1120 intro to pharmacy law

• Pharmaceutical Product & Medicine: used in diagnosis, treatment, mitigation, alleviation or prevention of disease or any symptom, abnormal physical or physiological state; Altering, modifying, correcting or restoring any organic function in humans and animals
• only pharmaceutical products that is registered with the Pharmacy and Poisons Board can be sold
• Successful registration is dependent on

  • Safety,• Efficacy • Quality
• a registered pharmaceutical product has a unique Hong kong Registration Number, HK-XXXXX
• identify a registered pharmaceutical product:

  1 - buy a physical copy of compendium of pharmaceutical products

  2 - visit the drug office website
• 藥房： authorised sellers of poisons
• 藥行/藥妝： listed sellers of poisons (no pharmacists)
• sources of drug products:

  • Holders of Wholesale Poisons Licence (for Part I & Part II Poisons),
  • Holders of Certificate of Registration as an Importer / Exporter (for Non-Poisons)
  • Local Retailers
  • Local Licensed Manufacturers
• Listed Sellers of Poisons (LSP) can only sell:

  • non poisons
  • part II poisons
  • in closed or original container, no broken bulk
• Authorised Sellers of Poisons (ASP) requirements

  • 藥房
  • Display of Rx logo
  • certificate of registration
  • Part I Poisons can only be sold under supervision of registered pharmacist
• 4 Types of Non-Chinese Medicine

  • non poison
  • poison (under Poisons List Regulations; PLR)
  • part I
  • schedule 1 (under Pharmacy and Poisons Regulations; PPR)
  • schedule 2
  • schedule 3
  • part II
  • Dangerous drug (under Dangerous Drugs Ordinance; DDO)
  • part I, II, IV
  • antibiotic (under Antibiotics Ordinance; AO)
• Non poison

  • no selling restrictions
  • OTC drug in any retail premises (LSP, ASP)
  • for minor ailments
  • have history of being safe and effective
• examples of non poisons: vitamins, loperamide, laxatives, dequalinium, antacids, contraceptives with less than 50 mg oestrogen and 5 mg progesterone
• dequalinium -  antiseptic, disinfectant, used in 喉糖
• laxatives - 通便
• loperamide - treating diarrhoea
• antacid -  heartburn and indigestion relief
• Poisons - Increasing level of strictness and danger

  PII < PI < PISI < PIS3
• part II poison / Part 4 DD

  • can be sold in LSP, ASP
  • without supervision of registered pharmacists
  • example: paracetamol
• Part I poison / Part 2 DD

  • can be sold in ASP only
  • with supervision of registered pharmacists
  • exmaple: insulin, bronchodilators (characteristics: meds that are used regularly or urgently, so can't be too strict)
• Part I Schedule 1 Poison

  • can be sold in ASP only
  • with supervision of registered pharmacists
  • prescription needed
  • if no prescription →record in Poison book
  • stored in locked receptacle
  • example: dextromethorphan (cough meds - sleepy and addictive)
• Part 1 Schedule 3 Poison & Antibiotics

  • can be sold in ASP only
  • with supervision of registered pharmacists
  • prescription needed → record in prescription book
  • *if you want antibiotics for animal husbandry and have permit from Agricultural, Fisheries and Conservation Department → record in antibiotics book (no need prescription)
  • stored in locked receptacle
  • example: steroids, sleeping pills, antidepressant (lot of side effects, death if abused)
• Prescription requirements

  • handwritten
  • date
  • presriber signature
  • name, phone, address of prescriber
  • name and address of patient
  • drug names, dosage, frequency
  • duration of treatment / total amount supplied
  • have phrase: for dental/animal treatment only
• Part 1 Dangerous Drugs Examples

  • very dangerous and addictive
  • Hallucinogens - LSD, ketamine
  • Amphetamines - stimulant
  • Opioid drugs - pain relief, eg. morphine
  • Phentermine - for weight loss
  • Benzodiazepoxide - depressants/sleeping pills
• Part I Dangerous Drugs

  • prescription needed
  • in permanent ink
  • contains ID card number of patient
  • kept in a locked receptacle which can only be opened by pharmacist
  • record in prescription book and dangerous drug register
• DD register

  • name
  • strength
  • written permanent ink
  • enter in chronological sequence
  • must be filled within 48 hours after transaction took place
  • no cancellation, obliteration, alteration
  • correction could be only made with marginal note or footnote
• labelling dispensed medicine

  • patient name
  • drug name
  • instructions
  • quantity
  • date dispensed
  • name and address of pharmacy
  • important precautions
• legal records should be kept for 2 years

  • prescriptions
  • prescription book
  • poison book (for P1S1 if no prescription)
  • dangerous drug register
• when receiving prescriptions, what should be written on the prescription?

  • name, address, phone number of the pharmacy
  • date dispensed
• Advertising is prohibited for diseases and conditions in UMAO Sch 1 Col 1, for example, malignant tumours and heart diseases
• Advertising is allowed for diseases and conditions in UMAO Sch 1 Col 2 , for example, common colds, headaches, indigestions, diarrhoea, travel sickness, blocked sinuses (stuffy nose)
• advertising is allowed if it is published in medical publications (eg magazines) ; "publication of a technical character"
• Advertisement grey areas:

  • if the drug name is not mentioned they can claim it is a health promotional video
  • if the advertisement does not 'intend' to advertise the drug for treatment (eg viagra's poster on differentiating real and fake viagra)
• what types of drugs can be sold by LSP?

  1. Non poisons
  2. Part 2 poisons
• Which type of drug has no restrictions for selling?

  Non poison
• What types of drugs do not require a prescription?

  1. Non poison
  2. Part 2 poison
  3. Part 1 poison
  4. Part 1 schedule 1 (need to record in poisons book)
• What types of drugs must require a prescription?

  1. Part 1 schedule 1 schdule 3
  2. Antibiotics (unless you are using it for animal husbandry)
  3. Part 1 dangerous drugs
• Codeine < 0.2% w/v = part 1 schedule 1 poison
• 0.2% w/v ≤ Codeine ≤ 0.5% w/v = part 1 schedule 1 schedule 3 poison
• Codeine > 0.5% w/v = part 1 DD