Standards

Record for
keeping management
medicines
Guidance for nurses
and midwives

15105_Record Keeping_A5_proof 3.indd 1 09/03/2010 09:47

We are the nursing and midwifery regulator for England, Wales, Scotland, Northern
Ireland and the Islands.

• We exist to safeguard the health and wellbeing of the public.

• We set the standards of education, training and conduct that nurses and midwives
need to deliver high quality healthcare consistently throughout their careers.

• We ensure that nurses and midwives keep their skills and knowledge up to date
and uphold the standards of their professional code.

• We ensure that midwives are safe to practise by setting rules for their practice and
supervision.

• We have fair processes to investigate allegations made against nurses and

midwives who may not have followed the code.

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Introduction
The Nursing and Midwifery Council (NMC) is the UK regulator for two professions:
nursing and midwifery. The primary purpose of the NMC is protection of the public.
It does this through maintaining a register of all nurses, midwives and specialist
community public health nurses eligible to practise within the UK and by setting
standards for their education, training and conduct. One of the most important ways of
serving the public interest is through providing advice and guidance to registrants on
professional issues. The purpose of this booklet is to set standards for safe practice in
the management and administration of medicines by registered nurses, midwives and
specialist community public health nurses.

Standards for medicine management replace the Guidelines for the

administration of medicines 2004, although many of its principles remain relevant
today, for example:

“The administration of medicines is an important aspect of the professional practice

of persons whose names are on the Council’s register. It is not solely a mechanistic
task to be performed in strict compliance with the written prescription of a medical
practitioner (can now also be an independent and supplementary prescriber). It
requires thought and the exercise of professional judgement...”

Many government and other agencies are involved in medicines management

from manufacture, licensing, prescribing and dispensing, to administration. As the
administration of a medicinal product is only part of the process, these standards
reflect the process from prescribing through to dispensing, storage, administration and
disposal. There exists an extensive range of guidance on medicines management from
a range of relevant bodies. Sources of information are listed on pages 55–58. One of
the best sources of advice locally is the pharmacist.

As with all NMC standards, this booklet provides the minimum standard by which
practice should be conducted and will provide the benchmark by which practice
is measured. Due to the complexity, speed and extent of change in contemporary
health care, it is not intended to cover every single situation that you may encounter
during your career. Instead, it sets out a series of standards that will enable you to
think through issues and apply your professional expertise and judgement in the best
interests of your patients. It will also be necessary to develop and refer to additional
local and national policies and protocols to suit local needs.

Definitions
Medicinal products
“Any substance or combination of substances presented for treating or preventing
disease in human beings or in animals. Any substance or combination of substances
which may be administered to human beings or animals with a view to making a
medical diagnosis or to restoring, correcting or modifying physiological functions in
human beings or animals is likewise considered a medicinal product.” Council Directive
65/65/EEC.

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Medicines management
“The clinical, cost-effective and safe use of medicines to ensure patients get the
maximum benefit from the medicines they need, while at the same time minimising
potential harm.” (MHRA 2004).

Blood and blood products

Blood is not classified as a medicinal product although some blood components are.
Products derived from the plasma component of blood such as blood clotting factors,
antibodies and albumin are licensed and classified as considered to be medicinal
products. For the purpose of the administration of medicinal products registrants
would be expected to apply the standards for medicines management to all medicinal
products but should consider additional guidance by the National Patient Safety Agency
– guidance launched on 9 November 2006; Right patient, Right blood (available at
www.npsa.nhs.uk). A key requirement of this guidance is that all staff involved in blood
transfusion undergo formal competency assessment on a three-yearly basis.

Use of the word ‘patient’ throughout the document

Throughout this document where the word ‘patient’ is used this refers to whoever
the medication may be administered to, for example, patient, client, user or woman
(midwifery).

Use of the word ‘registrant’ throughout the document

Throughout this document where the word ‘registrant’ is used this refers to nurses,
midwives and specialist community public health nurses who are registered on the
NMC register.

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Summary of standards
This section provides a summary of the standards for easy reference. For further detail
you should read, follow and adhere to the standards as detailed later in the document. It
is essential that you read the full guidance.

Section 1
Methods of supplying and/or administration of medicines

Standard 1: Methods

Registrants must only supply and administer medicinal products in accordance with one
or more of the following processes:

• Patient specific direction (PSD)

• Patient medicines administration chart (may be called medicines administration

record MAR)

• Patient group direction (PGD)

• Medicines Act exemption

• Standing order

• Homely remedy protocol

• Prescription forms

Standard 2: Checking
Registrants must check any direction to administer a medicinal product.

Standard 3: Transcribing
As a registrant you may transcribe medication from one ‘direction to supply or
administer’ to another form of ‘direction to supply or administer’.

Section 2
Dispensing

Standard 4: Prescription medicines

Registrants may in exceptional circumstances label from stock and supply a clinically
appropriate medicine to a patient, against a written prescription (not PGD), for
self-administration or administration by another professional, and to advise on its safe
and effective use.

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Standard 5: Patients’ own medicines

Registrants may use patients’ own medicines in accordance with the guidance in this
booklet Standards for medicines management.

Section 3
Storage and transportation

Standard 6: Storage

Registrants must ensure all medicinal products are stored in accordance with the patient
information leaflet, summary of product characteristics document found in dispensed
UK-licensed medication, and in accordance with any instruction on the label.

Standard 7: Transportation

Registrants may transport medication to patients including controlled drugs, where

patients, their carers or representatives are unable to collect them, provided the
registrant is conveying the medication to a patient for whom the medicinal product has
been prescribed, (for example, from a pharmacy to the patient’s home).

Section 4
Standards for practice of administration of medicines

Standard 8: Administration

As a registrant, in exercising your professional accountability in the best interests of

your patients:

• you must be certain of the identity of the patient to whom the medicine is to be
administered

• you must check that the patient is not allergic to the medicine before administering it

• you must know the therapeutic uses of the medicine to be administered, its normal
dosage, side effects, precautions and contra-indications

• you must be aware of the patient’s plan of care (care plan or pathway)

• you must check that the prescription or the label on medicine dispensed is clearly
written and unambiguous

• you must check the expiry date (where it exists) of the medicine to be administered

• you must have considered the dosage, weight where appropriate, method of
administration, route and timing

• you must administer or withhold in the context of the patient’s condition,

(for example, Digoxin not usually to be given if pulse below 60) and co-existing
therapies, for example, physiotherapy

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• you must contact the prescriber or another authorised prescriber without delay
where contra-indications to the prescribed medicine are discovered, where the
patient develops a reaction to the medicine, or where assessment of the patient
indicates that the medicine is no longer suitable (see Standard 25).

• you must make a clear, accurate and immediate record of all medicine
administered, intentionally withheld or refused by the patient, ensuring the signature
is clear and legible. It is also your responsibility to ensure that a record is made
when delegating the task of administering medicine.

In addition:

• Where medication is not given, the reason for not doing so must be recorded.

• You may administer with a single signature any prescription only medicine (POM),
general sales list (GSL) or pharmacy (P) medication.

In respect of controlled drugs:

• These should be administered in line with relevant legislation and local standard
operating procedures.

• It is recommended that for the administration of controlled drugs a secondary

signatory is required within secondary care and similar healthcare settings.

• In a patient’s home, where a registrant is administering a controlled drug that has

already been prescribed and dispensed to that patient, obtaining a secondary
signatory should be based on local risk assessment.

• Although normally the second signatory should be another registered health care
professional (for example doctor, pharmacist, dentist) or student nurse or midwife,
in the interest of patient care, where this is not possible, a second suitable person
who has been assessed as competent may sign. It is good practice that the second
signatory witnesses the whole administration process. For guidance, go to
www.dh.gov.uk and search for safer management of controlled drugs: guidance on
standard operating procedures.

• In cases of direct patient administration of oral medication from stock in a substance

misuse clinic, it must be a registered nurse who administers, signed by a second
signatory (assessed as competent), who is then supervised by the registrant as the
patient receives and consumes the medication.

• You must clearly countersign the signature of the student when supervising a
student in the administration of medicines.

Standard 9: Assessment

As a registrant, you are responsible for the initial and continued assessment of patients
who are self-administering and have continuing responsibility for recognising and acting
upon changes in a patient’s condition with regards to safety of the patient and others.

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Standard 10: Self-administration – children and young people

In the case of children, when arrangements have been made for parents or carers or
patients to administer their own medicinal products prior to discharge or rehabilitation,
the registrant should ascertain that the medicinal product has been taken as prescribed.

Standard 11: Remote prescription or direction to administer

In exceptional circumstances, where medication has been previously prescribed and

the prescriber is unable to issue a new prescription, but where changes to the dose are
considered necessary, the use of information technology (such as fax, text message or
email) may be used but must confirm any change to the original prescription.

Standard 12: Text messaging

As a registrant, you must ensure that there are protocols in place to ensure patient
confidentiality and documentation of any text received including: complete text
message, telephone number (it was sent from), the time sent, any response given, and
the signature and date when received by the registrant.

Standard 13: Titration

Where medication has been prescribed within a range of dosages, it is acceptable for
registrants to titrate dosages according to patient response and symptom control and to
administer within the prescribed range.

Standard 14: Preparing medication in advance

Registrants must not prepare substances for injection in advance of their immediate use
or administer medication drawn into a syringe or container by another practitioner when
not in their presence.

Standard 15: Medication acquired over the internet

Registrants should never administer any medication that has not been prescribed, or
that has been acquired over the internet without a valid prescription.

Standard 16: Aids to support compliance

Registrants must assess the patient’s suitability and understanding of how to use an
appropriate compliance aid safely.

Section 5
Delegation

Standard 17: Delegation

A registrant is responsible for the delegation of any aspects of the administration of

medicinal products and they are accountable to ensure that the patient, carer or care
assistant is competent to carry out the task.

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Standard 18: Nursing and midwifery students

Students must never administer or supply medicinal products without direct supervision.

Standard 19: Unregistered practitioners

In delegating the administration of medicinal products to unregistered practitioners, it is

the registrant who must apply the principles of administration of medicinal products as
listed above. They may then delegate an unregistered practitioner to assist the patient
in the ingestion or application of the medicinal product.

Standard 20: 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.

Section 6
Disposal of medicinal products

Standard 21: Disposal

A registrant must dispose of medicinal products in accordance with legislation.

Section 7
Unlicensed medicines

Standard 22: Unlicensed medicines

A registrant may administer an unlicensed medicinal product with the patient’s informed
consent against a patient-specific direction but NOT against a patient group direction.

Section 8
Complementary and alternative therapies

Standard 23: Complementary and alternative therapies

Registrants must have successfully undertaken training and be competent to practise

the administration of complementary and alternative therapies.

Section 9
Management of adverse events (errors or incidents) in the administration of
medicines

Standard 24: Management of adverse effects

As a registrant, if you make an error you must take any action to prevent any potential
harm to the patient and report as soon as possible to the prescriber, your line manager
or employer (according to local policy) and document your actions. Midwives should
also inform their named supervisor of midwives.

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Standard 25: Reporting adverse reactions

As a registrant, if a patient experiences an adverse drug reaction to a medication, you

must take any action to remedy harm caused by the reaction. You must record this in
the patient’s notes, notify the prescriber (if you did not prescribe the drug) and notify via
the Yellow Card Scheme immediately.

Section 10
Controlled drugs

Standard 26: Controlled drugs

Registrants should ensure that patients prescribed controlled drugs are administered
these in a timely fashion in line with the standards for administering medication
to patients. Registrants should comply with and follow the legal requirements and
approved local standard operating procedures for controlled drugs that are appropriate
for their area of work.

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Contents
Standards
Section 1: Method of supplying and/or administration of medicines
Standard 1: Methods............................................................................................... 13
Standard 2: Checking.............................................................................................. 18
Standard 3: Transcribing......................................................................................... 18

Section 2: Dispensing
Standard 4: Prescription medicines......................................................................... 20
Standard 5: Patients’ own medicines....................................................................... 20

Section 3: Storage and transportation

Standard 6: Storage................................................................................................ 22
Standard 7: Transportation...................................................................................... 23

Section 4: Standards for practice of administration of medicines

Standard 8: Administration...................................................................................... 24
Standard 9: Assessment.......................................................................................... 26
Standard 10: Self-administration – children and young people............................... 28
Standard 11: Remote prescription or direction to administer .................................. 28
Standard 12: Text messaging.................................................................................. 30
Standard 13: Titration.............................................................................................. 30
Standard 14: Preparing medication in advance....................................................... 30
Standard 15: Medication acquired over the internet................................................ 31
Standard 16: Aids to support compliance................................................................ 32

Section 5: Delegation
Standard 17: Delegation.......................................................................................... 33
Standard 18: Nursing and midwifery students......................................................... 33
Standard 19: Unregistered practitioners.................................................................. 33
Standard 20: Intravenous medication...................................................................... 34

Section 6: Disposal of medicinal products

Standard 21: Disposal............................................................................................. 35

Section 7: Unlicensed medicines

Standard 22: Unlicensed medicines........................................................................ 35

Section 8: Complementary and alternative therapies

Standard 23: Complementary and alternative therapies......................................... 36

Section 9: Management of adverse events (errors or incidents) in the

administration of medicines
Standard 24: Management of adverse events......................................................... 37
Standard 25: Reporting adverse reactions.............................................................. 38

Section 10: Controlled drugs

Standard 26: Controlled drugs................................................................................. 38

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Annexes
Annexe 1
Legislation

Annexe 2
Guidance on labelling and over-labelling of medicines

Annexe 3
Suitability of patients’ own medicinal products for use

Annexe 4
Exclusion criteria for self-administration medicines

Annexe 5
Administering medicinal products in research clinical trials

Annexe 6
Information and publications

Annexe 7
Glossary

Annexe 8
Contributors

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The standards: Section 1
Methods of supplying and/or administration of medicines
Methods to enable nurses, midwives and specialist community public health nurses to
supply and/or administer may include the following:

Standard 1: Methods

1 Registrants must only supply and administer medicinal products in accordance with
one or more of the following processes:

1.1 Patient-specific direction (PSD)

1.2 Patient medicines administration chart (may be called a medicines

administration record (MAR))

1.3 Patient group direction (PGD)

1.4 Medicines Act Exemption (where they apply to nurses)

1.5 Standing order

1.6 Homely remedy protocol

1.7 Prescription forms

2 Once a medicinal product has been prescribed and dispensed to an individual,

the drug is the individual’s own property. To use it for someone else is theft .
Registrants should refer to DH (2006) Medicines Matters: A guide to mechanisms
for the prescribing, supply and administration of medicines.

Patient-specific direction (PSD)

3 A patient-specific direction (PSD) is a written instruction from a qualified and
registered prescriber for a medicine including the dose, route and frequency or
appliance to be supplied or administered to a named patient. In primary care, this
might be a simple instruction in the patient’s notes. Examples in secondary care
include instructions on a patient’s medicines administration chart. The direction
would need to be specific as to the route of administration it cannot simply authorise
a course of treatment to several patients. Where a PSD exists, there is no need for
a patient group direction.

4 Each individual patient must be identified on the PSD. An example of using a PSD
is in the administration of routine vaccine where a list of patients due a vaccine may
be identified beforehand. In the case of controlled drugs, it is essential to comply
with full prescription requirements. Go to www.dh.gov.uk and search for controlled
drugs.

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Patient medicines administration chart

5 The patient medicines administration chart is not a prescription but a direction to

administer medication. It must be signed by a registered prescriber and authorises
the delegation to administer medication on the prescriber’s behalf. However, in
doing so the registrant is accountable for their actions and for raising any concerns
about the direction with the prescriber, for example, in respect to clarity.

Patient group direction (PGD)

6 Patient group directions (PGDs) are specific written instructions for the supply or
administration of a licensed named medicine including vaccines to specific groups
of patients who may not be individually identified before presenting for treatment.
Guidance on the use of PGDs is contained within Health Service Circular (HSC)
2000/026.

7 See Home Office circular 049/2003. Controlled Drugs Legislation – Nurse

Prescribing And Patient Group Directions. Go to www.dh.gov.uk and search for
controlled drugs.

8 Guidance has also been issued in Wales (WHC 2000/116), and in Scotland and
Northern Ireland.

9 The circular also identifies the legal standing of PGDs plus additional guidance on
drawing them up and operating within them. It is vital that anyone involved in the
delivery of care within a PGD is aware of the legal requirements. PGDs are not a
form of prescribing.

10 PGDs are drawn up locally by doctors, dentists, pharmacists, and other health
professionals where relevant. They must be signed by a doctor or dentist and a
pharmacist, both of whom should have been involved in developing the direction,
and must be approved by the appropriate health care organisation. The NMC would
consider it good practice that a lead practitioner from the professional group using
the PGD and senior manager where possible, are also involved and sign off a PGD.

11 PGDs can be used by independent providers for NHS commissioned services. As

medicines legislation does not apply outside the UK, a PGD would not be required
– for example – on cruise ships. However, the NMC would consider it good practice
for such bodies to develop protocols using PGD templates that are signed off by a
doctor, dentist, pharmacist, other health professionals where relevant and a senior
manager where possible.

12 PGDs should only be used once the registrant has been assessed as competent
and whose name is identified within each document. The administration of drugs via
a PGD may not be delegated. Students cannot supply or administer under a PGD
but would be expected to understand the principles and be involved in the process.
Where medication is already subject to exemption order legislation there is no
requirement for a PGD.

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13 When supplying under PGD, this should be from the manufacturer’s original
packs or over-labelled pre-packs so that the patient details, date and additional
instructions can be written on the label at the time of supply. Registrants must not
split packs. For more information on labelling see annexe 2.

14 See To PGD or not to PGD at:

www.portal.nelm.nhs.uk/PGD/viewRecord.aspx?recordID=422

15 PGDs in the NHS:

www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=148

16 PGDs in the private sector:

www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=147

Medicines Act Exemptions

17 Allow certain groups of healthcare professionals including occupational health

nurses under occupational health schemes and midwives to sell, supply and
administer specific medicines directly to patient and clients.

17.1 Provided the requirements of any conditions attached to those exemptions are
met, a PGD is not required.

17.2 Registrants must work to locally agreed written protocols and procedures, and
maintain auditable records.

17.3 Occupational health nurses that offer services, for example, open access
travel clinics outside of occupational health schemes must comply with
guidance from the appropriate regulator.

18 Registrants may only supply and administer under an exemption order where the
order pertains to them. Where nurses are working as emergency care practitioners
within an ambulance service they may not supply and administer under paramedic
exemptions unless they are also registered as a paramedic with the Health
Professions Council – to do so would contravene medicine legislation and the
employer’s vicarious liability would not apply.

19 Search for NMC Circular 1/2005 Medicine legislation: what it means for midwives at
www.nmc-uk.org

Standing orders

20 In the past, maternity service providers and occupational health schemes have
produced local guidelines, often referred to as ‘standing orders’, to supplement the
legislation on the medicinal products that practising midwives and occupational
health nurses may supply and/or administer. These guidelines are not a prerequisite
under any legislation. There is no legal definition for standing orders and this
term does not exist in any medicines legislation. The NMC would consider it good
practice where midwives and occupational health nurses are using standing orders
for medicinal products that are not covered by Medicines Act Exemptions that these
should be converted to PGDs.

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Homely remedy protocols

21 Homely remedy protocols cannot be used for prescription only medicines including
controlled drugs. These must be supplied and administered under a PSD, a
prescription or a PGD.

Guidance
22 Homely remedy protocols are not prescriptions but protocols to enable
administration of general sales list (GSL) and pharmacy only (P) listed medicines
in settings, for example, care homes, children’s homes and some educational
institutions. Although they have no legal standing they are required for liability
purposes. Any registrant using a homely remedy protocol must ensure there
is a written instruction that has been drawn up and agreed in consultation
with other relevant qualified professionals. (Where possible this should be a
medical practitioner or pharmacist.) The protocol should clarify what medicinal
product may be administered and for what indication it may be administered,
the dose, frequency and time limitation before referral to a GP. An example of a
homely remedy could be paracetamol for a headache. All registrants using the
protocol should be named and they should sign to confirm they are competent to
administer the medicinal product, acknowledging they will be accountable for their
actions.

23 The NMC considers it good practice that the employing organisation signs off all
protocols.

Prescription forms

24 NHS prescription forms are classified as secure stationery. Prescription forms are
serially numbered and have anticounterfeiting and anti-forgery features. Within
the NHS they are purchased by primary care trusts (PCTs), hospital boards
and hospitals via a secure ordering system, and distributed free. The range of
prescription forms used by registered prescribers can be found in each UK country
government website.

25 Specific controlled drug prescription forms are available from the local health care
organisation, for example, PCT, LHB, for use in the private healthcare sector.
Specific controlled drug prescriptions are used for treatment of addiction and for
private prescriptions for controlled drugs. Only the designated prescription form
should be used. Detailed guidance on how to complete prescription forms, including
special requirements when prescribing controlled drugs, is available from the
Department of Health (DH), Health Care Commission (HCC), Home Office, the
Prescription Prices Division of the NHS Business Services Authority website and
in the BNF. The Regulation and Quality Improvement Authority is equivalent to
the HCC in Northern Ireland. Registrants in Northern Ireland should access their
website for up-to-date information on their standards.
www.npc.co.uk/controlled_drugs/CDGuide_2ndedition_February_2007.pdf

26 For the Welsh Health circular, go to:

www.wales.nhs.uk/documents/WHC_2006_018.pdf

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27 Search for the Home Office Circular Controlled Drugs Legislation – Nurse
Prescribing and Patient Group Directions at:
www.knowledgenetwork.gov.uk/HO/circular.nsf

Who may write a prescription?

28 Any qualified and registered independent prescriber may prescribe all prescription
only medicines for all medical conditions. In addition, nurse independent prescribers
may also prescribe some controlled drugs.

29 Supplementary prescribers may prescribe in accordance with a clinical

management plan (CMP) in a tripartite arrangement with a doctor or dentist, the
patient and the supplementary prescriber. A supplementary prescriber, when acting
under and in accordance with the terms of a CMP, may administer and supply or
direct any person to administer controlled drugs in schedules 2, 3, 4 and 5, and
can prescribe unlicensed medicinal products. Please see section 5 of this document
on delegation.

Prescribing by nurses, midwives and specialist community public health nurses

30 The Medicinal Products: Prescription by Nurses Act 1992 and subsequent

amendments to the pharmaceutical services regulations allow nurses and
midwives, who have recorded their qualification on the NMC register, to become
nurse or midwife prescribers. There are two levels of nurse and midwife prescribers:

Community practitioner nurse prescribers

30.1 These are registrants who have successfully undertaken a programme of

preparation to prescribe from Community Practitioner Nurse Prescribers’
Formulary. They can prescribe the majority of dressings and appliances,
and a limited range of prescription only medicines. The Community Nurse
Prescribers’ Formulary can be found on the British National Formulary
website. Go to: www.bnf.org

Independent and supplementary nurse and midwife prescribers

30.2 These are nurses and midwives who are trained to make a diagnosis and
prescribe the appropriate treatment (independent prescribing). They may also,
in cases where a doctor has made an initial diagnosis, go on to prescribe or
review the medication, and change the drug, dosage, timing or frequency or
route of administration of any medication as appropriate as part of a clinical
management plan (supplementary prescribing).

31 Nurse or midwife independent prescribers can prescribe all prescription only

medicines including some controlled drugs, and all medication that can be supplied
by a pharmacist or bought over the counter. They must only prescribe drugs
that are within their area of expertise and level of competence, and should only
prescribe for children if they have the expertise and competence to do so.

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32 Nurse, midwife and specialist community public health nurse prescribers must
comply with current prescribing legislation and are accountable for their practice.

33 For Department of Health guidance go to www.dh.gov.uk and search: nurse

independent prescribing.

Standard 2: Checking

1 Registrants (1st and 2nd level) must check any direction to administer a medicinal
product.

2 As a registrant you are accountable for your actions and omissions. In administering
any medication, or assisting or overseeing any self-administration of medication,
you must exercise your professional judgement and apply your knowledge and skill
in the given situation. As a registrant, before you administer a medicinal product you
must always check that the prescription or other direction to administer is:

2.1 not for a substance to which the patient is known to be allergic or otherwise
unable to tolerate

2.2 based, whenever possible, on the patient’s informed consent and awareness of
the purpose of the treatment

2.3 clearly written, typed or computer-generated and indelible

2.4 specifies the substance to be administered, using its generic or brand name
where appropriate and its stated form, together with the strength, dosage,
timing, frequency of administration, start and finish dates, and route of
administration

2.5 is signed and dated by the authorised prescriber

2.6 in the case of controlled drugs, specifies the dosage and the number of dosage
units or total course; and is signed and dated by the prescriber using relevant
documentation as introduced, for example, patient drug record cards.

3 And that you have:

3.1 clearly identified the patient for whom the medication is intended

3.2 recorded the weight of the patient on the prescription sheet for all children,
and where the dosage of medication is related to weight or surface area
(for example, cytotoxics) or where clinical condition dictates recorded the
patient’s weight.

Standard 3: Transcribing

1 As a registrant you may transcribe medication from one ‘direction to supply or

administer’ to another form of ‘direction to supply or administer’.

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Guidance
2 This should only be undertaken in exceptional circumstances and should not be
routine practice. However, in doing so you are accountable for your actions and
omissions. Any medication that you have transcribed must be signed off by a
registered prescriber. In exceptional circumstances this may be done in the form
of an email, text or fax before it can be administered by a registrant.

3 Any act by which medicinal products are written from one form of direction to
administer to another is transcribing. This includes, for example, discharge letters,
transfer letters, copying illegible patient administrations charts onto new charts,
whether hand-written or computer-generated.

4 When medicine administration records in a care home are hand-written by a

registrant, they may be transcribed from the details included on the label attached
to the dispensed medicine. However, in doing so the registrant must ensure that
the charts are checked by another registrant where possible, and where not,
another competent health professional.

5 The registrant is accountable for what they have transcribed.

6 Managers and employers are responsible for ensuring there is a rigorous policy
for transcribing that meets local clinical governance requirements.

7 As care is being increasingly provided in more ‘closer to home’ settings that are
often nurse-led, managers and employers should undertake a risk assessment
involving registrants, pharmacists and responsible independent prescribers to
develop a management process to enable transcribing to be undertaken where
necessary. It should not be routine practice. Any transcription must include the
patient’s full name, date of birth, drug, dosage, strength, timing, frequency and
route of administration.

8 Transposing is the technical term used by pharmacists for transcribing.

9 Registrants are advised to read the Health Care Commission guidance for the
transcribing of prescribed medicines for individuals on admission to children’s
hospices. The principles apply to all settings. Go to www.cqc.org.uk. Registrants in
Northern Ireland should refer to the Regulation and Quality Improvement Authority
website at www.rqia.org.uk

19
The standards: Section 2
Dispensing
Standard 4: Prescription medicines

1 Registrants may in exceptional circumstances label from stock and supply a

clinically appropriate medicine to a patient, against a written prescription (not PGD),
for self-administration or administration by another professional, and to advise on its
safe and effective use.

Guidance
2 The definition of dispensing is “To label from stock and supply a clinically
appropriate medicine to a patient, client or carer, usually against a written
prescription, for self-administration or administration by another professional, and
to advise on safe and effective use”. (MHRA, 2006)

3 Dispensing includes such activities as checking the validity of the prescription, the
appropriateness of the medicine for an individual patient, assembly of the product,
labelling in accordance with legal requirements and providing information leaflets
for the patient.

4 If under exceptional circumstances you, as a registrant, you are engaged in

dispensing, this represents an extension to your professional practice. There is no
legal barrier to this practice. However, this must be in the course of the business
of a hospital, and in accordance with a registered prescriber’s written instructions
and covered by a standard operating procedure (SOP). In a dispensing doctor’s
practice, registrants may supply to patients under a particular doctor’s care, when
acting under the directions of a doctor from that practice. The patient has the legal
right to expect that the dispensing will be carried out with the same reasonable
skill and care that would be expected from a pharmacist.

Standard 5: Patients’ own medicines

1 Registrants may use patients’ own medicines in accordance with the guidance in
this booklet Standards for medicines management.

2 The NMC welcomes and supports the self-administration of medicinal products and
the administration of medication by carers wherever it is appropriate.

The use of patients’ own medicinal products in any setting

3 Where patients have their own supply of medicinal products, whether prescribed,
over the counter (from a pharmacy, supermarket or shop), complementary therapy,
herbal preparation or homely remedy such as paracetamol, the registrant has a
responsibility to:

3.1 ask to see the medicinal products

3.2 check for suitability of use

20
 3.3 explain how and why they will or won’t be used

3.4 establish if they are prescribed

3.5 ascertain if they meet the criteria for use.

4 These medicinal products including controlled drugs remain the patient’s property
and must not be removed from the patient without their permission and must only
be used for that named individual.

5 The registrant has a responsibility to document in the patient’s notes when a patient
refuses consent:

5.1 to use their own medicines

5.2 to dispose of their own medicinal products no longer required

5.3 to dispose of their own medicinal products not suitable for use

5.4 when in the hospital or care home setting to send their own medicinal products
home with a relative or carer

Storage of patients’ own medicinal products

6 As a registrant you have the following responsibilities:

6.1 to ensure that suitable facilities are provided to store patients’ own medicinal
products for their safe storage

6.2 to assess patients on a regular basis using local polices to ensure that the
individual patient is still able to self-administer

6.3 to document issues relating to storage in their records

6.4 that the medicines cabinet or locker is kept locked and that the master key is
kept secure

6.5 that if the patient is self-administering, consent is obtained from the patient to
keep the individual medicines cabinet/locker locked and the key secure with the
patient

6.6 that if a patient moves to another bed, to another ward or room or is

discharged, the patient’s medicinal products are transferred with the patient

6.7 In a hospital setting, best practice indicates that stock medicines should not be
placed in the patient’s locked cabinet or locker as they are not labelled for that
individual patient.

21
Administering medicines using the patient’s own supply in the hospital or care
home setting

7 When administering medicines from the patient’s own supply, the registrant must
check the medicines in the locked cabinet or locker with the prescription chart and
use only those medicines belonging to that named patient.

8 If a supply is not available, medicines belonging to another patient must not be

used.

9 For further guidance on the use of patients’ own medicinal products including
discharge and checking medications to take home (TTOs) see annexe 3. For
self-administration of medicines see standard 9 of this document
Self-administration of medicines.

One-stop dispensing

10 In some hospitals a system of one-stop dispensing is in operation and local policies

should be developed for this using the guidance for patients’ own medicinal
products as stated under standard 5 of this document.

Guidance
11 One-stop dispensing is a system of administering and dispensing medicinal
products adopted in hospitals throughout the UK (Audit Commission Report:
A Spoonful of Sugar 2002 – The Right Medicine (Scottish Executive 2002). It
involves using the patient’s own medicinal products during their stay in hospital,
either those dispensed by a community pharmacy or by the hospital pharmacy or
both, providing they contain a patient information leaflet and are labelled with full
instructions for use. Supplies are replenished should the supply run out whilst in
hospital or when any new items are prescribed. Patients are discharged with a
supply of medicinal products as agreed locally.

12 In one-stop dispensing, medicinal products are dispensed once only on or during

admission ready for discharge. Registrants should check that the medication
handed to the patient on discharge is as per the discharge prescription, as
medicines may be altered or stopped during hospital admission. If a particular
medicine has been stopped during admission and is not to be restarted on
discharge, the patient must be informed. The ward pharmacist is a useful
resource for advice.

The standards: Section 3

Storage and transportation
Standard 6: Storage

1 Registrants must ensure all medicinal products are stored in accordance with the
patient information leaflet, summary of product characteristics document found
in dispensed UK-licensed medication and in accordance with any instruction on
the label.

22
Guidance
2 The patient information leaflet or summary of product characteristics document for
UK-licensed medicinal products may be found at www.emc.medicines.org.uk.
Policies should be in place to ensure all storage environments meet the required
standards and it is the responsibility of the registrant to check such policies are
in place and are being adhered to. This is particularly important for medicines
requiring storage within a limited temperature range, for example, refrigeration
of vaccines when maintenance of the cold chain has to be considered during
transfer for school sessions or administration in the patient’s home.
Go to www.the-shipman-inquiry.org.uk/4r_page.asp?id=3119

Standard 7: Transportation

1 Registrants may transport medication to patients including controlled drugs (CDs),

where patients, their carers or representatives are unable to collect them, provided
the registrant is conveying the medication to a patient for whom the medicine has
been prescribed (for example, from a pharmacy to the patient’s home).

Guidance
2 However, it is considered good practice that registrants should not routinely
transport CDs in the course of their practice. This should only be undertaken in
circumstances where there is no other reasonable mechanism available. All drugs
should be kept out of sight during transportation.

3 When collecting CDs from a pharmacy, the registrant will be asked to sign for
them and prove identity in the form of their professional identity badge or Pin
(where self-employed). Midwives must be familiar with the use of midwives supply
orders. Go to NMC Circular 25/2005 which you can find at www.nmc-uk.org/
publications. It is anticipated as a recommendation from the Shipman Inquiry
Fourth Report that new documentary evidence will be required in the form of
a patient drug record card. Registrants would be expected to be aware of and
comply with any new legislation and guidance introduced.

The standards: Section 4

Standards for practice of administration of medicines
1 Having initially checked the direction to supply or administer that a medicinal
product is appropriate for your patient or client (standard 2) you may then
administer medication.

23
Standard 8: Administration

2 As a registrant, in exercising your professional accountability in the best interests of

your patients:

2.1 you must be certain of the identity of the patient to whom the medicine is to be
administered

2.2 you must check that the patient is not allergic to the medicine before
administering it

2.3 you must know the therapeutic uses of the medicine to be administered, its
normal dosage, side effects, precautions and contra-indications

2.4 you must be aware of the patient’s plan of care (care plan or pathway)

2.5 you must check that the prescription or the label on medicine dispensed is
clearly written and unambiguous

2.6 you must check the expiry date (where it exists) of the medicine to be
administered

2.7 you must have considered the dosage, weight where appropriate, method of
administration, route and timing

2.8 you must administer or withhold in the context of the patient’s condition (for
example, Digoxin not usually to be given if pulse below 60) and co-existing
therapies, for example, physiotherapy

2.9 you must contact the prescriber or another authorised prescriber without delay
where contra-indications to the prescribed medicine are discovered, where
the patient develops a reaction to the medicine, or where assessment of the
patient indicates that the medicine is no longer suitable (see standard 25)

2.10 you must make a clear, accurate and immediate record of all medicine
administered, intentionally withheld or refused by the patient, ensuring the
signature is clear and legible; it is also your responsibility to ensure that a
record is made when delegating the task of administering medicine.

In addition:
3 Where medication is not given, the reason for not doing so must be recorded.

4 You may administer with a single signature any prescription only medicine, general
sales list or pharmacy medication.

In respect of controlled drugs:

5 These should be administered in line with relevant legislation and local standard
operating procedures.

6 It is recommended that for the administration of controlled drugs, a secondary

signatory is required within secondary care and similar healthcare settings.
24
7 In a patient’s home, where a registrant is administering a controlled drug that has
already been prescribed and dispensed to that patient, obtaining a secondary
signatory should be based on local risk assessment.

8 Although normally the second signatory should be another registered health care
professional (for example doctor, pharmacist, dentist) or student nurse or midwife,
in the interest of patient care, where this is not possible a second suitable person
who has been assessed as competent may sign. It is good practice that the second
signatory witnesses the whole administration process. For guidance, go to
www.dh.gov.uk and search for Safer Management of Controlled Drugs: Guidance
on Standard Operating Procedures.

9 In cases of direct patient administration of oral medication, for example, from stock
in a substance misuse clinic, it must be a registered nurse who administers, signed
by a second signatory (assessed as competent), who is then supervised by the
registrant as the patient receives and consumes the medication.

10 You must clearly countersign the signature of the student when supervising a
student in the administration of medicines.

11 These standards apply to all medicinal products.

Guidance
Assessing competence to support a patient in taking their medication

12 A policy must be in place and adhered to in assessing the competence of an

individual to support a patient in taking medication. A record of the individual’s
training and assessment should be kept, and all refresher or continuing education
and training should also be routinely kept.

13 The registrant delegating should be satisfied that the individual has an appropriate
level of education and training and has been assessed as competent. Where this
is not the case, the registrant may refuse to delegate, even when requested to
do so by another health professional. The registrant is accountable for her own
actions including delegation.

Clarifying identity

14 Where there are difficulties in clarifying an individual’s identity, for example, in some
areas of learning disabilities, patients with dementia or confusional states, an
up-to-date photograph should be attached to the prescription chart(s). For patients
with burns where the wearing of a wristband is inappropriate and a photograph
would not resemble the patient, local policies should be in place to ensure all staff
are familiar with the patients and a system of identification is in place. Registrants
are responsible for ensuring the photograph remains up to date.

25
Drug calculations

15 Some drug administrations can require complex calculations to ensure that the
correct volume or quantity of medication is administered. In these situations, it
is good practice for a second practitioner (a registered professional) to check
the calculation independently in order to minimise the risk of error. The use of
calculators to determine the volume or quantity of medication should not act as a
substitute for arithmetical knowledge and skill.

Standard 9: Assessment

1 As a registrant you are responsible for the initial and continued assessment
of patients who are selfadministering, and have continuing responsibility for
recognising and acting upon changes in a patient’s condition with regards to safety
of the patient and others.

2 The NMC welcomes and supports the self-administration of medicinal products and
the administration of medication by carers wherever it is appropriate. Registrants
may assess the patients as suitable to self-administer medicinal products both in
the hospital and primary care settings.

Guidance
Duty of care relating to using patients’ own medicinal products

3 At all times the registrant jointly with other health care professionals has a duty
of care to the patient to ensure that only medicinal products which are prescribed
and meet the required criteria are used by the patient.

4 Where self-administration of medicinal products is taking place, you should

ensure that records are maintained appropriate to the environment in which
the patient is being cared for. The Mental Capacity Act 2005 requires all those
working with potentially incapacitated people to assess the individual’s capacity
at a particular moment about a particular decision or issue. All patients should
be assessed on a regular basis using local policies to ensure that the individual
patient is still able to self-administer and this should be documented in their
records.

5 Patients can be assessed for suitability at the following levels:

Level 1

5.1 The registrant is responsible for the safe storage of the medicinal products and
the supervision of the administration process ensuring the patient understands
the medicinal product being administered.

Level 2

5.2 The registrant is responsible for the safe storage of the medicinal products.
At administration time, the patient will ask the registrant to open the cabinet
or locker. The patient will then self-administer the medication under the
supervision of the registrant.
26
 Level 3

5.3 The patient accepts full responsibility for the storage and administration of
the medicinal products. The registrant checks the patient’s suitability and
compliance verbally.

6 The level should be documented in the patient’s notes.

Guidance
7 Where patients consent to self-administration of their medicines the following
points should be considered:

7.1 Patients share the responsibility for their actions relating to self-administration
of their medicines.

7.2 Patients can withdraw consent at any time.

7.3 The pharmacy will supply medicines fully labelled, with directions for use, to
every patient who is involved in self-administration.

8 Information given and supervision should be tailored to individual patient need.

9 The following information should be provided to a patient before commencing

self-administration:

9.1 the name of the medicine

9.2 why they are taking it

9.3 dose and frequency

9.4 common side-effects and what to do if they occur

9.5 any special instructions

9.6 duration of the course or how to obtain further supplies.

10 The registrant must ensure that the patient is able to open the medicine
containers or is offered assistance, for example, compliance aid.

11 Whilst the registrant has a duty of care towards all patients, the registrant is not
liable if a patient makes a mistake self-administering as long as the assessment
was completed as the local policy describes and appropriate actions were taken
to prevent re-occurrence of the incident.

12 Guidance on exclusion criteria for self-administration of medicines can be found in

annexe 4.

27
Standard 10: Self-administration – children and young people

1 In the case of children, when arrangements have been made for parents, carers
or patients to administer their own medicines prior to discharge or rehabilitation,
the registrant should ascertain that the medicinal products have been taken as
prescribed.

Guidance
2 This should preferably be done by direct observation but when appropriate also
by questioning the patient, parent or carer. The administration record should be
initialled and ‘patient self-administration’ documented.

3 The administration of medicinal products by parents or carers to their children

must be carefully controlled. There is the potential for inadvertent omission of
doses or administration of extra doses unless there is clear communication and
documentation.

4 Parents or carers can be encouraged to administer to their children in whatever

setting when this is appropriate to the clinical condition of the child and when
the registrant has assessed that the parent or carer is competent to do so. In
a hospital setting the registrant should provide the medicinal product from the
appropriate storage and supervise administration.

Unsupervised administration to children

5 Some parents and carers may administer to their children unsupervised if this has
been agreed with the registrant in charge and if the medicinal products are stored in
an appropriate secure locker. Responsibilities of the registrant and parent or carer
must be specifically agreed and approved by the registrant in charge and agreed
under local policies. Arrangements must be made for holding keys to the locker and
for ensuring their return on discharge, and that any medicinal products remaining
are supplied for discharge (if appropriately labelled and checked) or returned to the
pharmacy.

6 The employing organisation should ensure appropriate clinical governance

structures are in place.

Standard 11: Remote prescription or direction to administer

1 In exceptional circumstances, where medication (not including controlled drugs) has

been previously prescribed and the prescriber is unable to issue a new prescription,
but where changes to the dose are considered necessary, the use of information
technology (such as fax, text message or email) may be used but must confirm any
change to the original prescription.

28
Guidance
2 A verbal order is not acceptable on its own. The fax or email prescription or
direction to administer must be stapled to the patient’s existing medication chart.
This should be followed up by a new prescription signed by the prescriber who
sent the fax or email confirming the changes within normally a maximum of
24 hours (72 hours maximum – bank holidays and weekends). In any event,
the changes must have been authorised (via text, email or fax) by a registered
prescriber before the new dosage is administered. The registered nurse should
request the prescriber to confirm and sign changes on the patient’s individual
medicines administration record (MAR) chart or care plan.

3 Where a medication has not been prescribed before, a nurse or midwife

independent prescriber may not prescribe remotely if they have not assessed the
patient, except in life-threatening situations. See standard 20 of the Standards of
Proficiency for Nurse and Midwife Prescribers which you can find at
www.nmc-uk.org/publications

4 In exceptional circumstances, a medical practitioner may need to prescribe

remotely for a previously unprescribed medicine, for example, in palliative care
or remote and rural areas the use of information technology (such as fax, text
message or email) must confirm the prescription before it is administered. This
should be followed up by a new prescription signed by the prescriber who sent
the fax/email confirming the changes within normally a maximum of 24 hours (72
hours maximum – bank holidays and weekends). The registrant is accountable
for ensuring all relevant information has been communicated to the prescriber
and s/he may refuse to accept a remote prescription if it compromises care to
the patient. In this instance she should document accurately the communication
that has taken place. Registrants should note that remote prescribing cannot
be undertaken in a care home because they do not have access to a stock of
medicines.

5 A prescription is required when the drug is to be both supplied and administered.

For administration only, a direction to administer is sufficient.

6 It may be helpful to refer to the GMC Good Medical Practice Guide for further
information available on the GMC website.

29
Standard 12: Text messaging

1 As a registrant, you must ensure that there are protocols in place to ensure patient
confidentiality and documentation of any text received include: complete text
message, telephone number (it was sent from), the time sent, any response given,
and the signature and date when received by the registrant.

Guidance
2 An order to administer medication by text messaging is an increasing possibility.
A second signature – normally another registrant but where this is not possible
another person – should sign to confirm the documentation agrees with the text
message. It must be regarded as a patient contact and all documentation should
be in keeping with the NMC’s Record keeping: Guidance for nurses and midwives
(2009). All received messages should be deleted from the receiving handset after
documentation to maintain high standards of confidentiality. Further guidance may
be helpful including RCN – Use of text messaging services; Guidance for nurses
working with children and young people (March 2006).

3 Wherever possible local policies should ensure the use of web-based products
for texting that are secure and provide a robust audit trail. Clinical governance
procedures should be in place to support such practice.

Standard 13: Titration

1 Where medication has been prescribed within a range of dosages it is acceptable

for registrants to titrate dosages according to patient response and symptom
control, and to administer within the prescribed range.

Guidance
2 A registrant must be competent to interpret test results, for example, blood
results (heparin or glucose levels (insulin)), and assess, for example, withdrawal
symptoms or signs of intoxication in the management of drug or alcohol
withdrawal.

Standard 14: Preparing medication in advance

1 Registrants must not prepare substances for injection in advance of their immediate
use or administer medication drawn into a syringe or container by another
practitioner when not in their presence.

Guidance
2 An exception to this is an already established infusion, which has been instigated
by another practitioner following the principles set out above, or medication
prepared under the direction of a pharmacist from a central intravenous additive
service and clearly labelled for that patient. Where the specific summary of
product characteristic or patient information leaflet indicate it should be prepared
in advance, for example, some chemotherapy treatments, it is acceptable to do
so.

30
3 Where a registrant has delegated to a named individual for a named patient’s
medication, this may be drawn up in advance to enable the healthcare assistant
(HCA) or family to administer the medication. The registrant is accountable for
the delegation, and a full risk assessment should be documented in the patient’s
records ensuring the registrant is aware of the risks before agreeing to delegate.
The person to whom they are delegating the task is a ‘named individual’ who has
been assessed and documented as competent.

4 Where you may be required to prepare substances for injection by a doctor,

for example, in an emergency situation, you should ensure that the person
administering the drug has undertaken the appropriate checks as indicated above.

Standard 15: Medication acquired over the internet

1 Registrants should never administer any medication that has not been prescribed,
or that has been acquired over the internet without a valid prescription.

Guidance
2 Medication over the internet may not have been stored appropriately, the quality
and safety of the medication cannot be verified, and there is often no batch
number and so no redress from the manufacturer should adverse reactions occur.

3 Registered pharmacy premises can operate and provide internet pharmacy

services. Where medicines are supplied via the internet from a registered
pharmacy, the same standards are expected as would be received in a
face-to-face situation.

Patients’ own medication that has been purchased abroad and does not have a
UK product licence

4 In this situation, a registrant must seek to identify the source of the original
prescription to confirm its authenticity. Where this is not possible, the registrant
should ascertain whether or not the patient would be prepared to have prescribed
for them a drug with similar properties that is licensed in the UK. If the patient
is in agreement, the registrant should request a prescription from a registered
prescriber.

5 In a life-threatening situation or where the patient refuses to take anything but the
‘unlicensed product’ and they are unable to administer the medication themselves,
the registrant may administer the medication in conjunction with locally agreed
policies. In all circumstances a clear, accurate and contemporaneous record of all
communication and administration of medication should be maintained.

31
Standard 16: Aids to support compliance

1 Registrants must assess the patient’s suitability and understanding of how to use
an appropriate compliance aid safely.

Guidance
2 Before considering the use of compliance aids the registrant should explore with
the patient other possible solutions, for example reminder charts, large print
labels, non-childproof tops. Self-administration from the dispensed containers may
not always be possible for some patients. If an aid to compliance is considered
necessary, careful attention should be given to the assessment of the patient’s
suitability and understanding of how to use an appropriate aid safely. Ideally a
locally recognised assessment tool should be used. However, all patients will
need to be regularly assessed for continued appropriateness of the aid. Ideally,
any compliance aid, such as a monitored dose container or a daily or weekly
dosing aid, should be dispensed, labelled and sealed by a pharmacist. The sealed
compliance aids are generally referred to as monitored dosage systems.

3 Where it is not possible to get a compliance aid filled by a pharmacist, you should
ensure that you are able to account for its use. The patient has a right to expect
that the same standard of skill and care will be applied by you in dispensing into
a compliance aid as would be applied if the patient were receiving the medication
from a pharmacist. This includes the same standard of labelling and record
keeping. Compliance aids, which can be purchased by patients for their own use,
are aids that are filled from containers of dispensed medicines. If you choose to
repackage dispensed medicinal products into compliance aids, you should be
aware that their use carries a risk of error. You should also be aware the properties
of the drug might also change when repackaged and so may not be covered
by their product licence. Your employer needs to be aware of this activity and it
should be covered by a standard operating procedure (SOP). The NMC would
recommend that you confirm the appropriateness of re-packaging dispensed
medicinal products with the community pharmacist who dispensed the medicines.
You also need to consider how the patient will cope with medicines that cannot be
included in compliance aids.

Crushing medication

4 The mechanics of crushing medicines may alter their therapeutic properties

rendering them ineffective and are not covered by their product licence. Medicinal
products should not routinely be crushed unless a pharmacist advises that the
medication is not compromised by crushing, and crushing has been determined to
be within the patient’s best interest.

Disguising medication

5 As a general principle, by disguising medication in food or drink, the patient or client

is being led to believe they are not receiving medication, when in fact they are. The
NMC would not consider this to be good practice. The registrant would need to be
sure what they are doing is in the best interests of the patient, and that they are
accountable for this decision.

32
The standards: Section 5
Delegation
Standard 17: Delegation

1 A registrant is responsible for the delegation of any aspects of the administration

of medicinal products and they are accountable to ensure that the patient, carer or
care assistant is competent to carry out the task.

Guidance
2 This will require education, training and assessment of the patient, carer or care
assistant and further support if necessary. The competence of the person to
whom the task has been delegated should be assessed and reviewed periodically.
Records of the training received and outcome of any assessment should be
clearly made and be available.

3 See the guidance section 4, standard 8.

Standard 18: Nursing and midwifery students

1 Students must never administer or supply medicinal products without direct

supervision.

Guidance
2 In order to achieve the outcomes and standards required for registration, students
must be given opportunities to participate in the administration of medication but
this must always be under direct supervision. Where this is done, both the student
and registrant must sign the patient or woman’s medication chart or document in
the notes. The registrant is responsible for delegating to a student, and where it
is considered the student is not yet ready to undertake administration in whatever
form, this should be delayed until such time that the student is ready. Equally a
student may decline to undertake a task if they do not feel confident enough to
do so. The relationship between the registrant and the student is a partnership
and the registrant should support the student in gaining competence in order
to prepare for registration. As students progress through their training, their
supervision may become increasingly indirect to reflect their competence level.

Standard 19: Unregistered practitioners

1 In delegating the administration of medicinal products to unregistered practitioners,

it is the registrant who must apply the principles of administration of medicinal
products as listed above. They may then delegate an unregistered practitioner to
assist the patient in the ingestion or application of the medicinal product.

33
Guidance
2 Registrants may only delegate the ingestion or application of a controlled drug
where the unregistered practitioner remains under the direct supervision of the
registrant whether that is in a primary care, secondary care or independent sector
setting. In care homes (personal care), health care assistants, support workers
and care workers will not be skilled in giving medicines by invasive techniques
and appropriate delegation is essential.

3 In the care of children with complex needs where an individual care plan has been
written and signed off by a registrant, and the unregistered practitioner has been
assessed by a registrant as competent to undertake the specific administration
of medicinal products to a specific named patient, this may be undertaken, for
example, children with complex health needs in community settings, palliative
care.

Standard 20: Intravenous medication

1 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.

Guidance
2 In the exceptional circumstance where this is not possible, IVs should be
checked by one registrant with another competent person who knows the patient.
This could be a parent, carer or the patient themself. At a minimum, any dose
calculation must be independently checked.

3 Registrants should be aware of the risks identified in the NPSA fourth report from
the Patient Safety Observatory Safety in doses: medication safety incidents in the
NHS (2007 and 2009). Search for this report at www.npsa.nhs.uk

4 In relation to the administration of intravenous medication, throughout the duration

of intravenous medication therapy the registered nurse or midwife has a duty of
care to the patient to monitor the patient and their response. View the standards
for administration of IV therapy on the RCN website at www.rcn.org.uk

5 Registrants should also be familiar with the UK Injectable Medicines Guide

currently under development at www.ukmi.nhs.uk

34
The standards: Section 6
Disposal of medicinal products
Standard 21: Disposal

1 A registrant must dispose of medicinal products in accordance with legislation.

Guidance
2 A patient or their representative (who may be a registered nurse or midwife)
should return unwanted prescribed medicinal products to a pharmacy for
destruction. In primary care, unwanted medication should be returned to a
community pharmacy where it can be consigned as medicinal waste – classified
as household waste. The definition of household waste is taken from the
Controlled Waste Regulations 1992 and includes waste medicines from a patient’s
own home and waste medicines from a residential care home. The definition does
not extend to stock medicines from other healthcare professionals, for example,
midwives, nurses or doctors. There should be local procedures in hospital for
the disposal of medicinal waste often overseen by the pharmacy department. If
medication is taken to another health care environment it then becomes clinical
waste and must be disposed of in accordance with clinical waste regulations. A
community pharmacy cannot legally accept prescription medicines for disposal
from care homes registered to provide nursing care, or from care homes that
provide both residential and nursing care.
3 In this situation the care home (nursing) has to make its own arrangements for
disposing of medication with a licensed waste management company. When a
midwife is in possession of controlled drugs (CD) that are no longer required, they
should be returned to the pharmacist from whom they were obtained, or to an
appropriate medical officer. A record of the return should be made in the midwife’s
controlled drugs register. When a schedule 2 CD has been prepared or drawn
up but is no longer required or no longer usable, it should be destroyed by the
midwife, in accordance with current regulations.

The standards: Section 7

Unlicensed medicines

Standard 22: Unlicensed medicines

1 A registrant may administer an unlicensed medicinal product with the patient’s

informed consent against a patient-specific direction but not against a patient group
direction.

Guidance
2 An unlicensed medicine is the term used to refer to a medicine that has no
marketing authorisation. If an unlicensed medicine is administered to a patient,
the manufacturer may not have liability for any harm that ensues. The person who
prescribes and dispenses or supplies the medicine carries the liability. This may
have implications for you in obtaining informed consent.

35
Medicinal products used outside their licence

3 Medication which is licensed but used outside its licensed indications (commonly
known as ‘off-label’) may be administered under a patient group direction only
where such use is exceptional, justified by best practice, and the status of the
product is clearly described.

4 As a registrant, you should be satisfied that you have sufficient information to

administer a medicine prescribed off-label safely and, wherever possible, that
there is acceptable published evidence for the use of that product for the intended
indication.

5 As a registrant, you should be satisfied that you have sufficient information to

administer an unlicensed or off-label drug safely and, wherever possible, that
there is acceptable published evidence for the use of that product for the intended
indication. Liability for prescribing an off-label product sits with the prescriber and
the dispenser or supplier.

6 The British National Formulary for children provides useful information for the
administration of off-label medication for children. More information on
unlicensed and off-label drugs can be found in the NMC publication Standards
of proficiency for nurse and midwife prescribers which you can find at
www.nmc-uk.org/publications

The standards: Section 8

Complementary and alternative therapies
Standard 23: Complementary and alternative therapies

1 Registrants must have successfully undertaken training and be competent to

practise the administration of complementary and alternative therapies.

Guidance
2 Registrants are accountable for their practice and must be competent in this
area (please refer to The code: Standards of conduct, performance and ethics
for nurses and midwives). You must have considered the appropriateness of the
therapy to both the condition of the patient and any co-existing treatments. It is
essential that the patient is aware of the therapy and gives informed consent.

3 Complementary and alternative therapies may interact with other types of

medicinal products and laboratory tests. All complementary and alternative
medicines should be recorded alongside other medicinal products and prescribed
on inpatient prescription charts. You need to ensure that your employer has
accepted vicarious liability for any complementary or alternative therapy you may
undertake, or that you have indemnity insurance to cover your practice.

36
The standards: Section 9
Management of adverse events (errors or incidents) in the
administration of medicines
Standard 24: Management of adverse events

1 As a registrant, if you make an error you must take any action to prevent any
potential harm to the patient and report as soon as possible to the prescriber, your
line manager or employer (according to local policy) and document your actions.
Midwives should also inform their named supervisor of midwives.

Guidance
2 The NMC supports the use of a thorough, open and multi-disciplinary approach
to investigating adverse events, where improvements to local practice in
the administration of medicinal products can be discussed, identified and
disseminated.

3 It is important that an open culture exists in order to encourage the immediate

reporting of errors or incidents in the administration of medicines.

4 The NMC believes that all errors and incidents require a thorough and careful
investigation at a local level, taking full account of the context and circumstances,
and the position of the practitioner involved. Such incidents require sensitive
management and a comprehensive assessment of all the circumstances before
a professional and managerial decision is reached on the appropriate way to
proceed. If a practising midwife makes or identifies a drug error or incident,
she should also inform her supervisor of midwives as soon as possible aft er
the event. In the NHS, all errors (patient safety incidents) and near-misses
should be reported through local risk management systems. In England and
Wales you should then report the incident to the National Patient Safety Agency
(NPSA) through the National Reporting and Learning System (NRLS), whereas
in Northern Ireland you should report to the Northern Ireland Adverse Incident
Centre, and in Scotland through the NHS Quality Improvement Scotland
(NHSQIS).

5 When considering allegations of misconduct arising from errors in the

administration of medicines, the NMC takes great care to distinguish between
those cases where the error was the result of reckless or incompetent practice
and/or was concealed, and those that resulted from other causes, such as serious
pressure of work, and where there was immediate, honest disclosure in the
patient’s interest. The NMC recognises the prerogative of managers to take local
disciplinary action where it is considered to be necessary but urges that they also
consider each incident in its particular context and similarly discriminate between
the two categories described above. Registrants and their managers may find the
NPSA’s Incident Decision Tree Tool and Being Open Tool (details on
www.npsa.nhs.uk and/or www.saferhealthcare.org.uK) useful. Allegations
related to midwives would also be investigated by a supervisor of midwives as set
out in the NMC’s Midwives rules and standards, rule 5.

37
Standard 25: Reporting adverse reactions

1 As a registrant, if a patient experiences an adverse drug reaction to a medication

you must take any action to remedy harm caused by the reaction. You must record
this in the patient’s notes, notify the prescriber (if you did not prescribe the drug)
and notify via the Yellow Card Scheme immediately.

Guidance
2 Yellow cards are found in the back of the British National Formulary and online
on www.yellowcard.gov.uk. In addition you should report any near misses or
adverse events to the NPSA. For further information read the BNF or access
the Medicines and Healthcare Products Regulatory Agency website
www.mhra.gov.uk. Adverse drug reactions and patient safety incidents involving
medicines, where a side effect (adverse drug reaction) from a medicine was
preventable and still occurred, should be reported as a patient safety incident
(error) through local risk management systems to the NPSA NRLS.

The standards: Section 10

Controlled drugs
Standard 26: Controlled drugs

1 Registrants should ensure that patients prescribed controlled drugs (CDs) are
administered these in a timely fashion in line with the standards for administering
medication to patients. Registrants should comply with and follow the legal
requirements and approved local standard operating procedures for controlled
drugs that are appropriate for their area of work.

Guidance
Medicines management for controlled drugs

2 Standards for medicines management apply to controlled drugs. However,

following the government response to the fourth report of the Shipman Inquiry,
there has been legislative change and new governance arrangements for
controlled drugs (CDs), which impact on registrants. Registrants should be
familiar with the DH guide Safer Management of Controlled Drugs 2006 and the
DH document Guidance on the Management of Safe Use and Management of
Controlled Drugs in Secondary Care in England Controlled Drugs in Acute Care
2007.

3 Go to www.dh.gov.uk and search: controlled drugs.

4 Changes affecting the prescribing, record keeping and destruction of controlled

drugs were introduced as a result of amendments to the Misuse of Drugs
Regulations (MDR, 2001), Misuse of Drugs regulations (Northern Ireland), 2002,
thereafter referred to as Misuse of Drugs Regulations (MDR), and the Health Act
(2006), provided for regulations to be laid relating to governance and monitoring
of controlled drugs.
38
5 The Health Act 2006 is primary legislation and applies to the whole of the UK
although the regulations may differ in each of the devolved administrations. In
England, the Controlled Drugs (Supervision of Management and Use) Regulations
2006 came into force on 1 January 2007 and in Scotland on 1 March 2007.

6 Go to www.dh.gov.uk and search: The Controlled Drugs (Supervision of

Management and Use) Regulations 2006.

7 Within the provisions of the Act, Wales and Northern Ireland will make their
own regulations in relation to controlled drugs. These will be equivalent to the
Controlled Drugs (Supervision of Management and use of) Regulations 2006.

8 Controlled drugs are those defined in the MDR (2001) and MDR Regulations,
2002 (NI). See annexe 1. However, on occasions, health care organisations
choose to handle non-CDs in the same way as CDs to ensure a higher level of
governance. This is a local decision and does not form part of this guidance,
although registrants are reminded they should adhere to local policies where they
exist.

9 At local level, all healthcare organisations are accountable, through the

accountable officer, (not applicable to Wales or Northern Ireland until legislation
comes into effect until at least 2008) for ensuring the safe management of
controlled drugs.

10 The regulatory requirements for accountable officers are set out in full in the
Controlled Drugs (Supervision and Management of Use) Regulations 2006;
www.legislation.gov.uk/ and a summary of the main provisions is provided at
Appendix 2 of the DH Guidance on the Management of Controlled Drugs in
Acute Care 2007.

Standard operating procedures

11 Each of the activities concerned with CDs, regardless of where in an organisation

they occur, must be described in a standard operating procedure (SOP).
Registrants should be aware of all SOPs within their organisation.

Requisitioning of controlled drugs

12 All stationery which is used to order, return or distribute controlled drugs (CD
stationery) must be stored securely, and access to it should be restricted.

13 CD stationery should be kept in a locked cupboard or drawer.

14 There should be a list of the CDs to be held in each ward or department as stock
items. The contents of the list should reflect current patterns of usage of CDs in
the ward or department, and should be agreed between the senior pharmacist,
appropriate medical staff and the registrant in charge.

15 Only the CDs listed in the stock list may be routinely requisitioned or topped-up.

39
16 The registrant in charge of a ward, department, operating theatre or theatre suite
is responsible for the requisitioning of controlled drugs for use in that area.

17 The registrant in charge can delegate control of access (that is key-holding) to

the controlled drugs cabinet to another, such as a registered nurse or operating
department practitioner. However, legal responsibility remains with the registrant
in charge. (In Northern Ireland, it is not possible to delegate key holding to another
but they may allow access via the keys which are then returned to the registrant
in charge).

18 Orders must be written on suitable stationery (for example, a controlled drug

requisition book) and must be signed by an authorised signatory.

19 A copy of the signature of each authorised signatory should be available in the

pharmacy department for validation.

20 Requisitions must contain the:

20.1 hospital

20.2 ward or department

20.3 drug name, form, strength, ampoule size if more than one available

20.4 quantity

20.5 signature and printed name of nurse

20.6 date

20.7 signature to receive goods for transit

20.8 signature for receipt at ward or department.

Receipt of controlled drugs

21 When CDs are delivered to a ward or department they should be handed to

a designated person. On no account should they be left unattended. A local
procedure should define the persons who are permitted to receive CDs and the
way in which messengers identify them.

22 As soon as possible after delivery the registrant in charge should:

22.1 check the CDs against the requisition – including the number ordered
and received. If this is correct then the relevant (usually pink) sheet in
the controlled drug requisition book should be signed in the ‘received by’
section

22.2 place the CDs in the CD cupboard

22.3 enter the CDs into the ward controlled drug record book, update the
running balance and check that the balance tallies with the quantity that is
physically present. 40
Storage

23 The Misuse of Drugs (Safe Custody) Regulations 1973 cover the safe custody
of controlled drugs in certain specified premises. The regulations also set down
certain standards for safes and cabinets used to store controlled drugs.

24 Ward CD cupboards should conform to the British Standard reference BS2881 or

be otherwise approved by the pharmacy department. This is a minimum security
standard and may not be sufficient for areas where there are large amounts
of drugs in stock at a given time, or there is not a 24-hour staff presence, or
easy control of access. In this case the advice of security specialists or crime
prevention officers should be sought.

25 All controlled drugs should be stored in a locked receptacle which can only be
opened by a person who can lawfully be in possession, such as a pharmacist or
registrant in charge, or a person working under their authority.

26 General guidance for the storage of controlled drugs should include the following:

26.1 cupboards must be kept locked when not in use

26.2 the lock must not be common to any other lock in the hospital

26.3 keys must only be available to authorised members of staff

26.4 the cupboard must be dedicated to the storage of controlled drugs. No

other medicines or items may be stored in the controlled drug cupboard.
Controlled drugs must be locked away when not in use.

Key-holding and access to CDs

27 The registrant in charge is responsible for the CD key and should know its
whereabouts at all times.

27.1 Key-holding may be delegated to other suitably trained members of staff

but the legal responsibility rests with the registrant in charge

27.2 The controlled drug key should be returned to the registrant in charge
immediately after use by another registered member of staff

27.3 On occasions, for the purpose of stock checking, the CD key may be
handed to an authorised member of the pharmacy staff.

28 Northern Ireland registrants: see paragraph 17 on requisitioning of controlled

drugs above.

Missing CD keys

29 If the CD keys cannot be found then urgent efforts should be made to retrieve the
keys as speedily as possible, for example, by contacting nursing or midwifery staff
who have just gone off duty.

41
30 A procedure should be in place to ensure that the registrant in charge or duty
nurse manager and the duty pharmacist are informed as soon as possible. The
procedure should specify the arrangements for preserving the security of CD
stocks and for ensuring that patient care is not impeded.

Record keeping – controlled drug record books

31 Each ward or department that hold stocks of CDs should keep a record of
CDs received and issued in a CD record book. In primary care, the relevant
patient drug record card (where used) or CD record card for the administration
of controlled drugs should be used. The registrant in charge is responsible for
keeping the CD record book up to date and in good order.
32 The CD record book (acute care) should be bound (not loose-leaf), and it
should have separate pages for each preparation. Entries should be made in
chronological order, in ink. If a mistake is made, it should be crossed out with a
single line or bracketed in such a way that the original entry is still clearly legible.
This should be signed and dated, and witnessed by a second registered nurse or
midwife who should also sign the change.

33 A record should be kept of all (schedule 2) controlled drugs that are received or
issued.

34 All entries must be signed by two registrants, or one registrant and one student
nurse or midwife (for administration only). Exceptionally, the second signature can
be by another practitioner (for example, doctor or pharmacist) provided that they
have witnessed the administration of the drug.

35 For CDs received, the following details should be recorded:

35.1 date on which received

35.2 name of pharmacist making supply/serial number of requisition

35.3 amount received

35.4 form in which received

35.5 balance in stock

36 For CDs issued the following details should be recorded:

36.1 date on which issue was made

36.2 name of patient

36.3 amount issued

36.4 form in which issued

36.5 name/signature of nurse/authorised person making the issue

42
 36.6 name/signature of witness

36.7 balance in stock

37 If part of a vial is given to the patient, then the registrant should record the
amount given and the amount wasted, for example, if the patient is prescribed a
diamorphine 2.5mg and only a 5mg preparation is available, the record should
show, ‘2.5mg given and 2.5mg wasted’.

38 After every administration, the stock balance of an individual preparation must be

confirmed to be correct and the balance recorded in the controlled drug register.

39 In the community where there may not be two registrants available, a second
competent person (which may be the carer) may witness the administration and
balance of a controlled drug.

40 When recording controlled drugs received from pharmacy, the number of units
received should be recorded in words not figures (for example, ten, not 10) to
reduce the chance of entries being altered. On reaching the end of a page in the
CD record book, the balance must be transferred to another page. The new page
number must be added to the bottom of the finished page and the index updated.

Stock checks

41 The registrant in charge is responsible for ensuring that regular (locally

determined protocol) CD stock checks are carried out.

42 Two registered nurses or midwives, should perform this check (a student nurse or
midwife may be the second checker provided they have the necessary knowledge
to carry this out).

43 Checking of controlled drugs involves checking of entries in the register against

the contents of the controlled drug cupboard, not the reverse, to ensure all entries
are checked. It is not necessary to open packs with intact tamper-evident seals for
stock checking purposes.

44 A record indicating this check has been carried out and confirming the stock is
correct may be kept in a separate record book or sheet or in the controlled drug
register.

45 Stock balances of liquid medicines may be checked by visual inspection but

the balance must be confirmed to be correct on completion of a bottle. Any
discrepancy should be reported to the registrant in charge who should inform the
pharmacist.

Midwives and controlled drugs

46 A registered midwife may possess diamorphine, morphine, pethidine and

pentazocine in her own right so far as is necessary for the practice of her
profession. See the Misuse of Drugs Regulations 2001 at:
www.legislation.gov.uk/uksi/2001/3998/contents/made

43
47 Supplies of diamorphine, morphine, pethidine and pentazocine may only be made
to her on the authority of a midwife’s supply order signed by the supervisor of
midwives, or other appropriate medical officer who is a doctor authorised in writing
by the local supervising authority.

48 The supervisor of midwives or other appropriate medical officer should be

satisfied that locally agreed procedure is being followed before signing the supply
order (for example, that the amount being requested is appropriate etc).

49 The order must specify the name and occupation of the midwife, the purpose for
which the controlled drug is required and the total quantity to be obtained. Supplies
of pethidine, pentazocine, morphine and diamorphine may be obtained from a
hospital pharmacy. However, this is only when classed as within the course of the
business of the hospital the midwife works in, or it is a registered hospital pharmacy,
or it holds a wholesale dealer’s licence. The pharmacist who makes the supply
should ensure that medicines are only supplied on the instruction of an authorised
person. The pharmacist must retain the midwife’s supply order for two years.

50 Midwives should record full details of supplies of diamorphine, morphine and

pethidine received and administered in their controlled drugs register. This register
should be used solely for that purpose and be made available for inspection as
required by the supervisor of midwives.

51 Once medicines are received – by midwives working in the community or

independent midwives – they become the responsibility of the midwife, and should
be stored safely and securely.

52 Where it is necessary for midwives to keep medicines in their homes, the

medicines should be placed in a secure, locked receptacle. If necessary, this
should be provided by the employing body.

53 Administration of controlled drugs by midwives should be in accordance with

locally agreed procedures. A record of administration of the controlled drugs
should also be kept in the patient’s records.

Returns and disposal

54 When a midwife is in possession of CDs that are no longer required they should
be returned to the pharmacist from whom they were obtained, or to an appropriate
medical officer. A record of the return should be made in the midwife’s controlled
drugs register.

55 When a schedule 2 controlled drug has been prepared or drawn up but is no

longer required or no longer usable, it should be destroyed by the midwife, in
accordance with current regulations. A record of the destruction should be made.

56 Controlled drugs obtained by a woman by prescription from her doctor, for

use in her home confinement are her own property and are not the midwife’s
responsibility. Even when no longer required, they should not be removed by
the midwife, but the woman should be advised to return them to the community
pharmacy for destruction.

44
Returns to pharmacy (all registrants)

57 The following details should be recorded when controlled drugs are returned to
the pharmacy:

57.1 date

57.2 name, form, strength and quantity of drug being returned

57.3 reason for return

57.4 name and signature of pharmacist removing the drugs

57.5 name and signature of nurse witnessing the removal of drugs from the ward

58 The top copy will be taken from the book and transported with the drugs to
pharmacy.

59 In addition, an entry must be made on the relevant page of the ward controlled
drug record book, showing:

59.1 date

59.2 reason for return

59.3 names and signatures of both nurse and pharmacist

59.4 quantity removed

59.5 balance remaining.

60 The drugs must be transported to pharmacy in a safe and secure way.

Transport of CDs

61 At each point where a controlled drug moves from the authorised possession of
one person to another, a signature for receipt should be obtained by the person
handing over the drug.

62 Wherever possible, CDs must be transported in a secure, lockable or sealed,

tamper-evident container.

63 Registrants working in the community may transport CDs, however, they should
present their identity badge to the pharmacist and sign for them on receipt, and
should ensure they are transported securely to the patient’s home. Once in the
patient’s home, the registrant should sign the patient drug record card and it
should be witnessed that the CD has been received by the patient. Where a
second registrant is not available another competent person may witness receipt
(this could be a carer).

45
Disposal and destruction

64 Destruction on ward may take place at the same time as a pharmacy stock check.

65 CDs should be destroyed in such a way that the drug is denatured or destroyed
so that it cannot be retrieved, reconstituted or used.

66 Destruction must occur in a timely fashion, so that excessive quantities are not
stored awaiting destruction.

67 All destruction must be documented in the appropriate section of the register.

68 It must be witnessed by a second competent professional authorised under

Regulation 27 of the MDR. Both persons must sign the register.

69 For more detail on the methods of destruction for CDs, registrants are advised
to access table 2 of the Guidance on Controlled Drugs in Acute Care (2007),
which summarises where CDs may be destroyed and who should carry out the
destruction.

70 For guidance, go to www.dh.gov.uk and search for Safer Management of

Controlled Drugs: Guidance on Standard Operating Procedures.

46
Annexe 1
Legislation
There are a number of pieces of legislation that relate to the prescribing, supply, storage
and administration of medicines. It is essential that you comply with them. The following
is a summary of those that are of particular relevance.

Medicines Act 1968

This was the first comprehensive legislation on medicines in the UK. The combination
of this primary legislation and the various statutory instruments (secondary legislation)
on medicines produced since 1968 provides the legal framework for the manufacture,
licensing, prescribing, supply and administration of medicines. Among recent statutory
instruments of particular relevance to registered nurses, midwives and specialist
community public health nurses is The Prescription Only Medicines (Human Use) Order
1997, SI No1830. This consolidates all previous secondary legislation on prescription
only medicines and lists all of the medicines in this category. It also sets out who may
prescribe them. The sections on exemptions are of particular relevance to midwives,
including those in independent practice, and to nurses working in occupational health
settings. The Medicines Act 1968 classifies medicines into the following categories:

Prescription only medicines (POMs)

These are medicinal products that may only be sold or supplied to a patient on the
instruction of an appropriate practitioner. An appropriate practitioner is a doctor, dentist,
supplementary prescriber, or nurse or pharmacist independent prescriber. For more
information on the appropriate use of medicines and the relevant legislation, it is
advisable to consult with a pharmacist. The Royal Pharmaceutical Society of Great
Britain (RPSGB) can also provide more detailed information on medicines legislation.

Pharmacy only medicines (Ps)

These can only be purchased from a registered pharmacy. The sale must be by or
under the supervision of a pharmacist.

General sales list medicines (GSLs)

These need neither a prescription nor the supervision of a pharmacist and can be
obtained from retail outlets.

Controlled drugs (CDs)

The management of controlled drugs is governed by the Misuse of Drugs Act 1971 and
its associated regulations.

47
Misuse of Drugs Act 1971

The Misuse of Drugs Act (MDA) 1971 and its associated regulations provide the
statutory framework for the control and regulation of controlled drugs. The primary
purpose of the MDA is to prevent misuse of CDs. The MDA 1971 makes it unlawful
to possess or supply a controlled drug unless an exception or exemption applies. A
controlled drug is defined as any drug listed in schedule 2 of the Act.

Additional statutory measures for the management of controlled drugs are laid down in
the Health Act 2006 and its associated regulations.

Misuse of Drugs Regulations 2001 (MDR) and Misuse of Drugs Regulations

Northern Ireland (NI) 2002

The use of CDs in medicine is permitted by the Misuse of Drug Regulations (MDR).
The MDR classify the drugs in five schedules according to the different levels of control
required (see below). schedule 1 CDs are subject to the highest level of control,
whereas schedule 5 CDs are subject to a much lower level of control.

For practical purposes, health care staff need to be aware of the current regulations.

The MDR are periodically amended and revised. The MDR currently in force and its
amendments can be found at www.legislation.gov.uk/uksi/2001/3998/contents/made

Schedule 1 (CD licence)

Schedule 1 drugs include hallucinogenic drugs such as coca leaf, lysergide and
mescaline. Production, possession and supply of drugs in this schedule are limited, in
the public interest, to research or other special purposes. Only certain persons can be
licensed by the Home Office to possess them for research purposes. Practitioners (for
example, doctors, dentists and veterinary surgeons) and pharmacists may not lawfully
possess schedule 1 drugs except under licence from the Home Office.

The drugs listed in schedule 1 have no recognised medicinal use although Sativex©
(a cannabis-based product) is exempt from the requirements for a specific licence to
be held by the pharmacist or prescriber, and is currently being supplied on a
named-patient basis.

Schedule 2 (CD POM)

Schedule 2 includes more than 100 drugs such as the opioids, the major stimulants,
secobarbital and amphetamine.

Safe custody – schedule 2 CDs (except secobarbital) are subject to safe custody
requirements (under the Misuse of Drugs Safe Custody Regulations 1973 – see below).
They must be stored in a locked receptacle, such as an appropriate CD cabinet or
approved safe, which can only be opened by the person in lawful possession of the CD
or a person authorised by them.

A licence is required to import or export drugs in schedule 2.

48
Schedule 2 CDs may be administered to a patient by a doctor or dentist, or by any
person acting in accordance with the directions of an appropriately qualified prescriber
who is authorised to prescribe schedule 2 CDs.

Nurse independent prescribers are currently permitted to prescribe, administer, or direct

anyone to administer some CDs for specific conditions and routes of administration
(under review).

Schedule 3 (CD no register)

Schedule 3 includes a small number of minor stimulant drugs and other drugs, which
are less likely to be misused than drugs in schedule 2, or are less harmful if misused.

Safe custody – schedule 3 CDs are exempt from safe custody requirements. Exceptions
are flunitrazepam, temazepam, buprenorphine and diethylpropion, which must be stored
in a locked CD receptacle within a secure environment.

Schedule 4 (CD benzodiazepines and CD anabolic steroids)

Schedule 4 is split into two parts.

Part 1 (CD benzodiazepines) contains most of the benzodiazepines, plus eight other
substances including zolpidem, fencamfamin and mesocarb.

Part 2 (CD anabolic steroids) contains most of the anabolic and androgenic steroids
such as testosterone, together with clenbuterol (adrenoreceptor stimulant) and growth
hormones (5 polypeptide hormones).

There is no restriction on the possession of a schedule 4 part 2 (CD anabolic steroids)

drug when it is part of a medicinal product. However, possession of a drug from
schedule 4 part 1 (CD benzodiazepines) is an offence without the authority of a
prescription in the required form. Possession by practitioners and pharmacists acting in
their professional capacities is authorised.

Schedule 5 (CD invoice)

Schedule 5 contains preparations of certain CDs (for example, codeine, pholcodine,

morphine), which are exempt from full control when present in medicinal products of low
strengths, as their risk of misuse is reduced.

There is no restriction on the import, export, possession, administration or destruction of

these preparations and safe custody regulations do not apply.

Invoices must be retained for a minimum of two years.

Misuse of Drugs (Safe Custody) Regulations 1973 Misuse of Drugs

(Safe Custody) Regulations Northern Ireland 1973

The Safe Custody Regulations impose controls on the storage of controlled drugs. The
degree of control depends on the premises within which the drugs are being stored.

49
All schedule 2 and some schedule 3 CDs should be stored securely in accordance with
the MDR. These regulations state that such CDs must be stored in a cabinet or safe,
locked with a key. It should be made of metal, with suitable hinges and fixed to a wall or
the floor with rag bolts that are not accessible from outside the cabinet.

Misuse of Drugs (Supply to Addicts) Regulations 1997 and Misuse of Drugs

(Notification and Supply to Addicts (Northern Ireland) Regulations 1973

These regulations prohibit doctors from prescribing, administering or supplying

diamorphine, cocaine or dipipanone for the treatment of addiction or suspected
addiction except under Home Office licence. A licence is not required with such drugs
for the treatment of organic disease or injury.

Prescription Only Medicines (Human Use) Order 1997

This order sets out the requirements for a valid prescription. It also allows midwives to
possess and administer diamorphine, morphine, pethidine or pentazocine in the course
of their professional practice.

A number of health care professionals are permitted to supply or administer medicines

generally in accordance with a patient group direction (PGD) under Medicines Act
legislation.

Registered nurses are permitted to supply or administer some CDs in accordance with
a PGD under Misuse of Drugs legislation. www.legislation.gov.uk/uksi/2001/3998/
contents/made

Health Act 2006

The key provisions of the act are:

• all designated bodies such as healthcare organisations and independent hospitals

are required to appoint an accountable officer

• a duty of collaboration placed on responsible bodies, healthcare organisations and

other local and national agencies including professional regulatory bodies, police
forces, the Healthcare Commission and the Commission for Social Care inspection
to share intelligence on controlled drug issues

• a power of entry and inspection for the police and other nominated people to enter
premises to inspect stocks and records of controlled drugs.

Controlled Drugs (Supervision of Management and Use)

Regulations 2006

The Controlled Drug (Supervision of Management and Use) Regulations 2006

came into effect in England on the 1 January 2007. These regulations set out the
requirements for certain NHS bodies and independent healthcare bodies to appoint an
accountable officer, and describe the duties and responsibilities of accountable officers
to improve the management and use of controlled drugs.

50
The regulations also require specified bodies to cooperate with each other, including
with regard to sharing of information, concerns about the use and management of
controlled drugs, and the setting out arrangements relating to powers of entry and
inspection.

Annexe 2
Guidance on labelling and over-labelling of medicines

There may be occasions when registrants are required to dispense medicinal products
and it is important that they understand the requirements for labelling correctly.

General sale list medicines are sold over the counter in containers showing the product
in the box. Each medicinal product includes patient information either as a leaflet or on
the packet or both.

Medicines dispensed to a patient-specific prescription must be labelled with all the

required information.

The standard labelling requirements for all dispensed items are:

• the name of the person to whom the medicine is to be administered

• the name and address of the person who sells or supplies the medicinal product

• the date of dispensing

• directions for use

• the words ‘Keep out of the reach of children’ or words of direction bearing a similar
meaning (for example, ‘Keep out of the reach and sight of children’).

Medicines supplied for use under a patient group direction are already labelled. These
labels include all the standard labelling requirements apart from the patient’s name and
date of supply. On supplying these medicines to the patient, the patient’s name and date
of supply must be completed. This is sometimes known as over-labelling.

Registrants are advised to access the Medicines Ethics and Practice Guide at
www.rpsgb.org.uk/informationresources/downloadsocietypublications

51
Annexe 3
Suitability of patients’ own medicinal products for use
Additional guidance to Standard 5 of this document

The registrant must check that the medicinal products are suitable for use by ensuring:

• correct packaging and labelling

• dispensing date

• expiry date

• instructions for use

• dose

• the medicinal product matches what is on the label

• the patient information leaflet is enclosed

• correct patient name and ownership.

If the registrant is in any doubt as to the suitability of any of the medicinal products
they must discuss this with their line manager or the pharmacy department. The
registrant must seek consent to dispose of any unwanted medicinal product or
they must be returned to the patient. Every effort must be made to ensure the
patient understands the correct use of medications and the consequences of taking
unprescribed medicines.

Where the prescription is changed the registrant has a responsibility to ensure that the
medicinal products are re-dispensed as soon as possible.

Where a medicinal product is discontinued, it must be removed and with the patient’s
permission disposed of in the appropriate manner.

Administering medicines using the patient’s own supply in the hospital or care
home setting

When administering medicines from the patient’s own supply the registrant must check
the medicines in the locked cabinet or locker with the prescription chart and use only
those medicines belonging to that named patient.

If a supply is not available medicines belonging to another patient must not be used.

52
Discharge of patients from hospital who have used their own supply or when
checking medications to take home (TTOs/TTAs)

On discharge, the registrant is responsible for ensuring:

• the medicinal products have been clinically checked by the pharmacist

• the medicinal products are over-labelled for the patient

• the patient has the correct medicines, prescription or discharge summary and the
supply is checked by a pharmacist, registered nurse or by two registrants if out of
hours or according to local policy

• the patient has had sufficient medicinal products prescribed, dispensed and
supplied to cover a period of time to enable them to access further supplies from
their usual practitioner

• the patient is aware of any changes to their medication, that is, new medicine, dose,
brand, route

• the patient has been educated and given patient information leaflets relating to all
medication whether current or new

• the patient takes all their medicinal products home with them or has given
permission to dispose of the medicines no longer prescribed

• where the patient wishes to retain their discontinued medicines the risk of confusion
and possible under or overdose needs to be pointed out to them

• in the hospital setting, if the patient has been self-administering the key is returned
to the registrant in charge of the ward or unit before the patient is discharged or
care transferred

• if the bedside cabinet or locker key is lost, the appropriate hospital policy must be
followed.

Annexe 4
Exclusion criteria for self-administration of medicines
When assessing a patient’s suitability for self-administration of medicines, if the
assessing registrant, in his or her professional judgement, is at all unhappy to let the
patient self-administer, then the patient should be excluded and reassessed at another
point.

If the patient does not give consent to self-administer and other arrangements are
made, information about their medicines and what to do aft er discharge must still
be given.

Patients who may be confused must not be given custody of their medicines but
may administer on levels one and two only (see Standard 9 of this document).

53
In the hospital setting, this includes patients who are ‘nil by mouth’, immediately
post-op and under the influence of anaesthetic agents, acutely ill patients or confused
patients. The assessment should be carried out at an appropriate time in the course of
the patient’s admission to determine if they should be able to self-administer at a later
stage, that is, when the anaesthetic agents have worn off or the acute stage of their
illness is over.

Patients with a past history of drug or alcohol abuse do not have to be excluded
from self-administration of their medicines but the need for extra supervision and
reinforcement of education should be highlighted and documented. These patients
should spend more time on levels one and two to ensure they receive adequate
supervision and education. These patients may never get to administer at level 3 but
they can still be educated at levels 1 and 2.

Any change in the patient’s condition would necessitate a review of their self-
administration status.

Local policies should be developed for this using the guidance for self-administration of
medicinal products stated under Standard 9 of this document.

Registrants should be aware that the Mental Capacity Act 2005 requires all those
working with potentially incapacitated people to assess the individual’s capacity at a
particular moment about a particular decision or issue. This would be predominantly
older people and people with learning difficulties.

Annexe 5
Administering medicinal products in research clinical trials
Registrants involved in the supply or administration of a treatment or a placebo as
part of a clinical trial would not need to consent to the trial itself, however, patients are
required to do so. They would, however, need to know that the trial was taking place,
and be willing to take part to the extent that they would be supplying or administering
the medicine or placebo. The registrant’s employer would need to discuss the trial with
the registrant, and provide an information sheet in order to ensure that they had all the
information available and confirmation that ethical approval had been sought
and approved.

The purpose of the trial would be to establish whether the treatment is effective.
Therefore, patients taking the placebo are not being deprived of a medicine that is
known to be effective. There should be no reason for a registrant to object to taking part
in that they are not depriving a patient of effective treatment but rather contributing to
the evidence base for effective treatment in the future.

Also see Midwives rules and standards rule 8 on clinical trials which you can find at
www.nmc-uk.org/publications

54
Annexe 6
Information, advice and publications
Royal Pharmaceutical Society of Great Britain
1 Lambeth High Street
London SE1 7JN
Telephone 020 7735 9141
www.rpsgb.org.uk

The Pharmaceutical Society of Northern Ireland

73 University Street
Belfast BT7 1HL
Telephone 028 90 326 927
www.psni.org.uk

Scottish Pharmaceutical General Council

42 Queen Street
Edinburgh EH2 3NH
Telephone 0131 467 7766
www.communitypharmacyscotland.org.uk

Office of the Chief Pharmacist

Department of Health
Richmond House
79 Whitehall
London SW1A 2NS
Telephone 020 7210 5761
www.dh.gov.uk

Home Office
50 Queen Anne’s Gate
London SW1H 9AP
Telephone 020 7273 3474
www.homeoffice.gov.uk

Medicines and Healthcare Products Regulatory Agency

Market Towers
1 Nine Elms Lane
London SW8 5NQ
Telephone 020 7084 2000
www.mhra.gov.uk

The Association of the British Pharmaceutical Industry

12 Whitehall
London SW1A 2DY
0870 8904333
www.abpi.org.uk

The Association of the British Pharmaceutical Industry (Scotland)

Third Floor East

55
Crichton House
4 Crichton’s Close
Canongate
Edinburgh EH8 8DT
www.abpi.org.uk/Scotland/scot_intro.asp

European Council for Classical Homeopathy

at www.homeopathy-ecch.org

Prince of Wales Foundation for Integrated Health

at www.fih.org.uk

Publications
Royal Pharmaceutical Society of Great Britain. Medicines, Ethics and Practice: A guide
for pharmacists is published annually and is available from www.rpsgb.org.uk

National Prescribing Centre (NPC). (2004) A guide to good practice in the management
of Controlled Drugs in primary care (England). www.npc.co.uk

The British National Formulary and the British National Formulary for Children are
published jointly by the British Medical Association and the Royal Pharmaceutical
Society of Great Britain. Copies are available from the Pharmaceutical Press,
PO Box 151, Wallingford, Oxfordshire OX10 8QU.

The Monthly Index of Medical Specialities (MIMS) is available from MIMS

Subscriptions, PO Box 43, Ruislip, Middlesex HA4 0YT, telephone 020 8845 8545 or
fax 020 8845 7696.

The Review of Prescribing, Supply and Administration of Medicines: A Report on the

Supply and Administration of Medicines under Group Protocols, (Crown I)
(Department of Health, London, April 1998) was published under cover of Health
Service Circular (HSC) 1998/051 in England; Management Executive letter (MEL)
(98)29 in Scotland; Welsh Health Circular (WHC) (98)27 in Wales, and by each
Chief Professional Officer to their respective professional groups in Northern Ireland.
Copies are available from the NHS response line on 0541 555 455. The Review
of Prescribing, Supply and Administration of Medicines: Final Report (Crown II)
(Department of Health, London 1999) is available from the same source.

Non medical prescribing in Wales: a guide for implementation, July 2007, Welsh
Assembly Government

56
Drug Information at www.druginfozone.nhs.uk and includes a centrally maintained
archive of approved PGDs.

Medicines for Older People: Implementing medicines-related aspects of the NSF for
Older People. DH March 2001 Can be searched for, and downloaded at, www.dh.gov.
uk

Medicines Partnership Programme at www.npc.co.uk/med_partnership

National Electronic Library of Medicines www.nelm.nhs.uk

National Health Service Quality Improvement www.nhshealthquality.org

National Institute for Clinical Excellence www.nice.org.uk

National Patient Safety Agency (2007 and 2009) Safety in doses: medication safety
incidents in the NHS. Reports from the Patients’ Safety Observatory

PRODIGY www.prodigy.nhs.uk

Royal Pharmaceutical Society Great Britain (March 2005) The Safe and Secure
handling of medicines: a team approach. A revision of the Duthie Report (1988)

National Health Services Act 1977

Misuse of Drugs Act 1971

Misuse of Drugs Regulations 2001 SI2001 No 3998

Misuse of Drugs (Safe Custody) Regulations 1973 SI1973 No 798

Medicines Act 1968 (as amended)

POM Order 1983 (as amended)

Prescription by Nurses etc. Act 1992

NHS Executive (2000) The Prescriptions Only Medicines (Human Use) Amendment
(No2) Order 2000 SI No 22899 The Stationery Office, London

NHS Executive HSC 2000/026 Patient group directions (England only) (2000)

Royal Pharmaceutical Society of Great Britain (2004) Factsheet on patient group

directions www.rpsgb.org.uk/pdfs/factsheet10.pdf

MHRA Patient Group Directions in the NHS. Search for at www.mhra.gov.uk

MHRA Patient Group Directions in the Private Sector. Search for at www.mhra.gov.uk
EC 92/27 Labelling and Leaflet Directive

57
Self-administration of medicines by hospital inpatients www.audit-commission.gov.uk/
itc/doc/selfadmin.doc

Care Standards Act 2000

The Regulation of Care (Scotland) Act 2001

The Health and Social Care (Community Health and Standards) Act 2003

The Private and Voluntary Health Care (England) Regulations 2001

Department of Health National Minimum Standards for social care services

www.csci.org.uk/choose_and_find_care/your_rights/national_minimum_
standards.aspx

Royal Pharmaceutical Society of Great Britain (2003) Administration and control of

medicines in care homes and children’s services www.rpsgb.org.uk

MDA/2004/001 – Reporting adverse incidents and disseminating medical device alerts

Medicines and Healthcare Products Regulatory Agency www.mhra.gov.uk/home/

idcplg?IdcService=SS_GET_PAGE&nodeId=5

National Patient Safety Agency (2003) National Reporting and Learning System service
datasets. Go to www.npsa.nhs.uk

Nursing and Midwifery Council circular – Medicines legislation: what it means for
midwives, London: NMC 1/2005

Nursing and Midwifery Council circular – Midwives Supplies Orders, London: NMC
25/2005

Nursing and Midwifery Council – Midwives rules and standards, London: NMC 2004

Nursing and Midwifery Council – Standards of proficiency for nurse and midwife
prescribers, London: NMC 2006

Royal College of Midwives, Midwives and medicines legislation: An Information Paper,

London 2006

Royal Pharmaceutical Society of Great Britain (2005) Medicines, Ethics and Practice: A
Guide for pharmacists: 29th edition Pharmaceutical Press.

The British National Formulary online www.bnf.org

For a list of current NMC publications go to www.nmc-uk.org/publications

58
Annexe 7
Glossary

clinical governance Quality assurance activities which ensure that pre-determined

clinical standards that have been set, are seen to be maintained
by practitioners, and are evident within health care settings.

clinical The CMP is the foundation stone of supplementary prescribing.

management plan Before supplementary prescribing can take place, it is obligatory
(CMP) for an agreed CMP to be in place (written or electronic) relating
to a named patient or client and to that patient or client’s specific
condition(s) to be managed by the supplementary prescriber.
The CMP is required to include details of the illness or conditions
that may be treated, the class or description of medical products
that can be prescribed or administered, and the circumstances
in which the supplementary prescriber should refer to, or seek
advice from, the doctor or dentist. Supplementary prescribers
must have access to the same patient or client health records
as the doctor or dentist. Since April 2005, nurse supplementary
prescribers can prescribe controlled drugs, provided the doctor or
dentist has agreed to this within the clinical management plan.

competence Relates to the need for the student to demonstrate their

‘capability’ in certain skill areas to a required standard at a point in
time.

competencies Component skills which contribute to being competent

and achieving the standards of proficiency for registration.
Competencies might include skills arising from learning outcomes
or other requirements.

dispensing To label from stock and supply a clinically appropriate medicine to

a patient, client or carer, usually against a written prescription, for
self-administration or administration by another professional, and
to advise on safe and effective use.

Health Care The health watchdog in England. It has a statutory duty to

Commission assess performance of health care organisations, award annual
performance ratings for NHS and coordinate the review of health
care by others. (The Care Quality Commission has since taken
over the role of the Health Care Commission – see
www.cqc.org.uk).

59
independent A prescriber who is legally permitted and qualified to prescribe
prescriber and takes the responsibility for the clinical assessment of
the patient or client, establishing a diagnosis and the clinical
management required, as well as the responsibility for
prescribing, and the appropriateness of any prescribing.

licensed The Medicines and Healthcare products Regulatory Agency

medication (MHRA) operates a system of licensing before medicines are
marketed (see marketing authorisation). However, the Medicines
Act allows certain exemptions from licensing which include:

• the manufacture and supply of unlicensed relevant medicinal

products for individual patients or clients (commonly known
as ‘specials’)

• the importation and supply of unlicensed relevant medicinal

products for individual patients or clients

• herbal remedies exemption.

marketing Previously known as a ‘product licence’. This normally has to

authorisation be granted by the MHRA before a medicine can be prescribed
or sold. This authorisation, which confirms that medicines have
met standards for safety, quality and efficacy, considers all of the
activities associated with marketing medicinal products.

Medicines Act Allow certain groups of healthcare professionals including

exemptions occupational health schemes and midwives to sell, supply and
administer particular medicines directly to patients or clients.
Provided the requirements of any conditions attached to those
exemptions are met, a patient group direction is not required.

medicines Also known as patient administration chart, the record by which

administration medicinal products administered to a patient are recorded.
record

Medicines The government agency responsible for ensuring that medicines

Healthcare and medical devices work and are acceptably safe.
Products
Regulatory Agency
(MHRA)

National Patient A special health authority created to coordinate all the eff orts
Safety Agency of all those involved in health care to learn from patient safety
(NPSA) incidents occurring in the NHS.

60
nurse independent Nurses and midwives who are on the relevant parts of the NMC
prescribers register may train to prescribe any medicine for any medical
condition within their competence with the exception of controlled
drugs.

Nurse Prescribers The formulary from which nurses who have successfully
Formulary for completed the integrated prescribing component of the SPQ/
Community SCPHN programme may prescribe independently.
Practitioners (CPF)

one-stop One-stop dispensing is a system of administering and dispensing

dispensing medicinal products. It involves using the patient’s own medicinal
products during their stay in hospital, either those dispensed
by a community pharmacy or by the hospital pharmacy or both,
providing they contain a patient information leaflet and are
labelled with full instructions for use.

parts of the The NMC register, which opened on 1 August 2004, has three
register parts: nurses, midwives and specialist community public health
nurses. A record of prescriber qualifications on the register
identifies the registrant as competent to prescribe as community
practitioner nurse prescriber or a nurse independent and
supplementary prescriber.

patient group Written instructions for the supply or administration of named

direction (PGD) medicines to specific groups of patients who may not be
individually identified before presenting for treatment. Guidance
on the use of PGDs is contained within Health Service Circular
(HSC) 2000/026. (Note: In Wales WHC 2000/116. Separate
guidance has also been issued in Scotland and NI.) The circular
also identifies the legal standing of PGDs plus additional guidance
on drawing them up and operating within them. It is vital that
anyone involved in the delivery of care within a PGD is aware of
the legal requirements. It is not a form of prescribing. See also
guidance at www.npc.co.uk

patient information Data sheets found in all dispensed medicinal products which
leaflet should be brought to the patient’s attention on administering the
medicinal product.

patient specific Written instructions from a doctor, dentist or nurse prescriber for
direction a medicine to be supplied or administered to a named person.
This could be demonstrated by a simple request in the patient or
client’s notes or an entry on the patient or client’s drug chart.

61
prescription Is a division of the NHS Business Services Authority in England
pricing division responsible for processing all prescription items. Nurses,
(PPD) registrants midwives and specialist community public health nurses currently
entered in the NMC register.

repeat prescribing A partnership between patient or client and prescriber that allows
the prescriber to authorise a prescription so it can be repeatedly
issued at agreed intervals, without the patient or client having to
consult the prescriber at each issue.

Regulation Is an independent health and social care regulatory body for

and Quality Northern Ireland which encourages continued improvement
Improvement in quality of services through a programme of inspections and
Authority (RQIA) reviews.

rules Rules are established through legislation and they provide

the legal strategic framework from which the NMC develops
standards, for example, Education, Registration and Registration
Appeals Rules 2004 (SI 2004/1767). ‘Standards’ support the
rules. Standards are mandatory and gain their authority from the
legislation, in this case the order and the rules.

specialist A nurse who aims to reduce health inequalities by working

community public with individuals, families and communities, promoting health,
health nurse preventing ill health and in the protection of health. The
emphasis is on partnership working that cuts across disciplinary,
professional and organisational boundaries that impact on
organised social and political policy to influence the determinants
of health and promote the health of whole populations.

stakeholders Those who have a major interest in ensuring an effective

programme outcome, including programme providers, placement
providers, students, mentors, practice teachers, external
examiners, external agencies, service users and carers.

standards The NMC is required by the Nursing and Midwifery Order 2001
(the order) to establish standards of proficiency to be met by
applicants to different parts of the register. The standards are
considered to be necessary for safe and effective practice [Article
5(2)(a)]. These are set out within the Standards of proficiency
for each of the three parts of the register, and for the recorded
qualification of nurse or midwife prescriber.

summary of product Information on medicinal products dispensed may be found at the

characteristics Electronic Medicines Compendium.

62
supplementary A voluntary partnership between an independent prescriber
prescribing (doctor or dentist) and a supplementary prescriber, to implement
an agreed patient or client-specific clinical management plan with
the patient or client’s agreement.

transcribing Any act by which medicinal products are written from one form
(transposing) of direction to administer to another is ‘transcribing’. Including
discharge letters, transfer letters, copying illegible patient
administrations chart onto new charts (whether handwritten or
computer-generated).

unlicensed This term refers to medicines that are not licensed for any
medicines indication or age group. Reasons why a drug may not be licensed
include:

• the drug is undergoing a clinical trial, has been imported,

has been prepared extemporaneously or prepared under a
special manufacturing licence

• the product is not a medicine but is being used to treat a rare

condition.

unregistered Practitioners providing care who are neither registered or licensed

practitioners by a regulatory body and have no legally defined scope of
practice.

Yellow Card If a patient or client experiences an adverse drug reaction to a

Scheme medication the nurse or midwife should record this in the patient
or client’s notes, notify the prescriber (if they did not prescribe the
drug) and notify via the Yellow Card Scheme immediately. Yellow
cards are found in the back of the British National Formulary and
online on www.yellowcard.gov.uk For further information read
the BNF or access the MHRA website www.mhra.gov.uk

63
Annexe 8
Contributors
Anne Iveson, Medicines Manager,
General Healthcare Group of Private Hospitals

Anne Ryan,
Medicines and Healthcare Products Regulatory Agency

Cathy Cairns, Professional Adviser,

Children and Young People’s Nursing, NMC

Jan Palmer, Clinical Substance Misuse Lead, Prison Health,

Department of Health, London

Julie Matthews, Senior Lecturer,

Anglia Ruskin University

Liz Dimond, Professional Officer (Shipman),

Department of Health, London

Liz Plastow, Professional Adviser,

Specialist Community Public Health Nursing, NMC

Marion Russell, Clinical Development Nurse:

Medicines Management,
Guys & St Thomas NHS Foundation Trust

Maureen Morgan, Professional Adviser, CNO Team,

Department of Health, England

Meghna Joshi, Pharmacist,

Royal Pharmaceutical Society Great Britain

Professor Matt Griffiths,

Joint Prescribing and Medicines management Adviser,
Royal College of Nursing

Professor Molly Courtenay,

Joint Prescribing and Medicines management Adviser,
Royal College of Nursing

Dr Susan Way, Professional Adviser,

Midwifery, NMC

Theresa Rutter, Joint Director Community Health Services,

East and South East England Specialist Pharmacy Services,
Kensington and Chelsea PCT

64
Toni Bewley, Assistant to the Chief Nurse,
The Royal Liverpool Children’s NHS Trust, AlderHey

Trudy Granby, National Prescribing Centre

Valerie Smith, Professional Adviser Independent Sector,

Royal College of Nursing

65
First published by the Nursing and Midwifery Council in 2007.
This current design was introduced in April 2010 with the addition of paragraph numbers
to standards and guidance sections and updates to various references, however the
content has not changed.

66
Contact us
Nursing and Midwifery Council
23 Portland Place
London W1B 1PZ
020 7333 9333
www.nmc-uk.org

PB-STMM-A5-0410

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