reporting in india

Views:
 
     
 

Presentation Description

No description available.

Comments

Presentation Transcript

Madhuri.M ICRI:

Madhuri.M ICRI Spontaneous reporting in India

National Pharmacovigilance Program :

National Pharmacovigilance Program India has more than half a million qualified Doctors and 15,000 hospitals having bed strength of 6,24,000. It is the fourth largest producer of pharmaceuticals in the world & is emerging as an important Clinical trial hub in the world. Need: pharmacovigilance system in the country to protect the population from the potential harm that may be caused by some of these new drugs.

PowerPoint Presentation:

Central Drugs Standard Control Organization (CDSCO) has initiated a well structured and highly participative National Pharmacovigilance Programme. based on the recommendations made in the WHO document titled “Safety Monitoring of Medicinal Products – Guidelines for Setting up and Running a Pharmacovigilance Centre”.

PowerPoint Presentation:

The National Pharmacovigilance Program was officially inaugurated by the Honorable Health Minister Dr.Anbumani Ramadoss on 23 November, 2004 at New Delhi. specific aims of the Pharmacovigilance Programme: contribute to the regulatory assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective use

PowerPoint Presentation:

improve patient care and safety in relation to use of medicines and all medical and paramedical interventions improve public health and safety in relation to use of medicines promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public

PowerPoint Presentation:

The Programme aims to foster the culture of ADE notification in its first year of operation and subsequently aims to generate broad based ADR data on the Indian population and share the information with global health-care community through WHO-UMC (UPPASALA monitoring centre) One aim of the WHO Programme for International Drug Monitoring is the early identification of international drug safety problems not identified in clinical trials, known as signals. These signals are published in the Uppsala Monitoring Centre’s SIGNAL document, and represent varying levels of suspicions derived from examination of the data in the WHO Global Individual Case Safety Reports (ICSR) database – also known as VigiBase™

PowerPoint Presentation:

UMC role: The Uppsala Monitoring Centre is the field name of the WHO Collaborating Centre for International Drug Monitoring. core function is to screen and analyse international adverse drug reaction (ADR) data with the aim of finding drug safety signals as early as possible. UMC receives summary reports of suspected adverse reactions to medicines from over 100 national pharmacovigilance centres in countries participating in the WHO Programme for International Drug Monitoring.

PowerPoint Presentation:

The reports are collated in a single global database, VigiBase TM , which is managed by the UMC. Quarterly analysis of VigiBase data is performed with the aim of finding drug safety signals. Drug-ADR combinations considered to be signals are circulated in the SIGNAL Document. A signal from the UMC is to be seen as a hypothesis together with data and arguments; it is not only uncertain but also preliminary in nature and its significance may change substantially over time when more data are gathered.

PowerPoint Presentation:

Under the program 26 peripheral centers, 5 Regional Centers and 2 Zonal Centers were established. The National Pharmacovigilance Advisory Committee (NPAC) oversee the performance of various Zonal, Regional and Peripheral Pharmacovigilance centers as well as recommend possible regulatory measures

NATIONAL PHARMACOVIGILANCE POLICY :

NATIONAL PHARMACOVIGILANCE POLICY The purpose of the programme is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public. milestones: Short-term objectives: To foster a culture of notification Medium-term objectives: To engage several healthcare professionals and NGOs in the drug monitoring and information dissemination processes.

PowerPoint Presentation:

Long-term objectives: To achieve such operational efficiencies that would make Indian National Pharmacovigilance Programme a benchmark for global drug monitoring endeavors.

FRAMEWORK FOR PHARMACOVIGILANCE IN INDIA :

FRAMEWORK FOR PHARMACOVIGILANCE IN INDIA The Central Drugs Standard Control Organization (CDSCO) has initiated a country-wide Pharmacovigilance programme under the aegis of Directorate general of health services (DGHS), Ministry of Health & Family Welfare, Government of India. The programme is coordinated by the National Pharmacovigilance Centre at CDSCO. The National Centre is operating under the supervision of the National Pharmacovigilance Advisory Committee to recommend procedures and guidelines for regulatory interventions.

India's Central Drugs Standard Control Organization (CDSCO) :

India's Central Drugs Standard Control Organization (CDSCO) Headquartered in New Delhi, the CDSCO is India's main regulatory body for pharmaceuticals and medical devices. the Drug Controller General of India (DCGI) is responsible for the regulation of pharmaceuticals and medical devices The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).

PowerPoint Presentation:

Licensing and classification of medical devices are handled by the Central Licensing Approval Authority (CLAA). also responsible for setting and enforcing safety standards, appointing notified bodies to oversee conformity assessment, conducting post-market surveillance and issuing warnings and recalls for adverse events.

PowerPoint Presentation:

The CDSCO establishes safety, efficacy, and quality standards for pharmaceuticals and medical devices. It publishes and updates the Indian Pharmacopeia, a list of regulated pharmaceuticals and devices.

PowerPoint Presentation:

The CDSCO appoints notified bodies to perform conformity assessment procedures, including testing, in order to ensure compliance with their standards. The CDSCO is also divided into several zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when necessary.

PowerPoint Presentation:

In addition to its regulatory functions, the CDSCO offers technical guidance, trains regulatory officials and analysts, and monitors adverse events The CDSCO works with the World Health Organization to promote Good Manufacturing Practice (GMP) and international regulatory harmony. At present various pharmaceutical companies and contract research organizations (CROs) are using multiple / different formats and procedures for reporting serious adverse events (SAEs) to CDSCO.

PowerPoint Presentation:

most reports adhere to Appendix XI of Schedule-Y but multiple formats and missing information, including improper referencing for submission of follow-up reports have lead to difficulties in segregation and further processing of these reports by this office. The following guidelines have been developed to achieve uniformity and completeness of data received by this office with respect to SAE reporting in clinical trials.

SCOPE & RESPONSIBILITIES :

SCOPE & RESPONSIBILITIES should be reported as per the details provided in Appendix XI of Schedule Y (Annexure I) within the applicable timeline (14 calendar days), to, The Drugs Controller General (India) Directorate General of Health Services Central Drugs Standard Control Organization FDA Bhawan, Kotla Road, New Delhi – 110 002 Pharmaceutical company / the sponsor / CRO (Investigator in investigator-initiated studies) is responsible for reporting SAEs within the applicable timelines.

SAE REPORTING IN CLINICAL TRIALS :

SAE REPORTING IN CLINICAL TRIALS As per the regulations (Schedule Y of Drugs & Cosmetics Rules), all Unexpected SAEs have to be reported to CDSCO within 14 calendar days. Every report (both initial as well as follow-up reports) should be submitted along with a covering letter. A template of covering letter is available in Annexure II.

PowerPoint Presentation:

Covering letter should be prepared using the template as guide, and printed on the company’s/ CRO’s letter head. All the sections of the covering letter should be completed. When some information is not available at the time of report e.g. causality assessment by medical monitor of Sponsor / CRO, compensation provided for study related injury or death, the same has to be provided as a follow-up report

PowerPoint Presentation:

Covering letter of every report arising from the clinical trials (CT) has to capture, (at stipulated box provided in the template) as per the format (Annexure II) a. DCGI CT file number b. Complete address of Sponsor and CRO (if any) including phone & e-mail address c. Phase of clinical trial d. Category of clinical trial as per below codes, (Please mark the appropriate Code from the list provided in the covering letter using below details)

PowerPoint Presentation:

e. Protocol or Study No. / Code / ID and the study title f. Adverse event term / diagnosis (Whenever possible provide a „preferred term‟) g. A brief narrative of the event, not exceeding 10 lines. A detailed narrative may be enclosed, if available. h. Unexpected SAEs have to be submitted to this office as per Schedule Y of Drugs and Cosmetics Rules, 1945

PowerPoint Presentation:

i. Causality assessment by investigator and the medical monitor of Sponsor /CRO. The assessment report should clearly mention whether the SAE occurred is related or not related (Situations like unlikely, possibly, suspected, doubtful etc should not be used). j. Whether the outcome is fatal k. Details of compensations provided for injury or death. In case no compensation has been paid, reason for the same should be submitted. It is pertinent to mention that in case of study related injury or death, complete medical care as well as compensation for the injury or death should be provided.

PowerPoint Presentation:

Capture whether it is “initial” or “follow-up” report. For follow-ups, clearly mention the follow-up report number e.g Follow-up #01, Follow-up #02, etc. In case of follow-up reports, please mention the date of submission of initial (first) report somewhere in narrative. Filled CIOMS-I ( Council for International Organizations of Medical Sciences ), MedWatch or Any other forms (company specific, self designed) can be submitted. However, one needs to ensure that the forms capture basic (mandatory) information as per the Appendix XI of Schedule Y.

PowerPoint Presentation:

Forms should be completed in legible English. Illegible forms, incomplete with respect to critical information and improperly scanned / fax copies would be rejected. Relevant supportive documents may be enclosed.

DATA ELEMENTS FOR REPORTING SAE OCCURRING IN A CLINICAL TRIAL :

DATA ELEMENTS FOR REPORTING SAE OCCURRING IN A CLINICAL TRIAL 1. Subject details i. Subject initials & other relevant identifier* ii. Gender iii. Age and/or date of birth iv. Weight v. Height

PowerPoint Presentation:

2. Suspected Drug(s) i. Generic name of the drug* ii. Indication(s) for which suspect drug was prescribed or tested iii. Dosage form and strength iv. Daily dose and regimen (specify units - e.g., mg, ml, mg/kg) v. Route of administration vi. Starting date and time of day vii. Stopping date and time, or duration of treatment

PowerPoint Presentation:

3. Other Treatment(s) Provide the same information for concomitant drugs (including non prescription/OTC drugs) and non-drug therapies, as for the suspected drug(s). 4. Details of Serious Adverse Event (s) Full description of reaction (s) including body site and severity, as well as the criterion (or criteria) for regarding the report as serious has to be provided. In addition to a description of the reported signs and symptoms, whenever possible, describe a specific diagnosis for the reaction.* Causality assessment by the investigator. i. Start date (and time) of onset of event ii. Stop date (and time) or duration of event

PowerPoint Presentation:

iii. Dechallenge and rechallenge information iv. Setting (e.g., hospital, out-patient clinic, home, nursing home) v. Results of specific tests and/or treatment that may have been conducted 5 . Outcome Information on recovery and any sequelae; for a fatal outcome, cause of death and a comment on its relationship to the suspected reaction; any post-mortem findings Other information: anything relevant to facilitate assessment of the case, such as medical history including allergy, drug or alcohol abuse; family history; findings from special investigations etc.

PowerPoint Presentation:

6. Details about the Investigator* i. Name, Address & Telephone number ii. Profession (specialty) iii. Date of reporting the event to Licensing Authority iv. Date of reporting the event to Ethics Committee overseeing the site: v. Signature of the Investigator vi. Note: Information marked * must be provided.

Thank you:

Thank you

authorStream Live Help