Google Answers Logo
View Question
Q: Post-marketing survelliance - sources of information - For pafalafa-ga only! ( Answered 5 out of 5 stars,   0 Comments )
Subject: Post-marketing survelliance - sources of information - For pafalafa-ga only!
Category: Health > Medicine
Asked by: tom136-ga
List Price: $15.00
Posted: 08 Mar 2003 09:47 PST
Expires: 07 Apr 2003 10:47 PDT
Question ID: 173514
Dear pafalafa-ga:
Would you please indicate sources of information for post-marketing
survelliance activities? I know that they can be free resources, like
Medline, but also paid resources. I need, if possible, some comments /
tips related to these resources. I think that it is possible that most
of the resources can be accessed throuhgh the internet, but if you
know about some important and pertinent resources which are not
accessible through the Internet, please, give me the reference as
Note: I have asked a similar question to tehuti-ga, who did a really
good job. ("paid databases useful for screening adverse events"). But
now I would like also to know your view about this issue, and I also
would like to focus on databases specially good for post-marketing
activities, not general databases.
In a next question, connected with this one, I will ask you about
search strategies.
Kind regards,
Subject: Re: Post-marketing survelliance - sources of information - For pafalafa-ga only!
Answered By: pafalafa-ga on 08 Mar 2003 13:23 PST
Rated:5 out of 5 stars
Hello again Tom.

It's a great vote of confidence to be specifically requested for a
question.  I thank you for that confidence, and hope I can live up to

It's obvious from your several questions that you have much more than
a passing interest in this topic.  So think of my answer below as just
the opening dialogue:  if you need more or different types of
information, a simple Request for Clarification is all it takes.

I almost chose not to answer this question, since my fellow
researcher, Tehuti-ga, had done such a marvelous job on your earlier
questions.  It's a very tough act to follow.  But with some
reflection, I think there are at least a few additional resources you
should be aware of (and please forgive me if I duplicate something
Tehuti-ga's already made mention of -- redundancy is the highest form
of flattery!).


First off, is this excellent "let us do all the work for you
absolutely free" service, courtesy of Uncle Sam.  FDA's MedWatch
program (which I mentioned in my last answer to you) runs a listserve
that will automatically notify you of new adverse effects information:

"MedWatch E-list
Clinically important medical product safety alerts, delivered via

Concise, timely information about the drugs and devices you use,
prescribe, or dispense every day, directly from the U.S. Food and Drug

Each e-mail contains a summary of the safety alert. When you need to
know more, a hyperlink in the e-mail directs you to more detailed

The site includes straightforward instructions about signing up and
maintaining your free subscription.


Other countries certainly develop their own systems for dealing with
information about adverse reactions.  A few major sources, from
English-based systems, are:

--The Australian Department of Health [ ]

The Australian Adverse Drug Reactions Bulletin, a quarterly
publication, provides useful information on adverse reactions,
including important issues arising from reports submitted to ADRAC.
The Bulletin is distributed to physicians, pharmacists and other
health professionals and is available electronically at:


--The Medicines Control Agency in the UK [ ]

keeps adverse reaction records in Britan.  They maintain a site at:

"Monitoring the safety and quality of medicines: Important safety

which includes the latest bulletins issued by MCA on adverse reactions
of concern.  MCA also maintains an electronic database of so-called
"yellow card" reports (the initial submission of adverse reaction
reports) which *appears* to be accessible to health professionals --
their site is a bit ambiguous on this matter.  But you might want to
inquire with MCA directly as to electronic accesibility. They can be
reached at:


--Health Canada [ ]

offers several services to disseminate information on adverse
reactions.  A full list can be found at their "Adverse Reaction
Information" page at:

and includes:

Advisories for Health Professionals or Consumers 
Advisories Issued by MHPD, TPD and BGTD (subscribe) 
Advisories Issued by Industry (subscribe) 
ADR Expedited Reporting Summary for ADRs Occuring During Clinical
Medical Devices Problem Reporting Form 
Reactions to Marketed Drugs (Vaccines Excluded)
Canadian Adverse Reaction Newsletter (subscribe) 
Drugs of Current Interest (DOCI) List
FACT Sheets 


Europe, with the complicated emergence of the EU, isn't quite up to
speed with individual countries yet, but they are developing a
comprehensive system which is worth keeping an eye on (it's not clear
to me yet to what extent the general public will have access to the

"EudraVigilance is the new European data-processing network and
database management system for the exchange, processing and evaluation
of Individual Case Safety Reports related to medicinal products
authorised in the Community. The launch of EudraVigilance is a
significant milestone with major implications on the conduct of
pharmacovigilance and the implementation of the electronic exchange of
pharmacovigilance data, which has to be regarded as a top priority for
all stakeholders"

And there's the DrugSafety site -- [ ] -- which,
quite frankly, I'm not terribly familiar with, but stumbled across it
while searching.  Access is free to health professionals, but they
seemed fairly loose about who is included in that definition.  It may
be worth an explore.

They also offer commercial services which combine various information
sources, and may be of interest to you.  Two that looked particularly

Quickly generate event and demographic summaries using dsAnalysisTM,
and then download the data for further analysis. Access over two
million historic adverse drug reaction reports from the FDA’s
Spontaneous Reporting System (SRS) [NOTE from pafalafa-ga -- SRS has
been replaced by AERS] 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.

dsMonitorTM is a web-based safety tool which provides reported adverse
drug reaction and outcome rate reports in HTML or Microsoft Excel
format. Using Galt’s proprietary implementation of the FDA’s Freedom
of Information Act (FOIA) Adverse Event Reporting System data, along
with prescription volume data supplied by National Data Corporation
(NDC), dsMonitor generates quarterly and cumulative reported adverse
drug reaction and outcome rates (based on prescription volume).


Lastly, despite your request "to focus on databases specially good for
post-marketing activities, not general databases," I feel I must
mention three sources that I would urge you to consider, in addition
to the medical specialty sources.

Sometimes, information about adverse reactions surfaces in the general
press and lay discussion groups before becoming recognized by the
professional medical community.  It's worth rooting through newspaper
reports and chat rooms to see what's being said about such and such a
drug.  Three invaluable sources in this regard:

--Google Groups [ ] to search usenet groups such as:

These include both professional and lay discussions about experiences
with particular diseases and the medications used to treat them.

--Google News [ ] allows searches of recent news
stories from all over the world, and can highlight emerging issues
regarding adverse drug reactions.

--Nexis [ ] -- Also a news search, but more
comprehensive and more powerful searching than Google (sorry Google!).
 This is a fee-based service.  You can either subscribe over a long
term, or pay each time you use it.  A nice feature here is that you
can conduct a search at no charge and see brief summaries of the
results -- you only pay if you actually download a full article. 
Nexis is not easy to use.  I posted instructions for it way at the
bottom of another answer of mine at:

If you try out Nexis, and find you need some assistance with it, just
post a clarification request, and I'm happy to help out.

Again, hope this is what you're after.
tom136-ga rated this answer:5 out of 5 stars and gave an additional tip of: $5.00
Dear pafalafa-ga,
A very useful and focused to my current needs answer. That's exactly
what I was looking after. Thank you!

There are no comments at this time.

Important Disclaimer: Answers and comments provided on Google Answers are general information, and are not intended to substitute for informed professional medical, psychiatric, psychological, tax, legal, investment, accounting, or other professional advice. Google does not endorse, and expressly disclaims liability for any product, manufacturer, distributor, service or service provider mentioned or any opinion expressed in answers or comments. Please read carefully the Google Answers Terms of Service.

If you feel that you have found inappropriate content, please let us know by emailing us at with the question ID listed above. Thank you.
Search Google Answers for
Google Answers  

Google Home - Answers FAQ - Terms of Service - Privacy Policy