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PR3150 > Narcotic and Psychotropic Drug Controls > Flashcards

Narcotic and Psychotropic Drug Controls Flashcards

1
Q

What narcotic and psychotropic drugs are regulated under the Health Products (Therapeutic Products) Regulations?

A

Preparations containing “psychotropic substances:, codeine or dextromethorphan

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2
Q

What is the act regulating controlled drugs?

A

Misuse of Drugs Acts and misuse of drugs regulation

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3
Q

What governs the international trade and movement of narcotic drugs and psychotropic substances?

A

International conventions

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4
Q

What are the organizations involved in the international narcotics control board?

A

Ministry of Home Affairs and Central Narcotic Bureau

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5
Q

What is the purpose of the international conventions?

A

Provides a system of cross-checking all import-export transactions involving such substances necessary to curb diversion and illicit trade

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6
Q

List the two regulations that are involved in the import and export of therapeutic products containing psychotropic substance.

A

Regulation 6 (Import)
Regulation 8 (Export)

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7
Q

List the regulation involved in the export of codeine cough preparation.

A

Regulation 9

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8
Q

Import of therapeutics products for personal use without importer’s licence not applicable to psychotropic products, codeine and dextromethorphan is under regulation ___ and ____.

A

52(1a), 52(1b)

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9
Q

What is regulation 14 for?

A

Restriction on supply by retail sale of codeine cough preparation

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10
Q

Which regulation(s) are in placed to ensure provisions for lawful dealing in controlled drugs under misuse of drugs regulation?

A
  1. Regulation 3 to 9 (Part II)
  2. Regulation 10 to 18 (Part III)
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11
Q

What is regulation 3 to 9, part 2 for?

A

Exemptions from certain provisions of act

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12
Q

What is regulation 10 to 18, part 3 for?

A

Documentation and Record Keeping

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13
Q

Which schedule are products containing “psychotropic substance” specified in?

A

First schedule

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14
Q

Under regulation 6 and 8, _____ must be obtained from HSA before importing and exporting products with psychotropic substance

A

approval

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15
Q

What are the details that are required when getting approval for import and export?

A
  1. Name and address of importer and exporter
  2. Name and Quantity of product
  3. Total base substance content
  4. Purpose (import only)
  5. Method of import or export
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16
Q

Before approval is granted, exporter must show that intended importer has _____ from authorities in importing countries.

A

approval

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17
Q

Under regulation 14, who can supply codeine cough preparation by retail sales?

A

Qualified practitioner or pharmacist

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18
Q

What is the duration of opioid drugs that can be supplied?

A

Max 7 days

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19
Q

What are the two criteria for supply of opioids products by retail sales?

A
  1. Document purpose of treatment
  2. Provide professional counselling
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20
Q

How much of opioid containing product can be supplied?

A
  1. Liquid: 240mL
  2. Codeine (as base): 355mg
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21
Q

What are the 7 components of “traffic” or “trafficking” as specified under the misuse of drugs act?

A

Selling
Giving
Administering
Transporting
Sending
Delivering
Distributing

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22
Q

Who does the minister for home affairs appoints to administer control system to regulate lawful dealings in CD?

A

HSA officers

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23
Q

What are the 2 purposes of misuse of drugs regulation?

A
  1. Provide some exemptions to general prohibitions
  2. Allow lawful dealings for medical and scientific uses
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24
Q

List 2 ways in which lawful dealing in CD are provided.

A
  1. Licensing
  2. Specifying certain classes of persons allowed to handle CD under certain circumstances

Others: Controls and requirements to fulfil in course of dealings

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25
Q

CD under first schedule discuss about ____ abuse risk preparations containing CD.

A

low

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26
Q

CD under second schedule discuss about ____ abuse risk preparations containing CD which can also be used as medications.

A

high

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27
Q

CD under ______ schedule discuss about CD with uses as medications and have ____ abuse risk than that of those in second schedule.

A

third, lower

28
Q

CD under ______ schedule discuss about CD with _____ abuse risk and low therapeutic value.

A

fourth, high

29
Q

What can a person with CD licence do under regulation 4?

A

Manufacture, import, export, supply (wholesale only), possess

30
Q

Regulation 7(1) and 8(1) allows ____, _____, ______ to manufacture or compound CD in schedule 1 - 3.

A

practitioner, pharmacist, person lawfully conduction retail pharmacy business

31
Q

Which regulation allows those without licence to import or export CD in S1?

A

Regulation 3

32
Q

List 5 groups that can supply CD in schedule 1 to 3 under regulation 7(2) and 8(2).

A
  1. Practitioner
  2. Pharmacist
  3. Person lawfully conduction retail pharmacy business
  4. Nurse in charge of ward when administering CD to patient according to instructions of doctor or dentist
  5. Person in charge of laboratory engaged in scientific education or research
33
Q

Under regulation 7(4) and 8(4), ____ of Singapore flagged ship without a doctor can supply to own crew members and to persons who can lawfully supply CD.

A

Master

34
Q

Which two groups can the master of Singapore flagged ship without a doctor can supply CD to?

A
  1. Own crew members
  2. Persons who can lawfully supply CD.
35
Q

Which regulation provides lawful administration of CD in S2 and S3?

A

Regulation 6

36
Q

Who can administer CD in schedule 1 to another person?

A

Any person

37
Q

Which two groups can administer CD in schedule 2 and 3 to patients?

A
  1. Doctor/ Dentist
  2. Person acting on Doctor/ Dentist instructions
38
Q

What does regulation of 9(4) discuss about the possession of CD in s2 and s3?

A
  1. Master of ship without doctor or foreign ship in Singapore port
39
Q

Which regulations allow any person to have possession of CD in S2 or S3 for administration according to instructions of practitioner?

A

Regulation 9 (2)

40
Q

Which regulation allows other provisions for lawful possession of CD?

A

Regulation 5

41
Q

List three groups of people who can possess CD under regulation 5.

A
  1. Person engaged in (legitimate) businss of transporting or conveying CD to persons who can lawfully possess those CD
  2. Person in laboratory when engaged to examine CD
  3. CNB officer when in course of his duty or for official purposes.
42
Q

How is CD in S2 or S3 supplied?

A

Requisition order (wholesale) or prescription (retail for patients)

43
Q

What is the regulation on requisition order for CD in S2 or S3?

A

Regulation 10(2)

44
Q

What are the three criteria for requistion order for CD?

A
  1. Signed by recipient
  2. State name, address, and profession of recipient
  3. Specify purposes for which CD is required and the total quantity to be supplied
45
Q

Which regulation is for prescriptions for CD in S2 or S3?

A

Regulation 11(1)

46
Q

List the criteria for prescriptions for CD in S2 or S3?

A
  1. Be in ink or indelible
  2. Prescribr’s name and address
  3. Dated and signed by prescrirber with his usual signature
  4. Carry declaration, if for dental or veterinary use
  5. Specify name and address of patients
  6. Specify dose to be taken
47
Q

List the criteria for specification of dose for CD.

A
  1. Preparation: Form and strength
  2. Quantity (words and figures) or numbers (words and figures) of dosage units to be supplied
  3. Non-preparation: Quantity (words and figures) of CD to be supplied
48
Q

For prescription to be dispensed in instalments, what informaton is needed?

A

Amount of instalments of total amount which may be dispensed and intervals to be observed when dispensing

49
Q

Repeats for CD prescriptions are ________.

A

not allowed

50
Q

Under regulation 12(1), prescriptons cannot be dispensed under what conditions?

A
  1. Earlier than date of prescription or after than 30 days after date stated on prescription
  2. Prescriber’s address is not in SG
51
Q

Documentation of stock movement is required under ____ and ____.

A

Regulation 2 and 14(1)(a)

52
Q

How should documentation of CD be done?

A

“Bound book” and not a “loose leaf” cmpliation - r2
“Chronological order” - r14(1)(a)

53
Q

Format of register for CD should follow that specified in _____ schedule.

A

fifth

54
Q

Hospital wards can follow ______ schedule when recording CD movements.

A

sixth

55
Q

How should entries be recorded for different strength and preparation of CD under regulation 14(1)(b)?

A

As one set, separately from entries for other CD of different strengths or preparations

56
Q

What is regulation 15(a) about?

A

Class of CD to which entries on a page relate must be started at the head of that page

57
Q

What is regulation 15(b) about?

A

Entries must be made on the day of transaction (or latest the next day)

58
Q

Personnel are ______ to cancel, obliterate or alter entries, and only make correction by way of ________ or _______.

A

not allowed, dated marginal note or footnote

59
Q

What is regulation 15d about?

A

Entries must be made in ink or otherwise indelible

60
Q

What is regulation 15e about?

A

Register must not be used for any other purpose other than recording CD

61
Q

Under regulations 15(g) and (h), registers for each separate premises should be ____ and kept at the premises to which it relates.

A

separated

62
Q

How many years should documents and record relating to receipt or supply of CD be retained for?

A

at least 3 years after date of transaction

63
Q

Which regulation states that containers of CD other than schedule 1 or dispensed by or no prescriptioon of practitioner should be labeled?

A

Regulation 13

64
Q

List the three criteria that should be fulfilled when labelling the CD?

A
  1. Not preparation - show total amount of CD in container
  2. Unit dosage form - show each dosage unit and number of dosage units in container
  3. Preparation not in dosage unit form - total amount of preparaton in container and percentage of each CD in preparation
65
Q

What are the requirements for storage and safekeeping of CD under regulation 20?

A
  1. All stocks other than those in schedule 1 must be kept under lock and key in premises under control of person who is authorised to supply those CD
  2. The key must be in personal possession of authorized person at all times
66
Q

What are the requirements for disposal of CD in regulation 28?

A
  1. CD in schedule 2 and 4 must only be destroyed in presence of annd in accordance with directions given by a CD inspector
  2. CD inspector will endorse entry in CD register docuumenting date of destruction and quantity of CD destroyed

PR3150 (4 decks)

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