The Concepts of Pharmacovigillance and ADRs.pptx

Description about Pharmacovigilance

1. The Concept of Pharmacovigillance: PHAM CAIRO BOER

2. Learning Tasks By the end of this session students are expected to be able to: Explain pharmacovigillance Define terminologies used in pharmacovigillance List the aims of pharmacovigillance List key partners in pharmacovigillance Explain the importance of pharmacovigillance BOER

3. 2 FDA estimates 8 year time-span for entire process Pharmaceutical industry claims $802 million spent for each new drug brought to market Courtesy: www.fda.gov/cder/handbook/develop.htm, 2007. The New Drug Development Process: Steps from Test Tube to New Drug Application Review BOER

4. 13 Phase IV Post-approval studies to determine specific safety issues Clinical development of medicines Animal experiments for acute toxicity, organ damage, dose dependence, metabolism, kinetics, mutagenicity/teratoge carcinogenicity, n i c i t y Preclinical Animal E x p e r i m e n ts Phase I Phase II Development Post Registration Phase III Phase IV Spontaneous Post-approval Reporting Re g i s tr ation Phase I 20 – 50 healthy volunteers to gather preliminary data Phase II 150 – 350 subjects with disease - to determine safety and dosage recommendations Phase III 250 – 4000 more varied patient groups – to determine short-term safety and efficacy Drug Development

5. What is Pharmacovigilance BOER

6. Medicine Safety To undergo treatment you have to be very healthy, because apart from your sickness you have to stand the medicine. Molière BOER

7. Vigilance Vigilare = to watch Alert Watchfulness Forbearance Of Sleep; Wakefulness Watchfulness In Respect Of Danger; Care; Caution; Circumspection Process Of Paying Close And Continuous Attention BOER

8. Definition of pharmacovigilance (PV) The science and activities concerned with the Detection Assessment Understanding Prevention of adverse reactions to medicines or any other drug-related problem (i.e. adverse drug reactions or ADRs). BOER

9. Why Pharmacovigillance is needed? The processes involved in the clinical development of medicines once put onto the market ; A medicine leaves the secure and protected scientific environment of clinical trials and is legally set free for consumption by the general population. At this point, most medicines will only have been tested for short-term safety and efficacy on a limited number of carefully selected individuals . Rare or delayed serious reactions are likely to remain unnoticed BOER

10. Need for PVG Limited value of animal experiments in predicting human safety Clinical trials are limited in time and number of individuals (a few hundred), usually under favorable conditions, i.e . in the hospital, under close surveillance, over a short period , with few concomitant medications, and with few high-risk individuals (e.g. children, older individuals, pregnant women, or patients with renal or hepatic failure)

11. 12 Populations not studied in the pre-approval phase Children The elderly Pregnant or lactating women Patients with co-morbidity such as hepatic or renal disorders Sup-populations carrying known and relevant genetic polymorphisms Patients of different racial and/or ethnic origins

12. Definitions of terms Drug : A pharmaceutical product, used in or on the human body for the prevention, mitigation, diagnosis and/or treatment of disease, or for the modification of physiological function. This definition includes prescribed medicines, over-the-counter medicines, vaccines, herbal medicines, traditional medicines and biologicals including blood and blood- related products e.g. sera, plasma etc. BOER

13. Definition of Terms in Pharmacovigillance Adverse Drug Reactions (ADRs) a response to a medicinal product that is noxious or potentially harmful and unintended and which occurs at doses normally used in human for prophylaxis, diagnosis or therapy of a disease or for the modification of physiological function in which individual factors may play an important role. Adverse event Any unfavourable medical occurrence that in coincidence may present during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with the treatment . undesirable signs & symptoms disease or accidents abnormal lab finding ( leading to dose reduction / discontinuation / intervention BOER

14. ADE VS ADR . BOER ADE ADR

15. Constipation after Codeine Sedation with Antihistamine Nausea with Flu o xetine GIT upset with NSAIDs Common ADRs BOER

16. ▪ 1959 / 61– Thalidomide 4.000 – 16 Geneva 2005 10.000 cases (Phocomelia) Medicines are supposed to save lives Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. WHO.

17. On September 30, 2004, Merck and Co. voluntary withdrew rofecoxib (Vioxx) due to increased risk of CV events 9/28/2021 BOER

18. 9/28/2021 BOER

19. SEVERE VS SERIOUS The term "severe" is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe pain); the event itself , however, may be of relatively minor medical significance ( such as severe headache ). This is not the same as "serious" which is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning BOER

20. Cont. .. Benefit/risk analysis Examination of the favourable and unfavourable results of undertaking a specific course of action . Serious adverse drug reaction A noxious and unintended response to a drug that at any dose , may result in death. I s life threatening (such as Stevens-Johnson Syndrome ), requires patient hospitalization or prolongation of existing hospitalization, causes a congenital anomaly or birth defect , results in persistent or significantly in-ability or incapacity , or require intervention to prevent permanent impairment or damage. BOER

21. DEFINITIONS CONT. .. Life-threatening reaction is a reaction in which the patient was at risk of death at the time of the event and does not refer to an event, which hypothetically might have caused death if it was more severe. Side effect any unintended effect of a pharmaceutical product occurring at doses used in man for medical treatment which is related to the pharmacological properties of the product and in which there is no deliberate overdose. BOER

22. DEFINITIONS CONT … Unexpected adverse drug reaction An adverse reaction, the nature or severity of which is not mentioned in the summary of product characteristic or market authorization , or expected from characteristics Biological products Medical products prepared from biological material of human, animal or microbiologic origin (such as blood products, vaccines, insulin). BOER

23. CONT. .. Clinical trial A systematic study on pharmaceutical products in human subjects (including patients and other volunteers ) in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the objective of ascertaining their efficacy and safety. Efficacy The ability of a drug to produce the intended effect as determined by scientific methods , for example in pre-clinical research conditions (opposite of hazard). BOER

24. DEFINITIONS CONT. .. Potency  is a measure of drug activity expressed in terms of the amount required to produce an effect of given intensity. Individual case safety reports (ICSR ) A report that contains ‘information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient . Post-marketing The stage when a drug is generally available on the market. Pre-marketing The stage before a drug is available for prescription or sale to the public. BOER

25. DEFINITIONS CONT. .. Poly-pharmacy The concomitant use of more than one drug, sometimes prescribed by different practitioners Placebo An inactive substance (often called a sugar pill ) given to a group being studied to compare results with the effects of the active drug. Cohort study - A study that identifies defined populations and follows them forward in time, examining their rates of disease. BOER

26. DEFINITIONS CONT. .. National pharmacovigillance Centre - A single, governmentally recognized Centre within a country with the clinical and scientific expertise to collect, collate , analyze and give advice on all information related to drug safety. Active surveillance Active measures are taken to find adverse events (e.g. cohort event monitoring). BOER

27. Cont. ….. There are two major approaches in pharmacovigillance spontaneous or passive reporting and active surveillance systems. Passive reporting means that no active measures are taken to find adverse effects other than the encouragement of healthcare providers and others to report safety concerns. Passive reporting is voluntary and depends on the initiative and motivation of the reporter(s ). Active (or pro-active) s surveillance means that active measures are taken to find adverse events . BOER

28. Aims of Pharmacovigillance To improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions; To improve public health and safety in relation to the use of medicines ; To contribute to the assessment of benefit, harm, effectiveness and risk of medicines , encouraging their safe, rational and more effective (including cost-effective) use; To promote understanding, education and clinical training in pharmacovigillance and its effective communication to health professionals and the public BOER

29. AIMS CONT. . To identify and quantify new adverse drug reactions ( ADRs) To identify risk factors and populations at risk To detect increase in frequency of known ADRs To detect drug interactions BOER

30. Cont. … To monitor benefit-risk profile of a medicines and ensure that they remain within acceptable bounds ADR profile of medicines within therapeutic class To contribute to good clinical practice in pharmacotherapy To prevent patients from unnecessary harm BOER

31. Key Partners in Pharmacovigillance The management of the risks associated with the use of medicines demands close and effective collaboration between the key players in the field of pharmacovigillance. Key partners are listed below Government Industry Hospitals and academia Medical and pharmaceutical associations BOER

32. KEY PARTNERS CONT. .. Poisons and medicines centres information Health professionals Patients The media World Health Organization BOER

33. Importance of Pharmacovigillance The following are Importance of pharmacovigillance as a field of study ( Safety monitoring of medicinal products ) Pharmacovigillance is important study to all partners of pharmacovigillance , since it help to ensure; Equity of access to essential drugs , Drug quality and safety and rational use of drugs. Pharmacovigillance is important study to country’s drug authority a new medicine must pass three hurdles before its approval by the national drug regulatory authority. It help to provide Sufficient evidence required to show the new drug to be of good quality, effective, and safe for the purpose or purposes for which it is proposed. BOER

34. IMPORTANCE CONT . . Pharmacovigillance is important study post marketing researchers It help to detect drug interactions measuring the environmental burden of medicines used in large populations It help assess the contribution of ‘ inactive’ ingredients (excipients) to the safety profile It help to compare safety profiles of similar medicines Pharmacovigillance is important study of train in health professionals BOER

35. RECAP Pharmacovigillance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Key partners in PV include , Government, Industry, Hospitals and academia, Poisons and medicines centres information, Health professionals, Patients and the media The aims of pharmacovigillance are to improve patient care and safety , to improve public health and to promote understanding and education Adverse Drug Reactions (ADRs) a response to a medicinal product that is noxious or potentially harmful and unintended and which occurs at doses normally used in human for prophylaxis, diagnosis or therapy of a disease or for the modification of physiological function in which individual factors may play an important role. Pharmacovigillance is important in post marketing researchers and country’s drug authority. Pharmacovigillance is important source of drug information’ BOER

36. Evaluation What is pharmacovigillance? What is adverse drug reaction? What are the aims of pharmacovigillance? What are the key partners in pharmacovigillance? BOER

37. 37 Thank you ‘People who are vigilant do not die; people who are negligent are as if dead’. - Shakyamuni Buddha