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NMPA issued the Announcement on the Annual Report for National ADR Monitoring (2018)

CCFDIE|Updated: 2019-10-18

     

3. Average case report per million population 

As one of the important indicators to measure the level of national ADR monitoring, the average number of reports per million people in China marked 1,119 in 2018. 

4. ADR/ADE county reporting ratio 

ADR/ADE county reporting ratio marks an important indicator for measuring the balanced development and coverage of ADR monitoring in China. The proportion of county-level reports of ADRs/ADEs in China in 2018 was 97.9%. 

5. Source of ADR/ADE Reporting 

Pharmaceutical manufacturers, distributors and medical institutions constitute the responsible organizations for ADR/ADE reporting. As per source-specific statistics of ADR/ADE reports in 2018, a lion's share of 86.8% came from medical institutions; while a share of 8.0%, 5.1%, and 0.1% came from pharmaceutical distributors, manufacturers, individuals and other sources, respectively (Figure 3).

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6. Occupations of reporters 

In occupation-specific statistics, doctors accounted for 55.2%, pharmacists accounted for 23.0%, nurses accounted for 15.3%, and other occupations accounted for 6.5% (Figure 4).

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7. Patients involved in the ADR/ADE reports 

In the 2018 ADR/ADE reports, the ratio of male to female patients was 0.86:1, with men slightly outnumbered by women. Reports of pediatric patients under 14 years of age accounted for 9.8%; reports of elderly patients over the age of 65 accounted for 27.7% (Figure 5).

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8. Distribution of drug categories involved in ADR/ADE reports 

According to category-specific statistics of suspected drugs, reports of chemical drugs, TCM and bio-products accounted for 83.9%, 14.6% and 1.5%, respectively (Figure 6).

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As per the statistics of routes of administration of drugs involved in 2018 ADR/ADE reports, 60.0% were administered by intravenous injection, 4.2% by other injections, 32.2% by oral administration, and 3.6% by other routes of administration (Figure 7).

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9. Organ system damaged by ADRs/ADEs 

Among the ADRs/ADEs reported in 2018, the top 5 damaged organ systems are: skin and its appendages; gastrointestinal system damage; systemic damage, neurological impairment and cardiovascular system damage (Figure 8).

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III. Relevant Risks Contrl Meathods (Omitted) 

IV. Morograph (Omitted) 

V. Relevant Illustration (Omitted)


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