Implementation Path of the Pharmacovigilance System in China (3)

3 Effec’ve Implementa’on Of China’s Pharmacovigilance System Path Recommenda’ons 3.1 Promote Synergis1c Governance among Diversified Pharmacovigilance Subjects

Risk society is characterised by uncertainty and hazards, and the concept of consultative governance and risk sharing is more important in risk society to achieve the goal of balancing the benefits of drug safety risks through the communication and exchange of information between different subjects. Pharmacovigilance is an important means of drug safety risk management in China, and the concept of shared social governance needs to be integrated throughout. When an adverse drug event causes harm to the human body, factors such as the difficulty of verifying causality restrict the possibility of a single subject bearing the risk.

China needs to integrate internal and external resources to establish a pharmacovigilance system with close interaction and multi-party participation, to achieve scientific and orderly pharmacovigilance work. First, pharmacovigilance is a complex and systematic scientific activity, in addition to collecting, recording, and analysing ADR data, it also includes the evaluation of drug risk benefits and risk control measures, which cannot be completed only by the collaboration between one or two departments and institutions. Considering the systematic and scientific attributes of pharmacovigilance, the regulatory authorities need to build a cross-departmental organisational structure to effectively monitor and control the safety information during the whole life cycle of medicines. For example, regular pharmacovigilance seminars are held to build an environment for drug evaluation centres and drug evaluation centres to discuss safety risk signals; at the same time, on the basis of the gradual maturation of the national pharmacovigilance system, it is then permitted to open up the pharmacovigilance monitoring data to MAH, healthcare institutions and patients, so as to promote the disclosure and transparency of the information of pharmacovigilance.

Besides, as the main body of pharmacovigilance, the holders should take the initiative to enhance their awareness of the main responsibility, target and concretise their vigilance ability, and realise the change from passive reporting of adverse reactions to active risk monitoring.

In the end, the knowledge of pharmacovigilance should be popularised and publicised, so that medical staff and patients can accurately understand the risks of medicines, improve the accuracy and quality of

the report of suspected adverse reactions, and encourage their active participation in the process of pharmacovigilance risk co-management.

3.2 Expanding the Monitoring of Pharmacovigilance Information using Information Technology

Actively expanding the sources of pharmacovigilance information monitoring by improving both the spontaneous reporting system and the active monitoring system is appeared to be necessary for China Pharmacovigilance. The existing spontaneous reporting system should be upgraded and maintained with the assistance of big data, artificial intelligence, and other means, to improve the efficiency of the monitoring of adverse reaction information and reduce the errors caused by human factors. Pharmacovigilance active monitoring system, on the other hand, focuses on the monitoring of new and serious ADR information, which is more targeted in risk identification and control. China should continue to strengthen the development and popularisation of hospital pharmacovigilance system, conduct active risk signal identification of electronic records in the medical activities of healthcare institutions, and enhance and improve the rate and quality of ADR reporting in healthcare institutions.

In addition, the ICH guidelines should be actively applied in pharmacovigilance activities carried out by MAH, and scientific means should be actively adopted to carry out drug safety risk monitoring, reporting, analysis, and risk minimisation initiatives. In addition, China can also learn from the practice of patients in the EU and other countries of using social media to report adverse reaction-related information, and expand the collection channels of suspected adverse drug reaction monitoring data from patients by ensuring the safety of social media, meeting the requirements of the ICH standard in terms of terminology and format when collecting information, and applying the principle of informed consent and other information protection.

3.3 Continuing to Fulfil the Professional Role of Healthcare Institutions and Their Pharmacists

Due to the limited availability of ADR data at the clinical trial stage, the diversity of risks contained in drugs is more concentrated in the use of drugs, and ADR monitoring after the market launch of drugs is still an important part of pharmacovigilance. Therefore, as the main place of drug use, medical institutions are also an important subject of pharmacovigilance. To address the problems of under-reporting and concealment in the reporting of ADR in medical institutions, the importance and objective understanding of ADR by medical workers can be enhanced by strengthening professional publicity and training, stipulating incentives, and penalties, and simplifying the reporting procedure.

Meanwhile, the main duties of pharmacists in healthcare institutions are not only routine drug procurement, supply and dispensing, but also the responsibility of collaborating with doctors to carry out drug selection, prescription review, and provide specialised medication guidance to patients. As the gatekeepers to ensure the safety of patients’ medication, pharmacists need to focus more energy on reducing the occurrence of adverse reactions and avoiding threats to patients’ health caused by drug abuse and interactions.

Furthermore, pharmacists should reverse their roles and actively take up their important responsibilities in pharmacovigilance, provide professional pharmacological knowledge guidance to patients, doctors, and nursing staff, publicise national and drug-related policies, introduce risk dynamics of domestic and foreign drug, and be good advocates of pharmacovigilance.

Finally, it is also necessary to actively explore the construction of an effective risk information communication mechanism between medical institutions and MAH. MAH in China can pass drug safety

information to medical staff, patients, and the public through letters to medical staff, patient safety medication tips, etc. However, in addition to reporting adverse reactions to their local Adverse Drug Reaction Monitoring Centres, it is still necessary for medical institutions to take the initiative to establish a two-way communication network of safety information with MAH based on preventing duplicate reports.

3.4 Clarifying the Regulatory Logic and Establishing Mechanisms for Interfacing Pharmacovigilance Systems
The proposal of pharmacovigilance system is not the negation and replacement of the past adverse drug reaction reporting and monitoring work but needs to be established based on the theory and practice of adverse drug reaction monitoring. It is recommended that China’s health administrative department, in cooperation with the drug regulatory department, should revise and supplement the Provisions for Adverse Drug Reaction Reporting and Monitoring soon, to clarify the logical relationship between pharmacovigilance and ADR monitoring in the field of legal system, and to determine the positioning of the ADR reporting responsibilities of different subjects under the concept of the whole life-cycle regulation of pharmacovigilance. In addition, in view of the weakening of human, financial and material resources of the primary drug regulatory departments due to the sinking of the authority of the drug regulatory departments below the provincial level under the background of institutional reform, it is necessary to rationally allocate the regulatory powers and responsibilities of the regulatory bodies at different levels in the pharmacovigilance activities, and it is proposed to expeditiously issue a guiding document on the convergence of pharmacovigilance, and to make a clear delineation of the pharmacovigilance responsibilities and obligations of the different regulatory bodies, to prevent the interlocking of powers and responsibilities in the process of unclear regulatory logic.

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