AUTOMATED DATABASES

To test the hypothesis generated by spontaneous reporting

In phase three 500-3000 patients are exposed to drug
Studies of this size have the ability to detect drug effects
with an incidence as low as 1 per 1000 to 6 per 1000
postmarketing studies of drug effects must then generally
include at least 10 000 exposed persons
these studies often need to be
conducted quickly, to address acute and serious regulatory,
commercial, and/or public health crises
computerized databases containing medical care data,
socalled
automated databases, as potential data sources for
pharmacoepidemiology studies.

Large electronic databases can often meet the need

for a cost-effective and efficient means of conducting
postmarketing surveillance studies
To meet the needs of pharmacoepidemiology,
the ideal database would include records from
inpatient and outpatient care,
emergency care, mental health care,
all laboratory and radiological tests,
and all prescribed and over-the-counter medications,
as well as alternative therapies

Features

The population covered by the database

would be large enough to permit
discovery of rare events
population would be stable over its
lifetime
Representative of general population or
special disadvantaged group not
considered in pre marketing
Drugs from formulary and quantity high
enough to provide power for the study

Other requirements

Online linked using unique identification

number and updated on regular basis
Access with proper confidentiality
regarding compliance to drug therapy,
medication chart review and potential
confounders like smoking and alcohol

Databases

From 1980 in US as administrative on

request
In europe the have been developed for
research
No Database is ideal

Claims databases

Claims data arise from a persons use of the

health care system
Pharmacy
Hospital
Payor
Data
Physician
user
For insurance carrier in pharmacy details
of
medication dispensed should be evaluated
For insurance carrier for medical services type of
intervention should be evaluated.
If both are linked they could be analysed as a
longitudinal medical record

the hospital charges for the care and

justifies that charge by assigning
International Classification of Diseases
Ninth Revision
Clinical Modification (ICD-9-CM) codes
and a Diagnosis
Related Group (DRG)
Outpatient claims depend on the
services employed

Medical care databases

medical record databases are a more

recent development, arising out of the
increasing use of computerization in
medical care
Important among them is that the validity
of the diagnosis data in these databases is
better than that in claims databases
no need to validate the data against the
actual medical record, since the physicianmade diagnosis is already recorded

one needs to be concerned about,

especially the uncertain completeness of
the data from other physicians and sites
of care
inpatient and outpatient care are
unlikely to be recorded in a common
medical record

Strengths

very large sample size

these databases are relatively
inexpensive to use
do not need to incur the considerable cost
of data collection
The data can be complete, i.e., for claims
databases

weakness

Uncertain validity of diagnosis data

such databases can lack information on
some potential confounding variables
(claims no smoking data)
No outside insurance data
No data on OTC

Applications

1. when looking for uncommon outcomes because of the

need for a large sample size;
2. when a denominator is needed to calculate incidence
rates;
3. when one is studying short-term drug effects (especially
when the effects require specific drug or surgical therapy
that can be used as validation of the diagnosis);
4. when one is studying objective, laboratory-driven diagnoses;
5. when recall or interviewer bias could influence the
association;
6. when time is limited;
7. when the budget is limited.

Uniquely problematic situations include:

1. illnesses that do not reliably come to
medical attention;
2. inpatient drug exposures that are not
included in some of these databases

3. outcomes that are poorly defined by the ICD9-CM coding system, such as StevensJohnson
syndrome;
4. descriptive studies, since the population might be
skewed;
5. delayed drug effects, wherein patients can lose eligibility
in the interim;
6. important confounders about which information
cannot be obtained without accessing the patient,
such as cigarette smoking, occupation, menarche,
menopause, etc.
7. important medication exposure information that is not
available, particularly over-the-counter medications