Medicines Safety in the Globalized Context

Hussain, Rabia; Hassali, Mohamed Azmi; Babar, Zaheer-Ud-Din

doi:10.1007/978-981-15-2724-1_1

Cited by 6 publications

(7 citation statements)

References 58 publications

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“…The World Health Organization (WHO) defines an adverse drug reaction (ADR) as, "a response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function [1]. ADRs pose a major global concern causing substantial morbidity and mortality, thus requiring a surveillance system which could monitor the effects of drugs in the wider population [2].…”

Section: Introductionmentioning

confidence: 99%

Exploring healthcare professionals’ knowledge, attitude, and practices towards pharmacovigilance: a cross-sectional survey

Hussain

Hassali

Hashmi

2021

J of Pharm Policy and Pract

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Background Spontaneous reporting of adverse drug reactions (ADRs) is a method of monitoring the safety of drugs and is the basic strategy for the post-marketing surveillance of the suspected drugs. Despite its importance, there is very little reporting of ADRs by healthcare professionals. The present study has evaluated the knowledge, attitude and practices of health care professionals (HCPs) regarding pharmacovigilance activities in Lahore, Pakistan. Methods A cross-sectional questionnaire-based survey was employed, and a convenience sampling was opted to collect the data among physicians, pharmacists and nurses working in tertiary care public hospitals of Lahore, Pakistan from September 2018 to January 2019. Results Of the 384 questionnaires distributed, 346 health care professionals responded to the questionnaire (90.10% response rate). Most participants had good knowledge about ADR reporting, but pharmacist had comparatively better knowledge than other HCPs regarding ADR (89.18%) pharmacovigilance system (81.08%), its centres (72.97%) and function (91.89%). Most of the participants exhibited positive attitude regarding ADR reporting, such as 49.1% of physicians (P < 0.05), 70.2% pharmacists and 76.1% nurses showed a positive attitude that they are the most important HCPs to report an ADR. About 64.3% of physicians (P < 0.05) emphasized that consulting other colleagues is important before reporting an ADR. Of all, 77.7% physicians, 75.7% pharmacists and 68% of nurses had positive attitude that ADR reporting is a professional obligation and 67.6% of the pharmacists stated that they have reported ADRs in their workplace and 77.2% nurses have verbally reported ADRs to the concerned personnel or department. Conclusion Among all HCPs, pharmacists had better knowledge about ADR reporting and pharmacovigilance. All HCPs had positive attitude and inclination towards ADR reporting. The discrepancies were observed in the practices related to ADR reporting, whereas most of the participants including physicians and nurses did not report any ADR. Based on the above, strategies are needed to educate, train, and empower the HCPs in the domain of pharmacovigilance.

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Section: Introductionmentioning

confidence: 99%

Exploring healthcare professionals’ knowledge, attitude, and practices towards pharmacovigilance: a cross-sectional survey

Hussain

Hassali

Hashmi

2021

J of Pharm Policy and Pract

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“…After the thalidomide disaster, a committee on the safety of medicines (CSM) was established by the United Kingdom (UK). In 1965 yellow card scheme was introduced in the UK and the chairman of the CSM communicated to all HCPs especially doctors and dentists to report any unexpected reactions [ 53 ]. The suspected ADRs can be reported online or on the yellow card mobile application.…”

Section: Resultsmentioning

confidence: 99%

Pharmacovigilance in High-Income Countries: Current Developments and a Review of Literature

2023

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The world bank has classified 80 economies based on their Gross National Income (GNI) per capita as High-Income. European Medicines Agency (EMA), Food and Drug Administration (FDA), and Pharmaceuticals and Medical Devices Agency (PMDA) are the major regulatory stakeholders driving global pharmacovigilance regulations. The purpose of this article is to describe pharmacovigilance systems and processes in high-income countries, particularly those that are also members of the International Conference on Harmonization (ICH). All high-income countries are members of the WHO PIDM. The income level of a country has a direct relationship with medicine safety measures. All ten pioneering members of the Uppsala monitoring centre are from high-income countries and were the first responders after the thalidomide tragedy by making drug evaluation committees, introducing the ADR reporting forms and taking safety measures. Despite access to the VigiBase, some countries have separate databases for managing and analyzing data like Canada Vigilance online database, FDA Adverse Event Reporting System, the French pharmacovigilance database and European Union’s system Eudravigilance. All high-income countries have robust pharmacovigilance systems. USFDA and EMA are the world leaders in the field of pharmacovigilance. Most high-income countries follow EMA guidelines. Medicine safety is directly influenced by a country’s income level.

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“…A pharmacovigilance (PV) system is responsible for the detection, assessment, understanding, and prevention of ADRs [9,10]. Usually, drug-related ADRs are reported to the PV system through various channels in a healthcare system which may include spontaneous ADR reporting systems and post-marketing surveillance, etc.…”

Section: Introductionmentioning

confidence: 99%

“…The PV programme in Pakistan aims to detect ADR signals. The other aims of this programme are to make ADR reporting a mandatory task to be performed by healthcare professionals (HCPs), to start active surveillance, and to expand the scope of PV to all public hospitals including the basic healthcare centres in the country [9].…”

Section: Introductionmentioning

confidence: 99%

Barriers and facilitators to pharmacovigilance activities in Pakistan: A healthcare professionals-based survey

et al. 2022

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The timely reporting of adverse drug reactions (ADRs) could improve pharmacovigilance (PV) in a healthcare system. However, in almost all healthcare systems barriers exist that lead to the underreporting of ADRs. The objective of this study was to identify the barriers and facilitators regarding PV activities from the point of view of healthcare professionals (HCPs) in Lahore, Pakistan. A cross-sectional questionnaire-based survey was conducted between September 2018 to January 2019. The data was collected through convenience sampling of physicians, pharmacists, and nurses at tertiary care public hospitals in Lahore. A total of 384 questionnaires were distributed, and 346 HCPs responded to the survey. Over 62% percent of physicians and 54.8% of nurses agreed that they did not know how to report an ADR in their workplace. About 43.2% of pharmacists and 40.1% of nurses disagreed that they were not aware of the need for ADR reporting. Furthermore, 41.6% of nurses identified a lack of financial reimbursement and 51.8% highlighted a lack of support from a colleague as a reason that could lead to the underreporting of ADR. The majority of participants, including 69.6% physicians, 48.6% pharmacists, and 55.3% nurses identified the lack of knowledge about the existence of a national PV centre. Extra time for ADR reporting, incentives, continuous medical education, reminders, and availability of an online ADR reporting system was classed as the facilitators and were agreed upon by the majority of HCPs.

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Medicines Safety in the Globalized Context

Cited by 6 publications

References 58 publications

Exploring healthcare professionals’ knowledge, attitude, and practices towards pharmacovigilance: a cross-sectional survey

Exploring healthcare professionals’ knowledge, attitude, and practices towards pharmacovigilance: a cross-sectional survey

Pharmacovigilance in High-Income Countries: Current Developments and a Review of Literature

Barriers and facilitators to pharmacovigilance activities in Pakistan: A healthcare professionals-based survey

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