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Post marketing servillence

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  • 1. POST-MARKETINGSURVEILLANCESUBMITTED TO: SUBMITTED BY:HARISH DUREJA SIR RITU M.PHARM 1ST SEM. DRA
  • 2. INDEX Introduction History Benefits to a PMS system Sources of Post-marketing Surveillance Need of Post-marketing Surveillance (P.M.S) Vision of Post-marketing Surveillance (P.M.S) Opportunity Practical aspects of PMS PMS procedure Method of Post-marketing Surveillance Manufacturer PMS SYSTEM Possible Achievements Summary Reference
  • 3. PHASES OF CLINICAL TRIALS Phase I :First in man Safety Phase II: First in Patient – dose,dosage forms Phase III: Efficacy , ADRs Post-marketing Surveillance or Phase –IV :Evaluation of in the real clinical setting.
  • 4. INTRODUCTION To market a drug,the manufacturer must provide evidence of its efficacy and safety to the U.S.FOOD AND Drug Administration(FDA) In Premarketing testing,the numbers and type of patient used to demonstrate a drug`s efficacy and safety are limited as compared with the numbers and type of patient who will eventually be prescribed the drugs after it is marketed. Although post-marketing surveillance cannot provide knowledge of the safety or efficacy of the drug at the time of there introduction into the market. Post-marketing surveillance of drug therefore play an important role to discover an undesirable effect that might present at risk. It provide additional informationon the benefit and risk of the drugs.
  • 5. POST-MARKETING SURVEILLANCE No fixed duration/Patient population Starts immediately after marketing Report all ADRs Help to detect  Rare ADRs  Drug interaction  Also new uses for drugs[sometimes called Phase V]
  • 6. HISTORY In the 1960 at least two serious drugs reactions were observed in many patient.thalidomide causes limb deformities(phocomelia). observed in Japan,was the optic nerve damage(subacute myelooptic –neuropathy). The PMA,senator Edward Kennedy (D-Mass.) suggested that a better system was need for monitoring the use and effects of prescription drug after they are marketed. As a result, the joint commissionon Prescription Drugs Use was established in 1976,funded largely by the drug industry, with the mandate to design a post-marketing surveillance system to detect,quantify,and describe the anticipated and unanticipated effects of marketed drugs. The delayed discovery of the practolol`s adverse effects spurred effects to improve post-marketing surveillance.
  • 7. SOURCES OF PMS INFORMATION The following may be considered as sources of information, some source are proactive and some are reactive.  Expert user groups(“ focus groups‟‟)  Customer surveys.  Customer complaints and warranty claims  Post CE-market clinical trials.  Literature reviews.  Device tracking/implant registries.  User reaction during training programmers.  The media.
  • 8. ARE THERE BENEFITS TO APMS SYSTEM Detection of manufacturing problems;  improvement of medical device quality;  verification of risk analysis;  intelligence of long-term performance;  chronic complications;  performance trends;  performance in different user populations
  • 9.  mechanisms the device may be misused. feedback on indications for use,instructions for use. training required for users; use with other devices. customer satisfaction . market performance and sustainability. identification of incident reports (and field safety corrective action reports).
  • 10.  A manufacturer of intraocular lenses collected numerous complaints from users about broken lenses. The manufacturer assessed the complaints and deemed them statistically significant.
  • 11. WHY DO WE NEED POST-MARKETING SURVEILLANCE The primary objective of post-marketing surveillance is to develop information about drug effects under customary condition of drug use. Rare adverse events may not be detected in pre- licensure studies because in very large clinical trials have limitation. Access to more patient and given data Given diversity of data sources, innovative approaches to retrieval of key data may have great potential vs. single unified system. Better background rates,comparable “control‟‟ population. Increase in “non-medical‟‟ data sources- e.g.Pharmacy,supermarket,employer vaccination.
  • 12. VISION FOR POST-MARKETINGSURVEILLANCE All patient‟s vaccination and health outcomes are immediately and continuously Accessible in automated database allowing optimal detection and analysis of potential problem in vaccine safety.  Not there yet –both major limitation and opportunities in current health information system.  Both problems and solution to enhance vaccine safety information and analysis are applicable to safety initiatives for other medical products.
  • 13. POST-MARKETING SURVEILLANCEOPPORTUNITY Access to additional health system data. Access to global data:regulatory,inspectional,health system,international surveillance and pharmacovigilence. Better analytical tools and methods.
  • 14. PRACTICAL ASPECTS OF PMS PMS should be proactive. Manufacturer should document compliance. Manufacturer`s PMS procedure should discuss the information that will be collected and obtained as a part of system. CONT………..
  • 15. ABOUT PMS PROCEDURE It should assign departments or position a responsible for performing a particular function. Manufacturer may find it helpful to a have report at the end of year, as well as PMS tracking schedule and log. This information could constitute feedback received from user .
  • 16.  Information obtained from PMS system should be communicated , at a minimum, annually during a management review meeting-which is top managements examination of the organizations quality management system.
  • 17. METHODS OF SURVEILLANCE Thus, four types of studies are generally used to identify drugs effects: 1. Controlled clinical trials, 2. Spontaneous or voluntary recording 3. Cohort, studies and 4. Case control studies1. Controlled clinical trials: To minimize bias through such method as randomization and “double-blinding‟‟. Directly monitor patients for the duration of studies. For evaluating a drug‟s efficacy and safety. They are often costly.
  • 18. 2. Spontaneous or voluntary reporting By physician and other health provider & hospital may to alert FDA and pharmaceutical firms to possible adverse effects of drugs.3. Cohort studies : Studies follow a defined group of patient for a period of time. Patient are not randomly assigned , & there is no blinding.
  • 19.  If adverse reaction occur. A second group of patient with the same medical condition , who are not taking the drug and who may be receiving alternative treatment.4.Case-control studies : Case control studies identify patient with the adverse effects to be studied, and compare them with the sample drawn from the same cohort that gave rise to cases.
  • 20. MANUFACTURER PMS SYSTEMThese are some of the type of knowledge and feed back which can achieved from a PMS system. Detection of some manufacturing problems. Product quality improvement. Conformation (or otherwise) of risk analysis. Knowledge of long term performance/reliability and /or chronic complication. Knowledge of performance in different user population. CONTD…..
  • 21.  Feedback on indication of use. Feedback on instruction for use. Feedback on use with other devices. Feedback on customer satisfaction. Identification OF vigilance report. Feedback on continuing market viability.
  • 22. SUMMARY Postmarketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug . Device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs are approved on the clinical trials which involve relatively small numbers of people who have been selected for this purpose . CONTD……..
  • 23.  Post marketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions. Postmarketing surveillance uses a number of approaches to monitor the safety of licensed drugs, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries and record linkage between health database.
  • 24.  Pre-licesure clinical,product,and manufacturing data are critical foundation for evaluating safety and effectiveness. However , post-licensure surveillance is essential to assure product safety.
  • 25.  Absence of complete diagnostic information. Vaccines and other medical products have risk that may include rare serious adverse events not detected.
  • 26. REFERENCE1. Borden E.K, The upjohn Co., „„POST- MARKETING SURVEILLANCE OF out patient drugs using a pharmacy-based registration system-report of two studies,‟‟ presented at the drug information association Work shop, williamsburg va,DECEMBER 1981,10-32.2. CLARREN S.N.et al, “The evaluabdity Assessment of the developing experiment in post marketing surveillance of prescription drugs‟‟, prepared for the experiment technology incentives program, National Bureau of standards , 10-22.
  • 27. REFERENCE2.FOOD AND DRUGS ADMINISTRATION, „„Supplementary reports to contracts and grants committee on Medicaid”, from the division of Drugs Experience, BUREAU OF DRUGS,1982, 10-32.3.KAREN MIDTHUN, „„Deputy Director Centre for biologics Evaluation and Research”,FDA,ICDRA Pre-conference berne, SWITZERLAND september 15
  • 28. THANK YOU