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Drug Safety and Effectiveness in the Real World

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A special issue of Pharmacoepidemiology (ISSN 2813-0618).

Deadline for manuscript submissions: closed (30 November 2023) | Viewed by 6788

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Special Issue Editors

Dr. Li-Ting Kao

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Guest Editor

1. School of Pharmacy, National Defense Medical Center, Taipei, Taiwan
2. Department of Pharmacy Practice, Tri-Service General Hospital, Taipei, Taiwan
3. Graduate Institute of Life Sciences, National Defense Medical Center, Taipei, Taiwan
Interests: drug safety; drug–drug interaction; effectiveness; real world

Dr. Yu-Tien Chang

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Guest Editor

School of Public Health, National Defense Medical Center, Taipei, Taiwan
Interests: bioinformatics; cancer biomarkeres; pharmacology

Dr. Ke-Ting Pan

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Guest Editor

Institute of aerospace and undersea medicine, National Defense Medical Center, Taipei, Taiwan
Interests: epidemiology; statistics; environmental; occupational health

Special Issue Information

Dear Colleagues,

Drug safety evaluation is an important issue throughout the lifecycle of drug product development. It is considered an ongoing activity because the premarket testing of drugs cannot detect all potential adverse effects, especially rare events. Therefore, real-world evidence plays an essential role. It is extremely important for clinicians to confirm the effectiveness and safety of treatments and further provide the optimal therapeutic drugs to the patients. Randomized controlled trials are considered to provide the highest level of scientific evidence for clinical therapies. However, drug safety in the real world still presents several challenges. For instance, several specific populations such as children and elderly people are commonly excluded from randomized controlled trials due to ethical issues. Furthermore, drug–drug interactions, inappropriate usage of medications, overdosing and long-term and rare adverse effects are not easily evaluated in traditional clinical trials. Therefore, clinicians must evaluate the benefits and risks and make decisions regarding therapies from various sources, including clinical trials and real-world evidence. In general, using real-world data with appropriate study designs, suitable epidemiological methods and well-controlled bias and confounding effects, real-world evidence can be generated. Such evidence can also bridge the gap from randomized controlled trials to demonstrate the efficacy and safety of medications or medical products in the real world.

Authors are invited to submit original and review articles on drug safety, therapeutic effectiveness and the economic burden of all common therapies which can be published in the Special Issue ‘Drug Safety and Effectiveness in the Real World’ of Pharmacoepidemiology.

I look forward to your valuable contributions.

Dr. Li-Ting Kao
Dr. Yu-Tien Chang
Dr. Ke-Ting Pan
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. Pharmacoepidemiology is an international peer-reviewed open access quarterly 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 1000 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
drug–drug interaction
effectiveness
real world
real-world data
real-world evidence
big data

Published Papers (5 papers)

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Research

6 pages, 202 KiB

Open AccessArticle

Characteristics and Outcomes of Patients on Tofacitinib for Alopecia Areata or Rheumatoid Arthritis: A Retrospective Cohort Study

by Sarah Choe, Abhinav Birda, Jesse Salas, Olive Anagu and Natasha Mesinkovska

Pharmacoepidemiology 2024, 3(1), 51-56; https://doi.org/10.3390/pharma3010003 - 29 Jan 2024

Viewed by 554

Abstract

Tofacitinib is a Janus kinase inhibitor (JAKi) that is used off-label for the treatment of alopecia areata (AA). Its boxed warning includes an increased risk of serious adverse events (SAEs) based on the results of a safety trial in rheumatoid arthritis (RA) patients taking the medication. The purpose of this study was to investigate the differences in patients’ characteristics and SAEs profiles between RA and AA populations taking tofacitinib. The cohorts were constructed using the TrinetX database to identify the patients who were prescribed tofacitinib for RA or AA between October 2012 and October 2023. A total of 22,873 patients were included in this analysis, with 21,080 individuals in the RA cohort and 1793 individuals in the AA cohort. After matching for age, sex, and race, each cohort had a sample size of 1482. Data on the patients’ sex, age, race, comorbidities, concomitant medications, and associated SAEs were collected. The cohorts were compared by calculating the odds ratios and tested for significance associations using Fisher’s Exact Tests. Both the RA and AA cohorts were predominantly female (RA 79%, AA 70%), with mean ages of 61 ± 14 years and 38 ± 19 years (p-value < 0.0001), respectively. Both the groups showed similar racial distributions. The RA cohort had increased rates of hypertension, obesity, type 2 diabetes mellitus, and nicotine dependence compared to those of the AA cohort (p-value < 0.0001). With the exception of cyclosporine and azathioprine, the percentage of concomitant medication use was higher in all the categories in the RA cohort than those in the AA cohort (p-value < 0.0001). Higher rates of adverse events were seen in the RA cohort across all the categories, except myocardial infarction, stroke, and lymphomas/hematopoietic malignancies. Our findings show that the SAEs on the boxed warning of tofacitinib should be strongly considered when being used off-label for the treatment of AA. Clinicians must carefully assess the individual patient factors when determining the appropriateness of tofacitinib use. Full article

(This article belongs to the Special Issue Drug Safety and Effectiveness in the Real World)

10 pages, 247 KiB

Open AccessArticle

A Retrospective Review of COVID-19 Medicines Information Queries in a Quaternary Hospital with Unique COVID-19 Border Controls

by Jeanie Misko and Matthew D. M. Rawlins

Pharmacoepidemiology 2023, 2(4), 328-337; https://doi.org/10.3390/pharma2040028 - 10 Nov 2023

Viewed by 758

Abstract

Background: Medicines information (MI) is a specialist area of pharmacy that provides evidence-based answers to often complex medication queries, utilising resources such as textbooks and databases. With the advent of the COVID-19 pandemic, there was a need to change the way COVID-19-related queries were answered due to the rapid evolution of information on vaccination, treatment and prevention. Methods: Medicines information queries were retrospectively reviewed utilising the centre’s medicines information database from January 2020 through December 2022 using the COVID-19 keyword to retrieve relevant queries. Information was collected on the enquirer’s role, query category, time taken to complete the query, relevant keywords and references accessed. Keywords and references were analysed further to determine the types of queries asked and which references were helpful. Results: The centre received 214 COVID-19-related queries, predominantly in 2022. Most queries were from pharmacy staff (95.8%) and related to vaccination (n = 95, 44.4%) or treatment (n = 87, 40.7%). Government and specialist organisation websites were used most commonly as reference sources (24.6% and 16.5%, respectively) for their currency with COVID-19-specific resources (such as national guidelines, COVID-19 treatment interaction checkers) and textbooks/databases used less commonly. Conclusions: MI pharmacists have demonstrated their ability to obtain reliable COVID-19-related information, utilising and interpreting information from less traditional sources. Full article

(This article belongs to the Special Issue Drug Safety and Effectiveness in the Real World)

13 pages, 849 KiB

Open AccessArticle

Blood Pressure Control in the DIAbetes and LifEstyle Cohort Twente (DIALECT): The Role of Patient Adherence and Physician’s Follow-Up Action

by Simone L. Dam, Heleen M. Masselink-Haverkate, Christina M. Gant, Stephan J. L. Bakker, Roos M. Nijboer, Willemien J. Kruik-Kollöffel and Gozewijn D. Laverman

Pharmacoepidemiology 2023, 2(4), 307-319; https://doi.org/10.3390/pharma2040026 - 30 Oct 2023

Viewed by 1112

Abstract

We studied the role of adherence to antihypertensive drug therapy (AHT) in blood pressure (BP) control in a type 2 diabetes (T2D) population treated in secondary care in the DIAbetes and LifEstyle Cohort Twente-1 (DIALECT-1). In addition, intensification of AHT was assessed. Adherence was determined by using the medication possession ratio (MPR), calculated with pharmacy dispensing data for a period of two years following baseline. Adherence was defined as an MPR ≥ 80%. The proportion of adherent patients was compared between patients who had BP-on target (BP-OT) and BP-not on target (BP-NOT). Of the 385 patients included, 56% achieved their BP target. The proportion of adherent patients did not differ between BP-OT and BP-NOT (96% vs. 96%; p = 0.91). Intensification of AHT, including ‘increase in dosage’ and ‘start of a new drug’, was assessed in the two years following baseline. In only 37% of patients with uncontrolled BP during follow-up was AHT intensified. To conclude, adherence to AHT was high and there does not seem to be a relationship between adherence and BP control. There is an opportunity to improve AHT in patients who do not reach their BP target. Full article

(This article belongs to the Special Issue Drug Safety and Effectiveness in the Real World)

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11 pages, 2085 KiB

Open AccessArticle

Depression Events Associated with Proton-Pump Inhibitors in Postmarketing Drug Surveillance Data

by Tigran Makunts, Haroutyun Joulfayan, Kenneth Ta and Ruben Abagyan

Pharmacoepidemiology 2023, 2(3), 272-282; https://doi.org/10.3390/pharma2030023 - 30 Aug 2023

Viewed by 1370

Abstract

Proton-pump inhibitors, PPIs, are widely prescribed and are available over the counter for prolonged reduction of stomach acid production and related disorders. PPIs irreversibly inhibit the hydrogen/potassium ATPase in gastric parietal cells. Recent retrospective studies have described an association between PPI use and depression. However, there is conflicting evidence that PPI therapy improves depressive symptoms. Considering the widespread use and over-the-counter availability of these drugs, further investigation into depression adverse event was warranted with a larger-scale postmarketing set of reports. Here we analyzed over 125,923 reports from the FDA Adverse Event Reporting System consisting of PPI and histamine-2 receptor antagonist monotherapy records and found a statistically significant association between use of PPIs and depression. Additionally, we analyzed each of the six currently marketed PPIs individually and observed the association with the depression adverse reaction for all of them. Full article

(This article belongs to the Special Issue Drug Safety and Effectiveness in the Real World)

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13 pages, 297 KiB

Open AccessArticle

Knowledge and Practices among Dental Practitioners Regarding the Use of Antimicrobials for Periodontal Diseases: An Online Survey in Saudi Arabia

by Mohammed Sultan Al-Ak’hali, Esam Halboub, Mona Awad Kamil, Wafa Hassan Alaajam, Abdulaziz Mahnashi, Jabbar Khubrani, Abdullah Mahnashi, Khalid Mahnashi and Nuha Farea

Pharmacoepidemiology 2023, 2(1), 68-80; https://doi.org/10.3390/pharma2010007 - 01 Mar 2023

Cited by 1 | Viewed by 1667

Abstract

This study aimed to investigate the knowledge and practices among dental practitioners in Saudi Arabia regarding the use of antimicrobials for periodontal diseases. An online questionnaire was sent to senior dental students and dental practitioners including interns, general dental practitioners (GDP), and periodontists in Saudi Arabia. Two hundred and twenty-three dental practitioners responded and participated in the study. The potential associations between the use of antimicrobials and different variables were assessed by a chi-square test. The majority of the participants (84.3%) reported prescribing systemic antimicrobials for a periodontal abscess or acute necrotizing periodontal disease. Surprisingly, 31% of participants reported prescribing systemic antimicrobials for deep localized periodontal pockets or for acute gingivitis associated with herpes simplex in children. Noteworthy is that 66% of the participants thought that mechanical periodontal treatment alone, without adjunctive antimicrobial therapy, is adequate to resolve the clinical condition in most cases of periodontal diseases. Almost half of the participants recommended the use of local antimicrobials for a periodontal pocket (45.3%), a recurrent periodontal pocket (45.4%), and refractory periodontitis (43.7%). The barriers against the use of local antimicrobials were a lack of knowledge and a lack of continuous education after graduation, as reported by 64% of the participants. In conclusion, knowledge and practices regarding antimicrobial use for periodontal diseases were inadequate, especially among practitioners other than periodontists. Full article

(This article belongs to the Special Issue Drug Safety and Effectiveness in the Real World)

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