PATIENT GROUP DIRECTION

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1 PATIENT GROUP DIRECTION Supply / Administration of: By: Pharmacists Azithromycin 250mg capsules for Chlamydia In: Community Pharmacy It is the responsibility of the professional working under this PGD to verify that the patient fulfils the stated criteria for supply or administration of the treatment concerned. It is not appropriate to have a PGD in place that is infrequently used by healthcare professionals because of progressive unfamiliarity with its contents. Any healthcare professional that works to a PGD infrequently should consider whether to cease doing so. This PGD will be reviewed every 2 years, or sooner in light of new guidance. Review date: March 2011 Please Note: This PGD is part of the Chlamydia Screening Service Level Agreement for Community Pharmacies. PGD Azithromycin (chlamydia) Pharmacists v1.doc Page 1 of 6

2 1. Reason for introducing PGD Increased access to treatment for patients with confirmed Chlamydia Trachomatis. 2. Clinical Condition or situation to which this PGD applies 2.1 Define condition/situation Antibiotic treatment for male or female patients with a positive test for Chlamydia Trachomatis. 2.2 Criteria for inclusion Patients who have been screened for Chlamydia or sexual contacts of index patients (treat and offer screening at same visit do not wait for results). Patients under the age of 16 years need to be assessed according to the Fraser Guidelines, to assess competence to understand the advice given with regard to this treatment. Patients giving consent to the use of the PGD 2.3 Criteria for exclusion Patients with complicated Chlamydia Trachomatis infection Patients taking any drug listed in current BNF that interacts with azithromycin The patient is pregnant or suspected to be pregnant Any patients with a known allergy to azithromycin, other macrolides or any constituents of the capsules Breast feeding Children under 14 years of age Patients with Porphyria Patients with impaired hepatic function 2.4 Cautions [to include consideration of concurrent medication] 2.5 Patient consent [verbal, written, implied] 2.6 Action if patient excluded 2.7 Action if treatment declined by patient, parent, or guardian Patients with renal impairment Patients taking the following drugs: Antacids Anticoagulants Combined oral contraceptives Theophylline/aminophylline Informed consent as stated in the local consent policy Parent/guardian consent to be given, where necessary Refer to supervising doctor/receiving facility. Document action in patient s record. Refer to supervising doctor/receiving facility. Document action in patient s record. PGD Azithromycin (chlamydia) Pharmacists v1.doc Page 2 of 6

3 3. Characteristics of Staff 3.1 Class of healthcare professional for whom PGD is applicable & Professional qualifications required 3.2 Additional requirements/specialist qualifications required. 3.3 Continued training requirements 4. Description of treatment. 4.1 Generic name of medicine and form (e.g. tablets) 4.2 Legal status POM/P/GSL Pharmacist who has also completed: CPPE Sexual Health Testing and Treatment PCT Azithromycin PGD Workshop And signed up to the Dudley PCT Chlamydia Screening Service Level Agreement. This PGD will only apply whilst you are employed or contracted/working at the time for Dudley PCT. Has undertaken appropriate training to carry out clinical assessment of patient leading to conclusion that requires treatment according to the indications listed in this PGD. The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of individual scope of practice. Azithromycin 250mg capsules POM Licensed or unlicensed use Licensed [If unlicensed state rationale for use] 4.3 Dose [Where a range is applicable 1g (=4x250mg) include criteria for deciding on a dose] 4.4 Route / method of Oral administration 4.5 Frequency Single dose 4.6 Total dose and number of times treatment can be Once only administered; state time frame 4.7 Information on follow-up Advise to seek medical advice if more severe reactions to management 4.8 Written/verbal advice for patient/carer before/after treatment and management medication occur. 1. Explain treatment and course of action. Include possible side effects e.g. nausea, vomiting, diarrhoea, skin rash. 2. Give the patient a copy of any relevant patient information leaflet. 3. Advise that azithromycin capsules should be swallowed whole 1 hour before or 2 hours after food. 4. Advise that if vomiting occurs within 2 hours of taking capsules patient will need to be referred to doctor for re-treatment. 5. Avoid antacid (indigestion) medicines for two hours each side of dose. 6. Abstain from intercourse (even with condom) for 7 days after treatment and for 7 days after partner treatment (if applicable). PGD Azithromycin (chlamydia) Pharmacists v1.doc Page 3 of 6

4 4.9 Instructions on identifying, managing & reporting adverse drug reactions 4.10 Arrangements for referral for medical advice 4.11 Precautions, facilities & supplies Specify method of recording supply/administration, sufficient to enable audit trail. 5. Audit 7. If taking combined oral contraceptives (COC), advise that additional contraception (condoms) is required an additional 7 days after treatment. If less than 7 pills left in COC pack at end of this time then patient should omit 7 day pill-free interval. 8. Warn of risk of re-infection if sexual intercourse takes place with an untreated partner. 9. Discuss partner notification and contact tracing. 10. Encourage and facilitate full STI screening (see 4.10 below). Nausea, vomiting, diarrhoea, anorexia, headache, visual disturbances, rashes, arthralgia and myalgia. Please refer to current BNF or SPC for full details. Advise on self-treatment for minor reactions and to seek medical advice if more severe reactions occur. Report all serious adverse reactions to the CSM via yellow card system. Offer referral to Genito-Urinary Medicine Clinic or a Dudley Sexual Health Service Clinic for full screening for all Sexually Transmitted Infections. Professional must be able to advise patient/parent/carer what action to take in the event of the patient experiencing any side effects and the most appropriate medical service to contact. Store in a cool dry place. Order supplies from pharmacy. Patient notes (Manual, Computerised, Own Held): Patient s name, address, date of birth and consent given Contact details of GP (if registered) Diagnosis Dose and form administered (batch details if locally required) Advice given to patient (including side effects) Signature/name of staff who administered or supplied the medication, and also, if relevant, signature/name of staff who removed/discontinued the treatment Details of any adverse drug reaction and actions taken including documentation in the patient s medical record Referral arrangements (including self-care). Serious adverse reactions should be documented in the patient s health record and on their medical records. GP should also be informed The use of this PGD to be monitored by the service in which it is used PGD Azithromycin (chlamydia) Pharmacists v1.doc Page 4 of 6

5 6. Management 6.1 PGD Group Noel Aslett Mary Akufo-Tetteh Julie Burford Louise Storey Kate Owen Others Lisa Johnson Dr Hampson MichelleDyoss Heidi Mitchell Mayada Abu Affan 6.2 Authorisation Prescribing Adviser, PGD Chair Advanced Nurse Practitioner Advanced Nurse Practitioner Nurse Prescribing Lead Nurse Prescribing Lead Clinical Nurse Manager, C&SH Senior CMO C&SH Community Pharmacy Development Officer Black Country Chlamydia Screening Manager Consultant in Sexual Public Health This PGD has been approved on behalf of Dudley PCT by: Name Signature Date Prescribing Adviser Noel Aslett Signed Clinical Lead Medicines Management Dr P D Gupta Signed PEC Chair and Interim Medical Director Dr S Cartwright Signed Persons permitted to authorise staff they are responsible for to operate this PGD Senior Pharmacists Clinical Governance Leads Prescribing Leads Directors of Public Health Locality General Managers, General Managers and Clinical Service Managers 7. References and Sources of Information National Chlamydia Screening Programme, 3 rd edition, DH 2006 UK National Guideline for the management of genital tract infections with Chlamydia trachomatis, BASHH 2006 CMO/CNO/CPO updates Faculty of Family Planning and Reproductive Health Care Current edition of the British National Formulary Manufacturer s product literature PGD Azithromycin (chlamydia) Pharmacists v1.doc Page 5 of 6

6 PGD for supply of Azithromycin 250mg capsules by Pharmacists in Community Pharmacies within Dudley PCT It is the responsibility of the Authorising Person to keep this list up to date and in a safe place for reference. Any healthcare professionals who no longer meets the competency requirements or leave the service or practice must be removed from the list; likewise, any new healthcare professionals meeting the competency requirements have to be added to the list in order to work under the Patient Group Direction. The Authorising Person is only expected to confirm that the Healthcare Professionals meets the minimum training and competency requirements under this PGD. It is the responsibility of the Healthcare Professional themselves, their Professional Body and the PCT that they are fit to practice. This Patient Group Direction is to be read, agreed to and signed by all healthcare professionals it applies to. One copy should be given to each pharmacist with the original signed copy being kept by the Authorised Person with responsibility for PGDs within the service or practice. I confirm that I have read and understood the content of this patient group direction and that I am willing and competent to work under it within my professional code of conduct. Healthcare Professionals permitted to supply or administer under this PGD Name of Healthcare Professional Signature Authorised Person with responsibility for PGDs Signature Date approved PGD Azithromycin (chlamydia) Pharmacists v1.doc Page 6 of 6

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