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Pharmaceuticals
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Drug Safety and Relevant Issues in the Real-World 2024
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Drug Safety and Relevant Issues in the Real-World 2024

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

Deadline for manuscript submissions: 25 February 2025 | Viewed by 11480

Special Issue Editors

Dr. Maria Antonietta Barbieri

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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
Special Issues, Collections and Topics in MDPI journals
Dr. Natasha Irrera

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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

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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 Issues, Collections and Topics in MDPI journals

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

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Published Papers (6 papers)

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Research

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14 pages, 457 KiB  
Article
Persistence in the Methadone Maintenance Program and Its Relationship with the Medication Regimen Complexity Index in Opioid-Dependent Patients
by Elena Alba Álvaro-Alonso, María del Carmen Gómez-Álvarez, Beatriz Segovia-Tapiador, María Isabel Del-Pino-Illaconza, Jorge Valencia, Pablo Ryan, Antonio Aguilar-Ros and Ismael Escobar-Rodríguez
Pharmaceuticals 2024, 17(5), 567; https://doi.org/10.3390/ph17050567 - 29 Apr 2024
Viewed by 1258
Abstract
It has been shown that the Medication Regimen Complexity Index (MRCI) is a useful and reliable tool for calculating the complexity of the pharmacotherapeutic regimen (CPR). Furthermore, a high MRCI is associated with lower adherence. However, the MRCI of opioid-dependent patients (ODP) has [...] Read more.
It has been shown that the Medication Regimen Complexity Index (MRCI) is a useful and reliable tool for calculating the complexity of the pharmacotherapeutic regimen (CPR). Furthermore, a high MRCI is associated with lower adherence. However, the MRCI of opioid-dependent patients (ODP) has not been studied. The aim of this study is to calculate the Methadone Maintenance Program (MMP) persistence and the MRCI score in a ODP cohort. Second, to analyze its relationship and association with other variables. To accomplish this research, an observational study including adults with a confirmed diagnosis of opiate-dependency according to the DSM-5 in a MMP center was carried out. To define MMP-persistence, a group was created by the researchers who defined five weighted items according to their agreed importance. Our first contribution was to create a new definition of MMP-persistence. This study also identified age, comorbidities, and received methadone maintenance doses as successful predictors for MMP-persistence. We have also shown that the MRCI does not seem to be a useful tool to determine MMP-persistence, probably because there are multiple factors that influence it in addition to the CPR. It is necessary to continue searching for more precise selection and stratification tools for ODP to improve their persistence. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World 2024)
20 pages, 1736 KiB  
Article
Comprehensive Analysis of Drug Utilization Patterns, Gender Disparities, Lifestyle Influences, and Genetic Factors: Insights from Elderly Cohort Using g-Nomic® Software
by Bárbara Rodríguez Castillo, Marc Cendrós, Carlos J. Ciudad and Ana Sabater
Pharmaceuticals 2024, 17(5), 565; https://doi.org/10.3390/ph17050565 - 28 Apr 2024
Viewed by 1380
Abstract
Polypharmacy is a global healthcare concern, especially among the elderly, leading to drug interactions and adverse reactions, which are significant causes of death in developed nations. However, the integration of pharmacogenetics can help mitigate these risks. In this study, the data from 483 [...] Read more.
Polypharmacy is a global healthcare concern, especially among the elderly, leading to drug interactions and adverse reactions, which are significant causes of death in developed nations. However, the integration of pharmacogenetics can help mitigate these risks. In this study, the data from 483 patients, primarily elderly and polymedicated, were analyzed using Eugenomic®’s personalized prescription software, g-Nomic®. The most prescribed drug classes included antihypertensives, platelet aggregation inhibitors, cholesterol-lowering drugs, and gastroprotective medications. Drug–lifestyle interactions primarily involved inhibitions but also included inductions. Interactions were analyzed considering gender. Significant genetic variants identified in the study encompassed ABCB1, SLCO1B1, CYP2C19, CYP2C9, CYP2D6, CYP3A4, ABCG2, NAT2, SLC22A1, and G6PD. To prevent adverse reactions and enhance medication effectiveness, it is strongly recommended to consider pharmacogenetics testing. This approach shows great promise in optimizing medication regimens and ultimately improving patient outcomes. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World 2024)
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12 pages, 479 KiB  
Article
Discrepancies in Electronic Medical Prescriptions Found in a Hospital Emergency Department: A Prospective Observational Study
by David García González, Paulo Teixeira-da-Silva, Juan José Salvador Sánchez, Jesús Ángel Sánchez Serrano, M. Victoria Calvo and Ana Martín-Suárez
Pharmaceuticals 2024, 17(4), 460; https://doi.org/10.3390/ph17040460 - 3 Apr 2024
Viewed by 1051
Abstract
The medication in an electronic prescribing system (EPS) does not always match the patient’s actual medication. This prospective study analyzes the discrepancies (any inconsistency) between medication prescribed using an EPS and the medication revised by the clinical pharmacist upon admission to the observation [...] Read more.
The medication in an electronic prescribing system (EPS) does not always match the patient’s actual medication. This prospective study analyzes the discrepancies (any inconsistency) between medication prescribed using an EPS and the medication revised by the clinical pharmacist upon admission to the observation area of the emergency department (ED). Adult patients with multimorbidity and/or polypharmacy were included. The pharmacist used multiple sources to obtain the revised medication list, including patient/carer interviews. A total of 1654 discrepancies were identified among 1131 patients. Of these patients, 64.5% had ≥1 discrepancy. The most common types of discrepancy were differences in posology (43.6%), commission (34.7%), and omission (20.9%). Analgesics (11.1%), psycholeptics (10.0%), and diuretics (8.9%) were the most affected. Furthermore, 52.5% of discrepancies affected medication that was high-alert for patients with chronic illnesses and 42.0% of medication involved withdrawal syndromes. Discrepancies increased with the number of drugs (ρ = 0.44, p < 0.01) and there was a difference between non-polypharmacy patients, polypharmacy ones and those with extreme polypharmacy (p < 0.01). Those aged over 75 years had a higher number of prescribed medications and discrepancies occurred more frequently compared with younger patients. The number of discrepancies was larger in women than in men. The EPS medication record requires verification from additional sources, including patient and/or carer interviews. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World 2024)
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17 pages, 1882 KiB  
Article
Digital Technology Applications in the Management of Adverse Drug Reactions: Bibliometric Analysis
by Olena Litvinova, Andy Wai Kan Yeung, Fabian Peter Hammerle, Michel-Edwar Mickael, Maima Matin, Maria Kletecka-Pulker, Atanas G. Atanasov and Harald Willschke
Pharmaceuticals 2024, 17(3), 395; https://doi.org/10.3390/ph17030395 - 19 Mar 2024
Cited by 2 | Viewed by 2577
Abstract
Adverse drug reactions continue to be not only one of the most urgent problems in clinical medicine, but also a social problem. The aim of this study was a bibliometric analysis of the use of digital technologies to prevent adverse drug reactions and [...] Read more.
Adverse drug reactions continue to be not only one of the most urgent problems in clinical medicine, but also a social problem. The aim of this study was a bibliometric analysis of the use of digital technologies to prevent adverse drug reactions and an overview of their main applications to improve the safety of pharmacotherapy. The search was conducted using the Web of Science database for the period 1991–2023. A positive trend in publications in the field of using digital technologies in the management of adverse drug reactions was revealed. A total of 72% of all relevant publications come from the following countries: the USA, China, England, India, and Germany. Among the organizations most active in the field of drug side effect management using digital technologies, American and Chinese universities dominate. Visualization of publication keywords using VOSviewer software 1.6.18 revealed four clusters: “preclinical studies”, “clinical trials”, “pharmacovigilance”, and “reduction of adverse drug reactions in order to improve the patient’s quality of life”. Molecular design technologies, virtual models for toxicity modeling, data integration, and drug repurposing are among the key digital tools used in the preclinical research phase. Integrating the application of machine learning algorithms for data analysis, monitoring of electronic databases of spontaneous messages, electronic medical records, scientific databases, social networks, and analysis of digital device data into clinical trials and pharmacovigilance systems, can significantly improve the efficiency and safety of drug development, implementation, and monitoring processes. The result of combining all these technologies is a huge synergistic provision of up-to-date and valuable information to healthcare professionals, patients, and health authorities. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World 2024)
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15 pages, 617 KiB  
Article
Safety of Dual Orexin Receptor Antagonist Daridorexant: A Disproportionality Analysis of Publicly Available FAERS Data
by Giuseppe Cicala, Maria Antonietta Barbieri, Giulia Russo, Francesco Salvo and Edoardo Spina
Pharmaceuticals 2024, 17(3), 342; https://doi.org/10.3390/ph17030342 - 6 Mar 2024
Cited by 2 | Viewed by 2186
Abstract
Daridorexant (dari), as the first dual orexin receptor antagonist (DORA) marketed in Europe, offers a novel therapeutic approach to insomnia. However, data regarding its real-world safety are scarce. Thus, this study was aimed at assessing its safety profile using a large-scale pharmacovigilance database. [...] Read more.
Daridorexant (dari), as the first dual orexin receptor antagonist (DORA) marketed in Europe, offers a novel therapeutic approach to insomnia. However, data regarding its real-world safety are scarce. Thus, this study was aimed at assessing its safety profile using a large-scale pharmacovigilance database. Dari-related adverse drug reaction (ADR) reports from the Food and Drug Administration Adverse Event Reporting System were scrutinized, and ADRs were selected using reporting odds ratio (ROR) as a measure of disproportionality. Frequencies of events related to dari were compared to all other drugs (reference group, RG1) and only to other DORAs (RG2). Only significant disproportionalities to both RGs were evaluated in-depth. A total of 845 dari-related reports were selected; nightmares (n = 146; dari vs. RG1: ROR = 113.74; 95%CI [95.13, 136]; dari vs. RG2: ROR = 2.35; 95 CI% [1.93, 2.85]), depression (n = 22; dari vs. RG1: 2.13; [1.39, 3.25]; dari vs. RG2: ROR = 2.31; 95 CI% [1.45, 3.67]), and hangover (n = 20; dari vs. RG1: ROR = 127.92; 95 CI% [81.98, 199.62]; and dari vs. RG2: 3.38; [2.04, 5.61]) were considered as safety signals. These data provide valuable insights into the real-world safety profile of daridorexant, supporting the existence of safety signals related to nightmares, depression, and hangovers. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World 2024)
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Review

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26 pages, 1345 KiB  
Review
Misuse, Abuse and Medication Errors’ Adverse Events Associated with Opioids—A Systematic Review
by Moa Gustafsson, Vítor Silva, Carolina Valeiro, João Joaquim, Florence van Hunsel and Cristiano Matos
Pharmaceuticals 2024, 17(8), 1009; https://doi.org/10.3390/ph17081009 - 31 Jul 2024
Cited by 3 | Viewed by 1830
Abstract
Opioids are the strongest analgesics available and are crucial in the treatment of acute and chronic pain. The line between these critical medications and how they are used beyond standard therapeutics in cases such as abuse, misuse, and medication errors needs to be [...] Read more.
Opioids are the strongest analgesics available and are crucial in the treatment of acute and chronic pain. The line between these critical medications and how they are used beyond standard therapeutics in cases such as abuse, misuse, and medication errors needs to be understood, as it affects their safety, efficacy, and manner of use. The aim of this systematic review was to identify what is known about the adverse events resulting from the abuse, misuse, and medication errors associated with opioid use. A systematic search was conducted in the PubMed®, Scopus® and, EBSCO® databases to retrieve studies from the inception to December 2023 reporting abuse, misuse, and medication errors associated with medicinal opioid use. Two authors independently screened titles and abstracts and full text according to eligibility using Covidence® software. Full articles were examined by two independent reviewers, and disagreements were resolved by a third reviewer. The risk of bias was assessed by the JBI’s critical appraisal tools. A total of 934 articles were screened by their title and abstract. Then, 151 articles were selected for full text screening. Of these, 34 studies were eligible for inclusion in this review. The included studies varied significantly in their population sizes, ranging from 9 individuals to 298,433 patients, and encompassed a diverse demographic, including all ages and both sexes. The studies consistently reported a range of adverse events associated with opioid use. Fentanyl, morphine, oxycodone, tramadol, and hydrocodone were frequently implicated. The data heterogeneity in this field resulted in challenges in drawing conclusions. The review highlights that some opioids, particularly fentanyl, morphine, and oxycodone, are frequently associated with preventable adverse drug reactions, abuse, and medication errors, underscoring the need for robust preventative measures and ongoing research to mitigate opioid-related harm. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World 2024)
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