Worldwide study– RAPID pharmacovigilance

Categories: Research.

Medications are registered on the short term net effects balancing benefits and harms in highly selected populations. Often new medications are registered by studying people who have no other illnesses and are only affected by the disease or symptom that is being studied.

As medications become available, they are used:

  • in a broader population than the original study; and
  • for a wider number of clinical indications.

These useswill be particularly magnified as the population ages, and people have increasing numbers of co-morbidities.

It is therefore necessary to systematically study medications:

  • in the actual population for whom they are prescribed;
  • for the indications for which they are used (not simply the indications for which they are registered); and
  • in the care settings in which they are administered.

This is particularly important in palliative care where we apply knowledge from lots of other clinical disciplines into our clinical practice without necessarily understanding the net effect on the patients that we serve.

Net effect is defined as both the clinical benefits and the clinical harms that are caused as we prescribe medications. Net effects need to be measured across the time span that patients take these medications.

To address this issue, there is a new international collaboration to which we would welcome new participants.  The collaboration is called RAPID for several reasons:

  • Rapid data collection (each site has to collect data on only three consecutive patients newly started on the medication);
  • Rapid collation and analysis of these data (web based technology is used);
  • Rapid reporting those findings to clinicians (Journal of Palliative Medicine has agreed to publish these series of studies);
  • Rapid influence on clinical practice (for participating sites and for the broader clinical community).
  • Rapid aims to have a large number of sites around the world in different care settings each entering a very small amount of data on a small number of patients each in order to quickly improve the evidence base for clinical care. A new medication/indication is studied every three months. At any given time, a single indication will be studied even if a medication has more than one indication in hospice/palliative care practice.

Already 42 sites in 14 countries are participating and it is hoped that by the end of 2013 this will have grown to 100 sites in 25 countries.This will mean that we will have the capacity to capture data on 300 patients for each medication/indication dyad, four times each year. This will rapidly help to understand the net clinical effects of the medications that we prescribe – the clinical benefits, the clinical harms and particularly help to identify those people who get benefit with no harm and those people who get harm with no benefit.

For each patient there are three time points at which data are entered: at baseline; at time to immediate and short term benefit; and at time to immediate and short term harm. For each medication the time to benefit and time to harm will vary and will be defined by a committee drawn from participating sites around the world who have a particular interest in that medication/indication.

The sites also decide on the medications/indications that should be studied and which particular clinical benefits and harms should be part of the routine data collection.

Data collection takes three minutes at each of these three time points for the clinician providing care.  Only de-identified data are collected. For example, we ask for the person’s gender and age but not date of birth. The data are entered on a 128-bit secure website and the processes for analysing those data are increasingly being refined and automated.

The group has already studied metoclopramide for nausea and haloperidol for delirium, and is currently looking at gabapentin and pregabalin for neuropathic pain.

This program is suited to all countries no matter what their resourcing level.

We would welcome any sites around the world working in hospice/palliative care who would like to join this important initiative to improve the evidence base for our day-to-day prescribing. Please contact caroline.litster@flinders.edu.au today.

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