Pharmacist-led prescription writing educational intervention to final-year medical students: A pre-post nonrandomised longitudinal study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Pharmacist-led prescription writing educational intervention to final-year medical students: A pre-post nonrandomised longitudinal study Sophie Mokrzecki, Tarun Sen Gupta, Tilley Pain, Stephen Perks, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5823347/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background The skill of writing a medication prescription is multifaceted, incorporating multiple layers and dimensions. Prescribing is a competency expected of all junior doctors, however, many medical students feel a lack of preparedness and confidence to complete a medication prescription once graduated. Teaching the practical and clinical components separately may enhance understanding of the practical skill of prescribing prior to integrating the clinical knowledge to complete a medication prescription. The primary objective of this study is to determine if pharmacist-led multimodal education interventions change the prescribing skills of Australian final-year medical students. Our secondary aim is to review knowledge retention of prescribing skills in these same participants a year later as junior doctors. Thirdly, we aim to determine if there is an association between participants’ self-perceived confidence to prescribe and their practical ability to write safe and legal prescriptions. This manuscript will describe in detail the methods of this novel longitudinal study. Methods This is a nonrandomised pre-post longitudinal study to be conducted in two phases. The control for the study is students receiving curricula-based education throughout their medical degree. The intervention is pharmacist-led multimodal education (face-to-face, case-based learning with hands on experiences, online module, and placement) on prescription writing skills to final-year medical students. This study has been approved by the James Cook University Human Research Ethics Committee (H9114). Discussion This paper presents the methods and protocol of an approved and funded nonrandomised longitudinal study to investigate the potential of pharmacist educators to durably improve prescribing knowledge and skills amongst Australian final year medical students. Prescribing skills education for medical students may reduce the probability of potential incorrect or unsafe prescribing habits as junior doctors. Education standards do not acknowledge adhering to local legal regulations when prescribing and do not recommend mandatory teaching or assessment criteria. This study will review the effectiveness and need for additional education on the practical skill of writing a medication prescription. If positive, the findings of this study will have practical and policy impacts that may result in long term improvement in safe medicines practice and ultimately benefit patient care. Medical students Prescriptions Pharmacists Medical education Figures Figure 1 Figure 2 Background A medication prescription is a legal document that only approved prescribers may authorise, ensuring the safe use of medicines. Writing a medication prescription is a multifaceted skill incorporating multiple layers and dimensions (Fig. 1 ). While it is a competency expected of all junior doctors, many medical students feel a lack of preparedness and confidence to complete a medication prescription once graduated. 1 , 2 Unpreparedness may occur because of an unclear definition of the term ‘prescribe’ resulting in medical education governing bodies and providers not developing clear strategic learning and assessment resources 3 to teach the different aspects of prescribing. The definition of ‘to prescribe’ varies internationally based on local legislative or professional requirements. 4 , 5 Here we describe a prospective research study and intervention which will be conducted in Australia where the Health Workforce Australia definition of prescribe will be used: ‘ the process involving information gathering, clinical decision making, communication and evaluation, resulting in the initiation, continuation or cessation of a medicine’ . 4 This definition aligns with the steps within the medication management pathway 6 as recommended by the Australian Commission on Safety and Quality in Health Care ensuring safe and quality use of medications. The medication management pathway describes prescribing as multilayered (Fig. 1 ), 6 grouping clinical and practical knowledge and calling the combined process “prescribing”. We have previously proposed that education may be designed to teach the technical and practical skill of prescribing independently from clinical decision-making by separating the two components. 2 Separating the multilayered prescribing pathway allows education systems to restructure and develop specific learning objectives on the practical skill of writing a medication prescription. Teaching the practical and clinical components separately may enhance understanding of the practical skill of prescribing prior to integrating the clinical knowledge of prescribing into the completed prescription. Prescribing is also multidimensional (Fig. 1 ) with differences between inpatient ordering and outpatient or discharge prescription writing. Targeted education on the practical skill of writing a discharge or outpatient prescriptions is less than inpatient medication ordering. 2 , 7 Education on one type of medication authorisation fails to prepare future prescribers across other contexts or scenarios of medication authorisation and prescription. It is critical for medical students to gain knowledge and skills in prescription writing throughout their medical training so they understand, and can apply, the fundamentals of a prescription and medication supply authorisation by the time of graduation. 8 It is assumed this knowledge and understanding will produce efficient, safe, and legal prescribers using all prescribing domains (electronic and hand-written). Sound awareness of the fundamentals of a prescription may reduce prescribing errors when using unfamiliar systems to prescribe. Influencing early awareness of safe and legal prescribing can be challenging. Many educational interventions target junior doctors with less emphasis placed on educating medical students. Differences in medical education curricula (e.g. post-graduate versus undergraduate courses and varying length of degrees), and assessable criteria may contribute to inconsistent prescribing skills of graduates and thus, possible inadvertent medication error or harm. These education shortfalls may increase medication misadventure, harm to patients and costs on health systems. 9 , 10 The World Health Organisation (WHO) Guide to Good Prescribing (GGP) is a well-known and well-utilised resource within medical education curriculums worldwide. The GGP is a 6-step therapeutic problem-solving guide for teaching prescribing to medical students internationally but is not mandatory. It proposes that clinical training focus on diagnostic rather than therapeutic skills, and acknowledges prescribing skills do not improve much after graduation. 9 We recommend mandatory training on the practical skill of prescribing whilst acknowledging the importance of therapeutic knowledge. The identified gap in medical education is teaching the skill of writing a discharge or outpatient medication prescription. We have previously identified that Australian and New Zealand (NZ) final year medical students prefer pharmacists to provide multimodal education on prescription writing. 2 Students in their final year of medical school training are likely motivated to actively engage in prescription education and training given the proximate need to independently apply the knowledge in their subsequent first postgraduate or internship year. To our knowledge, there have not been any studies investigating the incorporation of a pharmacist educator with multimodal learning resources for final year medical students to improve multilayered and multidimensional prescribing skills studied across potential outpatient and discharge prescription settings. In this proposed study we build upon previous pilot findings 2 , 11 to conduct a pre-post nonrandomised longitudinal study of a pharmacist educator developed prescription education intervention for Australian final year medical students. Our primary objective is to determine if a pharmacist-led multimodal education intervention changes the discharge/outpatient prescribing skills of James Cook University (JCU), Australia final-year medical students. Our secondary aim is to review knowledge retention of prescribing skills in these same participants a year later as junior doctors. Thirdly, we aim to determine if there is an association between participants’ self-perceived confidence to prescribe and their practical ability to write safe and legal discharge/outpatient prescriptions. This manuscript will describe in detail the methods of this novel longitudinal study. Methods Study Design This is a nonrandomised pre-post longitudinal study to be conducted in two phases (Fig. 2 ). The control for the study is students receiving curricula-based education throughout their medical degree. The intervention is pharmacist-led multimodal education on prescription writing skills to final-year medical students. This is a non-randomised study based on ethics, fairness, and logistics of conducting the intervention over vast geographical locations, to ensure information sharing will not contaminate data that will be collected. Phase 2A Baseline data will be collected in 2023 and will assist in content validity of this two-phase study, informing phase-2B. This phase acts as the control, ensuring that students’ prescribing skills are comparable at similar time points, both between calendar years and prior to educational intervention. Phase 2B This interventional phase forms the pre-post design of this study. The principal investigator is a pharmacist who will develop and lead the multimodal educational intervention conducted after the pre-test. Participants will then attend a 5-week placement block prior to completing the post-test. Phase 3 Participants who acknowledge their participation in phase-3 will voluntarily provide a contact email after completing phase-2B. The follow-up test will result in the longitudinal design of this study. Study Setting This study will be developed and conducted in Queensland (QLD), Australia through the Medical School Program of the JCU College of Medicine and Dentistry. Bachelor of Medicine, Bachelor of Surgery at JCU is a 6-year undergraduate course. The course includes face-to-face and case-based learning modalities with mandatory clinical placements. Like other Australian medical schools, it undergoes periodic review and accreditation by the Australian medical Council. Participants As the recruited medical school, all JCU final-year medical students based in Townsville, Cairns, Mackay, rural and remote locations and on their elective rotation will be invited to participate. JCU medical students not in their final year of medical education or from other universities will be excluded from this study. This study will also exclude junior doctors from 2025 who are not actively involved in phase-2B during 2024. Phase-2A of this study was conducted in 2023 to JCU final-year medical students as baseline comparator data collection to phase-2B pre-test. Participation was voluntary and anonymous. This cohort will no longer be involved in the study. Using G*Power version 3.1.9.4, this study will require 76 participants. However, factoring a 25% drop-out rate, a total of 95 students is an ideal sample size. Between 2023 and 2024, there will be roughly 170 year-6 (final-year) medical students enrolled at JCU. Our randomised control trial pilot study produced a difference in total mean score of 8 points between groups. 11 However, the pilot study involved very small samples, so the lower bound of the 95% confidence interval for the mean difference was substantially less - approximately 3, so a conservative approach requires a sample size large enough to allow a difference as small as 3 to be detected. This is based on a two-tailed test, an alpha of 5% and a power of 80%. This difference in prescribing score is clinically meaningful and relevant to practice based on the literature. 11 , 12 Phase-2B will inform the number of participants in phase-3. We previously identified participants preference for prescription writing education is during the final year of medical education. 2 Phase-2B will include JCU final-year medical student cohort of 2024 from July to August. Phase-2B cohort will form the participant group for phase-3 in 2025 of junior doctors (interns). In the Australian context, the intern year is the first postgraduate year after completion of medical school and is completed in accredited hospitals and health services in accredited programs with provisional registration from the national clinician registration body (Australian Health Practitioner Regulation Agency - AHPRA). Progression to general registration as a medical officer is conditional upon successful completion of all required rotations in an accredited intern program. Voluntary participation in phase-2B and phase-3 will not be anonymous, to ensure data can be paired to assist with analysis. Data from phase-2B and phase-3 will be presented in deidentified formats. Intervention Intervention and assessment criteria will hold specificities to local state legal regulation of the Medicines and Poisons (Medicine) Regulation (2021). Some participants may be on placement in other locations external to QLD at the time. However, as their medical degree is based through JCU QLD, all education material and assessable criteria will adhere to QLD regulations. (Education modalities) Mokrzecki et al. phase-1 study identified, final-year medical students’ preference would be a multimodal education package delivered by a pharmacist provided during placement with hands-on experiences and tutorials on the skill of prescription writing. 2 This preference assisted in developing the intervention methods presented. Final-year medical students from 2023 (Phase-2A) completed only the online prescription writing test to ensure content validity during the intervention phase (phase-2B). Phase-2A was conducted in a whole cohort session where participants were then offered the face-to-face education package to meet ethics criteria. This study aims to cover all factors by providing face-to-face education with case-based learning and hands-on experiences (roughly 1.5 hours), supported by an online learning module (roughly 30 minutes), implemented during a five-week placement block (refer to Fig. 2 ). Education will be provided by a pharmacist on the skill of writing a prescription, separate from the clinical decision-making process within the medication management pathway. Education material will be supported by resources such as the Medicines and Poisons (Medicines) Regulation 2021, Pharmaceutical Benefits Scheme (PBS), and the Australian Medicines Handbook (AMH). To assess the content and remove bias from having one pharmacist educator, this intervention has recruited two other pharmacists to deliver the intervention to participants in Cairns and Online. All trainers have undergone training by SM to ensure consistency in education delivery. The effects of this multimodal education package on prescribing skills will be determined by assessing participants pre-post the intervention, and again as a junior doctor (intern year). Online learning module The online education is an interactive learning module developed through Articulate® by SM and will go live on LearnJCU® (digital learning environment utilised by JCU) after students complete the pre-test. It is an overview of the face-to-face education that participants are encouraged to complete. Participants can engage with the content as many times as they wish during the five-week placement. The content will be closed to access immediately prior to completing the post-test. Face-to-face education Face-to-face education will consist of an interactive hands-on teaching model, first reviewing the legal requirements of a prescription from the Queensland Medicines and Poisons (Medicines) Regulation 2021. This will guide case-based learning into training functionalities of the PBS and AMH, and how using these resources assist in writing medication prescriptions. Hands-on opportunities During the face-to-face education, cases will be used to assist participants in learning and practicing how to handwrite various medication prescriptions. Participants will also engage with the interactive features of the online learning module to complete a schedule 4 (prescription only medication) and schedule 8 (controlled drug) medication prescription. All prescription writing cases used during the educational interventions and the pre-post and follow-up tests will be different. Assessment and data collection methods To our knowledge, no assessment tool has been developed that has the functionality that we require to assess the skill of writing a complete discharge or outpatient medication prescription separate from making a clinical decision or inpatient medication ordering. The assessment tool for this study has been developed through Qualtrics®, allowing participants to type and submit a complete medication prescription online without prompting through an online formulary. All data from Qualtrics® will be imported into Microsoft Excel and an appropriate statistical software system for analysis. Participants will be assessed via an online prescription writing test consisting of preliminary questions and 5 cases yielding 6 prescriptions (see appendix 1 for example). All tests will have different cases used; however, each test will consist of Schedule 4 (S4), complex S4, S4 streamline, Schedule 8 (S8), and Mixed (S4 + S8) cases. After writing each prescription, participants will be asked if they are confident that their prescription is legal and safe by stating ‘yes’ or ‘no’. Each prescription will be critiqued according to set criteria as put forth in the legal Medicines and Poisons (Medicines) Regulation 2021 that must be adhered to when prescribing in QLD. Within this criterion are 4 domains established by the authors for the purposes of this study (DPSP – 6 drug factors, 5 prescriber factors, 4 safety factors and 3 patient factors) which are listed in Table 1 . This is predicted to be the first study to develop an assessment rubric or framework to critique discharge/outpatient prescriptions as described. This novel assessment framework will not require validation as the data collection is based on a local legal regulation and guidelines of assessment rather than the establishment of a research tool. Table 1 DPSP criteria Drug factors Prescriber factors Safety factors Patient factors 1. Name 2. Strength 3. Dose / Form 4. Directions 5. Quantity 6. Repeats 1. Name (with unique identifier – prescriber number) 2. Signature 3. Place of practice address 4. Contact number 5. Qualifications 1. Prescription date 2. Approved abbreviations 3. Legible 4. Extra S8 prescription requirements (quantity in words and figures) 1. Name 2. Home address 3. Date of birth (if monitored medicine / S8 prescription) Measuring the effectiveness - Comparisons There will be two control points of data collection. The first control will be the year 2023 phase-2A cohort. This phase establishes the usability and data extraction of the test. The second control will be the 2024 Phase-2B cohort pre-test with comparison made to both phase-2A and phase-2B participants post-test data. This ensures participants are comparable from 2023 to 2024 with similar baseline knowledge, and tests the outcome of possible change in prescribing skills post the interventional phase. Analysis of knowledge retention is a comparison of phase-2B data to phase-3 data. The three time points (pre-post-longitudinal, see Fig. 2 ) will assist in analysis and possible justification of the three factors – the educator, education modalities and when the education is delivered during the medical degree. Proposed Data Analysis Identifiable data for phase-2B and phase-3 is being collected for the purposes of performing paired data analysis. However, all quantitative data analysis will be presented and published in a deidentified manner. The following datasets will be compared and analysed, where a P value < 0.05 will be considered statistically significant in all cases: Dispensable versus un-dispensable: pre-phase-2A to pre-phase-2B, pre-post phase-2B and post-phase-2B to phase-3. Compare data within phase-2B and between post-phase-2B and phase-3. Compare phase-3 to phase-2B pre-post data. A new numerical variable will be created in calculating the difference in score (between and within pre-post-phase-2B and phase-3). Therefore, this may also be tested to determine if the results are normally distributed. Further analysis will be undertaken to seek specific insights into relative confidence of prescribing abilities in relation to script correctness. Ethics approval This study has been approved by the JCU Human Research Ethics Committee (H9114). The JCU medical school provided written support for the principal investigator to conduct this study. Medical Deans Australia and New Zealand are aware of this study and provided written support in conducting phase-1 (information not provided in this paper). No further site-specific approvals were required to be obtained as each study location will use JCU clinical medical school resources. This study has been peer-reviewed, and funding was awarded by the Townsville Hospital and Health Service Study, Education and Research Trust Account (SERTA) in the form of 12-months funding for 2023 and 24-months funding for 2025 and 2026. This allowed the principal investigator (SM) paid time to plan the study described. Discussion Early prescribing skills education for medical students may reduce the probability of potential incorrect or unsafe prescribing habits. 8 , 9 Australian medical education clinical practice standards explain prescribing as the graduates’ ability to appropriately, effectively and sustainably prescribe in line with quality and safety frameworks and clinical guidelines. 13 This standard does not acknowledge adhering to local legal regulations when prescribing and does not recommend mandatory teaching or assessment criteria. In Australia, it is not yet mandatory for a medical graduate to successfully complete a prescribing competency exam to gain conditional or general registration with the AHPRA. Unclear resources to guide teaching and assessment of prescription writing can result in inconsistent and possibly unsafe prescribing practices amongst some medical graduates. A similar pilot study presented the risks and benefits with a randomised controlled trial design. 11 The main limitation of this study was noted to be low sample size. Owing to this and other identified risks, we have designed a longitudinal nonrandomised study underpinned by high calibre methods to generate robust and generalisable data which will answer the study aims. This study represents the first to investigate if a pharmacist-led multimodal education interventions change the prescribing skills of JCU final-year medical students. In addition to this, we will determine participants’ knowledge retention by following them up a year later as junior doctors in their intern year. Therefore, this study will review the effectiveness and need for additional education on the practical skill of writing a discharge/outpatient medication prescription. Further, this study will assess the participants’ self-perceived confidence in relation to their prescribing skills. We will explore the Dunning-Kruger effect whereby participants pre-prescribing skill, compared to their post-prescribing skill and a self-assessment of confidence will determine the estimation of their abilities in relation to their competence. The potential limitations of this study include the non-randomisation of participants, recruitment from one university within one state of Australia (QLD) and data collection at only one time point within the intervention year. The limitations have been assessed and justifications made to assist in removing bias. Therefore, the strengths of this study include recruiting one university that has students enrolled and conducting placement over several locations (local, rural and remote, and elective rotations) across multiple hospital and health services and a diverse geography. The educational interventions will be offered face-to-face and online in a virtual setting, again removing bias by not excluding participants based on location and allowing for collection of this data through questioning technique within the preliminary questions of the test. High standard data collection methods adhering to QLD legal regulations will ensure integrity. Non-randomisation and one time-point data collection after participants have undertaken a minimum of three final year medical school clinical rotations have been carefully considered and proposed as appropriate methodological factors given the participant cohort to ensure information sharing will not contaminate the data that will be collected. Peer review by the approving human research ethics committee and the grant review panel of the funder have further supported this nuanced proposal. Engagement with stakeholders has been key to the design of this proposed study. The research team have consulted experts where appropriate to conduct and report on this topic. Support has been provided by Medical Deans Australia and New Zealand and JCU medical deans. The methodology of this study has been strongly considered and evaluated between the investigator team, medical education experts and statisticians to ensure rigor. Results from each phase of the study will be disseminated through appropriate presentations and publications and inform any methodological modifications that might become unexpectedly indicated. In summary, here we present the methods and protocol of an approved and funded nonrandomised longitudinal study to investigate the potential of pharmacist educators to durably improve prescribing knowledge and skills amongst Australian final year medical students. If positive, the findings of this study will have practical and policy impacts that may result in long term improvement in safe medicines practice and ultimately benefit patient care. Abbreviations QLD: Queensland NZ: New Zealand JCU: James Cook University Final year medical education: Within Australia medical education can range from a four to six-year degree and may be a post-graduate or undergraduate degree, depending on the university requirements. JCU offers a six-year undergraduate degree and students in “6 th year” will be in their final year of the medical course. AHPRA: Australian Health Practitioner Regulation Agency Internship: In Australia, this is the year following graduation from a medical degree once successfully registered with AHPRA PBS: Pharmaceutical Benefits Scheme AMH: Australian Medicines Handbook Declarations Ethics approval and consent to participate Ethics approval has been granted by James Cook University Human Research Ethics Committee (H9114). This study has been made aware to the Medical Deans Australia and New Zealand (MDANZ). Participants partaking in this voluntary study provide informed consent. Additionally, prior to completing each test, participants are required to “accept” consent to participate through a mandatory field. Consent for publication Participants are advised that de-identified data will be used in research publications and reports as outlined to them prior to consenting to start the voluntary test and interventions. Availability of data and materials Data sharing is not yet applicable as no dataset has been generated or analysed during publication of this current paper. Future datasets that are generated and/or analysed will not be publicly available due to confidentiality but may be available from the corresponding author on reasonable request. Competing interests Not applicable Funding This study has been funded by a peer reviewed and competitively granted; 2023 and 2024 Townsville Hospital and Health Service (THHS) Study Education and Research Trust Account (SERTA) Grants (AUD$209,820 for 36months). AJM is supported by a Queensland Health Advancing Clinical Research Fellowship. Clinical Trial Number Not Applicable Authors’ contributions This study contributes to the lead authors PhD. SM conceptualised, designed, implemented and planned the undertakings of each phase. SM is the lead investigator and author for all papers produced and published from this study. AJM is her primary advisor and has assisted with the construction of the study design and refining the methodology. AJM assisted in drafting this paper and provided final consent to its publishing. SP and TSG were insightful authors in contributing to the study design, assisting in planning the intervention and provided valued feedback to the draft of the paper. SP assists as an educator in the interventional phase. TP is a leading editor of this and future papers, also providing insight into data analysis. All listed authors have approved the submitted version. All authors have agreed both to be personally accountable for the author's own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. Acknowledgements The authors would like to acknowledge the contributions and assistance of: Dr Sarah Chalmers, Ms Leanne Southgate, Associate Professor Zaf Smith, Bronwyn Howes, the JCU medical and clinical school, TUH pharmacy department, participating JCU medical students, Haley Plaza, and Vaughan Schipplock. References Australian Medical Council, Medical Board of Australia. Australian Medical Council and Medical Board of Australia’s Preparedness for Internship Survey. 2019. https://www.amc.org.au/wp-content/uploads/2019/11/National-Report-2019-Survey-FINAL.pdf Mokrzecki S, Perks S, Pain T, Sen Gupta T, Mallett AJ. Australian and New Zealand medical students’ confidence and preparedness to prescribe. Preprint. BMC Med Educ. 2024. 10.21203/rs.3.rs-5406785/v1 . Newble D, Dawson B, Dauphinee D, et al. Guidelines for assessing clinical competence. Teach Learn Med. 1994;6(3):213–20. 10.1080/10401339409539680 . Health Workforce Australia. Health Professionals Prescribing Pathway (HPPP) Project - Final Report . 2013. NPS MedicineWise. Prescribing Competencies Framework: embedding quality use of medicines into practice. 2nd ed. Sydney, 2021. Australian Commission on Safety and Quality in Health Care. Safety and Quality Improvement Guide Standard 4: Medication Safety (October 2012). Sydney, ACSQHC, 2012. Mokrzecki S, Mallett AJ, Sen Gupta T, Perks S, Pain T. Do educational interventions improve prescribing skills of medical students compared to no additional learning? A systematic review. Med Educ Online. 2023;28(1). 10.1080/10872981.2023.2259166 . Malca CM, Siccha SC, Cardenas FE, Placencia MM. Improvement in drug prescription skills in medical students through in-person and remote simulated interviews. Preprint medRxiv. 2023. 10.1101/2023.04.11.23288429 . De Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA, WHO Action Programme on Essential Drugs. Guide to good prescribing: a practical manual . 1994. https://iris.who.int/handle/10665/59001 Haque M. Good prescribing to maximize patient benefit. Int J Nutr Pharmacol Neurol Dis. 2018;8(3):67–9. 10.4103/ijnpnd.ijnpnd_31_18 . Mokrzecki S, Pain T, Mallett AJ, Perks S. Pharmacist-Led Education for Final Year Medical Students: A Pilot Study. Front Med. 2021;8(732054). 10.3389/fmed.2021.732054 . Garbutt JM, DeFer TM, Highstein G, McNaughton C, Milligan P, Fraser VF. Safe Prescribing: An Educational Intervention For Medical Students. Teach Learn Med. 2006;18(3):244–50. 10.1207/s15328015tlm1803_10 . Australian Medical Council. Standards for Assessment and Accreditation of Primary Medical Programs. 2023. July 2023. Accessed September 2023. https://www.amc.org.au/wp-content/uploads/2023/08/AMC-Medical_School_Standards-FINAL.pdf Additional Declarations No competing interests reported. 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02:23:14","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5823347/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5823347/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":76663089,"identity":"49c8639f-3055-44bb-af4d-65d1e2e34105","added_by":"auto","created_at":"2025-02-19 12:13:05","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":202387,"visible":true,"origin":"","legend":"\u003cp\u003eInfographic describing the characteristics of what makes prescribing medication for the consumer multilayered and multidimensional (reproduced with permission)\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5823347/v1/b69efb2d505f62e59af203c8.png"},{"id":76663083,"identity":"549c8d3f-76a1-4654-8fa9-1687161ead53","added_by":"auto","created_at":"2025-02-19 12:13:05","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":90819,"visible":true,"origin":"","legend":"\u003cp\u003eDesign structure of two-phase nonrandomised pre-post longitudinal review study\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5823347/v1/debb97be7188b4de9b17b966.png"},{"id":79086190,"identity":"5d0e3f15-588e-4914-8b33-9f372832ff29","added_by":"auto","created_at":"2025-03-24 09:17:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":888441,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5823347/v1/5afc6b4a-5002-4875-abf7-c566ab270bcc.pdf"},{"id":76663084,"identity":"20c1c771-5571-42c4-8d44-6381e352e529","added_by":"auto","created_at":"2025-02-19 12:13:05","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":14908,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix1.docx","url":"https://assets-eu.researchsquare.com/files/rs-5823347/v1/14fc8b5928b9db51cda2ff43.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Pharmacist-led prescription writing educational intervention to final-year medical students: A pre-post nonrandomised longitudinal study","fulltext":[{"header":"Background","content":"\u003cp\u003eA medication prescription is a legal document that only approved prescribers may authorise, ensuring the safe use of medicines. Writing a medication prescription is a multifaceted skill incorporating multiple layers and dimensions (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). While it is a competency expected of all junior doctors, many medical students feel a lack of preparedness and confidence to complete a medication prescription once graduated. \u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e Unpreparedness may occur because of an unclear definition of the term \u0026lsquo;prescribe\u0026rsquo; resulting in medical education governing bodies and providers not developing clear strategic learning and assessment resources\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e to teach the different aspects of prescribing.\u003c/p\u003e \u003cp\u003eThe definition of \u0026lsquo;to prescribe\u0026rsquo; varies internationally based on local legislative or professional requirements. \u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e,\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e Here we describe a prospective research study and intervention which will be conducted in Australia where the Health Workforce Australia definition of prescribe will be used: \u0026lsquo;\u003cem\u003ethe process involving information gathering, clinical decision making, communication and evaluation, resulting in the initiation, continuation or cessation of a medicine\u0026rsquo;\u003c/em\u003e. \u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e This definition aligns with the steps within the medication management pathway\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e as recommended by the Australian Commission on Safety and Quality in Health Care ensuring safe and quality use of medications. The medication management pathway describes prescribing as multilayered (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e), \u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e grouping clinical and practical knowledge and calling the combined process \u0026ldquo;prescribing\u0026rdquo;. We have previously proposed that education may be designed to teach the technical and practical skill of prescribing independently from clinical decision-making by separating the two components. \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e Separating the multilayered prescribing pathway allows education systems to restructure and develop specific learning objectives on the practical skill of writing a medication prescription. Teaching the practical and clinical components separately may enhance understanding of the practical skill of prescribing prior to integrating the clinical knowledge of prescribing into the completed prescription.\u003c/p\u003e \u003cp\u003ePrescribing is also multidimensional (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) with differences between inpatient ordering and outpatient or discharge prescription writing. Targeted education on the practical skill of writing a discharge or outpatient prescriptions is less than inpatient medication ordering. \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e Education on one type of medication authorisation fails to prepare future prescribers across other contexts or scenarios of medication authorisation and prescription. It is critical for medical students to gain knowledge and skills in prescription writing throughout their medical training so they understand, and can apply, the fundamentals of a prescription and medication supply authorisation by the time of graduation. \u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e It is assumed this knowledge and understanding will produce efficient, safe, and legal prescribers using all prescribing domains (electronic and hand-written). Sound awareness of the fundamentals of a prescription may reduce prescribing errors when using unfamiliar systems to prescribe.\u003c/p\u003e \u003cp\u003eInfluencing early awareness of safe and legal prescribing can be challenging. Many educational interventions target junior doctors with less emphasis placed on educating medical students. Differences in medical education curricula (e.g. post-graduate versus undergraduate courses and varying length of degrees), and assessable criteria may contribute to inconsistent prescribing skills of graduates and thus, possible inadvertent medication error or harm. These education shortfalls may increase medication misadventure, harm to patients and costs on health systems. \u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e,\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e The World Health Organisation (WHO) Guide to Good Prescribing (GGP) is a well-known and well-utilised resource within medical education curriculums worldwide. The GGP is a 6-step therapeutic problem-solving guide for teaching prescribing to medical students internationally but is not mandatory. It proposes that clinical training focus on diagnostic rather than therapeutic skills, and acknowledges prescribing skills do not improve much after graduation. \u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e We recommend mandatory training on the practical skill of prescribing whilst acknowledging the importance of therapeutic knowledge. The identified gap in medical education is teaching the skill of writing a discharge or outpatient medication prescription.\u003c/p\u003e \u003cp\u003eWe have previously identified that Australian and New Zealand (NZ) final year medical students prefer pharmacists to provide multimodal education on prescription writing. \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e Students in their final year of medical school training are likely motivated to actively engage in prescription education and training given the proximate need to independently apply the knowledge in their subsequent first postgraduate or internship year. To our knowledge, there have not been any studies investigating the incorporation of a pharmacist educator with multimodal learning resources for final year medical students to improve multilayered and multidimensional prescribing skills studied across potential outpatient and discharge prescription settings.\u003c/p\u003e \u003cp\u003eIn this proposed study we build upon previous pilot findings\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e to conduct a pre-post nonrandomised longitudinal study of a pharmacist educator developed prescription education intervention for Australian final year medical students. Our primary objective is to determine if a pharmacist-led multimodal education intervention changes the discharge/outpatient prescribing skills of James Cook University (JCU), Australia final-year medical students. Our secondary aim is to review knowledge retention of prescribing skills in these same participants a year later as junior doctors. Thirdly, we aim to determine if there is an association between participants\u0026rsquo; self-perceived confidence to prescribe and their practical ability to write safe and legal discharge/outpatient prescriptions. This manuscript will describe in detail the methods of this novel longitudinal study.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design\u003c/h2\u003e \u003cp\u003eThis is a nonrandomised pre-post longitudinal study to be conducted in two phases (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The control for the study is students receiving curricula-based education throughout their medical degree. The intervention is pharmacist-led multimodal education on prescription writing skills to final-year medical students. This is a non-randomised study based on ethics, fairness, and logistics of conducting the intervention over vast geographical locations, to ensure information sharing will not contaminate data that will be collected.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePhase 2A\u003c/h3\u003e\n\u003cp\u003eBaseline data will be collected in 2023 and will assist in content validity of this two-phase study, informing phase-2B. This phase acts as the control, ensuring that students\u0026rsquo; prescribing skills are comparable at similar time points, both between calendar years and prior to educational intervention.\u003c/p\u003e\n\u003ch3\u003ePhase 2B\u003c/h3\u003e\n\u003cp\u003eThis interventional phase forms the pre-post design of this study. The principal investigator is a pharmacist who will develop and lead the multimodal educational intervention conducted after the pre-test. Participants will then attend a 5-week placement block prior to completing the post-test.\u003c/p\u003e\n\u003ch3\u003ePhase 3\u003c/h3\u003e\n\u003cp\u003eParticipants who acknowledge their participation in phase-3 will voluntarily provide a contact email after completing phase-2B. The follow-up test will result in the longitudinal design of this study.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e\n\u003ch3\u003eStudy Setting\u003c/h3\u003e\n\u003cp\u003eThis study will be developed and conducted in Queensland (QLD), Australia through the Medical School Program of the JCU College of Medicine and Dentistry. Bachelor of Medicine, Bachelor of Surgery at JCU is a 6-year undergraduate course. The course includes face-to-face and case-based learning modalities with mandatory clinical placements. Like other Australian medical schools, it undergoes periodic review and accreditation by the Australian medical Council.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eParticipants\u003c/h2\u003e \u003cp\u003e As the recruited medical school, all JCU final-year medical students based in Townsville, Cairns, Mackay, rural and remote locations and on their elective rotation will be invited to participate. JCU medical students not in their final year of medical education or from other universities will be excluded from this study. This study will also exclude junior doctors from 2025 who are not actively involved in phase-2B during 2024.\u003c/p\u003e \u003cp\u003ePhase-2A of this study was conducted in 2023 to JCU final-year medical students as baseline comparator data collection to phase-2B pre-test. Participation was voluntary and anonymous. This cohort will no longer be involved in the study.\u003c/p\u003e \u003cp\u003eUsing G*Power version 3.1.9.4, this study will require 76 participants. However, factoring a 25% drop-out rate, a total of 95 students is an ideal sample size. Between 2023 and 2024, there will be roughly 170 year-6 (final-year) medical students enrolled at JCU. Our randomised control trial pilot study produced a difference in total mean score of 8 points between groups. \u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e However, the pilot study involved very small samples, so the lower bound of the 95% confidence interval for the mean difference was substantially less - approximately 3, so a conservative approach requires a sample size large enough to allow a difference as small as 3 to be detected. This is based on a two-tailed test, an alpha of 5% and a power of 80%. This difference in prescribing score is clinically meaningful and relevant to practice based on the literature. \u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e,\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e Phase-2B will inform the number of participants in phase-3.\u003c/p\u003e \u003cp\u003eWe previously identified participants preference for prescription writing education is during the final year of medical education. \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e Phase-2B will include JCU final-year medical student cohort of 2024 from July to August. Phase-2B cohort will form the participant group for phase-3 in 2025 of junior doctors (interns). In the Australian context, the intern year is the first postgraduate year after completion of medical school and is completed in accredited hospitals and health services in accredited programs with provisional registration from the national clinician registration body (Australian Health Practitioner Regulation Agency - AHPRA). Progression to general registration as a medical officer is conditional upon successful completion of all required rotations in an accredited intern program.\u003c/p\u003e \u003cp\u003eVoluntary participation in phase-2B and phase-3 will not be anonymous, to ensure data can be paired to assist with analysis. Data from phase-2B and phase-3 will be presented in deidentified formats.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eIntervention\u003c/h3\u003e\n\u003cp\u003eIntervention and assessment criteria will hold specificities to local state legal regulation of the Medicines and Poisons (Medicine) Regulation (2021). Some participants may be on placement in other locations external to QLD at the time. However, as their medical degree is based through JCU QLD, all education material and assessable criteria will adhere to QLD regulations.\u003c/p\u003e\n\u003ch3\u003e(Education modalities)\u003c/h3\u003e\n\u003cp\u003eMokrzecki et al. phase-1 study identified, final-year medical students\u0026rsquo; preference would be a multimodal education package delivered by a pharmacist provided during placement with hands-on experiences and tutorials on the skill of prescription writing. \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e This preference assisted in developing the intervention methods presented. Final-year medical students from 2023 (Phase-2A) completed only the online prescription writing test to ensure content validity during the intervention phase (phase-2B). Phase-2A was conducted in a whole cohort session where participants were then offered the face-to-face education package to meet ethics criteria.\u003c/p\u003e \u003cp\u003eThis study aims to cover all factors by providing face-to-face education with case-based learning and hands-on experiences (roughly 1.5 hours), supported by an online learning module (roughly 30 minutes), implemented during a five-week placement block (refer to Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eEducation will be provided by a pharmacist on the skill of writing a prescription, separate from the clinical decision-making process within the medication management pathway. Education material will be supported by resources such as the Medicines and Poisons (Medicines) Regulation 2021, Pharmaceutical Benefits Scheme (PBS), and the Australian Medicines Handbook (AMH). To assess the content and remove bias from having one pharmacist educator, this intervention has recruited two other pharmacists to deliver the intervention to participants in Cairns and Online. All trainers have undergone training by SM to ensure consistency in education delivery.\u003c/p\u003e \u003cp\u003eThe effects of this multimodal education package on prescribing skills will be determined by assessing participants pre-post the intervention, and again as a junior doctor (intern year).\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eOnline learning module\u003c/h2\u003e \u003cp\u003eThe online education is an interactive learning module developed through Articulate\u0026reg; by SM and will go live on LearnJCU\u0026reg; (digital learning environment utilised by JCU) after students complete the pre-test. It is an overview of the face-to-face education that participants are encouraged to complete. Participants can engage with the content as many times as they wish during the five-week placement. The content will be closed to access immediately prior to completing the post-test.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eFace-to-face education\u003c/h2\u003e \u003cp\u003eFace-to-face education will consist of an interactive hands-on teaching model, first reviewing the legal requirements of a prescription from the Queensland Medicines and Poisons (Medicines) Regulation 2021. This will guide case-based learning into training functionalities of the PBS and AMH, and how using these resources assist in writing medication prescriptions.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eHands-on opportunities\u003c/h2\u003e \u003cp\u003eDuring the face-to-face education, cases will be used to assist participants in learning and practicing how to handwrite various medication prescriptions. Participants will also engage with the interactive features of the online learning module to complete a schedule 4 (prescription only medication) and schedule 8 (controlled drug) medication prescription. All prescription writing cases used during the educational interventions and the pre-post and follow-up tests will be different.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eAssessment and data collection methods\u003c/h2\u003e \u003cp\u003eTo our knowledge, no assessment tool has been developed that has the functionality that we require to assess the skill of writing a complete discharge or outpatient medication prescription separate from making a clinical decision or inpatient medication ordering. The assessment tool for this study has been developed through Qualtrics\u0026reg;, allowing participants to type and submit a complete medication prescription online without prompting through an online formulary. All data from Qualtrics\u0026reg; will be imported into Microsoft Excel and an appropriate statistical software system for analysis.\u003c/p\u003e \u003cp\u003eParticipants will be assessed via an online prescription writing test consisting of preliminary questions and 5 cases yielding 6 prescriptions (see \u003cspan refid=\"Sec19\" class=\"InternalRef\"\u003eappendix 1\u003c/span\u003e for example). All tests will have different cases used; however, each test will consist of Schedule 4 (S4), complex S4, S4 streamline, Schedule 8 (S8), and Mixed (S4\u0026thinsp;+\u0026thinsp;S8) cases. After writing each prescription, participants will be asked if they are confident that their prescription is legal and safe by stating \u0026lsquo;yes\u0026rsquo; or \u0026lsquo;no\u0026rsquo;.\u003c/p\u003e \u003cp\u003eEach prescription will be critiqued according to set criteria as put forth in the legal Medicines and Poisons (Medicines) Regulation 2021 that must be adhered to when prescribing in QLD. Within this criterion are 4 domains established by the authors for the purposes of this study (DPSP \u0026ndash; 6 drug factors, 5 prescriber factors, 4 safety factors and 3 patient factors) which are listed in Table \u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. This is predicted to be the first study to develop an assessment rubric or framework to critique discharge/outpatient prescriptions as described. This novel assessment framework will not require validation as the data collection is based on a local legal regulation and guidelines of assessment rather than the establishment of a research tool.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDPSP criteria\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDrug factors\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePrescriber factors\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSafety factors\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePatient factors\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Name\u003c/p\u003e \u003cp\u003e2. Strength\u003c/p\u003e \u003cp\u003e3. Dose / Form\u003c/p\u003e \u003cp\u003e4. Directions\u003c/p\u003e \u003cp\u003e5. Quantity\u003c/p\u003e \u003cp\u003e6. Repeats\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1. Name (with unique identifier \u0026ndash; prescriber number)\u003c/p\u003e \u003cp\u003e2. Signature\u003c/p\u003e \u003cp\u003e3. Place of practice address\u003c/p\u003e \u003cp\u003e4. Contact number\u003c/p\u003e \u003cp\u003e5. Qualifications\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. Prescription date\u003c/p\u003e \u003cp\u003e2. Approved abbreviations\u003c/p\u003e \u003cp\u003e3. Legible\u003c/p\u003e \u003cp\u003e4. Extra S8 prescription requirements (quantity in words and figures)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1. Name\u003c/p\u003e \u003cp\u003e2. Home address\u003c/p\u003e \u003cp\u003e3. Date of birth (if monitored medicine / S8 prescription)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eMeasuring the effectiveness - Comparisons\u003c/h2\u003e \u003cp\u003eThere will be two control points of data collection. The first control will be the year 2023 phase-2A cohort. This phase establishes the usability and data extraction of the test. The second control will be the 2024 Phase-2B cohort pre-test with comparison made to both phase-2A and phase-2B participants post-test data. This ensures participants are comparable from 2023 to 2024 with similar baseline knowledge, and tests the outcome of possible change in prescribing skills post the interventional phase.\u003c/p\u003e \u003cp\u003eAnalysis of knowledge retention is a comparison of phase-2B data to phase-3 data. The three time points (pre-post-longitudinal, see Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) will assist in analysis and possible justification of the three factors \u0026ndash; the educator, education modalities and when the education is delivered during the medical degree.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eProposed Data Analysis\u003c/h2\u003e \u003cp\u003eIdentifiable data for phase-2B and phase-3 is being collected for the purposes of performing paired data analysis. However, all quantitative data analysis will be presented and published in a deidentified manner.\u003c/p\u003e \u003cp\u003eThe following datasets will be compared and analysed, where a P value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 will be considered statistically significant in all cases:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eDispensable versus un-dispensable: pre-phase-2A to pre-phase-2B, pre-post phase-2B and post-phase-2B to phase-3.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eCompare data within phase-2B and between post-phase-2B and phase-3.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eCompare phase-3 to phase-2B pre-post data.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eA new numerical variable will be created in calculating the difference in score (between and within pre-post-phase-2B and phase-3). Therefore, this may also be tested to determine if the results are normally distributed. Further analysis will be undertaken to seek specific insights into relative confidence of prescribing abilities in relation to script correctness.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eEthics approval\u003c/h2\u003e \u003cp\u003e This study has been approved by the JCU Human Research Ethics Committee (H9114). The JCU medical school provided written support for the principal investigator to conduct this study. Medical Deans Australia and New Zealand are aware of this study and provided written support in conducting phase-1 (information not provided in this paper). No further site-specific approvals were required to be obtained as each study location will use JCU clinical medical school resources.\u003c/p\u003e \u003cp\u003eThis study has been peer-reviewed, and funding was awarded by the Townsville Hospital and Health Service Study, Education and Research Trust Account (SERTA) in the form of 12-months funding for 2023 and 24-months funding for 2025 and 2026. This allowed the principal investigator (SM) paid time to plan the study described.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eEarly prescribing skills education for medical students may reduce the probability of potential incorrect or unsafe prescribing habits. \u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e,\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e Australian medical education clinical practice standards explain prescribing as the graduates\u0026rsquo; ability to appropriately, effectively and sustainably prescribe in line with quality and safety frameworks and clinical guidelines. \u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e This standard does not acknowledge adhering to local legal regulations when prescribing and does not recommend mandatory teaching or assessment criteria. In Australia, it is not yet mandatory for a medical graduate to successfully complete a prescribing competency exam to gain conditional or general registration with the AHPRA. Unclear resources to guide teaching and assessment of prescription writing can result in inconsistent and possibly unsafe prescribing practices amongst some medical graduates.\u003c/p\u003e \u003cp\u003eA similar pilot study presented the risks and benefits with a randomised controlled trial design. \u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e The main limitation of this study was noted to be low sample size. Owing to this and other identified risks, we have designed a longitudinal nonrandomised study underpinned by high calibre methods to generate robust and generalisable data which will answer the study aims.\u003c/p\u003e \u003cp\u003eThis study represents the first to investigate if a pharmacist-led multimodal education interventions change the prescribing skills of JCU final-year medical students. In addition to this, we will determine participants\u0026rsquo; knowledge retention by following them up a year later as junior doctors in their intern year. Therefore, this study will review the effectiveness and need for additional education on the practical skill of writing a discharge/outpatient medication prescription. Further, this study will assess the participants\u0026rsquo; self-perceived confidence in relation to their prescribing skills. We will explore the Dunning-Kruger effect whereby participants pre-prescribing skill, compared to their post-prescribing skill and a self-assessment of confidence will determine the estimation of their abilities in relation to their competence.\u003c/p\u003e \u003cp\u003eThe potential limitations of this study include the non-randomisation of participants, recruitment from one university within one state of Australia (QLD) and data collection at only one time point within the intervention year. The limitations have been assessed and justifications made to assist in removing bias. Therefore, the strengths of this study include recruiting one university that has students enrolled and conducting placement over several locations (local, rural and remote, and elective rotations) across multiple hospital and health services and a diverse geography. The educational interventions will be offered face-to-face and online in a virtual setting, again removing bias by not excluding participants based on location and allowing for collection of this data through questioning technique within the preliminary questions of the test. High standard data collection methods adhering to QLD legal regulations will ensure integrity. Non-randomisation and one time-point data collection after participants have undertaken a minimum of three final year medical school clinical rotations have been carefully considered and proposed as appropriate methodological factors given the participant cohort to ensure information sharing will not contaminate the data that will be collected. Peer review by the approving human research ethics committee and the grant review panel of the funder have further supported this nuanced proposal.\u003c/p\u003e \u003cp\u003eEngagement with stakeholders has been key to the design of this proposed study. The research team have consulted experts where appropriate to conduct and report on this topic. Support has been provided by Medical Deans Australia and New Zealand and JCU medical deans. The methodology of this study has been strongly considered and evaluated between the investigator team, medical education experts and statisticians to ensure rigor. Results from each phase of the study will be disseminated through appropriate presentations and publications and inform any methodological modifications that might become unexpectedly indicated.\u003c/p\u003e \u003cp\u003eIn summary, here we present the methods and protocol of an approved and funded nonrandomised longitudinal study to investigate the potential of pharmacist educators to durably improve prescribing knowledge and skills amongst Australian final year medical students. If positive, the findings of this study will have practical and policy impacts that may result in long term improvement in safe medicines practice and ultimately benefit patient care.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eQLD: Queensland\u003c/p\u003e\n\u003cp\u003eNZ: New Zealand\u003c/p\u003e\n\u003cp\u003eJCU: James Cook University\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFinal year medical education: Within Australia medical education can range from a four to six-year degree and may be a post-graduate or undergraduate degree, depending on the university requirements. JCU offers a six-year undergraduate degree and students in \u0026ldquo;6\u003csup\u003eth\u003c/sup\u003e year\u0026rdquo; will be in their final year of the medical course.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAHPRA: Australian Health Practitioner Regulation Agency\u003c/p\u003e\n\u003cp\u003eInternship: In Australia, this is the year following graduation from a medical degree once successfully registered with AHPRA\u003c/p\u003e\n\u003cp\u003ePBS: Pharmaceutical Benefits Scheme\u003c/p\u003e\n\u003cp\u003eAMH: Australian Medicines Handbook\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch3\u003eEthics approval and consent to participate\u003c/h3\u003e\n\u003cp\u003eEthics approval has been granted by James Cook University Human Research Ethics Committee (H9114). This study has been made aware to the Medical Deans Australia and New Zealand (MDANZ).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eParticipants partaking in this voluntary study provide informed consent. Additionally, prior to completing each test, participants are required to “accept” consent to participate through a mandatory field.\u003c/p\u003e\n\u003ch3\u003eConsent for publication\u003c/h3\u003e\n\u003cp\u003eParticipants are advised that de-identified data will be used in research publications and reports as outlined to them prior to consenting to start the voluntary test and interventions. \u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eAvailability of data and materials\u003c/h3\u003e\n\u003cp\u003eData sharing is not yet applicable as no dataset has been generated or analysed during publication of this current paper. Future datasets that are generated and/or analysed will not be publicly available due to confidentiality but may be available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003ch3\u003eCompeting interests\u003c/h3\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003ch3\u003eFunding\u003c/h3\u003e\n\u003cp\u003e\u0026nbsp;This study has been funded by a peer reviewed and competitively granted; 2023 and 2024 Townsville Hospital and Health Service (THHS) Study Education and Research Trust Account (SERTA) Grants (AUD$209,820 for 36months). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAJM is supported by a Queensland Health Advancing Clinical Research Fellowship.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical Trial Number\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot Applicable\u003c/p\u003e\n\u003ch3\u003eAuthors’ contributions\u003c/h3\u003e\n\u003cp\u003eThis study contributes to the lead authors PhD. SM conceptualised, designed, implemented and planned the undertakings of each phase. SM is the lead investigator and author for all papers produced and published from this study. AJM is her primary advisor and has assisted with the construction of the study design and refining the methodology. AJM assisted in drafting this paper and provided final consent to its publishing. SP and TSG were insightful authors in contributing to the study design, assisting in planning the intervention and provided valued feedback to the draft of the paper. SP assists as an educator in the interventional phase. TP is a leading editor of this and future papers, also providing insight into data analysis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll listed authors have approved the submitted version. All authors have agreed both to be personally accountable for the author's own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature.\u003c/p\u003e\n\u003ch3\u003eAcknowledgements\u003c/h3\u003e\n\u003cp\u003eThe authors would like to acknowledge the contributions and assistance of: Dr Sarah Chalmers, Ms Leanne Southgate, Associate Professor Zaf Smith, Bronwyn Howes, the JCU medical and clinical school, TUH pharmacy department, participating JCU medical students, Haley Plaza, and Vaughan Schipplock.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAustralian Medical Council, Medical Board of Australia. Australian Medical Council and Medical Board of Australia\u0026rsquo;s Preparedness for Internship Survey. 2019. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.amc.org.au/wp-content/uploads/2019/11/National-Report-2019-Survey-FINAL.pdf\u003c/span\u003e\u003cspan address=\"https://www.amc.org.au/wp-content/uploads/2019/11/National-Report-2019-Survey-FINAL.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMokrzecki S, Perks S, Pain T, Sen Gupta T, Mallett AJ. Australian and New Zealand medical students\u0026rsquo; confidence and preparedness to prescribe. Preprint. BMC Med Educ. 2024. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.21203/rs.3.rs-5406785/v1\u003c/span\u003e\u003cspan address=\"10.21203/rs.3.rs-5406785/v1\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNewble D, Dawson B, Dauphinee D, et al. Guidelines for assessing clinical competence. Teach Learn Med. 1994;6(3):213\u0026ndash;20. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1080/10401339409539680\u003c/span\u003e\u003cspan address=\"10.1080/10401339409539680\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHealth Workforce Australia. \u003cem\u003eHealth Professionals Prescribing Pathway (HPPP) Project - Final Report\u003c/em\u003e. 2013.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNPS MedicineWise. Prescribing Competencies Framework: embedding quality use of medicines into practice. 2nd ed. Sydney, 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAustralian Commission on Safety and Quality in Health Care. Safety and Quality Improvement Guide Standard 4: Medication Safety (October 2012). Sydney, ACSQHC, 2012.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMokrzecki S, Mallett AJ, Sen Gupta T, Perks S, Pain T. Do educational interventions improve prescribing skills of medical students compared to no additional learning? A systematic review. Med Educ Online. 2023;28(1). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1080/10872981.2023.2259166\u003c/span\u003e\u003cspan address=\"10.1080/10872981.2023.2259166\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMalca CM, Siccha SC, Cardenas FE, Placencia MM. Improvement in drug prescription skills in medical students through in-person and remote simulated interviews. Preprint medRxiv. 2023. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1101/2023.04.11.23288429\u003c/span\u003e\u003cspan address=\"10.1101/2023.04.11.23288429\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDe Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA, WHO Action Programme on Essential Drugs. \u003cem\u003eGuide to good prescribing: a practical manual\u003c/em\u003e. 1994. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://iris.who.int/handle/10665/59001\u003c/span\u003e\u003cspan address=\"https://iris.who.int/handle/10665/59001\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaque M. Good prescribing to maximize patient benefit. Int J Nutr Pharmacol Neurol Dis. 2018;8(3):67\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.4103/ijnpnd.ijnpnd_31_18\u003c/span\u003e\u003cspan address=\"10.4103/ijnpnd.ijnpnd_31_18\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMokrzecki S, Pain T, Mallett AJ, Perks S. Pharmacist-Led Education for Final Year Medical Students: A Pilot Study. Front Med. 2021;8(732054). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3389/fmed.2021.732054\u003c/span\u003e\u003cspan address=\"10.3389/fmed.2021.732054\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGarbutt JM, DeFer TM, Highstein G, McNaughton C, Milligan P, Fraser VF. Safe Prescribing: An Educational Intervention For Medical Students. Teach Learn Med. 2006;18(3):244\u0026ndash;50. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1207/s15328015tlm1803_10\u003c/span\u003e\u003cspan address=\"10.1207/s15328015tlm1803_10\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAustralian Medical Council. Standards for Assessment and Accreditation of Primary Medical Programs. 2023. July 2023. Accessed September 2023. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.amc.org.au/wp-content/uploads/2023/08/AMC-Medical_School_Standards-FINAL.pdf\u003c/span\u003e\u003cspan address=\"https://www.amc.org.au/wp-content/uploads/2023/08/AMC-Medical_School_Standards-FINAL.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Medical students, Prescriptions, Pharmacists, Medical education","lastPublishedDoi":"10.21203/rs.3.rs-5823347/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5823347/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe skill of writing a medication prescription is multifaceted, incorporating multiple layers and dimensions. Prescribing is a competency expected of all junior doctors, however, many medical students feel a lack of preparedness and confidence to complete a medication prescription once graduated. Teaching the practical and clinical components separately may enhance understanding of the practical skill of prescribing prior to integrating the clinical knowledge to complete a medication prescription.\u003c/p\u003e\n\u003cp\u003eThe primary objective of this study is to determine if pharmacist-led multimodal education interventions change the prescribing skills of Australian final-year medical students. Our secondary aim is to review knowledge retention of prescribing skills in these same participants a year later as junior doctors. Thirdly, we aim to determine if there is an association between participants’ self-perceived confidence to prescribe and their practical ability to write safe and legal prescriptions. This manuscript will describe in detail the methods of this novel longitudinal study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is a nonrandomised pre-post longitudinal study to be conducted in two phases. The control for the study is students receiving curricula-based education throughout their medical degree. The intervention is pharmacist-led multimodal education (face-to-face, case-based learning with hands on experiences, online module, and placement) on prescription writing skills to final-year medical students.\u003c/p\u003e\n\u003cp\u003eThis study has been approved by the James Cook University Human Research Ethics Committee (H9114).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis paper presents the methods and protocol of an approved and funded nonrandomised longitudinal study to investigate the potential of pharmacist educators to durably improve prescribing knowledge and skills amongst Australian final year medical students. Prescribing skills education for medical students may reduce the probability of potential incorrect or unsafe prescribing habits as junior doctors. Education standards do not acknowledge adhering to local legal regulations when prescribing and do not recommend mandatory teaching or assessment criteria. This study will review the effectiveness and need for additional education on the practical skill of writing a medication prescription. If positive, the findings of this study will have practical and policy impacts that may result in long term improvement in safe medicines practice and ultimately benefit patient care.\u003c/p\u003e","manuscriptTitle":"Pharmacist-led prescription writing educational intervention to final-year medical students: A pre-post nonrandomised longitudinal study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-02-19 12:13:01","doi":"10.21203/rs.3.rs-5823347/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"
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