Media: it is responsible for the life and health of patients if the instructions are not standardized

category:Global
 Media: it is responsible for the life and health of patients if the instructions are not standardized


u25b2 screenshot of the official website of the drug evaluation center of the State Drug Administration.

If the information in the drug manual is inaccurate, untrue or misleading, it will be judged as a fake drug After 14 years, the State Food and drug administration adjusted the current regulations on the management of drug instructions, which aroused social concern.

According to the notice, the holder of drug marketing license (hereinafter referred to as the holder) is the main body responsible for the formulation, revision and maintenance of drug manuals and labels. If the holder neglects or does not pay attention to the safety information of the drug, or does not timely revise the instruction manual, resulting in inaccurate, untrue and misleading information in the instruction manual of the listed drug, or does not provide enough safety information and warning information, etc., the drug will be judged as a fake drug and punished according to the provisions of the drug management law on fake drugs.

In the context of drug safety and public health, this is very valuable.

Drug abuse and misuse caused by nonstandard instructions are common

Drugs are the most consumed consumer goods besides food. According to the regulations of the drug evaluation center of the State Drug Administration, both self-developed drugs and generic drugs have been included in the standardized management, which undoubtedly provides a scientific umbrella for public safety and a firewall.

After all, drug abuse and misuse caused by nonstandard instructions are frequent. In 2019, the national ADR monitoring network received 1514000 ADR / event reports, among which a large number of adverse events were caused by nonstandard drug descriptions. Among them, children are the focus of adverse drug reactions.

In this context, the standardization of drug instructions also echoes peoples expectation of drug safety.

The first requirement of the drug description specification is that the holder should introduce the drug situation in a rigorous and concise language, including the drug development and scientific mechanism, as well as the way of use, such as the pharmaceutical chemistry, pharmaceutics, pharmacology, pharmacokinetics, toxicology evaluation, clinical trials, side effects and adverse reactions, oral or injection , several times a day.

This kind of comprehensive introduction should be understood by the clinical professionals first, so as to use the medicine safely and effectively, and guide the patients to use it; for over-the-counter medicine, the instructions such as please read this instruction carefully and use it under the guidance of the doctor or pharmacist should be added.

But in the past and now, the contents of many drug instructions are not comprehensive. Take Qingkailing injection, an injection with frequent adverse reactions, as an example. The column of chemical components in the instruction manual contains cholic acid, mother of Pearl (powder), Hyodeoxycholic Acid, gardenia, buffalo horn (powder), isatis root, baicalin, honeysuckle, and the auxiliary materials are disodium edetate, sodium thiosulfate and glycerin.

But no one knows how many macromolecules these ingredients contain. It is not clear what role these macromolecules will play in the human liver and blood.

As early as in 2009, the food and Drug Administration pointed out in its notice that serious adverse reactions of Qingkailing injection had been received since 2001. Among them, systemic damage mainly manifested as anaphylactic shock, anaphylactic reaction, shiver, high fever, etc., in which anaphylactic shock accounted for 23% of the serious adverse reactions. Its also said to have something to do with the macromolecules.

Data chart. Its not about text. Figure / Beijing News

It is necessary to manage the manual dynamically

It is worth noting that in many drug manuals in the past, the descriptions of adverse reactions and side effects were vague, only the words unknown, unknown and not found.

But according to the new rules, such careless words will not appear frequently in the future at least, but will tell the public clear information. Because there is an important content in the notice - dynamic management of new drug instructions.

Generally speaking, due to the small number of users of a new drug on the market and the sporadic and gradual disclosure and reporting of adverse drug reaction reports, it is impossible to obtain all the information of adverse drug reactions in a short period of time.

However, according to the requirements of the notice, if a new serious drug use risk is found, involving contraindications, special warnings and precautions for use, dosage and method of use, and other information that may significantly affect the benefit / risk ratio of patients drug use, the marketing license holder shall submit an application for revising the drug specification as soon as possible (the maximum time limit shall not exceed 3 months). For newly found non serious adverse reactions or risks, the application for revision of the specification shall be submitted within 3-6 months.

This means that when there are adverse reactions, doctors and patients must be informed in time through the dynamic management of the drug instructions to avoid a large number of adverse drug reactions causing harm to the lives and health of consumers.

We have many lessons in this regard. ADR / event report form received by national ADR monitoring network in 2019 one hundred and fifty-one point four New and serious ADR / event reports accounted for 10000 forty-seven point seven Million, accounting for the total number of reports in the same period 31.5% u3002

(function(){( window.slotbydup=window .slotbydup||[]).push({id:u5811557,container:ssp_ 5811557, async:true });})(); Now, the State Food and drug administration has issued a notice detailing the contents of the instruction manual; the holder is required to submit an application for revising the instruction manual within three months, otherwise it will be punished as fake medicine; if the doctor or the patient uses the medicine improperly and causes various damages to the patient due to the lack of sufficient warning information, the holder of the drug listing license shall bear the economic and legal responsibilities according to law Legal responsibility These are undoubtedly a big step in promoting drug safety. This is by no means a censure to pharmaceutical enterprises, but a reflection of the principle of Whoever produces is responsible. On this basis, strengthening the regulatory fence and tightening the regulatory standards is the progress of scientific management, and is also responsible for the life and health of the public. In the end, the specification of the manual can also make those pharmaceutical enterprises with real R & D level survive, let safe and effective drugs be used by consumers, and avoid the recurrence of bad money expelling good money in the pharmaceutical and medical industry. Relevant recommendations state food and Drug Administration: the drug specification is not standardized or is judged to be fake. Source: responsible editor of new Beijing Daily: Cao Bin_ NA5394

Now, the State Food and drug administration has issued a notice detailing the contents of the instruction manual; the holder is required to submit an application for revising the instruction manual within three months, otherwise it will be punished as fake medicine; if the doctor or the patient uses the medicine improperly and causes various damages to the patient due to the lack of sufficient warning information, the holder of the drug listing license shall bear the economic and legal responsibilities according to law Legal responsibility These are undoubtedly a big step in promoting drug safety.

This is by no means a censure to pharmaceutical enterprises, but a reflection of the principle of Whoever produces is responsible. On this basis, strengthening the regulatory fence and tightening the regulatory standards is the progress of scientific management, and is also responsible for the life and health of the public. In the end, the specification of the manual can also make those pharmaceutical enterprises with real R & D level survive, let safe and effective drugs be used by consumers, and avoid the recurrence of bad money expelling good money in the pharmaceutical and medical industry.