Patient Group Direction (PGD) template

Transcription

1 Patient Group Direction (PGD) template Initial supply of doxycycline 100mg capsules to adults and children aged eight (8) years and over exposed to a suspected biological agent Version no: 2014/2 Valid from: 2 nd July 2014 Review date: 2 nd July 2015 Expiry date: 2 nd July 2016 Public Health England is not a legal authority for the authorisation of PGDs. Each organisation using this PGD must ensure that it is formally authorised and signed by a pharmacist, medical lead and governance lead for the organisation so that this document meets legal requirements for a PGD. The PGD is not legal or valid without this local, formal authorisation. THE PRACTITIONER MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT. This Patient Group Direction template has been produced by Public Health England to assist o r g a n i s a t i o n s s u c h a s NHS England Area Teams or others to develop and authorise a PGD that is consistent with current national guidance. Page 1 of 9

2 1. Clinical condition Situations 1. Initial chemoprophylaxis is required because of known or suspected exposure to: Anthrax or Tularemia or Another biological agent as advised by the national public health authority (Public Health England) OR where there are clinical contraindications to the use of ciprofloxacin. Note: For children aged eight (8) to twelve (12) years, follow on treatment after the initial ten (10) day course must be with a different antibiotic, not doxycycline, normally amoxicillin (unless contra-indicated). 2. A complete course of chemoprophylaxis is required because of known or suspected exposure to plague Note: No follow on course for plague is required Inclusion criteria Adults and children aged eight (8) years or over who have been exposed to a biological agent as identified above Exclusion criteria 1 Hypersensitivity to doxycycline or other tetracyclines Pregnant or breastfeeding mothers Circumstance when further advice should be sought from the doctor: 1. Patients with any exclusion criteria 2. Patients with any of the following: Systemic lupus erythematosus Hepatic impairment Porphyria Myasthenia gravis 3. Patients taking any of the following medication: Methysergide Methotrexate Sucralfate. Quinapril contains magnesium carbonate and may interfere with the absorption of doxycycline. Anticoagulants eg warfarin Penicillins Barbiturates Carbamazepine Primidone Phenytoin Ciclosporin 1 Exclusion under this patient group direction (PGD) does not necessarily mean the medication is contraindicated but it would be outside the remit of the PGD and another form of authorisation will be required Page 2 of 9

3 Action if excluded Action if patient declines Rifampicin Retinoids (isotretinoin, acitretin, tretinoin) Explain why they have been excluded and refer the patient to the supervising doctor Refer to supervising doctor. 2. Description of treatment Name of medicine Dosage form/strength Legal status Route Black Triangle Dose/s Frequency Number of doses to be supplied Is the use outwith the SPC Doxycycline Capsules 100mg Prescription Only Medicine (POM) Oral No One capsule to be taken twice daily. Twice daily Anthrax, Tularemia 20 Plague 20 - instruct patient to take one capsule twice daily for 7 days only Other biological agents as advised by the national public health authority (Public Health England) Yes doxycycline capsules are not licensed for use in people aged under 12 years. The national public health authority (Public Health England) would issue guidance in the event of incidents identified as potential severe public health risks. Storage requirements Store in original container below 25 o C Warnings including possible adverse reactions/ side effects Store out of reach and sight of children The patient should be informed of possible side effects and their management by giving the patient a copy of the marketing authorisation holder s Patient Information Leaflet and drawing their attention to the information on possible side effects. If any of the side effects become serious severe or prolonged, or if the patient notices any side effects not listed in the Patient Information leaflet, patients should not stop antibiotic treatment, but should contact their local doctor or pharmacist. Page 3 of 9

4 Reporting procedure for adverse reactions All suspected adverse reactions in children and severe adverse reactions in adults should be reported using the Yellow card system on Any serious adverse reaction to the drug should be documented in the individual s record. Medical staff should also be informed. Page 4 of 9

5 Advice to patient Check the patient has been given a copy of the manufacturer s patient information leaflet (PIL). Remind the patient that medical advice should be sought if side effects or any other unexplained effects on health are experienced. Advise the patient to swallow the capsules whole with plenty of fluid during meals in either the resting or standing position. Do not take indigestion remedies or medicines containing iron or zinc, 2 hours before or after you take this medicine. Space the doses evenly throughout the day. Keep taking this medicine until the course is finished, unless you are told to stop. Documentation Follow-up Recording/audit trail The approved practitioner must ensure maintenance of records for each supply, using the Clinical Details Form provided, and may be required to share information with appropriate parties in line with confidentiality protocols. Contact details for the patient/parent/carer must be recorded. There must be appropriate records kept and maintained by the approved practitioner to enable verification of service provision and training requirements, and provide information for internal and external audit and evaluation purposes. In all cases where a supply is made, manual records, computer records and data collection should include as a minimum the following information - Patient s name, address and date of birth - Name of medicine - Dose and form supplied - Date supplied and by whom References/resources and comments Doxycycline Summary of Product Characteristics Inhalational Anthrax - Antibiotic Schedule & Dosing Rationale for People of All Ages. CBRN Incidents: A Guide to Clinical Management and Health Protection: Pre and Post exposure prophylaxis Page 5 of 9

6 BNF 67 (2014) Tularemia, post-exposure prophylaxis Characteristics of staff Professional qualifications Pharmacists, Registered nurses. (Additional healthcare workers may be identified by the Director of Public Health Medicine or nominated deputy). Additional requirements You must be authorised by name as an approved practitioner under the current terms of this Patient Group Direction (PGD) before working to it; You must have undertaken appropriate training for working under a PGD for supply of medicines; Continued training requirements You must have undertaken training appropriate to this PGD; To be familiar with the biological agent to which the patient has been exposed, the treatment and the ability to counsel the patient on the condition. To be aware of the side effects of doxycycline. Page 6 of 9

7 4. PGD Development PGD developed, peer reviewed and ratified by the following on behalf of Public Health England: Developed & produced by: Name Date Pharmacist 2 nd July 2014 Doctor (Lead Author) 2 nd July 2014 Representative of the healthcare professionals who will work to this PGD Rosie Furner Acknowledgements Name Dr Sally Millership Jackie Lamberty Designation Doctor Pharmacist Page 7 of 9

8 5. ORGANISATIONAL AUTHORISATIONS The PGD is not legally valid until it has had the relevant organisational authorisation. It is the responsibility of the organisation that has legal authority to authorise the PGD, to ensure that all legal and governance requirements are met. Complete details below or use format agreed according to local policy. Organisation Approvals Lead Doctor DATE Lead Pharmacist Local Clinical Governance Committee e.g. DTC/MMT Additional signatories according to local policy e.g. independent contractor providers. Organisations must add an Individual Practitioner Authorisation sheet or List of Authorised Practitioners. This varies according to local policy but this should be a signature list or an individual agreement according to local policy. Page 8 of 9

9 PATIENT GROUP DIRECTION FOR INITIAL SUPPLY OF DOXYCYCLINE CAPSULES TO ADULTS AND CHILDREN OVER 8 YEARS EXPOSED TO A SUSPECTED BIOLOGICAL AGENT Individual Authorisation This PGD does not remove inherent professional obligations or accountability It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. It is also your responsibility to ensure that all consultation with patients allows a suitable level of confidentiality. Note to Authorising Authority: authorised staff should be provided with an individual copy 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 doxycycline capsules to adults and children aged over 8 years exposed to a suspected biological agent only in accordance with this PGD. Name of approved practitioner Designation/profession Professional registration number Signature Date Where required, name and signature of line manager/ professional lead authorising the above named individual Name: Signature: Date Signed copy to be returned to NHS Trust/ Board Page 9 of 9

10 NHS Greater Glasgow & Clyde Patient Group Direction (PGD) for Healthcare Professionals Doxycycline AUTHORISATION: NHSGG&C PGD & Non-medical Prescribing Sub-Committee of ADTC Chairman in BLOCK CAPITALS Signature: Date: Dr Craig Harrow 14/07/2014 Lead of the professional group to which this PGD refers: Name: Signature: in BLOCK CAPITALS Date: Gavin Gorman 14/07/2014 Pharmacist representative of PGD & Non-Medical Sub-Committee of ADTC Name: in BLOCK CAPITALS Signature: Date: Elaine Paton 14/07/2014 Antimicrobial use If the PGD relates to an antimicrobial agent, the use must be supported by the NHS GG&C Antimicrobial Management Team (AMT). A member of this team must sign the PGD on behalf of the AMT. Microbiology approval Name: Michael Da Silva Neto Designation: Antimicrobial Pharmacist Signature: Date: 14/07/2014 (on behalf of NHS GG&C AMT) Date Approved: 14 July 2014 Version: 3 Review Date: July 2015 Expiry Date: July 2016 Template Version: 2011 Page 1 of 2

11 NHS Greater Glasgow & Clyde Patient Group Direction (PGD) for Healthcare Professionals Doxycycline Local Authorisation: Service Area for which PGD is applicable: I authorise the supply/administer medicines in accordance with this PGD to patients cared for in this service area. Lead Clinician for the service area (Doctor) Name: Signature: Designation: Date: contact address: I agree that only fully competent, qualified and trained professionals are authorised to operate under the PGD. Records of nominated individuals will be kept for audit purposes. Name (Lead Professional): Signature: Designation: Date: contact address: Description of Audit arrangements: Frequency of checks: (Generally annually) Names of auditor(s): PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. Note to Authorising Managers: 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. I acknowledge that it is a legal document and agree to supply/administer this medicine only in accordance with this PGD. Name of Professional Signature Date Date Approved: 14 July 2014 Version: 3 Review Date: July 2015 Expiry Date: July 2016 Template Version: 2011 Page 2 of 2