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New: Expert consensus on the centralized procurement of antibiotic products (a total of 20 articles), with great impact

 Last Update: 2023-01-05
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Centralized procurement clinical expert consensus, centralized procurement products cardiovascular and cerebrovascular products expert consensus and other provinces, the association has issued documents, antibiotic products expert consensus recently released, a total of 20, Fengyun medicine talk according to the release content to sort out and key content identification;

Expert Consensus on the Management of Centralized Procurement of Antimicrobial Drugs in Medical Institutions

The Clinical Pharmacy Branch of the Chinese Medical Association, the Bacterial Infection and Drug Resistance Prevention and Control Branch of the Chinese Medical Association, the compilation group of the "Expert Consensus on the Management of Centralized Procurement of Antibacterial Drugs in Medical Institutions"

As of January 17, 2019 Since the General Office of the State Council issued the "Pilot Program for the Centralized Procurement and Use of Drugs by the State" [1], the centralized procurement of drugs organized by the state has been expanded from pilot projects in some regions to national implementation, and the coverage of drug varieties has been continuously expanded, effectively reducing drug prices and significantly reducing the burden
of drug costs on patients.
2021 January 28 On Sunday, the General Office of the State Council once again issued the "Opinions of the General Office of the State Council on Promoting the Normalization and Institutionalization of Centralized Drug Procurement"[2], proposing to promote the normalization and institutionalization of centralized procurement of drugs, so as to achieve "exhaustion"
.

Antibacterial drugs are a class of drugs commonly used in clinical practice
.
According to statistics, in 2021, the sales of terminal drugs in China's public medical institutions were 1,297.
3 billion yuan, of which systemic anti-infective drugs were the third largest class of drugs in the market, occupying the market 15.
04% market share [3].

As of the first seven batches of national organized centralized procurement of drugs, 42 antibacterial drugs (excluding topical drugs) have been included in it, including 26 oral agents and 16 injections species
.
Compared with other drugs, antibacterial drugs have the particularity of their clinical application and management.

Including: (1) effective antibacterial drugs play a role in treating infectious diseases by killing pathogenic microorganisms, and the course of treatment is often short, most of the time only 3~14 d, Timely and effective anti-infective therapy, including appropriate medications and dosing regimens, is a determinant of outcomes for patients with infectious disease
.

These include: (1)

(2) At present, the situation of microbial resistance is grim, which poses a threat to human health, and countries around the world are very concerned about
the clinical application management of antibacterial drugs.
Recently China has successively issued a number of regulations and documents, and gradually strengthened the clinical application management of antibacterial drugs [4-5].

②

(3) At present, the clinical application of antibacterial drugs adopts hierarchical management, that is, antibacterial drugs are divided into non-restricted use grade, restricted use grade and special use level, and the clinical application management requirements of antibacterial drugs at all levels are different, including the level of the hospital, the title of the prescribing physician and the consultation before use, etc.
, which have corresponding restrictions and requirements, aiming to reduce the increase in microbial resistance rate caused by their irregular use [6].

③

The particularity of antimicrobial drugs has brought new problems and challenges to medical institutions after they are included in the centralized procurement of drugs (hereinafter referred to as "centralized procurement"), and medical institutions need to take into account the clinical application management of antibacterial drugs and the
completion of the agreed procurement volume of antimicrobial drugs.

In view of the particularity of the clinical rational use of centralized procurement of antibacterial drugs, the agreed procurement ratio of antibacterial drugs in the seventh batch of centralized procurement plans of national organizations has decreased by 10%~30%
compared with other drugs.

On October 28, 2022, the National Health Commission and 13 other departments jointly issued the National Action Plan for Curbing Microbial Resistance (2022-2025).
[7], proposing to scientifically carry out medical insurance negotiations on antimicrobial drugs, organize centralized drug procurement and reform of medical insurance payment methods by the state, and strengthen the evaluation
of the effect of policy implementation.

In this context, the Clinical Pharmacy Branch of the Chinese Medical Association and the Bacterial Infection and Drug Resistance Prevention and Control Branch of the Chinese Medical Association jointly wrote this expert consensus
on the problems faced by medical institutions in the implementation of the centralized procurement of antibacterial drugs.

Under the background of normalization of drug centralized procurement, medical institutions should take the initiative to carry out the selection and evaluation of the antibacterial drug supply list in a timely manner, and ensuring that the antibacterial drug list of the medical institution is scientific and reasonable is an important prerequisite for the scientific management of centralized procurement of antibacterial drugs
.
After the selected antibacterial drugs are included, the variety and number of antibacterial drugs of medical institutions should, in principle, comply with the relevant regulations
of the higher health administrative department.
If the number of antibacterial drugs exceeds the provisions due to the needs of clinical work, they shall be filed in accordance with the provisions of the Measures for the Administration of the Clinical Application of Antibacterial Drugs, and can only be implemented
after they are passed.

The list of antibacterial drugs of medical institutions should comply with the "one product, two regulations", and the Measures for the Administration of the Clinical Application of Antibacterial Drugs clearly stipulate that the same generic name of antibacterial drug varieties, injection dosage forms and oral dosage forms shall not exceed 2 each , but the regulations for drugs for children's use (limited to drugs that have clear indications for children and dosage for children in the drug label) are not subject to this restriction
.
Therefore, medical institutions need to carry out the original antibacterial drug varieties after implementing the antibacterial drug collection policy Adjust and optimize.

The adjustment and optimization of antimicrobial varieties should be to "optimize the structure and ensure the reasonable clinical needs" In order to ensure the diversification of antibacterial drug categories, select varieties with strong antibacterial activity, good pharmacokinetic properties, few adverse reactions, excellent cost performance, more evidence-based medical evidence and authoritative guidelines among similar products
.

In terms of quality level, the state organizes centralized procurement of drugs with a centralized procurement of chemical drugs, and the quality level requirements for chemical drugs are the original drug and the reference preparation for the consistency evaluation of the quality and efficacy of generic drugs issued by the national drug regulatory department, or the generic drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs, or generic drugs
approved and proved that the quality and efficacy are consistent with the reference preparation according to the new classification of chemical drug registration.
Medical institutions should give preference to the above under the same generic name Drugs
with a higher level of quality.

Testimonials 1: It is recommended that medical institutions stop collecting generic drugs (except for children's drug regulations) that have not passed the consistency evaluation under the same generic name (recommendation level: strong recommendation).

Testimonials 1 (Recommended level: Strong recommendation)

Testimonials 2: It is recommended that medical institutions retain the original research drugs that have real clinical needs and the reference preparations for the consistency evaluation of the quality and efficacy of generic drugs issued by the national drug administration (recommendation level: strong recommendation)
on the premise of giving priority to the use of selected drugs in centralized procurement.

Testimonials 2.
The reference preparation of the original drug can be retained (recommendation level: strong recommendation).

Recommendation 3: According to the Guidelines for Skin Testing of β Lactam Antimicrobial Drugs (2021) issued by the National Health Commission [8], it is not recommended that β lactam antibacterial drugs other than penicillins routinely do skin tests before use, so it is recommended that medical institutions do not use β lactam antibacterial drugs (except penicillins) that require skin tests in the instructions (recommendation level: strong recommendation).

Recommendation 3 (Recommendation Level: Strong Recommendation).

2.
2 Procurement of Centralized Antimicrobial Drugs Measurement The procurement volume of drugs collected by medical institutions is usually based on the procurement volume of drugs under the generic name of medical institutions in the previous year and the trend of changes in the use of drugs in the past year, and the usage in the next year is measured based on changes in disease types, updates of evidence-based medical evidence, changes in medical insurance attributes, and the impact of similar drugs
.
Compared with other drugs, antibacterial drugs make The dosage is also affected by factors such as changes in bacterial resistance, the continuous strengthening of the management of the clinical application of antimicrobial drugs, and the improvement of the diagnosis and treatment of infectious diseases in medical institutions, so it is more difficult to accurately estimate future dosage
.

If excessive reporting leads to the irrational use of antibacterial drugs, it will not only endanger the health of patients, but also induce bacterial resistance and cause serious public health problems
.
Moreover, the higher the level of management of antimicrobial drugs, the greater the harm caused by their irrational use
.
Therefore, medical institutions should be more cautious
in calculating the procurement volume of centralized antimicrobial drugs than other drugs.
At the same time, the measurement of the procurement volume of centralized antimicrobial drugs should be coordinated
with medical institutions to optimize the list of antibacterial drugs and strengthen the clinical application management of antibacterial drugs.

Recommendation 4: It is recommended that medical institutions take the use of non-restricted use, restricted use and special use antimicrobial drugs in the past one year as a reference, reduce the proportion one by one with the increase of management level to calculate the reporting base, and on the basis of this base, adjust it with reference to the recent usage trend, the results of bacterial resistance monitoring in the region or the whole country and other influencing factors
。 If the level of the centralized collection of antibacterial drugs in the provincial antimicrobial grading catalogue changes during or after the statistical period, the usage from the implementation of the new grading catalogue to the current period shall be counted and converted into one year's usage as a reference (recommendation level: strong recommendation).

Recommendation 4:

Testimonials 5: It is recommended that medical institutions take the initiative to strictly limit the use of antibacterial drugs with potential safety hazards, uncertain efficacy and serious drug resistance, and appropriately reduce the reporting base of such antibacterial drugs
.
In addition, it is not recommended that medical institutions continue to use the above antimicrobials in excess of the agreed purchase volume (recommendation level: strongly recommended).

Testimonials 5: (Recommended level: Strong recommendation).

Recommendation 6: If there is an unreasonable use of antibacterial drugs in medical institutions, such as the use of antibacterial drugs without indications, the selection of antibacterial drugs is inappropriate, the combination of antibacterial drugs is not appropriate, etc.
It is recommended that medical institutions should reduce the amount of antibacterial drugs that need to focus on strengthening clinical application management in proportion (recommendation level: strong recommendation).

Recommendation 6: (Recommendation level: Strong recommendation)

2.
3 Due to the particularity of clinical use and the difference in management, it is not appropriate for medical institutions to adopt a unified task decomposition method
for all antibacterial drugs.
It is recommended to "one drug, one policy, use it only when it should be used, and strictly prevent abuse", and conduct specific analysis of the previous clinical application of each centralized antibacterial drug to formulate a reasonable implementation plan
.

Testimonials 7: In the process of implementing the centralized procurement policy of antibacterial drugs, if the clinical situation is indeed unable to complete the task of using antibacterial drugs under the premise of rational clinical use due to objective reasons, For example, changes in medical insurance payment policies, adjustments to provincial antimicrobial drug grading catalogues, updates to specialty guidelines, public health emergencies, etc.
, suggest that medical institutions should reduce or cancel the tasks and assessment requirements for the centralized procurement of antimicrobial drugs in clinical departments on the premise of ensuring rational drug use, and continue to do a good job in clinical drug monitoring, and make dynamic adjustments when necessary (recommendation level: strong recommendation).

Testimonials 7.
Unable to complete the usage task (recommendation level: strong recommendation)

Testimonials 8: If the annual agreed purchase volume of the medical institution cannot be completed due to objective reasons, it is recommended that the medical institution should take the initiative to make a written explanation to the competent department and reduce the amount reported when renewing the contract (recommendation level: strong recommendation).

Testimonials 8 and reduce the amount reported at the time of renewal

2.
4 Monitoring and management of clinical application of antimicrobial drugs in medical institutions Medical institutions should actively promote the clinical rational use of selected antibacterial drugs in centralized procurement, and at the same time need to strengthen the monitoring and management of clinical application of antibacterial drugs, focusing on two possible problems: first, clinical failure to rationally use antibacterial drugs selected in centralized procurement in order to complete the agreed procurement volume of antibacterial drugs selected in centralized procurement; The second is clinical Irrational use of other antibacterial drugs due to distrust of the selected antibacterial drugs
in collective procurement.

Testimonials 9: It is recommended that medical institutions focus on strengthening the review and review of antimicrobial drug prescriptions, focusing on the indication grasp of the clinical application of antimicrobial drugs and the selection of varieties, including non-finger Requisitioned drugs, overdose medication, over-course medication, over-administration route, improper selection of varieties, improper combination of drugs, etc
.
For the irrational drug use problems found, it is recommended that medical institutions follow them Or specially formulate relevant systems to include notification, assessment and punishment, and continuously track the results of rectification (recommendation level: strong recommendation).

Testimonials 9 Focus on the clinical application of antimicrobial drugs (recommendation level: strongly recommended)

Testimonials 10: It is recommended that medical institutions strengthen the monitoring of clinical use indicators of antimicrobial drugs, conduct statistics and analysis of indicators every month, and focus on strengthening the monitoring
of indicators such as the use rate of antibacterial drugs, the intensity of antibacterial drug use in hospitalized patients, and the preventive use rate of antibacterial drugs in class I incisions.
If there is a significant increase (the year-on-year or sequentially increased by more than 30%), the reasons
should be analyzed in time.
For the problem of irrational drug use, it is recommended that medical institutions include notification, assessment and punishment in accordance with or specially formulate relevant systems, and continuously track the results of rectification (recommendation level: strong recommendation).

Testimonials 10 (Recommended level: Strong recommendation)

Testimonials 11: It is recommended that medical institutions strengthen the monitoring of the clinical use of non-selected and alternative antimicrobials, such as a significant increase in the amount of non-selected or alternative antimicrobials (the year-on-year or month-on-month increase is exceeded 30%), the reasons
should be analyzed in time.
For the problem of irrational drug use, it is recommended that medical institutions include notification, assessment and punishment in accordance with or specially formulate relevant systems, and continuously track the results of rectification (recommendation level: strong recommendation).

Testimonials 11 (Recommended level: Strong recommendation)

Testimonials 12: It is recommended that medical institutions strengthen the monitoring
of bacterial resistance data.
According to the "Measures for the Administration of the Clinical Application of Antimicrobial Drugs", antibacterial drugs with a main target bacterial resistance rate of more than 30% shall promptly notify the medical staff of the institution of early warning information; The primary target bacterial resistance rate is exceeded 40% of antibacterial drugs should be used with caution; Antimicrobial drugs with a resistance rate of more than 50% of the main target bacteria should be selected with reference to the results of antimicrobial susceptibility testing; The primary target bacterial resistance rate is exceeded 75% of antimicrobials, clinical use against this target bacterium should be suspended, Based on the results of tracking bacterial resistance surveillance, the decision to resume clinical use
is made.
Centralized collection of antibacterial drugs should be managed in accordance with the above requirements (recommendation level: strong recommendation).

Testimonials 12 (Recommended level: Strong recommendation).

Testimonials 13: Medical institutions should strictly implement the graded management of antibacterial drugs, including centralized procurement of antibacterial drugs, and it is recommended to focus on supervising the implementation of the graded management of special use-level centralized procurement regulations (recommendation level: strong recommendation).

Testimonials 13.
Strictly implement the graded management of antibacterial drugs (recommendation level: strong recommendation)

Testimonials 14: For physicians/departments who do not complete the task of selecting antimicrobials in centralized procurement without legitimate reasons, or do not give priority to selecting antimicrobial drugs in centralized procurement without legitimate reasons, it is recommended that medical institutions take measures
such as communication feedback, training, notification, admonition talks, and inclusion in the performance appraisal of physicians/departments.
Under the premise of ensuring the rational use of antibacterial drugs, the above departments can be treated if necessary or the use of non-selected drugs or alternative drugs by physicians to adopt control measures such as limiting, restricting the right to prescribe or even suspending use (recommendation level: strong recommendation).

Testimonials 14 (Recommended level: Strong recommendation)

2.
5 Management of the rational use of antimicrobial drugs in the centralized procurement of clinical departmentsClinical departments are the specific responsible departments for the use of centralized antibacterial drugs, and clinical departments shall take necessary management measures to promote the rational use
of antibacterial drugs selected in centralized procurement in the department.

Testimonials 15: It is recommended that clinical departments should strengthen the education and training of medical staff in the department, ensure that the medical staff of the department understand the relevant policies of the national organization of centralized drug procurement and the relevant management regulations of the medical institution, and are familiar with the centralized procurement of antibacterial drugs commonly used in the department (recommendation level: strong recommendation).

Testimonials 15 (Recommended level: Strong recommendation).

Testimonials 16: It is recommended that clinical departments should prioritize the use of selected antibacterial drugs in centralized procurement into the clinical pathway management of common infectious diseases in this specialty under the premise of rational drug use (recommendation level: strong recommendation).

Testimonials 16

Testimonials 17: It is recommended that clinical departments incorporate the rational use of centralized antibacterial drugs into the internal assessment of the department (recommendation level: strong recommendation).

Testimonials 17 (Recommended level: Strong recommendation).

2.
6 Centralized collection of antimicrobial adverse drug reaction monitoring "2021 National Adverse Drug Reaction Monitoring Annual Report" [9] shows 2021 In the annual national adverse drug reaction report, the number of anti-infective drug reports ranked first
.
Among the serious adverse reactions, anti-infective drugs ranked second, accounting for 28.
1% of the total reported number, of which injections accounted for 78%
。 Therefore, medical institutions should attach great importance to the monitoring of adverse reactions of antibacterial drugs
.

Testimonials 18: It is recommended that medical institutions focus on strengthening the training and education of clinical medical staff to improve the ability to detect suspected adverse reactions, and formulate incentive measures to encourage clinical departments to actively report adverse reactions of antibacterial drugs (recommendation level: strong recommendation).

Testimonials 18 (Recommended level: Strong recommendation).

Testimonials 19: Medical institutions should focus on strengthening the adverse reaction reporting of antibacterial drugs in accordance with the relevant requirements of the national adverse drug reaction reporting, and analyze and evaluate
the adverse reaction monitoring results.
When necessary, it can be used to guide the reporting and use management of antibacterial drugs collected in the hospital (recommendation level: strong recommendation).

Testimonials 19

2.
7 Comprehensive Clinical Evaluation of Centralized Procurement of Antibacterial Drugs According to the survey, the personnel of medical institutions have a different understanding of whether the generic drugs selected for centralized procurement of antibacterial drugs can achieve clinical consistency in terms of safety and efficacy of the reference preparations for the quality and efficacy consistency evaluation of generic drugs issued by the national drug regulatory department, which hinders the selection of centralized antibacterial drugs to a certain extent Clinical rational use
of generic drugs.
Therefore, it is very necessary
to carry out comprehensive clinical evaluation of such drugs.

2.
7 Comprehensive Clinical Evaluation of Centralized Antimicrobial Drugs According to the survey, the personnel of medical institutions have a different understanding of whether the generic drugs selected in the centralized procurement of antibacterial drugs can achieve clinical consistency in terms of safety and efficacy in terms of safety and efficacy of the reference preparations for the consistency of the quality and efficacy of generic drugs issued by the national drug regulatory department.

Testimonials 20: Encourage medical institutions to improve the construction of a methodological system for the comprehensive clinical evaluation of antimicrobial drugs collected and purchased, make full use of real-world data of medical and health institutions at all levels, organize and carry out scientific and standardized comprehensive clinical evaluation of antimicrobial drugs in accordance with the "Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (2021 Trial)" [10], and attach importance to the quality evaluation and transformation and application of evaluation results.
To promote the rational use
of centralized antimicrobials.
(Recommended level: strongly recommended)

Testimonials 20 (Recommended level: Strong recommendation)

(Source: Medical Herald Fengyun Medicine Talk)

Special note: If the content is infringing, please inform and contact to delete!

So far, from the first batch to the seventh batch of antibiotic varieties have been collected are very large varieties (marked in red), about to be collected (marked in blue), and there are not many products with a certain volume left (yellow background + black and bold)

Marked in red, blue and yellow on a yellow background + black and bold

(Source: Relevant policy documents Fengyun Medicine Talk)

Antibiotic injections and oral dosage forms were mainly concentrated in cephalosporins, penicillins and related compound preparations; Quinolones are also sold on a large scale; Cephalomycin is more general than the previous categories; Antifungals are also very large, old drugs, new drugs; Aminoglycosides have not made much progress; Carapenems have not made much progress, meropenem has been collected, and the price is almost the same
.
From the category and quantity of collective procurement, the antimicrobial field of drugs is in the forefront in terms of quantity and scale, and some of the remaining large varieties are either in the next batch, or shortly after the announcement of reference preparations, or there are no reference preparations
for the time being.
This time, the release of the expert consensus on the centralized procurement of antibiotic products will have a very positive impact
on standardizing the rational use of clinical antibiotics, children's dosage forms and specifications, the graded management of antibiotics, and the use of centralized procurement products.

Expect the boots to hit the ground!!!

Author: Zhang Tingjie

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