Ashutosh pharmacovigilance

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Ashutosh pharmacovigilance

  1. 1. PHARMACOVIGILANCE ASHUTOSH MISHRA, M.Pharm, (P’COLOGY) KSOP
  2. 2. WHAT IS PHARMACOVIGILANCE (PV)The science and activities relating to thedetection, assessment, understandingand prevention of adverse effects or anyother medicine-related problems -
  3. 3. Pharmaco - Vigilance• Pharmaco = medicine• Vigilare = to watch – alert watchfulness – forbearance of sleep; wakefulness – watchfulness in respect of danger; care; caution; circumspection – the process of paying close and continuous attention
  4. 4. Pharmacovigilance Aims• Early detection of unknown safety problems• Detection of increases in frequency• Identification of risk factors• Quantifying risks• Preventing patients from being affected unnecessarily
  5. 5. Objectives of Pharmacovigilance• 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 understanding, education and clinical training
  6. 6. Scope of Pharmacovigilance• Improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions,• Improve public health and safety in relation to the use of medicines,• Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost- effective) use, and• Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public
  7. 7. • ADVERSE Drug Events- ADE, harm caused by the drug (ADR & overdoses) and harm from the use of the drug (including dose reductions & discontinuations of drug therapy).• ADVERSE Drug Reactions- A response to drug which is noxious & unintended which occurs at doses at normally used in man for the prophylaxis, diagnosis or therapy of disease. There is causal link between a drug & an adverse drug reaction.• SIDE Effect- is an expected & known effect of a drug that is not the intended therapeutic outcome.
  8. 8. Adverse Reactions:Possible Causes• INTRENSIC FACTORS OF THE DRUG -P’COLOGICAL -IDIOSYNCRATIC -CARCINOGENICITY, MUTAGENICITY -TERATOGENICITY• EXTRENSIC FACTORS -ADULTERANTS -CONTAMINATION• UNDERLYING MEDICAL CONDITIONS• INTERACTION
  9. 9. NEED FOR PVReason 1:• Humanitarian concern – – Insufficient evidence of safety from clinical trials – Animal experiments – Phase 1 – 3 studies prior to marketing authorization
  10. 10. CONT…Reason 2• Medicines are supposed to save lives Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Lepakhin V. Geneva 2005
  11. 11. • UK It has been suggested that ADRs may cause 5700 deaths per year in UK• UK ADRs were 4th-6th commonest cause of death in the US in 1994
  12. 12. Reason 3: ADRs are expensive !!• Cost £446 million per annum• 6.5% of admissions are due to ADRs• Seven 800-bed hospitals are occupied by ADR patients
  13. 13. Reason 4:Promoting rational use of medicines and adherence Reason 5: Ensuring public confidenceIf something can go wrong, it will – Murphys law
  14. 14. Reason 6: Ethics To know of something that is harmful to another person who does not know, and not telling, is unethical
  15. 15. WHY PV IS NEEDED
  16. 16. Why Pharmacovigilance?• Post-marketing Topics Unexpected adverse reactions Interactions Dependence Long-term efficacy, Resistance Risk factors Quality (Counterfeit) Cost assessment
  17. 17. Why Pharmacovigilance?• Adverse Drug Reactions are the 4th to 6th largest cause of mortality in the US • The percentage of hospital admissionsdue to drug related events in some countries is about or more than 10%.
  18. 18. Some Examples Medicine ADRThalidomide Congenital malformationsAmidopyrine AgranulocytosisClioquinol Myeloneuropathy (SMON)Statins RhabdomyolyisOral Contraceptives Thromboembolism
  19. 19. NEED OF PV IN INDIA• INDIA RATES BELOW 1% OF PV WHILE WORLD 5% DUE TO IGNORANCE OF SUBJECT AND LACK OF TRAINING• PROBLAM OF A LARGE POPULATION THAT IS PREDOMINENT RURAL AND EXTENT USE OF TRADITIONAL MEDICINE• LACK OF PHYCISIAN AND CONSUMER AWAIRNESS PROGRAM
  20. 20. Pharmacovigilance in WHO• Exchange of Information• Policies, guidelines, normative activities• Country support• Collaborations
  21. 21. CURRENT SCENARIO• Increased awareness and interest amongst doctors and pharmacists to report ADRS as they have seen some benefit in reporting• GCP training for investigators served to increase awareness of SAE and ADR reporting amongst health care professionals and the industry
  22. 22. CONT…..• More hospitals and companies using on-line reporting system – less hassle than submitting hard copy reports• Increasing involvement by hospital pharmacists in pharmacovigilance – during clinical ward rounds and when counseling patients
  23. 23. Who are the partners?• Government• Industry• Hospitals and academia• Medical and pharmaceutical associations• Poisons information centres• Health professionals• Patients• Consumers• Media• WHO
  24. 24. WHAT TO REPORT?SERIOUS ADRS• A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: – results in death, – is life-threatening, – requires inpatient hospitalization of prolongation of existing hospitalization, – is a congenital anomaly/birth defect. NOTE: The term “life-threatening” in the definition of “serious” refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe.
  25. 25. WHAT SHOULD BE REPORTED• 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
  26. 26. WHAT SHOUD 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
  27. 27. INNOVATOR PRODUCTS– Limited information available at time when drug is first marketed– Minimal information on use in Asian population, interactions with indigenous medicines– Conduct intensive monitoring to identify new, unlabeled adverse reactions, monitor for “rare” reactions– Provide updates to prescribers on new findings, labelling changes, safety issues
  28. 28. NON-PRESCRIPTION MEDICATIONS• Quality defects can also lead to ADRs e.g. Pan Pharmaceuticals (Australia) case• Patients can develop ADRs to food supplements, “health products”• Overuse of supplements• Current issue of dioxin contamination in Cod Liver Oil preparations resulting in product withdrawals in UK
  29. 29. TRADITIONAL & COMPLEMENTARY MEDICINES• Minimal information available on traditional medicines – ADRs – Drug interactions – At risk groups e.g. alfalfa and exacerbation of SLE• Misnomer of “because it is natural, it is safe – Association of Black Cohosh with liver problems• Health professionals should try to get as much information as possible – Name of product – Indication – Place of purchase (esp for unregistered products)
  30. 30. PREGNANCY– Very little information available on outcome data for drugs used in pregnancy • Current issue of association between lamotrigine use and cleft palate syndrome • ACE Inhibitors and congenital anomalies– Should follow-up cases where drugs are prescribed intentionally or have been used inadvertently to monitor outcome of pregnancy, effect to the foetus/baby
  31. 31. ACTIVE INGREDIENTS WITHDRAWN– THALIDOMIDE (1961) Congenital limb defects– BENOXAPROFEN (1982) Hepatotoxicity– PHENFORMIN (1982) Lactic acidosis– FENFLURAMINE (1997) Heart-valve abnormalities– ASTEMIZOLE Many drug interactions– PHENYLPROPANOLAMINE(2000) Haemorragic stroke– KAVA KAVA Liver abnormalities– CERIVASTATIN Rhabdomyolysis– CISAPRIDE Cardiac arrythmias– ROFECOXIB (2004) Cardiovascular events– VALDECOXIB (2005) Cardiovascular events, serious skin reactions– COMFREY, SENECIO Nephrotoxicity– TEGASEROD (2007) Cardiovascular events– CLOBUTINOL (2007) Cardiac arrhythmia
  32. 32. COMMUNICATING THE OUTCOME OF PV• Product Alerts – National Health Authorities• Media statements - National Health Authorities/Pharmacovigilance Centres• Newsletters – National Pharmacovigilance Centres and WHO• Feedback to reporters – National Pharmacovigilance Centres
  33. 33. SO….WHAT IS OUR ROLE? • SEND NOT ONLY QUANTITY BUT…. QUALITY REPORTS
  34. 34. HOW?• Monitor clinical status of patients• Identify the correct ADRs not side effects• Get more information• Investigate at hospital level• Help doctors to fill-up the forms• Keep patient’s record if more information needed
  35. 35. REFERANCE• WHO Safety of medicines. A guide to detecting and reporting adverse drug Reaction. Geneva WHO 2002• DRUG ALERT,volume1, issue 1 nov 2005 regional pv centre (south) JIPMER, Pondicherry INDIA• http://cdsco.nic.in/pharmacovigilance_intro.htm#Progr amme Communications• PROTOCOL FOR NATIONAL PV PROGRAM, CDSCO Ministry of health &family walfare, gov of INDIA 2004

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