pharmacy law and practice

Question 1

The Humans Regulation (HMRS) 2012:

WHAT IS IT ?

Answer 1

set out legislation relating to the authorisation of medicinal products for human use

includes :
legislation relating to manufacture licensing and pharmacovigilance of a medicine as well as regulation surrounding the import and export of medicines or the sale and supply

it also covers the legal classification of medicines labeling requirements and advertising laws

Question 2

The Humans Regulation (HMRS) 2012:

LEGAL CLASSIFICATION OF MEDICINES

Answer 2

3 legal classes of medicinal products under the HMRs:
general sale medication(GSL)
pharmacy medicine(P)
Prescription only medicines (POM)

new drugs are automatically classed as POMs - one possible reason is the “safety , efficacy, quality “ test applied by the MHRA before a marketing authorisation is issued

Question 3

finding the legal class of a product

Answer 3

in practice a pharmacist would :

check the container

check the summary of product characteristics (SPC)- the SPC is found in the electronics medicines compendium(EMC)
(the SPC is part of the paperwork that a manufacture submits in order to obtain a marketing authorisation)

use the BNF along with the SPC/EMC

Question 4

prescriptions and prescription only medicines

Answer 4

POMS usually available to the public ONLY ON PRESCRIPTION

Appropriate prescribers under HMRs :

Doctors and dentists registered in the UK appropriate practitioners for all POMs

doctors , dentists , prescribing pharmacists and prescribing nurses registered in the EEA/Switzerland are appropriate practitioners for all POMs ACEEPT SOME CONTROLLED DRUGS AND UNLICENSED MEDICINES

Veterinary surgeons and veterinary practitioners are also appropriate prescribers for veterinary medicines

there are various types of prescribers (no medical prescribers) who are appropriate practitioners for certain types of POMs

Question 5

UK prescription forms

Answer 5

NHS prescription forms :

FP10 DT (EPS TOKEN)
white
GP(doctor)
non medical independent prescribers 
supplementary prescribers 

FP10
green 
GP (doctor)
non medical independent prescribers 
supplementary prescribers 

FP10 P
lilac
community practitioner nurse prescribers

FP10 D
yellow
dentists

FP10 MDA
blue
prescribers in substance misuse

Question 6

community pharmacists

Answer 6

they require an NHS contract to dispense NHS prescriptions and then are bound by regulations (NHS terms of service)

not all items can be prescribed on an NHS prescription and there is a list of items which cannot be supplied

Question 7

charges for a prescription

Answer 7

patients in England only pay a fixed charge for each item dispensed (£9.15) at the time of writing unless they are exempt
this fixed charge is collected by the community pharmacist then sent onto the government

at then end of each month the community pharmacist sends all of the NHS prescriptions to the ‘NHS prescription services’ (NHSBSA).
the NHS Business Services Authority calculates the cost of the items dispensed and the value of any professional fees

the value of the prescription charges collected is subtracted and the pharmacist receives payment for the dispensing service in due course

Question 8

what are doctors (UK) permitted to prescribe on the NHS?

Answer 8

GP can prescribe every medicine , food or cosmetic on the NHS UNLESS it appears on the list found in the DRUG TARIFF SECTION XVIIIA (drugs medicines and other substances that may not be ordered under the NHS)

some items may only be prescribed in certain circumstances such as those covered by the BORDERLINE SUBSTANCES PROVISIONS (part XV of the drug tariff) or the SELECTED LIST SCHEME (part XVIIIB of the drug tariff)

different rules apply to the prescribing of appliances such as dressings and catheters

GPs can prescribe anything on a PRIVATE PRESCRIPTION - a special prescription form will be used when prescribing CD drugs privately

Question 9

drugs, medicines and other substance that may NOT be ordered on the NHS

Answer 9

the list was introduced in 1985 to help reduce NHS costs - the list has reduced the prescribing of some expensive products where equally effective and less expensive generic products are available

DOCTORS AND PHARMACISTS as well as NON MEDICAL INDEPENDENT PRESCRIBERS and SUPPLEMENTARY PRESCRIBERS who dispense products o the list are in breach of their terms of service

Question 10

the consequence of dispensing a blacklist item

Answer 10

Dispensing a blacklist item puts a pharmacist in breach of their NHS terms of service - this is a breach of administrative law and the NHS is empowered to penalise such pharmacists

the NHS will not reimburse the cost of the item essentially this means that the dispensing pharmacist (or business) must bare the cost of the item

Question 11

non doctor prescribing : DENTAL PRACTITIONERS

THE CONTRACT :

Answer 11

Dentists’ working in primary care , general practitioners and community pharmacists have a ‘contract’ with the NHS which defines how and under what circumstances they provide NHS services
- they are called NHS CONTRACTORS ;the contract is made up in part by the TERMS OF SERVICE

for pharmacy contractors the terms of service arise from the NATIONAL HEALTH SERVICE (pharmaceutical and local pharmaceutical services) regulations 2013

under the dentists terms of services an NHS prescription written by a dentist is valid ONLY if the medicinal products ordered are in the DENTAL PRACTITIONERS FORMULARY (DPF)
DPF is found at the back of the BNF and in the Drug Tariff

Question 12

Non medical prescribing on the NHS :

Supplementary Prescribers

Answer 12

supplementary prescribing :
a voluntary prescribing partnership between an independent prescriber and a supplementary prescriber
to implement an agreed patient specific CLINICAL MANAGEMENT PLAN (CMP) with the patients agreement
THE CMP SETS OUT THE DETAILS OF WHAT THE SUPPLEMENTARY PRESCRIBER MAY PRESCRIBE.

THE INDEPENDENT PRESCRIBER (IP) : the partnership must be a doctor or dentist
the IP is responsible for making the initial diagnosis

THE SUPPLEMENTARY PRESCRIBER (SP): (may be a pharmacist or a nurse) the SP may take responsibility for the clinical management of the patient
its a form of REPEAT PRESCRIBING - the SP can change the dosage and drug of the patient
the SP also monitors the patients clinical condition

THE PATIENT MUST CONSENT TO THE SP PRESCRIBING AGREEMENT & BOTH PRESCRIBERS MUST HAVE ACCESS TO A COMMON PATIENT RECORD
(some pharmacists are qualified as supplementary prescribers)

Question 13

who can be a supplementary prescriber ?

Answer 13

pharmacists and other healthcare professionals are also lawfully allowed to administer/supply medicines via this mechanism

Question 14

what can a supplementary prescriber prescribe ?

Answer 14

there are no legal restrictions on the clinical conditions which a SP may treat
there is no specific formulary or list
if it can be prescribed by a doctor or dentist at NHS expense and is referred to in the patients CMP then a SP can prescribe it
MOST CDS AND UNLICENSED MEDICINES MAYBE PRESCRIBED

Question 15

when is supplementary prescribing most useful ?

Answer 15

its a longterm , ongoing prescribing partnership - it is most likely to be useful in treating patients with chronic conditions or those with long terms health needs (such as anti-coagulation)

SUPPLEMENTARY PRESCRIBING IS NOT SUITED TO EMERGENCY , URGENT OR ACUTE PRESCRIBING

Question 16

the clinical management plan (CMP)

Answer 16

IT IS A LEGAL REQUIREMENT FOR AN AGREED CMP BEFORE SUPPLEMENTARY PRESCRIBING CAN TAKE PLACE
the CMP must relate to a NAMED PATIENT and to their SPECIFIC CONDITION(S) to he managed by the supplementary prescriber
this should be included in the patient record -

regulations specify that the CMP must include the following :
the name of the patient to whom the plan relates

the illness/conditions which may be treated by the SP

the date on which the plan is to take effect and when its to be reviewed by the doctor or dentist who acts are the independent prescriber

reference to the class or descriptions of medicines or types of appliances which may be prescribed or administered under the plan

reference warnings about known sensitivities of the patient/ know difficulties that the patient may have with particular medicines/appliances

the arrangements for the modification of suspected or known reactions of clinical significance to any medicine which may be prescribed or administered under the plan and the circumstances in which the supplementary prescriber should refer to/seek the advise of the IP

the CMP should be kept simple

Question 17

Non medical prescribers : pharmacist Independent prescribers

Answer 17

They can prescribe any GSL ,P or POM medicine for any medical condition including most controlled drugs- they are permitted to prescribe both licensed and unlicensed medicines

THEY CAN PRESCRIBE ANYTHING THAT A DOCTOR CAN PRESCRIBE ON THE NHS (some CD exceptions)

Question 18

Non medical prescribers : pharmacist Independent prescribers

Patient benefits :

The healthcare system can benefit from :

Pharmacists can benefit from:

Answer 18

Patient benefits :
Improved access to healthcare practitioner who can provide advice, information about medicines ,appropriate referrals and medicine supplies
Greater flexibility choice and convenience
Speedier discharge from hospitals by the elimination of delays in providing supplies of post discharge medicines and advise on their use
Medicines managed to eliminate duplication, confusion and to improve understanding at discharge from hospitals
Enhanced concordance with agreed clinical management plans

The healthcare system can benefit from :
Additional professional involvement 
Reduced patient waiting times in hospital and primary care 
Better services for vulnerable group 
Economic gains through waste reduction 

Pharmacists can benefit from:
Enhanced professional fulfilment and job satisfaction
The ability to put their skills to better use by more appropriate participation in the wider healthcare team, when u qualify as a pharmacist (available when we qualify)

Question 19

Nurse prescribing on the NHS:

COMMUNITY NURSE PRACTITIONERS:

Answer 19

Only appropriate for certain types of POMs

District nurses and health visitors who have completed the relevant training are permitted to prescribe items in the nurse prescribers formulary(NPF) for community practitioners.
All newly qualified district nurses and health visitors are automatically qualified to prescribe from the NPF as the training was provided in their course

This formulary is provided in the BNF- it contains a number of POMs some GSL and P meds and a list of dressings and appliances relevant to community nursing and health visiting practice
Most pharmacists in practice rely on their dispensing system to alert them if anything inappropriate is prescribed (it’s always best to check the bnf)

Question 20

Nurse prescribing on the NHS:

NURSE INDEPENDENT PRESCRIBERS

Answer 20

They are able to prescribe any licensed GSL,P,POM for any medical condition including s2-s5 controlled drugs

Question 21

NON MEDICAL PRESCRIBING ON THE NHS -

optometrist, podiatrist, physiotherapist and Therapeutic Radiographer Independent Prescribers:

Answer 21

Optometrist Independent Prescribers:
can prescribe any licensed medicine for ocular conditions affecting the eye and surrounding tissue- they cannot prescribe :
Any controlled drugs
Any parenteral medicines

Podiatrist and physiotherapist independent prescribers :
Can prescribe all POMs and some controlled drugs within their professional competence

Therapeutic Radiographer Independent Prescribers :
The can prescribe all POMs within their professional competence
They can not prescribe S1,2&3 CDs (awaiting legislative approval)

Question 22

PRIVATE PRESCRIPTIONS:

Answer 22

A patient may receive a private prescription for several reasons:
If the patient has opted to receive private rather than NHS care
If the patient is not a UK of EEA resident
If the patient requires treatment that is not available on the NHS
If the patient has a prescription written by the EEA (European Economic Area)health professional

Private prescriptions for POMs don’t need to be written on a special form, a prescriber can write a private prescription for a POM on any piece of paper,so long as all of the legally required information is present .
The only exception to this is private prescriptions for controlled drugs (CDs ). Prescribers need to use a standardised form called a FP10PCD for S2&3 CDs

The NHS does not pay for this service - its paid for privately by the patient

The community pharmacist is free to set the fee charged for the charged item which generally includes a fee for dispensing the item plus the cost of the medicine with additional profit added
(the charge paid for by the patient is exempt from VAT( value added tax ).)
Sometimes a repeat supply made against a private prescription
( regulations around prescriptions for patients for another EEA may change from jan 2021 when we leave the EU)

Question 23

WHICH PRESCRIBERS CAN ISSUE PRIVATE PRESCRIPTIONS?:

DOCTORS:

DENTISTS:

Answer 23

DOCTORS:
The can lawfully prescribe any POM on a private prescription
This mean that even if an item appears on the limited list a doctor may prescribe it on a private prescription

DENTISTS:
Dentists working in a private practice outside of the NHS and so that they will then issue a private prescription for their patients - dentists are appropriate for ALL POMs so they may lawfully prescribe any POM on a private prescription.
This means that even if an item is not listed in the DPF , a dentist may prescribe it on a private prescription. However dentists are bound by a professional obligation to prescribe only within their competence

Question 24

WHICH PRESCRIBERS CAN ISSUE PRIVATE PRESCRIPTIONS?:

Answer 24

NON MEDICAL PRESCRIBERS :
Pharmacist, Nurse Optometrist, podiatrist, physiotherapist and therapeutic radiographer Independent prescribers are all lawfully permitted to issue private prescriptions

COMMUNITY PRACTITIONER NURSE PRESCRIBERS (CPNPs)
The law is unclear about whether this professional group is permitted to prescribe privately and the Royal college of Nursing (professional body of nursing ) is unable to answer this question .
However since CPNPs seem to be employed exclusively within the NHS and the and the list of items they are permitted to prescribe is so limited its unlikely that a CPNP would ever wish to prescribe privately.

Question 25

ELECTRIC PRESCRIPTIONS (EPS):

EPS common terminology explained :

NHS spine:

EPS Tokens :

Prescription ID :

Answer 25

This enables prescriptions to be sent electronically from the GP surgery to the pharmacy and then onto the NHS Prescription Services for payment.

The main difference between FP10 prescriptions and electronic prescriptions is the absence of the DOCTORS SIGNATURE .

EPS common terminology explained :

NHS spine.
This is the term used by Pharmacy staff when they are checking to see if a patients’ prescription has been received.

EPS Tokens :
The paper copies that are printed to accompany electronic prescriptions are known as ‘tokens’. The barcode (Prescription ID) on the tokens can be scanned to retrieve the electronic prescription from the spine.

Prescription ID :
This is a unique barcode that is generated on the right hand side of all NHS electronic prescriptions. This helps identify the prescription. This is useful when the prescription needs to be returned to the NHS spine.
This happens when a Pharmacy may not have a particular medicine in stock which the patient urgently needs. In this case the Pharmacy can contact another Pharmacy to see if the item is in stock and then give them the Prescription ID which will allow them to locate the prescription and retrieve it

Question 26

EPS common terminology explained :

NHS smart card :

EPS Tracker:

EPS Nomination:

Answer 26

NHS smart card :
This is required by all staff that access the NHS spine. It is a security measure that ensures that only authorised users are able to access patient data. Without your smart card you are unable to work!

EPS Tracker:
This enables EPS-using staff working at pharmacies and prescriber’s to check the status of a prescription. Again in practice useful when you are having trouble locating a prescription!

EPS Nomination:
This is the Pharmacy that the patient chooses/ nominates to collect their prescription from. Please note that Pharmacies can nominate patients to their own Pharmacy. GP practices can also nominate patients to a Pharmacy of their choice. It is also possible to check the patients nominated Pharmacy. This sometimes is necessary when a prescription cannot be located. In practice we often find that the patient has come to a particular Pharmacy to collect their prescription but has in fact nominated another one!

Question 27

PRESCRIPTIONS FOR NON-POMs:

Answer 27

P and GSl meds are available without a prescription they may sometimes be prescribed

The decision by a doctor to prescribe a P or GSL medicine is not a related legal requirement but may also be related to social, ethical, administrative, clinical or professional requirements.

Another reason why P or GSL medicines may be prescribed relates to the fact that medicines prescribed for human use are not subject to VAT whereas medicines brought over the counter have VAT added to their price.
Therefore a medicine purchased on private prescription could be 20% cheaper than the same medicine bought over the counter

The NHS policy on the move self - care means that many GP surgeries have a policy of not prescribing GSL and P medicines for certain conditions (eg.hayfever

Question 28

WHAT HAPPENS AFTER A PRESCRIPTION HAS BEEN DISPENSED:

Answer 28

NHS PRESCRIPTIONS :
Are never recorded in the in the prescription only register :
Paper prescriptions- are sorted in the pharmacy then sent to NHS prescription services at the end of each month
Electronic prescriptions - are sent electronically to the NHS prescription services. They then calculate the cost of the drugs and fees for providing pharmacy service to the pharmacy contractor.

Private prescriptions for POMs:
Are recorded in the prescription only register
Are returned to the patient if they are repeatable and there are undispensed repeats available on the prescription
Are retained for a minimum of 2yrs when they have been dispensed for the final time

Question 29

ENDORSING PAPER PRESCRIPTIONS :

Answer 29

At the end of the dispensing process are also endorsed by the dispensing pharmacist :
The prescription is stamped by the dispensing pharmacist with the pharmacist stamp - NHS prescriptions have space for this at the top left corner ;this ensures that NHS prescription services know which pharmacy dispensed the item
In the case of private prescriptions, this should be added near to the prescribers signature ;this ensures that the prescription is returned to the patient. The patient cannot remove the stamp from the prescription

The date of dispensing is written or stamped on the prescription - there is space for this in the middle of the pharmacy

In the case of private prescriptions the POR reference number is added - this links the POR entry to the prescription . this reference number should be added in the space in the pharmacy stamp

In the case of NHS prescriptions the information regarding what was dispensed is added- this allows NHS prescription Services to pay the pharmacist properly for what they have supplied.

Question 30

HOW IS THE CATEGORY INTO WHICH A MEDICINE FALLS DECIDED ?

Answer 30

Medicinal products can change classification (but only 50 treatments switching from POM to P between status between 1992 and 2002)

Before a medicine can be switched from POM to P, ministers must be satisfied that it would be safe to allow it to be prescribed without prescription .

New medicine is usually authorised for use as POMs. After some years of use if adverse reactions to the medicines are few and minor It is possible that the medicine may be safely used without a doctor’s supervision. If there is sufficient evidence of safety a medicine may be reclassified as a P medicine

Pharmacy medicines which have been safely used for suitable for general sale and may be reclassified as GSL

Reclassification of a substance normally foLlows a request from the the company which holds a marketing authorisation for it - however requests can be made by any interesting party such as a professional body or initiated by the MHRA

Very occasionally a P medicine will be re-classified as a POM if there are serious concerns about its safety- several have switched classification over the past few years

Before a medicine can be switched from POM to P, ministers must be satisfied that it would be safe to allow it to be supplied without a prescription. In order switch from POM to P it must NOT be a medicine which (HMRs Reg.62 (3))

Is likely to present a direct or indirect danger to human health, even when used correctly , if used without the supervision of a doctor or dentist ;
Is frequently and to a very wide extent used incorrectly as a result is likely to present a direct or indirect danger to human health;
Contains substances or preparations of substances of which the activity requires or the side effects require,further investigation or is normally prescribed by a doctor dentist for parenteral administration .

Question 31

GSL Medicines :

Pharmacy Medicines (p):

Answer 31

GSL Medicines :
A general sale list medicine is one which in the opinion of the appropriate Minister can with reasonable safety be sold or supplied otherwise than by or under the supervision of pharmacists . The wording came for old Regulations made under the Medicines Act and although the wording no longer appears in law the effect of the control of the GSL medicines means the same thing.
Historically GSLs appear on a list of medicines called the General Sale List Order although this has not been updated for over 10years. Where a product has marketing authorisation its classifications for the purposes of the GSL Order is determined by that authorization

Pharmacy Medicines (p):
A pharmacy medicine is a medicinal which is :
Not a prescription only medicine
Not a General Sale List Medicine

Question 32

THE SALE AND SUPPLY OF HUMAN MEDICINES :

Professional judgement

Answer 32

Pharmacist need to apply their knowledge of the relevant medicines legislation when selling or supplying medicines to take :

Pharmacist may exercise their clinical judgment and refuse the sale or supply of any medicine

Professional Judgement :
Use of knowledge and experience as well as critical reasoning to make an informed decision
This may include related legal and ethical considerations alongside relevant standards
Identify the problem
Gather the relevant information
Identify the possible options
Weigh up the benefits and risks of each option
Choose an option
Record the decision and your reasoning

Question 33

THE SALE AND SUPPLY OF HUMAN MEDICINES :

Clinical Judgement

Answer 33

The sale and supply of human medicines - clinical judgement :

Assessment of prescription or request of a medicine
Identify pharmacotherapeutic issues through the evaluation of :
Patient factors
Disease states
Medication history
Lab results

Patient factors:
Age 
Children 
Eldery 
Women who as pregnant and breastfeeding 
Certain ethnic groups 
Gender 
Comorbidities 
Patient intolerances or preferences 

(Marketing authorisations:
By law before a medicine can be placed on the market , it must have a product licence.
In the uk these are issued by the medicines and healthcare products regulatory agency (MHRA)
A specially trained panel of medicines assessors reviews all the available evidence about the medicine
This comes from pr-clinical research and clinical trials ; the manufacturer may also be asked to supply additional information
The MHRA also inspects the factory where the medicine is to be made,to make sure that supplies will be of a uniformity and consistently high standard)

Question 34

UNLICENSED USAGE OF MEDICINES :
(Sometimes called off-label usage )

Off licence usage

How can you find out the legal classification of a medicine?

Answer 34

Off licence usage is - usage outside the terms of the marketing authorisation
(selling or prescribing the product other than in accordance with the terms of the marketing authorisation )
There may not be a suitable product already on the market and so a ‘special’ order may be needed
This is permitted but there are legal risks for both the prescriber and the supplier (pharmacist)

How can you find out the legal classification of a medicine?
Summary of Product Characteristics (SPCs)
Electronic medicines compendium (emc)

Online BNF

Question 35

WHAT IS PRESCRIPTION ONLY MEDICINE ?

Some exemptions to sale or supply without a prescription :

Examples of exemptions from POM status :

Answer 35

It used to be anything that was included in the POM order but now most POMs are classified simply by their marketing authorisation
Generally subject to restriction of requiring a prescription form and appropriate prescriber before it can be sold or supplied

Some exemptions to sale or supply without a prescription :
PGD
Emergency Supply 
Signed orders 
Pandemics 

Examples of exemptions from POM status :

When the FORM of medicine with a specific marketing authorisation
Hydrocortisone 1%cream 15g

Some CONTROLLED DRUGS in some preparations
Codeine , morphine in low strengths

For specified CONDITIONS
Clotrimozole for the treatment of vaginal of thrush in some forms

At dosages not exceeding a STATED MAXIMUM
Ibuprofen maximum dose 400mg 3 times a day (1.2mmd)

PACK SIZE of product
Paracetamol 500mg tablets pack size 16= GSL 32= P pack size 100 = POM

Question 36

MORE ABOUT SALE OR SUPPLY OF POMs:

Answer 36

Patient specific Directions (PSDs) used in hospital
Patient’s drug chart /notes
Do not need to comply with the requirements for prescriptions
Must have sufficient information for the requirements for person administering medicine to do safely
Can be verbal ; it is a direction to administer not supply (recommend it in writing where practical
If in writing is clear can be taken as authority to make supply ;take home medication

Question 37

PATIENT GROUP DIRECTION (PGD)

Answer 37

A written direction relating to supply and administration /administration only of a POM to persons generally signed by a doctor or dentist and a pharmacist

Allows supply or administration of medicines to patient without having to meet the usual requirements

PGDs can also be used for P & GSL medicines

Question 38

PHARMACY MEDICINES (P):

Answer 38

Default category, if not a POM or GSL then it must be a P (regulation 220 states this )
There is no actual list of P medicines but includes all medicines which can only be sold through registered pharmacy
The sale must be by a pharmacist or under the supervision of a pharmacist
Supervision includes need for trained assistants and Pharmacy Medicines being kept behind a counter

Pharmacy medicines can only be sold or supplied by retails sales when :
The person is in the respect of that business a person lawfully conducting a retail pharmacy business
The product sold supplied or offered /offered for sale /supply on premises which are a registered pharmacy
That person or if the transaction is carried out on his or her behalf by another person;that person acts under the supervision of the pharmacist

Question 39

SUPERVISION OF PHARMACY MEDICINE SALES:

Answer 39

The presence of the pharmacist in the vicinity of all pharmacy related transactions

Ability to intervene in a sale (GSL and P)

Supervision of the dispensing process and any advice / information necessary to give to the patient

Medicines counter assistants (MCA)
Involved in the sale of over the counter medicine and works under the supervision of a pharmacist
Must be trained or undergoing training to offer advice on common ailments and must know when to refer to a pharmacist
Training must start within 3 months of starting role and be completed within the 3 years of starting
(pharmacy service skills NVQ level 2(QCF) qualification)

Question 40

GENERAL SALE MEDICINES (GSL):

Answer 40

Can be sold or supplied at places other than pharmacy premises and without the supervision of a pharmacist
Regulation 5 states that a medicinal product may be subject to general sale if it is NOT a POM or P med
Authorisation of which it is a term that the product is to be available on general sale
EU marketing authorisation and it is not classified in the authorisation as a POM and the licencing authority has determined should be available on general sale

May be safely sold or supplied without the supervision of pharmacists

However within a registered pharmacy general sale medicines can only be sold when Responsible Pharmacist has signed in that day .

They are also medicines which can be sold with reasonable safety from premises which can be excluded from public

A product with a Traditional Herbal Registration (THR) or certificate of registration for homeopathic use is also included in this (can also include products without a MA or THR)

Question 41

AMENDMENT TO CONDITIONS RELATING TO SALE OR SUPPLY :

Answer 41

Amendment in 2013 to HMRs now permits sale of GSL from aircrafts and trains subject to certain conditions and provided that the product :
Has been made up for sale or supply in a container elsewhere that at the place at which it is sold or supplied
It is stored in a part of the aircraft or train which the operator is able to close as to exclude the public

Vending machines
HMRs reg.222
GSL products may be sold from vending machines located in premises that can be closed of to exclude the public

Never from a market stall or from the back of a vehicle
Car boot

Question 42

MEDICINES NOT ALLOWED ON THE GENERAL SALES LIST :

Answer 42

Eye ointments
Most anthelmintic (antiparasitic drugs)
Parenteral preparations
Medicines promoted as enemas or use as irrigations
Aspirin for children under the age of 16yrs
Associated with Reye’s syndrome

Question 43

LEGAL CLASS CHANGE :

Answer 43

MHRA is the advisor to the government on POM P GSL switches
Example : GSL to P , omeprazole 20mg GR tablets
The MHRA has taken the decision to approved General Sales List legal status of Omeprazole Tablets with the following terms of reclassification :
For oral use in the form of tablets
For the short term treatment of reflux symptoms (heartburn,acid regurgitation)in adults
Maximum strength : 20mg
Maximum dose: 20mg
Maximum daily dose :20mg
Maximum duration of treatment:14 days
Maximum pack size : 14 tablets

RECENT POM TO P SWITCHES :
Malloff tablets (atovaquone and proguanil)
Nasonex allergy control nasal spray (mometasone furoate)
Dovonex psoriasis ointment (calcipotriol)
Viagra connect (sildenafil) available without prescription for use by men over 18 who have erectile dysfunction

Question 44

Types of token

Answer 44

Types of token
There are two types of token - prescription tokens and dispensing tokens. Prescription tokens are printed on green stationery at the GP practice and dispensing tokens on white stationery at the pharmacy.
Following the introduction of EPS Phase 4, the NHS Prescription Services will now process green prescribing tokens as well as white dispensing tokens.

Question 45

About prescription tokens

Answer 45

About prescription tokens
are usually printed at the GP practice on FP10 prescription forms
are only a copy of the electronic prescription and should never be signed by the authorising prescriber any attempted manual amendment or endorsement has no impact on the electronic prescription which can only be amended or cancelled electronically
will always have the name and address of the nominated dispensing contractor printed on them. This ensures the patient always knows who they have nominated
can be scanned at the pharmacy to retrieve the prescription, but in most cases for repeat prescriptions they will have already been downloaded in advance of the patient arriving
will show any notes the prescriber has added to the electronic prescription for the patient or pharmacy to be aware of. This can be a useful way of communicating clinical information to the patient

Question 46

About dispensing tokens

Answer 46

About dispensing tokens
are printed by the dispensing contractor on white stationery (FP10DT) which can be ordered from your NHS PCS Supplier
should be printed when a patient needs to sign for payment or exemption declaration purposes. No signature is required if the patient is age exempt
should be printed when a patient needs to visit another pharmacy to collect their medication. Remember to return the prescription to the NHS Spine and give the dispensing token to the patient to take to another pharmacy. They can then scan the token to retrieve the prescription
can contain notes added by the prescriber to communicate clinical information to the patient
are not seen by the NHS Prescription Services. They are only used for counter fraud purposes. Anything you write on a dispensing token will be ignored and all endorsements must be completed on your pharmacy system.

Question 47

The end of month process

Answer 47

At the end of the month, white dispensing tokens and tokens and green Phase 4 prescribing tokens should:
be sent to the NHS Prescription Service if they have been signed by the patient to capture payment / exemption declarations (except age exemptions) and must be sent in the same month that the electronic claim is submitted, for counter fraud purposes
be confidentially destroyed if they have not been used for dispensing purposes and have not been used to capture exemptions or payment declarations
be separated from the FP10 paper prescriptions before they are sent to NHS Prescription Services. Dispensing Tokens do not need to be sorted in the same way as FP10’s as they do not need to be sorted by group

Question 48

Benefits of electronic prescriptions

Answer 48

Prescriptions are processed more efficiently
Electronic prescriptions contain the patient’s information, so there is less need to type this into your dispensing system.
Prescribers use a standardised drug dictionary to complete electronic prescriptions, improving prescription accuracy and reducing the risk of patients receiving the wrong medication.
Receive fewer reimbursement queries due to electronic prescription endorsement.
Reduced risk of duplicate prescriptions as electronic prescriptions can’t be lost.
Less paperwork
Only signed tokens need to be sent to the NHS

Question 49

Benefits of electronic prescriptions

Answer 49

Business Services Authority in the month end prescription submission - there’s no need to file and sort them like FP10s.
No need to send and collect paper prescriptions to and from GP practices.
No need to wait for paper prescriptions to arrive in the post.
Better stock control
Accessing electronic prescriptions in advance of the patient’s arrival means you have time to order any out of stock items.
Electronic prescriptions can be integrated with stock control modules to further reduce administration.
Improved patient satisfaction
Electronic prescriptions allow you to order and prepare prescriptions in advance, reducing waiting times for patients and ensuring stock is available.
Notes can be added to electronic prescriptions, allowing messages from prescribers to be passed on to patients.

Question 50

PRESCRIPTION ONLY MEDICINES (POMs):

Answer 50

A POM is generally a medicine that may only be supplied against a prescription written by an appropriate prescriber.
There are some exceptions to this in specific circumstances - eg) making a supply of z POM in an emergency

Also some types of medicinal products can only be classified as POM, this includes :
Those which are administered parenterally
Controlled drugs , unless they have marketing authorisation which classifies them otherwise

Question 51

POM SPECIAL CASES - ASPIRIN, PARACETAMOL, PSEUDOEPHEDRINE AND EPHEDRINE:

Answer 51

Paracetamol and Aspirin :
The legislation says they should only be supplied against a prescription even if they are classified as being P or GSL in their marketing authorisation.

However they can be bought at supermarkets, newsagents and OTC in a pharmacy :
There is an other provision in the legislation (HMRs)which says the following:
There is an exemption in the HMRs for (aloxiprin),aspirin and paracetamol (reg.236)
Those products listed are exempt from the restrictions on supply (ie. that they be supplied only on prescription)
This exemption applies only if the quantity of the product sold or supplied to a person at any one time DOESN’T EXCEED 100 TABLETS OR CAPSULES

Question 52

WHAT DOES THIS MEAN IN PRACTICE ?

Answer 52

Products containing aspirin and paracetamol which are licenced as P and GSL in their marketing authorisation may be sold OTC, but no more than 100 tablets/capsules can be sold to a person at any one time (any more and the medicine becomes a POM)

However you should use your professional judgement when a patient requests more than one packet of these products
You need to be happy that the patient has good reason to be requesting more; eg) where a patient is treating long term pain and you have to be happy selling more than 32 tablets and ensure its not harmful for the patient in any way

Pseudoephedrine or Ephedrine :
There is an exemption from Pom control so long as provisos are met , these are :
A product containing Pseudoephedrine or Ephedrine cannot be sold or supplied at the same time as each other
That a person may only purchase a maximum of each drug at any one time which is :
A max of 720mg of Pseudoephedrine salts
A max of 180 mg of Ephedrine base or salts
Pseudoephedrine or Ephedrine can be used in the illicit production of a class A controlled drug called methylamphetamine (crystal meth)

Question 53

EXEMPTIONS FROM PRESCRIPTION ONLY CONTROL :

Answer 53

Some drugs are usually classified as POMs, but may be exempt from prescription only control under certain circumstances. These drugs are listed in something called the POM order.

A product listed in the POM Order and which does not hold a marketing authorisation (e.g. something manufactured extemporaneously(made by the pharmacist as the drug is not readily available) in a pharmacy) will always be a POM unless it complies with one of the conditions listed in the appropriate section of Schedule 1 to the POM Order

What this means simply is that if you are making up an extemporaneous product in your pharmacy from a variety of medicines that have a marketing authorisation of P or GSL, this product will automatically become a POM, and as such you would not be able to supply this without a prescription.

Question 54

pharmacists can use various sources to determine whether any particular exemption applies.

These include:
Advice from the MHRA
The POM Order, itself

Answer 54

IN THE PAST : pharmacists used to make up their own medicines to a specific formulation, called Chemist Nostrums, and would sell them to patients over the counter. This is no longer permitted unless the formula is in the POM order.

A medicines marketing authorisation should always be supplied in preference to an unlicensed product, where the licensed product can meet the patient’s needs. This means that most pharmacists are now unlikely to wish to manufacture medicines routinely, for retail sale. Also, some medicines are only exempt from POM control when in the form of a licensed product (i.e. one which has a marketing authorisation).

“Hydrocortisone is a POM but when in the form of a licensed product, for which the indications fall within the terms specified for an exemption, the product is licensed as a pharmacy medicine. Hydrocortisone at a strength of 1% may be sold as a cream, ointment or spray where the container or package contains not more than 15g of medicinal product as a cream or ointment, or 30ml of a spray.

It can either be used alone or in conjunction with Crotamiton in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and either in combination with Clotrimazole for athlete’s foot and candidal intertrigo or in combination with lignocaine for anal and perianal itch associated with haemorrhoids. It is limited for use in adults and children not less than 10 years

Question 55

Examples of some other drugs exempt from POM control :

Answer 55

Naloxone is administered as an intramuscular injection used as a reversal agent for opioid overdose (e.g. heroin). Deaths in the UK involving heroin and other opiates have increased in recent years.

Naloxone falls into a unique category in that it is still a POM but staff involved in “lawful drug treatment services” ,as community pharmacies are, can make direct supplies to patients without a prescription or PGD (patient group direction).

The lawful drug treatment services community pharmacy are involved in are needle and syringe exchange programmes and drug treatment programmes.

Question 56

EXTEMPORANEOUS PREPARATION OF EXEMPTED PRODUCTS :

Answer 56

some medicinal products are exempted from POM status when sold or supplied for the treatment of specified conditions, and at dosages not exceeding stated maxima.

Under section 10 of the Medicines Act (this part of the Act still exists), it is perfectly legal for a pharmacist to manufacture such a product extemporaneously, for retail sale, in certain circumstances. However, pharmacists are generally advised not to engage in this type of activity. Instead pharmacists must only sell or supply licensed products (i.e. those holding a marketing authorisation) where such products exist in a suitable form and are available.

There are three reasons for this
Firstly, it is much safer (for patients) to use a licensed product wherever possible. Such products are manufactured according to Good Manufacturing Practice, in licensed facilities and have been subject to the MHRA’s tests of safety, efficacy and quality.
Secondly, the labelling of such products is complex, and pharmacists may easily fall foul of the labelling regulations.
Finally, if a medicinal product does not hold a marketing authorisation, the person who compounded the product (i.e. the pharmacist) assumes complete product liability for any adverse events arising from the use of the product.

Question 57

Sale of products outside of their marketing authorisation

Answer 57

if a pharmacist knowingly sells a medicinal product for a purpose outside that indicated by its marketing authorisation, the pharmacist assumes liability for any adverse events arising from the use of the product.
For example, proprietary OTC (over the counter) brands of hydrocortisone cream are not licensed for use on the face. If a pharmacist sells such a cream to treat a rash on a customer’s forehead, the pharmacist assumes liability, whilst the manufacturer becomes exempt from any “product liability”.

Question 58

ADMINISTRATION OF PARENTERAL POMs:

Answer 58

The HMRs state that no one may administer a parenteral POM to anyone other than to himself, unless he is a practitioner or is acting in accordance with the directions of a practitioner.
(no one other than the patient can administer a parenteral POM to himself unless the person administering the injection is a practitioner or acting with the permission or directions of the practitioner)

If this was always the case, it would be unlawful for anybody to administer an injection to a person unless he or she was working under the direct orders of a doctor. However, some POMs for parenteral administration are exempt from this restriction when they are administered for the purpose of saving life in an emergency.

Question 59

Schedule 19, Regulation 238 of the HMR 2012 outlines a list of medicinal products for parenteral which may be administered in an emergency situation:

Answer 59

Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis (allergic reactions, used in CPR)
Atropine sulphate and obidoxime chloride injection - use in CPR
Atropine sulphate and pralidoxime chloride injection- use in CPR
Atropine sulphate injection- use in CPR
Atropine sulphate, pralidoxime mesilate and avizafone injection- use in CPR
Chlorphenamine injection- used in allergic reactions
Dicobalt edetate injection- cyanide poisoning
Glucagon injection- low blood sugar
Glucose injection- low blood sugar
Hydrocortisone injection- allergic reactions
Naloxone hydrochloride- opioid overdose
Pralidoxime chloride injection- organic phosphorus pesticides (poisoning)
Pralidoxime mesylate injection- poison
Promethazine hydrochloride injection- allergic reactions
Snake venom antiserum
Sodium nitrate injection- poisoning
Sodium thiosulphate injection-poisoning
Sterile pralidoxime- poison

Question 60

PATIENT GROUP DIRECTION :

Answer 60

Usually, a patient will receive individual care from a specific prescriber, for example such as that which you receive from your general practitioner. In these cases, the prescriber will write an individual prescription, bearing the name of the patient and intended to be supplied for use by that individual patient.

Sometimes, however, situations arise where a group of patients may benefit from receiving care outside of this relationship.
In such cases, patients can access POMs from a practitioner, other than via a prescription.

These are called Patient Group Directions (PGDs).
A PGD is a written direction relating to the supply and/or administration of a POM to a group of people, which is signed by a senior doctor (or dentist, if appropriate) and by a senior pharmacist, both of whom should have been involved in developing the direction. Additionally the PGD must be authorised by the relevant appropriate body as set out in the legislation (e.g. a Health Authority or NHS Trust).

The Department of Health recommends that in the majority of cases, patients should receive individualised care. However, use of PGDs is appropriate in the following general circumstances:

The medicines to be given, and the circumstances under which they should be given, can be clearly defined in the written direction
There are ‘high volume’ groups of patients who present for treatment, such as people needing vaccines, or ‘routine’ treatments such as eye drops before clinical examination
Medicines are to be supplied and administered by one of the registered health professionals allowed to use PGDs.
Note also that it is not just pharmacists who can administer or supply medicines via a PGD; other healthcare professionals are also lawfully allowed to administer or supply medicines via this mechanism, including pharmacy technicians.

You will see a number of PGDs used by pharmacists out in practice, including the supply of emergency contraception, malaria prophylaxis and smoking cessation. The Department of Health can also issue a set of PGD templates that will enable pharmacists to supply treatment to people in specific emergency situations for example if people were exposed to biological agents such as anthrax or plague in mass casualty situations. There is also a PGD for registered health care professionals to supply potassium iodate tablets to people thought to have been, or expected to be, exposed to radioactive iodine.

Question 61

PGDS - REAL LIFE SITUATIONS :

Answer 61

Seasonal flu vaccination
In 2015 / 2016, all community pharmacies in England were commissioned to provide seasonal flu vaccinations to eligible adult patients; the service has been recommissioned for the 2018/19 flu season. This is an Advanced Service under the Community Pharmacy Contract (see lecture on Retail Pharmacy Business) which can be provided by any community pharmacy in England that has a consultation room, can procure the vaccination and meet the data recording requirements, and has appropriately trained staff.

COVID-19 vaccination service
On the 2nd December 2020 the MHRA approved the first COVID-19 vaccines in the UK and on the 8th December 2020, the first person received the COVID-19 vaccine. Pharmacists are just one of the large group of Healthcare Professionals who can administer the vaccine under the PGD.

Question 62

UNLICENSED MEDICINES

Answer 62

licensed medicine is one that holds a valid Marketing Authorisation.
An unlicensed medicine is one that does not hold a valid Marketing Authorisation, and includes, for example:

‘Specials’ – medicines made under a specials licence by a manufacturer

Imports – products with a licence, usually in another country, which are imported into the UK

Extemporaneous products – formulations for an individual patient made by a pharmacist compounding ingredients, this can include tablet manipulation by crushing or suspending

Manipulated products – medicines in which the formulation has been altered e.g. by crushing tablets or opening capsules and may be undertaken by a pharmacist as extemporaneous dispensing or by the medicines administrator/ carer

Question 63

OFF-LABEL MEDICINES

Answer 63

Off-label usage of a medicine is where a licensed medicine is used outside the terms of its Marketing Authorisation. For example a medicine might be used for a non-licensed indication. One common area of off-license medicines provision is the re-packaging of medication from the manufacturer’s original packaging into a Monitored Dosage System of some sort.
Off-label usage also commonly occurs in paediatrics, where a medicine normally licensed only for use in adults, is administered to a child.

Licensed medicines:
have been assessed for efficacy, safety, and quality by the MHRA or EMA
have been manufactured to appropriate quality standards
are accompanied by appropriate product information and labelling, when placed on the market

Unlicensed medicines do not have the same assurances. However, there are some clinical situations when the use of unlicensed medicines may be judged to be in the best interests of the patient, for example if there is no existing licensed product to meet a patient’s clinical needs.

Question 64

Legal risks of using unlicensed or off-label medicines:

Answer 64

The HMRs make it unlawful to “sell or supply, or offer to sell or supply, an unauthorised (i.e. unlicensed) medicinal product.” There are exemptions to this, for example to allow a pharmacist to extemporaneously prepare a product. However, the sale or supply of an unlicensed or off-label product carries liabilities, both under the laws of negligence and under Consumer Protection legislation

Question 65

RETAIL PHARMACY BUSINESS :

Answer 65

A retail pharmacy business includes the sale or supply of medicines other than GSL products - the term covers businesses involved in the sale or supply of P and POM meds
The pharmacy premises must also legally have a Responsible Pharmacist present who is in charge during business hours

The Retail Pharmacy Business may be registered by one of the following :
Pharmacist (Or a representative of a pharmacist who is deceased, bankrupt or who is someone who now lacks mental capacity)
A partnership consisting entirely of pharmacists
A Body corporate - In this situation one pharmacist acts as a superintendent pharmacist for more than one pharmacy as is the case with a large multiple pharmacy organisation. The superintendent pharmacist would take responsibility for the way the company carries out its professional pharmaceutical activities. Each individual pharmacy would still be required by law to have a Responsible Pharmacist on the premises to operate as a Retail Pharmacy Business

Question 66

RETAIL SALE OF GSL MEDICINES :

Answer 66

GSL medicines can be sold from premises, other than a registered pharmacy, but this is only where specific conditions are met. These conditions include:
The premises from which the medicinal product in sold should be such that it can be closed as to exclude the public.
The medicinal product that is sold has been produced and packaged for sale or supply at a site different to the place where it is being sold. It must also be in its original packaging from the source of production and have not been opened since it was made up for sale.
That the medicinal product is as listed in Schedule 15 of HMRs and presented in accordance with the requirements specified. This includes details such as the pack size, indication or duration of treatment permitted.
GSL medicines can also be sold or supplied from aircrafts and trains, as long as:
The medicinal products was made up and package at a place other than the one in which it is being sold.
That the medicinal product is stored in a part of the aircraft or train which can be excluded from the public, by the operator.
You may also see GSL medicines sold from automatic machines, but again, these must be located in places that can be excluded from the public, therefore inside a building and not on an external wall.

Question 67

PHARMACY(P)MEDICINES :

Answer 67

A Pharmacy medicine is a medicinal product which is:

Not a Prescription Only Medicine
Not a General Sale List medicine

It is interesting to note that there is no definitive list of pharmacy medicines. If a medicine is not classified as being a POM or a GSL it is generally a Pharmacy medicine.

Part 12 on the HMR is concerned with the sale and supply of medicines. It states that medicinal products may only be sold or supplied through registered pharmacies, unless they are classified as GSL or subject to some other exemption under the regulations. Simply put P and POM medicines must be supplied from a registered pharmacy, under the supervision of a pharmacist.
A retail pharmacy business must be under the control of a Responsible Pharmacist for the sale or supply of these medicinal products

Question 68

THE RESPONSIBLE PHARMACIST:

Answer 68

The Responsible Pharmacist Regulations are relevant to the sale and supply of GSL and P medicines. (These Regulations still exist – they have not been revoked by the HMRs).
There are five key areas that the law covers:
Securing the safe and effective running of the pharmacy
The display of the notice
The pharmacy record
Pharmacy procedures
Absence from the pharmacy

Question 69

SUPERVISION :

Answer 69

GSL medicines may only be legally sold from a retail pharmacy, if there is a responsible pharmacist in place for the premises, but these sales do not require supervision
pharmacists are legally required to supervise the sale / supply of P and POM medicines
But what is the legal situation when a GSL medicine is prescribed?
The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 state that dispensing must be carried out “either by or under the direct supervision of a pharmacist”.
The interpretation of “dispensing” has traditionally been that it includes all aspects of the dispensing and checking process, and that this process is not complete until the dispensed product is handed to the patient.
Therefore, if a pharmacist is acting as the responsible pharmacist, but is not exercising supervision:
It IS permissible to sell a GSL medicine to a customer (under the HMRs)
It is NOT permissible to hand over a GSL medicine which has been dispensed (under the NHS Pharmaceutical Services Regulations 2013

Question 70

ONLINE AND INTERNET PHARMACY :

Answer 70

Pharmacy owners can choose to provide pharmacy services ‘at a distance’, which includes internet services. It is important that patients still receive the same level of care in this situation, with medicines and advice being provided in a safe and effective way, even in a distanced setting. An online business still needs to adhere to the same rules as a ‘bricks and mortar’ pharmacy and their needs to be a responsible pharmacist leading the pharmacy team. The pharmacy must still be registered with the General Pharmaceutical Council (GPhC) and the registration number clearly display on their website.

From 1 January 2021 Great Britain (England, Wales and Scotland) based online sellers are no longer required to display the EU common logo (in the UK known as the Distance selling Logo). The MHRA are considering an alternative Distance selling logo and in the meantime will continue to monitor online retailers and, when needed enforce the removal of any illegitimate online retailers. The MHRA keeps a register of all legitimate retailers who are approved to supply medicines online.

Question 71

Emergency supply of POMS

Answer 71

POMs are usually available to the public only on production of a legally valid prescription, issued by a relevant prescriber.
However, sometimes a patient will have an urgent need for a POM, but will be unable to access a prescription in time. In such an emergency a community pharmacist (i.e. a person lawfully conducting a retail pharmacy business) can lawfully sell or supply a POM, if and only if certain conditions are satisfied. When this happens, it is called an emergency supply.

Question 72

EMERGENCY SUPPLY AT THE REQUEST OF A UK REGISTERED PRESCRIBER

Answer 72

The first type is an emergency supply made at the request of a UK registered doctor, dentist, supplementary prescriber, community practitioner nurse prescriber or one of the following non-medical independent prescribers: nurse, optometrist, pharmacist, physiotherapist, podiatrist or therapeutic radiographer.
Essentially, the rules are the same for all of these professional groups
In this situation the prescriber would contact the pharmacy directly and discuss the request with the pharmacist. The following conditions must be satisified before a supply can be made at the prescribers request:

Relevent prescriber - the pharmacist must be included in the lists of prescribers authorised to make this request.

Background to the emergency - the pharmacist needs to be satisfied that there is an immediate need for the supply as a result of an emergency situation, for example the prescriber is unable to provide a prescription to the patient or pharmacy and the patient needs their medication urgently.

Prescription required within 72 hours - the prescriber must agree to provide the pharmacist with a prescription for the medicines requested within 72 hours of the emergency supply request

Directions for use - the pharmacist must follow the directions for use provided by the prescriber when making the supply

Not for Controlled Drugs* (except phenobarbital) - Schedule 1, 2 and 3 controlled drugs cannot be supplied in an emergency, with the exception of the medicine phenobarbital, if it is being prescribed for the treatment of epilepsy.

A record must be made - A record of the supply must be made in the relevant POR/POM register. The next section covers the record entry requirements.

Labelling - usual label requirements are needed.
*The supply of controlled drugs in a emergency, during a pandemic is an example of the relaxation of legislation in this situation.

Question 73

EMERGENCY SUPPLY AT THE REQUEST OF A PATIENT

Answer 73

A request made by a patient for a medicine in an emergency situation
Interview - The pharmacist must interview the patient making the request. This is required under regulation 225 of the Human Medicines Regulations 2012. See MEP section 3.3.10.2 for exceptions to interviewing the patient in person.
Immediate need - The pharmacist must establish if there is an immediate need for the medication and be happy that is not practical for the patient to obtain a prescription at this time.
Previous treatment - The patient must have been previously prescribed the medication by a UK registered prescriber and this should still be current treatment, appropruate for the condition being treated.
Dose - The pharmacist must be satisified that the dose is appropriate for the patient based on the information that they have been provided with or which they have access too (for example a Summary Care Record for the patient)
Not for Controlled Drugs* (except phenobarbital) - Schedule 1, 2 and 3 controlled drugs cannot be supplied in an emergency, with the exception of the medicine phenobarbital, if it is being prescribed for the treatment of epilepsy. You will consider controlled drugs in more detail in Year 3.
Length of treatment which may be supplied
A record must be made - A record of the supply must be made in the relevant POR/POM register. The next section covers the record entry requirements.
Labelling - usual labelling requirements are needed, with the addition of the words ‘Emergency supply’ which must also be added to the dispensing label
Note, this is an emergency supply at the request of a patient is a private transaction between the patient and the pharmacist and as such, the prescriber does not need to provide the pharmacist with a prescription.

Question 74

Other points to consider

Answer 74

Pharmacists should always be mindful of the potential for patients to abuse the ability to make requests for emergency supplies in order to obtain medicines for other reasons. Pharmacists should consider whether the medicine could be misused or look for evidence of whether emergency suppply requests have been made on previous occasions by the patient concerned. If a pharmacist decides to refuse a supply after considering all the information which they have been presented with, they should make a record of their decision making process and also ensure that the patient is advised as to how they might obtain a prescription for the mediciation requested. This could involve the patient going to an NHS walk-in-centre or to an Accident and Emergency department.

Question 75

Dispensing Private Prescriptions

Answer 75

The arrangements for dispensing private prescriptions fall outside the NHS. Therefore the NHS does not pay for this service. It is paid for privately by the patient. The community pharmacist is free to set the fee to be charged for the item. Note, however, that the charge paid by the patient is exempt from VAT (Value Added Tax – a Government Tax levied on most goods and services). Remember that, sometimes, a repeat supply may be made against a private prescription.

Question 76

Private Prescriptions - Record Keeping

Answer 76

Unlike NHS prescriptions, private prescriptions for POMs are NOT sent to the NHSBSA since they are not part of the NHS service (different rules apply to private prescriptions for certain classes of Controlled Drugs but we will consider these later). Instead, the community pharmacist should retain the prescription when it has been dispensed for the final time.

The pharmacist is also required to keep a record of the supply, in the Prescription Only Register (POR). Remember, NHS prescriptions are not recorded in the POR register.

Question 77

How should the register be laid out?

Answer 77

It is important that your register is clearly laid out, as well as including all of the important information. An example of how you might set out this record is attached to this page, but there is no set format which you have to use. The key thing is to ensure that all the required information is clearly recorded.

Question 78

What information should be recorded?

Answer 78

The nature of the transaction – i.e. a ‘heading’ for your entry
E.g. ‘PRIVATE PRESCRIPTION.’ The Prescription Only Register is used to record various types of transactions. It is helpful to know what type of transaction the register entry relates to.

The dose
While it is not a legal requirement to record the dose, it is generally accepted to be good practice to record this information. If you consider the register entry to be a copy of the prescription it makes sense to record this important piece of information.

A reference number
The reference number is made up of:
the register identifier – when a new register is started it is given some form of identifer (e.g. register A) to distinguish it from earlier or later registers held within that pharmacy
the page number – each page of the register is numbered (e.g page 1, 2 etc)
an entry number – each entry has a unique number on the page (1, 2 etc).

The reference number must appear:
on the dispensing label (typed in by the pharmacist – not handwritten on)
in the register (it is part of the register, as explained above)
on the prescription (the pharmacist endorses this onto the prescription, when the item is dispensed).

When written on the label and prescription, it is written as, for example the first entry in a new register would be, A/1/1 the second A/1/2 and so on.

Question 79

Summary Care Record

Answer 79

The Summary Care Record (SCR) is an electronic record, compiled from information held at the patient’s GP surgery, containing information about patients including allergies, medications and adverse reactions. The SCR can be viewed by other health professionals, including pharmacists, involved in a patient’s care. The SCR is an invaluable tool, when making decisions about the provision of emergency supplies to patients, since it contains up to date and accurate information about the patient’s medication history. There are strict protocols for accessing the service

Question 80

Wholesale dealing

Answer 80

There a special circumstances that allow some people to purchase POMs without prescription. These circumstances are usually connected with the work that certain groups of people do, as they have cause to use POMs in the course of their work. When people purchase medicines in this way is is called ‘Wholesale dealing’.

“Wholesale dealing” of a medicinal product occurs if it is sold to a person for the purpose of:
selling or supplying it, or administering it to one or more human beings, in the course of a business carried on by the purchaser.
So, for example, if a pharmacist sells a medicinal product to a doctor, for the purpose of the doctor supplying or administering it to a patient, this constitutes wholesale dealing.

The MHRA permits pharmacists, who do not hold a Wholesale Dealers Authorisation, to sell small quantities of medicines to another person (on a not-for-profit basis), for them to sell / supply / administer to a third party, in order to secure the provision of healthcare services in the UK.

some community pharmacies do apply for and hold a Wholesale Dealer’s Authorisation
A pharmacist is only permitted to sell P or POM medicines by way of wholesale dealing if the person buying them from the pharmacist is lawfully permitted to sell or supply those goods to somebody else, or to administer them to human beings in the course of their business.
This means that a pharmacist cannot sell P or POM medicines by way of wholesale to just anybody

Question 81

Wholesale dealing: Supply POMs to Schools

Answer 81

Legislation has changed over the last few years to enable pharmacies to supply Salbutamol inhalers for asthma and Adrenaline Auto Injectors for anaphylaxis direct to schools.
In both cases a written signed order signed by the principle or head teacher must be provided by the school.
On that signed order to be a legal supply, must be the following information
Signature of the principle or head teacher.
Name of the school.
The purpose for which that product is intended.
The total quantity required

Question 82

Wholesale dealing: Signed orders and record keeping

Answer 82

Every person lawfully conducting a retail pharmacy business is required to keep a record in respect of every sale or supply of a Prescription Only Medicine unless a specific exemption applies. Hence, it may be necessary to make records of any wholesale transactions involving POMs.

Question 83

WHAT YOU NEED TO KNOW

Answer 83

This is a fairly complex area of Medicines legislation.
You do not need to know the list of exempted persons, and the drugs and circumstances surrounding the exemptions from memory.
You must, however, be able to use the information in the reference sources to be able to decide who you could (or could not) sell medicines (by wholesale, or circumstances corresponding to wholesale, to secure the provision of healthcare services) to as a pharmacist, in what circumstances such sales can take place and what documentation and record keeping are necessary.

Question 84

REMEMBER!!!

Answer 84

Sales of GSL, pharmacy or prescription-only medicines by way of wholesale dealing may only take place if the purchaser is authorised to sell or supply the goods, or to administer them to human beings in the course of their business.
This means that you can lawfully make a sale to “exempted persons”, so long as that person can then lawfully sell / supply or administer the medicinal product, in the course of their business.

You can ONLY sell the product if the purchaser intends to use it for a lawful purpose.
Pharmacists who wish to engage in commercial trading in medicines are entitled to do so only if they hold a Wholesale Dealer’s Authorisation (WDA) and comply with all the relevant requirements.
Sales to other healthcare providers in the UK who need to hold medicines for treatment of, or onward supply to, their patients falls within the definition of ‘provision of healthcare services’. In such circumstances, the MHRA does not require the pharmacist to hold a WDA
Records
When a POM is supplied against a signed order, an entry should be made in the POM/POR register or the signed order/invoice should be retained for two years from the date of supply.
Even when the signore order/invoice is retained, it is still good practice to make a written entry and as such we expect you to do this whilst you are an undergraduate student as part of any teaching or assessments which you undertake.
Details needed for your record
Date the POM was supplied
Name, quantity and, where not apparent, the formulation and strength of the product
Name, address, trade, business or profession of the person to whom the supply was made
Purpose for which it was sold