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Since the official implementation of the new version of the Physicians Law in March this year, Guangdong, Shandong, Liaoning, Jilin and Heilongjiang provinces have successively issued the "2022 edition of the Ultra Drug Manual Drug Catalogue", which includes more than 600 drugs in total, involving eight major treatment areas such as pediatric drugs, antitumor drugs, antibacterial drugs, and cardiovascular drugs, including ibuprofen, paclitaxel, azithromycin and other commonly used varieties
。 The increase in the demand for clinical drugs, the lag of drug instructions is prominent, the use of ultra-instructions is becoming more and more common, under the premise of legal compliance of the process and ensuring safety, the use of drugs in the instructions may unlock the "new usage" of more drugs, further benefiting more drug patients
.
。 The increase in the demand for clinical drugs, the lag of drug instructions is prominent, the use of ultra-instructions is becoming more and more common, under the premise of legal compliance of the process and ensuring safety, the use of drugs in the instructions may unlock the "new usage" of more drugs, further benefiting more drug patients
.
Five major provinces preemptively announced that more than 600 drugs can be used beyond the instructions
"Medication beyond the instructions" refers to the act of taking drugs beyond the scope of indications indicated in the instructions for
the drug.
the drug.
In August 2021, the 30th Session of the Standing Committee of the 13th National People's Congress passed the Medical Doctor Law of the People's Republic of China, which came into effect on March 1, 2022, and for the first time wrote the ultra-instruction medication under diagnosis and treatment guidelines and evidence-based medical evidence into the law
.
This means that the problem of "super-instruction manual medication" that is easy to cause doctor-patient disputes has been regulated from the legal level, giving doctors the autonomy of "super-manual medication", and super-manual medication has since been legally guaranteed
.
.
This means that the problem of "super-instruction manual medication" that is easy to cause doctor-patient disputes has been regulated from the legal level, giving doctors the autonomy of "super-manual medication", and super-manual medication has since been legally guaranteed
.
Source: Official website of the National People's Congress
Since the beginning of this year, the five provinces of Guangdong, Shandong, Liaoning, Jilin and Heilongjiang have successively issued the "2022 edition of the Expert Guide for the Medication of Ultra Drug Instructions"
.
.
In June, the Guangdong Pharmaceutical Association issued the "Ultra-Drug Manual Drug Catalogue (2022 Edition)", which included a total of 269 drugs and added 37 new drug information, including commonly used drugs
such as ibuprofen, aspirin, levofloxacin, etc.
such as ibuprofen, aspirin, levofloxacin, etc.
In August, the Shandong Pharmaceutical Association published the "Catalogue of Super-Drug Instructions (2022 Edition)", a total of 156 varieties, including 247 recommendations; Among them, there are 25 antibacterial drugs, 15 antitumor drugs, 14 cardiovascular drugs, 16 psychiatric and neurological drugs, 11 intrarenal and wind exemption drugs, 33 pediatric drugs, 35 obstetric reproductive drugs and 11 other drugs
.
.
In September, the "Expert Consensus on Drugs in Ultra Drug Instructions (2022 Edition)" jointly prepared by Liaoning, Jilin and Heilongjiang "Three Eastern Provinces" was released, which included 643 relevant drug information
covering 16 departments.
The catalogue variety information only includes chemical drugs and biological products, and has not yet included traditional Chinese medicine and natural medicine
.
(Attached at the end of the article: the list of super-drug labels and drug varieties included in the "three eastern provinces" in 2022)
covering 16 departments.
The catalogue variety information only includes chemical drugs and biological products, and has not yet included traditional Chinese medicine and natural medicine
.
(Attached at the end of the article: the list of super-drug labels and drug varieties included in the "three eastern provinces" in 2022)
The three super-instruction manual drug catalogues are generally similar, and all of them are compiled into a consensus of experts on super-manual drugs that conform to the disease and clinical reality in the region through the summary analysis, collation and standardization of problems related to the use of super-instructions in relevant areas, aiming to expand the application of drugs based on evidence-based medical evidence, standardize the use of drugs in ultra-instructions, strengthen rational drug management, reduce the practice risks of medical institutions and medical personnel, and provide evidence-based reference for
improving the effectiveness and safety of drug treatment.
improving the effectiveness and safety of drug treatment.
Ibuprofen, paclitaxel.
.
.
Equal weight list, a single product included up to 11 indications
.
.
Equal weight list, a single product included up to 11 indications
There is a consensus at the clinical drug end that there is a lag in the drug specification in the treatment plan that is difficult to replace the solution, and the standardization of the use of the super-specification of the drug will undoubtedly help the choice
of clinical drug needs such as pediatric drugs that are in short supply, antitumor drugs that are prone to drug resistance, and antibacterial drugs.
of clinical drug needs such as pediatric drugs that are in short supply, antitumor drugs that are prone to drug resistance, and antibacterial drugs.
Ibuprofen suspension is a commonly used antipyretic drug for children in clinical practice, its main ingredient is ibuprofen, which has antipyretic and analgesic and anti-inflammatory effects, and is used to relieve fever headache, joint pain, neuralgia headache, toothache and so on
caused by the common cold or flu.
According to the data of the Mi Intranet, the sales of the product in the six major markets of China's three major terminals in 2021 (see the statistical scope at the end of this article) exceeded 800 million yuan, an increase of 32.
37%
year-on-year.
caused by the common cold or flu.
According to the data of the Mi Intranet, the sales of the product in the six major markets of China's three major terminals in 2021 (see the statistical scope at the end of this article) exceeded 800 million yuan, an increase of 32.
37%
year-on-year.
In recent years, the sales of ibuprofen suspension in China's three major terminal 6 major markets (:10,000 yuan)
Source: Intranet Database
Since the beginning of this year, ibuprofen suspension has been allowed to be used in the ultra-manual for the treatment of pediatric patent ductus arteriosus (Shandong, Liaoning, Jilin and Heilongjiang), preterm infants with patent ductus arteriosus (Guangdong, Liaoning, Jilin and Heilongjiang), and the product sales scale is expected to continue to expand at the hospital end
.
.
Omeprazole enteric-coated capsules are proton pump inhibitors (PPIs) and are mainly used to treat duodenal ulcers, Zoe syndrome (gastrinoma), gastric ulcers and reflux esophagitis
.
Affected by the collection, the terminal sales of the drug in China's public medical institutions have declined in the past two years, falling back to the sales level
of 1 billion yuan in 2021.
.
Affected by the collection, the terminal sales of the drug in China's public medical institutions have declined in the past two years, falling back to the sales level
of 1 billion yuan in 2021.
In recent years, the sales of terminal omeprazole enteric-coated capsules in China's public medical institutions (:10,000 yuan)
Source: Intranet China's public medical institutions terminal competition pattern
At present, omeprazole enteric-coated capsules have been included in the ultra-manual drug catalogue by Shandong, Liaoning, Jilin and Heilongjiang provinces, which are used for the treatment of pediatric erosive esophagitis-gastroesophageal reflux disease, pediatric helicobacter pylori-related duodenal ulcers, etc.
, while entering the pediatric field, it is expected to fill part of the profit gap
of the product under the influence of collection.
, while entering the pediatric field, it is expected to fill part of the profit gap
of the product under the influence of collection.
Paclitaxel for injection (albumin-conjugated) is indicated for the treatment of metastatic breast cancer that fails with combined chemotherapy or breast cancer
that recurs within 6 months after adjuvant chemotherapy.
As the second batch of national varieties, the drug is still strong in the hospital-end market with excellent efficacy
.
According to intranet data, the terminal sales scale of paclitaxel for injection (albumin-conjugated) in China's public medical institutions will be close to 4 billion yuan in 2021, an increase of 26.
5% year-on-year, ranking seventh
in the top 10 anti-tumor products.
that recurs within 6 months after adjuvant chemotherapy.
As the second batch of national varieties, the drug is still strong in the hospital-end market with excellent efficacy
.
According to intranet data, the terminal sales scale of paclitaxel for injection (albumin-conjugated) in China's public medical institutions will be close to 4 billion yuan in 2021, an increase of 26.
5% year-on-year, ranking seventh
in the top 10 anti-tumor products.
Top 10 Terminal Anti-tumor Products in China's Public Medical Institutions in 2021 (:100 million yuan)
Source: Intranet China's public medical institutions terminal competition pattern
It is learned from the latest ultra-manual drug catalogue released by the "Three Eastern Provinces" that there are as many as 11 indications for the ultra-manual medication of paclitaxel (albumin-conjugated type) for injection, namely platinum-sensitive or platinum-resistant recurrent ovarian cancer, melanoma, combined gemcitabine as the first-line treatment of metastatic pancreatic cancer, biliary malignant tumors, metastatic nasopharyngeal cancer, etc.
, which may further consolidate its leading position
in anti-tumor drugs.
, which may further consolidate its leading position
in anti-tumor drugs.
Azithromycin is a second-generation macrolide antibiotic, which is mainly used to treat lower respiratory tract infections
such as bronchitis and pneumonia caused by sensitive bacteria.
According to the data of Mi Intranet, the total sales scale of this product in the six major markets of China's three major terminals in 2021 will exceed 2 billion yuan, an increase of 14.
88%
year-on-year.
Among them, the sales share of tablets, injections and suspensions accounts for nearly 90%, and the above dosage forms have been included in the 2022 edition of the "Eastern Three Provinces" Intensive and Anti-Infective Drugs Super Instruction Manual Drug Catalog
.
such as bronchitis and pneumonia caused by sensitive bacteria.
According to the data of Mi Intranet, the total sales scale of this product in the six major markets of China's three major terminals in 2021 will exceed 2 billion yuan, an increase of 14.
88%
year-on-year.
Among them, the sales share of tablets, injections and suspensions accounts for nearly 90%, and the above dosage forms have been included in the 2022 edition of the "Eastern Three Provinces" Intensive and Anti-Infective Drugs Super Instruction Manual Drug Catalog
.
Sales of azithromycin in China's three major terminal 6 major markets in recent years (:10,000 yuan)
Source: Intranet Database
Indications for the approved use of the drug beyond the instructions include: community-acquired pneumonia, bronchiectasis and whooping cough in infants under three months of age caused by Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumoniae, Moraxella catarrhalis, Staphylococcus aureus or Streptococcus pneumoniae that require intravenous infusion treatment first, which is obviously a great boon
for children with severe respiratory infections.
for children with severe respiratory infections.
With the law to follow, "abiding by the premise" and "examining the future" are indispensable
It is a good thing that the drug super-instructions are used to write the legal provisions, which embodies the spirit of respecting science and respecting practice, and the boundaries of responsibility are clearly delineated, so as to make the medical cause more harmonious as possible, but it is not possible to blindly follow the contents of the super-instructions to follow the script, and it is even more necessary to clearly define the premise and rationality of the super-instructions for the use of drugs
.
.
A careful review of the provisions of the new edition of the Physicians Law reveals four major prerequisites, one of which is indispensable:
(1) The drug has evidence-based medical evidence;
(2) There is no other safer, more effective, economical and reasonable treatment;
(3) Informed consent of the patient;
(4) The hospital has established relevant management mechanisms
.
.
With the improvement of the law, the standardized management of super-manual drugs by the Pharmaceutical Society and corresponding medical institutions will be gradually established
.
Ultra-manual medication is not a doctor's personal behavior, but a kind of diagnosis and treatment behavior attributed to the level of medical institutions, and it is necessary to establish a management system to strictly regulate the medication behavior, such as prescription review, clinical consultation, etc.
The doctor himself needs to report to the hospital for the record when the super-manual is used, and the hospital will conduct regular assessment, prevention and control of risks
.
.
Ultra-manual medication is not a doctor's personal behavior, but a kind of diagnosis and treatment behavior attributed to the level of medical institutions, and it is necessary to establish a management system to strictly regulate the medication behavior, such as prescription review, clinical consultation, etc.
The doctor himself needs to report to the hospital for the record when the super-manual is used, and the hospital will conduct regular assessment, prevention and control of risks
.
The standardization of super-instruction manual medication allows us to see that all the contents that are guided by clinical needs and take the interests of patients as the fundamental purpose are worthy of
encouragement.
Similarly, we also need to look at the ultra-manual medication with the right eyes, and fully explore its development and future
.
encouragement.
Similarly, we also need to look at the ultra-manual medication with the right eyes, and fully explore its development and future
.
First of all, it must be understood that the root of ultra-manual medication is for the needs
of disease treatment.
of disease treatment.
Clinical medicine continues to advance in exploration and discovery, and its development puts forward new demands on therapeutic drugs: or the development of new drugs; Or find new uses
in existing drugs.
For the latter, super-instructional medication will be inevitable, which also promotes the development of
clinical pharmacy to some extent.
in existing drugs.
For the latter, super-instructional medication will be inevitable, which also promotes the development of
clinical pharmacy to some extent.
Second, to a certain extent, break the limitations of children's medication
.
.
Super-instruction manual medications include drugs that exceed the indications, applicable age, route of administration and dosage of the instructions, and are relatively more
used in pediatrics.
Because the organ function of children (especially newborns) is immature, the absorption of drugs is not easy to determine, it is difficult to carry out clinical trials of drugs, and there are not many
pediatric drugs that have passed the approval.
In order to treat children, ultra-instruction manual medication is also one of the ways to
solve the problem.
used in pediatrics.
Because the organ function of children (especially newborns) is immature, the absorption of drugs is not easy to determine, it is difficult to carry out clinical trials of drugs, and there are not many
pediatric drugs that have passed the approval.
In order to treat children, ultra-instruction manual medication is also one of the ways to
solve the problem.
Third, as far as possible to make up for the lag of
the manual.
the manual.
The discipline of medicine is a practical science, and the drug specification always lags behind the practice and development of medicine, so that the content of the drug specification has the characteristics of
lag and incompleteness.
With the release of drugs and the accumulation of clinical drug experience, the content of drug instructions also needs to be updated
.
However, because the revision of the drug specification is the same as the revision of the law, it takes a certain period of time, and it is sometimes difficult to synchronize with the progress of clinical drugs, and the super-manual drugs can better meet the clinical treatment needs and fill the treatment gap
.
lag and incompleteness.
With the release of drugs and the accumulation of clinical drug experience, the content of drug instructions also needs to be updated
.
However, because the revision of the drug specification is the same as the revision of the law, it takes a certain period of time, and it is sometimes difficult to synchronize with the progress of clinical drugs, and the super-manual drugs can better meet the clinical treatment needs and fill the treatment gap
.
epilogue
Overall, although the use of drugs beyond the instructions may bring some risks, if they can be strictly supervised, under the premise of legal compliance and safety of the process, more new drug functions can be "unlocked" and benefit more drug patients.
Note: Minet's "China's three major terminals 6 major market competition pattern", the statistical scope is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; The above sales are calculated
based on the average retail price of the product at the terminal.
based on the average retail price of the product at the terminal.
Since the official implementation of the new version of the Physicians Law in March this year, Guangdong, Shandong, Liaoning, Jilin and Heilongjiang provinces have successively issued the "2022 edition of the Ultra Drug Manual Drug Catalogue", which includes more than 600 drugs in total, involving eight major treatment areas such as pediatric drugs, antitumor drugs, antibacterial drugs, and cardiovascular drugs, including ibuprofen, paclitaxel, azithromycin and other commonly used varieties
。 The increase in the demand for clinical drugs, the lag of drug instructions is prominent, the use of ultra-instructions is becoming more and more common, under the premise of legal compliance of the process and ensuring safety, the use of drugs in the instructions may unlock the "new usage" of more drugs, further benefiting more drug patients
.
。 The increase in the demand for clinical drugs, the lag of drug instructions is prominent, the use of ultra-instructions is becoming more and more common, under the premise of legal compliance of the process and ensuring safety, the use of drugs in the instructions may unlock the "new usage" of more drugs, further benefiting more drug patients
.
Five major provinces preemptively announced that more than 600 drugs can be used beyond the instructions
Five major provinces preemptively announced that more than 600 drugs can be used beyond the instructions "Medication beyond the instructions" refers to the act of taking drugs beyond the scope of indications indicated in the instructions for
the drug.
Medicines and medicinesthe drug.
In August 2021, the 30th Session of the Standing Committee of the 13th National People's Congress passed the Medical Doctor Law of the People's Republic of China, which came into effect on March 1, 2022, and for the first time wrote the ultra-instruction medication under diagnosis and treatment guidelines and evidence-based medical evidence into the law
.
This means that the problem of "super-instruction manual medication" that is easy to cause doctor-patient disputes has been regulated from the legal level, giving doctors the autonomy of "super-manual medication", and super-manual medication has since been legally guaranteed
.
.
This means that the problem of "super-instruction manual medication" that is easy to cause doctor-patient disputes has been regulated from the legal level, giving doctors the autonomy of "super-manual medication", and super-manual medication has since been legally guaranteed
.
Source: Official website of the National People's Congress
Since the beginning of this year, the five provinces of Guangdong, Shandong, Liaoning, Jilin and Heilongjiang have successively issued the "2022 edition of the Expert Guide for the Medication of Ultra Drug Instructions"
.
.
In June, the Guangdong Pharmaceutical Association issued the "Ultra-Drug Manual Drug Catalogue (2022 Edition)", which included a total of 269 drugs and added 37 new drug information, including commonly used drugs
such as ibuprofen, aspirin, levofloxacin, etc.
such as ibuprofen, aspirin, levofloxacin, etc.
In August, the Shandong Pharmaceutical Association published the "Catalogue of Super-Drug Instructions (2022 Edition)", a total of 156 varieties, including 247 recommendations; Among them, there are 25 antibacterial drugs, 15 antitumor drugs, 14 cardiovascular drugs, 16 psychiatric and neurological drugs, 11 intrarenal and wind exemption drugs, 33 pediatric drugs, 35 obstetric reproductive drugs and 11 other drugs
.
.
In September, the "Expert Consensus on Drugs in Ultra Drug Instructions (2022 Edition)" jointly prepared by Liaoning, Jilin and Heilongjiang "Three Eastern Provinces" was released, which included 643 relevant drug information
covering 16 departments.
The catalogue variety information only includes chemical drugs and biological products, and has not yet included traditional Chinese medicine and natural medicine
.
(Attached at the end of the article: the list of super-drug labels and drug varieties included in the "three eastern provinces" in 2022)
covering 16 departments.
The catalogue variety information only includes chemical drugs and biological products, and has not yet included traditional Chinese medicine and natural medicine
.
(Attached at the end of the article: the list of super-drug labels and drug varieties included in the "three eastern provinces" in 2022)
The three super-instruction manual drug catalogues are generally similar, and all of them are compiled into a consensus of experts on super-manual drugs that conform to the disease and clinical reality in the region through the summary analysis, collation and standardization of problems related to the use of super-instructions in relevant areas, aiming to expand the application of drugs based on evidence-based medical evidence, standardize the use of drugs in ultra-instructions, strengthen rational drug management, reduce the practice risks of medical institutions and medical personnel, and provide evidence-based reference for
improving the effectiveness and safety of drug treatment.
improving the effectiveness and safety of drug treatment.
Ibuprofen, paclitaxel.
.
.
Equal weight list, a single product included up to 11 indications
Ibuprofen, paclitaxel. .
.
Equal weight list, a single product included up to 11 indications
.
.
Equal weight list, a single product included up to 11 indications
There is a consensus at the clinical drug end that there is a lag in the drug specification in the treatment plan that is difficult to replace the solution, and the standardization of the use of the super-specification of the drug will undoubtedly help the choice
of clinical drug needs such as pediatric drugs that are in short supply, antitumor drugs that are prone to drug resistance, and antibacterial drugs.
of clinical drug needs such as pediatric drugs that are in short supply, antitumor drugs that are prone to drug resistance, and antibacterial drugs.
Ibuprofen suspension is a commonly used antipyretic drug for children in clinical practice, its main ingredient is ibuprofen, which has antipyretic and analgesic and anti-inflammatory effects, and is used to relieve fever headache, joint pain, neuralgia headache, toothache and so on
caused by the common cold or flu.
According to the data of the Mi Intranet, the sales of the product in the six major markets of China's three major terminals in 2021 (see the statistical scope at the end of this article) exceeded 800 million yuan, an increase of 32.
37%
year-on-year.
Children and childrencaused by the common cold or flu.
According to the data of the Mi Intranet, the sales of the product in the six major markets of China's three major terminals in 2021 (see the statistical scope at the end of this article) exceeded 800 million yuan, an increase of 32.
37%
year-on-year.
In recent years, the sales of ibuprofen suspension in China's three major terminal 6 major markets (:10,000 yuan)
Source: Intranet Database
Since the beginning of this year, ibuprofen suspension has been allowed to be used in the ultra-manual for the treatment of pediatric patent ductus arteriosus (Shandong, Liaoning, Jilin and Heilongjiang), preterm infants with patent ductus arteriosus (Guangdong, Liaoning, Jilin and Heilongjiang), and the product sales scale is expected to continue to expand at the hospital end
.
.
Omeprazole enteric-coated capsules are proton pump inhibitors (PPIs) and are mainly used to treat duodenal ulcers, Zoe syndrome (gastrinoma), gastric ulcers and reflux esophagitis
.
Affected by the collection, the terminal sales of the drug in China's public medical institutions have declined in the past two years, falling back to the sales level
of 1 billion yuan in 2021.
.
Affected by the collection, the terminal sales of the drug in China's public medical institutions have declined in the past two years, falling back to the sales level
of 1 billion yuan in 2021.
In recent years, the sales of terminal omeprazole enteric-coated capsules in China's public medical institutions (:10,000 yuan)
Source: Intranet China's public medical institutions terminal competition pattern
At present, omeprazole enteric-coated capsules have been included in the ultra-manual drug catalogue by Shandong, Liaoning, Jilin and Heilongjiang provinces, which are used for the treatment of pediatric erosive esophagitis-gastroesophageal reflux disease, pediatric helicobacter pylori-related duodenal ulcers, etc.
, while entering the pediatric field, it is expected to fill part of the profit gap
of the product under the influence of collection.
, while entering the pediatric field, it is expected to fill part of the profit gap
of the product under the influence of collection.
Paclitaxel for injection (albumin-conjugated) is indicated for the treatment of metastatic breast cancer that fails with combined chemotherapy or breast cancer
that recurs within 6 months after adjuvant chemotherapy.
As the second batch of national varieties, the drug is still strong in the hospital-end market with excellent efficacy
.
According to intranet data, the terminal sales scale of paclitaxel for injection (albumin-conjugated) in China's public medical institutions will be close to 4 billion yuan in 2021, an increase of 26.
5% year-on-year, ranking seventh
in the top 10 anti-tumor products.
that recurs within 6 months after adjuvant chemotherapy.
As the second batch of national varieties, the drug is still strong in the hospital-end market with excellent efficacy
.
According to intranet data, the terminal sales scale of paclitaxel for injection (albumin-conjugated) in China's public medical institutions will be close to 4 billion yuan in 2021, an increase of 26.
5% year-on-year, ranking seventh
in the top 10 anti-tumor products.
Top 10 Terminal Anti-tumor Products in China's Public Medical Institutions in 2021 (:100 million yuan)
Source: Intranet China's public medical institutions terminal competition pattern
It is learned from the latest ultra-manual drug catalogue released by the "Three Eastern Provinces" that there are as many as 11 indications for the ultra-manual medication of paclitaxel (albumin-conjugated type) for injection, namely platinum-sensitive or platinum-resistant recurrent ovarian cancer, melanoma, combined gemcitabine as the first-line treatment of metastatic pancreatic cancer, biliary malignant tumors, metastatic nasopharyngeal cancer, etc.
, which may further consolidate its leading position
in anti-tumor drugs.
, which may further consolidate its leading position
in anti-tumor drugs.
Azithromycin is a second-generation macrolide antibiotic, which is mainly used to treat lower respiratory tract infections
such as bronchitis and pneumonia caused by sensitive bacteria.
According to the data of Mi Intranet, the total sales scale of this product in the six major markets of China's three major terminals in 2021 will exceed 2 billion yuan, an increase of 14.
88%
year-on-year.
Among them, the sales share of tablets, injections and suspensions accounts for nearly 90%, and the above dosage forms have been included in the 2022 edition of the "Eastern Three Provinces" Intensive and Anti-Infective Drugs Super Instruction Manual Drug Catalog
.
such as bronchitis and pneumonia caused by sensitive bacteria.
According to the data of Mi Intranet, the total sales scale of this product in the six major markets of China's three major terminals in 2021 will exceed 2 billion yuan, an increase of 14.
88%
year-on-year.
Among them, the sales share of tablets, injections and suspensions accounts for nearly 90%, and the above dosage forms have been included in the 2022 edition of the "Eastern Three Provinces" Intensive and Anti-Infective Drugs Super Instruction Manual Drug Catalog
.
Sales of azithromycin in China's three major terminal 6 major markets in recent years (:10,000 yuan)
Source: Intranet Database
Indications for the approved use of the drug beyond the instructions include: community-acquired pneumonia, bronchiectasis and whooping cough in infants under three months of age caused by Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumoniae, Moraxella catarrhalis, Staphylococcus aureus or Streptococcus pneumoniae that require intravenous infusion treatment first, which is obviously a great boon
for children with severe respiratory infections.
for children with severe respiratory infections.
With the law to follow, "abiding by the premise" and "examining the future" are indispensable
With the law to follow, "abiding by the premise" and "examining the future" are indispensable It is a good thing that the drug super-instructions are used to write the legal provisions, which embodies the spirit of respecting science and respecting practice, and the boundaries of responsibility are clearly delineated, so as to make the medical cause more harmonious as possible, but it is not possible to blindly follow the contents of the super-instructions to follow the script, and it is even more necessary to clearly define the premise and rationality of the super-instructions for the use of drugs
.
.
A careful review of the provisions of the new edition of the Physicians Law reveals four major prerequisites, one of which is indispensable:
(<>) The drug has evidence-based medical evidence;
(2) There is no other safer, more effective, economical and reasonable treatment;
(<>) Informed consent of the patient;
(<>) The hospital has established relevant management mechanisms
.
.
With the improvement of the law, the standardized management of super-manual drugs by the Pharmaceutical Society and corresponding medical institutions will be gradually established
.
Ultra-manual medication is not a doctor's personal behavior, but a kind of diagnosis and treatment behavior attributed to the level of medical institutions, and it is necessary to establish a management system to strictly regulate the medication behavior, such as prescription review, clinical consultation, etc.
The doctor himself needs to report to the hospital for the record when the super-manual is used, and the hospital will conduct regular assessment, prevention and control of risks
.
.
Ultra-manual medication is not a doctor's personal behavior, but a kind of diagnosis and treatment behavior attributed to the level of medical institutions, and it is necessary to establish a management system to strictly regulate the medication behavior, such as prescription review, clinical consultation, etc.
The doctor himself needs to report to the hospital for the record when the super-manual is used, and the hospital will conduct regular assessment, prevention and control of risks
.
The standardization of super-instruction manual medication allows us to see that all the contents that are guided by clinical needs and take the interests of patients as the fundamental purpose are worthy of
encouragement.
Similarly, we also need to look at the ultra-manual medication with the right eyes, and fully explore its development and future
.
encouragement.
Similarly, we also need to look at the ultra-manual medication with the right eyes, and fully explore its development and future
.
First of all, it must be understood that the root of ultra-manual medication is for the needs
of disease treatment.
of disease treatment.
Clinical medicine continues to advance in exploration and discovery, and its development puts forward new demands on therapeutic drugs: or the development of new drugs; Or find new uses
in existing drugs.
For the latter, super-instructional medication will be inevitable, which also promotes the development of
clinical pharmacy to some extent.
in existing drugs.
For the latter, super-instructional medication will be inevitable, which also promotes the development of
clinical pharmacy to some extent.
Second, to a certain extent, break the limitations of children's medication
.
.
Super-instruction manual medications include drugs that exceed the indications, applicable age, route of administration and dosage of the instructions, and are relatively more
used in pediatrics.
Because the organ function of children (especially newborns) is immature, the absorption of drugs is not easy to determine, it is difficult to carry out clinical trials of drugs, and there are not many
pediatric drugs that have passed the approval.
In order to treat children, ultra-instruction manual medication is also one of the ways to
solve the problem.
used in pediatrics.
Because the organ function of children (especially newborns) is immature, the absorption of drugs is not easy to determine, it is difficult to carry out clinical trials of drugs, and there are not many
pediatric drugs that have passed the approval.
In order to treat children, ultra-instruction manual medication is also one of the ways to
solve the problem.
Third, as far as possible to make up for the lag of
the manual.
the manual.
The discipline of medicine is a practical science, and the drug specification always lags behind the practice and development of medicine, so that the content of the drug specification has the characteristics of
lag and incompleteness.
With the release of drugs and the accumulation of clinical drug experience, the content of drug instructions also needs to be updated
.
However, because the revision of the drug specification is the same as the revision of the law, it takes a certain period of time, and it is sometimes difficult to synchronize with the progress of clinical drugs, and the super-manual drugs can better meet the clinical treatment needs and fill the treatment gap
.
Medicine and medicinelag and incompleteness.
With the release of drugs and the accumulation of clinical drug experience, the content of drug instructions also needs to be updated
.
However, because the revision of the drug specification is the same as the revision of the law, it takes a certain period of time, and it is sometimes difficult to synchronize with the progress of clinical drugs, and the super-manual drugs can better meet the clinical treatment needs and fill the treatment gap
.
epilogue
epilogue Overall, although the use of drugs beyond the instructions may bring some risks, if they can be strictly supervised, under the premise of legal compliance and safety of the process, more new drug functions can be "unlocked" and benefit more drug patients.
Note: Minet's "China's three major terminals 6 major market competition pattern", the statistical scope is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; The above sales are calculated
based on the average retail price of the product at the terminal.
Hospital Hospital Pharmacy Pharmacy based on the average retail price of the product at the terminal.
