Program Guide for Pharmacists

Transcription

1 Program Guide for Pharmacists Supporting Quality Use of Medicines February Version 1 An initiative of

2 Protocol This document provides information for the Brintellix Patient Program (Program). Detailed are the specific requirements as outlined in the Terms and Conditions of the Program. Additionally, practical tips are included to assist in integrating this Program with efficient workflow practices in your pharmacy. Table of Contents Program Objective... 3 Program Overview... 3 Program Timetable... 3 Terms and Conditions... 4 Program Tasks... 4 Implementation... 5 The Kit... 5 Where to Start... 6 Implementation Checklist... 6 Staff Meeting Agenda... 6 Personalised Patient Information Leaflets... 7 Collateral/ Software Information... 8 Collateral... 8 Software... 8 Patient Identification... 8 Delivery of the Service... 9 Pharmacist Service Non-Compliance Factors Affecting Adherence Scope of Practice Information Staff Roles Clinical Basis Program Administration Good Record Keeping is Key Appendix Collateral

3 Program Objective The purpose of the Brintellix Patient Program (Program) is to assist participating pharmacies to provide patients prescribed the new anti-depressant therapy, Brintellix (vortioxetine), with additional medication support. As part of this Program a number of quality use of medicines (QUM) initiatives are to be discussed with patients in a structured manner as set out in this protocol. This is in addition to any counselling and support which a pharmacist would normally provide in the dispensing of the medicine. The Program will facilitate pharmacist engagement with patients to help ensure their quality use of medicines. Program Overview Brintellix is currently a non-pbs funded medication and Lundbeck Australia Pty Ltd is providing an enhanced professional opportunity for a select number of pharmacies to be enrolled as Brintellix Patient Program Pharmacies (Program Pharmacies). These Program Pharmacies must agree to the Program terms and conditions which are detailed in this Program protocol. The Program includes dispensing Brintellix to patients on presentation of a prescription at a price of no more than $62.00 per pack of 28 tablets for any strength (available in 5mg, 10mg, 15mg and 20mg strengths). It is envisaged that the price to patient of $62.00 will contain little or no mark-up for the pharmacy. For your assistance in dispensing and supporting patients participating in the Brintellix Patient Program, Lundbeck will pay Program Pharmacies a service fee of $25 per prescription for each original and repeat dispensing. Pharmacies are required to keep in stock one pack of the 10mg strength of the medicine as part of the Program. Lundbeck will offer guaranteed return of supply option for Program Pharmacies on stock which is held for a minimum of 4 months. Lundbeck asks Program Pharmacies to provide patients with the additional support of the Program where a number of quality use of medicines initiatives are to be discussed with patients in a structured manner as outlined in the Program. The aim of this Program is to provide patients to whom you have dispensed Brintellix, with information regarding the importance of compliance during the course of Brintellix prescribed, and to ensure health outcomes are maximised. Doctors will be informed of the name and location of Program Pharmacies where this additional patient support will be provided. Program Timetable The Program will launch on Monday, 2 February At this point in time, pharmacists will be able to initiate the Program with patients as they have their prescription for Brintellix dispensed. The pharmacy will also be able to make a claim for payment following the completion of the service. The Program materials may be updated from time to time. Any Program changes will be notified via and there will be a sixty day minimum notice period for those changes to be implemented. 3

4 Terms and Conditions A pharmacy which has agreed to become a Program Pharmacy, and has signed a participation form to enrol in the Program, has agreed to the obligations of the terms and conditions. Program Tasks In addition to the usual counselling involved with the dispensing of the medication, pharmacists and interns will support patients within the Program whereby the prescription is identified at dispensing as Original Dispense, First Repeat, Second Repeat, Third Repeat, Fourth Repeat, Fifth Repeat or Subsequent Repeat. The pharmacist is to provide to the patient the corresponding one page counselling SmartForm PDF Patient Information Leaflet (Information Leaflet). The Information leaflet file on the USB Drive is provided in two formats for each dispensing sequence number. The first format provides the ability for the pharmacist to embed the brand logo of their pharmacy in the top left corner and pharmacy details in the top right corner. The alternative format enables the two fields to be completed with the pharmacy details. On completing the dispensing of the prescription, the pharmacist or intern will approach the patient to discuss the key quality use of medicines counselling initiatives as detailed in the Information Leaflet. This leaflet also documents the elements of the Program which patients will receive from their pharmacist. Following the counselling interaction with the pharmacist or intern, a printed copy of the Patient Information Leaflet is to be provided to the patient to take home. 1. maximum price on supply to patients: Supply is on the condition that your dispensed price to patients is capped at no more than $62 per pack. Naturally, otherwise, price is at your discretion. 2. Patient program counselling by participating pharmacists/ interns: Provision of patient education by the pharmacist is not compulsory with normal dispensing of medicines; however payment of the service fee to a participating pharmacy is contingent upon your performance of the Brintellix Patient Program tasks as outlined. 3. records and audit: For each service fee claim, the Program Pharmacy is required to complete a Pharmacy Claim Form. There is an electronic option and a manual fax option for submission of the Claim Form to the Program Administration Centre. With either option the receipt must be de-identified prior to submission to ensure no personal patient details are provided to the Program Administration Centre. a. Fax option: The pharmacy may provide either a dispense prescription receipt or a point-of- sale receipt. This is then to be faxed together with the completed Claim Form to the Program Administration Centre for payment. b. option: The SmartForm PDF Claim Form has an option to insert a receipt image into the specified area. This image may be captured by photo or scan and saved as a PDF to be inserted into the document. Alternatively, a separate pdf attachment of the dispense software receipt may be ed together with the Claim Form to the Program Administration Centre. We recommend Program Pharmacies keep a record of all correspondence. We reserve the right to request further information and records. 4. Payment terms: Lundbeck will pay the service fees monthly via EFT. 5. Adverse events: The following events are to be reported to Lundbeck as soon as possible and within 24 hours of their occurrence by calling , faxing the Lundbeck Adverse Event Form to or to safetyluaustralia@lundbeck.com: a. Adverse Events (AE) defined as any untoward medical occurrence in a patient, consumer or clinical investigation subject administered a medicine and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding, symptom, or disease temporarily associated with the use of a medicine, whether or not considered related to the medicine) associated with Brintellix. b. Special cases (whether or not an AE occurred): Pregnancy or breastfeeding exposure, paternal drug exposure during conception (transmission of drug via semen), lack of drug effect, overdose, abuse/misuse, medication error, interactions, off label use, transmission of infectious agent, occupational exposure, complaint cases/ quality issue with associated medication error, unexpected therapeutic/beneficial effects. 4

5 Implementation The Kit A Brintellix Patient Program Pack (Kit) was either delivered in person or mailed to the pharmacy following the pharmacy having submitted the completed Brintellix Patient Program - Enrolment Form. The Kit includes a number of pieces of collateral to assist pharmacists and staff to implement the Program. Items Included in the Kit; 1) Cover Letter 2) Implementation Checklist 3) Staff Meeting Agenda 4) Shelf Talker (Wobbler) 5) Quick Reference Guide x 2 6) Brintellix Patient Program Information Brochure x 10 and 7) USB Drive The USB Drive contains the following files; 1) Brintellix Patient Program - Implementation Checklist 2) Brintellix Patient Program - Staff Meeting Agenda 3) SmartForm PDF Patient Information Leaflet Original Dispensing (two formats available) 4) SmartForm PDF Patient Information Leaflet First Repeat Dispensing (two formats available) 5) SmartForm PDF Patient Information Leaflet Second Repeat Dispensing (two formats available) 6) SmartForm PDF Patient Information Leaflet Third Repeat Dispensing (two formats available) 7) SmartForm PDF Patient Information Leaflet Fourth Repeat Dispensing (two formats available) 8) SmartForm PDF Patient Information Leaflet Fifth Repeat Dispensing (two formats available) 9) SmartForm PDF Patient Information Leaflet Subsequent Repeat Dispensing (two formats available) 10) Brintellix Patient Program Protocol - Program Guide for Pharmacists 11) Brintellix Patient Program - Pharmacy Enrolment Form 12) Brintellix Patient Program - Pharmacy Claim Form 13) Brintellix Patient Program - Pharmacy Wholesaler Order Form 14) Brintellix Patient Program - Pharmacy Staff Q & A 15) Brintellix Patient Program - PowerPoint for Pharmacist Training 16) Brintellix Patient Program - PowerPoint for Staff Training 17) Brintellix Patient Program - Information Brochure Program Web Portal The Brintellix Patient Program Web Portal is located at The site contains a pharmacy locator where prescribers can assist patients to locate a participating Brintellix Patient Program Pharmacy. The resources page on the site has been set up to assist pharmacists including a link to the Brintellix Approved PI and as versions of documents get updated they will be located here. This section can be accessed directly from the home page. This section of the site is not for public viewing and thus requires a Username and Password to access. Username: lundbecksupport Password: pharmacist1@ Pharmacist Login Username Password Login LogoUt Your pharmacist can provide you a free service designed to assist you with your medicine regime. Each time you visit the pharmacy to fill your prescription, you will be attended to personally by the pharmacist who will discuss your experience thus far with your medications and answer any questions or concerns you may be having. To find your nearest participating pharmacy enter your postcode here: FinD 1. Terry White Chemists Buranda Buranda Villiage Cr Ipswich Rd & Cornwall St, Buranda QLD 4102 ( Thank you for supporting the Brintellix Patient Program. Lundbeck Australia Pty Ltd is pleased to make available to Australian patients a new anti-depressant therapy, Brintellix (vortioxetine). Your pharmacy has made the choice to provide patients taking this medication with additional support. Following your program enrolment, you would have received the complete Brintellix Patient Program Pack (Kit) by mail in late January The files below are an electronic version of all of those files which can be downloaded at your convenience. Brintellix (vortioxetine) Consumer Medicine Information (CMI) Brintellix (vortioxetine) Approved PI Brintellix Patient Program - Implementation Checklist Brintellix Patient Program - Staff Meeting Agenda 2. Good Price Pharmacy Warehouse 268 Ipswich Road Annerley QLD 4103 (07) Healthworld Pharmacy Stones Corner Villiage 405 Logan Road Greenslopes QLD 4120 (07) SmartForm PDF Patient Information Leaflet Original Dispensing (Pharmacy Logo) SmartForm PDF Patient Information Leaflet Original Dispensing (No Pharmacy Logo) SmartForm PDF Patient Information Leaflet First Repeat Dispensing (Pharmacy Logo) SmartForm PDF Patient Information Leaflet First Repeat Dispensing (No Pharmacy Logo) SmartForm PDF Patient Information Leaflet Second Repeat Dispensing (Pharmacy Logo) SmartForm PDF Patient Information Leaflet Second Repeat Dispensing (No Pharmacy Logo) SmartForm PDF Patient Information Leaflet Third Repeat Dispensing (Pharmacy Logo) SmartForm PDF Patient Information Leaflet Third Repeat Dispensing (No Pharmacy Logo) SmartForm PDF Patient Information Leaflet Fourth Repeat Dispensing (Pharmacy Logo) SmartForm PDF Patient Information Leaflet Fourth Repeat Dispensing (No Pharmacy Logo) SmartForm PDF Patient Information Leaflet Fifth Repeat Dispensing (Pharmacy Logo) SmartForm PDF Patient Information Leaflet Fifth Repeat Dispensing (No Pharmacy Logo) SmartForm PDF Patient Information Leaflet Subsequent Repeat Dispensing (Pharmacy Logo) SmartForm PDF Patient Information Leaflet Subsequent Repeat Dispensing (No Pharmacy Logo) Copyright. December Brintellix Patient Program Protocol - Program Guide for Pharmacists Brintellix Patient Program - Pharmacy Enrolment Form Brintellix Patient Program - Pharmacy Claim Form Brintellix Patient Program - Pharmacy Wholesaler Order Form Brintellix Patient Program - Pharmacy Staff Q & A 5

6 . December Where to start This protocol outlines the recommended implementation process and how to use the resources included in the Kit. After reviewing Program material, pharmacies may tailor the proposed implementation process, systems and procedures to suit the pharmacy operations. Implementation Checklist The Brintellix Patient Program - Implementation Checklist is the best place to start as it outlines a number of initial tasks. As each task is completed, sign off as indicated on the checklist. The first task is to nominate one senior pharmacist staff member responsible for implementing the Program. The aim of the remaining tasks on the document is to establish the pharmacy s system and procedures for implementing the Program. Each pharmacy will tailor a procedure to ensure the efficient implementation of the Program. Each pharmacy will adapt their procedure to their dispensary workflow. As an example, a pharmacy using a dispensing robot to dispense medications will implement a different process to facilitate the Program compared to a pharmacy with a traditional dispensary design. As each task is completed it is important to mark the task as completed on the checklist. It is important that the tasks on the Implementation Checklist are completed prior to 2 February 2015, when the Program starts. PATIENT PrOgrAM IMPLEMENTATION CHECKLIST Implementation Checklist This checklist will facilitate a streamlined implementation of the Brintellix Patient Program ensuring that all staff are confident with this new Program. Please complete the below and maintain with your Quality Care Pharmacy Program (QCPP) records. Pharmacy Details Pharmacy Address: City: State: Postcode: Implementation 10 9 NO. TASK SIGNED 8 7 PATIENT PrOgrAM IMPLEMENTATION CHECKLIST Schedule a staff meeting Use the staff meeting agenda and the Kit collateral to explain the Program to staff. Ensure all staff have a copy of the Q&A sheet which is available on the USB. Ensure staff are familiar with the Q&A document. Once the staff have been trained, undertake a mock patient role play to ensure that the setup is the most efficient possible. It is important to integrate this Program in normal dispensing workflow. This Program service needs to be implemented on each and every occasion that a Brintellix prescription is dispensed, therefore it is important to ensure that all staff involved with dispensing understand the Program. This includes interns and dispensary assistants (technicians) who are involved in prescription processing. Establish a pharmacy policy administration process for submitting claims for payment, including the protocol for the pharmacy to indicate in a de-identified manner that the patient has been charged no more than $62. Other key issues NO. TASK SIGNED 1 Ensure the pharmacy owner/ manager has submitted a completed Brintellix Patient Program - Pharmacy Enrolment Form. (Copy on USB Drive) include the location where the SmartForm PDF Brintellix Patient Program Pharmacy Claim Forms are to be kept and if hard copy or electronic copy is preferred. The pharmacy owner or employee pharmacists, on the next regular contact with local GPs should inform practice staff that the pharmacy is participating in the Brintellix Patient Program. 2 A senior pharmacist staff member has been nominated as responsible for the implementation of Brintellix Patient Program Following the first month of implementation, review the systems and procedures that have been utilised in the pharmacy. Seek feedback from staff as part of this review process. The Brintellix Patient Program Web Portal is located at The site contains a pharmacy locator where prescribers can assist patients to locate a participating Brintellix Patient Program Pharmacy. The resources page on the site has been set up to assist pharmacists including a link to the Brintellix Approved PI and as versions of documents get updated they will be located here. This section can be accessed directly from the home page. This section of the site is not for public viewing and thus requires a Username and Password to access. Username: lundbecksupport Password: pharmacist1@ Ensure the Pharmacy has ordered Brintellix from your wholesaler including at least 1 (one) Brintellix 10mg x 28. Review the Wholesaler Order Form in your Kit. 3 All staff members involved in accepting prescriptions from patients at the Scripts In counter are to become familiar with the Brintellix Patient Program and should read the Protocol. This familiarisation includes elements of the Kit and materials contained on the Program USB Drive and dedicated Brintellix Patient Program web portal, Schedule a staff meeting and use the Brintellix Patient Program Staff Meeting Agenda from the Kit. Add additional meeting items if necessary Create a folder on your hard drive or server named Brintellix in order for your staff to locate the folder at any time. Save all file elements from the USB and web portal into the folder. For each of the SmartForm PDF Patient Information Leaflets, insert pharmacy brand logo and complete the pharmacy details in the top left and right corners (pharmacy name, address, opening hours, phone and fax numbers, , owner s name/s etc.) and then save the files to the folder. If you save the SmartForm PDF files with your pharmacy details you will not have to rekey these details each time this form is prepared for a patient. Depending on your dispensary layout and IT setup it may be desirable to save key Program documents in a folder on your desktop at each dispensary station. Place the hard copy pharmacy Kit collateral in the pharmacy location as indicated in the Brintellix Patient Program Protocol Program Guide for Pharmacists (this includes Shelf Talker, Quick Reference Guide, Patient Brochures, etc.) Pharmacist: Comments:. December Brintellix Patient Program - Implementation Checklist Staff Meeting Agenda Once all collateral elements are in place in the pharmacy, a staff meeting should be held and the Brintellix Patient Program - Staff Meeting Agenda, included in the Kit, should form the agenda for the meeting. All staff involved in either accepting prescriptions from patients for dispensing or handing out prescriptions once dispensed, should be included in this meeting. The meeting will go through the pharmacy s system and procedures for implementing the Program. Importantly, pharmacy assistants will understand by the end of the meeting which administrative tasks they can assist with and which tasks must be undertaken by a pharmacist or an intern. One of the agenda items undertakes a role-play of the Brintellix patient engaging with the pharmacy staff and the Program being executed. As this Program is to be implemented on each and every occasion the medication Brintellix is dispensed, it is important that any staff members who are absent from the staff meeting are provided with a one-to-one training of the pharmacy s system and procedures. It is important that this meeting is held prior to 2 February 2015 when the Program starts. PATIenT ProgrAM staff MeeTIng AgenDA Brintellix Patient Program Implementation Time: Meeting Facilitator: Attendees: AgenDA ITeMs TOPIC SPEAKER 1. Introduction to Brintellix Patient Program What are the aims of the Program? What collateral is contained in the kit including USB? How are these elements used within the Program? 2. System and Procedures Which staff member is responsible for implementing and managing the Program? Undertake a role play walk through of a patient presenting a prescription for Brintellix, through to collecting medicine and leaving the pharmacy. Explain the system and procedures that are enacted. Cost of the medication to the patient. 3. Identification of a Patient (collateral support) Accepting Brintellix prescriptions from patients. Detail the steps required up to the stage where Pharmacist, Pharmacy Intern or Dispensary Assistant processes the prescription. 4. Delivery of the service (protocol) What forms are required to be completed and printed? Where can the SmartForm PDFs be accessed? Following assembly of prescription and completed forms being printed, what process does the pharmacist/ intern undertake? What are the patient engagement points for the Program? 5. Documentation of the service (SmartForm PDFs) How are the SmartForm PDFs completed? What happens with the Pharmacy Claim Form once completed? What de-identified evidence will the pharmacy add to the Pharmacy Claim Form to indicate the charge of no more than $62.00? 6. Staff Roles Individual staff roles, including Pharmacists, Pharmacy Interns, and Pharmacy Assistants. Which clinical roles and which administration tasks can be undertaken by each level of staff? 7. Questions Brintellix Patient Program - Staff Meeting Agenda 6

7 Personalised Pharmacy Patient Information Leaflets The primary tool to support Program engagement with patients is a set of SmartForm PDFs. A SmartForm is an electronic form (in this Program s case it is PDF-based) that offers user-friendly data entry amongst other benefits. Insert the USB Drive into each of the dispensary computer terminals. Open the Brintellix Patient Program SmartForm PDF Patient Information Leaflet. There are seven Information Leaflets in total which correspond to the dispensing sequence number as patients have their prescription for Brintellix dispensed. Before saving the seven files to the local drive complete the pharmacy details on the preferred version of the Information Leaflet. The first version enables the pharmacist to insert the pharmacy brand logo in the top left corner of the information leaflet and their pharmacy identification details in the top right corner. The alternative version enables the two data fields to be completed with pharmacy identification details. Ensure the layout is consistent across all seven versions. For each of the SmartForm PDF Patient Information Leaflets complete the pharmacy details by including the pharmacy name, address, opening hours, phone and fax numbers, , owner s name/s etc. Insert the pharmacy brand logo as preferred. Save the files to the local drive or to a server as previously decided per the pharmacy s implementation checklist. On subsequent occasions when instigating the Program, these personalised templates should be accessed as the pharmacy details will be preloaded into the Information Leaflet. Version 1 Enables the pharmacist to insert the pharmacy brand logo (must be a PDF file unless using Acrobat Pro from which you can insert other file types) Version 2 Enables the two data fields to be completed with pharmacy identification details 7

8 Collateral/ Software Information Collateral The Program Kit also includes a number of pieces of collateral to assist pharmacists to implement the Program. This protocol includes a best practice example of implementation, however you can tailor the protocol to suit your workflow. Software The primary tool to support Program execution is a set of SmartForm PDFs. The protocol will detail how these documents will be used. There are three elements to assist with Program implementation Identification of a patient (collateral support) Delivery of the service (protocol) Documentation of the service (SmartForm PDFs) Patient Identification The Program is to be implemented on each and every occasion Brintellix is dispensed and the patient receives their medication. In the kit there are two key elements to assist to identify patients and trigger the Program to be implemented. The first element is a Shelf Talker/ Wobbler which is a visual aid that is to be inserted into the dispensary shelf ticket stripping or displayed adjacent to where Brintellix is stored on the dispensary shelf. There will also be two Quick Reference Guides which should be placed vertically adjacent, or close-by to the location of Brintellix on the dispensary shelf. During standard pharmacy workflow, the pharmacist, intern or pharmacy assistant selects the Brintellix medication from the dispensary shelf and places the item together with the prescription for Brintellix, into a basket ready for the pharmacist to dispense the medicine. The shelf talker/ wobbler acts as a visual reminder to instigate the Program. The staff member then picks up the Quick Reference Guide and places it into the basket with the Brintellix. As staff become familiar with the Program, at the time in which the prescription is presented by the patient, staff will make a note on the Script in form whether there is a Brintellix listed on the prescription, and thus the Program process can be initiated. Lundbeck Australia Pty Ltd ABN Ground Floor, 1 Innovation Road, North Ryde NSW Ph.: Fax: Medical Information: PaTienT Program Quick reference guide This Quick Reference Guide is to be used as a reminder of the key steps to be implemented in the Brintellix Patient Program. For more detailed information please refer to the Protocol Program Guide for Pharmacists. Key StepS 1. Dispense the prescription for Brintellix. 2. Open the SmartForm PDF Brintellix patient Information Leaflet template file on your hard drive or server which corresponds to the original or appropriate repeat number. 3. Complete the appropriate fields on the SmartForm PDF Brintellix Patient Information Leaflet and print a copy. This copy will be provided to the patient following counselling. 4. Save the PDF to your hard drive or server in the designated Brintellix folder for record purposes. For ease of reference the PDF should be saved using the following file name protocol: patient surname_patient christian name_brintellix_dispensing date. This will also allow you to have a record of notes added to the leaflet (optional). 5. Open the Brintellix Claim Form template on your hard drive or server. 6. Complete the appropriate fields on the Brintellix Claim Form and print copy. Save the PDF to your hard drive or server in the designated Brintellix folder. This is required for audit purposes. For ease of reference the PDF should be saved using the following file name protocol: pharmacy name_patient initials_brintellix_dispensing date. 7. When handing out the Brintellix medication, counsel the patient and step through the key QUM initiatives on the Brintellix Patient Information Leaflet. Provide the patient with the Information Leaflet to take home. 8. Ensure the patient is charged no more than $62.00 and keep a receipt record for claiming purposes. 9. Send the Claim Form together with a de-identified dispensary receipt or a point-of-sale receipt to the Brintellix Program Administration Centre for payment. (Payment will automatically be processed the following month as a batch payment) February Version 1 Lundbeck Australia Pty Ltd ABN Ground Floor, 1 Innovation Road, North Ryde NSW December The patient receiving this medicine is eligible for Include the Brintellix Quick Reference Guide in the workflow process to prompt the dispensing pharmacist. Brintellix Patient Program - Shelf Talker/ Wobbler Brintellix Patient Program - Quick Reference Guide When the pharmacist completes the processing of the prescription the Quick Reference Guide is to be returned to the dispensary shelf where the Brintellix is located. 8

9 Delivery of the Service At the dispensary computer terminal, as the pharmacist processes the prescription and dispenses the Brintellix, the Quick Reference Guide prompts the pharmacist to initiate the Program service. There are a number of steps that are part of this process. There are two key SmartForm PDF documents that need to be accessed from the hard drive, or server, completed and then printed; 1/ Brintellix Patient Program SmartForm PDF Patient Information Leaflet - The most efficient workflow requires that the SmartForm PDF Patient Information Leaflet is completed immediately after the prescription has been processed for dispensing. The pharmacist needs to identify the sequence number of the Brintellix dispensing. If it is the first time that the patient has presented a prescription for Brintellix, then the pharmacist would open the SmartForm PDF Patient Information Leaflet - Original Dispensing. (If it is the first repeat then the corresponding SmartForm PDF Patient Information Leaflet is accessed. There are seven versions of the SmartForm PDF Patient Information Leaflet). It is important to tailor the document to the individual patient. This is achieved by inserting their personal details and the pharmacist is able to add clinical recommendations in the free data field located towards the base of the SmartForm PDF. In addition, the pharmacist may mark on the SmartForm PDF Patient Information Leaflet other pharmacy services which they believe the patient should consider as benefits. These services include a pharmacy follow-up, MedsCheck Service, or Dose Administration Aid (DAA) Service. The Information Leaflet is to be printed and this copy is to be provided to the patient at the completion of the counselling session. The patient may wish to take home the document and peruse the information at a later time. It is also recommended to save a copy of the Information Leaflet in order that all staff involved in the dispensing process can refer back to the document if needed. This is important in the case where the pharmacist has added notes to the SmartForm PDF Patient Information Leaflet. It is recommended to save a copy in the format of the patient s Surname first, followed by Christian name, Brintellix then followed by the date of dispensing. This file format will allow the document to be searched by name at a later time. Original Dispensing Address: ORIGINAL DISPENSING Prescription Number: Refill Repeat 1 Address: Refill Repeat 2 Address: REfILL REPEAt 1 Refill Repeat 3 Address: Refill Repeat 4 REfILL REPEAt 2 Address: Prescription Number: REfILL REPEAt 3 Address: Refill Repeat 5 treatment results: Prescription Number: treatment. REfILL REPEAt 4 Address: Refill Repeat 6 Welcome back to the Brintellix Patient Program. Symptoms of major depression can make you feel very lonely at times. Overcoming major depression isn't easy, but a strong social network can help. Here are 2 tips to maximise your treatment outcomes: Welcome back to the Brintellix Patient Program. Most people with major depression symptoms start treatment with their primary care doctor, but your doctor may also refer you to a psychologist or other counsellor to assist with your treatment. Welcome back to the Brintellix Patient Program. As your treatment starts to take effect, you may find yourself starting to enjoy your favourite activities again. Here are 3 tips to maximise your treatment outcomes: Here are 3 tips to maximise your treatment outcomes: Prescription Number: 1. Continue to take Brintellix at the same time each day and follow all directions given to you by your doctor or pharmacist. Prescription Number: REfILL REPEAt 5 2. Brintellix Patient Support Program 2. Brintellix Patient Support Program 2. Brintellix Patient Support Program 2. Brintellix Patient Support Program Our Pharmacist explained the following key Brintellix Program elements to you: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Pharmacist Initials: information is used to Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. Welcome back to the Brintellix Patient Program. You have successfully completed the first 6 months of It is important to maintain a healthy lifestyle. Here are 3 tips to help with your treatment outcomes: 1. To support depression treatment, nourish your body with nutrient-rich food. Eating a well-balanced diet with a lot of variety will likely ensure you have sufficient nutrition. 2. It's tempting to self-medicate with alcohol or drugs to cope with the symptoms of depression, but with a history of depression, you're more vulnerable to negative side effects when the alcohol or drugs wear off. Reduce the use of alcohol and other drugs, as they can cause long-term problems and make it much harder to recover. It is best not to consume alcohol while you are taking Brintellix. 3. Remember to follow all directions given to you by your doctor and pharmacist. Take the dose your doctor tells you to. If your depression resolves while taking Brintellix, speak to your doctor about how long you will be required to take Brintellix. Our Pharmacist explained the following key Brintellix Program elements to you: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Pharmacist Initials: information is used to Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. Welcome back to the Brintellix Patient Program. Here are a further 3 tips to help maximise your 1. Depression is often associated with sleep problems. The less you sleep, the more things bother you and the harder it is to get a good night's rest. It's essential to restore a regular sleep pattern to make a full recovery, so here are some tips: Try to get up at about the same time each morning. If you're worrying about things during the night, set aside some time for problem-solving during the day. Allow yourself time to wind down before going to bed. If you are working or studying, stop at least 30 minutes before bedtime and do something relaxing. 2. A psychiatrist or psychologist may be able to teach you techniques to help you deal with emotional stress. 3. Persistence with your medication is the key. Continue to take Brintellix at about the same time each day and follow all directions given to you by your doctor or pharmacist. If you take the wrong dose, Brintellix may not work as well and your condition may not improve. If you forget to take it, take the next dose at the usual time. If your depression resolves while taking Brintellix, speak to your doctor about how long you will be required to take Brintellix. Our Pharmacist explained the following key Brintellix Program elements to you: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Welcome back to the Brintellix Patient Program and 3 more tips to help maximise your treatment outcomes: 1. For people who are depressed, stress can be overwhelming, triggering a downward slide. Chronic stress may change behaviour in ways that fuel clinical depression, for example, people who are stressed tend not to go out as much or sleep as well, or they may overeat or drink too much. 2. It may take some time to successfully treat depression. Your doctor is the best person to help manage your symptoms. It is important to be open and honest in your communications with your doctor and to follow your doctor s instruction to achieve the best results. 3. Remember to take your Brintellix exactly as your doctor and pharmacist recommend. Do not stop taking Brintellix, or lower the dosage, without checking with your doctor. If you stop taking it suddenly, or reduce the amount you take, your condition may worsen. If your depression resolves while taking Brintellix, speak to your doctor about how long you will be required to take Brintellix. 1. Having emotionally supportive relationships helps to put problems into perspective. If you pulled away from friends and family while depressed, now is the time to start rebuilding those bonds. Friends and family can also be a source of encouragement on days when depression symptoms or worries about symptoms get you down. To make socializing easier, form friendships with people who share your goals or interests. Here are a few examples: Find an exercise buddy. Take yoga classes, take a regular walk or train for a race, or do laps at a pool. You'll get to know each other while you work out. Volunteer your time. Hospitals, places of worship, community centres and other groups often need help. You can form strong connections with other volunteers and the benefits of helping other people add to your wellbeing. Join a book, movie, theatre or cooking club. Join a depression support group. It is a place to find other people who know what you're going through because they've had depression themselves. 2. Spending time with family and friends helps boost your mood. They can also encourage you to have better health practices, exercise more, remind you to continue taking your medication as prescribed. Remember to continue to take Brintellix for as long as your doctor recommends. If your depression resolves while taking Brintellix, speak to your doctor about how long you will be required to take Brintellix. 1. Psychotherapy (also called counselling or behavioural therapy) in conjunction with medication can be more effective than medication alone. Psychotherapy allows you to talk through your depressed feelings and can help you learn coping strategies for clinical depression symptoms. 2. As you start to overcome major depression, you can boost your success by being an active member of your own treatment team. Watch for signs that you're feeling better. Keep track of changes in your symptoms, make a weekly list and bring it to your doctor and/or psychologist appointment. Here are some examples for your checklist: I took my antidepressant medication daily I ate regularly and healthfully most days of the week I'm interested at work and able to concentrate I exercised at least 3 times this week My energy level seems to be improving I engaged in an activity with friends or family 3. A combination of antidepressant medication and psychotherapy may offer the best chance for lasting relief from major depression. Talk to your doctor about developing a GP Mental Health Treatment Plan for you. You may be eligible for referral to a clinical psychologist providing psychological therapies for up to 10 sessions a year with a Medicare rebate. And remember to take Brintellix at the same time every day and continue to take Brintellix for as long as your doctor recommends. In addition to medication for major depression, there are other steps you can take to help lift your mood and 2. Although depression can rob you of energy, motivation, and the desire to do things that you once enjoyed, inactivity can actually make depression worse. Exercise boosts neurotransmitters in your brain and helps you to feel calm and focused. Staying active is one of the best things you can do to cope with major depressive disorder. 3. Physical exercise helps relieve the tension in your muscles, relaxes your mind and distracts you from negative thoughts and worries. Try to do some physical exercise every day. Here are some tips to get you started: Return to simple activities you enjoy. If you are new to exercise, start slowly. Plan a routine and set realistic and achievable goals. Exercise outdoors if possible or try simple yoga poses. Participate in activities with family and friends. Gradually work up to more vigorous exercise. Welcome to the Brintellix Patient Program. Your pharmacist will provide important information to help you maximise the benefits during your initial 7 months of treatment. Major Depressive Disorder (clinical depression or major depression) affects your mood, mind, body and behaviour and can interfere with your ability to work, sleep, and interact with family and friends. The goal of treatment is to alleviate your symptoms and help you return to your normal activities. Here are 3 tips to maximise your treatment outcome: 1. Continue to take Brintellix as it may take up to two weeks, sometimes longer, before you feel any improvement. Take Brintellix as a single dose at the same time each day, either in the morning or the evening. Here are a few tips to help you remember to take your medication: Combine taking your Brintellix with a regular daily task such as making your morning coffee or cleaning your teeth. Use electronic reminders or set a daily alarm. 2. If you have private health insurance, you may be eligible for reimbursement of all or part of the prescription fee. Call your health fund to find out more. 3. Read the Consumer Medicine Information (CMI) leaflet contained in the medicine carton. All medicines may cause side effects. Brintellix side effects are generally mild to moderate and occur within the first two weeks of treatment. They are usually temporary and generally do not require treatment cessation. If you notice any unusual effects, please contact Lundbeck Australia to discuss, by phone on , or to SafetyLuAustralia@lundbeck.com. You should also speak to your doctor or pharmacist. 2. Brintellix Patient Support Program 2. Brintellix Patient Support Program Our Pharmacist explained the following key Brintellix Program elements to you: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Our Pharmacist explained the following key Brintellix Program elements to you: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Our Pharmacist explained the following key Brintellix Program elements to you: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Pharmacist Initials: Pharmacist Initials: Pharmacist Initials: Pharmacist Initials: information is used to Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. information is used to Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. information is used to Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. information is used to Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. Prescription Number: REfILL REPEAt 6 Prescription Number: support your recovery. 2. Brintellix Patient Support Program Our Pharmacist explained the following key Brintellix Program elements to you: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Brintellix Patient Program - Refill Repeat 1 Brintellix Patient Program - Refill Repeat 2 Brintellix Patient Program - Refill Repeat 3 Brintellix Patient Program - Refill Repeat 4 Brintellix Patient Program - Refill Repeat 5 Brintellix Patient Program - Refill Repeat 6 Pharmacist Initials: There are seven SmartForm PDF Patient Information Leaflets that will be used to counsel patients on key QUM initiatives. Each relates to a specific dispensing sequence number. information is used to Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. Brintellix Patient Program - Original Dispensing 9

10 In summary the general features of the Information Leaflet include: Patient details Brintellix Medicine Information Patient Support Program Elements Pharmacist Recommendations as optional extra to assist patient QUM initiatives Check boxes for referral to other services It is important to note that the Brintellix Patient Program does not involve any personal patient information being transferred out of the pharmacy to a third party. Because of this program element there is no requirement for patients to sign consent forms. The program administrator may however collect non-personal usage data. 2/ Brintellix Patient Program - Pharmacy Claim Forms - from a workflow perspective it is important to complete the Claim Form immediately following dispensing the prescription for Brintellix. The Claim Form has a number of fields in the SmartForm PDF format that need to be completed by the dispensing pharmacist. There are seven fields to complete and all seven fields need to be completed for payment to occur. It is recommended to save this Claim Form in the format of Pharmacy Name, Patient Initials, followed by date of dispensing. In addition you may consider including the word Brintellix in the file name. This maintains patient confidentiality as this form is submitted to the Program Administration Centre for payment. This naming protocol will also allow the pharmacy to search the files on the local drives or servers at any time. Following the completion of the sale and the patient having left the pharmacy, it is then recommended to immediately send off the Claim Form. Program protocol and terms and conditions require that evidence needs to be submitted, to the Program Administration Centre, that the prescription for Brintellix was supplied at a price of no more than $62 per pack. That evidence can be in the form of a patient de-identified dispense system receipt or point-of- sale receipt. The claim form and evidence needs to be then faxed or ed to the Program Administration Centre. In summary, at the end of the administration element of the process; 1/ The prescription for Brintellix has been dispensed and is ready to be handed out to the patient 2/ The relevant SmartForm PDF Information Leaflet has been filled in, saved, and printed. Information Leaflets are not to leave the pharmacy electronically. Therefore the saved file name format can include the patient s Surname and Christian name. Claim forms however leave the pharmacy for payments and thus the protocol for saving names should just use the patient initials. This protocol will maintain patient confidentiality. 3/ The Pharmacy Claim Form has been completed, saved and printed, together with a patient de-identified dispensary receipt or point of sale receipt. The point of sale receipt can be accessed and printed at the conclusion of the sale process. A pharmacist or intern is now in a position to hand out the prescription and deliver the Brintellix Patient Program Service. The Program terms and conditions dictate that the pharmacist or intern must undertake the counselling service. Patient Program Pharmacy claim Form Please complete the following details and attach or insert evidence of purchase. to: admin@lundbeckpharmacyprogram.com.au or Fax to: Pharmacy Name Address Details Pharmacist Completing Claim Pharmacist Contact Details - Phone or Prescription Dispensing Date Specify Prescription Number Original (O), Repeat 1 (1), Repeat 2 (2), Repeat 3 (3), Repeat 4 (4), Repeat 5 (5) or, Subsequent Repeat (7 or greater) Prescription Number (for audit purposes) Insert Pharmacy Name Insert Address Line 1 Insert Pharmacist Name Insert Contact Details Specify Prescription Number Insert Prescription Number Please complete the checklist below and or fax this form, together with evidence of Brintellix receipt, to claim $25 service fee: I confirm that I have adhered to the Brintellix Patient Program requirements at the time of dispensing Brintellix by counselling on the key quality use of medicines initiatives on the SmartForm PDF Patient Information Leaflet. I have provided a printed copy of the Information Leaflet to the patient to take home. Name of Authorised Pharmacist: Insert Pharmacist Name (Name and signature required if faxing hard copy) Please attach below a patient de-identified copy of the Dispense/ Point-of-sale receipt with price to patient visible. Option 1 - Insert image and then (image must be a PDF file unless using Acrobat Pro from which you can insert other file types) or Option 2 - Attach patient de-identified Dispense or Point-of-sale receipt, and then fax Option 1 - Insert receipt image and then (image must be a PDF file unless using Acrobat Pro from which you can insert other file types) or Option 2 - Attach patient de-identified Dispense or Point-of-sale receipt, and then fax Brintellix Patient Program Administration Centre Level 1, 263 Mary Street Richmond, VIC 3121 Phone: Fax: admin@lundbeckpharmacyprogram.com.au Lundbeck Australia Pty Ltd ABN Ground Floor, 1 Innovation Road, North Ryde NSW Ph.: Fax: Medical Information: December Brintellix Patient Program - Pharmacy Claim Form 10

11 Pharmacist Service The patient service element of the Brintellix Patient Program will follow the outlined protocol and structure. The pharmacist or intern will approach the patient with the dispensed prescription and the completed one-page SmartForm PDF Patient Information Leaflet. The pharmacist is to explain the Program to the patient utilising the simple to follow steps on the Information Leaflet. On each dispensing, the critical clinical elements are to be discussed with the patient, in addition to any normal patient counselling. An overarching aim of the Program is to maximise compliance with the medication according to the prescriber s instructions. Furthermore, a key priority is to ensure that patients are persistent with their medication and do not abruptly cease therapy. In relation to compliance there are different forms of non-compliance and by the nature of this Brintellix prescription, particular forms of non-compliance are more likely to occur. Non-Compliance Non-compliance has historically been categorised as: Erratic Unwitting Intentional Under erratic non-compliance the requirement of treatment is understood and agreed by the patient, yet not followed. There are numerous reasons why this occurs including the fact that the patient may be too busy, forgetful or suffers from psychological distress, amongst other reasons. Additionally, the overall medicines regimen may be too complex for the patient. Erratic non-compliance is the most common form of non-compliance. The average MedsIndex Score for patients taking an antidepressant is a MedsIndex Score of only Effectively this means that the patient is missing four out of ten doses. With that level of non-compliance the full therapeutic action of the medication is not achieved. A related issue is the concern of medication persistence. The three month dropout rate following new medication therapy initiation is as high as 60% 2. It is likely that a patient initiated on Brintellix would have been prescribed another form of antidepressant previously and therefore supporting the patient through the initial few months of new therapy is critical. Following this time, the full benefit of the therapy will be realised if compliance is achieved. The Program facilitates this support to occur. Under unwitting non-compliance the prescriber and patient, and indeed the pharmacist, may believe that the patient is complying appropriately. This commonly results from poor understanding of regimen. Alternatively there may be language barriers with the patient, cognitive impairment or other impeding health concerns. The simplest way to address this issue is to measure compliance via a MedsIndex Score. Under intentional non-compliance the patient may have made the clear decision to cease therapy, and this can occur for a number of reasons. The patient may be feeling better, or they believe the medicine is no longer required. Of concern with this particular Program is the key reason that the patient may believe that the medicine is costly. The fact that Brintellix requires a $62.00 out-of-pocket payment by the patient, prior to any refund from private health insurance, highlights this as a key issue that needs to be addressed by the pharmacist. Other antidepressants may be available at the general co-payment out-of-pocket cost and therefore the prescriber should have indicated clearly to the patient why this therapy is preferred. Another reason for intentional non-compliance is concern regarding side effects or even the fear of addiction. The engagement points that the Program provides should enable conversations with Brintellix patients to address these delicate issues. It is important to understand that every patient is different. The pharmacist should consider all strategies that may improve compliance with the medicine. After the initial dispensing of Brintellix, on subsequent visits to the pharmacy the pharmacist should review the MedsIndex with a view of monitoring compliance to therapy. Depending on the circumstances of the individual patient a clinical intervention as defined in the Fifth Community Pharmacy Agreement may be triggered. Clinical intervention is a professional activity undertaken by a registered pharmacist directed towards improving quality use of medicines (QUM) and resulting in a recommendation for a change in the patient s medication therapy, means of administration or medication-taking behaviour. It must relate to a medicine and be recorded using the D.O.C.U.M.E.N.T. classification system. (Note: interventions under the M.E.N. components of the classification system cannot be claimed) 3 Pharmacies are paid a periodic incentive payment when delivering Clinical Interventions in accordance with the PPI Program Specific Guidelines. View for more information. 1. Sinapse, Sinapse,

12 Factors Affecting Adherence Factors affecting adherence can be identified under three categories: External Physical Psychological Examples of external factors affecting adherence include mistrust of medical staff, treatment complexity set by the prescriber of the medication, misinformation and social isolation amongst other reasons. With mental health conditions these factors impact heavily on patient adherence. Physical factors affecting adherence include physical disability, obesity, and side effects of medicines. As a category of medications, antidepressants can have significant side effects and therefore identifying non-adherence with patients can assist to overcome barriers. Physiological factors affecting adherence may be depression or anxiety disorders, unrealistic expectations from the medication, poor motivation or a sceptical approach concerning the effectiveness of the regimen amongst other reasons. With a structured program such as the Brintellix Patient Program, the multiple engagement opportunities with patients present an opportunity to address these concerns. The recognition of barriers to adherence can assist patients to address the issue. Through this Program pharmacists will be better placed to assist patients. The Program allows pharmacists to execute educational strategies and support patients. This support can be undertaken by standalone education or utilising existing community pharmacy programs, some of which are paid for by the Fifth Community Pharmacy Agreement. The following pharmacy services should be considered where appropriate; 1) empower the Patient - When a patient becomes aware that compliance is important they will seek feedback from the pharmacist as to the progress of their treatment and compliance to the medication. A MedsIndex Score calculation can be used as part of a formal Clinical Intervention. 2) mental Health Education - any support which the pharmacist can provide to the patient regarding general mental health genesis to improve medication compliance and persistence. 3) medscheck - Understating the Regimen A MedsCheck program may be indicated to patients who are struggling with their overall regimen. A formal appointment will assist in creating a structured report where key issues are discussed with the patient. A MedsCheck provides an in-pharmacy review of a patient s medicines. It focuses on education and self-management, aiming to identify problems that the patient may be experiencing with their medicines, helps the patient to learn more about their medicines, improves the patient s effective use of medicines and educates the patient concerning how to best store their medicines 4. For more information on MedsCheck view the 5CPA web site medscheck-diabetes-medscheck/ 4) medicines Packed/ Dose Administration Aid (DAA) - the type of non-compliance may identify the benefit of a DAA. DAA s are a pharmacy service that assist consumers in the community to better manage their medicines, with the objective of avoiding medication misadventure and associated hospitalisation. 5 A Fifth Community Pharmacy Agreement incentive specifically relates to service delivery to patients living within the community. There are other program rules which should be reviewed. 5) Written / Verbal Tools Consumer Medicines Information (CMI) a pharmacist may consider the use of a CMI for Brintellix to assist the patient, with the aim of improving compliance. The Brintellix Patient Support Service should be completed within a few minutes and at the conclusion, the onepage Information Leaflet is provided to the patient

13 Scope of Practice Information Staff Roles The permitted undertakings by the relevant staff member are displayed below. As part of the terms and conditions of the Program a pharmacist or Intern pharmacist is required to deliver the service to the patient. Administrative tasks however can be undertaken by all staff. Identification of a patient Delivery of the service Documentation of the service Pharmacist Yes Yes Yes Intern Pharmacist Yes Yes Yes Pharmacy Assistant Yes No No Clinical Basis The Program aims to align with the National Strategy for Quality Use of Medicines. A key component of this strategy is the QUM Pyramid: Level 1: Awareness Strategies at this level aim to: Raise awareness of medicines as a health issue. Explore, inform and change community attitudes and beliefs about the risks and benefits associated with medicines. Provide information on resources available to all groups to support quality use of medicines. Level 2: Knowledge and skills Strategies at this level aim to: Provide opportunities to develop knowledge and skills as well as utilise resources available to make appropriate decisions. Provide opportunities for people to discuss quality use of medicines issues and to trial and adopt behaviours that support quality use of medicines and deliver best health outcomes. Level 3: Action and evaluation Strategies at this level aim to: Reinforce and maintain actions needed to use medicines wisely. These involve issues of monitoring outcomes, quality improvement, problem solving, positive reinforcement and feedback. 13

14 Program Administration Good Record Keeping is Key While this protocol provides to you some guidance regarding the implementation and execution of the Program, it is important to establish a documented system and procedure for the specific administration procedures in the pharmacy. This will ensure that the pharmacy is paid promptly for undertaking the service. Brintellix Patient Program Claim Forms - the Claim Form is a critical element of the administration process. The following elements need to be included in the pharmacy s system and procedures; Where is the electronic format of the SmartForm PDF Claim Form template located? Which staff are empowered to fill in Claim Forms, print and save these forms? What is the naming file protocol for these completed Claim Forms? (It is recommended to save in the format of Pharmacy Name, Patient Initials, followed by date of dispensing. In addition you may consider including the word Brintellix in the file name. This naming protocol will allow the pharmacy to search the files on local drives or servers at any time) Will the pharmacy keep a physical copy of the Claim Forms in the dispensary or office? Where are hard copy versions of documents to be stored and filed? What audit trail is there in the pharmacy to track the process and ensure that claims are being made promptly following the completion of the service? Is there a process in place in the pharmacy where claims can be marked off the statement? (Payment will be made automatically as a batch in the month following the submission of the Claim Forms) How does the pharmacy comply with the Program terms and conditions that require evidence of the deidentified patient details receipt to be submitted? (This can be complied with by printing a dispensary receipt with dispensed medicine price listed or alternatively a point of sale receipt) Does the pharmacy use a system of faxing the claim with evidence or scanning and ing the Claim Form and evidence? From a workflow perspective it is important to complete the Claim Form immediately following the dispensing of the Brintellix prescription. The Claim Form has a number of fields in the SmartForm PDF format that need to be completed by the dispensing pharmacist. There are seven fields to complete and all seven fields need to be completed for payment to occur. After the process is finalised and the patient has left the pharmacy it is recommended to immediately send off the Claim Form. Program protocol and terms and conditions require that evidence to be submitted to the Program Administration Centre, documents that the prescription for Brintellix was supplied at a price of no more than $62 per pack. That evidence can be in the form of a dispense system generated receipt or a point-of-sale receipt. The claim form and evidence needs to be faxed or scanned and ed to the Program Administration Centre.. December

15 Appendix Collateral INVITATION FOR YOUR PHARMACY TO BECOME A PATIENT PrOgrAM IMPLEMENTATION CHECKLIST PATIENT PROGRAM PHARMACY PATIenT ProgrAM staff MeeTIng AgenDA Implementation Checklist Lundbeck Australia Pty Ltd is pleased to make available to Australian patients a new anti-depressant therapy, Brintellix (vortioxetine). To support this launch, an Australia-wide network of Brintellix Patient Program Pharmacies will be established to provide patients taking this medication with additional support. This letter invites your pharmacy to participate and enrol in the network. Please consider the merits of the Program. Brintellix (vortioxetine) is currently a non-pbs medication and Lundbeck Australia Pty Ltd is providing an enhanced professional opportunity for a select number of pharmacies to participate in this patient support Program. These participating pharmacies must agree to the Program terms and conditions which will be detailed in the Program protocol. The Brintellix Patient Program includes dispensing Brintellix to patients on presentation of a prescription at a price of no more than AUD $62.00 per pack of 28 tablets for any strength (available in 5mg, 10mg, 15mg and 20mg strengths). It is envisaged that the price to patient of $62.00 will contain little or no mark-up for the pharmacy. For your assistance in dispensing and supporting patients participating in the Brintellix Patient Program, Lundbeck will pay Program Pharmacies a service fee of $25 per prescription for each original and repeat dispensing. Pharmacies are required to keep in stock one pack of the 10mg strength of the medicine as part of the Program. Lundbeck will offer guaranteed return of supply option for Program Pharmacies on stock which is held for a minimum of 4 months. Additionally, Lundbeck asks participating pharmacies to provide patients with the additional support of the Brintellix Patient Program where a number of quality use of medicines initiatives are to be discussed with patients in a structured manner as outlined in the Program. The aim of this Program is to provide patients to whom you have dispensed Brintellix with information regarding the importance of compliance with the course of Brintellix prescribed, and to ensure health outcomes are maximised. Doctors will be informed of the name and location of Brintellix Patient Program Pharmacies, where this additional patient support is provided. Thanks again for your consideration of this opportunity. We invite you to join the Program by completing the attached Brintellix Patient Program - Pharmacy Enrolment Form. Lundbeck looks forward to working in partnership with your pharmacy. Brintellix Patient Program Implementation This checklist will facilitate a streamlined implementation of the Brintellix Patient Program ensuring that all staff are confident with this new Program. Please complete the below and maintain with your Quality Care Pharmacy Program (QCPP) records. Time: Pharmacy Details Meeting Facilitator: Attendees: Pharmacy Address: City: State: Postcode: Implementation NO. TASK SIGNED 1 Ensure the pharmacy owner/ manager has submitted a completed Brintellix Patient Program - Pharmacy Enrolment Form. (Copy on USB Drive) 2 A senior pharmacist staff member has been nominated as responsible for the implementation of Brintellix Patient Program 3 All staff members involved in accepting prescriptions from patients at the Scripts In counter are to become familiar with the Brintellix Patient Program and should read the Protocol. This familiarisation includes elements of the Kit and materials contained on the Program USB Drive and dedicated Brintellix Patient Program web portal, 4 Schedule a staff meeting and use the Brintellix Patient Program Staff Meeting Agenda from the Kit. Add additional meeting items if necessary. 5 Create a folder on your hard drive or server named Brintellix in order for your staff to locate the folder at any time. Save all file elements from the USB and web portal into the folder. For each of the SmartForm PDF Patient Information Leaflets, insert pharmacy brand logo and complete the pharmacy details in the top left and right corners (pharmacy name, address, opening hours, phone and fax numbers, , owner s name/s etc.) and then save the files to the folder. If you save the SmartForm PDF files with your pharmacy details you will not have to rekey these details each time this form is prepared for a patient. Depending on your dispensary layout and IT setup it may be desirable to save key Program documents in a folder on your desktop at each dispensary station. AgenDA ITeMs TOPIC Introduction to Brintellix Patient Program What are the aims of the Program? What collateral is contained in the kit including USB? How are these elements used within the Program? 2. System and Procedures Which staff member is responsible for implementing and managing the Program? Undertake a role play walk through of a patient presenting a prescription for Brintellix, through to collecting medicine and leaving the pharmacy. Explain the system and procedures that are enacted. Cost of the medication to the patient. 3. Identification of a Patient (collateral support) Accepting Brintellix prescriptions from patients. Detail the steps required up to the stage where Pharmacist, Pharmacy Intern or Dispensary Assistant processes the prescription. 4. Delivery of the service (protocol) What forms are required to be completed and printed? Where can the SmartForm PDFs be accessed? Following assembly of prescription and completed forms being printed, what process does the pharmacist/ intern undertake? What are the patient engagement points for the Program? 5. Documentation of the service (SmartForm PDFs) How are the SmartForm PDFs completed? What happens with the Pharmacy Claim Form once completed? What de-identified evidence will the pharmacy add to the Pharmacy Claim Form to indicate the charge of no more than $62.00? 6. Staff Roles Individual staff roles, including Pharmacists, Pharmacy Interns, and Pharmacy Assistants. Which clinical roles and which administration tasks can be undertaken by each level of staff? 7. Questions Yours sincerely, Lorena Di Carlo Managing Director Brintellix Patient Program Administration Centre Level 1, 263 Mary Street Richmond, VIC 3121 Phone: Fax: admin@lundbeckpharmacyprogram.com.au Lundbeck Australia Pty Ltd ABN Ground Floor, 1 Innovation Road, North Ryde NSW Ph.: Fax: Medical Information: December Brintellix Patient Program Pharmacy Enrolment Form 6 Place the hard copy pharmacy Kit collateral in the pharmacy location as indicated in the Brintellix Patient Program Protocol Program Guide for Pharmacists (this includes Shelf Talker, Quick Reference Guide, Patient Brochures, etc.). December Brintellix Patient Program Implementation Checklist PATIENT PROGRAM PhARMAcy WhOlEsAlER ORdER NuMbERs The Launch of Brintellix (vortioxetine) - Monday, 2 February 2015 Brintellix is currently a non-pbs medication and Lundbeck Australia Pty Ltd is providing an enhanced professional opportunity for enrolled Brintellix Patient Program Pharmacies (Program Pharmacies) to participate in the Program. These Program Pharmacies must agree to the Program terms and conditions which are detailed in the Program Protocol. The Program includes dispensing Brintellix to patients on presentation of a prescription at a price of no more than A$62.00 per pack of 28 tablets for any strength (available in 5mg, 10mg, 15mg and 20mg strengths). The price for the medicine for these 4 strengths will be the same. Pharmacies are required to keep in stock one pack of the 10mg strength of the medicine as part of the Program. Lundbeck will offer a guaranteed return of supply option for Program Pharmacies on stock which is held for a minimum of 4 months. Brintellix Patient Program Staff Meeting Agenda Patient Program Staff Q&a Dear Pharmacist, Lundbeck is launching a new anti-depressant product, the brand name is Brintellix, and the active ingredient is vortioxetine. The product has received TGA approval for treatment of major depressive disorder in adults including prevention of relapse.1 We are delighted to provide you with the product order numbers for your preferred wholesaler. Ordering from Wholesaler Brintellix (vortioxetine) is available to order though your preferred wholesaler. Supplier PDE numbers Brintellix (vortioxetine) 5mg blister 28 tablets Brintellix Brintellix Brintellix (vortioxetine) 10mg (vortioxetine) 15mg (vortioxetine) 20mg blister 28 tablets blister 28 tablets blister 28 tablets API CH CHS BRIT5 BRIT10 BRIT15 BRIT20 Sigma Symbion Brintellix Approved Product Information This Quick Reference Guide is to be used as a reminder of the key steps to be implemented in the Brintellix Patient Program. For more detailed information please refer to the Protocol Program Guide for Pharmacists. Q: What is Brintellix? A: Lundbeck Australia Pty Ltd is launching a new anti-depressant product, the brand name is Brintellix, and the active ingredient is vortioxetine (Brintellix ). It is a prescription only medicine. The product has received TGA approval for the treatment of major depressive disorder in adults including prevention of relapse.1 Key StepS 1. Dispense the prescription for Brintellix. Q: Is Brintellix listed on the Pharmaceutical Benefits Scheme (PBS)? A: No - Brintellix is available on private prescription. It is available in four strengths (5mg, 10mg, 15mg and 20mg strengths). All four strengths will cost the same ex-wholesaler price. As part of the criteria for being a Brintellix Patient Program Pharmacy (Program Pharmacy) patients on presentation of a prescription will pay no more than A$62.00 per pack of 28 tablets. 2. Open the SmartForm PDF Brintellix patient Information Leaflet template file on your hard drive or server which corresponds to the original or appropriate repeat number. 3. Complete the appropriate fields on the SmartForm PDF Brintellix Patient Information Leaflet and print a copy. This copy will be provided to the patient following counselling. Q: Will our pharmacy keep Brintellix in stock? A: Yes Initially as part of the criteria for qualifying as a Program Pharmacy the pharmacy will keep at least one (1) of the 10mg strength of Brintellix in stock. Stocking the other strengths is encouraged however the demand of particular strengths will depend of the prescribing preferences of local doctors and specialists. 4. Save the PDF to your hard drive or server in the designated Brintellix folder for record purposes. For ease of reference the PDF should be saved using the following file name protocol: patient surname_patient christian name_brintellix_dispensing date. This will also allow you to have a record of notes added to the leaflet (optional). Brintellix Patient Program Administration Centre Level 1, 263 Mary Street Richmond, VIC 3121 Phone: Fax: admin@lundbeckpharmacyprogram.com.au Lundbeck Australia Pty Ltd ABN Ground Floor, 1 Innovation Road, North Ryde NSW Ph.: Fax: Medical Information: December Brintellix Patient Program Pharmacy Wholesaler Order Form Original Dispensing Include the Brintellix Quick Reference Guide in the workflow process to prompt the dispensing pharmacist. Brintellix Patient Program Quick Reference Guide Brintellix Patient Program Shelf Talker (Wobbler) Insert Pharmacist Details and Contact Information Click here to insert your logo Insert Contact Phone Number Address: Insert Address Line 1 Insert Name Insert Contact Phone Number Address: Insert Address Line 1 Prescription Number: Insert Prescription Number Insert Name Refill Repeat 4 Refill Repeat 4 Insert Contact Phone Number Address: Insert Address Line 1 Prescription Number: Insert Prescription Number Insert Pharmacist Details and Contact Information Click here to insert your logo (Must be a PDF file unless using Acrobat Pro from which you can insert other file types) Refill Repeat 3 Refill Repeat 3 Brintellix Patient Program Information Brochure Insert Pharmacist Details and Contact Information Click here to insert your logo (Must be a PDF file unless using Acrobat Pro from which you can insert other file types) Refill Repeat 2 Refill Repeat 2 Prescription Number: Insert Prescription Number February Version 1 Lundbeck Australia Pty Ltd ABN Ground Floor, 1 Innovation Road, North Ryde NSW December (Must be a PDF file unless using Acrobat Pro from which you can insert other file types) Refill Repeat 1 Refill Repeat 1 Insert Name 9. Send the Claim Form together with a de-identified dispensary receipt or a point-of-sale receipt to the Brintellix Program Administration Centre for payment. (Payment will automatically be processed the following month as a batch payment) Insert Pharmacist Details and Contact Information Click here to insert your logo Your Pharmacist is here to help you Lundbeck Australia Pty Ltd ABN Ground Floor, 1 Innovation Road, North Ryde NSW Ph.: Fax: Medical Information: December Ensure the patient is charged no more than $62.00 and keep a receipt record for claiming purposes. 1. Brintellix Approved Product Information Brintellix Patient Program Pharmacy Staff Q & A The patient receiving this medicine is eligible for 6. Complete the appropriate fields on the Brintellix Claim Form and print copy. Save the PDF to your hard drive or server in the designated Brintellix folder. This is required for audit purposes. For ease of reference the PDF should be saved using the following file name protocol: pharmacy name_patient initials_brintellix_dispensing date. a. Fax Option: The pharmacy may provide either a dispensed prescription receipt or a point-of- sale receipt. This is then to be faxed together with the completed Claim Form to the Program Administration Centre for payment. Brintellix Patient Program PowerPoint for Staff Training INFORMATION 7. When handing out the Brintellix medication, counsel the patient and step through the key QUM initiatives on the Brintellix Patient Information Leaflet. Provide the patient with the Information Leaflet to take home. Q: How will the pharmacy be paid for the service? A: For each service fee claim, the Program Pharmacy is required to complete a Pharmacy Claim Form. There is an electronic option and a manual fax option for submission of the claim form to the Program Administration Centre. With either option the receipt must be de-identified prior to submission to ensure that no personal patient details are provided to the Program Administration Centre. (Must be a PDF file unless using Acrobat Pro from which you can insert other file types) ORIGINAL DISPENSING Address: Insert Address Line 1 5. Open the Brintellix Claim Form template on your hard drive or server. Q: Is there any payment to the pharmacy for undertaking this service? A: It is envisaged that the price to patient of A$62.00 will contain little or no mark-up for the pharmacy. For your assistance in dispensing, and supporting patients with the Brintellix Patient Program, Lundbeck will pay participating pharmacies a service fee of $25 per prescription for each original prescription and each subsequent repeat dispensing. Insert Pharmacist Details and Contact Information Click here to insert your logo (Must be a PDF file unless using Acrobat Pro from which you can insert other file types) Q: What is the Brintellix Patient Program? A: The purpose of the Program is to assist participating pharmacies to provide patients prescribed the new antidepressant therapy, Brintellix, with additional medication support. As part of this Program a number of quality use of medicines (QUM) initiatives are to be discussed with patients in a structured manner as set out in the protocol. This is in addition to any counselling and support which a pharmacist would normally provide in the dispensing of the medicine. The Program will facilitate pharmacist engagement with patients to help ensure their quality use of medicines. b. Option: The SmartForm PDF Claim Form has an option to insert a receipt image into the specified area. This image may be captured by photo or scan. Alternatively, a PDF attachment of the dispense software receipt may be ed together with the Claim Form to the Program Administration Centre. We recommend Program Pharmacies keep a record of all correspondence. We reserve the right to request further information and records. Brintellix Patient Program PowerPoint for Pharmacist Training PaTienT Program Quick reference guide The following questions and answers will assist in the streamlined implementation of the Brintellix Patient Program (Program) ensuring that all staff are confident to execute their respective tasks within this new Program. Q: Is there any support material to assist patients or pharmacy staff? A: Yes - there are number of resources available in the Kit to support pharmacy staff and there is a structured Program to support patients called the Brintellix Patient Program. There is also a web portal which forms part of this structured Program Quality Use of Medicines Initiatives The pharmacist has a key role to play in the transition to this medicine and to ensure there is ongoing compliance to the medicine. To support compliance, materials have been developed for medical practitioners and community pharmacists aimed to assist the patient to better understand this medicine. SPEAKER 1. Lundbeck Australia Pty Ltd ABN Ground Floor, 1 Innovation Road, North Ryde NSW Ph.: Fax: Medical Information: DETAILS OF TERMS AND CONDITIONS Dear Pharmacy Owner, Insert Name Insert Contact Phone Number Address: Insert Address Line 1 Prescription Number: Insert Prescription Number Insert Name Insert Contact Phone Number Prescription Number: Insert Prescription Number Welcome to the Brintellix Patient Program. Your pharmacist will provide important information to help you maximise the benefits during your initial 7 months of treatment. Welcome back to the Brintellix Patient Program. As your treatment starts to take effect, you may find yourself starting to enjoy your favourite activities again. Welcome back to the Brintellix Patient Program. Symptoms of major depression can make you feel very lonely at times. Overcoming major depression isn't easy, but a strong social network can help. Welcome back to the Brintellix Patient Program and 3 more tips to help maximise your treatment outcomes: Major Depressive Disorder (clinical depression or major depression) affects your mood, mind, body and behaviour and can interfere with your ability to work, sleep, and interact with family and friends. The goal of treatment is to alleviate your symptoms and help you return to your normal activities. Here are 3 tips to maximise your treatment outcomes: Welcome back to the Brintellix Patient Program. Most people with major depression symptoms start treatment with their primary care doctor, but your doctor may also refer you to a psychologist or other counsellor to assist with your treatment. Here are 3 tips to maximise your treatment outcomes: 1. Having emotionally supportive relationships helps to put problems into perspective. If you pulled away from friends and family while depressed, now is the time to start rebuilding those bonds. Friends and family can also be a source of encouragement on days when depression symptoms or worries about symptoms get you down. To make socializing easier, form friendships with people who share your goals or interests. Here are a few examples: Here are 3 tips to maximise your treatment outcome: 1. Continue to take Brintellix as it may take up to two weeks, sometimes longer, before you feel any improvement. Take Brintellix as a single dose at the same time each day, either in the morning or the evening. Here are a few tips to help you remember to take your medication: Combine taking your Brintellix with a regular daily task such as making your morning coffee or cleaning your teeth. Use electronic reminders or set a daily alarm. 2. If you have private health insurance, you may be eligible for reimbursement of all or part of the prescription fee. Call your health fund to find out more. 3. Read the Consumer Medicine Information (CMI) leaflet contained in the medicine carton. All medicines may cause side effects. Brintellix side effects are generally mild to moderate and occur within the first two weeks of treatment. They are usually temporary and generally do not require treatment cessation. If you notice any unusual effects, please contact Lundbeck Australia to discuss, by phone on , or to SafetyLuAustralia@lundbeck.com. You should also speak to your doctor or pharmacist. 1. Continue to take Brintellix at the same time each day and follow all directions given to you by your doctor or pharmacist. In addition to medication for major depression, there are other steps you can take to help lift your mood and support your recovery. 2. Although depression can rob you of energy, motivation, and the desire to do things that you once enjoyed, inactivity can actually make depression worse. Exercise boosts neurotransmitters in your brain and helps you to feel calm and focused. Staying active is one of the best things you can do to cope with major depressive disorder. 3. Physical exercise helps relieve the tension in your muscles, relaxes your mind and distracts you from negative thoughts and worries. Try to do some physical exercise every day. Here are some tips to get you started: Return to simple activities you enjoy. If you are new to exercise, start slowly. Plan a routine and set realistic and achievable goals. Exercise outdoors if possible or try simple yoga poses. Participate in activities with family and friends. Gradually work up to more vigorous exercise. 1. Psychotherapy (also called counselling or behavioural therapy) in conjunction with medication can be more effective than medication alone. Psychotherapy allows you to talk through your depressed feelings and can help you learn coping strategies for clinical depression symptoms. 2. As you start to overcome major depression, you can boost your success by being an active member of your own treatment team. Watch for signs that you're feeling better. Keep track of changes in your symptoms, make a weekly list and bring it to your doctor and/or psychologist appointment. Here are some examples for your checklist: I took my antidepressant medication daily I'm interested at work and able to concentrate My energy level seems to be improving I ate regularly and healthfully most days of the week I exercised at least 3 times this week I engaged in an activity with friends or family 3. A combination of antidepressant medication and psychotherapy may offer the best chance for lasting relief from major depression. Talk to your doctor about developing a GP Mental Health Treatment Plan for you. You may be eligible for referral to a clinical psychologist providing psychological therapies for up to 10 sessions a year with a Medicare rebate. And remember to take Brintellix at the same time every day and continue to take Brintellix for as long as your doctor recommends. 2. Brintellix Patient Support Program 2. Brintellix Patient Support Program 2. Brintellix Patient Support Program Our Pharmacist explained the following key Brintellix Program elements to you: Our Pharmacist explained the following key Brintellix Program elements to you: Our Pharmacist explained the following key Brintellix Program elements to you: Here are 2 tips to maximise your treatment outcomes: Find an exercise buddy. Take yoga classes, take a regular walk or train for a race, or do laps at a pool. You'll get to know each other while you work out. Volunteer your time. Hospitals, places of worship, community centres and other groups often need help. You can form strong connections with other volunteers and the benefits of helping other people add to your wellbeing. Join a book, movie, theatre or cooking club. Join a depression support group. It is a place to find other people who know what you're going through because they've had depression themselves. 2. It may take some time to successfully treat depression. Your doctor is the best person to help manage your symptoms. It is important to be open and honest in your communications with your doctor and to follow your doctor s instruction to achieve the best results. 3. Remember to take your Brintellix exactly as your doctor and pharmacist recommend. Do not stop taking Brintellix, or lower the dosage, without checking with your doctor. If you stop taking it suddenly, or reduce the amount you take, your condition may worsen. If your depression resolves while taking Brintellix, speak to your doctor about how long you will be required to take Brintellix. 2. Spending time with family and friends helps boost your mood. They can also encourage you to have better health practices, exercise more, remind you to continue taking your medication as prescribed. Remember to continue to take Brintellix for as long as your doctor recommends. If your depression resolves while taking Brintellix, speak to your doctor about how long you will be required to take Brintellix. 2. Brintellix Patient Support Program 2. Brintellix Patient Support Program Our Pharmacist explained the following key Brintellix Program elements to you: 1. For people who are depressed, stress can be overwhelming, triggering a downward slide. Chronic stress may change behaviour in ways that fuel clinical depression, for example, people who are stressed tend not to go out as much or sleep as well, or they may overeat or drink too much. Our Pharmacist explained the following key Brintellix Program elements to you: Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Insert Pharmacist Recommendation Insert Pharmacist Recommendation Insert Insert Pharmacist Name Pharmacist Initials: Insert Insert Pharmacist Name Pharmacist Initials: Insert Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Insert Pharmacist Name Insert Pharmacist Recommendation Insert Insert Pharmacist Name Pharmacist Initials: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Insert Pharmacist Recommendation Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Insert Pharmacist Recommendation Pharmacist Initials: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Pharmacist Initials: Insert Insert Pharmacist Name information is used for Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. information is used for Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. information is used for Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. information is used for Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. information is used for Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. Brintellix Patient Program - Original Dispensing SmartForm PDF Patient Information Leaflet Original Dispensing (two formats available) Insert Pharmacist Details and Contact Information Click here to insert your logo (Must be a PDF file unless using Acrobat Pro from which you can insert other file types) Refill Repeat 5 Refill Repeat 5 SmartForm PDF Patient Information Leaflet First Repeat Dispensing (two formats available) Insert Pharmacist Details and Contact Information Click here to insert your logo (Must be a PDF file unless using Acrobat Pro from which you can insert other file types) Brintellix Patient Program - Refill Repeat 1 Refill Repeat 6 Refill Repeat 6 Insert Name Address: Insert Address Line 1 Insert Contact Phone Number Address: Insert Address Line 1 Insert Name Insert Contact Phone Number SmartForm PDF Patient Information Leaflet Second Repeat Dispensing (two formats available) Patient Program Pharmacy claim Form Please complete the following details and attach or insert evidence of purchase. to: admin@lundbeckpharmacyprogram.com.au or Fax to: Pharmacy Name Insert Pharmacy Name Address Details Welcome back to the Brintellix Patient Program. Here are a further 3 tips to help maximise your treatment results: Welcome back to the Brintellix Patient Program. You have successfully completed the first 6 months of treatment. Insert Address Line 1 Pharmacist Completing Claim Insert Pharmacist Name 1. Depression is often associated with sleep problems. The less you sleep, the more things bother you and the harder it is to get a good night's rest. It's essential to restore a regular sleep pattern to make a full recovery, so here are some tips: It is important to maintain a healthy lifestyle. Pharmacist Contact Details - Phone or Insert Contact Details Prescription Dispensing Date Prescription Number: Insert Prescription Number Try to get up at about the same time each morning. If you're worrying about things during the night, set aside some time for problem-solving during the day. Allow yourself time to wind down before going to bed. If you are working or studying, stop at least 30 minutes before bedtime and do something relaxing. Prescription Number: Insert Prescription Number Here are 3 tips to help with your treatment outcomes: 1. To support depression treatment, nourish your body with nutrient-rich food. Eating a well-balanced diet with a lot of variety will likely ensure you have sufficient nutrition. Brintellix Patient Program - Refill Repeat 2 Specify Prescription Number Original (O), Repeat 1 (1), Repeat 2 (2), Repeat 3 (3), Repeat 4 (4), Repeat 5 (5) or, Subsequent Repeat (7 or greater) Prescription Number (for audit purposes) Specify Prescription Number Insert Prescription Number 2. It's tempting to self-medicate with alcohol or drugs to cope with the symptoms of depression, but with a history of depression, you're more vulnerable to negative side effects when the alcohol or drugs wear off. Reduce the use of alcohol and other drugs, as they can cause long-term problems and make it much harder to recover. It is best not to consume alcohol while you are taking Brintellix. Please complete the checklist below and or fax this form, together with evidence of Brintellix receipt, to claim $25 service fee: 3. Persistence with your medication is the key. Continue to take Brintellix at about the same time each day and follow all directions given to you by your doctor or pharmacist. If you take the wrong dose, Brintellix may not work as well and your condition may not improve. If you forget to take it, take the next dose at the usual time. If your depression resolves while taking Brintellix, speak to your doctor about how long you will be required to take Brintellix. 3. Remember to follow all directions given to you by your doctor and pharmacist. Take the dose your doctor tells you to. If your depression resolves while taking Brintellix, speak to your doctor about how long you will be required to take Brintellix. I confirm that I have adhered to the Brintellix Patient Program requirements at the time of dispensing Brintellix by counselling on the key quality use of medicines initiatives on the SmartForm PDF Patient Information Leaflet. I have provided a printed copy of the Information Leaflet to the patient to take home. 2. Brintellix Patient Support Program 2. Brintellix Patient Support Program Our Pharmacist explained the following key Brintellix Program elements to you: Our Pharmacist explained the following key Brintellix Program elements to you: 2. A psychiatrist or psychologist may be able to teach you techniques to help you deal with emotional stress. Name of Authorised Pharmacist: Insert Pharmacist Name (Name and signature required if faxing hard copy) Please attach below a patient de-identified copy of the Dispense/ Point-of-sale receipt with price to patient visible. Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Our pharmacist may also discuss additional information about Brintellix which they believe is important for you to know. Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Insert Pharmacist Recommendation Insert Insert Pharmacist Name Pharmacist Initials: Insert Insert Pharmacist Name information is used for Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. information is used for Program Administration and record keeping. You are entitled to access your personal information held by us or on our behalf. Brintellix Patient Program - Refill Repeat 5 SmartForm PDF Patient Information Leaflet Fifth Repeat Dispensing (two formats available) Option 1 - Insert image and then (image must be a PDF file unless using Acrobat Pro from which you can insert other file types) or Option 2 - Attach patient de-identified Dispense or Point-of-sale receipt, and then fax Pharmacist Initials: Our pharmacist explained that you are now enrolled in the Brintellix Patient Support Program. This leaflet will be given to you to Insert Pharmacist Recommendation Brintellix Patient Program - Refill Repeat 6 SmartForm PDF Patient Information Leaflet Subsequent Repeat Dispensing (two formats available) Brintellix Patient Program Administration Centre Level 1, 263 Mary Street Richmond, VIC 3121 Phone: Fax: admin@lundbeckpharmacyprogram.com.au Lundbeck Australia Pty Ltd ABN Ground Floor, 1 Innovation Road, North Ryde NSW Ph.: Fax: Medical Information: December Brintellix Patient Program Pharmacy Claim Form 15 Brintellix Patient Program - Refill Repeat 3 SmartForm PDF Patient Information Leaflet Third Repeat Dispensing (two formats available) Brintellix Patient Program - Refill Repeat 4 SmartForm PDF Patient Information Leaflet Fourth Repeat Dispensing (two formats available)