Post marketing surveillance

PMS

1. POST MARKETING SURVEILLANCE PRESENTED BY SURAJ MUNGASE M PHARM 1 sem PHARMACY PRACTICE DEPARTMENT

2. FLOW OF PRESENTATION INTRODUCTION HISTORY IMPORTANCE OF PMS GOAL OF PMS BENEFITS OF PMS SOURCE OF PMS PROCESS OF PMS METHODS OF PMS

3. INTRODUCTION Phases of clinical trial Microdosing study ( Phase 0) :Done in very small number of people. Investigators use a very small dose of medication to make sure that it isn’t harmful to humans before they start using higher doses for lateral phase. 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 . PHASE 4(POST MARKETING SURVEILLANCE ): 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. HISTORY 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 concern.

7. Edward Kennedy (senator) suggested that a better system was needed for monitoring the use and effects of prescription drugs after they were marketed. As a result, the Joint Commission on Prescription Drug Use was established in 1976, funded largely by the drug industry, with the mandate to design a postmarketing surveillance

8. Importance of PMS 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-market surveillance is a passive, multifactorial, performance-based process for health professionals, manufacturers, regulators and the public to monitor the performance during the lifecycle of a product in the open market. It is important for manufacturers and regulators to share common goals for safety surveillance keeping consumers in mind.

9. Goal of PMS The goal of surveillance system is to identify the product use patterns or conditions responsible for adverse effects and characterize relative incidence rates compared to market penetration, units sold or other denominator-generating benchmarking data.  To determine the frequency of adverse reactions or safety attributable to a product, spontaneous reports, information on utilization and extent of consumption is essential. Compare a new products or treatments with existing options and the standard of care . Update clinical guidelines as certain populations or groups find more benefit than others .

10. Benefits of PMS Real world evidence delivered through PMS . P ost-market surveillance can provide additional information on the natural history of disease and the relative performance  of their product to the disease, as well as other marketed products. P ost-market surveillance can provide information on how products perform relative to others in the context of real-world patient populations, which are often materially different from clinical trial populations. This can then inform treatment decisions, including off-label use of products P ost-market surveillance can shed light on which products and drugs are the safest and most cost-effective.

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

12. Post Market Surveillance System

13. ACTION CAPA Corrective Action :The action was taken to rectify ,fix or correct a specific deviation ,defect or undesirable situation . Preventive Action : The action was taken to eliminate the cause of deviation ,defect in order to prevent the future occurrence of such an event . UPDATE: The dosage strength or composition of dosage form.

14. Process of PMS

15. Methods of PMS The essence of the various methods of postmarketing surveillance of drugs is the ability to make observations about drug effects in an environment where the drugs are being used in a customary therapeutic or diagnostic situation. In order to accomplish this, the investigation of marketed drugs requires the application of observational rather than experimental methods. The ability of a particular surveillance method to detect a drug’s effect depends on two factors. 1) ) The time that transpires between use of that drug and the occurrence of the drug’s effect (the latency period). 2) How often the effect occurs (its frequency).

16. 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 .

17. Control clinical trials 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.

18. 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.

19. Case control study Case-control studies are retrospective.  They clearly define two groups at the start: one  with  the disease and one  without  the disease. They look back to assess whether there is a statistically significant difference in the rates of exposure to a defined risk factor between the groups .

20. Advantages Cheaper Quicker Good for diseases with long latency periods Disadvantages Retrospective / more prone to bias. Can only assess one Disease.