Poisons (Psychotropic Substances) Regulations 1989

Introduction

Today, we are going to have a small discussion on application of Poisons (Psychotropic Substances) Regulations 1989 under Poisons Act 1952 in community or hospital pharmacy setting.

  • Psychotropic Substance
  • Posession
  • Control of Import and Export
  • Prescription
  • Register
  • Storage
  • Disposal



Psychotropic Substance

Psychotropic Substance is anything found in Third Schedule of the Poisons Act 1952. Some examples are:

  • Buprenorphine
  • Clobazam
  • Clotiazepam
  • Diazepam
  • Methylphenidate
  • Phentermine
  • Zolpidem
  • Any product which is registered under the Control of Drugs and Cosmetics Regulations 1984 and contains any of the following substances
    • Alfentanil
    • Dihydrocodeine
    • Fentanyl
    • Ketamine
    • Methadone
    • Morphine
    • Oxycodone
    • Pethidine
    • Sulfentanil

NOTE: Morphine powder is regulated under Dangerous Drugs Act 1952 and Regulations, but morphine sulphate 10 mg tablet is regulated under Poisons (Psychotropic Substances) Regulations 1989.



Possession

Under Regulation 3, a person shall not be in possession of a drug or preparation unless it is lawfully supplied by a registered medical practitioner, registered dentist Division I, veterinary surgeon or on a prescription.

  • Also, the following persons or class of persons shall be authorised to be in possession of psychotropic susbtance
    • A licensed pharmacist
    • A registered medical practitioner
    • A registered dentist Division I
    • A veterinary surgeon
    • The holder of a permit issued under regulation 15
    • A person employed in any hospital at which human ailments are treated and for the time being in charge of any ward, operating theatre or of other sections of such hospital who possesses psychotropic substance for use in such ward, operating theatre or sections
    • A person concerned with scientific education or research or chemical analysis in a department, university or institution wholly maintained by the Government or approved by the Director General of Health
    • A pharmacist in the public service
    • An officer of Customs, police officer or an officer of the Postal Department when acting in the course of his duty as such
    • A Drug Enforcement Officer
    • A person engaged in the delivery of any psychotropic substance from a lawful supplier to a person authorised to have it in his possession, for such period as in the circumstances of the case is reasonably sufficient to enable the delivery to the recipient to be effected
    • A person acting on behalf of the class of the persons lawfully supplied with such psycotropic substance (patient)
    • A person possessing psychotropic substance for administration to a patient or animal in accordance with the direction of a registered medical practitioner, registered dentist Division I or a veterinary surgeon, as the case may be.



Control of Import and Export

Under Regulation 4, no person shall import or import any psychotropic unless

  • He has in his possession a valid and subsiting import or export authorisation relating to such psycotrophic substnace; and
  • Such import or export is in accordance with the terms and conditions specified in the import or export authorisation.

The provision of Regulation 4 shall not apply to

  • Any person arriving in or leaving Malaysia who carries as part of his personal luggage and solely for his personal use or for the use of his family, a prepared or packaged medicine containing any psychotropic substance, not exceeding such quantities as may be reasonably required for one month's use by one person, which has been lawfully supplied to such person by or on the prescription of a qualified medical practitioner; or
  • The international carriage by ships, aircrafts or other forms of international public transport entering or leaving Malaysia of such limited quantities of any psychotropic substance as may be required during their journey or voyage for first aid purposes or emergency cases.



Prescription

As stated in Regulation 11(2) of Poisons (Psychotropic Substances) Regulations 1989, every prescription for any psychotropic substance prescribed by a registered medical practitioner, registered dentist Division I or veterinary surgeon shall:

  • be writing, signed and dated by the prescriber
  • state the full name, address and telephone number of the prescriber
  • state the age, full name and address of the patient or, in the case of a prescription by a veterinary surgeon, the full name and address of the person to whom such psychotropic substance is to be delivered
  • indicate the total amount of psychotropic substance to be supplied and the dose
  • specify the number of times (not exceeding 3) the psychotropic substance may be supplied, and if supplied more than once, at what intervals.

On top of the requirement above, under Regulation 11(3), no person shall sell or supply any psychotropic substance on a prescription which is presented to him more than 90 days after date of the prescription.

At the time of selling or supplying the psychotropic substance on a prescription, the licensed pharmacist shall endorse upon the face of the prescription above the signature of the prescriber, his name and address and the date on which such psychotropic substance was sold or supplied.

Every prescription of the sale or supply of psychotropic substance shall be kept for a period of at least 2 years from the date of sale or supply.



Emergency Supply

As stated in Regulation 11(6) of Poisons (Psychotropic Substances) Regulations 1989, if it shall appear to the seller or supplier that any psychotropic substance is required urgently in cases of emergency and that it is impossible without unreasonable delay to obtain a prescription complying with the requirements, it shall be lawful for the pharmacist to sell or supply such psychotropic substance without a prescription, after making an entry to that effect in his prescription register for psychotropic substance, upon the verbal or telephoned instructions of a registered medical practitioner, registered dentist Division I or veterinary surgeon, personally known to him.

In every such case, the seller or supplier

  • Shall take all necessary steps to obtain, and the prescriber shall deliver, a prescription as required within one day of the date of such sale or supply;
  • Shall not sell or supply more than one day's supply of such psychotropic substance; and
  • Shall take such reasonable steps to ascertain the authenticity of the person who gave the instructions.



Register

Records under Poisons (Psychotropic Substances) Regulations 1989

  • Regulation 19 - Prescription Register for Psychotropic Substance
    • The date on which the psychotropic substance was sold or supplied or administered and the serial number of the entry in such register
    • The name and strength of the psychotropic substance and the quantity sold or supplied or administered
    • The name, identity card number, passport number or any other legal identification document and address of the patient, or where the prescriber is a veterinary surgeon or the prescription relates to animal treatment, the name and address of the recipient
  • Regulation 20 - Supply Register for Psychotropic Substance
    • The full name and address of the prospective purchaser or recipient, the date of the sale or supply, the name, strength and quantity of the psychotropic substance sold or supplied and the purposes for which it is stated to be required
    • The prospective purchaser or recipient has affixed his signature to the entry or has forwarded to the seller or supplier a written order in respect of such sale or supply signed by such person
  • Regulation 21 - Production Register for Psychotropic Substance
    • The date of which the psychotropic substance was used for manufacture and the amount used
    • The pharmaceutical dosage form of the psychotropic substance manufactured and the quantity of psychotropic substance found in each unit of the pharmaceutical dosage form
    • The theoretical yield of the psychotropic substance in pharmaceutical dosage form manufactured and the batch number assigned to it
    • The actual yield of the psychotropic substance in pharmaceutical dosage form manufactured
    • The total units of the psychotropic substance in pharmaceutical dosage form sampled for the purpose of quality control
    • The total units of the psychotropic substance in pharmaceutical dosage form transferred for the purpose of sale or supply
  • Regulation 21A - Register of Psychotropic Substance Received, Delivered or Administered
Under Regulation 22, every person
  • Shall use a separate register or a separate part of the register with respect to each type of psychotropic substance
  • Shall enter in the register
    • every quantity of psychotropic substance received, delivered or administered, as the case may be, by him whether for the purpose of sale, supply, administration or any other purpose,
    • the total stock of such psychotropic substance in his possession,
    • the name and address of the supplier or the recipient of such psychotropic substance, and
    • the date on which such psychotropic substance was received, delivered or administered by him or the reference number of the patient or client such psychotropic substance was administered to
  • Shall not make any cancellation, obliteration or alteration of an entry in any register, and any correction of an entry must be made by way of a marginal note or a footnote which must specify the date on which the correction is made.
Under Regulation 23, every register required shall be
  • be in the form of a bound book or in the form which has the written approval of the Licensing Officer subject to the terms and conditions as he may impose
  • be preserved for a period of 2 years from the date of the last entry


Storage

Any room, cabinet, safe or receptacle used to store any psychotropic substance shall be locked and unlocked by the person authorized to possess such psychotropic substance, and the keys to such room cabinet, cabinet, safe or receptacle shall be kept by him only.



Disposal

No person shall dispose of the psychotropic substance in his possession except in the presence and in accordance with the instructions of a Drug Enforcement Officer.

  • The true particulars of the date of disposal and the quantity shall be entered in the register to which it relates and shall be acknowledged by the Drug Enforcement Officer.

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