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Pharm Law > ModA x Modr > Flashcards

ModA x Modr Flashcards

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1
Q

ModA vs Modr

A

ModA

  • Generally PROHIBITIVE against all dealing and usage
  • Under CNB

Modr:

  • Generally ENABLING with EXCEPTIONS
  • Under MHA + HSA
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2
Q

What are the type of drugs subjected to additional controls under:

  1. ModA x Modr
  2. HP(TP)r
A
  1. CDs

2. Pdt containing “Psychotropic substances”

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3
Q

In general, how does Modr “enables” dealings and usage of CDs?

A
  1. CD Lc

2. Specify controls and requirements for lawful dealings and use

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4
Q

Describe the classifications of CDs under MoDr, and rank them according to the tightness of controls

A

Four categories:

  • S1: Small qty CD, low abuse risk
  • S3: CD have uses as medicines, but less abuse risk than S2
  • S2: CDS, therapeutic, but high risk of abuse
  • S4: CDs, little therapeutic value, high potential abuse

Tightness: 1 < 3 < 2 < 4

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5
Q

For dealers and suppliers of CDs, what licenses must they have?

A

IN ADDITION to dealers’ Lc (Mf/Ipt/Whs), they must have CD Lc

(i.e. need both Lc)

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6
Q

Comment on the following statement

“Qihan has obtained a Mf Lc for a specific CDs. She is now authorised to Mf all Cds”

A

Statement is WRONG

- Mf enablement is specific to the CD stated in Lc

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7
Q

Johannes is a registered Pcist working in a hospital. One day, he was tasked by a registered Doctor to prepare an extemporaneous suspension of Morphine (an S3 CD) from tablets. He is unsure whether he is able to do so lawfully.

Justify whether Johannes can do so.

r7(1), r8(1)

A

Yes he can

  • Extemprep = Mf
  • But Johannes is registered Pcist
  • Modr exemptions: Can Mf S1, S2, S3 CDs without Lc

(exemption applies for practitioners and persons lawfully conducting repharm business too)

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8
Q

Kim is planning to import new CDs which are classified as S1 into Singapore and sell to hospitals. Explain whether he needs CD Lc to do so

A
  • Rq CD Lc for selling to hospitals

- S1 CDs EXEMPTED from Lc for Ip/xport

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9
Q

Any persons which can SUPPLY CDs in S1, S2 or S3 are similar to what kind of TP under HPA?

r7, r8

A

POM medications

  • Special: IC of lab engaged in sci education research (simliar to Lc exemption too anw)
    (i. e. practitioner, Pcist, repharm, nurse under instructions)
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10
Q

Who and what classes of CDs can persons ADMINISTER to patients?

r7, r8

A
  • S1: Any persons (no need Rx/instructions)

- S2, S3: Doctor, Dentist, or anyone under their instructions

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11
Q

How does Modr controls usage of CDs by end-user?

r9(2), r3

A

Mainly under POSSESSION

  1. Anyone can possess S2/S3 for administration according to instructions of practitioner PROVIDED CDs were not obtained from >1 practitioner CONCURRENTLY by fraud (r9)
  2. Any person can posses S1 (r3)
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12
Q

Who can POSSESS CDs lawfully (other than end-users)?

r5

A
  1. CD Lc can posses CD specified in Lc
  2. Those who can ss
  3. Master of SG ship w/o doctor, or foreign ship (S2, S3)
  4. Transporters in legit business
  5. Laby guy examining CD
  6. CNB officer doing duties
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13
Q

How long before a CD Rx expires

r12

A

30 days after date on Rx

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14
Q

CD register to record movement of CDs for which classification of CDs?

r15

A

S2 & S4

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15
Q

Upon inspection, authorities have found out that a hospital was using a CD register according to the Fifth Schedule of Modr. They register was made up of stapled pieces of foolscap.

Upon further inspections, the entries were made in chronological orders and written in erasable pen ink. Each set of register recorded for Morphine 10mg and Morphine 30mg (S2 classified) and had cancellations for wrong entries.

Describe the mistakes that the hospital made in recording movement of CDs in the register.

r15

A
  1. Stapled foolscap unacceptable (cannot “loose leaf”)
  2. Had more than two drugs for a register
  3. Cannot have two different strength in a single record
  4. Cannot cancel. Make footnotes (indicating date of edit) instead
  5. Erasable pen ink: NO, must be indelible
  6. (optional?) Hospitals can follow simpler format in SIXTH schedule instead of 5th
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16
Q

Julie is a Pcist who received a prescription containing Morphine 10mg (CD). The Rx came from Korea, and the patient was wondering whether Julie could fill the Rx for him.

Can Julie fill the Rx?

r12

A

No

- Rx-er address MUST be in SG for CD Rx to be dispensed

17
Q

How long must records of receipt and ss of CD be kept for?

r17, r18

A

3y, after date of transaction

18
Q

Labelling rules of CD if it is

  1. Not a prep
  2. A unit dosage form (E.g. tabs/caps)
  3. A prep, but not unit dosage form (E.g. eyedrops)

r13

A
  1. Total amt. CD in container (e.g. raw cocaine powder)
  2. CD in EACH dosage unit AND number of dosage units (E.g. Morphine 50mg/tab, 10 tabs)
  3. Total amount of PREP + %CD in prep (E.g. XX 5%w/v Cream (30mg))
19
Q

What are requirements for storage and safekeeping of CDs?

r20

A
  1. All under “lock n key”, key with person who is authorised to supply CD
  2. Key must be in PERSONAL POSSESSION of authorised persons at all times
20
Q

What are requirements for Disposal of CDs? What classification of CD do those requirements apply to?

r28

A

Apply to S2 and S4

  • Destroyed only in presence and under instruction of CD inspector
  • CD inspector endorse entry in CD register, say date of destruction and Qty destroyed
21
Q

The additional controls under HP(TP)r applies to what kind of substances or products?

A
  1. “Psychotropic substance”, or “mind-altering’ properties that have high abuse potential
  2. Products containing certain opioids
22
Q

Briefly explain the controls of EXPORTING CDs under HP(TP)r

r8, r9

A
  • Exporter obtain HSA approval before each consignment
  • Exporter ensure that intended importer is legit, before approval is given

(basically to ensure all CDs are accounted for, in case someone import then sell in black market)

23
Q

Briefly explain the controls of IMPORTING CDs under HP(TP)r, that is NOT for personal use (i.e. with Ipt Lc)

r6

A
  • Ipt obtain HSA approval before each consignment
24
Q

Briefly explain the controls of IMPORTING CDs for PERSONAL use (without Lc)

r52

A

NOT ALLOWED for pdt containing:

  • Psychotropic substance
  • Codeine or dextromethorphan exceeding limits in Seventh Schedule

(basically just cannot bring in for personal use, unless small qty enough for those 2 in 7h schedule)

25
Q

Besides CD register, what other records must be done for CD, and what classification of CDs must they be done for? Specify the details to be inside the document

r10

A

Requisition order fo S2 and S3

Details:

  • Signed by RECIPIENT
  • State Name, address and profession of RECIPIENT
  • Specify purpose of CD, and qty ss
26
Q

Rx drug information requirements when CD is a preparation

r11

A
  • Specify form, strength
  • Specify qty (Words and figures) OR number of dosage units (words and figures) to be supplied
  • Specify dose to be taken

(dose taken is common for prep/nonprep)

27
Q

Rx drug information requirements when CD is NOT a preparation

r11

A
  • Specify qty (words and figures) of CD to be supplied

- Specify dose to be taken

28
Q

Patient information that MUST be inside a CD Rx

r11

A
  • Name

- Address

29
Q

Rx-er information that MUST be inside a CD Rx

r11

A
  • Name and Address
  • Date
  • Signed
  • Dental or vet use: Declare
30
Q

CD can only be supplied in what scenario and in accordance with what? What class of CD does this apply to?

A

Applies to S2 and S3. Supplied in accordance with:

  • Requisition order (Whs ss)
  • Rx (retail ss to patients)

Pharm Law (5 decks)

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