Submit to Healthcare Review for Healthcare Propose a Special Issue

Journal Menu

Journal Browser

► Journal Browser

Pharmacovigilance and Appropriate Drug Use

Print Special Issue Flyer
Special Issue Editors
Special Issue Information
Keywords
Related Special Issue
Published Papers

A special issue of Healthcare (ISSN 2227-9032). This special issue belongs to the section "Medication Management".

Deadline for manuscript submissions: closed (31 October 2023) | Viewed by 19750

Share This Special Issue

Special Issue Editor

Dr. Lucia Gozzo

E-Mail Website
Guest Editor

1. Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, 95123 Catania, Italy
2. Department of Biomedical and Biotechnological Sciences, University of Catania, 95123 Catania, Italy
Interests: pharmacology; pharmacovigilance
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Pharmacovigilance is a key public health process which helps in monitoring the safety of medicines and reducing the risks related to drug use in the post-marketing phase.

It works through the detection, assessment, understanding and prevention of adverse effects, or of any medicine-related problems in general.

At the time of authorisation, each drug has been tested for a limited length of time in a small number of strictly selected patients. Therefore, its benefit–risk profile cannot be definitely known, and certain side effects may be detected with use in healthcare practice in a larger number of patients, for a longer period of time and with other medications.

The emergence of safety signals (new or changing safety issues) in this phase may result in regulatory action translating into modification of the terms of the marketing authorization or the way the drug can be used to protect public health. Regulatory actions include the following measures:

Informing about the new information on the quality, safety or efficacy of a medicine;
Advising to modify prescribing behaviour or how to use medicines to prevent or minimise risks;
Restricting the use to exclude certain patient population.

Prior studies showed that almost all regulatory actions in the post-marketing phase have a negative impact on drug risk.

Nevertheless, the safety of a medicine is related not only to its pharmacological properties, but also to the product’s quality and to how it is used in clinical practice.

According to the World Health Organization (WHO), inappropriate drug use has been reported for more than 50% of all medicines in the market and results in various health risks and costs.

The appropriate prescribing, dispensing, and use of drugs include several steps performed both by healthcare professionals (good diagnosis and good prescribing, providing the right drug to the right patient in the right formulation and posology, patient instructions, and good stock-management practice) and by patients (good adherence/compliance).

Inappropriate drug use has been associated with an increased risk of adverse events, morbidity, mortality and healthcare utilisation.

Therefore, appropriate drug use helps to avoid medication errors and increase drug safety.

Regulatory agencies can use several tools to control and manage each step of the process (from prescription to drug utilization) in order to guarantee the appropriateness of medicine use.

The aim of this Special Issue is to provide an updated panorama of pharmacovigilance issues which resulted (or may result in the future) in regulatory actions and which can be prevented by changing and controlling the prescribing behaviour.

Dr. Lucia Gozzo
Guest Editor

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. Healthcare is an international peer-reviewed open access semimonthly 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 2700 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

pharmacovigilance
safety
adverse drug reactions
risk
regulatory action
appropriateness

Related Special Issue

Pharmacovigilance and Appropriate Drug Use—2nd Edition in Healthcare

Published Papers (11 papers)

Download All Papers

Order results

Result details

Show export options Show export options

Select all

Export citation of selected articles as:

Editorial

Jump to: Research, Review

4 pages, 174 KiB

Open AccessEditorial

Pharmacovigilance and Appropriate Drug Use

by Lucia Gozzo

Healthcare 2024, 12(6), 669; https://doi.org/10.3390/healthcare12060669 - 16 Mar 2024

Viewed by 547

Abstract

This Special Issue collects updated evidence about pharmacovigilance and regulatory actions which can be translated into the change and control of prescribing behaviour [...] Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

Research

Jump to: Editorial, Review

13 pages, 1056 KiB

Open AccessEditor’s ChoiceArticle

Pharmacologic Stewardship in a Rural Community Pharmacy

by Chrysanthi Sardeli, Theodoros Athanasiadis, Eleni Stamoula and Dimitrios Kouvelas

Healthcare 2023, 11(19), 2619; https://doi.org/10.3390/healthcare11192619 - 25 Sep 2023

Viewed by 888

Abstract

Background: Pharmacotherapy is an essential part of patient care. In order to achieve optimal health outcomes, safe and effective prescribing and administering of medications is crucial, especially since the process of pharmacotherapy can cause serious problems, mainly adverse events and/or interactions, that often pass undetected. Objective(s): To investigate the feasibility of using community pharmacies as checkpoints to detect errors and failures in prescribing, as well as patients’ compliance with pharmacotherapy. To this end, analysis and recording of the prescribing process was carried out and error-prone points were identified. Methods: Patients and caregivers filling prescriptions during the first 4 weeks of November 2017 and February 2018 answered questions in order to evaluate their attendance of regular checkups and their compliance with prescribing instructions. All prescriptions filled at the pharmacy were examined for detection of prescription errors and drug–drug interactions. Statistical analyses, including calculations of the correlation coefficient phi (φ), chi-square, and confidence intervals, were carried out. Detected errors and failures were evaluated by application of the Health Failure Mode Effect Analysis (HFMEA) quality tool. Results: A significant number of patients (16.7%) failed to regularly attend checkups regarding known health problems (95% CI: 10.6–22.7%), a corresponding percentage (16%, 95% CI: 10.1–21.9%) did not comply with prescribed pharmacotherapy, and a significant proportion of patients self-medicated regularly (32%, 95% CI: 24.5–39.5%). A total of 8.6% of prescriptions included medication combinations with a potential for severe drug–drug interactions (95% CI: 7.1–10.2%) while 58.7% of the prescriptions included combinations that could lead to moderate ones (95% CI: 56.1–61.4). The HFMEA indicated that all problems recorded required immediate interventions, except for prescribing errors. Conclusions: Community pharmacies can be potential checkpoints for the detection and evaluation of prescribing errors and pharmacotherapy failures. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

► Show Figures

Figure 1

12 pages, 265 KiB

Open AccessArticle

Generic Substitutions and Therapeutic Interchanges in Hospital Pharmacies: A Qualitative Study from Western Saudi Arabia

by Manar Hassan Alsufyani, Manayer Hammad Alghoribi, Thekra Omar Bin Salman, Asma Fayez Alrabie, Ibtihal Saud Alotaibi, Abdullah Mosa Kharbosh, Mona Yaser Alsheikh, Ali Mofleh Alshahrani and Ahmed Ibrahim Fathelrahman

Healthcare 2023, 11(13), 1893; https://doi.org/10.3390/healthcare11131893 - 30 Jun 2023

Cited by 1 | Viewed by 1103

Abstract

Background: The aim of the present study was to understand hospital pharmacists’ views and practices regarding generic substitution and therapeutic interchange. Method: This was a qualitative study involving pharmacists from three Western Saudi governorates: Taif, Makkah, and Jeddah. It included respondents from the Ministry of Health (MoH), military and private hospitals. Pharmacists were selected using a convenient sampling technique and data were collected using a structured face-to-face interview. Results: Fifty-seven pharmacists agreed to participate in this study. In MoH and private hospitals, generic substitution is a pharmacist-initiated act, while therapeutic interchange requires physician approval. Medication unavailability, side effects, patient characteristics, outcomes, and economic status justified most substitution decisions. In military hospitals, both types of substitutions are controlled by an auto-switch policy and physicians should be informed. In all hospitals, there are policies regulating substitution. Medications eligible for interchange mentioned by pharmacists from different hospitals were comparable to some extent. Pharmacists from the private sector considered substitution a supportive economic measure for both hospitals and patients. Most pharmacists highlighted that patient convenience and physician approval are the most challenging situations in substitution practice. Conclusions: An enhanced understanding of substitution and knowledge about medications included in the hospital formulary will be valuable support to the implementation of substitution practice which responds to the patients’ needs to improve their outcomes. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

12 pages, 806 KiB

Open AccessEditor’s ChoiceCommunication

Severe Gastrointestinal Toxicity Following the Use of Gilteritinib: A Case Series and Analysis of Postmarketing Surveillance Data

by Lucia Gozzo, Antonella Nardo, Serena Brancati, Antongiulio Judica, Andrea Duminuco, Cinzia Maugeri, Marina Parisi, Laura Longo, Daniela Cristina Vitale, Rosy Ruscica, Giovanni Luca Romano, Elisa Mauro, Paolo Fabio Fiumara, Giuseppe Alberto Maria Palumbo, Francesco Di Raimondo, Calogero Vetro and Filippo Drago

Healthcare 2023, 11(10), 1479; https://doi.org/10.3390/healthcare11101479 - 18 May 2023

Cited by 1 | Viewed by 1146

Abstract

Gilteritinib has been approved as monotherapy in adults with acute myeloid leukemia (AML) FLT3 mutated with relapsed or refractory disease, in light of its advantages in terms of survival and the favorable safety profile. Hepatobiliary disorders and musculoskeletal and connective tissue disorders represent the most frequent adverse reactions associated with gilteritinib, whereas the most frequent serious adverse reaction is acute kidney injury. In the summary of product characteristics, gastrointestinal (GI) events are indicated as very common, in particular diarrhea, nausea and stypsis. Furthermore, serious GI disorders have been observed with gilteritinib in clinical trials, including GI hemorrhage, GI perforation and GI obstruction. However, the association with the FLT3 inhibitor has not been confirmed. Nevertheless, serious GI AEs have been recognized as an important potential risk to be monitored in postmarketing surveillance. We present three cases of serious self-limiting GI events observed in patients on gilteritinib treatment for AML, and an analysis of relevant available postmarketing surveillance data. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

► Show Figures

Figure 1

13 pages, 588 KiB

Open AccessArticle

Pharmacovigilance and Adverse Drug Reaction Reporting among the General Public in Lithuania: A Cross-Sectional Study

by Agne Valinciute, Rima Jurate Gerbutaviciene, Renata Paukstaitiene and Loreta Kubiliene

Healthcare 2023, 11(8), 1133; https://doi.org/10.3390/healthcare11081133 - 14 Apr 2023

Cited by 1 | Viewed by 2681

Abstract

Background: Despite the fact that for over ten years, Lithuanian consumers have been able to report adverse drug reactions (ADR) directly to the competent authority, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding ADRs is needed to ascertain further factors impacting their engagement in ADR reporting. This study aimed to assess consumer knowledge of, attitude toward, and practice of reporting ADRs. Methods: A questionnaire-guided cross-sectional survey among 404 consumers between October 2021 and June 2022 was conducted. The semi-structured questionnaire comprised open-ended and closed-ended questions to explore the sociodemographic characteristics and general knowledge of ADRs and pharmacovigilance. Other question items evaluated attitudes toward ADR reporting and ADR reporting practice. The data were summarised using descriptive statistics, while the chi-square test was used to assess categorical variables at p < 0.05. The overall percent score in the knowledge and attitude domains was divided into groups of “poor”, “moderate”, and “good” knowledge, as well as “positive” and “negative” attitudes. Results: While having a generally poor understanding, this study demonstrates that Lithuanian consumers have a favourable attitude toward pharmacovigilance, particularly regarding issues involving the requirement for reporting. The data also revealed the justifications for reporting and not reporting ADRs. Conclusions: The current study provided the first understanding of consumer awareness and ADR reporting intentions, which can help to develop educational campaigns and interventions addressing pharmacovigilance and ADR reporting. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

► Show Figures

Figure 1

17 pages, 1453 KiB

Open AccessArticle

Italian Translation and Validation of the Original ABC Taxonomy for Medication Adherence

by Sara Mucherino, Marina Maffoni, Clara Cena, Lucrezia Greta Armando, Marta Guastavigna, Valentina Orlando, Giancarlo Orofino, Sara Traina, Anna Giardini, Enrica Menditto and the Collaborative Working Group

Healthcare 2023, 11(6), 846; https://doi.org/10.3390/healthcare11060846 - 13 Mar 2023

Cited by 1 | Viewed by 1623

Abstract

Medication adherence represents a complex and multifaceted process. Standardized terminology is essential to enable a reproducible process in various languages. The study’s aim was to translate and adapt the original Ascertaining Barriers for Compliance (ABC) Taxonomy on medication adherence, first proposed in 2012, into Italian language. The study was carried out according to the Preferred Methods for Translation of the ABC Taxonomy for Medication Adherence adopted by the ESPACOMP. Key steps included: (1) a systematic literature review using PubMed and Embase according to the PRISMA Guidelines to identify published Italian terms and definitions, and Italian adherence experts; (2) a forward translation of terms and definitions; (3) panelists’ selection; (4) a three-round Delphi survey. From the systematic review, 19 studies allowed detection of 4 terms, 4 definitions and 767 Italian experts. To these, Italian ESPACOMP members and experts though snowball sampling were added. The identified Italian adherence experts received the Delphi questionnaire. The Italian ABC Taxonomy was achieved after three rounds of Delphi survey by reaching at least a moderate consensus on unambiguous naming and definition of medication adherence-related terms. The Taxonomy is intended to be used in research, academic, and professional fields in order to harmonize adherence terminology and avoid confusion in comparing research findings. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

► Show Figures

Figure 1

10 pages, 666 KiB

Open AccessArticle

Patterns and Trends in Pharmacological Treatment for Outpatients with Postherpetic Neuralgia in Six Major Areas of China, 2015–2019

by Gang Han, Yun Han, Lingyan Yu, Yuhua Zhao and Zhenwei Yu

Healthcare 2023, 11(5), 764; https://doi.org/10.3390/healthcare11050764 - 06 Mar 2023

Cited by 3 | Viewed by 1603

Abstract

The aim of this study was to assess the patterns and trends of pharmacological treatment for outpatients with postherpetic neuralgia (PHN) in China in the period 2015–2019. Prescription data for outpatients with PHN were extracted from the database of the Hospital Prescription Analysis Program of China according to the inclusion criteria. The trends in yearly prescriptions and corresponding costs were analyzed and stratified by drug class and specific drugs. A total of 19,196 prescriptions from 49 hospitals in 6 major regions of China were included for analysis. The yearly prescriptions increased from 2534 in 2015 to 5676 in 2019 (p = 0.027), and the corresponding expenditures increased from CNY 898,618 in 2015 to CNY 2,466,238 in 2019 (p = 0.027). Gabapentin and pregabalin are the most commonly used drugs for PHN, and more than 30% of these two drugs were combined with mecobalamin. Opioids were the second most frequently prescribed drug class, and oxycodone accounted for the largest share of the cost. Topical drugs and TCAs are rarely used. The frequent use of pregabalin and gabapentin was in accordance with current guidelines; however, the use of oxycodone raised concerns about rationality and economic burden. The results of this study may benefit the allocation of medical resources and management for PHN in China and other countries. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

► Show Figures

Figure 1

13 pages, 256 KiB

Open AccessArticle

Medication Adherence of People Living with HIV in Japan—A Cross-Sectional Study

by Yoji Inoue, Shinichi Oka, Seiji Yokoyama, Koichi Hasegawa, Jörg Mahlich, Ulrike Schaede, Noriyuki Habuka and Yoko Murata

Healthcare 2023, 11(4), 451; https://doi.org/10.3390/healthcare11040451 - 04 Feb 2023

Viewed by 1968

Abstract

Long-term medical care for people living with HIV (PLHIV) is critical for treatment efficacy, and various studies have examined reasons for antiretroviral therapy (ART) non-adherence. In Japan, doctors assume patients maintain high adherence. However, little is known about real-world treatment adherence. We conducted an anonymous self-administered web-based survey asking about adherence for a total of 1030 Japanese PLHIV who were currently on ART. Adherence was determined using the eight-item Morisky Medication Adherence Scale (MMAS-8), for which scoring ranged from 0 to 8 and scores < 6 points were classified as low adherence. Data were analyzed based on patient-related factors; therapy-related factors; condition-related factors, such as a comorbidity with depression (utilizing the Patient Health Questionnaire 9, PHQ-9); and healthcare/system-related factors. Among 821 PLHIV who responded to the survey, 291 responders (35%) were identified as being in the low adherence group. A statistically significant relationship was found between the number of missed anti-HIV drug doses within the previous 2 weeks and long-term adherence, per the MMAS-8 score (p < 0.001). Risk factors for low adherence included age (younger than 21 years, p = 0.001), moderate to severe depression (p = 0.002, using the PHQ-9), and drug dependence (p = 0.043). Adherence was also influenced by a shared decision-making process, including treatment selection, doctor–patient relations, and treatment satisfaction. Adherence was mainly affected by treatment decision factors. Hence, support of care providers should be considered critical for improving adherence. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

13 pages, 267 KiB

Open AccessArticle

Hospitalisations Related to the Combination of ACE Inhibitors and/or Angiotensin Receptor Blockers with Diuretics and NSAIDs: A Post Hoc Analysis on the Risks Associated with Triple Whammy

by Irene Mattioli, Alessandra Bettiol, Giada Crescioli, Roberto Bonaiuti, Guido Mannaioni, Alfredo Vannacci and Niccolò Lombardi

Healthcare 2023, 11(2), 238; https://doi.org/10.3390/healthcare11020238 - 12 Jan 2023

Cited by 2 | Viewed by 2359

Abstract

This post hoc analysis aimed to assess and characterise adverse events (AEs) related to the triple whammy (i.e., combination therapy of ACE inhibitors, ACE-I, and/or angiotensin receptor blockers, ARBs, with diuretics and non-steroidal anti-inflammatory drugs, NSAIDs) leading to emergency department (ED) visits and/or hospitalisations in the Italian setting. The MEREAFaPS database was analysed. ED visits related to co-treatment with ACE-I and/or ARBs, diuretics, and NSAIDs were considered. Information on the AE (including classification, seriousness, and outcome), suspected and concomitant drugs, and concomitant conditions was retrieved and analysed. Logistic regression was used to estimate the reporting odds ratios (RORs) of hospitalisation associated with the drugs of interest. Between 1 January 2007, and 31 December 2018, 80 patients visited the ED for AEs related to the triple whammy, and a total of 261 suspected drugs were involved. Patients were mostly Caucasian females, with a median age of 85 years, and only 9 of them had renal manifestations. In this subset, drug–drug interaction contributed to kidney injury. Most patients presented a Charlson comorbidity index of 4–5. Overall, 47 patients were hospitalised (58.75%), but no significant differences in the risk of hospitalisation were found according to demographic, clinical, or therapeutic features. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

15 pages, 655 KiB

Open AccessArticle

Determining Current Medications Usage within a Cohort of Patients in the UK—A Descriptive Retrospective Study

by Adel S. Alhlayl, Haitham A. Alzghaibi and Qazi Mohammad Sajid Jamal

Healthcare 2022, 10(12), 2421; https://doi.org/10.3390/healthcare10122421 - 30 Nov 2022

Viewed by 1529

Abstract

Swansea University’s United Kingdom (UK) Multiple Sclerosis (MS) Register is a platform that contains information on more than 17,600 people with MS living in the UK. The register has been in operation since 2011 and represents comprehensive information about people living with MS in the UK. It is considered the first register of its kind that can link information from patients to clinical data and has been established to answer different information needs about MS. Aim: To elucidate the trends in patterns of medicines currently used by people with MS in the UK MS register. Methods: This study follows an exploratory descriptive design using the UK MS register as data resource. A number of 4516 people completed the EQ-5D survey out of 8736 people who have given their consent to answer online questionnaires which represents around 52% of the register total population. Descriptive analysis and tests were performed with SPSS to address the research objectives. Results: There are several medicine names entered by people with MS in their profiles. These medicines are used either to manage MS symptoms or to treat its associated complications. Among the medicine types revealed in this study, disease modifying drugs (DMDs), muscle relaxants, and anticonvulsants are the medicine types mainly used by people with MS followed by antidepressant and antianxiety medicines. Conclusions: From the antidepressants used most widely, amitriptyline was chosen as a subject medicine for further investigation in the remaining studies of this research due to its high frequency use, the elevated depression rates discovered among people with MS who seek information on it online, and the high online content noted on websites about this medicine. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

► Show Figures

Figure 1

Review

Jump to: Editorial, Research

12 pages, 366 KiB

Open AccessReview

Bioequivalence, Drugs with Narrow Therapeutic Index and the Phenomenon of Biocreep: A Critical Analysis of the System for Generic Substitution

by Lucia Gozzo, Filippo Caraci and Filippo Drago

Healthcare 2022, 10(8), 1392; https://doi.org/10.3390/healthcare10081392 - 26 Jul 2022

Cited by 7 | Viewed by 3443

Abstract

The prescription of generic drugs represents one of the main cost-containment strategies of health systems, aimed at reducing pharmaceutical expenditure. In this context, most regulatory authorities encourage or obligate dispensing generic drugs because they are far less expensive than their brand-name alternatives. However, drug substitution can be critical in particular situations, such as the use of drugs with a narrow therapeutic index (NTI). Moreover, generics cannot automatically be considered bioequivalent with each other due to the biocreep phenomenon. In Italy, the regulatory authority has established the Transparency Lists which include the medications that will be automatically substituted for brand-name drugs, except in exceptional cases. This is a useful tool to guide prescribers and guarantee pharmaceutical sustainability, but it does not consider the biocreep phenomenon. Full article

(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use)

► Show Figures

Journal Menu

Journal Browser

Pharmacovigilance and Appropriate Drug Use

Share This Special Issue

Special Issue Editor

Special Issue Information

Keywords

Related Special Issue

Published Papers (11 papers)

Editorial

Research

Review

Further Information

Guidelines

MDPI Initiatives

Follow MDPI