Patient Group Direction For the supply of Fusidic Acid 2% Cream This Patient Group Direction (PGD) is a specific written instruction for the supply of Fusidic Acid 2% Cream to groups of patients who may not be individually identified before presentation for treatment. This will enable the appropriate registered healthcare professional to supply/administer treatment in accordance with the following protocol, the recommendations of the Department of Health 1998, the codes and standards of conduct of their professional bodies and any guidelines issues by those bodies on the supply and administration of medicines. The majority of clinical care should be provided on an individual, patient specific basis. The supply of medicines under Patient Group Directions should be reserved for those limited situations where this offers an advantage for patients care (without compromising patient safety) and where it is consistent with appropriate professional relationships and accountability. Definition of clinical situation/condition Name of organisation(s) within which the PGD will operate Name(s) of clinical areas and locations where the PGD will operate Criteria for inclusion For the treatment of localised lesions due to staphylococcal skin infections. (Impetigo) Community Pharmacies in NHS Tayside Adults and children aged 2 years or older presenting with minor skin infection limited to a few lesions in one area of the body (i.e. isolated lesions). The rash consists of vesicles that weep and then dry to form yellow-brown crusts (golden crusting with crusty scales and signs of infection). Must obtain parental/guardian consent for treating a child under the age of 16 years. Patient must be present at consultation. PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 1 of 12
Criteria for exclusion 1. Children under the age of 2 years. 2. Multiple skin site or widespread or bullous impetigo 3. Signs of systemic illness 4. Known hypersensitivity to any ingredients of the preparation (refer to patient information leaflet) 5. Had impetigo within the last 3 months 6. Patient refuses treatment 7. Presenting with any underlying skin condition on the same area of the body as impetigo 8. Concerns regarding patient compliance with topical medication. Action if excluded Action if patient declines Follow up of patient If exclusion refer to GP or OOH for further medical attention as appropriate Document advice given. Refer to own GP or OOH for review To GP if remains symptomatic after 7 days PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 2 of 12
Characteristics of staff authorised to take responsibility for the supply or administration of medicines under this patient group direction Qualifications Required Additional Requirements Continuing Training Requirements Profession Applicable professional codes and standards of conduct Applicable guidelines for supply and administration of medicines Pharmacist currently registered with the General Pharmaceutical Council GPhC. Must have undergone training in the use of PGDs and in the legal issues associated with prescribing medication under PGDs. The pharmacist must maintain their own level of competence and knowledge in this area to provide the service. They must also be familiar with the fusidic acid cream Summary of Product Characteristics. The pharmacist must undertake an antimicrobial/infection management CPD annually. Pharmacist The current GPhC Standards of Conduct, Ethics and Performance http://www.pharmacyregulation.org/standards/c onduct-ethics-and-performance None, but guiding principles laid out in the above document. PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 3 of 12
DESCRIPTION OF TREATMENT AVAILABLE UNDER THIS PATIENT GROUP DIRECTION Name of Medicine POM/P/GSL PGD Ref No Dose/s Route Total dose number Duration Maximum or minimum treatment period Quantity to supply Advice to be given to the patient/carer Fusidic Acid 2% cream Prescription only medicine (POM) Apply thinly and evenly to affected area FOUR times daily for maximum of 7 days Topical Not more than four times daily Maximum treatment 7 days Use for a maximum of 7 days. Maximum of one supply in three months. 1 x 15g tube 1. Symptomatic improvement should be seen within a few days. Advise to seek further medical advice if no improvement in condition within 7 days. 2. Wash hands before and after applying cream. 3. Extended or recurrent application may increase the risk of contact sensitisation and the development of antibiotic resistance. 4. Successful treatment requires appropriate cleaning of the area failure to wash away the crust is a common cause of relapse. Advise crusting skin lesions should be softened by soaking in warm soapy water and where possible be removed prior to applying treatment. 5. Infection can be passed by direct contact with the lesion or through contaminated clothes or towels. Advise avoid sharing of towels, flannels etc until infection has gone. Change towels frequently to stop spread of infection and use a hot wash cycle for used towels. 6. Give advice on preventative measures to avoid reoccurrence of infection e.g. good personal hygiene, such as keeping PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 4 of 12
Identification and management of possible adverse effects Referral for medical advice Facilities and supplies required The designated hospital pharmacies OR fingernails clean and short. Do not scratch or pick spots. 7. As impetigo is easily transmitted, advise that the child should not go to nursery/school or adult to work until lesions are crusted or healed. Inform school of condition. 8. Do not share cream with anyone else. 9. Suggest applying cream three times daily on school days and four times at other times. 10. If the skin infection spreads or there is no improvement after 5 days, seek medical advice from GP. Inform of possible side effects and their management. Side effects with this product are rare however hypersensitivity reactions may 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 www.medicines.org.uk All adverse reactions that are serious or result in harm should be reported to the MHRA through the Yellow Card Scheme. Occasionally patients may experience a local mild burning sensation following use. Patients/carers should be informed of who to contact should they experience an adverse drug reaction. See action if excluded information. Ensure patient/carer is aware that if symptoms worsen or the skin infection spreads then they should seek medical advice from their GP or through the OOH centre If symptoms have not improved after five days treatment, then patients should be advised to seek further medical advice. The medication will be supplied by the community pharmacy. PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 5 of 12
community pharmacy are the sole procurement point for medicines Treatment Records A treatment record sheet must be completed in all cases and signed and dated by the patient/carer and the pharmacist. In all cases a record of supply should be made on PMR which includes: Name, strength, form and pack size of medicine supplies Drug dose and route of administartion Date of supply and name of person making supply The medicine must be labelled in accordance with requirements detailed in the current in the current version of Medicines, Ethics and Practice. The patient s GP must be notified that a supply has taken place. The patient s GP must be informed if the patient experiences an adverse drug reaction Records of supply must be kept for 8 years. Patients on concurrent medication Patient Consent Audit Trail No known problems identified Informed consent will be obtained from the patient prior to treatment. The approved practitioner must ensure maintenance of records for each supply. The information relating to the supply of medication to each individual must include as a minimum Patient s name and date of birth Date given and by whom Date and details of communication with patients GP All records must be clear and legible, and ideally, in an easily retrievable format. This information should also be stored in the PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 6 of 12
individual s medication records. Adverse Reactions Any adverse events/incidents should be reported to the PGD group in addition to any existing pharmacy processes. Pharmacists should document and report all adverse incidents through their own internal governance systems or the NHS Tayside Datix system if available. All adverse reactions (actual and suspected) will be reported to the appropriate medical practitioner and recorded in the appropriate place. Pharmacist should record in their PMR and send and SBAR to the GP as appropriate. Where appropriate a Yellow Card Report will be forwarded to the Committee on Safety of Medicines. A supply of these forms can be found at the rear of the British National Formulary. Online reporting is available at http://yellowcard.mhra.gov.uk/ AUDIT OF PATIENT GROUP DIRECTION Annual audit of documentation and recording of information - Who will carry this out and to whom will it be reported? Periodic audit of clinical outcome(s) - How often will audit be carried out? - What are the audit questions? - Who will carry out the audit(s) - To whom will the audit be reported? - To be carried out locally within each service - To be reported to Diane Robertson & Hazel Steele Audit will be carried out annually by the pharmacy. Data to be collected will include How many patients accessed this service? How many patients had antibiotics supplied? How many patients did not require fusidic acid? Any adverse events/incidents PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 7 of 12
MANAGEMENT & MONITORING OF PATIENT GROUP DIRECTION Developed By: Medical Practitioner: Dr Andrew Russell Pharmacist: Hazel Steele On Behalf of antimicrobial committee : Dr Busi Mooka Signature: Signature: Signature: Approved By: Dr Andrew Russell Lead Clinician Name: Dr Andrew Russell Signature: Tayside Area Drug & Therapeutics Committee Name: Professor Colin Fleming Signature: Date Effective: October 2017 Review Date: October 2019 Plans must be made to ensure completion of a review on or by the date above. The revised PGD will then follow on immediately. If the review date is reached and no review has taken place, then the PGD will be null and void. Interim review will be required as and when new safety information comes to light. PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 8 of 12
Declaration This protocol is authorised for use with (community pharmacy) by the individuals named below Pharmacist Date I have read and understood this PGD and have received the specified local training to implement it effectively. Name.. Designation... Signed. Date. Name.. Designation Signed. Date. Name.. Designation... Signed. Date. A copy of this agreement must be signed by each pharmacist who wishes to be authorised to use the PGD for Supply of Fusidic Acid 2% by Community Pharmacists working in Tayside Pharmacies. Please return this form (page 9) to The Pharmacy Department, East Day Home, Kings Cross Hospital, Clepington Road, Dundee DD3 8EA and retain a copy in each pharmacy premises they wish to provide the medicine from. A copy of the PGD must also be available in the pharmacy for reference. Each authorised pharmacy practitioner should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. A complete register or practitioners authorised to use this PGD will be held by Diane Roberson, Community Pharmacy Development Pharmacist. PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 9 of 12
REGISTER OF NAMED INDIVIDUALS WHO MAY SUPPLY CARE UNDER THIS PATIENT GROUP DIRECTION Date Name Qualifications PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 10 of 12
PATIENT GROUP DIRECTION TREATMENT RECORD SHEET AMEND FROM HERE PHARMACY FIRST DOCUMENTATION A treatment record sheet is required for each patient treated under a Patient Group Direction Patient Group Direction Patient Record Proforma For The Supply Of Fusidic Acid 2% Cream Under Patient Group Direction 1. PATIENT AND CONSULTATION DETAILS Date of Consultation Patient Name CHI Place of Issue 2. PATIENT HISTORY AND EXAMINATION Does the patient present with symptoms Details of minor skin infections due to impetigo? 3. CRITERIA FOR INCLUSION The patient may receive care under this Patient Group Direction (PGD) if she/he presents with symptoms of a mild (singular lesions) minor skin infections due to impetigo and is aged 2 years of age or over. 4. CRITERIA FOR ABSOLUTE EXCLUSION The patient 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: Where the patient is less than two years of age Yes No The patient/carer requests to consult with a medical practitioner on this Yes No occasion The patient has uncertainty about the safety of Fusidic Acid 2% Cream Yes No despite counselling In so far as it can be ascertained the patient/carer has not given informed Yes No consent The patient has a known hypersensitivity to any ingredients of the Yes No preparation Where the patient has signs of widespread infection or systemic illness Yes No 5. CRITERIA FOR CAUTION If the patient is taking a medicine known to interact with Fusidic Acid 2% Cream 6. COUNSELLING Mode of action, efficacy and failure rate discussed? Yes No Method and manner of administration discussed? Yes No PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 11 of 12
Advise may experience a local mild burning sensation following use. Yes No Advise on cross infection, ease of transmission and reoccurrence Yes No Advise on follow up Yes No Issue written information Yes No 7. ACTION TAKEN Supply Fusidic Acid 2% Cream - Apply thinly and evenly to affected area to FOUR times daily for maximum of 7 days Batch number of Fusidic Acid 2% Cream supplied Expiry date of Fusidic Acid 2% Cream supplied Yes No Referred to: Referral Advice Given: 8. DECLARATION 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 practitioner. Patient s/carer s Signature: Date: The patient/carer is unable to give written consent. He/She has given verbal consent. Practitioner s Signature: Date: The action specified was based on the information given to me by the patient, which, to the best of my knowledge, is correct Practitioner s Signature: Date: PATIENT GROUP DIRECTION PATIENT INFORMATION SHEET A patient information sheet has to be given to each patient treated under a Patient Group Direction PGD Fusidic Acid 2% cream, Date Effective: October 2017 Page 12 of 12