PATIENT GROUP DIRECTION FOR THE SUPPLY OF FUSIDIC ACID CREAM 2% FOR THE TREATMENT OF IMPETIGO BY COMMUNITY PHARMACISTS UNDER THE PHARMACY FIRST SERVICE IN NHS HIGHLAND THE COMMUNITY PHARMACIST SEEKING TO SUPPLY FUSIDIC ACID FOR IMPETIGO MUST ENSURE THAT ALL PATIENTS HAVE BEEN SCREENED AND MEET THE CRITERIA BEFORE SUPPLY TAKES PLACE NHS Highland has authorised this patient group direction to help patients by providing them with more convenient access to an efficient and clearly defined service within NHS Highland. It cannot be used until Appendices 4 & 5 are completed for each clinical area Warning- Document uncontrolled when printed Further information on the use of Patient Group Directions in NHS Highland and the PGD procedure can be obtained from http://intranet.nhsh.scot.nhs.uk/organisation/adtc/pgdsg Page 1 of 12 Date direction is not valid after: 21/12/2020
Clinical indication to which this patient group direction applies Definition of situation/condition Clinical criteria for inclusion Clinical criteria for exclusion Minor staphylococcal infection of skin (Impetigo) which does not respond to first line treatment with Emulsiderm ointment. 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 yellowbrown crusts. Must obtain parental/guardian consent for treating a child under 16 years of age. Patient must be present at consultation. Multiple site skin infection. Had impetigo within the last 3 months. Use of topical fusidic acid 2% 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 Criteria for seeking further clarification from doctor Action if patient excluded from treatment Action if patient declines treatment Refer to authorised prescriber; GP or 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 Refer to authorised prescriber Document in PMR or PCR Page 3 of 12 Date direction is not valid after: 21/12/2020
Characteristics of staff authorised to take responsibility for the supply of medicines under the patient group direction Qualifications required Initial training Pharmacist registered with the General Pharmaceutical Council. The pharmacist must have successfully completed training approved by NES Pharmacy and NHS Highland. Has undertaken CPD in antimicrobial stewardship. Received and understood training to undertake the supply of medicines under a PGD and must be familiar with the content of the NHS Highland PGD PowerPoint presentation. Has undertaken appropriate training to carry out clinical assessment of patients leading to a diagnosis that requires treatment according to the indications listed in the PGD. 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. Ongoing training and competency The Pharmacist is expected to attend any additional training sessions organised by NHS Highland on an on-going basis. Maintenance of own level of updating with evidence of continued professional development. Page 4 of 12 Date direction is not valid after: 21/12/2020
Description of treatment available under the patient group direction Name, form & strength of medicine Legal status Indicate any off-label use (if relevant) Route/Method of Administration Frequency of dose/ duration of treatment Quantity to be supplied Maximum or minimum treatment period Follow-up advice to be given to patient or carer Identifying and managing possible adverse reactions Fusidic acid cream 2% (non proprietary) POM None Topical application Apply to lesions three or four times a day for five days 15g 5 day treatment Maximum of one supply within 3 months. 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 or nursery 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. Use of cream beyond 10 days will result in 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. Referral for medical advice If the skin infection spreads or there is no improvement after 5 days, seek medical advice from GP. Page 5 of 12 Date direction is not valid after: 21/12/2020
Facilities required Special considerations/ additional information Details of records required Consultation room Patient s name, address, date of birth and GP details; Date supplied & name of the pharmacist who supplied the medication; Reason for inclusion; Name and address of patient/parent/guardian/person with parental responsibility Advice given to patient/ carer; Details of any adverse drug reaction and actions taken including documentation in the patient s medical record via GP; All adverse drug reactions should be reported using the Yellow Card reporting system. References Summary of Product Characteristics last accessed [02/06/2017] last updated 23.12.15 via https://www.medicines.org.uk/emc/medicine/2374 British national Formulary (BNF) Latest edition available at https://www.medicinescomplete.com/mc/ Page 6 of 12 Date direction is not valid after: 21/12/2020
Appendix 1 Management and monitoring of Patient Group Direction Pharmacist Agreement (Authorisation Form) Supply of Fusidic Acid 2% Cream by Community Pharmacists I, confirm that I have read and understood the above Patient Group Direction. I confirm that I have the necessary professional registration, competence, and knowledge to apply the Patient Group Direction. I confirm that I have successfully completed the required training for the treatment of impetigo. I will ensure my competence is updated as necessary. I will have ready access to a copy of the Patient Group Direction in the clinical setting in which the supply of the medicine will take place and agree to provide this medicine only in accordance with this PGD. I understand that it is the responsibility of the pharmacist to act in accordance with the Code of Ethics for Pharmacists and to keep an up to date record of training and competency. Name of Pharmacist GPharm Council Registration No. Normal Pharmacy Location Signature Date Note: A copy of this agreement must be signed by each pharmacy practitioner who wishes to be authorised to use the PGD for the supply of fusidic acid 2% cream. Please fax a copy of this page to Pharmacy services on 01463 713844 or Email: nicola.mcgibbon@nhs.net Post: Pharmacy Services, Assynt House, Beechwood Park, Inverness IV2 3HG Each authorised pharmacy practitioner should be provided with an individual copy of the authorised PGD. Page 7 of 12 Date direction is not valid after: 21/12/2020
Fusidic Acid 2% Cream Clinical Risk Assessment Form Appendix 2 Pharmacy Stamp Patient name: Address: Telephone number: Date of birth: GPs name & address: Factor Yes No Notes Multiple site skin infection. If yes - refer Had impetigo within the last 3 months. Used fusidic acid 2% cream within 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 If yes refer` If yes - refer If yes - refer If yes - refer If yes - refer If yes - refer Special circumstances and any other relevant notes: Only make a supply if you are certain that, to the best of your knowledge, it is appropriate to do so. Action taken: Supply: Referral to: Advice given: The above information is correct to the best of my knowledge. I have been counselled on the use of fusidic acid 2% cream and understand the advice given to me by the pharmacist. I have been informed that information relating to the supply of fusidic acid 2% cream will be passed to my GP Carer/ Patient s signature: Date: The action specified was based on the information given to me by the patient or carer, which, to the best of my knowledge, is correct Pharmacist s signature: Date: Page 8 of 12 Date direction is not valid after: 21/12/2020
Dear Dr Patient s name: Address: DOB: Treatment of impetigo which was unresponsive to first line treatment Notification of Supply through Community Pharmacy using fusidic acid cream 2% The above patient has attended this pharmacy for assessment and treatment of impetigo. Yours sincerely..(signature).(print NAME).(PRINT Pharmacy Name).(Pharmacy phone number) Page 9 of 12 Date direction is not valid after: 21/12/2020
Appendix 3 Health professionals approved to provide care under the direction To be retained in the community pharmacy as a record of those pharmacists who have signed the PGD. An Individual Authorisation Form (Appendix 4) should be completed and returned to the Pharmacy Services Office The lead professional of each clinical area is responsible for maintaining records of all clinical areas where this PGD is in use, and to whom it has been disseminated. The manager who approves a healthcare professional to supply medicines under the patient group direction, is responsible for ensuring that he or she is competent, qualified and trained to do so and for maintaining an up-to-date record of such approved persons in conjunction with the Head of Profession. The healthcare professional who is approved to supply medicines under the direction is responsible for ensuring that he or she understands and is qualified, trained and competent to undertake the duties required. The approved person is also responsible for ensuring that administration or supply is carried out within the terms of the direction, and according to his or her code of professional practice and conduct. PATIENT GROUP DIRECTION FOR THE SUPPLY OF FUSIDIC ACID CREAM 2% FOR THE TREATMENT OF IMPETIGO BY COMMUNITY PHARMACISTS UNDER THE PHARMACY FIRST SERVICE IN NHS HIGHLAND Local clinical area(s) where these healthcare professionals will operate this PGD: Name of Healthcare Professional Signature Date Name of Manager Signature Date Page 10 of 12 Date direction is not valid after: 21/12/2020
Name of Healthcare Professional Signature Date Name of Manager Signature Date Page 11 of 12 Date direction is not valid after: 21/12/2020
Appendix 4 PATIENT GROUP DIRECTION FOR THE SUPPLY OF FUSIDIC ACID CREAM 2% FOR THE TREATMENT OF IMPETIGO BY COMMUNITY PHARMACISTS UNDER THE PHARMACY FIRST SERVICE IN NHS HIGHLAND Individual Authorisation This PGD does not remove inherent professional obligations or accountability The healthcare professional who is approved to supply medicines under the direction is responsible for ensuring that he or she understands and is qualified, trained and competent to undertake the duties required. They should submit a copy of their NES Assessment Results Training along with this authorisation form. The approved person is also responsible for ensuring that the supply is carried out within the terms of the direction, and according to his or her code of professional practice and conduct. They should also ensure that the organisation that provides their professional indemnity insurance has confirmed that this activity is included in their policy. Note to Authorising Authority: authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction and agree to provide the fusidic acid 2% cream in accordance with this PGD. Name of Pharmacist GPhC Registration Number Normal Pharmacy Location (if pharmacy locum please provide contact details) Signature Signed copy to be returned to Date Admin Assistant Pharmacy Services Office Assynt House, Beechwood Park INVERNESS. IV2 3BW FAX: 01463 713844 Page 12 of 12 Date direction is not valid after: 21/12/2020