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Adverse Effect
A noxious and unintended response to a medicine occurring at normal therapeutic doses, used for prophylaxis, diagnosis, or therapy of disease.
Types of ADR
Categories include Augmented (Dose-related), Bizarre (Non Dose Related), Chronic or Continuous (Dose Related and Time Related), Delayed (Lag time), Ending of Use (Withdrawal), and Failure of efficacy (no response).
Side Effects
Any unintended effect of a pharmaceutical product at normal therapeutic dose related to its pharmacological properties.
Serious Adverse Effect
An untoward medical occurrence resulting in death, hospital admission, prolonged stay, disability, or life-threatening situations.
Causality
The probability that a particular medicine is responsible for an isolated effect of an ADR.
Signal
Reported information on a possible causal relationship between an adverse event and medicine, often unknown or incompletely documented.
Drug Re-introduce
Reintroducing a drug with unique benefits and manageable risks.
Drug Utilization Review
A program reviewing and analyzing drug use patterns against predetermined standards.
Types of Hypothesis
Includes Null negative, Accept or Reject, and Hypothesis Testing.
Aims of Pharmacoepidemiology
Signal Generation, Risk Quantification, and Reasons for Performing Studies.
Applications of Pharmacoepidemiology
Estimation of drug use risks, patient counseling, public health policy formulation, and economic evaluation.
Research Methods
Cross-sectional study, Case-control study, Cohort study, and Clinical trials.
Sources of Data
Institutional record systems, National databases, Field data, and Experimental data.
Problem Solving with Pharmacoepidemiology
Addressing medical and nonmedical drug use, health outcomes, and drug-related issues.
Health
Defined as complete physical, mental, and social well-being, influenced by socioeconomic factors and the environment.
Global Challenges
Include Globalization, Urbanization, Poverty, Socioeconomic Inequality, Food Insecurity, Environmental Degradation, and Demographic Transition.
Health Inequality Monitoring
Monitoring health inequalities to evaluate health inequity and inform policies to reduce health disparities.
Health Inequalities
Disparities in health outcomes that arise from social disparities.
Equity Stratifies
Categories used to differentiate groups and individuals based on social conditions like socioeconomic status, education, place of residence, race, occupation, gender, and religion.
Mortality Rate
The number of deaths due to a disease divided by the total population.
Crude Death Rate
The number of deaths in a given period divided by the population exposed to the risk of death in that period.
Specific Mortality Rates
Rates calculated for specific groups by dividing the number of deaths in a specified group by the midyear population of the same group.
Cause-of-Death Rate
The number of deaths from a specific cause divided by the midyear population, multiplied by a factor.
Infant Mortality Ratio
The number of deaths under 1 year old divided by the number of live births in the same year, multiplied by 100.
Maternal Mortality Ratio
The number of maternal deaths divided by the number of live births, multiplied by 100.
Case Fatality Rate
The proportion of cases that end up fatally, calculated by dividing the number of deaths from a specified cause by the number of cases of the same disease, multiplied by 100.
Morbidity Rate
The rate at which an illness or disease occurs within a population, calculated by dividing the number of cases of a disease in a specific period by the total population during the same period, multiplied by 100.