Patient Group Direction (PGD) for the supply of Azithromycin BY COMMUNITY PHARMACISTS. Version Two

Transcription

1 North Somerset Patient Group Direction (PGD) for the supply of Azithromycin BY COMMUNITY PHARMACISTS Valid from: 1 st July 2012 Expiry date: 30 th June 2014 (or earlier if new information or guidance necessitates a change to the PGD) PGD Reference Number: 052/12 Version Two An electronic copy of this PGD can be accessed at North Somerset Primary Care Trusts website Originally developed by Dr Gerry Keysell and Johanna Topps in June Updated June 2012 by Johanna Topps This patient group direction has been approved on behalf of North Somerset Primary Care Trust by: Name and Job Title Signature Date Doctor Pharmacist Organisation Representative Dr Mary Backhouse Chair of North Somerset Clinical Commissioning Group Mrs Debbie Campbell Head of Medicines Management NHS North Somerset Ms Becky Pollard Director of Public Health Version updated to include: -Treatment of individuals identified by contact tracing -Exculsion added; myasthenia gravis -Exculsion added; systemic lupus erythmatosus -Exclusion added; Has received azithromycin in last 24 hours -Reduced burden of documentation for treatment suppliers -Removal of Oral Contraception interaction -Inclusion of 250mg and 500mg tablets and 250mg capsules Contact details for the Chlamydia Screening Office Monday to Friday 9am-5pm (excluding bank holidays) 1

2 Patient Group Direction (PGD) for the supply of Azithromycin This Patient Group Direction (PGD) is a specific written instruction for the supply of azithromycin to groups of patients within the area covered by North Somerset Primary Care Trust. This PGD will enable designated pharmacists to supply treatment in accordance with the following protocol and the recommendations of the Department of Health and the NHS North Somerset Medicines Policy for the safe prescribing, dispensing, administering, recording and reporting of medicines. The majority of clinical care should be provided on an individual patient basis. The supply of medicines under Patient Group Directions should be reserved for those limited situations where this offers an advantage for patient care (without compromising patient safety) and where it is consistent with appropriate professional relationships and accountability. 1. Clinical condition or situation to which the direction applies Indication Criteria for confirmation of the clinical condition Criteria for inclusion Criteria for exclusion Provision of the antibiotic Azithromycin to clients who test positive for genital chlamydia trachomatis infection diagnosed through the National Chlamydia Screening Program. Provision of the antibiotic Azithromycin to the sexual partner(s) of clients who test positive for genital chlamydia trachomatis infection diagnosed through the National Chlamydia Screening Program. Following laboratory confirmation of a chlamydia trachomatis infection the client will be contacted and informed of their test result by their local chlamydia screening office. The pharmacy has received confirmation from the local chlamydia screening office that the presenting client has tested positive for chlamydia trachomatis infection The pharmacy has received confirmation from the local chlamydia screening office that the presenting client has been a sexual contact of a chlamydia trachomatis infected client and requires treatment for suspected chlamydia trachomatis infection. Over the age of 12 years. However if the client is aged less than 16 years, they must be assessed as competent using the Fraser Guidelines/Gillick competency. The client must be excluded from receiving treatment under this PGD if one or more of the following applies: The pharmacy has NOT received confirmation from the local chlamydia screening office that the presenting client has tested positive for chlamydia trachomatis infection The pharmacy has NOT received confirmation from the local chlamydia screening office that the presenting client has been a sexual contact of a chlamydia trachomatis infected client and requires treatment for suspected chlamydia trachomatis infection The client lacks the capacity to provide written or verbal informed consent to treatment The client is 12 years or younger 2

3 Criteria for exclusion.cont d Client aged less than 16 years, thought not to be Fraser/Gillick competent Client aged less than 16 years who weights less than 45kg There is a possible or established pregnancy Breast feeding The client has known hepatic impairment The client has known renal impairment The client has known myasthenia gravis The client has known systemic lupus erythematosus. The client has known human immunodeficiency virus (HIV) infection The client has known or suspected alcohol dependence Known hypersensitivity to Azithromycin, erythromycin, macrolide antibiotics, ketolide antibiotics, azalide antibiotics or any excipients If the client has known QT-prolongation or is currently taking medications which are known to prolong the Q-T interval. Clients taking any medicine known to interact with azithromycin as listed in appendix 1 of the BNF or in the product summary of product characteristics and including but not limited to ciclosporin, Cisapride, digoxin, ergotamine, terfenadine, theophylline, disopyramide, rifabutin and coumarin anticoagulant therapy, such as warfarin. Treatment with Azithromycin within the previous twenty four hours Action if excluded Discuss the reasons for exclusion with the client Inform the Avon Chlamydia Screening Office that treatment was not supplied. Encourage the client to contact the Avon Chlamydia Screening Office as soon as possible to discuss treatment options or to visit their GP. The consultation must be documented on the PGD patient record form. Action if patient declines treatment Encourage the client to contact the Avon Chlamydia Screening Office or their GP as soon as possible to discuss treatment options 2. Description of treatment Name of Drug Formulation Quantity to supply Azithromycin Capsule or Tablet Four x 250mg capsules Four x 250mg tablets Two x 500mg tablets The current most cost effective strength/formulation should be supplied Method/route Dose and frequency of administration Oral 1000mg (one thousand milligrams) of azithromycin to be taken as a single dose, under pharmacist supervision in the consultation room. 3

4 Legal status Advice to be given to the patient before treatment is provided Advice to be given to the patient before treatment is provided...cont d POM - Prescription only medicine. Medication Capsules should be taken at least 1 hour before or 2 hours after food (this restriction does not apply to azithromycin tablets) Should be swallowed whole with plenty of fluid Avoid iron and indigestion remedies for a few hours either side of the dose Warn of risk of gastro intestinal upset and skin rashes Advise about possible candidiasis Avoid direct exposure to sunlight, ultraviolet light and sun beds. Advise client to contact the Avon Chlamydia Screening Office if they experiences vomiting within three hours of taking the azithromycin treatment Advise client that if vomiting or diarrhoea occurs this may affect hormonal methods of contraception. Discuss common side effects likely to occur in less than 1 in 10 people stomach upset, stomach cramps, feeling or being sick or diarrhoea Discuss uncommon side effects that occur in less than 1 in 100 people loss of appetite or taste disturbance loose stools, wind or indigestion soreness or itching of the vagina skin rash and /or itching joint pains dizziness, vertigo, headache, sleepiness, fits or fainting Discuss the possibility of rarer side effects that occur in less than 1 in 1,000 people.which can include the following: numbness or pins and needles skin more sensitive to sunlight than normal severe skin rash causing redness and flaking rapid or irregular heartbeat low blood pressure constipation inflammation of the bowel tiredness or weakness tongue discolouration yeast infections of the mouth and vagina (thrush) inflammation of the pancreas (pancreatitis) inflammation of the kidney or kidney failure inflammation of the liver (hepatitis), changes in liver enzymes, yellowing of the skin or eyes (jaundice) or liver failure (rarely lifethreatening) feeling nervous, angry, irritable or anxious sleeplessness (insomnia), feeling hyperactive poor hearing, temporary deafness or ringing in the ears reductions in white blood cells Swelling, oedema urticaria, including anaphylaxis bruising or prolonged bleeding after injury Advise clients that azithromycin will not treat other sexually transmitted infections 4

5 Sexual Activities Clients should be advised to abstain from any sexual contact even with condoms (vaginal/anal/oral and genital contact) for one week after receiving treatment If a current sexual partner is receiving treatment clients should refrain from sexual contact until both parties are one week post treatment. To avoid false positive results, Chlamydia testing should not be repeated until at least 6 weeks after treatment with azithromycin. Written Advice Provide the client with a copy of the manufacturer s Patient Information Leaflet (PIL) Identification and management of adverse reactions Advise the client to contact an appropriate practitioner e.g GP if the client is concerned about any changes in health that they feel may be due to azithromycin e.g problematic side-effects. Ask the client to report any adverse outcomes / side-effects from azithromycin to the pharmacy as soon as practically possible. All suspected reactions in children and serious suspected reactions in adults should be reported to the Commission on Human Medicines using the Yellow Card scheme. Supplies And Resources Available At Sites Where this PGD is in use Access to a telephone. A consultation room Access to disposable cups and potable drinking water Supplies of Azithromycin within the manufacturer s expiry date. The following will be available for reference (current editions): British National Formulary; Summary of Product Characteristics for Azithromycin BASHH UK National Guidelines for the Management of Genital Tract Infection with Chlamydia trachomatis Treatment Records Audit Trail 5 and A PGD patient record form will be completed for each consultation made under this PGD. Ideally to be completed when the client is present in the consulting room. Any adverse drug reactions subsequently reported to the pharmacy should be recorded on the PGD patient record form. Where possible record the following in clients electronic pharmacy record: Client name Client date of birth Relevant Medical history Relevant Drug history Manufacturer, brand, batch number, expiry date Dose supplied Date supplied Time(s) of supply Name of staff member who made supply Informed consent received/given (and if not given by client by whom and relationship to client) Details of any adverse reactions reported & actions taken Details of Frazer rules/gillick assessment if under 16

6 3. Characteristics of staff It is the professional responsibility of the Health Care professional to work within their level of competence. The healthcare professional will ensure he/she has the relevant training and is competent to work under this PGD. Qualification requirements The pharmacist must be a full registered member of the General Pharmaceutical Council. Additional requirements The pharmacist, working in a retail pharmacy, has undergone training for supply of Azithromycin under this PGD (completion of the CPPE package for Chlamydia screening and treatment is desirable) Trained and competent in all aspects of providing treatment via a Patient Group Direction Maintains a suitable level of knowledge with evidence of continued professional development. Has been trained in the use of the Fraser Guidelines/Gillick Competency Reference to national/local policies or guidelines Review of Prescribing, Supply and Administration of Medicines. Final Report Annex C. The Review Team, Dr. June Crown. (March 1999). SIGN Guidance Management of genital Chlamydia trachomatis infection Clinical guidelines for genital Chlamydia infection. Royal College of Physicians RPSGB Medicines, Ethics and Practice June 2004 BNSSG Contraception & Sexual Health Services Guidelines Group 2005; Training and experience requirements for BNSSG Contraception & Sexual Health Services nurses prior to use of PGDs October 2005 Department of Health (DH), Review of Prescribing, Supply and Administration of Medicines. Final Report Department of Health (DH), Patient Group Directions (England only) (HSC) 2000/026 Clinical Effectiveness Group (Association for Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases) National Guideline on the Management of Chlamydia trachomatis Genital Tract Infection Department of Health 2004, Best practice guidance for doctors and other health professionals on the provision of advice and treatment to young people under 16 on contraception, sexual and reproductive health. Gateway reference number July 2004 Faculty of Family Planning & Reproductive Healthcare 2005 Clinical Effectiveness Unit Guidance; The use of contraception outside the terms of the product licence July Faculty of Family Planning & Reproductive Healthcare 2005 Clinical Effectiveness Unit Guidance; Drug interactions with hormonal contraception April Electronic Medicines Compendium accessed Faculty of Family Planning & Reproductive Healthcare. Drug Interactions with Hormonal Contraception, Clinical Effectiveness Unit January 2011 (Updated January 2012) Centers for Disease Control and Prevention, The Sexually Transmitted Diseases Treatment Guidelines, accessed

7 4. DECLARATION BY PHARMACIST I confirm that I am competent to undertake supply of this medicine and that I have been appropriately trained to understand the criteria listed and the administration required to supply azithromycin in accordance with this Patient Group Direction Name of Pharmacist Signature of Pharmacist GPhC registration number Date signed 7

8 Date of Consultation Avon Screening Office client identification Number Pharmacy Name and Address Patient Name and DOB (optional) Patient record for the supply of Azithromycin under PGD CRITERIA F INCLUSION The pharmacy has received confirmation from the local chlamydia screening office that the presenting client has tested positive for chlamydia trachomatis infection The pharmacy has received confirmation from the local chlamydia screening office that the presenting client has been a sexual contact of a chlamydia trachomatis infected client and requires treatment for suspected chlamydia trachomatis infection. YES YES NO NO CRITERIA F ABSOLUTE EXCLUSION The client must be excluded from receiving treatment under this PGD, and referred to a medical practitioner as soon as possible, if one or more of the following criteria apply: 8 The pharmacy has NOT received confirmation from the local chlamydia screening office that the presenting client has tested positive for chlamydia trachomatis infection The pharmacy has NOT received confirmation from the local Chlamydia screening office that the presenting client has been a sexual contact of a chlamydia trachomatis infected client and requires treatment for suspected chlamydia trachomatis infection The client lacks the capacity to provide written or verbal informed consent to treatment YES NO The client is 12 years or younger YES NO Client aged less than 16 years, who is felt not to be Fraser/Gillick competent YES NO Client aged less than 16 years who weights less than 45kg YES NO Record date of last menstrual period (females only) There is a possible or established pregnancy YES NO The client is Breast feeding YES NO The client has known hepatic impairment YES NO The client has known renal impairment YES NO The client has known myasthenia gravis YES NO The client has known systemic lupus erythematosus YES NO The client has known human immunodeficiency virus (HIV) infection YES NO The client has known or suspected alcohol dependence YES NO Known hypersensitivity to Azithromycin, erythromycin, macrolide antibiotics, ketolide antibiotics, azalide antibiotics or any excipients YES NO The clients is taking any medicine known to interact with azithromycin YES NO The client has known QT-prolongation or is currently taking medications which are known to prolong the Q-T interval. The client has received treatment with Azithromycin in the previous twenty four hours YES NO ADVICE TO BE GIVEN TO CLIENT BEFE TREATMENT Capsules should be swallowed whole with plenty of fluid (not applicable to tablets) Advise avoidance of iron and indigestion remedies for a few hours either side of treatment Advise of risk of gastro intestinal upset and skin rashes Advise about possible candidiasis in clients taking antibiotics YES YES NO NO

9 Avoid direct exposure to sunlight or ultraviolet light or sunlamps/beds Advise client to contact the Avon Chlymidia Screening Office if they experiences vomiting within three hours of taking the azithromycin treatment Advise client that if vomiting or diarrhoea occurs this may affect hormonal methods of contraception. Discuss common side effects Discuss uncommon side effects Discuss possibility of rarer side effects Clients should be advised to abstain from any sexual contact even with condoms (vaginal/anal/oral and genital contact) for one week after receiving treatment Advise clients that azithromycin will not treat other sexually transmitted infections If a current sexual partner is receiving treatment clients should refrain from sexual contact until both parties are one week post treatment. Inform client that to avoid false positive results, Chlymidia testing should not be repeated until at least 6 weeks after treatment with azithromycin. Provide the client with a copy of the manufacturer s Patient Information Leaflet (PIL) DECLARATIONS The above information is correct to the best of my knowledge. I have been talked to about the use of azithromycin. I understand the advice given to me by the Pharmacist and I consent to receiving treatment. Client s Signature Date The client is unable to give written consent but has given verbal consent. Pharmacists name Pharmacists Signature Date ACTION TAKEN Azithromycin 1000mg as single dose under supervision Yes No Strength and formulation (please circle) 250mg or 500mg Tablet or Capsule Manufacturer Batch number of azithromycin Expiry date of azithromycin Pharmacists name Pharmacists Signature GPhC Registration No. Date SUSPECTED ADVERSE DRUG REACTIONS List symptoms experienced: ADR reported to pharmacy by client Date reported to pharmacy Date reported to CHM 9