The Pharmacy Law

Question 1

Why was The Medicines Act 1968 introduced?

Answer 1

It was introduced due to Thalidomide tragedy, where this drug caused fatal development issues

Question 2

What did The Medicines Act 1968 do?

Answer 2

This made distinctions between prescription drugs, drugs that can only be sold from pharmacy and drugs available for general sale- allowed for medicine classification

Question 3

What was set up following The Medicine Act 1968?

Answer 3

The yellow card scheme was set up.
This allowed patients and healthcare professionals to report any adverse side-effects to drugs

Question 4

What is the Human Medicines Regulations 2012?

Answer 4

It is a consolidation of medicines legislation- they repealed, revoked or re-enacted most existing UK legislation regulating the authorisation, sale and supply of medicinal products for human use

Question 5

What does the Human Medicines Regulation 2012 cover?

Answer 5

Medicines may only be supplied to the public from pharmacies except medicines which can be sold without the pharmacist with reasonable safety
Covers matters relating to labelling of medicines, containers

Question 6

What legislation is not covered in The Human Medicines Regulations 2012?

Answer 6

-legislation concerned with clinical trials
-legislation concerned with the administration of radioactive medicinal products
-fees charged y the MHRA for the administration of procedures under the provision
-left parts of the 1968 act which deals with the registration and conduct of pharmacies
-neither 1968 nor 2012 apply to medical devices or veterinary medicine

Question 7

What are the three legal classifications of drugs?

Answer 7

GSL (general sales list medicines)
P (pharmacy only medicines)
POM (Prescription only medicines)

Question 8

What legislation and regulation is covered in The Medicines Act 1968?

Answer 8

-regulates the licensing, supply and administration of medicines
-POM can only be given in accordance with the directions of an appropriate prescriber

Question 9

What is The misuse of drugs Act 1971?

Answer 9

-consolidates and extends previous legislation and controls the export, import, production, supply and possession of dangerous or otherwise harmful drugs (controlled drugs)
-drugs listed in act are subject to control and are separated according to harmfulness (Class A, Class B, Class C)

Question 10

What is the Misuse of Drugs Regulations 2001?

Answer 10

-define the classes of people who are authorised to supply and possess controlled drugs while acting in their professional capacities and lay downs under the conditions under which these activities may be carried out
-drugs divided into 5 schedules, each specifying the requirements governing such activities as import, export, production, supply, possession, prescribing and record keeping which apply to them (schedules 1 to 5)

Question 11

What is The Poisons Act 1972?

Answer 11

-concerned with the sale, supply, storage, record keeping and labelling of poisons
-pharmacies are required to report suspicious transactions and significant stock loss
-with dangerous, poisonous chemicals the pharmacy team is required to check the license is valid

Question 12

Who decides the final sale or supply of a medicine?

Answer 12

Pharmacist

Question 13

Are prescriptions issued from EEA or Switzerland valid?

Answer 13

-if they are issued by an approved health professional in an approved country they are legally recognised in the UK
-emergency supplies for patients of these healthcare professionals are also permitted
-if prescription originates from country or prescriber that is not approved, then prescription is not valid and should use professional judgement to find the best way to help the patient

Question 14

What are the legal requirements of a prescription?

Answer 14

-signature of prescriber
-prescriber’s address
-date (legally valid for 6 months after date) - CD have different period of validity
-something to indicate the type of prescriber
-address of patient
-age of patient if less than 12 years old
-should be in indelible ink

Question 15

What are the requirements for a private prescription?

Answer 15

They have the same requirements as a NHS prescription, but it doesn’t need to be on a FP10 form, can be written on any piece of paper

Question 16

What is the EPS?

Answer 16

-allows prescribers to send prescriptions electronically to the dispenser

Question 17

What are EPS tokens?

Answer 17

-paper copies of electronic prescriptions
-act as a hard copy of the details contained within electronic prescription
-2 types: prescription (green), dispensing (white)

Question 18

Tell me about prescription tokens.

Answer 18

-electronic prescription can only be amended or cancelled electronically
-it will show any notes the prescriber has added to the electronic prescription for the patient or pharmacy to be aware of
-should not dispense from town, should always print prescription from token

Question 19

Can Private prescription be repeated?

Answer 19

Yes if they contain directions can be repeated
If it says Repeat x5 = can be dispensed 5 times
If it says repeat can be repeated twice

Question 20

What are FP10D prescriptions?

Answer 20

These are dental prescriptions

Question 21

What are dentists able to prescribe?

Answer 21

-on a private prescription can prescribe any POM (except cocaine, dipainone or diamorphine) but prescribing should be restricted to dental conditions
-if they are prescribing on a NHS prescription, they are restricted to medicines within the Dental Practitioners’ Formulary

Question 22

What is an FP10P prescription?

Answer 22

Prescription on which Community Nurse prescribers prescribe on

Question 23

What are community Nurse Prescribers able to prescribe?

Answer 23

-found in the nurse prescribing formulary
-includes: dressings, appliances, licensed medicines

Question 24

What are supplementary prescribers?

Answer 24

-voluntary partnership between an independent and supplementary prescriber within an agreed patient specific clinical management plan with the patient’s agreement (can only prescribe within the clinical management plan)
-patient will be clinically assessed by IP
-continuing prescribing/ dose titration/ introduction of new agents will be done by supplementary prescriber

Question 25

What is wholesale dealing?

Answer 25

When pharmacies engage in commercial trading in medicines e.g. buy directly from pharmaceutical company

Question 26

What body is the selling of medicines regulated by?

Answer 26

MHRA

Question 27

What are the requirements for anyone trading in medicines?

Answer 27

-hold a whole sale license (WDA)
-comply with good distribution practise (GDP) and pass regular inspections
-have a suitable named responsible person on license to ensure that medicines are precedured, stored and distributed appropriately

Question 28

What are some WDA exemptions?

Answer 28

-pharmacies supplying stock to another pharmacy within the same legal entity are not required to have a WDA
-registered pharmacies and hospitals supplying small quantities of meds to healthcare professionals for treatment or onward supply to patients are not required to hold WDA
-this can occur as long as transaction occurs on an occasional basis, quantity of meds is small, supply of meds is based on a non-profit basis, supply is not for onward wholesale distribution

Question 29

What is required when a POM is supplied from a registered pharmacy to healthcare professionals or organisations?

Answer 29

A signed order
Legally entry needs to be made in the POM register or the signed order be retained for 2 years from the date of supply

Question 30

What should an entry in the POM register include?

Answer 30

-date POM was supplied
-name, quantity and formulation and strength of POM supplied
-name and address, trade, business or profession of the person whom it was supplied to
-purpose for which it was sold or supplied