Importance of Pharmacovigilance
for Pharmaceutical Industry
JARIR AT THOBARI, MD, DPHARM, PHD
FACULTY OF MEDICINE
GADJAH MADA UNIVERSITY
YOGYAKARTA, INDONESIA
Role of Pharma Company Globally
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
Ref: Adams CP, Brantner VV (2010). Spending on New Drug Development. ‘Health Econ. 19: 130–141 (2010)
Drug Safety Report Worldwide
Sources: http://who-umc.org/graphics/26929.gif
Drug safety and risk
The challenge of maximizing drug safety and
maintaining public confidence has become
increasingly complex.
Pharmaceutical and biotechnology companies must
not only monitor, but also proactively assess and
manage drug risk throughout a product’s lifecycle,
from development to post market.
Pharmacovigilance
WHO defined as
'the pharmacological science and activities relating to the
detection, assessment, understanding and prevention of adverse
effects or any other drug-related problem‘
An umbrella term used to describe the processes for
monitoring and evaluating ADRs
is a key component of effective drug regulation systems, clinical
practice and public health programs.
It is the study of the safety of marketed drugs
examined under the practical conditions of clinical use
in large communities
Pharmacovigilance rational
Pre Approval Data Post Approval Data - Solicited Safety
- Controlled - Real life ; uncontrolled Data
- Limited # Pts - Off label use - Unsolicited Safety
- Safety data not mature -Generic Data
Population
Subjects for
approval
Pharmacovigilance important?
Drugs appear to be safe and well-tolerated, but the safety in
the ‘real world’ is unclear
Chronically/repeatedly use of drugs
Use with other drugs
Safety in vulnerable groups is unknown
Pregnant women & brestfeeding mother, elderly, young
children
Significant harm to a few patients, rumours and myths
can destroy the credibility, adherence to and success of a
treatment.
Pharmacovigilance important?
Pharmacovigilance provide evidence
medicine-related problems : treatment failure,
counterfeit/poor quality medicines, drug interactions,
incorrect use.
Generate evidence that will inspire public confidence and
trust.
Pharmacovigilance systems is strongly recommended
Is system of reporting exists?
capacity for monitoring?
Pharmacovigilance – Major Aims
Early detection of unknown safety problems
Detection of increases in frequency
Identification of risk factors
Quantifying risks
Preventing patients from being affected
unnecessarily
Pharmacovigilance Partnership
Patient Policy maker (regulator)
Physician and PHARMACOVIGILANCE Pharmaceutical
association Industry
Public Press (media)
Pharmacovigilance Practice within
the Industry
Clinical development of medicines
Pharmacovigilance during clinical research
Adverse events during clinical studies
Submit to regulatory authorities within specified time
frame
Notify all investigators and ethics committees
Safety review by independent Drug Safety Monitoring
Boards
Provide annual reports
Summary and analysis of all the serious adverse events
New safety findings from animal studies
Evaluations of benefit and risk
When Product is Marketed
Safety reporting is an obligation for companies in
Marketing Phase
Include:
Phase IV Studies (Post authorization studies)
Clinical trials (intervene disease management )
Pharmacoepidemiological studies (non-interventional or
observational)
Risk Management Plan
Periodic Safety Updates Report (PSUR)
Spontaneous Reports
Risk Management Planning (RMP)
RMP : a strategic safety program designed to decrease product
risk
Three main elements
1) Safety reports in pre-clinical and clinical phases
2) Pharmacovigilance Plan - company must indicate how to resolve
the uncertainties (e.g., extra studies)
3) Risk minimization plan – how the company propose to reduce
the severity or frequency of known adverse reactions (e.g.,
special communication programmes, or educational exercices,
registration programmes for patients or pharmacists)
Indicate timelines for those plans
Periodic Safety Update Reports (PSUR)
Overview of the safety of the product, including all
Adverse Drug Reports
Summary of the worldwide registration and usage status
Actions taken about safety issues
A regulatory requirement for authorized medicine
Generated every 6 months for the first 2 years of launch,
then annually for 5 years
Spontaneous Reporting
Spontaneous reporting
Reporting by HCPs
Any serious adverse reactions : Legal obligations on the
company to report within a specified time frame to the
regulatory authority
Non-serious reactions: included in periodic safety update
reports
Entered on the data base of company and regulatory body
Literature screening on weekly basis
Pharmacovigilance Team at the Company
Each R&D international company has a dedicated
Clinical Safety team for:
Overseeing the above plans
Signal detection from ADR reporting
Perform trend analysis
Local Office of R&D company has dedicated
regulatory/medical affairs expert for looking after
the local pharmacovigilance plans and coordinating
with the global team
Sources of Report at WHO-UMC
Source: Drug Information Journal, Vol. 42, pp. 409–419, 2008
Number of Medicinal Products
Source: Drug Information Journal, Vol. 42, pp. 409–419, 2008
Improving Pharmacovigilance
Increase the awareness of healthcare professionals and the public on
the understanding of importance of pharmacovigilance
Develop and promote an effective channel for ADR reporting, such as
online reporting system
All the parties involved in pharmacovigilance reporting are coordinated
under a platform from BPOM
A centralized database for safety reports to facilitate systematic follow
up and detailed analyses
Improve communication among stakeholders in the reporting of
adverse events such as, the regulator, the health care providers, and
manufacturer for pharmacovigilance
Good Pharmacovigilance Practice (GVP)
Modules
Pharmacovigilance system and its quality system
Pharmacovigilance master file
Pharmacovigilance inspection
Pharmacovigilance audit
Risk management system
Management and reporting of ADR medicinal product
Periodic safety update report (PSUR)
Post-authorisation safety studies
Additional monitoring
Safety communication
