Patient Group Direction for PROCHLORPERAZINE (Version 02) Valid From 1 October September 2019

Transcription

1 Version Control This PGD has been agreed by the following organisations FCMS PDS Medical Doncaster CCG Lancashire CCGs including East Lancashire, Fylde and Wyre and North Lancashire CCGs Change history 31/07/17 V02 Review. No changes needed. 28/08/17 V02 Review. Minor editing changes. 28/08/2017 Page 1 of 7

2 Staff Characteristics Qualifications Specialist competencies or qualifications Continuing training and education CLINICAL CONTENT OF PATIENT GROUP DIRECTION Registered nurse, Paramedic practitioner, ECP (Paramedic) or Nurse practitioner Received training to undertake administration and supply of medicines under PGD. Has undertaken appropriate training to carry out clinical assessment of patient, leading to diagnosis. Also that such diagnosis requires treatment according to the indications listed in this PGD. 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 development and to work within the limitations of individual scope or practice. Clinical Details Indication Severe nausea or vomiting, e.g. in labyrinth disorders or vertigo. Inclusion criteria Patients with the above indications. Exclusion criteria Hypersensitivity to prochlorperazine, phenothiazines or any other constituent of the product. Pregnancy or breast feeding. Patients aged under 12 years. Phaeochromocytoma. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Moderate or severe renal impairment (chronic kidney disease stages 3b, 4 or 5, or egfr <45ml/min). Hepatic impairment or history of jaundice. Patients with Parkinson s disease, myasthenia gravis, uncontrolled hypothyroidism, heart failure, prostatic hypertrophy, narrow angle glaucoma (or history of), agranulocytosis (or history of). Significantly dehydrated patients. Patients already taking antipsychotic medication. Patients taking anti-arrhythmics, antimalarials, arsenic trioxide, atomoxetine, citalopram, desferrioxamine, escitalopram, lithium, methadone, moxifloxacin, cimetidine, pramipexole, pentamidine isetionate, ritonavir, ropinirole, rotigotine, saquinavir, sotalol, tramadol, tricyclic antidepressants, and any other drugs known to prolong the QT interval. PGDs should be used only where appropriate, suitable and legal. PGDs should not be routinely used when an independent prescriber is available. Precautions The elderly: more susceptible to adverse effects, use lower doses. Epilepsy: may decrease seizure threshold. 28/08/2017 Page 2 of 7

3 Management of excluded patients Action for patients not wishing / unable to receive care under this PGD Patients with cardiovascular disease, family history of QT prolongation, or risk factors for ventricular arrhythmias (e.g. cardiac disease, electrolyte imbalance, alcoholism, starvation, concomitant use of other QT-prolonging medications). Severe respiratory disease. Uncontrolled depressive disorders. Patients taking hypotensive drugs (additive effects), sedating drugs (additional sedation), sulphonylureas (antagonised hypoglycaemic effect), antimuscarinic drugs (enhanced antimuscarinic adverse effects), diuretics (increased risk of electrolyte imbalance leading to arrhythmias). Discuss with GP or Clinical Lead or refer. Make patient aware of risks and potential consequences of not taking medicine. Discuss any alternatives if available. Discuss alternative options with GP or Clinical Lead. Document discussion with patient. Description of Treatment Name of medicine Prochlorperazine Formulation and route Oral Tablets and Buccal tablets Strength 5mg tablets 3mg buccal tablets Dosage 5mg tablet up to three times daily or One or two 3mg buccal tablets twice daily Place buccal tablets between the top lip and gum and leave to dissolve Repeated dose See above instructions Duration of treatment Up to 5 days Quantity to supply 5mg tablet pre packed box of 28, buccal tablets pre packed box of 8 Legal status POM Special precautions Explain indications, contraindications and cautions (refer to BNF) Adverse effects Extra pyramidal effects, acute dystonias and dyskinesias, drowsiness, apathy, excitement, insomnia, agitation, convulsions, dizziness, headache, confusion, gastric disturbance, dry mouth, blurred vision. Risk of photosensitisation therefore to avoid direct sunlight. Respiratory depression and ECG changes may occur in susceptible patients. Avoid handling tablets as much as possible to avoid skin sensitisation. It is imperative that treatment be discontinued in the event of unexplained fever, as this may be a sign of neuroleptic malignant syndrome (pallor, hyperthermia, autonomic dysfunction, altered 28/08/2017 Page 3 of 7

4 28/08/2017 Page 4 of 7 consciousness, muscle rigidity). Signs of autonomic dysfunction, such as sweating and arterial instability, may precede the onset of hyperthermia and serve as early warning signs. This is not a complete list. Refer to BNF or SPC (summary of product characteristics) for full information. Advice necessary Provide the patient with the manufacturer s Patient Information Leaflet. Advise on dose and administration with reference to the cautionary label information and give any further instructions to aid compliance. Advise on storage or expiry details and to dispose of any unused medicines appropriately. Give advice on practical self-care if appropriate, including management of likely symptoms (including fever management where appropriate). Make patient aware of potential adverse effects and the action to take if they occur. Provide appropriate worsening advice describing the range of signs and symptoms to monitor for and the action to take if they occur. Consider whether the provision of health promotion material is appropriate e.g. on smoking or lifestyle factors. Provide any advice relevant to the patient from the Precautions section above. Prescribing guidance Doncaster, East Lancashire, Fylde and Wyre and North Lancashire CCG local guidelines. Relevant NICE guidelines and advice from Clinical Knowledge Summaries. Records and Follow Up Referral arrangements Inform GP as soon as possible. Advise if worsening or no improvement to seek further medical advice. Records to be kept Patient s name, address, date of birth and consent given. Contact details of GP (if registered). Diagnosis. Dose and form administered. Batch and expiry details. Advice given to patient (including side effects). Signature / name of staff who administered or supplied the medication. If relevant, signature / name of staff who removed / discontinued the treatment. Details of any adverse drug reaction and actions taken, including documentation in the patient s medical record. Referral arrangements (including self-care). Any serious side effects attributable to drug should be recorded and medicine management advised via yellow card system found in BNF.

5 Follow up Advise follow up with GP/ Practice nurse. Patient Group Direction, organisation and individual authorisation signatures can be found on the managerial content sheet along with other non-clinical details relating to this patient group direction. 28/08/2017 Page 5 of 7

6 Patient Group Direction Owner Details of PGD owner FCMS (NW) Ltd Newfield House Vicarage Lane Blackpool FY4 4EW Patient Group Direction Authorisation Lead Doctor MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION Lead Pharmacist Lead Nurse Dr Jonathan Bundy Magnus Hird Lead Paramedic Alison O Connor Organisational Authorisation for FCMS Organisational Authorisation for East Lancashire CCG Gillian Gregory Patient Group Direction Peer Review Reviewed by Wendy Lambert, Nurse Practitioner 28/08/2017 Page 6 of 7

7 Individual Authorisation BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT. PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT. IT IS YOUR RESPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION. NOTE TO AUTORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THIS PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION. Name of Professional Signature Authorising Manager Date 28/08/2017 Page 7 of 7