IASM 79: Drugs (Laws and Regulations)

Question 1

There are 4 phases for the clinical development of drugs

1. Verify _____ and _______, focus on ____________
2. Determine _______
3. Expand testing on _______ and ______
4. Collection information from _________ after _____

Answer 1

There are 4 phases for the clinical development of drugs

1. Verify safety and tolerability, focus on pharmacokinetics
2. Determine effectiveness of drug
3. Expand testing on safety and effectiveness
4. Collection information from patients after marketed

Question 2

Originally, Viagra was used to treat hypertension and angina.

cGMP leads to vasodilation.
_____ breaks down cGMP, inhibiting vasodilation.
Viagra inhibits ______, promoting vasodilation.
But in human vessels, we use PDE_ while in the penis we use PDE_. That’s why it promotes penile erection.

Answer 2

Originally, Viagra was used to treat hypertension and angina.

cGMP leads to vasodilation.
PDE breaks down cGMP, inhibiting vasodilation.
Viagra inhibits PDE, promoting vasodilation.
But in human vessels, we use PDE1 while in the penis we use PDE5. That’s why it promotes penile erection.

Question 3

Physiological modification of drugs
Gastric acid secretion is using ___ receptor
Traditional antihistamine is ___ receptor antagonist
So we have to modify the structure of the traditional antihistamine to produce the effect

Answer 3

Physiological modification of drugs
Gastric acid secretion is using H2 receptor
Traditional antihistamine is H1 receptor antagonist
So we have to modify the structure of the traditional antihistamine to produce the effect

Question 4

What is the difference between
‘Listed Sellers of Poisons’ and
‘Authorized Seller of Poisons’

Answer 4

Listed Sellers VS Authorized Sellers

• No pharmacist VS Yes pharmacist
• Cannot use Rx Logo VS Can use Rx logo

Question 5

The order for ‘severity’ of drugs to be sold are like this:
Do they need Pharmacists and Prescription?

• Non-poison
• Part II Poison
• Part I Poison
• Part I Schedule I Poison
• Part I Schedule III Poison or Antibiotics
• Dangerous Drugs

Answer 5

The order for ‘severity’ of drugs to be sold are like this:
Do they need Pharmacists and Prescription?

• Non-poison: No Pharmacists, No Prescription
• Part II Poison: No Pharmacists, No Prescription
• Part I Poison: Yes Pharmacists, No Prescription
• Part I Schedule I Poison: Yes Pharmacists, Yes Prescription
• Part I Schedule III Poison or Antibiotics: Yes Pharmacists, Yes Prescription
• Dangerous Drugs: Yes Pharmacists, Yes Prescription in ink and indelible, Yes ID card of patient, Stored in locked receptacle, Write in Dangerous Drug Register

Question 6

The order for ‘severity’ of drugs to be sold are like this:
Give examples for the following:

• Non-poison
• Part II Poison
• Part I Poison
• Part I Schedule I Poison
• Part I Schedule III Poison or Antibiotics
• Dangerous Drugs

Answer 6

• Non-poison: Paracetamol, Vitamin
• Part II Poison: Antihistamine
• Part I Poison: Bronchodilator, Anti-fungal agent
• Part I Schedule I Poison: Dextromethorphan
• Part I Schedule III Poison or Antibiotics: Antihypertensive, Steroids
• Dangerous Drugs: Opioid like morphine, Diazepam