The Concept of Pharmacovigillance – PST06211 Monitoring and Evaluation of Medicine Use
NTA Level 6 • Semester 2 • PST06211 The Concept of Pharmacovigillance Monitoring and Evaluation of Medicine Use • Source Session/Topic 8 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 8: The Concept of Pharmacovigillance: Total Session Time: 120 minutes Prerequisites • None 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 Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 2 05 minutes Presentation Explanation of Pharmacovigillance 3 15 minutes Presentation Definition of Terms in Pharmacovigillance 15 minutes Presentation and 4 Aims of Pharmacovigillance Buzzing 5 10 minutes Presentation Key Partners in Pharmacovigillance 50 minutes Presentation and 6 Importance of Pharmacovigillance Group discussion 7 10 minutes Presentation Key Points 8 10 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 62 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Pharmacovigillance(5 minutes) • The etymological roots for the word "pharmacovigillance" are: pharmakon (Greek for drug) and vigilare(Latin for to keep watch). As such, pharmacovigillance heavily focuses on adverse drug reactions. • Pharmacovigillance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem(According to WHO definition) • 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. STEP 3: Definition of Terms in Pharmacovigillance (15 minutes) The following are some of pharmacovigillance terminologies as adopted in TFDA guideline: • 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 eventAny 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. • Benefit/risk analysis Examination of the favourable and unfavourable results of undertaking a specific course of action. • Life-threatening reaction isa 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. • Serious adverse drug reaction A noxious and unintended response to a drug that at any dose, may result in death, is life threatening (such as Stevens-Johnson Syndrome), requires patient hospitalization or prolongation of existing hospitalization, causes a congenital PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 63 anomaly or birth defect, results in persistent or significantly is ability or incapacity, or require intervention to prevent permanent impairment or damage. • 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. • 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). • 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). • 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. • 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. • National pharmacovigillance centre – A single, governmentally recognized centre within a country with the clinical and scientific expertise to collect, collate, analyse and give advice on all information related to drug safety. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 64 STEP 4: Aims of Pharmacovigillance (15 minutes) Activity: Buzzing (5minutes) ASK students to pair up and buzz on the following questions for 5 minutes • What are the aims of pharmacovigillance? ALLOW few pairs to