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					                                                                      North Somerset

  Patient Group Direction (PGD) for the administration of Diclofenac Sodium
   Suppositories and Injection BY Registered Nurses and Emergency Care
                 Practitioners working in Minor Injury Units

                                Valid from: 11th August 2011
                                 Expiry date: August 2013

                              PGD Reference Number: 038/11

          An electronic copy of this PGD can be accessed from the NHS North Somerset website

                         Name and Job Title                   Signature                   Date
                    Jan Huckle
                    Hospital Manager
 manager/ lead
                    Clevedon Hospital
                    Margaret Clacher
                    Lead Nurse
 clinical lead
                    Clevedon Minor Injuries Unit

This patient group direction has been approved on behalf of NHS North Somerset by:

                         Name and Job Title                   Signature                   Date
                    Dr Mary Backhouse
 Doctor             Professional Executive
                    Committee Chair
                    Debbie Campbell
 Pharmacist         Head of Medicines
 PCT                Becky Pollard
 representative     Director of Public Health
  Patient Group Direction (PGD) for the supply of Diclofenac Sodium
  This Patient Group Direction (PGD) is a specific written instruction for the supply of diclofenac
  sodium suppositories and injection to groups of patients within the area covered by NHS
  North Somerset.
  This PGD will enable designated Minor Injuries nurses and Emergency Care Practitioners
  at Clevedon Hospital to supply treatment in accordance with the following protocol and the
  recommendations of the Department of Health and NHS North Somerset’s Medicines Policy.
  The majority of clinical care should be provided on an individual patient basis. The supply of
  medicines under Patient Group Directions should be reserved for those limited situations where
  this offers an advantage for patient care (without compromising patient safety) and where it is
  consistent with appropriate professional relationships and accountability.

                                     Background information

Patients attend MIU at Clevedon Hospital requiring prompt and appropriate treatment for their
medical condition. Independent non medical prescribers are not always immediately available
and this PGD is intended to provide timely access to appropriate medicines for use by trained
nurses and emergency care practitioners in this setting

1. Clinical condition or situation to which the direction applies
Indication                     For the relief of severe pain
Criteria for confirmation      Prior to using this PGD nurses should view guidance at
of the clinical condition for renal colic
(if applicable)
                               Adults with severe pain due to acute trauma, suspected fracture or
Criteria for inclusion
                               renal colic
                               • Under 18 years
                               • No valid consent
                               • Fever or signs of systemic infection
                               • Hypersensitivity to the active substance, sodium metabisulphite
                                  or any of the excipients.
                               • Active, gastric or intestinal ulcer, bleeding or perforation
                               • History of gastrointestinal bleeding, ulceration or perforation
                               • Patients in whom attacks of asthma, angioedema, urticaria or
                                  acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid
                                  or other non-steroidal anti-inflammatory drugs.
Criteria for exclusion         • History of cardiovascular disease including MI, angina,
                                  cerebrovascular disease, ischaemic heart disease and
                                  peripheral vascular disease
                               • NSAID taken in previous 8 hours
                               • Renal transplant patients
                               • Patients with one kidney
                               • Pregnancy and breastfeeding
                               • Known hepatic, renal and cardiac failure
                               • Current use of interacting drugs – oral anticoagulants,
                                  corticosteroids, ACE inhibitors, phenytoin, digoxin, lithium,
                                  methotrexate, quinolone antibiotics
                              •   Elderly – increased risk of side effects, including bleeding
                              •   Concomitant use of other NSAIDs, including COX II inhibitors –
                                  potential for additive adverse events
Cautions / Need for
                              •   Concurrent treatment with ACE inhibitor or angiotensin II
further advice
                                  receptor antagonist or diuretic – increased risk of acute renal
                              •   Hypovolaemia and dehydration
                              •   Document clearly in patients records
Action if patient declines    •   Advise patient of possible consequences of refusing treatment
treatment                         and of alternative sources of treatment
                              •   Refer to GP or A&E Department

2. Description of treatment
Name of Drug                  Diclofenac Sodium
                              Solution for injection
                              75mg/3ml injection – one
Quantity to supply            50mg suppository – one
                              100mg suppository - one
                              Injection: One ampoule once intramuscularly by deep intragluteal
                              injection into the upper outer quadrant.
Method/route                  Suppositories: The suppositories should be inserted well into the
                              rectum. It is recommended to insert the suppositories after passing
                              Injection: 75mg by deep intramuscular injection
Dose or dose range and
                              Suppositories: 50-100mg rectally
frequency of
                              Once only in the department
Legal status                  POM – Prescription only medicine.
                              • Advise on treatment and course of action
                              • Provide patient information leaflet
                              • Advise a normal fluid intake to maintain colourless urine
                              • Advise or administer and anti-emetic if required
                              • Advise of further supplies of analgesics and anti-emetics
                              • Explain that the stone may pass spontaneously and advise, if
                                possible, to sieve the urine through a tea strainer, a nylon
Advice to be given to the
                                stocking or filter paper (such as a coffee filter) to capture the
patient before treatment
                                stone. This can be done directly as the urine is passed.
is provided
                                Alternatively, the urine can be collected into a container before
                              • If a stone is captured, send it to the laboratory for analysis
                              • Advise the person to seek urgent medical assistance
                                    o If they develop a fever or rigors
                                    o If the pain worsens
                                    o If they have abrupt recurrence of severe pain
                            • Gastro intestinal disturbances including: discomfort, nausea,
                              diarrhoea. Occasionally bleeding and ulceration occur
                          • Gastrointestinal damage
                          • Hypersensitivity reactions (particularly rashes, angioedema,
                          • Headache, dizziness, nervousness, depression, drowsiness,
Identification and
                              insomnia, vertigo, hearing disturbances, photosensitivity
management of adverse
                          • Fluid retention
                          • Blood disorders
                          • Renal failure
                          • Injection site reactions
                          Rarely – hepatic damage, alveolitis, pulmonary oesinophilia,
                          pancreatitis, visual disturbances, Stevens_johnson syndrome, toxic
                          epidermal necrolysis
                          Any adverse reaction to the medicine supplied / administered
                          under this PGD should be documented in the practices / clinic
                          patient’s treatment record. The managing doctor and GP should
Reporting procedure for   also be informed
adverse reactions         Any serious adverse events that may be attributable to the
                          medicine supplied / administered under this PGD should be
                          reported to the CSM/MHRA using the “Yellow Card” system
                          • Access to a telephone.
                          • Supplies of diclofenac injection
                          • Equipment for injection
                          • Urinalysis reagent testing strips
Supplies and resources
                          • Thermometer
that must be available at
                          • Must have access to a current copy of the ‘British National
sites where this PGD is
                              Formulary’ and access to the summary of product
in use
                          • Facilities for the emergency treatment of anaphylactic reactions
                              must be available and easily accessible.
                          • Relevant NHS North Somerset procedures and guidelines
                          • Undesirable effects may be minimised by using the lowest
                              effective dose for the shortest duration necessary to control
Special                       symptoms
considerations/additional • Use with caution in the elderly refer to BNF
                          • Risk of acute renal failure especially if patient is dehydrated or
                          A computer or manual record of all individuals receiving treatment
                          under this Patient Group Direction should be kept for audit
                          purposes within each practice. Records may be written, computer
                          records, or both according to practice protocol.
Records to be kept for    Information entered into a patient clinical record should include
legal and audit purposes      • Patient’s name/address/date of birth
                              • Indications for use
                              • Results of urinalysis
                              • Temperature
                              • Informed consent obtained and documented
                                 •    Advice given to patient/carer to (include side effects).
                                 •    Brand, batch number and expiry date of medicine
                                 •    Name of medicine / dose/ quantity supplied
                                 •    Signed and dated. (Where computer records are used
                                      nurses must have individual identifier to enable audit trail)
                                  • Document any adverse reactions
                              All significant events/incidents/near misses occurring in relation to
                              the supply / administration of a medicine under this PGD must be
                              reported to the PCT on the relevant PCT incident form in a timely

3. Characteristics of staff
It is the professional responsibility of the Health Care professional to work within their level of
competence. The healthcare professional will ensure he/she has the relevant training and is
competent to work under this PGD.
                              Registered Nurse with current NMC registration
Qualification                 Registered Emergency Care Practitioners with current HPC
requirements                  registration
Additional requirements • Has undertaken appropriate training to carry out clinical
                                   assessment of patient leading to diagnosis that requires
                                   treatment according to the indications listed in the PGD
                              • Has undertaken appropriate training for working under PGDs
                                   for the supply and administration of medicines.
                              • 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
                              Current edition of British National Formulary (BNF)
Reference to                  Current edition of British National Formulary for Children (BNFC)
national/local policies or
guidelines                    Department of Health Medicines Act 1968.
                              NHS Executive (2000) Patient Group Directions [England only].
                              Health Service Circular HSC 2000/026. (Available at
                              Nursing & Midwifery Council (2008) Standards of Conduct,
                              Performance and Ethics for Nurses and Midwives. (Available at
                              Royal Pharmaceutical Society of Great Britain (2005) The Safe &
                              Secure Handling of Medicines: A Team Approach. London,
                              RPSGB. (A revision of the Duthie Report 1988) (Available at
                     accessed on 25.6.2011
                              Clinical Knowledge Summaries – acute renal colic -

 Paper written and prepared by:             Margaret Clacher
                                            Lead Nurse Minor Injuries Unit
 Paper checked by:                          Danielle Gorman
                                            Rapid Response and Rehab Pharmacist

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