Pv Definitions

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Glossary11.doc - 1 - March 2011

Glossary of terms used in Pharmacovigilance

Absolute risk

Risk in a population of exposed persons; theprobability of an event affecting members of aparticular population (e.g. 1 in 1,000). Absoluterisk can be measured over time (incidence) or at agiven time (prevalence). Also seeAttributable riskand Relative risk.

Adverse Event (AE)

Any untoward medical occurrence that maypresent during treatment with a pharmaceuticalproduct but which does not necessarily have acausal relationship with this treatment. Also seeAdverse reactionand Side Effect.Synonym:Adverse experience

Adverse (Drug) Reaction (ADR)

A response which is noxious and unintended,and which occurs at doses normally used inhumans for the prophylaxis, diagnosis, ortherapy of disease, or for the modification ofphysiological function. (WHO, 1972).

An adverse drug reaction, contrary to an adverseevent, is characterized by the suspicion of acausal relationship between the drug and theoccurrence, i.e. judged as being at least possiblyrelated to treatment by the reporting or areviewing health professional.

In theEU Directive 2010/84, which will becomeapplicable in July 2012 an adverse reaction isdefined as:

A response to a medicinal product which isnoxious and unintended.

Allopathy

Non-traditional, western scientific therapy,usually using synthesised ingredients, but mayalso contain a purified active ingredient extractedfrom a plant or other natural source; usually inopposition to the disease. Also see Homeopathy.

AssociationEvents associated in time but not necessarilylinked as cause and effect.

Attributable risk

Difference between the risk in an exposedpopulation (absolute risk) and the risk in anunexposed population (reference risk). Alsoreferred to as Excess risk.

Attributable risk is the result of an absolutecomparison between outcome frequencymeasurements, such as incidence.

Benefit

An estimated gain for an individual or apopulation. Also seeEffectiveness/Risk.

Benefit - risk analysis

Examination of the favourable (beneficial) andunfavourable results of undertaking a specificcourse of action. (While this phrase is stillcommonly used, the more logical pairings ofbenefit-harm and effectiveness-risk are slowlyreplacing it).

Biological products

Medical products prepared from biologicalmaterial of human, animal or microbiologicorigin (such as blood products, vaccines, insulin).

Causal relationship

A relationship between one phenomenon orevent (A) and another (B) in which A precedesand causes B. In pharmacovigilance; a medicinecausing an adverse reaction.Synonym: Causality

Causality assessment

The evaluation of the likelihood that a medicinewas the causative agent of an observed adverse

reaction. Causality assessment is usually madeaccording established algorithms.

Caveat document

The formal advisory warning accompanying datarelease from the WHO Global ICSR Database: itspecifies the conditions and reservationsapplying to interpretations and use of the data.

CemFlow

Software developed by UMC for collection andanalysis of data in Cohort Event Monitoring.Also see Cohort Event Monitoring.

Clinical trial

A systematic study on pharmaceutical productsin human subjects (including patients and othervolunteers) in order to discover or verify theeffects of and/or identify any adverse reaction toinvestigational products, and/or to study theabsorption, distribution, metabolism andexcretion of the products with the objective ofascertaining their efficacy and safety.


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Cohort Event Monitoring

Cohort Event Monitoring (CEM) is aprospective, observational study of events thatoccur during the use of medicines, for intensifiedfollow-up of selected medicinal products phase.

Patients are monitored from the time they begintreatment, and for a defined period of time. Seealso Prescription Event Monitoring.

Compliance

Faithful adherence by the patient to theprescribers instructions.

Control group

The comparison group in drug-trials not beinggiven the studied drug.

Critical terms

Some of the terms in WHO-ART are marked asCritical Terms. These terms either refer to ormight be indicative of serious disease states, andwarrant special attention, because of theirpossible association with the risk of seriousillness which may lead to more decisive actionthan reports on other terms.

Also see Serious adverse event or reaction.

Data mining

A general term for computerised extraction ofpotentially interesting patterns from large datasets, often based on statistical algorithms. A

related term with essentially the same meaning ispattern discovery. In pharmacovigilance, thecommonest application of data mining is socalled disproportionality analysis, for exampleusing the Information component (IC). See alsoDisproportionality analysis, Information component,Omega.

Dechallenge

The withdrawal of a drug from a patient; thepoint at which the continuity, reduction ordisappearance of adverse effects may beobserved.

Disproportionality analysisScreening of ICSR databases for reporting rateswhich are higher than expected. For drug-ADRpairs, common measures of disproportionalityare the Proportional Reporting Ratio (PRR), theReporting Odds Ratio (ROR), The InformationComponent (IC), and the Empirical BayesGeometrical Mean (EBGM). There are alsodisproportionality measures for drug-drug-ADR

triplets, such as Omega (). See also Informationcomponent, Omega.

Effectiveness/risk

The balance between the rate of effectiveness ofa medicine versus the risk of harm is aquantitative assessment of the merit of a

medicine used in routine clinical practice.Comparative information between therapies ismost useful. This is more useful than the efficacyand hazard predictions from pre-marketinginformation that is limited and based on selectedsubjects.

Efficacy

The ability of a drug to produce the intendedeffect as determined by scientific methods, forexample in pre-clinical research conditions(opposite of hazard). See alsoAbsolute risk,Reference risk, Attributable risk and Relative risk.

EpidemiologyThe science concerned with the study of thefactors determining and influencing thefrequency and distribution of disease, injury andother health-related events and their causes in adefined human population for the purpose ofestablishing programs to prevent and controltheir development and spread (DorlandsIllustrated Medical Dictionary). Also seePharmacoepidemiology.

Essential medicines

Essential medicines are those that satisfy the

priority health care needs of the population.They are selected with due regard to publichealth relevance, evidence on efficacy and safety,and comparative cost-effectiveness. Seehttp://www.who.int/selection_medicines/en/

EudraVigilance

The European Union data-processing networkand management system, established by theEuropean Medicines Agency (EMA) to supportthe electronic exchange, management, andscientific evaluation of Individual Case SafetyReports related to all medicinal products

authorised in the European Economic Area(EEA). EudraVigilance also incorporates dataanalysis facilities.

Excipients

All materials included to make a pharmaceuticalformulation (e.g. a tablet) except the active drugsubstance(s).


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Formulary

A listing of medicinal drugs with their uses,methods of administration, available dose forms,side effects, etc, sometimes including theirformulas and methods of preparation.

Frequency of ADRs

In giving an estimate of the frequency of ADRsthe following standard categories arerecommended:Very common* > 10%Common (frequent) >1% and 0.1% and < 1%Rare >0.01% and


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Omega ()

A measure of disproportionate reporting fordrug-drug-ADR triplets in ICSR databases,designed to highlight potential signals of drug-drug interactions. Just like the more establisheddisproportionality measures for drug-ADR pairs, is based on a contrast between the observed

and expected number of reports. A positive indicates higher reporting than expected.

OTC (Over The Counter) medicine

Medicinal product available to the public withoutprescription.

PaniFlow

Software developed by UMC for collection andanalysis of data in relation to vaccinations in apandemic situation.

Periodic Safety Update Report

(PSUR)A systematic review of the global safety datawhich became available to the manufacturer of amarketed drug during a specific time period.Produced in an internationally agreed format.

Pharmacoepidemiology

Study of the use and effects of drugs in largepopulations. Also seeEpidemiology.

Pharmacology

Study of the uses, effects and modes of action ofdrugs.

Pharmacovigilance

The science and activities relating to thedetection, assessment, understanding andprevention of adverse effects or any other drug-related problem.

Phocomelia

Characteristic deformity caused by exposure tothalidomide in the womb, also very rarelyoccurring spontaneously. Meaning: limbs like aseal.

Phytotherapy

Western-style, scientific treatment using plantextracts or materials.

Placebo

An inactive substance (often called a sugar pill)given to a group being studied to compareresults 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 onthe market.

Predisposing factors

Any aspect of the patients history (other thanthe drug) which might explain reported adverseevents (genetic factors, diet, alcoholconsumption, disease history, polypharmacy oruse of herbal medicines, for example).

Pre-marketing

The stage before a drug is available forprescription or sale to the public.

Prescription Event Monitoring (PEM)

System created to monitor adverse drug eventsin a population. Prescribers are requested toreport all events, regardless of whether they aresuspected adverse events, for identified patientsreceiving a specified drug. Also more accuratelynamed Cohort Event Monitoring.

Prescription Only Medicine (POM)

Medicinal product available to the public only onprescription.

Prevalence

Number of existing cases of an outcome in adefined population at a given point in time.

Prophylaxis

Prevention or protection.

Rational drug use

An ideal of therapeutic practice in which drugsare prescribed and used in exact accordance withthe best understanding of their appropriatenessfor the indication and the particular patient, andof their benefit, harm effectiveness and risk.

Rechallenge

The point at which a drug is again given to a

patient after its previous withdrawal - also seedechallenge.

Record linkage

Method of assembling information contained intwo or more records, eg in different sets ofmedical charts, and in vital records such as birthand death certificates. This makes it possible torelate significant health events that are remotefrom one another in time and place.


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Reference risk

Risk in a population of unexposed persons; alsocalled baseline risk. Reference risk can bemeasured over time (incidence) or at a given time(prevalence). The unexposed population refers to areference population, as closely comparable tothe exposed population as possible, apart from

the exposure.

Regulatory authority

The legal authority in any country with theresponsibility of regulating all matters relating todrugs.

Relative risk

Ratio of the risk in an exposed population(absolute risk) and the risk in an unexposedpopulation (reference risk). Relative risk is theresult of a relative comparison between outcomefrequency measurements, e.g. incidences.

Risk

The probability of harm being caused; theprobability (chance, odds) of an occurrence.

Serious Adverse Event or Reaction

A serious adverse event or reaction is anyuntoward medical occurrence that at any dose:

results in death requires inpatient hospitalisation or

prolongation of existing hospitalisation

results in persistent or significantdisability/incapacity

is life-threateningTo ensure no confusion or misunderstanding ofthe difference between the terms serious andsevere, the following note of clarification isprovided:

The term severe is not synonymous withserious. In the English language, severe is usedto describe the intensity (severity) of a specificevent (as in mild, moderate or severe); the eventitself, however, may be of relatively minormedical significance (such as severe headache).Seriousness (not severity) which is based onpatient/event outcome or action criteria servesas guide for defining regulatory reportingobligations.

Side effect

Any unintended effect of a pharmaceutical productoccurring at normal dosage which is related to thepharmacological properties of the drug.

Signal

Reported information on a possible causalrelationship between an adverse event and adrug, the relationship being unknown orincompletely documented previously. Usuallymore than a single report is required to generatea signal, depending upon the seriousness of the

event and the quality of the information. Thepublication of a signal usually implies the needfor some kind of review or action.

Summary of Product Characteristics(SPC)

A regulatory document attached to themarketing authorization which forms the basisof the product information made available toprescribers and patients.

Spontaneous reporting

System whereby case reports of adverse drug

events are voluntarily submitted from healthprofessionals and pharmaceutical manufacturersto the national regulatory authority. AlsoseeICSR.

Thalidomide

Drug prescribed in the 1950s as a mild sleepingpill and remedy for morning-sickness forpregnant women. Led to serious birth defectsand the start of modern pharmacovigilance.Returning to favour in treatment of seriousdiseases such as cancer and leprosy.

Traditional medicinesTraditional medicine is the sum total of theknowledge, skills, and practices based on thetheories, beliefs, and experiences indigenous todifferent cultures, whether explicable or not,used in the maintenance of health as well as inthe prevention, diagnosis, improvement ortreatment of physical and mental illness. Also seeAllopathic medicine.

Unexpected adverse reaction

An adverse reaction, the nature or severity ofwhich is not consistent with domestic labelling

or market authorization, or expected fromcharacteristics of the drug.

VigiBase

The name of the WHO Global ICSR Database.


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VigiFlow

VigiFlow is a complete ICSR managementsystem created and maintained by the UMC. It isweb-based and built to adhere to the ICH-E2Bstandard. It can be used as the national databasefor countries in the WHO Programme as itincorporates tools for report analysis, and

facilitates sending reports to VigiBase.

Vigimed

Sharepoint based conferencing facility, exclusiveto member countries of the WHO Programmefor International Drug Monitoring for fastcommunication of topical pharmacovigilanceissues.

VigiMine

A statistical tool within VigiSearch with vaststatistical material calculated for all Drug-ADRpairs (combinations) available in VigiBase. The

main features include the disproportionality

measure (IC value) stratified in different waysand useful filter capabilities.

VigiSearch

A search service for accessing ICSRs stored inthe VigiBase database offered by the UMC tonational pharmacovigilance centres and other

third-party inquirers.WHO-ART

Terminology for coding clinical information inrelation to drug therapy. WHO-ART ismaintained by UMC.

WHO Drug Dictionary (WHO DD)

The WHO Drug Dictionary is an internationalclassification of drugs providing proprietary andon-proprietary names of medicinal productsused in different countries, together with allactive ingredients.

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Pv Definitions