China
Africa
Explore chapters and articles related to this topic
Contrast enhancement agents and radiopharmaceuticals
Published in A Stewart Whitley, Jan Dodgeon, Angela Meadows, Jane Cullingworth, Ken Holmes, Marcus Jackson, Graham Hoadley, Randeep Kumar Kulshrestha, Clark’s Procedures in Diagnostic Imaging: A System-Based Approach, 2020
A Stewart Whitley, Jan Dodgeon, Angela Meadows, Jane Cullingworth, Ken Holmes, Marcus Jackson, Graham Hoadley, Randeep Kumar Kulshrestha
Each regulatory authority has a scheme to monitor the safety of prescribed medicines and healthcare products to ensure that patients and staff are protected and informed of safety concerns. An example of this is the Yellow Card Scheme, which helps the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK monitor the safety of all healthcare products. The scheme recommends reporting all problems with medicines and medical devices as the reports help identify new problems with products and allows monitoring of rates of adverse events.
Pharmacovigilance
Published in Christine Bond, Ann Lewis, Using Medicines Information, 2018
Pharmacovigilance is concerned with detection, assessment and prevention of adverse effects or any other possible drug related problems, with the ultimate goal of achieving rational and safe therapeutic decisions in clinical practice. There are many sources of data for the process of pharmacovigilance in the United Kingdom (UK), and this chapter describes two co-existing and complementary pharmacovigilance systems. These are a spontaneous reporting system used in the UK called the Yellow Card Scheme, and a targeted system known as Prescription-Event Monitoring.
Health systems
Published in Liam J. Donaldson, Paul D. Rutter, Donaldsons' Essential Public Health, 2017
Liam J. Donaldson, Paul D. Rutter
The agency carries out regular inspections of medicine and medical device manufacturers and suppliers, distribution and storage facilities, clinical trials, testing laboratories and blood establishments. Around 3000 samples of marketed medicines are carried out each year at manufacturers’ premises, wholesalers and pharmacies. It has a particularly important role in the process of detecting untoward reactions from drugs, and adverse incidents involving medical devices. For medicines, the mechanism for doing this is the yellow card scheme that receives reports from health professionals, patients, carers and parents on suspected adverse reactions to medicines. These reports are evaluated and form part of the wider process of pharmacovigilance by which the risk or benefit of medicines is continually monitored in population use.
How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting
Published in Expert Opinion on Drug Safety, 2020
Leila Asfour, Zenas Z.N. Yiu, Richard B. Warren
The World Health Organization (WHO) has as a core activity the collection of data on spontaneous reports of suspected drug adverse events as part of the management of an international database of AEs. There have been several treatments that have been withdrawn from the market following spontaneous reporting. An example is Terfenadine an antihistamine that had been marketed in 1985 and previously used by dermatologists for chronic spontaneous urticaria, which was withdrawn from the market in 1998 due to concern of fatal cardiac arrhythmias[57]. The ‘thalidomide tragedy’ is another example where the spontaneous reporting has enabled to set-up robust monitoring systems to prevent drug-related toxicity/morbidity[58]. The Yellow Card scheme was set up by the MHRA in 1964 in view of the thalidomide cases which requires health professionals to report any suspected adverse events to medicines[59]. Thalidomide is also currently used as an off-label treatment in dermatology for debilitating conditions such as actinic prurigo.
Making medicines safer: analysis of patient reports to the UK’s Yellow Card Scheme
Published in Expert Opinion on Drug Safety, 2019
B. O’ Donovan, Ruth M. Rodgers, Anthony R. Cox, Janet Krska
Direct patient reporting via the Yellow Card Scheme is increasingly providing a significant proportion of pharmacovigilance data. The majority of direct patient reports of suspected ADRs to the MHRA are submitted electronically, regardless of age and include a high proportion concerning vaccines. The latter should provide re-assurance that patients and carers are more aware of reporting systems. Most reports cite only one drug and a small number of reaction terms and 70% are considered serious. We believe this indicates the increasingly important role which patient reporting plays in pharmacovigilance, since it suggests that the potential usability of patient reports has improved in comparison to the first two years of patient reporting, although their value in generating signals also depends on their clinical quality.
An investigation of pharmacovigilance and reporting of adverse drug reactions in hospitals: a cross-sectional study in China
Published in Current Medical Research and Opinion, 2021
Zhigang Zhao, Jiashu Shen, Chuanyong Shen, Bin Zhu, Jun Sun, Jinyang Yu, Feng Sun, Haibo Song
A previous study showed that including patients as potential ADR reporters can increase reporting rates48. Since 2005, patients in the United Kingdom have been able to report ADRs through the Yellow Card Scheme49,50. However, there is no similar system in China at present, and most Chinese patients do not know about feedback pathways23. According to 2019 ADR reporting statistics, only 0.1% of reports in China were from patients34 compared to 55% in The Netherlands51. The present investigation also revealed that more than 20% hospitals did not consider patient feedback as an ADR reporting pathway.