Pharmacoepidemiology and Pharmacovigilance in Drug Therapy: New Issues, Challenges, and Applications

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

Deadline for manuscript submissions: 25 June 2025 | Viewed by 2431

Special Issue Editor


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Guest Editor
Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu Ave. 13, LT-50166 Kaunas, Lithuania
Interests: pharmacovigilance; drug therapy problems; pharmaceutical care

Special Issue Information

Dear Colleagues,

Pharmacoepidemiology and pharmacovigilance are critical disciplines that serve to optimize drug therapy and ensure patient safety through monitoring and evaluating the effects of drugs used across large populations. These fields face evolving challenges and new issues as the pharmaceutical landscape becomes increasingly complex and globalized. Adverse drug reactions (ADRs) and medication errors are a significant health burden, emphasizing the need for robust pharmacovigilance systems in order to mitigate these risks effectively. The challenges are manifold, including the integration of vast amounts of data from electronic health records, patient registries, and other sources, which require sophisticated analytical tools to yield actionable insights. Moreover, the globalization of pharmaceutical markets demands harmonized regulatory frameworks to manage drug safety effectively across different regions with varying health policies. Recent advancements in data analytics, artificial intelligence, and machine learning have revolutionized these fields, enhancing the ability to detect, analyze, and prevent medication-related issues. These technologies facilitate the identification of patterns that might elude traditional analysis, offering the potential to preemptively address safety concerns before they pose significant risks to patients.

In this Special Issue, we are excited to bring together leading research that not only addresses these challenges, but also highlights innovative strategies and tools that are pushing the boundaries of what pharmacoepidemiology and pharmacovigilance can achieve. We aim to explore cutting-edge approaches in drug safety monitoring, regulatory practices, and the application of new technologies that promise to enhance the effectiveness and safety of drug therapies.

This Issue is dedicated to showcasing the latest developments and fostering a dialogue that will propel pharmacoepidemiology and pharmacovigilance into a new era of drug safety and efficacy.

Dr. Loreta Kubilienė
Guest Editor

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Keywords

  • pharmacoepidemiology
  • pharmacovigilance
  • drug safety monitoring
  • regulatory practices
  • hospitalization
  • adverse drug events
  • drug safety
  • preventability

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Published Papers (2 papers)

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22 pages, 1908 KiB  
Article
Real-Life Data on the Safety of Pasireotide in Acromegaly: Insights from EudraVigilance
by Ioana Rada Popa Ilie, Carmen Maximiliana Dobrea, Anca Butuca, Calin Homorodean, Claudiu Morgovan, Andreea Loredana Vonica-Tincu, Felicia Gabriela Gligor, Steliana Ghibu and Adina Frum
Pharmaceuticals 2024, 17(12), 1631; https://doi.org/10.3390/ph17121631 - 4 Dec 2024
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Abstract
Background/Objectives: Pasireotide (PAS) is a somatostatin receptor ligand (SRL) used to treat acromegaly, a chronic condition caused by excess growth hormone. While it offers significant benefits as a second-line treatment for uncontrolled acromegaly, its use raises major concerns due to hyperglycemic side effects [...] Read more.
Background/Objectives: Pasireotide (PAS) is a somatostatin receptor ligand (SRL) used to treat acromegaly, a chronic condition caused by excess growth hormone. While it offers significant benefits as a second-line treatment for uncontrolled acromegaly, its use raises major concerns due to hyperglycemic side effects and gastrointestinal issues, the latter being similar to those seen with first-generation SRLs. The aim of this study is to evaluate the real-world evidence on adverse drug reactions (ADRs) reported for PAS in the EudraVigilance database, in comparison to other established drug-based therapies for acromegaly. Methods: A descriptive analysis and a disproportionality analysis were conducted. Results: The fewest individual case safety reports (ICSRs) and adverse drug reactions (ADRs) were reported for PAS, with 698 (4%) ICSRs and 1,647 (4%) ADRs, which is even lower than for pegvisomant (PEG), which had 1765 (11%) ICSRs and 4842 (10%) ADRs. Both PAS and lanreotide (LAN) exhibited the lowest proportion of cases classified as serious. Among the total reported ADRs, those categorized as “Metabolic and nutrition disorders” were most frequent and severe for PAS (PAS—17.5% vs. OCT—4.6%, LAN—4.5%, and PEG—2.7%). Additionally, PAS demonstrated a higher likelihood of reporting endocrine disorders, which were frequently classified as serious, as well as stones affecting the hepatobiliary system compared to other drugs. Conclusions: Although PAS had the fewest ICSRs and ADRs, and less frequent serious ADRs, it had more reports frequently classified as serious in the “Metabolism and Nutrition Disorders” category (including events such as elevated blood glucose levels or diabetes) and “Endocrine Disorders” category compared to other SRLs and PEG. Furthermore, there was a higher likelihood of reporting hepatobiliary stones with PAS compared to OCT and PEG. This highlights the importance of adequately monitoring glycemic control and the biliary tract through ultrasound at the initiation and during follow-up of PAS therapy. Improved monitoring and reporting of these ADRs could enhance care for patients with acromegaly. Full article
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20 pages, 428 KiB  
Systematic Review
Real-Time Pharmacovigilance: Transforming Population-Based Monitoring of Post-Approval Vaccine Safety Through Rapid Cycle Analysis (RCA)—A Review of the Published Literature
by Sampada Gandhi, Michelle R. Iannacone, Andrea Leapley, Li Wang, Mwedusasa Mtenga, Muhammad Younus and Joanne Wu
Pharmaceuticals 2025, 18(1), 80; https://doi.org/10.3390/ph18010080 - 10 Jan 2025
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Abstract
Background/Objectives: Rapid cycle analysis (RCA) is an established and efficient methodology that has been traditionally utilized by United States health authorities to monitor post-approval vaccine safety. Initially developed in the Vaccine Safety Datalink (VSD) in early 2000s, RCA has evolved into a [...] Read more.
Background/Objectives: Rapid cycle analysis (RCA) is an established and efficient methodology that has been traditionally utilized by United States health authorities to monitor post-approval vaccine safety. Initially developed in the Vaccine Safety Datalink (VSD) in early 2000s, RCA has evolved into a valuable approach for timely post-approval signal detection. Due to the availability of additional near real-time data sources and enhanced analytic approaches, the use of RCA has expanded. This narrative review provides an in-depth assessment of studies that utilized RCA for safety surveillance to detect and evaluate safety signals in post-approval vaccine monitoring. Methods: Embase and Medline were searched on 8 August 2024 to identify post-approval non-interventional vaccine safety studies using RCA or other near real-time surveillance methods published from 1 January 2018 to 31 July 2024. Data on study characteristics (e.g., study population, data source, outcomes) and RCA methodological characteristics (e.g., type of comparator, sequential testing method, confounding control method) were extracted from the eligible RCA studies. Results: Of 1128 articles screened, 18 RCA vaccine safety studies were included, of which 17 (94.4%) were conducted in the United States (US). Twelve (67%) aimed at signal detection and six (33%) conducted further signal evaluation. Over 60% examined COVID-19 vaccine safety, with half using VSD. Over 80% conducted the RCA weekly or monthly and about 78% of the studies used a database-specific historical comparator group. Conclusions: This review indicates that most of the published articles on the application of the RCA methodology in vaccine safety studies are based on research conducted in the US. With increasing availability of near real-time data sources and advanced analytic methods capabilities, RCA is expected to be more widely deployed as an active surveillance tool to complement traditional pharmacovigilance. Future studies should explore the extension of vaccine RCA methodology for non-vaccine medicinal products. Full article
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