Title 11. SPONTANEOUS REPORTING.pdf ✅

PHARMD GURU Page 2  UK - „Yellow card‟ since 1964.  Australia - „Blue card‟ since 1964.  United States - „Med watch‟.  Form FDA 3500 - Voluntary reporting.  Form FDA 3500A - Mandatory reporting.  Studies in pharmacoepidemiology are intended to be either “hypothesis generating” or “hypothesis testing”.  Hypothesis-generating studies, with a recently marketed drug, aim to detect unexpected adverse drug reactions.  Hypothesis testing studies, aim to prove whether any suspicious that may have been raised are justified. HYPOTHESIS - GENERATING STUDIES: They are generally done by two methods: 1) Spontaneous ADR reporting. 2) Prescription event monitoring (PEM). 1) SPONTANEOUS ADR REPORTING:  Spontaneous reporting is defined as “A system whereby case reports of adverse drug reactions or events are voluntary submitted by health professionals and pharmaceutical companies to the National Pharmacovigilance Centre” (NPC).  Doctors (in some countries, other health care professionals and patients as well) are provided with forms, upon which, if they detect any suspected adverse drug reactions, they can notify it to the “central authority”.  In the United Kingdom, the „yellow card‟ has been used for this purpose since 1964.  The „blue card‟ system is used in Australia and Malaysia.  In the United States, the “Med watch” form is used, and is made broadly available to health professionals to encourage reporting. ADR REPORTING IN INDIA: For the purpose of reporting ADR‟s: 1) National Pharmacovigilance program was initiated.
PHARMD GURU Page 3 2) Central Drugs Standard Control Organization (CDSCO) was coordinating 2 zonal centers, 5 regional centers and 28 peripheral centers are established for monitoring ADR reporting in India. PHARMACOVIGILANCE PROGRAM OF INDIA:  CDSCO Directorate General of Health Services, under the aid of “Ministry of Health and Family Welfare”, Government of India in collaboration with “Indian Pharmacopoeia commission, Ghaziabad (U.P) has started Pharmacovigilance program for protecting the health of the patients by assessing drug safety in India.  Indian pharmacopoeia commission (IPC), Ghaziabad is functioning as a National Coordinating centre (NCC) for Pharmacovigilance Program of India (PVPI).  150 ADR Monitoring centers, were established in various medical institutions or hospitals across India to monitor and collect ADR reports under NCC-PVPI. WHAT TO REPORT:  PVPI encourages all types of suspected adverse drug reactions reporting, whether they are known, unknown, serious or non serious, etc.  Adverse drug reactions related with the use of allopathic medicines, vaccines, traditional medicines, medical devices, contrast media, etc. can be reported. WHERE TO REPORT:  All health care professionals (clinicians, dentists, pharmacists, nurses) and patients or Consumers can report ADR‟s to NCC or AMCs.  The pharmaceutical companies can also send individual case safety reports for their product to NCC. HOW TO REPORT:  Suspected ADR reporting forms for healthcare professionals and consumers are available on the website of IPC to report ADR.  To remove language barrier in ADR reporting, the consumer reporting form are made available in 10 vernacular languages (Hindi, Tamil, Telugu, Kannada, Bengali Gujarati, Assamese, Marathi, Oriya and Malayalam)