This is the 3691st article of Da Medical Care
In the practice of medical work, because the update of drug instructions lags behind the development of clinical practice, the phenomenon of drugs exceeding the drug instructions often occurs, and it does achieve good efficacy in a certain field, but the understanding of the phenomenon of over-instructions has always been controversial.
Let's take a look at the concepts. What are drug labels? What is a super-drug instructions? The drug instructions are provided by drug manufacturers and approved by the national drug supervision and administration department, including important scientific data, conclusions and information such as drug safety and efficacy, to guide the safe and rational use of drugs, which is an important basis for judging whether the drug use is appropriate.
Ultra-drug instructions for medication. It is also known as drugs outside the drug instructions, drugs that have not been registered for use, or drugs that exceed the scope. As a common drug use behavior in clinical practice, the concept of ultra-drug instructions has not been defined authoritatively and consistently, and some domestic societies have defined the concept as "the indications for drug use, the method of administration or the dosage are not within the instructions approved by the drug supervision and management department".
According to the "Expert Consensus on Over-label Drugs", the expert consensus recommendation for over-label drugs includes that the purpose can only be for the benefit of patients, weigh the advantages and disadvantages to maximize the interests of patients, have reasonable medical evidence to support, must be approved and filed by the relevant departments of the hospital, and need to protect the patient's right to know and respect their right to make their own decisions.
For the first time, the new Physicians Law responds to the problem of over-prescribed drug use in practice in the form of legislation, and there have been many relevant provisions on the rational use of drugs such as guidelines for the clinical application of drugs, clinical pathways, clinical diagnosis and treatment guidelines, and drug instructions:
1. Article 72 of the Drug Administration Law stipulates that medical institutions shall adhere to the principle of safe, effective, economical and reasonable drug use, follow the guidelines for clinical application of drugs, clinical diagnosis and treatment guidelines and drug instructions, and review the appropriateness of doctors' prescriptions and drug instructions.
2. Article 14 of the Measures for the Administration of Prescriptions stipulates that physicians shall prescribe according to the needs of medical treatment, prevention and health care, in accordance with the diagnosis and treatment specifications, drug indications, pharmacological effects, usage, dosage, contraindications, adverse reactions and precautions in the drug instructions.
3. Article 18 of the Provisions on the Administration of Pharmaceutical Affairs in Medical Institutions stipulates that medical institutions shall follow the relevant guidelines for the clinical application of drugs, clinical pathways, clinical diagnosis and treatment guidelines and drug instructions for the rational use of drugs; review the appropriateness of prescriptions and medication doctors' orders.
However, the relevant provisions on the use of drugs in excess of the instructions stay at the level of regulations and normative documents.
1. Article 6 (9) of the Measures for the Administration of Prescriptions stipulates that the dosage of drugs shall be used in accordance with the conventional dosage specified in the drug instructions, and when special circumstances require excessive dosage, the reasons shall be indicated and signed again.
2. The "Hospital Prescription Review Management Specification (Trial)" divides unreasonable prescriptions into irregular prescriptions, unsuitable prescriptions for medication and abnormal prescriptions. Article 19 stipulates that abnormal prescriptions include "medications that exceed the prescribed medication without a legitimate reason".
Article 29 of the new Physician Law clearly states that physicians shall adhere to the principle of safe, effective, and economical and reasonable drug use, and follow the guidelines for the clinical application of drugs, clinical diagnosis and treatment guidelines, and drug instructions. However, "in special cases such as the absence of effective or better treatment methods, after the physician obtains the patient's explicit informed consent, he may use the drug usage that is not specified in the drug label but has evidence-based medical evidence to carry out treatment." Medical institutions shall establish a management system to review the appropriateness of doctors' prescriptions and medication orders, and strictly regulate physicians' medication behavior."
The above provisions essentially put forward dual requirements for diagnosis and treatment and procedure of over-prescribed drugs. In terms of diagnosis and treatment, only the use of drugs with "evidence-based medical evidence" can be adopted, and the so-called "evidence of evidence-based medicine" can be specifically translated into guidelines for clinical application of drugs, clinical diagnosis and treatment guidelines, etc.; in terms of procedures, physicians are required to obtain clear informed consent and be reviewed internally by the hospital. In past judicial practice, the court also generally held that even if the over-instruction medication is in line with clinical diagnosis and treatment habits and is supported by reasonable medical evidence, if there are procedural problems such as not being approved by the relevant hospital departments for the record, or if the patient or his family members are not fully informed of the reasons for the use of the relevant drugs, treatment plans and possible risks, the hospital should still bear the liability for compensation.
It can be seen that in practice, in order to avoid medical disputes caused by over-prescribed drugs, but also from the consideration of maximizing the interests of patients, it is recommended to legally exceed the prescribed drugs: 1. The patient has no effective or better means of treatment; 2. There is evidence-based medical evidence for drug usage, such as the guiding principles for clinical application of drugs, clinical paths, clinical diagnosis and treatment guidelines, evidence-based medical literature, provincial or national expert consensus, etc.; 3, inform patients of various unpredictable dangers that may occur when using drugs beyond the instructions. And to obtain the patient's explicit informed consent, it is best to sign a written informed consent; 4, must be approved by the relevant departments of the hospital and filed for the record.
Author: Shanghai Boss & Young Zhongjian Zhonghui Law Firm
Zheng Jun, lawyer