POM part 1

Question 1

define a POM

Answer 1

A medicine listed in the POM Order or a medicine where the marketing authorisation lists the classification as POM
medicinal product which may only be sold by retail in accordance with a prescription signed by an appropriate practitioner

Question 2

what can a POM also be called?

Answer 2

A prescription can be called a ‘patient specific direction’ (PSD)

Question 3

what are some exceptions to a POPM which may be legally supplied without a prescription?

Answer 3

Patient Group Directions (see later)
* Emergency supplies (see later)
* Patient specific directions in hospitals (see later)

Question 4

what products are always POMs?

Answer 4

• Parenteral products
• CDs, unless the marketing authorisation of the
  product lists it as a P or GSL
• Cyanogenic substances, unless for external use
• Medicinal substances that on administration emit
  radiation
• New chemical entities

Question 5

when may a POM medicine also be a P medicine or GSL?

Answer 5

But some products may also be P or GSL depending on indication, pack size, strength, formulation, route of administration
eg paracetamol

Question 6

what are the legal requirements for POM prescriptions?

Answer 6

a) Be signed in ink by the appropriate practitioner giving it
b) Written in ink or so otherwise to be indelible. NHS prescriptions,
not for a CD in schedule 1,2 or 3, can be written by carbon paper
or similar material
c) Shall contain the following particulars:
i. Address of the appropriate practitioner
ii. The appropriate date
iii. An indication of the kind of appropriate practitioner giving it
iv. Name and address of the person for whose treatment it is
given
v. If that person is under 12, that person’s age
d) Is valid for 6 months from the appropriate date
e) The practitioner must be registered in the UK or be approved health professional in an approved country

Question 7

when must a repeatable prescription be dispensed for the first time?

Answer 7

for the first time within 6 months

Question 8

if a prescription doesnt specify the number of repeats how many times can it be repeated?

Answer 8

once unless its an oral contraceptive- then it can have 5 repeats

Question 9

are repeats allowed for control drugs?

Answer 9

Repeats of any kind are not allowed on normal NHS
prescriptions

Question 10

how long can owings be prescribed for?

Answer 10

must be supplied within a certain period from the
appropriate date and this also applies to any ‘owings’ i.e. the full quantity of medicine must be supplied within the legally valid period of the prescription

Question 11

what is an approved health professional in an approved country?

Answer 11

Approved health professionals include doctors and dentists as well as other professions with prescribing rights in their own country (which could be chiropodists or podiatrists, nurses (including community nurses), optometrists, paramedics, pharmacist, physiotherapists and therapeutic
radiographers)
* Approved countries include EEA countries (full list in MEP, page 64) and
Switzerland

Question 12

in order to dispense a prescription what do you need to know?

Answer 12

• Name of drug
• Form
• Strength
• Dose
• Frequency
• Quantity

Question 13

do private prescriptions have the same legal requirements as NHS ones?

Answer 13

yes
but they can be written on anything- no specific template

Question 14

when is the only time where there can be a repeat on an FP10?

Answer 14

• No repeats allowed on FP10 unless part of the NHS
  Repeat Dispensing scheme

Question 15

can a dentist prescribe a brand?

Answer 15

DPF only includes generic names but dentists may prescribe a branded version of a generic in the DPF

Question 16

what can a dentist prescribe?

Answer 16

A private prescription written by a dentist can legally be for any POM, P or GSL medicine but…..
* Dentists are required by their registration body (GDC) to restrict their prescribing to areas in which they are competent

Question 17

what can community nurse practitioners prescribe? on what prescription?

Answer 17

Community nurse practitioners may prescribe a limited range of medicines on a NHS prescription FP10P (lilac)
* The medicines are listed in the Nurse Prescribers’ Formulary for Community Practitioners (NPF) (found in the BNF)

Question 18

what does it mean by due diligence?

Answer 18

i. Address of the appropriate practitioner
ii. The appropriate date
iii. An indication of the kind of appropriate practitioner giving it
iv. Name and address of the person for whose treatment it is given
v. If that person is under 12, that person’s age

Question 19

what happens if a medicine is prescribed by brand?

Answer 19

only this branded product may be dispensed. A therapeutically equivalent generic product must not be dispensed. An alternative brand must not be dispensed.

Question 20

can you dispence a CD 2/3 by a faxed prescription?

Answer 20

Dispensing a CD Rx (schedules 2 and 3) from a fax is a criminal offence because this is dispensing a CD without a Rx being present in the pharmacy

Question 21

are photos or emails of prescriptions legally valid?

Answer 21

no

Question 22

when is dispensing a forged prescription not a criminal offence?

Answer 22

‘provided the pharmacist has exercised all
due diligence and believes on reasonable grounds that the prescription is genuine’ (‘due diligence clause’)

Question 23

do all the legal requirements still apply for electronic prescriptions?

Answer 23

yes and signed with an advanced electronic signature

Question 24

can CD 2/3 be sent via electronic signature?

Answer 24

yes

Question 25

what does advanced electronic signature mean?

Answer 25

• Uniquely linked to the person giving the Rx
• Capable of identifying the signatory
• Created using means that the signatory can maintain under his/her control
• Linked to the data to which it relates in such a way that any subsequent
  change of the data is detectable

Question 26

how is electronic signatures sent?

Answer 26

NHS spine

Question 27

what are the tokens electronic prescriptions are printed out on?

Answer 27

FP10DT

Question 28

what are the legal requirements for non-UK prescriptions?

Answer 28

Patients full first name(s), surname and date of birth
* Prescriber’s full first name(s), surname, professional qualifications,
direct contact details, including email address and telephone number
or fax number (with international prefix), work address (including the
country they work in)
* Name of medicine(s) (brand name where appropriate),
pharmaceutical form, quantity, strength and dosage details
* Prescriber’s signature
* Date of issue

Question 29

what can not be prescribed on a non-UK prescription?

Answer 29

Controlled drugs in schedules 1, 2 and 3, and products without a UK
marketing authorisation may not be prescribed

Question 30

why is caution needed in non-uk prescriptions?

Answer 30

• Rx likely to be written in a foreign language (legally ok but…….)
• Need to check the registration status of the prescriber and there is no
  international database of prescribers

Question 31

when does records not need to be kept for every private prescription?

Answer 31

• On a ‘health prescription’ or it is a Rx for an oral contraceptive or
• A separate record is made in the CD register or
• Wholesale dealing and the order or invoice (or a copy of it) is retained for two years

Question 32

where do records for prescriptions go?

Answer 32

• In a bound book (called the ‘POM register’ or ‘Prescription book’)
• Electronically, but with all particulars, adequate backups and a facility for inspectors to examine them without disrupting the dispensing
  process

Question 33

what details are to be recorded ?

Answer 33

• Date of sale or supply
• Name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the POM supplied
• Date on Rx
• Name and address of practitioner giving the Rx
• Name and address of person for whom medicine prescribed

Question 34

what do you do with a reference number?

Answer 34

need to give the entry in the POM reg a reference number and this is marked on the Rx and typed onto the dispensing labe

Question 35

what is the fate of a dispensed prescription?

Answer 35

NHS prescription
* Send to NHS Business Services Authority (NHSBSA),
Prescription Services Division at the end of the month
* Private prescription (non-repeatable)
* Keep at the pharmacy for 2 years
* Private prescription (repeatable)
* If there are still repeats outstanding, hand Rx back to patient or offer to retain at the pharmacy
* If the final repeat has been dispensed, keep at the
pharmacy for 2 years from the date of the final dispensing

Question 36

what is a hub and spoke model?

Answer 36

Rx handed in at spoke, sent to hub, hub sends meds to spoke, spoke supplies pt
– Rx handed in at spoke, sent to hub, hub supplies Rx to patient (sent/delivered)

Question 37

who can make use of the hub and spoke model currently?

Answer 37

In a ‘hub and spoke’ model some of these processes are done in the hub pharmacy but the Rx goes to the hub via the spoke pharmacy
Therefore, only ‘chain’ pharmacies can make use of this facility

Question 38

what are the advantages of dispensing from a hub?

Answer 38

• Better efficiency
• Lower operating costs (although initial set up
  costs may be high)
• Free up pharmacist time at the spoke
  pharmacy to do other clinical activities
• Use of automation in the hub (reduced errors,
  safer dispensing, cheaper) – but hubs are not
  under any obligation to use automated
  dispensing systems (e.g. dispensing robots)

Question 39

what are some of the disadvantages of dispensing from a hub?

Answer 39

• There are concerns about accountability and liability (*)
• Legally, the responsibility for the dispensing of the prescription is thought to rest with the pharmacist who supplies the medicine to the patient –there has been no case law to test this
• Some suggest that the clinical check is the responsibility of the spoke and the accuracy check is the responsibility of the hub
• Operational failure in a hub could have serious consequences for patients
• Confidentiality and security of information is more complicated (*)
• Could it affect the patient/pharmacy relationship (especially if the hub supplies the medicine to the patient directly)
• Not suitable if the patient needs the medicine quickly/urgently

Question 40

what is the 5 key principles of the GPHC guidance for pharmacies providing services at a distance?

Answer 40

1. The governance arrangements safeguard the health, safety and wellbeing of patients and the public
2. Staff are empowered and confident to safeguard the health safety and wellbeing of patients and the public
3. The environment and condition of the premises….. safeguards the health, safety and wellbeing of patients and the public
4. The way in which pharmacy services…….are delivered safeguards the health, safety and wellbeing of patients and the public
5. The equipment and facilities………. safeguard the health, safety and wellbeing of patients and the public

Question 41

what is a serious shortage protocols?

Answer 41

allow pharmacists to supply a different
medicine to that which is specified on a Rx

Question 42

what is the legal authority of the 4 possible actions for serious shortages protocols?

Answer 42

• Dispense a smaller quantity
• Dispense an alternative formulation or strength (of the same drug)
• Dispense a generic equivalent for a branded Rx
• Dispense an alternative drug with a similar therapeutic effect

Question 43

when must the GP be informed for a serious shortages protocols?

Answer 43

The patient’s GP must be informed if a switch of medicine has occurred but not if a different form or quantity has been dispensed

Question 44

what does the dispensing label need to entail for SSP?

Answer 44

The dispensing label needs to indicate that a supply was made under a SSP and state the reference number of the SSP

Question 45

when is there an exception to administer a POM to someone other than yourslef?

Answer 45

in a life threatening emergency
eg adrenaline