Pharmacovigilance
Pharmacovigilance
is the science and activities related to the detection, assessment,
understanding, and prevention of adverse effects or any other drug-related
problem.
History and Development of Pharmacovigilance
The history and development of pharmacovigilance can be traced back to the mid-20th century. The history and development of pharmacovigilance can be traced back to the mid-20th century. Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. The history and development of pharmacovigilance can be traced back to the mid-20th century.
In
the early 1960s, the thalidomide tragedy occurred, where thalidomide, a drug
prescribed to pregnant women to treat morning sickness, led to thousands of
birth defects. This incident raised concerns about the safety of drugs, and it
was recognized that there was a need for better monitoring of adverse drug
reactions (ADRs).
In
1961, the World Health Organization (WHO) established the Programme for
International Drug Monitoring (PIDM), which became the cornerstone of the
global pharmacovigilance system. The PIDM set up national centers in various
countries to collect and report information on adverse drug reactions. The
first national center was established in Sweden in 1965, followed by the UK in
1968
In
1992, the European Union (EU) implemented the Directive 92/28/EEC, which
established a pharmacovigilance system in Europe. The directive required
pharmaceutical companies to report all adverse drug reactions to the regulatory
authorities and to provide periodic safety update reports.
In
2004, the EU implemented the Pharmacovigilance Legislation, which further
strengthened the pharmacovigilance system. This legislation introduced a
requirement for pharmaceutical companies to appoint a qualified person
responsible for pharmacovigilance and to establish a risk management plan.
The
United States has also played a significant role in the development of
pharmacovigilance. In 1938, the Food, Drug, and Cosmetic Act was passed, which
required drug manufacturers to prove the safety of their products before they
could be marketed. In 1962, the Kefauver-Harris Amendment was passed, which
required drug manufacturers to prove the efficacy and safety of their products
before they could be approved.
In
2007, the US FDA established the Sentinel Initiative, which is a national
electronic system for monitoring the safety of drugs and medical products. The
Sentinel system uses electronic health data from various sources to detect and
analyze potential safety issues.
Today,
pharmacovigilance has become an essential component of drug development and
post-marketing surveillance. The global pharmacovigilance system continues to
evolve and improve, and new technologies and methods are being developed to
enhance the detection, assessment, and prevention of adverse drug reactions.
Importance of Safety
Monitoring of Medicine
Safety
monitoring of medicines, also known as pharmacovigilance, is crucial for
protecting public health and ensuring the safe use of medicines. The following
are some of the key reasons why safety monitoring of medicines is so important:
1. Detection of adverse reactions:
Safety monitoring of medicines helps to identify adverse reactions and other
drug-related problems that may not have been detected during clinical trials.
This information is important for ensuring that the benefits of the medicine
outweigh its potential risks.
2. Early detection of safety issues:
Safety monitoring can help to identify safety issues early, which can prevent
harm to patients and minimize the impact of any adverse events.
3. Monitoring of medicine use in the
real world: Clinical trials provide important information about the safety and
efficacy of medicines, but they are conducted in a controlled environment.
Safety monitoring provides information about how medicines are being used in
the real world, which can reveal potential safety issues that may not have been
detected during clinical trials
4. Identification of potential drug
interactions: Safety monitoring can help to identify potential drug
interactions that may not have been detected during clinical trials. This
information is important for ensuring that medicines are used safely in
combination with other medicines
5. Improved patient outcomes: Safety
monitoring can lead to improved patient outcomes by identifying potential drug
interactions, drug-related problems, and ADRs. This information can be used to
improve prescribing practices and to develop strategies for managing ADRs
In
conclusion, safety monitoring of medicines is crucial for ensuring the safe and
effective use of medicines. It provides important information about the safety
of medicines in the real world, helps to identify potential safety issues, and
informs the development of new medicines and the improvement of existing ones
WHO International Drug
Monitoring Programme
The WHO Programme for International Drug Monitoring is a global system
for the monitoring of the safety of medicines. It was established in 1968 and
is responsible for collecting and analyzing reports of adverse drug reactions
(ADRs) from around the world. The programme operates through a network of
national pharmacovigilance centres, which are responsible for collecting and
analyzing ADR reports from healthcare professionals, patients, and
pharmaceutical companies.
The main objectives of the WHO Programme for International Drug Monitoring are to:
1 Detect and evaluate ADRs and other drug-related problems
2. Monitor the safety of medicines after they have been marketed
3. Provide information to healthcare professionals and patients about the safety of medicines
4. Promote the safe and rational use of medicines
The WHO Programme for International Drug Monitoring uses a system of
individual case safety reports (ICSRs) to collect information on ADRs. An ICSR
is a report that contains information about a single ADR event, including the
drug involved, the patient, the ADR, and any other relevant information.
The
program maintains a global database of ADR reports, known as VigiBase, which
contains more than 22 million individual case safety reports from over 130
countries. The database is used by regulatory agencies, pharmaceutical
companies, and healthcare professionals to monitor the safety of medicines and
to inform regulatory decisions.
The information collected by the WHO Programme for International Drug
Monitoring is used to identify safety concerns associated with medicines and to
take appropriate regulatory and public health actions. This may include changes
to product labeling, the withdrawal of drugs from the market, or the
implementation of risk management plans.
The WHO Programme for International Drug Monitoring is a critical
component of global pharmacovigilance and plays an important role in ensuring
the safety and effectiveness of medicines worldwide.
