Pharmacovigilance and Appropriate Drug Use—2nd Edition

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

Deadline for manuscript submissions: closed (31 October 2024) | Viewed by 924

Special Issue Editor


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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
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Special Issue Information

Dear Colleagues,

Pharmacovigilance is a key public health process which helps monitor 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 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 the product’s quality and 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, resulting 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 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 prevent medication errors and increases drug safety.

Regulatory agencies can use several tools to control and manage each step of the process (from prescription to drug utilisation) 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 result (or may result in the future) in regulatory actions and can be prevented by changing and controlling the prescribing behaviour.

Dr. Lucia Gozzo
Guest Editor

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Keywords

  • pharmacovigilance
  • safety
  • adverse drug reactions
  • risk
  • regulatory action
  • appropriateness

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Published Papers (1 paper)

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Research

18 pages, 566 KiB  
Article
Analyzing Prescribing Trends of Gastric Acid Suppressants in the UK Using Segmented Regression: Evaluating the Influence of COVID-19 (2019–2024)
by Khalid Orayj
Healthcare 2025, 13(5), 442; https://doi.org/10.3390/healthcare13050442 - 20 Feb 2025
Viewed by 569
Abstract
Background: This study explored the prescribing patterns of proton pump inhibitors (PPIs) and histamine H2-receptor antagonists (H2RAs) across the UK during the COVID-19 pandemic, highlighting the dynamic relationship between emerging evidence, regulatory actions, and clinical practices. Methods: Using a repeated cross-sectional design, prescription [...] Read more.
Background: This study explored the prescribing patterns of proton pump inhibitors (PPIs) and histamine H2-receptor antagonists (H2RAs) across the UK during the COVID-19 pandemic, highlighting the dynamic relationship between emerging evidence, regulatory actions, and clinical practices. Methods: Using a repeated cross-sectional design, prescription data from July 2019 to May 2024 were analyzed across England, Scotland, Wales, and Northern Ireland. Segmented regression analysis was employed to assess trends before and after January 2022, reflecting the impact of emerging evidence on prescribing behaviors. Results: The results revealed a significant increase in famotidine prescriptions, from 57.56 to 303.31 per 100,000 population in England post-January 2022, reflecting early adoption of preliminary findings despite the lack of randomized controlled trial confirmation. Ranitidine prescriptions fell to near zero due to contamination concerns, while PPIs like omeprazole remained the most prescribed, with Wales reporting the highest post-2022 usage at 7445.71 per 100,000 population. Conclusions: Adherence to deprescribing guidelines was inconsistent, with a possibility that many PPI users lacked documented indications. Regional variations in prescribing trends highlighted differences in guideline implementation. These findings underscore the need for improved evidence dissemination and adherence to prescribing guidelines. Future research should include patient-level data and long-term evaluations to optimize healthcare practices. Full article
(This article belongs to the Special Issue Pharmacovigilance and Appropriate Drug Use—2nd Edition)
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