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The Need of The Hour!
Way towards a safe
(M.PHARM IInd Semister )
SKB COLLEGE OF PHARMACY NEW
KAMPTEE , NAGPUR
AIM AND OBJECTIVE
PARTENERS IN PHARMACOVIGILANCE
PHARMACOVIGILANCE IN DRUG REGULATION
PHARMACOVIGILANCE IN CLINICAL PRACTICE
CONCLUSION AND CONSIDARATION FOR FUTURE.
Pharmacovigilance (PV) is the pharmacological
science relating to the detection , assessment
,understanding and prevention of adverse effects,
particularly long term and short term side effect of
All medicines (pharmaceutical and vaccines) have side
effect some are known many are still unknown even
this medicine has been in clinical use. The important
to monitor both known and unknown side effects of
medicines in order to determine any new information
in relation to their safety profile .
• Pharmacovigilance looks at all available
information to assess the safety profile of a drug
• Pharmacovigilance should also take the benefit of
the drug in account
• Spontaneous reporting depends on the health
professional – YOU.
1 2 3 4
ADR ADR ADR Sharing
Suspicion Reporting Analysis of Findings
Aim And Objectives of
To identifying new information about hazards as
associated with medicines
Improve patient care and safety
Improve public health and safety
Encourage safe, rational and appropriate use of drugs
Promote understanding, education and clinical
training in pharmacovigilance
Adverse Drug Reactions Classifications
Adverse drug reaction
which is noxious ,unintended and which occurs A
response at doses normally used in humans for
Prophylaxis, Diagnosis or Therapy of disease , or for
modification of physiological function…..(WHO 1972)
Type A(Augmented) Type B(Bizarre)
Pharmacologically predictable Yes No
Dose dependent Yes No
Frequency Common Rarer
Incidence High Low
Mortality Low High
Treatment Adjust Dose Stop the Drug
Adverse drug reaction(ADR)
a)Serious adverse reaction.
b) Unexpected adverse reaction.
Any unintended effect of a pharmaceutical product
occurring at normal dosage which is related to the
pharmacological properties of the drug. e.g.
antihistamines producing sedation , anticholinergics
producing dryness ..
Phases of Product Development
It takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in
5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in
people is approved.
Phase I Phase II Phase III FDA Phase IV
Years 3.5 1 2 3 2.5
20 to 80 100 to 300 1000 to 3000
Test Laboratory and
healthy patient patient
Population animal studies
volunteers volunteers volunteers
File IND File NDA Review
at FDA at FDA process /
Assess safety Determine effectiveness, required by
Purpose and biological safety and monitor adverse FDA
look for side
activity dosage reactions from
compounds 5 enter trials 1 approved
Pharmacovigilance And India
India is is a hub of Global Clinical trials & a destination
for Drug Discovery & Development. However, whether
patients in India receive safe drugs or not is still very
Rapid induction of NCEs and high tech Pharma
products in the market throw up the Challenges of
monitoring Adverse Drug Reactions (ADRs) over
large multiethnic population base...
Who Should Report Safety Data
Pharmaceutical companies qualified persons –
Investigational products (clinical trials)
Post-approval reporting – Individual Case Safety Report
(ICSR), Periodic Safety Update Report (PSUR)
In many countries patients are encouraged (but not
obligated) to report side effects
What to Report
It is important to report serious unexpected ADRs.
Most cases of unexpected ADRs are associated with
medicines newly introduced on the market.
All suspected adverse reactions.
Every single problem related to the use of a drug.
ADRs associated with radiology contrast media,
vaccines, diagnostics, drugs used in traditional
medicine, herbal remedies, cosmetics, medical devices
Withdrawn Drugs From the Market
Drug Year Reason
Lumiracoxib 2008 Hepatotoxicity
Aprotinin 2008 Kidney and cardiovascular toxicity
Tegaserod 2007 Cardiovascular ischemic events
Ximelagatran 2006 Hepatotoxicity
Valdecoxib 2005 Dermatology adverse events
Pemoline 2005 Hepatotoxicity
Rofecoxib 2004 Thrombotic cardiovascular events
Levomethadyl 2003 Fatal Arrhytmia
Rapacuronium 2001 Risk of fatal bronchospasm
Cerivastatin 2001 Rhabdomyolosis
Trovafloxacin 2001 Hepatotoxicity
Amineptine 2000 Hepatotoxicity, dermatological side effects, abuse potential
Cisapride 2000 Cardiac arrhythmias
Troglitazone 2000 Hepatotoxicity
Four common drug banned in
other countries but not in India
IMPORTANCE OF PHARMACOVIGILANCE
Complete safety data (especially for unexpected and
serious adverse events) can only be captured through
It cannot be captured through clinical trials which are
conducted in an “artificial environment.”
In clinical trials
patients are not taking any other medications
do not have concomitant diseases
are taking the drug short-term (during the duration of the trials
are not part of vulnerable groups (e.g., children, pregnant women,
The WHO Quality Assurance and Safety : Medicines
The Uppsala Monitoring Centre (UMC)
The National Pharmacovigilance Centers
Hospitals And Academia
System of Safety Data Gathering
Patients National Regulatory
Companies International Safety
PHARMACOVIGILANCE IN DRUG
Clinical Trial Regulation
i) Collection of ADR
ii)monitoring clinical data
iii)reporting of clinical data
Post Marketing safety Monitoring
The RaPID is a PV program it conduct public health
It provide support to focal point.
Focus on RaPID HIV, T.B, Malaria and other program.
It is important to encourage and ensure reporting of
It consist of various department for working various
type of diseases
The Yellow Card Scheme is the main ADR reporting
scheme in the UK and was introduced in 1964 after the
thalidomide tragedy highlighted the urgent need for
routine monitoring of medicines. It receives more than
20,000 reports of possible side effects each year.
True challenge lies in….
In recognising at the earliest possible stage, the
adverse effects that a drug may induce , so that the
risk (unfavourable results) never becomes
disproportionate to benefit (Favourable results)
At the level of Clinicians …..
My Doctor is a good doctor, He made me no iller than I was…….
Willem Hussem (The Netherlands)1900 -1974
Translation: Peter Raven
There are no really safe biologically active drugs . There are only
safe physicians…. Harold A. kaminetzsky1963
1.Active reporting of ADVERSE DRUG REACTIONS as
forms are available freely e.g. Nimusulide
European Medicine Evaluation Agency Bans
Avoid Prescription errors
Articles highlighting the rise in prescription errors
To train Pharmacists in drug interactions,
side effects ,drug dosages
11. Students can start Pharmacy bulletins with help of
Respected Principal sir & coordinators…..
( Australian Prescriber, USPDI)
. Studentscan start Pharmacy bulletins with help of
Respected Principal sir & coordinators…..
( Australian Prescriber, USPDI)
Aims of Drug Alerts….
The information resources should be designed to
assist the health provider in their clinical choice of
drugs, in an effort to reduce the incidence and
severity of adverse effects & medication errors .
Drug Alert Leaflets
FDA pulls antiparkinsonism drug of Pergolide
EMEA bans Nimesulide
Petitions to remove Cox2 inhibitors
Cisapride under strict scrutiny
Phenylpropanolamine risk of Hemorragic
Animation of Pharmacovigilance: Students
have presented & posted on Google images
It is expected that 50 – 75 % of medical errors are
Think less about drug safety: more about
Use and react to concerns
Think less about regulating (incl. withdrawal)
and automating data input: more about useful
Think more about impact and consequences of
decisions and non-decisions