CONTENTSINTRODUCTIONAIM AND OBJECTIVESGOALS OF PHARMACOVIGILANCEFUNCTIONS OF PHARMACOVIGILANCE AT VARIOUS LEVELSADVERSE DRUG REACTIONSPHARMACOVIGILANCE IN DRUG REGULATIONPHARMACOVIGILANCE METHODS IN ADR DETECTIONROLES OF HEALTH PROFESSIONALSPARTNERS OF PHARMACOVIGILANCEPREVENTING OF ADRsMONITORING OF ADRsCONCLUSIONREFERENCES

WHAT IS PHARMACOVIGILANCE?Pharmakon (Greek) : Medicinal substancesVigilia (Latin) : To keep watch

DEFINITION : The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any drug related problems

All the medicines with the ability to produce the desired therapeutic effect also have the potential cause the unwanted adverse effects. The important to monitor both known and unknown side effects of medicines in order to determine any new information related to their safety profile.

AIM :To identify new information about hazards as associated with medicines.

OBJECTIVES :Improve patient care and safety.Improve public health and safety.Encourage safe, rational and appropriate use of drugs.Promote advertising, education and clinical training in pharmacovigilance.

GOALS OF PHARMACOVIGILANCEMonitors the quality of drugs.Identify the health risks involved in administration of certain drugs.Prevent harm to patients.Research and efficacy of the drugs.

NATIONAL PHARMACOVIGILANCE CENTRE

NATIONAL PHARMACOVIGILANCE PROGRAMME

PERIPHERAL PHARMACOVIGILANCE CENTRES

REGIONAL PHARMACOVIGILANCE CENTRE

ZONAL PHARMACOVIGILANCE CENTRE

HOW PHARMACOVIGILANCE WORK?

ADR SUSPICION ADR REPORTING

SHARING OFADR ANALYSISFINDINGS

ADVERSE DRUG REACTIONS

TYPES OF ADRsType A effects(augmented) : common ,dose dependent and predictableType B effects (bizzare) : rare, dose independent and unpredictableType C effects (chronic) : after long term therapy no time relationshipType D effects (delayed) :may be prevented years afterType E effects : absence of drug after withdrawn (end of treatment)FACTORS AFFECTING SUSCEPTABILITY TO ADRs1.Age 4.Ethnicity 2.Gender 5.pharmacogenetics3.co-mobidities & concomitant 6.porphyriasmedicines used

Drug combinationsIrrationality 1.Gramnegativeantibacterials+anti staphylococcal antibioticsE.g: ampicillin+ cloxacillin2.Antibacterials+antiamoebi c agents E.g:ciprofloxacin+metronidazole/ofloxacin+ornidazole3.NSAIDS combinationsE.g:nimeslide+diclofenac4.Antiemetics + AntacidsE.g:dompertidon+ranitidine5.Antacids+antianxiety drugsE.g:diazepam+antacidsResults increase resistanse of bacteria, greater side effects, increase duration of therapy & cost of treatment.Ameobiasis and bacterial diarrhoea are usually foond together in patient.one of the drugs is wasted.

Risk of nephrotoxicity I increasedPeptic ulcer is not always associated with emesis. increase cost of treatment.Antacids reduce the absorption of anti-anxiety drugs.

DRUGS BANNED IN INDIAAmidopyrine Fixed dose combinations of atropine in analgesics and antipyrineFixed dose combinations of strychnine and caffeine in tonicsTetracycline liquid oral preparationsFived dose combinations of penicillins with sulphonamidesFixed dose combinations of vitamins with analgesics.Penicillins skin/eye ointment.

DRUGS PROHIBITED FOR IMPORT

Drugs formulation Effective data Notification 1.cosmetics licensed as toothpaste/tooth powder containing tobacco2.Parenteral preparations fixed dose combinations of streptomycin with penicillin3.Fixed dose combination of phenobarbitone with anti-asthmatic drugs4.Fenformin 5.Rofecoxib

With immediate effect

Jan. 1, 1998

Jan. 1, 2002

Oct. 1 , 2003

Dec. 13, 2004GSR 444(E)

GSR 93(E)

GSR 170(E)

GSR 780(E)GSR 810(E)

PHARMACOVIGILENCE IN DRUG REGULATIONCLINICAL TRIAL REGULATION1.collection of ADR2.monitoring clinical data3.reporting of clinical data POST MARKETING SAFETY MONITORING

PHARMACOVIGILANCE METHODS IN ADR DETECTIONSPONTANEOUS REPORTING It is the core data generating system, relying on health care professionals to identify and report any adverse events to their NPC, health authority or drug manufacturer 1.Signal detection 2.causality assessmentYELLOW CARD SCHEME This scheme is operated MHRA ,they submit report on ADRs using yellow card or on-line formPUBLISHED CASE REPORTS The first suspicions of unpredictable reactions may often be seen in a case report from a practioner e.g: cases of thalidomide and practolol

COHORT STUDIES1. These studies monitor large group of patients taking a particular drug over a period of time2. These studies can indicate the relative risks associated with the adverse event in people exposed to drug being studiedCASE-CONTROL STUDIES 1. These studies are an effective method of confirming whether are not a drug causes given reaction once a suspicions has been raised.2.By comparing the prevalence of drug taking between the groups, it may be possible to identify whether significantly more people who experienced the event also took a particular drug.

WHO SHOULD REPORT SAFETY DATAPhysiciansPharmacists Pharmaceuticals companies qualified persons-(pharmacovigilance/regulatory managers).Investigational products (clinical trails).Post-approval reporting individual case safety report(ICSR), periodic safety update reports(PSUR).In many countries patients are encouraged to report side effects.

WHAT TO REPORT?It is important to report serious unexpected ADRs.Most cases of unexpected ADRs are associated with medicines newly introduced in the market.Al suspected adverse reactions.Every single problem related to the use of a drug.ADRs associated with the radiology contrast media, vaccines, diagnostics, drugs in traditionalmedicines, herbal remedies, cosmetics, medical devices and equipment.

SYSTEM OF SAFETY DATABASES HealthprofessionalPatientsPharmaceuticalcompaniesNationalRegulatoryAuthority ClinicalTrails InternationalSafety databases

Pre-approvalPost-approval

ROLES OF HEALTH PROFESSIONALS Ensuring medicines are used safely is fundamental to the role of all health professionals who prescribe, supply, administer, monitor or advise on their use.They should take of all relevant patent factors, which may predispose to an ADR as co-morbidities, concomitant drugs, renal &liver function and genetic predisposition.An important role all health professionals is the documentation identified ADRs.Identifying and assessing ADRs in clinical practice.Pharmacists in particular , because of their role in dispensing prescriptions, may also be involved in educating and supportying others in preventing ADRs.

PATNERS IN PHARMACOVIGILANCEThe WHO quality assurance and safety: medicines teamThe uppsala monitoring centre (UMC)Hospitals and academiaHealth professionalsPatients Other partners

PREVENTING OF ADRsADRs can be prevented by checking previous ADR history.Minimizing the use of drugs known to carry high risk of ADRs.Tailoring drug selection to individuals based on the factors which predispose them to ADRs.Increasing regular review of medicines.Improved sharing of information about patients between health care providers.Increasing availability of guidance on drug selection.Increase rational prescribing, which may have an effect on incidence on ADRs.

MONITORING THERAPYMonitoring the effects of drugs either by direct measurement of concentration or by measurement of physiological markers is another potential mechanism to reduce risk o ADRs.Advice on monitoring should be clear, provide an evidence-based frequency of monitoring and acceptable values.An examination of adequacy of manufacturers advice on monitoring for haematological ADRs found useful to prescribers.

CONCLUSIONPharmacovigilance is used for preventing patients from being effected unnecessarily.Work of WHO is the area of safety monitoring of medicines is necessary if we are to achieve the mission of EDM.Medicines should be available, affordable safe and properly used.Think less about drug safety and more about patient safety.Think more about impact and consequences of decisions and non-decisions.

REFERENCESClinical pharmacy and therapeutics, Roger walker and cate whittlesea ; fifth edition.The importance of WHO 2002.Who technical report no:498(1972).Pharmacovigilance pragmatic appraoches, 2001, Geneva. Administratio regulatory.WHO global ICSR database system: basic facts.Drug information journal 2008.ICH E2B standard E2B

Data elements for transition of individual case safety reports ICH E2B standard.Pharmacovigilance mann RD, Andrews EB, eds.john wiey & sons ltd, chichester,2002.Organization ICH.Organization of Steering committee.History of involvement in drug safety monitoring by WHOSara gambrill,2011 ,chnas pharmacovigilance system: the hunger for safety insights, clinical leader ,Dec 7,2011 accessed march 28 2014.

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