This Patient Group Direction () must only be used by registered pharmacists who have been named and authorised by their organisation to practice under it. The most recent and in date final signed version of the should be used. PATIENT GROUP DIRECTION () FOR THE SUPPLY OF DOXYCYCLINE 100MG CAPSULES / TABLETS FOR THE FIRST- LINE TREATMENT OF CHLAMYDIA TRACHOMATIS INFECTION POM CLASSIFICATION OF DOCUMENT: PURPOSE: Patient Group Direction Supply Doxycycline 100mg capsules/tablets for the treatment of Chlamydia infection to clients without a prescription under a Other relevant documents This should be used in conjunction with Local Enhanced Services Contract and Service Level Agreement. Eligibility criteria may vary between boroughs Document Number: 1.0 Version Number: 1.0 Controlled Document Sponsor: Controlled Document Lead: Approved By: On: 27/11/17 Review Date: 01/06/20 Expiry Date: 01/12/20 Directors of Public Health Newham, Tower Hamlets and Waltham Forest Lead Consultant Barts Health Sexual Health Primary Care Support Team Dr. J. Zelin Page 1 of 10
Distribution: Essential Reading for: Information for: All registered practitioners supplying Doxycycline 100mg capsules/tablets against this NEL Sexual Health Transformation Lead Sexual Health Commissioners in NE London Barts Health Sexual Health Primary Care Support Team Page 2 of 10
development Name Lead author / Lead doctor Lead pharmacist Representative of other professional group using Other members of the working group Job title and organisation Dr Jill Zelin Barts Health Hemant Patel Mr Andrew Ng Dr Jane Hutchinson Merle Symonds Dr Danielle Solomon Keiran Scott Simon Reid Jonathan Cox Authorisation Organisational authorisation Director of Public Health, London Borough of Newham Organisational authorisation Director of Public Health, London Borough of Tower Hamlets Organisational authorisation Director of Public Health, London Borough of Waltham Forest Lead Pharmacist, Secretary, North-East London Local Pharmaceutical Committee Lead Doctor for Barts Health Name: Signature: Date: Name: Somen Banerjee Signature: Date: 9th April 2018 Name: Mr J McDonnell Signature: Date: 04/04/18 Name: Mr H. Patel Signature: Date: 05/04/18 Name: Dr J. Zelin Signature: Date: 27/11/17 Page 3 of 10
Pharmacy to which the applies. Description of the medication to which the direction applies. Legal category Pharmacies offering supply of Doxycycline 100mg capsules/tablets under contract to Public Health for Sexual Health Services in Newham, Tower Hamlets and Waltham Forest. Doxycycline 100mg capsules/tablets Prescription Only Medicine (POM) Group of professional staff who are authorised to administer/supply under this. Training and method of assessment of competence. Community Pharmacists currently registered with the General Pharmaceutical Council (GPhC), who are working in a pharmacy contracted to NHS England (London) and providing the service under contract to Public Health for Sexual Health Services in Newham, Tower Hamlets and Waltham Forest who have been accredited by the service following completion of approved training. Registered Pharmacists must have accessed and completed training approved by Barts Health Sexual Health Primary Care Support Team The mandatory training will consist of: Completion of CPPE elearning and e-assessment for Chlamydia. Accessing the Barts Health Sexual Health Primary Care Support Team training as stipulated by the Barts Health Sexual Health Primary Care Support Team Completion of CPPE Declaration of Competence (DoC) on Chlamydia. Continued professional development Barts Health Sexual Health Primary Care Support Team will offer regular refreshers which will be mandatory for the Registered Pharmacist to access. In addition the Registered Pharmacist has the responsibility to update their own DoC every 3 years. Page 4 of 10
Clinical situation to which this direction applies. FIRST LINE TREATMENT of Chlamydia trachomatis infection Patient has either a written letter / report from non- Barts Health Sexual Health Professional stating Chlamydia positive or A text message, telephone message or letter from Barts Health Sexual Health confirming Chlamydia positive or Sexual partners of those diagnosed with genital Chlamydia Trachomatis attending for screening and epidemiological treatment Exclusion criteria Under 13 years of age Clients aged 14-16 if not Fraser Competent Pregnant Breastfeeding Known allergic reaction to tetracycline group of antibiotics. Complications present including epidydimo-orchitis and pelvic inflammatory disease Known hepatic impairment Known renal impairment Known alcohol dependence Patient complaining of rectal pain, painful defecation or rectal discharge must be referred to see a medical Doctor within Barts Health Sexual Health Patients taking other interacting medication: check appendix 1 of current BNF and product SPC for interactions If the client is receiving any concomitant medication or treatment it is the responsibility of the Registered Pharmacist to ensure that treatment with the drug detailed in this is appropriate. This information must be sought from a parent or carer if necessary. In case of any further doubt advice must be sought from an appropriate health professional and documented. Action to be taken when a patient is excluded from treatment according to the. The Registered Pharmacist will discuss reasons for exclusion and refer to the Barts Health Sexual health service Document action taken. Contact Barts Health Partner Management Bureau 020 Page 5 of 10
7377 7650 Action to be taken if patient declines treatment Contact Barts Health partner management bureau to advise 020 7377 7650 (Index patients only) Ensure the individual is aware of the need for treatment and refer/signpost to sexual health provider Patient should be advised of the risks associated with refusal of treatment Refer to an appropriate health service provider with information about further options Record refusal by individual and/or by community pharmacist if individual does not meet the inclusion criteria if appropriate Treatment to be supplied/ administered under the. Doxycycline 100mg capsules/tablets Security, storage and labelling of medicines. Do not store above 25 C. Store as a POM (Prescription Only Medicine) within dispensary. Medicines must be labelled as per usual labelling requirements for dispensed medicines under the Medicines Act 1968. Page 6 of 10
Route of administration and method. Oral Dose to be administered. Frequency of administration. 100mg Twice daily for 7 (seven) days Maximum dosage & minimum/maximum period over which the drug may be administered. Special considerations/ Additional information 14 doses (14 capsules/tablets) Offer the patient additional services as per LES: STI testing (provided to ALL 15-24 yr olds) Condom distribution Advice on contraception and signposting if required Emergency Contraception Suggest full STI screen at Barts Health Sexual Health Service Page 7 of 10
Warnings & potential adverse reactions. Main side effects include: nausea, vomiting, diarrhoea, dysphagia, oesophageal irritation may occur. If vomiting occurs within three hours of taking the medication the patient must return for advice and alternative medication (refer to No. US 0615/02 for the supply of azithromycin tablets). If a rash develops then the patient must access and be reviewed by a medical Doctor. Refer to Manufacturer s Product Information leaflet (PIL). See also Summary of Product Characteristics (SPC) and current BNF. All adverse reactions must be documented and the patient referred to a doctor. In the event of an adverse reaction follow the incident reporting procedure (see local policy) Report serious adverse reactions directly to the Committee for the Safety of Medicines (CSM) on a yellow card. Yellow Page 8 of 10
cards and guidance on their use are available at the back of the British National Formulary (BNF) or online via the link in ebnf or via the MHRA website www.mhra.gov.uk Follow up - circumstances under which further advice should be sought and arrangements for referral. Refer to Barts Health sexual health services as required Manage safeguarding concerns as per local arrangements Written or verbal advice to be given to patients or carers before, during or after treatment. The following will be provided to the patient: Contact slip given for all Sexual partners in the past 6 months (Available from Barts Health Sexual Health) Leaflet discussing Chlamydia The manufacturer s patient information leaflet (PIL) The following verbal advice must also be provided All sexual partners in the last 6 months will need to have testing and treatment Avoid sexual intercourse for one (1) week and until sexual partner(s) have also completed treatment. Tablets must be swallowed whole with plenty of fluids Do not take indigestion remedies concurrently avoid antacids and calcium, magnesium and iron salts two hours before and one hour after taking Doxycycline. Avoid exposure to sunlight or sunlamps during treatment course. Complete the course of treatment. Warn of risk of re-infection if sexual intercourse takes place with an untreated partner. For patient being treated as epidemiological contacts, do not wait to take treatment, before screening. Start treatment straight away. Discuss safer sex and encourage concurrent condom use, teaching this method if necessary. Patients should be informed that this medicine is being issued under a and is not prescribed Page 9 of 10
Record keeping. The Registered Pharmacist must record all significant information accurately and appropriately including assessment of Fraser Competence for clients less than 16 years. Complete PharmOutcomes Sonar Chlamydia treatment service Accurately record consultation outcome A record of the drug supplied, batch number and expiry dates must be documented. The date and time of supply. Names of professionals who are authorised to administer/supply drug according to the. A list of the Registered Pharmacists who have successfully completed training will be kept by Barts Health Sexual Health Primary Care Support Team Professional with responsibility for ensuring review of the takes place. A Consultant in Sexual Health and the Primary Care Facilitator for Barts Health Sexual Health will be responsible for review of the. Staff responsible for review of this. Lead Pharmacist for LPC, North East London Lead Consultant for Barts Health Sexual Health Primary Care Support Team Senior Nurse for Barts Health Sexual Health Primary Care Support Team Page 10 of 10