effectiveness, drug–drug interactions, short- and long-term drug safety, and all risk minimization measures of pharmacological treatments, especially for innovative therapies. Authors are invited to submit original articles as well as systematic reviews, meta-analyses, and review articles in this Special Issue to contribute to the implementation of real-world data for public health. We look forward to receiving your contributions on drug safety.

Dr. Maria Antonietta Barbieri
Dr. Natasha Irrera
Dr. Irma Convertino
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. Pharmaceuticals 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 2200 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

drug safety
real-world data
prescriptive appropriateness
effectiveness
pharmacovigilance
pharmacoepidemiology
patients’ clinical outcomes
adverse drug reactions

Published Papers (5 papers)

Download All Papers

Order results

Result details

Show export options Show export options

Select all

Export citation of selected articles as:

Research

Open AccessArticle

Prescriptive Appropriateness: Inhospital Adherence to Proton Pump Inhibitors Deprescription Flow Chart

and

Pharmaceuticals 2023, 16(5), 635; https://doi.org/10.3390/ph16050635 - 22 Apr 2023

Viewed by 445

Abstract

The prescriptive appropriateness of Proton Pump Inhibitors (PPIs) in polypharmacy is controversial. PPIs are often overprescribed and the risk of prescribing errors and adverse drug reactions increases for each additional drug added to therapy. Hence, guided deprescription should be considered and easily implementable in ward practice. This observational prospective study evaluated the implementation of a validated PPIs deprescription flow chart to real-life internal ward activity through the presence of a clinical pharmacologist as an enhancing additional factor by assessment of inhospital prescriber’s adherence to the proposed flow chart. Patients’ demographics and prescribing trends of PPIs prescriptions were analyzed by descriptive statistics. The final analysis of data included ninety-eight patients (forty-nine male and forty-nine female), aging 75.6 ± 10.6 years; 55.1% of patients had home-PPIs prescriptions, while 44.9% received inhospital-PPIs prescriptions. Evaluation of prescriber’s adherence to the flow chart revealed that the percentage of patients with a prescriptive/deprescriptive pathway conforming to that of the flow chart was 70.4%, with low symptomatologic recurrences. The clinical pharmacologists’ presence and influence in ward activity may have contributed to this finding, since continuous training of the prescribing physicians is deemed a success-related factor in the deprescribing strategy. Multidisciplinary management of PPIs deprescription protocols shows high adherence by prescribers in real-life hospital settings and low recurrence events. Full article

(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)

► Show Figures

Figure 1

Open AccessArticle

Effectiveness and Safety Profile of Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Real-Life Data in Tertiary Care

Cosimo Galletti

Maria Antonietta Barbieri

and

Pharmaceuticals 2023, 16(4), 630; https://doi.org/10.3390/ph16040630 - 21 Apr 2023

Viewed by 991

Abstract

Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by a type 2 pattern of inflammation resulting in the production of some cytokines. Dupilumab radically changes the treatment of CRSwNP, but, considering its recent approval, it may be useful to evaluate its safety profile in a real-world setting. This work aimed to prospectively highlight the effectiveness and safety profile of dupilumab in patients with CRSwNP enrolled in the Otorhinolaryngology Unit of the University Hospital of Messina. An observational cohort study was carried out considering all patients treated with dupilumab. A descriptive analysis was conducted reporting all demographic characteristics, endoscopic evaluations, and symptom conditions. A total of 66 patients were treated with dupilumab, but three patients were excluded due to a lack of adherence during the observational period. A statistically significant reduction in the Sino-Nasal Outcome Test 22 (SNOT-22) and nasal polyps score (NPS) was shown at the 6th and 12th months compared to baseline values (SNOT-22, −37 and −50, p < 0.001 for both comparisons; NPS, −3 and −4, p < 0.001 for both comparisons). During the follow-up, eight patients (12.7%) had a reaction at the site of injection, and seven (11.1%) had transient hypereosinophilia. Given the optimal treatment response and the minimal adverse effects observed, clinicians should consider dupilumab a safe and effective treatment. Further studies are necessary to better understand the long-term effects. Full article

(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)

► Show Figures

Figure 1

Open AccessArticle

Trends in the Use of Driving-Impairing Medicines According to the DRUID Category: A Population-Based Registry Study with Reference to Driving in a Region of Spain between 2015 and 2019

Eduardo Gutiérrez-Abejón

Paloma Criado-Espegel

M. Aránzazu Pedrosa-Naudín

Diego Fernández-Lázaro

Francisco Herrera-Gómez

and

F. Javier Álvarez

Pharmaceuticals 2023, 16(4), 508; https://doi.org/10.3390/ph16040508 - 29 Mar 2023

Viewed by 557

Abstract

The European DRUID (Drive Under the Influence of drugs, alcohol, and medicines) program classifies medications into three categories according to their effect on one’s fitness to drive. The trend in the use of driving-impairing medicines (DIMs) in a region of Spain between 2015 and 2019 was analyzed through a population-based registry study. Pharmacy dispensing records for DIMs are provided. The use of DIMs on drivers was weighted according to the national driver’s license census. The analysis was performed considering the population distribution by age and sex, treatment length, and the three DRUID categories. DIMs were used by 36.46% of the population and 27.91% of drivers, mainly chronically, with considerable daily use (8.04% and 5.34%, respectively). Use was more common in females than in males (42.28% vs. 30.44%) and increased with age. Among drivers, consumption decreases after 60 years of age for females and after 75 years of age for males. There was a 34% increase in the use of DIMs between 2015 and 2019, with a focus on daily use (>60%). The general population took 2.27 ± 1.76 DIMs, fundamentally category II (moderate influence on fitness to drive) (20.3%) and category III (severe influence on fitness to drive) (19.08%). The use of DIMs by the general population and drivers is significant and has increased in recent years. The integration of the DRUID classification into electronic prescription tools would assist physicians and pharmacists in providing adequate information to the patient about the effects of prescribed medications on their fitness to drive. Full article

(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)

► Show Figures

Figure 1

Open AccessArticle

Drug-Utilization, Healthcare Facilities Accesses and Costs of the First Generation of JAK Inhibitors in Rheumatoid Arthritis

and

Pharmaceuticals 2023, 16(3), 465; https://doi.org/10.3390/ph16030465 - 21 Mar 2023

Viewed by 801

Abstract

This study is aimed at describing tofacitinib and baricitinib users by characterizing their prescription and healthcare histories, drug and healthcare utilization patterns, and direct costs from a healthcare system perspective. This retrospective cohort study was performed using Tuscan administrative healthcare databases, which selected two groups of Janus kinase inhibitors (JAKi) incident users (index date) from 1st January 2018 to 31 December 2019 and from 1 January 2018 to 30 June 2019. We included patients ≥18 years old, at least 10 years of data, and six months of follow-up. In the first analysis, we describe mean time, standard deviation (SD), from the first-ever disease-modifying antirheumatic drug (DMARD) to the JAKi, and costs of healthcare facilities and drugs in the 5 years preceding the index date. In the second analysis, we assessed Emergency Department (ED) accesses and hospitalizations for any causes, visits, and costs in the follow-up. In the first analysis, 363 incident JAKi users were included (mean age 61.5, SD 13.6; females 80.7%, baricitinib 78.5%, tofacitinib 21.5%). The time to the first JAKi was 7.2 years (SD 3.3). The mean costs from the fifth to the second year before JAKi increased from 4325 € (0; 24,265) to 5259 € (0; 41,630) per patient/year, driven by hospitalizations. We included 221 incident JAKi users in the second analysis. We observed 109 ED accesses, 39 hospitalizations, and 64 visits. Injury and poisoning (18.3%) and skin (13.8%) caused ED accesses, and cardiovascular (69.2%) and musculoskeletal (64.1%) caused hospitalizations. The mean costs were 4819 € (607.5; 50,493) per patient, mostly due to JAKi. In conclusion, the JAKi introduction in therapy occurred in compliance with RA guidelines and the increase in costs observed could be due to a possible selective prescription. Full article

(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)

Open AccessArticle

Epidemiology, Patients’ Journey and Healthcare Costs in Early-Stage Non-Small-Cell Lung Carcinoma: A Real-World Evidence Analysis in Italy

Diego Luigi Cortinovis

and

Pharmaceuticals 2023, 16(3), 363; https://doi.org/10.3390/ph16030363 - 27 Feb 2023

Viewed by 812

Abstract

This real-world analysis aims to estimate the epidemiology and economic burden related to early-stage non-small-cell lung carcinoma (eNSCLC) in the clinical practice Italian setting. An observational analysis was performed using administrative databases linked to pathological anatomy data, covering around 2.5 mln health-assisted individuals. From 2015 to mid-2021, eNSCLC patients staged II–IIIA treated with chemotherapy after surgery were included. Patients were stratified into those presenting loco-regional or metastatic recurrence during follow-up and annualized healthcare direct costs covered by the Italian National Health System (INHS) were estimated. In 2019–2020, the prevalence of eNSCLC was 104.3–117.1/million health-assisted subjects, and the annual incidence was 38.6–30.3/million. Data projected to the Italian population estimated 6206 (2019) and 6967 (2020) prevalent and 2297 (2019) and 1803 (2020) incident cases. Overall, 458 eNSCLC patients were included. Of them, 52.4% of patients had a recurrence (5% loco-regional-recurrence, 47.4% metastatic-recurrence). Healthcare total direct costs/patient averaged EUR 23,607, in particular, in the first year after recurrence, costs averaged EUR 22,493 and EUR 29,337 in loco-regional and metastatic-recurrence patients, respectively. This analysis showed that about one-half of eNSCLC patients stage II–IIIA experience a recurrence, and in recurrence patients, total direct costs were almost two-fold those of no-recurrence patients. These data highlighted an unmet clinical need, as the therapeutic optimization of patients at early stages. Full article

(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)

► Show Figures

Journal Menu

Journal Browser

Special Issue "Drug Safety and Relevant Issues in the Real-World"

Share This Special Issue

Special Issue Editors

Special Issue Information

Keywords

Published Papers (5 papers)

Research

Further Information

Guidelines

MDPI Initiatives

Follow MDPI