Post Marketing Surveillance (Regulatory affairs).pptx

Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time.

1. POST MARKETING SURVEILLANCE Submitted to: A.Rekha Devi M.pharm Submitted by: K.G.Yuvaraj B.pharm Seven Hills College of pharmacy, Vekataramapuram,Tirupathi .

2. Post-marketing surveillance refers to the ongoing monitoring and assessment of a pharmaceutical product or medical device after it has been approved and introduced to the market. The primary goal is to identify and evaluate any adverse effects or potential safety concerns that may not have been apparent during pre-marketing clinical trials. j

3. Phases of Clinical Trials PHASE 1: Healthy volunteers (20-100) Safety & dosage PHASE 2: People with disease condition (100-300) Efficacy &side effects. PHASE 3: People with disease condition (300-3000) Confirm effectiveness and monitoring of adverse drug reaction.4. PHASE 4(POST MARKETINGSURVEILLANCE): Track adverse events and monitors effects in real world. PHASE 4(POST MARKETINGSURVEILLANCE): Track adverse events and monitors effects in real world.

4. Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with a drug. The majority of postmarketing surveillance concern adverse drug reactions (ADRs) monitoring and evaluation. Other important postmarketing surveillance components include unapproved or off-label drug use, problems with orphan drugs, and lack of paediatric formulations, as well as issues concerning international clinical trials in paediatric population.

5. The process of evaluating and improving the safety of medicines used in paediatric practice is referred to as paediatric pharmacovigilance.It requires special attention. Childhood diseases and disorders may be qualitatively and quantitatively different from their adult equivalents.

6. Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women.In 1961 in Germany an astute pediatrition (Lenz) expressed concern about the sudden large increase in the number of children referred to his clinic with limb deformitis ( Phocomelia ) and thalidomide tragedy has been identified.The prevention of unwanted drug effects became matter of worldwide public.

7. • Post market surveillance not only meets regulatory requirements while monitoring the safety of consumers, but also ensures continuous consumer acceptance of the products and financial viability. Post marketing surveillance is a passive, multifactorial, performance- process for health professionals, manufacturers, regulators and the monitor the performance during the lifecycle of a product in the open market. It is important for manufacturers and regulators to share common safety surveillance keeping consumers in mind.

8. Types & source of real world data A. Clinical data: 1)Electronic health records. 2) Case report forms . B. Patient generated data :1) Health & treatment history. 2) Patient reported outcomes . C. Cost & utilization data Claims datasets. D. Public health data: Government data source

9. Post marketing surveillance System

10. Process of PMS

11. Methods of PMS

12. Voluntary Reporting Voluntary reporting by physicians and other health care providers, hospitals, and consumers may act to alert FDA and pharmaceutical firms to possible adverse effects of drugs. These surveillance systems enable physicians and pharmacists to report suspected ADRs and thus act as a tool to identify new ADRs and risk factors predisposing to recognized ADRs It is acknowledged that only a small proportion of ADRs are actually reported to national reporting centres and pharmaceutical companies. Insight into reasons for underreporting should enable national reporting centres to take appropriate measures to increase reporting rates.

13. Control clinical Study Controlled clinical trials are used primarily for evaluating drug efficacy, not safety, because they are carried out on hundreds, or, at the most, a few thousand drug users. Their use for evaluating drugs already on the market is also limited by their high cost and logistical problems. These limitations of controlled clinical trials in evaluating the safety of marketed drugs have led to relying on cohort and case-control methods for postmarketing studies.

14. Cohort study Cohort design is a type of nonexperimental or observational study design. Cohort studies are important in research design.The term "cohort" is derived from the Latin word " Cohors "-"a group of soldiers.“ *In a cohort study, the participants do not have the outcome of interest to begin with. They are selected based on the exposure status of the individual. Thus, some of the participants may have the exposure and others do not have the exposure at the time of initiation of the study. They are then followed over time to evaluate for the occurrence of the outcome of interest.

15. PROSPECTIVE Prospective means looking forward ( into the future). It is a type of cohort study where the researchers enrol participants into the study before they develop the disease . Involves a group of people who don't have the disease under study. RETROSPECTIVE Retrospective means looking backwards (into the past) It is a cohort study that analyzes two group of people those with disease under study as well as a very similar group of people who do not have the disease . Involves a group of people who already have the disease under study

16. Case control study Case-control studies are retrospective. They clearly define two groups at the start: one with the disease and disease . They look back to assess whether there is a statistically significant rates of exposure to a defined risk factor between the groups.

17. Advantage Cheaper Quicker Good for diseases with long latency periods. Disadvantage Retrospective / more prone to bias . Can only assess one Disease.