Development and trial of an instrument to evaluate accredited pharmacists' clinical home medicines review reports in Australia

In Australia, clinical reports are written by an accredited pharmacist following in‐home patient consultations as part of a home medicines review (HMR). These reports communicate clinical findings and recommendations to the patient's general practitioner to optimise medicines and improve patient health. However, it is unknown if clinical HMR reports adhere to practice guidelines. This study aimed to develop an instrument from Australian practice guidelines, and then test the instrument by evaluating a small sample of clinical HMR reports written by accredited pharmacists. An instrument was developed from a consolidation of HMR practice guidelines and then applied to a small sample of de‐identified clinical HMR reports provided by accredited pharmacists. The instrument developed contained 30 criteria for clinical HMR report writing, and 20 HMR reports were evaluated from 12 accredited pharmacists. Seven of the 30 criteria were met by all clinical HMR reports evaluated (were consumer‐focused, documented a medicines list, medicines strengths, medicines directions, medication‐related problems, and included both evidence‐based and clinical recommendations for optimising medicines management). However, of the 20 HMR reports evaluated only 30% (n = 6) documented the general practitioner's reason for HMR referral, 60% (n = 12) detailed allergies/adverse drug reactions, 50% (n = 10) documented an adherence statement, and 20% (n = 4) documented vaccination status. Clinical HMR reports evaluated in this small study were aligned with practice guidelines for some criteria. Future research is warranted in a larger study to further investigate clinical HMR report writing adherence to practice guidelines in Australia.


INTRODUCTION
An integral aspect of the Australian home medicines review (HMR) program is to identify, resolve, and prevent medication-related problems and enable quality use of medicines in the community using a patientcentred approach. 1 Critical to the health service is communication contained in clinical HMR reports written by accredited pharmacists (APs) following a referral from a general practitioner (GP). APs conduct in-home patient consultations as part of the systematic assessment of the patient's medicines and the management of those medicines. These written clinical HMR reports contain clinical findings and recommendations for the patient's GP to consider to optimise their medicines and improve patient health. 2,3 One instance of HMR provision for a single patient can be time-intensive, and quality synthesis of information and knowledge transfer is imperative for clinical recommendations and documentation contained in clinical HMR reports to be enacted by GPs to achieve medication optimisation goals. [4][5][6] Home medicines review practice guidelines by various Australian professional pharmacy organisations include guidance for APs around the generation and collation of clinical HMR reports. These guidelines describe effective communication, knowledge transfer, and sharing of patient preferences between various health professionals as part of patient-centred care for home-based patients. 7 HMR clinical recommendations are likely to result in *Address for correspondence: Marea Patounas, Faculty of Health, School of Clinical Sciences, Queensland University of Technology (QUT), Brisbane, QLD, Australia. E-mail: marea.patounas@qut.edu.au positive outcomes for patients, 2,8,9 therefore the quality of HMR reports is a crucial factor in determining whether the potential of HMRs is realised. Despite these clinical benefits, it is unknown if clinical HMR reports align with practice guidelines. Previous studies mentioned the need to improve written clinical HMR reports. 10,11 Due to the prevalence of medication-related problems and the unmet needs of the Australian population for HMR services 12 as cognitive pharmacy services continue to evolve and grow, evaluation is important for ongoing improvement and to confirm if practice guidelines are met. 13 This study aimed to develop an instrument from Australian practice guidelines, and then test the instrument by evaluating a small sample of clinical HMR reports written by APs.

Participants
APs were invited to participate via email using the Australian Association of Consultant Pharmacy public register, 14 using purposive and snowball sampling. APs who identified as having performed at least one HMR in the previous 12 months were asked for samples of deidentified clinical HMR reports (2017-2018).

The Instrument and Evaluation of Clinical HMR Reports
Five HMR practice guidelines by Australian professional pharmacy organisations were identified (2017-2018). [15][16][17][18][19] The evaluation instrument was created by performing a quantitative content analysis, comparing, and documenting criteria in each of the five practice guidelines into a consolidated criteria checklist in Microsoft Excel (Microsoft Corporation, Redmond, Washington, USA). Multiple cycles of iteration were performed by two researchers to reach agreement (MP and EL). The de-identified clinical HMR reports were then evaluated using the instrument to evaluate adherence to practice guidelines. Two researchers discussed and reached consensus (MP and DR, 2018-2019).

Participants
A total of 12 participants from two states (Queensland and New South Wales), representative of a range of HMR practice experience (Table 1), each provided one or two recent copies of de-identified clinical HMR reports for evaluation (n = 20).

The Instrument and Evaluation of Clinical HMR Reports
The mapping and consolidation of HMR practice guidelines resulted in a 30-item evaluation instrument ( Table 2). Two criteria were 'the how' of clinical HMR report writing, while the remaining criteria centred on 'the what' of clinical HMR report criteria. The instrument mainly comprised the Pharmaceutical Society of Australia's guideline as it was the most comprehensive. 17 A total of 20 clinical HMR reports were evaluated ( Table 2). HMR reports were written in letter format and ranged from 2-7 pages (median 3 pages) in length.  All HMR reports (100%) evaluated met seven of the 30 criteria (were consumer-focused, documented a medicines list, medicines strengths, medicines directions, medication-related problems, and included both evidence-based and clinical recommendations for optimising medicines management), 80-85% met two of the 30 criteria (written clearly and concisely and included non-prescription medicines and complementary medicines), 50-75% met 11 of the 30 criteria (medical history/ medical conditions, allergies/adverse drug reactions, medication reconciliation list, pathology/laboratory test summary, medication management statement/acknowledgement if consumer self-administers or if done by carer/partner, adherence to medications, patient's rights, beliefs and preferences considered as part of clinical decision-making for medicines management, patient lifestyle factors, patient education and advice/resources provided, invitation for GP for further discussion regarding the HMR report, disclaimer saying that recommendations are made on available data), and 10 of the remaining 30 criteria (reason for GP's HMR referral, prescriber of each drug/any medicines prescribed by others, starting date for each drug, both generic drug names and brand names specified for each prescribed drug in medicines list, vaccination status/history, acknowledgement of medication aids or therapeutic devices [e.g. dosage administration aids, spacers], record of interventions undertaken and resolved by AP at the in-home patient consultation, patient clinical assessments conducted during in-home patient consultation, details of other health providers contacted, reference list/references) were met in 40% or less than 40% of Disclaimer saying that recommendations are made based on available data 14 (70%) Documentation mostly appeared at the end of HMR reports, with some at the start AP = accredited pharmacist; GP = general practitioner; HMR = home medicines review; N = number of HMR reports evaluated that adhered to each of the 30 criteria in the instrument. a Criteria listed are not necessarily in order of priority for HMR report writing, but represent a general structure of HMR reports. b Criteria such as the details of the HMR patient, AP, or GP were not included in the instrument as part of ethical research and were not evaluated.

DISCUSSION
This study contributes new knowledge and differs to other retrospective HMR report evaluations, which focused on specific aspects of HMR reports/practice, e.g. types of clinical recommendations, the evidence-based measures used, the number and types of medicationrelated problems identified, and the timeliness and completion rate of HMR reports pre-post pharmacist integration into the GP clinic. 2,20,21 Consistent with the existing body of literature, this study showed clinical HMR reports documented medication-related problems as clinical findings and made clinical recommendations for the referring GP to implement to optimise medicines and improve patient health. 2,3 However, previous studies were not evaluations that specifically tested a unique instrument composed of a consolidation of HMR practice guidelines regarding the extent and complexity of clinical criteria documented within HMR reports. It was beyond the scope of the current study to understand reasons why documentation did not meet some of the recommended criteria and it acknowledges that practice guidelines are meant to provide a guide and not to be prescriptive. Nevertheless, good documentation is a fundamental aspect of pharmacy practice to ensure other health professionals and patients/carers are fully informed about pharmacists' assessment and clinical recommendations. [22][23][24] This also demonstrates clinical interventions performed for continuous quality improvement and enables appropriate and fair remuneration of the significant time investment required for HMR health services. 5,6 Some clinical HMR reports documented patient beliefs with medication, including preferences and attitudes that shaped their medicines experience and impacted on the way they use medicines. 25 This enables effective healthcare knowledge transfer and comorbid patient preferences to be shared between patients, carers, prescribers, and various health professionals, and is critical for patient-centred care. [26][27][28][29] While HMR provision requires a GP referral to initiate the service, most clinical HMR reports evaluated did not document the GP's reason for HMR referral. In addition, they were also lengthy. These factors can impact GPs' willingness to read or implement HMR clinical findings and recommendations. 10,11 Lengthy clinical reports could potentially contribute to extensive time investment during HMR report generation and collation. 5 It was also noted that HMR report formatting could be improved to enhance their visual appeal for the referring GPs and provide clear sections for GPs to accept or decline written AP clinical recommendations.
A main strength of this small study was the generation of a unique instrument and the comprehensive nature of the evaluation of clinical HMR reports. Key limitations include the small sample size, and potential bias around participants' selection and provision of redacted HMR reports. Some HMR guidelines have been updated since this study was conducted. However, it is not anticipated that major changes to practice guidelines for clinical HMR reports are likely, and the study methods used are contemporary and relevant to practice and provide context for future research in a larger study.
Despite the overall general adherence to HMR guidelines, this study highlights the potential for auditing and mentoring for ongoing practice improvement. Given the time-intensive nature of clinical HMR reports 5 and the lack of routine auditing, further education and training may be needed to enhance quality. However, conducting education programs is expensive and may exclude the need to individualise HMR reports to meet the needs and preferences of individual GPs. 15 Further research is warranted in a larger study to expand on these initial findings, including incorporating reputable grey literature from recent recommendations for applying a person-centred approach to writing medication management review reports. A example of such literature is Medication Management Review Reports: Best practice recommendations. 30 Self-assessment and benchmarking of clinical HMR reports using a validated instrument could be an alternative. This study's instrument could be validated for this purpose. Future studies could uncover reasons for the absence of documentation of GPs' reasons for HMR referral and explore the GP-AP interface for desired information to include in HMR reports. Performing a multiple stakeholder, expert panel process could assess the importance of the data elements required, including their inclusion in healthcare infrastructure and digital health pathways. As cognitive pharmacy services such as the HMR service continue to evolve, understanding the complexity of clinical HMR reports is important for ongoing quality improvement. 13 Understanding the associated time investment for generation of clinical HMR reports and their health system relationship is critical for patient safety and medicines optimisation, 5 especially given the high prevalence of medication-related problems reported in community-dwelling adults and the unmet HMR needs of the Australian population. 12

CONCLUSION
A unique instrument was developed and tested on a small sample of clinical HMR reports. The evaluation showed clinical HMR reports generally adhered to the instrument's criteria, with some gaps evident. Future work in a larger study could further investigate clinical HMR reports to improve adherence to practice guidelines and to support medication optimisation and patient health outcomes.