Patient Group Direction (PGD) for the Supply of:
AZITHROMYCIN 200mg in 5ml SUSPENSION
Prescription Only Medicine (POM)
YOU MUST BE AUTHORISED BY NAME UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION TO WHICH DIRECTION APPLIES For 1st line treatment of uncomplicated genital Chlamydia Indication Trachomatis infection and treatment of sexual contacts of clients with confirmed genital Chlamydia Trachomatis infection. For prophylaxis at time of emergency intrauterine device (IUD) insertion.
Inclusion Criteria
Azithromycin suspension is to be reserved for use for clients who cannot swallow tablets. Informed consent has been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine. Male and female clients aged 13 years or older who have had a positive genital Chlamydia result and cannot swallow azithromycin tablets. (Clients under 16 may be supplied with Azithromycin only if they fulfil Fraser Competency). Confirmed contacts, aged 13 years and over, of a Chlamydia positive partner and who cannot swallow azithromycin tablets. (Clients under 16 may be supplied with Azithromycin only if they fulfil Fraser Competency). For prophylaxis at time of emergency intrauterine device insertion.
Exclusion Criteria
Clients who have, since treatment, been at risk of re-infection from an untreated sexual partner. Informed consent has NOT been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine. Clients who can swallow azithromycin tablets. Current acute febrile illness. Seek advice as appropriate - refer to action if patient declines or is excluded (below). Age under 13 years. Refer to action if patient declines or is excluded (below). A confirmed anaphylactic reaction to a previous dose of Azithromycin or to any constituent of the medicine. Hypersensitivity to Azithromycin, or any other macrolide antibiotics (clarithromycin or erythromycin), or any of the excipients in azithromycin suspension. Pregnant or breast feeding mothers. Refer to action if patient declines or is excluded (below). Porphyria Clients aged under 16 years and weighing less than 45kg
PGD No 61 v3- Azithromycin 200mg in 5ml Suspension Approval Date: 16.2.2012 Review date: 31.3.2014 Page 1
Exclusion Criteria Continued
Cautions/Need for Further Advice
Action if Patient Declines or is Excluded
Clients aged under 16 who are assessed as not being fraser competent. History of hepatic, cardiac or renal disease. Refer to action if patient declines or is excluded (below). Currently receiving treatment with other active substance known to prolong QT interval such as Citalopram. Ref :Drug Safety Update Vol 5, Issue 5, Dec11 and SPC. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Immunocompromised clients Clients with known HIV infection Male clients with testicular pain/urinary symptoms i.e dysuria, penile discharge, haematuria Female clients with abdominal pain/unusual vaginal discharge and/or bleeding Concomitant conjunctivitis and/ or joint pain/swelling indicative of possible reactive arthritis. Patients taking any interacting drug, as listed in appendix 1 of the current BNF. Concurrent medication should always be checked for interactions before supply under the PGD. Clients unable to give full details of their current medication. Clients with any medical condition of unknown significance. Please also see Cautions/Need for Further Advice Section When the client has reservations/concerns about side effects of the antibiotic Azithromycin should be administered with caution to patients with neurological or psychiatric disorders. Hormonal combined contraceptives – some antibacterials may reduce the efficacy of combined oral contraceptives and contraceptive patches. Refer to chapter 7 of current BNF for further information. Patients who are excluded from treatment under the contraindications identified above should be referred to an appropriate medical practitioner/prescriber. This should be documented clearly in the patient‟s record. Where patients do not wish to receive treatment under this PGD, refusal and action taken should be documented in the patient‟s record. Give information about risks of disease and benefits of treatment. Advise to abstain from intercourse until treatment obtained and completed. Give information about how to recognise signs and symptoms of the disease. Give information about when the medicine may be given Consider alternative management by other PGD‟s. Consider use of Doxycycline if known hyper sensitivity to Azithromycin has been previously recorded within patient history.
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DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine Route/Method
Azithromycin 200mg in 5ml Suspension
Dosage
1g (1 x 25ml dose)
Frequency
Once only per episode of Chlamydia
Duration of Treatment
Single course of treatment
Maximum or Minimum Treatment Period Quantity to Supply Licensing Information
Single course of treatment
Oral – Azithromycin Suspension can be taken with food.
25ml ‘Off-Label’ Use of Azithromycin The manufacturer‟s Summary of Product Characteristics (SPC) for Azithromycin states that it is indicated for the treatment of uncomplicated genital infections due to Chlamydia Trachomatis. The use of Azithromycin as prophylaxis following emergency insertion of intrauterine contraception is therefore classed as „off label‟ use. Medicines can be used outside their licensing indication and be given under a PGD if such use is exceptional, justified by best practice and the status of the product is clearly described. In addition, you should be satisfied that you have sufficient information to administer the drug safely and, wherever possible, that there is acceptable evidence for the use of that product for the intended indication. (NMC 2010). This PGD follows guidance issued by the Faculty of Sexual and Reproductive Healthcare which recommends prophylactic antibiotics are considered for women at higher risk of STIs (good practice point). See references.
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Common side effects include: Gastro-intestinal upset, (nausea, vomiting, abdominal discomfort, flatulance and diarrhoea). Less common side effects include: Vaginitis, anorexia, dizziness/vertigo, convulsions, headache, drowsiness, disturbances of smell and/or taste, dyspepsia, rash, pruritus and arthralgia Refer to the current British National Formulary (BNF) and the current product SPC for a full list of side effects.
Side Effects
Report all serious suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card or on- line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Yellow cards may be completed by any healthcare professional or the patient. It is the responsibility of the healthcare professional identifying the suspected ADR to report it.
Special Considerations / Additional information Advice to Client
Azithromycin must be kept in a lockable cabinet when not in use, in conditions under 25 degrees centigrade.
The client must be given an explanation that he/she is agreeing to treatment by the relevant staff member under a Patient Group Direction and that he/she should be offered an appointment to a doctor as an option. Clients should always be signposted appropriately if this is the case, and should be followed up with reference to care pathways. Provide the manufacturerâ€&#x;s leaflet and advise the patient to read it. Give advice on Chlamydia Trachomatis infection and discuss treatment. Advise on possible side effects, including the possibility of gastrointestinal upset and skin rash, and encourage client to report serious side effects to the service or GP. Advise to contact service, GP, or attend Accident and Emergency if severe drug reaction occurs. Dose to be taken ideally whilst in the clinic setting. The medicine can be taken with food. After taking the suspension a bitter after-taste can be avoided by drinking fruit juice directly after swallowing. Advise complete abstinence from any sexual contact for 7 whole days after treatment and for 7 days after partner has completed treatment Emphasize the importance and need for sexual partner(s) to be treated. Warn of the risk of re-infection if sexual contact with an untreated partner.
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Follow Up
Advise patient to return to clinic for alternative treatment if vomiting occurs within 3 hours of administering medication. Advise on the potential reduction of contraceptive effect of combined hormonal contraception and also if sickness and Diarrhoea occur. Refer to chapter 7 of current BNF for further information. Advise patient on follow up care arrangements if required. Follow up is not required for clients with uncomplicated infection unless compliance is poor (and where re-treatment is suggested according to BASHH guidelines). Advise patient to seek further medical advice if: The condition worsens, does not improve, or they have not fully complied with treatment. Client vomits within 3 hours of taking Azithromycin. There has been a re-infection risk. They experience any hypersensitivity reaction
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REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements
Referral arrangements (including self-care) to be documented in patients notes. If patient is excluded from this PGD refer to an appropriate medical practitioner/prescriber. Patients should be either referred, as appropriate, to an independent prescriber, the GP, clinic doctor, Local Care Direct, GUM clinic or A&E for further assessment and advice. This should be recorded in the client‟s case notes.
Records/Audit Trail
The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary: Patient‟s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented. Contact details of GP if applicable Dose supplied and route Batch number and expiry date Advice given to patient (including side effects) Date supplied Name of staff who supplied the medicine Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patient‟s medical record. Current medication Known allergies Diagnosis CaSH Services The following additional records should also be taken: Sexual history Menstrual history Contraception used BMI LMP Blood pressure Weight Height Bleeding pattern Any problems Information given (written/verbal) Past medical history Family history Drug treatment Follow up appointment Signature of clinician
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Records/Audit Trail continued
Chlamydia Screening Service The following additional records should also be taken: Sexual history Menstrual history Contraception used LMP Bleeding pattern Any problems Information given (written/verbal) Past medical history Drug treatment Signature of clinician
Staff Characteristics Qualifications Specialist Training or Qualifications
Continuing Training & Education
Registered nurse with current registration working within Locala Registered nurses working in CaSH must also hold a recognised post registration qualification in Contraception and Sexual Health. Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent in working under PGDs for the supply and administration of medicines Has undertaken training and is competent in the recognition and treatment of anaphylaxis. Has undertaken training and is competent in resuscitation skills. Has undertaken training appropriate to this PGD such as updates in contraception and sexual health at recommended intervals and understanding the clinical aspects of sexually transmitted infection screening and treatment Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD. Keep updated via departmental meetings and updates Has undertaken training appropriate to 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 their scope of practice. Practitioner should have access to current BNF, Faculty of Contraception and Sexual Health Guidance, and updated DOH advice where appropriate. Annual training at the Locala update on resuscitation skills and management of anaphylaxis within the community. In service training/awareness in the treatment of Chlamydia Trachomatis.
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References/Resources SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ and comments BNF 62 September 2011 chapters 5 and 7 http://www.bnf.org/bnf/ DH http://www.dh.gov.uk/ MHRA http://www.mhra.gov.uk/ - Drug Safety Update Vol 5, Issue 5, Dec2011 at http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON137769 Faculty of Sexual Health & Reproductive Healthcare Clinical Guidance – Intrauterine Contraception, November 2007. Available online at: http://www.fsrh.org/pdfs/CEUGuidanceIntrauterineContraceptionNov07.pdf Faculty of Sexual Health & Reproductive Healthcare Clinical Guidance Emergency Contraception August 2011 Updated Jan 2012 Available online at: http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf NMC 2010 Standards for medicines Management http://www.nmcuk.org/Documents/Standards/nmcStandardsForMedicinesManagement Booklet.pdf BASHH : The 2006 BASHH guidelines for the management of genital infection with Chlamydia trachomatis available at http://www.bashh.org/documents/61/61.pdf And 2010 update to Chlamydia testing : Chlamydia trachomatis UK Testing Guidelines 2010
Notes: SPC – Summary of Product Characteristics BNF – British National Formulary DOH – Department of Health MHRA –Medicines and Healthcare Products Regulatory Agency
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This PGD is an amended version of PGD No 61v2 ‘Azithromycin 200mg in 5ml Suspension’, which was produced in January 2010. It was updated for use within Locala Community Partnerships by the authors as listed below
Name
Position
Date
Dawn Broadbent Shirley Tabner Linda Fox Lucianne Ricketts Dawn Toothill
CaSH Clinical Nurse Manager Clinical Lead – Locala CaSH Services Community Services Pharmacy Manager Head of Medicines Management. Specialist Technician, Community Services
February 2012 February 2012 February 2012 February 2012 February 2012
Advice contained in the individual Summary of Product Characteristics (SPC) may have been overridden in accordance with guidance issued by the relevant Dept of Health (if this is applicable) This will result in an unlicensed use of a licensed product following current DOH guidance.
REVISION PROFORMA The following amendments have been made to PATIENT GROUP DIRECTION: No 61 v2 SECTION Exclusion criteria
CHANGES MADE The following exclusions have been added Currently receiving treatment with other active substance known to prolong QT interval such as Citalopram. Ref :Drug Safety Update Vol 5, Issue 5, Dec11 Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Advice to Client
Added “If sickness and diarrhoea occur following treatment” to the following statement Advise on the potential reduction of contraceptive effect of combined hormonal contraception and also if Sickness and Diarrhoea occur following treatment. Refer to chapter 7 of the BNF for further information. Advise patient on follow up care arrangements if required. Added After taking the suspension a bitter after-taste can be avoided by drinking fruit juice directly after swallowing.
Qualifications
Removed “Pharmacist – This service was never developed for this professional group.
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Individual Authorisation for the Supply of: AZITHROMYCIN 200mg in 5ml SUSPENSION by: Nurses working in Locala CaSH Service Nurses working for Locala Chlamydia Screening Programme LOCALA DOES NOT ACCEPT LIABILITY IN REPECT OF INDEPENDENTLY EMPLOYED STAFF 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. I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD. In signing this declaration the registered healthcare professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct. Name of Professional
Signature
Authorising Manager and
Date
signature
Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials. Authorising Managers For Locala staff this will be the team leader, or relevant clinical manager. Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may supply/administer medicines away from the base should have an individual copy of the relevant signed PGD with them when supplying/administering the medicine.
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Organisational Approval This patient group direction must be agreed to and signed by all health care professionals involved in its use. Locala Community Partnerships will hold the original signed copy. The PGD must be easily accessible in the clinical setting.
ORGANISATION Director of Clinical and Operational Services
Locala Community Partnership Name : Christina Quinn
Signature: Head of Medicines Management
Name: Lucianne Ricketts
Signature: Medical Lead
Date
Date:
Name: Dr Stephen Warner
Signature:
PCT Authorisation ORGANISATION Director of Patient Care and professions
NHS Kirklees Name : Sheila Dilks
Signature: Senior Medicines Management Advisor
Date
Name: Eric Power
Signature: Medical Director
Date:
Date:
Name: Jim Lee Signature:
Date:
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