Medicines and the Law

Question 1

What tragedy led to stricter regulations around the supply and prescription of drugs?

Answer 1

The thalidomide tragedy

Question 2

What act was created after the thalidomide tragedy?

Answer 2

Medicines Act 1968

Question 3

Into what three categories does the medicine act 1968 group drugs?

Answer 3

Prescription only medicines (POM)
Pharmacy medicines (P)
General sales list medicines (GSL)

Question 4

What are prescription only medicines?

Answer 4

Prescription only medicines cannot be without a prescription from an appropriate prescriber - this includes independent prescribers

Question 5

Can all prescribers prescribe controlled drugs?

Answer 5

No, controlled drugs such as morphine, pethidine and methadone are regulated more strictly and only prescribed by doctors.

Question 6

What are pharmacy medicines?

Answer 6

Pharmacy Medicines can only be sold from pharmacies and a pharmacist must make or supervise the sale

Question 7

Why is it good practice to have a different prescriber and dispenser of the same drug/prescription?

Answer 7

Having the supply of the drug overseen essentially by two people now instead of one reduces the likelihood of error - it is for this reason pharmacists often enquire about the patient’s health conditions before dispensing any drug.

Question 8

What are general sales list medicines?

Answer 8

General Sales List (GSL) medicines can be sold by a wide range of shops, such as newsagents and supermarkets

Question 9

How may a general sales list medicine differ to that sold in a pharmacy?

Answer 9

Often, only a small pack size or low strength of the medicine may be sold e.g:
The largest pack size of paracetamol that shops can sell is 16 tablets but pharmacies can sell packs of 32 tablets
The highest strength of ibuprofen tablets that shops can sell is 200mg but pharmacies can sell tablets at 400mg strength

Question 10

What was the medicines act 1968 surpassed by?

Answer 10

Medicines and Healthcare products Regulatory Agency (MHRA) to consolidate and review UK medicines legislation

Question 11

How does the medicines act 1968 affect optometrists?

Answer 11

Provided it is in the course of their professional practice, registered optometrists may sell or supply the following medicinal products to a patient:
All medicinal products on the General Sale List (GSL)
All P medicines

Question 12

Which Prescription only medicines (POMs) may optometrists sell or supply?

Answer 12

0.5% chloramphenicol eyedrops or 1% eye ointment
Cyclopentolate hydrochloride
Fusidic Acid
Tropicamide
Independent prescribers have an extended list.

Question 13

What’s the difference between a signed order and a prescription?

Answer 13

A prescription is for an individual. A signed order is ‘for use in the practice’ or by a certain professional.

Question 14

What must a signed order for prescription only medicines include?

Answer 14

An order for POMs should include:
Optometrist’s name and address
Date
Name and address of the patient (if applicable)
Name of the drug
Quantity, pharmaceutical form and strength of the POM (e.g. 0.5% eye drops 10ml)
Labelling directions (where applicable)
Original signature of the optometrist

Question 15

What conditions must a signed order satisfy?

Answer 15

The signed order must be in indelible ink; this includes typewritten and computer-generated orders.

College of Optometrists’ guidance recommends that the optometrist’s GOC number should also be included

Question 16

What prescription only medicines can be administered by optometrists but not sold or supplied?

Answer 16

Tetracaine hydrochloride 0.5% (Amethocaine)
Lidocaine hydrochloride 4% (Lignocaine)
Oxybuprocaine hydrochloride 0.4% (Benoxinate)
Proxymetacaine hydrochloride 0.5%
Basically the corneal anaesthetics

Question 17

True or false- the law allows for local arrangements for non-prescribing professionals to supply or administer specific drugs

Answer 17

True - this can be given in two ways:
Patient specific direction
Patient group direction

Question 18

What is patient specific direction in relation to the supply and administration of drugs?

Answer 18

It is essentially the act of an independent prescriber giving instructions to another professional to administer a drug to a specific person

Question 19

What is patient group direction in relation to the supply and administration of drugs?

Answer 19

It is a written instruction for the supply or administration of drugs to a specific group of patients, by a named healthcare professional which must be signed and agreed upon by a senior doctor and pharmacist.

Question 20

How did the crown review affect optometry?

Answer 20

It basically stated that not only doctors should be allowed to prescribe and that other healthcare professionals like optometrists should be able to too within their field.
Thus gave way to independent prescribing and supplementary prescribing

Question 21

What is independent prescribing?

Answer 21

To be a sole prescriber

Question 22

What is supplementary prescribing?

Answer 22

3-way partnership between a medical practitioner (independent prescriber) who establishes the diagnosis and initiates treatment, a (supplementary prescriber) who monitors the patient and prescribes further supplies of medication and the patient who agrees to the supplementary prescribing arrangement

Question 23

What conditions must be satisfied for a prescription to be valid?

Answer 23

A prescription for a medicine should be written legibly in ink or computer generated and should contain the following information:
Date
Name and address of patient
Patents age and DOB (legal requirement in under 12’s)
Name of drug, dose and number of days of treatment required
Prescribers signature

Question 24

What does the following abbreviation mean?

“ac”

Answer 24

ac- ante cibum (before food)

Question 25

What does the following abbreviation mean?

“pc”

Answer 25

pc- post cibum (after food)

Question 26

What does the following abbreviation mean?

“bd”

Answer 26

bd - bis die (twice daily)

Question 27

What does the following abbreviation mean?

“tds”

Answer 27

tds - ter die sumendum (three times daily)

Question 28

What does the following abbreviation mean?

“qds”

Answer 28

qds - quater die sumendum (four times daily)

Question 29

What does the following abbreviation mean in relation to drugs?
“od”

Answer 29

od - omni die (every day)

Question 30

What does the following abbreviation mean?

“om”

Answer 30

om - omnni mane (every morning)

Question 31

What does the following abbreviation mean?

“on”

Answer 31

on - omni nocte (every night)

Question 32

What does the following abbreviation mean?

“prn”

Answer 32

prn - pro re nata (when required)

Question 33

Who gives out licenses for drugs to be used in the UK?

Answer 33

Medicines and Healthcare products Regulatory Agency (MHRA)

and technically the European Medicines Agency (EMEA) which can grant licences for medicines in the European Union (EU)

Question 34

What is a medicines license also known as?

Answer 34

The licence is also known as a marketing authorisation

Question 35

What information does a license for medicines include?

Answer 35

The licence for a medicine includes information such as:
what health condition the medicine should be used to treat
the dose, form and who can use the medicine e.g. age restrictions
how long treatment with the medicine should last
warnings about known safety issues, such as side effects and interactions with other medicines
basically an SPC ( summary product characteristics).

Question 36

True or False- Specified POMs included in the entry level exemptions list and additional supply medicines can be supplied directly to patients in an emergency and routinely supplied by pharmacists upon presentation of an order signed by optometrists

Answer 36

True