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Dr.N.K.Sahoo M.Pharm,PhD , Assoc.Prof . Pharmaceutical Analysis MNR College of Pharmacy

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INTRODUCTION Pharmacovigilance (PV) also called as drug safety Pharmakon -------in greek ----drug Vigilare -----------in latin ------to keep watch Def : Pharmacovigilance is the science &activities relating to the detection , assessment, understanding and prevention of adverse effects (WHO collaborating centre for international drug monitoring )

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AIMS To improve patient care and safety To improve public health and safety To contribute to the assessment of benefit, harm ,effectiveness and risk of medicines To promote education and clinical training To promote rational and safe use of medicines

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RESPONSIBILITIES Timely collection of data ,recording and notification Appropriate assessments (data completeness , seriousness) Expedited and periodic reporting Creates appropriate structures for communication

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1.HUMANITARIAN CONCERN -Animal toxicology is often not a good predictor for human effects . -Evidence of safety from clinical trials is insufficient due to some limitations LIMITATIONS (phase 1-3): limited size , narrow population (age &sex specific), narrow indications (only specific disease), short duration NEED OF PHARMACOVIGILANCE

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2. SAFE USE OF MEDICINES it has been suggested that ADRs may cause 5700 deaths per year in UK 3.ADRs ARE EXPENSIVE 4.PROMOTING RATIONAL USE OF MEDICINES 5.ENSURING PUBLIC CONFIDENCE 6.ETHICAL CONCERN not reporting is serious reaction is unethical

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The pharmaceutical industry Regulatory authorities WHO collaborating centre for international drug monitoring CIOMS(Council for International Organization of Medical Sciences ) GOVERNING BODIES

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METHODS 0F PHARMACOVIGILANCE Individual case safety reports Clinical review of case reports Cohort event monitoring Longitudinal electronic patient records Spontaneous reporting Periodic Safety Update Reports (PSUR) Expedited report Record linkage

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1.INDIVIDUAL CASE SAFETY REPORTS : -Like yellow card system of the Pharmacovigilance section of the U.K. -Their strength in signaling causal associations depend on the skill and experience of the reporter and the documentation and characteristics of the event.

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2.CLINICAL REVIEW OF CASE REPORTS : -The quality of reports is variable , large national and international organizations collect hundreds of thousands of reports each year , every one of which can’t possibly be reviewed by the available experts. -Even if each report could be reviewed , important reporting patterns would be missed. -Computational have therefore been developed to help highlight the most urgent problems .

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3.COHORT EVENT MONITORING : -Cohort Event Monitoring (CEM) systems for intensified follow up of selected medicinal products. -The main limitations are its restriction to small subset of medicinal products , the relatively small fraction of the population covered .

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4.LONGITUDINAL ELECTRONIC PATIENT RECORDS: -It is extremely valuable but underused. -They cover large populations, provide detailed information on both exposed and unexposed patients. -Information is extracted directly from the computer systems in which physicians store patient’s data. -Privacy protection for patients and physicians is of the utmost importance.

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5.SPONTANEOUS REPORTING : -The reporting might be directly to the company , or it could be to the regulatory authority. -Main limitation is under reporting. -However , their main purpose is not the quantification of the frequency, but identification of signals.

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- When becoming aware of a serious adverse drug reaction , health care providers, pharmacies, pharmaceutical companies shall report to the health authority. -Time frame of reporting , report within a specific time frame(ex:7days) upon knowing of any serious ADR .

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-REPORTING METHODS AND TEMPLATE : shall submit reports by post, fax or internet . -A verbal report is acceptable in urgent situations, but written submission should be completed before the deadline. -Additional information on a serious ADR report, not available at the time of the initial report , should be provided in follow up reports.

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6.PERIODIC SAFETY UPDATE REPORTS(PSUR): - Pre marketing clinical trials may not be sufficient to reflect the product safety profile. -Therefore medically advanced countries impose the “post marketing drug safety monitoring period ” on new drugs. -license holders shall proactively collect post marketing safety data, prepare PSUR and submit them to the health authority.

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-According to the “regulation of medical products under safety monitoring” ,if pharmaceutical companies fail to submit PSUR as required , then the health authority may reassess the safety of the concerned product. -The last PSUR should be submitted before the expiration of the drug safety monitoring period. -The “summary bridging report” provides summarized information of the PSURs.

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7.EXPEDITED REPORT : -If there has been spontaneous reporting of a suspected ADR to a pharmaceutical company , there are legal obligations on the company to report serious reactions within a specified time frame to the regulatory authority. -based on the results of drug safety assessment , license holders shall report to the health authorities in an expedited manner

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8.RECORD LINKAGE: - Bring together a variety of patient records . - A specific example is prescription event monitoring scheme. - It is less expensive but time consuming method.

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PHARMACOVIGILANCE INSPECTION two types - 1.routine inspection 2.targeted inspection 1.Routine inspections - To make sure that pharmaceutical companies have the ability in performing Pharmacovigilance activities

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2.targeted inspections a) inspections irrelevant to drug safety -companies that have not yet been inspected -companies that launch their first product -companies which are newly merged b) inspections relevant to drug safety -companies that delay or fail to take their obligations on safety monitoring -companies that delay to submit or submit incomplete periodic safety update reports -companies that failed to report drug safety related issues (like drug withdrawal with out reporting )

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ADVERSE DRUG REACTIONS Adverse event reporting –comprises 4 elements identifiable patient identifiable reporter 3.a suspect drug 4.a suspected adverse event

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NON IMMUNOLOGICAL TYPE A (or) predictable 1.side effects 2.secondary effects 3.toxic effects 4.mutagenicity&carcinogenicity 5.drug interactions 6.teratogenicity 7.nonimmunological activation of effector pathways 8.exacerbation of disease 9.Metabolic alterations 10.drug induced chromosomal damage 11.effect on spermatogenesis

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TYPE B (or) unpredictable 1. intolerance 2. idiosyncrasy

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Type A 1.Side effects : - undesirable and unavoidable effects of drugs due to their pharmacological property at recommended doses. Ex-dry mouth from atropine therapy 2.Secondary effect: - Indirect effects of drug due to its principal action. Ex-occurrence of TB in corticosteroid therapy.

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3.toxic effect: -It is a pharmacological action due to over dosage or prolonged usage. Ex-coma with barbiturates 4.mutagenicity & carcinogenicity : -metabolites from drugs can cause structural changes in chromosomes to produce mutations. Ex-anti cancer drugs

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5.drug interactions : -Can occur before its absorption into systemic circulation . Ex- phenobarbitone inhibits griseofulvin absorption from intestine 6.teratogenicity: -Fetal abnormalities produced due to drug intake by the pregnant woman Ex-androgens cause virilization of fetus

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Type B 1.intolerance: - Appearance of toxic effects in a recipient to therapeutic doses of drug Ex- trifluperazine single dose causing muscle dystonia in children 2.idiosyncrasy: - Uncertain reaction to a drug in a genetically defect patient Ex- chloramphenicol causes bone marrow depression

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Steps of ADR monitoring : 1. identifying adverse drug reactions 2. assessing causality 3. documentation of ADR 4. reporting serious ADRs to PV centres/ADR regulatory authorities

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APPLICATION OF PHARMACOVIGILANCE 1. in national drug policy 2. in the regulation of medicines 3. in clinical practice 4. in disease control public health programmes (problems are apparent in situations for the treatment of tropical diseases)

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TERMINOLOGY 1.SIGNAL -reported information on a possible causal relationship which is being unknown or incompletely documented previously. -usually more than 1 report is required to generate a signal -before signals are published they are first clinically assessed by PV experts at UMC(Uppsala monitoring centre ,Sweden)

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-there are 3types of signals 1.confirmed signals-causal relationship between the drug and adverse event 2.refuted(false) signals-no causal relationship 3.unconfirmed signals-require further investigation

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Post marketing surveillance(PMS) -Is the practice of monitoring the safety of a pharmaceutical drug or medical device often it has been released on the market and is an important part of the science of Pharmacovigilance . -Since drugs are approved on the basis of clinical trials, which involve relatively small numbers of people & do not have other medical conditions. Approaches are – spontaneous reporting database - prescription event monitoring -electronic health records -patient registries

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Uses - no fixed duration or patient population starts immediately after marketing report all ADRs helps to detect rare ADRs PMS - consists of 3 systems 1.ADR collecting and reporting system 2.reexamination system 3.reevaluation system

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Sources - focus groups - customer surveys - customer complaints& warranty claims - literature reviews - media Benefits - improvement of medical device quality -verification of risk analysis -detection of chronic complaints -performance in different user population - customer satisfaction

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Needs of PMS- -to develop information about drug effects - to find rare adverse events -assess to more patient data Methods of surveillance- - controlled clinical trials - spontaneous recording - cohort studies - case control studies -All adverse events occurring in a PMS should be submitted to UMC in the form of fact sheet.

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Fact sheet should be-email to - confirmation will be sent of received cases within 3 days - case report format-ICH E2B - both serious and non serious cases should be submitted - reporter qualification should be specified in the ICSR - ICSR on veterinary medicines , cosmetics should not be submitted to UMC - either of the two ADR terminologies WHOART (or)MedDRA can be used .

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Pharmacovigilance programme of India (PVPI) Introduction – - officially started on 23 November 2004 at new Delhi -pharmaceutical industry in India is valued at 90,000crore and is growing at the rate of 12-14% per annum -total export of pharma products is to the extent of 40,000crore. - India is now being recognized as the “global pharmacy of generic drugs ”

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Pharmacovigilance Programme of India Dr. G.N. Singh Secretary – Cum – Scientific Director, Drug Controller General of India ADR Monitoring Centres (AMC) Total No. Of Govt AMCs: 43 Total No. Of Non Govt AMCs: 17 IPC, Ghaziabad NATIONAL COORDINATING CENTRE (NCC) 355 MBBS teaching colleges in India

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Notification Boxes- placed all over hospitals with notification forms If any ADR occurs, healthcare Professionals will write the ADR & put it in red box Or directly they may report ADRs by phone or mail Technical associate will collect ADR & write it in a red form Assessment of ADRs by Pharmacologists Under supervision of Coordinator / Sub coordinator ADR processing steps in AMCs

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Red form will be checked & signed by Coordinator / Sub coordinator ADRs will be entered in Vigiflow, WHO database ADRs reviewed & analyzed for any alerts/signals by signal review committee & sent to CDSCO ADRs will be reviewed & sent to UMC. Vigiflow ADR processing steps in AMCs

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What to report? 1)NEW DRUGS all suspected reactions 2) ESTBLISHED/WELL KNOWN DRUGS all serious , unexpected and unusual ADRs Serious ADRs- - result in death -life threatening - inpatient or prolongation of hospitalization - congenital anomaly - disability(significant, persistent or permanent) - require intervention to prevent permanent impairment or damage

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What to report?(cont…) 3)Change in frequency of a given reaction 4)ADRs to traditional medicines 5)All suspected drug-drug, drug-food, drug-food supplement interactions 6)ADRs associated with drug withdrawals 7)ADRs due to medication errors 8)ADRs due to lack of efficacy or pharmaceutical defects

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ADR Notification form (Yellow form )

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ADR reporting form (Red form )

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PVPI is under control of- 1.CDSCO(Central Drugs Standard Control Organization) 2.directorate general of health services 3.indian pharmacopeia commission (Ghaziabad) - The programme is conducting by NCC(National Coordinating Centre) .

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Goals & objectives- goal- to ensure that the benefits of use of medicine outweighs the risks objectives - 1. to monitor ADRs 2. to create awareness among health care professionals about ADRs monitor benefit –risk profile of medicines 4. generate independent ,evidence based recommendations the CDSCO 6.communicate findings with all stake holders 7.create a national centre

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PVPI will be administered and monitored by the following committees 1.steering committee 2.strategic advisory committee Technical support by – 1.signal review panel 2.core training panel 3.quality review panel

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STEERING COMMITTEE Chairman-drugs controller general (India), N ew Delhi Members- 1.scientific director , Indian pharmacopoeia commission , Ghaziabad 2.head of dept of pharmacology ,AIIMS 3.Nominee of director general ,ICMR 4.Assisstant director general as representative of directorate general health services 5.under secretary as representative of the ministry of health & family welfare 6.nominee of vice chancellor of medical/pharmacy university 7.nominee of the medical council of India 8.nominee of the pharmacy council of India

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- PVPI is a 3 layered structure consisting of 1.peripheral 2.regional 3.zonal centres

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programme road map

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Collaboration with WHO- UMC Long term objective of the PVPI is to establish a centre of excellence- for that training of the staff at the PVPI NCC Usage of UMC s vigiflow (for medicines), paniflow (for vaccines) Access to vigibase Access to early information about safety hazards

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OPERATIONAL ASPECTS Roles and responsibilities of different personnel in PVPI Centre management Processing and reporting of suspected ADRs Quality assurance in the programme Regulatory decision making Communication among various stake holders

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Risk management Ensure availability and management of funds Conduct frequent training and awareness Detect and respond to under reporting ADRs Quality review of filled ADR forms Proper supervision of the centres Feed back to the health care professionals

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WHO Pharmacovigilance programme Introduction : - Started in 1978 - Known as WHO programme for international drug monitoring, which is located in Uppsala, Sweden. -As of October 2013, 117 countries have joined Functions – 1. identification and analysis of new ADR signals from national centres & sent to the WHO ICSR database 2. provision of the WHO database as a reference source. 3. information exchange between WHO UMC , national centres through vigimed

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4 . Publications, news letters, guidelines and books in the pharmacovigilance 5. supplying tools like WHO drug dictionary and WHO adverse reaction terminology 6. training to national centres 7. Maintaining of computer software(vigiflow) 8. annual meetings 9. research on Pharmacovigilance

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REPORTING TRENDS : 1. preferred report format is the ICH E2B 2.but some members still use the old WHO format(INTDIS) 3.ICSRs should be sent once every month but at least every quarterly

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PHARMACOVIGILANCE OF MEDICAL DEVICES - medical device reporting(MDR) which is the reporting of adverse events with medical devices PHARMACOVIGILANCE OF HERBAL MEDICINES - the safety of herbal medicines has become a major concern to both national health authorities and public -however mass media reports of adverse events with herbal medicines can be incomplete and therefore misleading regarding the use of herbal medicines

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Thank you ‘People who are vigilant do not die; people who are negligent are as if dead’. - Shakyamuni Buddha 68

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