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  1. 1. PHARMACOVIGILANCE The Need of The Hour! Way towards a safe medical practice…………. PRESENTED BY NILESH.S.JAWALKAR (M.PHARM IInd Semister )SKB COLLEGE OF PHARMACY NEW KAMPTEE , NAGPUR 2012-2013
  3. 3. INTRODUCTION Pharmacovigilance (PV) is the pharmacological science relating to the detection , assessment ,understanding and prevention of adverse effects, particularly long term and short term side effect of medicines. All medicines (pharmaceutical and vaccines) have side effect some are known many are still unknown even this medicine has been in clinical use. The important to monitor both known and unknown side effects of medicines in order to determine any new information in relation to their safety profile .
  4. 4. • Pharmacovigilance looks at all available information to assess the safety profile of a drug• Pharmacovigilance should also take the benefit of the drug in account• Spontaneous reporting depends on the health professional – YOU.
  5. 5. How Pharmacovigilance works 1 2 3 4ADR ADR ADR SharingSuspicion Reporting Analysis of Findings
  6. 6. Aim And Objectives of Pharmacovigilance Aim:- To identifying new information about hazards as associated with medicinesObjective:- Improve patient care and safety Improve public health and safety Encourage safe, rational and appropriate use of drugs Promote understanding, education and clinical training in pharmacovigilance
  7. 7. Adverse Drug Reactions Classifications Adverse drug reaction  which is noxious ,unintended and which occurs A response at doses normally used in humans for Prophylaxis, Diagnosis or Therapy of disease , or for modification of physiological function…..(WHO 1972) Type A(Augmented) Type B(Bizarre) Pharmacologically predictable Yes No Dose dependent Yes No Frequency Common Rarer Incidence High Low Mortality Low High Treatment Adjust Dose Stop the Drug
  8. 8. Adverse drug reaction(ADR)a)Serious adverse reaction.b) Unexpected adverse reaction. Data Analysis Response
  9. 9. Side effect Any unintended effect of a pharmaceutical product occurring at normal dosage which is related to the pharmacological properties of the drug. e.g. antihistamines producing sedation , anticholinergics producing dryness ..
  10. 10. Phases of Product Development  It takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved. Clinical Trials Preclinical Phase I Phase II Phase III FDA Phase IV Testing 12 Years 3.5 1 2 3 2.5 Total 20 to 80 100 to 300 1000 to 3000 Test Laboratory and healthy patient patientPopulation animal studies volunteers volunteers volunteers Additional File IND File NDA Review Post at FDA at FDA process / marketing Verify Approval Evaluate testing Assess safety Determine effectiveness, required by effectiveness, Purpose and biological safety and monitor adverse FDA look for side activity dosage reactions from effects long-term use 5,000 Success compounds 5 enter trials 1 approved Rate evaluated
  11. 11. Pharmacovigilance And IndiaIndia is is a hub of Global Clinical trials & a destinationfor Drug Discovery & Development. However, whetherpatients in India receive safe drugs or not is still verymuchin question Rapid induction of NCEs and high tech Pharmaproducts in the market throw up the Challenges ofmonitoring Adverse Drug Reactions (ADRs) overlarge multiethnic population base...
  12. 12. 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
  13. 13. What to Report It is important to report serious unexpected ADRs. Most cases of unexpected ADRs are associated with medicines newly introduced on the market. All suspected adverse reactions. Every single problem related to the use of a drug. ADRs associated with radiology contrast media, vaccines, diagnostics, drugs used in traditional medicine, herbal remedies, cosmetics, medical devices and equipment.
  14. 14. Withdrawn Drugs From the MarketDrug Year ReasonLumiracoxib 2008 HepatotoxicityAprotinin 2008 Kidney and cardiovascular toxicityTegaserod 2007 Cardiovascular ischemic eventsXimelagatran 2006 HepatotoxicityValdecoxib 2005 Dermatology adverse eventsPemoline 2005 HepatotoxicityRofecoxib 2004 Thrombotic cardiovascular eventsLevomethadyl 2003 Fatal ArrhytmiaRapacuronium 2001 Risk of fatal bronchospasmCerivastatin 2001 RhabdomyolosisTrovafloxacin 2001 HepatotoxicityAmineptine 2000 Hepatotoxicity, dermatological side effects, abuse potentialCisapride 2000 Cardiac arrhythmiasTroglitazone 2000 Hepatotoxicity
  15. 15. Four common drug banned inother countries but not in India
  16. 16. IMPORTANCE OF PHARMACOVIGILANCE Complete safety data (especially for unexpected and serious adverse events) can only be captured through pharmacovigilance It cannot be captured through clinical trials which are conducted in an “artificial environment.”  In clinical trials  patients are not taking any other medications  do not have concomitant diseases  are taking the drug short-term (during the duration of the trials only) and  are not part of vulnerable groups (e.g., children, pregnant women, elderly, etc.)
  17. 17. PATNERS IN PHARMACOVIGILANCE The WHO Quality Assurance and Safety : Medicines team The Uppsala Monitoring Centre (UMC) The National Pharmacovigilance Centers Hospitals And Academia Health Professionals Patients Other Partners
  18. 18. System of Safety Data Gathering Clinical Trials Healthcare Professionals Pre-Approval Post-Approval Patients National Regulatory Authority Pharmaceutical Companies International Safety Databases
  19. 19. PHARMACOVIGILANCE IN DRUG REGULATION Clinical Trial Regulation i) Collection of ADR ii)monitoring clinical data iii)reporting of clinical data Post Marketing safety Monitoring
  20. 20. THE RaPID The RaPID is a PV program it conduct public health program. It provide support to focal point. Focus on RaPID HIV, T.B, Malaria and other program. It is important to encourage and ensure reporting of ADR. It consist of various department for working various type of diseases
  21. 21. I964 :U. K. starts "Yellow Card"system..
  22. 22.  The Yellow Card Scheme is the main ADR reporting scheme in the UK and was introduced in 1964 after the thalidomide tragedy highlighted the urgent need for routine monitoring of medicines. It receives more than 20,000 reports of possible side effects each year.
  23. 23. What should be our contribution……
  24. 24. True challenge lies in…. In recognising at the earliest possible stage, the adverse effects that a drug may induce , so that the risk (unfavourable results) never becomes disproportionate to benefit (Favourable results)
  25. 25. At the level of Clinicians ….. My Doctor is a good doctor, He made me no iller than I was……. Willem Hussem (The Netherlands)1900 -1974 Translation: Peter Raven There are no really safe biologically active drugs . There are only safe physicians…. Harold A. kaminetzsky1963
  26. 26.  1.Active reporting of ADVERSE DRUG REACTIONS as forms are available freely e.g. Nimusulide European Medicine Evaluation Agency Bans NIMESULIDE
  27. 27. Avoid Prescription errorsArticles highlighting the rise in prescription errors
  28. 28. Illegible prescriptions? Who is toblame……
  29. 29. At the level of Pharmacists &Pharmacologists
  30. 30. To train Pharmacists in drug interactions,side effects ,drug dosages
  31. 31.  11. Students can start Pharmacy bulletins with help of Respected Principal sir & coordinators….. ( Australian Prescriber, USPDI)
  32. 32. Student involvement. Studentscan start Pharmacy bulletins with help ofRespected Principal sir & coordinators….. ( Australian Prescriber, USPDI)
  33. 33. Aims of Drug Alerts…. The information resources should be designed to assist the health provider in their clinical choice of drugs, in an effort to reduce the incidence and severity of adverse effects & medication errors .
  34. 34. Student involved in making Drugalerts
  35. 35. Presenting Drug Alerts
  36. 36. Drug Alert Leaflets FDA pulls antiparkinsonism drug of Pergolide from market EMEA bans Nimesulide Petitions to remove Cox2 inhibitors Cisapride under strict scrutiny Phenylpropanolamine risk of Hemorragic stroke
  37. 37. Animation of Pharmacovigilance: Studentshave presented & posted on Google images
  38. 38. conclusionIt is expected that 50 – 75 % of medical errors arepreventable.Think less about drug safety: more aboutpatient safety Use and react to concernsThink less about regulating (incl. withdrawal)and automating data input: more about usefulinformation outputThink more about impact and consequences ofdecisions and non-decisions