Incoming and Outgoing Shipments in 1 STEP Using Odoo 17
basic information resource.pptx
1. Information resources in Pharmacovigilance
DEFINTION:-The branch of science who`s activities
relating to the detection, assessment, understanding, and
prevention of adverse effects or any other drug related
problem.
OBJECTIVE:
• 1. To know what are the various sources of drug
information.
• 2. To select the appropriate source depending on the
information.
2. BASIC DRUG INFORMATION RESOURCES
• Drug information is current, critically examined, relevant
data about drugs and drug use in a given patient or
situation.
• Current information uses the most recent, up-to-date
sources possible.
• Critically examined information.
• Relevant information must be presented in a manner
that applies directly to the circumstances under
consideration (e.g. patient parameters, therapeutic
objectives, alternative approaches).
5. • PRIMARY RESOURCES-
– Researcher`s and manufacturer`s information.
– Patents containing original information regarding the
discovery of drug.
– Reports containing scientific data before product can
be sold, supplied or represented.
– Scientific Journals
– Provide original studies or reports
6. ADVANTAGES
– Most current evidences.
– Provide data on new drugs.
– Original document that was created at the time of the
actual events.
DISADVANTAGES
– Data can be controversial.
– Every study has limitation
– Complicated
– Time consuming.
7. SECONDARY RESOURCES
• Abstract or index which summarizes the information
arising in primary resource.
• Indexing and abstracting services are valuable tools
for quick and selective screening of the primary
literature for specific information, data, citation, and
article.
• Bibliographic database that provide abstract or full-
text of studies.
8. ADVANTAGES-
– Find specific information at high granularity.
– Pick out key point.
– Quick to read
DISADVANTAGES-
• Detail missing.
•Two different authors can interpret the same piece of
original material in two widely different ways.
• May be inaccurate.
10. ADVANTAGES-
• Provide comprehensive information.
• Information reflects views of multiple experts in field.
• Fast, easy to use, and may be good for patients.
DISADVANTAGES-
• Information may be dated due to gap between when
resources is written and published.
• Chances of distorting a topic.
17. Establishing pharmacovigilance programme
• PV is a major post-marketing tool to ensure the safety
of a medicinal product.
• Apart from the respective drug regulating authorities
in each country, International Conference on
Harmonization (ICH) of Technical Requirements for
Registration of Pharmaceuticals for Human Use,
Pharmacovigilance Planning ICH E2E and World
Health Organization-Uppsala Monitoring Centre
(WHOUMC) also play key roles towards developing,
enhancing and monitoring global PV system.
18. Essential for a Pharmacovigilance program
• Pharmacovigilance is all about drug regulations and is based
on thorough collaborative ties, coordination, communications,
and public relations.
• The most suitable location for setting up a PV centre is
dictated by the political governance and its healthcare
priorities, including willingness to do, law enactment, its
enforcement, funding, organisation, staffing, training, and
development.
19. To Ensure a Good PV System, Certain Operational
Requirements must be met, which include
• Assure an organized structure and smooth functioning.
Meetings among the PV physicians, managers, and technical
agencies need to be held from time to time
• A countrywide database which provides provision for
collecting and managing ADR reports
• A national PV advisory committee
• A clear approach, to be communicated in detail, in regular
situations as well as situations of crisis
• Funding to run different grounds of a system.
20. Basic Steps in Setting up a PV System Include
• Getting into regular communications with the health
authorities, local, regional and national bodies, and
professionals involved in clinical medicine,
pharmacology, toxicology, epidemiology, briefing
them about the importance of the project and its
applicability in modern therapeutics
21. Establishing Pharmacovigilance Center in Hospital
• Although surface clinical trials reveal a fair percentage of
ADRs, but they may not always give the fuller picture due to
relatively fewer number of patients from a specified
geographic location on trial, limited duration of trial,
differences in the conditions of use from clinical practice.
• Gross variations in the effects of medicines exist among
populations of different countries and also various regions of
the same country which may be attributed to the differences in
prescribing practices and diseases, genetics, food habits, and
pharmaceutical manufacturing protocols.
22. • India as herbal remedies are widely used.
• India, now being a signatory to the World Trade Organization
(WTO) and a hub of clinical trials, is fast becoming a market
for new molecules whose safety data are not available from
other countries.
• Clinical trials may not always pick up rare adverse reactions.
Also with the prevailing heterogeneity in clinical practices in
India – allopathy, ayurvedic, homeopathy, unani, siddha
23. GETTING STARTED
• Political governance and its healthcare priorities, including
willingness to do, law enactment, its enforcement, funding,
organization, staffing, training, and development.
• Governmental support and sustained monitoring are necessary
for the national coordination of PV.
• A center can be started in a hospital or any department,
preferably in pharmacology, medicine, clinical pharmacy, or
clinical toxicology.
24. • One hospital locally and then extended to other hospitals to
cover the entire region which could communicate closely with
a zonal center.
• All zonal centers in turn can report to the national nodal center
which would collate the data gathered from the entire country
and channel it to the Uppsala Monitoring Center (UMC),
Sweden,
25. • The center should have at least one clinical
pharmacologist, clinical pharmacist or a physician to
start working
26. PLANNING THE BASICS
• A blueprint should be drawn up to establish and get a PV
system to work. Care needs to be taken to establish the
following:
Communication process
• Getting in conversation with health authorities and local,
regional, national bodies and groups engaged in clinical
medicine, pharmacology, toxicology, epidemiology, briefing
them about the importance of the project and its applicability
in modern therapeutics
27. Data acquisition
• Designing a template for ADR reporting and making available
ADR reporting forms at all times, to hospital departments and
general practitioners, on which they can furnish relevant
information to the data bank of the center
Dissemination
• Conducting meetings or workshops in hospitals and academia
28. Establishment
• Hiring the right qualified and interested staff
• making arrangements for telephones,
• computers,
• printers,
• word processors,
• database management,
• bibliography support services, and
• internet
29. Internal education
• Ensuring proper education and frequent updating of the staff
belonging to the PV centers
• Filtration, mining, verification, interpretation and coding of
ADRs, medicines coding, causality assessment, signal
detection, risk management, and action in case of serious/fatal
adverse drug events (ADE).
30. Database
• Creating a safely stored, classified database which is
retrievable and guarded by required degrees of confidentiality
Promotion
• To promote the habit of reporting ADRs to the higher center,
medical journals, health bulletins and other professional
healthcare publications
31. Networking
• To encourage healthcare professionals to contact institutions
working on a global scale in PV e.g. Uppsala Monitoring
Centre (UMC) WHO department of Essential Medicines and
Medicines Policy, Geneva, and net groups like International
Network for the Rational Use of Drugs (INRUD), E-drug, and
Network for Rational Use of Medicines (NetRUM)
32. DATAACQUISITION
• Patient: Age, gender, medical history in brief, ethnic origin (in
some countries)
• ADE monitoring: Detailed description (nature, localization,
severity, characteristics), reports of investigations and tests,
date of appearance, course, outcome
• Suspected medicines: Name (brand, formulation, ingredient,
concentration, manufacturer), dose, route of administration,
date of initiation of therapy/date of withdrawal of therapy,
indications for use, and rechallenge in case of non serious
ADEs
33. • Other medicines: All other medicines used by the patient
(including self medication) including their name, dose,
route, date of initiation and withdrawal
• Risk factors: e.g. impaired renal function, past exposure
to suspected medicines, history of allergy, and social drug
use
• Reporter: Name and address of the reporter (confidential
and to be used for data completion, verification, and
follow up)
34. BRINGING A REPORTING CULTURE
• Easy and free availability of prepaid reporting forms and other modes of
reporting
• Duly acknowledging the receipt of ADR reports telephonically or through
personal communication
• Providing journal articles, ADR bulletins, newsletters to reporters
• Actively involving the PV center staff in scientific meetings, undergraduate
and postgraduate education
• Collaborating with other PV committees
• Collaborating with professional associations
• Utilizing PV data for the development of clinical pharmacy and clinical
Pharamcology
35. Importance of Pharmacovigilance for Pharmaceutical Industry
• Investment in R&D of new compounds
• Commitment to bring new drug to market to enhance patients’
health and quality of life
• Strict governance to conduct clinical trials and product
development activities
• Conduct relations with patients and healthcare professionals in
accordance with ethical and legal principles
36. Clinical research organisations (CROs)
• Specialized in providing comprehensive pharmacovigilance
(PV) and risk management services for Sponsors of clinical
trials and Marketing Authorisation Holders
37. Case Processing & Reporting
Individual Case Safety Reports (ICSR) in Pharmacovigilance
• The collection and processing of Individual Case Safety
Reports (ICSRs) is a fundamental component of the
pharmacovigilance system.
• Systems must be in place to ensure the collection and
management of Serious Adverse Events (SAEs) and Adverse
Events of Special Interest (AESI) from interventional clinical
trials.
38. Requirements for ICSRs reporting
• Increasingly, reporting of ICSRs is performed electronically
via transmission of an eXtensible Markup Language (xml) file
following the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals
for Human Use (ICH) ICSR format
[(ICH-E2B(R2) or ICH HL7/ISO-E2B(R3) specification].
• Comprehensive management of cases, from receipt, data entry,
coding, medical assessment and follow-up, through reporting
to Competent Authorities, Ethics Committees/Institutional
Review Boards and Investigators and exchange with partners.
39. Case Processing & Reporting Services
• Receipt and triage of initial and follow-up cases SAEs, AESIs,
SUSARs, ICSRs, regulatory cases
• Data entry
• MedDRA coding
• Narrative production
• Analysis of Similar Events
• 100% case quality control (QC)
• Medical assessment
• Case closure and locking
• Generation and distribution of follow-up queries
• Global expedited case reporting
• EudraVigilance reporting using EV Web and E2B (R3) compliance
• Reporting to Competent Authorities, Ethics Committees/Institutional
Review Boards and Investigators
• Reconciliation with external data collection partners (CROs,
affiliates, partners, etc.)
