L69: Development And Regulation Of Drugs

Question 1

Drug discovery based on

Answer 1

1. History: cocaine, morphine, quinine
2. Chance observation: penicillin, cisplatin
3. Random screening: taxol
4. Clinical observation of side effects: viagra
5. Physiological substance: cimetidine (H2 blocker, orally active, no granulocyclopenia)

Question 2

Phases of drug development

Answer 2

Drug discovery

Early phase:

• PK study (routes, ADME)
• Toxicology (acute, chronic, reproductive, carcinogenicity)

Clinical phase:
1. Phase I (safety and tolerability, 6-9 months, small number of individuals)
—> ADME
2. Phase II (effectiveness, 6 months-3 years, several hundred patients)
—> minimum and maximum effective dose
3. Phase III (expanded study on effectiveness and safety, 1-4 years, several thousand patients)
4. Phase IV (post-marketing, collect information from patients)
—> long-term effectiveness
—> side effects

Question 3

Sale of drugs law

Answer 3

1. Pharmacy and Poisons ordinance
   - Pharmacy nad poisons regulations
   - Poisons list regulations
2. Antibiotics ordinance
   - Antibiotics regulations
3. Dangerous drugs ordinance
   - Dangerous drugs regulations

Question 4

Listed sellers of poisons vs Authorized sellers of poisons

Answer 4

Listed sellers of poisons:

• no pharmacist
• cannot dispense
• cannot use Rx logo
• no broken-bulk

Authorized sellers of poisons:

• pharmacist present
• can dispense
• can use Rx logo

Question 5

Non-poisons

Answer 5

• for minor ailments
• paracetamol, loperamide, laxative, contraceptive
• Supermarkets or above

Question 6

Part II poison (Hospital or above)

Answer 6

• Part II of Poisons List
• Antihistamine
• Hospital or above
• sold without supervision of pharmacist
• no prescription required

Question 7

Part I poison (no listed sellers of poisons, under supervision)

Answer 7

• Part I of Poisons List
• Bronchodilator, antifungal, GTN
• Hospital or above (no listed sellers of poisons)
• Under supervision of pharmacist
• No prescription required

Question 8

Part 1 Schedule 1 (有schedule —> 要prescription)

Answer 8

• Part I of Poisons List and First Schedule in Pharmacy and Poisons Regulations
• Dextromethorphan
• Hospital or above (no listed sellers of poisons)
• Under supervision of pharmacist
• Prescription required
• no prescription —> Poison book

Question 9

Part 1 Schedule 3 (有schedule —> 要prescription)

Answer 9

• Part I of Poisons List and Third Schedule in Pharmacy and Poisons Regulations
• Antihypertensive, Steroids, Antidepressant, Sedatives
• Hospital or above (no listed sellers of poisons)
• Under supervision of pharmacist
• Prescription required

Question 10

Prescription requirement

Answer 10

Name and address of patient

“For dental treatment only”
“For animal treatment only”

Question 11

Antibiotics

Answer 11

• Antibiotics Regulations
• Hospital or above (no listed sellers of poisons)
• Under supervision of pharmacist
• Prescription required

Question 12

Dangerous drugs (Indelible ink, DD register)

Answer 12

• Part I of First Schedule in Dangerous Drugs Ordinance
• Opioid, benzodiazepine, amphetamine, hallucinogen
• Hospital or above (no listed sellers of poisons)
• Under supervision of pharmacist
• Prescription required (Indelible Ink, ID card no.)
• Dangerous Drug Register (DD register; entry within 48 hours, marginal note)

Question 13

Undesirable Medical Advertisements Ordinance (UMAO)

Answer 13

Advertisement allowed for:
disease in Column 2 of Schedule 1 of UMAO e.g. common cold, indigestion

Advertisement allowed for:
medicine, surgical appliances, treatment for disease in Column 1 of Schedule 1 of UMAO e.g. cancer, venereal disease (STD), heart disease
Exemption: publication intended fo registered medical practitioners