The blockbuster report was released, and the number of adverse reactions of such drugs increased the most!

Adverse drug reactions refer to harmful reactions that occur under the normal dosage of qualified drugs that are not related to the purpose of medication. Adverse drug reactions are inherent properties of drugs, and in general, all drugs will have more or less, light or severe adverse reactions.

Adverse drug reaction monitoring is an important support for post-marketing safety supervision of drugs, and its purpose is to timely discover and control drug safety risks. Holders, operating enterprises, and medical institutions shall report the adverse drug reactions found, and the State encourages citizens, legal persons, and other organizations to report adverse drug reactions. The average number of reports per million population is one of the important indicators to measure the level of monitoring of adverse drug reactions in a country.

In order to fully reflect the monitoring of adverse drug reactions in mainland China in 2021, improve the level of safe drug use, and better protect the safety of public drug use, the National Adverse Drug Reaction Monitoring Center organized and compiled the "National Adverse Drug Reaction Monitoring Annual Report (2021)", which was released on March 30, 2022!

In this paper, the overall situation of adverse drug reactions/event reports and the monitoring of adverse drug reactions in the metabolic and endocrine systems are sorted out, hoping to be helpful to relevant medical workers.

Overall situation of adverse drug reactions/events reported

1. Reporting of adverse drug reactions/events in 2021

In 2021, the National Adverse Drug Reaction Monitoring Network received 1.962 million copies of the Adverse Drug Reaction/Event Report Form. From 1999 to 2021, the National Adverse Drug Reaction Monitoring Network received a cumulative total of 18.83 million adverse drug reaction/event report forms (Figure 1).

Figure 1 The growth trend of the number of adverse drug reactions/events reported nationwide from 1999 to 2021

2. Reporting of new and serious adverse drug reactions/events

In 2021, the National Adverse Drug Reaction Monitoring Network received 597,000 new and serious adverse drug reaction/event reports; new and serious adverse drug reaction/event reports accounted for 30.4% of the total number of reports in the same period.

In 2021, the National Adverse Drug Reaction Monitoring Network received 216,000 reports of serious adverse drug reactions/events, and serious adverse drug reactions/event reports accounted for 11.0% of the total number of reports in the same period (Figure 2).

Figure 2 Proportion of new and severe and severe adverse drug reactions/events reported, 2004-2021

3. Adverse drug reaction/event reporting relates to the patient's condition

In the 2021 adverse drug reaction/event report, there were more women than men, and the sex ratio between men and women was 0.86:1. In terms of age distribution, 8.4% of children under 14 years of age and 31.2% of elderly patients aged 65 years and older (Figure 3).

Figure 3 Adverse drug reaction/event reports in 2021 involve patient age

4. Adverse drug reaction/incident reports relate to the drug situation

(1) According to the statistics of suspected drug categories, chemical drugs account for 82.0%, Chinese medicines account for 13.0%, biological products account for 2.0%, and unclassifiables account for 3.0% (Figure 4).

Figure 4 Adverse drug reaction/event reports in 2021 relate to drug categories

(2) According to the statistics of drug routes, in the adverse drug reaction/event reports in 2021, injection administration accounted for 55.3%, oral administration accounted for 37.9%, and other routes of administration accounted for 6.8%. Of the injectable administrations, intravenous administration accounted for 90.5% and other injectable administrations accounted for 9.5% (Figure 5).

Figure 5 Adverse drug reaction/event reports in 2021 involve routes of administration

5. Adverse drug reactions/events affecting organ systems

Among the adverse drug reactions/events reported in 2021, the top three organ system involvement were gastrointestinal system diseases, skin and subcutaneous tissue diseases, systemic diseases, and various reactions at the site of administration (Figure 6).

Figure 6 Adverse drug reactions/events affecting organ systems in 2021

Monitoring of adverse drug reactions in the metabolic and endocrine systems

Drugs for the metabolic and endocrine system refer to drugs that treat endocrine and metabolic-related diseases, including glucocorticoids, diabetes treatment drugs, anti-gout drugs, thyroid disease drugs, pituitary gland disease drugs, etc. In recent years, the number of adverse reactions/events reported and the proportion of severe reports of adverse reactions/events in the metabolic and endocrine systems have shown an upward trend, suggesting that more attention should be paid to the risks of such drugs.

In 2021, the National Adverse Drug Reaction Monitoring Network received a total of 81,000 reports of adverse drug reactions/events in the metabolic and endocrine systems, of which 7,422 were severe reports, accounting for 9.2%. Reports of adverse drug reactions/events in the metabolic and endocrine systems accounted for 4.1% of the overall reports in 2021.

1. Situation involving drugs

2021 Metabolic and Endocrine System Medications:

The top 3 drug categories in terms of the number of adverse reactions/events reported were glucocorticoids, biguanides, and other diabetes treatment drugs (except insulin, insulin secretory drugs, biguanides, α-glycosidase inhibitors, and other diabetes treatment drugs other than thiazolidinediones, the same below).

The top 3 drug categories in terms of reported number of serious adverse reactions/events were glucocorticoids, insulin, and antithyroid drugs. 2021 Metabolic and Endocrine System Medications:

Adverse reactions/event reports accounted for 56.6% of oral formulations, 37.2% of injections and 6.2% of other dosage forms.

Serious adverse reactions/event reports accounted for 50.7% of oral formulations, 42.0% of injections and 7.3% of other dosage forms.

2. Organ system involvement

Overall reported and severely reported adverse drug reactions/events involving organ systems in the 2021 Metabolic and Endocrine System Adverse Drug Reactions/Events Report (see Figure 7 for details).

Compared with the overall report of drugs for the metabolic and endocrine systems, the proportion of severely reported adverse drug reactions/events involving organ systems, metabolic and nutritional diseases, various neurological diseases, various examinations, respiratory, thoracic and mediastinal diseases, and cardiac organ diseases is significantly higher.

Figure 7 Adverse drug reactions/events involving the metabolic and endocrine system in 2021

In the overall adverse reactions/event reports of metabolic and endocrine system medications, the top 5 organ system diseases of oral preparations involving organ systems were gastrointestinal system diseases, skin and subcutaneous tissue diseases, metabolic and nutritional diseases, various neurological diseases and systemic diseases and various reactions at the site of administration;

The top 5 organ system involved in injections are gastrointestinal system diseases, skin and subcutaneous tissue diseases, metabolic and nutritional diseases, systemic diseases and various reactions at the site of administration, and various neurological diseases.

In the report on serious adverse drug reactions/events of metabolic and endocrine system medications, the top 5 organ systems involved in oral preparations are gastrointestinal system diseases, metabolic and nutritional diseases, skin and subcutaneous tissue diseases, various nervous system diseases, and various examinations.

The top 5 organ systems involved in injections are metabolic and nutritional diseases, gastrointestinal system diseases, various neurological diseases, skin and subcutaneous tissue diseases, and various examinations.

3. Monitoring situation analysis and safety risk tips

In terms of the absolute number of reports, the number of reported diabetes treatment drugs has increased the most compared with 2020; from the ranking of the total reports and the number of severe reports of various varieties, some of the newer diabetes treatment drugs (such as polyethylene glycol lotherna peptide, dulaglucide, dapagliflozin) have risen rapidly.

On the one hand, this may reflect the increase in the incidence and/or diagnosis rate of diabetes due to the aging of the mainland population and the improvement of medical security, which may lead to the expansion of the use of diabetes treatment drugs, and on the other hand, it also suggests that prescribers and patients should pay attention to the associated risks when choosing diabetes treatment drugs, especially newer drugs.

Through the efforts of all parties, the enthusiasm of holders, operating enterprises and medical institutions to report adverse drug reactions has gradually increased, and the number of adverse drug reaction reports in the mainland has generally shown an upward trend. However, the new and serious adverse drug reaction reports, especially the larger number of serious adverse drug reaction reports, do not indicate that the level of drug safety has declined, but means that the information held by the regulatory authorities is more and more comprehensive, the risks of drugs are more understood, the risks are more controllable, the evaluation of drugs is more based, and the regulatory decisions are more accurate. Similarly, in medical practice, it is also an important measure to ensure the safety of patient medication to understand the performance and extent of adverse drug reactions in a timely manner and avoid them to the greatest extent.

Source | Health Community - Endocrine Frontline Collation Published

References[1] National Adverse Drug Reactions Monitoring Center. National Adverse Drug Reaction Monitoring Annual Report (2021). 2022.3.30