On March 29, there was a new progress in the case of children with rare epilepsy seeking to purchase clobazam. Announcement for public comments on the plan. In response to the children’s medication needs, the National Health and Medical Commission proposed in the plan a list of 50 medical institutions that plan to lead the import and use of clobazam.
On March 30, a number of parents of children with rare epilepsy told The Paper that they felt that a stone in their hearts was finally about to fall when they saw the announcement of soliciting opinions initiated by the state. At the same time, many children are facing the situation of discontinuing or have already discontinued the medicine, hoping to “implement it sooner.”
Picture of Dudu mother with empty pillbox in rare epilepsy children
< p>The National Health and Medical Commission has formulated a work plan to respond to urgent drug needs.
At the end of last year, a joint letter for help from the parents of children with epilepsy titled “How to Keep Our Children Live?” attracted attention. The letter mentioned that clobazam, which has been marketed in foreign countries, is effective for children with rare epilepsy, but it belongs to the second category of psychotropic drugs in China and has not been approved for marketing.
Many families of children choose to purchase drugs from overseas. However, with the occurrence of a series of incidents such as the alleged “drug trafficking” of the purchasing agent “Iron Horse Glacier” for purchasing clobazam, overseas purchasing has become more and more difficult. Young children face drug withdrawal, and each seizure can cause double damage to both the body and the mind.
On December 27, 2021, on the issue of clobazam for children with epilepsy, the relevant departments of the National Health and Health Commission replied to The Paper, saying that they have recently paid attention to relevant media reports and are currently organizing a response to the disease group. Carry out a thorough investigation to understand the demand for drug dosage, and coordinate relevant agencies and departments to organize centralized application and import in accordance with the relevant provisions of the “Drug Administration Law” to meet patients’ drug needs.
In the “Working Plan for Temporary Import of Clobazam” (Draft for Comment) published by the National Health and Health Commission, the specific application process for the use of clobazam is as follows: Demand, determine the list of medical institutions to be used, and select the medical institution to lead the import; the medical institution leading the import shall submit a temporary import application to the State Food and Drug Administration and provide relevant materials as required; the State Food and Drug Administration receives the relevant application from the medical institution Afterwards, for those who meet the requirements, within 3 working days, a reply letter of approval to import will be issued in the form of a comprehensive department letter of the bureau, and an import permit will be issued; the importer will directly go through the customs clearance procedures with the import permit. Such imported drugs do not need to undergo port inspection.
It is worth mentioning that the conditions of the selected 50 medical institutions for the import and use of clobazam include: 1. tertiary hospitals; 2. doctors with epilepsy subspecialty or related specialties, engaged in epilepsy Or more than 10 years of diagnosis and treatment of children with epilepsy; 3. Have the clinical safe use of clobazam and emergency plans, and establish a clinical, pharmacy, and medical multidisciplinary diagnosis and treatment team.
List of medical institutions that plan to take the lead in importing and using clobazam National Health Commission’s official website p>
The family of the child: “I hope it can be implemented sooner”
Beijing’s mother Dudu is the mother of a child with rare epilepsy. Dudu suffered from encephalitis when she was five years old. She has refractory epilepsy with sequelae and has been taking clobazam for 4 years. “I don’t know the pharmacology, the ingredients of the drugs, I only know that clobazam is helpful for children to control epileptic seizures, and the side effects are relatively small.” She told The Paper that the children also took oxcarbazepine, levetiracetam, and lacosa at the same time. amine.
Mother Dudu said that lacosamide also needed to be purchased before 2019. It was called lacosamide at that time. Now she passes through Beijing Children’s Hospital, offline Golden Elephant Pharmacy, and online. The Jingdong Pharmacy has purchased it. Go to the hospital to register and prescribe medicine for one month, and online for about 3 months. The same dose/number of tablets is cheaper than purchasing on behalf of others, and medical insurance can also partially reimburse, and online pharmacies can save a little if they have activities.
She hopes that clobazam can also fully consider the particularity of the group of children with rare epilepsy in terms of purchasing channels, purchasing doses, and purchasing prices, especially during the special period of epidemic prevention and control. “The most important thing is to hope that it can be implemented faster!” At present, she has bought a box of clobazam from a patient, which can last for a while.
On the same day, the father of children with rare epilepsy and the group owner of the patient group “Songsong Dad” told The Paper that he was both happy and sad when he saw this policy. He was happy that the problem of drug use in this group began to be taken seriously. Sadly, since July last year, a large number of children taking clobazam have been discontinued, resulting in the recurrence of epilepsy, aggravation of seizures and even death in some children.
Songsong’s father said that every day there are children who stop taking medicine, and he hopes that the policy can be implemented as soon as possible. “I see that the draft for comments is as of April 28, which means that it will take another month to implement it. Can it be faster?”
He noted that the comments stipulated The hospital that prescribes the medicine, the relevant professional doctors and “the maximum amount of each prescription should not exceed 1 month”, he believes that this may increase the difficulty of medication. “Some cities do not have designated hospitals, and it is not easy to go to designated hospitals to get an expert number.”
In addition, he suggested that, in addition to clobazam, more rare disease drugs such as cannabidiol, Nonamide, ethosuximide, hydroxycobalamin, betaine anhydrous, levocarnitine injection, quinidine, fenfluramine, stiripentol, diazepam enema, diazepam nasal spray, midar Drugs such as Zolam nasal spray can also be taken seriously. Dudu’s mother and Songsong’s father said that they had submitted relevant suggestions to the National Health Commission.
Source: The Paper