There is a medicine, old and famous, affectionately called "small medicine" by the people, which is the hospital preparation. In-hospital preparations should have been used in medical institutions, but now through the Internet hospital, detour supervision, sold to the "outside the hospital", is it model innovation or rubbing the edge ball?
Recently, Shenyang Xingqi Eye Medicine Co., Ltd. (hereinafter referred to as "Xingqi Eye Drug", SZ. 300573) Shenyang Xingqi Eye Hospital, a subsidiary of Shenyang, has caused social controversy through the large-scale sale of the in-hospital preparation atropine sulfate eye drops through the Internet hospital.
The health industry combed and found that the hospital preparations sold through the Internet hospital channels are not the only ones in Shenyang Xingqi Eye Hospital. Changsha Aier Eye Hospital in private medical institutions, Nanjing Children's Hospital and Tianjin Children's Hospital in public medical institutions have quietly opened the in-hospital preparation distribution function on the Internet hospital.
According to the Measures for the Administration of The Registration of Preparations of Medical Institutions (Trial Implementation), preparations of medical institutions (i.e., "in-hospital preparations") refer to fixed prescription preparations prepared and used by medical institutions for their own use according to the approval of the clinical needs of the unit, and can only be transferred and used between the units or medical institutions.
Is it compliant for hospitals to expand the scope of use of in-hospital preparations without authorization through Internet hospital channels? After the Internet hospital, is there still a difference between "in-hospital" and "out-of-hospital"? Will the circulation of preparations in the hospital be "unbound"?
The deputy chief pharmacist of a third-class hospital told the health community, "If the hospital can sell the in-hospital preparations to all parts of the country through the Internet, then why bother to register drugs?"
However, some pharmacists believe that internet hospitals are responsible for a specific physical hospital, and from the perspective of the diagnosis and treatment system (including diagnostic prescription, prescription review, allocation, etc.), online and offline should adopt homogeneous management.
"Selling in-hospital preparations through the Internet hospital cannot be called 'selling drugs', but doctors carry out reasonable diagnosis and treatment according to the patient's condition, and the key is that the qualifications and processes of diagnosis and treatment should be compliant." The director of the pharmacy department of a tertiary hospital said.
The "miracle medicine" has grown by leaps and bounds from inside the hospital to outside the hospital
Selling in-hospital atropine sulfate eye drops through Internet hospital channels is the "secret device" of Shenyang Xingqi Eye Hospital's soaring revenue in recent years.
Atropine is a popular "miracle drug" by parents on the Internet, it is extracted from belladonna and other solanaceous plants, and is an anticholine drug. Studies have shown that low concentrations of atropine can effectively delay myopia in adolescents, but the safety and side effects of the drug have always been questionable in the industry. In mainland China, there are no officially approved atropine eye drops, and only a few hospitals are approved to produce in the form of in-hospital preparations.
Shenyang Xingqi Eye Hospital obtained approval on January 28, 2019, allowing the configuration of atropine sulfate eye drops with a specification of 0.4ml: 0.04mg (i.e. a concentration of 0.01%).
In August 2017, Shenyang Xingqi Eye Hospital was registered and established, in May 2018, it obtained a medical institution license, and officially opened for operation in early 2019. That is to say, Shenyang Xingqi Eye Hospital almost opened the door to receive treatment at the same time as getting the approval of the preparation in the Atropine Hospital, and Shenyang Xingqi Eye Hospital achieved revenue of 23.68 million yuan that year.
At the end of December 2019, the Internet Hospital of Shenyang Xingqi Eye Hospital was approved to be established, and the hospital can provide medical services to patients through the Internet medical service platform. In 2020, Xingqi Eye Hospital achieved revenue of 138 million yuan, an increase of nearly 5 times over 2019. From January to July 2021, the hospital's revenue reached 160 million yuan, exceeding the annual revenue of 2020.
A few days ago, Xingqi Eye Medicine said in a reply to the letter of concern of the Shenzhen Stock Exchange that in 2019, 2020 and January to July 2021, the drug revenue of Shenyang Xingqi Eye Hospital was 14.01 million yuan, 114 million yuan and 142 million yuan, accounting for 59.17%, 83.01% and 88.67% of the hospital's revenue, respectively. At the same time, Xingqi Eye Medicine also revealed in the reply letter that the main component of the drug revenue of Shenyang Xingqi Eye Hospital is atropine sulfate eye drops, a medical institution preparation product.
2020 is the year of the outbreak of the epidemic, all walks of life in society have been impacted, and offline activities have come to a large-scale halt. In this context, Shenyang Xingqi Eye Hospital has achieved leapfrog revenue growth through "selling drugs", and it is self-evident in what channels this "medicine" is sold.
Private hospitals entered the bureau, and public hospitals followed
Shenyang Xingqi Eye Hospital is not the only hospital that "eats crabs".
On February 1, 2021, Aier Eye Hospital Group Co., Ltd. (hereinafter referred to as "Aier Ophthalmology", SZ. 300015) issued an announcement that Changsha Aier Eye Hospital, a subsidiary of Aier Ophthalmology, has obtained the "Approval for the Registration of Preparations of Medical Institutions" approved and issued by the Hunan Provincial Drug Administration. Changsha Aier Eye Hospital and Hunan Maiou Medical Technology Co., Ltd. jointly developed atropine sulfate eye drops in line with the relevant provisions of the "Measures for the Administration of Preparation Registration of Medical Institutions", and agreed to register and issue the preparation approval number.
On July 6, 2021, Aier Ophthalmology revealed in reply to investors on the investor interactive platform that the Internet Hospital of Aier Ophthalmology Group has been officially launched, and currently provides services mainly through WeChat Mini Programs, and the business carried out includes atropine sales.
In fact, not only are private medical institutions involved in selling in-hospital preparations through Internet hospitals, but public medical institutions are also involved.
On July 1, 2020, the Internet Hospital of Nanjing Children's Hospital was officially launched in the form of an APP. The app homepage mainly has three functional sections: appointment registration, online follow-up consultation, and expert consultation, in addition to outpatient and inpatient payment, report inquiry and other functions. It is understood that the "online follow-up" mainly provides online follow-up services for parents of children who have been treated in Nanjing Children's Hospital within 3 months, and online follow-up can distribute more than 300 kinds of conventional drugs in addition to cold-chain drugs and psychotropic drugs, including in-hospital preparations.
On December 25, 2020, the Internet Hospital of Tianjin Children's Hospital was put into trial operation, and on January 25, 2021, its Internet Hospital was further upgraded to launch the "In-hospital Preparation Express" function, and patients who returned to the clinic can purchase in-hospital preparations through the Internet Hospital. It is understood that the first batch of in-hospital preparations issued by the Internet Hospital of Tianjin Children's Hospital include 8 kinds of viral mixtures, pediatric brown ammonium oral solutions, brown ammonium oral solutions, etc., and provide services for drug delivery to home, and will expand the varieties of in-hospital preparations that can be issued thereafter.
"In-hospital preparations" is a "leak detection and filling" of drugs in the market
"Medical institution preparations are varieties that are clinically needed and not supplied on the market, usually have the characteristics of small varieties, short efficacy and small profits, and pharmaceutical companies are reluctant to produce them, but there is a clinical demand." Gong Chunyan, director of the Department of Pharmacy at the Dermatology Hospital of the Chinese Academy of Medical Sciences, told the health community.
In-hospital preparations are the product of a special era. At the beginning of the founding of the People's Republic of China, due to the backwardness of the mainland pharmaceutical industry, the production and supply of drugs could not meet the social needs, so the state encouraged hospitals to develop and modulate drugs used within hospitals according to clinical needs to fill the market gap.
This move has greatly promoted the development of in-hospital preparations, and many hospital "star" preparations were also formed during this period, but at the same time, some hospital preparation rooms also have problems such as many varieties, miscellaneous dosage forms, rough quality standards of preparations, and backward testing equipment.
In the past two decades, with the development of the mainland pharmaceutical industry, the research and development and production capacity of new drugs by pharmaceutical companies have been continuously enhanced, the process of marketization of drug supply has accelerated, and a large number of drugs with precise efficacy, broad indications and novel dosage forms have poured into the clinic. In view of the uneven quality of preparations in the hospital, the state has issued a series of policies to promote its standardized development.
In 2000 and 2005, the government promulgated the "Good Management Practice for the Preparation of Medical Institutions (Trial Implementation)" and the "Measures for the Administration of The Registration of Preparations in Medical Institutions (Trial Implementation)" to clean up, rectify, re-declare and approve the preparations of medical institutions nationwide.
After the two rectifications, the number of preparations and the number of preparation rooms in medical institutions in all provinces and municipalities across the country have decreased. According to statistics, the number of medical institution preparation approvals in Beijing decreased from 4503 in 2007 to 3419 in 2010, shanghai from 9712 in 2000 to 1655 in 2008, and Jiangsu Province from 5862 in 2008 to 4274 in 2012. In addition, the number of preparation rooms in medical institutions nationwide decreased from 8398 before the acceptance of the certificate to 4944, a decrease of 44.70%; in 2005, compared with 2010, the number of preparation rooms in medical institutions in Beijing dropped from 67 to 49, and in Shanghai from 39 to 18.
"Existing medical institution preparations are usually formulated and produced by three types of hospitals: Traditional Chinese Medicine Hospital, Children's Hospital, and Skin Hospital, and some maternity hospitals also have in-hospital preparations." Gong Chunyan said.
In Gong Chunyan's view, medical institution preparations are "checking and filling gaps" for drugs in the market, and have played an active role in solving the problems of difficult and expensive drugs for patients.
Ma Linyu, chairman of the Ophthalmic Pharmacy Professional Committee of the Yunnan Pharmaceutical Association and deputy director of the Department of Pharmacy of the Affiliated Hospital of Yunnan University, told the health community, "The preparations in the hospital undertake the mission of innovation and development of traditional Chinese medicine and ethnic medicines, are indispensable in clinical use, and are also the cradle of new drugs in mainland China."
Figureworm creative
Can the circulation of preparations in the hospital be "unbound"?
Can in-hospital preparations be sold through Internet hospitals? At present, there is no explicit prohibition in the country.
Song Yuejin, former dean of the School of Pharmaceutical Business of Guangdong Pharmaceutical University, told the health community that the use of medical institution preparations in this hospital is a small-scale, short-term medication, and doctors can monitor the use effect and adverse reactions, but the audience of Internet hospitals is relatively uncontrollable, and there is a certain risk of medication.
"The government clearly stipulates that narcotic drugs and psychotropic substances cannot be prescribed on the Internet, so shouldn't there also be relevant provisions on in-hospital preparations?" The deputy chief pharmacist of a third-class hospital told the health community that the regulatory authorities should actively intervene and provide clear provisions and guidelines for the sale of in-hospital preparations in Internet hospitals.
Some experts believe that as a new thing, Internet hospitals can be allowed to innovate within a certain range, but they must comply with relevant national laws and regulations.
"The production of in-hospital preparations must be approved, there must be qualified production sites, production materials, production personnel, etc., under the premise of ensuring quality and safety, through the Internet hospital for patients with needs for standardized diagnosis and treatment and online prescriptions."
Gong Chunyan also said that the sale of in-hospital preparations through the Internet hospital should have three conditions: 1) have a qualified preparation registration document number; 2) have the medical institution practice license of the Internet hospital; 3) strictly follow the diagnosis and treatment system of the Internet hospital for management, such as only for repeat patients, and by the doctors of the medical institutions who have passed the qualification certification, and the prescription review and allocation is carried out by the pharmacist.
According to Gong Chunyan, in order to prevent patients from having adverse reactions or medication problems, the Internet Hospital of the Dermatology Hospital of the Chinese Academy of Medical Sciences has strict restrictions on online prescriptions.
"First of all, it is forbidden to use sperm and anesthetic drugs, injectable drugs, high-warning drugs, etc. in Internet hospitals; secondly, the medication course adopts "three urgent and slow seven", the emergency department prescribes 3 days, the chronic disease prescribing 7 days, and the prescribed dosage for patients with chronic diseases can be extended to 1 month, but it is impossible to exceed one month. In addition, there are some restrictions on the dose of a single variety." Gong Chunyan said.
Sources | the health community
Written by | Fluttery
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