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stupid 50 CA > narcotic and psychotropic drug control > Flashcards

narcotic and psychotropic drug control Flashcards

1
Q

additional control on psychotropic and narcotic drugs

A
  • preparations containing “psychotropic substances”, codeine, or dextrometorphan require additional control under Health Products (therapeutic products) regulations
    ** phenobarbital, diazepam, mazindol
  • controlled drugs (CD) are under Misuse of Drugs Act and Misuse of Drugs Regulations + Health Products Act
  • international trade and movement of narcotic drugs and psychotropic substances governed by international conventions (International Narcotics Control Board)
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2
Q

provisions for psychotropic drugs - R6

A

import of therapeutic products containing psychotropic substances

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3
Q

provisions for psychotropic drugs - R8

A

export of therapeutic products containing psychotropic substances

  • exporter (wholesale) must obtain HSA’s approval before exporting each consignment of any product containing psychotropic substances
  • before approval is granted, exporter must show that intended importer has approval from authorities in importing country
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4
Q

provisions for psychotropic drugs - R52(1)(a)

A

import of therapeutic products for personal use without importers license not applicable to products containing psychotropic substances

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5
Q

provisions for opioid drugs - R9

A

additional requirements for export of codeine cough preparations

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6
Q

provisions for opioid drugs - R14

A

restrictions on supply by retail sale of codeine cough preparations

  • must not supply more than stated amount to any individual within a period of 7 days
    ** codeine liquid: 240ml
    ** codeine base (solid form): 355mg
  • must provide counselling and record purpose of treatment
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7
Q

provisions for opioid drugs - R(52)(1)(b)

A

import of therapeutic products for personal use without license not applicable to codeine and dextromethorphan exceeding maximum quantities

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8
Q

provisions for lawful dealings in controlled drugs under misuse of drugs regulation

A

1) purpose: control addiction and abuse
2) part II (R3-R9): exemptions from certain provisions of Act
3) part IIII (R10-R18): documentation and record keeping relating to medical use of CD

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9
Q

misuse of drug act

A
  • under ministry for home affairs, administered and enforced by CNB
  • to control CD
  • key definitions

1) Controlled Drug (CD): any substances/product specified in First schedule or anything that contains such substances/product

2) Traffic or trafficking: selling, giving, administering (to another person), transporting, sending, delivering, distributing

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10
Q

misuse of drug regulations - general

A
  • some exemptions to general prohibitions in Misuse of Drug Act
  • allow lawful dealing in CD for med/science
    ** licensing
    ** specifying certain classes of person allowed to handle CD under certain circumstances
  • ministry of home affairs appoints HSA officer to administer control system that regulate lawful dealings in CD
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11
Q

misuse of drug regulations - CD schedules

A

1) First Schedule (S1)

  • preparations containing CD in small quantities or formulated in such manner as to have relatively low risk of being abused

2) Second schedule (S2)

  • mostly CD that have high risk of abuse but also have uses as medicine

3) Third schedule (S3)

  • CD that have uses as medicines but relatively less risk of abuse compared to CD in S2

4) Fourth Schedule (S4)

  • CD that have high potential for abuse and little therapeutic value
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12
Q

misuse of drug regulations - manifacture

A
  • persons w CD license can manufacture CD specified in license
  • practitioner, pharmacist, or “people lawfully conducting a retail pharmacy business” can manufacture or compound in S1/2/3
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13
Q

misuse of drug regulations - import and export

A
  • person w CD (import/export) license can import/export CD specified in license
  • person can import/export CD in S1 wo CD license
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14
Q

misuse of drug regulations - supply

A
  • person w CD license can supply CD specified in CD license (intended for wholesale supply)
  • who can supply?
    1) practitioner
    2) pharmacist
    3) person lawfully conducting retail pharmacy business
    4) nurse in charge of hospital ward when administering CD to pt according to instruction of doctor or dentist
    5) person in charge of lab engaged in scientific education or research
    6) master of Singapore flagged ship that does not have its own doctor can supply CD in S1/2/3 to own crew members or to persons who can lawfully supply CD
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15
Q

misuse of drug regulations - administration

A
  • provisions for lawful administration
  • doctor or dentist who can administer CD in S2/3 to pt
  • person acting according to instructions of doctor or dentist can administer CD in S2/3 to pt
  • any person can administer CD in S1 to another person
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16
Q

misuse of drug regulations - possession

A
  • person w CD license can have in his possession CD specified in license
  • person who can lawfully supply CD in S2/3 can have in his possession the corresponding CD
  • master of ship in his possession CD in S2/3 as required for ship’s medical supplies
    ** SG flagged ship that does not have own doctor
    ** foreign ship in SG port
  • any person can have have CD in S2/3 for administration according to instructions of practitioner
    ** provided CD not obtained from more than one practitioner concurrently by fraud
  • any person can have CD in S1
  • other provision for lawful possession of CD

1) engaged in legitimate business of transporting CD or conveying CD to persons who can lawfully possess those CD
2) person in lab when engaged to examine CD
3) CNB officer when in course of duty or for official purposes

17
Q

misuse of drug regulations - documentation and records

A

CD in S2/3 can only be supplied in accordance to

1) wholesale supply: requisition order

  • signed by recipient
  • state name, address and profession of recipient
  • must specify purpose for which CD is required and total quantity to be supplied

2) retail supply to pt: prescription

  • must be in ink or otherwise indelible
  • must specify prescriber name and address
  • must be dated and signed w usual signature
  • must carry declaration (Dental/vet use)
  • must specify name and address of pt
  • mut specify dose to be taken
  • if CD is preparation
    ** specify form and strength of preparation to be supplied
    ** specify quantity of preparation or number of dosage units to be supplied
  • if CD is not preparation: specify quantity of CD to be supplied
  • if dispensed in instalment: specify amt of instalment of total amt which may be dispensed and intervals to be observed when dispensing
  • NO repeat for CD prescriptions
18
Q

misuse of drug regulations - dispensing

A

CD prescriptions cannot be dispensed if

1) before date stated on prescription or later than 30 days after date on prescription
2) unless prescriber address is in SG

19
Q

misuse of drug regulations - CD register

A

1) kept to record all movement of stock in S2/S4
2) form of a bound book and not loose leaf compilation
3) entries must be in chronological order
4) format should follow what is specified in Fifth schedule (Sixth if in hospital)
5) entries for each different strength of preparation recorded as one set, separate from entries for other CD of different strengths or preparations
6) class of CD to which entries on a page relate to must be at the head of the page
7) entries must be made on the date of transaction (latest the ay after)
8) not allowed to cancel or alter dates, only can correct by way of dated marginal note/footnote
9) entries must be made in INK
10) register must be ONLY used for recording CD
11) keep separate registers for separate premises and each register to be kept at the premise it relates to
12) all documents and records relating to receipt or supply of CD must be retained for at least 3 years after date of transaction

20
Q

misuse of drug regulations - labelling

A

show total amt of CD, number of dosages or % in container

21
Q

misuse of drug regulations - storage

A
  • all stocks kept under lock and key in premise under control of person authorised to supply CD
  • key must be kept in personal possession of authorised person at all times
22
Q

misuse of drug regulations - disposal

A
  • CD in S2/4 must be destroyed in presence of and in accordance with directions given by CD inspector
  • CD inspector endorse entry in CD register documenting date of destruction and quantity of CD destroyed

stupid 50 CA (5 decks)

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