Patient Group Direction Approved on Behalf of the Trust By

Patient Group Direction (PGD) For the supply administration of: Varenicline (Champix®) by community pharmacistsFor practitioners: Registered Pharmacists in Community Pharmacies commissioned by NELFT to provide smoking cessation services In Services: Community Pharmacy PGD Number: 20-2014-15 Date PGD valid from: 01 September 2014 Date of Review: 01 January 2014 Date PGD expires: 01 September 2017 (Unless change in clinical practice indicates otherwise)Authorisation:Patient Group Direction approved on behalf of the Trust by:Name: Authorisation: Date: Medical Director Steve Feast Authorisation by email 01.09.14Chief Pharmacist Heather Walker Authorisation by email 01.09.14Chief Nurse Stephanie Dawe Authorisation by email 01.09.14PGD Development Group:Name and Title: Authorisation: Date: Clinical Support Mary Knower Authorisation by email 21.08.14 Vitality Service LeadDoctor Afifa Qazi Authorisation by email 29.08.14 Associate Medical Director Pharmacist Olubusola Daramola Authorisation by email 20.08.14 PharmacistContact person (owner/clinical lead): Nicola Hill, NELFT (Smoking cessation service) Havering. Tel: 0208 532 6284 Contact person (owner/clinical lead): Mary Knower, NELFT (Vitality Health & Wellbeing Service) Thurrock. Tel: 01708 805093 Storage of master copy: NEFLT Medicine management and prescribing TeamPGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 1 of 22 Review: Audit must be undertaken at least six months before expiry of the PGD and is a requirement before it can be reviewed. Audit and monitoring is the responsibility of the smoking cessation service. Audit Tools attached (Appendix 6)Supersedes PGD (if applicable): PGD 025/121. Clinical Condition1.1 Indication and rationaleNicotine dependent smokers over the age of 18 who are accessing the Pharmacy Stop Smoking Service for help to stop smoking. Supply of varenicline would be part of a treatment programme combined with behavioural support 1.2 Criteria for Inclusion Dependent tobacco users identified as sufficiently motivated to quit with Varenicline ▼or are allergic to Nicotine or any excipients of Nicotine replacement therapy products.  Clients aged 18 and over  The client agrees to receive behavioural support according to an agreed protocol.  A full medical history is taken and documented and there are no contraindications or cautions for treatment with Varenicline▼ (see Criteria for exclusion and referral).  Client consent has been obtained and recorded after o Client and Pharmacist have discussed advantages and dis-advantages of nicotine replacement therapy and varenicline. o Explanation that the programme combines treatment with behavioural support o An informed choice of varenicline has been made. o Potential adverse effects explained and what to do if they occur o Assessment of eligibility for varenicline has been made  A paper or electronic copy of the client assessment form completed (Appendix 1)  Client has consented for information to be shared with GP, Public Health England, NELFT Smoking Cessation Service and recorded on client assessment form.  Clients who are taking other medication should be advised to keep their GP informed as to their cessation status.1.3 Criteria for Exclusion Tobacco users not sufficiently motivated to quit or use Varenicline▼  Client has had an unsuccessful attempt to quit using Varenicline ▼ in the last 3 months and has been smoking for four weeks or longer.  Hypersensitivity to Varenicline▼ or any of its excipients  Clients on other smoking cessation therapies  Patients with current (or a history of) psychiatric illness such as schizophrenia, bipolar disorder and major depressive disorder.  Any psychiatric patients – smoking cessation has been associated with an exacerbationPGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 2 of 22 of underlying psychiatric illness. Certain antipsychotic medication can be affected by stopping smoking (notably Clozapine and Olanzapine)  Client under 18 years of age  Clients over 65 years of age if renal status cannot be established.  Pregnant (or if there is a likelihood of being pregnant) or breastfeeding women  Clients with a history of renal impairment.  Clients with end stage renal disease  Clients taking Cimetidine with reduced renal function  Clients with epilepsy.  Clients with a history of myocardial infarction or at risk of myocardial infarction.  Clients taking theophylline, insulin or warfarin and other drugs metabolised by CYP1A2.  Where there is no valid consent.  Patient not registered with a GP  No consent to share information with GP, Public Health England, NELFT Smoking Cessation Service  Client is unable to supply sufficient information regarding possible exclusions to enable a decision to supply to be made(Refer to the latest version of the SPC Home - electronic Medicines Compendium (eMC) )1.3.1 Interacting drugs  Cimetidine (in severe renal impairment)  Nicotine replacement therapy (safety in combination with varenicline has not been established)  Smoking induces CYP1A2; smoking cessation may result in an increase of plasma levels of CYP1A2 substrates. Hence monitoring and /or dosage adjustment may be required for certain drugs if clients embark on a smoking cessation programme. (See list below)  Hence clients on other medications should be advised to inform their GP about starting the treatment These drugs include: o Caffeine o Clozapine o Dextropropoxyphene o Flecainide o Fluvoxamine o Olanzapine o Pentazocine o Phenylbutazone e.g. Oxazepam o Some beta blockers e.g. Propranolol o Tacrine o Tricylic Antidepressants such as imipramine Please note: This list is not exhaustive and further clarification using relevant reference sources, cross referencing the patients current medication profile, should be made by the pharmacist supplying Varenicline1.4 Action if Excluded PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 3 of 22 Discuss alternative products if suitable and/or offer a referral to their GP to provide Varenicline under their supervision if deemed appropriate by the GP. Document action in notes1.5 Action if patient declines supply / administrationNo action. Clients are free to decline treatment as motivation is required to successfully quit smoking. Document action in notes. 1.6 Adverse Drug ReactionsAll adverse drug reactions must be reported immediately to the patient’s GP.All adverse reactions must be reported for black triangle drugs and only serious adverse reactions (e.g. anaphylaxis) of all other medicines Should such a reaction occur the nurse must inform their line manager and professional lead and complete an Incident Form immediately and should be reported to the Medicines and Healthcare Products Regulation Agency (MHRA) using the Yellow Card System. Yellow Cards are available in the BNF as well as online (www.yellowcard.mhra.gov.uk). MHRA/CHM advice on Suicidal behaviour and varenicline2. Description of Treatment2.1 Name of Medicine and Legal Status Specify brand name and manufacturerVarenicline ▼( Champix®) POM – Prescription Only Medicine, Black Triangle ▼ PFIZER LIMITED2.2Name / Strength / FormVarenicline ▼0.5 mg film coated tablets Varenicline ▼1 mg film coated tablets2.3Quantity to be supplied PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 4 of 22 1st supply – 2 weeks (initiation pack containing 0.5mg x 11, 1mg x 14)2nd supply – 2 weeks (1mg x 28)3rd supply – 2 weeks (1mg x 28)4th supply – 2 weeks (1mg x 28)5th supply – 4 weeks (1mg x 56)Where the dose is reduced to 0.5mg twice a day a pack of 28 or 56 x 0.5mg tablets to be supplied as aboveTo be supplied with a pharmacy label and patient information leaflet (PIL) 2.4 DoseSmokers should set a date to stop smoking and treatment with Varenicline▼ should commence 1 to 2 weeks before this date. Day 1-3 Take one 0.5mg (white tablets) once daily Day 4-7 Take one 0.5mg twice daily Day 8 – end of treatment Take one 1mg (blue tablets) twice daily Clients who cannot tolerate the side effects (principally nausea) of varenicline, but are still motivated to continue treatment, may have their dose lowered temporarily or permanently to 0.5 mg twice daily Tablets should be swallowed whole with plenty of water and can be taken with or without food (this will help minimise possible nausea) 2.5 StorageStore at room temperature (below 300C)2.6 Route/Method of AdministrationOrally2.7 Frequency / DurationPGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 5 of 22 1st Consultation (initial) – 2 weeks (titration pack)2nd Consultation – 2 weeks3rd Consultation – 2 weeks4th Consultation – 2 weeks5th Consultation – 4 weeks (to complete the course)12 week course 2.8Management of care An agreed quit date should be recorded, preferably 7-14 days after initiation of treatment  At the end of the treatment course dose tapering (reducing to 1mg per day during last week) can be recommended if client is concerned about suddenly stopping medication.  Clients should be assessed for any signs of changes in mental status at every visit to the pharmacy2.9Advice to Patient/CarerAdvice to clients should include: Specific product advice on dosage, method of administration and side effects  Contact details for Pharmacy Stop Smoking Service  Champix information leaflet (Appendix 2)  Attend pharmacy weekly in first month, then 2 weekly until the end of the course.  Advise on common nicotine withdrawal symptoms and common side effects of varenicline  If depressed mood, stop tablets and inform GP and pharmacist. See below for more information on depressed mood  Get emergency medical help right away if you have symptoms of heart attack or stroke.  Pharmacists should be aware of the possible emergence of depressive symptoms in patients undertaking a smoking cessation attempt and advise patients accordingly. Patients should be advised to seek medical advice if symptoms occur.  It is important that client be encouraged to declare any current or history of mental illness (see information on exclusion criteria). Pharmacists should be aware of the possible stigma associated with the declaration of such conditions and therefore ensure that the client has sufficient privacy during the initial consultation to facilitate such conversations.  It is important to make sure that the client understands the following points: 1. Varenicline is not a magic cure: effort and determination are crucial; 2. It works by acting on the parts of the brain which are affected by nicotine in cigarettes; PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 6 of 22 3. It does not remove all the temptation to smoke, but it does make abstinence easier (it takes the edge of the discomfort by reducing the severity of tobacco withdrawal symptoms such as craving to smoke, irritability, poor concentration and low mood) 4. Varenicline is safe, but about a third of clients may experience mild nausea usually about 30 minutes after taking it. This reaction often diminishes gradually over the first few weeks, and most patients tolerate it without problems. MHRA/CHM advice on Suicidal behaviour and vareniclineThe following general advice should also be given:  Follow-up and obtaining further supplies  Possible changes in the body on stopping smoking e.g. weight gain  Varenicline may cause drowsiness if affected, the patient should be advised not to drive or operate machinery  If the patient forgets to take Varenicline, they should not take a double dose to make up for the one they missed. It is important they take the medication regularly and at the same time each day. If they have forgotten to take a dose, they should take it as soon as they remembered but not less than 8 hours before the next dose is due.  At the end of treatment, discontinuation of Varenicline has been associated with an increase in irritability, urge to smoke, and/or insomnia in up to 3% of patients. The pharmacist should inform the patient accordingly and discuss or consider the need for dose tapering.  The major reasons for Varenicline failure are: o Unrealistic expectations; o Lack of preparation for the fact that tablets may cause nausea; o Insufficient support from trained smoking cessation advisor Side Effects Include: Nausea is the most common side effect (about 30% of patients). This can be reduced by taking the tablet after food and with a full glass of water.  Sleep disorders/ abnormal dreams  Headache  Appetite changes  Dry mouth /taste disturbances  Drowsiness  Dizziness  Abnormal thinking  Mood swingsPGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 7 of 22 See to the latest version of the SPC for less common side effects Home - electronic Medicines Compendium (eMC) Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation and suicide attempt has been reported in patients while undergoing a smoking cessation attempt. These symptoms have also been reported when attempting to quit smoking with Varenicline▼3. Records Date of supply  Client assessment form (Appendix 1) must be completed in full and signed by pharmacist and client  Dose  Manufacturer / Brand  Batch number  Expiry date  Any adverse reactions experienced  Advice giveRecords will be kept in a secure locked place and pharmacist will comply with the Data Protection Act, Caldicott guidelines. 4. FacilitiesPharmacies must have a suitable consultation room that meets the specification for provision of advanced services (MUR) under the Pharmacy Contract. All medicines dispensed under this PGD must be procured and stored according to the requirements of the Medicines Act 2012. Details of the product(s) supplied, invoices and prescription charges collected should be recorded.5. Consent A written or electronic record of consent must be maintained in accordance with Trust Consent to Examination or Treatment Policy  Clients must be informed that information relating to the supply of Varenicline▼ under a PGD needs to be passed to other health service organisations, in particular their GP, Public Health England and NELFT Smoking Cessation service6. References6.1 References1. NICE guidance: Varenicline for smoking cessation PH 123 (2007)PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 8 of 22 2. Summary of Product Characteristics http://www.medicines.org.uk/emc/ Last Updated on eMC 25-Mar-2014 3. NHS Evidence: NHS Stop Smoking Services: service and monitoring guidance 2011/12 7. Staff Characteristics 7.1 Professional QualificationsAuthorised community pharmacist with a valid professional registration with the GPhC and accredited to provide Level 2 smoking cessation advice AND accredited to use the PGD by NELFT.7.2 Training and Competency requirements The superintendent Pharmacist must maintain records and names of individuals who are competent and signed up to operate the PGD in the pharmacy. For business with more than one pharmacy, this must be maintained for each pharmacy premise in the group.  The pharmacy must have a standard operating procedure (SOP) in place for all aspects of the service  The pharmacy must complete and submit the Pharmacy self-declaration statement (Appendix 3) and Training and competency log (Appendix 4) to NELFT smoking cessation services at the start of the financial year or if the superintendent or responsible pharmacist change. 7.3 Continuation Training & EducationThe pharmacists 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 of practiceSee ‘Providing commissioned Smoking Cessation Service for NELFT Information for Pharmacists’ for full information on competency pathway. (Appendix 5)It is essential that pharmacists involved in PGDs in any way have adequate indemnity insurance to cover the tasks they are undertaking. These apply equally to those involved in the drawing up of PGDs, accuracy checking, reviewing, those responsible for signing them (authorising), and those responsible for administering and / or supplying medicines under a PGD.Appendix 1 (1 of 2) Varenicline (Champix®) Client Assessment SheetPast/current medical historyPGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 9 of 22 Have you a history of depression or other psychiatric disorder?Have you been prescribed medication for low mood, depression or anxiety?Have you a history of kidney disease, reduced kidney function or kidney impairment?Have you even been diagnosed with a seizure (fits) disorder?Have you had a heart attack, heart disease or are you at increased risk of heart disease?Are you breast feeding, pregnant or could you be pregnant?Have you an allergy to Varenicline (Champix®) or any of the ingredients in the tablets?Have you any allergies?What medicines are you taking?Appendix 1 (2 of 2) Varenicline (Champix®) Client Assessment Sheet (continued)PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 10 of 22 Client Name:Client signature Pharmacist Date signature1st supply2nd supply3rd supply4th supply5th supplyI confirm that the information provided is a true reflection and allows my community pharmacist to provide me with the most appropriate, safe, advice and treatment for me.PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 11 of 22 Appendix 2Champix® (Varenicline) Patient Information LeafletChampix is a non-nicotine drug that is used to help people stop smoking. The drug mimics the effect of nicotine on the body and is thought to work by both reducing the urge to smoke and the pleasurable effects of smoking whilst also relieving withdrawal symptoms. It is not a magic cure and you will still need a lot of determination to stop smoking and support from your local NHS Stop Smoking clinic. You will start taking Champix® before you stop smoking and stop smoking on day 8 to14. You start taking 0.5mg once daily on days 1-3, then 0.5mg twice daily on days 4-7, then 1mg twice a day for the next 11 weeks. It is recommended that you swallow Champix® tablets whole with water. Having food as well is a good idea to prevent nausea. The course of treatment is for 12 weeks:Days 1-3 0.5mg once daily Days 4-7 0.5mg twice daily Days 8 for a further 11 weeks 1mg twice dailyMissed DoseIf you forget to take Varenicline, do not take a double dose to make up for the one you missed. It is important you take the medication regularly and at the same time each day. If you have forgotten to take a dose, take it as soon as you remember but not less than 8 hours before the next dose is due.As with all medicines, Champix® is associated with certain side effects. These have to be carefully weighed up against the known health benefits of stopping smoking. Champix® may not be suitable for all people that wish to stop smoking and it is important that you discuss your suitability for Champix® treatment with your doctor or nurse who will be familiar with your medical history. Do not drive or operate machinery until you are sure how Champix® affects you.Side EffectsVery Common Nausea Insomnia Headache Abnormal dreamsCommon Increased appetite Dizziness Metallic taste Fatigue Constipation Diarrhoea Stomach discomfort Indigestion Wind Dry mouth VomitingPlease also read the leaflet that will come with the tablets for the less common side effects. Not everyone will experience side effects. If you experience a side effect that concerns you, please consult your doctor or nurse. Champix ® is not suitable for: PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 12 of 22 People who are hypersensitive to Champix® Young people under 18 Pregnant women/breast feeding women People with severe renal diseaseCardiovascular Disease New or worsening heart and blood vessel problems have been reported primarily in people who already have cardiovascular problems. Tell your doctor if you have any changes in symptoms during treatment with Champix®. Get emergency medical help right away if you have symptoms of heart attack or stroke.Depression Depression, suicidal thoughts and behaviour as well as suicide attempts have been reported in patients trying to quit smoking with Champix® in post marketing experience. If you experience anxiety, depression or suicidal thoughts whilst taking Champix®, you must stop taking it and contact your GP or nurse.Epilepsy/Seizures Some people have reported seizures while taking Champix®. Use cautiously in patients with a history of seizures. Interactions with other medicines Champix® has no clinically meaningful drug interactions.PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 13 of 22 Appendix 3 (1of 2): Superintendent Pharmacist Copy. (Pages 1 and 2 To be completed by superintendent for each pharmacy within the group)Pharmacy self-accreditation statement for the smoking cessation serviceSIGNED for and on behalf of NELFTSignatureTitle Integrated Care Director Thurrock LocalityDate 8th April 2014SIGNED for and on behalf of the Pharmacy SignatureNameTitleDatePharmacy Name/AddressTel no: Fax no: Email: (pharmacy email)Statement: I declare that I understand the requirements of the Stop Smoking Service and I am responsible for ensuring that all staff delivering this service, on behalf of the contractor, has the necessary knowledge and competence to deliver it. I understand that I will be required to keep evidence that staff meet this requirement, which will be made available to NELFT staff during monitoring visits or on request. The information will also be shared with the Local Counter Fraud Specialist for verification, if required.I declare that I understand the requirements of the Level 2 Stop Smoking Service and that we have systems in place to deliver the service in accordance with the terms in the service level agreement and service specifications for the full duration of the pharmacy opening hours.PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 14 of 22 Appendix 3 (2of 2) (Pages 1 and 2 To be completed by superintendent for each pharmacy within the group)Name and address of pharmacy premisesName of Pharmacists Signature of Signature of Date Pharmacist Designated assessor*A copy should be available for the Practitioner’s Personal PortfolioPGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 15 of 22 Appendix 4 Training LogTraining and competency log for Smoking Cessation NCSCT Note: this is not when you have been trained by NELFT but when you have completed the NCSCT training. Name Job Title NCSCT stage 1 Date NCSCT stage 2 Date Evidence of training or competence assessment (e.g. photocopy of certificate) NB evidence need not be provided with this statement but it must be kept on the pharmacy premises and be available for inspection)PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 16 of 22 A copy of the self-accreditation statement and training log must be submitted to NELFT annually at the start of the financial year. Continue on additional sheet(s) if necessary. PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 17 of 22 Appendix 5 Providing commissioned Smoking Cessation Service for NELFT Competency Pathway Information for PharmacistsWithin NELFT, the commissioned smoking cessation services for the supply of Varenicline (Champix®) can only be provided by a Pharmacist who has: Completed the CPPE Declaration of Competence (DoC) for stop smoking form (every 2 years) http://www.cppe.ac.uk/sp/sp6.asp?PID=191&ID=205  Completed Level 2 NCSCT training  Completed the Pharmacy self –accreditation statement and Training competency log  Submits the above forms to NELFT smoking cessation services  Receives confirmation of their accreditation and the inclusion of their name within NELFT smoking cessation as a provider of this service. Vareniclince (Champix ®) for smoking cessation pathway to providing the service Steps Supporting Information 1 Understand the Model Access the information  Review the information available on the CPPE at: website so that you have an understanding of http://www.cppe.ac.uk/ the Declaration of Competence model and mycppe/ssl/myserviced your responsibilities under this model. ocs/ComPharmNara1.p df Under the DoC model a pharmacy professional is or responsible and accountable for reflecting on their www.cppe.ac.uk under learning needs and completing the relevant training to my services, learn declare themselves competent to deliver the service in more about DoC for question. community pharmacy link2 Self-Assessment Framework  Assess the competencies, suggested learning Access the information and self-assessment and review your at: competence against the framework. http://www.cppe.ac.uk/s  Identify any gaps in competency p/sp6.asp? PID=191&ID=205 The DoC framework supports and guides pharmacy or professionals in reflecting on their current competence www.cppe.ac.uk under to my services, learn deliver a service and identifies the steps needed to more about DoC for develop practice. community pharmacy link 3 Learning and Development  Use the recommended learning on CPPE Pharmacists need to PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 18 of 22 website, if needed, to fill any gaps in access CPPE competence. programmes and book It is suggested that as a minimum most pharmacists the CPPE workshop via will need to complete: the CPPE website, o LPC/NELFT PGD training for the supply www.cppe.ac.uk/ and/or administration of Varenicline (Champix®) o Level 2 NCSCT or similar Level 2 training which is available via CPPE or any other provider o LPC/NELFT Level 2 Stop Smoking Support (full day) o LPC/NELFT update training (half day) yearly. 4 Complete the self-assessment Framework Access ‘print the self- Print the self-assessment tool and complete the assessment tool’ from framework by inserting a response for each http://www.cppe.ac.uk/ competency. myCPPE/ssl/myservice 2012.asp? Ensure that you are able to answer ‘yes’ to all of the ID=205&Srv=4 self Assessment questions and would be able to or demonstrate how you meet each competency www.cppe.ac.uk under my services, access the DoC Framework then click ‘stop smoking’ under the services title 5 Declaration of Competence Certificate Access ‘print my  Generate your personalised Declaration of declaration’ from competence and Qualifications certificate. http://www.cppe.ac.uk/  Print-out, sign and date the declaration myCPPE/ssl/myservice statement (the certificate will include relevant 2012.asp? CPPE packs that have been completed). ID=205&Srv=4The self-declaration certificate has been developed to or provide evidence that a pharmacy professional has reflected on their learning needs and completed the www.cppe.ac.uk under relevant learning to declare themselves competent to my services, access deliver the service in question the DoC Framework then click ‘stop smoking’ under the services title 6 NELFT Documentation  NELFT Pharmacy self-accreditation statement for smoking cessation service. Superintendent PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 19 of 22 Pharmacist copy (Appendix 3)  NELFT Training and competency log for smoking cessation (Appendix 4)Download and complete these two forms7 NELFT Submission of Documents Thurrock Submission of information to NELFT smoking cessation NELFT Vitality Health & services: Wellbeing Service 1. NELFT Pharmacy self-accreditation statement for smoking cessation service. Superintendent Tel: 01708 805084 Pharmacist copy (Appendix 3). One to be Fax: 01708 805096 submitted for each pharmacy within a group. Email: mary knower 2. NELFT Training and competency log for @nelft.nhs.uk smoking cessation (Appendix 4) 3. Individual Pharmacist’s self-declaration Purfleet Care Centre, 4. Individual Pharmacist PGD training certificate (if Tank Hill Road, training was not done by NELFT) Purfleet. RM19 1SXIn order to meet the requirements of the PGDs used within the services, smoking cessation services within Havering NELFT NELFT Stop smoking will hold a list of pharmacists who have been service accredited to provide the service Tel: 0208 532 6284 Fax: 0203 644 2633 Email: stopsmokingservice.bd [email protected]Thames View Health Centre Barnstable Ave Barking IG11 0PR 8 NELFT Accreditation NELFT will send an accreditation to each pharmacist/pharmacy once all the relevant documents have been received and approved.This completes the pathway, pharmacist who have completed the pathway and submitted all relevant documents will be sent accreditation by NELFT. Pharmacist are able to start provide smoking cessation services for the supply of for the supply administration of Varenicline (Champix®) commissioned by NELFT after they have receive their accreditation. Sexual Health (EHC) Pathway to providing the PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 20 of 22 PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 21 of 22 Appendix 6Audit Tool Template 1 of 3 Form for the audit of compliance with governance processes for PGD or PGDs Manager or Service Lead to completeAll PGDs should be audited at least 6 months before they expireName and post of Designated Pharmacist within each pharmacy: Name and Address of PharmacyDate of audit:Tick as appropriate. If ‘no’, state action required Y N Action Required For all PGDs: Does the Superintendent Pharmacist and/or Pharmacy manager listed on the PGD or PGDs hold a current list of authorised staff? Y/NAre all Pharmacists (including locums) authorised to work under the PGD on this list? Y/NAre you confident that all medicines supplied or administered under the PGD or PGDs are stored according to the PGD where this is specified? Y/NDo the staff working under the PGD or PGDs have an up to date copy of the PGD which has governance sign off and is in date and, available for reference at the time of consultation? Y/NDo all Pharmacies have a suitable consultation room that meets the specification for provision of advanced services (MUR) under the Pharmacy Contract? Are all medicines used are procured and stored according to the requirements of the Medicines Act 2012. Y/N Does the pharmacy have a standard operating procedure (SOP) in place for all aspects of the service Y/N The questions below refer to the two audit forms which follow: Was all the information completed on audit form (Template 2 of 3) for staff records? Y/N Was all the information completed on audit form (Template 3 or 3) for patient records? Y/N Additional commentsPGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 22 of 22 Appendix 6Audit Tool Template 2 of 3 Form for audit of completion of staff training and eligibility to work under the PGDQuestion Staff Record (initials only)1. Do all the pharmacists working under this PGD have Level 2 smoking cessation training? 2. Please indicate who provides your training? (1)NCSCT (2)(NELFT) Other (please specify)2. Have all the pharmacists working under this PGD gone through the CPPE competency pathway? Y/N Do all the pharmacists working under this PGD have a copy of their CPPE personalised Declaration of competence and Qualifications certificate on the premise? 3. Have all pharmacists working in the pharmacy been authorised by NELFT to work under this PGD? Y/N CommentsPGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 23 of 22 Appendix 6Audit Tool Template 3 of 3 Form for audit of completion of Patient Records for supply or administration under this PGDQuestion Patient Record (initials only)1. Was there a written or electronic record of consent kept for each patient? 2. Was a client assessment carried out and documented for each client?3. Was a client assessment signed by each client?4. Was the exclusion criteria checked? Y/N5. Was a drug history taken? Y/N6. Was allergy status documented? Y/N7. Was the medication strength and quantity given/supplied recorded? Y/N8. Were all the contact with the client documented? 9. Was expiry date and batch number recorded of the medication supplied recorded? Y/N or N/A10. Was the health professional’s signature recorded? Y/N11. Was the patient information leaflet supplied to patient Y/N12. Did it state “given under PGD?” in the notes Y/N13. Was there a separate log by drug name to record what was supplied/given including batch number or expiry date etc.? Y/NCommentsPGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 24 of 22 PGD for the supply administration of: Varenicline (Champix®) by community pharmacists PGD No: 20-2014-15 Page 25 of 22

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