Text/Yangcheng Evening News all-media reporter Zhang Hua Lin Qingqing
On March 1, the revised Physician Law of the People's Republic of China made the use of drugs in excess of the prescribed medicine truly a legal basis. The introduction of this regulation has made all doctors and pharmacists feel happy. Because in the past decade, as long as it is a lawsuit involving over-the-label drugs, many lawsuits will sentence doctors to be responsible or guilty.
Guangdong Pharmaceutical Association is a pioneer in the standardized management of ultra-prescribed drugs in the mainland, and Wu Junyan, chairman of the Pharmacy Professional Committee of the Hospital of the Guangdong Pharmaceutical Association and director of the Pharmacy Department of Sun Yat-sen Memorial Hospital of Sun Yat-sen University, introduced to reporters that the introduction of this regulation fully illustrates the indispensability of over-prescription drugs in the clinic. Reasonable, reasonable and legal over-the-label medication will be a new task for clinicians, pharmacists and hospital management.
status quo:
The drug use of ultra-drug instructions exists objectively
The higher the physician title, the more frequently it is used
What is the ultra-drug instructions? Director Wu Junyan gave a typical case to reporters. "Metformin extended-release tablets are a drug used to treat diabetes. However, gynecologists often use it to treat POLYCYS. But if you look up the instructions for this drug, any metformin indication approved for marketing in any country is hypoglycemic. However, many global guidelines, such as the American Society for Reproductive Medicine Guidelines, the Chinese Diagnosis and Treatment Guidelines for Polycystic Ovary Syndrome, and the Chinese Medical Guidelines, clearly point out that metformin can be used to treat polycystic ovary syndrome in women. In fact, we gynecologists basically prescribe metformin to patients with POLYOS. This is typical of hyper-indication medications. ”
According to the reporter's understanding, in addition, there are over-dose drugs, ultra-adaptive population drugs, over-administration frequency and over-treatment courses, which all belong to the category of ultra-drug instructions.
According to statistics, anti-tumor drugs, drugs for immune-related treatment, and drugs for children rank in the top three in the types of drugs exceeding the instructions.
Clinically, the higher the doctor's title, the more cases of over-the-instruction medication. "In general, the chief physician's prescription for medication beyond the instructions is definitely higher than that of the general doctor. In terms of the use of the population, the proportion of over-instruction medication in the two age groups of young children and preschool children is the highest. Wu Junyan said: "This is because senior doctors deal with more acute critical cases and complex cases than ordinary doctors, and the choice of drugs is often not covered by the instructions; and children are rarely able to participate in clinical trials, and many new drugs do not have relevant children's indications, so in the absence of choice, clinical existence will only reduce the dose of drugs with adult indications on children." ”
For doctors:
There is an increase in the "evidence" of medication adherence
It is a good thing that the super-manual is written into the law
Article 29 of the new version of the Physician Law stipulates that physicians shall adhere to the principle of safe, effective, and economical and reasonable use of drugs, and follow the guidelines for the clinical application of drugs, clinical diagnosis and treatment guidelines, and drug instructions. In special cases such as the absence of effective or better treatment methods, after obtaining the patient's explicit informed consent, the physician may use the drug usage that is not specified in the drug label but has evidence-based medical evidence to carry out treatment.
The "Regulations" broke the drug instructions as the only guidance for rational use of drugs, but revised and supplemented the "guidelines for clinical application of drugs, clinical diagnosis and treatment guidelines", Wu Junyan pointed out that this is a breakthrough in law, so that clinical ultra-drug instructions have a basis for judging drugs. Taking tumor drugs as an example, in special cases, the evidence-based medical evidence for the adoption of anti-tumor drugs is, in turn, the usage indicated in the drug instructions of other countries or regions, the diagnosis and treatment norms and clinical diagnosis and treatment guidelines issued by international authoritative academic associations or organizations, and the diagnosis and treatment norms, clinical diagnosis and treatment guidelines and clinical paths issued by national academic associations.
Well-documented, rationale, super-adaptive medication has taken a difficult first step. The Guangdong Pharmaceutical Association is the pioneer of the standardized management of the use of drugs in the mainland, and Zheng Zhihua, vice president and secretary general of the Guangdong Pharmaceutical Association, pointed out that it is a good thing that the super-instructions are written into the law, reflecting the spirit of respecting science and respecting practice, and drawing a clear line of responsibility, in order to make the clinical work more harmonious as possible, clinical drugs have complex specific conditions, whether it is the use of drugs in the instructions or the use of drugs in the super instructions, the interests of patients are the first.
For patients:
"Informed consent" is a prerequisite
Not just verbally, but literally
Patients rarely learn about the indications for drugs other than those on the instructions, which can lead to many disputes. In 2014, there was a case in which doctors across the country paid attention to the use of ultra-drug instructions. On July 21, Mr. Quan's daughter, who was only 26 days old, went to Xi'an Children's Hospital for medical treatment, and was diagnosed with congenital heart disease, neonatal sepsis, neonatal pneumonia and other diseases, and needed ventilator assisted treatment after admission.
After a week of treatment, the attending doctor prescribed Mr. Kwon the purchase of "sildenafil (Viagra)" for oral administration of the child. The next morning, the doctor informed Mr. Quan that he was critically ill, and after many days of rescue treatment, the child finally died. Mr. Quan suspected that the aggravation of the child's condition was related to taking sildenafil, and after reading the drug instructions, he found that sildenafil was used to treat male sexual dysfunction and was contraindicated in women and children.
The patient's family members "discussed the arguments" in the hospital, and a large number of media reported on the incident, pushing the "ultra-instructional medication" to the cusp of the storm. Later, it turned out that sildenafil was taken to treat pulmonary hypertension caused by congenital heart disease, in line with the 2013 edition of the Guidelines for the Treatment of Pulmonary Hypertension in Newborns.
Wu Junyan pointed out that in this case, the doctor did not fully communicate with the patient, and the patient did not know, which may be the key to the dispute. Therefore, at present, the hospital pharmacy professional committee emphasizes that doctors should fully explain to patients and their families before using drugs in excess of the instructions, and inform patients in writing of the medical basis, treatment benefits, and possible risks of ultra-indications and obtain consent.
"Not only verbal consent, according to the provisions of the Civil Code, 'explicit' informed consent is required, and the so-called 'clear' is best to write down the words 'I know that this medication is beyond the drug instructions and the risks it generates, and agree to use the drug', so that patients can sign the "Informed Consent Form", which can effectively reduce the occurrence of disputes."
At the same time, when patients find that the doctor is taking drugs beyond the instructions, they can communicate with the doctor or the pharmacist of the hospital's pharmacy clinic to get a more detailed answer." This is also a kind of protection for patients. Wu Junyan said.
For managers:
Hospitals strengthen the management of medications beyond the instructions
Eliminate the phenomenon of indiscriminate drug abuse
At present, the regulations give doctors more room to use drugs, but how can we better protect the rights and interests of patients? According to a study published in JAMA Internal Medicine, the rate of adverse reactions caused by over-label medication is much higher than that of the corresponding drug prescribed in the manual. Although sometimes some convincing evidence-based evidence still supports over-label medication, the study still found that 80% of the reviewed prescriptions did not have enough evidence-based clinical data to support it, such as antidepressants, antipsychotics, anticonvulsants, etc.
As the pharmacy department of the hospital, it is necessary to take the initiative to assist and supervise the rational use of drugs in the clinic. Wu Junyan pointed out, "In terms of hospital management, the use of drugs in excess of the instructions needs to be discussed and approved by the hospital's pharmaceutical affairs management and pharmacotherapeutic committee (pharmacy council), and at the same time, the hospital's pre-trial party system will identify the over-instructions in the doctor's prescription, identify the bullet frame, give the doctor relevant tips, and prompt the doctor to adjust the corresponding prescription or make informed consent." At the same time, we also wrote the "Evaluation of Prescriptions for Ultra-Drug Instructions" for clinicians' reference. ”
The use of drugs beyond the instructions requires the hospital to establish relevant management systems to eliminate the phenomenon of arbitrary abuse of drugs. Wu Junyan also suggested that the relevant departments can urge drug manufacturers or enterprises to initiate relevant research on new indications and new usage of drugs proposed in the guidelines, and update the instructions in a timely manner. For the declaration of drugs for special groups such as children, whether it is possible to establish a green channel that can accept real-world research data and other green channels to improve the accessibility of children's medications in the instructions.
Wu Yilong: Three major prerequisites to avoid abuse
Wu Yilong (Internationally renowned oncologist, Honorary Director of Guangdong Institute of Lung Cancer, President of Guangdong Medical Doctor Association)
Text/Yangcheng Evening News all-media reporter Lin Qingqing
"Over-the-instruction medication" should be called "rational medication"
"Clarifying the legality of 'over-the-instruction medication' is a highlight of the new Physician Law. But in fact, in contrast to 'ultra-prescribed medication' or 'hyper-indication medication', I prefer to use the term 'rational medication'. "Internationally renowned oncologist Wu Yilong is not only a lung cancer expert, but also the president of the Guangdong Medical Doctor Association.
"Because there is a premise for the use of the drug in a supra-indication, that is, there must already be evidence-based medical evidence of effectiveness." Wu Yilong said, "In order to overcome malignant tumors, global medical scientists continue to explore from different perspectives. There are currently various clinical trials at the forefront of global medicine, including exploring the 'rational use' of drugs in different situations. Therefore, as long as it is used on the basis of valid clinical trial evidence, it should not be considered to be over-limit use, but used on a basis, that is, fair use. ”
Three prerequisites to avoid abuse
In fact, 4 years ago, in the "Guidelines for the Clinical Application of New Anti-tumor Drugs (2018 Edition)" led by Wu Yilong and issued by the National Health Commission, the rational use of drugs has been written as an important content. Wu Yilong said in an interview with reporters that in the case of the mainland has not yet approved the indications, there are three prerequisites for rational use: first, although China has not yet approved the indications, but advanced countries such as Europe or the United States and Japan have approved, indicating that the use is based; second, the results of the relevant phase III clinical trials published in major international societies have confirmed that the efficacy of the use is effective; third, the application must be fully informed by patients.
In fact, in the field of overcoming tumors, over-prescribed medication is not a new thing. "Medicine is a process of constant exploration, and if the diagnosis and treatment plan is too limited to the existing plan or guidelines, it will sometimes bring greater damage to the patient." For example, Wu Yilong explained that lung cancer, as the malignant tumor with the highest incidence and mortality in mainland China, is currently the standard treatment plan in China is chemotherapy after surgery. But in 2017, the medical community has received new evidence. If the patient has a genetic mutation, the actual benefits of using targeted drugs far outweigh chemotherapy.
But it takes a while from the results of the latest clinical trials to the approval of the indications for entry. It wasn't until last year that the mainland approved the latest indications for this targeted therapy drug. So in the 4 years from 2017 to 2021, if you stick to the current indications of the drug and cannot give patients targeted therapy drugs, is this beneficial or unfavorable to the patient?
"The development and application of clinical medicine is too complex, especially for tumors. Therefore, when using drugs beyond the instructions, we must remember that we must be patient-centered, provide patients with the best treatment plan, and comply with the above three rational use premises. Wu Yilong said that this is also the "bottom line" to avoid the risk of drug abuse. (For more news, please pay attention to Yangcheng Pie pai.ycwb.com)
Source | Yangcheng Evening News Yangcheng Pie
Image | Visual China
Editor-in-charge | Chen Liang