IMPROTANCE OF SAFETY MONITORING OF MEDICINES.pptx

Pharmacovigilance -importance of safety monitoring of medicines

1. IMPROTANCE OF SAFETY MONITORING OF MEDICINES By Hema Sri M ( M.Pharm,RPh -DHA) Asst.Professor , Pharmacy Practice Dept. AM REDDY COLLEGE OF PHARMACY.

2. WHO’s Programme for International Drug M onitoring International drug monitoring began in 1968,with Uppsala Monitoring center(UMC) in Sweden being the collaborative center for this global initiative. Function: Communication of safety signals recognised through analysis of global data. WHO promotes PV at the country level At the end of 2020 ,127 countries were the part of the WHO PV programme . India became member of WPIDM in 1998

3. IMPORTANCE OF DRUG SAFETY MONITORING Drug safety monitoring is mitigation exercise in which the ADR’s caused by therapeutic drugs ,biologicals or devices can explored, prevented or minimised. It is an essential element for the effective use of medicines & for high quality medical care. It has the potential to inspire confidence & trust among patients and healthcare professionals in medicines & contributes to raising standards of medical practice. ADR’s can significantly diminish the quality of life. Increase the rate of duration of hospitalisation

4. As the newer discoveries are becoming available for the needy population at the faster rate & drug related adverse reactions are also becoming more common, severe & more complex. PV is the process of identifying expected & unexpected adverse reactions resulting from the use of medicines in the post marketing phase. PV benefits everyone & patients are protected from unsafe drugs Drug regulators receive pertinent data that helps them to take regulatory decision. Analysis of ADR data helps to make regulatory decisions Prevent drug related damages if appropriate care is taken by physicians on the basis of feedback from the PV system.

5. Increased Necessity of Drugs S afety Monitoring There are multiple reasons for the increased necessity for a drug safety monitoring. 1.Limitatons of clinical trails 2.Unreliability of preclinical safety data Preclinical drug development processes involves evaluation of drug safety & efficacy in animal experiments. However, often it may not be appropriate to extrapolate the results of preclinical studies to human being. 3.Changing pharmaceutical marketing strategies(aggressive) 4.changing physician & patient preferences 5.Easy accessibility of drug

6. 1.Limitations of Clinical Trails Homogenous population sample strict inclusion/exclusion criteria. subjects usually have a single disease. Specific group of children ,elderly & pregnant are excluded Small sample size-detection of rare adverse event is difficult. Short duration of trail-limits the detection of long-term adverse events

7. 2.Unreliability of preclinical safety data Difficult to predict adverse effects & total risk benefit ratio under actual clinical settings. Inability to detect ADR’s under real conditions- Drug interactions Drug food interactions Large number of other unpredictable conditions Detection of risk factors

8. 3.Aggresaive marketing strategies Efforts to launch new product in many countries by Pharmaceutical companies has increased the exposure of larger population to newly launched understudies drugs So large population is at risk of experiencing ADR’s. Direct to consumer advertising has les the physicians to prescribe new drugs .

9. 4.Changing physician & patient preferences Increasing use of new drugs Newer Drugs with complicated MOA  Develops complicated ADR’s Shift of supervised to self administered therapy. The shift makes it difficult to identify the occurrence ,frequency severity & actual characteristics of ADR

10. 5.Easy accessibility of drugs By easy access to internet Easy availability of complimentary medicines They largely escapes official requirements of approved & quality control Increasing penetration of market by substanded drugs in recent years Above reasons makes it necessary to implement an effective and robust safety monitoring through PV Programme