POST-MARKETINGSURVEILLANCESUBMITTED TO: SUBMITTED BY:HARISH DUREJA SIR RITU M.PHARM 1ST SEM. DRA
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
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.
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.
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]
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.
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.
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
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).
A manufacturer of intraocular lenses collected numerous complaints from users about broken lenses. The manufacturer assessed the complaints and deemed them statistically significant.
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.
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.
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.
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………..
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 .
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.
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.
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.
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.
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…..
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.
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……..
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.
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.
Absence of complete diagnostic information. Vaccines and other medical products have risk that may include rare serious adverse events not detected.
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.
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