| PGD DETAILS |
| Penthrox (Methoxyflurane)- for the treatment of moderate to severe pain associated with trauma Valid from 14/01/2025Review date 01/06/2026Expiry date 31/12/2027 |
| Version Control- Record of Amendments | |
| January 2025 | Introduction of new PGD- version 1.0 |
| RATIONALE FOR PATIENT GROUP DIRECTIONS (PGDs) | |
| Eligible Healthcare Professional | Only healthcare professionals specified in the PGD (e.g., registered nurses, paramedics) who have completed the required training and are authorized may administer this medication. Unauthorized administration is prohibited and may result in disciplinary or legal consequences. Always adhere to PGD guidelines to ensure patient safety and compliance. Registered Paramedic [ü] Registered Nurse [ü] |
| Qualifications and Professional Registration | Current registration with the HCPC as a Paramedic. Current registration with the NMC as an Advanced Nurse Practitioner |
| Training and Competency | All registered healthcare professionals are personally accountable for their practice and in the exercise of professional accountability. There is a requirement to demonstrate and maintain competence in the following before undertaking administration under this PGDAn understanding of professional standards for the administration of medicinesFamiliarity with the local policies and procedures relating to medicines. Appropriate training to carry out the clinical assessment of a patient.Basic training in the legal framework and use of PGDs for the supply and administration of medicinesUnderstanding of pharmacology of drugs being administered to patients and relevant medical condition. |
| Continued Training and Competency | The clinician must meet the requirements of the prevailing level of education required for PGD use at this level of practice.All ongoing regular training requirements (e.g. statutory and mandatory training) as required by the company for this role must be completed. The clinician is responsible for keeping themself 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.This PGD should be read in conjunction with JRCALC Guidelines |
| CLINICAL CONDITION | |
| Indication: | For the treatment of moderate to severe pain associated with trauma (under close supervision) |
| Inclusion Criteria: | Adults only – who are to be conveyed to a receiving facility |
| Exclusion Criteria/ Contra-indications: | Cardiovascular diseaseLiver diseaseMild pain or pain from a non traumatic causeReduced levels of consciousness GCS14 or lessPatients with respiratory distress/reduced lung capacityHypothermiaHypersensitivity to Penthrox, any fluorinated anaesthetic or to butylated hydroxytoluene (E321).Patients with a known family history of severe adverse reactions after being administered with inhaled anaestheticsClinically significant renal impairmentPatients who are known to be or be genetically susceptible to malignant hyperthermiaChildren under 18 years of ageAdministration within the previous 24 hours, or more than 15ml in a week. |
| Cautions: | elderly >65yrs due to risk of hypotensionConcomitant use of Penthrox with CNS depressants, such as opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects. If opioids are given concomitantly with Penthrox, the patient should be observed closely, as is normal clinical practice with opioids. Use with caution in elderly or other patients with known risk factors for renal disease, hypotension and tachy/brady arrythmias.Pregnancy and Breastfeeding:Manufacturer advises in both cases to use with caution. Limited information available |
| Drug Interactions | BNF List of Drug Interactionshttps://bnf.nice.org.uk/drugs/methoxyflurane/#interactions |
| Action if patient declines or is excluded: | Offer alternative analgesia. Ensure a full handover is provided and that all findings and actions are recorded on the patient’s clinical record. Transport as clinically indicated to the nearest appropriate ED or refer to a medical practitioner.Capacity of patient to decline treatmentDocument on PRF |
| DRUG DETAILS | |
| Name, form and strength of medication covered under this PGD: | Penthrox (methoxyflurane) in 3ml nebules for vaped inhalation |
| Legal Category | Prescription Only Medicine (POM) |
| Storage Conditions | There are no recommended storage conditions for Penthrox |
| Route/Method: | Penthrox is self-administered under supervision of a person trained in its administration, using the handheld Penthrox Inhaler. Onset of pain relief is rapid and begins after 6 – 10 inhalations. Patients should be instructed to inhale intermittently to achieve adequate analgesia with the minimum amount of agent. |
| Dosage: | A single dose (one 3 mL bottle) will provide analgesia for 25-30 minutes if used continuously. Intermittent inhalation may provide longer analgesic relief. |
| Frequency: | Single use administration as above dose |
| Duration of Treatment: | See above |
| Maximum or Minimum Treatment Period: | Single Dose Only |
| Quantity to Administer | As Dosage above. This medication should be administered and taken in sight of attending Clinician. Staff are not permitted to provide medications to be taken at a later date. |
| Side Effects: | § Anxiety§ Cough§ Dizziness§ Drowsiness§ Headache§ Nausea§ Altered mood§ Altered tasteAlso see BNF:-https://bnf.nice.org.uk/drugs/methoxyflurane/#side-effects |
| Advice to Patient/Carer: | Advise on the effects this may have on the patient.The patient should have the treatment and the course of treatment explained including any adverse effects.,In addition they should be informed that they will be transferred to the nearest and most appropriate Emergency Department for further treatment.The individual/parent/carer should be advised to seek medical advice in the event of an adverse reactionThe patient should be given the Patient Information Leaflet (provided in the pack) and a Penthrox Patient Alert Card which also contains information on potential side effectshttps://www.medicines.org.uk/emc/files/pil.1939.pdf |
| Management of Adverse Reactions | Healthcare professionals and individuals/carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme; 08081003352 or on: http://yellowcard.mhra.gov.uk |
| REFERAL ARRANGEMENTS & DOCUMENTATION | |
| Referral Arrangements: | As per local arrangements/national guidelines |
| Records/Audit Trail: | Patients name, address, date of birth and consent given.Contact details of GP (If registered)DiagnosisDose and form administeredBatch and expiry date detailsAdvice given to patient (including side effects)Signature/name of staff who administered or supplied medication, and also, if relevant, signature/name of staff who removed/discontinued the treatmentDetails of any adverse drug reaction and actions taken including documentation in the patients’ medical record. Usage documented on PRF & drug Administration book |
| References/ Resources and Comments: | Penthrox 99.9%, 3mL inhalation vapour, liquid, UK Summary of Product Characteristics (SPC) Accessed Dec 2024 https://www.medicines.org.uk/emc/product/1939British National Formulary https://bnf.nice.org.uk/drug/methoxyflurane.html#indicationsAndDoses |
| PGD AUTHORISATION | ||
| ORGANISATION | Coast Medic Ambulance Ltd | |
| MEDICAL DIRECTOR | Name: | Dr Rhys Owens |
| Signature: | | |
| Date: | 14.01.2025 | |
| PHARMACIST | Name: | Neil Hayward |
| Signature: | ||
| Date: | 14.01.20205 | |
| CHIEF EXECUTIVE | Name: | Luke Tudor |
| Signature: | | |
| Date: | 14.01.2025 |
| Individual Authorisation | |||
| Name: | Signature: | Authorising Manager: | Date: |