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1 DICLOFENAC v01 1/8 DICLOFENAC PGD Details Version 1.0 Legal category Staff grades Approved by POM Paramedic (Non-ECP) Nurse (Non-ECP) Emergency Care Practitioner (Paramedic) Emergency Care Practitioner (Nurse) Medicines Management Group Date issued 01/02/2013 Review date 31/01/2015 Clinical Publication Category Mandatory (Red) - No deviation from document permissible Clinical Requirements Competencies Continuing education Successful completion of a competency assessment in the use of this medicine for the indications stated; Completion of education in both the legal and professional aspects of PGD administration and the supply of medicines; Registered paramedics must have successfully completed a recognised Emergency Care Practitioner course; Registered nurses must be employed as Nurse Practitioners or have successfully completed a recognised Emergency Care Practitioner course. The clinician is responsible for keeping him/herself aware of any changes to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their own individual scope of practice.

2 DICLOFENAC v01 2/8 Clinical Situation Clinical situation Inclusion criteria Exclusion criteria Management of renal colic; Management of acute back pain; Adjuvant treatment for pain in palliative care (suppositories only). Adults 18 years and over with renal colic (IM); Adults aged 18 years and over with acute disabling back pain that requires immediate management to mobilise the patient (IM); Palliative patients requiring adjuvant treatment for pain (suppositories only). Patients with a hypersensitivity to diclofenac or any other NSAID (including those in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by aspirin or any other NSAID); Asthmatic patients who have never taken an NSAID (check OTC use of ibuprofen); Pregnancy; Breast-feeding; Patients with coagulation defects; Known severe heart failure; Previous or active peptic ulceration; Children under 18 years of age; Moderate or severe renal impairment; Known severe liver disease; Hypovolaemia or dehydration; Porphyria; Patients already taking: NSAIDs (check OTC use); Lithium; Corticosteroids; Anti-coagulants (warfarin, dabigatran, rivaroxaban, etc); Clopidogrel; Ciclosporin; Methotrexate; Tacrolimus; SSRIs; Quinolone antibiotics.

3 DICLOFENAC v01 3/8 Cautions CSM Warning (asthma): Any degree of worsening of asthma may be related to the ingestion of NSAIDS, either prescribed or (in the case of ibuprofen and others) purchased over the counter; CSM Advice (Aspirin 75mg): The combination of a NSAID and low-dose aspirin may increase the risk of GI side-effects. This combination should only be used if absolutely necessary and the patient monitored closely; CSM advice (gastro-intestinal side-effects): All NSAIDS are associated with gastrointestinal toxicity; the risk is higher in the elderly. Evidence on the relative safety of 7 non-selective NSAIDS indicates differences in the risks of serious upper GI side-effects. Ibuprofen is associated with the lowest risk, diclofenac with intermediate risk; The use of an injection may reduce the incidence of dyspepsia but a major GI event may still be precipitated using these routes of administration due to the systemic effects of the diclofenac; Patients with hypertension should be treated with caution as diclofenac may antagonise the effect of anti-hypertensive drugs by causing fluid retention and therefore increasing blood pressure; Diclofenac may increase the plasma concentration of cardiac glycosides, e.g. digoxin; Aseptic meningitis has rarely been reported with NSAIDs. Patients with connective tissue disorders such as systemic lupus erythematosus may be especially susceptible; Diclofenac may provoke renal failure in someone who is dehydrated especially if the person has diabetes; All patients greater than 65 years of age are at risk of an adverse event even in the absence of cardiovascular or renal risk factors; Excessive alcohol consumption, smoking and H. pylori infection are additional GI risk factors; Consider co-morbidity: Cardiovascular disease, renal disease (including dehydration), diabetes, hypertension and hepatic disease as they increase the risk of an adverse event.

4 DICLOFENAC v01 4/8 Side effects Action if excluded Action if patient declines Hypersensitivity reactions including skin rashes (common), angioedema and bronchospasm; Gastro-intestinal discomfort, nausea, diarrhoea and occasionally bleeding and ulceration. (NB: Systemic as well as local effects contribute to GI damage); Intramuscular injection only: local pain and induration. Rarely, abscesses and local necrosis; CNS toxicity including headache, dizziness, nervousness, depression, drowsiness, insomnia and vertigo; Hearing disturbances including tinnitus; Photosensitivity; Haematuria; Suppositories may cause rectal irritation; Renal failure may be provoked especially in patients with renal impairment; Hepatic damage, alveolitis, eye changes, and pancreatitis If patient meets exclusion criteria, refer to medical practitioner; Record on patient clinical record the reason for exclusion and any action taken. If patient declines treatment or advice, ensure the patient clinical record details: The advice given by the clinician; Details of any referral made; The intended actions of the patient (including parent or guardian).

5 DICLOFENAC v01 5/8 Description of Treatment Generic name Presentation Route Diclofenac. Injection 75mg in 3ml or suppositories 50mg. Intramuscular injection or rectal administration. Administration Supply (Suppositories only) Method Dose Frequency Duration of treatment Quantity to supply One ampoule (75mg) by deep intragluteal injection into the upper outer quadrant. A further ampoule may be administered after 30 minutes if necessary but it is advised that the alternative buttock is used for the second injection. N.B It is important to adhere to these instructions for the intramuscular administration of diclofenac in order to avoid damage to a nerve or other tissue at the injection site. Intramuscularly: 75mg (one ampoule) A further ampoule may be administered after 30 minutes if necessary; Rectal: 50 to 150mg (one to three suppositories). Intramuscularly: single dose. A further ampoule may be administered after 30 minutes if necessary; Rectal: daily in divided doses. One or two ampoules (injection); 3 to 4 days (rectal treatment). Suppositories only: 1 x 10; Ensure that each pack of medicine supplied is labelled with the patient s name, the date and the Trust s contact details.

6 DICLOFENAC v01 6/8 Follow Up Referral arrangements and safety netting Advice to patients Records References Ensure that there is a communication to the patient s registered GP to inform him/her about the consultation, the outcomes of that consultation and any treatment given using local mechanisms. This information must also be available to other healthcare professionals who may be required to administer care to the patient following the consultation; Patients should be told to seek further medical advice if they become generally unwell, if there is no improvement within 48 hours or if there is a deterioration in their condition. Patients who experience dizziness or other CNS disturbances after the injection should refrain from driving or operating machinery; Using alternative routes of administration can only partially eliminate symptoms such as dyspepsia; Contact a doctor if you experience any unusual indigestion or heartburn. Complete the Patient Clinical Record; British National Formulary 64, September Clinical Knowledge Summaries nhs.uk.

7 DICLOFENAC v01 7/8 Authorisation Chief Executive Officer Medical Director Pharmaceutical Advisor Name Ken Wenman Signature Date 01/02/2013 Name Dr Andy Smith Signature Date 01/02/2013 Name Sue Oakley Signature Date 01/02/2013 This must be signed by the Chief Executive Officer, Medical Director and Pharmaceutical Advisor to be legally valid.

8 DICLOFENAC v01 8/8 Individual Authorisation (Staff Copy) Individual Name Signature Date / / Authorising officer Name Signature Date / / I have read and understood the Patient Group Direction and agree to administer/supply this medicine only in accordance with this document. 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. This signed page must be retained by the member of staff, together with the full PGD, which must be available in clinical practice.

9 DICLOFENAC v01 Individual Authorisation (Trust Copy) Individual Name Signature Date / / Authorising officer Name Signature Date / / I have read and understood the Patient Group Direction and agree to administer/supply this medicine only in accordance with this document. 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. This signed page must be retained by the member of staff, together with the full PGD, which must be available in clinical practice.

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