PHARMACOVIGILANCE:

The science and activities relating to the • detection, • assessment, • understanding and • prevention of
adverse effects or any other drugrelated problem.

OR

Pharmacovigilance is the study of the safety of marketed drugs under the practical conditions of clinical
usage in large communities.

MEDICATION ERROR:

Any error in the process of planning, ordering, dispensing or administering a drug.

Drug Utilization Research Definition:

The study of the use and effect/side effect of drugs in a large number of people with the purpose of
supporting the rationale and cost-effect use of drugs –thereby improving health outcomes.

Efficacy (effect of a drug in perfect conditions/controlled environment)

Effectiveness (effect of a drug in a real world setting)

Anticipated beneficial effects are the desirable effects that are known to be caused by the drug (the
reason for prescribing)

Unanticipated beneficial effects are desirable effects of drugs that were not anticipated at the time of
drug approval

PHARMACOECONOMICS:

Pharmacoeconomics is a branch of health economics that applies the economic evaluation framework of
pharmaceutical products and devices.

COMPLIANCE:

The extent to which the patient’s dosing history conforms to the prescribed regimen

OR

Compliance is the extent to which a patient’s behavior matches the prescriber’s advice.

ADHERENCE: The degree to which the person’s behavior corresponds with the agreed recommendations
from a health care provider.

SIDE EFFECT:

any unintended effect of a pharmaceutical product occurring at doses normally used by a patient which
is related to the pharmacological properties of the drug.

• more predictable than ADRs. • can be beneficial or harmful. E.g. Hypoglycemia due to most
antidiabetic agents.
ADVERSE DRUG REACTION (ADR):

a response to a medicine which is noxious and unintended, and which occurs at doses normally used in
man.

• not related to the drug action • more unexpected than side effects • always harmful E.g. Penicillin-
containing antibiotics may cause anaphylaxis.

PHARMACOEPIDEMIOLOGY:

The study and effects of drugs in large number of people.

The branch of science that analyzes in a great number of people the usage, effects and costs of
medication.

PHARMACOLOGY deals with the study of drugs

CLINICAL PHARMACOLOGY deals with the study of drugs in humans.

• This includes drug’s characteristics, effects, reactions, therapeutic uses, toxicology, safety,
pharmacokinetics and pharmacodynamics.

ABSORPTION:

It is the process by which a drug is transferred from its site of entry into the body (e.g. GIT, skin, muscle)
to the circulating fluids (i.e. blood and lymph) for distribution.

The rate and extent of absorption depends upon certain factors: • The dosage form & route of
administration. • Age, pregnancy, disease states. • Food and other drugs.

DISTRIBUTION:

It refers to the ways in which drugs are transported by the circulating body fluids to the sites of action,
metabolism and excretion.

• Includes transport throughout the entire body by the blood and lymph and transport from these
circulating fluids into and out of the fluids that bathe the receptor sites.

METABOLISM:

Biotransformation is the ability of the body to change substances into water-soluble, more readily
excretable forms. It is the process by which the body inactivates drugs.

• It occurs in liver, GIT, kidneys, brain and plasma.

BIOAVAILABILITY:

The fraction (F) or percentage of the drug that reaches the systemic circulation.

• Depends upon the route of administration

• The ability of the drug to pass through membranes or barriers in the body
e.g. drugs administered i/v are 100% bioavailable while those given by other routes (i/m; oral) are often
less than 100% bioavailable.

ELIMINATION:

The movement of a drug or its metabolite from the tissues back into the circulation and then to the
organs of excretion.

• The organs of elimination include: kidneys, GIT, respiratory system, sweat, saliva, tears and breast
milk.

HALF–LIFE (T1/2):

The amount of time required for 50% of the drug to be eliminated from the body.

PHARMACODYNAMICS:

It is the study of the relationship between the concentration of a drug and the response.

• Most commonly, the sites of action are receptors on the specific cell, tissues or organ.

ANTAGONISTS:

• Drugs that occupy receptors but do not activate them

• No biological response • Have affinity but NO intrinsic activity

AFFINITY:

The strength of the attraction of a drug to its receptor sites and is related to the potency and the
concentration of drug occupying receptors.

• Drugs with high affinity are potent drugs that elicit response at lower dose.

• Drugs with low affinity are weak drugs that require large doses to elicit a response e.g.10 mg of
morphine sulfate = 1 mg of hydromorphine.

POTENCY:

A measure of the amount of drug required to produce an effect of a given magnitude.

The concentration producing an effect that is 50% of the maximum is used for its determination called
EC50 or ED50.

EFFICACY:

The ability of a drug to illicit a physiologic response when it interacts with a receptor.

The maximal response (Emax) is more important than the drug potency.

TOLERANCE:

When a subject's response to a specific drug and concentration of the drug is progressively reduced
THERAPEUTIC INDEX (TI):

It relates the dose of a drug required to produce a desired effect to that producing an adverse or toxic
response.

• It expresses the margin of safety of a drug; drugs with a high TI are said to be safe while those with a
low TI are relatively unsafe.

TI = TD50 ÷ ED50

TD50 : the dose that would be toxic in 50% of subjects

ED50 : the dose that produces the desired therapeutic effect in 50% of subjects

CONFOUNDING BY INDICATION occurs “when the underlying diagnosis or other clinical features that
affect the use of a certain drug are also related to the outcome under study.

CHANNELING BIAS OCCURS when interventions having similar indications are differentially prescribed to
groups of patients at varying levels of risk or with prognostic differences.

HEALTHY USER BIAS refers to “the propensity for patients who receive one preventive therapy to also
seek other preventive services or partake in other healthy behaviors.”

PROTOPATHIC BIAS refers to “interpreting a factor to be a result of an exposure when it is in fact a

determinant of the exposure, and can occur when an early sign of the disease under study led to the
prescription of the drug under study.”

PREVALENT USER BIAS refers to systematic distortion of study findings associated with “the extent that
time-dependent risk can result in the early attrition of those individuals most susceptible to the event
and in the follow-up of low-risk individuals.”

IMMORTAL TIME BIAS refers to systematic distortion of study findings resulting from the
misclassification or exclusion of immortal time, “a period of follow-up during which, by design, death or
the study outcome cannot occur.”

MISCLASSIFICATION BIAS can result from exposure, outcome, and/or confounder misclassification.

EXPOSURE MISCLASSIFICATION BIAS refers to “the error resulting from classifying study subjects as
exposed when they truly are unexposed, or vice versa.”

OUTCOME MISCLASSIFICATION BIAS refers to the error resulting from classifying study subjects as
having the outcome when they truly did not have the outcome, or vice versa.

CONFOUNDER MISCLASSIFICATION BIAS refers to the error resulting from classifying study subjects as
having the confounding factor when they truly did not have the confounding factor, or vice versa.

MISSING DATA refers to the unavailable information in a study which can result from subjects that are
not able to be followed for the duration of the study (loss to follow up), as well as multiple other factors
including “failure to attend medical appointments, lack of measurements, failure to send or retrieve
questionnaires, and inaccurate transfer of data from paper registration to an electronic database.