4. Pharmacovigilance

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PHARMACOVIGILANCE Dr. Maulik M Patel Assistant Professor Department of pharmacology, MMC

The Thalidomide Disaster :

The Thalidomide Disaster 1956 : Thalidomide launched in market 1959-61 : Reports of foetal abnormalities (max. in Germany) 1962 : USA revised law requiring to prove safety and efficacy before issuing marketing authorisation 1963-64 : British Committee on Safety of drug monitoring and “yellow cards” system

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1964-68 : (Pilot Project)National ADR reporting system (UK , Australia, New Zealand, Canada, West Germany ) 1978 : WHO Programme for International Drug Monitoring -now co-ordinated by the Uppsala Monitoring Centre (UMC) in Uppsala, Sweden Currently, 118 National PV centres (89 full members +29 Associate members), co-ordinated by the UMC


Definition pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert ” T he science and activities relating to the Detection Assessment Understanding & Prevention of A dverse drug reactions or any other drug-related problems Recently, it includes herbals, traditional and complementary medicines, blood products , medical devices and vaccines.


OTHER AREAS IN PV Detecion of Drug interactions Measuring the Environmental burden of medicines used ( EcoPharmacovigilance ) Contribution of inactive ingredients to safety profile

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Adverse Drug Reaction(ADR) A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. Adverse Drug Event(ADE) Any untoward medical occurrence that may present during treatment with a medicine but which does not necessarily have a causal relationship with this treatment.

Severity of ADR:

Severity of ADR Mild : No need of therapy, antidote, or hospitalization Moderate Requires drug change , specific treatment, hospitalization Serious Potentially life threatening; permanent damage, and prolonged hospitalization . Severe Increase intensity of reaction

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TYPE A(Augmented) : extension of the pharmacological effect. e.g. SALBUTAMOL and tachycardia TYPE B(Bizarre) : Non dose- related. unexpected, unpredictable, or idiosyncratic reactions. e .g. Penicillins -rash – AINES TYPE C (Chronic ) : Associated with long-term use. e.g. Captopril and cough TYPE D ( Delayed effects ): such as carcinogenesis and teratogenesis e.g. Thalidomide TYPE E ( End-of-use) : Withdrawal e.g. Angina pectoris after stopping -blockers. TYPE F (Failure of therapy ): due to diverse causes : Prescription, diagnosis, missed selection of the medicine or doses Classification of ADRs

ADR incidence:

ADR incidence fourth to sixth leading cause of death among hospitalised patients occurs in 0.3 to 7 per cent of all hospital admissions. The incidence of serious ADRs is 6.7 per cent More with polypharmacy and in elderly

Goals of Pharmacovigilance :

Goals of Pharmacovigilance Continuous monitoring of the safety of medicinal products (both marketed and investigational) Assessing the risks and benefits of all products To promote rational use of these products by providing information about ADRs. Identification, quantification and improving understanding of previously unknown adverse drug reactions. Identification of patients at particular risk of having an ADR Monitoring the impact of any action taken.

Objectives :

Objectives To improve patient care and safety. To improve public health and safety. To contribute to the assessment of benefit and risk of medicines. To promote education and clinical training. To promote rational and safe use of medicines.


Functions Collects , records, codes ADEs /ADRs. Analyses and assesses the reports. Identifying new information about hazards associated with medicines . Creates appropriate structures and means of communication needed to perform its tasks.

India ?:

India ?

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1986   ADR m on i t oring s y st em f or Ind i a p r op o sed 1997   Ind i a j oi n ed WH O - ADR moni t ori n g p r o g r amme (3 ce n t r e s : A I I M S , KEM, JLN)   2004 – 2008   N a tion a l Pharmac o vi g il a nce p r o g . ( 2 Z onal, 5 R egional, 24 P eriphe r al Ce n t r es )

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July,2010 Pharmacovigilance Programme of India( PvPI )

Pharmacovigilance Programme of India:

Pharmacovigilance Programme of India started by The Central Drugs Standard Control Organization (CDSCO) under the aid of Ministry of Health & Family Welfare, GOI in collaboration with AIIMS,Delhi as National coordinating centre (NCC) In April-2011, The NCC then shifted to the Indian Pharmacopeia commission(IPC), Ghaziabad  The PvPI started with the enrolment of 22 ADR monitoring centres across the country in the year 2010, which has increased to 90 by the end of 2012

Objectives of PvPI :

Objectives of PvPI To monitor , analyse the Adverse Drug Reactions (ADRs) in Indian population. To monitor benefit-risk profile of medicines . To create awareness Support the CDSCO for formulating safety related regulatory decisions for medicines. Communicate findings with all key stakeholders.

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Pharmacovigilance Methods:

Pharmacovigilance Methods spontaneous ADR reporting Intensified reporting Active surveillance : - Sentinel sites - Drug event monitoring and registers Comparative observational studies ( Pharmacoepidemiology ) - Cross-sectional studies (surveys) - Case control studies - Cohort studies Meta-analysis

Spontaneous Adverse Drug Reaction Monitoring:

Spontaneous Adverse Drug Reaction Monitoring

Structural and Functional Aspects:

Structural and Functional Aspects Collecting new information from reliable scientific resources. Classifying and analyzing the above information . Circulating its contents as well as any action taken on specific drug to all health sectors. Four Elements of ADR Reporting: A Patient, A drug, An adverse reaction, reporter of the report.

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WHAT TO REPORT? ALL adverse events suspected to have been caused by new drugs and ‘Drugs of current interest’ ALL suspected drug interactions & serious adverse reactions. WHO CAN REPORT? Any health care professionals (Doctors including Dentists, Nurses, and Pharmacists ) WHERE TO REPORT? any one of the country vide Pharmacovigilance Centres nearest to the reporter .


WHAT HAPPENS TO THE INFORMATION SUBMITTED? Peripheral Pharmacovigilance Centres will forward this form to the Regional Pharmacovigilance Centres , where the causality analysis is carried out and the information is forwarded to the Zonal Pharmacovigilance Centres . Finally the data is statistically analysed and forwarded to the Global Pharmacovigilance Database managed by WHO Uppsala Monitoring Center (UMC) in Sweden.

Advantages of Spontaneous Reporting:

Advantages of Spontaneous Reporting Inexpensive and simple to operate Covers all drugs during their whole life cycle Covers the whole patient population Does not interfere with prescribing habits

Disadvantages of Spontaneous Reporting:

Disadvantages of Spontaneous Reporting limited clinical information to permit a thorough case evaluation Underreporting decreases sensitivity The reporting rate is seldom stable over time

Reasons for not reporting in India:

Reasons for not reporting in India Belief – that only safe drugs are allowed on the market Ignorance of the requirements for reporting . Fear of involvement of litigation Guilt because harm to the patient has been caused by the treatment the doctor has prescribed Lethargy – an mix of adjournment, lack of interest or time, an inability to find a report form ,etc.


CAUSALITY ASSESSMENT SCALES WHO probability scale Naranjo’s algorithm Kartch Lasagna`s algorithm European ABO system Spanish quantitative imputation scale Kramer's scale Jones scale Bayesian system

WHO Causality Assessment:

WHO Causality Assessment

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Certain: Response to dechallenge - plausible Event must be definitive pharmacologically / immunologically Positive rechallenges (if performed). Probable/ Likely : Clinical event, lab test abnormality with reasonable time relationship to drug intake Clinically reasonable response to withdrawal ( dechallenge ) Rechallenge not required Possible: Clinical event lab test abnormality with reasonable time relationship to drug intake Could also be explained by concurrent disease or other drugs or chemicals Information on drug withdrawal may be lacking or unclear Unlikely : Other drugs , chemicals or underlying disease provide plausible explanations unclassifiable : Insufficient /contradictory evidence which cannot be supplemented or verified unclassified More data is essential for proper assessment or additional data are under examination

Where is Pharmacovigilance in the drug development?:

Where is Pharmacovigilance in the drug development?


IMPORTANCE OF PMS AND ADR REPORTING Tests in animals are insufficient to predict human safety Patients used in clinical trials are selected and limited in number By the time of licensing , exposure of less than 5000 human subjects to a drug allows only the more common ADR to be detected At least 30,000 people need to be treated with a drug to detect an incidence of 1 in 10,000 exposed individuals

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EcoPharmacovigilance science and activities concerning detection, assessment, understanding, and prevention of adverse effects or other problems related to the presence of pharmaceuticals in the environment , which affect human and other animal species .

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Consumed drug passes out of the system either as metabolites or unchanged through excretion. Drugs are usually water soluble and therefore find their way into the sewage Industrial waste of the pharmaceutical companies also contributes toward the entry of drugs into the environment. Few drugs are not entirely removed by treatment process leaving their traces to go into water in environment. Cocaine has been detected in Po river in Italy . In Niagara river antidepressant drugs, carbamazepine and other antileptics , and lipid-regulating agents were detected.

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A study from Pakistan revealed that due to the use of diclofenac in treatment of livestock and consumption of their dead bodies by vultures led to the kidney failures . Consequently over a period of time population of vultures declined so drastically that they were declared endangered species. Similarly, Government of India also banned diclofenac in India for veterinary use . Sterility in frogs due to traces of oral contraceptive pills in water became the cause of decrease in number of frogs .

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