PATIENT GROUP DIRECTION (PGD)
Administration of buccal midazolam by registered Paramedics and Nurses for the management of seizures
BrisDoc Healthcare Services
Version Number 1.1
Change History | |
Version and Date | Change details |
Version 1
May 2020 |
New template |
Version 1.1
March 2022 |
Inclusion and exclusion criteria updated to:
· include neonates from birth; · note buccal/PR routes first line in babies/small children. Off label section updated to reflect use in under 3 months. Dosage section updated to reflect updated JRCALC guidance to include neonates from birth. Guidance added on handling of newly added doses. |
Version 1.1
September 2023 |
Reviewed – No Changes – Dates of review and expiry updated |
This Patient Group Direction (PGD) must only be used by registered professionals who have been named and authorised by their organisation to practise under it (See Appendix A). The most recent and in date final signed version of the PGD must be used.
This PGD template has been peer reviewed by the Ambulance Service critical care PGD Short Life Working Group in accordance with their Terms of Reference. It has been approved by the National Ambulance Service Medical Directors (NASMeD) in April 2020.
This section MUST REMAIN when a PGD is adopted by an organisation.
Name | Designation |
Sumithra Maheswaran | Pharmacist |
Sue Oakley (V1.0) | Pharmacist |
Elizabeth Miller (V1.1) | Pharmacist |
Tim Edwards | Consultant paramedic |
Paul Brennan | Advanced Paramedic |
Julie Ormrod | Consultant Paramedic |
Stuart Cox | Critical Care Nurse |
Jez Pinnell | Doctor |
Philip Cowburn | Doctor |
Tracy Rogers | Associate Director Specialist Pharmacy Service |
Jo Jenkins (Woking Group Co-ordinator) | Specialist Pharmacist PGDs Specialist Pharmacy Service |
Samrina Bhatti (V1.0)
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Chief Pharmaceutical Officer’s Clinical Fellow Specialist Pharmacy Service |
ORGANISATIONAL AUTHORISATIONS
Name | Job title and organisation | Signature | Date |
Senior doctor | Medical Director | 01.05.22 | |
Senior pharmacist | Lead Pharmacist | 01.05.22 | |
Senior representative of professional group using the PGD | Director of Nursing, Allied Health Professionals and Governance | 01.05.22 | |
Person signing on behalf of authorising body | Medical Director | 01.05.22 |
- Characteristics of staff
Qualifications and professional registration | Professional registration with HCPC as a Paramedic.
Professional registration with NMC as a Nurse or Midwife. Current contract of employment with BrisDoc healthcare Services as non-prescribing registered clinician. |
Initial training | The registered healthcare professional authorised to operate under this PGD must have undertaken appropriate training as defined by the employing organisation and successfully completed the competencies to undertake clinical assessment of the individual leading to diagnosis of the conditions listed. They must be competent to recognise and manage unintended but expected side effects including such as anaphylaxis. |
Competency assessment | Staff operating under this PGD are encouraged to review their competency using the NICE Competency Framework for health professionals using patient group directions
Individuals operating under this PGD are personally responsible for ensuring they remain up to date with the use of all medicines included in the PGD – if any training needs are identified these should be discussed with the senior individual responsible for authorising individuals to act under the PGD and further training provided as required. |
Ongoing training and competency | Organisation PGD or medication training as required by employing Trust/organisation.
Annual anaphylaxis and resuscitation training. Completion and submission of Continuous Professional Development (CPD) as required by HCPC or NMC. |
The decision to administer any medication rests with the individual registered practitioner who must abide by the PGD and any associated organisation policies. | |
In the context of the clinical scenario described in this PGD the individual will not be able to make an informed choice nor consent to treatment. Therefore, the clinician should act in the best interests of the individual at all times and within their professional competency and code of conduct. |
- Clinical condition or situation to which this PGD applies
Clinical condition or situation to which this PGD applies | Treatment of seizures in adults and children from birth as detailed below. |
Criteria for inclusion | · Treatment of seizures in adults, children and neonates from birth (weighing 3.5kg or greater) who:
· Have convulsions lasting 5 minutes or more and who are still convulsing where IV access cannot be established (note in babies/small children consider buccal/PR routes first line). · Have had three or more convulsions in an hour and who are still convulsing where IV access cannot be established (note in babies/small children consider buccal/PR routes first line). · Treatment of eclamptic convulsion – initiate treatment if the seizure lasts over 2-3 minutes or is recurrent where IV access cannot be established. |
Criteria for exclusion | · IV access established.
· Babies weighing less than 3.5kg · Prior administration of two doses of a benzodiazepine during the current episode of care (including those given by carer from an individual’s own medication). · Known hypersensitivity to benzodiazepines or to any component of the product – see Summary of Product Characteristics · Currently presenting with Psychogenic Non-Epileptic Seizure (PNES) – follow individualised treatment plan. |
Cautions including any relevant action to be taken
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Where a caution is present the practitioner should be aware of the possible effects of administration but should continue to administer where the benefit outweighs risk. Contact the local senior on call clinician for advice on the below if required.
· Uncorrected hypoglycaemia or hypoxia. If the seizure is due to hypoxia or hypoglycaemia ensure that this is corrected. · Concomitant use of opioids – increased risk of adverse effects including respiratory depression. · Known myasthenia gravis or any other marked neuromuscular respiratory weakness. · Known sleep apnoea syndrome. · Known concomitant use of anti-depressants or other CNS depressants or recent alcohol consumption – may potentiate adverse effects. · Breast-feeding – midazolam passes in low quantities into breast milk. · Pregnancy – the administration of high doses of midazolam in the last trimester of pregnancy or during labour has been reported to produce maternal or foetal adverse reactions. Use during pregnancy if clearly necessary. · A delayed respiratory depression as a result of high active metabolite concentrations may be observed in the 1-6 months age group. · Chronic respiratory insufficiency: midazolam may cause respiratory depression. · Renal impairment: elimination of midazolam may be delayed and the effects prolonged. · Hepatic impairment: clearance of midazolam may be delayed and the effects prolonged. · Impaired cardiac function: clearance of midazolam may be delayed. Life-threatening incidents are more likely to occur in those with pre-existing respiratory insufficiency or impaired cardiac function, particularly when a high dosage is administered. · Extreme caution should be use if administering midazolam to individuals with personality disorders. Benzodiazepines have a disinhibiting effect. · Known history of drug or alcohol abuse. |
Action to be taken if the individual is excluded | · Seek senior clinical support immediately.
· Record reasons for exclusion in clinical record and ensure in handover to receiving hospital. |
Arrangements for referral for medical advice | · Babies weighing less than 3.5kg
· If the seizures are not controlled within dosage regimen of the PGD seek senior clinical support immediately. · Individuals treated with benzodiazepines should always be transported to hospital unless their care plan states otherwise. · If individual has capacity to consent and refuses hospital transfer, then seek senior clinical support immediately. · Where an individual is left at home, every effort must be made to ensure they are in the care of a responsible adult. The responsible adult must be told to call 999 immediately if the individual experiences further seizures or their condition deteriorates in any way. |
- Description of treatment
Name, strength & formulation of drug | Oromucosal solution containing midazolam hydrochloride 5mg in 1ml (e.g. Buccolam®) as 2.5mg, 5mg, 7.5mg and 10mg pre-filled syringes | ||||||||||||||||||||||||||||||||||||||||||
Legal category | CD POM Schedule 3 No Reg | ||||||||||||||||||||||||||||||||||||||||||
Off-label use | · Buccolam® – off-licence use in adults aged 18 years and over and under 3 months of age
The use of buccal midazolam in adults and children from birth is supported. |
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Route / method of administration |
The full amount of solution should be inserted slowly into the space between the gum and the cheek. If necessary (for larger volumes and/or smaller individuals), approximately half the dose should be given slowly into one side of the mouth, then the other half given slowly into the other side.
If individual continues to convulse 10 minutes after the second dose seek additional clinical support and advice (see ‘Arrangements for referral for medical advice’). |
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Dose and frequency of administration
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Oromucosal solution containing midazolam hydrochloride 5mg in 1ml (e.g. Buccolam®) as 2.5mg, 5mg, 7.5mg and 10mg pre-filled syringes
* Doses for children 0 to 3 months cannot be achieved using the Buccolam® pre-filled syringe range. The dose of 1.25mg must be measured and excess volume (0.25ml from a 2.5millgram pre-filled syringe) discarded before the dose is administered. Measure and discard using an appropriate enteral syringe as per local guidelines. |
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Duration of treatment | Single episode of care. | ||||||||||||||||||||||||||||||||||||||||||
Drug interactions | A detailed list of drug interactions is available in the SPC, which is available from the electronic Medicines Compendium website or BNF: www.medicines.org.uk https://bnf.nice.org.uk/
There are many drug-drug interactions reported with midazolam as it is metabolized by CYP3A4. This does not affect the dose of midazolam to be given under this PGD but may lead to reduced clearance/the effects of any concurrent interacting medication. Therefore it is important that a full, current drug history is taken and supplied to the receiving medical team so a review of any interaction with current medications can be undertaken. |
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Identification & management of adverse reactions | A detailed list of adverse reactions is available in the product’s SPC, which is available from the electronic Medicines Compendium website: www.medicines.org.uk
Common adverse effects include: · Sedation, somnolence, depressed levels of consciousness · Respiratory depression · Nausea and vomiting · Midazolam may cause anterograde amnesia. · Buccal administration can provoke gagging, coughing and aspiration |
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Management of and reporting procedure for adverse reactions | · The practitioner acting under this PGD must ensure that all necessary drugs and equipment are available for immediate treatment should a hypersensitivity reaction occur and must be trained to manage anaphylaxis and be prepared to support ventilation including immediate availability of equipment to support airway management and ventilation.
· Healthcare professionals and indiviudals/carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme on: http://yellowcard.mhra.gov.uk · Record all ADRs in the clinical record. · Report via organisation incident policy. |
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Advice / follow up treatment | If the individual is not transferred to hospital inform the individual/parent/carer of possible side effects and their management (e.g. increased drowsiness, do not drive or operate machinery if affected, do not drink alcohol).
The individual/parent/carer should be advised to seek medical advice in the event of an adverse reaction. |
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Special considerations / additional information |
· For oral use only.
· The oral syringe cap should be removed before use to avoid risk of choking. · No needle, intravenous tubing or any other device for parenteral administration are compatible and must not be attached to the oral syringe. · The two available preparations are different strengths so caution should be taken to check the concentration. · Oral syringes are not graduated so the correct syringe for the dose required should be selected. |
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Storage | Stock must be securely stored according to organisation medicines policy and in conditions in line with SPC, which is available from the electronic Medicines Compendium website: www.medicines.org.uk | ||||||||||||||||||||||||||||||||||||||||||
Records | Record:
· name of individual, address, date of birth and GP with whom the individual is registered (if relevant) · name of practitioner · name of medication administered · date of administration · dose, form and route of administration · quantity administered · advice given, including advice given if excluded or declines treatment · details of any adverse drug reactions and actions taken · if treatment did not proceed under this PGD record reason/s why and actions taken · supplied via Patient Group Direction (PGD) All records should be clear, legible and contemporaneous. A record of all individuals receiving treatment under this PGD should also be kept for audit purposes in accordance with local policy. |
- Key references
Key references (accessed December 2019) |
· Electronic Medicines Compendium http://www.medicines.org.uk/
· Electronic BNF https://bnf.nice.org.uk/ · Reference guide to consent for examination or treatment https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/138296/dh_103653__1_.pdf · NICE Medicines practice guideline “Patient Group Directions” https://www.nice.org.uk/guidance/mpg2 · JRCALC guideline https://www.jrcalc.org.uk/ · Resuscitation Council (UK) www.resus.org.uk · Safety in Lactation https://www.sps.nhs.uk/articles/safety-in-lactation-drugs-used-in-status-epilepticus/ |
Appendix A – Registered health professional authorisation sheet
PGD Name/Version: Midazolam V1.1 Valid from: 01.05.22 Expiry: 15.12.2025
Before signing this PGD, check that the document has had the necessary authorisations. Without these, this PGD is not lawfully valid.
Registered health professional
By signing this patient group direction, you are indicating that you agree to its contents and that you will work within it.
Patient group directions do not remove inherent professional obligations or accountability. It is the responsibility of each professional to practise only within the bounds of their own competence and professional code of conduct.
I confirm that I have read and understood the content of this Patient Group Direction and that I am willing and competent to work to it within my professional code of conduct. | |||
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Authorising manager
I confirm that the registered health professionals named above have declared themselves suitably trained and competent to work under this PGD. I give authorisation on behalf of BrisDoc Healthcare Services for the above named health care professionals who have signed the PGD to work under it. | |||
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Note to authorising manager
Score through unused rows in the list of registered health professionals to prevent additions post managerial authorisation.
This authorisation sheet should be retained to serve as a record of those registered health professionals authorised to work under this PGD. Practice and application must be compliant with the medicines management policy.