Pharmacy Law lecture

Question 1

What do pharmacists need to understand about law?

Answer 1

Access to medicines - licensing, classification etc.
Supply of medicines - sale and dispensing
Supply of ‘poisons’
Misuse of drugs
Standards of Practice
NHS law
Other relevant areas - e.g. Health and Safety, Employment, Control of Waste, Information Governance etc.

Question 2

Context of the law

Answer 2

Before middle of 19th century no legal restrictions in England on the sale of poisons or drugs
Pharmacy Act 1852 established the framework of the Pharmaceutical
Society
The Pharmaceutical Society had power to hold examinations, issue certificates and restrict title pharmaceutical chemist to members of the Society
Royal prefix in 1988
2010 The Society was replaced by 2 bodies
* The General Pharmaceutical Council (regulate us) (GPhC)
* The Royal Pharmaceutical Society (founder by jacob bell) (promote pharmacy) (RPS)

Question 3

Medicines act 1968
the different chapters

Answer 3

Licensing of medicines
Sales promotion
Regulation of retail pharmacy businesses
Legal classification of medicines
Wholesale dealing
Herbal, homeopathic, veterinary medicines
Containers
Pharmacopoeias

Question 4

Legal classification of medicines

Answer 4

Established by Medicines Act 1968 to control safe supply of medicines
* All products MUST have a marketing authorisation (formerly a product licence) issued by MHRA - Medicines and Healthcare
Products Registration Agency
* Concerns are for quality and safety
* MA will include legal classification of the product

Question 5

what are the three legal classes of drugs

Answer 5

—> POM - prescription only medicine

P - Pharmacy medicine (a medicine not listed as POM or GSL)

GSL - medicine on the general sales list (you can buy it from anywhere really)

Both POM and GSL lists are amended regularly

A change in legal status can only occur through application for such a change

The main route by which a Pharmacist can sell or supply a POM is under the authority of an RX from an appropriate practitioner

Question 6

what does legal classification of medicines relate to

Answer 6

the product and not the active substance
The same drug substance may be included in products with different legal class
Use may also affect the legal class e.g. chloramphenicol
Legal class attributesticion indussie election of the degree
Relates to the need for control or to limit public access

Question 7

Legal class of paracetamol

Answer 7

Examples of medicines where the pack size has a bearing on the classification :
* Paracetamol can be GSL, P or POM dependent on pack size
* Paracetamol 500mg tablets
* 16 GSL (anything up to)
* 32 P (only pharmacy)
* 100 POM (prescription only medicine)

Question 8

legal class - aspirin

Answer 8

Can be sold to the public provided packs contain no more than 32 capsules or tablets; pharmacists can sell multiple packs up to a total quantity of 100 capsules or tablets in justifiable circumstances.
* Aspirin can be GSL, P or POM dependent on pack size
same as paracetamol)

Question 9

dihydrocloride and codeine

Answer 9

Tighter controls introduced by MHRA in September 2009
* Aim- to minimise risk of overuse and addiction
* Indication- short term treatment of acute, moderate pain not relieved by paracetamol, ibuprofen or aspirin alone

• POM for over 32 dose units
• Additional warnings put on the pack:
  Can cause addiction. For 3 days use only

PIL- additional information about overuse headache if used continually for more than 3 days (patient leaflet)

Question 10

Pseudoephedrine and Ephedrine

Answer 10

Legal restrictions on quantities that may be sold (Regulation 237 of Human
Medicines Regulations 2012)

why? crystal meth was made out of it
* Unlawful to supply a product or combination of products that contain more than 720mg of pseudoephedrine or 180mg of ephedrine at any one time without a prescription

• Unlawful to sell any pseudoephedrine product at the same time as an ephedrine product without a prescription

Question 11

emergency hormonal contraception (EHC)

Answer 11

Levonogestrel 1500 microgram tablet and ulipristal acetate 30mg tablets licenced
as P medicines (used to be POMS)

• Pharmacist should be involved in assessing suitability and approving sales
• Marketing authorisation-
  16 and over for levonogestrel

woman of child bearing age- ulipristal

• Sexual activity with a child under the age of 16 is am offence, but may be
  consensual- more in year 2

Question 12

Legal class for ibuprofen, bisacodyl, ranitidine

Answer 12

Ibuprofen 200mg max strength as a GSL
* Bisacodyl (for adults); 40 tablets are GSL more are P

• Pack size GSL/ POM
• Ranitidine is usually POM but becomes GSL at 75mg dose and for maximum pack size of
  12 tablets
• Pack size P/POM
• Daktacort 15g is a P
• Daktacort 30g is POM

Question 13

legal class 2 (PO is not a legal clasS)

Answer 13

Pharmacy Medicines (P) or PO

• P- Under Supervision of a Pharmacist- a legal class
• PO medicine is a substance which contains only GSL ingredients but is licensed for sale through pharmacies only- NOT a legal Class

Question 14

The health act 1999

Answer 14

• Introduced to modernise and strengthen regulation of healthcare professions
• Replaces Pharmacy Act 1954 (registration and regulation of pharmacists)
  Pharmacists and Technicians Order 2007
• The Medicines (Pharmacies) (Responsible Pharmacist)
  Regulations 2008
• Registration of Pharmacy Technicians
• Same system for regulation of pharmacists and technicians
• Continuing Professional Development (CPD) became a statutory requirement

Question 15

The Responsible pharmacist

Answer 15

After 1st October 2009
Statutory duty for RP to secure safe and effective running of pharmacy
To establish, maintain and keep under review procedures for safe working
* Keep a record of the pharmacist responsible at any one time
* Display a notice- name and registration number of RP and the fact that they are in charge
statutory duty for pharmacy owner to ensure RP properly maintains the pharmacy record

Question 16

RP Regs

Answer 16

Enable the RP to be absent from the pharmacy for a max of 2 hours (in 24 hours)
* RP must remain contactable
* GSL can be sold
* See RPS guidance for further advice of what activities can take place

Question 17

human medicines regulation (2012)

Answer 17

first major consolidation and review of UK medicines legalisation since 1968
minor updates to reflect modern practice
What major change did the Human
Medicines Regulations 2012 make to practice?
* Legislation allowed for the use of professional judgement when labelling medicines
* Can change directions (if we feel they are not correct)
* Can change name or common name of medicine
* Can change precautions for use on label

Question 18

HMR continued Can change directions

Answer 18

Can change directions
* Arbitrary dose not supporting patient e.g - 1 at 8 am and 1 at 2pm (if patient works nights then you can change it)
* Dose interval error
* Overdose: paracetamol oral suspension in children)
* Directions that differ from advice of GP (paracetamol in chronic pain in regular, NSAIDS in pain to prn)
* Poorly constructed/phrased directions
Arbitrary dose not supporting patient:
can change name or common name of medicine
can change precautions

Question 19

limitations of human medicine regulation

Answer 19

Limitations:
* Only allows changes to labelling
* Does not allow generic substitution
* Cannot change strength or quantity
* Doesn’t change conventions for incomplete prescriptions
* Does not apply to schedule 2 and 3 controlled drugs

Question 20

Pharmacy regulations 2013

Answer 20

These regulations came into effect on 1 April 2013, and replace the 2012 regulations.

Reflect the new NHS architecture,

NHS England (the NHS Commissioning Board, NHSCB) is responsible for maintaining pharmaceutical lists.

The Health and Wellbeing Boards (HWB) are responsible for developing and publishing the Pharmaceutical Needs Assessments, which are used in the determination of routine applications for new pharmacies.

Question 21

Human Medicines regulation 2016

Answer 21

On 01 April 2016, a number of changes to the Human Medicines Regulations 2012 come into effect which include:

• Permitting registered therapeutic radiographers independent prescribers to mix, prescribe, sell or supply certain types of prescription only medicines.
• Adding registered dietitians to the list of health professionals who are included in the definition of a supplementary prescriber.
• Enabling the general sale, pharmacy and certain prescription only medicines to be supplied by registered orthoptists.
• Enabling the prescription only medicines diamorphine, morphine and pethidine hydrochloride to be supplied by registered midwives.

Question 22

types of prescriptions

Answer 22

NHS
* Need to be aware of what vou can x
* NB: Supplementary Rxers can prescribe any drug agreed with independent prescriber as part of the CMP
* Private
* Same drugs as for NHS but also additional ones not allowed on the NHS.
* Details summarised in BNF

Question 23

what are the types of prescriptions

Answer 23

Each version has a different colour and different code
* FP10, GP, green
* FP10 (D) dentist, yellow
* FP10 (MDA) GP treating drug addiction, blue
* FP10 (P) prescribing nurse, lilac
* FP10PCD Private prescription for Schedule 2 and 3 CDs,

Question 24

writing the rx

Answer 24

> POMs only but we treat P & GSL the same
_ Summarised in
BNF - Prescription writing
signed in ink
dated
Address of Practitioner
* Particulars to indicate identity of Ryer
* Name & Address of Pt
* Age or DOB if under 12 years
*Rx is valid for 6 months (except
CDs)

Question 25

poisons regulating substances

Answer 25

Before supplying to a member of the public you must
* 1. Check the purchaser has a Home Office licence
* 2. Check to see if it is unaltered and in-date
* 3. Check ID - supplies CANNOT be made to third party
* 4. Check substance requested and total quantity match the details on the licence
* 5. Record details of the transaction onto the licence
15
Labelling needs to be REACH (Registration, Evaluation, Authorisation and restriction of Chemical) compliant
* For P2 regulated poisons make an entry into the poisons register:
* 1. Date of supply
* 2. Name and address of purchaser
* 3. Name and quantity of regulated poison
* 4. Purpose of purchase
* 5. Signature of purchaser

Question 26

How to find the legal class

Answer 26

Marked on the pack
Annotation in BNF
* Listed in Chemist and Druggist (Community Pharmacy)
Manufacturer / SPC
MHRA Authorisations
RPS website A-Z list (has not been updates since 2014)
Remember it is the product and not the substance which is classified and that Pack size, strength and use may determine the legal class