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Indicators of health statistics - Part 8: Drugs and medical material supply
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Basic data
| Standard ID | WS/T 598.8-2018 (WS/T598.8-2018) |
| Description (Translated English) | Indicators of health statistics - Part 8: Drugs and medical material supply |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C07 |
| Word Count Estimation | 13,175 |
| Date of Issue | 2018-04-17 |
| Date of Implementation | 2018-10-01 |
| Regulation (derived from) | State-Health-Communication (2018) 5 |
| Issuing agency(ies) | National Health Commission |
WS/T 598.8-2018: Indicators of health statistics - Part 8: Drugs and medical material supply
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Indicators of health statistics - Part 8. Drugs and medical material supply
ICS 11.020
C 07
WS
People's Republic of China Health Industry Standard
Health statistics
Part 8. Supply of medicines and health materials
Indicators of health statistics
Part 8. Drugs and medical material supply
Published on.2018 - 04 - 17
2018 - 10 - 01 implementation
National Health and Wellness Committee of the People's Republic of China
Foreword
The WS/T 598 Health Statistics Indicators are divided into the following nine sections.
- Part 1. General;
- Part 2. Health status of residents;
- Part 3. Health impact factors;
- Part 4. Disease Control;
- Part 5. Maternal and Child Health Care;
- Part 6. Health supervision;
- Part 7. Medical services;
- Part 8. Supply of medicines and sanitary materials;
- Part 9. Health resources.
This part is the eighth part of WS/T 598.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part is proposed by the National Health Standards Committee Information Standards Committee.
This section is mainly drafted by. General Hospital of the People's Liberation Army, National Health and Family Planning Commission Statistical Information Center, National Health and Family Planning Commission
Department of Materials Policy and Essential Medicines, Information Center of the State Food and Drug Administration, and State Food and Drug Administration
Product Registration Management Division, Consumer Products Division of the Ministry of Industry and Information Technology, Department of Market Order of the Ministry of Commerce, School of Medicine, Shanghai Jiaotong University.
The main drafters of this section. Feng Dan, Wu Xiaoling, Han Huixue, Xiao Wei, Pang Hongyan, Yu Huan, E Xueting, Zhong Chengfa, Zhu Xi, Niu Ya
Hui, Han Yuzhe.
Health statistics
Part 8. Supply of medicines and health materials
1 Scope
This section specifies the statistical indicators and indicators related to the supply of medicines and sanitary materials in the health statistics indicators.
This section applies to the use, distribution and sharing of statistical data of health administrative departments and medical and health institutions at all levels.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document.
For undated references, the latest edition (including all amendments) applies to this document.
WS/T 598.1 Health statistics indicators Part 1. General
3 Terms and definitions
The following terms and abbreviations, as defined by WS/T 598.1, apply to this document.
3.1
Indicators of drugs and medical material supply
It reflects statistical indicators such as the production, circulation, procurement, distribution, use, quality and safety of pharmaceuticals and sanitary materials in a certain period of time.
4 Description of the supply guarantee indicators for pharmaceuticals and sanitary materials
4.1 Drug and Sanitation Materials Supply Support Indicators Public Attributes
The public attributes of the supply and safety indicators for pharmaceuticals and sanitary materials are shown in Table 1.
Table 1 Public Attributes of Statistical Indicators for Supply of Medicines and Sanitary Materials
Attribute type attribute name attribute value
Identification class
Version V1.0
Registration Authority National Health Standards Committee Information Standards Committee
Relational classification classification
Management class
National Health and Family Planning Commission Statistical Information Center
Registration status standard status
Submitted to the General Hospital of the Chinese People's Liberation Army
4.2 Special properties of statistical indicators for the supply of medicines and materials
4.2.1 Drug supply security
4.2.1.1 Pharmaceutical production and circulation
IHS04.01.001 identifier
Chinese name drug registration number
English name Number of registered drugs
Unit of measurement
Define the total number of drugs that have been reviewed and approved by the national food and drug regulatory authorities at the end of the year.
Calculation method
The indicator shows the number of approved drug registrations at the end of the year. Drugs are diseases that are used to prevent, treat, and diagnose people, and purposefully regulate human physiology.
And specify substances with indications or functional indications, usage and dosage, including Chinese herbal medicines, Chinese herbal medicines, Chinese patent medicines, chemical raw materials and their preparations.
Agents, antibiotics, biochemicals, radiopharmaceuticals, serum, vaccines, blood products and diagnostics. Drug registration refers to national food and drug
The supervisory and administrative department shall, according to the application of the drug registration applicant, follow the legal procedures, the safety, validity and quality of the drug to be marketed for sale.
Control, etc., to review and decide whether to agree with the approval process of their application.
Survey method comprehensive investigation
Data source drug registration database
Release frequency year
IHS04.01.002 identifier
Chinese name Chinese medicine protection varieties
English Name Number of protected Traditional Chinese Medicine
Unit of measurement
Define the total number of Chinese medicine protection varieties approved by the State Food and Drug Administration at the end of the year.
Calculation method
The indicator indicates the total number of traditional Chinese medicine protection varieties during the protection period, including the number of first-time protected varieties, the number of extended protected varieties and the number of protections of the same variety.
investigation method
Data source Chinese medicine variety protection database
Release frequency year
IHS04.01.003
Chinese name "Pharmaceutical Production License"
Number of enterprises with drug production licences
Unit of measure
Define the number of companies approved by the provincial food and drug regulatory authorities and issued to the Pharmaceutical Production License at the end of the year.
Calculation method
The indicator description includes the number of certified enterprises that were issued to the Pharmaceutical Production License issued during the reporting period and issued within the validity period.
Survey method comprehensive investigation
Data source food and drug regulatory statistics annual report
Release frequency year
IHS04.01.004
Chinese name "Pharmaceutical Business License"
Number of enterprises with drug business licences
Unit of measure
Define the number of enterprises approved by the prefecture-level food and drug supervision department and issued to the Pharmaceutical Business License at the end of the year.
Calculation method
The indicator description includes the provincial food and drug supervision department issued to the pharmaceutical wholesale enterprise and the county-level food and drug supervision and administration department to the pharmaceutical retail enterprise.
The sum of the number of Pharmaceutical Business Licenses. According to the certificate issued in the report period, issued before the year and within the validity period.
Survey method comprehensive investigation
Data source food and drug regulatory statistics annual report
Release frequency
IHS04.01.005
Number of pharmaceutical manufacturers with Chinese name certified by GMP
Number of drug manufacturing enterprises with GMP certifications
Unit of measure
According to the provisions of the “Administrative Measures for the Certification of Pharmaceutical Production Quality Management Regulations” at the end of the year, the on-site inspection and audit are in compliance with the “Quality Management Regulations for Pharmaceutical Production”.
Fan requires the number of pharmaceutical production enterprises issued by the State Food and Drug Administration to the Drug GMP Certificate.
Calculation method
The indicator shows the cumulative number as of the end of the year.
Survey method comprehensive investigation
Data source GMP certified enterprise database
Release frequency year
IHS04.01.006
Chinese name pharmaceutical production enterprise main business income
Main business income of drug manufacturing enterprises
Unit of measurement
Define the income from the main business such as sales of goods and provision of labor services by pharmaceutical production enterprises in a certain region during the reporting period.
Calculation method
Indicators indicate that medicines include chemical raw materials, chemical preparations, Chinese medicine decoction pieces, proprietary Chinese medicines, and biological preparations.
Survey method comprehensive investigation
Data source medical statistics annual report
Release frequency year
IHS04.01.007
Chinese name, total profit of pharmaceutical production enterprises
Total profits of drug manufacturing enterprises
Unit of measurement
Defining the income of various pharmaceutical production enterprises in a certain area during the production and operation process after deducting various expenses.
Calculation method
Indicators indicate that medicines include chemical raw materials, chemical preparations, Chinese medicine decoction pieces, proprietary Chinese medicines, and biological preparations.
Survey method comprehensive investigation
Data source medical statistics annual report
Release frequency year
4.2.1.2 Drug purchase and distribution
IHS04.01.008
Chinese name national essential drug list number
Number of drug varieties in national essential drug list
Unit of measurement
Define the number of drug varieties in the National Essential Drugs List issued by the National Health and Health Commission.
Calculation method
Indicator description
Survey method administrative record
Data source national essential medicines list
Release frequency is not regular
IHS04.01.009 identifier
Chinese name
Number of supplemented statistics essential drug varieties in essential drug lists
Unit of measurement
Define the number of drugs used by grassroots medical and health institutions other than the National Essential Drugs List determined by the provincial government at the end of the year.
Calculation method
Indicator description
Survey method administrative record
Data source The list of supplements determined by the provincial people's government.
Release frequency year
IHS04.01.010 identifier
Chinese name. Number of pharmaceutical manufacturers involved in centralized procurement of provincial drugs
Number of drug manufacturing enterprises involved in provincial centralized drug procurement
Unit of measure
Define the number of pharmaceutical production enterprises registered on the provincial centralized drug procurement platform at the end of the year.
Calculation method
The indicator indicates the number of users of the production enterprises registered on the centralized drug procurement platform at the end of the year.
Survey method comprehensive investigation
Data source country drug supply security integrated management information platform
Release frequency year
IHS04.01.011 identifier
Chinese name Number of medical and health institutions involved in centralized procurement of provincial drugs
Number of health care institutions involved in provincial centralized drug procurement
Unit of measure
Define the number of medical and health institutions at all levels at the end of the year registered at the provincial drug centralized procurement platform and purchasing drugs through the platform.
Calculation method
The indicator shows the number of users of medical and health institutions registered according to the provincial centralized drug procurement platform at the end of the year.
Survey method comprehensive investigation
Data source country drug supply security integrated management information platform
Release frequency year
IHS04.01.012 identifier
Chinese name Number of companies involved in drug distribution in medical and health institutions
Number of enterprises involved in medical institutions drug delivery
Unit of measure
The number of pharmaceutical companies that have obtained the Drug Administration License from the Food and Drug Administration at the end of the year and distributed the drugs to medical and health institutions.
Calculation method
Indicator description
Survey method comprehensive investigation
Data source country drug supply security integrated management information platform
Release frequency year
IHS04.01.013 identifier
Chinese name drug 3 day delivery rate (by amount)
English name Ratio of delivered amount to ordered amount of drugs in 3 days
unit of measurement%
Define the ratio of the amount of medicines delivered to the order amount within 3 days after the delivery company receives the purchase order from the medical institution within a certain period of time.
Calculation method The amount of the medicine delivered by the distribution company within 3 days after receiving the purchase order from the medical institution/the delivery enterprise receiving the purchase order from the medical institution
Amount × 100%.
Indicator description
Survey method comprehensive investigation
Data source country drug supply security integrated management information platform
Release frequency year
IHS04.01.014 identifier
Chinese name medical institution within 30 days return rate
English name Ratio of payment to warehoused value in 30 days
unit of measurement%
Define the ratio of the amount of the medical payment settled by the medical institution within 30 days to the warehousing amount within a certain period of time.
Calculation method. The amount of money returned within 30 days after the medical institution's drugs are put into storage, the amount of the same period of storage × 100%
The indicator indicates that the payment within 30 days means that the medical institution's drug storage time and settlement completion time are not more than 30 days.
Survey method comprehensive investigation
Data source country drug supply security integrated management information platform
Release frequency year
4.2.1.3 Drug use
IHS04.01.015 identifier
Chinese name drug fee
English name Drug pregnancy
Unit of measurement
Define the total cost of medicines used to treat and prevent human diseases in a certain area in a given year, including the outpatient and inpatient drug income of medical and health institutions in the jurisdiction,
Drug sales at retail pharmacies.
Calculation method
The indicator indicates that the outpatient drug cost refers to the total amount of drug expenses in the outpatient expenses of various types of medical and health institutions at all levels, and the cost of hospitalization drugs refers to various types of medical and health care at all levels.
The total amount of medicines in the hospitalization expenses of the institution, and the cost of retail medicines refers to the total amount of medicines sold in retail pharmacies.
Survey method accounting
Data source health cost accounting (institutional law)
Release frequency year
IHS04.01.016 identifier
Chinese name per capita medicine fee
English name Drug expenditure per capita
Unit of measure
Define the ratio of drug costs in a certain region to the average annual population.
Calculation method The drug cost in a certain area in a certain year/the average population of the area in the same year.
The indicator indicates the average population = (the population at the end of the year is the population at the end of the year)/2.
Survey method accounting
Data source health total cost accounting
Release frequency year
IHS04.01.017 identifier
Chinese name drug costs as a percentage of total health expenditure
English name Drugu as a percentage of total
unit of measurement%
Define the ratio of drug costs to total health costs in a certain region in a given year.
Calculation method The drug cost in a certain area in a certain year/the total health expenditure in the same area in the same year × 100%.
Indicator description
Survey method accounting
Data source health total cost accounting
Release frequency year
IHS04.01.018 identifier
Chinese name national basic drug use amount ratio
English rate of national essential drugs
unit of measurement%
Define the proportion of national essential drugs in medicines used by medical institutions within a certain period of time
Calculation method National essential medicine purchase amount of medical institutions/Total amount of medicine purchases of medical institutions in the same period × 100%
The indicator indicates that the amount of drug purchases in medical institutions is based on the drug fees of medical institutions.
Survey method comprehensive investigation
Data source health statistics direct reporting system
Release frequency year
4.2.1.4 Quality and safety of drugs
IHS04.01.019 identifier
Chinese name drug electronic supervision system coverage
Coverage of electronic drug supervision system
unit of measurement%
Define the proportion of enterprises or institutions included in the national drug electronic supervision system in pharmaceutical production and operation enterprises and medical and health institutions in a certain region in a certain year
example.
Calculation method In a certain year, a certain area is included in the national drug electronic supervision system (the number of drug manufacturing enterprises, the number of medical enterprises, the number of medical and health institutions)/the same
In this year (the total number of medical and health institutions in total number of drug-operated enterprises in pharmaceutical production enterprises) × 100%.
The indicator shows the number of registered users according to the drug electronic supervision system.
Survey method comprehensive investigation
Data source drug electronic regulatory information system
Release frequency year
IHS04.01.020 identifier
Chinese name report number of adverse drug reactions per million population
Number of reported cases of adverse drug reaction per 1000000 population
Unit of measurement 1/1 million
Define the ratio of the number of reported adverse drug reactions in a given year to the population. Usually expressed in parts per million.
Calculation method Number of reported cases of adverse drug reactions in a certain area in a certain year/Number of permanent residents in the same area × 1000000 in the same year.
The indicators indicate that the number of adverse drug reactions reports refers to drug manufacturers, drug companies, medical and health institutions, and individuals.
The sum of the number of adverse reactions reported in the Reporting and Monitoring Management Measures. Adverse drug reactions are when drugs are used for human prevention and diagnosis.
Harmful and undesired reactions that occur at normal doses when broken, treated, or mediated.
Survey method comprehensive investigation
Data source adverse drug reaction monitoring system, Food and Drug Administration
Release frequency year
IHS04.01.021 identifier
Chinese name investigation and handling of drug cases
English name Number of drug cases investigated and punished
Unit of measurement
Define the food and drug supervision department of a certain region in a certain year to investigate and deal with illegal drugs in the production and operation of pharmaceutical products in accordance with the Provisions on the Administrative Punishment Procedures for Drug Administration.
The sum of the number of cases.
Calculation method
Indicator description
Survey method comprehensive investigation
Data source food and drug regulatory statistics annual report
Release frequency year
IHS04.01.022 identifier
Chinese name banned drugs unlicensed business households
Number of banned enterprises without drug business licences
Unit of measurement
Define the drug regulatory authority of a certain region during the year in accordance with the Provisions on the Administrative Punishment Procedures for Drug Administration, and ban the drug production and operation license or
The number of households in the production and operation of pharmaceutical products under the Pharmaceutical Production and Operation License.
Calculation method
Indicator description
Survey method comprehensive investigation
Data source food and drug regulatory statistics annual report
Release frequency year
4.2.2 Supply of sanitary materials
IHS04.02.001 identifier
Chinese name Health materials manufacturing enterprise's main business income
Main business income of medical material manufacturing enterprises
Unit of measurement
Define the income from the main business such as sales of goods and provision of labor services by sanitary material production enterprises in a certain area in a certain year.
Calculation method
Indicators indicate that sanitary materials include visceral wound damage, functional dressings, biomaterials, surgical materials, adhesive materials, protective materials, medical textiles, medical
Non-woven fabrics, dressing machinery. wet tissue packaging machine, medical band-aid machine, infusion paste machine, slicer, winder, ultrasonic mask machine,
Medical gauze folding machine, cotton machine, mattress machine and other processing equipment.
Survey method comprehensive investigation
Data source medical statistics annual report
Release frequency year
IHS04.02.002 identifier
Chinese name, total profit of sanitary material production enterprises
Profits of medical material manufacturing enterprises
Unit of measurement
Defining the income of various materials in the production and operation process of a sanitary material production enterprise in a certain area in a certain year, after deducting various expenses.
Calculation method
Indicator description
Survey method comprehensive investigation
Data source medical statistics annual report
Release frequency year
IHS04.02.003
Chinese name. Number of high-value medical consumables manufacturers participating in provincial centralized procurement
Number of high-value medical material manufacturing enterprises involved in provincial centralized
Purification
Unit of measure
Define the number of high-value medical consumables enterprises actually registered on the provincial drug centralized procurement platform at the end of the year
Calculation method
The indicator shows the number of users of high-value medical consumables manufacturers registered on the provincial-level centralized drug procurement platform at the end of the year.
Survey method comprehensive investigation
Data source country drug supply security integrated management information platform
Release frequency year
IHS04.02.004
Chinese name refers to the number of enterprises involved in the distribution of high-value medical supplies
Number of enterprises involved in high-value medical material delivery
Unit of measure
Define the number of high-value medical consumables distribution enterprises determined by open tendering, invitation to tender, inquiry and purchase, and individual bargaining at the end of the year.
Calculation method
Indicator description
Survey method comprehensive investigation
Data source country drug supply security integrated management information platform
Release frequency year
IHS04.02.005
Chinese name high value medical supplies delivery rate
English name Ratio of warehoused value to order value of high-value medical consumable
unit of measurement%
Define the ratio of the cumulative storage amount of high-value medical consumables in medical institutions to the cumulative order value of high-value medical consumables in a certain period of time
Calculation method Medical institution high value medical supplies cumulative storage amount/medical institution high value medical supplies cumulative order amount × 100%
The indicator indicates that the accumulated amount of high-value medical consumables refers to the procurement through the provincial drug centralized procurement platform, the distribution of the distribution enterprise, and the inspection of the income of the medical institution.
The total amount of high value medical supplies. The cumulative order value of high-value medical consumables refers to the high-value medical consumables purchased through the provincial drug centralized procurement platform.
Amount (excluding medical instrument equipment order amount)
Survey method comprehensive investigation
Data source country drug supply security integrated management information platform
Release freq...
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