LIKKI FINAL (1).pptx pharmacovigilance history and development of pharmacovigilance

Presentation

1. 1. INTRODUCTION OF PHARMACOVIGILANCE Pharmacovigilance is an important and integral part of clinical research. Both clinical trials safety and post marketing pharmacovigilance are critical throughout the product lifecycle. Pharmacovigilance is the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problems. These adverse drugs reactions (ADRs) not only add to suffering of patients but also increase morbidity and mortality along with a financial burden on society. The overall incidence of ADRs in hospitalized patients is estimated to be 6.7% (range 1.2-24.1%) and that of fatal ADRs 0.32% (0.1-0.85%).Data indicates that in patients who experience ADRs, death rates are 19.18% higher and the length of hospital stay is 8.25% higher

2. Definition Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines.”

3. HISTORY OF PHARMACOVIGILANCE

4. Passive or active pharmacovigilance 1. Passive pharmacovigilance Passive surveillance means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns. Reporting is entirely dependent on the initiative and motivation of the potential reporters. This is the most common form of pharmacovigilance. It is commonly referred to as “spontaneous” or “voluntary” reporting. In some countries this form of reporting is mandatory. Clinicians, pharmacists and community members should be trained on how, when and what to report.

5. 2. Active pharmacovigilance Active (or proactive) safety surveillance means that active measures are taken to detect adverse events. This is managed by active follow-up after treatment and the events may be detected by asking patients directly or screening patient records. This surveillance is best done prospectively. Active pharmacovigilance is sometimes very descriptively referred to as hot pursuit. The most comprehensive method is cohort event monitoring (CEM). Cohort event monitoring is often referred to as prescription event monitoring (PEM), but this terminology is inappropriate where individual prescriptions with subsequent dispensing are not part of the process of provision of medicines. Examples of CEM are the Intensive Medicines Monitoring Programme (IMMP) in New Zealand and Prescription Event Monitoring (PEM) in England.

6. Steps In Pharmacovigilance Programme Finding the risk of a drug Clinical trials Pharmacoepidemiological study Case report Developing case series Analysis of case series Use of data mining to identify product- event combination Spontaneous reporting

7. NEED, AIM AND IMPORTANCE OF PHARMACOVIGILANCE Need of pharmacovigilance

8. Aims of pharmacovigilance Improve patient care and safety in relation to the use of medicines and all medical and Para medical interventions Research the efficacy of drug and by monitoring the adverse effects of drugs right from the lab to the pharmacy and then on for many years. Pharmacovigilance keeps track of any drastic effects of drugs. The identification and quantification of previously un-recognized adverse drug reaction (ADR). 5 . The continued monitoring of a safety of a product, throughout the duration of it use, to ensure that its risks and benefits remains acceptable. This includes safety monitoring following significant newly approved I indications.

9. Importance of Pharmacovigilance Safety monitoring of medicinal products Clinical trials Pharmacoepidemiological studies Case reports Developing case series Analysis of case series Use of data mining to identify product -event combination Spontaneous reporting.  

10. METHODS UTILIZED IN PHARMACO-VIGILANCE Many researchers developed different methods of causality assessment of ADRs by utilizing different criteria like chronological relationship between the administration of the drug and the occurrence of the ADR, screening for non-drug related causes, confirmation of the reaction by in vivo or in vitro tests, and antecedent information on homogeneous events attributed to the suspect drug or to its therapeutic class, etc., to define ADRs in different categories ADRs and a discussion of the pros and cons of each method. Dangaumou’s French method Kramer et al. method Naranjo et al. methodology (Naranjo scale) Balanced assessment method Ciba-Geigy method Loupi et al. method Roussel Uclaf casuality assessment method Australian method

11. Dangaumou’s French method Dangaumou's French method is  a tool used to assess suspected drugs along with other drugs taken at the same time . It takes more time to use than other causality assessment scales. The scores are grouped into likely, possible, and dubious. This method uses seven criteria in two different tables. Kramer et al. method This method applies when the offending drug is administered and a single adverse drug event has taken place. Each adverse event is assessed independently and assessment is prepared. One of the advantages of this algorithm is its transparency. However, certain levels of experience, expertise, and time are required to use this method effectively Naranjo et al. method (Naranjo scale) It is utilized to verify causality in a variety of clinical situations utilizing the categories and definitions of definite, probable, possible, and doubtful. It consists of ten questions which are answered as yes, no and unknown. The event is assigned to a probability category predicated on the total score after totaling. A total score of ≥9 is definite, probable is 5-8, possible is 1-4 and doubtful ≥0. This scale is more powerful when the adverse event is associated with only one drug, but when multiple drugs are involved or there is any interactions between drugs, this scale fails to identify the offending agent.

12. Balanced assessment method This method evaluates a case report on various visual analog scale (VAS) models that each criterion is fulfilled individually. It has an added advantage that it considers an alternative causative factor as a possibility and not just as a separate factor. Each case is assessed independently by different assessors and the evaluation depends on the assessor’s skills knowledge. Ciba-Geigy method Expert consensus meetings have resulted in Ciba-Geigy method. Experts used their clinical judgment to assess adverse drug events and assign causality on a VAS. This method uses a checklist which is composed of 23 questions, which is split into three sections: ( i ) History of present adverse reaction, (ii) patient’s past adverse-reaction history, and (iii) monitoring-physician’s experience. This updated method was found to have a high degree of agreement (62%) when compared with evaluator’s assessments.

13. Loupi et al. method This method developed to assess the teratogenic potential of drug. The first sections of the algorithm sanction for the drug to be omitted if not implicated in the inception of the abnormality. The second section weighs the bibliographical data. The three questions consider alternative etiological candidates other than the drug; chronology of the suspect drug and other bibliographical data, to arrive at a conclusion on causality. Roussel Uclaf causality assessment method This method is used in disease states such as liver and dermatological problems. A retrospect assessment of the reproducibility of this method among four experts had showed a 37-99% agreement rate. Australian method Australian method involves the evidence which helps in to draw the conclusion, such as timing, and laboratory information from case reports presented and the antecedent cognizance on the suspect drug profile is deliberately omitted in the assessment.

14. Adverse Drug Reaction (ADR) in Pharmacovigilance A response to a drug that is 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 CLASSIFICATION OF ADVERSE DRUG REACTIONS

15. Adverse Drug Reactions Reporting When the adverse reaction to drugs is potentially serious or clinically important, all health care workers including doctors, pharmacists, nurses and other health experts are requested to clarify it. It is necessary to report an adverse drug reaction to pharmacovigilance. Spontaneous Reporting System Regionalization Repossession of further data Access to all important pre and post marketing information Detailed drug utilization data. Standardized Evaluation of causality and significance Encouragement

16. Documentation of ADRs The significant adverse reaction of any drug should be notified within seven days. The other facts related to adverse events should be informed within eight days. The ADR form can be collected through any pharmacovigilance center. After reviewing the form, the center forwards it to the regional center and after that, it is propelled to the zonal center. The details are then statistically inspected and forwarded to WHO-Uppsala Monitoring committee (UMC ). Procedure for Reporting A dr s

17. Monitoring of ADRs AND BENEFITS OF ADR MONITORING ADR monitoring is the practice of continuously monitoring the undesirable effects caused using any drug. Pharmacovigilance plays an imperative impersonation in monitoring ADRs. It caters information about quality and safety of pharmaceutical products. It initiates risk-management plans. It prevents the predictable adverse effects and helps in measuring ADR adherence. It instructs health care team i.e., patients, pharmacists and nurses about adverse drug effects and creates awareness regarding ADRs. ADR monitoring and reporting program can furnish following benefits:

18. CLINICAL TRIAL

19. It is the fourth largest producer of pharmaceuticals in the world. It is emerging as an important trial hub in the world. Many new drugs are introduced in our country. Therefore, there is a need for a vibrant pharmacovigilance system in the country to protect the population from the potential harm that may be caused by some of these new drugs. Elixir of Sulphanilamide (1937) which resulted in poisoning in children. It was identified that it was a formulation defect which led to improvements in Pharmaceutical regulation. Thalidomide tragedy (1961) which resulted in phocomelia (absence of limbs) in the children of mothers who took this apparently ‘safe drug’, led to National and international collections of ADR reports and resulted in the introduction of yellow card system initiated in the UK in 1964. PHARAMACOVIGILANCE IN INDIA Some of the issues which are important in the historical point of view are:

20. Pharmacovigilance Programme In India Pharmacovigilance Programme: Administrative Body: Steering committee, Technical support committee, Strategic advisory committee. National PV center: Zonal PV center, regional PV center, peripheral PV center ADRs monitoring center: MCI approved medical college, private hospital\health center, and autonomous institution. Goals Pharmacovigilance Programme In India To develop and implement pharmacovigilance system in India To encourage the health professionals in reporting of adverse drugs, vaccines, medical devices, and biological products To expand the pharmacovigilance programme to all hospitals and centers public health programs located in India To make ADR reporting mandatory for healthcare professionals.

21. Drugs Reason for ban Terfenadine Cause cardiac arrhythmia Rofecoxib and its formulations Myocardial infarction was reported Valdecoxib and its formulations Heart attack and stroke Cisaprid Caused cardiac arrhythmias Gatifloxacin formulations Causes hyperglycemia and liver damage Tegaserod and its formulations Cardiovascular ischemic events occurred followed by heart attack Nimusulide formulations for human use in children below 12 years of age Hepatotoxicity Drugs banned by CDSCO

22. E2A Clinical Safety Data Management: Definitions and standards for expedited reporting E2B Clinical Safety Data Management: Data elements for transmission of individual case safety reports E2C Clinical Safety Data Management: Periodic safety update reports for marketed drugs E2D Post-approval Safety Data Management: Definitions and standards for expedited reporting E2D Pharmacovigilance planning E2F Development Safety Update Report India’s pharmacovigilance guideline

23. Safety monitoring of medicines in common use should be an integral part of clinical practice. The degree to which clinicians are informed about the principles of pharmacovigilance, and practise according to them, has a large impact on the quality of health care. Education and training of health professionals in medicine safety, exchange of information between national pharmacovigilance center, the coordination of such exchange, and the linking of clinical experience of medicine safety with research and health policy, all serve to enhance effective patient care. Pharmacovigilance in Clinical Practice