Patient Group Direction

Transcription

1 This Patient Group Direction (PGD) must only be used by registered community 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 PGD should be used. Patient Group Direction for the supply of Azithromycin 250mg tablets by registered community pharmacists for uncomplicated chlamydia trachomatis infection in Public Health Dorset Version number: 3 CHANGE HISTORY Version Change details Date number First draft November Second draft, minor amendments in line with comments from December 203 Medicines Optimisation Group 3 Final version, amendments to align with revised service February 204 specification (training requirements, number of condoms, care pathway), and revised section on cautions. so" June 206 November 203 3st October 206

2 PGD DEVELOPMENT Name Job title and organisation Signature Date Emma Wilson Senior Health Programme Advisor, Dorset County Council ~,L Dr Paul Mason GPAdvisor to the Dorset CCG,fiJ)~ ~/2-II't Medicines Team Katherine Gough Representative of other professional group using PGD Other members of the PGD working group Head Of Medicines Management, Dorset CCG "'/A' Hayley Howells, Pharmacy Technician, Dorset CCG tllt~lln f/~{i't " V\~~ 5/l/ (4-- " PGD AUTHORISATION Name Job title and organisation Signature Date Senior doctor Consultant in Public Health, 3/4/204 Dr Jane Horne Dorset County Council ~"" Senior pharmacist Katherine Gough Senior representative of professional group using the PGD Person signing on behalf of authorising body Head Of Medicines Management, Dorset CCG N/A Dr Jane Horne Consultant in Public Health, Dorset County Council. u kpj..{m q (LI't ~ ", 3/4/204 PGD ADOPTION BY THE PROVIDER Name Joi)title'and organisation Signature Date Lead Pharmacist so" June 206 November 203 3st October 206 2

3 TRAINING AND COMPETENCY OF REGISTEREDCOMMUNITY UNDER THE PGD Qualifications and professional registration Initial training PHARMACISTS WORKING Requir.el'lents of registered community pharmacists working under the PGD Registered Pharmacist Before offering the service, all Pharmacistsproviding treatment under this PGDmust complete the CPPEonline assessmenton Safeguarding Children Relevant CPDsuch as CPPEchlamydia screening and treatment training or a similar course. Competency assessment Ongoing training and competency Regular updates through CPPEchlamydia screening and treatment training or a similar course Able to demonstrate competency in line with the NICE Good Practice Guidance: Patient group directions: competency framework for health professionals using patient group directions. Accessto relevant up to date information and to comply with the standards for safe administration of medicines. The pharmacy must have a copy ofthe Current BNF available for reference and be familiar with the information in the BNFabout azithromycin. Linesof accountability A registered pharmacist is accountable for his or her actions in accordance with the General Pharmaceutical Council. All registered pharmacists are personally accountable for their practice and in the exercise of professional accountability there is a requirement to maintain and improve their professional knowledge and competence. The PGDmay only be used within the confines of the service specification by pharmacists and pharmacies contracted by PH Dorset. ReferenceNumber: Reviewdate: so" June206 Validfrom: Expirydate: November203 3st October206 3

4 CLINICAL CONDITION Clinical condition or situation to which this PGDapplies Inclusion criteria Exclusion criteria Cautions (including any relevant action to be taken) Arrangements for referral for medical advice Action to be taken if patient excluded Action to be taken if patient declines treatment Uncomplicated chlamydia trachomatis infection diagnosed by positive or equivocal Nucleic Acid Amplification Technique (NAAT)test Epidemiological treatment of contacts of men and women diagnosed with chlamydia trachomatis infection Asymptomatic sexually active men and women aged under 25 years. Asymptomatic contacts of men and women with known chlamydia (including those aged 25 and over) Symptoms of chlamydia or its complications Symptoms suggestiveof other STls(any discharge or unusual lumps, bumps, blisters or sores around genital or anal area) Renalor hepatic impairment History of cardiac disease Pregnancyor breast feeding Known hypersensitivity to azithromycin, any macrolide antibiotic or any excipient Patients taking azithromycin for any other infection Patients taking any of the medicines listed ascontraindications in drug interaction section (see below) Patients who weigh lessthan 45kg Patients under 6 years of agewho are considered not to be sufficiently mature to make an informed choice (Fraser Competence) Patients taking drugs that prolong QT interval Patients with myasthenia gravis Refer to GPor local GUM clinic as below. Referral back to locally commissioned sexual health provider as outlined in Care Pathway for Chlamydia Positive Service Users Attending Satellite Treatment Venues including Pharmacy Refer to general practitioner or GUM clinic (urgent, especially if symptoms suggestcomplicated chlamydia infection). Document on the PGDconsultation form. Advise the patient of the risks of remaining infected with chlamydia. Offer information about other local GUM services. so" June 206 November 203 3st October 206 4

5 Drugs that are contraindicated due to interactions are: Interactions Ciclosporin Terfenadine Theophylline Digoxin Disopyramide Rifabutin Ergotamine and ergot derivatives Coumarin anticoagulant therapy, e.g.warfarin Please see current BNF for full details of all interactions. DETAILS OF THE MEDICINE Name, form and strength of medicine Azithromycin 250mg tablets Legal category Prescription Only Medicine Indicate any off-label use (if relevant) Route/method of administration Dose and frequency Quantity to be administered and/or supplied Maximum or minimum treatment period Adverse effects Not relevant Oral 4 x 250mg azithromycin tablets (not capsules) 4 x 250mg azithromycin tablets (not capsules) A single 9 (4 x 250mg tablets) dose to be taken at the time of the consultation As with erythromycin and other macrolides, rare serious allergic reactions including angioneurotic oedema and anaphylaxis have been reported with azithromycin Azithromycin may causedizzinessand drowsiness so affected individuals should not drive or operate machinery. Common side effects: nausea,vomiting, diarrhea and abdominal discomfort (pain, cramps) Uncommon side effects: convulsions (asseen with other macrolides), headache, somnolence, taste perversions, syncope loose stools, flatulence, digestive disorders, anorexia, dyspepsia, allergic reactions including pruritus and rash, arthralgia, vaginitis Report all serious suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using a Yellow Card (even if they are listed in the product information, in the BNF,or above). 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 a doctor, pharmacist or nurse. so" June 206 November 203 3st October 206 5

6 Recordsto be kept Follow-up advice to be given to patient or carer PATIENT INFORMATION Written information to be given to patient or carer Complete the PGDconsultation form including where appropriate the assessmentof FraserCompetence The completed form must be signed by the pharmacist and kept in the pharmacy for a minimum of 5 years The pharmacy must make a record of the supply on the patient medication record Re-treatment may be needed in patients who have not completed the course of treatment or have had unprotected sex with an untreated partner, including within one week of starting treatment if both treated simultaneously If re-treatment is required refer to GUM clinic or GP Take all four tablets together as a single dose with a glassof water Tablets can be taken with or without food Where possible avoid antacids. If using antacids, take azithromycin tablets at least one hour before or two hours after the antacid In females taking oral contraceptives, if they do experience vomiting or diarrhoea after taking azithromycin tablets, this may lead to contraceptive failure. They should refer to the instruction leaflet that comes with their oral contraceptive pill, to minimise the risk of contraceptive failure. There is no interaction between azithromycin and oral contraceptives; the warning is related to risk of vomiting/diarrhoea after taking azithromycin They and their partner(s) should refrain from sex (including vaginal, oral, anal sex and using sex toys) until both (all) of them have been treated and they have waited for seven days after the last person of the partnership has been treated Patients should be advised to seek urgent medical attention if they develop early symptoms of anaphylaxis such as breathlessness,swelling or rash Patients should be advised to seek medical attention if they develop symptoms of hypersensitivity reactions The product information leaflet must be given to the patient. Written and verbal information about chlamydia and other sexually transmitted infections and safer sex must be provided A supply of three condoms must be offered to the patient. so" June 206 November 203 3st October 206 6

7 APPENDICES Appendix A Key references. Summary of Product Characteristics for azithromycin, accessed via: 2. The current edition of the BNF ( 3. NHS Executive HSC2000/026. Patient Group Directions (England Only), London Practice Guidance: Azithromycin (RPSGB,November 2008) so" June 206 November 203 3st October 206 7

8 Appendix B Health professionals' agreement to practise Patient Group Direction for the Supply and/or Administration of azithromycin (4 x 250mg) tablets This Patient Group Direction is for use in...pharmacy Or by a locum pharmacist in pharmacies approved to offer the service D D The direction must be read, agreed to and signed by each of the pharmacists who work within it. All professions must act within their appropriate Code of Professional Conduct. One copy should be given to each pharmacist with the master copy being kept by the manager of each pharmacy approved to offer the service. I confirm that I have read and understood the content of this Patient Group Direction and that I have received the appropriate training in order to implement it effectively. I agree to work within its parameters. Name of community pharmacist Senior representative Signature authorising community Date pharmacist so" June 206 November 203 3st October 206 8

9 Azithromycin PGD consultation form A B C Patient is aged under 25 and chlamydia infection has been diagnosed by positive or equivocal NAATtest Patient is any age and is a contact of a patient diagnosed with chlamydia Patient is asymptomatic Either A or B must apply and C must apply in all cases. If not, refer to a medical practitioner. Name Date of Birth Age (if under 6 assess Fraser Competence) Date Seen Time Seen Do any of the following apply to the person? YES NO Symptoms of Chlamydia or its complications: Women: pain when passing urine, bleeding between periods, unusual vaginal discharge, bleeding after sex, pain when having sex, any lower abdominal or pelvic pain. Men: discharge from penis, pain when passing urine, pain or swelling in the testicles. Symptoms suggestive of other STls: Any discharge or unusual lumps, bumps, blisters or sores around genital or anal area. Renal or hepatic impairment History of cardiac disease Pregnant or breast feeding Known hypersensitivity to azithromycin, any macrolide antibiotic or any excipient Taking azithromycin for any other infection Patient weighs less than 4Skg Patient is under 6 years of age and is not considered to be sufficiently informed choice (Fraser Competence) mature to make an Young people under the age of 8 years where there is known or suspected child abuse Taking any of the following drugs: Ergotamine or ergot derivatives, ciclosporin, digoxin, theophylline, disopyramide, rifabutin, terfenadine or coumarin type anticoagulants (such as warfarin) If the answers to any of the above are YES,the person must be referred to the GUM clinic or a GP. The advice given should be documented and a referral form completed. so" June 206 November 203 3st October 206 9

10 When supplying Azithromycin tablets under the PGD please ensure that verbal advice is given and backed up with written advice. Azithromycin operate machinery. may cause dizziness and drowsiness so affected individuals should not drive or Common side effects: nausea, vomiting, diarrhea and abdominal discomfort (pain, cramps) Uncommon side effects: convulsions (as seen with other macrolides), headache, somnolence, taste perversions, syncope loose stools, flatulence, digestive disorders, anorexia, dyspepsia, allergic reactions including pruritus and rash, arthralgia, vaginitis As with erythromycin and other macrolides, rare serious allergic reactions including angioneurotic oedema and anaphylaxis have been reported with azithromycin Advice Take all four tablets together as a single dose with a glass of water Tablets can be taken with or without food Where possible avoid antacids. If using antacids, take azithromycin tablets at least one hour before or two hours after the antacid In females taking oral contraceptives, if they do experience vomiting or diarrhoea after taking azithromycin tablets, this may lead to contraceptive failure. They should refer to the instruction leaflet that comes with their oral contraceptive pill, to minimise the risk of contraceptive failure. There is no interaction between azithromycin and oral contraceptives; the warning is related to risk of vomiting/diarrhoea after taking azithromycin They and their partner(s) should refrain from sex (including vaginal, oral, anal sex and using sex toys) until both (all) of them have been treated and they have waited for seven days after the last person of the partnership has been treated Patients should be advised to seek urgent medical attention if they develop early symptoms of anaphylaxis such as breathlessness, swelling or rash Patients should be advised to seek medical attention ifthey develop symptoms of hypersensitivity reactions The product information leaflet must be given to the patient. Written and verbal information about chlamydia and other sexually transmitted infections and safer sex must be provided A supply of six condoms must be given to the patient. Advise the patient to recommend that sexual contacts who may also be infected with chlamydia to seek medical advice. Re-treatment may be needed in people who have not completed the course of treatment or have had unprotected sex with an untreated partner, including within one week of starting treatment if both treated simultaneously (refer to GUM or GP). Patient understands advice given I have understood the information given to me by the pharmacist so" June 206 November 203 3st October 206 0

11 The action specified was based on the information given to me by the client, which, to the best of my knowledge, is correct. Pharmacist's name: Pharmacist's Signature: _ FRASERCOMPETENCE lis the client under the age of 6? I Yes If a client is believed to be under 6 years of age, the pharmacist must assessthe client's competence using Fraser Guidelines, and complete this separate section of the protocol. Discussion with the young person should explore the following issues at each consultation. This should be documented below: Assessment of Fraser competence Does the client appear to understand the advice given? Have you discussed informing the client's parents about the treatment? Has consideration been given to the effect on the physical or mental health of the young person if advice or treatment is withheld? YES NO IF YOU HAVE ANSWERED NO TO ANY OF THE ABOVE QUESTIONS,THE CLIENTCANNOT BE DEEMEDTO BE 'FRASER COMPETENT'. IN THIS CASE,YOU WILL NEEDTO ENSURETHEYATTEND A SEXUAL HEALTH CLINICOR SEEA GP AS SOON AS POSSIBLE. The Sexual Offences Act 2003 states that no child under 3 years is able to consent to any sexual activity. If the client is believed to be under 3 years of age, providing they have been assessed as 'Fraser competent', you should not withhold treatment, as the duty to safeguard the child from most harm, would include treating them for a sexually transmitted infection. You should record all the details of the consultation and discuss at the earliest opportunity with the Child Care Duty Team at the Local Authority (Social Services) or a member of the PCTSafeguarding Children Team (See contact details overleaf). In an emergency, you can contact the police. SAFEGUARDING CHILDREN GUIDANCE If a client appears to be under 8 years of age, the pharmacist must assess the welfare of the young person using the following protocol: SAFEGUARDINGCHILDRENASSESSMENT YES NO Is the client under 3 years of age? Is there any concern about Fraser competency? Is there any evidence of a coercive relationship young person to be seen alone) (such as older partner, reluctance to allow Is the client under 8 years of age and is the partner in a position of trust e.g. teacher/sports coach/youth worker? Is there any evidence that the young person may be engaged in prostitution? Is there any evidence of domestic violence? Is there any evidence of drug or alcohol misuse, relating to the sexual activity? Is there any evidence of threats, or attempts to gain secrecy? Is there any evidence of self-harm/psychiatric illness? Are there any other issues, which lead you to be concerned about the young person's safety or welfare? If yes, please give details: so" June 206 November 203 3st October 206

12 If you have answered yes to any of the above questions, or you have any other concerns regarding the welfare of the young person, please contact the child care duty team at the local authority (social services) or one of the CCG safeguarding children team as follows; CONTACT CONTACT DETAILS Safeguarding Children Team helpline Open 9am to 5pm Monday to Friday Your call will be transferred to the on-call safeguarding children advisor. Dorset County Council out of hours children's social work department Bridport Christchurch Ferndown North Dorset Weymouth/Portland Purbeck Dorchester/Sherborne Poole Bournemouth Out of Hours PLEASEREMEMBERTHATIFYOUSUSPECTHATA CHILDISBEINGABUSED: Discusswith the Child CareDuty Team at the LocalAuthority (SocialServices) ORDiscusswith a member of the CCGSafeguardingChildren Team ORInform the police, if you suspect a crime has been committed Don't think someone else is doing something Doing nothing is NOTan option so" June 206 November 203 3st October 206 2