The number of reports of adverse reactions to anti-infective drugs tops the list

On May 15, the State Food and Drug Administration issued the 2013 annual report on the monitoring of adverse drug reactions in the country. In 2013, the national adverse drug reaction monitoring network received a total of 1.317 million reports of adverse drug reactions/incidents, an increase of 9% over 2012. Among them, 517,000 cases of anti-infective drugs were reported, and the number of reports still ranked first.

"Can be taken orally without injection and can be intramuscularly injected without intravenous injection"

According to the report, in 2013, the National Adverse Drug Reaction Monitoring Network received 1.317 million reports of adverse drug reactions/incidents, an increase of 9% from 2012. Among them, chemical drugs accounted for 81.3%, Chinese medicine accounted for 17.3%, and biological products accounted for 1.4%. The number of reported anti-infective drugs still ranks first, accounting for 47.6% of chemical drugs.

Why does the adverse reaction report of anti-infective drugs always rank first in all kinds of drugs? According to the analysis of the State Food and Drug Administration, anti-infective drugs are commonly used in clinical treatment. They have a large amount of clinical use and many injections. For example, third-generation cephalosporin antibiotics are not absorbed orally and can only be used by injection. Compared with oral dosage forms, injections are more prone to adverse reactions. Experts reminded that the principle of “can be taken orally without injection and can be injected intramuscularly without intravenous injection” should be followed to reduce the use of injection dosage forms.

In addition, the frequency and number of combinations of anti-infective drugs are high, and drug interactions also increase the risk of adverse reactions.

Chinese medicine injection should be used in combination

According to the report, in 2013, the national adverse drug reaction monitoring network received a total of 121,000 injections of Chinese medicine injections, of which serious reports accounted for 5.6%. Compared with 2012, it has increased by 17.0%, and the number of serious reports has increased by 22.3%.

The report pointed out that the phenomenon of joint use of TCM injections with other drugs still exists, and the combined use of drugs may cause drug interactions. For example, aspirin combined with clopidogrel may increase the risk of bleeding. The combination of clarithromycin and digoxin may cause high ground. Xin poisoning and so on.

The report recommends that clinicians should use Chinese medicine injections alone and prudently combine medications as required.

Elderly adverse reaction report rate rose for 4 years

The report pointed out that the adverse reactions of elderly people over the age of 65 accounted for 17.8%, an increase of 1.4% compared with 2012. This is the ratio that has been reported for 4 consecutive years showing a slight upward trend since 2009. In the report of serious adverse reactions to some drugs, the proportion of elderly patients is also larger. For example, in the treatment of gout drug allopurinol tablets, elderly patients over the age of 65 accounted for 45.1% of the total cases of severe cases.

According to the analysis of the report, the proportion of elderly patients is increasing year by year. Older people suffer from multiple diseases such as geriatric and chronic diseases, and the overall drug dosage increases year by year. In addition, the elderly patients have special characteristics due to the degeneration of liver and kidney function or comorbid diseases. Often need to adjust the dose or liver and kidney function monitoring, but in the actual medication process often ignore these factors, so that the risk of adverse reactions increased.

data

â—Ž According to drug category statistics, in 2013, the adverse drug reactions/incidents report involved 81.3% of suspected drugs, 17.3% of Chinese medicines, and 1.4% of biological products.

â—Ž The number of reported anti-infective drugs still ranked first, accounting for 4.6% of chemical drugs. In 2013, a total of 517,000 adverse reactions/events were reported to anti-infective drugs, of which more than 20,000 cases were reported. In the adverse reactions of anti-infective drugs, injections accounted for 74.3%.

Interpretation

Increased adverse reaction reports, drug insecurity

The State Food and Drug Administration explained that the change in the number of reports was mainly affected by two factors. One was the ability to discover adverse drug reactions, and the other was the use of drugs. In recent years, with the improvement of grass-roots ADR monitoring agencies and the improvement of information systems, the ability and timeliness of the discovery of drug safety problems have greatly increased. Secondly, with the advancement of medical reform, the state’s investment in medicine and health has increased, and the number of people who use drugs and the types and quantities of drugs used are rapidly increasing, and the number of reported adverse drug reactions has increased.

The State Food and Drug Administration stated that the increase in the total number of reports of adverse drug reactions/events does not mean that the level of drug safety is declining, but it means that the acquired information is becoming more comprehensive and more aware of the risks of drugs and more controllable. .

Serious adverse drug rankings

2013 Anti-infective Drugs Serious Adverse Reactions Top 10

Ceftriaxone, levofloxacin, cefoperazone sulbactam, penicillin G, cefuroxime, cefotaxime, clindamycin, azithromycin, rifampin, azlocillin.

2013 report of serious adverse reactions of traditional Chinese medicine injections

Qingkailing injection, Shenmai injection, Danshen injection, Shuanghuanglian injection, Xiangdan injection, Xuesaitong injection, Mailuoning injection, Shuxuening injection, Shengmai injection and Huangqi injection.