Patient Group Direction (PGD) for the supply of Varenicline Stoke on Trent City Council Service Commencement Date - 1st January 2016
Service Specification - Premises Pharmacies providing this Service must meet the following requirements: Pharmacies will be located within the Stoke-on-Trent Local Authority boundaries. Service provision should be carried out in the private consultation room which meets standard contractual requirements The pharmacy must have access to PharmOutcomes to record the data and claim reimbursement. All pharmacy staff will have access to information on all pharmacies which have been accredited to ensure that in the event of an unexpected absence by an accredited Pharmacist, Service Users can be referred on appropriately. Expectation that service will be provided during all opening hours when a Pharmacist accredited to supply Varenicline is on duty. The Authority is looking for a range of opening times which will enable Service Users to access Varenicline at a time that is convenient to them. The pharmacy owner or the Pharmacist must notify the Authority of any planned changes to service opening times. The pharmacy owner must notify the Authority where an accredited Pharmacist moves/leaves or where the pharmacy closes or relocates.
Pharmacist - professional requirements Pharmacists supplying Varenicline via a PGD will meet the following requirements: Work in an accredited Stoke-on-Trent Pharmacy (as defined by the Authority boundaries) Ensure that professional indemnity cover is in place (NPA or other similar organisation), and confirm that this activity is included in their policy Fully registered member of the General Pharmaceutical Council (GPhC) The Pharmacist must be compliant with the Equality Act 2010 Registered with the Centre for Pharmacy Postgraduate Education (CPPE) Able to demonstrate their competencies for supplying Varenicline via a PGD through completing the CPPE Declaration of Competence (DoC) Will have completed a local face to face training session (subject to review and change by the Authority) Will supply Varenicline in accordance with the PGD
Additional requirements Will provide an initial appointment for Service Users wishing to receive Varenicline within 48 hours of being contacted by the accredited Stop Smoking Provider. All staff within the pharmacy should be made aware of this requirement. If no suitable appointments can be found the Stop Smoking Provider will need to identify a different Pharmacist. Arrangements should be put in place to enable the Service User to receive their full course of treatment at the same pharmacy At the initial appointment the accredited Pharmacist will book in advance subsequent appointments with the Service User. If Pharmacists are aware of a planned leave of absence which will affect a Service Users ability to access subsequent supplies of Varenicline this must be accounted for through either ensuring another accredited Pharmacist is available within the same pharmacy or ensuring an appointment is made with another accredited Pharmacist in a different pharmacy.
Initial referral and subsequent supplies Varenicline must only be supplied to Service Users accessing the Stoke-on-Trent Stop Smoking Service and in accordance with the PGD The initial referral will be via a telephone call to make an appointment with the Pharmacist. Pharmacists should only accept Service Users who provide a letter from an accredited Stop Smoking Provider at their initial appointment (Appendix 1a) The letters are valid for one month from the date of completion by the Stop Smoking Provider This letter will include a unique supply reference code which will need to be entered onto PharmOutcomes, to prevent fraudulent claims. All subsequent supplies must only be made upon receipt of a ‘Subsequent Supply’ letter (Appendix 1b) issued by the Stop Smoking Provider. These will also contain a unique supply code. If the system identifies that the code has already been used, the Authority and the Stop Smoking Provider should be informed immediately. If this occurs during the consultation then the Service User should not receive the supply.
Action if Pharmacist is unavailable to supply subsequent supplies of Varenicline After the initial supply of Varenicline the Service User should normally receive subsequent supplies from the same pharmacy by an accredited Pharmacist. The PharmOutcomes records for the Service User are specific to the pharmacy and if a different, service accredited Pharmacist carries out a subsequent supply they should view the initial consultation record on PharmOutcomes to confirm that this was completed to their professional satisfaction. Where a Service User is not able to use the same pharmacy for subsequent supplies (for example due to sickness absence) then the Service User can attend another participating pharmacy. In this situation the ‘new’ Pharmacist will need to re -assess the suitability for Varenicline and complete the initial assessment again.
Discharge from service Service Users will be discharged from the stop smoking service by the Accredited Stop Smoking Provider when one of the following occurs; The Service User completes the 12 week service and successfully stops smoking The Service User completes the 12 week service but does not stop smoking The Service User informs the Stop Smoking Advisor that he/she no longer wishes to receive the service Service Users who fail to attend their behavioural support sessions with the Stop Smoking Advisor will be discharged after 3 failed contacts and will be notified accordingly. When the Pharmacist experiences one of the following, the Accredited Stop Smoking Provider should be notified within 2 working days, The Service User fails to attend their appointment for Varenicline . Note: it is the Accredited Stop Smoking Providers responsibility to make 3 attempts to contact the Service User. The Service User informs the Pharmacist that he/she no longer wishes to receive the service
Key Performance Indicators Information will need to be provided on a quarterly basis % of Service Users who received an appointment within 48 hours of contacting the Pharmacist % of Service Users who’s data has been entered onto PharmOutcomes within 48 hours following their appointment. % of GPs who were informed within two working days of their patient receiving an initial supply of Varenicline % of Accredited Stop Smoking Providers who were informed within 2 working days that the Service User failed to attend their appointment for Varenicline , or who informed the Pharmacist that they no longer wish to receive the Service Service User Experience – Questionnaire The service will be subject to mystery shopper visits to ensure compliance with the service specification. General quality standards (as per all Local Authority Contracts) will have to be met
Payment details Service Charge Pharmacists will be paid monthly in arrears as follows Initial consultation fee - £15.00 Subsequent consultations - £2.50 Payment for Medication The Pharmacist will be reimbursed for the cost of Varenicline that is purchased and supplied to Service Users accessing the stop smoking service Additional requirements Prescription charges will be collected where applicable. Where clients are exempt from prescription charges Pharmacists will need to ask clients if they have evidence to support their claim All relevant information must be entered onto PharmOutcomes within 48 hours to receive payment
Questions/Queries on Specification?
Varenicline interferes with the receptors in the brain that nicotine stimulates. It partially stimulates the nicotine receptors, mimicking the effects of nicotine to reduce cravings and withdrawal effects when you stop smoking. At the same time, it partially blocks the receptors and prevents nicotine from attaching to the receptors. This blocks or blunts the effect of nicotine in people who give in to temptation and have a cigarette.
Pharmacokinetic properties Absorption Maximum plasma concentrations of Varenicline occur typically within 3-4 hours after oral administration. Following administration of multiple oral doses to healthy volunteers, steady-state conditions were reached within 4 days. Oral bioavailability of Varenicline is unaffected by food or time-of-day dosing. Biotransformation Varenicline undergoes minimal metabolism with 92% excreted unchanged in the urine and less than 10% excreted as metabolites. In vitro studies demonstrate that Varenicline does not inhibit or induce cytochrome P450 enzymes and therefore, Varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes
….continued Elimination The elimination half-life of Varenicline is approximately 24 hours Pharmacokinetics in special patient populations There are no clinically meaningful differences in Varenicline pharmacokinetics due to age, race, gender, smoking status, or use of concomitant medicinal products. Therefore dose adjustment of Varenicline is not required.
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