PATIENT GROUP DIRECTION FOR THE SUPPLY OF FUSIDIC ACID CREAM 2% TO TREAT MINOR STAPHYLOCOCCAL SKIN INFECTIONS (IMPETIGO) IN PATIENTS AGED OVER 2 YEARS BY PHARMACISTS WORKING WITHIN NHS LOTHIAN COMMUNITY PHARMACIES MANAGEMENT OF PATIENT GROUP DIRECTION This Patient Group Direction must be read, agreed to and signed by all healthcare professionals involved in its use. The original signed copy should be held by a designated person and must be easily accessible to healthcare professionals in the clinical setting. In all cases the healthcare professional will follow the code of conduct as defined by their professional body. Name Signature Date Developed by LOCAL DEVELOPMENT TEAM Doctor Dr Sian Tucker Pharmacist Dawn Owen Approved by PGD SUB-GROUP OF THE MEDICINES POLICY COMMITTEE Chairperson Garry Todd Approved by AUTHORISED NHS LOTHIAN DRUGS AND THERAPEUTICS COMMITTEE Professor Simon Chairperson/Deputy of Committee Maxwell AUTHORISED BY Medical Director Dr Tracey Gillies LOCAL MANAGEMENT Practice/Ward/Department/Directorate Clinical Lead Practitioner Manager (if applicable) Pharmacist (if applicable) Name of Designated PGD Holder (Responsible for ensuring names of healthcare professionals issuing under this PGD are kept up to date DATE AUTHORISED FOR USE REVIEW DATE EXPIRY DATE 02/06/2017 02/06/2019 02/06/2020 1 of 7
Contractor Code Locum AUTHORISED PRACTITIONER LIST: I have read and understood the Patient Group Direction and agree to use it and acknowledge that it is my responsibility to maintain my knowledge, skills and competencies through CPD. Name Signature GPhC registration number Date 2 of 7
1. CHARACTERISTICS OF STAFF Define Practitioner Group Pharmacists working in community pharmacy within NHS Lothian Qualifications Required General Pharmaceutical Council Registration Additional requirements Undertaken appropriate training to carry out clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in this PGD Has undertaken CPD in antimicrobial stewardship Undertaken appropriate training for working under PGDs for the supply and administration of medicines. Able to assess the patient s/guardian s capacity to understand the nature and purpose of the medication in order to give or refuse consent. Continued training requirements Undertake refresher training when PGD expires Up to date knowledge in therapeutic area Undertake appropriate training as deemed necessary by NHS Lothian 2. DESCRIPTION OF TREATMENT Names of Medicines included Marketing Authorisation (previously UK Product Licence) Outwith terms of the Summary of Product Characteristics Fusidic acid cream 2% (non proprietary) YES NO 2 nd Pharmacist Check YES June Edwards Controlled Drugs Antibiotic If YES, consultation with Microbiologist/Antimicrobial Management Team Children under 13 years of age to be treated If YES, consultation with Neonatologist, Paediatrician, Public Health or Unscheduled Care NO YES Discussed with Antimicrobial Management Team YES Discussed and supported by Unscheduled Care 3 of 7
Record / Audit trail An electronic or paper record for recording the screening of patients and the subsequent supply of the drug specified in this PGD must be completed in order to allow audit of practice. This should include: Name and address of patient/parent/guardian/person with parental responsibility Patient s date of birth GP details Symptoms reported Name, strength, form and pack size of medicine supplied Dose and route of administration Date of supply to patient Signature and name in capital letters of practitioner who supplied the drug The medicine must be labelled in accordance with current version of Medicines, Ethics and Practice The patient s General Practitioner should be advised of the supply of fusidic acid cream 2% on the same, or next available working day. Exclusion criteria, record why drug not supplied These records should be retained for 8 years 4 of 7
3.1 MEDICINES and CLINICAL CONDITION Name of medicine Fusidic Acid cream 2% Define situation/condition Criteria for inclusion (including patient group) Minor staphylococcal infection of skin (Impetigo) Patient is over 2 years of age. Minor skin infection limited to a few lesions in one area of the body. The rash consists of vesicles that weep and then dry to form yellow-brown crusts. Must obtain parental/guardian consent for treating a child under 16 years of age. Patient must be present at consultation. Criteria for exclusion Multiple site skin infection. Children under 2 years of age. Had impetigo within the last 3 months. Known hypersensitivity to any component of the medicine. Presenting with any underlying skin conditions on the same area of the body as impetigo Concerns regarding patient compliance with topical medication. Non consent Action if excluded Refer to authorised prescriber; GP or Lothian Unscheduled Care NHS 24 Document in pharmacy medication record (PMR) or patient care record (PCR) Inform GP of decision to exclude and action taken (referral made), the patient medical record can be updated accordingly Action if patient declines Refer to authorised prescriber Document in Medical Records Pharmaceutical form and strength of medicine POM / P / GSL / Dose/s Route/Method Frequency (To include maximum/minimum timescales) Total dose/number Drug interactions and action to be taken Fusidic acid cream 2% POM Apply to lesions three or four times a day for seven days Topical application Apply three or four times a day for a maximum of seven days. Maximum of one supply within 3 months 15g Interactions are minimal, systemic absorption of topical Fusidic acid is negligible. See BNF for latest information. 5 of 7
Cautions (including action to be taken if caution applies) Adverse reactions and side effects including actions to be taken if adverse drug reaction is suspected ( - include yellow card details) Avoid contact of cream with the eyes Bacterial resistance among staphylococcus aureus has been reported to occur with the use of topical fusidic acid. Extended or recurrent use may increase the risk of developing antibiotic resistance. Side effects are rare, occurring in less than 1% of patients. The most frequently reported adverse reactions during treatment are: various skin reactions such as pruritus and rash, followed by application site conditions such as pain and irritation. Hypersensitivity and angioedema have also been reported. Advise to contact nurse/gp if side effects occur. For a full list of side effects-refer to the marketing authorisation holder s Summary of Product Characteristics (SPC). A copy of the SPC must be available to the health professional administering medication under this Patient Group Direction. This can be accessed on https://www.medicines.org.uk/emc/medicine/2374 If a serious adverse reaction is suspected please report to the Commission on Human Medicines (CHM) via the Yellow Card Scheme http://yellowcard.mhra.gov.uk/ Any adverse events/incidents should also be reported to the patient s GP. Additional advice and information Wash hands before and after applying cream Where possible remove scabs by bathing in warm water before applying the cream Impetigo is very infectious, to prevent it spreading ensure patients use own flannels and towels and these should be washed in a hot wash after use. Do not scratch or pick spots Suggest applying cream three times a day on school days and four times daily at other times. Inform school of the condition Do not share the cream with anyone else Advise to contact nurse/gp if condition worsens or symptoms persist Manufacturers Patient Information Leaflet should be offered. Referral, patient monitoring and follow-up If the skin infection spreads or there is no improvement after 5 days, seek medical advice from GP. 4. REFERENCES 6 of 7
1. Summary of Product Characteristics last accessed [02/06/2017] last updated 23.12.15 via https://www.medicines.org.uk/emc/medicine/2374 2. BNF [online] last accessed [02/06/2017] via http://www.bnf.org 7 of 7