PHARMACOVIGILANCE ORGANISATION:

CONEPT OF SAFTEY REPORTING SERVICESMADE BY:SOMYA

PHARMACOVIGILANCE ORGANISATION:

PHARMACOVIGILANCE

Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. PV heavily focuses on: adverse drug reactions, or ADRs Medication errorssuch as overdose, and misuse and abuse of a drug drug exposure during pregnancy and breastfeeding

WHY PV ID NEEDED? Most medicines will only have been tested for short-term safety Efficacy on a limited number of carefully selected individuals Treatments are monitored for their effectiveness and safety under real-life conditions post releaseMore information is generally needed about use in specific population group

HOW IS PV DONE?Since 1978 , WHO International Drug Monitoring Programme, through which over 130 member nations have systems in placeencourage healthcare personnel to record and report adverse effects of drugs in their patients,Member countries send their reports to theUppsala Monitoring Centrewhere they are processed, evaluated and entered into the WHO International Databaseif similar reports are being made elsewhere lead to the detection of a signal, and an alert about a possible hazard communicated to members countries after detailed evaluation and expert review.

Monitoring the safety of medicines: key partners

Government Industry Hospitals and academia Medical and pharmaceutical associations Poisons and medicines centres information Health professionals Patients Consumers The media World Health Organization

SIGNAL DETECTION

Identification and analysis of new adverse reaction signals from the case report information submitted to the National Centressent from them to the WHO ICSR(Individual Case Safety Report) databasedata-mining approach (IC analysis) is used at the UMC to support the clinical analysis made by a panel of signal reviewers

SIGNAL STRENTHNINGThe signal generation is followed by preliminary assesment of available dataPreliminary data can be qualitative derived from clinical observation or quantitative derived from epidemiological studies, CRF,experimetsMost of cases of data supportive evidence is required to measure ther the relative risk Higher is the relative risk higher stronger is the signalPeriodic analysis ofVigiBasedata is performed, in accordance with UMCs current routine signal detection process, to find previously unrecognised ADRs

SIGNAL EVALUATION

To qualify as a signal through the current routine signal detection process, a drug-ADR combination has togo through and meet the criteria in the following procedure:relative reporting rates for all drug-ADR combinations reported in VigiBase are calculated. The IC value highlights the drug-ADR combination as being reported unexpectedly more frequently relative to the database background.drug-ADR combinations the triage algorithms (filtering methods) select combinations for which the ICSRs derive from at least two countries and meet one of the following criteria:new drug and serious reaction (drug first entered into the database in the last five years and ADR is a WHO-ART critical term) significantly increased IC value since the previous quarter

Drug-ADR combinations filtered out by the triage algorithms are subsequently checked by UMC staff for occurrence in available product information and literature. If the reaction is not found or not described well enough, the individual case reports are retrieved from VigiBase.A thorough clinical assessment of the individual case reports is then done either internally by UMC staff or externally by members of the UMC Signal Review Panel.Thus UMC signals are found by a combination of data-mining methodology, together with expert clinical evaluation.

FACTORS AFFECTING IN SIGNAL STRENGTHNINGQuantitative strength of the associationNumber of individual case reportsStatistical disproportionalityConsistency of the data (pattern)Exposure-response relationshipSite, timing, dose, reversibilityBiological plausibility of hypothesisPharmacological, pathologicalExperimental findingse.g. dechallenge, rechallange, blood levels, metabolites, drug-dependent antibodiesNature and quality of the dataObjectivity, documentation, causality assessment

SOURCES AND METHODS OF SIGNAL DETECTIONSPONTANEOUS REPORTING SYSTEM(SRS): Spontaneous reports are termed spontaneous as they take place during the clinicians normal diagnostic appraisal of a patient, when the clinician is drawing the conclusion that the drug may be implicated in the causality of the event. Voluntary participation by health profession,pharamcists,nurses ad pateints. INTENSIVE HOSPITAL BASED DRUG SURVELLIENCE SYSTEM hospital based survellience involves use of in-pateint record records that are maintained with details drug used ,indication, dose,roue of administration, the date of starting etc.

3. PRESCRIPTION- EVENT MONITORING: Large scale PMS method in UK. All NHS prescriptions issued by general practitioners are analyzed centrally. Sytem identified the pateint reciving particular drugs and doctor who prescribed the drug and follow up questionnaire is sent.4. EPIDEMIOLOGICAL STUDIES: Carefully designed studies specifically directed to study adverse effect related to use of a particular drug.CASE REPORT IN LITERATURE: The case report forms by observant physicians contribute significantly in signal detection. Although a single report by itself do not generate a signal it can stimulate others to be watchful for same.

ROLE OF NATIONAL PV CENTER IN SIGNAL DETECTION Regional centers

National PV center

National pharmacovigilance centers are the organisation designated by the ministeries of health of member countries responsible for collecting and processing of ADR reports.National pharmacovigilance centers of member countries works in coorperation with UMC and send ADR reports, which is source of database in WHO data base.The pharmacovigilance data from national center is communicated to WHO-ADR database(vigibase) where further analysis is done either confirm or disprove the signal and decide accordingly for necessary action

UMC monitoring reportsThe number of countries has raised to 130 from 10 since 1968

THE WHO PROGRAMME Members of the WHO Programme for International Drug Monitoring, 1968 - 20142014-05-06

PV PROGRAMME IN INDIAPharmacovigilance in India was conceived way back in 1986 when 12 regional centers were proposedIndia then joined the WHO-Adverse Drug Reaction (ADR) monitoring program, based in Uppsala, Sweden. Three centers were assigned the task of ADR monitoring of marketed medicines - All India Institute of Medical Sciences (AIIMS) New Delhi, King Edward Memorial (KEM) Hospital Mumbai, JLN Hospital Aligarh Muslim University.

the WHO sponsored and World Bank funded National Pharmacovigilance Program (NPP) was launched, which is overseen by National Pharmacovigilance Advisory Committee. There are 24 PV centers at present under this program. the Drug Controller General of India (DCGI) has announced the CDSCO's "VISION 2020" which proposes to create a PV center in every medical college in the country which is an ambitious task keeping in view the fact that it is still at low ebb in many government medical colleges and the condition is the same or may be worse in the private institutes

REFRENCEShttp://apps.who.int/medicinedocs/en/d/Js6164e/1.htmlhttp://www.who-umc.org/DynPage.aspx?id=98081&mn1=7347&mn2=7252&mn3=7322&mn4=7325https://en.wikipedia.org/wiki/Pharmacovigilancehttp://www.jpharmacol.com/article.asp?issn=0976-500X;year=2011;volume=2;issue=4;spage=295;epage=299;aulast=Chakrabarty