LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
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PGD FOR THE SUPPLY OF METRONIDAZOLE 400MG TABLETS FOR THE TREATMENT OF BACTERIAL VAGINOSIS (BV) AND TRICHOMONAS VAGINALIS (TV)
PATIENT GROUP DIRECTION (PGD) FOR THE
SUPPLY OF METRONIDAZOLE 400mg TABLETS
FOR THE TREATMENT OF BACTERIAL VAGINOSIS (BV) OR TRICHOMONAS VAGINALIS (TV)
BY REGISTERED NURSES IN
SEXUAL & REPRODUCTIVE HEALTH SERVICES
Version Number 1.2.1
Change HistoryVersion 1.2
May 2015 / New template.
Updated SPC/BNF/NICE/BASHH and other references
Version 1.2.1
July 2015 / Minor amendments to contents page highlighted in blue
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
Supply of metronidazole 400 mg tablets / Pages 1-12
Staff Characteristics / Page 10
Authorisation and signatures / To be added by approving organisation
Individual authorisation to supply metronidazole under this PGD / To be added by approving organisation
CLINICAL CONDITION TO WHICH THIS DIRECTION APPLIES / · Bacterial vaginosis (BV)
· Trichomonas vaginalis (TV)
INCLUSION CRITERIA / · Any symptomatic individual diagnosed with BV or TV
· Any asymptomatic individual diagnosed with BV who wishes to be treated, including pregnant women (other than those with a history of preterm birth – see exclusions)
· Sexual contacts of individuals diagnosed with TV
EXCLUSION CRITERIA / Personal Characteristics
· Individuals under 13 years of age
· Individuals under 16 years of age and assessed as not competent using Fraser Guidelines
· Individuals 16 years of age and over and assessed as not competent to consent using local safeguarding guidelines
· Known allergy/hypersensitivity to metronidazole or tinidazole or any of the constituents found within the medication
· Pelvic pain/suspected pelvic inflammatory disease (PID)
· Known moderate to severe hepatic impairment
· Porphyria
· Alcohol dependence
· Pregnant with a history of preterm birth
Medical history
· Recurrent or unresolved symptoms of BV within 4 weeks of being treated
· Four or more treated episodes of BV in past 12 months
· Two or more documented episodes of grade 3 flora on microscopy within the preceding 3 months
· Treatment and failure within the same episode
· Itching and soreness indicating inflammation suggest the possibility of other conditions
Medication history
· Individual is taking interacting medicines. Check appendix 1 of current edition of British National Formulary (BNF) for full list.
CAUTIONS
(INCLUDING ANY ACTION TO BE TAKEN) / · Individuals under 13 years of age, follow local safeguarding policy
· Offer full sexually transmitted infection (STI) screen if not already done
· For contacts of TV, do not wait for test results to treat.
The 2g single dose should not be given if the individual is pregnant or breast feeding. Use alternative regimen.
ACTION IF EXCLUDED / · Refer to appropriate doctor/independent nurse prescriber
· Discuss with appropriate doctor/independent nurse prescriber any condition/medicine of which the nurse is unsure/uncertain
· Pregnant women with history of preterm birth – refer to senior doctor
ACTION IF PATIENT DECLINES TREATMENT / Document refusal in clinical record
Bacterial vaginosis
· Make individual aware of the benefits of treatment
· Refer to appropriate doctor/independent prescriber
· Asymptomatic women who decline treatment do not require further input from nurse prescriber/doctor
Trichomonas vaginalis
· Make individual aware of the need for treatment as TV is a sexually transmitted infection
· Refer to appropriate doctor/independent nurse prescriber
DRUG DETAILS
NAME, FORM & STRENGTH OF MEDICINE / Metronidazole 400 mg tablets
ROUTE/METHOD / Oral
LEGAL CATEGORY / Prescription Only Medicine (POM)
USE OUTSIDE THE TERMS OF THE MARKETING AUTHORISATION / N/A
QUANTITY / Five day course 400mg x 10 tablets
Seven day course 400mg x 14 tablets
Single dose 400 mg x 5 tablets
DOSAGE/FREQUENCY / Metronidazole 400mg twice a day, orally for five days or seven days according to local protocol
or
Metronidazole 2g orally as a single dose.
Individual choice may determine which regimen to supply.
The 2g single dose should not be given if the individual is pregnant or breast feeding. Use alternative regimen.
DURATION OF TREATMENT / As above depending on regime
MAXIMUM OR MINIMUM TREATMENT PERIOD / As above depending on regime
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 this medicine.
Refer to current Summary of Product Characteristics (SPC) of relevant product and current British National Formulary (BNF) for full list and further information.
Common side effects include:
· Nausea, vomiting and gastrointestinal disturbance
· An unpleasant taste in the mouth may occur which will continue throughout the duration of treatment but will resolve once treatment finishes
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 procedure 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 www.yellowcard.mhra.gov.uk.
The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so.
ADVICE TO INDIVIDUAL / Medicine
· Provide Manufacturer’s Patient Information Leaflet (PIL) and discuss
· Explain mode of action, side effects, and benefits of the medicine
· Provide verbal and written information on BV or TV
· Advise that no alcohol should be taken for the duration of the treatment and for 48 hours afterwards
· Advise to swallow the tablets whole with plenty of water
· Take with food
· If adverse reaction to treatment occurs advise individual to contact clinic for further advice
· Women who are breast feeding should be advised that metronidazole can cause breast milk to have a bitter taste which may cause some difficulties with feeding
Condition
Bacterial vaginosis
· If symptoms persist/worsen advise individual to contact clinic
· Use of aqueous cream/emulsifying ointment as a soap substitute
· BV is not an STI
· No screening or treatment of male partners is required
· Give general advice including information about possible triggers for BV
· Avoid local excessive washing, bubble baths, soaps, douching
· Use condoms because the alkalinity of semen causes bacteria in the vagina to release amines
Trichomonas vaginalis
· TV is an STI
· Screening and treatment of male partners is required
· Abstain completely from sexual intercourse (even with condom) including oral sex, for 7 days after treatment and for 7 days after partner’s treated, and follow up is complete
· Warn of risk of re-infection and further transmission of infection, if sexual intercourse takes place within 7 days of treatment or with an untreated partner
· Discuss implications of incomplete treatment
FOLLOW UP / Bacterial vaginosis
· No follow-up is required if symptoms resolve
Trichomonas vaginalis
· Compliance review is recommended
· Test of cure according to local policy
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)
· Inclusion or exclusion from PGD
· A statement that supply or administration is by using a PGD
· Advice given about the medication 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 13 years of age record action taken.
· If individual is under 16 years of age document competency using Fraser guidelines
· If individual is 16 years of age and over and assessed as not competent, record action taken
· Record the name/brand, dose of the medication and quantity supplied
· Record batch number and expiry date according to local policy or 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 the medicine
REFERENCES / · Manufacturers’ Summaries of Product Characteristics
Flagyl 400mg tablets, Zentiva
Date of last revision 10.9.2014 Accessed 3.3.15
https://www.medicines.org.uk/emc/medicine/21216
Metronidazole 400mg tablets, Aurobindo Pharma-Milpharm Ltd Date of last revision 8.5.12 Accessed 3.3.15
https://www.medicines.org.uk/emc/medicine/23050
Metronidazole tablets BP 400mg, Actavis UK Ltd.
Date of last revision 21.3.2012 Accessed 3.3.15
https://www.medicines.org.uk/emc/medicine/24143
· Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed 3.3.15
http://www.medicinescomplete.com
· National Institute for Health and Care Excellence (2013). Patient Group Directions. Medicines Practice Guidelines 2
http://www.nice.org.uk/guidance/mpg2
· British Association for Sexual Health and HIV (BASHH) (2014) UK National Guideline on the management of Trichomonas vaginalis http://www.bashh.org/documents/UK%20national%20guideline%20on%20the%20management%20of%20TV%20%202014.pdf
· British Association for Sexual Health and HIV (BASHH) (2012) UK National Guideline on the management of Bacterial Vaginosis
http://www.bashh.org/documents/4413.pdf
STAFF CHARACTERISTICS
The named nurse authorised to supply medications under the PGD must meet the following criteria: / THE 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)
Education/training, qualifications and competencies
Nurses must satisfy the following criteria
· Qualifications in sexual health (university modules/BASHH/in house equivalent). Note: an introduction to sexual health is not sufficient
· Has had training in the use of PGDs
· Has had training which enables the nurse to make a clinical assessment in order to establish the treatment need and supply the medication according to this PGD
· Has undertaken the competency training appropriate to this PGD
· Is competent in the assessment of individuals using Fraser guidelines
· Has undergone regular training and updating in safeguarding children and vulnerable adults
Has undergone regular updating in basic life support and anaphylaxis
Maintenance of competencies
· The nurse should ensure she/he is aware of any changes in recommendations for this medication
· 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
· The nurse should be familiar with current BASHH guidelines on BV and TV
An up to date list and signatures of registered practitioners 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: / 27/05/2015Review date / 30/11/2017 or earlier in the light of significant changes in best practice
Expiry date: / 27/05/2018
This template was peer reviewed and ratified by London Contraception and Sexual Health PGD Working Group:
NAME/ROLE / POSITION / DATEKathy French
Chair - Working Group / Independent Nurse Advisor SRH
Project Lead / 22/05/2015
Angela Bussey
Advisor - Working Group / Principal Pharmacist Medicines Information Projects.
Guy’s and St Thomas’ NHS Foundation Trust. / 27/05/2015
Dr Nneka Nwokolo Lead Medical Consultant / Consultant Physician HIV/GUM Chelsea and Westminster NHS Foundation Trust / 23/05/2015
Josie Mansell Lead Pharmacist / Community Health Services Pharmacist
Guy’s and St Thomas’ NHS Foundation Trust / 22/05/2015
Rosie Jackson Lead Sexual Health Nurse / Head of Nursing Women’s & Sexual Health. Lewisham & Greenwich NHS Trust / 22/05/2015
Marielle Perraut Lead Sexual Health Nurse / Matron, Sexual and Reproductive Health, Guy’s and St Thomas’ NHS Foundation Trust / 22/05/2015
The 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 clinical governance lead on behalf of an NHS Trust.
Whilst this PGD is written according to national guidance such as BASHH and NICE, 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 are met.
To meet legal requirements, organisations must add an Individual Practitioner Authorisation sheet or List of Authorised Practitioners. 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.