Post marketing surveillance informations

Post marketing surveillance

1. SPONTANEOUS REPORTING Unsolicated Pt, Pc, HCP NPP, UMC, PCC Communication PURPOSE To provide EARLY WARNING SIGNAL of previously unrecognized drug toxicity. ADR

2. SPONTANEOUS REPORTING SCHEME Health professional who are willing to participate Simplicity in submission of report Prompt entry of reports onto a data base Follow up of serious reports Analytical tools detect signals Process for dealing with the signals Feed back of reporters

3. Pros 1.Covers the whole population Includes all medicines 2.Continual monitoring throughout life- cycle of a medicine 3.Detects signals of new, rare or serious ADRs 4.Most commonly used method & Easiest method to establish 5.Relatively inexpensive

4. Cons Inherent under-reporting Captures only suspected ADRs Reporting bias-e.g. Seriousness, severity New medicine. Advertising of product, Publicity of specific ADR Difficult to detect   delayed ADRs &  ADRs with high background incidence

5. Case series  A series of case-reports can deliver signs of an association between a medicine and an adverse event , but they are normally more valuable for producing theories than for confirming a relationship between medicine exposure and outcome.

6. ACTIVE SURVEILLANCE It pursues to determine the particular number of adverse events through a constant pre-organized process.  Method :- Follow up of pt who treated with a drug is important. Pt who fill prescription for a drug may be asked to fill or complete a survey & give permission to contact later.

7. SENTINEL SITES Sentinel- an indicator of the presence of disease. Active surveillance can be attained by revising medical records or questioning patients and/or physicians in a section of sentinel sites to guarantee that comprehensive and precise data on reported adverse events are collected from these sites. LIMITATIONS Small no.of patient augmented cost

8. DRUG EVENT REPORTING Medicine event monitoring This is a process of active Pharmacovigilance surveillance. Studies using this process are cohort-based and prospective and observational. For medication event monitoring, patients can be acknowledged from electronic or automated health insurance claims. A single prescription or a series might be composed over the period of monitoring. A follow-up questionnaire can then be sent to each prescribing physician or patient at pre-specified intervals to acquire outcome data . Requests for data on patient demographics, indication for treatment, duration of therapy, dosage, clinical events, reasons for termination and applicable past history can be involved in the questionnaires.  Limitations - the poor physician and patient reply rates.

9. Cohort Event monitoring A prospective, longitudnal observational study for defined group of patient to identify ADR associated with one or more monitored medicines . Pt on specific drug initially recruited clinical visit, home visit, phone call Questionnaire fill at initial & post treatment complete follow up is taken

10. It records all clinical even not just suspected . PROS Early detection of signals of unsuspected ADR Near complete profile of AE/ADR for medicine of interest. Assessment of risk & identification of risk factors. Drug comparision Preganancy outcome Death recorded

11. Cohort Event monitoring CONS More labour intensive than SR More costly New to health professionals & PV centres . Training requires.

12. Registries A registry is a list of patients presenting with the identical representative(s). This representative can be a disease (disease registry) or a specific exposure (medicine registry ). Disease registries , such as registries for blood dyscrasias , severe cutaneous reactions, or congenital malformations can help to gather data on medicine exposure and other factors related to a clinical condition . Exposure (medicine) registries address populations exposed to the medicines of interest to govern if a medicine has a distinct influence on this group of patients. Some exposure (medicine) registries address drug exposures in specific populations, such as pregnant women .

13. ACTIVE SURVELLIANCE PASSIVE SURVELLIANCE Data is actively collected Data is passively collected Health system staff goes to the patients to gather data Data itself reported to health system Ex:- health worker goes house to house to detect fever cases & collect blood samples Ex:- pt’s coming to PHC, CHC, Private practioners etc.. Mostly used when disease is targeted for elimination or eradication Mostly used when disease is targeted for control. Includes mainly NVBDCP & NLEP Includes most of the National Health Programs in India. More expensive Less expensive Diseases :- Poliomyelitis, leprosy, neonatal tetanus. Diseases:- Diptheria , Hepatitis B, Mumps.

14. COMPARITIVE OBSERVATIONAL STUDIES COHORT STUDIES Group of people with defined characteristics who are followed up to determine incidence of, or mortality from, some specific diseases, all causes of death or some other outcome. OBJECTIVE Incidence Natural history Cause Prognosis

15. TYPES OF COHORT STUDIES PROSPECTIVE A group of people chosen who do not have the outcome of interest. Investigator measure variety variables that might be relevant to the development of the condition. Over a period of time people in this sample are observed whether they develop outcome of interest. In single cohort----people who do not develop outcome of Interest consider Internal control.

16. RETROSPECTIVE These use data collected for other purposes. Methodology remains same. Study performed Posthoc The study period may be many years but the time to complete the study is only as long as it take to collect & analyze the data. Cheaper & Quicker.

17. Cohort study design Population selected sample Variable + Variable - Condition develops Condition does not develop Condition develops Condition does not develop

18. PROS Gather data regarding sequence of events, can assess causality. Examine multiple outcomes for a given explorer. Good for investigating rare exposure Can calculate rate of disease in exposed & unexposed individuals over time. CONS Large number of subjects are required to study rare exposure .