Pharmacy Law

Question 1

What was the first body that put legal restrictions on the sales of poisons and drugs?

Answer 1

Pharmacy Act 1852-Established the framework for the pharmaceutical society.

Question 2

What was the Pharmaceutical Society replaced by?

Answer 2

In 2010 it was replaced by two bodies
GPhC (General pharmaceutical Society)- Regulates you against pharmacy standards to protect the public.
RPS (Royal Pharmaceutical Society)- It promotes what pharmacy is and what it can do for public and government

Question 3

What is the Medicine Act 1968

Answer 3

It allows the safe selling of drugs so separates them into 3 legal classifications’:
GSL - General sales list
P- Pharmacy Only
POM- Prescription Only medicine

Question 4

Paracetamol Legal Class

Answer 4

Paracetamol 500mg
0-32 GSL
32-100 P
100+ POM

Question 5

Aspirin Legal Class

Answer 5

Aspirin 500mg
0-32 GSL
32-100 P
100+ POM

Question 6

Codeine and Dihydrocodeine Legal Class

Answer 6

Treats acute to moderate amounts of pain. Works stronger than medicine like paracetamol ,ibuprofen and aspirin. In September 2009 there was tighter controls due to overdose and addiction
32 dose units- GSL

Question 7

Pseudoephedrine and Ephedrine Legal Class

Answer 7

Pseudoephedrine- 720mg POM
Ephedrine- 180mg POM
Both cannot be sold at the same time with POM

Question 8

Emergency Hormonal Contraception (EHC) Legal Class

Answer 8

Levonorgestrel- 16+ P
Ulipristal Acetate - 16 - P
(Ask if they’ve been raped)

Question 9

Ibuprofen Legal Class:

Answer 9

200mg Max strength tablets

Question 10

Bisacodyl Legal Class

Answer 10

0-40 tablets GSL
40+ P

Question 11

Raninditine Legal Class

Answer 11

Mostly POM
Can be sold as a GSL - 75mg max 12 tablets

Question 12

Daktacort Legal Class

Answer 12

15g- P
30g- POM

Question 13

What is the Health Act 1999?

Answer 13

Strengthens and modernises the regulations for healthcare professionals.
Replaced the Pharmacy Act 1958
Regulated Pharmacists and Technicians in 2007

Question 14

Explain what RP is

Answer 14

RP is a responsible pharmacist that is in charge for the safe and effective running of a pharmacy
- Maintains and reviews procedures
- Keep a record of RP at any one time
- Name and registration must be displayed

Question 15

RP regulations:

Answer 15

-Enables pharmacist to leave pharmacy for two hours in a space of 24 hours
- GSL can be sold
-RP must be contactable

Question 16

What is the Humans Regulations Act 2012?

Answer 16

Updates were made. This legislation allows pharmacists to make professional judgment on labelling of medicine
So they are able to make changes on the
-Name or common name of drug
- Change directions
- Change precautions of use

Question 17

Limitations of the Human Regulations Act 2012

Answer 17

-ONLY allows changes to be made to labels
-Strength and quantity cannot be changed of drug
-Cannot change conventions on a incomplete prescription
-Cannot make generic substitutions.

Question 18

What is Pharmacy Act Regulations 2013?

Answer 18

Replaced 2012 regulations After reflecting on the NHS structure. NHS is responsible for pharmaceutical list. Health and Wellbeing Board is responsible for the applications of the openings of new pharmacies.

Question 19

Types of Prescriptions:

Answer 19

FP10 GP- Green
FP10 D dentist- Yellow
FP10 MDA (GPs treating drug addicts)- Blue
FP10 P (prescribing nurses)- Lilac
FP10 PCD (private)- Pink

Question 20

What is the Poisons Act?

Answer 20

In 2015 the poisons act 1972 was ammended vhanging how poisons are classified
- Regulated substances
- Reported Substances

Question 21

Poisons Act (Regulating substances before supplying)

Answer 21

Before you supply you must
-Check the purchaser has a Home Office Licence
-Check its unaltered and in date
-Check ID supplied cannot be made to third party
-Check the substance requested and total quantity matches details on licence
-Record details of transaction

Question 22

Poisons (Regulated Substances)

Answer 22

Label needs to be REACH (Registration, Evaluation, Authorisation and restriction of chemicals) Complaint

Question 23

Poisons (Reportable Substances)

Answer 23

Supplies do not require purchaser to hold a home office licence
If pharmacy supplies poisons or chemicals check if its suspicious and if commercial alternatives can be sold
Label needs to REACH complaint

Question 24

Controlled drugs
Misuse of Drug Act 1971 and Misuse of Drug Regulations 2001

Answer 24

Substances controlled by this act
- Scheduled according to risk and potential harm from abuse
-Schedules determine degree of control, storage requirements and record keeping required.