rochak presentation....current challenges of pharmacovegilence
TRANSCRIPT
The Challenges of Pharmacovigilance
Presented by:- Dr. ROCHAK SONI ICRI (DELHI).
Content:
1. Pharmacovigilance
2. Need for Pharmacovigilance
3. Challenges of Pharmacovigilance overall
4. Challenges of pharmacovigilence in india
5. Need to do
6. Conclusion
Dr.ROCHAK SONI
WHO definition of WHO definition of PharmacovigilancePharmacovigilance
The science and activities relating to the The science and activities relating to the detection, assessment, understanding detection, assessment, understanding
and prevention of adverse effects or any and prevention of adverse effects or any other drug-related problemother drug-related problem
Dr.ROCHAK SONI
Need for pharmacovigilance
• Limitation of preclinical safety data• Changing pharmaceutical marketing strategies
-direct consumer advertising
• Changing physician and patient preferences
-increase use of drug to improve QoF
• Easy accessibility
Dr.ROCHAK SONI
Challenges of pharmacovigilience
• Detection of ADRs• Assessment • Other challenges:-
a) sponsor related
b) industry related
Dr.ROCHAK SONI
The education of doctors, The education of doctors, pharmacists, industry and pharmacists, industry and
patients about drug safety and the patients about drug safety and the importance of ADR reporting can importance of ADR reporting can
certainly be listed among the certainly be listed among the greatest challenges.greatest challenges.
Detection of ADRs:-
Dr.ROCHAK SONI
Size and severity of the ADR problem Patient safety signals.
• 39 prospective studies from US hospitals• Overall incidence of serious ADRs = 6.7%• Overall incidence of fatal ADRs = 0.32%
(106 000 individuals)• 4th - 6th leading cause of death
Dr.ROCHAK SONI
Experience
report
Drugexperience
report
DrugInformation
DrugInformation
Patient
Health professional
Drug info/ADR reportingCentre
Drug AuthorityDr.ROCHAK SONI
Managing a signal
A first signal
Increasing information and knowledge
Public Information 1
Public Information 1
Public Information2
Public Information2
Media coverageMedia coverage
Also negative response
SCARESCARE
Dr.ROCHAK SONI
Activities essential to pharmacovigilance:
• Suspected ADR signal detection and formation of hypotheses
• Analysis of all issues around the signal, particularly confirmation of hypothesis, estimation of the size of the risk and whether susceptible patients exist
• Communication of information to health professionals and patients in a useful way. And possible regulatory action.
• Consequence evaluation.
Dr.ROCHAK SONI
Assessment of Problems in withdrawal & regulation
Dr.ROCHAK SONI
Example of a decision problem to be solved [1] ...
Cisapride - heart rhythm disorders• 1986: double blind study “cisapride
produced tachycardia”• 1992 WHO Signal published in Br Med J on
serious arrhythmia• 1995 case report published, Lancet “QT
prolongation and tachycardia”– Dear Doctor letter in USA by manufacturer
Should cisapride still be marketed?
Dr.ROCHAK SONI
Example of a decision problem to be solved [2] ...
• Piroxicam is the most GI toxic of the NSAIDS in several comparative studies– GI toxicity is a major cause of morbidity– Should piroxicam replace rofecoxib in
Venezuela?
Dr.ROCHAK SONI
Discussion point
• How often is drug withdrawal really necessary?
• Does withdrawal harm more people than it helps? (example-micturin- it cause cardic arrhythmias but people still want it to maintain there QoF)
• How can we reduce the time from signal to useful and properly used information
Dr.ROCHAK SONI
Other Challenges of pharmacovigilience
Dr.ROCHAK SONI
Sponsors related challenges
• Timely reporting from all the sponsor is challengeable
• Different safety reporting software –repeat work and time
• Data shared between sponsor is very slow• Difficult to obtain data from other sponsors
Dr.ROCHAK SONI
For generic manufactures:-
• Reporting the same molecules of others manufactures whenever the information is received or call
• Aggregate safety report/ signal detection-• Assessment of safety operation across all case
reported for the active moiety from all manufactures
• Difficult to obtain data from other manufactures
Dr.ROCHAK SONI
Industry related challenges
• To maintain the standardization of processes and data within organization
• To maintain harmonization• Delay in making better decisions• If manufacturing process is different it may lead
to different effect and also side effect
Dr.ROCHAK SONI
Challenges of pharmacovigilence in india
Dr.ROCHAK SONI
Dr.ROCHAK SONI
Dr.ROCHAK SONI
Dr.ROCHAK SONI
Where does fault lie?
• Adequate sharing of information between stockholder is poor
• No rapport with practising physician and peripheral centers
• Lack of documentation
Dr.ROCHAK SONI
It is said that pharmacovigilance is not easy and its errors and problems tend to be
repeated.[1] True, we have seen that before. We have had our share of errors and problems. We should now hope that the new programme
will have a smooth sailing. It will help us improve the patient safety significantly.
Dr.ROCHAK SONI
NEED TO DO
• There are much more active approaches needed for education of HPs and public in all countries
-more active use of the media
-much more interest in patient safety issues• There is a great need to know the basis for
regulatory decisions• Medication errors
–Root –cause analysis
Dr.ROCHAK SONI
Managing a signal: the future
Increasing information and knowledge also negative response
Public Information 1
Public Information 1
Public Public InformationInformation22
Public Public InformationInformation22
Media coverageMedia coverage
Pre-marketing riskPre-marketing risk managementmanagement
What do HPs and patients think and want
A first signal
Dr.ROCHAK SONI
Cont.-Patient involvement
• Patients need more general information about drugs and their effectiveness and risk
• VERY IMPORTANT– We need much more information about
what risks patients are prepared to take for what benefit to them. Until we know this we will continue to ‘second-guess’ about what is acceptable or not
Dr.ROCHAK SONI
Conclusions
• Think less about drug safety: more about patient safety
• Think less about regulating (incl. Withdrawal) more about useful information output
• Think more about impact and consequences of decisions and non-decisions
Dr.ROCHAK SONI
Conclusions
• ‘..Drug safety information must serve the health of the public. Such information should be ethically and effectively communicated in terms of both content and method. Facts, hypotheses and conclusions should be distinguished, uncertainty acknowledged, and information provided in ways that meet both general and individual needs...’
• Erice Declaration, 1998.
Dr.ROCHAK SONI
Questions?
Dr.ROCHAK SONI
Dr.ROCHAK SONI
