LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
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PGD FOR THE SUPPLY AND ADMINISTRATION OF CEFTRIAXONE INJECTION (RECONSTITUTED WITH LIDOCAINE 1% w/v INJECTION) BY INTRAMUSCULAR (IM) INJECTION FOR THE TREATMENT OF UNCOMPLICATED NEISSERIA GONORRHOEAE INFECTION
PATIENT GROUP DIRECTION (PGD) for the
supply and administration of
CEFTRIAXONE INJECTION (RECONSTITUTED WITH
LIDOCAINE 1% w/v INJECTION)
BY INTRAMUSCULAR (IM) INJECTION FOR THE TREATMENT OF UNCOMPLICATED
NEISSERIA GONORRHOEAE INFECTION BY REGISTERED NURSES
in SEXUAL and REPRODUCTIVE HEALTH SERVICES
PENICILLIN ALLERGIC PATIENTS ARE EXCLUDED FROM THIS PGD
Version Number 1.4
Change HistoryVersion and Date / Change details
Version 1.2 / New template.
Updated SPC/BNF/NICE and other references
Amendments in line with BASHH guidelines
Version 1.3 / Amendments in blue
Clinical condition – minor amendment with reference to supply of azithromycin [unless sensitivity results demonstrate azithromycin resistance]. (Public Health England. Surveillance of antimicrobial resistance in Neisseria gonorrhoeae 2014)
Removed requirement for record keeping of supply/administration for under 13s because they are excluded from treatment under the PGD.
Version 1.4 / Change to advice regarding reconstitution of ceftriaxone injection p5
Each organisation using this PGD must ensure that it is formally authorised by a pharmacist, a medical lead and a governance lead on behalf of the authorising organisation to ensure that this document meets legal requirements for a PGD.
This Patient Group Direction (PGD) must only be used by registered nurses who have been named and authorised by their organisation to practise under it. The most recent and in date final signed version of the PGD must be used.
TABLE OF CONTENTSCONTENTS / PAGE NUMBER
PGD for the supply and administration of ceftriaxone 500mg Injection reconstituted with Lidocaine 1% Injection / 1-13
Staff Characteristics / 11
Authorisation and Signatures / To be added by approving organisation
Individual authorisation to use this PGD / To be added by approving organisation
DRUG NAME /STRENGTH/FORM
Ceftriaxone injection reconstituted with Lidocaine 1% w/v injection
CLINICAL CONDITION TO WHICH THIS DIRECTION APPLIES /
- Uncomplicated Neisseria gonorrhoeae (GC) and contacts of gonorrhoea
INCLUSION CRITERIA / Personal characteristics
- Individuals with a diagnosis of Neisseria gonorrhoeae
- Sexual contacts of individuals with a positive gonorrhoea result
- Individuals who have had sexual intercourse within 7 days of receiving treatment or who have had sex with an untreated partner
EXCLUSION CRITERIA / Personal characteristics
- Individuals under 13 years of age
- Individuals aged under 16 years of age and assessed as not competent using Fraser guidelines
- Individuals aged 16 years and over and assessed as not competent to consent
- Males with epididymitis or testicular pain
- Females with or suspected to have pelvic inflammatory disease
- Three or more treated episodes of GC in the past 12 months
- Severe hepatic impairment
- Severe renal impairment
EXCLUSION CRITERIA
(CONTINUED) / Continued from previous page
- Proctitis
- Intramuscular injection is contraindicated e.g. where individual has known thrombocytopenia (low platelet count) or coagulopathy (bleeding tendency) or is receiving treatment with anticoagulants
- Contraindications to lidocaine e.g. known cardiac arrhythmias, complete heart block, hypovolaemia
- Acute porphyria
- Myasthenia gravis
- Epilepsy
- Individual is taking interacting medicines. Check Appendix 1 of current edition of the British National Formulary (BNF) for full list of interacting medicines for ceftriaxone and lidocaine
- Known allergy or hypersensitivity to ceftriaxone and/or other cephalosporin antibiotics and /or known immediate or delayed hypersensitivity reaction to penicillins or other beta-lactam antibiotics (see current BNF for full list)
- Known hypersensitivity to lidocaine and/or other anaesthetics of the amide type
ACTION IF EXCLUDED /
- Refer to appropriate doctor/independent non-medical prescriber
CAUTIONS/NEED FOR FURTHER ADVICE/ACTION TO BE TAKEN /
- Ensure emergency drugs and equipment are available for the treatment of emergencies, according to local protocol
- Discuss with appropriate doctor/independent non-medical prescriber any medical condition or medication for which the nurse is unsure/uncertain
- Do not wait for test results before treating GC contacts
ACTION IF PATIENT DECLINES TREATMENT /
- Make individual aware of the need for treatment and refer to appropriate doctor/ independent non-medical prescriber
- Record refusal in the clinical record
DRUG DETAILS
NAME, FORM & STRENGTH OF MEDICINE / Ceftriaxone injection (dry powder vial) reconstituted with Lidocaine 1% w/v injection
The 500 mg dose will be given from either
2x250mg vials or HALF a 1g vial as follows:
Using 2x250 mg vials to administer 500mg
Each 250mg vial of ceftriaxone should be constituted with 1mL lidocaine 1% w/v injection.
The entire contents of the two vials should be drawn up to give the total dose of 500mg to be administered.
Using HALF a 1g vial to administer 500 mg
The 1g vial should be reconstituted with 3.5mL lidocaine 1% w/v injection
Displacement values; It is the responsibility of the practitioner to check the manufacturer’s literature for displacement values, to ensure that the correct dose is administered.
Single use only. Discard any unused injection.
ROUTE/METHOD /
- Intramuscular injection
- Site is the outer upper quadrant of the buttock
LEGAL CATEGORY / Prescription Only Medicine (POM)
USE OUTSIDE THE TERMS OF THE MARKETING AUTHORISATION / The dose of ceftriaxone is taken from the British Association for Sexual Health and HIV (BASHH) guideline.
Of the three manufacturers of ceftriaxone injection, two (Roche and Stravencon) list 500mg as a licensed dose for the treatment of gonorrhoea. The third (Wockhardt) does not and therefore administration of 500mg using this brand is different from the manufacturer’s Summary of Product Characteristics (SPC)
Women who are pregnant or known to be at risk of pregnancy must be fully informed of the following:
- The use of these medicines in pregnancy is outside the manufacturers’ SPCs. She must formally give verbal consent to treatment outside the SPCs and this must be documented in the clinical record.
- The risks and benefits of this treatment, including:
Lidocaine can cross the placenta but the benefit of treatment is thought to outweigh the risk to pregnancy or leaving the GC untreated
The availability of alternative treatment.
She should be given the option of seeing a doctor
Breastfeeding:
- Small amounts of ceftriaxone and lidocaine may be excreted into the breast milk.
QUANTITY / Single injection of 500mg ceftriaxone reconstituted with lidocaine 1% w/v injection
DOSAGE/FREQUENCY / Single dose
DURATION OF TREATMENT / Single dose
MAXIMUM OR MINIMUM TREATMENT PERIOD / Single dose
SIDE EFFECTS
Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction, particularly to black triangle medicines. / This list may not represent all reported side effects of these medicines. Refer to current Summary of Product Characteristics (SPC) of both products for full list and further information.
Ceftriaxone
Common side effects
- Gastrointestinal – loose stools, nausea, vomiting Haematological reactions (e.g. anaemia)
- Pain or discomfort at the site of intramuscular injection immediately after administration but is usually well tolerated and transient.
- Nausea and vomiting
- Urticaria
Warn of possible side effects of treatment as listed in the Patient Information Leaflets (PILs) for both ceftriaxone and lidocaine
In the event of untoward or unexpected adverse reactions:
- If necessary seek appropriate emergency advice and assistance
- Document in the individual’s clinical record and inform appropriate doctor/independent nurse prescriber
- Complete incident report if adverse reaction is severe (refer to local organisational policy)
- Use yellow card system to report serious adverse drug reactions directly to the Medicines and Healthcare products Regulatory Agency (MHRA).
- Yellow cards are available in the back of the BNF or obtained via Freephone 0808 100 3352 or online at
ADVICE TO INDIVIDUAL /
- Provide Manufacturer’s Patient Information Leaflet (PIL) and discuss
- Explain mode of action, side effects, and benefits of the medicine
- Verbal and written information on gonorrhoea
- Discuss partner notification and issue contact slips if appropriate
- Offer condoms and advice on safer sex practices
FOLLOW UP /
- According to local protocol
RECORDS / The authorised registered nurse must ensure the following is documented in the clinical record:
- Individual’s name, address and date of birth
- GP contact details where appropriate
- Attendance date
- Reason for attendance
- Relevant past and present medical and family history, including drug history
- Any known allergy
- Relevant examination findings (where appropriate)
- Sites where swabs were taken from
- A statement that supply or administration is by using a PGD
- Advice given about the treatment including side effects, benefits, and when and what to do if any concerns
- Details of any adverse drug reactions and what action taken
- Any referral arrangements
- Any administration outside the terms of the product licence
- The consent of the individual
- If individual is under 16 years of age document competency using Fraser guidelines
- Individuals aged 16 years of age or more and not competent, record action taken
- Record the name/brand, dose and route/site of the medication and quantity supplied
- Record batch number and expiry date according to local policy and national guidelines
- Record follow up and/or signposting arrangements
- Any other relevant information that was provided to the individual
- Name and signature (which may be an electronic signature) of the nurse supplying or administering the medicines (follow local procedures for computer records)
REFERENCES / Manufacturers’ Summaries of Product Characteristics
- Ceftriaxone powder for solution for injection, Wockhardt UK Ltd.
- Ceftriaxone sodium 1g Injection, Stravencon Ltd
- Rocephin 250mg, 1g and 2g vials, Roche Products Limited
- Lidocaine Hydrochloride injection BP 1% w/v, Hameln Pharmaceuticals Ltd.
- Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press < [Accessed on 29.09.2014]
- National Institute for Health and Care Excellence (2013) Patient Group directions. Medicines Practices Guidelines 2
- British Association for Sexual Health and HIV (BASHH) (2011) Guidelines- Management of gonorrhoea in adults,June 2011
- Public Health England. Surveillance of antimicrobial resistance in Neisseria gonorrhoeae 2014.
STAFF CHARACTERISTICS
The named registered nurse authorised to supply and/or administer medications under the PGD must meet the following criteria: / THE REGISTERED NURSE MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT
Registration
- Nurses must be registered with the Nursing and Midwifery Council (NMC)
Nurses must satisfy the following criteria
- Qualification/training in sexual health (BASHH competencies or equivalent post registration qualification or in house training/competencies in STIs )
- Has been assessed as competent to provide care and treatment of genital infections
- Has had training in the use of this PGD
- Has had training which enables the nurse to make a clinical assessment in order to supply the medication according to this PGD
- Is competent in the use of Fraser Guidelines
- Has undergone regular training and updating in safeguarding children and vulnerable adults
- Has undergone regular updating in basic life support and anaphylaxis
- The nurse must ensure she/he is aware of any changes to the recommendations for these medicines
- It is the responsibility of the nurse to keep up to date with continuing professional development and take part in audit of clinical records on a regular basis
- Is familiar with current BASHH guidelines on Neisseria gonorrhoeae
An up to date list and signatures of registered nurses who are authorised to practise under this PGD is kept in by
Practitioners not listed are not authorised to practise under this PGD.
PGD DEVELOPMENT GROUP
Date PGD template comes into effect: / 04/12/2015Review date / 31/08/2017 or earlier in the light of significant changes in best practice
Expiry date: / 28/02/2018
This template was peer reviewed and ratified by London Contraception and Sexual Health PGD Working Group:
NAME/ROLE / POSITION / DATEKathy French
Chair - Working Group / Project Lead
Independent Nurse Advisor SRHC / 10/03/2016
Angela Bussey
Advisor - Working Group / Principal Pharmacist Medicines Information Projects
Guy’s and St Thomas’ NHS Foundation Trust. / 11/03/2016
Lead Medical Consultant
Dr Nneka Nwokolo / Consultant Physician HIV/GUM Chelsea and Westminster NHS Foundation Trust / 10/03/2016
Lead Pharmacist
Josie Mansell / Community Health Services Pharmacist, Guy’s and St Thomas’ NHS Foundation Trust. / 10/03/2016
Rosie Jackson / Head of Nursing - Women’s and Sexual Health, Lewisham and Greenwich NHS Trust / 10/03/2016
Peer reviewers - Lead Contraception/Sexual Health Nurses
Marielle Perraut / Matron, Sexual and Reproductive Health, Guy’s and St Thomas’ NHS Foundation TrustThe PGD template is not legally valid until it has had the relevant organisational approval.
See next page
ORGANISATIONAL AUTHORISATIONS AND OTHER LEGAL REQUIREMENTS
The PGD is not legally valid until it has had the relevant organisational authorisations.
To ensure compliance with the law, organisations must add local authorisation details i.e. clinical authorisations and the authorising organisation. Complete details below or use format agreed according to local policy.
Name / Job title and organisation / Signature / DateSenior doctor
Senior pharmacist
Senior representative of professional group using the PGD e.g. Lead Contraception /Sexual Health Nurse
Lead Specialist Reviewer
e.g. microbiology* if relevant
Person signing on behalf of authorising body / e.g. Director of Public Health on behalf of a local authority or a clinical governance lead on behalf of an NHS Trust.
Whilst this PGD is written according to national guidance such as BASHHNICE PGD Guidelines recommend that each organisation ensures that a local antimicrobial specialist or antimicrobialstewardship committee lead isinvolved in its approval and local adoption.
It is the responsibility of the authorising organisation to ensure that all legal and governance requirements for authorising the PGD. It is the responsibility of the provider organisation to ensure that all legal and governance requirements for using the PGD are met.
To meet legal requirements, organisations must add an Individual Practitioner Authorisation sheet or List of Authorised registered nurses. This varies according to local policy and how the service is managed but this should be a signature list or an individual agreement.
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. Individual practitioners must declare that they have read and understood the Patient Group Direction and agree to supply/administer medicines listed only in accordance with the PGD.
ORGANISATIONS MAY ALSO ADD:
- Local training and competency assessment documentation
- Other supporting local guidance or information
- Links to local PGD Policy and other supporting guidance
Version No: 1.4 / Expiry date:28.02.2018
Approving Organisation Name:
Approval Committee Name: / Reference Number :
Date of authorisation: / Page 1 of 13