PaCCSC RAPID Pharmacovigilance program
A blog post written by Linda Devilee, National Manager, PaCCSC
The Palliative Care Clinical Studies Collaborative (PaCCSC) is a national research network that has two main aims:
1. Firstly, to generate high quality research evidence to support the use of medicines and other interventions at the end of life to better manage or alleviate symptoms.
2. Secondly, to build capacity and embed research within the health workforce to enable the conduct of high quality clinical research and the uptake of new evidence into clinical practice.
Clinical research helps to support clinical practice, it adds to the knowledge that underpins clinical decision making. We know that many of the medications commonly used at the end of life to assist with managing patients’ symptoms have little or no evidence to support their use. We know that many of the medications are old and off patent and as a consequence pharmaceutical companies are not attracted because there are few, if any, commercial gains and in Australia we are very aware that there is considerable variation in service delivery which is further hindered by our geographic distribution. A nationally conducted multi-site approach, supported by a central infrastructure, makes clinical research in palliative care in Australia possible. Such a collaboration is a critical component for the generation of high level evidence and PaCCSC is now the world leader.
PaCCSC has adopted a ‘pipeline’ approach to its program of clinical research. It undertakes hypothesis generating studies (RAPID pharmacovigilance), through pilot and feasibility studies, leading to high quality, high level phase III trials. The research program is focused on six symptom nodes being: pain, nausea, breathlessness, appetite/anorexia, cognitive disorders and gastro-intestinal problems such as bowel obstruction and constipation.
The PaCCSC RAPID pharmacovigilance program is an initiative that was conceived in 2011. It is the brain child of three PaCCSC investigators David Currow, Matt Doogue and Debra Rowett who, because of this dynamic approach, have placed clinical research within reach of every palliative care service.
The regular use of medications in our specific population for indications not included in the approved product information, aka off-label use, suggests there is a significant need to track the performance of medications commonly used in the palliative care clinical settling, and to do this independent of any industry.
We know that treatment decisions do not remain static, they change as does the prevalence and combinations of comorbid illnesses that evolve over time again leading to shifts in the relative safety and efficacy of medications. Given the increasing frailty, varying degrees of organ system impairment, and the need to add symptom control medications while simultaneously managing long term comorbidities, it is reasonable to see the palliative care population as the subgroup in clinical practice at greatest risk of iatrogenic harm given that this risk increases greatly with the number of medications prescribed.
Not only do palliative care practitioners need to know when to initiate a medication but they also need to constantly update their knowledge of the available evidence to remain informed of how and when to use the medication, when to cease a medication, when to change or substitute medications, and when to add a new medication. All the while being mindful of the prescribing cascade.
So in an attempt to capture these changes PaCCSC have developed a systematic web based platform to quantify the overall net clinical benefit of medications commonly used in palliative care. Multisite collection of data with minimal impact on clinicians and no impost to patients allows a range of data to be collected prospectively. Each series concentrates very deliberately on a single medication prescribed for a single indication so that aggregation of the data is made easy.
The program is called RAPID for several reasons:
Rapid data collection
Rapid collation and analysis of these data
Rapid reporting of the findings, and
Rapid uptake in clinical practice.
RAPIDs ultimate aim is to have a large number of sites around the world in different care settings each entering a very discrete amount of data on a small number of patients in order to quickly improve the evidence base for clinical care.
The program provides a platform for palliative care professionals to participate in an international network made up of experts and amateurs alike who share the same ideas in wanting to improve the care provided to people nearing the end of life.
To date there have been six medication series undertaken and one non-pharmacological series completed. The program is expanding to include a medication series for each of the six symptom nodes of concentration in the PaCCSC research program.
Please contact Linda Devilee, National Manager, PaCCSC at paccsc@flinders.edu.au or on +61 (0)8 8275 1926 for more information.
Linda Devilee, National Manager, PaCCSC