Tiêu đề 11. SPONTANEOUS REPORTING.pdf ✅

PHARMD GURU Page 1 INTRODUCTION:  Spontaneous reporting system is a passive surveillance system.  Health professionals are encouraged to report adverse reactions which they believe to be drug-related directly to: 1) The regulatory authorities (or) 2) The company making the suspected product on a voluntary basis.  Spontaneous reporting system has three steps: 1) Data Acquisition 2) Data assessment 3) Data interpretation 1) DATA ACQUISITION: Which depends largely on the input of information derived from the reports submitted by the health professionals, who have encountered, what they suspect is an ADR. 2) DATA ASSESSMENT: Involves assessment of the individual case reports and assessment of pooled data obtained from various sources, such as the international database of the WHO. 3) DATA INTERPRETATION:  Based on the available data and assessments made, a signal related to the adverse reaction may be generated.  Pharmacovigilance aims at detecting adverse effects of marketed drugs. It is generally based on a spontaneous reporting system (SRS) that consists of the spontaneous reporting, by health professionals, of events that are supposed to the adverse effects of marketed drugs.  Automated signal generation methods have been proposed.  The success or failure of any Pharmacovigilance activity depends on the reporting of suspected adverse reactions.  Different countries have different adverse drug reporting forms (or) systems. Those are:  India - Suspected Adverse Drug reaction reporting form. SPONTANEOUS REPORTING
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)
PHARMD GURU Page 4 SPONTANEOUS REPORTING - IN UNITED KINGDOM: Authority function: Control of medicines by MHRA (UK medicines and Health care Products Regulatory Agency) formed on April 2003 from the merger of medicines Control Agency (MCA) & Medical Devices Agency (MDA). Key functions: Safety, quality and efficacy of medicines and safeguard public health. INTRODUCTION OF THE YELLOW CARD SCHEME:  Introduced in 1964 (Sir Derrick Dunlop) after thalidomide tragedy.  Over 600,000 confidential reports have been received in the UK by: Doctors, dentists, pharmacists, nurses, midwife, health visitors, non-medical prescribers and now patients.  MHRA can detect duplicate reports.  A survey in 1984: Only 16% of doctors who are eligible to report suspected adverse drug reactions to the scheme had actually submitted a yellow card between 1972 and 1980.  Analysis of Yellow card reports submission between 1992 and 1995 showed that around one- third of the practicing doctor submitted reports. INFORMATION TO INCLUDE ON A YELLOW CARD: 4 critical pieces of information that must be included on the report: 1) Suspected drug(s). 2) Suspected reaction(s). 3) Patient details. 4) Reporter details. 1. SUSPECTED DRUG(S):  Name of the medicine,  Include brand and batch number, if known route of administration.  Daily Dose  Date medicine started and stopped, if applicable.  Reason why the medication was given.  Multiple drugs can be listed, if more than one drug is suspected of causing the reaction.