Refractory epilepsy "special drugs" are still difficult to buy after they are legal

The drug clobazam has been legally on the market for nine months, and some patients' families still choose to purchase
overseas due to reasons such as "long distance" and "frequency" to go to the hospital to prescribe drugs

At the end of May this year, Mr. Chen, a parent of a child with refractory epilepsy, reported to the Beijing News reporter that the drug clobazan purchased by himself and the families of three patients from direct mail from Germany was detained by Fuzhou Customs, and he received a call from a police station in Fuzhou City on the afternoon of May 5, asking him to go for questioning. As at 5 June, the inquiry had not been conducted.

On June 6, Mr. Lu, who was also detained for medicine, told reporters that he had received the package of clobazan that morning, and was immediately summoned by the Pingnan County Public Security Bureau in Ningde City, Fujian Province to investigate, and the drug was also detained. The relevant staff of the bureau verified with reporters that this was indeed the case.

Wang Hongbing, a lawyer at Beijing Yingke (Guangzhou) Law Firm, explained that clobazam is a Class II psychotropic substance in China, and according to relevant regulations, individuals or institutions importing or exporting clobazam should hold an import and export license from the drug administration department under the State Council; If clobazam is mailed in China, a mailing certificate issued by the drug administration department at or above the prefecture-level city is required.

However, Wang Hongbing also said that behind the continuous phenomenon of direct mail purchase of clobazam is that there are too few designated hospitals that can prescribe clobazam, and many patients' families still have "a bit difficult" to go to the hospital to prescribe drugs.

As a "life-saving drug" for refractory epilepsy, before clobazan was approved for marketing, it caused a sensational "Iron Horse Glacier" case - in the summer of 2021, the parents of children with epilepsy with the online name "Iron Horse Glacier" were charged with smuggling and drug trafficking for purchasing clobazam from overseas. On March 2023, 3, "Iron Horse Glacier" was commuted to the crime of illegal business operation and exempted from criminal punishment.

On September 2022, 9, the temporarily imported chlorbazan was issued the first party in the country at Peking Union Medical College Hospital. On October 22, Yichang Renfu Pharmaceutical Co., Ltd. held a press conference for the listing of domestic chlorbazhan.

At the end of November 2022, Fuzhou Children's Hospital affiliated to Fujian Medical University issued the first prescription for clobazam in Fujian Province. Song Shiwei, an expert at the hospital's pediatric epilepsy diagnosis and treatment center and deputy chief physician of neurosurgery at the Union Hospital affiliated to Fujian Medical University, said that according to relevant regulations, the hospital can prescribe a maximum of two weeks at a time.

Through interviews with the families and attending physicians of several patients with refractory epilepsy, the Beijing News reporter found that due to the "long distance", "frequent frequency" and "high cost" of going to the hospital to prescribe drugs, nine months after the legal listing, overseas purchasing or direct mail clobazan is still the choice of many patients' families. The doctors, lawyers and family members interviewed all explained that this was a "helpless choice". Is there still a legal risk behind this choice? What room for improvement can we expect?

Dilemma 1

The cost of prescribing drugs is high, and there are many purchasing agents

In November 2022, as the first in Fujian Province, Fuzhou Children's Hospital began to supply domestic clobazan with a specification of 11 mg / tablet, 10 tablets per box, and a price of 28 yuan. Ms. Li, who lives in a village in Yongchun County, Quanzhou City, Fujian Province, is still anxious — Fuzhou Children's Hospital only prescribes medicine to patients under the age of 84, and her brother, then 18-year-old patient with refractory epilepsy, does not meet the requirements.

In the following six months, two more hospitals in Fujian Province that could open chlorbazam were located in Xiamen City and Ningde City. The two hospitals can prescribe drugs to adult patients, but the two cities are more than 100 kilometers and nearly 300 kilometers away from Ms. Li's home, respectively.

Song Shiwei, deputy chief physician of the Department of Neurosurgery at the Union Hospital Affiliated to Fujian Medical University, said that according to drug management regulations, general hospitals can only prescribe a maximum of two weeks' dosage of clobazam at a time, "That is to say, to maintain medication, the patient's family needs to come to the hospital every two weeks at most." Ms. Li's father earns about 100 yuan a day as a construction worker and electrician, while her mother works as a part-time worker outside the home with a monthly salary of 3,000 yuan. Running to Ningde or Xiamen every two weeks has a cost that their family cannot afford. Ms. Li said that her brother could only switch to clonazepam, which had poor results and side effects, "I ate every day and wanted to sleep." ”

Mr. Chen, who also crossed nearly 160 kilometers to Fuzhou to prescribe clobazan for his son with refractory epilepsy, recalled that on the day of the prescription, he went out at 200 a.m., took a bus to the train station, took the train before 50 o'clock, and arrived in Fuzhou two hours later. Spend another hour taking the subway to Fuzhou Children's Hospital, queuing for registration, prescriptions, and medicines. I returned the same way in the afternoon, and when I got home, it was often time for dinner. "The train is <> yuan round trip, plus the cost of the subway and bus, and every time the medicine is prescribed, the travel fee alone costs <> yuan." Each registration also costs <> yuan. The expense was too big and it took too long, and he felt that it was difficult to stick to it, so he only went twice and chose to buy it from overseas direct mail.

Wang Yun, a family member of a patient living in Wafangdian in Liaoning Province, said that of several family members of patients he knows in his own province, only one person prescribes chlorbazan at Shenyang Shengjing Hospital "because he lives in Shenyang." The rest, including himself, chose to buy or direct mail most of the time, "20 yuan a box, 50 mg <> capsules." After paying the money, adding some postage, the medicine was sent directly to the house. And there is no limit, you can buy three boxes and five boxes at once. ”

"After the 'Iron Horse Glacier' case last year, the state still attached great importance to it, and at the end of the year, a batch of chlorbazan was imported, and our hospital divided several hundred boxes." An epilepsy doctor in a tertiary hospital said. However, the hospital he works for is the only one in his province that provides clobazam to adults, and "many patients come from far away and may come again in two weeks..."

Volunteer Min Wen, who manages a group of tens of thousands of epilepsy patients, observed that there are still many family members of patients who choose overseas purchasing or direct mail. His statistics show that as of February this year, more than 2 hospitals nationwide can open imported chlorbazhan, and more than 20 hospitals can open domestic chlorbazhan, "On average, there are only two or three hospitals in each province that can prescribe medicine, and many people have to travel hundreds of kilometers at a time." If every patient's family can really prescribe medicine nearby, it may take seven or eight hundred hospitals to meet the requirements. ”

Dilemma 2

It takes time for domestic drugs to enter the hospital There are many application processes for imported drugs

Ms. Li remembers that more than 38 years ago, her brother, who was watching TV at home, suddenly collapsed, his whole body convulsed, and was diagnosed with refractory epilepsy in the county hospital. Today, the <>-year-old brother's intelligence is still in his early tens.

In order to control the disease, my brother has tried compound phenobarbital sodium bromide tablets, carbamazepine, phenytoin sodium and other drugs. In May 2021, under the suggestion of Song Shiwei, deputy chief physician of the Department of Neurosurgery at Union Hospital Affiliated to Fujian Medical University, he began to take clobazan and the effect was very good.

At that time, there was no formal channel for the purchase of clobazan in China. She purchased chlorbazan through the patient group, a box of three to four hundred yuan, two or three boxes each time, which can be eaten by her brother for more than 2021 days. In the second half of <>, Anhui daigou, which goes by the online name "Iron Horse Binghe", was prosecuted for selling and reselling the second class psychotropic drug chlorbazam that has not yet been approved for marketing, suspected of smuggling, transporting and trafficking drugs.

Since then, the daigou has disappeared, and the price of clobazhan, which is still in circulation, has soared to nearly 2022,<> yuan per box. Ms. Li's family couldn't afford it. At the beginning of <>, my brother stopped taking clobazam and switched to clonazepam on the advice of the doctor at the county hospital.

According to previous reports by the Beijing News, on March 2022, 3, the National Health Commission and the State Food and Drug Administration issued an announcement on the "Temporary Import Work Plan for the Temporary Import of Clobazam" for public consultation. On June 29 of the same year, the State Medical Products Administration issued the Notice on Printing and Distributing the "Work Plan for the Temporary Import of Urgently Needed Clinical Drugs" and the "Work Plan for the Temporary Import of Clobazam", announcing that Peking Union Medical College Hospital and a total of 6 hospitals in various provinces, municipalities and autonomous regions across the country jointly initiated the provisional import application of clobazam original research drugs to the State Food and Drug Administration. On September 29 of the same year, the temporary import of clobazan was issued at Peking Union Medical College Hospital. A month later, Yichang Renfu Pharmaceutical Co., Ltd. announced the listing of domestic clobazam.

"Iron Horse Glacier" was released on bail in April of the same year. On March 4, 2023, the case of "Iron Horse Glacier" was publicly tried in the first instance of the Zhongmu County People's Court in Henan Province, and "Iron Horse Glacier" was commuted to the crime of illegal business operation and exempted from criminal punishment.

At the end of 2022, domestic chlorbazam was logged on the Fujian Sunshine Procurement Platform, and Song Shiwei introduced that for domestic chlorbazam that has been on the procurement platform, even if a doctor submits a procurement application, the pharmaceutical council meeting to review the application is often held once every few months. For example, in the Union Hospital Affiliated to Fujian Medical University, where he works, the pharmaceutical council meets quarterly, and the purchase application he submitted more than a month ago has not yet been reviewed.

It is even more troublesome to apply for imported clobazhan, "to advance the procurement platform of each province, to set the price, go through the process of the Food and Drug Administration, and then it is the doctor's turn to apply and hold a drug conference." Song Shiwei analyzed, "Foreign manufacturers may feel that there is not enough interest to drive to do these things." ”

He explained that the epilepsy profession has not yet developed in many parts of the country, and there are few corresponding doctors, which has also led to many hospitals not paying attention to the use of clobazam. For example, he said that clonazepam, which is also a second-class psychotropic drug, is "very good to prescribe" and can be prescribed by county-level hospitals. First, because clonazepam has been on the market for a longer time, and second, because it has been widely used and recognized by the medical community.

The relevant person in charge of Renfu Pharmaceutical told reporters that hospitals that purchase domestic clobazan have no level requirements, and they can have the qualification to operate second-class psychotropic drugs. At present, they are stepping up the work of bringing chlorbazam to the provinces that have not yet been covered by the country. Min Wen said that he will keep in touch with the medical representative of Renfu, "There will be an increase in the number of designated hospitals in the future, and I will communicate with me in time, and then I will pass it on to the patients." The pharmaceutical company means that the target of admission in the short term is at least 100. ”


Let hospitals in more areas introduce clobazam and appropriately extend the prescription time

Families of patients who can't wait can only rely on overseas purchasing or direct mail. According to Min Wen's observation, since the listing of chlorbazhan and the conclusion of the "Iron Horse Glacier" case, the control of customs in various places over the entry of chlorbazhan has become more humane, and "basically I have not heard of any seizure." The reporter called Shenzhen, Changsha and other customs customs, and the operator said that chlorbazan theoretically does not allow individuals to import without a license. Whether clobazam is seized or not depends on the judgment of customs personnel on site. If the recipient can submit medical documents such as prescriptions and medical records to prove their own use, in some cases, the drug may be released. "If you haven't bought it yet, it's not recommended to buy it, but if you have already bought it, you can try it (can you pass customs)." A Beijing customs worker said.

Mr. Chen's direct mail from the patient's family member, chlorbazhan, was detained by Fuzhou customs. On the afternoon of May 5, Mr. Chen received a call from the Antai Police Station in Fuzhou City, asking him to go for questioning. As at 31 June, the inquiry had not been conducted.

On June 6, Mr. Lu, who was also detained for medicine, told reporters that he had received the package of clobazan that morning, and was immediately summoned by the Pingnan County Public Security Bureau in Ningde City, Fujian Province to investigate, and the drug was also detained. The reporter spoke with the relevant staff of the bureau and learned that clobazan is a controlled drug, "through the hospital (prescribed), through the doctor's prescription, and must be registered in real name." Whoever buys the medicine in the hospital, we have to register, we have to go to the hospital every month for examination. Such drugs cannot be bought casually. As for the follow-up treatment of Mr. Lu and the drug, the staff member said that it would follow the procedure and it was not convenient to disclose it for the time being.

In this regard, Wang Hongbing, a lawyer at Beijing Yingke (Guangzhou) Law Firm, said that the customs on-site staff has a certain room for handling changes.

"According to Article 66 of the Drug Administration Law, the import of chlorbazhan, a state-controlled drug, shall be subject to an import permit issued by the drug administration department under the State Council, even if it is imported by individuals; If controlled drugs such as clobazam are mailed in China, a mailing certificate issued by the drug administration department at or above the prefecture-level city is also required. Whether it is sent back from abroad or sent domestically, each time it is sent, a permit or mailing certificate is required. Therefore, it is normal for customs to confiscate controlled drugs. "However, Article 44 of the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances also stipulates that due to the need to treat diseases, individuals can bring narcotic drugs and Class I psychotropic substances within the maximum dosage of a single prescription with a medical certificate issued by a medical institution and their identity certificate - clobazan is a Class II psychotropic drug, but as long as they can provide medical materials to prove their own use, the customs may still choose to release them." ”

"After the 'Iron Horse Glacier' case, both the judiciary and society have progressed, and I judge that the possibility of purchasing clobazan being prosecuted for drug trafficking is now very small. But unless it can be proved for self-use, the biggest risk is that it will be identified as smuggling. Wang Hongbing said.

Wang Hongbing said that at present, there are very few designated hospitals in chlorbazhan, "coastal cities are better, the transportation is convenient, and it is not so laborious across cities and provinces." However, in most parts of the country, it is difficult to frequently go to big cities to prescribe medicine. He suggested to this end, "In terms of national policy orientation, can it promote and encourage further expansion of the scope and number of designated hospitals?" ”

This is also the common wish of the doctors interviewed. "The state's control of chlorbazam is understandable, but if it is possible to introduce clobazam in hospitals in more areas, or allow hospitals to mail clobazam to patients, I believe that the number of patient families who purchase overseas or mail directly will be further reduced." Song Shiwei said.

He also mentioned that there should be more communication between epilepsy doctors, "activities such as exchange meetings, publicity meetings and training can be held across hospitals, so that many doctors who do not know can also understand clobazamp, so that more doctors can lead hospitals to apply for the purchase of this drug." ”

In addition, doctors also recommend that the prescription time be appropriately extended under the premise of strict management. A doctor of epilepsy at a third-class hospital in Guangdong revealed that his department received a new policy document at the end of April, "In the past, the state's management of refined class II drugs generally required that the prescription should not exceed seven days, and if there were previous chronic diseases, it could be prescribed for 4 days." However, the latest documents we have received indicate that for chronic diseases, prescriptions can be issued for up to 15 days. The doctor said that the increase in the prescription limit has undoubtedly appropriately reduced the trouble of patients' families going back and forth, and the number of family members who choose to prescribe drugs in the hospital may increase.

Beijing News reporter Feng Yuxin Intern Zou Bingqian