[Contribution] AI Is Watching? Prescribing Narcotics: Legal Standards Medical Staff Should Know

The government's approach to managing medical narcotics is changing. From July 2026, the Ministry of Food and Drug Safety is operating a 365-day, round-the-clock monitoring system using artificial intelligence (AI) and is conducting special surveillance of medical anesthetics with a high risk of addiction and misuse, such as propofol. Even before this, the prescription and administration records of medical narcotics have been managed through the Narcotics Information Management System (NIMS).

Now, however, the surveillance system is becoming more sophisticated, analyzing accumulated data with AI to screen for anomalies suspected of misuse or illegal diversion and connecting these to on-site inspections. For medical institutions, it may no longer be enough simply to have "prescribed narcotics lawfully." This is because they are now practicing in an environment where data on to whom, for what condition, at what dosage, and for how long a prescription was issued is accumulated and analyzed. So what must medical staff check, and what must they prepare?

If AI detects an anomaly, is it immediately an illegal prescription?

First, there is a point to clearly distinguish. The fact that a particular medical institution uses a large amount of propofol, or that zolpidem is prescribed to the same patient over a long period, does not in itself constitute a violation of the Narcotics Control Act. Medical narcotics are drugs that are strictly managed because of their potential for misuse, while at the same time being drugs that can be legally used for treatment.

Therefore, the statistical fact that a prescription volume is high and the legal judgment that an individual prescription is unlawful are not the same. An important function of AI round-the-clock monitoring is to find anomalies that differ from general patterns among vast amounts of narcotics-handling information and thereby select inspection targets more effectively.

The problem is what comes next. If an anomaly is confirmed and leads to an administrative investigation or criminal investigation, the medical staff must ultimately explain whether there was a medical necessity to prescribe and administer that drug to the patient concerned. Therefore, from a medical institution's standpoint, the most dangerous situation is not simply a high prescription volume, but rather a case where the prescription volume is high yet the reason for it is hard to confirm from the medical records.

Medical narcotics: what is regulated?

When medical staff prescribe medical narcotics, they must distinguish and examine several issues. The first is the medical purpose and the appropriateness of the prescription. A medical narcotics-handling practitioner may administer or prescribe narcotics or psychotropic drugs for medical purposes. However, administration or prescription that deviates from a medical purpose, or repeated or excessive prescriptions suspected of misuse, may become problematic under the Narcotics Control Act.

In particular, the Ministry of Food and Drug Safety has established separate safe-use standards for ingredients with a high risk of misuse—such as propofol, zolpidem, appetite suppressants, and medical narcotic analgesics—to encourage appropriate prescribing. Therefore, rather than prescribing simply because a drug is approved, medical staff must also examine the indication, single dose, daily dose, duration of administration, whether it is used in combination, and the patient's past administration history.

There is a caveat here as well. The mere fact of deviating from the Ministry's safe-use standards does not immediately make every prescription subject to criminal punishment. This is because, depending on the patient's condition, a prescription different from the standard may be medically necessary. Conversely, the mere fact of formally complying with the safe-use standards does not make every prescription lawful either. In the end, the medical grounds for which the prescription was necessary for the individual patient and the actual content of the examination are the key.

Confirmation of administration history now expanded to zolpidem—the pre-prescription confirmation procedure is important

From June 19, 2026, zolpidem was added to the ingredients subject to the medical narcotics administration-history confirmation system. The medical narcotics administration-history confirmation system is a system by which a doctor, before prescribing, checks a patient's medical narcotics administration history over the past year to prevent so-called 'medical shopping,' in which patients go from one medical institution to another to be prescribed the same or similar drugs, as well as excessive or duplicate prescriptions. What is important for medical staff is that the same confirmation obligation does not apply to all medical narcotics. One must distinguish, by target ingredient, whether confirmation is a legal obligation or a recommendation, and each time the system changes, one must check which category the drug one is currently prescribing falls into. In particular, if it is confirmed that a patient has been prescribed the same ingredient at another hospital, or if a record of repeated prescriptions from multiple medical institutions within a short period is confirmed, one must be careful about repeating the previous prescription while ignoring this. Therefore, medical institutions need to establish internal procedures determining for which drugs the administration history must be checked when prescribing, who checks it, and where the results are recorded.

A single line of record saying 'insomnia' may not be enough

In medical narcotics cases, the ultimately important material is the medical record. For example, suppose that in the medical record of a patient prescribed zolpidem over a long period, only 'insomnia' is recorded at each visit. Even if the patient's insomnia was in fact severe and required continuous drug treatment, if the reason the same dosage was repeatedly prescribed over months or years cannot be confirmed from the records, it becomes difficult to explain the medical necessity of the prescription at the investigation stage.

Therefore, for patients with repeated or long-term prescriptions, it is desirable to record not simply the diagnosis but also whether and to what degree the symptoms persist, the effect of previous prescriptions, adverse reactions, whether other treatment methods were attempted, the reason for maintaining, increasing, or decreasing the dose, and the necessity of continued prescription, so that they can be confirmed from the records. In particular, when a patient repeatedly requests an early prescription or dose increase, or requests a re-prescription claiming to have lost the drug, or when prescription records from multiple medical institutions are confirmed, such circumstances and the medical staff's judgment need to be left in the records.

The same goes for propofol. Rather than merely recording the procedure name and the amount administered, one should be able to confirm what procedure required sedation, and if repeated administration occurred, what the reason was, and what the patient's condition and the course of administration were. What matters is not the quantity of records. What matters is whether a third party, later looking at the records, can understand why the doctor made that prescription at the time.

Even if the prescription is appropriate, an erroneous NIMS report becomes a separate issue

There is a part medical staff commonly overlook. One may think, 'There is no problem since I appropriately prescribed the drug the patient needed,' but with medical narcotics, the appropriateness of the prescription and the appropriateness of the handling report may be treated as separate issues. A narcotics handler must report to the Narcotics Information Management System the handling records prescribed by law—such as purchase, use, administration, dispensing, transfer, acquisition, and disposal—of narcotics. Therefore, even if the actual administration was carried out normally, a problem may arise if the NIMS report is omitted, if the actual amount used differs from the reported amount, or if the inventory on the books does not match the actual inventory.

In particular, medical institutions that use injectables such as propofol must be even more careful. If the EMR shows that one vial was used but NIMS reports a different quantity, or if the disposal process of leftover narcotics after use cannot be confirmed, or if the actual stored inventory and the system inventory continuously fail to match, it may not end as a mere administrative error. Therefore, a medical institution needs to have a structure in which the EMR prescription amount → actual dispensing amount → actual administration amount → remaining/disposed amount → NIMS reported amount → actual inventory amount are all connected to one another.

What is problematic if you violate the rules?

Depending on the type, a violation of medical narcotics management may lead to criminal punishment and administrative disposition under the Narcotics Control Act, and may also lead to dispositions that directly affect the operation of the medical institution, such as suspension of narcotics-handling operations. In particular, the act of administering narcotics or psychotropic drugs or issuing prescriptions in deviation from a medical purpose, illegal handling by a non-narcotics-handler, and false or fraudulent reporting or repeated violations of the reporting obligation may, depending on the case, lead to criminal proceedings.

In addition, cases where a medical institution issues a narcotics prescription even though it did not actually examine the patient, or prescribes under another person's name, or where a medical practitioner self-administers an ingredient whose self-administration is prohibited or issues a prescription for themselves, may give rise to separate legal issues. Therefore, medical institutions must not view narcotics-related issues merely as a matter of 'prescription-volume management.' They should view the medical necessity of the prescription, patient verification and examination, confirmation of administration history, actual administration, handling reports, and storage, inventory, and disposal as a single management system.

What medical institutions should check now

In the era of AI round-the-clock monitoring, what medical institutions should do is not to uniformly reduce prescriptions. First, they need to make a list of the medical narcotics currently used at the institution and check, for each drug, the latest safe-use standards and whether it is subject to administration-history confirmation. Next, they should independently review prescription records over a recent period to select patients with potential long-term prescriptions, high-dose prescriptions, repeated short-term prescriptions, early re-prescriptions, and duplicate prescriptions across multiple institutions, and check whether the medical records contain grounds to explain such prescriptions.

The EMR also needs to be reorganized. For repeat-prescription patients, it should be possible to record symptoms and treatment effects, adverse reactions, whether administration history was checked, and the reason for maintaining or changing the prescription; and a method of alerting medical staff when a high-risk prescription is made can also be considered. A medical institution that directly stores and administers drugs such as propofol should also separately check its NIMS management. It should regularly compare the actual inventory with the system inventory and, if a discrepancy arises, identify the cause. The disposal procedure and the person in charge also need to be clearly designated.

Finally, such work must not be left to a single specific employee. It is necessary to reorganize internal work procedures and establish a system of regular self-inspection so that doctors, nursing staff, administrative staff, and the person in charge of narcotics handling and reporting can all operate under the same standards throughout prescription-administration-reporting-inventory-disposal.

In the AI era, what matters is not 'prescribing less' but 'explainable prescribing'

As regulation of medical narcotics is strengthened, there is also a concern that medical staff may excessively hesitate even over necessary prescriptions. However, it is inaccurate to understand the purpose of AI round-the-clock monitoring as 'a system to punish doctors who prescribe a lot of narcotics.' Data can be a starting point for detecting anomalies, but the appropriateness of an individual prescription must ultimately be evaluated through the patient's condition and the medical staff's medical judgment. However, that judgment may not be sufficiently supported by after-the-fact memory or explanation alone.

It is an entirely different matter for medical staff to explain, after an investigation has begun, that "at the time it was a medically necessary prescription," versus being able to confirm that judgment process from records written at the time of treatment. Therefore, the question medical staff who prescribe medical narcotics should ask themselves is simple. It is not 'How much can I prescribe?' but 'Can I explain, with records, why I prescribed this drug to this patient at this dosage for this period?'

Now that AI-based round-the-clock monitoring of medical narcotics has begun, the first thing a medical institution should do is not to reduce prescriptions unconditionally. It is to make necessary prescriptions for patients who need them, while building a system in which the entire process—from that medical judgment to actual administration, NIMS reporting, and inventory management—is connected through records.

|Contribution| Attorney Yoon Soyoung, Daeryun Law Firm

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