An investigation into the incontinence of children's medicine
Children as a disadvantaged group, its special drug regulation and use has been a public concern, SMW reporter on holiday after the launch of the children's medicine outside the forbidden use survey first sparked public attention. Recently, nandu reporters have launched an investigation into the reasons for the domestic sale of children's medicines banned or restricted by foreign countries.
Some pharmaceutical enterprises internal control standards inside and outside?
Problems for children's drugs, the clinical doctors in addition to fewer drugs category for children, children's medicine less legislation, the state pharmacopoeia, drug registration management measures and other relevant laws and regulations on children's medicine to do special regulations. Is a significant problem, some in a foreign country has been disabled or restrict the use of, or in some domestic academic journals is often in the "name" drug adverse reaction on the high side of children also popular in China.
As a popular drug in China, it is one of the best-selling drugs in China. Data from drugs.com shows that the drug is only produced in China. In this survey, doctors from the guangzhou sanjia hospital raised the issue of ai chang to nandu reporters. According to the doctor, aichang was clearly not used in some parts of the country as early as the age of 6, but China is still allowed to use in newborns.
Like YiChang, Pfizer wyeth pharmaceutical co., LTD developed to alleviate children cold cause symptoms such as cough, runny nose HuiFei ning (common name: sensitive pseudo hemp solution), illustrations of the website in the United States, according to the same can not be used in children under the age of four, but in China, the drug, according to the instructions of 2 years of age or older children can use.
Pfizer's response can be achieved for this is that, HuiFei ning strictly in accordance with the relevant provisions of the state food and drug administration, usage, dosage, adverse reactions on manual, taboo and matters needing attention has made the detailed instructions and reminders. The manual clearly indicates that children under 2 years of age are prohibited. Please consult a physician or pharmacist before taking the children aged 2 to 6.
Pfizer also said that the company has a comprehensive collection, statistics, reporting process and system for improved drug safety and adverse events. When adverse events are found, they will be reported to the global drug safety department for the first time. It will also be reported to the relevant regulatory authorities in time.
And Johnson &johnson, did not YiChang production abroad, to adapt to the crowd and more light adverse situation, only said: "YiChang under a doctor's prescription, can be applied to relieve the 0 to 3 years old infants and young children due to colds, hay fever or other upper respiratory allergies symptoms such as stuffy nose, runny nose, cough."
Johnson & Johnson has stressed that the safety and well-being of patients, consumers and their families has been the primary responsibility of the company. The company strictly abides by the relevant laws and regulations of the market and continuously and effectively monitors the product safety of the company. In addition, qiqiang said it has been working with all parties to promote the safe development of children's drug use.
The drug terminal can only "listen and act"
"We will certainly try to avoid using foreign ones that have been banned or restricted in foreign countries when we prescribe them, but sometimes we will find some problems when dealing with patients who are rediagnosed." This is the statement by zhang hongyu, associate professor of pediatrics at sun yat-sen university affiliated to the first hospital.
He admits that, as pediatricians, it is sometimes difficult to find safe children. Children's intestines and stomach medicine, for example, some are referral of children, including children in some prescription version ding Lin or ding Lin tablet, but the drug is approed for sale in the United States did not (in accordance with the company, at present, though in the United States to sell ding Lin belong to illegal behavior, but patients in the United States still can through to the United States food and drug administration (FDA) requested more Pan Li ketone medicines).
When asked about the disabled or restricted foreign children why medicine has been used in domestic problems, professor in department of nanfang hospital, southern medical university medicine shi-ting liu to SMW reporter also said in an interview: "domestic pediatricians to drugs less selective.
According to its introduction, the part of the standard difference of children's medicine both at home and abroad, once the problems found in clinical use, adverse reactions, pediatricians usually a dedicated website, reported and evaluated, but need to for a long time and a lot of evidence to prove the safety of the drug problem, so the modified instructions or restrict the use of drugs is a long process.
If the hospital terminal is disabled by the professional sex of the pediatrician, the children's medicine that is banned and restricted in foreign countries can be police-specific, then, the retail pharmacies in this respect, the lack of internal control. In an interview with nandu, liu guichun, vice President of guangdong pharmaceutical retail industry association, said that retail pharmacies' control of children's medicine is based on the policy actions of the national pharmaceutical supervision department. It will not be affected by foreign ban or restriction. Once the state administration of food and drug administration has issued a directive requiring a certain drug, the retail industry will process a product according to instructions.
Does the access exit mechanism not integrate with the international?
The adverse reactions of children's medicines in China have been in high trend with the difference of internal and external standards and the need for the drug terminal to be strengthened. According to the white paper on the 2016 report on the safety of children's drug use, the adverse reaction rate of children in China is twice as high as that of adults.
In contrast, in the United States, the access and withdrawal mechanism of children's medicine and the standard of drug use are relatively perfect.
According to song yan, CEO of guangzhou guansheng medical technology co., LTD., the access and exit mechanism of children's medicine in the United States is basically the same as that of adult drugs, and it also needs to be pre-clini-cal, clinical phaseI/II/III. NDA, and post-ipo research; But the preclinical study was mainly about the toxicological data of juvenile animals. The clinical trial requires patients of the corresponding age group, such as those mentioned in the manual for more than 3 months, 6 months or more, under 12 years of age. The exit mechanism is based on the question of drug safety. By considering the risk benefit ratio, the FDA makes relevant decisions.
Specific to the stages of drug use, it is also necessary to support the data in clinical trials or clinical use of specific drugs. For example, acetaminophen and ibuprofen are the most commonly used acetaminophen and ibuprofen in children. And ibuprofen can only be used for children over 6 months. And that doesn't include the American guidelines for children's medicine. These guidelines are generally published in the form of diagnostic guidelines, including clinical diagnostic and drug treatment, and the most authoritative and authoritative guide to the American academy of pediatrics (AAP) website.
China association of enterprises with foreign investment in drug research and development industry committee, a director, said in an interview with SMW reporter, who in some children's medicine "outside the forbidden use" phenomenon may also exist the following two reasons. One is that some drug dosage forms signed up for adults and children in the United States, but may only listed the adult dosage forms in China, children dose is just according to the adult dosage forms of Chinese listed against children to calculate the weight. If later in the process of use, the drug dosage forms of children in the United States did recall or restricted, but because children dosage form not registered in China, related or limit could recall does not involve China.
There is also a situation is, under normal circumstances, a multinational companies of the children's medicine in the United States and other countries have been recalled or restricted or warning, the company has listed that will inform the rest of the countries and regions of the drug regulatory agency. But as for other countries and regions that will not follow suit, they will need to be implemented in accordance with the requirements and regulations of each country and region.
"After all, to make a medicine successful listing is too difficult for children around the usage and dosage will differ, there may be differences in race. Eventually influence factors is restricted or banned, will be based on involved in local adverse drug reaction monitoring data." The director added.
The interest is also winding
In fact, besides the regulation, the benefit may also be a winding.
Huatai securities (17.870, 0.08, 0.45%) in 2015, citing the state food and drug administration and southern institute of medicine economic data, according to children's cold medicine due to chemical medicine quick effect, clinical effect is stable, occupied 80% market share, which, Johnson &johnson YiChang, tylenol respectively accounted for 16. 1% and 10. 4% of the sample city children's cold medicine market share.
The market for children's cold medicines in China is expected to exceed 7 billion yuan in 2015, according to a previous estimate by the Chinese company.
Gui-chun liu, vice chairman of guangdong pharmaceutical retail industry, said in an interview with SMW reporter, Chinese (45.670, 0.80, 1.72%) and the concept of cognitive level is lower, more focus on the effect of drugs, not too much concerned about the side effects of drugs may produce, have banned or restricted abroad for some children's medicine provides the living space.
He admitted that some children's medicine of synchronization on the market in China and abroad, in foreign countries is banned or restricted, still in use at home, there are a handful of big pharma to deliberately hide interests, even use some pr effort to cover up the drug problem. |
