International Day Against Drug Abuse and Illicit Trafficking - Midazolam is being “upgraded to a higher level of management”. Are you ready?

In April 2024, the National Medical Products Administration, the Ministry of Public Security, and the National Health Commission jointly issued an announcement that from July 1, 2024, midazolam APIs (including salts, isomers, the same below) and injections will be adjusted from Class II psychotropic drugs to Class I psychotropic drugs. What is the role of midazolam? Why should it be adjusted from Class II psychotropic drugs to Class I psychotropic drugs for management? What changes will there be in the work of doctors, pharmacists, and nurses after the adjustment? Today, the editor will show you how.

1. What kind of psychotropic drug is midazolam? Why should its regulatory category be adjusted?

Midazolam is a short-acting benzodiazepine central nervous system depressant characterized by rapid onset and short duration of action. Oral midazolam has hypnotic and sedative effects, while injectable midazolam is often used for sedation/anxiety/amnesia before surgery and general anesthesia induction due to its anxiolytic, anticonvulsant and muscle relaxant effects. Continuous intravenous infusion of midazolam can also be used as a sedative for intubated and mechanically ventilated patients. Midazolam has impaired psychomotor function after single and/or multiple doses, but has minimal effects on hemodynamics. Intravenous midazolam can cause respiratory depression and respiratory arrest, especially when used for sedation under non-intensive care conditions. If not discovered and treated in time, it can cause death or hypoxic encephalopathy. Midazolam intravenous solution should only be used in medical institutions that can provide respiratory and cardiac function monitoring (such as pulse oximetry). Everything has two sides. On the one hand, midazolam takes effect quickly, making it a powerful aid in some medical scenarios that require rapid sedation. On the other hand, midazolam is also metabolized quickly, making it easy for some thrill-seekers to become their "new favorite." In addition, long-term use of midazolam can lead to dependence, and overdose or abuse can also lead to respiratory depression. Therefore, it is necessary and urgent to raise the regulatory level of midazolam.

2. What changes will there be in work after the regulatory level of midazolam is upgraded?

Physician: After midazolam injection is upgraded to the first category of psychotropic drugs under supervision, physicians who prescribe drugs should be qualified to prescribe narcotic drugs and first category psychotropic drugs in the medical institution, but they cannot prescribe such drugs for themselves. When prescribing midazolam injection for outpatients, each prescription should be for one common dose; when prescribing midazolam injection for inpatients, prescriptions should be issued daily, and each prescription is for one daily dose. Medical institutions should establish corresponding medical records for patients using midazolam injection, and it is limited to use within the medical institution or by medical staff visiting the patient's home. When printing prescriptions, pink prescription paper should be used for printing, and the doctor's handwritten description of the condition and signature are valid.

Pharmacist: Medical institutions should set up special warehouses or counters to store midazolam injection. Special warehouses should be equipped with anti-theft facilities and alarm devices; special counters should use safes. Special warehouses and counters should be managed by two people with two locks and settle accounts every day. When storing midazolam injection, a specific person should be designated to be responsible, responsibilities should be clarified, and records should be kept for handovers. When dispensing and checking midazolam injection, the person should have the qualifications to dispense narcotic drugs and first-class psychotropic drugs. After receiving the prescription, the dispenser and checker should check it carefully, sign their names and seals, and register it in a special book; for prescriptions that do not comply with the provisions of laws and regulations, the dispenser and checker of the prescription should refuse to dispense the medicine. Midazolam injection cannot be directly distributed to patients and their families, and should be picked up by medical staff or nursing staff. For the recovered prescriptions, pharmacists should compile serial numbers by year, month and day, and the prescriptions should be kept for at least 3 years. According to the prescription of midazolam injection, its consumption should be registered in a special book, and the registration content should include the patient's (agent's) name, gender, age, identity certificate number, medical record number, disease name, drug name, specifications, quantity, prescribing physician, prescription number, prescription date, drug dispenser, and reviewer. The special account book should be kept for no less than 5 years after the expiration of the drug's validity period.

Nursing staff: The storage of midazolam injection in wards and operating rooms should be equipped with corresponding anti-theft measures. A specific person should be designated to be responsible for storage, and responsibilities should be clearly defined. Records should be kept for shift changes. Batch number management and tracking should be implemented when drugs are collected and used. If necessary, they can be found or recovered in time. Two people should operate the drugs. If the single dose of midazolam injection is less than the single package specification, the residual liquid should be discarded into the sewer under video surveillance when the drug solution is absorbed. When midazolam injection is dispensed and used in wards, operating rooms, etc., empty ampoules should be collected, the batch number and quantity should be checked, and records should be made. The remaining drugs should go through the return procedure. A specific person is responsible for counting the collected ampoules, supervising their destruction, and making records.

References

1. Announcement of the National Medical Products Administration, the Ministry of Public Security and the National Health Commission on the Adjustment of the Catalogue of Psychotropic Drugs. No. 54 of 2024

2. Notice of the National Medical Products Administration and the National Health Commission on strengthening the management of dextromethorphan and other drugs. National Medical Products Administration [2024] No. 16

3. Prescription Management Measures. Order No. 53 of the Ministry of Health of the People's Republic of China

4. Regulations on the Administration of Narcotic and Psychotropic Drugs. Order No. 442 of the State Council of the People's Republic of China