The use of Electronic Health Record Monitoring for the Pharmacovigilance of Medicinal Cannabis.
Project Details
The aim of this project is to quantify the reporting of medicinal cannabis prescribing and identify associations between patient characteristics, conditions, adverse events, and service utilisation as found in Patron general practice EMR records from 1 January 2015 to 31 December 2023.
Patron ID: PAT033/1109
Project Lead:
Medicinal cannabis was legalised in Australia in 2016. This led to the establishment of a pathway by the Australian Therapeutic Good Administration (TGA) to enable physicians to prescribe medicinal cannabis to patients under the TGA Special Access Scheme. Following legalisation, medicinal cannabis prescription approvals rose exponentially from 33 approvals in the month of February 2017 to 13,622 in September 2021.[1] Since then, monthly approvals have stabilized at around 10,000 per month.[1] Whilst rates of approvals have steadied, 10,000 approvals per month still represent a significant volume of prescribing, as physician applications approved by the TGA often provide prescriptions with ‘repeat scripts’, as well as patient access to multiple medicinal cannabis products. Some prescriptions can contain up to ten repeats. From January 2017 to January 2023, 4,798 physicians submitted prescription applications for a cumulative total of 334,813 approvals, on behalf of at least 50,000 patients.[1]
To address this, we have undertaken a suite of methods to inform potential innovative pharmacovigilance approaches, which include qualitative research to gain an understanding of prescriber, [2] dispenser, [3] and stakeholder perspectives, [2-5] and quantitive research to gather evidence on the volume and quality of data found in primary care electronic medical records (EMRs) that reports on medicinal cannabis use. [6] We also gathered data on the number of medicinal cannabis prescriptions approved per month by the Australian Government therapeutic regulator body, the TGA. [7] Additionally, we investigated the use of social media data for the surveillance of medicinal cannabis. [8,9] Through our research, we established that there is no robust comprehensive national monitoring system in place to ascertain medicinal cannabis effects and detect ‘signals’ indicating the presence of side-effects and adverse events that could be attributed to medicinal cannabis use. We found novel approaches such as EMR monitoring, TGA registry analysis, and social media surveillance could provide opportunities for pharmacovigilance through the application of rule-based, natural language processing, data mining machine learning, and hybrid approaches.
The primary aim of this project is to quantify the reporting of medicinal cannabis prescribing and identify associations between patient characteristics, conditions, adverse events, and service utilisation as found in Patron general practice EMR records from 1 January 2015 to 31 December 2023.
A secondary aim of this project is to test the validity of Observation Medical Outcomes Partnership Common Data Model (OMOP-CDM) converted data for use in future Patron projects. To do this, we will investigate if Patron OMOP converted data produces the same (or similar) results that are obtained using a tranche of data from the local Patron database. The only difference between data in the Patron repository and Patron data that has been OMOP converted, is the data in the OMOP-CDM has been transformed into a standardised format which is consistent with the structure of data in other local and international OMOP converted repositories. We are doing this, as an increasing number of Australian and international organisations in health care and university settings are transforming their local databases into an OMOP-CDM.
The conversion of raw data held within the Patron database into an OMOP-CDM provides an opportunity to ‘up-scale’ and ‘de-risk’ data analysis, as aggregated and de-identified data can be easily combined with other OMOP converted datasets located across regions in Australia and overseas. This aggregation is possible because disparate data in each OMOP converted database has a similar format so it can be easily merged without conversion, and it can be shared across secure firewalled network without the sharing of individual data files. Another advantage of OMOP converted data is, it facilitates collaborations between research partners through the use of shared study protocols within each data custodian’s firewalled network so that the protocols can be executed across multiple databases. The use of Patron data from OMOP-CDM provides the impetus to undertake a validation study to assess the how closely data from an OMOP database represents the data that is held in the local database.
References:
1.TGA. Medicinal Cannabis Access Data Dashboard Therapeutic Good Administration Canberra: Australian Capital Territory: Australian Government Department of Health 2023. Available from: https://www.tga.gov.au/medicinal-cannabis-access-data-dashboard.
2.Hallinan CM, Gunn JM, Bonomo YA, Implementation of medicinal cannabis in Australia: innovation or upheaval? Perspectives from physicians as key informants, a qualitative analysis. BMJ Open, 2021; 11:e054044.
3.Sabmeethavorn Q, Bonomo YA, Hallinan CM, Pharmacists' perceptions and experiences of medicinal cannabis dispensing: A narrative review with a systematic approach. Int J Pharm Pract, 2022; 30: 204-214.
4.Hallinan CM, Eden E, Graham M, Greenwood LM, Mills J, Popat A, Truong L, Bonomo Y. Over the counter low-dose cannabidiol: A viewpoint from the ACRE Capacity Building Group. J Psychopharmacol. 2022 36:661-665.
5.Erku D, Greenwood LM, Graham M, Hallinan CM, Bartschi JG, Renaud E, Scuffham P. From growers to patients: Multi-stakeholder views on the use of, and access to medicinal cannabis in Australia. PLoS One. 2022; 17:e0277355.
6.Hallinan CM, Gunn JM, Qian Y, Bonomo YA. Use of electronic medical records to monitor the safe and effective prescribing of medicinal cannabis: is it feasible? Aust J Prim Health, 2022; 28:564-572
7.Hallinan CM, Bonomo YA. The Rise and Rise of Medicinal Cannabis, What Now? Medicinal Cannabis Prescribing in Australia 2017-2022. Int J Environ Res Public Health. 2022; 19(16):9853
8.Hallinan, C.M., et al., Social media discourse and internet search queries on cannabis as a medicine: A systematic scoping review. PLoS One, 2023. 18(1): p. e02
9.Khademi S, Hallinan CM, Conway M, Bonomo Y. Using Social Media Data to Investigate Public Perceptions of Cannabis as a Medicine: Narrative Review. J Med Internet Res. 2023 Feb 27;25:e36667. doi: 10.2196/36667. PMID: 36848191.
Research Publications
- Christine M. Hallinan, Jane M. Gunn, Yining Qian and Yvonne A. Bonomo. Use of electronic medical records to monitor the safe and effective prescribing of medicinal cannabis: is it feasible? Australian Journal of Primary Health, 2022, 28(6), 564–572. doi:10.1071/PY22054