National Adverse Drug Reaction Monitoring Center: The number of adverse reaction reports is generally on the rise

Text/Figure Yangcheng Evening News all-media reporter Zhang Hua

Recently, the National Adverse Drug Reaction Monitoring Center released the "National Adverse Drug Reaction Monitoring Annual Report (2021)". The "Report" pointed out that at present, the number of adverse drug reactions reported in the mainland is generally on the rise.

Among them, the adverse reactions of traditional Chinese medicines, tumor drugs, and endocrine drugs (new drugs for diabetes) have increased. The proportion of elderly patients aged 65 years and above continues to increase, and the adverse reactions of injections in children increase, suggesting that clinical attention should be paid to the safety of medication in elderly patients and the route of administration of drugs in children.

Reports of adverse drug reactions in mainland China showed an upward trend

At present, the number of adverse drug reactions reported in mainland China is generally on the rise. In 2021, the National Adverse Drug Reaction Monitoring Network received 1.962 million adverse drug reaction/event reports, of which 597,000 were new and serious adverse drug reaction/event reports, accounting for 30.4% of the total number of reports in the same period.

It is understood that adverse drug reactions are inherent properties of drugs. In general, all drugs will have more or less, light or heavy 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.

According to the occupational statistics of the reporters of adverse drug reactions, doctors accounted for 55.6%, pharmacists accounted for 25.5%, nurses accounted for 13.0%, and other occupations accounted for 5.9%. 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, children under 14 years of age account for 8.4%, and elderly patients aged 65 years and older account for 31.2%. Compared with previous years, the proportion of elderly patients aged 65 and above continues to increase.

The "Report" pointed out that the increase in the number of adverse drug reaction reports in 2021 does not mean 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.

It is a three-point poison of medicine, and Chinese medicine is no exception

"It is a three-point poison of medicine", Chinese medicine, like other drugs, may also produce certain adverse reactions. In the 2021 adverse drug reaction/event report, 2.104 million cases of suspected drugs were involved, of which Chinese medicines accounted for 13.0%; in 2021, serious adverse reactions/event reports involved 278,000 suspected drugs, of which Chinese medicines accounted for 5.1%.

According to the Report, among the Chinese medicines involved in the adverse drug reactions/event reports in 2021, the top 5 categories in the number of cases were blood-activating and stasis drugs in blood-rational agents (24.5%), antipyretic and anti-virus drugs in antipyretic agents (11.7%), anti-dampening dehumidification drugs (7.1%), anti-damping drugs in anti-damping agents (5.2%), and beneficial qi and yin nourishing drugs in tonics (4.9%).

The Report points out that compared with 2020, the number of reports of adverse reactions/events in Chinese medicines has increased in 2021. From the perspective of drug categories, the number of reported drugs to activate blood and dissolve stasis is still the first. Therefore, the public is reminded that if the principles of TCM dialectics and treatment are not followed or the dialectical and super-prescribed function is used for treatment, the risk of adverse reactions/events in Chinese medicine may increase.

Focus on the adverse effects of new drugs

Among the serious adverse drug reactions/events involving chemicals in 2021, the largest number of reported drugs is tumor drugs, which suggests that the clinical need to continue to strengthen the risk management of such drugs. For example, PD-1/PD-L1 immunotherapy is currently a new anti-cancer therapy in addition to conventional surgical treatment, chemoradiotherapy and targeted therapy.

In 2018, the mainland approved the first PD-1 class of anti-tumor drugs navulijumab, and in the following three years, more than ten PD-1/PD-L1 products were listed, such as triprimumab, sindilizumab, carriolizumab, atenibizumab, etc. Immunotherapy-related adverse reactions of clinical concern include pneumonia, elevated liver enzymes, hypothyroidism/hyperthyroidism, adrenal insufficiency, pititis, etc., some of which may be life-threatening and require active medical attention.

The "Report" pointed out that the incidence of adverse reactions and the risk of serious adverse reactions in tumor drugs are higher than those of other types of drugs. Patients should understand the adverse reactions and disposal measures of anti-tumor drugs, cooperate with doctors to actively treat and rationally use drugs, so as to obtain the greatest health benefits.

In addition, it is worth noting that in the monitoring of adverse drug reactions in the metabolic and endocrine system, it was found that the number of reported diabetes treatment drugs increased the most compared with 2020, and some newer diabetes treatment drugs (such as polyethylene glycol lotherna peptide, dulaglucide, dapagliflozin) rose rapidly. This suggests that prescribers and patients should be aware of the risks associated with choosing medications for diabetes treatments, especially newer ones.

Can take medicine without injection, can inject without infusion

From the perspective of dosage form statistics, the overall number of reported adverse reactions/events of injections (excluding vaccines) in 2021 increased by 14.7% compared with the same period in 2020, and the proportion of overall drug reports was basically the same as that of recent years. From the statistics of the drug population, the number of reported adverse reactions/events of injectables (without vaccines) in children increased by 19.7% compared with the same period in 2020.

According to the monitoring of injections, it is recommended that clinicians always follow the principle of "can take medicine without injection, can inject without infusion" to choose the drug reasonably. As a special drug population, children are affected by factors such as incomplete organ development, are more sensitive to drugs, have poor tolerance, and should be used with caution.

Because different routes of administration have different clinical significance, such as oral routes of administration are the most commonly used, relatively safe, convenient and economical routes of administration. The injection route of administration has the advantage of fast absorption, accurate and controllable dosage, and the disadvantage is that it does not pass through the natural barrier of the human body and directly enters the body, which can cause tissue damage, pain, infection, and even serious adverse reactions.

The "Report" pointed out that clinically, according to the actual use of drugs, follow the principle of "oral administration, do not choose injection; if intramuscular injection is administered, intravenous injection or drip administration", the route of administration should be reasonably selected. (For more news, please pay attention to Yangcheng Pie pai.ycwb.com)

According to the monitoring data of adverse drug reactions in 2021 and the results of analysis and evaluation, the State Drug Administration issued the announcement of the cancellation of the registration certificate of 10 varieties of drugs such as pediatric amine granules and ammonia non-coffee tablets. A total of 48 issues of revision announcements were issued for the revision of drug instructions such as large active preparations, sulfasalazine preparations, and methimazole preparations, and safety information such as warnings, adverse reactions, precautions, and contraindications in the instructions of 74 (categories) was added or improved.

In addition, professionals analyze the association of drugs with adverse reactions/events, and when the benefits of drugs no longer outweigh the risks, drugs are withdrawn from the market.

Source | Yangcheng Evening News Yangcheng Pie

Editor-in-charge | Cui Wencan