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

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

Deadline for manuscript submissions: closed (5 March 2021)

Special Issue Editor


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Guest Editor
University of Huddersfield, Huddersfield, UK
Interests: quality and safe use of medicines; pharmacoepidemiology; quantitative synthesis and analyses, scale development & validation

Special Issue Information

Dear Colleagues,

Drug therapy produces both positive (therapeutic effect) and negative effects (adverse events). Pharmacoepidemiology helps us to understand the uses and effects of medicines in populations, aims at improving the appropriateness and safety of drug therapy. This process of understanding the uses and effects of medicines in pharmacoepidemiology is supported by pharmacologic basis and thus bridging pharmacology and epidemiology. Pharmacoepidemiology and pharmacovigilance play a critical role in relating to the collection, assessment, and monitoring of drug therapy and adverse drug events. Because of its importance, many countries have established services to conduct regular audits and to publish reports on the use of medicines and adverse effects at the regional or national level. There is a general acceptance or consensus that pharmacoepidemiology and pharmacovigilance can play a crucial role in providing critical information about drug therapy but there are challenges concerning the methodology and reporting of results. During the novel coronavirus 2019 (COVID-19) pandemic, we have witnessed a surge of interest in drug repositioning or repurposing and this provides an opportunity for researchers to use pharmacoepidemiologic approaches in evaluating drug therapy. These approaches are extensively employed to understand the uses and effects of various drugs used in the treatment and management of COVID-19.

This special issue has the aim to summarize the state-of-the-art, and the latest findings published in the pharmacoepidemiology and drug safety field, as well as to elucidate future directions. The journal invites both reviews and original articles shedding light on the challenges and opportunities in pharmacoepidemiology and pharmacovigilance approaches. Topics include the application of pharmacoepidemiology in understanding the uses and effects of drugs in communicable and non-communicable diseases, challenges in conducting large pharmacoepidemiologic studies, methods used in reporting of adverse events, etc.

Dr. Syed Hasan
Guest Editor

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Keywords

  • pharmacoepidemiology
  • pharmacovigilance
  • adverse events reporting approaches
  • challenges for pharmacoepidemiology
  • opportunities for pharmacoepidemiology

Published Papers (3 papers)

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Research

15 pages, 1525 KiB  
Article
Safety and Tolerability of Mass Diethylcarbamazine and Albendazole Administration for the Elimination of Lymphatic Filariasis in Kenya: An Active Surveillance Study
by Christabel Khaemba, Abbie Barry, Wyckliff P. Omondi, Kefa Bota, Sultani Matendechero, Cecilia Wandera, Fred Siyoi, Elvis Kirui, Margaret Oluka, Pamela Nambwa, Parthasarathi Gurumurthy, Sammy M. Njenga, Anastacia Guantai and Eleni Aklillu
Pharmaceuticals 2021, 14(3), 264; https://doi.org/10.3390/ph14030264 - 15 Mar 2021
Cited by 8 | Viewed by 3928
Abstract
Preventive chemotherapy with diethylcarbamazine citrate (DEC) and albendazole (ALB) is the core intervention strategy to eliminate lymphatic filariasis (LF). We conducted a large-scale prospective active safety surveillance study to identify the incidence, type, severity, and risk factors for adverse events (AEs) following mass [...] Read more.
Preventive chemotherapy with diethylcarbamazine citrate (DEC) and albendazole (ALB) is the core intervention strategy to eliminate lymphatic filariasis (LF). We conducted a large-scale prospective active safety surveillance study to identify the incidence, type, severity, and risk factors for adverse events (AEs) following mass drug administration (MDA) of single-dose DEC and ALB in 10,010 participants from Kilifi County, Kenya. AEs were actively monitored and graded at 24 h, 48 h, and on day 7 Post-MDA. Out of 10,010 enrolled study participants, 1621 participants reported a total of 3102 AEs during a seven-day follow-up. The cumulative incidence of AEs was 16.2% (95% CI, 15.5–16.9%). The proportion of participants who experienced one, two, or ≥three types of AEs was 9.2%, 4.6%, 2.4%, respectively. AEs were mild (87.3%), moderate (12.4%), and severe (0.3%) and resolved within 72 h. The five most common AEs were dizziness (5.9%), headache (5.6%), loss of appetite (3.3%), fever (2.9%), and drowsiness (2.6%). Older age, taking concurrent medications, ≥three tablets of DEC, and type of meal taken before MDA were significant predictors of AEs. One in six participants experienced systemic mild-to-moderate severity grading and transient AEs. DEC and ALB co-administration for the elimination of LF is generally safe and well-tolerated. Full article
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15 pages, 1361 KiB  
Article
Prevalence of Drug-Related Problems and Complementary and Alternative Medicine Use in Malaysia: A Systematic Review and Meta-Analysis of 37,249 Older Adults
by Chee-Tao Chang, Ju-Ying Ang, Md Asiful Islam, Huan-Keat Chan, Wee-Kooi Cheah and Siew Hua Gan
Pharmaceuticals 2021, 14(3), 187; https://doi.org/10.3390/ph14030187 - 25 Feb 2021
Cited by 18 | Viewed by 3960
Abstract
Drug-related problems (DRPs) in the elderly include polypharmacy, potentially inappropriate medications, nonadherence, and drug-related falls. In this systematic review and meta-analysis, the prevalence of DRPs and complementary and alternative medicine (CAM) use among the Malaysian elderly was estimated. PubMed, Scopus, Web of Science, [...] Read more.
Drug-related problems (DRPs) in the elderly include polypharmacy, potentially inappropriate medications, nonadherence, and drug-related falls. In this systematic review and meta-analysis, the prevalence of DRPs and complementary and alternative medicine (CAM) use among the Malaysian elderly was estimated. PubMed, Scopus, Web of Science, and Google Scholar databases were searched to identify studies published since their inception up to 24 August 2020. A random-effects model was used to generate the pooled prevalence of DRPs along with its corresponding 95% confidence interval (CI). The heterogeneity of the results was estimated using the I2 statistics, and Cochran’s Q test and sensitivity analyses were performed to confirm the robustness of the results. We identified 526 studies, 23 of which were included in the meta-analysis. (n = 29,342). The pooled prevalence of DRPs among Malaysian elderly was as follows: (1) polypharmacy: 49.5% [95% CI: 20.5–78.6], (2) potentially inappropriate medications: 28.9% [95% CI: 25.4–32.3], (3) nonadherence to medications: 60.6% [95% CI: 50.2–70.9], and (4) medication-related falls 39.3% [95% CI: 0.0–80.8]. Approximately one in two Malaysian elderly used CAM. The prevalence of polypharmacy and potentially inappropriate medications among the Malaysian elderly population was high, calling for measures and evidence-based guidelines to ensure the safe medication use. Full article
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18 pages, 522 KiB  
Article
Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project
by Giorgia Teresa Maniscalco, Vincenzo Brescia Morra, Ciro Florio, Giacomo Lus, Gioacchino Tedeschi, Maddalena Cianfrani, Renato Docimo, Stefania Miniello, Felice Romano, Leonardo Sinisi, Daniele L. A. Spitaleri, Giuseppe Longo, Ugo Trama, Maria Triassi, FASM Group, Cristina Scavone and Annalisa Capuano
Pharmaceuticals 2020, 13(12), 466; https://doi.org/10.3390/ph13120466 - 15 Dec 2020
Cited by 5 | Viewed by 2546
Abstract
Background and aim: Disease-modifying therapies (DMTs) used in multiple sclerosis (MS) have distinct safety profiles. In this paper, we report preliminary results of an on-going pharmacovigilance project (the FASM study). Results: Neurologists working at involved multiple sclerosis centers collected 272 Individual Case Safety [...] Read more.
Background and aim: Disease-modifying therapies (DMTs) used in multiple sclerosis (MS) have distinct safety profiles. In this paper, we report preliminary results of an on-going pharmacovigilance project (the FASM study). Results: Neurologists working at involved multiple sclerosis centers collected 272 Individual Case Safety Reports (ICSRs). Adverse drug reactions (ADRs) mainly occurred in adult patients and in a higher percentage of women compared to men. No difference was found in ADRs distribution by seriousness. The outcome was reported as favorable in 61% of ICSRs. Out of 272 ICSRs, almost 53% reported dimethyl fumarate, fingolimod and IFN beta 1a as suspected. These medications were commonly associated to the occurrence of ADRs related hematological, gastrointestinal, general, infective or cancer disorders. The median time to event (days) was 177 for dimethyl fumarate, 1058 for fingolimod and 413 for IFN beta 1a. The median time to event for the remaining suspected drugs was 226. Conclusion: We believe that our results, together with those that will be presented at the end of the study, may bring new knowledge concerning the safety profile of DMTs and their proper use. This will provide the opportunity to draw new recommendations both for neurologists and patients. Full article
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