Beruflich Dokumente
Kultur Dokumente
Classification: Policy
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Introduction .............................................................................................................. 4
10
11
12
13
14
Unlicensed medicines.......................................................................................... 59
15
16
Use of Patients Own Drugs (PODs) and Supply of Named Patient Medicines .... 67
17
18
Carriage of Medicines.......................................................................................... 73
19
20
21
Appendix 1- Protocol for safe and secure handling of medicines in Community Services
...................................................................................................................................... 79
Appendix 2 Patient Group Direction Template ........................................................... 85
Appendix 3 - Guidance for Unregistered Staff in the Administration of Medicines ........ 90
Appendix 4 - Standard Operating Procedure for Controlled Drugs for Royal Bolton
Hospital and Bolton Community Unit ............................................................................. 95
Appendix 5 - Storage and Recording Requirements for Controlled Drugs .................. 100
Appendix 6 - Protocol for the Use of Controlled Drug Denaturing Kits in Community
Services ...................................................................................................................... 101
Appendix 7 - Form for the removal or destruction of unauthorised drugs or other
suspicious substances ................................................................................................ 103
Appendix 8 - Self Administration of Medicines Assessment Algorithm ........................ 104
Appendix 9 - Self Administration of Medicines Assessment Record ........................... 105
Appendix 10 - Self Administration Consent Form ........................................................ 106
Medicines Policy, version 3
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Appendix 11 - Information for Patients about Self Administration of their Medicines .. 107
Appendix 12a Disclaimer for the Prescribing of Unlicensed Medication Single
Consultant ................................................................................................................... 109
Appendix 12b Disclaimer for the Prescribing of Unlicensed Medication Multiple
Consultants ................................................................................................................. 110
Appendix 13 List of Unlicensed Medicines that do not require a disclaimer ............. 111
Appendix 14 - Fridge Monitoring Sheet ....................................................................... 112
Appendix 15 - Algorithm for the use of patients own drugs (PODs) ........................... 113
Appendix 16 - Protocol to remove discontinued and out of date medication from patients
home ........................................................................................................................... 114
Appendix 17 Medicines Policy Monitoring Grid ........................................................ 117
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1 Introduction
1.1
This Medicines Policy is intended to be read by all individuals who deal with
medicines within the Trust.
1.2
1.3
This is the first edition of the Bolton NHS Foundation Trust Medicines Policy; this
policy is based on the Royal Bolton Hospital and the Bolton Primary Care Trust
(PCT) Medicines Policies. It supercedes these two previous policies and
encompasses relevant pharmacy and nursing policies relating to drug
administration.
1.4
The Nil by Mouth Chapter has been removed and is now a separate guideline.
1.5
The policy will be subject to biennial revision and may be modified by local
protocols, which must be agreed by the Drugs & Therapeutics Committee.
Comments and suggestions should be directed to the Chief Pharmacist on
extension 5555.
1.6
This policy should be read in conjunction with the Foundation Trust (FT)
Formulary, the FT Guidelines for Antimicrobial Therapy and other relevant local
policies and procedures.
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Medicines Trail
Prescribing / initiation of
treatment
Influenced
by
pharmacists,
Trust
Formulary, Evidence
Based Practice, D+T
Procurement / acquisition of
medicines
Manufacture / manipulation
of medicines
Receipt of
medicines
Preparation / manipulation of
medicines for administration
Use of medicines /
administration
Influenced
by
pharmacy procedures,
contracting issues, risk
management, financial
considerations
Influenced by pharmacy
procedures,
nursing
procedures,
risk
management, IV Guide,
Clinical Skills / Training
Influenced by trust
waste policy, COSHH
and
environmental
issues
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3 Monitoring Arrangements
Adherence to this policy will be monitored as a key part of the pharmacy service
delivery. Specific audits are detailed in the Pharmacy Department Audit Calendar.
Pharmacy staff visit trust wards daily (Monday Friday) and monitor prescribing for
clinical efficacy, safety, appropriateness and compliance with Bolton NHS Foundation
Trust Formulary (including Trust Antibiotic Guidelines).
Additional monitoring is as stated below.
Prescribing in the Royal Bolton Hospital
Prescribing is monitored by the pharmacy department. All outpatient prescriptions
(with the exception of a very small number of FP10s(HP) prescriptions written in
emergency situations outside pharmacy hours) are monitored and checked in the
dispensary. This monitoring by a pharmacist is a legal and professional
requirement. The dispensary is a Registered Pharmacy and as such is subject to
inspection and audit by the General Pharmaceutical Council Inspectorate and
Enforcement Division.
Quality of Medicines
This is a professional requirement for pharmacists. External support is provided
by Quality Control North West (QCNW) and the Regional Tendering Process for
Pharmaceuticals. Any defects are reported through the pharmacy to QCNW who
hold a database of defects and cascade any MHRA Safety Alerts. Action on
these defects and alerts is stored in pharmacy.
Storage of Medicines
Pharmacy Technicians carry out a three monthly audit on the storage of
medicines in hospital clinical areas. Any discrepancies are reported through
senior nursing staff.
Administration of Medicines
Training is provided as part of Mandatory Training Programme and update events
on responsibilities of staff regarding the administration of medicines (Safe
Medicines Awareness, Level 1). It is the responsibility of Ward Managers and
individual staff to ensure competency in administration of medicines.
Controlled Drugs (including the use of Methadone and Illicit Substances)
Pharmacy staff carry out a three monthly audit on the use and storage of
controlled drugs. This is reported through the Trust Accountable Officer for
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Controlled Drugs and further reported to the Controlled Drugs Local Information
Network. This Network produces an annual report to the PCT Executive Board.
Pharmacy and a Divisional Manager audit any returned controlled drugs / illicit
substances (or substances believed to be illicit) twice a year.
The Exemplar Programme
In bed based services, the Exemplar Programme has been developed as a tool to
raise standards in patient care. This programme utilises a regionally developed
audit tool (North West Care Indicators), localised where required, which measures
compliance over nine different domains on a monthly basis including:
Medicines Prescribing and Administration
Pain Management
Venous Thrombo Embolism (VTE) assessment
Further information on the Exemplar Programme is available on the Bolton NHS
Foundation Trust Website.
Community Services
In Community Services, all areas that handle medicines carry out an annual audit
to ensure that medicines are stored safely and securely.
A sample audit is included in Appendix 1 and each team should use this as a
template to complete the audit.
It should be completed and returned to the line manager with an action plan, if
appropriate.
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4 Prescribing of Medicines
4.1
All prescriptions must be written by a medical or dental practitioner or an approved NonMedical Prescriber. Medical students, physician assistants or nursing staff not
registered as Non-Medical Prescribers are not allowed to sign prescriptions or to
prepare prescriptions for signature by medical staff.
The patients name, hospital number, date of birth, ward, allergy status and the name of
the consultant must be clearly visible on the prescription sheet. This may be handwritten
or preferably a combination of handwritten and ID label.
For paediatric patients, date of birth and weight should also be entered.
The patients weight must also be entered if prescribing drugs with dose dependant on
weight e.g. LMWH, animoglycosides, aminophylline infusion. The weight should be
documented in the weight box on the front of the prescription.
The use of drugs in patients with reduced renal function should be considered when
prescribing.
The date on which treatment is to commence must be entered on the prescription sheet.
Dates where treatment is not intended must be crossed out on the chart (eg treatment
to start the next day or post op or treatment to be stopped after a number of days)
The name of the medicine should be written legibly in black ink using approved names.
Proprietary names (i.e. brand names) must not be used. The only exceptions to this rule
are multi-ingredient preparations with no approved names or products whose
proprietary names define a specific formulation (e.g. slow-release theophylline
preparations). Prescribe solid oral dose forms of morphine and oxycodone preparations
using both approved and proprietary names.
Prescribers should consider the contraindications and interactions with other medicines
and arrange for appropriate monitoring of medication & its effects If the drug being
prescribed requires the patients renal function to be confirmed before the drugs is
commenced, U&Es should be taken as a base line before the drug is prescribed e.g.
LMWH and aminoglycosides. Liver function should be monitored in the same way for
eg amiodarone, methotrexate
The dose must be expressed in S.I. Units. Quantities less than 1 gram must be written
as milligrams. Decimal points should be avoided, for example 500mg not 0.5g to avoid
confusion. Whenever a decimal point is necessary, great care must be exercised by
both the prescriber and the nurse administering the drug. The terms MICROGRAM and
Medicines Policy, version 3
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NANOGRAM must not be abbreviated but must be printed in full and used for quantities
less than one milligram. When prescribing drugs expressed as Units, the full word must
be used and not abbreviated to U. Only the following abbreviations are acceptable:Quantity
Approved Abbreviation
milligram
mg
gram
g
kilogram
kg
litre
L
millilitre
ml
millimole
mmol
The dose required must not be expressed in terms of the dosage form for
single ingredient preparations e.g. ATENOLOL 2 tablets is not acceptable.
It should be written as e.g. ATENOLOL 100mg.
4.1.2 ROUTE OF ADMINISTRATION
Only the following abbreviations are acceptable:
Route
Intramuscular
Inhalation
Intravenous
Nebulised
Oral
Rectal
Vaginal
Subcutaneous
Sublingual
Topical
Nasogastric
Percutaneous Endoscopic
Gastrostomy
Approved Abbreviation
IM
INH
IV
NEB
PO
PR
PV
SC
SL
TOP
NG
PEG
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4.1.6 All medicines must be written on the prescription sheet, including details of
oxygen therapy, irrigations, gentamicin, parenteral nutrition and dressings
supplied by pharmacy, all of which are prescription only medicines. Dieticians will
add dietary supplements to the prescription sheet. Cross reference must be
made on the front of the prescription chart (using the spaces provided) to other
drugs prescribed on separate charts e.g.
Anticoagulants.
I.V. fluids and additives (including TPN, blood and blood products).
Insulin.
Dialysis fluids.
Cytotoxics.
Bladder instillations.
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In the interests of patient safety, prescriptions in bed based services must not be given
or accepted over the telephone or verbally, except in an emergency. An emergency in
this case is defined as a life threatening situation. Telephone / verbal orders will not be
accepted by pharmacy.
4.1.7.2
Community Services
In Community Services instructions may be accepted by fax as long as they are dated
and signed by the prescriber and it is clear who the signing prescriber is. Any changes
in drug regime must also be dated and recorded by the prescriber.
Under exceptional circumstances where a medicine has already been prescribed for
that patient, and with agreement of both parties, a registered nurse may accept a
telephone message from a prescriber for an alteration (e.g., dose alteration) to a
prescription to be administered in the patients home under following conditions:
Two persons must acknowledge the message, one of which must be a registered
nurse. The second person will be selected at the discretion of the registered
nurse.
The nurse receiving the call must repeat the prescription to the prescriber to
ensure accuracy.
A record must be made of the nature of the message, date, time; name of the
prescriber and both parties receiving the instruction must witness the record.
The alteration must be confirmed in writing by the prescriber on the next normal
working day.
Verbal alteration cannot be accepted for Controlled Drugs.
4.1.8 VALIDITY OF PRESCRIPTIONS
Unless the course of treatment is clearly specified, the prescription will be considered
valid until cancelled by the prescriber (see 4.1.5 and 4.1.11) except in the case of
antibiotics which are issued for 7 days, unless the prescriber indicates a specific
duration of treatment. This should be done by using the stop date box, all IV
antibiotics should be reviewed daily, with the exception of deep seated/high risk
infections (e.g. meningitis, endocarditis, bone and joint infection) which MUST have a
stop or review date. See the Trust Guide Antibiotic Policy for further information on
prescribing antibiotics.
Prescriptions must be re-written if the patient is re-admitted or transferred from another
hospital.
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Medicines Charts are only valid in the organisation where originally written. This
includes patients transferred between sites within Royal Bolton Hospital NHS
Foundation Trust and Community Services. This does not include Greater Manchester
West Mental Health Trust wards.
Only Bolton NHS Foundation Trust Medicines Charts can be used in any FT service.
4.1.10
RE-WRITING OF PRESCRIPTIONS
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Medicines are unlike any other items of commerce and for this reason the purchase,
storage and distribution must be under the control of a pharmacist. The Trust Standing
Financial Instructions delegates the financial responsibility, within pre-set limits, for
tenders and the signing of orders for medicines to the Chief Pharmacist and authorised
deputy, who have procedures to ensure that legal and ethical requirements are met.
Medical, nursing, technical and other staff are not permitted to undertake contracting or
tendering for, or purchasing of, medicinal products intended for administration to
patients within the Trust.
They must also not accept free samples of any medication for use within the Trust.
4.3
OUT-PATIENT PRESCRIPTIONS
The requirements for out-patient prescriptions are generally as indicated in for inpatient
prescription but see also prescriptions for controlled drugs. Drugs may only be
prescribed when there is an urgent clinical need and referral for GP prescribing is
deemed detrimental to the patients treatment. Hypnotics will not normally be supplied,
unless the patient was admitted on them. A maximum of 28 days supply (prn
analgesics only small packs supplies unless they are being taken regularly when two
packs will be supplied, and an original pack for inhalers and topical preparations) will be
dispensed unless circumstances dictate that a different supply is necessary. This
includes:
1. Hospital only medicines - these cannot be prescribed by General Practitioners.
2. Clinical trial medicines.
3. Pulsed / cyclical treatment.
4. Reducing doses of drugs e.g. steroids will be supplied for up to 4 weeks, then
passed on to GP
5. Drugs for tuberculosis treatment.
6. Haematology treatment.
7. Chemotherapy treatment
8. Drugs to ensure sufficient supply over public / bank holidays.
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4.4.
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4.4.1
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All sections must be completed. Known allergies and intolerances as well as the record
of completion of the VTE Risk Assessment must be completed and signed by the
prescriber. A patient sticker should be used but if none are available the patient name
must be clearly written together with their RBH Unit Number.
4.4.2 Medication at Admission
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This section is generally completed by pharmacy staff. When pharmacy staff are not
available at admission it is acceptable to complete the medication history section and
the remainder will be completed by pharmacy staff.
4.4.3 Intravenous Antibiotics
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A stop date or a review by date must be added at the time of prescribing. All
prescriptions for intravenous antibiotics turn Red after two days. This means that
nursing staff will question the validity of the prescription if it has not been reviewed. The
P section in all parts of the chart is for pharmacy annotation. Pharmacy staff may also
provide additional information / instruction in the Additional Instructions box.
Pharmacists write in green pen to distinguish their entries from the prescriber.
The same requirement for indication, stop or review date and extended duration apply
for oral anti-infectives as for intravenous anti-infectives. The IV antibiotic section does
not have a stop date or extended duration box as the prescribing should be reviewed
daily.
The indication must be completed as well as the maximum dose in 24 hours (should this
be applicable).
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This includes topical, inhaled, rectal etc as well as oral. It is NOT for IVs.
As with all other prescriptions, each entry must be signed and dated. Once stopped, the
date and the reason for stopping the prescription must be added. The prescription
requires bleep number, signature and printed name of the prescriber.
4.4.8 Once Only Medications
This section is intended for pre-operative medications or medications that will only
normally be administered once, such as prophylactic antibiotics, sedation vaccines, etc.
4.4.9 Insulin
This section is intended to be used for patients who are prescribed insulin by injection.
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5.2
All PGDs have to be drawn up locally and must meet legal, ethical and trust
criteria. The following should be referred to when developing or updating PGDs:
Pharmacy Department - NHS Bolton Foundation Trust. SOP for the
Introduction of a new Patient Group Direction (PGD) and Review Process for
Existing PGDs. (2012).
The template for development of a local PGD is contained as Appendix of this
Policy.
National Prescribing Centre (NPC) Patient Group Directions guide and
competency
framework
(2009)
http://www.npc.nhs.uk/non_medical/resources/patient_group_directions.pdf
5.3
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5.4
5.5
The healthcare professional should refer to the relevant PGD at all times
when operating within them i.e. a copy of the relevant PGD should be
readily available.
5.6
All staff operating within PGDs are expected to participate in audit of the
use of PGDs, if necessary/appropriate.
5.7
A PGD can include flexible dose ranges so that staff can select the most
appropriate dose for the patient.
5.8
5.9
5.10
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6 Administration of Medicines
6.1
The administration of medicines is an integral and essential entry criterion for the
Professional registration (NMC, 2009). Medicines administration is not solely a
mechanistic task but a task that requires thought and the application of
professional judgments. Registered practitioners must have the knowledge and
skills required for the safe administration of medicines and keep those skills up to
date (NMC, 2008).
This section of the policy sets out guidance for practitioners and their
responsibilities in the safe and effective administration of medicines to a correctly
identified patient.
This applies to all Practitioners who are required to administer medicines in the
course of their work, including temporary staff
See policy introduction (Section Introduction) which outlines staff group
roles and responsibilities in relation to medicines.
Refer to relevant statutory and professional guidance alongside this policy.
Please see Appendix 3 to this Policy for GUIDANCE FOR THE ASSISTANT
PRACTITIONER (AP) IN THE ADMINISTRATION OF MEDICINES
6.2
DEFINITIONS
For the purpose of this policy, a Practitioner is a person who is registered with a
recognised professional body and where the administration of medicines is within
their agreed scope of professional practice e.g. Nursing and Midwifery Council
(NMC).
A Wardex is the term used for the patient prescription chart used in inpatient
bed areas.
Medicine Administration Record Sheet (MARS) is the term used for the patient
prescription chart used in community areas.
An FP10 is the term used for prescriptions issued by GPs, non-medical
prescribers or hospital doctors in a clinic setting.
Bed based services is the term used to refer to services that provide in-patient
care e.g. wards in Hospital, Intermediate Care (Darley Court) and Bolton
Community Unit.
Medicines Policy, version 3
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6.3
The safe and reliable administration of medicines is at the heart of patient safety.
Patients require the correct drug, in the correct dose, at the correct time. The
policy supports this through setting out the processes to support staff in the safe
administration of medicines.
6.4
GUIDELINES/ PROCEDURES/METHODS
6.4.1
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6.4.3
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Identify the patient: Check the name, date of birth and hospital number on
the Wardex/MARS with the patient and check the details correspond with
the wristband (bed based services only). Where possible ask the patient to
state their name and date of birth. Refer to Positive Identification Policy.
Always check the Wardex/MARs that the patient has no known allergies or
contra indications to the prescribed medicine - even if none are recorded
check allergy status with patient.
Note any instructions from pharmacy indicating potential interactions
between prescribed medicines.
Inform the prescribing practitioner immediately where allergies are found or
contra-indications to any prescribed medicine are identified/observed.
Ensure the prescribed medicine has not already been given.
Review all parts of the Wardex /MARS, so no drugs are missed or
duplicated. Community teams should also check the record of visit sheet.
Medicines dispensed for a named patient should only be administered to
that patient.
Check expiry date for all medications and the date when solutions opened
discard if dates not found.
Administration:
Select the medicine required and follow the 5Rs for each;
Right Patient
Right medicine
Right date and time
Right dose
Right route
Discuss the medications being administered with the patient and or carer
and check there is an understanding of the purpose of the drug and any
common side effects.
The person administering the drugs can assign another person to support
the patient to take their medicine, but this remains under their direct
supervision.
Initial, date and time as indicated on the Wardex/MARs, that the medicine
has been given and taken by the patient.
Record any adverse effects or variables using your clinical and professional
judgement to determine any necessary follow up actions.
The overall responsibility for the administration of the drugs lies with the
registered practitioner. Under no circumstances should medicines be left on
a patients locker or at the bedside, unless otherwise specified in this Policy.
Refusal of Medication and Covert Administration of Medicines
Where the patient refuses a medicine:
Ensure they are aware of the risks of omitting these.
Document this clearly in the patient record and where appropriate inform the
medical staff.
If the patient is not capable of consenting to take their medication:
Medicines Policy, version 3
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6.6
Most medicines can be given plus or minus one to two hours from the time
prescribed on the Wardex/MARS with the exception of Critical Medicines (see
section 5.2 below)
Reasons for any omissions or delays of medicines must be recorded using the
appropriate codes on the Wardex/MARs.and also in the collaborative/patient
records.
If there is no identifiable clinical reason/justification for omitting the dose, this
MUST be reported as a clinical incident. Any omissions based on a clinical need
are exempt from reporting as a clinical incident.
6.7
CRITICAL MEDICINES
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Critical Medicines
The following set out the critical medicines where it is crucial that these are
administered at the stated time:
Critical Medicines
Resuscitation medicines including colloid or crystalloid intravenous fluids
First doses of injected:
o Antibiotics
o anticoagulants or thrombolytics.
o anticonvulsants including bendodiazepines.
Parkinsons disease medicines
Stat doses of any medicine.
Insulin or oral hypoglycaemics - linked to when food will be eaten
Strong analgesia
Bronchodilators
Glyceryl Trinitrate
If 1 dose is missed this MUST be reported as a Clinical Incident.
All staff should be aware that omission or delay of critical medicines are patient
safety incidents and should be reported (NPSA, 2010 / RRR 009).
6.8
RECORD KEEPING
Record keeping
The administering practitioner must make an indelible record of administration in
the patients records by completing the Wardex/MARS and in the Controlled Drug
Register/ Home Controlled Drug Register Card.
Any errors in the recording of administration must be clearly cancelled with a single
line in indelible ink through the initials. The reasons for this must be explained and
captured in the collaborative record/nursing record.
6.9
Seek Advice
If a patient has swallowing difficulties or is nil by mouth the practitioner must contact the
prescriber or seek advice directly from Pharmacy Department.
6.10
VERBAL MESSAGES
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where failure to administer would result in serious harm to the patient. In this case, the
Practitioner must fully justify and be accountable for his or her actions.
In the community setting a registered nurse may accept a telephone message from a
prescriber for an alteration (e.g., dose alteration) to a prescription to be administered in the
patients home:
When taking a verbal message the Practitioner must provide the Doctor with full details of
the symptoms, relevant medical history, current medication record and any known allergies
or contra-indications to drugs.
In the community setting, the registered nurse and where possible a second practitioner will
be selected for the receiving of verbal messages. In bed based services two registered
nurses must acknowledge the message. All verbal messages must be documented in the
Wardex/MARs and collaborative records.
The following should be confirmed with the Doctor:
Patient's identity
Name and form of medicine
Route of administration
Dose prescribed
Date and time for administration
Name of Practitioner
Name of Doctor.
A record of the message must be made in the patient's Health Record and in the once only
section of the prescription sheet and both parties receiving the instruction must witness the
record. The Doctor must confirm and sign the prescription before going off duty. The
alteration must be confirmed in writing by the prescriber within 24hours in community
setting.
Verbal alteration cannot be accepted for Controlled Drugs.
6.11
TRANSCRIBING
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6.12
Medicines, which are provided by the Trust for the use of patients, must never be
taken or given for personal use by hospital/community staff.
Staff who become ill on duty should be referred to either Occupational Health,
Accident and Emergency or their General Practitioner (GP).
The Hospital Pharmacy Department has a small stock of over the counter
medicines available to purchase within Pharmacy working hours.
6.13
REFERENCES
Department of Health (2003) Building a safer NHS for patients: Improving medication
safety. A report by the Chief Pharmaceutical Officer, London, department of Health.
Medicines Act and ensuing statutory instruments 1968
Mental Health Act Commission Guidance Note, Nurses, the Administration of Medicines
for the Mental Health Act 1983 ref GN 2/2001
Misuse of Drugs Act and ensuing statutory instruments 1971
Nursing Midwifery Council Midwives Rules & Standards August 2004. NMC
Nursing Midwifery Council The Code April 2008. Standards of conduct, performance and
ethics for nurses and midwives. NMC
Nursing Midwifery Council. (February 2008) Standards for Medicines Management. NMC
(reprinted Aug. 2008)
Nursing Midwifery Council. April 2006. Standards of proficiency for nurse and midwife
prescribers NMC
National Patient Safety Agency (June 2010) Rapid response report
NPSA/2010/RRP013. safer administration of insulin.
National Patient Safety Agency (February 2010) Rapid response report
NPSA/2010/RRP0009: Reducing harm from omitted and delayed medicines and delayed
medicines in hospitals.
National Patient Safety Agency (March 2007) Promoting safer measurement and
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7 Controlled Drugs
7.1
DEFINITIONS
7.1.1 Controlled Drugs are those drugs covered by the Misuse of Drugs Act
1971 and associated Regulations. Medicines classed as controlled drugs
can be found in the current Misuse of Drugs Regulations at
www.homeoffice.gov.uk or in the current issue of the BNF
7.1.2 Under the Health Act 2006, the Trust has appointed an Accountable
Officer for the safe and effective use of Controlled Drugs. This
Accountable Officer is the Chief Pharmacist, who will audit the use of
controlled drugs at regular periods and report the results to the Trust
Board and the Local Information Network.
7.1.3 Medical, Pharmacy, Nursing and other staff still retain their own
professional and legal responsibilities around the use of Controlled Drugs.
7.1.4 The ward / department managers are responsible for the safe and secure
storage and the use of Controlled Drugs within their own areas.
7.1.5 All areas that handle Controlled Drugs should have Standard Operating
Procedures (SOPs). These SOPs should cover all aspects of risk
management and audit trails for ordering, storing, prescribing, dispensing,
recording, supplying, administration, and destruction of CDs appropriate to
the setting and the team. Each team should have clear written SOPs in
place that are known, understood and followed by practitioners and staff.
Standard Operating Procedure for Royal Bolton Hospital and Bolton
Community Unit (wards and also other areas) constitutes part of this
Policy (Appendix 4)
7.2
7.2.1 All medical staff (not students and unregistered locums) may prescribe
Controlled Drugs, but may not prescribe diamorphine or cocaine for the
treatment of addiction unless licensed by the Home Office to do so.
Prescribing of diamorphine for pain control (including for addicts if clinically
appropriate) is allowed under Home Office guidelines.
7.2.2 Non-Medical Prescribers are limited by the type of prescribing being used.
Under the Supplementary Prescribing regulations, Controlled Drugs may
be prescribed if included in an approved Clinical Management Plan.
7.2.3 On 23rd April 2012, the Misuse of Drugs Regulations 2001 was amended
to enable independent nurse and pharmacist prescribers to prescribe
controlled drugs listed in Schedule 2 to 5, except diamorphine, cocaine
Medicines Policy, version 3
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7.2.7 Prescribers must not prescribe or administer CDs for themselves, family or
friends
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7.2.8 Prescribe solid oral dose forms of morphine and oxycodone by both
approved and proprietary name
7.3
7.3.1 All Controlled Drugs must be received into the area by a designated
person.
7.3.2 All Controlled Drugs must be stored in a locked safe, cabinet or room,
which is so constructed and maintained as to prevent unauthorized access
to the drugs. A purpose built CD cabinet is recommended. The designated
person(s) must at all times be responsible for carrying the keys to allow
access to the CD cupboard.
7.3.3 For list of medicines to be stored in the CD cupboard, see Appendix 5
(Storage Requirements for Controlled Drugs).
7.3.4 No medicines other than Controlled Drugs should be stored in a CD
cupboard unless specified by a Trust policy or agreed with Pharmacy (e.g.
storage of concentrated IV potassium solutions, Propess or mifepristone).
7.4
RECORD KEEPING
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7.4.7 In a patients own home, CDs that are administered by a registered nurse
must be recorded on the Home Controlled Drug Register Card (CH226)
and if possible verified by a second member of staff, who will also provide
advice on safe storage.
7.6
7.6.1 Any out of date stock of Controlled Drugs (i.e. any controlled drugs not
dispensed for individual patients) must be destroyed by a person
specifically authorized by the Trust Accountable Officer.
7.6.2 Any out of date Controlled Drugs that have been dispensed for a particular
patient must be destroyed by a pharmacist in the presence of an
appropriate witness.
7.6.3 Patients own Controlled Drugs may be destroyed in patients own homes
if deemed appropriate. Such destruction may only be performed by a
registered healthcare professional using a controlled drug denaturing kit in
the presence of a suitable witness. The denaturing kit should subsequently
be returned to the licensed waste carrier. (See Appendix 6)
7.7
DISCREPANCIES
MONITORING
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8 Use of Methadone
GUIDELINES FOR PRESCRIBING METHADONE FOR PATIENTS ADMITTED
FOR AN UNRELATED MEDICAL / SURGICAL REASON
8.1
INTRODUCTION
8.1.1 Opioid withdrawal symptoms are unpleasant but not life threatening. In
contrast, methadone overdose, or its administration to the opioid naive,
can be fatal. Opioid withdrawal is not a medical emergency, so methadone
does not need to be prescribed in the Accident and Emergency
Department.
8.1.2 In pregnancy, opioid or benzodiazepine withdrawal can precipitate serious
foetal problems. Rapid stabilisation of symptoms is essential.
8.1.3 For a comprehensive review, see the Dept of Health publication Drug
Misuse & Dependence Guidelines on Clinical Management, 1999.
8.2
8.3.1 The doctor must write on the prescription chart Do not give if drowsy.
8.3.2 The nurse must monitor the patient every time.
8.3.3 Do not give methadone to a patient who is drowsy, sedated, ataxic, with
slurred speech or asleep. Never wake a patient up to give methadone. If
any of these applies, the nurse must ask for a medical review. Do not give
methadone if the patient has been absent from the ward and you suspect
illegal drug use.
8.4
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In addition to taking a full drug history, the doctor must find out whether
the patient is:
(a) Established on a methadone programme with the Community drugs
team or a GP.
Or
(b) Using street drugs or on an unconfirmed dose of methadone.
8.5
8.6
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8.8
Occur
When an opioid-dependent individual is without their usual source of opioid
for a period of time.
Severity
Is variable and depends on:
The amount of opioid usually taken.
Route of administration - usually made more severe in intravenous
users.
Psychological factors, e.g. coping strategies/anxiety.
Time of onset
Depends on the opioid used.
Short-acting opioids: 6 - 8 hours after last use e.g. Heroin, morphine,
dihydrocodeine.
Long-acting opioids: 16-24 hours after last use e.g. Methadone.
Symptoms
Subjective
Craving for opioids
Anxiety symptoms
Pains and cramps in muscles, particularly stomach, back and legs
Medicines Policy, version 3
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Unable to sleep
Feeling hot and cold
Objective
Cold, sweating, clammy and goose flesh
Yawning
Nausea, vomiting and diarrhoea
Restlessness and insomnia
Tremor
Lachrymation and rhinorrhea
BP and tachycardia
Note:
These symptoms may occur in other medical conditions or co-exist with
other conditions.
Seizures or fits do not occur in pure opioid withdrawal.
Drowsiness, sedation, disorientation or confusional states do not occur in
pure opioid withdrawal.
Pyrexia is not a symptom of opioid withdrawal.
Opioid withdrawal may be masked or attenuated by other drugs or
substances, e.g. benzodiazepines, barbiturates, alcohol, phenothiazines
8.9
Analgesics
Patients in hospital may require treatment for painful conditions. Their usual
daily dose of methadone may not control additional pain, so they may
require pain relief as in any other patient. Non-steroidal anti-inflammatory
drugs may be used as appropriate. Opioids may be necessary, but should
be dictated by clinical need for analgesia.
Benzodiazepines
Where possible, these should be avoided. If night sedation is required, do
not initiate temazepam. Patients who are prescribed benzodiazepines by
their GP or CDT should continue to receive them.
Cyclizine
Avoid cyclizine because of its abuse potential.
Others
The BNF lists drugs with abuse potential (see under Misuse of Drugs Act).
If in doubt, check with a pharmacist.
8.10
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8.11
SOURCES OF ADVICE
The Community Drugs Team and pharmacy are available for advice
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9.1
Introduction
9.1.1 Many patients who misuse drugs are admitted, treated or visit the Trust,
either as a direct result of drug misuse or for other reasons. In some
cases, the fact that a patient misuses drugs is already known to the
medical and nursing staff. In others, it is not.
9.1.2 There is a risk of illicit substances being used on Trust premises so all
staff are expected to be vigilant and act accordingly should any illicit
substance be located or they are suspicious of substances being brought
into the Trust by visitors or patients.
9.1.3 When a member of staff takes possession of the substance, he or she is
placed in a vulnerable position unless it can be demonstrated that the
substance was taken for the purpose of delivering it into the safe custody
of a person lawfully entitled to possess it or destroy it. It is therefore
important that all actions relating to the taking into safe custody or
destruction of suspected substances are fully and correctly documented
and witnessed and the procedures below followed. The senior nurse in
charge and the senior doctor on duty must be consulted. If the senior
doctor is not a consultant, he/she should discuss it with the duty
consultant. Unless large quantities of drugs are involved, the main aim is
to ensure that the drugs are handled and destroyed in a safe and legal
manner.
9.1.4 Where large quantities of unauthorised drugs or other substances are
found on a patients person, i.e. greater than that considered to be for
personal use the police should always be informed and fully assisted in
their enquiries. An officer will attend the ward / department and initiate
enquiries. The legal position is that the public interest overrides that of
confidentiality.
9.1.5 The discovery of quantities of unauthorised drugs consistent with the
patients own personal use rarely leads to a successful prosecution.
Furthermore, a heavy handed response can compromise patient care and
cause considerable disruption of ward routines and the waste of much
time and effort. The police are aware of this and do not wish to
compromise patient care. Consequently, following discussions with
Greater Manchester Police, it is recommended that the decision to contact
the police or dispose lawfully of the substance should be taken jointly by
the ward manager in conjunction with the consultant with clinical
responsibility for the patient.
Medicines Policy, version 3
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9. Each case will be treated on its own merits and it is therefore not possible
to indicate the precise action the police will take. However, the patient will
never be questioned or removed from the ward or department if it is
considered by the consultant in charge to be inappropriate on clinical
grounds.
10. Following his enquiries, the police officer will remove the suspicious
substance from the ward. Part D should be signed by the police officer and
the nurse witnessing the transfer. One copy should be given to the police
officer, and one copy filed in the patients medical record.
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Introduction
Definition
Admission
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1.
2.
3.
4.
10.4.1 As part of their duties, some staff may on occasion take a patients
medication history; any practitioner should consider why they need to take
this history if purely for recording purposes.
10.4.2 If it is felt that a medication history is needed, then the information should
come from a recognised source, such as:
The latest recent repeat medication slip provided by the GP
practice which should be confirmed with the prescriber, patient or
carer as appropriate
the patients medication containers, (ensuring that the medication is
current by contacting the appropriate community pharmacy),
A recent hospital discharge summary. The dates of the last
admission should be checked wherever possible.
10.4.3 Wherever possible confirmation should be sought from the patient/carer
that the information matches the medication that they are actually taking
and any discrepancies are recorded along with the source of the
information.
10.4.4 If a practitioner is concerned about the effects of a medicine on a patient,
they should refer to the prescriber or to a pharmacist and if necessary
contact the patients doctor themselves.
10.4.5 Some practitioners may be competent to give general information on the
effects of medicines e.g. general side effects of non-steroidal antiinflammatory drugs (NSAIDs). It is inappropriate for staff who are not
prescribers to change any parameter of a Prescription Only Medicine
without first discussing it with the GP, doctor, or other independent
prescriber, unless working within the remit of a Patient Group Direction or
Supplementary Prescribing framework.
Medicines Policy, version 3
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10.4.6 Prescribed treatments that are not licensed medicines, e.g. nutritional
supplements, should not be amended unless the practitioner is working
within their own professional competence and accountable for their
actions. Professionals should contact the dietician for guidance if there are
concerns regarding nutritional products prescribed. Any advice given, in
relation to the medication, must be recorded in the patients notes and any
concerns referred back to the prescriber.
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11 Medicines on discharge
11.1
Introduction
11.1.1
11.1.2
11.1.3
11.2
11.2.1
11.2.2
11.2.3
11.2.4
11.2.5
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11.2.7
11.2.8
Immediately prior to discharge the TTO list must be printed off and
the nurse must check all the medicines against the TTO list adhering to
the principles set out on the Assembly of Discharge Medicines
competency.
11.2.9
Medicines not listed on the TTO list should not be supplied to the
patient on discharge, they must be removed, labels crossed through and
returned to Pharmacy. Medicines brought to hospital by the patient
however constitute patients property and can only be removed with
patients consent. If such consent is declined, medicines need to be clearly
marked as stopped by crossing through the label and writing STOPPED
on it. This should also be documented in patients notes.
11.2.10
The nurse discharging patient must check that the patient
understands how to take their medications at home, including changes
and discontinued medicines and record it on the discharge checklist (at
the end of the Patient Assessment & Care Document (R276).
11.2.11
The patient must be given a printed copy of their Electronic
Discharge Summary.
11.2.12
On discharge the nurse must leave the empty locker open ready for
cleaning prior to the next patient allocated to the bed.
11.2.13
Staff are encouraged to complete the Assembly of Discharge
Medicines competency.
11.3
Community Services
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11.3.1.3
The FP10 should be dispensed by a Community Pharmacy prior to
the patient being discharged from the unit, the out of hours taxi service
may be used if necessary. If this is not possible, the patient or their carer
should be supplied with the FP10 and advised to obtain a supply of the
prescribed medicine(s) from a community pharmacy at the earliest
opportunity.
11.3.1.4
It is the responsibility of the Medical Prescriber on the unit to
complete the discharge letter detailing any medication changes. This
information should be faxed to the patients GP within 24/48 hours of
discharge.
11.3.2 Darley Court
11.3.2.1
The Pharmacy team should be informed of any planned discharges
to enable them to work with the Prescribers to obtain a supply of
medication necessary for discharge.
11.3.2.2
The Pharmacy team, when available, will assemble the discharge
medication, ensuring the patient has a minimum of seven days supply,
reconciling the medication against the current medication chart.
11.3.2.3
A Discharge Medication Letter will be generated; detailing all
current medication and any items discontinued or amended during the
patients stay and where appropriate a Medication Administration Record
Sheet (MARS) for carers use.
11.3.2.4
The Pharmacy team ensures the discharge medication letter is
faxed to the patients GP within 24/48 hours of the patients discharge.
11.3.2.5
When Pharmacy staff, are unavailable, it is the nurses
responsibility to ensure medication is assembled against the current
medication chart and discharged with the patient.
11.3.2.6
If the medication is unavailable an FP10 prescription should be
requested from the Medical Prescriber and obtained from the community
Pharmacy using the out of hours taxi service if necessary.
11.3.2.7
It is the responsibility of the nursing staff to inform the Pharmacy
team of any discharges they have not been involved in to enable them to
forward a Discharge Medication Letter to the patients GP.
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13.1.1
13.1.2
13.1.3
13.1.4
13.1.5
13.2
13.2.1
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13.2.2
13.2.3
13.2.4
13.3
Other requirements
13.3.1 Medicines will be kept in the medicines locker with the exceptions of
specified medicines such as GTN spray or asthma reliever inhalers which
may be kept with the patient and self administered as required, however
these medicines must not be left unattended.
13.3.2 At each medicine round the nurse must check with the patient if the
medicine has been taken and must document the date, time taken and
confirm self-administration with the relevant code on the Wardex. The
code to be used is S. Any change in the patients condition that affect the
level of self medicating ability needs to be picked up and acted on
immediately and the self-medicating status reassessed.
13.3.3 Please seek advice from a senior pharmacist within the Pharmacy
Department if an individual patient is assessed as able to and benefitting
from self-administration.
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14 Unlicensed medicines
14.1
Definitions
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14.3
Prescribers responsibility
Pharmacists responsibility
To obtain unlicensed medicines only on the written authority of a
consultant.
To ensure a disclaimer has been completed for an unlicensed medicine
before dispensing the prescription.
To explain to healthcare staff the practical implications of using unlicensed
medicines or medicines for unlicensed uses.
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Nurses responsibility
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15 Storage of Medicines
15.1
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cupboard.
Stock checks should be carried out on controlled drugs held on wards and
departments by the ward manager or designated deputy at agreed regular
intervals and this check recorded in the designated log book.
Discrepancies should be reported immediately to the appropriate
Divisional Nurse. and to Pharmacy in working hours
Medicines refrigerator
For the storage of medicines marked Store in Refrigerator store between
2-8 C e.g. TPN, CIVAS, stock insulins etc. The fridge should be defrosted
regularly ensuring build up of frost does not occur, kept locked and reported
for repair if the temperature dial indicates a fault. The temperature dial should
be checked each time the fridge is accessed and at least daily if not in regular
use. No food or drink for staff, visitors or patients should be stored in the
medicines fridge. The fridge monitoring sheet should be completed daily
(Appendix 14).
Disinfectant cupboard
For preparations which are not used for patients. eg for Haztabs
Reagents cupboard
Contains urine testing and blood testing strips.
Sterile fluids for infusion and irrigation
Fluids are normally stored in a designated area on wards / departments; it is
usually impractical to store them in cupboards. Stock should be rotated to
ensure use within expiry dates.
Epidural infusion fluids should be stored in a separate area to IV fluids, those
containing controlled drugs can be stored in the standard Controlled Drug
Cupboard providing IV infusions are not stored in the same cupboard.
Patients own drugs / bedside lockers and patient transfer
When a new patient is admitted, a check that the locker is empty must be
performed. When a bed is empty, the locker must be empty and kept
unlocked with the door open to ensure no medicines remain unchecked.
All patients own drugs or drugs dispensed for discharge for that patient
must be supplied only against the discharge prescription as per protocol to
that patient. All the patients drugs in the locker- either own or dispensed
whilst in- must be transferred with the patient to any new bed based
service.
Part of the discharge or transfer procedure must include checking that the
patients drugs have been removed from the locker and are with the
patient. When a new patient is admitted, a check that the locker is empty
must be performed. When a bed is empty, the locker must be empty and
kept unlocked with the door open to ensure no medicines remain
unchecked.
For all patients transferred during an in-patient stay, the receiving nurse
must amend the prescription chart with the new ward and consultant and
confirm with the transferring nurse that all drugs have been transferred
Medicines Policy, version 3
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15.2.2.10
Vaccines should be stored in a cool box with an ice pack prefrozen, (which is not touching the vaccines), for 5 hours when not
refrigerated and ideally individual vaccines should not be returned to the
fridge on more than one occasion. Any that are returned should be marked
as such with the date and used first on the next occasion that the vaccine
is required.
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BACKGROUND
The NHS Plan for Pharmacy England and Wales advocates the more costeffective use of medicines, the re-use of patients own drugs (PODs) is one way
of reducing unnecessary duplication of supply and waste. Patients are
encouraged to bring their medicines into hospital / community services so that
they may be administered to them during their stay. Named patient drugs are
medicines supplied and labelled by a Hospital / Community Pharmacy.
16.2
16.2.1.3 Exceptions to the rule will be dispensed for named patients use at
the discretion of the pharmacist/pharmacy technician where there is a
reasonable likelihood that the patient will be discharged on the medication.
Otherwise, stock should be used during the patients stay. Items will be
dispensed on discharge if necessary.
Medicines Policy, version 3
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Community Services
The out of hours (OOH) service should be accessed. OOH GPs will provide an
FP10 prescription which can be obtained from a Community Pharmacy.
16.2.4.3
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The nurse transferring the patient must ensure the locker is empty and all
appropriate medicines are with the patient before the transfer can be completed.
If the bed is empty, the locker must be open.
16.2.5.2
Community Services
These should be removed from the patients locker by the nursing staff or
Pharmacy staff as soon as they are crossed off the prescription. The change
must be brought to the attention of the ward pharmacy team.
16.2.6.2
Community Services
Discontinued items should NOT be transferred with the patient. The patients
verbal permission should be obtained before removing the discontinued items
which should be disposed of in the green PHS waste bin.
16.2.7 RE-LABELLING OF MEDICINES
16.2.7.1
16.2.7.1.1
PODs and named patient medicines should only be re-labelled by
Pharmacy staff.
16.2.7.1.2
Medicines must be in packaging with a clearly visible expiry date.
Other medicines may be re-labelled at the discretion of a pharmacist.
Following a dose adjustment to an existing medication, a POD or named
patient medicine can continue to be used for the patient, but following the
new prescribed dose instructions. The nursing staff must alert the
pharmacy staff to the change on the next working day.
16.2.7.1.3
Pharmacy staff will then re-label the medicine with the new dose
instructions at the earliest convenience. Re-labelling may be delayed if it is
likely that the dose will be changed again before discharge. It is essential
that this be done before the medicine is issued on a discharge
prescription.
16.2.7.2
Community Services
Medicines should not be relabelled. For any changes in doses a new supply
should be requested via the medical prescriber and obtained via a community
pharmacy
Medicines Policy, version 3
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Pharmacy will resupply medicines to patients when their own supply, or those
issued by Pharmacy, has diminished to less than 7 days worth. New supplies
should be locked in the patients locker for use when the original supply runs out
completely. Do not start the new pack until the previous pack is finished.
16.2.8.2
Community Services
16.3.1 PODs can only be administered to the patient they belong to. These drugs
remain the property of the patient and permission must be sought from the
patient to dispose of any discontinued or out of date medicines prior to
discharge. They must not be administered to any other patient.
16.3.2 PODs must be assessed for suitability to re-use. See Appendix 15 for the
procedure.
16.3.3 During normal pharmacy working hours, this process will be carried out by
pharmacy staff.
16.3.4 Outside pharmacy hours, the ward nurse or admitting doctor may assess
and authorise the use of PODs until pharmacy authorisation can be given
on the next working day.
16.3.5 All suitable PODs must be stored in the individual patients locker, which
must be kept locked.
16.3.6 Any PODs found to be unsuitable for re-use should be ordered from the
Pharmacy Department when they are next open. Should the pharmacy be
closed and the medications are required urgently, they may be obtained
from the emergency cupboard, or other wards, in the usual way for shortterm use. The pharmacy will re-label or supply a patient labelled pack
(described previously), on the next working day.
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17.2
Medicines should be prescribed only when they are necessary, and in all
cases the benefits of administering the medicine should be considered to
the risk involved. (BNF 63, 2012 www.bnf.org.uk).
17.3
Medicines shall be obtained only from bona fide suppliers. These will be:
Pharmacy Department at the Royal Bolton Hospital
Farillon (usual national supplier of vaccines)
Directly from the manufacturer
National Pharmaceutical Wholesalers
Community Pharmacies
17.4
17.5
The list and the quantity of stock to be held in each clinic shall be decided
by consultation between the Pharmacy Team, staff working in the clinics
and appropriate senior medical, nursing or other professional staff.
17.6
17.7
17.8
The designated person must be from the appropriate staff group listed in
the paragraph 17.9. The responsible lead/manager must be notified of any
discrepancies between stock records and levels.
17.9
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Registered Podiatrist
Registered Physiotherapist
Registered Pharmacist
Registered Orthoptist
Registered Pharmacy Technician
Other designated FT staff
17.10 Specimen signatures of the above must be provided to the supplier (if
necessary) to confirm authorisation for supply and should be updated on
an annual basis or when a designated manager wishes to amend the
register.
17.11 Medicines to be ordered from a supplier will be ordered on an official order
form or on-line. A copy of an order form will be retained to check against
the goods received. N.B. Telephone orders will not be accepted.
17.12 Order forms/prescription pads must be kept in a secure area at all times
i.e. in a locked cupboard/drawer within a locked room.
17.13 When available, sugar-free medicines
patients/clients, especially children.
should
be
requested
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for
18 Carriage of Medicines
18.1
COMMUNITY SERVICES
18.1.1 Bolton NHS FT Community Services staff may carry Prescription Only
Medicines that have been prescribed for named patients. The drugs must
be transported out of sight in a locked car from the dispensing pharmacy
direct to the patient. Alternatively, the dispensing pharmacy may be
prepared to deliver directly to the patient.
18.1.2 Registered nurses should carry adrenaline 1 in 1000, ideally in the form of
a pre-assembled syringe and needle in approved anaphylaxis packs.
Suitably trained professionals should have access to adrenaline 1 in 1000
in clinics where local anesthetics are administered. Staff will then be able
to respond to anaphylactic reactions in patients and administer the drug
according to the Patient Group Direction. Staff should ensure that they are
up to date with training requirements for the treatment of anaphylaxis.
18.2
18.2.1 Bolton NHS FT Hospital Services staff, wearing a valid trust ID badge,
may transfer medicines from the Pharmacy Department to clinical areas.
18.2.2 If the drugs are not transported by Pharmacy staff then they must be
transported in a sealed container from the pharmacy direct to the end
user.
18.2.3 When transferring a patient, their drugs should be transported in a green
transfer bag.
18.2.4 A Standard Operating Procedure exists in Pharmacy Department for the
transfer of medicines to and from Bolton Hospice.
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COMMUNITY SERVICES
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19.2
Please refer to Bolton NHS FT Healthcare Waste Management Policy and the
DH document Safe Management of Healthcare Waste
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20.2
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References:
Greater Manchester Strategic Health Authority (2005) Medicine
Matters Assistant Practioner Guidance GMSHA.
Nursing and Midwifery Council (2004) Standards for Medicine
Administration NMC (Section 5 Delegation)
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Annual review
Year .
These standards apply to all Bolton NHS Foundation Trust employed staff
working in community services
It should be available for inspection as necessary.
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4. Administration of medicines.
Individual staff must ensure that:
They are trained and competent to administer medication and comply with all
professional standards, local policy and national guidance
A record of administration is made in the appropriate Medication Record
Chart. If medicines cannot be administered for any reason the MAR is
annotated accordingly.
A named person is responsible for ensuring that
A regular audit takes place of a sample of the Medication Record Chart to
ensure they are completed correctly.
An action plan is completed and forwarded to the line manager where
appropriate.
Person responsible for regular MAR sheet
audit is:5. Disposal of medicines. Out of date medication should be appropriately packaged
and returned to a licensed waste carrier for destruction. The Pharmacy Department
at RBH should be contacted for advice relating to excess stock. Details of stock
returned should be recorded and stock lists amended as necessary
6. Controlled Drugs. All areas that handle Controlled Drugs (CDs) should have
Standard Operating Procedure (SOP). The SOP should cover all aspects of
controlled drug risk management and audit trails for the ordering, storing,
prescribing, dispensing, recording, supply, administration, and destruction of CDs
appropriate to the setting and the team.
THE CHECKLIST ON PAGE 5 MUST BE COMPLETED (EVERY.......)
Staff member responsible for ensuring an
SOP is available and controlled drugs are
handled as detailed in the SOP
The nominated staff holding keys to the CD
cupboard are:-
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Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Comments/actions
Yes/No
Yes/No
Job title
Signature
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Yes/No
The current Standard Operating
Procedure (SOP) is available.
The CD cupboard is kept in a
lockable area not normally
accessible to patients
The room containing the CD
cupboard is kept tidy
The CDs are stored in a locked
secure container that is not
portable
If a safe is used to store CDs there
is a separate receptacle within the
safe to keep the CDs
actions
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Yes/No
Comments/
required
Yes/No
Actions required:-
Job title
Signature
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Protocol checked by
(Signature)
..
Job Title
Date
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ADMINISTRATION / SUPPLY*
*delete as appropriate
OF
..
name of the drug(s)
IN THE
.
name of the ward/department
Document Type: Patient Group Direction
Scope:
Author:
Groups Consulted:
Validated By: Divisional Governance / Quality
Board
Date of Authorisation:
leave blank
Review Date:
leave blank
Key Words:
Patient Group
Direction
INDEX
Purpose and Scope of document
Page 1
Guidelines/Procedure/Methods
Page 2 onwards
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Clinical Condition
Indication
Inclusion Criteria
Exclusion Criteria
Cautions / Further Advice
Action if Patient Declines or is
Excluded
Drug Details
Name, Form
Medicine
&
Strength
of
Route/Method of Administration
Dosage
Frequency
Duration
of
Treatment
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Staff Characteristics
EXAMPLE:
Named Registered General Nurse
Qualifications
Specialist
Competencies
Qualifications
or
EXAMPLE:
Has undertaken appropriate training to carry out clinical
assessment of the patient leading to a decision that
requires treatment according to the indications listed in
this PGD
Has undertaken appropriate training for working under
PGDs for the supply and administration of medicines
Has undertaken training appropriate to this PGD
Continuing
Education
Training
&
EXAMPLE:
The practitioner should be aware of any change to the
recommendations for the medicine listed. It is the responsibility of
the individual to keep up to date with continued professional
development.
EXAMPLE:
A record of administration supply must be maintained
according to local procedure. Records must contain:name of the medicine
dose/number of doses given
time of administration/supply
batch number and expiry date if applicable
a record of medicines administered/supplied under this
Patient Group Direction must be kept in the subjects
health record
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This patient group direction must be agreed to and signed by all health care professionals involved in its use.
The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical
setting.
Organisation
Authorisation Part 1
Lead Doctor
Name:
Signature:
Name:
Signature:
Chief Pharmacist
Date:
Date:
Name:
Signature:
Date:
Confirmed by:
Date:
Authorisation Part 2
Ratified by the Divisional Governance
/ Quality Board
Division:
Divisional Governance / Quality Board Meeting Date:
Ratified by the Drugs & Therapeutics
Committee
Name:
Signature:
Date:
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Authorisation
PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR
ACCOUNTABILITY.
It is the responsibility of each professional to practice only within the bounds of
their own competence and in accordance with their own Code of Professional
Conduct.
Note to Authorising Managers: authorised staff should be provided with an individual
copy of the clinical content of the PGD and a photocopy of the document showing their
authorisation.
I have read and understood the Patient Group Direction and agree to supply/administer this
medicine only in accordance with this PGD.
Name of Professional
Signature
Authorising Manager
Date
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1.
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Assisting Administration
Include
Oral medication
Nebulisers
No restrictions
0.9% Sodium Chloride, Combivent,
Salbutamol 2.5mg/5mg
Ipratroprium 250micrograms/500micrograms
Pulmicort/Budesonide 250micrograms/500micrograms
Respules only
No Restrictions
Glycerine and Bisacodyl Suppositories
Diclofenac and Paracetamol Suppositories
Phosphate/microlax only
Skin Preparations i.e. Iodine, Emla, Ametop, Instillagel,
Emollients and topical steroids
No restrictions
Hydroxycobalamin
Inhalers
Suppositories
Enemas
Topical skin preparations
Eye, ear, nose preparations
Vitamin B12 (IM) Injection
In hospital/bed based area the registered nurse retains responsibility for checking both
the medicine and the patient, before the AP administers the medicine; the AP is
accountable for the safe administration of the medicine and to report back to the
registered nurse that the medication has been administered. The registered nurse can
then sign the prescription sheet. In community nursing the AP will be delegated the task
of administering the medication on a "patient specific basis". The AP will then be
responsible for checking the medication and identity of the patient, in addition to the
safe administration of any prescribed medication. This will include completion
of the necessary Medication Administration Record (MAR) documentation.
Intravenous Fluids
On completion of the Trusts IV Therapy training and Cannulation training and the
associated clinical skills competencies the AP can establish and maintain an intravenous
infusion, that has been prescribed, of the following;
Normal Saline Flush when performing Cannulation
Sodium Chloride 0.9%
Dextrose Saline 5%
Dextrose/Saline 0.45% / 0.9%
Hartmans solution
The AP can use infusion pumps after the appropriate competency and medical device
training have been completed, as part of the clinical skills competencies, or Trust
training.
Second Checking
Page 91 of 119
There are a number of restrictions and the AP cannot carry out any of the
following tasks;
Hold the drug keys or complete drug rounds
Administer medicines by injection, including sub-cutaneous (apart from IM Cytamen
in community)
Sign for any medication alone, in the case of IV infusions these should be
countersigned by a registered nurse - APs in Community/District Nursing may sign
the MAR sheet alone, unless the visit requires a Registered Nurse to attend then the
registered nurse should sign the MAR sheet.
Act as second checker for intravenous antibiotics, or insulin
Act as a second checker where a dose calculation needs to be performed
Administer a saline flush or commence fluids via a central venous line
There are some exceptions to the above as additional assurances have been put into
place so that the specific requirements of discrete areas have been matched. Without
having these competencies, the role of the AP would be severely restricted. This range
of exceptions includes;
In Endoscopy and on completion of a specific competency workbook:
The AP can draw up medications to pass to clinicians for intra-operative
administration.
The AP can administer specific drugs via the scope under direct supervision of
the clinician, as they are unable to do so due to holding the instruments.
2
GUIDANCE FOR STUDENT NURSES IN THE ADMINISTRATION OF
MEDICINES
Student nurses can participate in the administration of medicines following theoretical
preparation from Higher Educational Institute (HEI). They must be under the direct
supervision of a registered practitioner who must ensure that the student has received
instruction in the administration of medicines; knowledge of the Medicines Policy,
Positive Patient Identification Policy and Medical Devices Policy, and is competent to
undertake the task.
Once a 2nd/ 3rd year student has completed the observed practice checklist for second
checking they can carry out second checks, in all areas except high risk areas which are:
Neonatal Unit, Intensive Care Unit, High Dependency Unit and Coronary Care Unit. The
registered practitioner should ask for verification of the observed practice checklist. At all
times the registered practitioner is accountable.
Page 92 of 119
There are a number of restrictions and the Student Nurse cannot carry out any of
the following tasks;
Hold the drug keys or complete drug rounds
Sign for any medication alone, in the case of IV infusions these should be countersigned
by a registered nurse
Act as second checker for intravenous antibiotics, or insulin
Act as a second checker where a dose calculation needs to be performed
Administer a saline flush or commence fluids via a central venous line
Page 93 of 119
References:
Greater Manchester Strategic Health Authority (2005) Medicine Matters
Assistant Practioner Guidance GMSHA.
Nursing and Midwifery Council (2004) Standards for Medicine Administration NMC
(Section 5 Delegation)
Page 94 of 119
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IV morphine injections
Patient-controlled analgesia (PCA)
Epidural analgesia
Page 98 of 119
Page 99 of 119
CD
Morphine
Dexamphetamine
Diamorphine
Pethidine
Methadone
Methylphenidate
Oxycodone
Fentanyl
Pentazocine inj
Alfentanil inj
Remifentanil inj
Codeine inj.
Cocaine
CD
Buprenorphine
Temazepam
Pentazocine tablets
Midazolam
Phenobarbital
Physeptone
Ritalin, Concerta XL,
Medikinet
OxyNorm
OxyContin
Various brands and
formulations available
Fortral
Store in a CD cupboard
Record in the CD register.
CD
Diazepam
Zopiclone
Zolpidem
The drugs will be denatured using supplied kits and by the following procedure.
4. For patients of the District Nursing Service the used denaturing kit will be
exchanged for an unused kit. These Kits are stored at Blackrod and
Waters Meeting Health Centres. Used denaturing kits MUST be hand
delivered and exchanged on the next working day. If this is not possible
then the used kit will be kept in a locked cupboard until exchange is
possible. Other services are required to make suitable systems for
collection and distribution of denaturing kits.
5. Monthly collections will be made from Waters Meeting and Blackrod health
centres for used denaturing kits. The used kits will be kept in a container
supplied by the waste collection company in a locked storage room.
6. When a CD is destroyed, details of the destruction must be recorded in the
CD register.
This should include:
the name of the drug
form
strength
quantity
date it was destroyed
the signature of the person who witnessed the destruction
the signature of the professional destroying the CD
Community Nurses are not responsible for the disposal or destruction of CDs in
Care Homes.
Please note:
The instructions with the kit indicate that the ampoules should be crushed
prior to disposing of them. However, it may be appropriate to dispose of
them into a sharps receptacle (as indicated above) as this is a safer and
more practicable action.
Yes
2
No
3
No
Yes
Level 2
Re-assess regularly
Yes
Yes
Level 2
Re-assess regularly.
Yes
Does the patient have a history of, or
show signs of, drug abuse, alcoholism or
suicidal tendencies?
No
Level 2
Assess individually
Yes
No
6
Level 2
Re-assess regularly
No
Yes
Level 2
Exclude from Self Medication
Supply support regarding
medicines.
No
Level 2
Assess individually, refer to
Patient Experience Team if
additional support is required
Yes
7
No
Yes
8
No
Level 2
Assess individually, Pharmacy
staff can advise on dexterity
aids
Level 1
Initiate education and reassess as
required
Yes
9
Yes
No
Level 1
Patient may be competent at home
but needs supervision on ward
21.1.1 Patient
Label
Ward
Admission Date
Initial Assessment
Level
Review of
Assessment Level
Review of
Assessment Level
Review of
Assessment Level
Review of
Assessment Level
Assessed by
Date
Assessed by
Date
Assessed by
Date
Assessed by
Date
Assessed by
Date
Level 0b
Level 1
Patient needs supervision with their medicines. The locker key is in possession of the nurse.
As a minimum the nurse and patient must together check the medicine dose to be taken. The
nurse will if appropriate educate the patient on how the medicines are to be administered and
why they are prescribed.
Level 2
Level 3
Date of birth.
I agree to be responsible for my medicines, as detailed below, whilst in hospital.
Medicines for self administration include:
..
A nurse or pharmacist has explained what my medicines are for and any other important
information.
I will:
Ensure my medicines are either on my person or locked up securely in the locker
provided. I will not leave them unattended on my locker or bedside table
Tell the nurse looking after me when I have taken my medicines
Ask the nurses or pharmacy staff if I am unsure about anything
Only takes medicines that are prescribed for me
Tell the nurse or pharmacy staff if I am running out of a medicine.
I understand that I can change my mind at any time and ask the nurses to resume
administering my medicines to me.
Signature of patient
To be completed by the assessor:
Signature of assessor.
Name of assessor
Date of assessment
If you need this leaflet in other languages or larger print then please ask a
member of staff.
Drug name:__________________________________________________
Strength:____________________________________________________
I wish to use
Form:_______________________________________________________
in clinical practice because there is no suitable licensed alternative available.
I
understand that this medicine does not have a UK product license and that I take full
responsibility for its use.
B:
Date received:
I wish to use
B:
Patients name:
__________________________________________________
Hospital number:
___________________________________________________
Date of birth:
___________________________________________________
Reason:
___________________________________________________
OR
Selected patients with a diagnosis of ______________________________________
_______________________________________________________________________
Date____________________
Date____________________
Date____________________
Date____________________
Date received:
Time
Min
Temp
Current
Temp
Max
Temp
Reset
Signature
Action taken
1st
2nd
3rd
4th
5th
6th
7th
8th
9th
10th
11th
12th
13th
14th
15th
16th
17th
18th
19th
20th
21st
22nd
23rd
24th
25th
26th
27th
28th
29th
30th
31st
Fridge temperatures must be monitored daily, with the minimum and maximum function
of the thermometer reset daily. Fridges must be between 2 and 8 C, if they are not the
following must be done at the earliest opportunity:
Contact estates to come and look at the fridge (Ext 5995)
Contact pharmacy medicines information (ext 5478) or the on-call pharmacist via
switchboard to check if medications can still be used. Move drugs to an alternative
monitored fridge until the problem has been resolved. i.e a neighbouring ward.
No
Do not use
2.
Dispensed within the last six months if not marked with a manufacturers expiry date?
If the product is a liquid, inhaler, injection, cream, suppository or pessary, is it in a manufacturers original pack with a
clearly visible expiry date?
Yes
4.
7.
No
Do not use
If there are loose tablets or capsules in a bottle, are they easily identifiable by colour or markings?
Yes
6.
Do not use
5.
No
No
Do not use
If the product is an eye drop or ointment, has it been dispensed within the last month?
(These must be re-supplied within one week)
Yes
No
Do not use
Yes
Yes
Do not use
No
Are you satisfied that the cold storage
requirements have been met?
8. Are there any dosette type boxes (compliance aids) and dispensed within 28days?
No
Yes
No
Do not use
No
Refer to Pharmacist /
Prescriber
If you are satisfied with the general condition, packaging and labelling, the
product is safe to use
Medicines Policy, version 3
Patients GP:
I (patient) give permission for the
following medicines (unwanted/expired/discontinued) to be removed from my home
(address as above) for safe disposal and destruction at the pharmacy.
Name of medicine
Return codes
A
B
Out
of Excess
date
amount
Strength
Form
Quantity (state if
bottled/boxed/loose)
Return
code
Comments
C
D
E
Dr stopped / no longer Unwanted Other, state reason
needed
comments
in
If any controlled drugs are being removed, clearly document name, form and quantity. Any
receipts obtained from the community pharmacy should be attached to the duplicate copy in
the book.
Signature of patient or
representative:
Print name:
Signature of health
professional:
Print name:
Date:
Date:
Designation:
Print name: .
...
Designation:
...
Date: .
Process for
monitoring
e.g. audit
Responsibl
e individual/
group/
committee
Frequency of
monitoring
Responsible
individual/
group/
committee for
review of results
Responsible
individual/grou
p/ committee
for
development of
action plan
Responsible
individual/gro
up/
committee for
monitoring of
action plan
a) Monitoring
of prescribing
and
administration
of medicines
Daily
(weekday)
monitoring by
pharmacy
team
Chief
Pharmacist
Daily
(weekdays)
Chief Pharmacist
Chief
Pharmacist
Clinical
Governance
and Quality
Committee.
b) techniques
to be used in
the
prescribing
and
administration
of medicines
Accident/
incident
reports
Professional
Leads /
Chief
Pharmacist
Monthly
Professional
Leads / Chief
Pharmacist
Professional
Leads / Chief
Pharmacist
Clinical
Governance
and Quality
Committee.
c) Security /
storage of
medicines
Audit of
storage areas
on wards
Chief
Pharmacist
Quarterly
Chief Pharmacist
Professional
Leads / Chief
Pharmacist
Clinical
Governance
and Quality
Committee.
d) Security /
storage of
Controlled
Drugs
Audit of
storage and
documentation
on wards
Chief
Pharmacist /
Accountable
Officer
Quarterly
Chief Pharmacist /
Accountable
Officer
Professional
Leads / Chief
Pharmacist
Clinical
Governance
and Quality
Committee.
e) Monitoring
of prescribing/
administration
standards
Audit of 30
drug charts
Medicines
Safety Nurse
6 monthly
Chief Pharmacist
Clinical
Governance and
Quality
Committee.
Clinical
Governance
and Quality
Committee.
N/A
yes
no
Positive*
A. Age
B. Disability
C. Gender
D. Race
E. Religion/Belief
F. Language
G. Sexual Orientation
H. Gypsy/Roma/Traveller
I. Carers
J. Employees
9. Consultation/Involvement during the development of this activity? (see Guidance)
Groups Consulted:
Medicines Policy task and finish group. Paediatric department.
10. Details of positive and negative impacts
Positive Impacts:
Nil
Negative*
Negative Impacts
Persons under 18 years will not be permitted to self-administer medication. It was agreed that this
was necessary under medicines safety as all paediatric drugs administered within the trust require a
second check due to their complex nature and high risk of error.
11. Give details of actions required to remedy any negative impact(s) identified above.
Medicines Policy, version 3
Who
Target Date
Sexual
Orientation
Gypsy/roma
Traveller
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Employees
Race
N
N
N
Carers
Employees
Language
Carers
Religion/Belief
Gender
Gypsy/roma
Traveller
Sexual
Orientation
Language
Religion/
Belief
Race
Gender
Disability
Positive impact
Disability
Age
Negative Impact
Age
N
N
N
N
N
N
N
N
Decision
Work through the flowchart on page 24 of the Guidance, to determine whether you need to complete
a Full EIA or not.
Details of any objective justifications or amendments agreed with Divisional E&D Lead:
Full EIA required?
Yes
Completed by: SSchneider
No