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According to the official website of the Guangdong Provincial Food and Drug Administration, not long ago, Guangdong Province sent a total of 81 inspection teams to carry out unannounced inspections
of 138 pharmaceutical wholesale enterprises and 76 pharmaceutical retail chain enterprises in the province by means of double randomization.
Through inspection, it was found that some enterprises had unsound
quality management systems, failure of quality managers to perform their duties, violations of the requirements of the "seven unifications", and unauthorized change of registered address.
In response to the above behaviors, the Guangdong Provincial Food and Drug Administration requires relevant enterprises to strictly implement rectification measures, eliminate potential risks in a timely manner, and at the same time take risk control measures
to suspend sales (distribution) for eight pharmaceutical trading enterprises with more serious quality and safety risks.
The Guangdong Provincial Food and Drug Administration said that the next step will continue to increase the intensity of
supervision and inspection.
In this flight inspection, the Guangdong Food and Drug Administration focused on checking whether enterprises had illegal purchases and sales of drugs such as "affiliation" and "ticket taking", forging qualification documents, leasing and lending licenses, illegally recycling drugs, or fraudulently purchasing and arbitraging state-controlled drugs from pharmaceutical production and trading enterprises, and focused on checking whether the headquarters of pharmaceutical retail chains can ensure the effective implementation of chain operation and management measures such as unified procurement and distribution, unified quality management, unified computer systems, unified financial management, and unified pharmaceutical services
。 Judging from the actual situation, the focus of these inspections is also the hardest hit areas
where violations have been found in the past "flight inspections" in many places.
Among them, the inspection of drug purchase and sales channels is the top priority, and in the cases reported in many places, many pharmacies have received huge fines
because they cannot provide complete purchase and sales information.
According to Article 57 of the Drug Administration Law, pharmaceutical trading enterprises shall have true and complete purchase and sales records
when purchasing and selling drugs.
If the purchase and sales information of retail pharmacies is incomplete, it is a violation of Article 57 of the Drug Administration Law, and according to Article 130 of the Drug Administration Law, the market supervision and administration department shall order corrections and give warnings; where the circumstances are serious, the drug business license
shall be revoked.
The inspection of licensed pharmacists is often combined with
the inspection of prescription drug sales.
Previously, the Market Supervision Bureau of Huangshan City, Anhui Province, required the market supervision departments of all districts and counties to "review" the rectification of the "hanging license" behavior of licensed pharmacists over the years on the basis of daily supervision and inspection, and combine the practice registration information of the national licensed pharmacist registration management information system to improve the pertinence and effectiveness of
supervision and inspection.
Where it is verified that a pharmaceutical retail enterprise fraudulently obtains the "Drug Business License" by means of "hanging a certificate" by a licensed pharmacist, its "Drug Business License" shall be revoked in accordance with law, and those who are found to have failed to sell prescription drugs in accordance with the provisions shall be punished
in accordance with law.
In addition, the inspection of drugs sold online and drugs with a near-term effect is also the main content
.
The regulatory authorities focus on investigating the issue of unqualified online drug sales, the illegal sale of drugs by online drug sellers through the Internet, and the performance of responsibilities by third-party platforms for online transaction services
.
Quality risk control involving counterfeit and inferior drugs (business scope, automatic control of drug validity period, near-expiration drug inventory management, etc.
), whether the inspection of drug packaging and characteristics is strictly in
accordance with the requirements of GSP.
As an important means of medical insurance fund supervision, medical insurance flight inspection has played an important role
in ensuring the safety of medical insurance funds.
In June this year, the National Medical Insurance Bureau again solicited opinions on the "Measures for the Administration of Unannounced Inspections of Medical Security Funds (Draft for Comments)", and proposed "annual work plan arrangement" in terms of the start-up situation, which shows that unannounced inspections have become a part of the daily work of the Medical Insurance Bureau, which is carried out on a regular basis and should be carried out
according to the annual work arrangement 。 The Draft Opinions also mention that the medical security administrative department organizing the unannounced inspection shall include the results of the unannounced inspection into the comprehensive evaluation system for the work of the medical security department of the province (municipality) being inspected, supervise the handling of the results of the unannounced inspection, and organize forces to carry out the unannounced inspection "looking back"
in a timely manner if the follow-up investigation and rectification are ineffective.
The Draft Opinions require that the medical security administrative department organizing the unannounced inspection should promptly notify
the relevant results of the unannounced inspection to the relevant departments of health, traditional Chinese medicine, finance and other relevant departments at the same level.
The administrative departments for medical security organizing unannounced inspections shall disclose the results of unannounced inspections to the public in accordance with laws and regulations, and expose typical cases
.
Just one month before the release of the consultation draft, the National Health Insurance Administration issued the 2022 Medical Security Fund Unannounced Inspection Work Plan (hereinafter referred to as the Plan), officially announcing the official start of a new round of unannounced inspection of the medical insurance fund, and framing the inspection time frame for the use
of medical insurance funds since January 1, 2020.
Among them, the "Plan" mentioned that the objects of this flight inspection are designated medical institutions and county-level medical insurance handling institutions nationwide, and the inspection of relevant institutions and insured persons can be extended according to the situation, in other words, designated retail pharmacies also belong to the scope
of this extended inspection.
The flight inspection has been extended to January 1, 2020, and the requirement of "retrospective inspections for two and a half years" sends a signal of strong supervision, and the determination of the regulatory authorities to thoroughly investigate violations can be seen
.
In July this year, the Heilongjiang Launch Meeting of the National Medical Insurance Fund Unannounced Inspection was held in Harbin, marking the official launch
of the 2022 National Medical Insurance Fund unannounced inspection.
Subsequently, in accordance with the unified deployment of the National Medical Insurance Bureau, various localities have launched the 2022 medical insurance fund flight inspection work, including Jilin Province, Guangxi, Hebei, Inner Mongolia, Jiangxi, Jiangsu, Fujian and other places have successively held the national medical insurance fund flight inspection kick-off meeting
.
Unannounced visits are upgraded again With the normalization of epidemic prevention and control, "flight inspection" has also become an important means
for special inspections of epidemic prevention and control in pharmacies.
Strengthen the control of antipyretic, cough, antibacterial, antiviral "four categories" of drugs, Henan Jiaozuo law enforcement personnel adopted the method of "no notice, no greeting, straight to the grassroots level, directly inserted into the scene" to implement the "two suspensions and two registrations" system (that is, suspend the sale of antipyretic and cough drugs, and register all antibacterial and antiviral drugs sold) system at 31 retail pharmacies in the urban-rural integration demonstration zone and other places, and found that all retail pharmacies posted notices or propaganda slogans in conspicuous positions at the door.
Prompt the suspension of sales of antipyretic and cough drugs, and establish a sales register of
antibacterial and antiviral drugs.
Nowadays, unannounced visits have become the norm in the field of drug circulation
.
Since the beginning of this year, the Shanghai Yangpu District Market Supervision Bureau has continued to strengthen supervision measures, adopting the "four not two straights" approach, and repeatedly carried out unannounced visits and inspections of retail pharmacies in its jurisdiction
.
Grasp the key and weak links, and focus on checking: whether to strengthen the inspection of entering the store, staggering the peak and limiting the flow, including customers wearing masks, taking body temperature, scanning venue codes, checking key information
, etc.
In addition, in accordance with the requirements of epidemic prevention and control, day and night inspections, pharmacies are required to strictly implement the online and offline sales management of four types of drugs "antipyretic, cough, antiviral, and antibiotic", and carry out real-name drug purchase registration through the special drug supervision system, so as to achieve "should be registered, not missing a person, not missing a drug", and effectively keep the epidemic prevention and control work of pharmacies in mind at all times
.
On the basis of "unannounced visits", an upgraded form of unannounced visits has emerged - "mystery buyers"
.
The "mystery buyer" form launched by the regulatory authorities of Changping District in Beijing was used during the epidemic prevention and control period
.
The regulatory authorities mainly adopt the method of video evidence collection throughout the process to ensure that the content of the unannounced interview is true and accurate
.
The "mystery buyer" simulates a patient with mild cough, sometimes breathlessness, chest tightness and other symptoms, and needs to buy cough medicine to relieve the current symptoms
.
In the process of purchasing drugs, check whether the pharmacy adopts the contactless drug sales method without entering the store, whether the temperature is measured and the code is scanned and the mask is worn when entering the store, and whether it is registered
as required if the conditions for scanning the code are not met.
Whether the purchase of anti-fever, cough, antibiotics, and antiviral drugs asked consumers whether they had a history of travel and residence in high-risk areas, whether they had fever symptoms, and whether they had contact with close contacts
.
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