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PR3150 > Pharmacy law part 1 > Flashcards

Pharmacy law part 1 Flashcards

1
Q

What must you accomplish to be classified as a fully registered pharmacist in Singapore w a local degree?

A
  1. At least 12 months of practice in pharmacy
    - 9 out the the 12 months must be under direct supervision of a fully registered pharmacist at an approved establishment in SG.
  2. Complete competency assessment post graduation.
    - No additional forensic examination
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2
Q

What is the criteria for a foreign pharmacy graduate to be able to work in SG?

A
  1. Graduated w a university degree accepted by Singapore Pharmacy Council (SPC)
    - List is maintained by SPC
    - There is another list known as the gazetted list. Foreign graduates before 1 Aug 2020 are allowed to apply for under the gazetted list. Those that enrolled in the course after Aug 2020 are not allowed to to register under SPCC.
  2. Registered as a pharmacist w a valid license in the country of study
  3. Pass forensic and competency examination
  4. English language proficiency examination - if degree is outside of UK, USA, Canada, Aus, NZ
  5. At least 3 months of practical experience in a SPC approved training center
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3
Q

What kind of license can a foreign graduate w a degree and fulfilled all requirements apply for in SG?

A

Conditionally registered pharmacist license

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4
Q

What is the duration of conditional registration?

A

1 to 2 years

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5
Q

What are the downsides of being a conditionally registered pharmacist

A
  1. Restricted to practicing in SPC-approved training centers only
  2. Subjected to supervisory framework
    - Supervised every 3 or 6 months in the 1st year, every 6 months in the 2nd year
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6
Q

After 1-2 years as a conditionally registered pharmacist, what is next?

A

Being allowed to apply for the role of a fully registered pharmacist

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7
Q

What are the 7 specialties in pharmacy?

A
  1. Oncology
  2. Cardiology
  3. Infectious disease,
  4. Paediatrics
  5. Geriatrics
  6. Critical care
  7. Pyschiatry
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8
Q

What are temporary registered pharmacists?

A

Pharmacist that are residing in SG temporarily for teaching, research or graduate studies only.

Maximum length of registration is 2 years. May be renewed.

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9
Q

What are the CPE requirements for (1)Active practising cert, (2)inactive practising cert?

A

Renewal of active practising certificate:
- 50 CPE points in 2 years

Renewal of inactive practising certificate:
- 20 CPE points in 2 years

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10
Q

What are the 4 ways that your name will be removed from the SPC register?

A
  1. 5 consecutive years of not renewing your license
  2. Deceased
  3. Obtained registration by fraudulent or incorrect statement
  4. Had registration withdrawn, suspended or cancelled in another country
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11
Q

How to reregister yourself if you did not renew your practicing certificate after 5 years?

A
  1. Pass forensic and competency exams
  2. Fulfill 25 CPE points within 12 months of applying for reregistration
  3. Provide certificate of good standing by a professional body
  4. Certified fit to practise
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12
Q

Is an organisation / employer responsible for their employees?

A

Yes

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13
Q

Is an organisation / employer responsible for their non-employees who act as ostensible agents (e.g. Part time workers, locum pharmacist)

A

Yes

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14
Q

Is an organisation / employer responsible for independent contractor?

A

No

E.g A surgeon using Gleneagles Hospital OT as an independent contractor. A patient cannot sue Gleneagles for the surgeon’s negligence.

However, if during the surgery, there is a fault w the OT, the fault lies with Gleneagles & not the surgeon.

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15
Q

What is the difference between Criminal Law & Civil Law?

A

Criminal law:
- not following the rules and regulation of the law set by the government.

Criminal law are prosecuted by the police.

Civil law:
- the law is based on contracts

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16
Q

Pharmacists owe a duty of care to:
1.
2.
3.
4.
5.

A
  1. Patients in the wards & clinics
  2. Patients who have care encounters w pharmacists for minor ailments, P meds, etc
  3. Patient who have sought and obtained the pharmacist’s advice
  4. Patients who are referred to the pharmacists by other HCP
  5. Patient in clinical trials & research studies that they are participating in

and the list goes on…

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17
Q

Under the Bolam test, how would one not be found guilty of negligence?

A

One would not be found guilty of negligence if other expert witnesses might make the same mistake in the same scenario.

18
Q

How does a healthcare professional defend themselves in practice?

A

Have good and detailed documentation of their encounter with the patient.

19
Q

What substances present in certain products can cause addiction if misused or abused?

A

Narcotic and psychotropic substances can cause addiction if misused or abused.

E.g dextromethorphan, codeine

20
Q

Controlled drugs have additional controls as compared to regular therapeutic drugs.

What are 2 additional controls for controlled drug?

A
  1. In SG, there is the Misuse of Drugs Act & Misuse of Drugs Regulations
  2. International trade and movement of narcotic and psychotropic substances are overseen by International Narcotics Control Board
21
Q

Name 2 examples of products containing psychotropic substance.

A
  1. Phenobarbital - barbiturates
  2. Diazepam - benzodiazepines
22
Q

Who’s approval must be obtained before importing substances containing psychotropic substances?

A

HSA’s approval

23
Q

Is importing psychotropic substances for personal use allowed?

A

No, it is not allowed to import psychotropic substances for personal use.

24
Q

Who’s approval must be obtained before exporting substances containing psychotropic substances?

A
  1. HSA’s approval
  2. The approval of the country that the product is being exported to
25
Q

Can products containing codeine or dextromethorphan be imported for personal use?

A

No, it is not allowed to import codeine of dextromethorphan containing products for personal use.

26
Q

Who’s approval must be obtained before exporting substances containing codeine?

A

HSA’s

27
Q

Who can supply codeine cough preparation by retail?

A

A qualified practitioner or pharmacist

28
Q

What is the maximum amount of codeine cough preparation that can be supplied?

A
  1. Total of 240ml (liquid) in 7 days
  2. Total of 355mg of codeine (solid) in 7 days
29
Q

What must be done after a qualified practitioner or pharmacist have supplied the codeine?

A
  1. Patient counselling
  2. Record purpose of treatment
30
Q

What does trafficking mean under the Misuse of Drugs Act?

A

Trafficking means:
1. Selling
2. Giving
3. Administering to another person
4. Transporting
5. Sending
6. Delivering
7. Distributing

31
Q

What are the 5 areas that Misuse of Drugs Act mainly target?

A
  1. Manufacturing
  2. Importing & exporting
  3. Trafficking
  4. Possession
  5. Consumption
32
Q

What does the Misuse of Drug Regulations do?

A

It provides some exemptions to Misuse of Drugs Act.

It allows lawful dealing in Controlled Drugs for medical and Scientific uses.
- E.g Licensing
- Specifying certain classes of persons allowed to handle CD under certain circumstances

33
Q

Schedules are lists of drugs that contain narcotic and psychotropic substances in the Misuse of Drugs Regulations.

What are the class of drugs do the 1st, 2nd, 3rd and 4th schedules contain?

A

First schedule:
- Preparations with small amount of controlled drugs, and have relatively low risk of being abused

Second schedule:
- Preparations with CD that have high risk of abuse, but also have uses as medicines

Third schedule:
- CDs that have lesser risk of abuse compared to those in the second schedule

Fourth schedule:
- CDs that have high potential for abuse, but little therapeutic value.

34
Q

Which schedules can a pharmacist or a qualified practitioner manufacture?

A

Only drugs in the 1st, 2nd and 3rd Schedules.

35
Q

Who else can administer medications from the schedules to patients apart from pharmacist and qualified practitioners?

A
  1. Person acting according to instructions of doctor or dentist can administer CD in the 2nd and 3rd schedule to pt
  2. Any person can administer CD in the 1st schedule to another person.
36
Q

What are rules to follow when recording an order or prescription of a drug containing narcotic and psychotropic substances to a recipient?

A
  1. Must be signed in ink
  2. Prescriber must specify his/her name and address
  3. Recipient must specify his/her name, address & profession
  4. Declare the purpose of the CD
  5. If CD is not a preparation, specify quantity supplied
  6. If CD is a preparation, record the dosage form, strength and quantity
  7. For prescription dispensed in instalments, specify the amount of instalments and intervals.
37
Q

Where to record down all the information regarding CD?

A

A CD register must be used to record all movement of stocks of CD in 2nd and 4th schedule in chronological order and kept.

The CD register must be in the form of a bound book & not a loose leaf compilation.

38
Q

What are the requirements to include in a CD register?

A
  1. Class of CD must be stated at the head of that page
  2. Entries for each different strength of preparation of each CD to be recorded together as one set, separated away from entries for other CD.
39
Q

Are you allowed to cancel, obliterate, alter entries?

A

No

40
Q

Which is the only schedule that does not require a mandatory label on CD containers?

A

First Schedule.

It is mandatory for all other schedules to label their containers of CD.

41
Q

How must CD be stored?

A

All stocks of CD, except 1st schedule, must be kept under “lock & key”, under the control of an authorised personnel to supply the CD.

42
Q

How to dispose CD?

A
  1. CD in S2 and S4 can only be disposed in the presence of a CD inspector
  2. CD inspector will endorse the entry in the CD register when documenting date and quantity disposed.

PR3150 (5 decks)

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