Issues with regulatory pharmacovigilance in East European countries: The industry perspective

Hanzl-Dujmović, Ivana; Sulić-Milišić, Zrinka; Starešinić-Šernhorst, Ivana

doi:10.1016/j.toxlet.2006.10.019

Cited by 7 publications

(3 citation statements)

References 6 publications

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“…It will be better to report when the pharmaceutical business is in charge of the pharmacovigilance program, especially for new medications. The aims of pharmacovigilance service (PV), which involves the pharmaceutical manufactures in addition to health care providers, is to ensure the safety of medicines in use with the primary objective of protecting the community, and other nations are now moving to adopt this goal (Hanzl-Dujmović et al 2007).…”

Section: Discussionmentioning

confidence: 99%

Explore Adverse Drug Reactions (ADRs) reporting by clinical and community pharmacists in Duhok, Kurdistan region- Iraq: hampered and perspective

Al-lela¹

2022

PHAR

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Background: Pharmacovigilance systems are crucial for monitoring, ensuring the safe use of medications, and reducing the frequency of adverse drug reactions (ADRs). They also raise awareness of the importance of reporting ADRs to healthcare systems. Aim: Explore the hampered and perspective held by Duhok pharmacists, particularly those employed in hospitals and private pharmacy sectors, about pharmacovigilance and ADR reporting. Methods: A cross-sectional study was carried out from 20 February to 20 March 2019 using a self-administered questionnaire that had been previously created and modified. The data were examined using SPSS version 20, a statistical application for social software. Results: The majority of respondents, pharmacists, stated that it is their responsibility to report adverse drug reactions (ADRs), and that drug safety monitoring is crucial (91%). More than 85% of pharmacists agreed that ADRs that result in life-threatening situations and those that result in congenital abnormalities should be reported immediately. The majority of them, however, were unaware of the Iraqi pharmacovigilance system, had never reported any adverse drug reactions, were unable to get reporting forms, and lacked the clinical knowledge required to recognize ADRs. Conclusion: Underreporting was the main issue identified by the study because the majority of respondents were unable to define the term “pharmacovigilance” correctly, but they were aware of ADRs and displayed a positive attitude toward ADR reporting despite the fact that the majority of them had never reported any ADRs. To raise pharmacists’ knowledge and awareness of the ADR reporting procedure, however, required steps should be made to establish interventional programs.

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Section: Discussionmentioning

confidence: 99%

Explore Adverse Drug Reactions (ADRs) reporting by clinical and community pharmacists in Duhok, Kurdistan region- Iraq: hampered and perspective

Al-lela¹

2022

PHAR

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“…Therefore, EU and US legislations primarily tend toward the intensification of pharmacovigilance, moving from passive to proactive, although the usefulness of the tools provided by the legislation is controversial [13][14][15][16][17][18]. The second trend is a partial harmonization of the different pharmacovigilance systems in order to simplify the sponsors' activities and increase the efficacy of pharmacovigilance [19,20].…”

Section: Discussionmentioning

confidence: 99%

Recent Developments in EU and US Pharmacovigilance Legislation

Montanari-Vergallo¹

2013

J Pharmacovigilance

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“…Pharmacovigilance (Pv) is a science dealing with the continuous identification, assessment, evaluation, and prevention of acute and chronic adverse reactions caused by newly launched and already marketed medicines [5][6][7][8][9][10]. Pv these days also covers drug therapy-related problems (DTRPs) shown by herbals, traditional, complementary, and alternative medicines (TCAMs), biologicals and blood products, medical devices, and vaccines [6,11,12].…”

Section: Pharmacovigilance and Emergence Of Materiovigilancementioning

confidence: 99%

Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

Sapkota

Palaian

Shrestha

et al. 2023

Ther Innov Regul Sci

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Materiovigilance (Mv) has the same purpose and approach in ensuring patient safety as pharmacovigilance but deals with medical devices associated with adverse events (MDAEs) and their monitoring. Mv has been instrumental in recalling many defective or malfunctioning devices based on their safety data. All MDAEs, such as critical or non-critical, known, or unknown, those with inadequate or incomplete specifications, and frequent or rare events should be reported and evaluated. Mv helps to improve medical devices’ design and efficiency profile and avoid device-related complications and associated failures. It alerts consumers and health professionals regarding counterfeit or substandard devices. Common events reported through Mv are device breakage and malfunction, entry- and exit-site infections, organ perforations or injuries, need for surgery and even death, and life cycle assessment of devices. Health authorities globally have developed reporting frameworks with timeframes for MDAEs, such as MedWatch in the USA, MedSafe in New Zealand, and others. Health professionals and consumers need to be made aware of the significance of Mv in ensuring the safe use of medical devices and getting familiar with the reporting procedures and action plans in case of a device-induced adverse event.

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Issues with regulatory pharmacovigilance in East European countries: The industry perspective

Cited by 7 publications

References 6 publications

Explore Adverse Drug Reactions (ADRs) reporting by clinical and community pharmacists in Duhok, Kurdistan region- Iraq: hampered and perspective

Explore Adverse Drug Reactions (ADRs) reporting by clinical and community pharmacists in Duhok, Kurdistan region- Iraq: hampered and perspective

Recent Developments in EU and US Pharmacovigilance Legislation

Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

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Issues with regulatory pharmacovigilance in East European countries: The industry perspective

Cited by 7 publications

References 6 publications

﻿Explore Adverse Drug Reactions (ADRs) reporting by clinical and community pharmacists in Duhok, Kurdistan region- Iraq: hampered and perspective

﻿Explore Adverse Drug Reactions (ADRs) reporting by clinical and community pharmacists in Duhok, Kurdistan region- Iraq: hampered and perspective

Recent Developments in EU and US Pharmacovigilance Legislation

Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

Contact Info

Product

Resources

About

Explore Adverse Drug Reactions (ADRs) reporting by clinical and community pharmacists in Duhok, Kurdistan region- Iraq: hampered and perspective

Explore Adverse Drug Reactions (ADRs) reporting by clinical and community pharmacists in Duhok, Kurdistan region- Iraq: hampered and perspective