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3150 > narcotics > Flashcards

narcotics Flashcards

1
Q

what regulation provides additional controls for import of therapeutic pdts containing psychotropic substances under the Health Products (Therapeutic Products) Regulations?

A

R6

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2
Q

what regulation provides additional controls for export of therapeutic pdts containing psychotropic substances under the Health Products (Therapeutic Products) Regulations?

A

R8

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3
Q

what regulation provides additional controls for import of therapeutic pdts for personal use without importer’s license not applicable to pdts containing psychotropic substances under the Health Products (Therapeutic Products) Regulations?

A

R25(1)(a)

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4
Q

what regulation provides additional controls for export of codeine cough preparations under the Health Products (Therapeutic Products) Regulations?

A

R9

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5
Q

what regulation provides additional controls for restrictions on supply by retail sale of codeine cough preparations under the Health Products (Therapeutic Products) Regulations?

A

R14

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6
Q

what regulation provides additional controls for import of therapeutic pdts for personal use without importer’s license not applicable to codeine and dextromethorphan exceeding maximum quantities under the Health Products (Therapeutic Products) Regulations?

A

R25(1)(b)

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7
Q

What is the purpose of the Misuse of Drugs Regulations?

A

to control drug addiction and abuse

provisions for lawful dealings for medical use

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8
Q

what provisions provides for exemptions from certain provisions of Act under the Misuse of Drugs Regulations?

A

Part II (R3-R9)

Part II, containing regulations 3-9

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9
Q

what provisions provides for additional control for documentation and record keeping under the Misuse of Drugs Regulations?

A

Part III (R10-R18)

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10
Q

Where are products containing “psychotropic substance” specified under the Health Products (Therapeutic Products) Regulations?

A

products containing “psychotropic substance” are specified in the First Schedule

e.g.
- phenobarbital (barbituate)
- diazepam (benzodiazepine)
- mazindol (CNS stimulant)

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11
Q

importer must obtain HSA’s approval before importing ech consignment of any pdt containing psychotropic substance

A

R6

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12
Q

import of therapeutic pdts for personal use (i.e. without license) NOT allowed for products containing psychotropic

A

R52(1)(a)

i.e. any person who wishes to import pdts containing psychotropic substance for personal use will have to apply for importer’s license from HSA

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13
Q

exporter (i.e. wholesaler) must obtain HSA’s approval before exporting each consignment of any product containing psychotropic substance

A

R8

before approval is granted, exporter must show that intended importer has approval from authorities in importing country

  • part of international agreemt on psychotropic substances to ensure that pds are legally permitted to be brought into importing country before they leave exporting country
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14
Q

what products are under opioid drug controls?

A

products containing certain opioids:
- codeine (codeine cough preparation)
- dextromethorphan

opioid drug controls are imposed to curb/reduce local abuse problems

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15
Q

Import for personal use (i.e. without license not allowed for pdts containing codeine or dextromethorphan (exceeding limits specified in the Seventh Schedule)

A

R52(1)(b)

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16
Q

exporter (i.e. wholesaler) must obtain HSA’s approval before exporting each consignment of codeine cough preparation

A

R9

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17
Q

R14: qualified practitioner/pharmacist supplying codeine cough preparation by retail sale

A

must NOT supply more than stated amt to any indiv within a period of 7 days:
- total of 240mL (in liquid form)
- total of 355mg of codeine (as base) [in solid form]

must provide professional counselling on use of preparation

must record purpose of treatment for which the preparation was supplied

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18
Q

export of codeine cough preparation

A

R9

  • obtain HSA’s approval for each consignment to be exported
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19
Q

what is the purpose of the Misuse of Drugs Act?

A

intended to conrol “dangerous or otherwise harmful drugs”– “controlled drugs” (CD)

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20
Q

provisions for lawful dealings in CD for medical and scientific uses

A

under Misuse of Drugs Regulations

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21
Q

Who is in charge of Misuse of Drugs Act?

A

Minister for Home Affairs

  • administered and enforced by Central Narcotics Bureau (CNB)
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22
Q

define controlled drug under Misuse of Drugs Act s2

A

CD: any substance or product… specified in… the First Schedule or anything that contains any such substance or product…

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23
Q

Define “traffic” or “trafficking” under Misuse of Drugs Act s2

A

“traffic”/”trafficking” includes selling, giving, administering to (another person), transporting, sending, delivering, distributing

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24
Q

what section provides aprohibitions for import and export of CD under the Misuse of Drugs Act?

A

S7

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25
Q

what section provides prohibitions for “trafficking” of CD (incl ss) under the Misuse of Drugs Act?

A

S5

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26
Q

what section provides prohibitions for possession of CD under the Misuse of Drugs Act?

A

S8(a)

27
Q

what section provides prohibitions for consumption of CD (incl self-administration) under the Misuse of Drugs Act?

A

S8(b)

28
Q

what section provides prohibitions for manufacture of CD under the Misuse of Drugs Act?

A

S6

29
Q

misuse of drugs regulations

A
  • provides for some exemptions to general prohbitions under Misuse of Drugs Act
  • to allow lawful dealings in CD for medical and scientific uses (e.g. ss by doctors for treatmt of pts, dispensing by pharmacists, ss for laboratory testing)
  • Minister for Home Affairs appoints HSA offficers to administer control system taht regulates lawful dealings in CD
30
Q

How does Misuse of Drugs Regulations provide for lawful dealings in CD

A
  • through licensing i.e. CD license
  • by specifying certain classes of persons allowed to andle CD under certain circumstances

Regulations also specify controls and requirements to be met in the course of those lawful dealings

31
Q

why are CD scheduled under Misuse of Drugs Regulations?

A

for purposes of access control

32
Q

what drugs are specified in the First Schedule (S1) of Misuse of Drugs Regulations?

A

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

33
Q

what drugs are specified in the Second Schedule (S2) of Misuse of Drugs Regulations?

A

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

e.g. ibuprofen, morphine, oxycodone

34
Q

what drugs are specified in the Third Schedule (S3) of Misuse of Drugs Regulations?

A

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

e.g. benzphetamine, phendimetrazine, pipradrol

35
Q

what drugs are specified in the Fourth Schedule (S4) of Misuse of Drugs Regulations?

A

mainly CD that have high potential for abuse and also of little therapeutic value

e.g. cannabinol, concentrate of poppy-straw, non-medicinal opium

36
Q

person with CD license can manufacture CD specified in license

A

R4 (MoDR)

37
Q

practitioner, pharmacist or “person lawfully conducting a retail pharmacy business” can manufacture or compound CD in S1, S2 or S3

A

r7(1) and r8(1) [MoDR]

38
Q

person with CD (import) license can import CD specified in license

A

r4 (MoDR)

39
Q

person with CD (export) license can export CD specified in license

A

r4 (MoDR)

40
Q

any person can import or export CD in S1 (without CD license)

A

r3 (MoDR)

41
Q

person with CD license can supply CD specified in license

A

r4 (MoDR)

in practice, license to supply mainly intended for wholesale supply

42
Q

who can supply CD in S1, S2 or S3 [r7(2) and r8(2), MoDR]

A
  • practitioner
  • pharmacist
  • “person lawfully conducting a retail pharmacy business”
  • nurse in charge of hosp ward, when administering CD to pt according to instructions of doctor or dentist
  • person in charge of laboratory engaged in scientific education or research
43
Q

master of a (Singapore-flagged) ship that does NOT have its own doctor can supply CD in S1, S2 or S3: to own crew members & to persons who can lawfully supply CD

A

r7(4) and r8(4) [MoDR]

44
Q

provisions for lawful administration of CD

A

r6 (MoDR)

  • doctor/dentist can administer CD in S2 or S3 to his pt
  • person acting according to instructions of doctor/dentist can administer CD in S2 or S3 to the pt
  • any person can administer CD in S1 to another person
45
Q

person with CD license can have in his possession CD specified in the license

A

r4 (MoDR)

46
Q

person who can lawfully supply CD in S2 or S3 [according to r7(2) & r8(2)] can have in his possession the corresponding CD

A

r9(1) [MoDR]

47
Q

master of ship can have in his possession CD in S2 or S3 as required for the ship’s medical supplies:
- a (Singapore-flagged) ship that does not have its own doctor
- a foreign ship in port (in Singapore)

A

r9(4) [MoDR]

48
Q

any person can have in his possession CD in S2 or S3 for administration according to instructions of practioner

A

r9(2) [MoDR]

  • provided CD were not obtained from more than one practitioner concurrently by fraud
49
Q

any person can have in his possession CD in S1

A

r3 (MoDR)

50
Q

other provisions for lawful possession of CD

A

r5 (MoDR)

  • person engaged in (legitimate) business of transporting CD or conveying CD to persons who can lawfully possess those CD
  • person in laboratory when engaged to examine a CD
  • CNB officer, when in the course of his duty or for official purposes
51
Q

Misuse of Drugs Regulations state that CD in S2 or S3 can only be supplied in accordance with:

A
  • requisition order (for wholesale-type of supply)
  • prescription (for retail supply to pts)
52
Q

requisition order for CD in S2 or S3

A

r10(2) [MoDR]

  • must be signed by recipient
  • must state name, address and profession of recipient
  • must specify purpose for which CD is required, and total quantity to be supplied
53
Q

prescriptions for CD in S2 or S3

A

r11(1) [MoDR]

  • must be in ink or otherwise indelible
  • must specify prescriber’s name and address
  • must be dated and signed by prescriber with his usual signature
  • must carry declaration if for dental or veterinary use
  • must specify name and address of pt
  • must specify dose to be taken
  • if CD is a preparation, must specify form (and strength) of preparation to be supplied
  • if CD is a preparation, specify quantity (in words and figures) of preparation or number (words and figures) of dosage units to be supplied
  • if CD is not a preparation, specify quantity (words and figures) of CD to be supplied
  • for prescription to be dispensed in instalments, must specify no. of instalments of total amt which may be dispensed, and intervals to be observed when dispensing

NOTE: NO repeats for CD prescriptions

54
Q

CD prescriptions cannot be dispensed:

A

r12(1) [MoDR]

  • before date stated on prescription or later than 30 days after date stated on prescription
  • unless prescriber’s address is in Singapore
55
Q

CD register must be kept to record all movements of stocks of CD in S2 and S4

A
  • must be in the form of a “bound book” and NOT a “loose leaf” compilation– r2 [MoDR]
  • entries in register must be made in chronological order– r14(1)(a) [MoDR]
56
Q

format of CD register should follow that specified in Fifth Schedule

A

r14(1)(a) [MoDR]

  • in hosp wards, can be in simpler format specified in Sixth Schedule
57
Q

entries for each different strength or preparation of each CD to be recorded together as one set, separately from entries for other CD of different strengths or preparations

A

r14(1)(b) [MoDR]

58
Q

CD register:
- class of CD to which entries on a page relate must be stated at the head of that page

  • entries must be made on the day of transaction (or latest the next day)
A

r15(a) ; r15(b) [MoDR]

59
Q

CD register:
- not allowed to cancel, obliterate or alter entries, and only make corection by way of dated marginal not or footnote

  • entries must be made in ink or otherwise indelible
A

r15(c) ; r15(d) [MoDR]

60
Q

CD register:
- register must NOT be used for any other purpose other than recording CD

  • to keep separate registers for each separate premises, and each register to be kept at the premises to which it relates
A

r15(e) ; r15(g) & (h) [MoDR]

61
Q

record keeping:
all documents and records relating to recipt or supply of CD must be retained for (at least) 3 yrs after the date of transaction

A

r17 & r18(3) [MoDR]

62
Q

labellling:
containers of CD (other than CD in S1 or CD dispensed by or on a prescription of a practitioner) must be labelled

A

r13 (MoDR)

  • if CD is NOT a preparation, total amt of CD in container must be labelled
  • if CD is a preparation in unit dosage form, show amt of CD in each dosage unit and number of dosage units in container
  • if CD is a preparation NOT in unit dosage form, show total amt of preparation in container and percentage of each CD in preparation
63
Q

storage:
requirements for storage and safekeeping of CD

A

r20 (MoDR)

  • all stocks of CD (other than those in S1) must be kept under “lock and key” in premises under control of person who is authorised to supply those CD
  • the key must be in personal possession of authorised person at all times
64
Q

disposal:
requirements for disposal of CD

A

r28 (MoDR)

  • CD in S2 and S4 must only be destroyed in the presence of, and in accordance with directions given by a CD inspector
  • CD inspector will endorse entry in CD register documenting date of destruction and quantity of CD destroyed

3150 (1 decks)

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