Version Control This PGD has been agreed by the following organisations FCMS PDS Medical Doncaster CCG Lancashire CCGs including East Lancashire, Fylde and Wyre and North Lancashire CCGs Change history 31/07/17 V02 Review. No changes needed. 28/08/17 V02 Review. Minor editing changes. 17/05/18 V03 Addition of bites. 28/08/2017 Page 1 of 8
CLINICAL CONTENT OF PATIENT GROUP DIRECTION Staff Characteristics Qualifications Specialist competencies or qualifications Continuing training and education Clinical Details Indication Inclusion criteria Registered nurse, Paramedic practitioner, ECP (Paramedic) or Nurse practitioner Received training to undertake administration and supply of medicines under PGD. Has undertaken appropriate training to carry out clinical assessment of patient, leading to diagnosis. Also that such diagnosis requires treatment according to the indications listed in this PGD. The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up to date with continued professional development and to work within the limitations of individual scope or practice. Treatment of bacterial vaginosis (BV). Second line treatment of human and animal bites in patients who cannot receive co-amoxiclav (East Lancashire only). Bacterial vaginosis: Follow current CKS (Clinical Knowledge Summaries) guidance on bacterial vaginosis, including diagnosis and investigation. Note that women with asymptomatic bacterial vaginosis do not usually require treatment, unless they are undergoing termination of pregnancy. Treatment may be offered to: o Symptomatic women with a confirmed diagnosis via high vaginal swab. o Women with characteristic symptoms, who meet ALL of the following criteria: Are NOT high risk for STI (i.e. age over 25, and no new sexual partner in last 12 months, and only one sexual partner in last 12 months). Does NOT have symptoms suggestive of other conditions causing vaginal discharge (for example itch, abdominal pain, abnormal bleeding, dyspareunia, or fever). Is NOT post-natal, post-miscarriage, or post-termination. Has NOT developed symptoms after a gynaecological procedure. Has NOT had a recurrence of symptoms soon after treatment for BV or persisted following treatment for BV. Is NOT pregnant. 28/08/2017 Page 2 of 8
Human and animal bites: Patients with a human or animal bite wound. Patients with a penicillin allergy or other reason why they cannot take co-amoxiclav. Patients not receiving co-amoxiclav must receive metronidazole AND either clarithromycin (human bites) or doxycycline (animal bites) refer to other appropriate PGD also. Generally antibiotic prophylaxis is recommended for: o All human bites under 72 hours old or if there are signs of infection. o All cat bites. o All animal bites to the hand, foot, face or genitalia. o All animal puncture or crush wounds or those requiring surgical debridement. o Animal bite wounds involving bones, joints, tendons, ligaments, or suspected fractures. o Animal bites on limbs with impaired circulation. o Animal bite wounds that have undergone primary closure. o Animal bites in people who are at risk of serious wound infection (for example those who are diabetic, cirrhotic, asplenic, immunocompromised, or at extremes of age), or who have a prosthetic valve or joint. o Animal bites with delayed presentation (more than 8 hours but less than 24 48 hours). Exclusion criteria Unconfirmed (by HVS) cases not meeting criteria above. Hypersensitivity to metronidazole, nitroimidazoles or any component of the product. Pregnant or breastfeeding. Under the age of 16 years. Haemodialysis patients. Alcohol dependent or unwilling to abstain from alcohol during course. Severe hepatic impairment or hepatic encephalopathy. Patients taking busulfan, cimetidine, disulfiram, fluorouracil, lithium, mycophenolate, phenytoin. Patients with bites from non-domestic, exotic or potentially venomous animals. PGDs should be used only where appropriate, suitable and legal. PGDs should not be routinely used when an independent prescriber is available. Precautions Disulfiram-like reaction with alcohol: avoid consumption during course. Patients with peripheral or central nervous system disease: may exacerbate symptoms. Patients on coumarin anticoagulants, e.g. warfarin, will need an INR 28/08/2017 Page 3 of 8
Management of excluded patients Action for patients not wishing / unable to receive care under this PGD check within 7 days. Recent administration of oral typhoid vaccine (vaccine may be inactivated and become ineffective). Discuss with GP or Clinical Lead or refer. Make patient aware of risks and potential consequences of not taking medicine. Discuss any alternatives if available. Discuss alternative options with GP or Clinical Lead. Document discussion with patient. Description of Treatment Name of medicine Formulation and route Strength Dosage Repeated dose instructions Duration of treatment Quantity to supply Legal status Special precautions Adverse effects Metronidazole Oral tablets 400mg Bacterial vaginosis: 400mg twice daily Human and animal bites: 400mg three times daily See above 7 days Pre packed 21 tablets (discard remainder where necessary). POM Explain indications, contraindications and cautions (refer to BNF) Gastro-intestinal disturbances (including nausea and vomiting), taste disturbances, furred tongue, oral mucositis, anorexia; very rarely hepatitis, jaundice, pancreatitis, drowsiness, dizziness, headache, ataxia, psychotic disorders, darkening of urine, thrombocytopenia, pancytopenia, myalgia, arthralgia, visual disturbances, rash, pruritus, and erythema multiforme; on prolonged or intensive therapy peripheral neuropathy, transient epileptiform seizures, and leucopenia; also reported aseptic meningitis, optic neuropathy. This is not a complete list. Refer to BNF or SPC (summary of product characteristics) for full information. Advice necessary Provide the patient with the manufacturer s Patient Information Leaflet. Advise on dose and administration with reference to the cautionary label information and give any further instructions to aid compliance. Advise on storage or expiry details and to dispose of any unused medicines appropriately. Give advice on practical self-care if appropriate, including management of likely symptoms (including fever management where appropriate). Make patient aware of potential adverse effects and the action to take if they occur. 28/08/2017 Page 4 of 8
Provide appropriate worsening advice describing the range of signs and symptoms to monitor for and the action to take if they occur. Consider whether the provision of health promotion material is appropriate e.g. on smoking or lifestyle factors. Provide any advice relevant to the patient from the Precautions section above. Avoid alcohol during the course. May darken the colour of urine. Complete the course. Refer to CKS (cks.nice.org.uk/bites-human-and-animal) for current guidance on associated management and cover all points, including: o Document who was bitten, by whom/what, where and how and whether the skin was broken or blood was involved. If bitten by an animal record whether it was wild or domesticated, its state of health/behaviour, if known, and whether the attack was provoked. o Consider if any safeguarding concerns exist. o Assess the risk of tetanus and provide or arrange immunization or immunoglobulin as appropriate. o Assess the risk of blood borne viruses (human bites) and provide or arrange testing, immunisation or immunoglobulin as appropriate. o Assess the risk of rabies and refer as appropriate. o Consider whether referral for specialist care is indicated. o Provide appropriate wound management with or without closure as appropriate. o If the wound appears infected send a sample of pus or a deep wound swab for culture before cleaning the wound. o Review all bites not receiving co-amoxiclav at 24 and 48 hours to ensure they are responding to treatment. Prescribing guidance Doncaster, East Lancashire, Fylde and Wyre and North Lancashire CCG local guidelines. Relevant NICE guidelines and advice from Clinical Knowledge Summaries. Public Health England guidance on primary care management of infection. Records and Follow Up Referral arrangements Inform GP as soon as possible. Advise if worsening or no improvement to seek further medical advice. Records to be kept Patient s name, address, date of birth and consent given. Contact details of GP (if registered). Diagnosis. Dose and form administered. 28/08/2017 Page 5 of 8
Batch and expiry details. Advice given to patient (including side effects). Signature / name of staff who administered or supplied the medication. If relevant, signature / name of staff who removed / discontinued the treatment. Details of any adverse drug reaction and actions taken, including documentation in the patient s medical record. Referral arrangements (including self-care). Any serious side effects attributable to drug should be recorded and medicine management advised via yellow card system found in BNF. Follow up Advise follow up with GP/ Practice nurse. Patient Group Direction, organisation and individual authorisation signatures can be found on the managerial content sheet along with other non-clinical details relating to this patient group direction. 28/08/2017 Page 6 of 8
Patient Group Direction Owner Details of PGD owner FCMS (NW) Ltd Newfield House Vicarage Lane Blackpool FY4 4EW Patient Group Direction Authorisation Lead Doctor Dr Mark Spencer Lead Pharmacist Magnus Hird Lead Nurse Jared Tobin-Bennett Lead Paramedic Philip Glannan Organisational Authorisation for FCMS Suzy Layton Organisational Authorisation for Doncaster CCG MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION Patient Group Direction Peer Review Reviewed by Wendy Lambert, Nurse Practitioner Authorised signed copy of this PGD is held centrally at ELCCG 28/08/2017 Page 7 of 8
Individual Authorisation BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT. PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT. IT IS YOUR RESPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION. NOTE TO AUTORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THIS PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION. Name of Professional Signature Authorising Manager Date 28/08/2017 Page 8 of 8