Final Principle - 4 - GPHC - Action - Plan

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G P h C P RI N C I P L E 4: ACT I O N P L A N

The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients
and the public.

4.1 THE PHARMACY SERVICES PROVIDED ARE ACCESSIBLE TO PATIENTS AND THE PUBLIC
Question Details of action required Reference Comments Actioned

1 How can patients access the services Pharmacy staff are able to explain to the Numark -
provided by the pharmacy? inspector how they can help patients Accessible
access the services, for example, hearing Information
loops, large print, use of a doorbell to Standard
attract the attention of a member of the
Numark Accessible
team.
Information
Standard SOP
2 What services does the pharmacy offer? Pharmacy provides information to promote Numark -
What about services the pharmacy does services offered and signposts people who Signposting
not offer? need services they do not offer.

3 Are practice leaflets available for Pharmacy practice leaflet are available CPE practice
customers? to your customers. It contains important leaflet
information for example, it informs your requirements
customers about some of the services you
offer, how they can provide feedback and
raise a complaint.

4.2 PHARMACY SERVICES ARE MANAG ED AND DELIVERED SAFELY AND EFFECTIVELY
Question Details of action required Reference Comments Actioned

4 Are owing slips produced when an item is If the patient chooses to take what is Numark Owings
not fully available? available, generate an owing ticket for the procedure SOP
remainder and order the stock required.
The PMR must be amended and owing
labels generated for all items that are
outstanding. The owing labels produced
must be placed in the owing book, with
one of the slips provided to the patient or
representative and the other slip kept in
the owing book.
5 Can the team explain what a Look-Alike LASA medicines are Look-Alike Sound- Numark - LASA
Sound-Alike (LASA) medicine is and give Alike medicines, which are often incorrectly errors
an example? selected during the dispensing process
CPPE - Reducing
due to their similar names. The risk of
LASA errors
incorrect selection can increase where
they begin with the same letter meaning
they are stored near each other on the
shelf and that they will come up next to
each other on the computer during the
labelling process. A further complication
can be they often share the same range of
strengths, packaging and forms.
6 Are the team aware of specific LASA It is for the RP and the pharmacy team Numark - LASA
medicines that cause near miss and can to decide what are the most appropriate errors
they provide evidence of actions they have actions to reduce the chances of a LASA
taken to mitigate the risks? error occurring in their pharmacy. Actions
taken should be clearly documented on
Near Miss Logs and then reviewed monthly
as part of your Patient Safety Review. Only
by documenting and reviewing incidents as
a team will you understand which LASAs
present the greatest risk in your pharmacy
and be able to take action.
7 Are there audit trails in place to identify Dispensing labels have a ‘dispensed by’ Numark
who was responsible for professional and a ‘checked by’ box which are filled in Assembling
activities? when an item has been dispensed and and labelling
accuracy checked. Pharmacist should also prescriptions SOP
have completed a clinical check.
8 Is there a services folder in use for the It should contain the details of all Locally Numark Pharmacy
pharmacy? Commissioned Services, commissioners services pages
and dates of contracts for services offered
in the pharmacy. You must be able to show
the inspector any service specifications /
SLAs / PGDs relevant to services offered in
the pharmacy and these must be stored in
a services folder to be used as a reference
source for provision of the service.
9 How are patients on compliance aids Pharmacy staff are able to explain the Numark Supplying
managed? governance in place to keep accurate medicines in a
patient records. Each patient should have compliance aid
a medication record which identifies the SOP
patient and provides an accurate and up
to date reflection of the patient’s current
medication.
10 For patients on compliance aids, have the The medication records are Numark Supplying
medication records for each patient been pharmaceutically assessed by a medicines in a
assessed by a pharmacist? pharmacist prior to dispensing. This compliance aid
process must include a clinical and SOP
accuracy check to ensure that the record
accurately reflects the patient’s currently
prescribed medication. The patient’s
medication must be pharmaceutically
assessed when the patient receives new
medication, any changes are made to
their prescribed medication or a minimum
of every 6 months, whichever is sooner.
In the event of any amendments, a
pharmaceutical assessment must be
completed as soon as practically possible
and signed off by the pharmacist. This
must be completed before the next
dispensing.
11 For patients on compliance aids, what Staff are able to explain the process for Numark Supplying
is the process to deal with changes to dealing with a change to the medication medicines in a
medication? to ensure the patient receives the correct compliance aid
medication in their next supply of trays. All SOP
medication changes must be recorded in
a Medication Change record form which
should be stored within the patient’s
records for a period of at least 6 months.
4.3 MEDICINES AND MEDICAL DEVICES ARE:
• OBTAINED FROM A REPUTABLE SOURCE
• SAFE AND FIT FOR PURPOSE
• STORED SECURELY
• SAFEGUARDED FROM UNAUTHORISED ACCESS
• SUPPLIED TO THE PATIENT SAFELY
• DISPOSED OF SAFELY AND SECURELY

Question Details of action required Reference Comments Actioned

12 Is there a cleaning rota in place? Cleaning rotas should be assigned to Numark Cleaning
colleagues weekly. Once completed the rota
cleaning rotas should be annotated to
provide evidence.
13 What is the date checking process for the Date checking should be assigned to Numark Date
pharmacy colleagues weekly. Once completed check for
the date checking sheets should be dispensary stock
annotated to provide evidence. All areas SOP
of the pharmacy should be covered
Numark Date
every 3 months. The shortest expiry date
check for counter
stock must be placed at the front of the
stock SOP
shelf so it will be used first. Remember to
include the fridge, Controlled Drug cabinet,
drawers and stock that is stored out of the
dispensing area.
14 Is date expired medicine stock being Any out of date dispensary stock must Numark Disposal
written off within the month it was be written off in your pharmacy within the of unwanted
identified? month it was identified. medicines SOP
15 Are fridge temperatures recorded and Fridge temperatures must be recorded Specialist
what are the processes if the temperature daily. If there is more than 1 fridge, the Pharmacy Service
is outside the required range? temperatures must be clear which fridge - using a fridge
the record belongs to. Pharmacy staff know or freezer to store
what actions to take when the fridge is medicines
outside the temperature range (2-8°C) All
Specialist
actions should be clearly documented.
Pharmacy Service
- managing
temperature
excursions
Numark Cold
Chain medicines
SOP
16 Who has access to the CD keys? CD keys are locked away when the RPS - Professional
pharmacy is closed. Check who has access guidance on the
to the CD keys when the pharmacy is safe and secure
closed. CD keys should be stored in a handling of
sealed envelope overnight which has been medicines
signed by the RP. They should be signed
Numark CD1-
over to the pharmacist when the pharmacy
Legality of CD
is open. The RP must sign the diary the
prescribing SOP
following day to state that the key has
been received back sealed.
17 Who has access to the CD cabinets? The CD keys must be under the personal Numark CD1-
control of a pharmacist and must be kept Legality of CD
on their person at all times. prescribing SOP
18 What is the process for patient returned Patient returned CD medication must be Numark CD4
CDs? clearly segregated in the CD cabinet - – Disposal of
This medication should be segregated unwanted CDs
from other pharmacy stock and be clearly SOP
marked (e.g. mark the stock as ‘patient
returns waiting to be destroyed’).
19 What is the process for out of date CDs? Out of date or obsolete CD stock - All Numark CD3 –
out of date or obsolete schedule 2 and stock control and
schedule 3 CD stock requiring safe record keeping
custody should be segregated in the CD SOP
cabinet and clearly marked as out-of-date
CD Reporting
stock (e.g. mark the stock as ‘out of date
website
waiting authorised witness to destroy’).
Schedule 3 CD stock denaturing does
not require the presence of an authorised
witness, but it is good practice to have
another member of the pharmacy team
witness the denaturing and a record made
in the POM register.
20 What is the process for denaturing CDs? CD medication in schedule 2,3 and 4 (Part Numark CD4
1) needs to be denatured before disposal. – Disposal of
unwanted CD SOP
21 How are split packs of medication All medication is to be stored in the original Numark Stock
identified in the pharmacy? packaging. To alert colleagues to packs handling SOP
that have been opened the container must
be marked with a cross or leave the carton
flap out so that it is easily identifiable and
obvious that the pack does not contain
the full quantity. Ensure that any split
blisters contain the expiry date and batch
numbers.
22 Do all split boxes of CDs contain Do not mix any batches of any medicines. Numark CD2 –
medication with the same batch number / Ensure all split boxes are clearly marked. Assembly and
expiry date? If there are mixed batches, these must be supply of CD
clearly segregated and put into plain boxes prescriptions SOP
making sure the name, form, strength of
the drug, the batch number and expiry date
are included.
23 What process is in place for oral liquids The date of opening an oral liquid medicine
that have been opened? or a medicine with a shelf life once the
container has been opened is clearly
recorded.
24 How is medicines waste stored in the Different types of waste are stored in Numark Disposal
pharmacy? different bins / bins with different coloured of unwanted
lids depending on the type of waste. When medicines SOP
full, seal the disposal container and store in
CPE - Disposal
a safe place, away from empty containers,
of unwanted
ready for collection. Full DOOP bins must
medicines
be stored with the tops securely sealed.
25 How is returned waste handled in the Waste should be sorted in a designated Numark Disposal
pharmacy area and that you use gloves. Do not put of clinical waste
your hands directly into a bag of patient SOP
returned waste. All equipment is present to
handle returned medicines including trays.
Ask the person to place each item into
the tray. Staff must not do this on behalf
of the patient. If waste has been returned
with the delivery driver, gently empty out
the contents of the bag or container into a
large shallow plastic container used solely
for the purpose of medicines disposal.
Controlled drugs / cytotoxic or hazardous
waste must be identified and disposed of
appropriately.
26 What is the process for returned waste for Pharmacy staff are able to explain the Numark Delivery
delivery drivers from patient’s homes/care process the delivery driver follows for service SOP
homes? collecting waste medicines from a person’s
home - The driver should annotate the
record book with a statement indicating
that they have collected waste medicines
and detail if it contains CD items. All
patient returned medication must be
returned to the pharmacy on the same
day and highlighted to an appropriate
colleague in the pharmacy.
27 How are dispensed fridge items and CDs All fridge items and CDs requiring safe Numark CD2 –
stored prior to them being collected? storage are bagged separately in a Assembly and
clear plastic bag to facilitate another supply of CD
accuracy check at the point of prescription prescriptions SOP
collection.
28 Do CDs items awaiting collection have All prescriptions containing schedule 2,3 Numark CD2 –
a clear date of when they need to be & 4 CDs have a CD sticker attached to Assembly and
collected by? the bag which states the 28 day expiry supply of CD
date to reduce the chances of supplying prescriptions SOP
medication without a legally valid
prescription at the time of collection.
29 How are high risk medication highlighted? Highlight high risk medicines such as NHS England -
warfarin, methotrexate, lithium and High risk medicines
valproate by using a label attached to audit report
the prescription bag. This enables the
pharmacist to provide any advice and
counselling to the patient and make any
necessary notes on the patient’s PMR, for
example a record should be made of the
patient’s International Normalised Ratio
(INR) value for warfarin.
30 When dispensing prescriptions for oral The following guidance must also be Numark
methotrexate, can the team evidence followed - methotrexate should be Dispensing and
compliance with the SOP? dispensed, except where necessary, as checking oral
the 2.5mg strength. If the prescriber has methotrexate SOP
requested 10mg tablets this should be
confirmed with the patient and/ or the
patient’s monitoring book and should be
ordered specially. It is important to store
the 10mg tablets separately from the
2.5mg strength to avoid confusion (this
could be in the CD cupboard). A note
should be added to the PMR system that
the 10mg has been ordered for a specific
patient and should not routinely be re-
ordered. The prescription and dispensing
label must have a weekly dosage.
31 What process is in place for the handout Team members make appropriate checks Numark Handing
of medication? when they hand out medicines, to make out prescriptions
sure they are supplied correctly – patients SOP
are asked to confirm the first line of their
address and this is cross checked against
the bag label and the prescription.
32 When dispensing prescriptions for lithium, Patient monitoring booklets or similar Numark
can the team evidence compliance with recording booklet should be requested Dispensing
the SOP? / patient should be asked if they take and checking
any other medicines (prescribed, OTC procedure for
medicines, vitamins, supplements or Lithium therapy
herbal products) / ask the patient about SOP
possible side-effects / check monitoring
information to ensure the results are within
target range and these are monitored
regularly (this should be recorded on the
patient record as necessary) / check for
drug interactions. The patient must be
maintained on the same brand of lithium.
Pharmacy teams should be trained to
identify the symptoms of lithium toxicity
to ensure they can be signposted to the
pharmacist.
33 When dispensing prescriptions for Whenever you dispense a medicine related Numark
valproate, where appropriate, can the to valproate for a female of childbearing Dispensing
team evidence compliance with guidance potential, she must receive a patient and checking
for women and pregnancy? card and booklet if they have not already procedure for
received one. Remind the patient of the valproate and
risks of taking valproate in pregnancy and valproic acid
need for effective contraception. Refer medicines SOP
patients not complying with the Pregnancy
Prevention Programme, planning a family,
who may be pregnant, or who report not
taking their medicine as prescribed by their
prescriber. All patients should be advised
NOT to stop taking their valproate in any
circumstances without consulting their
prescriber. Make a record on the PMR of
conversations and advice offered.
34 How is the retrieval system managed? Staff have a process to manage Numark
prescriptions awaiting collection. Also Uncollected
have a system in place to remove older prescriptions SOP
prescriptions. Have patients got an option
to register for text notification to inform
them that their medication is ready to
collect at their pharmacy.
4.4 CONCERNS ARE RAISED WHEN IT IS SUSPECTED THAT MEDICINES OR MEDICAL DEVICES ARE NOT FIT FOR
PURPOSE
Question Details of action required Reference Comments Actioned

35 Are drug recalls and alerts actioned and It is a good idea to print two off, place Numark Medicines
stored in the Patient Safety Folder? one with the action, signature and date and Medical
of action in the Patient Safety Folder Devices Recalls
and place the other on the wall of the and Notifications
dispensary for everyone to read and sign page
when they have read it so everyone is
Numark Patient
aware of it. After all relevant colleagues
safety and drug-
have signed it, this should be filed in your
device alerts SOP
Patient Safety Folder and kept for 2 years.
Action must be taken as instructed by the GOV.UK - alerts,
alert to comply with the stated deadline. recalls and safety
information
CPE - patient
safety information
36 Can the pharmacy team explain what The primary concern is for the patient’s Numark Adverse
actions are required if an Adverse Drug welfare and all staff are responsible for Drug Reporting
Reaction (ADR) is suspected? referring patients with suspected Adverse page
Drug Reactions (ADR) to the pharmacist.
Numark
The pharmacist on duty should take any
Management of
necessary steps to ensure the wellbeing
adverse events
of the patient. This may involve referral to
the GP or an ambulance being called. It Numark Record
may simply be a recommendation that of adverse events
the patient stops taking a particular template
medication. The yellow card scheme
NICE - adverse
should be used to report all suspected
drug reactions.
ADRs. This can be either completed using
the electronic form at www.mhra.gov.uk/ GOV.UK - Yellow
yellowcard or using the prepaid yellow card Card Scheme
at the rear of the BNF. This is particularly
the case for black triangle drugs. If the
pharmacist has satisfactorily completed
the yellow form it is good practice to retain
a copy in the branch.

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