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1 DIAZEPAM v01 1/9 DIAZEPAM PGD Details Version 1.0 Legal category Staff grades Approved by CD Benz 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 DIAZEPAM v01 2/9 Clinical Situation Clinical situation Inclusion criteria Exclusion criteria The treatment of severe muscle spasm causing lower back pain or torticollis; Acute restlessness in patients receiving end of life care. Adults aged 18 years and over. Children under 18 years of age; Known sensitivity to benzodiazepines; Respiratory depression; Presence of neurological features of cauda equina syndrome; Rapid neurological deficit and sudden urinary / faecal incontinence; Pregnancy; Breast feeding; Personality disorder; Psychological deficit; Concomitant use of alcohol, anti-depressants, anxiolytics, hypnotics, phenytoin or other CNS depressants (unless the patient is being treated for restlessness at end of life when the clinician should treat with caution); Acute pulmonary insufficiency; Sleep apnoea syndrome; Unstable myasthenia gravis; Porphyria; Severe hepatic impairment; History of drug or alcohol abuse; Patients receiving end of life care who have alternative provision for the management of restlessness provided in a Just in Case box.
3 DIAZEPAM v01 3/9 Cautions Side effects Elderly or debilitated patients may require a reduced dose; Respiratory disease, muscle weakness and myasthenia gravis; Patients may attempt to obtain this drug by deception. If you have any doubts about the authenticity of the presenting symptoms refer the patient to a medical practitioner and document your concerns in the patient record; If a patient is supplied with diazepam for muscle spasm associated with back pain or torticollis, avoid supplying opioid drugs concomitantly for analgesia; Respiratory disease, muscle weakness and myasthenia gravis; The level of consciousness that must be maintained when managing restlessness is further defined as V or greater on the AVPU scale; the patient may feel sleepy and or close their eyes when not disturbed, but will respond appropriately to verbal stimulus. Drowsiness and light-headedness the next day; Confusion and ataxia (especially in the elderly); Respiratory depression (especially in the presence of alcohol or opioids); Acute pulmonary insufficiency; Dependence; Paradoxical increase in aggression; Muscle weakness; Visual disturbance, vertigo & tremor; Changes in libido; Incontinence/urinary retention; Skin reactions & jaundice; Blood disorders; Salivation changes; Hypotension (may be significant if moved from the horizontal position); Drowsiness, light-headedness, confusion and ataxia; Occasionally amnesia may occur.
4 DIAZEPAM v01 4/9 Action if excluded Action if patient declines 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 carer, parent or guardian). Description of Treatment Generic name Presentation Route Method Diazepam. Tablets 2mg; Rectal tubes 2.5mg and 5mg; Emulsion for injection 5mg in 1ml. Oral, rectal and intravenous injection. Restlessness Oral, rectal or intravenous Administration Supply Muscle spasm Oral route only Administration Supply
5 DIAZEPAM v01 5/9 Restlessness: Administration only: 2 to 4mg orally; 2.5 to 5mg rectally; 2 to 5mg intravenously. Dose The following procedure must be followed for intravenous doses: Establish IV access; Administer slow IV injection: Patients aged 18 years and over, and under 80 years old - 2.5mg (0.5ml); Patients aged 80 years and over - 1mg (0.2ml); Administer 10ml of saline flush IV; Wait 5 minutes; Assess effect on respiratory rate, GCS, and restlessness; Repeat dose once if required; Record medicines and patient response on patient clinical record. Patients aged 80 years and over are often particularly sensitive to the effects of central depressant drugs and may experience confusion, especially if organic brain changes are present; the dosage of diazepam is therefore one-half of that recommended for younger adults. Muscle spasm, adults aged 18 years and over: One or two tablets (2mg or 4mg). Frequency Duration of treatment Quantity to supply Restlessness: Single dose; Muscle spasm: three times a day. Restlessness: Single dose; Muscle spasm: Up to three days. 1 to 3 x 6 tablets; Ensure that each pack of medicine supplied is labelled with the patient s name, the date and the Trust s contact details.
6 DIAZEPAM v01 6/9 Follow Up Referral arrangements and safety netting Torticollis: refer patients presenting with persistent torticollis, ocular imbalance or cervical dystonia to a medical practitioner; Refer patients with lower back pain and red flag symptoms suggesting more serious pathology to a medical practitioner; Refer a restless patient at the end of life to specialist services for ongoing management; 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. Request follow-up where necessary; 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 deterioration in their condition; Advise the patient that Diazepam may cause drowsiness which can persist until the following day. They should not drive or operate machinery if affected. The sedative effect is increased if they take alcohol, opioid analgesics, antihistamines, antipsychotics, some antivirals, certain ulcer healing drugs (esomeprazole and omeprazole) and other muscle relaxants such as baclofen or tizanidine; Diazepam interacts with most antihypertensive drugs to increase their hypotensive effect which may make the patient feel light-headed or dizzy; Diazepam has a high potential for tolerance and dependence and should only be taken in short courses lasting 3-7 days.
7 DIAZEPAM v01 7/9 Advice to patients Records References Diazepam is a muscle relaxant and anxiolytic; Explain illness and negotiate treatment plan; Ensure patient receives a manufacturer s patient information leaflet and discuss where necessary; Advise not to drive or operate machinery during treatment and for a full day after stopping the tablets; Advise patient to seek further medical attention if their condition worsens or if new symptoms develop; Alert patient to risk of dependency if taken for a prolonged period. Complete patient clinical record; Diazepam is a lower schedule controlled drug. Staff must carry out a stock check when supplying or administering this drug. Any discrepancy in the stock level that is discovered must be reported to your line manager and an investigation instigated as detailed in the Trust s Medicines Management Policy. British National Formulary 64, September 2012; National Prescribing Centre NPCi Clinical Knowledge Summaries nhs.uk; Weldmar Hospice Trust (2012) The Palliative Care Handbook. Advice on Clinical Management.
8 DIAZEPAM v01 8/9 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.
9 DIAZEPAM v01 9/9 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 supply or administer 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.
10
11 DIAZEPAM 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 supply or administer 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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