Presentation on:

Automated Database
By: Binu Thapa
Binita rupakheti
Aayusma Pradhan
 INTRODUCTION
• Database technology is a software science that researches,
manages, and applies databases which are processed and analyzed
by studying the basic theory and implementation methods of the
structure, storage, design, management and application of the
database.
• Medical databases are organized collections of health data,
stored electronically and accessible from a computer.
• The medical databases focus on streamlined medical
services, improve patient safety, and enhance the quality of
care.
• It tracks the information from Electronic health records,
Billing and claims information, Financial data, Inventory use.
What is Automated Database?

• Automated databases are computerized databases

containing medical care data.
• It is a potential data sources for pharmacoepidemiologic
studies that can often meet the need for a cost‐effective
and efficient means of conducting post marketing studies.
• The population covered by the database would be large
enough to permit discovery of rare events for the drug(s) in
question, and the population would be stable over its
lifetime.
 Contd..
• Automated databases allows the study of infrequent drug effects and
their longer follow-up times and representativeness, in terms of
routine clinical practice, make it possible to study real-world
effectiveness, safety and utilization patterns.
• The use of databases of routinely collected healthcare information in
pharmacoepidemiology has expanded in the last decade as awareness
has increased and more and larger resources have become available.
• The increased speed, limitation of biases, such as some recall and
reporting bias, and lower cost afforded by such databases are
important, for example, when there is pressure for timely information
to allow prompt public health decisions.
 Contd..
• Large electronic databases can often meet the need for a cost-
effective and efficient means of conducting post-marketing
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
 Required elements of a database

• Quality: validity, completeness

• Identifier
• Exposure: outpatient drug prescription/dispensing
• Disease: hospitalization diagnoses
• Patient: demographics
• Longitudinal data collection
• Appropriate size
• Hardware systems & data entry / storage / retrieval
• Linkage methodology & software
• Patient data protection & confidentiality
Features of automated database
• 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
• Information on potential confounders, such as smoking
and alcohol consumption, may only be avail- able through
chart review or, more consistently, through patient
interviews
 Types of database

• There are two types of database:

• 1. Claims databases(administrative databases)
• 2. Medical care databases
A combination of these two databases is known as the
Medical-claim database which is used by all the health care
service nowadays for the better outcome.
 Claims databases
• Claims data arise from a person’s use of the health care system.
• It puts electronic records of millions of transactions that are purported
to have occurred between patients and healthcare providers.
• They include information entered on bills (claims) submitted by
hospitals, clinics, nursing homes, pharmacies, individual providers, and
other medical professionals to public (e.g. Medicare and Medicaid) and
private (e.g. Blue Cross/Blue Shield) insurance entities.
• For insurance carrier in pharmacy details of medication dispensed should
be evaluated (e.g. patient goes to a pharmacy and gets a drug
dispensed, the pharmacy bills the insurance carrier for the cost of that
drug, and has to identify which medication and mg of the drug were
dispensed).
• For insurance carrier for medical services type of
intervention should also be evaluated.
• If both are linked they could be analyzed as a longitudinal
medical record
• Claim data are anonymous, plentiful, inexpensive, and
widely available in electronic format which may be
beneficial in research that is attempting to learn sensitive
information about groups and also research in rare
condition disease.
• The purpose of a claim is to collect payment, so it is
convenient for researchers to consult fee schedules and
reimbursement data and perform cost-effectiveness
analyses.
 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 physician-made 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
 Examples of Automated database:
1.Group Health Cooperative
2.Kaiser Permanente Medical Care Program
3.HMO Research Network
4.UnitedHealth Group
5.Medicaid Databases
6.Health Services Databases in Saskatchewan
7.Automated Pharmacy Record Linkage in the Netherlands
8.Tayside Medicines Monitoring Unit (MEMO)
9.UK General Practice Research Database
How it works?
• It is the organization that deliver health care services to meet
Health care
the health needs of target populations. Eg: Group Health
system Cooperative, HMO etc.

• We can choose health insurance as per our need and the filled
Membership form is submitted via electronic medium.

• The health insurance company provides unique identifier

Unique number to the members which is a lifetime number that
identifier
number
uniquely identifies each beneficiary.

• Data are recorded from pharmacy, hospital, labs, cancer surveillance

system, community health service system, outpatient and others. Data
Data
recordings are recorded automatically as well as manually in the software in codes.

• Medical follow-ups are routinely updated using data from clinical and
Updates
and
administrative computer systems when we visit hospital or pharmacy.
followups

• with approval from regional institutional review boards, researchers in

each center access a host of administrative and clinical databases which
Data
evaluation helps in pharmacoepidemiologic evaluation
 • computerized record happens when prescription is filled. It includes

Pharmacy demographic information, drug name, dosage, drug number, strength,

prescriber name, etc.

• contain records of every discharge, including newborn and stillborn

Hospital infants. It includes patient characteristics, diagnoses, procedures,

diagnostic related group (DRG), and discharge disposition. coding (ICD-9-
CM)

• The online laboratory system interconnects all GHC laboratories that

gives patient-specific information on all laboratory tests like name of the
Laboratory test ordered, date ordered, specimen source, results, and date of the
results.

Cancer • The database contains information for each newly diagnosed cancer
case, including patient demographics, anatomical site, stage at diagnosis,
Surveillance and vital status at follow-up, which is ongoing for all surviving cases in the
register.
System
• includes selected information about each outpatient visit like date of
Outpatient Visit visit, provider seen, provider’s specialty, and location of care.

• This database contains immunization record infants, children as well

Immunizations as adult thereby preventing a loss of immunization information
Database when children/adult change health plans or providers.
 Group Health
Cooperative
• GHC a nonprofit consumer-directed HMO established in 1947
• provides health care on a prepaid basis to approximately 562 000 persons in
Washington State.
• Both case-control and cohort studies can be performed using these data because
individual records can be linked through time and across data sets by the unique
consumer number assigned to each enrollee.
• Strengths of GHC as a setting for epidemiological research include its
identifiable and relatively stable population base, accessible and complete
medical records for each enrollee, and computerized databases.
• Limitation is: its limited size
• Studies of some medications that are solely administered as over-the-counter
(OTC) products are limited since such OTC data are not routinely captured by the
GHC pharmacy database.
• The GHC formulary limits the study of many newly marketed drugs. The elderly
and the poor tend to be underrepresented
 Kaiser Permanente Medical Care Program

• 8.2 million patients that are enrolled in one of the oldest and largest prepaid HMO
in the US, covering eight states.
• Patient records across multiple databases (pharmacy records with hospitalizations,
outpatient laboratory results, claims received from non-KP providers, etc.) and
across time (for at least 10 years) can be linked, using a unique medical record
number assigned to each patient for all encounters with the program
• Cohort studies with considerable follow-up (and case-control studies with similar
lengths of follow-back) are feasible in the KP database because of its size, diversity,
representativeness, relative stability, and richness of its computerized clinical data.
• The advantages of using these health maintenance organizations include high-
quality data and a predominantly working, middle-class, and middle-aged
population.
• limitations: absence of complete, standard information on race/ethnicity or other
indicators of socioeconomic status for all KP members; incomplete capture of all
outpatient diagnoses; restrictive formularies; slower incorporation of some newer
drugs compared with the fee-for-service environment; and reliance on records of
prescriptions filled, which are not perfect measures of drug consumption.
 HMO Research Network

• HMO Research Network provide information on over 7 million patients in

which data are submitted from 19 healthcare delivery organizations, in US
• The purpose of the HMORN is to provide a means by which to conduct
broad spectrum population-based research studies to ultimately improve
patient health and transform health care practice.
• The combined study populations from HMOs provide sufficiently large
sample size with a wide range of comorbid conditions such as hypertension,
diabetes, and congestive heart failure.
• HMO is unable to record data of the elderly, turnover of the population,
some constraints on formularies, and lack of information on potential
confounders that are not captured in automated data or written medical
records
  
UnitedHealth Group

• UnitedHealth Group databases provide extensive data sources to study post

marketing drug safety and to evaluate risk communication efforts to more
than 50 million members throughout the US.
• UnitedHealth Group-affiliated geographically diverse health plans facilitate
pharmacoepidemiologic evaluation of the use of prescription drugs in
general medical practice.
• The longitudinal nature of the data, ability to link sites of care, and large
database size facilitate the study of rare exposures and rare outcomes.
• These databases have been used extensively to study drug safety and
adverse drug reactions, augmented with medical record abstraction as
applicable for study design.
• The elderly are under-represented in other databases as well, since most
UnitedHealth members are enrolled in employment-based plans.
 Medicaid Databases

• it enrolls 51 million persons,

• The US Medicaid program provides medical coverage for certain categories
of disadvantaged individuals. (i) low-income pregnant women and families
with children, (ii) persons with chronic disabilities, and (iii) low-income
seniors, including those receiving Medicare benefit.
• Data on prescription drugs are audited to detect fraud and be accurate.
• The advantages of this type of system are that it is population-based, it is very
large, and it includes inpatient and outpatient diagnoses
• The limitation of this is only drugs covered by Medicaid can be studied
using Medicaid encounter data. Also, one cannot access patients or providers
to obtain information that is not included in the medical records.
• requires careful consideration of the validity and reliability of each data
element
 Health Services Databases in Saskatchewan

• Data are population-based and cover most of the province’s 1 million

residents in Canada.
• Subjects are identified by a unique health services number that is used in
each of the health care services databases (e.g., prescription drug data,
hospitalizations, physician services) and can be used to link records across
the databases and longitudinally.
• Data have a long tenure (over 30 years) which enables compilation of
extensive information about drug use and disease experience.
• Adv: it is population-based, it has a relatively representative and stable
population, and questionnaires can be sent to patients to gather information
which is not available in the computer files.
• Limitations: limited formulary of drugs, a moderate population size; no
updated diagnosis coding system is used for inpatient and outpatient
diagnosis.eg(ICD-9-CM)
 Automated Pharmacy Record Linkage in the Netherlands

• There have been strong regulatory and reimbursement incentives

for Dutch patients to frequent a single GP(general practitioners)
and pharmacy, enabling the compilation of individual prescription
drug and medical histories.
• The Dutch health care landscape can be considered due to its size,
organization, information technology sophistication, and linkage to
hospital and laboratory data as a “population laboratory”.
• Typical Dutch pharmacoepidemiology highlights are exposure
characterization, channeling bias, and exposure time-windows.
• Unreliable or outdated information in the patient file has
occasionally undermined the quality of pharmacy records
 Tayside Medicines Monitoring Unit (MEMO)

• The MEMO database is a community-based database

reflecting a “real-world” population and representing all
socioeconomic groups.
• The MEMO database is a validated record-linkage database.
• The core of the MEMO resource is a unique database that
contains longitudinal data of dispensed prescribing and health
outcomes over a 15-year period.
• MEMO has the capabilities to do a wide variety of population-
based research projects such as pharmacoepidemiology,
pharmacoeconomics research, pharmacogenetics, and
outcome research.
 UK General Practice Research Database
• The General Practice Research Database (GPRD) contains anonymized data on
diagnoses, therapies, and health-related behaviors recorded by GPs as part of
the patients’ electronic medical records.
• The GPRD is broadly representative of the UK and has population-based data on
over 9 million patients, with over 44 million years of follow-up time allowing
researchers to investigate rare outcomes.
• The GPRD has been validated and used to study a variety of medical conditions
including cardiovascular, cancer, intestinal, dermatologic, pulmonary, and
ophthalmologic outcomes.
• The GPRD may have incomplete information on some data from specialists as
well as health-related behaviors. Investigators may obtain additional information
by sending questionnaires to GPs through third-party vendors.
• The size and complexity of the GPRD requires that individuals or institutions
working with it have adequate computer software and hardware, as well as
experienced data managers.
Strengths of Automated database
• Very large sample size
The databases could be used to calculate population-
based rate, such as prevalence or incidence of specific
disease among the whole population.
• 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, as
they do not rely on patient recall or interviewers to
obtain their data.
Weakness of Automated database
• Uncertain validity of diagnosis data in claim database,
unlike medical records.
• lack information on some potential confounding variables.
For example, smoking, alcohol, date of menopause, etc. in
claim data
• do not include information on medications obtained
without a prescription or outside of the particular insurance
plan
• instability of the population due to job changes, employers’
changes of health plans,
Applications of Automated databases:
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
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 ICD-9-CM coding system, such
as Stevens–Johnson 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,
menopause, etc.
7. important medication exposure information that is not available,
particularly over-the-counter medications
Conclusion:
The increasing availability of large automated healthcare databases
represents a unique opportunity to study the landscape of drug use patterns
and both beneficial and adverse drug effects in routine clinical practice. But,
research on the assessment of medicines under real-life conditions is
methodologically complex and can be challenging.

This Presentation describes automated databases and its nine existing

medical databases that have been useful and productive in the conduct of
pharmacoepidemiologic research. Most are databases of paid billing claims.

Over the past few decades, such databases have become a central means of
performing hypothesis-testing studies in pharmacoepidemiology. It will not
infrequently result in biased drug effects estimates if epidemiological
principles are not followed properly. The trend of utilization of healthcare
databases for pharmacoepidemiology will continue to increase in the coming
years.
 References
• Strom, B. L., Kimmel, S. E., & Hennessy, S. (2013). Textbook of
pharmacoepidemiology. Chichester, West Sussex: John Wiley & Sons.
• Strom, B. L., & Carson, J. L. (1990). Use Of Automated Databases For
Pharmacoepidemiology Research. Epidemiologic Reviews, 12(1), 87-
107. doi:10.1093/oxfordjournals.epirev.a036064
• Rodríguez, L. A., & Gutthann, S. P. (1998). Use of the UK General
Practice Research Database for pharmacoepidemiology. British Journal
of Clinical Pharmacology, 45(5), 419-425. doi:10.1046/j.1365-
2125.1998.00701.x
• Ray, W. A., & Griffin, M. R. (1989). Use Of Medicaid Data For
Pharmacoepidemiology. American Journal of Epidemiology, 129(4),
837-849. doi:10.1093/oxfordjournals.aje.a115198
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