Legislation Lecture 3:Classification of Medicinal Products

Question 1

GSL

Answer 1

general sale list

Question 2

P

Answer 2

pharmacy medicines

Question 3

POM

Answer 3

prescription only medicines

Question 4

General Sale List (GSL)

Answer 4

These are MPs which can with reasonable safety be sold or supplied other than under the supervision of a pharmacist.
Conditions which apply
(a) Premises able to exclude the public
(b) Products manufactured elsewhere & sold in unopened containers
(c) Business must be carried out in accordance with prescribed conditions

Limits are imposed on the pack sizes of certain GSL products when sold from non pharmacy businesses.
If sold outside these limits they are classified as P or POM
Examples:
Effervescent Aspirin ≯ 325mg Tabs - 30 tabs
Aspirin enteric coated tabs ≯75mg - 28 tablets
Paracetamol tabs/caps – 16 tablets
Aspirin Tabs/caps – 16 tablets
Ibuprofen Tabs/Caps – 16 tablets
Paracetamol liquid – 160ml (>12 years old)
Paracetamol liquid – 5ml unit dose and max of 20 doses (less than 12 years old))

Question 5

Pharmacy Only (PO)Medicinal Products

Answer 5

PO: A substance which is licensed as a GSL medicinal product but the manufacturer stipulates that it be available only through pharmacies:
Eg Fybogel Sachets
Cystemme cystitis satchets 6 PO
Gaviscon Advance PO
PO - not an official class of MP under the HMR 2012

Question 6

Pharmacy Medicines (P)

Answer 6

From HMR 2012: ..a medicinal product that is not a POM product or a medicinal product subject to general sale but is –
Covered by an authorisation which states that it should be available only from a pharmacy

MPs requiring more stringent control than GSL

There is no definitive list of P medicines – now within Marketing Authorisation.

MP is classified as P under following conditions
1. Is in GSL but
Sold in larger quantities than allowed by GSL
At higher concentration than specified by GSL
At higher dose than in GSL
2. Is POM but exempt on the grounds of
A. Dose B. Concentration (Strength)
C. Route of administration D. Use
3. Is not included in either GSL or POM list
4. Is made up in a Pharmacy and ingredients are not POM
E.g. two GSL products mixed together would be classed as a P medicine.

Question 7

Supply of P medicines

Answer 7

A person may not sell or supply, or offer for sale or supply, a MP that is not subject to general sale, unless:
It is by a person lawfully conducting a retail pharmacy business
From premises that are a registered pharmacy
Acts under the supervision of a pharmacist.
A responsible pharmacist has taken control of premises

Question 8

Supervision

Answer 8

Supervision means that the Pharmacist must be aware of what is going on and must be in a position to intervene in the transaction.
This could change to a Pharmacy Professional
Could become remote supervision?

Question 9

Obtaining a GSL or P Medicine

Answer 9

GSL from
registered pharmacy
or
non-pharmacy outlet under specified conditions

P from
registered pharmacy under the supervision of a pharmacist

Question 10

Exemptions from POMEphedrine & Pseudoephedrine

Answer 10

Although exempted from POM classification under specified circumstances, additional restrictions on sale of products containing these substances was brought in in 2008 because of the potential for abuse
It is unlawful to supply without a prescription
A product or combination of products containing more than 720mg pseudoephedrine or 180mg ephedrine in a single transaction
A product containing ephedrine together with a product containing pseudoephedrine

Question 11

Exemptions from POMExempted Controlled Drugs

Answer 11

All Controlled Drugs are POM but some CDs may be P under certain conditions
(i) In specified Pharmaceutical Form
(ii) In packages labelled to show dose not exceeding maximum
Not for veterinary use
Not exceeding specified strength of base
Codeine 1.5%
Dihydrocodeine 1.5%
Ethylmorphine 0.2%
Morphine 0.02% liquid 0.04% solid
Medicinal Opium 0.02% liquid 0.04% solid
Pholcodine 1.5%

Question 12

New Medicinal Products

Answer 12

New MPs are POM for 5 years after first licensing unless there is existing evidence of safety

Question 13

MP

Answer 13

medicinal products

Question 14

POM to P to GSL changes

Answer 14

POM to P when MP is safe to be supplied without a prescription and NOT
Likely to present danger to human health if used without the supervision of a prescriber
Frequently and to a great extent used incorrectly
Containing substances of which the activity or side effects require investigation
Normally prescribed for parenteral administration
P to GSL when MP is safe to be supplied without the supervision of a pharmacist

Question 15

GSL to P to POM changes

Answer 15

GSL to P when MP is no longer safe to be supplied without the supervision of a pharmacist

P to POM if new risks are identified which require the involvement of a prescriber
Domperidone
Diclofenac

Question 16

POM to P change examples

Answer 16

Ibuprofen

Hydrocortisone preparations

Aciclovir

Levonorgestrel

Question 17

Cold and Cough Medicines for Children

Answer 17

Medicines containing certain
Antitussives
Expectorants
Nasal decogestants
Antihistamines
Should not be used for children
No change in legal classification but changes in
Warning labelling
Duration of treatment

Question 18

Patient Group Direction PGD - in the HMR

Answer 18

A written direction relating to the supply and/or administration of a POM to persons generally and is signed by a doctor or dentist and by a pharmacist
PGD’s used to assist a doctor/dentist in the provision of NHS primary medical/dental services.
No prescription is involved
PGDs for P, GSL medicines and CDs can be allowed under certain circumstances
Not a form of prescribing

Question 19

PGD

Answer 19

“patient group direction” or “PGD” means a written direction that relates to the sale or supply and to the administration of a description or class of medicinal product and that—
(a) is signed—
(i) by a doctor or dentist and by a pharmacist, and
(ii) by any other person who may be required to sign it in the circumstances specified for its use in any provision of this Part; and
(b) relates to sale or supply and to administration to persons generally (subject to any exclusions that may be specified in the PGD);

Question 20

Details required for valid PGD

Answer 20

Clinical Condition
Condition / situation defined
Inclusion & exclusion criteria
Cautions

Description of Treatment
Name, Dose, etc
Advice to patient – verbal or written
Records required

Characteristics of Pharmacist or other HCP
Qualifications and training required

Management of PGD

Question 21

Records in the Pharmacy

Answer 21

Signed Orders
For POM – Record in POM Book unless a wholesale transaction where no record legally required but signed order must be retained for 2 years
POM book for good practice.
NHS Prescriptions
GSL : P : POM - No records legally required
CD (Sch2) - CD Register entry legally required
Private Prescriptions
GSL & P – POM Book entry for Good Practice
POM – Record in POM Book legally required
CD (Sch2) – CD Register entry legally required

Question 22

Fate of the Prescription

Answer 22

FP10 (NHS)
Retain until the end of the calendar month, sort and send to NHS Business Services Authority (NHSBSA).
Daily via EPS

Private
GSL or P – Endorse & return to patient
POM – Retain in Pharmacy for 2 years unless ‘repeatable’. If repeatable, return to patient until final supply made. Then retain for 2 years. (1st supply within 6 months)
FP10PCD – Send to PPD. Retain photocopy in Pharmacy for 2 years. ‘Repeats’ not allowed

Question 23

What is the legal class of:Ibuprofen Tablets 400mg for headache

Answer 23

P

Question 24

What is the legal class of Injection of Hydrocortisone 100mg/ml

Answer 24

POM

Question 25

What is the legal class of Paracetamol Tablets 500mg 16

Answer 25

GSL

Question 26

What is the legal class of Chloramphenicol 0.5% Eye Drops 10ml

Answer 26

POM or P

Question 27

What is the legal class of Water for injection 10ml

Answer 27

POM