After a lapse of 14 years, the country's first drug use regulations ushered in a major overhaul!

On December 7, 2021, in order to implement the "Pharmaceutical Administration Law of the People's Republic of China" and other laws and regulations, implement the "four strictest", and continue the reform of the drug regulatory system, the Standing Committee of the 13th People's Congress of Shandong Province The thirty-second meeting decided to amend the "Regulations on the Use of Medicines in Shandong Province" issued in 2007.
The regulations were called the first regulations on the use of medicines in the country by industry insiders.
This was a comprehensive overhaul after 14 years
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The new version of the "Regulations on the Use of Medicines in Shandong Province" has seven chapters and 43 articles, which are divided into general provisions, drug purchase and storage, drug deployment and application, pharmacovigilance, supervision and management, legal responsibilities, and supplementary provisions.
This article issues the "Regulations on the Use of Drugs in Shandong Province" The background and main new and revised content of the company are analyzed
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PART.
01 The new and old editions of the "Regulations on the Use of Medicines in Shandong Province" have changed the basic structure Chapter 4 pharmacovigilance related regulations, it can be seen that this amendment to the Measures regulates pharmacovigilance and legal liability, as shown in the table below: Comparison table of chapters of the new and old "Shandong Regulations on the Use of Drugs" PART.
02 New version of the "Shandong Regulations on the Use of Drugs" The main highlights of the content are first to see the revised interpretation of the general provisions of Chapter 1: 1.
Article 2 is amended to: "The drug users mentioned in these regulations delete the family planning technical service agency
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" 2.
Article 4 is amended to: "The increase in the use of drugs shall be Health-centered, comply with laws, regulations, rules, standards and norms, and ensure the authenticity, accuracy, completeness, and traceability of information, so as to clarify the fundamental compliance and basic requirements for drug use
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3.
Article 6 The supervisory responsibilities of the department shall be revised according to the current actual situation
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The blue font is the new content of the new version, the red strikethrough is the deleted content of the old version, the following are similar
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Chapter II Drug Purchase and Storage Amendment Interpretation: To add MAH and drug users to purchase drugs, a purchase inspection and acceptance system should be established and implemented, and the drug production license or drug business license, business license, and business license of the supplier shall be verified and verified.
Power of attorney, drug qualification certificate and other marks, and have true and complete purchase and acceptance records
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Electronic materials and paper materials have the same effect and other content
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Chapter III Drug Blending and Application Revision Interpretation: 1.
Modification of Article 19 drug users is prohibited from blending drugs
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2.
Amend Article 20 to read: Drug users shall be equipped with pharmacists or other pharmacists who have been certified in accordance with the law to be responsible for the unit’s drug management, prescription review and deployment, and rational drug use guidance
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Medical institutions above the second level shall be equipped with clinical pharmacists
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Clinical pharmacists shall perform the duties of prescription review, medication monitoring and evaluation, providing medication consultation, instructing physicians in the rational use of medications, participating in ward rounds and consultations, and formulating treatment plans
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Chapter IV Pharmacovigilance Amendment Interpretation: Added a chapter "Pharmacovigilance" as Chapter IV, and a separate chapter (1) Establishing the system: The provincial people’s government should organize the drug supervision and management, health and health departments to establish a pharmacovigilance system to treat drugs Adverse reactions in use and other harmful reactions related to medication shall be monitored, identified, evaluated and controlled
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(2) Establish sentinel sites: The provincial people’s government drug supervision and administration, and health and health departments should establish sentinel sites for adverse drug reaction monitoring to carry out post-marketing active monitoring, research and evaluation of adverse drug reactions, discover and verify drug safety risk signals, and organize experts to participate Drug safety risk assessment
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(3) Subject responsibility: clarify the requirements of institutions and personnel for drug users to carry out pharmacovigilance, and stipulate the obligation of reporting and cooperating in investigations
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Corresponding to this, legal responsibilities are stipulated for drug users who fail to report suspected adverse drug reactions in accordance with regulations
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Chapter V Supervision and Administration Revised interpretation: The newly-added drug supervision and administration, health and health departments shall conduct random supervision and random inspection and assessment of the pharmaceutical technicians of drug users and announce the assessment results
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Implement credit management on drug users and their legal representatives, main persons in charge, directly responsible persons in charge and other responsible personnel, carry out punishments for dishonesty in accordance with the law, and drug users shall organize annual health inspections for persons who are in direct contact with drugs and establish health records; Health checkups are undertaken by medical institutions or disease prevention and control institutions above the second level, and those who suffer from infectious diseases or other diseases that may contaminate drugs shall not engage in direct contact with drugs and other requirements
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Chapter VI Legal Responsibility Revision and Interpretation: If there are similar provisions in the upper law, they are directly cited to ensure legality; if there are no provisions in the upper law, the "four most stringent" requirements of the Party Central Committee and the State Council on drug safety shall be implemented at the meeting On the basis of the supplementary establishment of the administrative penalty demonstration meeting, the lower and upper limits of the penalty range have been correspondingly increased; the penalty is added to the person
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If a drug user violates the drug use quality management regulations, in addition to imposing penalties on the drug user, at the same time the legal representative, the main person in charge, the directly responsible person in charge and other responsible personnel shall be confiscated from the company during the period of the violation In addition, a fine of 10% or more and less than 50% of the income received shall be imposed, and Article 40 shall be added: “If a drug user fails to report a suspected adverse drug reaction in accordance with the provisions of this Regulation, he shall be ordered to make corrections within a time limit and be given Warning; if you fail to make corrections within the time limit, a fine of not less than 50,000 yuan but not more than 500,000 yuan will be imposed
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" PART.
03 Summary The drug use link is one of the important links to ensure the safety of the people's drug use.
In this link, supervision is an important measure
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The overhaul of the "Regulations on the Use of Medicines in Shandong Province" is an inevitable process to strengthen the system construction.
In order to continuously adapt to and protect the people's drug needs, this revision is made.

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The revision of the 2021 edition is more in line with the requirements of the new version of the Drug Administration Law of the 2019 edition, more clarifies the basic principles of drug use, and adapts to the needs of modern drug regulatory system reforms (such as more clarification of departmental regulatory responsibilities, new pharmacovigilance regulations).
The intensity of large administrative penalties has deeply fulfilled the "four most stringent" requirements
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Reference materials: Columnist on the official website of Shandong Provincial Drug Administration, etc.
Columnist Dr.
Sinan, a senior biomedical engineer, licensed pharmacist, and a porter of pharmaceutical policies and regulations in the self-media era.
He is committed to the goal of lifelong learning, adheres to the combination of learning and application, and strives to achieve the unity of knowledge and practice
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