[Contribution] Nursing Facility Residents' Receipt of Prescription Medication and the Pharmacist's Duty of Medication Guidance

Attorney Chae Yeong-jae, Daeryun LLC

Article 24, Paragraph 4 of the Pharmaceutical Affairs Act provides that when a pharmacist compounds a drug, the pharmacist shall provide the necessary medication guidance to the patient or the patient's guardian. Here, medication guidance is not merely a procedure of adding a formal explanation while handing over the compounded drug. It is a core obligation under the Pharmaceutical Affairs Act to enable patients to use drugs safely and appropriately by providing information on the name, dosage and administration, efficacy and effects, storage methods, side effects, and interactions of the drug.

The problem arises when the patient cannot visit the pharmacy in person. In particular, residents of elderly medical welfare facilities such as nursing homes often find it difficult to submit prescriptions, receive compounded drugs, and understand and manage medication methods on their own due to dementia, stroke, or mobility impairment. In such cases, the practice arises where a nursing facility worker visits the pharmacy with the prescription, requests compounding, and receives the compounded drug. In such cases, the question arises as to whom the pharmacist should provide medication guidance, and whether the nursing facility worker can be regarded as a "patient's guardian" under the Pharmaceutical Affairs Act.

The Pharmaceutical Affairs Act does not separately define the meaning of "patient's guardian." That does not mean, however, that the patient's guardian must be limited only to relatives such as spouses, lineal ascendants and descendants, or siblings. The purpose of medication guidance under the Pharmaceutical Affairs Act is not to confirm the status relationship with the patient, but to ensure that the compounded drug is safely delivered to the patient and correctly taken. Therefore, the counterpart of medication guidance should be determined not by a formal kinship relationship alone, but by whether the person is in a position to actually manage the patient's drug intake and storage.

The Welfare of Senior Citizens Act likewise regulates the guardian not as limited to a support-obligated person in a kinship relationship, but with the intent of including even a person who in fact protects the elderly through relationships such as work or employment. An elderly medical welfare facility is responsible for the health management and medication management of its residents, and under its operating standards, certain personnel such as nursing staff and care workers are assigned to protect residents at all times. Therefore, if a nursing facility worker, in the course of performing the facility's duties, visits the pharmacy with a resident's prescription and receives the compounded drug and medication guidance from the pharmacist, it is difficult to regard that worker as a mere errand-runner.

However, the mere circumstance of being a nursing facility worker does not automatically make every case lawful. Article 50, Paragraph 1 of the Pharmaceutical Affairs Act prohibits pharmacy establishers, etc., from selling drugs at a place other than the pharmacy or store. Since the sale of a drug consists of a series of acts such as ordering, compounding, delivery, and medication guidance, what matters is whether the major part of these was carried out inside the pharmacy by the pharmacist. If a nursing facility worker, in the position of the patient's guardian, visited the pharmacy, submitted the prescription, received the drug compounded inside the pharmacy, and received medication guidance from the pharmacist, the major part of the drug sale can be assessed as having been carried out inside the pharmacy.

Conversely, when a third party who is not a nursing facility worker receives the compounded drug, the situation is different. If it is not confirmed that the third party is a family member of the patient or is in a position to protect the patient and manage medication under law, contract, or in fact, it is difficult to regard them as the patient's guardian under the Pharmaceutical Affairs Act. In this case, the pharmacist would have failed to properly identify the counterpart of medication guidance, and there is a further risk that the substantive part of the delivery of the compounded drug and the medication guidance may be assessed as having been carried out outside the pharmacy through a non-pharmacist.

Meanwhile, the Pharmaceutical Affairs Act does not explicitly state that when providing medication guidance to a patient's guardian, the pharmacist must confirm and retain a power of attorney, identification card, employment certificate, etc. Unlike provisions that establish separate documentary requirements, such as the proxy prescription receipt system or the compounding-record inspection system under the Medical Service Act, the medication guidance provision itself does not specifically stipulate such a confirmation obligation. Therefore, it is necessary to be cautious about immediately concluding that there is a violation of the medication guidance obligation solely on the ground of failure to confirm documents, without an express legal basis.

However, in practice it is dangerous to leave no records at all. When a pharmacy repeatedly dispenses compounded drugs for nursing facility residents, it needs to internally record the recipient's name, affiliated facility, position, contact information, time of receipt, and method of medication guidance. Even if there is no explicitly stated legal obligation to retain a power of attorney, this is because, in a later on-site investigation or administrative disposition procedure, the pharmacist must be able to explain that they actually provided medication guidance to the patient or the patient's guardian inside the pharmacy.

Nursing facilities, too, must move away from the approach of simply sending personnel to pick up the drugs. They must establish procedures whereby a staff member in charge of the residents' medication management receives the compounded drug and connects the medication guidance received from the pharmacist to medication management within the facility. In particular, a structure in which an outsider, an acquaintance of a commissioned physician, or a driver whose protective relationship with the patient is unclear receives the compounded drug can be a legal risk for both the pharmacy and the facility.

Ultimately, the core of the medication guidance obligation under the Pharmaceutical Affairs Act is not formal documents but patient safety. When the patient cannot receive medication guidance in person, the focus of the judgment becomes who actually protects the patient and manages the drug intake, and whether the pharmacist provided sufficient medication guidance to that person inside the pharmacy. The practice of nursing facility residents receiving compounded drugs must be designed to fit the purpose of the Pharmaceutical Affairs Act—patient protection and drug safety—rather than convenience.

|Contribution| Attorney Chae Yeong-jae, Daeryun LLC

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