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Submitted by: Sumit Kumar Mittal I.S. F College of Pharmacy, Moga (Punjab) DEPARTMENT OF QUALITY ASSURANCE PHARMACOVIGILANCE


According to WHO : Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. DEFINITION


To improve public health and safety in relation to medicines , cosmetics, herbal products etc. To contribute to the assessment of benefits , harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective use . To promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public. 3 AIM OF PHARMACOVIGILANCE WHO policy 2004


Tests in animals are insufficient to predict human safety. Patients used in clinical trials are selected and limited in number, the conditions of use differ from those in clinical practice and the duration of trials is limited. By the time of licensing exposure of less than 5000 human subjects to a drug allows only the more common ADR to be detected. Information about rare but serious adverse reactions, chronic toxicity , use in special groups (such as children, the elderly or pregnant women) or drug interactions is often incomplete or not available. NEED OF PHARMACOVIGILANCE


Data gathering related to the detection, assessment, understanding, and prevention of adverse events Identifying new information about hazards associated with medicines, preventing harm to patients Post-marketing surveillance Medical errors are broader category which includes adverse reactions but also other factors (diagnostic errors, equipment failure. ) ‏ 5 STEPS UNDER PHARMACOVIGILANCE


An adverse drug reaction (ADR) is ‘ a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man’. An adverse event is defined as ‘ any untoward medical occurrence that may present during treatment with a medicine but which does not necessarily have a causal relationship with this treatment’. A side effect is ‘ any unintended effect of a pharmaceutical product occurring at doses normally used by a patient which is related to the pharmacological properties of the drug’. TERMS


TERMS An unexpected adverse reaction is ‘ an adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorisation, or expected from characteristics of the drug’. Serious Adverse Event or Reaction A serious adverse event or reaction is any untoward medical occurrence that at any dose: • results in death • requires inpatient hospitalisation or prolongation of existing hospitalisation • results in persistent or significant disability/incapacity • is life-threatening


NATIONAL PHARMACOVIGILANCE PROGRAMME(NPP) National Pharmacovigilance Programme (NPP) The nation wide programme , sponsored and coordinated by the country’s central drug regulatory agency – Central Drugs Standard Control Organization (CDSCO) – to establish and manage a data base of Adverse Drug Reactions (ADR) for making informed regulatory decisions regarding marketing authorization of drugs in India for ensuring safety of drugs.


FUNCTIONS OF NPP Monitor the adverse drug reactions of medicines . Review Periodic Safety Update Reports (PSURs). Maintain contacts with international regulatory bodies working in pharmacovigilance and exchange information on drug safety . Provide information to end-users through adverse drug reaction news bulletins, drug alerts and seminars. Assess the regulatory information relating to safety.


TYPES OF ADR’S Type A adverse effects (‘drug actions’): pharmacological adverse effects Common (>1%) Dose relationship Suggestive time relationship Reproducible occurring in special situations or patients with increased susceptibility Organ selective injury carcinogenicity, mutagenicity Interactions childhood renal failure pregnancy lactation

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Type B adverse effects (‘patient reactions’) Immunoallergic reactions Metabolic intolerance Idiosyncrasy rare (<1%) unexpected causality uncertain mechanism uncertain no dose relationship not reproducible experimentally characteristic, serious

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Type C adverse effects (‘statistical effects’) Increased frequency of ‘spontaneous’ disease High background frequency Less typical for a drug reaction No suggestive time relationship Often long latency Mechanism unknown Difficult to reproduce experimentally

How do we know if a patient’s condition is an ADR?:

1. Take a Proper History and do a proper examination. 2. Establish time relationships. 3.Do a thorough physical examination with appropriate laboratory investigations. 4. Effect of Dechallenge and Rechallenge should be determined. (when necessary). Dechallenge = withdraw of drug Rechallenge = reintroducing the drug after a dechallenge 5. Check the known pharmacology of the Medicine. How do we know if a patient’s condition is an ADR?

How can we prevent ADRs from occurring in our patients?:

1. Use few drugs, whenever possible 2. Use drug that you know well 3. Do not change therapy from known drugs to unfamiliar one without good reasons. 4. Use text books and other reference material providing information on drug reactions and interactions. 5. Take extra care when you prescribe drugs known to exhibit a large variety of interactions and adverse reactions (anticoagulants, hypoglycemic, and drug affecting the CNS) with careful monitoring of patients with such reactions. 6. Beware of the interaction of drugs with certain food stuffs, alcohol and even with house hold chemicals. How can we prevent ADRs from occurring in our patients?

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7. Review all the drug used by your patients regularly, taking special notice with those bought without prescription .(Over the counter, herbal ,preparations). 8. Be particularly careful when prescribing to children, the elderly, the pregnant and nursing women, the seriously ill and patients with hepatic and renal diseases. Careful ongoing monitoring is also essential in these patients is essential. 9. If your patients show signs or symptoms not clearly explained by the course of their illness, think of adverse drug reaction. 10. If you suspect an adverse reaction, consider stopping the drug or reduce the dosage as soon possible and please notify the adverse drug reaction to { Pharmacoviglance Programme Co- ordinator } or the{drug regulatory authority}. 15


Medicine Year Thalidomide 1965 Practolol 1975 Clioquinol 1970 Benoxaprofen 1982 Terfenadine 1997 Rofecoxib 2004 Veralipride 2007 DRUGS WITHDRAWN FROM MARKET Examples of serious and unexpected adverse events leading to withdrawal of medicine Phocomelia Sclerosing peritonitis Subacute nephropathy Nephrotoxicity , cholestatic jaundice Torsade de pointes Cardiovascular effects Anxiety, depression


Medicines Adverse reactions Phenylpropanolamine Strokes Rofecoxib &Valdecoxib Heart attacks Rosiglitazone Heart attacks Cisapride Irregular heartbeat Analgin Bone marrow depress Nimesulide Liver failure Nitrofurazone Cancer Phenformin Lactic acidosis Droperidol Irregular Heartbeat DRUGS BANNED IN INDIA

Why do we need pharmacovigilance? :

Reason 1: Humanitarian concern – Insufficient evidence of safety from clinical trials Animal experiments Phase 1 – 3 studies prior to marketing authorization 18 Why do we need pharmacovigilance ?

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Reason 2 Medicines are supposed to save lives Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable . UK: 19 It has been suggested that ADRs may cause 5700 deaths per year in UK. Reason 3: Promoting rational use of medicines and adherence.

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Reason 4: ADRs are expensive !! Cost of drug related morbidity and mortality exceeded $177.4 billion in 2000 ( Ernst FR & Grizzle AJ, 2001: J American Pharm. Assoc) ADR related cost to the country exceeds the cost of the medications themselves. Reason5: Ensuring public confidence. Reason 6: Ethics To know of something that is harmful to another person who does not know, and not telling, is unethical 20

Who Should Report Safety Data:

Who Should Report Safety Data Physicians Pharmacists Pharmaceutical companies qualified persons – ( Pharmacovigilance /Regulatory manager) ‏ Investigational products (clinical trials) ‏ Post-approval reporting – Individual Case Safety Report (ICSR), Periodic Safety Update Report (PSUR) ‏ In many countries patients are encouraged (but not obligated) to report side effects


It is expected that 50 – 75 % of medical errors are preventable Introduction of advanced medical information systems Electronic Health Record (EHR) Automatic checks for dose, interactions, allergies, resistance Personalized prescription (on base of pharmacogenetic data) ‏ Written procedures, quality management and safety audits Analyze all errors, research what enabled them Try to design uncomplicated processes 22 SOLUTIONS

WHO Guidelines on safety monitoring in pharmacovigilance systems:

WHO Guidelines on safety monitoring in pharmacovigilance systems Guidelines The Importance of Pharmacovigilance Safety Reporting - A guide to detecting and reporting adverse drug reactions Pharmacovigilance in public health Safety monitoring of herbal medicines Advisory Committee on the Safety of Medicines (ACSOMP)

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The guideline describes a method for summarising the important identified risks of a drug, important potential risks, and important missing information, including the potentially at-risk populations and situations where the product is likely to be used that have not been studied pre-approval. The guideline is divided into the following sections: 1. Safety Specification : important identified risks of a drug, important potential risks, and important missing information. Identified and Potential Interactions, Including Food-Drug and Drug-Drug Interactions ICH harmonised guidelines (E2E) Pharmacovigilance Planning

2.Pharmacovigilance plan:

A plan proposed by a sponsor for the ongoing evaluation of safety signals identified with the use of a product to monitor at-risk populations which have not been adequately studied Plan may be developed at the time of product launch or after a signal is identified A sponsor’s plan may involve: Submission of adverse event report summaries at more frequent, pre-specified intervals Conduct of additional observational studies or clinical trials Implementation of active surveillance activities to identify as yet unreported adverse events 25 2.Pharmacovigilance plan

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Summary of Ongoing Safety Issues • Important identified risks; • Important potential risks; • Important missing information. Routine Pharmacovigilance Practices Systems and processes that ensure that information about all suspected adverse reactions that are reported to the personnel of the company are collected. The preparation of reports for regulatory authorities: o Expedited adverse drug reaction (ADR) reports; o Periodic Safety Update Reports (PSURs). 26


RISK DEPENDENT ON PATIENTS Kidney insufficiency – failing excretion of drugs/active metabolites Liver disease – failing drug metabolism Polymorbidity – combination of factors such as drug interactions, multi-organ injury Immunocompetence – higher doses of some drugs (antibiotics) may be needed in decreased immune response New born age – drug metabolizing systems are not fully developed Allergies – risk of drug allergies is higher in patients with already suffer from another allergy Some specific diseases – such as contraindication of beta blockers in asthma


WHO ARE THE PARTNERS? Government Industry Hospitals and academia Medical and pharmaceutical associations Poisons information centres Health professionals Patients Consumers Media WHO


Pre-clinical studies Clinical trials (pre- and post-marketing) ‏ Spontaneous adverse reaction reporting Epidemiological studies Data collected for other purposes Routine statistics Databases of prescription and outcomes SOURCES OF INFORMATION ON DRUG SAFETY

Pre-clinical Studies:

Standard toxicology pre-clinical tests are: Acute toxicity Repeat use toxicity Local irritation tests Pyrogenity Reproductive toxicity Mutagenity Carcinogenity Pre-clinical Studies

Clinical Trials:

Principal aim of clinical trials is to collect safety (and efficacy) data. The investigational drug shall prove safety profile consistent with human testing on base of pre-clinical studies. Clinical trials are subject of regulatory approval. The sponsor shall keep detailed records of all adverse events and he shall submit these records on request of regulatory authority. The sponsor shall ensure that all relevant information about suspected serious unexpected adverse reactions have to be recorded and reported to regulatory authority Other investigators participating in multicentric trials shall also be informed on serious unexpected adverse events Clinical Trials

Clinical Trials:

Safety profile of investigational drug is described in Investigator`s Brochure. Procedures for reporting of adverse events in clinical trials slightly differ from post-approval reporting. Standard are CIOMS forms, electronic reporting is now preferred Detailed guidance on the collection, verification and presentation of adverse reactions reports arising from clinical trials on medicinal products for human use, European Commission, April 2006 Serious events such as deaths are relatively rare and may present reason for termination of a clinical trial Clinical Trials


Tests in animals are insufficiency predictive of human safety In clinical trials patients are selected and limited in number Conditions of use in trials differ from those in clinical practice Duration of trials is limited Information about rare but serious adverse reactions, chronic toxicity, use in special groups such as children, the elderly or pregnant woman or drug interactions is often not available RATIONALE FOR POST-MARKETING SURVEILLANCE


New drugs Report all suspected reactions including minor ones For established or well known drugs All serious, unexpected, unusual ADRs Change in frequency of a given reaction ADRs to generics not seen with innovator products ADRs to traditional medicines WHAT SHOULD BE REPORTED


All suspected drug-drug, drug-food, drug-food supplement interactions Statement highlighting marine source of supplements such as glucosamine so that can be avoided by those with allergy to sea food ADRs associated with drug withdrawals ADRs due to medication errors eg vincristine given IT ADRs due to lack of efficacy or suspected pharmaceutical defects WHAT SHOUD BE REPORTED

Content of Report (MHRA recommendations)‏:

The symptoms or a description of a side effect Information about the person who experienced the side effect (as a minimum, their initials, sex, and age at the time of side effect) ‏ The name of the medicine(s) thought to have caused the side effect The name and full address of the reporter so that the report can be acknowledged and contact made for further information, if neccessary . Content of Report (MHRA recommendations) ‏


REFERENCES WHO Policy Perspectives on Medicines- Pharmacovigilance : Ensuring the safe use of Medicines, geneva .(2004). Safety of medicines-A guide to detecting and reporting adverse drug reactions,WHO geneva (2002). National Pharmacovigilance Protocol , Ministry of Health & Family Welfare, Government of India, March 2003. Central Drugs Standard Control Organization Adverse reactions, postmarketing surveillance and pharmacoepidemiology by Judith K. Jones & Juhana E. Idanpaan-Heikkila in Pharma . Medicine by Denis M. Burley. Guidelines for Good Pharmacoepidemiology Practices (GPP), International Society for Pharmacoepidemiology , August 2004. Journal- of Regulatory Toxicology and Pharmacology

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World health organization Technical report no.498 (1972) The Erice Report. International Conference on Developing Effective Communications in Pharmacovigilance , Erice , Sicily, 24-27 September 1997, at which a policy statement was drawn up known as The Erice Declaration.

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