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Pharmaceuticals
Special Issues
Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety
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Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmacology".

Deadline for manuscript submissions: 25 April 2026 | Viewed by 4650

Special Issue Editors

Dr. Cristina Sofia De Jesus Monteiro

E-Mail Website
Guest Editor
Pharmacovigilance Unit, Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal
Interests: pharmacovigilance; drug safety; adverse drug reactions
Prof. Dr. Samuel Martins Silvestre

E-Mail Website
Guest Editor
RISE-Health, Faculty of Sciences, University of Beira Interior, Rua Marquês d'Ávila e Bolama, 6201-001 Covilhã, Portugal
Interests: design of bioactive compounds; chemical synthesis; biological evaluation; compounds with medicinal and pharmaceutical interests
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The evolution of pharmacovigilance is increasingly challenged by phenomena such as drug misuse, off-label use and medication errors, all of which can be linked to underlying pharmacological mechanisms. These issues not only pose a significant risk to patient safety but also emphasise the importance of understanding how pharmacodynamic and pharmacokinetic factors contribute to adverse drug reactions (ADRs) and treatment failures. This Special Issue, entitled “Insights into Pharmacovigilance: Addressing Drug Misuse and Enhancing Drug Safety”, seeks contributions that explore the pharmacological basis of drug safety issues and propose mechanism-based approaches to improve pharmacovigilance systems. We invite original research articles and systematic reviews that go beyond observational data to investigate molecular targets, receptor interactions, metabolic pathways, drug–drug interactions or genetic polymorphisms that may affect drug safety.By linking pharmacological insights with regulatory and clinical perspectives, this Special Issue aims to provide a science-based framework for the optimisation of post-market surveillance and the advancement of drug safety science.

Dr. Cristina Sofia De Jesus Monteiro
Dr. Samuel Martins Silvestre
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 250 words) can be sent to the Editorial Office for assessment.

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 2900 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

  • adverse drug reaction
  • pharmacovigilance
  • drug safety
  • signal detection
  • risk management

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Published Papers (2 papers)

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Research

19 pages, 1157 KB  
Article
Prescribed Drugs and Interpersonal Violence: A Case–Non-Case Study in the Spanish Pharmacovigilance Database
by Ana Avedillo-Salas, Ana Fanlo-Villacampa, Francisco Javier Lanuza-Giménez and Jorge Vicente-Romero
Pharmaceuticals 2025, 18(12), 1845; https://doi.org/10.3390/ph18121845 - 3 Dec 2025
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Abstract
Background/Objectives: Interpersonal violence is an increasing public health concern, and its prediction and prevention remain global challenges. This study aimed to identify prescribed medications associated with interpersonal violence in Spain. Methods: A descriptive, longitudinal and retrospective study and case-non case study of [...] Read more.
Background/Objectives: Interpersonal violence is an increasing public health concern, and its prediction and prevention remain global challenges. This study aimed to identify prescribed medications associated with interpersonal violence in Spain. Methods: A descriptive, longitudinal and retrospective study and case-non case study of spontaneous reports of adverse drug reactions corresponding to interpersonal violence recorded in the Spanish Pharmacovigilance Database (FEDRA®) from 1984 to 31 March 2021. Results: 533 cases were reported in the study period. The mean age was 46.70 years with ages ranging from 1 to 99 years. There were no sex differences except in child and adolescent age group where most reports were from male. Main therapeutic groups involved were nervous system (62.3%), anti-infectives for systemic use (10%) and respiratory system (8.6%). Mostly drugs reported were montelukast, levetiracetam, bupropion, donepezil, perampanel, quetiapine, fluoxetine, and lorazepam. A statistically significant association/disproportion in the notification has been found in the reporting of interpersonal violence and different drugs according to the literature, notably atomoxetine, perampanel, memantine, donepezil, montelukast and methylphenidate. Conclusions: The results highlight that interpersonal violence, while rare, could occur as a clinically relevant adverse reaction to a small subset of medications. They underscore the importance of careful prescribing, especially in vulnerable populations and in individuals with a history of psychiatric disorders. Full article
(This article belongs to the Special Issue Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety)
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25 pages, 1030 KB  
Article
Real-World Evidence of Neuropsychiatric Adverse Reactions to Isotretinoin: Insights from EudraVigilance (2005–2025)
by Denisa Viola Szilagyi, Delia Mirela Tit, Claudia Teodora Judea-Pusta, Andrei-Flavius Radu, Gabriela S. Bungau, Ada Radu, Laura Maria Endres and Ruxandra-Cristina Marin
Pharmaceuticals 2025, 18(9), 1252; https://doi.org/10.3390/ph18091252 - 24 Aug 2025
Cited by 1 | Viewed by 3973
Abstract
Background/Objectives: Isotretinoin is a highly effective therapy for severe acne, but its potential neuropsychiatric adverse reactions (NPsRs) have been controversial. This study evaluated EudraVigilance data from 2005 to 2025 to better understand the frequency, typology, and predictors of such events. Methods: We conducted [...] Read more.
Background/Objectives: Isotretinoin is a highly effective therapy for severe acne, but its potential neuropsychiatric adverse reactions (NPsRs) have been controversial. This study evaluated EudraVigilance data from 2005 to 2025 to better understand the frequency, typology, and predictors of such events. Methods: We conducted a retrospective analysis of 33,381 individual case safety reports (ICSRs) related to isotretinoin. Using descriptive statistics, chi-square tests, and logistic regression, we assessed associations between NPsRs and variables such as age, sex, geographic region, and reporter type. Results: A total of 9793 cases (29.3%) involved at least one NPsR. Depression (31%) and suicidal ideation (8.6%) were the most frequently reported symptoms. Adolescents (12–17 years) had the highest proportion of NPsR cases, while male patients and reports submitted by non-healthcare professionals were significantly overrepresented. Reports from non-European Economic Area countries also had slightly increased odds of including NPsRs. All predictors were statistically significant in the logistic regression model, though the explained variance was modest (Nagelkerke R2 = 0.065). Conclusions: Neuropsychiatric reactions remain a prominent and persistent signal in isotretinoin pharmacovigilance, particularly among younger patients and non-professional reporters. Although causality cannot be inferred from spontaneous reporting data and confounding factors like acne-related depression cannot be excluded, these findings highlight the clinical value of pre-treatment psychiatric screening, patient-centered education, and proactive mental health monitoring throughout isotretinoin therapy. Full article
(This article belongs to the Special Issue Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety)
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