Drug Safety and Relevant Issues in the Real-World

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

Deadline for manuscript submissions: closed (30 September 2023) | Viewed by 23847

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Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy
Interests: pharmacovigilance; pharmacoepidemiology; real-world data; adverse drug reactions; post-marketing surveillance
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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

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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 setting. 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

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Keywords

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

Published Papers (14 papers)

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Editorial

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4 pages, 203 KiB  
Editorial
Drug Safety and Relevant Issues in the Real-World
by Maria Antonietta Barbieri, Natasha Irrera and Irma Convertino
Pharmaceuticals 2023, 16(12), 1689; https://doi.org/10.3390/ph16121689 - 05 Dec 2023
Viewed by 771
Abstract
The global impact of the COVID-19 pandemic has underscored the pivotal role of drug safety and effective communication within the realm of pharmacovigilance, particularly in times of unprecedented public health emergencies [...] Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)

Research

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15 pages, 299 KiB  
Article
Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System
by Elena Mirabela Velișcu, Valerio Liguori, Antonietta Anatriello, Giorgia Teresa Maniscalco, Andrea Cantone, Luigi Di Costanzo, Pasquale Stefanelli, Cristina Scavone and Annalisa Capuano
Pharmaceuticals 2023, 16(8), 1071; https://doi.org/10.3390/ph16081071 - 27 Jul 2023
Cited by 2 | Viewed by 1426
Abstract
Background. Cladribine belongs to the group of disease-modifying therapies (DMTs) used to treat multiple sclerosis (MS). According to the highlights of a meeting held by the Pharmacovigilance Risk Assessment Committee (PRAC) on 14 January 2022, cladribine may be associated with the occurrence of [...] Read more.
Background. Cladribine belongs to the group of disease-modifying therapies (DMTs) used to treat multiple sclerosis (MS). According to the highlights of a meeting held by the Pharmacovigilance Risk Assessment Committee (PRAC) on 14 January 2022, cladribine may be associated with the occurrence of liver injury, and thus liver function monitoring is recommended. Objectives and methods. Using data from the European spontaneous reporting database (EudraVigilance-EV), we aimed to describe the main characteristics of Individual Case Safety Reports (ICSRs) reporting cases of hepatobiliary disorders related to cladribine. The reporting odds ratio (ROR) was calculated to provide the probability of reporting hepatobiliary ICSRs among DMTs used to treat MS. Results. Overall, 118 ICSRs described the occurrence of cladribine-induced hepatobiliary ADRs. The majority of the ICSRs reported ADRs that were classified as serious (93%), and the outcome was mostly reported as “unknown” (50.8%). The most reported hepatobiliary disorders were drug-induced liver injury, abnormal hepatic function, ALT increases, liver disorders, hepatic failure, jaundice, lymphocyte count decreases, hepatotoxicity and hypertransaminasemia. The majority of cladribine-induced hepatic ADRs occurred in female patients belonging to the age group of 18–65 years. Conclusion. Considering the seriousness of cladribine-induced hepatic ADRs, a close monitoring of patients receiving this drug is highly recommended. In this context, further pharmacovigilance studies evaluating the hepatic safety profile of cladribine are strongly needed. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
17 pages, 695 KiB  
Article
Results of Induction of Labor with Prostaglandins E1 and E2 (The RIPE Study): A Real-World Data Analysis of Obstetrical Effectiveness and Clinical Outcomes of Pharmacological Induction of Labor with Vaginal Inserts
by Maciej W. Socha, Wojciech Flis, Miłosz Pietrus and Mateusz Wartęga
Pharmaceuticals 2023, 16(7), 982; https://doi.org/10.3390/ph16070982 - 08 Jul 2023
Cited by 1 | Viewed by 2301
Abstract
Despite extensive knowledge of the mechanisms responsible for childbirth, the course of labor induction is often unpredictable. Therefore, labor induction protocols using prostaglandin analogs have been developed and tested to assess their effectiveness in labor induction unequivocally. A total of 402 women were [...] Read more.
Despite extensive knowledge of the mechanisms responsible for childbirth, the course of labor induction is often unpredictable. Therefore, labor induction protocols using prostaglandin analogs have been developed and tested to assess their effectiveness in labor induction unequivocally. A total of 402 women were collected into two groups—receiving vaginal Misoprostol or vaginal Dinoprostone for induction of labor (IOL). Then, the patients were compared in groups depending on the agent they received and their gestational age. Most patients delivered within 48 h, and most of these patients had vaginal parturition. Patients who received the Dinoprostone vaginal insert required statistically significantly more oxytocin administration than patients who received the Misoprostol vaginal insert. Patients who received the Misoprostol vaginal insert used anesthesia during labor statistically more often. Patients who received Misoprostol vaginal inserts had a statistically significantly shorter time to delivery than those with Dinoprostone vaginal inserts. The prevalence of hyperstimulation was similar in all groups and remained low. Vaginal Misoprostol-based IOL is characterized by a shortened time to delivery irrespective of the parturition type, and a lower need for oxytocin augmentation, but also by an increased demand for intrapartum analgesia administration. A vaginal Dinoprostone-based IOL protocol might be considered a more harmonious and desirable option in modern perinatal care. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
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12 pages, 282 KiB  
Article
Gender Differences in Potentially Inappropriate Medication Use among Older Adults
by Monira Alwhaibi and Bander Balkhi
Pharmaceuticals 2023, 16(6), 869; https://doi.org/10.3390/ph16060869 - 12 Jun 2023
Cited by 3 | Viewed by 1292
Abstract
Background: Use of potentially inappropriate medication (PIMs) is a prominent concern that leads to significant medication-related issues among older adults. Notably, older women tend to utilize more medicines than men; older women frequently take more drugs. In addition, some evidence suggests that prescription [...] Read more.
Background: Use of potentially inappropriate medication (PIMs) is a prominent concern that leads to significant medication-related issues among older adults. Notably, older women tend to utilize more medicines than men; older women frequently take more drugs. In addition, some evidence suggests that prescription PIMs vary by gender. This study examines the gender-based variation in prescribing PIM among older adults in Saudi Arabia. Methods: A cross-sectional retrospective analysis of electronic medical records from a large hospital in Saudi Arabia was carried out. Patients over the age of 65 who received ambulatory treatment were included in the study. The utilization of PIM was assessed based on Beers criteria. Descriptive statistics and logistic regression were employed to describe patterns of PIM utilization and identify factors associated with their use. All statistical analyses were performed using Version 9.4 of the Statistical Analysis Software (SAS® 9.4). Results: The study comprised 4062 older people (age 65) who visited ambulatory care clinics; the average age was (72.6 ± 6.2) years. The majority of the study sample was women (56.8%). Among older adults, 44.7% of older men and 58.3% of older women reported having PIMs that should be avoided, indicating a higher prevalence of PIMs among women compared to men. In terms of the PIM categories used, women had a much higher utilization rate of cardiovascular and gastrointestinal drugs than men. In men, the use of PIMs was frequently associated with hypertension, ischemic heart disease, asthma, osteoarthritis, and cancer, while in women PIM use was associated with age, dyslipidemia, chronic kidney disease, and osteoporosis. Conclusions: This study revealed sex differences in PIM prescribing among older adults; PIM use is more common among women. Sex differences exist in clinical and socioeconomic characteristics and factors related to using potentially inappropriate medications. This study revealed essential areas that could be targeted by further interventions to improve drug-prescribing practices among older adults at risk of PIM. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
16 pages, 1610 KiB  
Article
The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity
by Eman Mostafa Hamed, Ahmed R. N. Ibrahim, Mohamed Hussein Meabed, Ahmed M. Khalaf, Doaa Mohamed El Demerdash, Marwa O. Elgendy, Haitham Saeed, Heba F. Salem and Hoda Rabea
Pharmaceuticals 2023, 16(6), 868; https://doi.org/10.3390/ph16060868 - 12 Jun 2023
Cited by 4 | Viewed by 1490
Abstract
Immune thrombocytopenia (ITP) treatment has evolved recently. However, none of the treatments have only benefits without drawbacks. This study aimed to compare the clinical outcomes and adverse drug patterns of Eltrombopag, Romiplostim, Prednisolone + Azathioprine, High Dose-dexamethasone (HD-DXM) (control group), and Rituximab in [...] Read more.
Immune thrombocytopenia (ITP) treatment has evolved recently. However, none of the treatments have only benefits without drawbacks. This study aimed to compare the clinical outcomes and adverse drug patterns of Eltrombopag, Romiplostim, Prednisolone + Azathioprine, High Dose-dexamethasone (HD-DXM) (control group), and Rituximab in primary ITP Egyptian patients. All patients were initiated with corticosteroids, HD-DXM, as a first-line treatment for the first month immediately following diagnosis. Four hundred sixty-seven ITP patients were randomly assigned to five groups. The outcome measures were judged at baseline, at the end of treatment (6 months), and after an additional 6-month free treatment period. The follow-up period for which relapse is noted was 6 months after the end of treatment. Eltrombopag and Romiplostim resulted in a significantly higher incidence of sustained response than Rituximab, HD-DXM, and Prednisolone + Azathioprine (55.2% and 50.6% vs. 29.2%, 29.1%, and 18%, respectively; p-value < 0.001). More patients on immunomodulators (Prednisolone+ Azathioprine, HD-DXM, and Rituximab) relapsed than those on Romiplostim and Eltrombopag (81.9%, 70.8%, and 70.7% vs. 49.3%, and 44.7%, respectively; p-value < 0.01). We also describe 23 reports of pulmonary hypertension with Prednisolone+ Azathioprine and 13 reports with HD-DXM. The thrombotic events occurred in 16.6% and 13% of patients who received Eltrombopag and Romiplostim treatment, respectively. Most patients had at least one or two risk factors (92.8% of cases). Corticosteroids are effective first-line therapy in primary ITP patients. However, relapse is frequent. Eltrombopag and Romiplostim are safer and more effective than Prednisolone, HD-DXM, and Rituximab. They might be reasonable beneficial options after a one-month HD-DXM regimen. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
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10 pages, 745 KiB  
Article
Prescriptive Appropriateness: Inhospital Adherence to Proton Pump Inhibitors Deprescription Flow Chart
by Giammarco Baiardi, Giulia Calvini, Serena Panarello, Chiara Fioravanti, Manuela Stella, Antonietta Martelli, Giancarlo Antonucci and Francesca Mattioli
Pharmaceuticals 2023, 16(5), 635; https://doi.org/10.3390/ph16050635 - 22 Apr 2023
Viewed by 1209
Abstract
The prescriptive appropriateness of Proton Pump Inhibitors (PPIs) in polypharmacy is controversial. PPIs are often overprescribed and the risk of prescribing errors and adverse drug reactions increases for each additional drug added to therapy. Hence, guided deprescription should be considered and easily implementable [...] Read more.
The prescriptive appropriateness of Proton Pump Inhibitors (PPIs) in polypharmacy is controversial. PPIs are often overprescribed and the risk of prescribing errors and adverse drug reactions increases for each additional drug added to therapy. Hence, guided deprescription should be considered and easily implementable in ward practice. This observational prospective study evaluated the implementation of a validated PPIs deprescription flow chart to real-life internal ward activity through the presence of a clinical pharmacologist as an enhancing additional factor by assessment of inhospital prescriber’s adherence to the proposed flow chart. Patients’ demographics and prescribing trends of PPIs prescriptions were analyzed by descriptive statistics. The final analysis of data included ninety-eight patients (forty-nine male and forty-nine female), aging 75.6 ± 10.6 years; 55.1% of patients had home-PPIs prescriptions, while 44.9% received inhospital-PPIs prescriptions. Evaluation of prescriber’s adherence to the flow chart revealed that the percentage of patients with a prescriptive/deprescriptive pathway conforming to that of the flow chart was 70.4%, with low symptomatologic recurrences. The clinical pharmacologists’ presence and influence in ward activity may have contributed to this finding, since continuous training of the prescribing physicians is deemed a success-related factor in the deprescribing strategy. Multidisciplinary management of PPIs deprescription protocols shows high adherence by prescribers in real-life hospital settings and low recurrence events. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
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11 pages, 730 KiB  
Article
Effectiveness and Safety Profile of Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Real-Life Data in Tertiary Care
by Cosimo Galletti, Maria Antonietta Barbieri, Francesco Ciodaro, Francesco Freni, Francesco Galletti, Edoardo Spina and Bruno Galletti
Pharmaceuticals 2023, 16(4), 630; https://doi.org/10.3390/ph16040630 - 21 Apr 2023
Cited by 9 | Viewed by 3168
Abstract
Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by a type 2 pattern of inflammation resulting in the production of some cytokines. Dupilumab radically changes the treatment of CRSwNP, but, considering its recent approval, it may be useful to evaluate its safety profile [...] Read more.
Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by a type 2 pattern of inflammation resulting in the production of some cytokines. Dupilumab radically changes the treatment of CRSwNP, but, considering its recent approval, it may be useful to evaluate its safety profile in a real-world setting. This work aimed to prospectively highlight the effectiveness and safety profile of dupilumab in patients with CRSwNP enrolled in the Otorhinolaryngology Unit of the University Hospital of Messina. An observational cohort study was carried out considering all patients treated with dupilumab. A descriptive analysis was conducted reporting all demographic characteristics, endoscopic evaluations, and symptom conditions. A total of 66 patients were treated with dupilumab, but three patients were excluded due to a lack of adherence during the observational period. A statistically significant reduction in the Sino-Nasal Outcome Test 22 (SNOT-22) and nasal polyps score (NPS) was shown at the 6th and 12th months compared to baseline values (SNOT-22, −37 and −50, p < 0.001 for both comparisons; NPS, −3 and −4, p < 0.001 for both comparisons). During the follow-up, eight patients (12.7%) had a reaction at the site of injection, and seven (11.1%) had transient hypereosinophilia. Given the optimal treatment response and the minimal adverse effects observed, clinicians should consider dupilumab a safe and effective treatment. Further studies are necessary to better understand the long-term effects. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
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18 pages, 2431 KiB  
Article
Trends in the Use of Driving-Impairing Medicines According to the DRUID Category: A Population-Based Registry Study with Reference to Driving in a Region of Spain between 2015 and 2019
by Eduardo Gutiérrez-Abejón, Paloma Criado-Espegel, M. Aránzazu Pedrosa-Naudín, Diego Fernández-Lázaro, Francisco Herrera-Gómez and F. Javier Álvarez
Pharmaceuticals 2023, 16(4), 508; https://doi.org/10.3390/ph16040508 - 29 Mar 2023
Cited by 1 | Viewed by 1184
Abstract
The European DRUID (Drive Under the Influence of drugs, alcohol, and medicines) program classifies medications into three categories according to their effect on one’s fitness to drive. The trend in the use of driving-impairing medicines (DIMs) in a region of Spain between 2015 [...] Read more.
The European DRUID (Drive Under the Influence of drugs, alcohol, and medicines) program classifies medications into three categories according to their effect on one’s fitness to drive. The trend in the use of driving-impairing medicines (DIMs) in a region of Spain between 2015 and 2019 was analyzed through a population-based registry study. Pharmacy dispensing records for DIMs are provided. The use of DIMs on drivers was weighted according to the national driver’s license census. The analysis was performed considering the population distribution by age and sex, treatment length, and the three DRUID categories. DIMs were used by 36.46% of the population and 27.91% of drivers, mainly chronically, with considerable daily use (8.04% and 5.34%, respectively). Use was more common in females than in males (42.28% vs. 30.44%) and increased with age. Among drivers, consumption decreases after 60 years of age for females and after 75 years of age for males. There was a 34% increase in the use of DIMs between 2015 and 2019, with a focus on daily use (>60%). The general population took 2.27 ± 1.76 DIMs, fundamentally category II (moderate influence on fitness to drive) (20.3%) and category III (severe influence on fitness to drive) (19.08%). The use of DIMs by the general population and drivers is significant and has increased in recent years. The integration of the DRUID classification into electronic prescription tools would assist physicians and pharmacists in providing adequate information to the patient about the effects of prescribed medications on their fitness to drive. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
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11 pages, 271 KiB  
Article
Drug-Utilization, Healthcare Facilities Accesses and Costs of the First Generation of JAK Inhibitors in Rheumatoid Arthritis
by Irma Convertino, Valentina Lorenzoni, Rosa Gini, Giuseppe Turchetti, Elisabetta Fini, Sabrina Giometto, Claudia Bartolini, Olga Paoletti, Sara Ferraro, Emiliano Cappello, Giulia Valdiserra, Marco Bonaso, Corrado Blandizzi, Marco Tuccori and Ersilia Lucenteforte
Pharmaceuticals 2023, 16(3), 465; https://doi.org/10.3390/ph16030465 - 21 Mar 2023
Cited by 2 | Viewed by 1524
Abstract
This study is aimed at describing tofacitinib and baricitinib users by characterizing their prescription and healthcare histories, drug and healthcare utilization patterns, and direct costs from a healthcare system perspective. This retrospective cohort study was performed using Tuscan administrative healthcare databases, which selected [...] Read more.
This study is aimed at describing tofacitinib and baricitinib users by characterizing their prescription and healthcare histories, drug and healthcare utilization patterns, and direct costs from a healthcare system perspective. This retrospective cohort study was performed using Tuscan administrative healthcare databases, which selected two groups of Janus kinase inhibitors (JAKi) incident users (index date) from 1st January 2018 to 31 December 2019 and from 1 January 2018 to 30 June 2019. We included patients ≥18 years old, at least 10 years of data, and six months of follow-up. In the first analysis, we describe mean time, standard deviation (SD), from the first-ever disease-modifying antirheumatic drug (DMARD) to the JAKi, and costs of healthcare facilities and drugs in the 5 years preceding the index date. In the second analysis, we assessed Emergency Department (ED) accesses and hospitalizations for any causes, visits, and costs in the follow-up. In the first analysis, 363 incident JAKi users were included (mean age 61.5, SD 13.6; females 80.7%, baricitinib 78.5%, tofacitinib 21.5%). The time to the first JAKi was 7.2 years (SD 3.3). The mean costs from the fifth to the second year before JAKi increased from 4325 € (0; 24,265) to 5259 € (0; 41,630) per patient/year, driven by hospitalizations. We included 221 incident JAKi users in the second analysis. We observed 109 ED accesses, 39 hospitalizations, and 64 visits. Injury and poisoning (18.3%) and skin (13.8%) caused ED accesses, and cardiovascular (69.2%) and musculoskeletal (64.1%) caused hospitalizations. The mean costs were 4819 € (607.5; 50,493) per patient, mostly due to JAKi. In conclusion, the JAKi introduction in therapy occurred in compliance with RA guidelines and the increase in costs observed could be due to a possible selective prescription. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
14 pages, 1540 KiB  
Article
Epidemiology, Patients’ Journey and Healthcare Costs in Early-Stage Non-Small-Cell Lung Carcinoma: A Real-World Evidence Analysis in Italy
by Diego Luigi Cortinovis, Valentina Perrone, Elisa Giacomini, Diego Sangiorgi, Margherita Andretta, Fausto Bartolini, Giuseppe Taurino, Marco Belfiore, Emilia Sicari and Luca Degli Esposti
Pharmaceuticals 2023, 16(3), 363; https://doi.org/10.3390/ph16030363 - 27 Feb 2023
Viewed by 1591
Abstract
This real-world analysis aims to estimate the epidemiology and economic burden related to early-stage non-small-cell lung carcinoma (eNSCLC) in the clinical practice Italian setting. An observational analysis was performed using administrative databases linked to pathological anatomy data, covering around 2.5 mln health-assisted individuals. [...] Read more.
This real-world analysis aims to estimate the epidemiology and economic burden related to early-stage non-small-cell lung carcinoma (eNSCLC) in the clinical practice Italian setting. An observational analysis was performed using administrative databases linked to pathological anatomy data, covering around 2.5 mln health-assisted individuals. From 2015 to mid-2021, eNSCLC patients staged II–IIIA treated with chemotherapy after surgery were included. Patients were stratified into those presenting loco-regional or metastatic recurrence during follow-up and annualized healthcare direct costs covered by the Italian National Health System (INHS) were estimated. In 2019–2020, the prevalence of eNSCLC was 104.3–117.1/million health-assisted subjects, and the annual incidence was 38.6–30.3/million. Data projected to the Italian population estimated 6206 (2019) and 6967 (2020) prevalent and 2297 (2019) and 1803 (2020) incident cases. Overall, 458 eNSCLC patients were included. Of them, 52.4% of patients had a recurrence (5% loco-regional-recurrence, 47.4% metastatic-recurrence). Healthcare total direct costs/patient averaged EUR 23,607, in particular, in the first year after recurrence, costs averaged EUR 22,493 and EUR 29,337 in loco-regional and metastatic-recurrence patients, respectively. This analysis showed that about one-half of eNSCLC patients stage II–IIIA experience a recurrence, and in recurrence patients, total direct costs were almost two-fold those of no-recurrence patients. These data highlighted an unmet clinical need, as the therapeutic optimization of patients at early stages. Full article
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Review

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24 pages, 1316 KiB  
Review
Insight into Risk Factors, Pharmacogenetics/Genomics, and Management of Adverse Drug Reactions in Elderly: A Narrative Review
by Carlo Maria Bellanca, Egle Augello, Anna Flavia Cantone, Rosaria Di Mauro, Giuseppe Antonino Attaguile, Vincenza Di Giovanni, Guido Attilio Condorelli, Giulia Di Benedetto, Giuseppina Cantarella and Renato Bernardini
Pharmaceuticals 2023, 16(11), 1542; https://doi.org/10.3390/ph16111542 - 01 Nov 2023
Viewed by 1639
Abstract
The European Medicine Agency (EMA) has defined Adverse Drug Reactions (ADRs) as “a noxious and unintended response to a medicine”, not including poisoning, accidental, or intentional overdoses. The ADR occurrence differs based on the approach adopted for defining and detecting them, the characteristics [...] Read more.
The European Medicine Agency (EMA) has defined Adverse Drug Reactions (ADRs) as “a noxious and unintended response to a medicine”, not including poisoning, accidental, or intentional overdoses. The ADR occurrence differs based on the approach adopted for defining and detecting them, the characteristics of the population under study, and the research setting. ADRs have a significant impact on morbidity and mortality, particularly among older adults, and represent a financial burden for health services. Between 30% and 60% of ADRs might be predictable and preventable, emerging as a result of inappropriate prescription, drug chemistry inherent toxicity, cell-specific drug toxicity, age- and sex-related anomalies in drug absorption, distribution, metabolism, and elimination (ADME), and drug–drug interactions (DDIs) in combination therapies or when a patient is treated with different drugs for concomitant disorders. This is particularly important in chronic diseases which require long-term treatments. Rapid developments in pharmacogenetics/genomics have improved the understanding of ADRs accompanied by more accurate prescriptions and reduction in unnecessary costs. To alleviate the burden of ADRs, especially in the elderly, interventions focused on pharmaceutical principles, such as medication review and reconciliation, should be integrated into a broader assessment of patients’ characteristics, needs, and health priorities. Digital health interventions could offer valuable solutions to assist healthcare professionals in identifying inappropriate prescriptions and promoting patient adherence to pharmacotherapies. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
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20 pages, 410 KiB  
Review
Drug Safety and Suicidality Risk of Chronic Pain Medications
by Osman Syed, Predrag Jancic, Adam B. Fink and Nebojsa Nick Knezevic
Pharmaceuticals 2023, 16(10), 1497; https://doi.org/10.3390/ph16101497 - 20 Oct 2023
Cited by 4 | Viewed by 1331
Abstract
Chronic pain is one of the main leading causes of disability in the world at present. A variety in the symptomatology, intensity and duration of this phenomenon has led to an ever-increasing demand of pharmacological treatment and relief. This demand for medication, ranging [...] Read more.
Chronic pain is one of the main leading causes of disability in the world at present. A variety in the symptomatology, intensity and duration of this phenomenon has led to an ever-increasing demand of pharmacological treatment and relief. This demand for medication, ranging from well-known groups, such as antidepressants and benzodiazepines, to more novel drugs, was followed by a rise in safety concerns of such treatment options. The validity, frequency, and diversity of such concerns are discussed in this paper, as well as their possible effect on future prescription practices. A specific caution is provided towards the psychological safety and toll of these medications, regarding suicidality and suicidal ideation. Most significantly, this paper highlights the importance of pharmacovigilance and underscores the necessity of surveillance programs when considering chronic pain medication. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
18 pages, 1256 KiB  
Review
Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous Reporting Systems Studies
by Valerio Ciccone, Marina Ziche, Andrea Spini and Sandra Donnini
Pharmaceuticals 2023, 16(6), 867; https://doi.org/10.3390/ph16060867 - 12 Jun 2023
Viewed by 1033
Abstract
Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of antiangiogenic drugs (AADs) in cancer patients and [...] Read more.
Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of antiangiogenic drugs (AADs) in cancer patients and highlight if the found disproportionality signals of adverse events (AEs) were validated and thus mentioned in the respective Summary of product Characteristics (SmPC). This scoping review was conducted according to PRISMA guidelines for scoping reviews. A knowledge gap on the safety of AADs was found: firstly, several cardiovascular AEs were not mentioned in the SmPCs and no pharmacovigilance studies were conducted despite the well-known safety concerns about these drugs on the cardiovascular system. Second, a disproportionality signal (not validated through causality assessment) of pericardial disease was found in the literature for axitinib with no mention in SmPC of the drug. Despite the exclusion of pharmacoepidemiological studies, we believe that this scoping review, which focuses on an entire class of drugs, could be considered as a novel approach to highlight possible safety concerns of drugs and as a guide for the conduction of a target postmarketing surveillance on AADs. Full article
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15 pages, 2533 KiB  
Systematic Review
Effects of Preoperative Chronic Steroid Use on Postoperative Outcomes in Orthopedic Surgery: A Systematic Review and Meta-Analysis
by Yu-Ting Hung, Wei-Kai Hung and Ching-Chi Chi
Pharmaceuticals 2023, 16(9), 1328; https://doi.org/10.3390/ph16091328 - 20 Sep 2023
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Abstract
Higher rates of postoperative complications have been found in preoperative chronic steroid users. However, the effects of preoperative chronic steroid use on outcomes in orthopedic surgery were unclear. We performed a systematic review of cohort studies examining the effects of chronic steroid use [...] Read more.
Higher rates of postoperative complications have been found in preoperative chronic steroid users. However, the effects of preoperative chronic steroid use on outcomes in orthopedic surgery were unclear. We performed a systematic review of cohort studies examining the effects of chronic steroid use on postoperative outcomes following orthopedic surgery and searched PubMed, Embase, and CENTRAL through 29 April 2023. We included 17 studies with 1,546,562 patients. No increase in 30-day mortality (adjusted odds ratio (aOR) 1.40, 95% confidence interval (CI) 0.64–3.09) and composite thromboembolic events (aOR 1.61, 95% CI 0.99–2.63) but increases in 30-day overall complications (aOR 1.42, 95% CI 1.16–1.75), wound dehiscence (aOR 2.91, 95% CI 1.49–5.66), infectious complications (any infection (aOR 1.61, 95% CI 1.44–1.80), sepsis (aOR 2.07, 95% CI 1.34–3.21), superficial surgical site infection (SSI) (aOR 1.73, 95% CI 1.03–2.89) and deep SSI (aOR 1.96, 95% CI 1.26–3.05)), re-admission (aOR 1.62, 95% CI 1.48–1.77), both 30-day (aOR 1.28, 95% CI 1.03–1.59) and 1-year re-operation (aOR 1.78, 95% CI 1.09–2.92), pulmonary embolism (aOR 5.94, 95% CI 1.52–23.29), and deep vein thrombosis (aOR 2.07, 95% CI 1.24–3.46) were detected in preoperative steroid users. An increased risk of adverse outcomes following orthopedic surgery in chronic steroid users was found. Full article
(This article belongs to the Special Issue Drug Safety and Relevant Issues in the Real-World)
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