1. REVIEW ON PHARMACOVIGILANCE
Aman. S. Maharaj, Abhishek. D. Nagdeve, Abhishek. A. Pachghare, Aasma. D. Shah (B Pharmacy 4th Year)
Guide By Miss. Smita Mankar (M. Pharm Pharmaceutic)
P R Patil Institute of Pharmacy, Talegaon (S.P.) Dist- Wardha 442202
ABSTRACT
Pharmacovigilance is an important and integral part of clinical
research. Pharmacovigilance is “defined as the pharmacological
science relating to the detection, assessment, understanding and
prevention of adverse effects, particularly long term and short term
adverse effects of medicines. This addresses what exactly is
pharmacovigilance. What do we know of its benefits and risks,
challenges and the future hold for pharmacovigilance in Indian
medicine. Here the main focus on the aims and role of
pharmacovigilance in medicines regulation and their Partners.
INTRODUCTION
WHO definition
Pharmacovigilance is a science and activities related to detection,
assessment, understanding and prevention of adverse effects or
any other medicine related problem.
As such, pharmacovigilance heavily focuses on adverse drug
reactions, Medication errors such as overdose, and misuse and
abuse of a drug as well as drug exposure during pregnancy and
breastfeeding, are also of interest, even without an adverse event,
because they may result in an adverse drug reaction.
Pharmacovigilance is still in its infancy in India and there exists
very limited knowledge about the discipline.
While major advancements of displine of pharmacovigilance have
taken place in the western countries not much has been achieved
in India. There is an immense need to understand the importance
of pharmacovigilance and how it impacts the life cycle of the
product. This will enable integration of good pharmacovigilance
practice in the process and procedures to help ensure regulatory
compliance and enhance clinical trials safety and post marketing
surveillance.
Pharmacovigilance is not new to India and has infact been going
on from 1998. When India decided to join the uppasla centre for
adverse event monitoring. The importance of pharmacovigilance
is withdrawls the regulatory agencies, media; consumers have
become more aware about the benefit and risks of medicines.
Presented at P. R. Patil Institute of Pharmacy , Talegaon (S.P.) during On 16 February 2023
GLOBAL PHARMACOVIGILANCE MARKET
SEGMENTATION
This report forecasts revenue growth at the global, regional, and country levels and
provides an analysis of the latest industry trends and opportunities in each of the sub-
segments from 2017 to 2030. For this study, Grand View Research has segmented the
global pharmacovigilance market report on the basis of service provider, product life
cycle, type, process flow, therapeutic area, end-use, and region:
• Service Provider Outlook (Revenue, USD Million, 2017 - 2030)
• In-house
• Contract Outsourcing
• Product Life Cycle Outlook (Revenue, USD Million, 2017 - 2030)
• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV
• Type Outlook (Revenue, USD Million, 2017 - 2030)
• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining
• Process Flow Outlook (Revenue, USD Million, 2017 - 2030)
• Case Data Management
• Case Logging
• Case Data Analysis
• Medical Reviewing & Reporting
• Signal Detection
• Adverse Event Logging
• Adverse Event Analysis
• Adverse Event Review & Reporting
• Risk Management System
• Risk Evaluation System
• Risk Mitigation System
• Therapeutic Area Outlook (Revenue, USD Million, 2017 - 2030)
• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others
• End-use Outlook (Revenue, USD Million, 2017 - 2030)
• Pharmaceuticals
• Biotechnology Companies
• Medical Device Manufacturers
• Others
• Regional Outlook (Revenue, USD Million, 2017 - 2030)
• North America
• U.S.
• Canada
• Europe
• U.K
• Germany
• France
• Italy
• Spain
• Russia
• Asia Pacific
• Japan
• China
• India
• Latin America
• Brazil
• Mexico
• Middle East and Africa
• South Africa
• Kingdom of Saudi Arabia
CONCLUSION
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. Pharmacovigilance required for
systematically identifying and correlating drugs and side effects and
taking corrective actions.
REFERENCE
1. WHO, Pharmacovigilance: ensuring the safe use of medicines,
Geneva: WHO 2004.
2. WHO, Safety of medicines in public health programmes :
pharmacovigilance an essential tool, WHO, 2006.
3. WHO, Pharmacovigilance: ensuring the safe use of medicines,
Geneva: WHO 2002.
NATIONAL PROGRAMME PHARMACOVIGILANCE
Information about rare but serious adverse drug reactions, chronic toxicity, use in special
groups (e.g. pregnant women, children, elderly) and drug interactions is often incomplete or
not available. Certain adverse drug reactions may not be detected until a very large number of
people have received the medicine.
Pharmacovigilance is therefore one of the important post-marketing tools in ensuring the
safety of pharmaceutical and related health products.
• Assessing the risks and benefits of medicines in order to determine what action, if any, is
necessary to improve their safe use.
• Providing information to users to optimise safe and effective use of medicines.
• Monitoring the impact of any action taken.
PARTNERS IN PHARMACOVIGILANCE
The management of the risks associated with the use of medicines demands close and effective
collaboration between the key players in the pharmacovigilance. Sustained commitment to such
collaboration is vital if the future challenges in pharmacovigilance are to
be met, and if the discipline is to continue to develop and flourish.
Monitoring the safety of medicines: key partners
• Government
• Industry
• Hospitals and academia
• Medical and pharmaceutical associations
• Poisons and medicines information centres
• Health professionals
• Patients
• Consumers
• The media
• World Health Organization
AIMS OF PHARMACOVIGILANCE
Improve patient care and safety in relation to the use of medicines
and all medical and Paramedical interventions.
• Research the efficacy of drug and by monitoring the adverse
effects of drugs right from
the lab to the pharmacy and then on for many years.
• Pharmacovigilance keeps track of any drastic effects of drugs.
• Improve public health and safety in relation to the use of
medicines.
• Contribute to the assessment of benefit, harm, effectiveness and
risk of medicines,
encouraging their safe, rational and more effective (including
cost-effective)
use.
• Promote understanding, education and clinical training in
pharmacovigilance and its effective communication to the
public.
More information is generally needed about use in specific
populat ion groups, notably children, pregnant women and the
elderly, and about the efficacy and safety of chronic use,
especially in combination with other medicines. Experience has
shown that many adverse effects, interactions (i.e. with foods or
other medicines) and risk factors come to light only during the
years after the release of a medicine.
Medicine Adverse reaction
Reserpine Depression
Aminophenazone
(amidopyrine)
Agranulocytosis
Practolol Sclerosing peritonitis
Fluothane Hepatocellular hepatitis
Chloramphenicol Aplastic anaemia
Oral contraceptives Thromboembolism
Statins Rhabdomyolysis
Classical example of serious and unexpected adverse
reactions
NEED FOR PHARMACOVIGILANCE
Reason 1: Humanitarian concern - Insufficient evidence of safety from clinical trials Animal
experiments Phase 1-3 studies prior to marketing authorization.
Reason 2: Medicines are supposed to save lives Dying from a disease is sometimes
unavoidable; dying from a medicine is unacceptable.
Reason 3: ADR-related cost to the country exceeds the cost of the medications themselves.
Reason 4: Promoting rational use of medicines and adherence.
Reason 5: Ensuring public confidence.
Reason 6: Ethics, to know of something that is harmful to another person who does not know, and
not telling, is unethical.
ROLE OF PHARMACOVIGILANCE” IN MEDICINES
REGULATION
• Clinical trials;
• The safety of complementary and traditional medicines, vaccines and biological medicines;
• The development of lines of communication between all parties which have an interest in
medicine safety, ensuring that they are able to function efficiently and ethically, particularly at
times of crisis.
DIFFERENT PHARMACOVIGILANCE CENTER IN
INDIA
