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PGD 1
PATIENT GROUP DIRECTION (PGD) FOR THE
ADMINISTRATION OF DICLOFENAC SODIUM 100mg SUPPOSITORY BY
MIDWIVES FOR POST NATAL PAIN RELIEF FOR WOMEN WITH
PERINEAL TRAUMA IN THE MATERNITY UNIT, WISHAW GENERAL
HOSPITAL WHEN MEDICAL STAFF ARE NOT AVAILABLE .
This document authorises the administration of diclofenac sodium 100mg suppository by
midwives to patients who meet the criteria for inclusion under the terms of the document.
THE MIDWIFE SEEKING TO ADMINISTER DICLOFENAC SODIUM 100mg
SUPPOSITORY MUST ENSURE THAT ALL PATIENTS HAVE BEEN SCREENED AND
MEET THE CRITERIA AS SET OUT IN THIS PGD BEFORE ADMINISTRATION TAKES
PLACE.
This document does not exclude the obstetric doctors giving diclofenac sodium 100mg
suppositories under the above circumstances.
The purpose of this patient group direction is to help patients by providing more convenient
access to an efficient and clearly defined service.
3rd draft Feb
2006
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PATIENT GROUP DIRECTION FOR ADMINISTRATION OF DICLOFENAC SODIUM 100mg SUPPOSITORY BY
MIDWIVES FOR POST NATAL PAIN RELIEF FOR WOMEN WITH
PERINEAL TRAUMA IN THE MATERNITY UNIT, WISHAW GENERAL
HOSPITAL WHEN MEDICAL STAFF ARE NOT AVAILABLE .
Part 1. Clinical condition to which the direction applies
(i) Definition of condition to be treated,
by whom and the clinical setting
Administered by midwives to women for
postnatal pain relief where the perineum has
been traumatised during delivery and medical
staff are unavailable .
(ii) Clinical criteria for inclusion Women who require pain relief for postnatal
trauma to the perineum and medical staff not
available.
(iii) Clinical criteria for exclusion • Women who deliver when medical
staff are available.
• Patients with a history of active or
suspected gastro-intestinal ulcers or
bleeding.
• Patients with a known sensitivity to
diclofenac sodium, aspirin or other
non-steroidal anti-inflammatory
drugs.
• Patients with ulcerative or acute
inflammatory conditions of the anus,
rectum and sigmoid colon.
• Porphyria
• Renal, hepatic or cardiac impairment
• Thrombocytopenia
• Asthma
• Prescribed another non-steroidal
(NSAID) e.g. ibuprofen
(iv) Action if patient is excluded from
treatment
Document in notes and refer to medical staff.
(v) Action if patient declines treatment Document in notes and refer to medical staff.
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from nurse
Part 2. Characteristics of staff authorised to take responsibility for the supply or administration of medicines under the Patient Group Direction (PGD)
(i) Qualifications required Registered Midwife
(ii) Additional requirements, specialist
qualifications, training, experience
and competence necessary
Has received training in the use of the PGD
and has been deemed competent.
(iii) Continuing Training requirements Through annual personal development plan
has provided evidence that he/she has kept up
to date with the uses, interactions, reaction
and contra-indications of diclofenac sodium.
(iv) Location of list of staff approved to
use the PGD
NHS Lanarkshire
Associate Director of Nursing
Maternity Unit
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PATIENT GROUP DIRECTION FOR ADMINISTRATION OF DICLOFENAC SODIUM 100mg SUPPOSITORY BY
MIDWIVES FOR POST NATAL PAIN RELIEF FOR WOMEN WITH
PERINEAL TRAUMA IN THE MATERNITY UNIT, WISHAW GENERAL
HOSPITAL WHEN MEDICAL STAFF ARE NOT AVAILABLE .
Part 3. Description of treatment available under the Patient Group Direction (PGD)
(i) Name/form/strength of medicine Diclofenac sodium 100mg suppository
(ii) Route/method of administration
Per rectum
(iii) Dose of medicine to be administered/
supplied
1 x diclofenac sodium 100mg suppository
(iv) Frequency of dose Once only
(v) Total dosage/number of times the
treatment can be administered and
over what time period.
Once only post delivery
(vi) Pre-treatment assessment, monitoring,
and follow up treatment or monitoring
Monitor pain score using Lanarkshire Pain
Score Tool 30 minutes after administration.
If pain not reduced or severity increased
contact medical staff.
Identify whether patient has suffered from
bronchial asthma in the past – if so monitor
for signs of bronchospasm and take
appropriate action if this occurs.
(vii) Warnings, adverse reactions and
contraindications.
Contra indications as per Part 1 iii.
Warnings:
Observe for signs of gastro-intestinal
bleeding/ulceration.
Methotrexate and diclofenac sodium should
not be given within 24 hours of each other.
Convulsions may occur if used concomitantly
with quinolone antimicrobals e.g.
ciprofloxacin
Concomitant administration with aspirin or
conticosteroids may increase the risk of
gastro-intestinal bleeding.
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May inhibit the activity of diuretics.
When use concomitantly with potassium
sparing diuretics may be associated with
increased potassium levels.
Concomitant use with digoxin may
exacerbate cardiac failure, reduce GFR and
increase plasma digoxin levels.
Do not use for 8-12 days after mifepristone.
May inhibit effect of antihypertensive drugs.
Undesirable effects:
Epigastric pain
GI disorders eg Nausea,Vomiting, Diarrhoea
Dyspepsia.
Gastro-intestinal bleeding
Constipation
Headache
Dizziness
Urticaria
(viii) Advice to be given to patient before
the treatment. A copy of all advice
listed here must be given to the
patient
Advise midwife if any side effects
(ix) Referral for medical advice If pain not subsiding or intensity increasing.
If patient exhibits signs of gastro-intestinal
bleeding.
If patient has convulsions.
(x) Facilities and supplies required on site
Locked storage cupboard.
Supply of diclofenac sodium 100mg
suppositories
Emergency resuscitation facilities.
(xi) Details of treatment records required Name of drug, strength, dose, date, reason for
administration and outcome, time of
administration entered by nurse in patient’s
record and signed for and note details on
patient’s prescription sheet.
Any adverse reactions and action taken are
recorded in the patient’s notes and the
appropriate documentation completed i.e.
clinical incident form and yellow card.
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PATIENT GROUP DIRECTION FOR ADMINISTRATION OF DICLOFENAC SODIUM 100mg SUPPOSITORY BY
MIDWIVES FOR POST NATAL PAIN RELIEF FOR WOMEN WITH
PERINEAL TRAUMA IN THE MATERNITY UNIT, WISHAW GENERAL
HOSPITAL WHEN MEDICAL STAFF ARE NOT AVAILABLE .
Part 4. Record of Persons Preparing and Approving the PGD
Professionals preparing
the PGD
Name and Status
Date
Practitioner(s)
Consultant(s)
Senior Pharmacist
Professionals approving
the PGD
Name and Status
Date
Senior Nurse /
Professional Manager
Service Manager
Clinical Director
Consultants
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Once all sections are completed and signed this form must be submitted to the hospitals Drug
Administration Review Group (DARG) , via the Pharmacy Manager. The DARG group will
review the document for accuracy and then have it reviewed for its impact on other clinical
specialities.
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LANARKSHIRE ACUTE HOSPITALS (PGD2)
Patient Group Direction
Authorisation for Use and Indemnification
Title: ADMINISTRATION OF DICLOFENAC SODIUM 100mg SUPPOSITORY
BY MIDWIVES FOR POST NATAL PAIN RELIEF FOR WOMEN WITH
PERINEAL TRAUMA IN THE MATERNITY UNIT, WISHAW GENERAL
HOSPITAL WHEN MEDICAL STAFF ARE NOT AVAILABLE .
PGD Ref.: ________
The Drug Administration Review Group will attach Forms PGD2 and PGD3 to the above
document and initiate the review process. Review
� The above PGD has been reviewed for drug and licensing issues (Pharmacy Manager
to sign)
� The above PGD has been reviewed for completeness by the Drug and Administration
Review Group and was found to be satisfactory (DARG Chairman to sign on behalf
of this group).
� The above PGD has been reviewed for clinical implications for other specialities and
was found to be satisfactory (Chairman of Acute Drug &Therapeutics Committee to
sign on behalf of the Committee).
Chairman of DARG Committee: _____________________ Date:________________
Pharmacy Manager: ________________________________ Date:________________
Chairman Acute D & T:_____________________________ Date:________________
The PGD should be returned to the Directorate for the Authorisation and Indemnification
stage. Authorisation
Forms PGD1 and PGD2 should be submitted by the Directorate to the Hospital
Management Team for authorisation to use the PGD and indemnification of staff
providing the service.
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� The above PGD has been authorised for use within the hospital and the approved
practitioners indemnified for actions taken in accordance with the directions therein
(Medical Director / Associate Medical Director to sign on behalf of the Trust /
Hospital Management).
Medical / Assoc. Director: ____________________________ Date: __________________
The PGD should be returned to the Directorate for the Training and Archiving stage.
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LANARKSHIRE ACUTE HOSPITALS (PGD3)
Patient Group Direction Training and Archiving Record
Title : ADMINISTRATION OF DICLOFENAC SODIUM 100mg
SUPPOSITORY BY MIDWIVES FOR POST NATAL PAIN RELIEF FOR
WOMEN WITH PERINEAL TRAUMA IN THE MATERNITY UNIT, WISHAW
GENERAL HOSPITAL WHEN MEDICAL STAFF ARE NOT AVAILABLE .
PGD Ref.: _________ On authorisation of the above PGD, the original forms must be passed to the Associate
Nurse Director for implementation of the PGD and for identification of the necessary
management and training requirements. Training
Training requirements detailed within the patient group direction will be provided by the
following staff and records of training recorded as detailed.
Responsible Manager : ___________________________________________________
Training Format : ______________________________________________________
Training Record : ______________________________________________________
Training Staff : _________________________________________________________
Archiving
All patient group direction original documents require to be stored in a safe manner for
retrieval and review purposes after 2 years. If discontinued the original must be retained
for a period of thirty years after withdrawal.
Review Date : ________________________________________________________
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Name : __________________________________
Title : Associate Director of Nursing
Signature : __________________________________ Date :________
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LANARKSHIRE ACUTE HOSPITALS ( PGD4)
PGD TITLE ADMINISTRATION OF DICLOFENAC SODIUM 100mg
SUPPOSITORY BY MIDWIVES FOR POST NATAL PAIN
RELIEF FOR WOMEN WITH PERINEAL TRAUMA IN
THE MATERNITY UNIT, WISHAW GENERAL
HOSPITAL WHEN MEDICAL STAFF ARE NOT
AVAILABLE .
DATE FORM PREPARED
PRACTITIONERS
Name
Position
Signature
Date
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This list must be updated 6 monthly
Review Date: ______________________________________
PGD4-form.doc