HOSPITAl PHARMACOEPIDEMIOLOGY

 Pharmacoepidemiology is the study of the use of and the effects of drugs in large
number of people.
 Hospitals are complex institutions where patients go to have their health problem
diagnosed and treated
 But, hospitals and medical/surgical interventions introduce risks that may harm a
patient’s health.
The fundamental roles of hospital epidemiology are to:
 Identify risks
 Understand risks
 Eliminate or minimize risks

Why do we need hospital epidemiology??

 Managed care and competition are creating pressures to control costs and prevent
adverse outcomes in health care.
 Tracking the drug administered to patient during the entire stay in hospital.
 Systematical recording of ADR.
 Creation of databases has enabled the storage of large number of patient data over
longer period of time.

History of hospital pharmacoepidemiology

 In the late 50s, numerous article were published showing increased interest in
monitoring ADRs,mostly in hospital settings.
 In scotland finney in 1965 proposed a framework for monitoring ADEs based on
recordings of demographics, clinical information and administered drugs.
  In the late 1960s, series of cohort studies done at john hopkins university, Boston
tracked the drugs administered to patients during their hospital stay and systemically
recorded adverse events possibily linked to these exposures.
 Boston collaborative drug surveillance program
 Early efforts followed by creation of several inpatient databases like HIS, Medimetric,
brigham and women hospital, SUNY Buffalo clinical pharmacy Network etc which helped
in storing and processing large number of data from large no.of patients.

 Creation of these databases was made possible by the availability of computers capable
of storing and processing voluminous data collected on large numbers of patients with
large numbers of exposures over long periods of time.
 However, it was recognized that much of drug exposure was in the outpatient setting,
and interest was growing in studying the effects of drugs in that setting. In time, with the
increasing availability of claims databases and more recently medical record databases,
research has shifted to the larger drug-exposed populations in the outpatient setting.

CLINICAL PROBLEMS IN
PHARMACOEPIDEMIOLOGIC RESEARCH

1. Volume and Characteristics of Hospital admission

2. Characteristics of hospitalized patients and hospital drug use

Volume and Characteristics of Hospital admission

• In the US in 2002, there were 33.7 million hospital discharges (excluding newborn infants).
• Hospital discharge rate of 1174.6 per 10000 population.
• That same year, 31% of total national health spending was for hospital care.
• Heart disease is most common cause of hospital discharge diagnosis – 154.8 per 10000
population.
• Respiratory disease ranking the next.

• Variations in hospital care outcomes can be ascribed to the characteristics of the hospitals
and patients admitted to them.
• People with high-risk cardiovascular or cancer surgeries are more likely to survive in
hospitals that performed a high volume of these complicated surgical procedures.
• Elderly patients hospitalized for heart attack at teaching hospitals were more likely to
survive and receive better care than those treated at hospitals that do not train physicians

Characteristics of hospitalized patients and hospital drug use

• Hospitalized patients receive multiple drugs during their hospital stay because these
patients are older, sicker, and have multiple concurrent diseases.
• Polypharmacy introduces the risks of unintended drug–drug interactions, prescribing
suboptimal drug regimens, and inadequate laboratory monitoring of drug therapy.
• Patients receiving multiple drugs during their hospital stay have higher rates of drug
reactions.
• Most drug reactions occur in the first 5 days on a drug; therefore, active surveillance of
drug use during this period help to detect most adverse reactions.

Methodological problems in Pharmacoepidemiology research:

• LOGISTIC ISSUES

• METHODOLOGICAL ISSUES
Logistical issues
 Developing complete information on total drug exposure during a hospital stay is a
major challenge for pharmacoepidemiologic research in the hospital setting.
 Patients are administered drugs at multiple sites, by multiple personnel, multiple record
forms.
 Databases are stand-alone products, without an interface with other institution-wide
systems.
Methodological issues
 Issue of uncertain validity of the drug information in the hospital medical record.
 Issue of uncertain validity of the diagnosis information in the hospital medical record.
 Issue of the absence of inpatient information linked to outpatient information.
 An adverse event occurring in a hospital within a few days after admission/discharge
may be linked to either prior to admission/IP drug use).
 Issue of uniqueness of drug exposure in the hospital setting.
 Hospitalized patients tend to be more severely ill than non hospitalized patients, they
are more likely to receive multiple drugs, and,consequently, more likely to experience an
adverse drug event and they` tend to have more underlying medical problems, so it
makes more difficult for a physician to discern an adverse reaction to a drug from an
event due to another cause.

 Because hospitalized patients tend to experience many events during the course of their
stay, there may be a tendency to record only the most extreme or dramatic events
 Referral bias will be present.
 Appropriate denominator for calculations of adverse drug reactions depends on the
question of interest.
 A different methodological problem emerges from problems in hospital staff
participation.
 Medical records are not organized for research purposes.
EXAMPLES OF CURRENTLY AVAILABLE SOLUTIONS
1.Intensive Hospital-Based Surveillance
 Boston Collaborative Drug Surveillance Program
The most comprehensive intensive in-hospital drug
surveillance program started in 1966 and accumulating
information on over 50,000 inpatients over 20 years.
Collected data were submitted to boston central
research office; it was tested for accuracy and
completeness.
It focused on drug use prior to hospitalization in relation to causes of admission and
confounders.Due to its large size it helped to study rare adverse events.
 Comprehensive Hospital Drug Monitoring Berne (CHDMB) was initiated in same period
in Switzerland.
 Similar efforts were reported from germany and newzeland.
2. In patient databases
 Multisite Databases
 Commercial
• Medimetric and IHS databases
Could support research on rare drug events because of its
large size, as data were contributed from 50 hospitals.
 Non-commercial

• Hospital (BWH),1981

• Beth israel Hospital (BIH),1984

• The Regentrief Automated Medical Record System(RMRS)
• US Department of Veterans Affairs(decentralized hospital computer program.
Advantages and Limitations
Advantages :
• Reducing medication errors
• Monitoring ADRs
• Support research
Limitations:
• Inpatient data systems are freestanding instead of integrated across institutions.
• The size and composition of patient populations in individual hospitals are likely to limit
the ability to
detect events of low incidence and produce generalizable results.

New Hospital-Based Adverse Drug Reaction Monitoring and Drug Use Evaluation Programs
 Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in 1989
established “medication use task force”.
 In response JCAHO initiative, the Hospital of the University of Pennsylvania(HUP)
established the Drug Use and Effects Committee(DUEC), as a subcommittee of the
Pharmacy and Therapeutics Committee.
 DUEC initiated Adverse Drug Surveillance Program and developed operational definitions
of ADEs, targeted drugs, patients, reporting to the FDA, tabulated and analyzing the
accumulated data on ADEs, review of these reports and proper follow up.