PATIENT GROUP DIRECTION see notes Direction for the administration or supply of: (Identify as appropriate) PGD Reference No. Aim of care this direction will provide: Azithromycin PGD/ Prophylaxis treatmentof Mycobacterium avium intracellulare (MAI) in HIV antibody positive people with a CD4 count of less than 50 that present to the HIV service within East Kent Hospitals NHS Trust. Date applicable: Date of expiry or renewal: Clinical Condition 1. Definition of clinical condition / situation 2. Criteria for confirming clinical condition 3. Specific patient criteria for inclusion in direction. 4. Patients excluded from this direction 5. Criteria for referral to Clinician or for further advice 6. Action for patients who do not wish to receive, refuse or do not adhere to care under this direction. HIV antibody positive with a CD4 count of less than 50. This count indicates how immunosuppressed a client is. This is for use with Adults only. A CD4 count of less than 50 would put an HIV antibody positive person at risk of contracting an opportunistic infection. ie: Mycobacterium avium intracellulare (MAI) HIV antibody positive patient with CD4 count of less than 50 as stated in the British HIV Association Guidelines (BHIVA) HIV antibody positive patient with CD count of less than 50. (Reference: Brian Gazzard, Chelsea and Westminster Hospital AIDS Care Handbook. Mediscript Ltd 1999) Patients known to have hepatic or renal impairment. Patients known to suffer with Porphyria. Pregnant or breast feeding women. Hypersentivity to Azithromycin or other macrolide antibiotics. Patients taking ergot derivatives eg: migraine medication.. Excluded clients Explain reasons for this medication. Discuss alternatives 1 Refer to HIV Consultant Staff Characteristics 7. Professional Qualifications to be held by staff using this PGD. 8. Specialist qualification, training, experience and competence required. 9. Continued training requirements and frequency. Level one Registered General Nurse (RGN) HIV clinical nurse specialist employed by East Kent Hospitals NHS Trust. Clinical nurse specialist ENB 934 course Professionally accountable Trained and competent in relevant pharmacology Yearly updates in treatment and care of HIV 2 Treatment 10. Name of Medicine Azithromycin 11. Legal status of medicine Prescription only medicine. Out of license indication. 12. Dose / Range Adult: 1,250mg weekly 13. Route / Method Oral capsules 14. Frequency and number of times treatment can be administered over what period of time. Adult- Once a week Until CD4 count above 100 on 2 separate blood results 1 month apart. Give 2 months supply and refer to HIV Physician Azithromycin is best taken on an empty stomach at least one hour before food or 2 hours after food to maximize absorption. It should be taken at least two hours apart from antacids 15. Special instructions 16. Maximum total dosage (where appropriate) Side effects include nausea, vomiting, diarrhoea, abdominal discomfort and allergy. See BNF for full list. Drug interactions include antacids, ciclsporin, digoxin, ergot derivatives, terfenadine, theophylinne and warfin. See BMF for full list 18. Written/ verbal advice for patient/ Provide patient with written carer before/after treatment. information if available Give patient advice re-adherence Give patient advice re special instructions and warnings Point out to patient drug information from the medication pack 19.Records to be completed. Enter date, details of patient and (Specify method of recording supply/ time into nursing held notes and administration sufficient to include audit when able into medical notes or trail) clinic GUM notes Signature and designation must be documented clearly. 20. Person responsible for maintaining Ann Broadhead central list for Trust of trained personnel under this Directive. 3 17. Warnings including potential adverse reactions. 4 Management and Monitoring 21. This Patient Group Direction has been prepared by: Name: Position: Signature: Date: Name: Position: Signature: Date: 22. This Patient Group Direction has been ratified by: Name: Position: Clinical Manager Authorising use Title: Signature: Name: Date: Position: For Quality & Practice Title: Signature: Name: Date: Position: For Drugs and Therapeutic Committee Title: Signature: 23. Approved on behalf of EKHT by: Date: Signature Date Clinical Director Director of Pharmacy Clinical Governance Lead 5 24. Each individual authorized to administer under this direction should receive a copy and sign it. Individual competency sheets are kept by the individual and their Manager. Training received and required for use of this Patient Group Direction EKHT PGD Reference No: PGD/ Type of training Knowledge of HIV and opportunistic infections 1. Understanding of the pharmacologisal issues in 2. relation to the use of azithromycin eg side effects, contraindications and interactions. Knowledge of the priciples of health education 3. Knowledge of the legislation around use of PGDs. 4. 5. 6. Date I have read the Patient Group Direction and agree to use it within the criteria specified. I fully understand my professional accountability. Name: Title: Signature: Date: 6 Notes on preparing a PGD: 1) Use a Patient Group Direction when the health professional administrating or supplying a drug is not doing so at the specific instruction of a registered medical practitioner. Otherwise use a Patient Specific Direction (PSD). 2) You do not need to use either a PSD or PGD when a doctor can write conveniently an individual prescription. 3) The only individuals allowed to supply and administer under a PGD are: a. Those who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State b. State registered paramedics. c. Pharmacists. d. Registered health visitors. e. Registered midwives. f. Registered nurses. g. Registered ophthalmic opticians. h. State registered chiropodists. i. State registered orthoptists. j. State registered physiotherapists. k. State registered radiographers. 4) Include in the Direction a. the period during which the Direction shall have effect; b. the description or class of prescription only medicine to which the Direction relates; c. whether there are any restrictions on the quantity of medicine which may be supplied on any one occasion, and, if so, what restrictions; d. the clinical situations which prescription only medicines of that description or class may be used to treat; e. the clinical criteria under which a person shall be eligible for treatment; f. whether any class of person is excluded from treatment under the Direction and, if so, what class of person g. whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances; h. the pharmaceutical form or forms in which prescription only medicines of that description or class are to be administered; i. the strength, or maximum strength, at which prescription only medicines of that description or class are to be administered; j. the applicable dosage or maximum dosage; k. the route of administration; l. the frequency of administration; m. any minimum or maximum period of administration applicable to prescription only medicines of that description or class; n. whether there are any relevant warnings to note, and, if so, what warnings; o. whether there is any follow up action to be taken in any circumstances, and, if so, what action and in what circumstances; p. arrangements for referral for medical advice; q. details of the records to be kept of the supply, or the administration, of medicines under the Direction. 7