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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