Medicines Regulation

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Medicines Regulation
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This Lecture

• Medicines
• What is a medicine?
• Classification of Medicines
• Where do you find a list of Medicines and their
  classifications?
• Manufacture of Medicines
• Who can manufacture Medicines?
• Can pharmacists dilute a medicine?

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What is a medicine?

• Section 3 Medicines Act 1981
• medicine means any substance or article, other
  than a medical device, that is manufactured,
  imported, sold, or supplied wholly or
  principally
• (a) For administering to one or more human beings
  for a therapeutic purpose or
• (b) For use as an ingredient in the preparation
  of any substance or article that is to be
  administered to one or more human beings for a
  therapeutic purpose, where it is so used
• (i) In a pharmacy or a hospital or
• (ii) By a practitioner, or registered midwife,
  or designated prescriber, or in accordance with a
  standing order or
• (iii) In the course of any business that consists
  of or includes the retail sale, or the supply in
  circumstances corresponding to retail sale, of
  herbal remedies or
• (c) For use as a pregnancy test.

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Meaning of therapeutic purpose

• Section 4 Medicines Act 1981
• In this Act, unless the context otherwise
  requires, the term therapeutic purpose means
• (a)Treating or preventing disease or
• (b)Diagnosing disease or ascertaining the
  existence, degree, or extent of a physiological
  condition or
• (c)Effecting contraception or
• (d)Inducing anaesthesia or
• (e)Altering the shape, structure, size, or
  weight of the human body or
• (f)Otherwise preventing or interfering with the
  normal operation of a physiological function,
  whether permanently or temporarily, and whether
  by way of terminating or reducing or postponing,
  or increasing or accelerating, the operation of
  that function, or in any other way or
• (g)Cleaning, soaking, or lubricating contact
  lenses

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Classification of Medicines
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Classification of Medicines

• Medicines are classified according to their
  active ingredients.
• The First Schedule to the Medicines Regulations
  1984 is a list of active ingredients grouped
  under their respective classifications.
• Classification changes occur approximately every
  six months.

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Classification of Medicines

• Consumer convenience
• Potency
• Current availability
• Therapeutic index
• Toxicity
• Abuse potential
• Inappropriate use
• Precautions
• Communal harm

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Classification of Medicines

• Pharmacy Only Medicines
• Prescription Medicines
• Restricted Medicines
• General Sale Medicines??

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Section 3 Medicines Act 1981

• pharmacy-only medicine means a medicine that is
  declared by regulations made under this Act or by
  a notice given under section 106 to be one that,
  except as may be permitted by the regulations,
  may be
• (a) sold by retail only
• (i) in a pharmacy or hospital or
• (ii) in any shop described in section 51(2) and
  in accordance with a licence issued under Part 3
  or
• (b) supplied in circumstances corresponding to
  retail sale only
• (i) in a pharmacy or hospital or
• (ii) in any shop described in section 51(2) and
  in accordance with a licence issued under Part 3
  or
• (iii) in accordance with a standing order

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Section 3 Medicines Act 1981

• Prescription medicine means a medicine that is
  declared by regulations made under this Act or by
  a notice given under section 106 to be one that,
  except as may be permitted by regulations made
  under this Act, may be
• (a) Sold by retail only under a prescription
  given by a practitioner, registered midwife,
  veterinarian, or a designated prescriber and
• (b) Supplied in circumstances corresponding to
  retail sale only
• (i) Under a prescription given by a practitioner,
  registered midwife, veterinarian, or a designated
  prescriber or
• (ii) In accordance with a standing order and
• (c) Administered only in accordance with
• (i) A prescription given by a practitioner,
  registered midwife, veterinarian, or a designated
  prescriber or
• (ii) A standing order

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Section 3 Medicines Act 1981

• Restricted medicine means a medicine that is
  declared by regulations made under this Act or by
  a notice given under section 106 to be one that,
  except as may be permitted by the regulations,
  may be
• (a) sold by retail only by a pharmacist in a
  pharmacy or hospital or
• (b) supplied in circumstances corresponding to
  retail sale only
• (i) by a pharmacist in a pharmacy or hospital or
• (ii) in accordance with a standing order.

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Where do you find a list of Medicines and their
classifications?

• Medicines Regulations 1984
• Regulation 3 Classification of medicines
• (1) All medicines and classes of medicines
  specified in Part 1 of Schedule 1 to these
  regulations are hereby declared to be
  prescription medicines.
• (2) All medicines and classes of medicines
  specified in Part 2 of Schedule 1 to these
  regulations are hereby declared to be restricted
  medicines.
• (3) Subject to subclause (4) of this regulation,
  all medicines and classes of medicines specified
  in Part 3 of Schedule 1 to these regulations are
  hereby declared to be pharmacy-only medicines.
• (4) Nothing in subclause (3) of this regulation
  shall apply to a remedy that is, and is described
  as, homoeopathic

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List of Classifications
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Manufacture of Medicines
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Section 26 Medicines Act 1981

• (1) Notwithstanding section 17 of this Act, but
  subject to subsections (2) and (3) of this
  section and to the other provisions of this Act
  and to any regulations made under this Act, a
  pharmacist may manufacture, pack, label, sell,
  and supply any medicine.
• (2) The authority conferred by subsection (1) of
  this section shall extend only to the
  manufacture, packing, labelling, selling, or
  supplying of medicines,
• (a) In the case of a pharmacist employed in a
  hospital, in the course of that pharmacist's
  employment as a pharmacist in that hospital
• (b) In any other case, by a pharmacist in a
  pharmacy.
• (3) Subsection (1) of this section shall not
  authorise
• (a) The sale or supply of any medicine, except
• (i) Pursuant to an order given or a request made
  by the person to whom the medicine is sold or
  supplied or
• (ii) In the ordinary course of business with
  reference to the needs expressed by that person
  or
• (b) The sale or supply of a prescription medicine
  otherwise than pursuant to a prescription.
• (4) Subject to subsection (2) of this section,
  nothing in section 20 or section 24 of this Act
  shall apply in respect of the sale or supply by a
  pharmacist of a medicine compounded by that
  pharmacist to suit the needs of a particular
  person

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Can pharmacists dilute a medicine?

• Regulation 5 Medicines Regulations 1984
• Pharmacist may dilute medicine in particular case
• Where any liquid medicine in respect of which a
  standard is prescribed by any of the provisions
  of these regulations is to be supplied by a
  pharmacist pursuant to a prescription issued for
  a particular patient, the pharmacist may add a
  compatible diluent to the medicine if he is
  satisfied that
• (a) Such dilution is necessary to adjust the dose
  to a quantity easily measurable by the patient or
  by any other person on behalf of the patient and
• (b) The addition of that diluent will not affect
  injuriously the composition of the medicine.

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47 Storage and delivery of medicines

• Section 47 Medicines Act 1981
• (1) No person who is in possession or charge of
  any prescription medicine or restricted medicine
  shall put it
• (a) In any cupboard, box, shelf, or other place
  of storage in which articles of food or drink are
  stored or kept for ready use or
• (b) In any place to which young children or
  unauthorised persons have ready access.
• (2) No person shall pack any medicine, or prepare
  it for use, in any room, or on any table or
  bench, that is used for the purpose of packing,
  preparing, or consuming any food or drink.
• (3) Except as otherwise provided in any
  regulations made under this Act, no person who is
  in possession, for the purposes of any business,
  of a prescription medicine or a restricted
  medicine that is kept for the time being within
  any building or vehicle shall leave that building
  or vehicle unattended, unless he has taken all
  reasonable steps to secure that building or
  vehicle, or the part of it in which the medicine
  is kept, against unlawful entry.
• (4) No person shall deliver on retail sale, or in
  circumstances corresponding to retail sale, any
  medicine otherwise than through the post or by
  handing it or causing it to be handed to the
  person, or another person reasonably believed to
  be acting on that person's behalf, to whom it is
  addressed or for whose use it is intended.
• (5) Every person commits an offence against this
  Act who, without reasonable excuse, contravenes
  any of the provisions of this section.

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32 Storage of medicines

• (1) Every person in possession or control of any
  medicine, related product, or cosmetic for sale,
  or of any container or appliance used for or in
  connection with the sale of any medicine, related
  product, or cosmetic, or the manufacture,
  storage, or packing of any medicine, related
  product, or cosmetic for sale, shall at all
  times
• (a) Keep the medicine, related product, cosmetic,
  container, or appliance clean and free from
  contamination by moisture, foul odours, or dust
  and
• (b) Protect the medicine, related product,
  cosmetic, container, or appliance from access by
  creatures likely to contaminate it.
• (2) Every person in possession of any medicine,
  related product, or cosmetic for sale shall at
  all times store and keep it packed in such manner
  as to minimise its deterioration, and shall
  comply with all requirements for storage stated
  on the label or contained in a specified
  publication in respect of that medicine, related
  product, or cosmetic.

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36 Storage to be separate

• No person shall store or keep for ready use any
  medicine, related product, or cosmetic in such
  manner that a food or drink may be contaminated
  by the escape or leakage of the medicine, related
  product, or cosmetic, or by the release of
  vapours from the medicine, related product, or
  cosmetic.

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34 Exposure to toxic substances prohibited

• Except as otherwise provided in these
  regulations, no person shall, in the course of
  the manufacture, storage, packing, or supply of
  any medicine, related product, or cosmetic for
  sale, keep, carry, spread, or use, or permit to
  be kept, carried, spread, or used, any toxic or
  noxious substance so as to expose the medicine,
  related product, or cosmetic to the risk of
  contamination by that substance at any time.
•  

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Places of Manufacture
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29 Places of manufacture, storage, and sale

• No person shall use any place or permit any place
  to be used for or in connection with the sale of
  any medicine, related product, or cosmetic, or
  the manufacture, storage, or packing of any
  medicine, related product, or cosmetic for sale,
  unless the place complies with the following
  requirements
• (a) The place shall be kept adequately lighted by
  daylight or artificial light, as the
  circumstances require, at all times when any work
  is being carried out there
• (b) The place shall be kept appropriately
  ventilated at all times while any medicine,
  related product, or cosmetic, or any container or
  material for the packing of any medicine, related
  product, or cosmetic, is present there
• (c) If a waste liquid is produced there, the
  place shall be provided with a means of drainage
  that is sufficient for the removal of the waste
  liquid, and that is kept in good, clean, working
  order and condition
• (d) The place shall be kept, so far as is
  practicable, clean and free from foul odours and
  free from dust and creatures likely to
  contaminate the medicine, related product, or
  cosmetic
• (e) The walls, floors, ceilings, and roofs shall
  be properly constructed and kept in good repair,
  and shall be easy to clean

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29 Places of manufacture, storage, and sale

• (f) The place shall not be used for any purpose
  (other than the sale of any medicine, related
  product, or cosmetic, or the manufacture,
  storage, or packing of any medicine, related
  product, or cosmetic for sale) that might affect
  the quality of the medicine, related product, or
  cosmetic
• (g) The place shall be provided with sinks and
  other sanitary fittings reasonably necessary for
  cleansing appliances used there, and all such
  sinks and other sanitary fittings shall be
  maintained in good, clean working order and
  condition
• (h) The place shall be provided with an adequate
  supply of hot and cold water, and soap or other
  detergent
• (i) The place shall be provided adequately with
  wash basins and toilets for the use of persons
  engaged or employed in or about the premises, and
  all such wash basins and toilets shall be
  maintained in good, clean working order and
  condition, and shall be provided with an adequate
  supply of hot and cold water, soap or other
  detergent, nail brushes, and towels or other
  drying equipment.