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Pharmaceuticals
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Drug Safety and Risk Management in Clinical Practice
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Drug Safety and Risk Management in Clinical Practice

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

Deadline for manuscript submissions: 25 September 2025 | Viewed by 2914

Special Issue Editor

Dr. Andreea Maria Farcas

E-Mail Website
Guest Editor
Pharmacovigilance Research Center, “Iuliu Hatieganu” University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania
Interests: drug safety; drug utilization studies; adherence studies; patient-centered research; risk minimization measure effectiveness

Special Issue Information

Dear Colleagues,

Safety monitoring of drugs throughout their whole life cycle is of paramount importance in order to protect public health and fulfill the whole scope of pharmacovigilance, which is to detect, assess, understand, and prevent adverse effects or any other medicine-/vaccine-related problems. Upon authorization on the market, all medications and vaccines have gone through an extensive clinical trial program to ensure their efficacy and safety. Nevertheless, some adverse effects might not become apparent until after these products have been used for an extended period of time and by a large and diverse population, including those with concurrent illnesses and medications. Therefore, drug safety surveillance through spontaneous reporting systems (SRS) and post-authorization safety studies (PASS) using real-world data will provide information and new insights into the safety profiles of the drugs. Such information must be continuously analyzed, and results should be made available for healthcare professionals and regulatory bodies in case new safety concerns are discovered. If the benefit-risk profile of the drugs is impacted, regulatory authorities can propose risk minimization interventions in order to prevent or reduce adverse effects. This Special Issue welcomes reviews and original papers related to drug safety, such as, but not limited to, studies using active or passive methods for drug/vaccine monitoring (PASS, analysis of data from SRS, including signal detection/disproportionality analysis), studies on risks in special populations, and studies on risk minimization measures, including evaluations of the effectiveness of risk minimization measures.

Dr. Andreea Maria Farcas
Guest Editor

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 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

  • drug safety
  • adverse drug reactions
  • risk minimization measures
  • effectiveness of risk minimization measures
  • drug utilization studies

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Published Papers (3 papers)

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Research

13 pages, 424 KiB  
Article
Impact of Co-Occurring Psychiatric Comorbidities and Substance Use Disorders on Outcomes in Adolescents and Young Adults with Opioid Use Disorder: A Retrospective Cohort Study
by Ligang Liu, Erin R. McKnight, Andrea E. Bonny, Heqing Tao, Pujing Zhao and Milap C. Nahata
Pharmaceuticals 2025, 18(5), 609; https://doi.org/10.3390/ph18050609 - 23 Apr 2025
Viewed by 281
Abstract
Background/Objectives: Adolescents and young adults (AYAs) with opioid use disorder (OUD) frequently have co-occurring psychiatric conditions and substance use disorders (SUDs). This study evaluated the association of psychiatric comorbidities and other SUDs with treatment retention and urine drug test (UDT) results in AYAs [...] Read more.
Background/Objectives: Adolescents and young adults (AYAs) with opioid use disorder (OUD) frequently have co-occurring psychiatric conditions and substance use disorders (SUDs). This study evaluated the association of psychiatric comorbidities and other SUDs with treatment retention and urine drug test (UDT) results in AYAs with OUD. Methods: This retrospective cohort study included AYAs enrolled in the Substance Use Treatment and Recovery clinic from 2009 to 2022. Participants were categorized into four groups: no comorbidities, only mental health disorders, only other SUDs, and both disorders. Treatment outcomes included retention time and UDT results for medication for OUD (MOUD) and illicit substances, including tetrahydrocannabinol (THC). Kruskal–Wallis tests were used to evaluate differences across groups, and regression models identified variables associated with outcomes. Statistical significance was set at p < 0.05. Results: Among 157 patients, the median retention time was 300 days. Depression (p = 0.04), post-traumatic stress disorder (p = 0.002), and alcohol use disorder (p = 0.04) were associated with prolonged retention, whereas cannabis use disorder predicted shorter retention (p = 0.02). The median proportion of positive UDTs was 0.9 for MOUD, 0.1 for illicit substances, and 0.0 for THC. Older age (p = 0.02) and the use of antidepressants and anxiolytics were associated with greater adherence to MOUD. Cannabis use disorder (p = 0.02) and male sex (p = 0.04) predicted positive UDTs for THC, while MOUD use was linked to lower THC positivity (p = 0.02). The main limitations of this study were related to its retrospective study design and single-center setting. Conclusions: Psychiatric and substance use comorbidities significantly influence retention and treatment adherence in AYAs with OUD. Integrated treatment may improve engagement and outcomes. Further research is needed to tailor interventions for AYAs with co-occurring disorders. Full article
(This article belongs to the Special Issue Drug Safety and Risk Management in Clinical Practice)
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17 pages, 1365 KiB  
Article
Oncoral Follow-Up for Outpatients Treated with Oral Anticancer Drugs Assessed by Relative Dose Intensity
by Virginie Larbre, Florence Ranchon, Delphine Maucort-Boulch, Elsa Coz, Chloé Herledan, Anne-Gaëlle Caffin, Amandine Baudouin, Magali Maire, Nicolas Romain-Scelle, Charles-Hervé Vacheron, Lionel Karlin, Gilles Salles, Hervé Ghesquières and Catherine Rioufol
Pharmaceuticals 2025, 18(4), 565; https://doi.org/10.3390/ph18040565 - 13 Apr 2025
Viewed by 226
Abstract
Objectives: The multidisciplinary city-hospital Oncoral follow-up of cancer outpatients has been set up to ensure the safety of oral anticancer drugs (OADs). The aim of this study was to assess Oncoral by Relative Dose Intensity (RDI) in patients with hematological malignancies treated [...] Read more.
Objectives: The multidisciplinary city-hospital Oncoral follow-up of cancer outpatients has been set up to ensure the safety of oral anticancer drugs (OADs). The aim of this study was to assess Oncoral by Relative Dose Intensity (RDI) in patients with hematological malignancies treated with ibrutinib as a model. Methods: The study included all outpatients treated with ibrutinib and followed in Oncoral between January 2016 and June 2020. Patients benefited from interviews leading to pharmacist and nurse interventions (PNI) on drug-related problems as adverse events (AE), drug–drug interactions (DDI), and drug intake. Results: In total, 83 patients were enrolled. At least one PNI was performed for 86.7%, focusing on drug intake and DDIs (54.5%), the management of AEs (27.0%), and community–hospital coordination (18.5%). Major DDIs with ibrutinib were found in 10 patients, with at least one moderate interaction in 28%. Grade 3–4 AEs mainly concerned cytopenia and infection. Adherence tended to decrease after the first 6 months. At 6 months, the mean RDI was 93.7 ± 11.3%; RDI reductions occurred in 43% patients. RDI was lower in patients who discontinued treatment before day 90 and worsened over time in patients still being treated at month 6 (Friedman’s test, p < 0.01). Age and gender were predictors of early treatment termination (OR 1.10 [1.03; 1.19] and 6.44 [1.65; 37.21]). The estimates of 30-month OS and PFS were 73.8% (95% CI [64.7%; 84.2%]) and 61.8% (95% CI [51.8%; 73.7%]). Conclusions: The Oncoral follow-up is a secure, coordinated pathway assessed by RDI. Multidisciplinary follow-up should be the gold-standard for outpatients receiving OADs. Full article
(This article belongs to the Special Issue Drug Safety and Risk Management in Clinical Practice)
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15 pages, 1154 KiB  
Article
Safety of Inclisiran: A Disproportionality Analysis from the EudraVigilance Database
by Giuseppe Cicala, Michelangelo Rottura, Viviana Maria Gianguzzo, Federica Cristiano, Selene Francesca Anna Drago, Giovanni Pallio, Natasha Irrera, Egidio Imbalzano, Edoardo Spina and Vincenzo Arcoraci
Pharmaceuticals 2024, 17(10), 1365; https://doi.org/10.3390/ph17101365 - 12 Oct 2024
Cited by 1 | Viewed by 1882
Abstract
Introduction: The discovery of serine protease proprotein convertase subtilisin-kexin type 9 (PCSK9) has revolutionized pharmacological lipid-lowering treatments. The first PCSK9 antagonists (PCSK9-A), evolocumab and alirocumab, were approved in 2015. Targeting PCSK9 synthesis marked a major advancement in this field, leading to the development [...] Read more.
Introduction: The discovery of serine protease proprotein convertase subtilisin-kexin type 9 (PCSK9) has revolutionized pharmacological lipid-lowering treatments. The first PCSK9 antagonists (PCSK9-A), evolocumab and alirocumab, were approved in 2015. Targeting PCSK9 synthesis marked a major advancement in this field, leading to the development of inclisiran, a long-acting siRNA targeting PCSK9 mRNA. However, real-world safety data on this drug are still limited. Therefore, this study aims to provide a real-world safety evaluation of inclisiran, comparing its characteristics to those of PCSK9-As. Methods: A retrospective pharmacovigilance study was conducted using EudraVigilance (EV). Inclisiran-related individual case safety reports (I-ICSRs) from 01/01/2021 to 06/30/2023 were retrieved. ICSRs for evolocumab or alirocumab from 01/01/2015 to 06/30/2023 were collected as a reference group (RG). ADRs were classified using the MedDRA dictionary. Data were evaluated using descriptive and disproportionality analyses. Crude reporting odds ratio (ROR) with 95% confidence intervals (CI) were used as disproportionality measures. Results: Of the 15,236 ICSRs, 3.7% (n = 563) involved inclisiran, with the rest in the RG. Most I-ICSRs involved female patients (51.7%) aged 18 to 64 (52.8%). The most-reported ADRs for inclisiran were “general disorders and administration site conditions” (n = 347) and “investigations” (n = 277). Significant disproportionality was found in I-ICSRs compared to the RG for “Myalgia” (ROR: 2.43; 95% CI: 1.94–3.04), “Low-density lipoprotein increased” (ROR: 11.95; 95% CI: 9.10–15.52), and “Drug ineffective” (ROR: 6.37; 95% CI: 4.64–8.74). Conclusions: The inclisiran safety profile aligns with the existing literature and pre-commercial data. However, further studies are needed to fully understand the observed differences with PCSK9-As. Full article
(This article belongs to the Special Issue Drug Safety and Risk Management in Clinical Practice)
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