intro to health pdt regulation

Question 1

health products include therapeutic products, complementary/ self-care products

Answer 1

true

Question 2

what are the pre-market phase of health products

Answer 2

• Product design
• Product testing
• Product Manufacture & Import

Question 3

What are the Post-market phase of health products

Answer 3

• Product Use
• Product Supply

Question 4

Which of the following are correct (multiple response):
- An anti-infective TP is subject to full range of pre-market & post-market controls
- Topical antiseptic is subject to full range of pre-market & post-market controls
- Health supplement is subject mainly to post-market controls with light touch pre-market controls
- GTP is subject to full range of pre-market & post-market controls

Answer 4

1,3,4

therapeutic product/ CTGTP -> full range of pre- & post-market controls applies

Health supplement/ complementary or self-care products: mainly post-market controls, pre-market not that impt

Question 5

Key controls for higher risk products

Answer 5

1. Clinical trial approval (except medical device)
2. Product registration *quality, safety & efficacy requirements
3. Dealer licensing *GMP,GDP
4. Advertisement control
5. Post-Market duties *product defect, AE reporting, product recall

Question 6

Key controls for LOWER risk products

Answer 6

Advertisement control
Post-market duties (pdt defect/ AE reporting, pdt recall requirements)

Question 7

Complementary healthcare/self-care products include

Answer 7

• Traditional medicines
• Health supplements
• Topical antiseptics
• Cosmetic products

Question 8

Primary legislation vs Subsidiary legislation

Answer 8

Primary legislation: ‘Acts of Parliament’
- enacted, amended & repealed by Parliament
- During conception - Acts known as ‘Bills’
- defines basic framework of control
- usually NOT changed/ amended :often

Subsidiary legislation
- “Rules”, “Regulation”, “Orders” etc
- Follows from a parent act (passed by Parliament & assented to by the President)
- Specifies more technical details
- May change more often (depending on changing circumstances & needs)

Question 9

What is the Statutes of the Republic of Singapore

Answer 9

Wide range of legislation relating to a whole spectrum of activities & affecting many aspects of society
eg. HPA, PRA
- Includes laws relating to control & regulation of:
-> PRA (pharmacists & practice of pharmacy)
-> HPA (Medical & health-related pdts)

Question 10

What are the 5 broad sections under the PRA

Answer 10

1. SPC
2. Pharmacist Registration
3. Practice of Pharmacy
4. Specialist Accreditation Board
5. Disciplinary & health inquiry

Question 11

What are the principles under the 3 main components of the Code of Ethics for pharmacists

Answer 11

1. Practices & Responsibilities
   - Patients First
   - Respect for All
   - Legal compliance
   - High Practice Standards
   - Fitness to Practice
2. Professional Qualities
   - Honesty & Integrity
   - Professional Competence
   - Research Ethics
3. Interprofessional Relationships
   - Collaboration with HCPs
   - Nurturing Future & new pharmacists

Question 12

The COE is published by ____ and enforced by _____.

Answer 12

SPC

Question 13

Where does the practices & responsibilties domain and professional qualities domain intersect?

Answer 13

Professional practice

Question 14

A pharmacist misusing a title, representing himself as a specialist pharmacist when in fact he is not, has flouted which of the following (COE, PRA, PRR)?

Answer 14

COE and PRA

PRR deals with practising cert/ compulsory CPE

Question 15

These are the situations that pharmacists can run afoul of the PRA - fraudulent registration, wrongful use of titles and qualifications, convicted by the law, falsely submitting CPE activities to obtain a practising cert (PC), failure to achieve the required CPE points for a PC, professional incompetence, known to be unfit but fail to report to SPC

Answer 15

False. CPE points is under PRR; not having required CPE points does not run afoul of PRA

PRA sections
- SPC
- Practice of Pharmacy
- Pharmacist registration
- Specialist Accreditation Board
- Disciplinary & Healthy inquiry

Question 16

What section is the PRR under in the PRA?

Answer 16

Section 74

Question 17

What is professional incompetence?

Answer 17

1. Knowledge deficit
2. Skill deficit
3. Judgement deficit

vs professional negligence (eg. willful disregard for pt care due to busyness/ other reasons)

Question 18

How are corporate (retail pharmacies, companies), public institution pharmacies, and individual pharmacists governed?

Answer 18

Corporate (retail pharmacies, companies) -> licenses by HSA

Public institution pharmacies -> Healthcare Services Act (HCSA)
*previously under Private Hospitals & Medical Clinics (PHMC) Act

Individual pharmacists -> COE, PRR, PRA

Question 19

What domains cover the professional duties, obligations & responsibilities of a pharmacist in the COE for pharmacists?

Answer 19

Practices & Responsibilities
Inter-Professional Relationships

Question 20

A pharmacist practising unethically is a tort according to the COE for pharmacists. What category of tort does this fall under - Negligent (act of omission), Liability (liable for), Intentional (act of commission)?

Answer 20

all 3

Question 21

Which of the following torts bring disrepute to the pharmacy profession?

• Complaint made of information given to SPC of a registered pharmacist
• Information given to SPC on the conviction in SG or elsewhere of a registered pharmacist
• Information given to SPC touching upon the physical & mental fitness of a registered pharmacist

Answer 21

1&2
- if complainant brings case to court + if pharmacist is convicted -> brings disrepute to pharmacy profession

physical & mental fitness dealt by Complaints Committee first -> referred up to Health Inquiry Committee if necessary for decision; settled internally