Medicines Act
1968
Records of sale and supply of
POMs
Itis a legal requirement to record sale or
supply of each supply of a POM in the
Prescription Only Register. Prescription &
Order
Exceptions:
Health Prescriptions
Oral Contraceptives
Supply for drug quality testing scheme
Controlled Drugs where a separate record is made in
the CD Register (still Good Practice to make POM
entry for private, but NOT NHS, prescriptions)
Wholesale supply where order/invoice retained for 2
years.
The POM Register
Must be retained in the pharmacy for
two years from the date of the last
entry
May be bound book or stored on
computer
All required details must be kept
Adequate backups must be made
Inspectors must be able to examine
records, with minimal disruption to
operation of the pharmacy.
POM Register Requirements
The entry must be made on the same day as
the supply, or the following day
Details to be recorded:
Name and address of Prescriber
Name and address of Patient
The Name, Quantity, and except where it is
apparent from the name, the Form and Strength of
the medicine
Date of prescription
Date of supply
NB Always enter both dates – even if they are the
same.
Prescription
Book Entry
Appropriate Date
Supply Date
Ref Prescription Details Cost
A42 John Smith Dr A Villa Cost
20/10/’07 33 High Street Aston Health Centre +
Astonbury Astonbury on-cost
17/10/2007 +
R Container
56 Atenolol 50mg Tablets +
One Daily Fee.
Recording Repeat Prescriptions
Subsequent issues of a repeat item only
need a reference to the original entry if
previously dispensed from the same
pharmacy
Ref Prescription Details Cost
A42 Jane Jones Cost
+
20/10/’07 First Repeat of prescription reference A35 on-cost
+
Container
+
Fee.
Recording Prescription Amendments
Prescriptions amended in consultation with the doctor
should have full details of the intervention recorded
along with details of the original
Ref Prescription Details Cost
A42 John Smith Dr A Villa Cost
20/10/’07 33 High Street Aston Health Centre +
Astonbury Astonbury on-cost
17/10/2004 +
R Container
56 Atenolol 50mg Tablets One Daily +
Fee.
Prescriber contacted to clarify
strength
Recording an Emergency Supply
Also use the POM register
For supply at request of patient
add
Nature of the emergency i.e. reason for
supply
Statement “Emergency Supply at Request
of Patient”
For supply at request of prescriber
As above
Date on prescription and date prescription
received in pharmacy
POM Register Entry
Supply at Patient’s Request
Ref Prescription Details Cost
A42 Emergency Supply at patient’s request Cost + %+
John Smith Container
3/10/’07
33 High Street + Fee. +
Astonbury VAT
R
1 x Salbutamol Inhaler
1-2 puffs prn
Saturday afternoon, Surgery closed; patient
has lost his inhaler and suffers frequent
asthma attacks
POM Register Entry
Supply at Doctor’s Request
Ref Prescription Details Cost
A42 Emergency Supply at request of Dr Villa
4/10/’07 John Smith Dr A Villa NHS
33 High Street Aston Health Centre supply:
Astonbury Astonbury
Patient is
R 28 Atenolol 50mg Tablets One Daily over 60
Date on Prescription __________
Called from patient’s home – unable to get
prescription to us. Dr Villa will drop
prescription in tomorrow
Date on Prescription __________
Date Prescription Received __________
“Wholesale Dealing” MEP 1.2.5
Another pharmacy
Practitioner for his/her use in practice
Person requiring them to administer to human
being in course of business (P or POM if
subject to exemption order in S3)
Person who may sell or supply P medicines
under exemption order (Optician for certain
POMs) – limited to exempt products
Authorities or persons carrying out business of
independent hospital/clinic
Holder of wholesale licence
NHS Trust
POM register Entry MEP 1.2.5
Entry must be made in POM register or keep
copy of invoice or order for supply
Details required for register entry:
Date POM sold or supplied
The Name, Quantity and except where it is
apparent from the name, the Form and Strength of
the medicine
Name and Address, and Trade, Business or
Profession of person supplied
The Purpose for which the medicine was supplied
Orders/POM entry to be kept for 2 years.
Supply of POMs not on Prescription
POM register Entry
Ref Prescription Details Cost
20/10/’07 Wholesale supply Cost of
Medicine
Dr A villa MbCHb +
The Health Centre Astonbury On-cost
+
VAT
100 Co-codamol 500/30 Tablets
For use in practice
NB it is Good Practice to make an entry
even when a written order is retained
Exemption from Control on Retail Sale
MEP 1.2.4
To Hospitals and Health Centres
By Practitioners: Dr or dentist to a patient of his hers
or vet for admin by himself or under his directions
To other Specified Classes – for supply and/or
administration.
Midwives:
Chiropodists:
Registered Opticians
Ambulance Paramedics:
Owners and Masters of Ships:.
Persons required under the Factories Act 1961
RNLI
Red Cross
Occupational Health schemes
First Aid personnel on offshore installation
Others
Example: supply to Chiropodists
Chiropodists may supply certain POMs to
patients if they hold a certificate of
competence issued by the Chiropodists
Board
They may also supply GSL medicines that
are for external use and
A defined list of Pharmacy medicines that
are for external use.
See MEP 1.2.4 for details
Labelling of Medicinal Products:
Definitions
Container: the receptacle that holds the
tablets, caps, liquid etc.
Packaging: The box, packet etc. in
which the the container is enclosed
________________________________
The dispensing label should be applied to
the Container of dispensed medicines
MEP 1.2.6
Types of Label
Standard Label: applies to all sold
products and covered by EU law.
Dispensed Label: reduced detail and
applicable to all medicines dispensed in
a pharmacy for a named patient
Products prepared in a pharmacy for an
individual patient (pharmacy
nostrums) may be labelled with
slightly extended dispensed medicines
label.
Medicines Marketing Authorisations etc Regulations 1994
Standard Labelling Requirements
EU Directive 2001/83/EC
Applies to “relevant medicinal products” i.e. all
except magistral and official. Exceptions apply
for medicinal product on prescription.
Also labelling must be
Legible
Comprehensive
Indelible
Either in English Language only or in English with
one or more but with all particulars in English.
(SI1992 No3273).
Fines (and Imprisonment) for failure to comply
Label for Appropriate MP (MEP pg 20)
Details of Product
Name, active ingredients, excipients, contents by
strength, form
Uses
Method of use, route of administration
Warnings
“Keep out of the reach and sight of children”,
special warnings, expiry, storage instructions,
disposal instructions
Manufacturer/Supplier
Name and address of MA holder, MA number,
capitals MA, batch number,
Instructions for use if for self
administration
Labelling for Sale
“Sale” Includes to the public (retail) and by
means of wholesale supply e.g. to doctors for
their surgery
RPSGB Statement:
“It is not possible to fulfil the requirements of
the [European] directive, or provide a product
information leaflet, for medicines packed
down from bulk. For this reason pharmacists
are advised to use commercially available
patient-packs.”
NB Extemporaneously dispensed products are not
covered by these requirements.
Statutory Warning Requirements MEP 1.2.6
Other Statutory Warning Requirements - MEP
1.2.6
In addition to regulations for Relevant Medicinal
Product labelling and labelling of Nostrums, there
are a series of specific warnings and other
particulars that must appear on medicine labels.
These apply for products other than dispensed
medicines
Cautionary labels are those recommended by
the BNF for dispensed medicines (and required
by code of ethics – service spec 3)
Statutory Warning Labels – Aspirin
“Contains Aspirin” plus “If symptoms
persist consult your doctor”
(together with the recommended dosage)
In case of Aloxiprin: “Contains an Aspirin
Derivative” plus “If symptoms persist
consult your doctor”
(together with the recommended dosage).
Statutory Warning Labels –
Paracetamol
“Do not take with any other Paracetamol
containing products”
Plus:
“If symptoms persist consult your doctor”
(together with the recommended dosage)
“Do not exceed the stated dose”
“Immediate medical advice should be sought
in the event of an overdose, even if you feel
well”.
For Child <12 years “Immediate medical
advice should be sought in the event of
overdose, even if the child seems well”
Paracetamol, Aspirin & Aloxiprin
Unless the product is for external use
“Do not give to children under 16
years, unless on the advice of a
doctor”
Labelling of Dispensed Medicines
Legal Requirements (MEP Pg18/19)
Name of person that the medicine is for
Name and address of supplier (i.e. the
Pharmacy)
Date of Dispensing
Directions for use
“Keep out of the reach and sight of children”
Details requested by prescriber
e.g. Product name, directions and warnings
For External Use Only (where appropriate)
Hexachlorophane warning (where appropriate).
Sample Label
10 Oct 2007
RPSGB Advice
MEP Service Specification 4
Labels must:
Be Clear and Legible
Mechanically or Computer-generated in
practice
Comply with legal requirements
Include BNF Cautionary and Warning labels
Also: previous advice, now accepted as
standard practice
Labels must include the Quantity in each
container.
Patient Information Leaflets
A legal requirement for a Patient Information
Leaflet (PIL) to be supplied with ALL Relevant
Medicinal Products (a Marketing Authorisation
granted or renewed after 13th Feb 1994
Leaflets must contain the particulars set out in
Council Directive 92/27/EEC.
The Medicines Act 1968 was amended in 1994 to
make the supply of a leaflet a legal requirement.
PIL – Required Information
Product Information e.g. name, ordinary
name, strength, all active ingredients and
exipients and quantities, pharmaceutical
form, drug group, MA holder
Therapeutic Indications
Information on taking the product e.g.
contra-indications, precautions, special
warnings,
Instructions on use
Description of undesirable effects
Reference to expiry date and storage
instructions
Date of Leaflet
PILs: The conflict…
We are required to give a PIL and
provide a fully labelled pack with every
dispensed medication but…
We are not always permitted to supply a
complete pack or packs under the NHS if
this does not match the prescribed quantity
Manufactures do not often provide spare
leaflets
To copy a leaflet may infringe copyright.
Legal issues about printing an own version
PILs: RPSGB Advice
“Pharmacists should, where
possible, supply fully labelled
packs accompanied by a patient
information leaflet and continue
as at present for dispensing by
breaking bulk until the
problems are resolved”.
PILs: in Hospital
Advice provided by the Chief Pharmacist
at the Department of Health:
For In-patients
PILs are not required to be included in the
packaging of hospital dispensed products –
but should be held in the pharmacy or on the
ward so that the PIL can be provided to
patient or prescriber on request
For Out-patients
PILs should always be provided.
Packaging –
Fluted Bottles
MEP 1.2.7
A fluted bottle must be used for any liquid
product for external use listed in S1 1978 No
40 (as in MEP)
“External Use” in this context, for human
beings means application to skin, hair, teeth,
and the mucosa of the mouth, throat, nose,
ear, vagina or anal canal
The following are exempted from the above
definition: Throat sprays, pastilles, lozenges, nasal
drops, nasal sprays, nasal inhalations, teething
preparations and dental gels.
Packaging - Child Resistant
Containers
All solid dose and liquid preparations for
internal and external use must be dispensed
in a reclosable child resistant container
unless…
It is already in an original pack that would make
this inadvisable
The patient will have difficulty opening the
container
A specific request is made not to
No suitable closure exists
In any case suitable advise must be given
regarding safe storage, out of children’s reach