Prescription drugs can be bought freely at some online pharmacies
Beijing Railway Inspection Institute: Public interest litigation urges to strengthen the supervision of online sales of prescription drugs
Remote diagnosis and treatment, online prescription, door-to-door delivery of medicines... With the vigorous development of Internet medical care, online pharmacies allow consumers to quickly obtain medicines without leaving home.
However, the resulting drug misuse, abuse, and overdose incidents also occur from time to time.
Drug safety is not a child's play, how to ensure the safety of online medication?
Recently, the Supreme People's Procuratorate released a batch of typical cases of drug safety public interest litigation.
Among them, the Beijing Railway Transportation Procuratorate (hereinafter referred to as the Beijing Railway Procuratorate) conducted a series of explorations on the issue of ensuring drug safety in the case of supervision and rectification of illegal sales of prescription drugs by online platform pharmacies.
Survey finds problems with online pharmacies selling prescription drugs
"Online pharmacies sell prescription drugs without a prescription" "You can easily buy prescription drugs for more than 12 weeks" "Pharmacist review is useless" "There is no signature of a licensed pharmacist on the prescription"... In July 2021, prosecutors from the Beijing Railway Procuratorate During the performance of duties, it was discovered that there were many irregularities in the online sales of prescription drugs.
At the same time, the Supreme Procuratorate also handed over relevant clues to the Beijing Railway Procuratorate.
The standardized management of prescription drugs is a key national drug management item, and many laws and regulations in my country have made clear regulations on the sales of prescription drugs.
The Drug Administration Law revised in 2019 clarified the principle of the same standards and integrated supervision of online and offline drug distribution.
A pharmaceutical retail enterprise engaged in pharmaceutical business activities shall have legally qualified pharmacists or other pharmaceutical technicians responsible for the enterprise's drug management, prescription review and dispensing, and guidance on rational drug use.
In August 2021, the "Notice on Printing and Distributing Long-term Prescription Management Regulations (Trial)" issued by the General Office of the National Health Commission and the Office of the National Medical Insurance Bureau pointed out that the prescription volume of long-term prescriptions is generally within 4 weeks; according to the characteristics of chronic diseases, the condition For stable patients, the treatment should be extended appropriately, and the longest period should not exceed 12 weeks.
"By reviewing relevant laws and regulations, we found that the illegal sales of prescription drugs by online pharmacies may bring hidden dangers to the safety of people's medication and harm the public interest. Therefore, we decided to file a case for investigation, targeting the drug safety issues that may be involved in the illegal sales of prescription drugs by online pharmacies. Carry out special supervision to investigate the sales of prescription drugs by drug online retail companies in Beijing." Kang Hui, a prosecutor at the Beijing Railway Procuratorate, said.
In September 2021, the Public Interest Litigation Procuratorial Department of the court will focus on pharmacies registered in Beijing on online platforms and pharmacies registered in Beijing on online platforms outside Beijing. Through big data screening, manual review, combing and analysis, etc., a comprehensive understanding of online prescription drugs sales.
The survey results show that there are 28 pharmacies on the 3 online platforms (including 2 registered in Beijing), where licensed pharmacists failed to fulfill their electronic prescription review responsibilities according to law, involving a total of 5 districts in Beijing.
Specific problems include: after receiving online drug purchase orders in some network platform pharmacies, the licensed pharmacists did not review the electronic prescriptions in accordance with relevant regulations and entered the offline delivery process, there were prescription drugs delivered in excess of the dosage, and the licensed pharmacists did not sign on the prescriptions and other illegal acts.
Prosecutor's suggestion sparks 'rectification storm'
The review of licensed pharmacists is the last hurdle for online sales of prescription drugs. It is related to whether consumers can take accurate medicines and take the right medicines.
To this end, in September 2021, the Beijing Railway Inspection Institute held discussions with the drug regulatory authorities at two levels in the urban area on the division of regulatory powers and responsibilities for online sales of prescription drugs. Have in-depth communication.
Subsequently, the Beijing Railway Inspection Institute issued pre-litigation recommendations to the drug supervision departments of the five districts, urging the administrative agencies to investigate and deal with relevant illegal acts, and strengthen the supervision of licensed pharmacists in online platform pharmacies to perform electronic prescription review duties.
After receiving the procuratorial suggestion, the drug regulatory department attached great importance to it and carried out a series of targeted work: through interviews and on-site inspections of the network platform pharmacies involved in the jurisdiction, the network with the problem of licensed pharmacists failing to review and dispense electronic prescriptions Pharmacies make administrative punishment decisions and order rectification within a time limit; carry out special supervision and law enforcement work on online sales of prescription drugs, conduct extended inspections and comprehensive investigations of pharmacies that sell prescription drugs online in their jurisdictions, and deal with illegal acts discovered during the investigation; For platform pharmacies, standardize and guide the specific operation of pharmacies in combination with relevant laws and regulations; promote online platform pharmacies to establish rules and regulations for electronic prescription services, and regularly publish special work magazines to organize learning exchanges.
Traceability governance promotes platform companies to accelerate technological updates
During the handling of the case, the prosecutor in charge also found that there were licensed pharmacists' signatures on some of the paper prescriptions filed, but not on the electronic prescriptions.
Is this phenomenon due to the negligence of the pharmacist, or the lag of technology?
"According to the drug supervision and management department, the operating system of the relevant Internet platform is not perfect, which makes it inconvenient for pharmacists to use in the diagnosis and treatment system." Kang Hui introduced that the "Prescription Management Measures" stipulate that pharmacists should sign or add to the prescription after completing the prescription adjustment. Cover with a special seal.
It can be seen that electronic prescriptions should also meet the above requirements.
In order to promote traceability governance, the prosecutors in charge held discussions with the three online platforms involved in the case, and suggested that the platforms further improve relevant mechanisms, speed up technological updates, provide convenient conditions for licensed pharmacists to review electronic prescriptions, and promote the standardized development of sales of prescription drugs on the platforms.
Subsequently, the relevant platform optimized and upgraded the system, which not only solved the problem of failure to upload the pharmacist's signature, but also monitored the amount of medicine issued by the prescription.
The system can automatically remind physicians and pharmacists of overdosage and other behaviors, and limit the authority to issue prescriptions that exceed the dosage.
Platform companies have also developed an auxiliary monitoring system to help online pharmacies carry out relevant audit matters.
It is reported that on December 1, 2022, the "Measures for the Supervision and Administration of Drug Online Sales" promulgated by the State Administration for Market Regulation came into effect, clearly stipulating that drug online retail enterprises should establish an online pharmacy service system, and pharmacists or other pharmacists who have been qualified in accordance with the law Technical personnel carry out prescription review and allocation, guidance on rational drug use, etc.; at the same time, it is clear that third-party platforms should strengthen inspections, manage drug information display, prescription review, drug sales and distribution, and other behaviors of pharmacies on the platform, and urge them to strictly perform statutory obligations.
"The management measures coincide with our previous thinking on handling cases. We will also continue to pay attention to the compliance issues of drug online sales to ensure the safety of medication for the public." At the same time, Kang Hui also reminded consumers that they must follow the guidelines when purchasing drugs online Under the guidance of Internet physicians, see clearly the drug name, approval number, expiration date, etc., pay attention to the review opinions of licensed pharmacists on electronic prescriptions, purchase medicines rationally and use them scientifically, and be the first person responsible for your own health.
Recently, after follow-up visits by the prosecutors of the hospital, it was found that the electronic prescriptions issued by consumers on the relevant platforms had been marked with the audit signatures of licensed pharmacists, and the reasons were marked on the long-term prescriptions issued, and the relevant pharmacies were also equipped with offline licensed pharmacists. .
(Procuratorial daily brief Tian Huijuan)