Handling of Psychotropic Substances in MOH Facilities

Introduction

To standardize operations and ensure strict statutory compliance with the Poisons (Psychotropic Substances) Regulations 1989 and the Dangerous Drugs Act 1952, the Ministry of Health Malaysia published the Garis Panduan Pengendalian Bahan Psikotropik di Fasiliti Kementerian Kesihatan Malaysia in 2024.

• A psychotropic substance refers to any substance or compound specified in the Third Schedule of the Poisons Act 1952.
• Under Regulation 3(1) of the Poisons (Psychotropic Substances) Regulations 1989, no person shall possess, supply, or administer any psychotropic substance unless explicitly authorized by law, held for an approved lawful purpose, and obtained in compliance with statutory provisions.

Scope of practice by healthcare personnel

• Pharmacists: Authorized to possess, compound, mix, and dispense psychotropic substances upon receipt of a valid prescription (Assistant Pharmacists assist under the direct personal supervision of a pharmacist).
• Registered Medical Practitioners & Dental Practitioners: Authorized to prescribe and administer psychotropic substances strictly for the medical or dental treatment of their patients.
• Assistant Medical Officers (AMOs): Authorized to compound, mix, or dispense in the absence of an assistant pharmacist upon a valid prescription; authorized to administer psychotropic substances to designated patients under the written prescription or verbal order of a registered medical or dental practitioner.
• Registered Nurses (RNs): Authorized to administer psychotropic substances strictly for patient treatment under the written direction or valid prescription of a registered medical or dental practitioner.

Registers and Formats (Regulations 19-23)

Under Regulations 22 and 23 of the Poisons (Psychotropic Substances) Regulations 1989, all receipts, issues, and administrations of psychotropic substances must be documented in a designated register.

• Every register must be maintained in the form of a bound book or an approved electronic format.
• A separate register or discrete section within the register must be allocated to each specific type, formulation, and strength of the psychotropic substance.
• All completed registers, supporting indent forms, and prescriptions must be retained and preserved for a minimum period of two (2) years from the date of the last recorded entry.

Register Types

• Supply Register
• Logistics Pharmacy, Inpatient Pharmacy
• Records incoming stock received from suppliers or central stores and outbound supplies issued to sub-units (e.g., wards, outpatient pharmacies).

• Prescription Register (Inpatient)
• Wards, Intensive Care Units, Emergency Departments
• Records patient-level administrations. Includes dedicated columns to record the disposal of residual/unadministered injection volume and the signature of a verifying witness.

• Prescription Register (Outpatient)
• Outpatient Pharmacy, Ambulatory Care Units
• Records dispensing to discharged or outpatient cases against valid serial-numbered prescriptions.

Documentation and Verification Standards

All transactions must be documented immediately upon receipt, supply, or administration in strict chronological order.

Standardized Ink Protocol:

• Red Ink: Used exclusively for recording stock receipts and official stock verification counts (checked and found).
• Blue or Black Ink: Used for recording regular stock issues, outpatient dispensing, and ward administrations.

Striking out text, scribbling, crossing through, or using correction fluid (liquid paper) is strictly prohibited.

• Corrections must be entered via an explanatory footnote written in red ink, accompanied by the correction date and officer's signature.

Every ledger entry must bear the legible name, official title stamp, and signature of the attending officer.

Under Regulation 11(6), when an urgent emergency supply is provided upon the verbal instruction of a medical or dental practitioner, a completed written prescription must be furnished within 24 hours (or one day) of administration.

Physical stock reconciliations (checked and found) must be conducted:

• At every shift handover by the outgoing and incoming staff nurses/AMOs.
• After each patient administration within clinical units.
• Periodically (at least once a month) by the Ward Sister or Unit Supervisor.

Ward Operations and Indenting Procedures

Floor Stock Indenting Requirements

To replenish ward floor stock on designated indent days, the authorized ward nurse or AMO must submit:

• A fully endorsed Psychotropic Substances Supply Request Form.

• A dual-custody locked transit box/bag.
• Clean, safe empty ampoules/vials returned in a quantity that corresponds directly to the stock consumed and documented.
• The updated Psychotropic Substances Prescription Register (Inpatient).
• A Psychotropic Substance Incident Notification Form, if any discrepancies, breakage, or loss occurred during the period.

Patient Transfers Between Units

Scenario A (New Ward Stocks the Psychotropic Substance as Floor Stock)

• The new ward supplies the patient using its existing ward floor stock.
• The previous ward returns any unused patient-specific units to the Pharmacy and reconciles its Inpatient Prescription Register.

Scenario B (New Ward Does Not Stock the Psychotropic Substance / Patient-Basis Supply)

• The remaining stock originally dispensed for the patient is transported securely alongside the patient to the receiving ward.
• The transfer of residual stock is documented in the Inpatient Prescription Registers of both originating and receiving wards.
• If a dosage adjustment occurs, the receiving unit must consult the Pharmacy to issue a new supply.

Security, Incident Management, and Disposal

Storage and Security

Psychotropic substances must be stored in a dedicated, heavy-gauge steel cabinet or safe that remains locked at all times.

• Access is strictly limited to authorized personnel, and all key transfers must be tracked in the official Key Movement Record Book.
• Any physical movement of psychotropic stock across facility transit routes must be secured inside a dedicated locked box or bag.

Breakage, Loss, and Theft Reporting

Any broken ampoule or unexplained discrepancy must be documented via the Psychotropic Substance Incident Notification Form and submitted to the Pharmacy within 24 hours.

• Physical fragments (including syringe barrels and ampoule necks) must be returned to the Pharmacy alongside the form for verification and re-indenting.

Incidents involving suspected theft, diversion, or criminal loss require an official police report lodged by the Head of Unit / Nursing Supervisor /Ward Sister within 24 hours, with the certified police report attached to Psychotropic Substance Incident Notification Form and forwarded immediately to Pharmacy administration.

Safe Disposal of Expired or Damaged Stock

Any unused portion of an opened ampoule following dose administration must be discarded immediately, witnessed and signed off by a second registered nurse, AMO, or medical practitioner directly inside Prescription Register (Inpatient).

Expired, deteriorated, or damaged units held in user wards must be quarantined and returned to the Pharmacy.

• Formal destruction of expired psychotropic stock is conducted by a Registered Pharmacist and witnessed by a designated Drug Enforcement Officer.
• All destruction activities are audited and documented in the Psychotropic Substances Disposal Record at least once annually or as warranted by facility inventory requirements.