Some children's medicines are still in the stage of clinical trials in foreign countries, and their effectiveness is not yet clear. However, in China, they have become expensive "miracle drugs". How difficult is it for children to safely take medication?
[Children's Medicine Safety Issues in China]
Pidotimod is just the tip of the iceberg when it comes to the safety issues of children's medicine in China. Anainjien has been banned in the United States for 40 years, but it is still widely used in China, with both adults and children taking it. The national pharmacopoeia, drug registration management measures, and other related regulations have not made special provisions for children's medicine. Among the more than 3,500 drugs currently available in China, there are only over 60 specifically for children, accounting for only 1.7% of the total. In order for children to safely take medication, banned and restricted drugs should be synchronized with the standards of developed economies, and adverse reactions should not be dismissed as "unclear". Chinese children should not continue to be used as guinea pigs.
Pidotimod is just the tip of the iceberg when it comes to the safety issues of children's medicine in China. In addition to the shortage of specialized children's medicines and the lack of legislation for children's medicine, the national pharmacopoeia, drug registration management measures, and other related regulations have not made special provisions for children's medicine. An issue that cannot be ignored is that some children's medicines that have been banned or restricted abroad or are often mentioned for their high adverse reaction rates in academic journals are still popular in China.
The most typical example is "Antipyretic Miracle" Anainjien. As early as 1977, the FDA in the United States withdrew all formulations of Anainjien from the market due to its serious side effects. Subsequently, more than 30 countries, including Japan, Australia, Iran, and several EU member states, successively banned Anainjien. The reason is that the probability of side effects of the drug is high, and the side effects can cause shock and death.
Embarrassingly, the drug that has been banned in the United States for 40 years is still widely used in China, with both adults and children taking it. Some township hospitals, health clinics, and even tertiary hospitals in prefecture-level cities prescribe Anainjien to patients.
In fact, as early as 1982, the Chinese Ministry of Health listed compound Anainjien tablets as eliminated drugs, but left behind the "siblings" of Anainjien tablets, nasal drops, injections, and injection solutions. As of June 22, 2017, there were still 1,339 production approval numbers for Anainjien nationwide.
[Why Are Banned Children's Medicines Still Being Used?]
The first reason why banned children's medicines are still being used is the shortage of specialized children's medicines in China.
China has less legislation on children's medicine, and the national pharmacopoeia, drug registration management measures, and other related regulations have not made special provisions for children's medicine. Among the more than 3,500 drugs currently available in China, there are only over 60 specifically for children, accounting for only 1.7% of the total. However, children's medicine accounts for 20% of the total medication used clinically.
Many children in China take adult medicines when they are sick, relying on guesswork for dosage.
In comparison, the proportion of drugs approved for use in children is much higher in the United States. Among the drugs approved by the FDA for use in adults, 20%-30% are approved for use in children, with clear dosage instructions for children on the package insert.
However, compared to the shortage of medicines, the problem of "halving the use" of adult medicines and the failure of Chinese children's medicine standards to keep up with those of developed economies is more urgent.
The FDA in the United States does not approve drugs for use in children that are not explicitly stated in the drug package insert or do not have specific dosage instructions for children. However, in China, children's medicine is often "adultified", and some package inserts for adult medicines will also include instructions for halving the dosage for children or consulting a doctor or pharmacist.
[Legislation on Children's Medicines]
During the recent two sessions (the National People's Congress and the Chinese People's Political Consultative Conference), many delegates and members mentioned the issue of legislation on children's medicines. In China's most important drug laws and regulations, the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, there are no special provisions for children's medicines or the use of adult medicines for children, nor is there a dedicated regulatory agency for children's medicines. In other words, from a guidance perspective, China does not make a detailed distinction between children's medicines and adult medicines. Moreover, in addition to making regulations and distinctions between children's medicines and adult medicines, legislation also encourages pharmaceutical companies to produce children's medicines.
In terms of legislation on children's medicines, the United States is the country that started the earliest. In 1997, the U.S. Congress passed the Food and Drug Administration Modernization Act, which stipulated that new drugs that have undergone clinical trials for pediatric drugs should be given an additional 6-month market exclusivity protection, thus establishing the legal system of "pediatric exclusivity" to incentivize the development of children's medicines.
Subsequently, the United States passed the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The former requires pharmaceutical companies to actively conduct clinical trials of pediatric drugs sponsored by the National Institutes of Health; the latter mandates that new drug applications or supplemental applications for new effective ingredients, indications, dosage forms, dosages, or routes of administration for drugs and biological products must provide safety and efficacy evaluation data for the pediatric population, even down to the specific dosage and route of administration data for each age group of children.
