According to W.H.O-C.C.I.D.M, the science and activities relating to detecting, assessing,
understanding, preventing, and reporting adverse effects or any other drug-related problem.
a. An identifiable reporter
b. An identifiable patient
c. A suspect product
d. An adverse drug event.
Any untoward medical occurrence that may present during treatment with a pharmaceutical
product but which does not necessarily have a causal relationship with this treatment.
If an event is associated with any one of the following, it is considered to be serious.
a. Death
b. Life-threatening
c. Hospitalization or prolongation of hospitalization.
d. Congenital anomaly
e. Disability
f. Medically significant.
USA: United States Food and Drug Administration (USFDA).
UK: European Medicines Agency (EMEA).
Japan: Ministry of Health, Labour and Welfare (MHLW).
India: IDA Indian Drug Administration, previously known as Central Drugs Standard
Control Organization (CDSCO).
A case is considered to be medically confirmed if it contains at least one event confirmed or
reported by an HCP (Health Care Professional).
Note: HCP can be a physician, nurse, pharmacist, coroner, or psychologist (only in
Germany).
Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the
relationship between the suspect product and the adverse drug event.
∙Is there a convincing relationship between the drug and the event?
∙Did the drug actually cause the event?
Patient demographics: Age, gender, and race.
Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and
indication. Adverse event details: Event, event onset date, seriousness criterion, event end
date and latency.
A narrative should consist of precise and concise information about the source of the report,
patient demographics, patient’s medical history, concomitant medications, suspect product
details and adverse event details in an orderly manner.
System Organ Class (SOC)
High-Level Group Term (HLGT)
High-Level Term (HLT)
Preferred Term (PT)
Lower-Level Term (LLT).
∙E2a: E2a guidelines give standard definitions and terminology for crucial aspects of
clinical safety reporting. It also guides mechanisms for handling expedited (rapid)
reporting of adverse drug reactions in the investigational phase of drug development.
∙E2b: E2b guidelines for maintaining clinical safety data management and information
about the data elements to transmit Individual Case Safety Reports.
∙E2c: E2b guidelines for maintaining clinical safety data management and information
about the Periodic Safety Update Reports for marketed drugs
This program will increase the knowledge and importance of Pharmacovigilance in the drug
discovery process and Clinical Research. Pharmacovigilance is becoming an essential part of
drug development as it deals with the patient’s safety & efficacy of the drug, resulting in new
job avenues. The participants, after the completion of this, would have new economic
pursuits as Pharmacovigilance's potential opportunities & growth prospects are enormous.
Pharmacovigilance Programme of India (PVPI) - launched in July 2010.
Goal: “To ensure the benefits of the use of medicine. Safeguard the health of the Indian
population.”
Manage and relay drug safety information, maintain current knowledge of global drug safety
regulations, summarise clinical safety data, participate in meetings with potential and actual
study sponsors, write narratives with medical input from a physician, report SADRs to the
Regulatory Authorities, participate in the training of operational staff on drug safety issues,
quality control work of other staff in the department, take on any other task as assigned by the
manager or Medical Director within the capabilities of the Drug Safety Associate.
Evidence - medicine-related problems
Public confidence
Identification of risk factors
Quantifying risks
Understanding the concepts of ADR, Medical Errors, Public Health Significance,
Regulatory Interventions, and ADR Monitoring schemes.
The science and activities relating to the detection, assessment, understanding and prevention
of adverse effects or any other drug-related problems.
Two types. 1. Active PV and 2. Passive PV
Active PV: Active (or proactive) safety surveillance means active measures are taken to
detect adverse events. This is managed by active follow-up after treatment, and the events
may be detected by asking patients directly or screening patient records. The most
comprehensive method is cohort event monitoring (CEM).
Passive PV: Passive surveillance means that no active measures are taken to look for adverse
effects other than the encouragement of health professionals and others to report safety
concerns. Reporting is dependent on the initiative and motivation of the potential reporters.
This is the most common form of pharmacovigilance. It is commonly called “spontaneous” or
“voluntary” reporting.
Safety reporting due dates are 7 days for IND Reporting and 15 days for NDA Reporting.
Data assessments are:
∙Individual case report assessment
∙Aggregated assessment and interpretation
∙Signal detection
∙Interactions and risk factors
∙Serial study
∙Frequency Estimation
∙Rapid identification of events that are likely to affect adherence to treatment and
determination of their rates and identification of the risk factors that make these events
more likely to reduce their occurrence;
∙Identification of signals (i.e., possible causal relationships between an adverse event and a
medicine; see Glossary) of ADRs of concern following the introduction of a new drug or
drug combination;
∙Assessment of signals to evaluate causality, clinical relevance, frequency, and distribution
of ADRs in particular population groups;
calculation of rates of events so that:
— risk can be measured;
— the safety of different medicines can be compared and informed choices made;
— risk factors can be clearly identified;
∙ Contribution to the assessment of benefit, harm, effectiveness, and risk of medicines,
leading to the prevention of harm and maximization of benefit;
∙Appropriate response or action in terms of drug registration, drug use and/or training and
education for health professionals and the public;
∙Measurement and evaluation of the outcome of the response or action taken (e.g.
reduction in risk, improved medicine use, or improved outcome for patients experiencing
a particular ADR);
∙Timely communication with and recommendations to authorities and the public; and
∙Feedback to the clinicians who provided the information.
The PvC of an individual country is responsible for meeting the requirements for
pharmacovigilance of all medicines. It is a centre of expertise for the art and science of
monitoring and analysing ADRs and using the information analysed to benefit patients.
National and regional PvCs should be set up with the approval or involvement of the
authority responsible for regulating medicines (“regulatory authority”). The centre may
function within the regulatory authority, a hospital, an academic institution, or an independent
facility such as a trust or foundation.
Spontaneous (or voluntary) reporting means that no active measures are taken to look for
adverse effects other than the encouragement of health professionals and others to report
safety concerns. Reporting is entirely dependent on the initiative and motivation of the
potential reporters. This is the most common form of pharmacovigilance, sometimes termed
passive reporting. In some countries, this form of reporting is mandatory. Clinicians,
pharmacists, and community members should be trained on how, when, what and where to
report.
∙Telephone
∙Fax
∙E-mail
∙Internet
The WHO Drug Dictionary (DD), MedDRA and the WHO Adverse Reactions Terminology
(WHO-ART).
WHODD= used for drug coding.
MedDRA, WHO-ART = coding of events.
CemFlow is a tool maintained by the UMC for database management in cohort event
monitoring (CEM). It is web-based, and the fields match the questionnaire data elements.
There are screens for patient demographics, treatment initiation, treatment review and
assessment of events. CemFlow is a tool for data entry into an online database maintained by
the UMC (Uppsala Monitoring Centre) for CEM. CemFlow provides for the entry of cohort
data as well as events.
∙Patient details (Name, Address, Sex, Date of birth, Weight, and height).
∙Patient's medical history of significance.
∙Details of medicines (this may be the brand or generic name, preferably brand) and
formulation, mode of administration (e.g. oral, rectal, or injection), Indication(s) for use,
dose).
∙Reaction details (Date of onset, outcome: resolved, resolving, no change, disabling,
worsening, death (with date), or congenital anomaly, Effect of rechallenge).
∙Reporter details
∙Date and place of report
Not severe, mild, moderate, or severe.
Related: Certain, possible, probable, likely.
Not related: Unlikely, Unclassified (or conditional), Unassessable.
Pregnancy.
Overdose (>MTD)
Off label use
Medication error
Lack of efficacy.
Patients may be more susceptible to particular ADRs if they also have other health problems,
either because of the concomitant condition or from the interaction of the medicines used to
treat the other condition(s).
Reported information on a possible causal relationship between an adverse event and a drug,
the relationship being unknown or incompletely documented previously. Usually, more than a
single report is required to generate a signal, depending upon the seriousness of the event and
the quality of the information. The publication of a signal usually implies the need for some
review or action.
There are four methods for identifying signals:
1. Clinical assessment of individual events
2. Clinical review of collated events
3. Record linkage
4. Automated signal detection.
∙ADRs- adverse reactions to medicines (adverse drug reactions)
ART- antiretroviral therapy
∙ARV- antiretroviral
∙ATC- Anatomic Therapeutic Chemical (Classification for medicines)
∙BCPNN- Bayesian Confidence Propagating Neural Network
∙CEM- cohort event monitoring
∙CemFlow- Cohort Event Monitoring data entry and analytical tool
∙DD (WHO)- Drug Dictionary
∙ICD 10- WHO International Classification of Diseases version 10
∙IMAI- integrated management of adolescent and adult illness
∙ICSR- individual case safety report(s)
∙MedDRA- Medical Dictionary for drug regulatory activities
∙OI- opportunistic infection
∙IMMP- (The New Zealand) Intensive Medicines Monitoring Programme
∙PEM- prescription event monitoring
∙PvC- Pharmacovigilance Centre
∙VigiBase- WHO database of individual case safety (ADR) reports (ICSR)
∙VigiFlow- spontaneous reporting data entry and analytical tool
∙VigiMine- data mining tool available as part of VigiSearch
∙VigiSearch- search tool for searching the VigiBase database
∙WHO- World Health Organization
∙WHO-ART WHO adverse reactions terminology.
∙SUSAR- Suspected Unexpected Serious Adverse Reaction
∙SAE- Serious Adverse Event
∙CIOMS- Council for International Organizations of Medical Sciences
∙ADE- Adverse Drug Event
∙SSAR- Suspected Serious Adverse Reaction
∙SOC- system organ class
∙SOP- standard operating procedure
∙UMC- the Uppsala Monitoring Centre
∙ADR- Adverse Drug Reaction
∙ICSR- Individual Case Safety Report
∙PSUR- Periodic Safety Update Report
∙ICH- The International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use
∙HIPAA- Health Insurance Portability and Accountability Act
∙ESTRI- Electronic Standards for the Transfer of Regulatory Information
∙IBD- International Birth Date
∙ATC- Anatomical Therapeutic Chemical (ATC) Classification.
The types of outcomes to be recorded are as follows, along with codes that can be used to
simplify recording:
R1 resolved;
R2 resolving;
RS resolved with sequelae;
NR not resolved.
The point at which a drug is again given to a patient after its previous withdrawal - also see de-challenge.
The withdrawal of a drug from a patient; the point at which the continuity,
reduction or disappearance of adverse effects may be observed.
This is an important international society. Their website gives information about meetings
and training courses.
Absolute risk
Risk in a population of exposed persons: the probability of an event affecting members of a
particular population (e.g. 1 in 1,000). Absolute risk can be measured over time (incidence)
or at a given time (prevalence).
Adverse Event (AE)
Any untoward medical occurrence that may present during treatment with a pharmaceutical
product but which does not necessarily have a causal relationship with this treatment.
Adverse (Drug) Reaction (ADR)
A noxious and unintended response occurs at doses typically used in humans for the
prophylaxis, diagnosis, or therapy of disease or the modification of physiological function.
(WHO, 1972).
“A response to a medicinal product which is noxious and unintended.”
Allopathy
Non-traditional, western scientific therapy, usually uses synthesized ingredients but may also
contain a purified active ingredient extracted from a plant or other natural source, usually in
opposition to the disease.
Association
Events are associated with time but not necessarily linked to cause and effect.
Attributable risk
Difference between the risk in an exposed population (absolute risk) and the risk in an
unexposed population (reference risk). Attributable risk results from an absolute comparison
between outcome frequency measurements, such as incidence.
Biological products
Medical products prepared from biological material of human, animal or microbiologic
Causal relationship
A relationship between one phenomenon or event (A) and another (B) in which A precedes
and causes.
Causality assessment
1.The evaluation of the likelihood that a medicine was the causative agent of an
observed
2.adverse reaction. Causality assessment is usually made according to established
algorithms.
Caveat document
The formal advisory warning accompanying data release from the WHO Global ICSR
Database specifies the conditions and reservations applying to interpretations and use of the
data.
Cem-Flow
Software developed by UMC for collection and analysis of data in Cohort Event Monitoring.
Clinical trial
A systematic study on pharmaceutical products in human subjects (including patients and
other volunteers) to discover or verify the effects of and/or identify any adverse reaction to
investigational products and/or to study the absorption, distribution, metabolism, and
excretion (ADME) of the products to ascertain their efficacy and safety.
Cohort Event Monitoring
Cohort Event Monitoring (CEM) is a prospective, observational study of events that occur
during the use of medicines for intensified follow-up of selected medicinal products phase.
Patients are monitored from when they begin treatment and for a defined period.
Compliance
Faithful adherence by the patient to the prescriber’s instructions.
Control group
The comparison group in drug trials is not being given the studied drug.
Critical terms
Some of the terms in WHO-ART are marked as ‘Critical Terms’. These terms either refer to
or might indicate serious disease states and warrant special attention because of their possible
association with the risk of serious illness. This may lead to more decisive action than reports
on other terms.
Data mining
A general term for computerised extraction of potentially interesting patterns from large data
sets often based on statistical algorithms. A related term with essentially the same meaning is
‘pattern discovery’. The most familiar data mining application in pharmacovigilance is
disproportionality analysis, for example, using the Information component (IC).
De-challenge
The withdrawal of a drug from a patient; the point at which the continuity, reduction or
disappearance of adverse effects may be observed.
Disproportionality analysis
Screening of ICSR databases for reporting rates, which are higher than expected. For drug-
ADR pairs, common measures of disproportionality are the Proportional Reporting Ratio
(PRR), the Reporting Odds Ratio (ROR), The Information Component (IC), and the
Empirical Bayes Geometrical Mean (EBGM). There are also disproportionality measures for
drug-drug-ADR triplets, such as Omega (Ω).
Effectiveness/risk
The balance between the rates of effectiveness of a medicine versus the risk of harm is a
quantitative assessment of the merit of a medicine used in routine clinical practice.
Comparative information between therapies is most beneficial. This is more useful than the
efficacy and hazard predictions from pre-marketing information that is limited and based on
selected subjects.
Efficacy
The ability of a drug to produce the intended effect is determined by scientific methods, for
example, in pre-clinical research conditions (opposite of hazard).
Epidemiology
Science is concerned with studying the factors determining and influencing the frequency and
distribution of disease, injury and other health-related events and their causes in a defined
human population to establish programs to prevent and control their development and spread.
Essential medicines
Essential medicines are those that satisfy the priority healthcare needs of the population. They
are selected due to public health relevance, evidence on efficacy and safety, and comparative
cost-effectiveness.
Excipients
All materials included to make a pharmaceutical formulation (e.g. a tablet) except the active
drug substance(s).
Formulary
A listing of medicinal drugs with their uses, methods of administration, available doses,
dosage forms, side effects, etc, sometimes including their formulas and methods of
preparation.
Harm
The nature and extent of actual damage that a drug could cause. Not to be confused with risk.
Frequency of ADRs
In giving an estimate of the frequency of ADRs, the following standard categories are
recommended:
Very common* > 10%
Common (frequent) >1% and <10%
Uncommon (infrequent) >0.1% and < 1%
Rare >0.01% and <0.1%
Very rare* <0.01%
* Optional categories
Generic (multisource product)
The term ‘generic product’ has somewhat different meanings in different jurisdictions.
Generic products may be marketed either under the non-proprietary approved name or under
a new brand (proprietary) name. They are usually intended to be interchangeable with the
innovator product, which is usually manufactured without a license from the innovator
company and marketed after the expiry of patent or other exclusivity rights.
Herbal medicine
Includes herbs, herbal materials, herbal preparations and finished herbal products.
Homeopathy
Homeopathy is a therapeutic system which works on the principle that ‘like treats like’. An
illness is treated with a medicine which could produce similar symptoms in a healthy person.
The active ingredients are given in highly diluted form to avoid toxicity. Homeopathic
remedies are virtually 100% safe.
Information component (IC)
The Information component (IC) measures the disproportionality in the reporting of a drug-
ADR pair in an ICSR database relative to the reporting expected based on the overall
reporting of the drug and the ADR. Positive IC values indicate higher reporting than
expected. The IC has also been implemented on electronic health records to detect interesting
temporal relationships between drug prescriptions and medical events.
Incidence
Several new cases of an outcome develop over a defined period in a defined population at
risk.
Individual Case Safety Report (ICSR)
A report that contains ‘information describing a suspected adverse drug reaction related to the
administration of one or more medicinal products to an individual patient.’
MedDRA
MedDRA is the Medical Dictionary for Regulatory Activities. WHO-ART, the WHO
Adverse Reactions Terminology, is now mapped to MedDRA.
Medical error
“An unintended act (either of omission or commission) or one that does not achieve its
intended outcomes.”
Member countries
Countries which comply with the criteria for and have joined the WHO Programme for
International Drug Monitoring.
National Pharmacovigilance centres
Organisations recognised by governments to represent their country in the WHO Programme
(usually the drug regulatory agency). A single, governmentally recognized centre (or
integrated system) within a country with the clinical and scientific expertise to collect,
collate, analyse and give advice on all information related to drug safety.
Odds
The probability of an occurrence p is divided by the probability of its non-occurrence (1 - p).
Odds ratio
The Odds ratio in each population and the Odds in another population.
Omega (Ω)
A measure of disproportionate reporting for drug-drug-ADR triplets in ICSR databases,
designed to highlight potential signals of drug-drug interactions. Just like the more
established disproportionality measures for drug-ADR pairs, Ω is based on a contrast between
the observed and expected number of reports. A positive Ω indicates higher reporting than
expected.
OTC (Over the Counter) medicine
Medicinal products are available to the public without prescription.
Pani-Flow
Software developed by UMC for data collection and analysis in relation to vaccinations in a
pandemic situation.
Periodic Safety Update Report (PSUR)
A systematic review of the global safety data which became available to the manufacturer of
a marketed drug during a specific time period. Produced in an internationally agreed format.
Pharmacoepidemiology: Study of the use and effects of drugs in large populations.
Pharmacology: Study of the uses, effects, and modes of action of drugs.
Phocomelia
Characteristic deformity caused by exposure to thalidomide in the womb rarely occurs
spontaneously. Meaning: limbs like a seal.
Phytotherapy
Western-style scientific treatment using plant extracts or materials.
Placebo
An inactive substance (often called a sugar pill) is given to a group being studied to compare
results with the effects of the active drug.
Polypharmacy
The concomitant use of more than one drug, sometimes prescribed by different practitioners.
Post-marketing
The stage when a drug is generally available on the market.
Predisposing factors
Any aspect of the patient’s history (other than the drug) which might explain reported adverse
events (genetic factors, diet, alcohol consumption, disease history, polypharmacy or use of
herbal medicines, for example).
Prescription Event Monitoring (PEM)
The system was created to monitor adverse drug events in a population. Prescribers are
requested to report all events, regardless of whether they are suspected adverse events, for
identified patients receiving a specified drug. Also more accurately named Cohort Event
Monitoring.
Prescription Only Medicine (POM)
Medicinal products are available to the public only on prescription.
Prevalence
Number of existing cases of an outcome in a defined population at a given point in time.
Prophylaxis
Prevention or protection.
Rational drug use
An ideal of therapeutic practice in which drugs are prescribed and used according to the best
understanding of their appropriateness for the indication, the particular patient, and their
benefit, harm effectiveness and risk.
Pre-marketing
The stage before a drug is available for prescription or sale to the public.
Record linkage
Method of assembling information contained in two or more records, e.g. In different sets of
medical charts and vital records such as birth and death certificates. This makes it possible to
relate significant health events that are remote from one another in time and place.
Reference risk
Risk in a population of unexposed persons; also called baseline risk. Reference risk can be
measured over time (incidence) or at a given time (prevalence). The unexposed population
refers to a reference population, as closely comparable to the exposed population as possible,
apart from the exposure.
Regulatory authority
The legal authority in any country with the responsibility of regulating all matters relating to
drugs.
Relative risk
The risk ratio in an exposed population (absolute risk) and the risk in an unexposed
population (reference risk). Relative risk results from a relative comparison between outcome
frequency measurements, e.g. incidences.
Risk
The probability of harm being caused; the probability (chance, odds) of an occurrence.
Serious Adverse Event or Reaction
A serious adverse event or reaction is any untoward medical occurrence that at any dose:
results in death
requires inpatient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity is life-threatening.
Side effect
Any unintended effect of a pharmaceutical product occurring at normal dosage which is
related to the pharmacological properties of the drug.
Signal
Reported information on a possible causal relationship between an adverse event and a drug,
the relationship being unknown or incompletely documented previously. Usually, more than a
single report is required to generate a signal, depending upon the seriousness of the event and
the quality of the information. The publication of a signal usually implies the need for some
kind of review or action.
Summary of Product Characteristics (SPC)
A regulatory document attached to the marketing authorization which forms the basis of the
product information made available to prescribers and patients.
Spontaneous reporting
A system whereby case reports of adverse drug events are voluntarily submitted from health
professionals and pharmaceutical manufacturers to the national regulatory authority.
Thalidomide
Drugs prescribed in the 1950s as a mild sleeping pill and remedy for morning sickness for
pregnant women. This led to serious birth defects and the start of modern pharmacovigilance.
Returning to favour the treatment of serious diseases such as cancer and leprosy.
Traditional medicines
Traditional medicine is the sum total of the knowledge, skills, and practices based on the
theories, beliefs, and experiences indigenous to different cultures, whether explicable or not,
used in the maintenance of health as well as in the prevention, diagnosis, improvement or
treatment of physical and mental illness.
Unexpected adverse reaction
An adverse reaction, the nature or severity of which is not consistent with domestic
labelling or market authorization, or expected from characteristics of the drug.
Vigi-Base
The name of the WHO Global ICSR Database.
Vigi-Flow
Vigi-Flow is a complete ICSR management system created and maintained by the UMC. It is
web-based and built to adhere to the ICH-E2B standard. It can be used as the national
database for countries in the WHO Programme as it incorporates tools for report analysis and
facilitates sending reports to Vigi-Base.
Vigi-med
Share point-based conferencing facility, exclusive to member countries of the WHO
Programme for International Drug Monitoring for fast communication of topical
pharmacovigilance issues.
Vigi-Mine
A statistical tool within Vigi-Search with vast statistical material calculated for all Drug-
ADR pairs (combinations) available in Vigi-Base. The main features include the
disproportionality measure (IC value) stratified in different ways and valuable filter
capabilities.
Vigi-Search
A search service for accessing ICSRs stored in the Vigi-Base database offered by the UMC to
national pharmacovigilance centres and other third-party inquirers.
WHO-ART
Terminology for coding clinical information concerning drug therapy. UMC maintains WHO-
ART.
WHO Drug Dictionary (WHO DD)
The WHO Drug Dictionary is an international classification of drugs providing proprietary
and non-proprietary names of medicinal products used in different countries, together with all
active ingredients.
WHO-UMC Causality Assessment Scale
Causality term Assessment criteria*
Certain Events or laboratory test abnormalities, with plausible time relationship to drug
intake
It cannot be explained by disease or other drugs
Response to withdrawal plausible (pharmacologically, pathologically)
Event definitive pharmacologically or phenomenologically (i.e., an objective and specific
medical disorder or a recognized pharmacological phenomenon)
Rechallenge satisfactory, if necessary
Probable/ Likely
Event or laboratory test abnormality, with a reasonable time relationship to drug intake
Unlikely to be attributed to disease or other drugs
Response to withdrawal clinically reasonable
Rechallenge not required
Possible
Event or laboratory test abnormality, with reasonable time relationship to drug intake
It could also be explained by disease or other drugs
Information on drug withdrawal may be lacking or unclear
Unlikely
Event or laboratory test abnormality, with a time to drug intake that makes a relationship
improbable (but not impossible)
Disease or other drugs provide plausible explanations
Conditional/Unclassified
Event or laboratory test abnormality
More data for proper assessment is needed, or
Additional data under examination
Unassessable/ Unclassifiable
A report suggesting an adverse reaction
Cannot be judged because the information is insufficient or contradictory
Data cannot be supplemented or verified
SUSAR: An unexpected adverse reaction (UAR) is an adverse reaction that is not consistent
with the product information in the SPC.
A suspected unexpected serious adverse reaction (SUSAR) is any UAR that at any dose:
a. Results in death;
b. Is life threatening (i.e., the subject was at risk of death at the time of the event)
c. Refer to an event which hypothetically might have caused death if it were more severe
d. Requires hospitalization or prolongation of existing hospitalization;
e. Results in persistent or significant disability or incapacity;
f. Is a congenital anomaly or birth defect.
SUSAR is a serious adverse drug reaction (SAR) that is unexpected or for which the
development is uncommon (unexpected issue) observed during a clinical trial and for which
there is a relationship with the experimental drug, whatever the tested drug or its comparator.
Day zero remains as the day that the first information was received.
Day zero should be considered the day on which the minimum criteria for a reportable
adverse reaction report becomes available.
Medication errors occur during prescribing, transcribing, dispensing, administering,
adherence, or monitoring of a drug. Examples of medication errors include misreading or
miswriting a prescription. Medication errors that are stopped before harm can occur are
sometimes called “near misses” or “close calls” or, more formally, a potential adverse drug
event. Not all prescribing errors lead to adverse outcomes. Some do not cause harm, while
others are caught before harm can occur (“near-misses”).
Medication errors are more common than adverse drug events but result in harm less than
1% of the time. About 25% of adverse drug events are due to medication errors.
This refers to situations where the medicine is intentionally and inappropriately used not
under the authorized PI or the directions for use on the medicine label.
The adverse effect of a drug should not be considered without taking account of its beneficial
effects.
Collect and record of AEs / ADRs
Causality assessment and analysis of ADRs
Collate and code in the database
Compute risk-benefit and suggest regulatory action
Communicate for the safe use of drugs among stakeholders
