Lecture 16: Medicines Regulation

Question 0

How are medicines classified?

Answer 0

According to their active ingredients

Question 1

What is the meaning of therapeutic purpose?

Answer 1

Treating or preventing disease
Diagnosing disease or ascertaining existence, degree or extent of a physiological condition.
Effecting contraception
Inducing anaethesia
Altering shape, structure size or weight of the human body
Otherwise preventing or interfering with the normal function operation of a physiological function permanently or temporarily by terminating, reducing, postponing, increasing or accelerating the operation of that function
Cleaning, soaking or lubricating contact lenses

Question 2

How often to medicines classification changes?

Answer 2

Every 6 months

Question 3

What is a medicine?

Answer 3

Any substance or article other than a medical device that is manufactured, imported, sold or supplied wholly or principally for

Administering to one or more human beings for a therapeutic purpose where it is to be used in a pharmacy or hospital,
By a practitioner, or registered midwife or designated prescriber
In the course of any business that consists of or includes the retail sale or supply in circumstances corresponding to retail sale of herbal remedies or for use as a pregnancy test

Question 4

What are the 4 main classifications of medicines?

Answer 4

Pharmacy only medicines
Prescription medicines
Restricted medicines
General sales medicines

Question 5

What is a pharmacy only medicine?

Answer 5

Medicine which is declared by the regulations made under this act or by a notice given under section 106 to be sold by retail only in a pharmacy or hospital or in any shop described in section 51(2)

It must be supplied in circumstances corresponding to retail sale only in a pharmacy hospital or in any shop described in section 51(2)

In accordance with a standing order

Question 6

Where do you find a list of medicines and their classification?

Answer 6

Under regulation 3 of medicines regulations 1984

Question 7

How does the regulation classify medicines?

Answer 7

All medicines and classes specified in part 1 of schedule 1 to these regulations are declared to be prescription medicines

All specified in part 2 of schedule 1 are declared to be restricted medicines

Subject to subclause 4, all medicines and classes specified in part 3 of schedule 1 are pharmacy only medicines

Nothing in subclause 3 of this regulation shall apply to a remedy that is and is described as homeopathic

Question 8

What is a prescription medicine?

Answer 8

Medicines which are sold by retail, supplied in circumstances to retail, and administered only under a prescription given by a practioner, registered midwife, vet or designated prescriber

In accordance with a standing order

Question 9

What factors influence the classification of medicines?

Answer 9

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

Question 10

What is a restricted medicine?

Answer 10

Medicine that is declared by regulations to be sold by retail only by a pharmacist in a pharmacy or hospital, or supplied in circumstances corresponding to retail only by a pharmacist in a pharmacy or hospital or in accordance with a standing order

Question 11

What does the regulation state about the manufacture of medicines?

Answer 11

Except as provided in sections 25-34 or as may be permitted by regulations made under this act, no person shall in the course of any business carried on by that person,

Manufacture any medicine
Sell any medicine by wholesle
Pack or label any medicine
Operate any pharmacy otherwise than in accordance with a license issued under part 3

Question 12

What does the regulation say about pharmacists and the manufacture of medicines?

Answer 12

A pharmacist may pack, label, sell and supply any medicine

In the case of a pharmacist employed at a hospital, in the course of their employment as a pharmacist at that hospital.
In any other case, by a pharmacist in a pharmacy

Question 13

Subsection j of this section does not authorise the sale of any medicine except what?

Answer 13

Pursuant to an order given or a request made by the person to whom the medicine is sold or supplied

Or in the ordinary course of businesses with reference to the needs expressed by that person or

The sale/supply of a prescription medicine otherwise than pursuant to a prescription

Question 14

What does section 20 or 24 of this act not apply to?

Answer 14

In respect of sale/supply of a pharmacist of a medicine compounded by that pharmacist to suit the needs of a particular person

Question 15

Can pharmacists dilute a medicine?

Answer 15

Under regulation 5 of the medicines regulations 1984, a pharmacist may dilute medicine in particular case:

Where liquid medicine in respect of which a standard is prescribed 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 can also add a compatible diluetent if they are satisfied that

The dilutent is necessary to adjust the dose to a quantity easily measurable by the patient or other person on behalf of patient

And the addition of the dilutent will not affect injuriously the composition of the medicine

Question 16

What are the regulations on the storage and delivery of medicines?

Answer 16

No one in possession of medicine caput it in a cupboard, box, shelf or other place where articles of food and drink are also stored
Or in any place where young children or unauthorised persons can access it

No one can pack or prepare medicine in a room, table or bench which is used for the purpose of packing, preparing or consuming food or drink

Except as otherwise stated, no one in possession of a prescription medicine, or restricted medicine that is kept for the time being in a building or vehicle shall leave it unattended unless they have taken reasonable steps to ensure the medicine is kept against unlawful entry.

No one 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 persons behalf to whom it is addressed or for whose use it is intended,

Question 17

What does the medicines regulations say about the storage of medicines?

Answer 17

Everyone in possession or control of any medicine, …… Etc. must at all times
Keep the medicine, … Etc clean and free from contamination by moisture, foul odours or dust.

They must protect the medicine from access by creatures likely to contaminate it

Every person in possession of any medicine …..etc shall at all times store and keep it packed in such a manner 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

Question 18

What does the medicines regulations say about storage of medicines separate from food?

Answer 18

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

Question 19

What does the medicines regulation say about the prohibition of exposure to toxic substances?

Answer 19

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

Question 20

What are the medicine regulations on the PLACES of manufacture, storage and sale?

Answer 20

No one can use any place for the sale of any medicine…. Etc unless the place complies with the following requirements:

The place shall be kept adequately lighted by daylight or artificial light at all times work is to be carried out
Appropriately ventilated at all times while any medicine… Etc or any container of the packing of any medicine… Etc is present
If a waste liquid is produced the place shall be provided with a means of drainage that is sufficient for the removal of waste liquid, and that is kept in a good, clean working order and condition.

The place shall be kept so it is practicable, clean, free from foul odours and free from dust and creatures likely to contaminate medicine…. Etc.

Walls, floors, ceilings and roofs must be properly constructed and kept in good repair, and shall be easy to clean.

The place shall not be used for any purpose other than the sale, storage and packaging of medicines… Etc that might affect the quality of the medicimes… Etc

The place shall be provided with sinks and other sanitary fittings necessary for cleansing appliances. These must be maintained in good working order

The place must be provided with an adequate supply of hot and cold water and soap or other detergent

The place shall be provided adequately with wash basins and toilets. Also drying equipment is required