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Direct patient reporting of adverse drug reactions. A twelve-country survey & literature review


Senior Member
Herxheimer A, Crombag MR, Alves TL: Direct patient reporting of adverse drug reactions. A twelve-country survey & literature review. Health Action International (HAI) (Europe). Amsterdam; 2010.

Background info:

I came across the aforementioned article via this piece
One could argue that Rxisk is doing the same thing as MedWatch, the FDA's online gateway for "reporting serious problems with human medical products." But Kalman Applbaum, a Rxisk founder and professor of medical anthropology and global studies at the University of Wisconsin, argues that MedWatch isn't for patients - especially those "trying to sort out whether it's the drug or the illness that's causing the suffering."

"We felt there were a number of things that were lacking on most or all of the FDA sites that collect information about drug side-effects," said Applbaum. "First, there's a reliance on doctor reporting, and doctors report very little, very infrequently - and this is true all over the world for a variety of reasons. And what they report is extremely slim. Very common is a single word to describe a side effect, such as hypertension, ataxia, etc." Meanwhile, said Applbaum, research (http://www.haiweb.org/14012010/14Jan2010ReportDirectPatientReportingofADRsFINAL.pdf) shows that patients are much more motivated to report than doctors. And more importantly, "their reported data is very high quality data, because they spend a lot of time," said Applbaum.

Since the November 2012 launch, Rxisk has received only 10,000 visitors per month. But Healy, Applbaum and the other founders, like Nancy Olivieri, a senior scientist at Toronto General Hospital and University of Toronto Professor of Pediatrics, Medicine, and Public Health Sciences, are not particularly concerned and plan to ramp up and market their efforts slowly. "We're doing something that's new and it's probably going to take awhile for people to cotton on to what's new about it," said Healy.

from: http://www.sott.net/article/262379-Meet-the-doctor-Big-Pharma-cant-shut-up

One reason I'm interested in this issue is to do with all the reports of patients saying that exercise programs of one type or another made them worse, but that this tending to be ignored.
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Senior Member
The report lists what is done in each of the 12 countries
Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal, Sweden, United Kingdom, and USA
which might be useful for people in the countries to know how things work in their country.

The Netherlands


The experience from three years from April 2004 was analysed (de Langen et al 2008).
Reports from patients (n=2522) were compared with reports from GPs, specialists and
pharmacists, looking at the most frequently reported ADRs, their seriousness (using the
CIOMS V criteria), and the outcome. The leading drug classes were statins, selective
serotonin reuptake inhibitor (SSRI) antidepressants, beta-blockers, anticoagulants, and
proton-pump inhibitors. The top-ranking 5 SOC [System/Organ/Class] categories were the
same; seriousness did not differ, but patients reported more life-threatening ADRs and more
(which official ADR reporting systems do not record). Patients noted outcomes and
non-recovery more often than did health professionals



In an important survey by Golomb et al patients taking a statin (94% of them from the USA)
who had discussed a possible ADR with their physician were asked how the physician had responded. A great many physicians had denied the possibility. The authors concluded that the yield of ADR reporting systems would be boosted if patients were encouraged to report such ADRs themselves. 2
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Senior Member
The second, by Blenkinsopp et al (2006), reviewed accounts of international experience from
six countries, and seven studies interviewing or surveying patients in hospital or primary
care.5 However none of the studies concerned spontaneous reporting by patients, where
patients themselves decide to report an adverse event that a drug may have caused. Patient
reports identified possible new ADRs that had not previously been reported by health
professionals. They conclude:

The quality of patient reports appears to be similar to that of health professional reports. There is some evidence that patients report an ADR when they consider that their health professional has not paid attention to their concerns. Patient reports may, at least initially, be more time consuming to process.
How do the reports compare with reports from professionals?

Four studies have compared spontaneous patient reports with reports from professionals.
Two of them examined patient reports that followed a television programme, one in the
United Kingdom on the adverse effects of paroxetine,6 the other in the Netherlands in 2007
on the benefits and harms of statins.7 .

The first compared a collection of 1374 emails sent to the broadcaster with Yellow Card
reports of similar ADRs sent to the MHRA in the years before the programme. The authors
concluded that the "reports from users and relatives…communicated information that
professional reporters can never be expected to provide. They were far richer, and described
suicidality and withdrawal symptoms much more clearly and intelligibly than the Yellow Card
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Senior Member
Do patient reports lead to earlier detection of ADRs?

Mitchell et al examined whether patients could be a direct source of information on ADRs.10 In their ingenious experiment patients being treated with amoxicillin or co-trimoxazole were given one form for reporting events, and another inviting them to report ADRs. Later telephone interviews confirmed that the reports of events were reliable and valid. Most of the events reported were related to the patient's illness, indicating the 'noise' to be expected in a system where patients report all events. But patients were conservative in attributing events to their treatment, and their ADR reports had low sensitivity.

The Dutch telephone medicines information service was also used earlier than the study described above8 to see how rapidly ADRs to a newly introduced antidepressant, paroxetine, were reported by patients and by health professionals.11 They found that the mean time lag for all suspected reactions to paroxetine was 229 days less for the telephone service than for Lareb. The mean difference in time lag was even greater (273 days) for nine reactions that had not been mentioned in the patient information leaflet.
Do patients' reports give further or clearer descriptive detail about the ADRs? Do they describe how the ADR affects the person's life?

The evidence is that if patients have space to report ADRs they will give much more detail and describe reactions more clearly than professionals who have little space on forms and are pressed for time. This emerged in the work of Medawar and Herxheimer6 and in the French pilot study cited above3.

Patients also do not hesitate to report how an ADR has affected and is still affecting their life, whereas professionals rarely know about this, and tend not to ask.