PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF DOXYCYCLINE 100MG TABLETS FOR THE FIRST-LINE TREATMENT OF CHLAMYDIA TRACHOMATIS INFECTION

Transcription

1 PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF DOXYCYCLINE 100MG TABLETS FOR THE FIRST-LINE TREATMENT OF CHLAMYDIA TRACHOMATIS INFECTION CLASSIFICATION OF DOCUMENT: PURPOSE: Patient Group Direction Document Number: US /01 Version Number: 1.0 Controlled Document Sponsor: Controlled Document Lead: Approved By: Supply of Doxycycline 100mg tablets for the treatment of Chlamydia infection to clients without a prescription under a PGD Medical Director Lead Consultant Umbrella Service MMAG On: 20 th September 2016 Review Date: 20 th September 2018 Expiry Date: 20 th September 2019 Distribution: Essential Reading for: All registered practitioners supplying Doxycycline 100mg tablets against this PGD Information for: All registered healthcare workers working in Sexual Health Services Page 1 of 7

2 Pharmacy to which the PGD applies. Pharmacies offering supply of Doxycycline 100mg capsules/tablets under the Umbrella Sexual Health Services in Birmingham and Solihull. Description of the medication to which the direction applies. Doxycycline 100mg tablets Group of professional staff who are authorised to administer/supply under this PGD. Pharmacists providing the service under Umbrella Sexual Health Services in Birmingham and Solihull who have been accredited by the service following completion of approved training. Training and method of assessment of competence. Must have accessed and completed training approved by the Umbrella training department. The mandatory training will consist of: Completion of CPPE elearning and e-assessment for Chlamydia. Accessing the Umbrella training as stipulated by the Umbrella training department Completion of CPPE Declaration of Competence (DoC) on Chlamydia. Continued professional development The Umbrella training department will provide regular refreshers which will be mandatory for the Pharmacist to access. In addition the Pharmacist has the responsibility to update their own DoC every 3 years. Clinical situation to which this direction applies. FIRST LINE TREATMENT of Chlamydia trachomatis infection Patient has either a written letter / report from non- Umbrella Health Professional stating Chlamydia positive or A text message or letter from an Umbrella Clinic confirming Chlamydia positive. Page 2 of 7

3 Exclusion criteria Under 13 years of age Clients aged 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 Umbrella. 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 PGD 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 PGD. The Registered Pharmacist will discuss reasons for exclusion and refer to the Umbrella Sexual health service Document action taken. Treatment to be supplied/ administered under the PGD. 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. Page 3 of 7

4 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. 14 doses (14 capsules/tablets) Special considerations/ Additional information Offer the patient additional services: Condom distribution STI kit ordering advice on contraception and signposting if required Warnings & potential adverse reactions. Main side effects include: nausea, vomiting, diarrhoea, dysphagia, oesophageal irritation may occur. Page 4 of 7 If vomiting occurs within three hours of taking the medication the patient must return for advice and alternative medication (refer to PGD 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 for the Umbrella Sexual Health Services in Birmingham and Solihull. Report serious adverse reactions directly to the Committee for the Safety of Medicines (CSM) on a yellow card. Yellow

5 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 Follow up - circumstances under which further advice should be sought and arrangements for referral. None 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 Umbrella) 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. 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 PGD and is not prescribed Record keeping. Page 5 of 7 The Registered Pharmacist must record all significant information accurately and appropriately including assessment of Fraser Competence for clients less than 16 years. Complete PharmOutcomes Chlamydia treatment service Accurately record consultation outcome

6 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 PGD. A list of the Registered Pharmacists who have undertaken and submitted the CPPE DoC with confirmation they have accessed approved training will be kept by Pinnacle Health Partnership LLP (PharmOutcomes) and will be accessible to Umbrella. Professional with responsibility for ensuring review of the PGD takes place. A Consultant in Sexual Health and the Senior Nurse for the Umbrella Sexual Health Services in Birmingham will be responsible for review of the PGD. Staff responsible for review of this PGD. Chief Pharmacist UHB Lead Consultant for Umbrella Service Senior Nurse for the Umbrella Sexual Health Services in Birmingham Page 6 of 7

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