BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
DRAFT MEDICINES POLICY
1
POLICY DRAFTED BY:
HEAD OF MEDICINES MANAGEMENT
PRESCRIBING ADVISERS
2
ACCOUNTABLE DIRECTOR:
DIRECTOR OF COMMISSIONING
3
APPLIES TO:
ALL GP PRACTICES
ALL ISLINGTON CCG COMMISSIONED
SERVICES
4
COMMITTEE& DATE APPROVED:
5
VERSION:
6
RELATED DOCUMENTS:
7
DATE OF IMPLEMENTATION:
FEBRUARY 2015
8
DATE OF NEXT REVIEW:
FEBRUARY 2017
1.1
DOCUMENT CONTROL
Date
19
September
2013
15 May
2014
Version
1.0
Action
First version
Amendments
Draft
1.1
Revised first version
31
December
2014
1.1
Revised first version – final
updates
Updated draft with comments
included and incident
reporting refined. Crossreferences added to NHS
England policies where
appropriate.
Updated hyperlinks, addition
of Medicines Safety Officer
details, rebate schemes
details and minor
amendments to guidance.
MEDICINES POLICY AND GUIDANCE
Page 1 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
1.
Introduction
The term ‘medicines’ embraces all products for the purpose of treating or preventing
disease, diagnosing disease or determining the extent of a physiological condition,
contraception, inducing anaesthesia, or otherwise preventing or interfering with the
normal operation of a physiological function. Medical gases, immunisations/
vaccines and pharmaceutical preparations such as medicated or interactive
dressings, disinfectants, reagents and similar products, and all medicinal products
covered by the European Directive on Medicines are included.
This policy will ensure high quality Clinical Commissioning Group (CCG)commissioned services through the safe, effective, economic and patient-centred
use of medicines.
Medicines optimisation encompasses a whole systems approach to ensure the
NHS is achieving maximum health gain and least harm from all medicines. It
involves maximising the use of medicines in preventing disease or the progression
of disease and in improving patient outcomes from the use of medicines.
This approach will be used to develop medicines services within Islington CCG
through application of the Royal Pharmaceutical Society’s four principles of
medicines optimisation:
i)
ii)
iii)
iv)
Aim to understand the patient’s experience
Evidence-based choice of medicines
Ensure medicines use is as safe as possible
Make medicines optimisation part of everyday practice
The key areas of legislation underpinning this policy include:





The Medicines Act 1968, as amended, which regulates the manufacture,
distribution, import, export, sale and supply of medicinal products
The Misuse of Drugs Act 1971 as modified, which controls the availability
of drugs liable for misuse
The Misuse of Drugs Regulations 2001, as amended, which enable
specified health care professionals to possess, supply, prescribe and/or
administer controlled drugs in the sphere of their practice.
The Misuse of Drugs Regulations 2005, which sets out arrangements for
the safer management of controlled drugs
Health and Social Care Act 2012, which sets out the statutory functions of
Clinical Commissioning Groups and new NHS organisational structures
within which they will function.
MEDICINES POLICY AND GUIDANCE
Page 2 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
2.
Policies statement
Islington CCG’s policies set out the organisation’s standards and intentions, and are
written with the aim of being as clear and comprehensive as possible. However, we
operate in a dynamic and evolving work environment and attention should be paid
to the spirit of the policy as well as the letter. Policies by themselves cannot
guarantee effective behaviour or the delivery of key objectives. While they are
designed to support the CCG, and the people working within it, our success
depends on continuous, high quality effort by everyone the policy covers. Therefore
thought must be given to good practice when applying or interpreting any of the
CCG’s policies, and you should read any guidance or supporting documentation
that relates to this policy to help you do this.
3.
Purpose and Scope of the Policy
This policy has been developed to summarise legislative requirements and best
practice relating to the safe and secure handling of medicines, including Controlled
Drugs and is intended for use by all staff commissioning services which include
medicines components in Islington CCG. It includes guidance on the ordering,
storage, prescribing, administration, disposal and optimisation of medicines.
The objectives of the policy are to provide organisation-wide assurance that:







Safe and appropriate arrangements for the use of medicines are in place
in all CCG-commissioned services and within CCG GP practices,
complying with legislation, regulators’ (e.g. CQC, NHS England, GMC,
GPhC) requirements and good practice guidance.
Patients have access to the medicines they require in line with the NHS
Constitution.
Medicines are correctly and appropriately prescribed by an authorised
prescriber.
Medicines are accurately and appropriately administered by authorised
staff.
Recording and safe and secure handling of medicines is correctly
performed to prevent harm, loss or inappropriate access.
Staff are accountable for their actions in relation to use of medicines and
adherence to this policy.
Staff are supported in working to the highest standards when involved in
the prescribing, dispensing, handling, storing, administration and
optimisation of medicines.
This policy replaces the former Islington PCT Medicines Policy.
4.
Who this policy applies to
The policy applies to all GP practices within Islington CCG, employees and staff of
Islington CCG and to all services commissioned by Islington CCG.
MEDICINES POLICY AND GUIDANCE
Page 3 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
5.
Medicines Guide
The full guidance to support this policy is set out in Appendix 1 below.
6.
Roles and Responsibilities
Responsibility of Commissioners
To ensure a copy of the policy is accessible to all commissioned services and that
service provider policies comply with this policy.
Prescribing and medicines should always be considered when commissioning or
redesigning services. Commissioners should contact the Medicines Management
team at the earliest opportunity to discuss medicines aspects of new or changed
services.
Responsibilities of commissioned organisations
Commissioned service providers will ensure they have an operational medicines
policy in place and that this is available for review by Islington CCG staff when
required. Provider units shall ensure that processes are in place covering (but not
limited to) ordering and receipt of medicines, prescribing and administration of
medicine, destruction of medicines, storage of medicines and medicines monitoring
and review.
Commissioned organisations should also adhere to the North Central London
Prescribing Guidance.
Responsibilities of GP practices
GP practices are accountable for their medicines arrangements to the Care Quality
Commission (CQC) under Outcome 9 –Management of Medicines. GP practices
are also contractually accountable to NHS England. The CCG Medicines
Management team can provide support and help practices with enquiries in relation
to the safe and appropriate use of medicines.
Responsibilities of community pharmacies
Community pharmacies are contractually accountable to NHS England and
professionally accountable to the General Pharmaceutical Council. Where
Community pharmacies are providing CCG commissioned services they should
adhere to the terms of their NHS contract and the requirements of this policy.
Responsibilities of nursing staff
All registered nurses, midwives and health visitors are accountable for their practice
and shall adhere to the current Nursing & Midwifery Council (NMC) guidelines
Each individual nurse has a responsibility for storing, handling, administering and
recording of medicines and disposal in a safe, correct and appropriate manner and
must be prepared to be accountable for his/her actions.
MEDICINES POLICY AND GUIDANCE
Page 4 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
7.
Breaches of Policy
Any breaches of this policy must be reported as an incident to the NEL
Commissioning Support Unit incident reporting service or in accordance with a
commissioned service provider’s incident reporting policy.
All incidents will be reviewed by the Medicines Optimisation Group for trends and
organisational learning and policy change and development.
8.
References
References are provided as hyperlinks throughout the policy to ensure links to the
most up-to-date versions of guidance and provide ease of reference. The policy will
be reviewed annually and the hyperlinks updated. If a hyperlink has expired, please
search for the item or contact your prescribing adviser.
MEDICINES POLICY AND GUIDANCE
Page 5 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
Appendix 1
MEDICINES GUIDE
This guidance applies to all staff in Islington CCG who are involved in any aspect of the
use of medicines including locum and agency staff.
MEDICINES POLICY AND GUIDANCE
Page 6 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
Contents
1. Introduction ................................................................................................................... 9
1.1 Staff Training ............................................................................................................ 10
1.2 The Pharmaceutical Industry .................................................................................... 10
1.3 Clinical Trials ............................................................................................................ 11
1.4 Medicines adherence ............................................................................................... 11
2. Prescribing .................................................................................................................. 12
2.1 General guidance ..................................................................................................... 12
2.2 NICE guidance ......................................................................................................... 12
2.3 Formulary ................................................................................................................. 13
2.4 Guidelines and pathways ......................................................................................... 13
2.5 Off-Label/Unlicensed Prescribing ............................................................................. 13
2.6 Prescription forms .................................................................................................... 14
2.7 Non-Medical Prescribing .......................................................................................... 14
2.8 Communications on transfer of care (Medicines Reconciliation) .............................. 15
3. Safe and secure handling of medicines....................................................................... 16
3.1 Administration of medicines ..................................................................................... 16
3.2
Authorisation to Administer Medicines .................................................................. 17
3.3
Administration of Medicines via the Intravenous Route ........................................ 18
3.4
Vaccine Administration ......................................................................................... 19
3.5
Administration by Nurses in Training .................................................................... 20
3.6
Supervision and Assessment of staff .................................................................... 20
3.7
Responsibilities of Registered Nurses .................................................................. 20
3.8
Consent ................................................................................................................ 20
3.9
Self-Administration of Medicines........................................................................... 20
3.10
Patient Group Directions ................................................................................... 21
3.11
Patient Specific Directions ................................................................................. 21
3.12 Emergency drugs ................................................................................................... 21
4. Medicines safety.......................................................................................................... 21
4.1
Medicines information ........................................................................................... 21
4.2
NHS England, Patient Safety function (formerly National Patient Safety Agency) 22
4.3 Incident reporting...................................................................................................... 22
4.4 Alerts ........................................................................................................................ 23
5 Controlled Drugs ............................................................................................................. 23
5.1 Accountable Officer .................................................................................................. 24
5.2 Prescribing of controlled drugs Schedule 2 and 3 .................................................... 24
5.3 Prescription forms in use. ......................................................................................... 24
MEDICINES POLICY AND GUIDANCE
Page 7 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
5.4 Monitoring of patterns of CD prescribing. ................................................................. 24
5.5 CD Declarations ....................................................................................................... 25
5.6 Prescribing of controlled drugs via a syringe driver .................................................. 25
5.7 Prescribing high doses of CDs ................................................................................. 25
5.8 Reducing dosing errors with opioid medicines ......................................................... 25
5.9 Advice regarding the safe administration of naloxone .............................................. 25
5.10 Reducing dosing errors with midazolam ................................................................. 25
MEDICINES POLICY AND GUIDANCE
Page 8 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
1. Introduction
The term ‘medicines’ embraces all products for the purpose of treating or preventing
disease, diagnosing disease or determining the extent of a physiological
condition,contraception, inducing anaesthesia, orotherwise preventing or interfering
with the normal operation of a physiologicalfunction. Medical gases, immunisations/
vaccines and pharmaceutical preparations such as medicated or interactive
dressings, disinfectants, reagents and similar products, and all medicinalproducts
covered by the European Directive on Medicines are included.
The Medicines Policy will ensure high quality Clinical Commissioning Group (CCG)commissioned services through the safe, effective, economic and patient-centred
use of medicines.
Medicines optimisation encompasses a whole systems approach to ensure the
NHS is achieving maximum health gain and least harm from all medicines. It
involves maximising the use of medicines in preventing disease or the progression
of disease and in improving patient outcomes from the use of medicines.
This approach will be used to develop medicines services within Islington CCG
through application of the Royal Pharmaceutical Society’s four principles of
medicines optimisation:
Aim to understand the patient’s experience
Evidence-based choice of medicines
Ensure medicines use is as safe as possible
Make medicines optimisation part of everyday practice
v)
vi)
vii)
viii)
The key areas of legislation underpinning this policy include:





The Medicines Act 1968, as amended, which regulates the
manufacture, distribution, import, export sale and supply of medicinal
products
The Misuse of Drugs Act 1971 as modified, which controls the
availability of drugs liable for misuse
The Misuse of Drugs Regulations 2001, as amended, which enable
specified health care professionals to possess, supply, prescribe
and/or administer controlled drugs in the sphere of their practice.
The Misuse of Drugs Regulations 2005, which sets out arrangements
for the safer management of controlled drugs
Health and Social Care Act 2012, which sets out the statutory
functions of Clinical Commissioning Groups and new NHS
organisational structures within which they will function.
MEDICINES POLICY AND GUIDANCE
Page 9 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
1.1 Staff Training
All staff involved in the prescribing, administration and/or handling of medicines
should be appropriately trained with regard to safety and storage of medicines and
with regard to safeguarding themselves and those under their supervision from any
risks posed by products (e.g. cytotoxics, sensitising, flammable or corrosive items).
Such training should include training and education about locally agreed procedures
as well as defining lines of responsibility and secure methods of handling both
medicines and controlled stationery.
All staff should understand their scope of practice and work within it, and must be
clearly instructed as to what documentation they may or may not complete.
Personnel involved in handling medicines should be trained to ensure
understanding of the need for risk management in relation to drug products and
procedures.
1.2 The Pharmaceutical Industry
Contact with the Pharmaceutical Industry must be in accordance with the CCG
Gifts and hospitality and declarations of interest policy and Anti-bribery policy.
GP Practices are advised to have their own policies in place for contact with the
pharmaceutical industry.
Pharmaceutical Industry representatives who wish to discuss products with the
CCG are advised to contact the CCG Head of Medicines Management.
Appointments are limited.
Samples should not be left with CCG staff without agreement by the Head of
Medicines Management.
Pharmaceutical industry representatives are requested not to make direct
approaches to CCG Board members.
Participation of the CCG in pharmaceutical industry price rebate schemes will be
considered in line with guidance from the London Procurement Programme and is
at the discretion of the CCG.
Participation of CCG staff in advisory boards or surveys is at the discretion of the
CCG. All participation will be declared and recorded in the CCG register of
interests.
All CCG staff must declare any competing interests when involved in decisionmaking for medicines or providing medicines advice.
All pharmaceutical industry staff should declare any competing interests when
involved in NHS-related meetings, e.g. Healthwatch.
MEDICINES POLICY AND GUIDANCE
Page 10 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
1.3 Clinical Trials
By law, all clinical trials must have prior approval of the necessary ethics
committees and research governance processes. See also North Central London,
Prescribing Guidance.
1.4 Medicines adherence
It is estimated that between a third and a half of all medicines prescribed for longterm conditions are not taken as recommended. NICE Clinical Guideline 76
provides full detail on how to improve and support medicines adherence. Key
components are:
o Healthcare professionals have a duty to help patients make informed
decisions about treatment and use appropriately prescribed medicines to
best effect.
o Unintentional non˗adherence occurs when the patient wants to follow the
agreed treatment but is prevented from doing so by barriers that are beyond
their control. Examples include poor recall or difficulties in understanding the
instructions, problems with using the treatment, inability to pay for the
treatment, or simply forgetting to take it.
o Intentional non˗adherence occurs when the patient decides not to follow the
treatment recommendations. This is best understood in terms of the beliefs
and preferences that influence the person's perceptions of the treatment and
their motivation to start and continue with it.
o To understand adherence to treatment we need to consider the perceptual
factors (for example, beliefs and preferences) that influence motivation to
start and continue with treatment, as well as the practical factors that
influence patients' ability to adhere to the agreed treatment. Applying this
approach in practice requires:

a frank and open approach which recognises that non˗adherence may be
the norm (or is at least very common) and takes a no˗blame approach,
encouraging patients to discuss non˗adherence and any doubts or
concerns they have about treatment

a patient˗centred approach that encourages informed adherence

identification of specific perceptual and practical barriers to adherence for
each individual, both at the time of prescribing and during regular review,
because perceptions, practical problems and adherence may change
over time.
Cultural and religious issues
Healthcare professionals need to be aware of the impact of a patient’s cultural and
religious beliefs on medicines adherence (e.g. consideration to gelatin, alcohol and
animal-derived products). Opportunity should be given to patients to discuss their
MEDICINES POLICY AND GUIDANCE
Page 11 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
concerns and appropriate and suitable medication and regimens should be
considered. Please contact the medicines management team for advice.
2. Prescribing
2.1 General guidance
Comprehensive guidance on prescribing is available in the British National
Formulary and British National Formulary for Children. All prescribers are expected
to follow this guidance where appropriate and are recommended to document
reasons for prescribing outside the guidance, following discussion and agreement
with the patient.
Prescribers should also follow the guidance set out by their professional regulator
(see appendices for guidance).
Prescribers have a responsibility when prescribing to inform the patient about the
medicines being prescribed and to discuss with the patient the risks and benefits of
treatment so that the patient may make an informed decision about their treatment.
This should include the aims of treatment and possible common side-effects.
Prescribers should monitor and document in the patients’ notes any side-effects of
treatment and take appropriate action if causing any concern e.g. reduce dose,
change medicine.If there is a suspected adverse reaction to a medication a report
should be made in accordance with the MHRA’s Yellow Card Scheme.
It is the prescriber’s responsibility to ensure all prescriptions are accurate and
comply with these requirements
The ICCG mission statement states that Islington practices are “committed to
working together as a Clinical Commissioning Group to ensure our communities
receive the best evidence based care possible within the available resources.”
Prescribers must consider the evidence base of any treatment and its effect on
resources of any prescription they issue.
Wherever possible self-care should be promoted and patients encouraged make
use of over-the-counter products for minor ailments available from local
pharmacies. The GMS contract requires a doctor to prescribe any medicines
necessary where there is a clinical need and the treatment is available on the NHS.
If the treatment is not available on the NHS a prescriber may issue a private
prescription.
2.2 NICE guidance
All NICE guidance for medicines will be reviewed by the Islington Medicines
Optimisation Group (IMOG) at the meeting following publication. IMOG will make
recommendations for implementation of guidance when required to inform local
commissioning arrangements.
The guidance represents the views of NICE and was arrived at after careful
consideration of the evidence available. Healthcare professionals are expected to
take it fully into account when exercising their clinical judgement. However, the
MEDICINES POLICY AND GUIDANCE
Page 12 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
guidance does not override the individual responsibility of healthcare professionals
to make decisions appropriate to the circumstances of the individual patient, in
consultation with the patient and/or guardian or carer.
IMOG will adhere to NICE guidance unless there is clear justification for local
deviation from the guidance.
Providers of Islington CCG-commissioned services should inform their
commissioner and turn, IMOG, in writing if their service will deviate from NICE
guidance clearly explaining their reasons.
2.3 Formulary
ICCG does not operate an independent formulary. ICCG expects all providers to
adhere to national formulary guidance in line with the NHS Standard Contract and
ICCG will publish local formularies on its website. ICCG expects that all medicines
(including herbal medicines, homoeopathic preparations etc.) requested by
secondary or tertiary care providers to be prescribed by Islington GPs on an NHS
prescription should have been assessed by their local formulary committee or the
Joint Formulary Committee.
Clinicians from providers should not ask GPs or other primary care prescribers to
prescribe medications which have not been accepted for use on their local
formulary. All these requests should be rejected by primary care prescribers and the
relevant formulary committee made aware of the request. In exceptional
circumstances providers may make a request for a non-formulary item to be
prescribed in primary care but prior approval should be sought from the ICCG
medicines management team.
2.4 Guidelines and pathways
All guidelines and pathways containing references to medicines which affect
primary care within Islington must be reviewed and approved by IMOG.
Groups developing pathways or guidelines should seek to involve IMOG at the
earliest possible point to ensure no delays in development.
All guidelines and pathways will be published on the Medicines Optimisation pages
on Map of Medicine (password required, available from ICCG Map of Medicine
team) and in other relevant communications from ICCG e.g. GP bulletins.
2.5 Off-Label/Unlicensed Prescribing
Off-label prescribing refers to prescribing of a UK licensed medicine outside the
terms of its Marketing Authorisation.
Unlicensed prescribing refers to prescribing of a medicine that does not have a UK
Marketing Authorisation.
Licensed medicines used within the terms of its Marketing Authorisation for licensed
indications should be prescribed routinely wherever possible.
MEDICINES POLICY AND GUIDANCE
Page 13 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
However in certain situations it may be necessary to prescribe an unlicensed
medication.
The GMC advice is summarised below:
You can prescribe unlicensed medicines but, if you decide to do so, you must:
 Be satisfied that an alternative, licensed medicine would not meet the
patient's needs
 Be satisfied that there is a sufficient evidence base and/or experience of
using the medicine to demonstrate its safety and efficacy
 Take responsibility for prescribing the unlicensed medicine and for
overseeing the patient's care, including monitoring and any follow up
treatment
 Record the medicine prescribed and, where you are not following common
practice, the reasons for choosing this medicine in the patient's notes.
Information for patients about the license of their medicines
 You must give patients (or their parents or carers) sufficient information
about the medicines you propose to prescribe to allow them to make an
informed decision.
 Some medicines are routinely used outside the terms of their licence, for
example in treating children. In emergencies or where there is no realistic
alternative treatment and such information is likely to cause distress, it may
not be practical or necessary to draw attention to the licence. The GMC
guidance gives further information and links to patient information leaflets
designed for use with paediatric medicines. The BNF for Children also
provides helpful prescribing advice.
Prescribers should refer to the Prescribers’ Guide – Introduction to Specials and
Prescribing Dilemmas – A guide for Islington Prescribers for more detailed advice.
2.6 Prescription forms
Prescriptions should be generated electronically wherever possible. If it is
necessary to handwrite a prescription (e.g. on a home visit) care should be taken to
make sure the prescription is written legibly. Details of handwritten prescriptions
should be added to the patient’s records by the prescriber within 24 hours.
All NHS prescriptions are controlled stationary and must be stored in a locked
cupboard and their use accounted for. ICCG recommends that all practices have
procedures in place for the management of NHS prescription forms within their
practice and clear advice on what to do if forms are stolen or lost. Further detailed
guidance is available here.
2.7 Non-Medical Prescribing
Evidence shows that non-medical prescribing can lead to improved patient care and
satisfaction, increased access to medicines, reduction in waiting times and delivery
of high quality care.
MEDICINES POLICY AND GUIDANCE
Page 14 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
All nurses who wish to prescribe must undertake a recognised Non-Medical
Prescribing Course and must have recorded their prescriber qualification on the
Nursing & Midwifery Council (NMC) register and adhere to the NMC Standards of
proficiency for nurse and midwife prescribers http://www.nmcuk.org/Documents/NMC-Publications/NMC-Standards-proficiency-nurse-andmidwife-prescribers.pdf . Before prescribing, individual non-medical Independent
Prescribers (NMIPs) must also be registered with the NHS Business Services
Authority. This process is managed locally by the Nursing and Organisational
Development Manager and Head of Medicines Management.
Nurses employed by GP practices who either wish to undertake non-medical
prescribing training or register as an Islington prescriber need to contact the
Nursing & Organisational Development Manager at the CCG for advice. Further
information for non-medical prescribers in Islington GP practices is provided in the
Islington CCG Non-Medical Prescribing Guidelines.
Provider organisations will have their own guidelines in place. Individual practices
that employ NMIPs, must ensure guidance is incorporated into their policies.
Community pharmacists wishing to undertake non-medical Independent Prescribing
should contact the Head of Medicines Management.
2.8 Communications on transfer of care (Medicines Reconciliation)
Efficient communication between different care settings is paramount to the safe
and effective use of medicines. When a patient is admitted to an in-patient setting it
is essential that a medicines reconciliation process takes place in line with NICE/
NPSA guidance. It is important that clinicians provide any information requested in
a timely manner.
Clinicians discharging patients from hospital settings shall communicate the
patient‘s drug regimen to GPs/carers in a timely and reliable way. Discharge
information shall be provided simultaneously to care homes and GPs. Providing a
copy to the patient’s community pharmacist can also significantly reduce errors.
Staff shall ensure that patients/carers understand their discharge medicines.
For some patients, referral to the community pharmacist for a Medicines Use
Review or New Medicines Service support would be beneficial and may reduce
drug related admissions.
Inpatients identified as requiring help with medication following discharge from
Whittington Health will be seen by the re-ablement pharmacist, for a post-discharge
domiciliary medicines use review. Information from the review will be communicated
to the patient’s GP and if necessary, other relevant healthcare professionals.
Patients with a diagnosed global learning disability can be referred to the learning
disabilities pharmacist.
MEDICINES POLICY AND GUIDANCE
Page 15 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
Contact Details:
Islington Learning Disabilities Partnership
52D Drayton Park
London
N5 1NS
Tel: 0207 527 6600
The learning disabilities pharmacist can provide accessible information on
medication, support patients on discharge and to manage their medication at home
and work with carers to ensure that medicines are being administered according to
medication policies and specific guidance.
3. Safe and secure handling of medicines
All staff, Islington CCG-commissioned services and GP practices involved in the
preparation, handling, ordering, storage, supply or administration of medicines
should do so in line with the CQC’s Essential Standards of Quality and Safety
Outcome 9: Management of Medicines.
3.1 Administration of medicines
General guidance
It is the responsibility of the member of staff administering a medicine to ensure that
the correct medicine is administered to the correct patient, in the correct form, by
the correct route, at the correct dose at the time specified by the prescriber.
The practitioner administering must always check for allergies before administering
a medicine.
Commissioned Service specific Standard Operating Procedures (SOPs) will
describe the process for:




Checking current prescribed medicines and doses.
Checking accuracy of prescription charts or transcribed Medication
Administration Record charts (describing which type is used within the
specific care environment).
Incident reporting involving medicines, (see section 4.3)
Administering medicines
Where there is any doubt as to the accuracy, completeness or appropriateness of
an individual prescription, or to the quality of the medicine, it is the responsibility of
the member of staff to confirm the details with the prescriber and/or a pharmacist as
well as their line manager before administering the medicine. Any concerns and
details must be recorded in the nursing record or case notes.
Documentation completed at the time of administration will be in accordance with
the “service specific SOPs for medicines”. Signatures and initials must be legible.
See also, NMC guidance.
MEDICINES POLICY AND GUIDANCE
Page 16 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
The practitioner should discuss the medicines with patients or carers at the time of
administration, involving them in checking where appropriate. They should provide
patients or carers with the opportunity to ask questions about their medicines.
3.2 Authorisation to Administer Medicines
The Medicines Act (1968) states that any person may legally administer a
prescription-only medicine provided that this is done in accordance with the written
directions of the prescriber (see additional information about injections below). The
written direction may take the form of a prescription, or patient specific direction
(PSD). This task is therefore not legally restricted to medical and nursing staff,
although this has been the practice in most hospital services.
Individual services will need to decide through local policies which grades of staff
may administer medication, and their training requirements. There may therefore be
some variation as to which staff will undertake this duty.
All medical and dental practitioners and registered nurses can perform full
administration of medicines. Other staff may only administer medicines after
receiving appropriate training and assessment at local level in relation to the task to
be performed.
Healthcare Assistants/support workers may administer medicines in accordance
with the guidance in the SOP for administering medicines – Community and District
Nursing Services, or other approved policies/procedures relevant to the specified
service, which should include training, competencies, assessment, documentation
and supervision. Registered staff must ensure the HCA/support worker has been
trained according to national minimum standards and are competent to do so before
delegating and that they follow guidance on delegation as laid out by their
professional registration body. The law does not permit them to work to Patient
Group Directions.
The administration of medicine by injection may only be carried out by;

a medical or dental practitioner,

a competent registered nurse,

Therapist/other grades of staff who have been authorised to administer
specific named medicines e.g. specific vaccines

Health care assistants/support workers who have been trained to administer
a specified medicine to a specified patient in line with service specific SOP
for medicines. This is a delegated task, and the delegating Registered Nurse
retains responsibility for the patient.
See National Patient Safety agency (NPSA) Alerts and Rapid Response Reports summary of requirements for provider services” for safer practice requirements from
the NPSA alert "safer practice with injectable medicines”.
MEDICINES POLICY AND GUIDANCE
Page 17 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
A second authorised person must be involved with administration of all blood and
blood products, unless service specific SOPs direct otherwise, and demonstrate risk
management processes.
Community Nursing Services should adhere to the “Protocol for the recording of
medication changes to be acted upon by nursing staff working in the community”.
This includes guidance on the use of verbal instructions in exceptional
circumstances only.
3.3 Administration of Medicines via the Intravenous Route
Medicines shall only be administered intravenously in the following circumstances:
 if there is no alternative route of administration that is suitable for the patient
 where there is a clear clinical advantage to the patient over other routes,
 where the medication is only licensed for intravenous use and there is no
suitable alternative.
Prescriptions for intravenous medicines must comply with general policies and
procedures on prescription writing and must include all relevant details. Compatible
diluents and flushes will also be prescribed, and checked by the administering
practitioner, as will rate of administration.
Prescriptions for intravenous medicines shall be reviewed regularly according to the
regime.
Practitioners authorised to administer intravenous medicines:
 all medical and dental practitioners
 Qualified nurses who are recognised as professionally competent through
authorised training, and appropriate experience.
Nurses should follow their operational policy for the administration of intravenous
medicines and any service specific SOPs or where appropriate, following
agreement with their line manager, written guidelines from the hospital that
prescribed the Intravenous medication. Wherever possible, two registrants should
check medication to be administered intravenously, one of whom should also be the
registrant who then administers the intravenous (IV) medication.
The UCL hospitals "Injectable Drug Administration Guide" current edition is a
suitable additional reference book for practitioners. The on-line NHS Injectable
Medicines Guide (registration required), is a further resource.
In community settings, the following must also be in place:




GP informed in advance, of IV administration details.
Clear pathway of clinical responsibility for prescribing, and named contact
should any problems or adverse reactions occur.
Sufficient trained nursing cover available, and frequency of IV administration
suits patient and community nurse schedules.
Monitoring requirements documented and potential adverse reactions/ drug
interactions identified.
MEDICINES POLICY AND GUIDANCE
Page 18 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
 Clear, timely arrangements for supply of drugs/appliances by referring
hospital.
 “Shared care guidelines” available, where GPs are requested to prescribe.
 Confirmation in advance with pharmacy, that drugs/diluents/infusion bags are
available on FP10 prescription, and whether required appliances are
available via FP10 (check Drug Tariff) or via NHS supply chain for
community nursing.
 Guidelines/shared care guidelines for community prescribing of specific IV
drugs to be approved by Medicines Committee, in liaison with Trust
Commissioning.
 Suitable arrangements for safe reconstitution (consider COSHH and infection
control) and for clinical waste disposal.
3.4 Vaccine Administration
The nurse should:









Have undertaken training in vaccine administration, and have achieved the
competencies required under any PGD arrangements or operational policies.
Attend CPR/anaphylaxis training annually, and be competent in the
recognition and treatment of anaphylaxis.
Have an in-date anaphylaxis kit.
Be conversant with and have signed the PGD for the relevant vaccines, or
follow the written patient specific direction of a doctor or other authorised
independent prescriber.
Refer to the current copy of the Immunisation Against Infectious Diseases
“Green Book”;
Have access to relevant Department of Health advice – e.g. Chief Medical
Officer (CMO) letters
Have access to a working telephone
Have patient consent
Check that the vaccines conform to the cold chain
The above guidelines also apply to vaccine administration by other authorised
practitioners, in accordance with “service specific SOP for medicines”. PGDs can
only be signed and used by certain registered professionals, including nurses,
pharmacists, podiatrists, physiotherapists.
See separate “service specific SOP for medicines” for childhood immunisations,
and handling and storage of vaccines.
Health Care Assistants who have been trained to at least minimum national
standards, to administer a specified vaccine to a specified patient in line with
service specific SOP for vaccinations, may administer influenza and pneumococcal
vaccines as part of seasonal immunisation programmes. This is a delegated task,
and the delegating Registered Nurse retains responsibility for the patient. Minimal
National Standards and Core Curriculum for Immunisation Training of Healthcare
Support Workers must be adhered to.
MEDICINES POLICY AND GUIDANCE
Page 19 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
3.5 Administration by Nurses in Training
For learning purposes, a nurse in training may be involved with an authorised
nurse, in the administration of medicines that have been prescribed for a named
patient by an authorised registered independent or supplementary prescriber.
However the responsibility for the administration of the medicines still attaches to
the authorised nurse, who should clearly countersign any signature of the student.
Students must never administer or supply medicinal products without direct
supervision.
3.6 Supervision and Assessment of staff
Supervision for newly qualified staff should be carried out by the preceptor. When
the individual and preceptor feel that the nurse is competent, they should be
assessed by a qualified assessor and cover all aspects of administration of
medicines.
Staff who are not newly qualified should be assessed by an appropriate preceptor,
against locally agreed competencies, through clinical supervision.
The Royal Marsden NHS Trust Manual of Clinical Nursing procedures (latest
edition) is a useful reference. See also Skills for Health website and NPSA website.
3.7 Responsibilities of Registered Nurses
In addition to the above criteria, the registered nurse should:





Be aware of their accountability
Be aware of the responsibilities associated with delegation
Have read the medicines policies and procedures
Comply with The Code: Standards of conduct, performance and ethics for
nurses and midwives. NMC
Have read the NMC documents:
o Standards for Medicines Management
o The Code: Guidelines for records and record keeping
3.8 Consent
Refer to the service specific policy on consent to treatment and the NMC advice
sheet on the covert administration of medicines
3.9 Self-Administration of Medicines
Patients are encouraged to self-medicate, where appropriate and facilities are
available, to increase their capability for independent living. See “service specific
SOP for medicines” to safely facilitate this and self-medication policies.
MEDICINES POLICY AND GUIDANCE
Page 20 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
3.10 Patient Group Directions
Refer to CCG Patient Group Direction policy, NHS England policy and
Memorandum of Understanding with CCGs, local Memorandum of Understanding
with Camden and Islington Local Authorities and MPC guidance.
3.11 Patient Specific Directions
Refer to MPC guidance
3.12 Emergency drugs
Refer to CQC advice available here.
4. Medicines safety
4.1 Medicines information
Lack of information about medicines can lead to medication errors. All staff should
have access to this policy and to supporting medicines information available from
the following websites:
 GP Extranet
 Map of medicine
 CCG website
 Joint Formulary Committee
Healthcare professionals, patients and carers can access medicines information
and advice from a variety of sources including:
 Islington CCG Prescribing Advisers
 Community pharmacists
 A printed copy of the BNF is sent annually to every GP principal and nonmedical prescriber and is available online in a version that is updated
monthly. Smartphone and tablet application versions that are updated
monthly are available free of charge to Athens account holders. All
prescribers and health care professionals are advised to refer only to
online/application versions of the BNF as these are updated monthly.
 Regional specialist medicines information centres are listed in the BNF
 Medicines information websites including:
o Summaries of product characteristics www.emc.medicines.org.uk
o National Institute for Clinical Excellence (NICE) www.nice.org.uk
 NICE Medicines and Prescribing Centre www.nice.org.uk/mpc
 NICE Evidence Search www.evidence.nhs.uk
 NICE Clinical Knowledge Systems cks.nice.org.uk
o BNF https://www.evidence.nhs.uk/formulary/bnf/current
o NPSA www.npsa.nhs.uk (now part of NHS England)
Islington CCG’s Medicines Management team offers “prescribing induction”
sessions for GPs, GP Registrars and non-medical prescribers new to the area. An
induction summary is available from the Map of Medicine page.
MEDICINES POLICY AND GUIDANCE
Page 21 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
A newsletter for GP practices and community pharmacies is produced bi-monthly
and copies are available here.
4.2 NHS England, Patient Safety function (formerly National Patient Safety Agency)
The NPSA produced patient safety alerts on specific medicine related problems
(and also on non-medicine related alerts). Each alert contains information on risks,
solutions (e.g. operating procedures, training, competencies), and audits required
to check compliance. All alerts must be implemented within the required
timescales. Important alerts with respect to improving medicines safety including
anticoagulation, methotrexate, insulin and oral anti-cancer drugs are available here.
In January 2014, a new alert system, the National Patient Safety Alert System
(NPSAS) was introduced with three stages of alert:
Stage One Alert: Warning
This stage ‘warns’ organisations of emerging risk. It can be issued very quickly once
a new risk has been identified to allow rapid dissemination of information.
Stage Two Alert: Resource
This alert may be issued some weeks or months after the stage one alert, and could
consist of:
 sharing of relevant local information identified by providers following a stage one
alert;
 sharing of examples of local good practice that mitigates the risk identified in the
stage one alert;
 access to tools and resources that help providers implement solutions to the
stage one alert; and
 access to learning resources that are relevant to all healthcare workers and can
be used as evidence of continued professional development.
Stage Three Alert: Directive
When this stage of alert is issued, organisations will be required to confirm they
have implemented specific solutions or actions to mitigate the risk. A checklist will
be issued of required actions to be signed-off in a set timeframe. These actions will
be tailored to the patient safety issue.
All staff must ensure that they are up-to-date with recommended best practice set
out by the alerts.
Where actions can be applied corporately across all services, these actions may be
included on CCG Medicines Optimisation guidance documents or incorporated
within SLAs or Locally Commissioned Service specifications.
A directory of all alerts issued is available from the Controls Assurance Service
(CAS).
4.3 Incident reporting
After taking any immediate steps within their ability to prevent patient harm, the
person discovering the incident should make a report of the incident. This should be
MEDICINES POLICY AND GUIDANCE
Page 22 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
notified to the commissioner of the relevant service. Incident reporting processes
are provided here (local, see Appendix 6 for reporting form) and here (national
guidance).
The Clinical Director fulfils the role of Medicines Safety Officer and Medical Devices
Officer for Islington CCG.
4.4 Alerts
www.mhra.gov.uk
The reporting and re-call of medicines which are known or suspected to be
defective must be carefully and promptly controlled, documented and carried out to
ensure that patients are not put at risk. This responsibility lies with the person
responsible for cascading recall information (unless delegated to another staff
within the team) which are as follows:

Read the alert. Assess for whom it is intended. If it is a specialist product, it
may only need to be cascaded to a limited number of recipients.

What “class” is the alert? Class 1 are related to potentially serious or life
threatening situations. The timescales on the Drug Recall indicates the
priority with which actions should be taken. Additional consideration should
be given to the mechanism of the cascade and the likely time for it to be
received and acted on by the relevant healthcare professional.

Stock should be checked for the affected product using the information
provided in the drug alert. The alert gives distribution dates as well as batch
and expiry information. If, based on the information provided, it is unlikely
that you have had any of the affected product you do not need to do anything
else, e.g. if you have not had any deliveries since the date of the affected
products, you are unlikely to have any stock.

If you may have had deliveries of the affected product, you should check
your stock and quarantine any affected product. You should consider any
outstanding orders and recent deliveries, as these may have been
dispatched before the recall notice was issued.

If the alert specifies that relevant patients should be contacted (Patient Level
Recall), ensure the specified investigations or actions are taken.
5 Controlled Drugs
Controlled Drugs (CDs) are subject to special legislative controls because there is
a potential for them to be misused or diverted, causing possible harm. In response
to the case of Dr Harold Shipman the government has introduced strengthened
measures underpinned by The Health Act 2006, and Controlled Drugs (Supervision
of Management and Use) Regulations 2006.
MEDICINES POLICY AND GUIDANCE
Page 23 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
Prescribing, non-medical prescribing, dispensing, supply and administration,
storage, safe custody, record-keeping and destruction issues must comply with the
Misuse of Drugs Act 1971 and subsequent updates.
Any service involving the use of CDs must include arrangements for their safe
management within the service-specific Standard Operating Procedure (SOP).
5.1 Accountable Officer
All incidents and concerns relating to the use of CDs must be reported to the
Accountable Officer. This can be done by completing an incident report (see section
4.3) and sending this to the Accountable Officer at
england.londonaccountableoffice@nhs.net and copied to the incident reporting email (ncl.incidents@nhs.net ).
The CCG has a statutory duty to support the Accountable Officer.
Details of NHS England CD processes and Memorandum of Understanding with
CCGs can be found here.
5.2 Prescribing of controlled drugs Schedule 2 and 3
A quick reference guide for prescribing and writing prescriptions for CDs is laid out
in the front of the BNF; section "Guidance for Prescribing; Controlled Drugs and
drug dependence ".
All medical staff (except medical students, unregistered locums or doctors with
restrictions placed on their prescribing by the GMC) may prescribe controlled drugs
schedule 2 and 3. They may not prescribe diamorphine, dipipanone, or cocaine in
the treatment of addicts unless they have a licence to do so. Independent nurse
prescribers may prescribe CDs only in accordance with DH guidelines. The list of
CDs and the indications, for which such nurses may prescribe them, is available in
the BNF (appendix Nurse Prescribers Formulary) and in the Drug Tariff.
Supplementary prescribers may prescribe CDs in accordance with a clinical
management plan agreed with the doctor and patient.
5.3 Prescription forms in use.
Please refer to the legacy NPC guide to Controlled Drugs for the latest list of
prescription forms and details of which practitioners may prescribe which CDs.
Updated NICE Medicines and Prescribing guidance is expected in 2016.
Private prescriptions for CDs require the use of FP10(PCD)s. Please contact the
Accountable Officer if you require a private prescription pad.
5.4 Monitoring of patterns of CD prescribing.
Prescribing advisers will monitor prescribing of CDs from e-PACT data by NHS
GPs, and non-medical prescribers using FP10 prescriptions.
NHS England will monitor private controlled drugs prescribing.
MEDICINES POLICY AND GUIDANCE
Page 24 of 25
BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO
DATE VERSION
5.5 CD Declarations
Periodic declarations are required from all services using CDs to record that CDs
are being safely managed. Declarations must be completed, signed and returned
within the required timescales. NHS England Area Team will co-ordinate this
function.
5.6 Prescribing of controlled drugs via a syringe driver
Additional care must be taken when prescribing CDs via a syringe driver. Please
refer to palliative care guidance and NPSA guidance.
5.7 Prescribing high doses of CDs
Where prescribers are prescribing high doses of CDs for palliative care, it is
recommended that the specialist palliative care teams are contacted for advice and
support, wherever feasible. Any actions resulting from such contact should be
recorded in the patient's notes.
If the prescriber is prescribing high doses of CDs for a patient, and where prolonged
use is expected, this should be reported to the Trust (prescribing adviser) to aid the
interpretation of e-PACT data.
5.8 Reducing dosing errors with opioid medicines.
See “National Patient Safety agency (NPSA) Alerts and Rapid Response Reports summary of requirements for provider services”
5.9 Advice regarding the safe administration of naloxone
Naloxone must be given with great caution to patients who have received longerterm opioid/opiate treatment for pain control or who are physically dependent on
opioids/opiates. Use of naloxone in patients where it is not indicated, or in larger
than recommended doses, can cause a rapid reversal of the physiological effects
for pain control, leading to intense pain and distress, and an increase in
sympathetic nervous stimulation and cytokine release precipitating an acute
withdrawal syndrome.
See NPSAS alert.
5.10 Reducing dosing errors with midazolam
See “National Patient Safety Agency (NPSA) Alerts and Rapid Response Reports summary of requirements for provider services”
MEDICINES POLICY AND GUIDANCE
Page 25 of 25