Expiry Date: January 2009 Template Version: Page 1 of 7
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1 YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Clinical Condition Indication: Inclusion criteria: Exclusion criteria: Cautions/Need for further advice/ Circumstances when further advice should be sought from the doctor: Action if patient declines or is excluded: Treatment of mild to moderate pain. Patients assessed as requiring analgesia using Emergency Nurse Practitioner Protocols. Adults and children 6 years or above who are assessed as requiring analgesia using Emergency Nurse Practitioner Protocols. are trained in the assessment of pain. Known hypersensitivity to paracetamol or any other ingredient in the product Known impaired liver or kidney function Patients who have taken paracetamol based analgesic within the previous 4 hours Patients who have taken the maximum recommended daily intake of paracetamol within the previous 24 hours Children under 6 years Any uncertainty regarding exclusion criteria, warnings or administration. Patients presenting with severe pain. Named nurse to document in patient records and refer to medical staff. Page 1 of 7
2 Drug Details Name, form & strength of medicine: Route/Method of administration: Dosage (include maximum dose if appropriate): Frequency: Duration of treatment: Maximum or minimum treatment period: Quantity to supply/administer: 500mg tablets 500mg soluble tablets 250mg/5ml suspension Oral Tablets Adults and children over 12 years: 500mg-1 gram three to four times a day at intervals of not less than four hours. Maximum eight tablets in 24 hours. Out-patient pack (16 tablets) Labelled with standard manufacturers dosage instructions. Suspension Children (6-12 years): 250mg-500mg three to four times a day at intervals of not less than four hours. Maximum four doses in 24 hours. Out-patient pack (100ml) Labelled with standard manufacturers dosage instructions. Doses can be repeated three to four times a day at intervals of not less than four hours. Maximum of four doses in 24 hours. Minimum: Once only administration Maximum: Completion of one out-patient pack. Minimum: Once only administration Maximum: Completion of one out-patient pack. Administration Tablets Adults and children over 12 years: Maximum single dose 1 gram Suspension Children (6-12 years): Maximum single dose 500mg Supply Tablets Adults and children over 12 years: Maximum 16 tablets 500mg out-patient pack per Page 2 of 7
3 patient Black Triangle Drug:* Legal Category: Is the use outwith the SPC:** Storage requirements: Suspension Children (6-12 years): Maximum 100ml suspension 250mg / 5ml outpatient pack per patient No 500mg tablets (16) GSL (For the treatment of adults only) 250mg / 5ml suspension (100ml) P No Locked pharmacy cupboard. Access by authorised nursing staff. * The black triangle symbol ( ) identifies newly licensed medicines that are monitored intensively by the MHRA/CSM **Summary of Product Characteristics Page 3 of 7
4 Warnings including possible adverse reactions and management of these: Patients should be monitored for the following adverse effects and referred to medical staff if an adverse effect occurs; Allergic reactions including skin rashes Please refer to current BNF or SPC for full details. Use the Yellow Card System to report adverse drug reactions directly to the CSM. Yellow Cards and guidance on its use are available at the back of the BNF. Advice to patient/carer including written information provided: Monitoring (if applicable): Follow up: Explain treatment and course of action Give patient a copy of any relevant patient information leaflet if available If condition worsens or symptoms persist then seek further medical advice Patients or carers should be advised not to take with any other paracetamol containing products or to take any paracetamol containing products within a four hours of dose. Patients or carers should be advised to seek immediate medical advice in the event of an overdose. Advise patient or carer to contact General Practitioner or Accident and Emergency Department if symptoms do not resolve or any adverse effects are experienced. Page 4 of 7
5 Staff Characteristics Professional qualifications: Specialist competencies or qualifications: Continuing education & training: Registered professional nurse with a current NMC registration Completion of Emergency Nurse Practitioner training Has undertaken appropriate training to carry out clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in this PGD Has undertaken appropriate training for working under PGDs for the supply and administration of medicines Has undertaken training appropriate to this PGD for local agreement; may be relevant for certain drugs 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. Referral Arrangements and Audit Trail Referral arrangements: Records/audit trail: As per local arrangements/national guidelines. Patient s name, address, date of birth and consent given Contact details of GP (if registered) Diagnosis Dose and form administered (batch details if locally required) Advice given to patient (including side effects) Signature/name of staff who administered or supplied the medication, and also, 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) References/Resources and comments: Notes: SPC Summary of Product Characteristics BNF British National Formulary BNF for Children Page 5 of 7
6 This patient group direction must be agreed to and signed by all health care professionals involved in its use. The original signed copy will be held at PPSU, Queen s Park House, Victoria Infirmary. The PGD must be easily accessible in the clinical setting Organisation: NHS Greater Glasgow & Clyde Antimicrobial use If the PGD relates to an antimicrobial agent, the use must be support by a consultant microbiologist with authority to the area in which the PGD is intended to be used. Cons Microbiologist: (Relevant to area where PGD is to be used) Name: Signature: Date: Page 6 of 7
7 Local Authorisation: Service Area for which PGD is applicable: Description of Audit arrangements: Accident and Emergency Department Frequency of checks: (Generally annually) Annually Names of auditor(s): Nominated individual who agrees to keep staff training and list of practitioners operating under the PGD current and up to date (Lead professional) Name: Signature: Designation: Date: Name of person checking any medicines Act issues on arrangements for keeping and retention of records and medicine stock security and storage (Pharmacist) Name: Signature: Designation: Date: 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. Note to Authorising Managers: authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction. I acknowledge that it is a legal document and agree to supply/administer this medicine only in accordance with this PGD. Name of Professional Signature Date I agree that the professionals listed above are authorised to provide/administer medicines in accordance with this PDG to patients under my care. Lead Clinician for the service area (Doctor) Name: Signature: Date: Page 7 of 7
Expiry Date: January 2009 Template Version: Page 1 of 7
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