The application of telepharmacy as an enabling technology to facilitate the provision of quality pharmaceutical services to rural and remote areas of Australia

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(1)This file is part of the following reference:. Kimber, Michael B. (2007) The application of telepharmacy as an enabling technology to facilitate the provision of quality pharmaceutical services to rural and remote areas of Australia. PhD thesis, James Cook University. Access to this file is available from: http://eprints.jcu.edu.au/2087.

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(15) 188. Taylor C, Maniar S. Closing Distance, Improving Learning. Video Conferencing 1998; Albuquerque, NM: SIPI; 1998. 189. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. 190. YouTube. Making and Optimizing Your Videos for YouTube. 2006 (accessed: 30 August 2006); Available from: www.youtube.com 191. Wallace D. Reliability of digital images when used to assess burn wounds. Journal of Telemedicine and Telecare. 2004;10(Letters to the Editor):185. 192. National Wholesale Retail & Personal Services Industry Training Council. WRP02: Community Pharmacy Training Package. 2002 (accessed: 6/4/2002); Available from: http://www.natwraps.com.au/training_packages/pharmacy_qualifications.htm 193. Community Services and Health Training Australia Ltd. Health Training Package HLT02. 2003 (accessed: 6/4/2003); Available from: http://www.cshta.com.au/htp.htm 194. Flynn EA, Barker KN, Carnahan BJ. National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies. Journal of the American Pharmaceutical Association. 2003 March/April;43(2):191-200.. Page 284 The application of telepharmacy as an enabling technology to facilitate the provision of quality pharmaceutical services to rural and remote areas of Australia..

(16) Appendices Page Numbers. Appendix A – Ethical Approvals Tiwi Islands and Birdsville Proposal and Approval Surveys and HMR Proposal and Approval. 1 -9 10 - 22. Appendix B – Surveys B1 – Survey of Pharmacists B2 – Survey of Doctors B3 – Survey of Nurses B4 – Survey of Nurse/Healthcare workers B5 – Free format responses from pharmacists and doctors.. 23 -28 29 -33 34 - 35 36 -40 41 - 45. Appendix C Patient Informed Consent Advertisement for volunteers Letters of Support HMR Reports. 46 -48 49 50 - 53 53 -73. Appendix D Publications. 74 -82. Appendix E West Coast Tasmania Visit. 83 -87. Appendix F Approval to distribute North Dakota Manuscript. 88 90 -101. Appendix G Patient Informed Consent Form - Approval to distribute DVD Patient Interview DVD. 102 Inside Back Cover. Appendices The application of telepharmacy as an enabling technology to facilitate the provision of quality pharmaceutical services to rural and remote areas of Australia..

(17) APPENDIX A. JAMES COOK UNIVERSITY Townsville Qld 4811 Australia Tina Langford, Ethics Administrator, Research Office. Ph: 07 4781 4342; Fax: 07 4781 5521. ETHICS REVIEW COMMITTEE Human Ethics Committee APPROVAL FOR RESEARCH OR TEACHING INVOLVING HUMAN SUBJECTS PRINCIPAL INVESTIGATOR. Mr Michael Kimber. SUPERVISORS. Dr Rohan Rasiah (Medicine, Health & Molecular Sciences). SCHOOL. Pharmacy & Molecular Sciences. PROJECT TITLE. Develop an appropriate pharmacist model for no pharmacy communities in rural and remote areas of northern Australia to ensure that populations in such towns are provided with quality pharmaceutical services.. APPROVAL DATE. EXPIRY DATE. 1 Nov 2003. 31 Dec 2004. CATEGORY. This project has been allocated Ethics Approval Number with the following conditions:. H. 1. 1671. 1. All subsequent records and correspondence relating to this project must refer to this number. 2. That there is NO departure from the approved protocols unless prior approval has been sought from the Human Ethics Committee. 3. The Principal Investigator must advise the responsible Ethics Monitor appointed by the Ethics Review Committee: . periodically of the progress of the project; when the project is completed, suspended or prematurely terminated for any reason; if serious or adverse effects on participants occur; and if any unforeseen events occur that might affect continued ethical acceptability of the project.. 4. In compliance with the National Health and Medical Research Council (NHMRC) “National Statement on Ethical Conduct in Research Involving Humans” (1999), it is MANDATORY that you provide an annual report on the progress and conduct of your project. This report must detail compliance with approvals granted and any unexpected events or serious adverse effects that may have occurred during the study. NAME OF RESPONSIBLE MONITOR. Leggat, Dr Peter. EMAIL ADDRESS:. [email protected]. ASSESSED AT MEETING. Date: 1 Nov 2003. APPROVED. Date: 1 Nov 2003. Associate Professor Peter Leggat Chair, Human Ethics Committee Tina Langford Ethics Officer Research Office [email protected]. Date: 29 September 2006. COPY REPRODUCED 29 SEPTEMBER 2006. APPENDICES Page 1 \\Research-server\RS\Ethics_Templates\ApprovalFormHuman.doc.

(18) APPENDIX A. Part 2. Title : . THE PROJECT Develop an appropriate pharmacist model for no pharmacy towns in rural and remote areas of northern Australia to ensure that populations in such towns are provided with quality pharmaceutical services.. Type of project :. Student research. Applicant: Michael Kimber Proposed commencement date of project : November 2003. Proposed completion date of project : December 2004 Project Outline Develop an appropriate pharmacist model for no pharmacy towns in rural and remote areas of northern Australia to ensure that populations in such towns are provided with quality pharmaceutical services. This will involve: 1 The identification of the training needs for healthcare professionals, working in rural hospitals and clinics, where there is no pharmacist available and who provide pharmaceutical services to the local population; 2 Conduct surveys at clinics in the Northern Territory and Queensland of the procedures used to provide pharmaceutical services to patients by healthcare workers in situations where there is no pharmacist available. 3 Conduct focus groups of patients and healthcare workers to determine the level of patient compliance in taking their medication as well as customer satisfaction with the level of service they are receiving. 4 Conduct a survey of existing training courses in pharmaceutical services available which would be suitable for rural healthcare workers. 5 Conduct a gap analysis – competencies in existing training courses versus required competencies identified in the survey of training needs and procedures. 6 Propose or develop training courses for these healthcare workers. 7 Propose solutions to deficiencies (if any) identified in procedures and work practices in the provision of pharmaceutical services: • Quality Control/Assurance. • Automation of work procedures. • Medicine information services. • Pharmacist counselling services – personal, telephone or video conferencing. • Provision of training.. APPENDICES Page 2.

(19) APPENDIX A. Repeat the surveys and focus groups interviews 6 to 12 months after the identified changes are implemented and training is completed to determine the effectiveness of the changes. 1.2 Detailed Methodology The project will be carried out at clinics in the Northern Territory and Western Queensland. Field trips will be made to gather information from a representative number of Aboriginal/TI healthcare workers in clinics in the Northern Territory and Western Queensland. The areas proposed are: Northern Territory • Tiwi Islands • Galwinku • Gove • Nhulunbuy • Oenpelli Western Queensland • Birdsville A formal application to the Tiwi Health Board was made in August 2003. The Tiwi Island Health Board’s Ethics subcommittee has approved the study. (copy of Email attached). Written approval is expected shortly. Discussions with Northern Territory Health have identified that Galwinku, Gove, Nhulunbuy, Oenpelli and Gove would be appropriate communities in which to also conduct the research. Formal applications have not yet been made to these communities. Further JCU Ethics Committee Applications will be made once the approval of the local communities and Northern Territory Health Ethics Committee has been obtained. The application for JCU Ethics approval to conduct research in Birdsville will be made in conjunction with a further application in conjunction with my co supervisor Dr Rohan Rasiah. The initial part of the research will consist of administering two sets of questionnaires. The first questionnaire will be administered to indigenous health workers at rural and remote clinics. A copy of the questionnaire is attached. The questionnaire. APPENDICES Page 3.

(20) APPENDIX A. seeks to gather information on the procedures and methods used by indigenous health workers to order, store and dispense pharmaceutical products. The number of participants who are expected to take place in this survey is approximately 12. The second questionnaire will be used to ascertain the level of patient satisfaction with the supply of their medication; the adequacy of the information they are given about their medicine and their level of medication compliance. A minimum of 50 patients will be surveyed to ensure statistical significance. The questionnaire may also be administered in a focus group setting, depending on the requirements of the clinic and the availability of patients to participate in the survey. In the Northern Territory, I, as the PhD candidate, will personally administer the questionnaires in conjunction with indigenous clinic workers or translators if required. Translators will be paid at standard rates for their services. In the Western Queensland (Birdsville), it is anticipated that the focus group method will be used and will conducted under the supervision of my co supervisor, Dr Rasiah. The information acquired in the first questionnaire will be analysed and used to determine the training needs required for indigenous health workers to provide quality pharmaceutical services to patients of the clinics. A training and assessment program for pharmacy technicians working in rural and remote indigenous communities will be prepared, authorised by the appropriate health authority (the Tiwi Health Board in the case of the Tiwi Islands) and then administered by myself to the indigenous health workers. I am a certified workplace trainer and assessor (Certificate IV, Workplace Training and Assessment, NQ TAFE). There is currently a tender evaluation process in place in the Northern Territory to award pharmaceutical supply services. The Tiwi Health Board has indicated that they are prepared to fund the training process if they are awarded the tender for the Tiwi Islands and Arnhem Land. This process will be repeated in the other centres in the Northern Territory and in Western Queensland. At an appropriate time after the training and assessment process has been completed (approximately 6 months), the questionnaires will be repeated to determine the improvement in the delivery of pharmaceutical services and the level of customer satisfaction and medication compliance. 1.3 Participant Welfare Particulars. APPENDICES Page 4.

(21) APPENDIX A. There are two “target” groups: Indigenous health workers and patients. I have spoken to the three indigenous health workers on the Tiwi Islands and they are willing to participate in the program and training. The program is voluntary. The patients will be recruited on a voluntary basis. Patients will need to be taking their medication in individual dose packs such as Dosett or Webster packs; and be defined as chronic patients for at least 6 months. The interviews will be held at the clinics and, although I do not anticipate any problems, health care workers will be alerted to assist if any distress is evidenced by the patients. If necessary, clinic health workers or other appropriate linguists will be requested to translate the project aims and questions to the survey participants. Translation services will be paid at normal hourly rates. During the course of the survey healthcare worker and patient opinions may be stated. No opinions will be attributed to any identifiable person. All manuscripts, which contain references to the information collected in the surveys, will be sent to the community leaders/managers for approval prior to submission for publication. I have attended the JCU workshop on Protocols for Research involving Indigenous Sea and Country conducted by Dr Donna Kwan and I have experience in working with indigenous people, having managed a community pharmacy in Swaziland for three years. 1.4 Confidentiality The questionnaires attached detail the information to be collected. Any data that is stored on computer/CD’s will be de-identified. During the project, data will be stored in locked cabinets at the School of Pharmacy (Cairns Office) of James Cook University and at the researcher’s home. 1.5 Data Retention and Storage Raw data from this study will be stored in a locked box/cupboard at the School of Pharmacy (Cairns Office) of James Cook University. Any data that is stored on computer/CD’s will be de-identified.. APPENDICES Page 5.

(22) APPENDIX A. Access during the project will be restricted to authorised Pharmacy Department personnel. Authorisation will be granted by the Head of the Pharmacy School, or Principal Supervisor on written application. After the project, the data will be stored at the School of Pharmacy, James Cook University, Townsville. This data will be retained for at least 5 years. 1.6 Comments Only a few of studies have been completed in similar areas. A study by Bill Dollman was aimed at determining whether a University supported training and support service, based is a rural region, is a cost effective model for developing sustainable rural pharmacy services (RRPIGS, 2001). A further study by Frances Vaughan resulted in the development an Aboriginal Health Worker Pharmaceutical Reference for Remote Health Centres (RRPIGS, 2002). There are no references in the literature to similar studies to this project proposal which have been conducted in the rural areas of the Northern Territory and Queensland. The O’Leary report, “A Study of the Demand and Supply of Pharmacists, 2000 2010”, identifies workforce requirements for both community and hospital pharmacists. The reference details are contained in the attached Project Proposal. In Appendix 5 of this report, the Pharmacy Guild details a vision statement for the future, where it is envisaged that the role of the pharmacist will become increasingly focused on providing service rather than just supply of product. In order to facilitate their vision, the Pharmacy Guild stated that certain structural changes are needed to pursue this development effectively. There needs to be a radical change in the work flow arrangements in the pharmacy to free up pharmacists’ time to provide this range of additional services, e.g.: optimum use of pharmacy assistants trained in the dispensary area; dispensary computers to be relocated so the pharmacist can involve consumers in examining their medication regimens on screen while providing counselling about the medication being dispensed. IT systems need to be implemented to facilitate the provision and recording of services and care/management plans for consumers. Training programs must be implemented for pharmacists and pharmacy staff in relation to specific diseases or conditions to guarantee clinical competency and product knowledge and to ensure standardised protocols are followed.. APPENDICES Page 6.

(23) APPENDIX A. I believe that this research program aligns with the Pharmacy Guild vision to provide better training for pharmacy assistants, improved IT systems and will also provide the necessary information to produce a model for non pharmacist communities, which is a defined Commonwealth Government priority. 2. Information Pages :. Three Information Pages are attached:. 1 2 3. For Healthcare Professionals. For Patients. For General Information.. 3. Informed Consent Two Informed Consent Forms are attached: 1 For Healthcare Professionals 2 For Patients 4. Letters of Approval / Support An email form the Ethics sub-committee of the Tiwi Health Board is attached indicating approval for the project. The official letter from the Tiwi Health Board is expected shortly and will forwarded on receipt. Letters of approval from the other health authorities will be forwarded on receipt. 5. Surveys/Questionnaires Two questionnaires are attached. 1 For Healthcare Professionals 2 For Patients The format for the proposed focus group workshops is not yet finalised, but will include the type and style of questions from the patient questionnaire attached. 6. Current First Aid Certificates Copies of these are attached. 7. Suitability Cards Not applicable 8. Research Involving Patients – Health Care Districts. APPENDICES Page 7.

(24) APPENDIX A. An email form the Ethics sub-committee of the Tiwi Health Board is attached, indicating approval for the project. The official letter from the Tiwi Health Board is expected shortly and will forwarded on receipt. Letters of approval from the other health authorities will be forwarded on receipt. 9. Reports on the Research Project I will report as follows: • • • •. periodically of the progress of the project; if the project is completed or if suspended or prematurely terminated for any reason; if serious or adverse effects on participants occur; and if any unforeseen events occur that might affect continued ethical acceptability of the project.. I will also provide an annual report to the Human Ethics Sub-Committee detailing security of records and compliance with conditions of approval.. APPENDICES Page 8.

(25) APPENDIX A. Michael Kimber [email protected] Tuesday, 26 August 2003 12:59 AM [email protected] Re: Research S/C. From: Sent: To: Subject:. Dear Bill The Research s/c met via telephone hook up this afternoon. Present were Cassie, Alberta, Eva & myself. Michael Kimber's research relating to the improvement of pharmacy services in rural Australia was approved. The research s/c would like a copy of his findings relating to his interviews with the Tiwi people and also a copy of his final report/ PhD thesis - the committee considered this obligatory if he undertakes research with the Tiwi people. The committee seeks approval to have Eva Williams, our Tiwi registered nurse, to join the Research & Ethics S/C. Regards. Penny. Dear Penny Will the S/C be meeting before the Board meeting on Thursday? Regards Bill. 1. APPENDICES Page 9.

(26) APPENDIX A. APPLICATION FOR RESEARCH OR TEACHING INVOLVING HUMAN PARTICIPANTS – PART 1 Human Ethics Sub-Committee Please forward an electronic copy of the application form to [email protected] HUMAN ETHICS NUMBER (Office Use ONLY). H. 1. TITLE OF PROJECT. Quality Pharmacy Services via Telepharmacy. 2. CATEGORY. 1. 3. PERIOD DURING WHICH ACTIVITIES REQUIRING ETHICS APPROVAL WILL OCCUR FINISH DATE. 30th September 2006. Last Name, First name and Title. ESN1. Discipline/School or Institution (Country). Kimber, Michael. E. Email. Phone. Fax. [email protected]. (07) 4059 0230. (07) 4059 0710. COMMENCEMENT DATE. 4. 1st April 2006. PRINCIPAL INVESTIGATOR’S DETAILS. REASON FOR RESEARCH. JCU School of Pharmacy. No. Does this research contribute towards a formal qualification?. Qualifications. 4a. Orgu. Yes X. If Yes, which degree (i.e. PhD, MSc) PhD. Dip.Pharm, Grad Dip Adv Management, MPS. DETAILS of CO-INVESTIGATOR 1 (if applicable) Last Name, First name and Title. ESN 1. Email. Phone. REASON FOR RESEARCH. Orgu. Discipline/School or Institution (Country). Fax. No. Yes. Last Name, First name and Title. ESN 1. Orgu. Email. Phone. If Yes, which degree (i.e. PhD, MSc). Does this research contribute towards a formal qualification?. Qualifications. 4b. DETAILS of CO-INVESTIGATOR 2 (if applicable). REASON FOR RESEARCH. No. Discipline/School or Institution (Country). Fax. Yes. If Yes, which degree (i.e. PhD, MSc). Does this research contribute towards a formal qualification?. Qualifications. 1. Indicate if the Researcher is currently an Employee or a Student of JCU, or a researcher who is Not affiliated with JCU. If the project APPENDICES Page 10 involves international cooperation, please specify the country.. page 1.

(27) APPENDIX A. APPLICATION FOR RESEARCH OR TEACHING INVOLVING HUMAN PARTICIPANTS – PART 1 Human Ethics Sub-Committee If there are more than two co-investigators involved in this project, please copy this page and attach the details of these co-investigators at the end of this application (Part 1).. 5. SUPERVISOR DETAILS (if applicable) Last Name, First name and Title. ESN 1. Orgu. Nimmo, Alan, Associate Professor. Discipline/School or Institution (Country) JCU. Email. Phone. Fax. [email protected]. JCU 4061. Qualifications PhD 5a. DETAILS of SUPERVISOR 2 (if applicable) Last Name, First name and Title. ESN 1. Email. Phone. Orgu. Discipline/School or Institution (Country). Fax. Qualifications If there are more than two supervisors involved in this project, please copy this page and attach the details of these supervisors at the end of this application (Part 1).. 6 6.1 6.2 6.3. PROJECT DETAILS How many subjects are expected to be involved in the study? Are any subjects involved in this study expected to be members of an Indigenous community Has this project been submitted to any other ethics committee?. 6.4. M. #. F. #. U/18yrs. #. Total. 12. M. #. F. #. U/18yrs. #. Total. NO. No. Yes. If Yes, which Ethics Committee?. X No. Yes. Is this project a clinical trial? X 6.5. Does this project involve patients (whether in hospital or in the community) of a health service district. 6.6. No. Yes. If YES, provide details of the health service district ethics committee that granted the ethics approval. Yes. Have you obtained a “suitability card” from the Qld Commission for Children & Young People?. Yes. If YES, which Commonwealth Agency?. X No. Does this project involve children? X 6.7. 6.8. Does this project involve gaining access to personal information from a Commonwealth Agency?. No X. Does this project involve the collection, use or disclosure of health information from a private sector organisation for use for research which is related to:. No. Yes. •. research relevant to public health or safety. X. •. the compilation or analysis of statistics relevant to public health or safety. X. •. management, funding or monitoring of a health service. X. APPENDICES Page 11. page 2.

(28) APPENDIX A. APPLICATION FOR RESEARCH OR TEACHING INVOLVING HUMAN PARTICIPANTS – PART 1 Human Ethics Sub-Committee 7. FUNDING SOURCE (If applicable) N/A. Project Title Funding Body Fund Scheme 8.. Value. $. DECLARATION OF PRINCIPAL INVESTIGATOR . I declare that all investigators of this research project are qualified and authorised to perform procedures described in this document;. . I certify that the assistants involved in this project have been fully briefed on procedures and relevant ethical considerations;. . I am aware of the responsibilities set out in the relevant legislation;. . I undertake to inform the Sub-committee of any changes to the proposed procedures or details given in this form subsequent to its submission (including change of contact details);. . I agree to assist the Sub-committee to monitor the conduct of research by completing and promptly returning project review forms, which will be sent to me/us annually and provide a final report upon completion of the project as appropriate;. . This project complies with the National Health and Medical Research Council “National Statement on Ethical Conduct in Research Involving Humans”.. . This project complies with the policy on Experimentation Ethics within James Cook University;. . The purpose of this project cannot be achieved by alternatives to the use of human participants.. rd. 3 March 2006 Date. Signature (Principal Investigator). 9. DECLARATION by SUPERVISOR(S) (Supervisor(s) must sign this declaration) I/We: . Declare that I/we am/are qualified and authorised to supervise procedures described in this document; Certify that the investigators and assistants involved in this project have been fully briefed on procedures and relevant ethical considerations;. . Am aware of the responsibilities set out in the relevant legislation (see the Human Ethics Manual);. . Suitable facilities including contingent facilities are available for this project;. . Adequate instructions have been given for participant welfare and post-project care and monitoring;. . The staff members involved are appropriately qualified and competent for the task described.. Signature (Supervisor). 10.. Date. Signature (Supervisor 2). Date. AUTHORISATION by HEAD OF SCHOOL: (Head of School must sign this authorisation) I certify that: . Suitable facilities including contingent facilities are available for this project;. . Adequate instructions have been given for participant welfare and post-project care and monitoring;. . The staff members involved are appropriately qualified and competent for the task described.. Signature (Head of School). Date. APPENDICES Page 12. page 3.

(29) APPENDIX A. APPLICATION FOR RESEARCH OR TEACHING INVOLVING HUMAN PARTICIPANTS – PART 1 Human Ethics Sub-Committee 11.. MONITOR’S RECOMMENDATIONS. Please indicate your recommendation: Yes. No. This application should be approved: This application should be approved with the following comments, provisions and/or reservations: This application should not be approved for the reasons listed below:. Monitor Name. Signature (Monitor). Date. OFFICE USE ONLY. ETHICS APPROVAL This application has been APPROVED by the Human Ethics Sub-Committee at meeting _____________ held _____ /_____ /_____. Signature (Chair – Human Ethics Sub-Committee). Date. EXECUTIVE APPROVAL This application has been APPROVED by the Ethics Review Committee at meeting _____________ held _____ /_____ /_____. Signature (Chair – Ethics Review Committee). Date. APPENDICES Page 13. page 4.

(30) James Cook University Part 2. Title :. APPENDIX A Ethics Application – Telepharmacy – M.B.Kimber. THE PROJECT To determine the attitudes of health professionals to the concept of telepharmacy and develop an appropriate telepharmacy model for no pharmacy towns in rural and remote areas of northern Australia to ensure that populations in such towns are provided with quality pharmaceutical services such as medication reviews.. Type of project: Student research (PhD) Applicant: Michael Kimber Proposed commencement date of project: 1st April 2006 Proposed completion date of project: 30th September 2006 1.1 Project Outline To determine the attitudes of health professionals to the concept of telepharmacy and develop an appropriate telepharmacy model for no pharmacy towns in rural and remote areas of northern Australia to ensure that populations in such towns are provided with quality pharmaceutical services such as medication reviews. This will involve: 1. 2. 3. 4 5. 6. Conduct surveys of rural healthcare workers (doctors, nurses and other healthcare workers) in the Northern Territory and Northern Queensland to ascertain their opinions of supplying pharmacy services via telepharmacy in situations where there is no pharmacist available. Conduct medication review trial by telepharmacy to determine the level of patient satisfaction with the level of a medication review service delivered via video conferencing. The identification of the training needs for healthcare professionals, working in rural hospitals and clinics, where there is no pharmacist available and who may assist in providing pharmaceutical services via telepharmacy to the local population; Conduct a survey of existing training courses in pharmaceutical services available which would be suitable for rural healthcare workers. Conduct a gap analysis – competencies in existing training courses versus required competencies identified in the survey of training needs and procedures. Propose or develop training courses for the pharmacists and other healthcare workers who would be involved in telepharmacy events.. APPENDICES Page 1 ofPage 7 14.

(31) James Cook University. APPENDIX A Ethics Application – Telepharmacy – M.B.Kimber. 1.2 Detailed Methodology Three postal surveys will be used to gather the opinions of rural pharmacist, rural nurses and healthcare workers and rural medical practitioners in Northern Queensland on telepharmacy and its potential to provide quality pharmaceutical services to rural and remote communities. Each postal survey will be accompanied by a reply paid addressed envelope to return the form to The JCU School of Pharmacy and Molecular Sciences. The second part of the project consists of a medication review trial using telepharmacy techniques at a medical centre in Clifton Beach, Far North Queensland. This trial will involve approximately twelve patients and will be consist of a medication review using video conferencing in conjunction with a data/image acquisition device (constructed by the researcher). A questionnaire will be used to ascertain the level of patient satisfaction with the medication review and the adequacy of the information they were given about their medicine and their level of medication compliance. The questionnaire may also be administered in a focus group setting, depending upon the availability of patients to participate in the survey. A minimum of 8 patients will be surveyed to ensure statistical significance. Information from the Cairns Division of General Practice indicates that 72 formal medication reviews were conducted in 2004 and 106 in 2005. The information acquired in these questionnaires will be analysed and used to determine the training needs required for nurses and health workers to assist in telepharmacy services to provide better quality pharmaceutical services to patients of the rural and remote areas. A pro-forma training and assessment program for telepharmacy assistants working in rural and remote communities will be prepared. 1.3 Participant Welfare Particulars The patients for the medication review will be recruited on a voluntary basis. The patients will be recruited by advertising for volunteers to participate in the trial. The advertisement will be displayed, with copies of the Patient Information and Informed Consent Form, in the waiting room of the QML facilities adjacent to the Clifton Beach Medical Centre. The patients will be selected with the approval and assistance of their medical practitioner. The medical practitioners at the Clifton Beach Medical Centre have agreed to assist in this regard. The telepharmacy interviews will be held at the Queensland Medical Laboratory (QML) rooms in Clifton Beach, adjacent to the Clifton Beach Medical Centre and, although I do not anticipate any problems, the GP’s will be alerted to assist if any. Page 2 of 7 APPENDICES Page 15.

(32) James Cook University. APPENDIX A Ethics Application – Telepharmacy – M.B.Kimber. distress is evidenced by the patients. If necessary, clinic health workers or other appropriate linguists will be requested to translate the project aims and questions to the participants. Translation services will be paid at normal hourly rates. The medication reviews will be conducted by pharmacists accredited to conduct such reviews. Medication review services will be paid at normal rates (currently $140 per interview). The participants will be reimbursed reasonable travel expenses, anticipated to be no more than $50 per participant. They will also be reimbursed the difference between the standard GP consultation fee at the medical centre and the Medicare rebate amount. 1.4 Confidentiality, Data Retention and Storage The questionnaires attached detail the information to be collected. Any data that is stored on computer/CD’s will be de-identified. During the project, data will be stored in locked cabinets at the James Cook University School of Pharmacy and Molecular Sciences and at the researcher’s home. Access during the project will be restricted to authorised Pharmacy Department personnel. Authorisation will be granted by the Head of the School of Pharmacy and Molecular Sciences, or Principal Supervisor on written application. After the project, the data will be stored at the James Cook University School of Pharmacy and Molecular Sciences. This data will be retained for at least 5 years. 1.5 Comments Introduction Informal discussions conducted by the applicant with rurally based pharmacists, health practitioners, nurses and healthcare workers in a previous west coast Tasmanian telepharmacy research project has indicated that there is support from these groups for the concept of telepharmacy. A survey of a group of pharmacists by Wai Yan Lee1, a pharmacy honours student at the Tasmanian School of Pharmacy, assisting the applicant in the west coast Tasmanian telepharmacy study, indicated that there was support by pharmacists for telepharmacy projects such as Home Medication Reviews (HMRs). The current project seeks to further clarify the attitudes of rural pharmacists in northern Australia to telepharmacy and remote pharmacy automation. The applicant also proposes to survey rural health practitioners, nurses and healthcare workers in. Page 3 of 7 APPENDICES Page 16.

(33) James Cook University. APPENDIX A Ethics Application – Telepharmacy – M.B.Kimber. northern Australia to formalise the positive impressions gained in previous research to determine the level of support for telepharmacy. Telepharmacy: an enabling technology The United States Health Resources and Services Administration has defined Telepharmacy as the use of electronic information and communication technology to provide and support comprehensive pharmacy services when distance separates the participants.2 Telepharmacy represents a unique and innovative way to deliver pharmacy services to rural areas incorporating all the safe practices offered by the traditional mode of delivery. Potential benefits to the rural communities include restoring access to health care, pharmacy services, and pharmacists and improving the chances of recruiting or retaining pharmacists in rural communities; and providing new clinical training sites for pharmacy students for teaching them how to deliver pharmacy services to rural communities in a unique way.3 Telepharmacy in Australia There have been several studies conducted in Australia. An evaluation was undertaken in 2002 to assess the effectiveness of a pilot videophone service in Victoria between a private pharmacy practice in Bairnsdale and a registered pharmacy depot in Omeo. This pilot project was undertaken by the Pharmaceutical Society of Australia with the assistance of the Monash University School of Rural Health from a grant provided by the Victorian Department of Human Services.4 The overall finding of the evaluation was that the project was successful in demonstrating that pharmacy advice and consultations can be delivered effectively by videophone. A second study carried out by Nissen and Tett was as less successful. In this study, videophones were again used as a communication tool. Significant technical and logistics difficulties were encountered but despite these, the pharmacists and health professionals taking part in the study all felt that telepharmacy had a potential role in activities such as case conferencing, patient counselling, support for new graduates working in rural locations, providing recommendations on over the counter medication and distance dispensing.5 These conclusions were further confirmed by a survey of pharmacists on telepharmacy conducted by Wai Yan Lee in 2005.1 The responses of community pharmacists servicing rural and remote areas around Australia were generally in favour of using telepharmacy to improve the delivery of healthcare, patient counselling, medication reviews and allowing pharmacies to function as hub sites to service surrounding outlying communities without access to physical pharmacies to rural and remote communities. Most of the respondents openly expressed their views about telepharmacy and were obviously enthusiastic about the prospect of providing pharmaceutical care to remote localities from a distance, in particular, among the group of respondents who service rural and remote zones, where there is no access to physical pharmacies. The majority of. Page 4 of 7 APPENDICES Page 17.

(34) James Cook University. APPENDIX A Ethics Application – Telepharmacy – M.B.Kimber. remote community pharmacists who responded to the survey and who were providing health services to surrounding remote areas without access to physical pharmacies strongly supported the potential of telepharmacy to improve healthcare delivery to these remote areas. Pharmacists who were not servicing outlying areas compared to those who were providing health services to remote zones were unsure if telepharmacy could improve provision of health services in rural and remote areas. Rural community pharmacists who had been servicing neighbouring remote communities agreed that telepharmacy would be able to provide pharmaceutical services to remote areas more effectively and efficiently. Despite positive support expressed in the survey on telepharmacy many respondents were conservative towards the system and either preferred to use existing systems that were already in place to deliver healthcare services or would only consider using telepharmacy, if certain issues were handled prior to implementation of the system. Legitimate issues and concerns were presented about this new approach to pharmacy practice. These included the need for proper regulations and legislation, technology limitations and the costs of implementing and maintaining the system costs. Other concerns were the time taken for a telepharmacy event; location issues and education and training for pharmacists and other healthcare personnel taking part in telepharmacy activities. These concerns are not unique to telepharmacy and in other professions, such as physiotherapy, similar concerns have been raised. However there have also been some considerable successes. An example of one of these successes was a prospective randomised controlled trial conducted by Russell (2004)6 in Queensland to assess the treatment efficacy of a physiotherapy telemedicine system. The research model chosen for this study was the rehabilitation of 65 subjects who had undergone total knee replacement surgery. Randomised assigned participants, in either a traditional face-to-face therapy group or a telemedicine rehabilitation group, received treatment over a six week period. The results of this study demonstrated that the rehabilitation outcomes produced via the telemedicine system were similar to those achieved in the traditional manner. The telemedicine therapy was found to produce greater improvements in a number of functional outcome measurements and a high level of satisfaction was expressed by participants who received treatment via the telemedicine method. The Importance of Pharmacist Involvement In Lee’s 2005 survey1, about 50% of pharmacists currently servicing remote areas indicated that they were interested in using telepharmacy to conduct Home Medication Reviews (HMRs)for rural and remote communities. Since HMRs are a key priority in the 4th Pharmacy Agreement7, this has the potential to provide a significant and important service to rural and remote communities which would normally require such reviews to be conducted by visiting pharmacists.. Page 5 of 7 APPENDICES Page 18.

(35) James Cook University. APPENDIX A Ethics Application – Telepharmacy – M.B.Kimber. The proposed telepharmacy study will therefore provide important information which can be used to provide quality pharmacy services to rural and remote communities which do not currently have a pharmacy or a pharmacist available for consultation. References 1.. 2.. 3.. 4. 5. 6.. 7.. Lee WY. Telepharmacy to Improve Healthcare Provision by Community Pharmacists in Rural and Remote Australia [Honours]. University of Tasmania; 2005. US Health Resources and Services Administration.Administration UHRaS. Glossary of Pharmacy-Related Terms. 2005. www.hrsa.gov/opa/glossary.htm. (accessed: 16/02/2006.) Peterson DC, Anderson, H.C. Jr. The North Dakota Telepharmacy Project: Restoring and Retaining Pharmacy Services in Rural Communities. J Pharm Technol. 2004;20(January/February):28 -39. Victoria Department of Human Services. Remote Pharmacy Pilot Project Evaluation. 2002; p. 1 - 59. Nissen L, Tett S. Can telepharmacy provide pharmacy services in the bush? J Telemed Telecare. 2003;9 Suppl 2:S39-41. Russell TG. Establishing the Efficacy of Telemedicine as a Clinical Tool for Physiotherapists: From systems design to randomised controlled trial [PhD]. University of Queensland; 2004. Commonwealth of Australia. Fourth Community Pharmacy Agreement between the Commonwealth of Australia and the Pharmacy Guild of Australia. 2005; p. 145.. 2. Information Pages Four Information Sections are attached: A. For Healthcare Professionals: a. Rural Pharmacists (Attachment p2/3); b. Rural Medical Practitioners (Attachment p4/5); c. Rural Nurses or Clinic Healthcare workers if there is no RN available (Attachment p6/7). B. For Patients 3. Informed Consent Patient Informed Consent Form is attached (Attachment p8/9). 4. Letters of Approval / Support. Page 6 of 7 APPENDICES Page 19.

(36) James Cook University. APPENDIX A Ethics Application – Telepharmacy – M.B.Kimber. Letters supporting the project from principal of the Clifton Beach Medical Centre, Dr Peter Smith, Dr Stuart Phillips (General Practitioner) and Mr Paul Raumer, Manager Cairns office of QML are attached (Attachment p19-21). 5. Surveys/Questionnaires Four documents are attached. A. Postal Surveys of Healthcare Professionals: a. Rural Pharmacists (Attachment p10-12) ; b. Rural Medical Practitioners (Attachment p13/14); c. Rural Nurses or Clinic Healthcare workers if there is no RN available (Attachment p15/16). B. For Patients: a. Telepharmacy experience survey (Attachment p17). 6. Current First Aid Certificates Copy attached (Attachment p18). 7. Suitability Cards Not applicable 8. Research Involving Patients – Health Care Districts The patients participating in the medication review trial are private patients, therefore District Ethics Committee approval is not required. 9. Reports on the Research Project I will report as follows: • periodically of the progress of the project; • if the project is completed or if suspended or prematurely terminated for any reason; • if serious or adverse effects on participants occur; and if any unforeseen events occur that might affect continued ethical acceptability of the project. I will also provide an annual report to the Human Ethics Sub-Committee detailing security of records and compliance with conditions of approval.. Page 7 of 7 APPENDICES Page 20.

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