An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice
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Date
2012-02-21
Authors
Currow, David Christopher
Rowett, Debra Sharon
Doogue, Matthew
To, Timothy H M
Abernethy, Amy Pickar
Journal Title
Journal ISSN
Volume Title
Publisher
Mary Ann Liebert, Inc.
Rights
Rights Holder
© Mary Ann Liebert, Inc.
Abstract
Background: Medication registration currently requires evidence of safety and efficacy from adequately powered
phase 3 studies. Pharmacovigilance (phase 4 studies, postmarketing data, adverse drug reaction reporting)
provide data on more widespread and longer term use. Historically, voluntary reporting systems for pharmacovigilance
have had low reporting rates, relying on ad hoc reporting and retrospective chart reviews, or prospective
registries have often been limited to specific drugs or clinical conditions. Furthermore, these data are
often irrelevant in hospice and palliative care due to the timeliness of which such data become available and the
unique characteristics of our population and prescribing: compounding comorbidities, progressive organ failure,
accumulation of symptom-specific medications, tendency to attribute toxicity to disease progression, use of old,
off-patent medications, and incorporation of evolving evidence. There is a need for prospective, systematic
pharmacovigilance in hospice and palliative care.
Method: Here we describe an international, Web-based, 128-bit secure initiative to collect pharmacovigilance
data documenting net clinical benefit and safety of common medications. The intention is for a diverse and large
group of clinical units to record data prospectively on a small deidentified consecutive cohort of patients started
on the medication of interest. A new medication would be studied every 3 months. Three key time points
(different for each medication) will be assessed for each patient, collecting easily codefiable data at baseline, a
point at which clinical benefit should be experienced, and a point at which short- to medium-term toxicities may
occur. Toxicities can additionally be recorded at any time they occur. Data collection will take a maximum of 10
minutes per patient.
Conclusion: The intention is to create an efficient, relevant system to improve hospice and palliative care with
maximally generalizable results.
Description
Keywords
Palliative care, Clinical Pharmacology
Citation
Currow, D.C., Rowett, D.S., Doogue, M., To, T.H.M. and Abernethy, A.P., 2012. An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice. Journal of Palliative Medicine, 15(3), 282-286.