Prescription drug sales chaos: Prescription drugs can be bought online and offline without a prescription

Prescription drugs can be bought online and offline without a prescription [Reporter investigates the chaos of prescription drug sales]

● Drugs are managed separately as prescription drugs and over-the-counter drugs in mainland China. Prescription drugs must be prescribed by a licensed physician or licensed physician assistant before they can be dispensed, purchased, and used

● In offline pharmacies, some pharmacy staff will verbally ask if they have taken these drugs or whether they have allergies, some will ask what symptoms they have, and some will ask for personal information, but few will ask for a prescription

● Some leading online drug sales platforms can issue electronic prescriptions based on the fictitious medical conditions of drug buyers without the need for the hospital's first diagnosis record

● To solve the safety problem of online prescription drugs, the key is to ensure the authenticity and legitimacy of prescriptions through technical means. Operators must strictly review prescriptions and sell them with prescriptions, and online trading platforms must fulfill more management obligations for operators selling prescription drugs on the platform

□ reporter Wen Lijuan

□ This newspaper is really Xi born

Selling prescription drugs without a prescription, dealing in drugs without a license, and selling prohibited drugs...... Recently, four typical cases of drug online sales announced by the State Drug Administration have aroused widespread concern in the society, and the chaos of prescription drug sales has once again entered the public eye.

In the past few days, reporters from the "Rule of Law Daily" have visited or called many pharmacies in Beijing, Hebei, Henan, Guangdong, Hunan and other places and found that it is not uncommon for prescription drugs to be bought directly without a doctor's prescription, including many well-known chain pharmacies. At the same time, prescription drugs can be purchased without a prescription in some online pharmacies, and some Internet hospitals can even quickly issue electronic prescription forms according to the needs of "patients".

Prescription drugs are drugs that are approved by the State Drug Administration in order to ensure drug safety, and can only be dispensed, purchased and used with a prescription from a licensed physician or a licensed assistant physician. Prescription drugs are dependent and can lead to abuse, or have potential risks such as toxicity, and it is not safe for patients to take them on their own.

The interviewed experts believe that the relevant departments should increase the review of the authenticity of prescription sources, establish a strict review system for prescription sources, and improve laws and regulations on prescription sources. In terms of specific system design, the QR code recognition function can be used to do a good job in the review of online prescriptions, and at the same time, the transaction records and transaction evidence can be completely retained to ensure that the supervision can be traced back to the source.

Offline:

Prescription drugs are available without a prescription

Zhang Wang (pseudonym), a resident of Chaoyang, Beijing, recently had symptoms such as cough and sore throat, and he searched online and learned that cefixime was effective, so he went to a chain pharmacy near the community to buy it. The pharmacy staff asked him if he was allergic, and after he answered that he was not allergic, he sold him two boxes of cefixime without registering his personal information or checking whether he had a doctor's prescription.

According to public information, cefixime is a prescription drug, need to rely on paper prescription to the pharmacy to buy, if there is no paper prescription, retail pharmacies in the premise of ensuring the authenticity and reliability of the source of electronic prescriptions, can be sold with electronic prescriptions, pharmacies to take the way of docking with medical institutions, the implementation of computer networking and through the information system to obtain electronic prescriptions from medical institutions, to ensure that the drug norms at the same time, to meet the needs of the masses to buy drugs.

Zhang Wang's experience of buying medicine is not an isolated case.

Recently, the reporter visited a number of pharmacies in Chaoyang District and Haidian District of Beijing on the grounds of buying drugs such as azithromycin and amoxicillin, and found that it is not uncommon to buy prescription drugs without a prescription. Some pharmacy staff will verbally ask reporters if they have taken these drugs or whether they have allergies, some will ask what symptoms they have, and some will ask for personal information registration, but few will ask reporters to show their prescriptions.

For example, in a pharmacy on Xueyuan South Road, Haidian District, Beijing, the pharmacy staff asked the reporter if he had taken these drugs before, and after receiving a positive reply, he directly took the medicine and billed the reporter for convenience. When the reporter asked if he needed to get a prescription, the other party vaguely said "yes".

The reporter also called a number of pharmacies in Henan, Hebei, Guangdong and other places to ask whether amoxicillin can be bought without a prescription, and received a positive reply, among which 3 pharmacies said that "electronic prescriptions can be issued online", but when the reporter said that he did not want to register personal information, the other party said that "you can come directly to the store to buy, no personal information is required".

There are also pharmacies that are more strict about the management of prescription drugs. At another pharmacy in Beijing's Haidian District, a staff member refused to sell the medicine when the reporter did not show a prescription, saying, "If you have taken this medicine before, it may not be a problem to sell it to you; In addition, several pharmacies in Hunan called by the reporter also said that amoxicillin is a prescription drug, and identity information must be registered when purchased in stores, and paper prescriptions or electronic prescriptions must be issued at the same time.

Online:

Prescriptions are issued based on a fictitious condition

In addition to offline pharmacies, there is also a lot of chaos in the online purchase of prescription drugs. In the past few days, the reporter has observed three leading online drug sales platforms and found that these platforms have varying degrees of the phenomenon that electronic prescriptions can be issued according to the reporter's fictitious condition without the first diagnosis record of the hospital, and the platform adopts the operation mode of "purchasing drugs first, then according to the drug formula, and even automatically generating prescriptions by artificial intelligence software".

After the reporter placed an order for the prescription drug oseltamivir phosphate granules on an online drug sales platform, the platform prompted "Please select an offline diagnosed disease". The reporter randomly checked a few items in the "disease column", left the "prescription/medical record/examination report column" blank, and confirmed that "the disease has been diagnosed and the drug has been used, and there is no history of allergies, no relevant contraindications and adverse reactions". Soon, the reporter's drug purchase order was verified. After submitting the checklist, the system will be redirected to the Ask a Doctor.

A few seconds later, the "doctor" on the platform received the consultation and sent several messages in succession, the first of which emphasized that "Internet medical treatment only provides medical services to returning users", and the subsequent messages were to confirm whether the reporter had a history of allergies or whether he was in a special period. After the reporter replied "none", in less than half a minute, an electronic prescription form and purchase link were sent to the other party.

On a drug sales app, the reporter asked the customer service if he could buy 10 boxes of amoxicillin, and the other party replied, "Do you want to spare", after getting the confirmation information, the other party verified the personal information, non-special groups and the loss of the follow-up certificate to the reporter, and finally said "A prescription can be issued up to 2 boxes, we will prescribe 5 prescriptions, you can pay for it together".

Xie Li (pseudonym), who lives in Huaihua, Hunan Province, told reporters that she had prescribed Pudilan anti-inflammatory oral liquid to her then-7-year-old child in an offline hospital in early 2020, and the doctor prescribed it at that time. In October 2023, the child had similar symptoms again, she tried to buy this drug on an online drug sales platform, and after she uploaded the prescription from 3 years ago, the "doctor" of the platform immediately sent her a purchase link.

Yang Mu (pseudonym), a resident of Beijing, often buys medicines online, and he is puzzled by whether the person who is being seen behind the screen is a real medical practitioner: "When buying prescription drugs on the platform, as long as you type it, the other party will reply within 10 seconds, and no professional advice is given." "On one occasion, he deliberately described situations that were not indications for the purchase of drugs, but the other party still quickly prescribed them.

According to a person in the Internet medical industry, formal Internet hospitals must have a qualified doctor to issue an electronic prescription, and the electronic prescription should have the doctor's signature and the electronic seal of the Internet hospital. "It is not excluded that some small Internet medical platforms use artificial intelligence, robots and other tools to automatically generate prescriptions. Some large internet medical platforms will use AI to assist doctors in consultations, such as asking patients how old they are and where they are uncomfortable, but the prescription must be issued by the doctor. ”

According to Deng Yong, a professor of law at Beijing University of Chinese Medicine, in order to ensure the safety of patients' medication, the current "Prescription Management Measures" and "Prescription Review Specifications for Medical Institutions" clearly stipulate that after a physician prescribes a prescription for a patient in the diagnosis and treatment activities, the pharmacist must conduct a review.

"In reality, some platforms choose the model of 'AI prescribing, customers directly pick up medicines', skipping the traditional prescription and review links, and directly turning prescriptions into 'selling drugs'. This kind of behavior seriously violates the mainland's drug administration regulations, and also lays hidden dangers for patients' drug safety. Deng Yong said.

Risk:

The safety of patients' medication cannot be guaranteed

The Measures for the Classification and Management of Prescription Drugs and Non-prescription Drugs (for Trial Implementation) stipulate that drugs shall be managed separately as prescription drugs and non-prescription drugs according to different drug varieties, specifications, indications, dosages and routes of administration. Prescription drugs must be prescribed by a licensed physician or licensed physician assistant to be dispensed, purchased, and used, while over-the-counter drugs can be dispensed, purchased, and used at the discretion of a licensed physician or licensed physician assistant.

According to industry insiders, prescription drugs in mainland China are divided into single-track prescription drugs and dual-track prescription drugs. The former refers to prescription drugs that can only be sold with a doctor's prescription, mainly referring to antibacterial drugs, including antibiotics and sulfonamides, quinolones, anti-tuberculosis and other drugs;

The cefixime, azithromycin and amoxicillin consulted by the reporter in offline pharmacies and online drug sales platforms are all single-track prescription drugs that require a doctor's prescription.

The above-mentioned industry insiders believe that if prescription drugs are not sold in accordance with regulations, there may be abuse problems, resulting in the inability to ensure the safety of patients' medication, and the risk is that it is "unsafe and ineffective", delaying the patient's condition. If a patient has a serious medication safety accident as a result, the responsible party is still the pharmacy or platform that illegally sells prescription drugs.

According to public information, the police in Chengdu, Sichuan Province recently seized 4 minors abusing dextromethorphan. They invited through the Internet, and then gathered together with liquor oral dextromethorphan, and were found by the police dancing and excited, and one of them was delirious and unconscious, and was sent to the hospital for first aid. Dextromethorphan is a prescription drug and is prohibited from being retailed online, and they are purchased through online gray channels and offline pharmacies in violation of regulations.

Supervision:

Rigorous review of prescriptions back to the source

In fact, in order to put an end to the chaos of prescription drug sales and standardize the environment for online drug sales, the State Food and Drug Administration and regulatory departments in many places continue to make efforts to strengthen supervision and promote the healthy development of drug sales.

On June 20, 2023, the General Department of the State Food and Drug Administration issued the Notice on Regulating the Display of Online Sales Information of Prescription Drugs (hereinafter referred to as the "Notice"), which is another important measure of the drug regulatory authority after the official implementation of the Measures for the Supervision and Administration of Drug Online Sales on December 1, 2022.

The "Notice" requires that the homepage of the drug online sales platform/website (including the application) and the homepage of the store of the platform merchant shall not display the information such as the packaging and labeling of prescription drugs;

Local regulatory authorities are actively following up.

In October 2023, the Shandong Provincial Drug Administration issued the "Implementation Measures for the Supervision and Administration of Drug Online Sales in Shandong Province", which will come into force on December 1 of the same year, emphasizing the principle of "online and offline consistency", clarifying that the business mode, business scope, and actual production and operation address of drug online sales enterprises should be consistent with the content of the production and operation license;

On October 31 of the same year, the Beijing Municipal Drug Administration issued the "Implementation Rules for the Supervision and Administration of Online Drug Sales in Beijing", which clarified that in addition to the real-name management of the information of drug purchasers for online prescription drugs, the homepage of the website and the homepage of the store of the platform merchant shall not display the packaging, labeling and other information of prescription drugs, and the record retention period of online prescription drugs shall not be less than 5 years.

On December 7 of the same year, the Tianjin Municipal Medical Insurance Bureau and the Tianjin Municipal Health Commission issued the "Notice on Supporting the Work Related to the Flow of Prescriptions within the Medical Alliance", requiring that the designated medical institutions in the medical alliance should strengthen the application of medical insurance electronic vouchers, face recognition technology, "Internet + video surveillance", etc., strictly manage real-name medical treatment and drug purchase, improve the management of prescription flow, implement the prescription review system, and ensure the safety of insured patients.

Interviewed industry insiders pointed out that these policies show that the online sale of prescription drugs has been recognized by the drug regulatory level, and the online and offline standards tend to be unified, realizing the basis for the online sales of prescription drugs. However, in the specific implementation, there may still be differences in the understanding of relevant regulations among regulatory authorities, third-party platforms, and drug retail enterprises, and it remains to be seen whether the drug display can truly achieve online and offline unity.

"If in an offline store, the customer asks for a drug, and the clerk can show the medicine to the customer. If the platform does not display the packaging information of prescription drugs, customers cannot determine whether the drugs are wanted, which will cause inconvenience for customers to purchase drugs. A director of a chain e-commerce chain in Guangdong said that therefore, the display specifications for drugs should not be "one-size-fits-all", and it is recommended that consumers can have a pharmacist consultation link before buying drugs online, and licensed pharmacists can show customers the corresponding drugs according to the customer's description of the disease, historical medication or the first prescription voucher, and guide customers to use drugs reasonably.

According to Zhao Zhanzhan, a lawyer at Beijing Jiawei Law Firm, the key to solving the safety problem of online prescription drugs is to ensure the authenticity and legality of prescriptions through technical means. At the same time, operators are required to strictly review prescriptions and sell prescriptions, and online trading platforms must fulfill more management obligations for operators on the platform to sell prescription drugs. For the authenticity and legitimacy of the prescription, it is necessary to review whether the physician has legal qualifications and whether the prescription is issued by a qualified physician.

Deng Yong believes that the rules for the responsibility of prescription drug sales should also be clarified. At present, in the process of Internet diagnosis and treatment, the rights and responsibilities between medical institutions and doctors are still adjusted through contracts. For physicians who practice in multiple locations, medical institutions are often in an advantageous position in the process of signing contracts, and if the contract stipulates that "if the damage caused by improper prescription issuance shall be mainly borne by the medical institution after compensation", then the medical institution essentially avoids the risk of compensation for damages, which violates the principle that rights and responsibilities should be equal.

"Relevant departments should increase the review of the authenticity of prescription sources, establish a strict review system for prescription sources, and improve laws and regulations on prescription sources. In terms of specific system design, the QR code recognition function can be used to do a good job in the review of online prescriptions, and at the same time, the transaction records and transaction evidence can be completely retained to ensure that the supervision can be traced back to the source. Deng Yong said.

Source: Rule of Law Daily