Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (11): 1259-1263.
DOI: 10.19803/j.1672-8629.20230476

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Establishment of patient reporting scheme in the UK and its implications

PANG Yu1, LIU Bo2△, WU Wenyu3, TIAN Yuejie4,*, WANG Tao5#   

  1. 1Remegen, Yantai Shandong 265503, China;
    2National Institutes for Food and Drug Control, Beijing 102629, China;
    3Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen Guangdong 518024, China;
    4Shandong Center for ADR Monitoring, Jinan Shandong 250014, China;
    5Center For Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China
  • Received:2023-08-09 Online:2023-11-15 Published:2023-11-13

Abstract: Objective To analyze the process in which the UK established the patient reporting scheme and provide reference for the start of an adverse drug reaction patient reporting scheme in China. Methods Based on literature review, the process of establishing the patient reporting scheme in the UK was analyzed. Results UK launched a nationwide pilot program to collect patients’ reports directly from patients, which greatly increased the total number of ADR reports. Subsequently, the patient reporting scheme was officially implemented. Conclusion The patient reporting scheme in the UK is a supplement to the existing yellow card scheme. Only through direct patient reporting can we get the expected results of the patient reporting scheme. It is recommended that China learn from the related experience in the UK to initiate a pilot program to start a patient reporting scheme that is workable in China.

Key words: pharmacovigilance, yellow card scheme, adverse drug reaction, patient reporting, scheme, UK

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