PHARMACOVIGILANCE-introduction metod .pptx

pharmacovigilanace

1. PHARMACOVIGILANCE Presented by: SUBHANALLA ABDULGANI

2. Pharmacovigilance - Definition History Aims & Objectives Sources of reporting ADRs/ ADE Purpose Why it is needed Responsibilities Organizations Partners?

3. Pharmacovigilance is the pharmacological sciences and activities relating to the: *Detection *Understanding *Assessment *Prevention *Reporting Of adverse effects or any other drug-related problem.

4. HISTORY OF PV:

5. AIMS & OBJECTIVES OF PHARMACOVIGILANCE: Early detection of hitherto unknown adverse reactions and interactions Detection of increases in frequency of (known) adverse reactions and to calculate the incidence of serious and non-serious adverse reactions Identification of risk factors and possible mechanisms underlying adverse reactions Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve drug prescribing and regulation.

6.  To evaluate the risk-benefit balance of a drug in comparison with other drugs, for the same indication or for other kinds of treatment. To communicate adequately the risk and to improve the clinical practice.

7. 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 pharmacovigilance and its effective communication to health professionals and the public.

8. Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Pharmacovigilance concentrate on only drug monitoring and its process includes Collect and record of AEs/ADRs Causality assessment and analysis of ADRs Collate and code in database Compute risk-benefit and suggest regulatory action Communicate for safe use of drugs among stakeholders

9. SOURCES OF ADR/AE : Reporting Systems: From Health care Professionals (voluntary)-high incidence of under reporting Published scientific literature: From Pubmed , Scopus etc . Periodic Safety Update Reports (PSUR ) The field of Pharmacovigilance has fully grown tremendously in recent years. This was caused by implementing advanced methods at pharmaceutical firms and at biotechnology companies through the addition of new products and in pioneering fields

10. PURPOSE OF PV : Herbals traditional and complementary medicines blood products biologicals medical devices vaccines .

11. Many other issues are also of relevance to the science: substandard medicines medication errors lack of efficacy reports use of medicines for indications that are not approved and for which there is inadequate scientific basis case reports of acute and chronic poisoning assessment of drug-related problems

12. mortality • abuse and misuse of medicines • adverse interactions of medicines with chemicals, other medicines, and food.

13. WHY Pharmacovigilance?

14. Limitations of clinical trials: Limited value of animal experiments in predicting human safety Small no of patients studied and limited in time Restricted populations eg : age, gender Short duration of drug exposure Rare or delayed serious reactions are likely to remain unnoticed

15. Reason 3: ADRs are expensive. Reason 4: Promoting rational use of medicines and adherence Reason 5: Ensuring public confidence Reason 6: Ethics to know of something that is harmful to another person who does not know and not telling is un ethical

16. Responsibilities: Receive, follow-up and report adverse events. Review and process adverse events reported by investigators. Prepare safety report Research and provide medical and scientific info to HCP and functional areas within the company. Conduct and analyse medical and scientific literaturre searches using clinical judgement and professional /

17. Scientific expertise to support projects or queries. Review clinical trial protocols and support them. Generates concise, accurate and well-written case narratives. Effectively maintains safety data base and corresponding entry guidelines, accurate data entry of data and assurance of quality of data. Performs consistent coding of diseases ,adverse events and medication according to the project specific coding conversations.

18. O rganisations of PV: FDA EMEA ( European Medicines Agency)- decentralised body of EU, london MHLW (Ministry of health, Labour and Welfare), Japan. CDSCO ( Central Drugs Standard Organisation )

19. PARTNERS OF PV: The WHO Quality Assurance and Safety: Medicines Team UMC- The principle function of  the  Uppsala Monitoring Centre is to manage the international database of ADR reports received from National PV Centres. National Pharmacovigilance Centres Hospital and Academia HCP and 6. Patients

20. The WHO Quality Assurance and Safety: Medicines Team: Responsible for providing guidance and support to countries on drug safety matters. The team is part of the Department of Essential Drugs and Medicines Policy, within the WHO Health Technology and Pharmaceuticals cluster.  implement national drug policies designed to ensure to ensure the quality, safety and efficacy of all medicines by strengthening and putting into practice regulatory and quality assurance standards.

21. UMC- The principle function of  the  Uppsala Monitoring Centre is to manage the international database of ADR reports received from National PV Centres . database held nearly three million case reports.  A sophisticated Bayesian confidence propagation neural network (BCPNN) programme was created in 1998, which partly automates the signal detection system, and provides earlier alert signals than previous methods.

22. The effectiveness of this system depends on: size of the database the quality of the reports received from the contributing centres the timeliness of such reporting an active and reliable reporting culture within participating countries.

23. In recent years  the  UMC has expanded its role as a communications and training centre and clearing-house for information on drug safety through: mail discussion groups , website development, newsletters annual National Centre meetings,

24. At present, post-marketing surveillance of medicines is mainly co-ordinated by national pharmacovigilance centres. In collaboration with  the  UMC the National Centres have achieved a great deal in : Collecting and analysing case reports of ADRs making regulatory decisions based on strengthened signals alerting prescribers, manufacturers and the public to new risks of adverse reactions.

25. Health Professionals The success or failure of any spontaneous reporting system depends on the active participation of reporters. Patients Only a patient knows the actual benefit and harm of a medicine taken. Observations and reports made by a health professional will be an interpretation of a description originally provided by the patient, together with objective measurements.

26. SCOPE OF PV: Pharmacovigilance conducting advanced drug monitoring study based Adverse drug reactions, adverse events report of new drugs include: Medication errors and irrational use of medicines Herbal, traditional or complimentary medicines Substandard medicines and counterfeit medicines Blood products, biologicals, medical devices and

27. The scope of pharmacovigilance continues to broaden as the array of medicinal products grows. Drug safety is concern more than the monitoring, detection and assessment of ADRs occurring under clearly defined conditions and within a specific dose range . Rather, it is closely linked to the patterns of drug use within society .

28. Problems resulting from: Irrational drug use Overdoses polypharmacy and interactions increasing use of traditional and herbal medicines with other medicines illegal sale of medicines and drugs of abuse over the Internet increasing self medication practices substandard medicines medication errors lack of efficacy