Internet diagnosis and treatment supervision rules open for public comments to "open gates" for online prescription drugs to strengthen safety dams

A few days ago, the Medical Administration and Hospital Administration of the National Health Commission publicly solicited opinions on the "Detailed Regulations for Internet Diagnosis and Treatment (Draft for Comment)" (hereinafter referred to as the "Draft for Comment")
.
The "Draft for Solicitation of Comments" not only puts forward detailed requirements on Internet diagnosis and treatment-related institutions, personnel, business, quality and safety, etc.
, but also expressly prohibits artificial intelligence consultations, first purchase of medicines and then replenishment of prescriptions, and drug rebates
.
Industry insiders believe that the "Draft for Solicitation of Comments" provides conditions for the release and reinforcement of safety dams for online prescription drugs
.
"Online sales of prescription drugs do not only refer to the buying and selling of prescription drugs through online platforms, but rather the online prescription drug dispensing business, including prescription preparation, prescription review, prescription dispensing, drug delivery, medication guidance, pharmaceutical services, and prescription drug procurement, transportation, and storage.
, Deployment, and use
.
" Kang Zhen, visiting professor of the School of Basic Medicine and Clinical Pharmacy of China Pharmaceutical University and deputy director of the National Licensed Pharmacist Development Research Center, believes that the conditional opening of online prescription drug business must not only strengthen the prescription drug business link Supervision, physicians, pharmacists, prescribing prescriptions, etc.
must also be strengthened, so as to help check the online prescription drug business from the source, not only to meet people's needs for the convenience of online drug purchase, but also to better protect the masses Medication is safe
.
Standardizing prescription management Prescription management has always been the focus of attention of all parties in the online sales of prescription drugs
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The "Draft for Comment" proposes that medical institutions should strictly abide by the "Prescription Management Measures" and other prescription management regulations when conducting Internet diagnosis and treatment activities, strengthen drug management, and prohibit problems such as unified prescriptions and supplements
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Electronic prescriptions, prescription review records, and prescription review records of medical institutions shall be traceable
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Li Wenqian, a lawyer from Beijing Lanqin Law Firm, stated that the long-discussed "Measures for the Supervision and Administration of Online Drug Sales (Draft for Comment)" also proposed that online prescription drugs should ensure that the source of electronic prescriptions is authentic and reliable, and prescription adjustments should be made in accordance with relevant requirements.
Review and electronically mark used prescriptions
.
Pharmaceutical retail companies that sell prescription drugs should also keep electronic prescription records
.
"This also means that the practice of selling prescription drugs without prescriptions even without a prescription will be strictly prohibited, and prescription management will be further regulated.

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"Li Wenqian emphasized
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"The prescription management of the online prescription drug business is the key.
Patients should obtain the prescription after diagnosis by a physician, and then hand it over to the pharmacist to make the prescription, and finally get the drug
.
"Kang Zhen said that at this stage, the source of prescriptions is mainly offline medical institutions.
The development of Internet medical services provides a path for the outflow of prescriptions, but it also brings certain risks, that is, it is difficult to guarantee the authenticity of prescriptions
.
"Consultation for comments.
" The Draft clearly further regulates the prescription management of Internet hospitals and provides a basis for the prescription management of online prescription drug business
.
In fact, various localities also emphasize the management of prescriptions when exploring the supervision of online prescription drugs .
In
November, Hainan Provincial Drug Administration Public comments on the "Interim Regulations on the Supervision and Administration of Drug Online Sales in Hainan Province (Draft for Solicitation of Comments).
"
Article 27 of the Draft for Comments proposes that pharmaceutical retail companies can rely on electronic prescription centers for sales, and third-party platforms can rely on electronic prescriptions The center provides transaction services
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"If this regulation is implemented, the authenticity and reliability of the prescription will be guaranteed to a certain extent
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"1 Yaowang Government Affairs General Manager Gao Jing said
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Improving pharmaceutical services Providing professional, high-level pharmaceutical services is the key to ensuring the safety of online prescription drugs
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The "Draft for Comments" proposes that medical institutions should have specialized departments to manage Internet diagnosis and treatment.
Establish corresponding management systems for medical quality, medical safety, pharmaceutical services, information technology, etc
.
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The "Measures for the Supervision and Management of Drug Online Sales (Draft for Comment)" also mentions that drug online sellers should establish an online pharmaceutical service system and keep it intact.
Online pharmacy services and other records
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"The rational use of prescription drugs is inseparable from correct pharmacy services
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"In the view of Fan Jiping, former vice president of the Chinese Academy of Chinese Medical Sciences and president of the WeDoctor Internet General Hospital, both offline and Internet hospitals are paying more and more attention to pharmaceutical services.

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In addition to the "Draft for Solicitation of Comments", the newly revised "Pharmaceutical Administration Law of the People's Republic of China" and "Measures for the Supervision and Administration of Drug Online Sales (Draft for Solicitation of Comments)" all proposed the development of pharmaceutical services
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For operators of online prescription drugs, the development of pharmaceutical services is essential
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"The "Draft for Comments" proposes that medical institutions should establish a pharmaceutical service system, which has a positive effect on the development of online prescription drug dispensing business
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" Kang Zhen said that online prescription drug business should not be a commercial process, but a professional service process.
need help patients with rational use of drugs, medication and provide guidance
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He also said that there is still much work to be done to effectively implement the pharmacy service system
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First, we must clarify the concept of pharmaceutical care.
Pharmaceutical care is not limited to prescription review and adjustment, but also includes a series of medication-related services such as medication guidance and treatment monitoring
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In addition, the main role of the pharmacist should be brought into play, clearly that the pharmacist is the main body of the pharmaceutical service, and the professional quality of the pharmacist should be improved
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In this regard, Gao Jing agreed
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He further added: "Improving the level of pharmacy services is not only a requirement for online prescription drugs, but also a requirement for the development of the entire pharmaceutical industry
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In addition to clarifying the concept of pharmacy services and improving the quality of licensed pharmacists, it is also necessary to improve patients' awareness of pharmacy services
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"Li Wenqian also said that to further improve pharmaceutical service capabilities and establish a strict pharmaceutical service management system is one of the prerequisites for the liberalization of online sales of prescription drugs
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Controlling artificial intelligence The "Draft for Comments" proposes to prohibit fraudulent use of artificial intelligence software to substitute doctors for medical consultations, and requires real-name authentication to ensure that doctors receive medical consultations in person
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This also means that technologies such as artificial intelligence cannot prescribe patients, and the prescription operation must be completed by qualified doctors
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"Medical treatment is a rigorous and serious behavior
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"Fan Jiping said that the prescription of prescriptions depends on the doctor's diagnosis and treatment of the patient's condition.
If artificial intelligence is used to receive a diagnosis, only a simple text narrative, a few pictures or the patient's self-report can not guarantee the rigor of the diagnosis and treatment process, nor can it.
Ensure that the prescriptions issued are valid and in line with the patient's own condition
.
"In addition, the division of responsibilities is also critical
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"Fan Jiping added that the Practicing Physician Law clearly stipulates the legal responsibilities of doctors in the process of diagnosis and treatment.
If artificial intelligence is used for consultation, it will be difficult to
hold accountable in the event of misdiagnosis, misdiagnosis and other medical accidents or disputes .
Similarly, doctors are right.
It is also responsible for the prescriptions issued, and artificial intelligence cannot bear the corresponding responsibilities
.
So, what impact does artificial intelligence have on the review of online prescription drug prescriptions? Is it also necessary to pass real-name authentication to ensure that the pharmacist himself reviews the prescriptions? In Li Wenqian's view At present, relevant laws and regulations do not prohibit artificial intelligence from participating in drug online sales
.
There are strict standardized procedures for the sale of drugs, and the procedures can be dismantled.
This is different from the diagnosis and treatment that requires rich clinical experience.
"Physician reception" is directly applied to drug network sales
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A clinical pharmacist in a tertiary hospital introduced that his hospital has begun to try to use artificial intelligence to conduct pre-review on outpatient and inpatient prescriptions
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Pharmacists analyze the characteristics of medications in different departments.
By setting review conditions or rules, artificial intelligence can be used to review prescriptions
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For those prescriptions that do not meet the conditions, artificial intelligence will intercept them and return them to the doctor for modification
.
The pharmacist reduces the burden
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However, in some cases, the artificial intelligence review party still needs manual intervention, and it cannot completely replace the pharmacist
.
"He emphasized
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It is not difficult to see from the "Draft for Comments" that the state has become stricter and more detailed in the management of Internet diagnosis and treatment.
The strict management of prescription management and pharmaceutical services is conducive to the orderly liberalization of online prescription drugs and to ensure the safety of patients' medication.

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Fan Jiping also said that the “opening” of online prescription drugs is the general trend, but it also needs to be opened in an orderly manner, and the establishment of related systems is indispensable
.