Hello saverio-ga,
The topic of fatal reactions to prescription and over-the-counter
medicines has received a great deal of attention and study. Depending
on who you believe, the number of deaths in the U.S. from adverse
reactions to drugs is either 200 per year, almost 7,000 per year, or
over 100,00 deaths per year...take your pick.
In order to explain this orders-of-magnitude variation -- and to
address your question as explicitly as possible -- I will present the
information I have compiled in the following manner:
1. A brief overview of adverse drug reactions -- how they are
classified and the difficulties involved in connecting use of a drug
with a fatal outcome.
2. A summary of the methods by which adverse drug reactions involved
in fatalities are recorded and analyzed.
3. A summary of the available incidence data on medicine-related
deaths -- how many such deaths occur in the U.S. in the course of a
year.
4. A review of the data linking medicine-related deaths to specific
medicines and classes of medicines.
5. A synopsis of the major studies and information sources that have
contributed to an understanding of the above topics.
If anything in the information I have presented is not clear -- or if
you would like additional information on any topic discussed -- please
let me know by posting a Request for Clarification, and I will do my
best to clarify my answer.
This topic has been one of the most fascinating that I have had the
chance to dive into as a Google Answers researcher, and I thank you
for providing me that opportunity.
All the best.
pafalafa-ga
P.S. There are numerous tables below. My apologies in advance if
they do not format properly (which is often the case, after an answer
is posted).
==========
The Incidence of Adverse Drug Reactions in the United States
1. A brief overview of adverse drug reactions -- how they are
classified and the difficulties involved in connecting use of a drug
with a fatal outcome.
The medical community distinguishes adverse drug reactions -- ADR?s --
from adverse drug events, or ADE?s. ADR?s are largely confined to
unintended results of reactions to medications that were administered
in a medically appropriate context. ADE?s refer to a broader category
of events that include ADR?s, but also include results from other
causes such as deliberate misuse of medicines -- recreational use,
suicide, attempts at murder or other harm, excessive self-medication,
etc.
Since the definition of ADR aligns most closely with the category you
are interested in, I have focused my attention on these data. I
should note, however, that although most researchers tend to adhere to
the distinctions between these two terms, they are occasionally used
more loosely or even interchangeably.
ADR?s are not, of course, restricted to fatal events, but can include
any medically significant, non-therapeutic reaction to a medication,
from a mild rash to a life-threatening cardiac arrhythmia. It is no
surprise, then, to note that most observers assume there are millions
of ADR?s every year, and that the majority of these are undocumented.
Medical personnel at all stages of the health care system, however,
are expected to be on the alert for ADR?s and to voluntarily report
significant ADR?s either to the company that makes the drug in
question (who then is required to report to the FDA) or directly to
federal surveillance programs. Patients and consumers can also report
a suspected ADR to medical authorities.
A report of an ADR does not mean an ADR has taken place, and this
brings me to the difficulties inherent in adequately documenting ADR
events. A report merely indicates an ADR is suspected; a good deal of
evaluation has to occur before a confirmation can be made that an
actual event -- an injury or fatality -- was actually caused by an
adverse reaction to a medication.
The classic example of this phenomenon is concern over vaccines.
Children get sick. Occasionally, a child falls ill shortly after
receiving a vaccination, and even more rarely, the illness is serious
or life-threatening. The child?s parents and his health care
providers may be convinced that the child is experiencing an ADR -- a
reaction to the vaccination. Epidemiological studies, however,
typically do not reveal any elevated incidence of specific diseases
related to receiving vaccinations (there have been exceptions,
however!).
So, given the temporal sequence -- vaccination, followed shortly
thereafter by serious illness -- is this an ADR or not? Different
observers will likely have different opinions, some classifying it as
an ADR, while others ascribe it to coincidence.
The vaccination scenario is actually one of the simplest scenarios to
consider. Patients in the health care system -- especially those who
are seriously ill, elderly, or both -- may be receiving multiple
drugs, and their well-being may be threatened by a number of causes,
not the least of which is their underlying medical condition. If such
a patient takes a sudden turn for the worse -- or dies -- should it be
considered an ADR? And if so, which drug, of the numerous being
taken, should the ADR be ascribed to? It may not even make sense to
point to a single drug as a potential culprit, since it could very
well be the interaction between drugs that is responsible for the
undesirable reaction.
In a nutshell, identifying for certain when an ADR has occurred is an
uncertain undertaking, at best, and successfully associating the event
with a specific drug adds a substantial additional element of
uncertainty.
2. A summary of the methods by which adverse drug reactions in
fatalities are recorded and analyzed.
In the United States, there are three primary sources of information
about the incidence of ADR?s that cause or contribute to death. These
are: death certificates, medical surveillance databases, and
epidemiological studies.
It is a requirement in the U.S. that a death certificate be filed for
all deaths. The data from these certificates are complied in the
databases of vital statistics for the nation, maintained by the
National Center for Health Statistics. The underlying cause of death
is noted on the certificate, as are contributing causes. Coding is
according to the World Health Organization?s ?International
Classification of Diseases? --the ICD -- and includes codes for
adverse reactions to medications.
The U.S. government?s Food and Drug Administration also maintains
several postmarketing surveillance databases that are used to compile
reports on suspected ADR?s. The mere suspicion of an ADR is all that
is needed to file a report. Drug companies are required to report
suspected ADR?s, while reporting by doctors, patients and others is
voluntary.
Lastly, researchers have conducted in-depth studies of the causes of
death of select populations -- often those at a specific facility,
such as a hospital or nursing home -- taking pains to identify major
and contributing causes of death, including ADR?s. Other studies have
focused on populations of patients taking specific types of drugs, or
suffering from a particular disease. By statistically extrapolating
the results of these studies on relatively small populations,
researchers have made estimates of the national incidence of deaths
due to ADR?s.
3. A summary of the available incidence data on medicine-related
deaths -- how many such deaths occur in the U.S. in the course of a
year.
Chyka (2000) published a widely-cited study that reviewed national
data from both death certificates and from medical surveillance
databases. Of the 2.3 million deaths that occurred in the U.S. in
1995, Chyka noted the following:
--206 death certificates attributed the death to an ADR
--4,721 death certificates listed an ADR as a contributing cause of death.
--FDA surveillance databases indicated 6,894 deaths due to ADR?s.
The numbers are a far cry from estimates from some mainstream
epidemiological studies. Probably the most widely-cited estimate is
that from a meta-analysis of 39 studies in U.S. hospitals from
Lazrarou et al (1998). The study concluded:
--15.1% of patients admitted to hospitals experience an ADR.
--6.7% of patients admitted to hospitals experience an ADR classified as ?serious?
--0.32% of hospitalized patients experience a fatal ADR.
In general, about a third of all ADR?s occurred prior to hospital
admission, while the remaining two-thirds of ADR?s occurred after
admission to the hospital.
--Based on a figure of 33.125 million hospital admissions a year (in
1994), these percentages translate to:
--4.986 million ADR?s in a year.
--2.216 million serious ADR?s in a year.
--106,000 fatal ADR?s.
4. A review of the data linking medicine-related deaths to specific
medicines and classes of medicines.
The data on specific drugs and categories of drugs is difficult to
analyze. Many studies do not even present such data, instead relying
on overall percentage/incidence types of analysis without
distinguishing impacts from individual drugs.
There are some studies, however, that offer some -- and occasionally,
considerable -- detail about the ADR?s associated with individual
drugs or categories of drugs. Chief amongst these is, once again, the
Chyka study.
Table 2 in Chyka is titled ?Ten Most Frequent Drug Categories
Associated with Adverse Drug Reactions...? Although the table
summarizes data from both the death certificates and FDA data bases,
the death certificate data set strikes me as too small to make any
meaningful comparisons, so I am focusing here on the FDA datasets,
which contained 6,894 fatal ADR?s. Of this number, specific drug
categories accounted for the following:
Antineoplastic and
immunosuppressive drugs
(ICD-9 code E933.1)................1,123.......16.3% of the total
Misc. and unspecified drugs (E947)...............................789........11.5%
Misc and unspec.
cardiac drugs (E942.9)...............565.........8.2%
Antidepressants (E939.0).............405.........5.9%
Other antipsychotics, neuroleptics,
and major tranquilizers (E939.3) ....294.........4.3%
Aromatic analgesics n.e.c
(E935.2).............................232.........3.4%
Fibrinolysis-affecting drugs (E934.4)..............................217.........3.1%
Antiallergenic and antiemetic
(E933.0)..............................214.........3.1%
Misc. antibiotics
(E930.8)..............................210.........3.0%
Sympathomimetics
(E941.2)..............................204.........3.0%
====================================================
Table 3 presents similar data for individual drugs. Chyka notes that
-- although 647 individual drugs were identified as associated with
ADR?s in the FDA data -- 36 drugs accounted for half of the total
ADR?s. The 15 drugs topping the list are:
Finasteride.................................338 deaths
Cisplatin...................................253
Encainide hydrochloride*....................242
Fluoxetine hydrochloride*...................200
Clozapine...................................195
Paclitaxel..................................166
Terfenadine*................................165
Cyclosporine................................142
Tacrine hydrochloride.......................131
Alteplase...................................124
Warfarin sodium.............................107
Salmeterol xinafoate.........................89
Tamoxifen citrate............................87
Risperidone..................................77
Quinapril hydrochloride......................70
*subsequently removed from the market
======================================================
Because of their widespread use, NSAID?s have received a good deal of
attention in the ADR literature. Wolfe?s (1999) review article noted
that:
--More than 70 million prescriptions for NSAID?s and more than 30
billion over-the-counter tablets are sold each year in the United
States.
--Given their prevalence, even a small percentage of ADR?s among NSAID
users would be expected to result in a substantial overall number of
ADR?s.
--In general, 10-20% of patients have some sort of gastrointestinal
reaction to NSAID?s.
--13 out of 1000 arthritis patients using NSAID?s experienced a
gastrointestinal complication classified as ?serious?.
--The percent of NSAID-related complications that are fatal is small.
However, given the large numbers of people using NSAID?s, Wolfe notes:
?It has been estimated conservatively that 16,500 NSAID-related deaths
occur among patients with rheumatoid arthritis or osteoarthritis every
year in the United States,? a statistic he labels a ?silent epidemic?.
Chyka discusses the 16,500 deaths figure, and notes that it is an
estimate that it exceeds somewhat the total number of recorded annual
deaths from gastrointestinal illnesses of all types, and as such, the
accuracy of the estimate is somewhat suspect.
The study by Clarkson and Choonara (2002) of fatal ADR?s in children
in the UK reveals a very different pattern of drugs associated with
ADR?s -- perhaps not a surprising finding since pediatric medicine
might be expected to employ a very different cadre of medicines than
would adult or geriatric care. The authors reviewed all cases in a
national UK database of fatal ADR?s involving children over several
decades. All told, 331 deaths were identified in children 16 years
old or younger, involving 390 suspect medicines.
As in other studies, the authors are careful to note that the fact of
an ADR having been reported merely reflects the suspicion of an
association between a fatality and an administered drug, but is not
conclusive evidence of such an event.
The most common categories of drugs involved in fatal ADR?s in
children in the UK were:
Anticonvulsants..........65 deaths........19.6% of all deaths
Cytotoxics...............34...............10.3%
Anaesthetics..............30................9.1%
Antibiotics...............29 ...............8.8%
Interestingly, the report details NSAID-linked fatalities as well.
There were 12 such fatal ADR?s overall -- 4 pertaining to
aspirin-linked Reye?s syndrome, and 1 to aspirin-linked
gastrointestinal hemorrhaging.
The five drugs most commonly associated with ADR?s were:
Valproate..................31................9.4%
Doxorubicin................13................3.9%
Propofol...................13................3.9%
Halothane..................12................3.6%
Carbamazepine..............11................3.3%
A study by Ebbesen et al. (2001) struck me as one of the more careful
evaluations of fatal ADR?s, in this case, in a hospital setting in
Norway. Over a two year period, there were 13,992 patients admitted
into the hospital, and of these, 732 (5.2%) of the patients died. All
of the 732 deaths were carefully reviewed by the researchers, who
determined that:
--132 (18.2%) of the deaths were associated with adverse drug reactions.
--64 of these were classified as directly attributable to drugs, while
in 69 cases drugs were indirectly associated with the patient?s death.
--In general, patients that were older, sicker, or taking multiple
drugs were far more susceptible to ADR?s than other patients. The
authors noted studies that indicated ADR risk in patients taking seven
or more drugs is 82%.
The Ebbesen paper also noted the major categories of drugs that were
associated with fatal ADR?s in the 132 deaths noted:
Cardiovascular.............................61 deaths
Antiasthmatic..............................55
Antithrombotic.............................45
Anti-infective.............................14
Antipsychotic or anxiolytic................12
Analgesic..................................12
NSAID.......................................6
Other......................................32
[Note: deaths don?t add to 132 because some deaths were associated
with more than one drug]
5. A synopsis of the major studies and information sources that have
contributed to an understanding of the above topics.
There is an extensive literature on ADR?s. Some of the key studies
relating to overall incidence of ADR?s and incidence related to
specific drugs and drug categories are listed below. I have excerpted
information from the article abstracts, where available, and have
provided links to the full abstracts.
----------
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10967153&dopt=Abstract
This paper was discussed in some detail above:
Am J Med. 2000 Aug 1;109(2):122-30.
How many deaths occur annually from adverse drug reactions in the United States?
Chyka PA.
Department of Pharmacy Practice and Pharmacoeconomics, University of
Tennessee, and Southern Poison Center, Memphis, Tennessee, USA.
PURPOSE: The numbers of deaths attributed to adverse drug reactions by
death certificates and by the Food and Drug Administration's (FDA)
spontaneous postmarketing surveillance system (MedWatch) were compared
in order to characterize national mortality statistics.
RESULTS: During 1995, 206 deaths were attributed to adverse drug
reactions on death certificates in the United States, whereas MedWatch
tabulated 6,894 fatalities. The proportions of men and women were
similar, and the majority of deaths involved persons 60 years of age
and older, in both data sets...
CONCLUSION: The numbers of deaths reported in these data sets varied
34-fold and were up to several 100-fold less than values based on
extrapolations of surveillance programs...
PMID: 10967153 [NOTE: This is the PubMed identification number for this article]
----------
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9555760&dopt=Abstract
Lazarou?s study is perhaps the most widely-cited study on the
incidence of fatal ADR?s.
JAMA. 1998 Apr 15;279(15):1200-5.
Incidence of adverse drug reactions in hospitalized patients: a
meta-analysis of prospective studies.
Lazarou J, Pomeranz BH, Corey PN.
Department of Zoology, University of Toronto, Ontario, Canada.
OBJECTIVE: To estimate the incidence of serious and fatal adverse drug
reactions(ADR) in hospital patients.
DATA EXTRACTION: Data extracted independently by 2 investigators were
analyzed by a random-effects model. To obtain the overall incidence of
ADRs in hospitalized patients, we combined the incidence of ADRs
occurring while in the hospital plus the incidence of ADRs causing
admission to hospital. We excluded errors in drug administration,
noncompliance, overdose, drug abuse, therapeutic failures, and
possible ADRs. Serious ADRs were defined as those that required
hospitalization, were permanently disabling, or resulted in death.
DATA SYNTHESIS: The overall incidence of serious ADRs was 6.7% (95%
confidence interval [CI], 5.2%-8.2%) and of fatal ADRs was 0.32% (95%
CI, 0.23%-0.41%) of hospitalized patients. We estimated that in 1994
overall 2216000 (1721000-2711000) hospitalized patients had serious
ADRs and 106000
(76000-137000) had fatal ADRs, making these reactions between the
fourth and sixth leading cause of death.
CONCLUSIONS: The incidence of serious and fatal ADRs in US hospitals
was found to be extremely high...
PMID: 9555760
----------
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10369853&dopt=Abstract
N Engl J Med. 1999 Jun 17;340(24):1888-99.
Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs.
Wolfe MM, Lichtenstein DR, Singh G.
Section of Gastroenterology, Boston University School of Medicine and
Boston Medical Center, MA 02118-2393, USA. michael.wolfe@bmc.org
PMID: 10369853
[No abstract provided, however, the article was discussed above]
----------
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12456539&dopt=Abstract
The Clarkson and Choonara study in children was discussed above:
Arch Dis Child. 2002 Dec;87(6):462-6
Surveillance for fatal suspected adverse drug reactions in the UK.
Clarkson A, Choonara I.
Academic Division of Child Health, University of Nottingham,
Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3NE, UK.
AIM: To determine the nature and number of suspected adverse drug
reactions (ADRs) associated with fatal outcomes in children...
METHODS: All reports of suspected ADRs with a fatal outcome in
children received by the UK Committee on Safety of Medicines through
its Yellow Card Scheme from 1964 until December 2000 were reviewed.
Reports associated with vaccines and overdose were excluded...
RESULTS: There were 331 deaths with 390 suspected medicines reported
for children aged 16 years or less. Medicines most frequently
mentioned were anticonvulsants (65 deaths), cytotoxics (34 deaths),
anaesthetic agents (30 deaths), and antibiotics (29 deaths). The
individual drug most frequently mentioned was sodium valproate (31
deaths)...
CONCLUSIONS: A wide range of suspected ADRs are associated with
fatalities in children. Anticonvulsants were associated with the
greatest number of reports of fatalities and hepatotoxicity in
particular.
PMID: 12456539
----------
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11606147&dopt=Abstract
Arch Intern Med. 2001 Oct 22;161(19):2317-23.
Drug-related deaths in a department of internal medicine.
Ebbesen J, Buajordet I, Erikssen J, Brors O, Hilberg T, Svaar H, Sandvik L.
Foundation for Health Services Research, Central Hospital of Akershus, N-1474
Nordbyhagen, Norway. justebbe@online.no
METHODS: During a 2-year period, a multidisciplinary study group
examined all 732 patients who died--5.2% of the 13992 patients
admitted to the Department of Internal Medicine, Central
Hospital of Akershus, Nordbyhagen, Norway. Decisions about the
presence or absence of fatal ADEs were based on aggregated clinical
records, autopsy results, and findings from premortem and postmortem
drug analyses.
RESULTS: In 18.2% of the patients (133/732) (95% confidence interval,
15.4%-21.0%), deaths were classified as being directly (64 [48.1%] of
133) or indirectly (69 [51.9%] of 133) associated with 1 or more drugs
(this equals 9.5 deaths per 1000 hospitalized patients). Those with
fatal ADEs (cases) were older, had more diseases, and used more drugs
than those without fatal ADEs (noncases). In 75 of the 133 patients
with fatal ADEs, autopsy findings and/or drug analysis data were
decisive for recognizing the ADEs; in 62 of the remaining 595
patients, similar data proved necessary to exclude the suspicion of a
fatal ADE. Major culprit drugs were cardiovascular, antithrombotic,
and sympathomimetic agents.
CONCLUSIONS: Fatal ADEs represent a major hospital problem, especially
in elderly patients with multiple diseases...
PMID: 11606147
----------
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12061133&dopt=Abstract
This fairly up-to-date review finds that 4.9% of hospital admissions
are ADR related, though the data is very sensitive to sample size, and
varied in studies from 0.2% to 41.3%.
Pharm World Sci. 2002 Apr;24(2):46-54.
Hospitalisations caused by adverse drug reactions (ADR): a
meta-analysis of observational studies.
Beijer HJ, de Blaey CJ.
Scientific Institute Dutch Pharmacists (WINAp), P.O. Box 30460, 2500
GL The Hague, The Netherlands. h.j.m.beijer@winap.nl
RESULTS: From the literature it is revealed that a considerable part
of all hospital admissions are related to adverse drug reactions.
However, these data are not homogenous, i.e. larger studies display a
lower percentage of ADR related hospital admission, while smaller
studies display a higher percentage. Subgroup analysis showed that for
elderly people the odds of being hospitalised by ADR related problems
is 4 times higher than for younger ones (16.6% vs. 4.1%). A
considerable part of these hospitalisations can be prevented. Subgroup
analysis revealed that in the elderly up to 88% of the ADR related
hospitalisations are preventable; for the non-elderly this is only
24%. Comparatively more elderly people are hospitalised than younger
ones. Combining these findings, twice as much elderly people are
hospitalised by ADR related problems than non-elderly, while
preventability of ADR related hospitalisation might yield 7 times more
people in the elderly than in the non-elderly...
CONCLUSION: Many elderly people are hospitalised by ADR related
problems; an important part of these hospitalisations can be avoided.
PMID: 12061133 .
----------
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7791255&dopt=Abstract
Although not reviewed above, this study by Bates et al. is a careful
look at adverse drug events in a hospital setting. Although the focus
is on all events, there is some useful data on fatal events.
JAMA. 1995 Jul 5;274(1):29-34.
Incidence of adverse drug events and potential adverse drug events.
Implications for prevention. ADE Prevention Study Group.
Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, Laffel
G, Sweitzer BJ, Shea BF, Hallisey R, et al.
Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, USA.
PARTICIPANTS--All 4031 adult admissions to a stratified random sample
of 11 medical and surgical units in two tertiary care hospitals over a
6-month period. Units included two medical and three surgical
intensive care units and four medical and two surgical general care
units.
METHODS--Incidents were detected by stimulated self-report by nurses
and pharmacists and by daily review of all charts by nurse
investigators. Incidents were subsequently classified by two
independent reviewers....
RESULTS--Over 6 months, 247 ADEs and 194 potential ADEs were
identified. Extrapolated event rates were 6.5 ADEs and 5.5 potential
ADEs per 100 nonobstetrical admissions, for mean numbers per hospital
per year of approximately 1900 ADEs and 1600 potential ADEs. Of all
ADEs, 1% were fatal (none preventable), 12% life-threatening, 30%
serious, and 57% significant.
Twenty-eight percent were judged preventable. Of the life-threatening
and serious ADEs, 42% were preventable, compared with 18% of
significant ADEs. Errors resulting in preventable ADEs occurred most
often at the stages of ordering (56%) and administration (34%);
transcription (6%) and dispensing
errors (4%) were less common. Errors were much more likely to be
intercepted if the error occurred earlier in the process: 48% at the
ordering stage vs 0% at the administration stage.
CONCLUSION--Adverse drug events were common and often preventable;
serious ADEs were more likely to be preventable....
PMID: 7791255
===========
Some key links to be aware of regarding ADR?s and related topics are:
http://www.fda.gov/cder/drug/drugReactions/default.htm
Preventable Adverse Drug Reactions:
A Focus on Drug Interactions
-----
http://www.fda.gov/cder/aers/default.htm
Adverse Event Reporting System (AERS)
The Adverse Event Reporting System (AERS) is a computerized
information database designed to support the FDA's post-marketing
safety surveillance program for all approved drug and therapeutic
biologic products. The ultimate goal of AERS is to improve the public
health by providing the best available tools for storing and analyzing
safety reports.
-----
http://www.fda.gov/medwatch/
MedWatch
MedWatch, The FDA Safety Information and Adverse Event Reporting
Program, serves both healthcare professionals and the medical
product-using public. We provide important and timely clinical
information about safety issues involving medical products, including
prescription and over-the-counter drugs, biologics, medical and
radiation-emitting devices, and special nutritional products (e.g.,
medical foods, dietary supplements and infant formulas).
-----
http://www.cdc.gov/nchs/
National Center for Health Statistics
Welcome to the National Center for Health Statistics' Web site, a rich
source of information about America?s health. As the Nation?s
principal health statistics agency, we compile statistical information
to guide actions and policies to improve the health of our people. We
are a unique public resource for health information?-a critical
element of public health and health policy.
-----
http://www.who.int/whosis/icd10/
The World Health Organization?s ICD website.
The International Statistical Classification of Diseases and Related
Health Problems, tenth revision.
-----
http://www.who.int/medicines/organization/qsm/activities/drugsafety/orgdrugsafety.shtml
The WHO Programme for International Drug Monitoring
The WHO Programme for International Drug Monitoring was established in
the wake of the thalidomide disaster in 1962, when the World Health
Organization was requested to study the feasibility of various
measures aimed at assuring the safety of pharmaceutical products in
international commerce including "securing prompt transmission to
national health authorities of new information on serious side-effects
of pharmaceutical preparations". This request resulted in the
establishment of an international system for monitoring adverse
reactions to drugs using information derived from national centres.
The system started with 10 countries that had already established
national systems for spontaneous adverse reaction reporting and who
agreed to contribute data. For an effective international system to
become operative, a common reporting form was developed, agreed
guidelines for entering information formulated, common terminologies
and classifications prepared and compatible systems for transmitting,
storing and retrieving and disseminating data were created.
The WHO Collaborating Centre for International Drug Monitoring at
Uppsala, Sweden, holds the operational responsibility for the
programme, including the maintenance of the database which currently
contains almost two million reports of suspected adverse drug
reactions. Over 60 countries now participate in the Programme.
-----
http://www.fda.gov/cder/pediatric/presentation/ac3-03mc/
Overview of Postmarketing Safety Surveillance in FDA (For Drugs and Biologics)
March 13, 2003
==========
Well...that about does it.
I hope...I *truly* hope...that this meets your needs, and then some.
But if you find you would like additional information on anything I
have presented here, just let me know, and I will do my best to fill
in any blanks.
Thanks again for providing me an opportunity to undertake such fascinating work.
pafalafa-ga |
