Download 20170203_PGD_Lidocaine_v1.3 - Specialist Pharmacy Service

LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD)
FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE
INJECTION BP 1% w/v BY NURSES/MIDWIVES IN SEXUAL
& REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL
Version Number 1.3
Version/Date
Version 1.1
Aug 2013
Change details
Version 1.1
Aug 2013
Updated SPC/BNF/NICE references
Minor changes to text highlighted in blue
Cautions – added – emergency drugs and equipment,
including adrenaline.
NMC Standards for medicines management (2008) added
Maximum dose not to exceed 2mL for insertion and/or
removal
Page 10 – Organisational approval statement amended to
reflect new PGD legislation e.g. local authorities.
Version 1.2
Nov 2015
New template
Black triangle deleted from Nexplanon®
Version 1.3
February 2017
Amendments to text highlighted in blue
Updated Summary of Product Characteristics (SPC)
references
To include registered midwives and altered nurse
prescribers to independent non-medical prescribers
Minor editorial changes
Each organisation using this PGD must ensure that it is formally authorised by a pharmacist,
a medical lead and a governance lead on behalf of the authorising organisation to ensure
that this document meets legal requirements for a PGD.
This Patient Group Direction (PGD) must only be used by registered nurses/midwives who
have been named and authorised by their organisation to practise under it. The most recent
and in date final signed version of the PGD must be used.
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 03/02/2020
Reference Number :
Page 1 of 10
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED
NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL.
TABLE OF CONTENTS
CONTENTS
PAGE NUMBER
PGD for the supply and administration of
subcutaneous Lidocaine Hydrochloride injection BP
1% w/v
1-10
Staff Characteristics
8
Authorisation and Signatures
To be added by approving
organisation
Individual Authorisation to supply and administer
subcutaneous Lidocaine Hydrochloride injection BP
1% w/v to facilitate subdermal implant
insertion/removal
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
To be added by approving
organisation
Expiry date: 03/02/2020
Reference Number :
Page 2 of 10
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED
NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL.
DRUG NAME /STRENGTH/FORM :
Lidocaine Hydrochloride BP 1% w/v subcutaneous injection
CLINICAL CONDITION
TO WHICH THIS
DIRECTION APPLIES
INCLUSION CRITERIA
EXCLUSION CRITERIA

Local anaesthetic for insertion and/or removal of subdermal
contraceptive implant
(See PGD template for the supply and insertion of
Etonogestrel (Nexplanon®) subdermal implant by
nurses/midwives in Sexual & Reproductive Health Services)
 Any individual requiring the insertion and/or removal of
subdermal contraceptive implant
 Individual requiring insertion and /or removal of subdermal
contraceptive implant should also meet the inclusion criteria of
the subdermal contraceptive implant PGD
Personal Characteristics & Reproductive History
 Known hypersensitivity to Lidocaine Hydrochloride or
anaesthetics of the amide type
 Individual who had received a previous maximum infiltration of
local anaesthetic within 4 hours
 Individuals under 16 years of age and assessed as not
competent using Fraser guidelines
 Individuals 16 years and over and not competent to consent
 Existing implant cannot be palpated (for removals only)
Cardiovascular Disease
 Complete heart block
 Hypovolaemia
CAUTIONS
(INCLUDING ANY
ACTION TO BE TAKEN)
ACTION IF EXCLUDED
ACTION IF PATIENT
DECLINES
TREATMENT
Other conditions
 Porphyria
 Inflammation or infection in the tissues to be injected
 Individual wishes to see a doctor
 If under 13 years of age follow local safeguarding policy
 Interacting medicines–see current BNF
 Discuss with appropriate doctor/independent non-medical
prescriber any medical condition or medication of which the
nurse/midwife is unsure/uncertain
 Ensure emergency drugs and equipment, including adrenaline
are available for the treatment of anaphylaxis and
emergencies according to local policy
 Refer to appropriate doctor / independent non-medical
prescriber
 Document all actions taken
 Record the refusal in the clinical record
 Refer to appropriate doctor/independent non-medical
prescriber where required.
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 03/02/2020
Reference Number :
Page 3 of 10
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED
NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL.
DRUG DETAILS
NAME, FORM &
STRENGTH OF
MEDICINE
Lidocaine (Lignocaine) 1% w/v (10 mg in 1 mL)
in 2mL, 5 mL or 10 mL ampoules
Subcutaneous
ROUTE/METHOD
Prescription Only Medicine
LEGAL CATEGORY
N/A
USE OUTSIDE THE
TERMS OF THE
MARKETING
AUTHORISATION
Maximum dose not to exceed 2mL for insertion and/or removal
QUANTITY
Single episode of treatment
DOSAGE/FREQUENCY
Single episode of treatment
DURATION OF
TREATMENT
Single episode of treatment
MAXIMUM OR MINIMUM
TREATMENT PERIOD
SIDE EFFECTS
Any drug may produce
unwanted or unexpected
adverse reactions.
Detection and recording of
these is of vital
importance. Patients
should be actively
encouraged to report any
suspected adverse
reaction, particularly to
black triangle medicines.
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Refer to current Summary of Product Characteristics (SPC) of
relevant product and current British National Formulary (BNF)
for full list and further information.
This list may not represent all reported side effects of this
medicine.
Serious symptoms
When used for surface anaesthesia rapid and extensive
absorption may result in systemic side effects.
CNS effects include:
 Confusion
 Respiratory depression
 Convulsions
 Hypotension
 Bradycardia
 Hypersensitivity
Expiry date: 03/02/2020
Reference Number :
Page 4 of 10
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED
NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL.
See next page
SIDE EFFECTS
Any drug may produce
unwanted or unexpected
adverse reactions.
Detection and recording of
these is of vital
importance. Patients
should be actively
encouraged to report any
suspected adverse
reaction, particularly to
black triangle medicines.
Continued from previous page
In the event of untoward or unexpected adverse reactions:
 If necessary seek appropriate emergency advice and
assistance
 Document in the individual’s clinical record and inform
appropriate doctor/independent non-medical prescriber
 Complete incident procedure if adverse reaction is
severe (refer to local organisational policy)

Use yellow card system to report serious adverse drug
reactions directly to the Medicines and Healthcare
products Regulatory Agency (MHRA). Yellow cards are
available in the back of the BNF or obtained via
Freephone 0808 100 3352 or online at
www.yellowcard.mhra.gov.uk.
The public can report adverse effects directly to the MHRA via
the yellow card scheme and should be encouraged to do so.
ADVICE TO INDIVIDUAL



FOLLOW UP
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:

Provide Manufacturer’s Patient Information Leaflet (PIL) and
discuss
Explain mode of action, side effects, and benefits of the
medicine
Ensure individual has the contact details of the service
Individual to return to clinic if she has any concerns
Expiry date: 03/02/2020
Reference Number :
Page 5 of 10
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED
NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL.
RECORDS
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
The authorised registered nurse/midwife must ensure the
following is documented in the clinical record:
 Individual’s name, address and date of birth
 GP contact details where appropriate
 Attendance date
 Reason for attendance
 Relevant past and present medical and family history,
including drug history
 Any known allergy
 Relevant examination findings (where appropriate)
 Inclusion or exclusion from PGD
 A statement that supply and administration is by using a
PGD
 Advice given about the medication including side effects,
benefits, and when and what to do if any concerns
 Details of any adverse drug reactions and what action taken
 Any referral arrangements
 Any administration outside the terms of the marketing
authorisation
 The consent of the individual
 If individual is under 13 years of age, record action taken
 If individual is under 16 years of age document competency
using Fraser guidelines
 If individual is 16 years of age and over and not competent,
record action taken
 Record the name/brand, dose of the medication and quantity
supplied and administered
 Record batch number and expiry date according to local
policy or national guidelines
 Record follow up and/or signposting arrangements
 Any other relevant information provided to the individual
 Name and signature (which may be an electronic signature)
of the nurse/midwife supplying and administering the
medicine
Expiry date: 03/02/2020
Reference Number :
Page 6 of 10
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED
NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL.
REFERENCES
All references and links correct at time of publication.
(February 2017)

Manufacturer’s Summary of Product Characteristics
Lidocaine hydrochloride injection BP 1%
Hemeln Pharmaceuticals. Date of revision of the text20/05/2015 accessed 11/01/2017
https://www.medicines.org.uk/emc/medicine/20887
Concordia International (formerly AMCo) Date of revision of the
text 06.12.2013 Date accessed 18/01/2017
https://www.medicines.org.uk/emc/medicine/25036

Joint Formulary Committee. British National Formulary (online)
London: BMJ Group and Pharmaceutical Press
http://www.medicinescomplete.com [Accessed on 11/01/2017]

National Institute for Health and Care Excellence (2013) Patient
Group Directions. Medicines Practice Guidelines 2
http://www.nice.org.uk/guidance/MPG2

Faculty for Sexual and Reproductive Healthcare (2016)
Standards for Resuscitation in Sexual Health Services
https://www.fsrh.org/documents/service-standards-forresuscitation-in-sexual-and-reproductive/

Faculty for Sexual and Reproductive Healthcare (2014)
Progestogen only Implants CEU
.http://www.fsrh.org/pdfs/CEUGuidanceProgestogenOnlyImplants
.pdf
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 03/02/2020
Reference Number :
Page 7 of 10
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED
NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL.
STAFF CHARACTERISTICS
The named
nurse/midwife
authorised to supply
and/or administer
medications under the
PGD must meet the
following criteria:
THE NURSE/MIDWIFE MUST BE AUTHORISED BY NAME, UNDER
THE CURRENT VERSION OF THIS PGD BEFORE WORKING
ACCORDING TO IT
Qualifications
The nurse/midwife must be registered with the Nursing and
Midwifery Council (NMC)
Education/training, qualifications and competencies
The nurse/midwife must satisfy the following criteria:
 Qualification in contraception/sexual health (university
modules/FSRH): Note: an introduction to contraception/
sexual health is not sufficient. Has had training in the use of
PGDs
 Has had training which enables the nurse/midwife to make a
clinical assessment in order to supply and administer the
medication according to this PGD

Has undertaken the competency training appropriate to this
PGD

Is competent in the assessment of individuals using Fraser
guidelines

Has undergone regular training and updating in
safeguarding children and vulnerable adults

Has undergone regular updating in basic life support and
anaphylaxis
Maintenance of competencies

The nurse/midwife must ensure she/he is aware of any
changes to the recommendations for these medicines

It is the responsibility of the nurse/midwife to keep up to
date with continuing professional development and take part
in audit of clinical records on a regular basis
An up to date list and signatures of registered practitioners who are authorised to practise
under this PGD is kept in
by
Practitioners not listed are not authorised to practise under this PGD.
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 03/02/2020
Reference Number :
Page 8 of 10
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED
NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL.
PGD DEVELOPMENT GROUP
Date PGD template comes into effect:
Review date
Expiry date:
03/02/2017
03/08/2019 or earlier in the light of
significant changes in best practice
03/02/2020
This template was peer reviewed and ratified by London Contraception and Sexual Health
PGD Working Group:
NAME/ROLE
POSITION
DATE
Independent Nurse Advisor
SRHC Project Lead
03/02/2017
Principal Pharmacist
Medicines Information
Projects.
Guy’s and St Thomas’ NHS
Foundation Trust.
03/02/2017
Lead Doctor
Sarah Pillai
Lead Associate Specialist,
Contraception and Sexual
Health Service, Central
London Community
Healthcare NHS Trust
03/02/2017
Lead Pharmacist
Sandra Wolper
Associate Director for
Specialist Pharmacy Service
Hounslow and Richmond
NHS Trust
03/02/2017
Lead Nurse
Lead Nurse
Integrated Sexual Health
Barts Health NHS Trust
03/02/2017
Kathy French
Chair - Working Group
Angela Bussey
Advisor - Working Group
Sandra Bennett
The PGD template is not legally valid until it has had the relevant organisational
approval.
See next page
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 03/02/2020
Reference Number :
Page 9 of 10
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED
NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE
SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL.
ORGANISATIONAL AUTHORISATIONS AND OTHER LEGAL REQUIREMENTS
This page may be deleted if replaced with a format agreed according to local PGD
policy with relevant approvals and authorisation.
The PGD is not legally valid until it has had the relevant organisational authorisations.
To ensure compliance with the law, organisations must add local authorisation details i.e.
clinical authorisations and the person signing on behalf of the authorising organisation.
You may either complete details below or delete and use a format agreed according to local
PGD policy which complies with PGD legislation and NICE MPG2 PGD 2013.
Name
Job title and
organisation
Signature
Date
Senior doctor
Senior pharmacist
Senior representative of
professional group using
the PGD e.g. Lead
Contraception /Sexual
Health Nurse
Person signing on behalf of
authorising body
e.g. Director of Public
Health on behalf of a local
authority or a clinical
governance lead on behalf
of an NHS Trust.
It is the responsibility of the authorising organisation to ensure that all legal and governance
requirements for authorising the PGD are met.
It is the responsibility of the provider organisation to ensure that all legal and governance
requirements for using the PGD are met.
To meet legal requirements, organisations must add an Individual Practitioner Authorisation
sheet or List of Authorised Practitioners. This varies according to local policy and how the
service is managed but this should be a signature list or an individual agreement.
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. Individual
practitioners must declare that they have read and understood the Patient Group Direction
and agree to supply/administer medicines listed only in accordance with the PGD.
ORGANISATIONS MAY ALSO ADD:
 Local training and competency assessment documentation.
 Other supporting local guidance or information.
 Links to local PGD Policy and other supporting guidance.
Version No: 1.3
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 03/02/2020
Reference Number :
Page 10 of 10