Hello again Tom :)
Apologies for the delay, the Internet is playing up tonight. Thank
you very much for this question!
The FDA’s postmarketing surveillance is supported by the AERS database
(Adverse Event Reporting System). I think that this is the most
relevant database for your needs.
“The FDA receives adverse drug reaction reports from manufacturers as
required by regulation. Health care professionals and consumers send
reports voluntarily through the MedWatch program. These reports become
part of an Oracle™ database… All reported adverse event terms are
coded using a standardized international terminology, MedDRA (the
Medical Dictionary for Regulatory Activities). Among AERS system
features are: the on-screen review of reports; searching tools; and
various output reports….
Information from the FDA web site http://www.fda.gov/cder/aers/
You can obtain the AERS database on CD at a subscription of $360 per
year from National Technical Information Service, which gives you
quarterly updates. Back issues are available at the same price per
year of data. “The system contains only adverse reactions detected and
reported after marketing of the drug during the quarter. The
information is not cumulative. The primary purpose for the AERS data
base is to serve as an early warning or signaling system for adverse
drug reactions not detected during premarket testing.”
A possible snag is that the CDROM only supplies the raw data, and
users have to provide the database side of things for themselves.
Information from the NTIS site:
http://www.ntis.gov/search/product.asp?ABBR=SUB5460&starDB=GRAHIST
However,
from Drugsafety.com (Galt Associates) comes dsAnalysis, a web-based
service, which includes the FDA AERS data: “With one click, you can
access over two million historic adverse drug reaction reports from
the FDA’s Spontaneous Reporting System (SRS) and Adverse Event
Reporting System (AERS) data - in an intuitive, Web-based,
user-friendly format. Quarterly AERS data releases are automatically
incorporated into the database on a regular basis.”
“Because you can access our system in a matter of minutes, there is no
need to purchase the data, build a database, make changes to your
desktop, develop analysis applications, document methodology, and
maintain the system with quarterly updates—all of which require a
great investment of time and money”
Unfortunately, no price information is given on the web site.
Instead, you are asked to contact Christine Lusk at 703-547-3388, or
send an email to info@galt-assoc.com I assume prices will depend on
the number of users, etc.
Information from: http://www.drugsafety.com/DrugSafety/products/default.asp
(select dsAnalysis)
A database for which I used to abstract journals some years ago, which
is very drug-focused, is Derwent Drug File. This covers all aspects
of the pharmaceutical field, so it will involve pre- and
post-marketing information.
“data includes the preparation and testing of potential drugs,
analysis, pharmaceutics, pharmacology, therapy, adverse effects and
toxicology, pharmacokinetics”
“Over 1,150 worldwide key journals, chosen in consultation with a
committee of user representatives to give comprehensive coverage, are
regularly and promptly scrutinized for relevant papers.”
From Dialog Blue Sheet for the database:
http://www.webworldinc.com/w&a/div/biomed/bl0377.htm
Otherwise, Dialog has a “Database Selection Aid for Searching
Pharmaceutical Topics on DIALOG and DataStar” at
http://support.dialog.com/searchaids/dialog/4314.shtml , which can
also be downloaded as a pdf document. Apart from the databases I have
mentioned so far, these are the ones listed there as being major
resources for adverse effects and toxicity:
ADIS Drug News (only on Datastar)
AIDS Database (only on Datastar)
AIDSLINE (this is now a subset of Medline at NLM)
BIOSIS Previews
CA Search
CANCERLIT (another former NLM resource subsumed into Medline)
Chemical Safety Database
Drug Information Fulltext
International Pharmaceutical Abstracts
LMS Drug Alerts Online (only on Datastar)
Martindale Online
Registry of Toxic Effects of Chem. Subs. RTECS
SciSearch
I thought these documents also might be of interest:
Part 3: How Does FDA Conduct Postmarketing Surveillance And Risk
Assessment?
http://www.fda.gov/oc/tfrm/Part3.html From Managing The Risks From
Medical Product Use : Creating A Risk Management Framework (FDA 1999)
There is an article in JAMA Vol 281:824-829 (1999) - Postmarketing
Surveillance and Adverse Drug Reactions : Current Perspectives and
Future Needs by Timothy Brewer and Graham A. Colditz
The summary is at http://jama.ama-assn.org/issues/v281n9/abs/jsc80012.html
The full text is available to non-subscribers for $9 from the same
web site.
An article on Biomed Central about how databases can fail:
Incomplete evidence: the inadequacy of databases in tracing published
adverse drug reactions in clinical trials
Sheena Derry , Yoon Kong Loke and Jeffrey K Aronson
Department of Clinical Pharmacology, University of Oxford, Radcliffe
Infirmary, Oxford
http://www.biomedcentral.com/1471-2288/1/7
Search strategy: 1. “postmarket surveillance” database 2. (on Dialog
site) adverse |
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