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| Pharmacovigilance |
Pharmacovigilance, also known as drug safety monitoring, is the science and
activities related to the detection, assessment, understanding and prevention
of adverse effects or any other possible drug-related problems. It is a very
important field that aims to ensure that the benefits of medication outweigh
any risks.
Monitoring drug safety post marketing
Most of the rigorous clinical trials are conducted before a drug is approved
for marketing. However, it is not possible to comprehensively study the effects
of a drug in the limited number of participants involved in clinical trials.
Adverse reactions and side effects that may not have been detected previously
often emerge once the drug is made available to a much larger population and
used in real-world settings. That is why monitoring drug safety does not end
with marketing approval but continues in the post marketing phase through PV
activities. Spontaneous reporting of adverse drug reactions (ADRs) by
healthcare professionals and patients help detect potential new safety issues
with medications as they are used by a wider population over longer durations
under real-life conditions. This ongoing monitoring plays a crucial role in
updating the known safety profiles of medications.
Role in risk management
When any new safety concerns are identified through post marketing
surveillance, regulatory authorities and pharmaceutical companies work together
on risk management plans. This involves analyzing risks versus benefits, communicating
newly emerging risks to healthcare professionals and patients, updating product
labels and information leaflets, and taking regulatory actions like additional
warnings, limiting indications or sometimes even market withdrawal, if deemed
necessary to manage risks. For example, restrictions were placed on the use of
some antidepressants in younger patients when increased risks of suicidal
behavior were detected through post marketing surveillance. Such risk
management helps ensure medications are used safely and their benefits outweigh
potential harms under all circumstances.
Global collaboration and data sharing
Given that drugs are often marketed globally, adverse reactions can occur and
be reported from any country. To fully understand potential safety issues with
a drug, pooling data from multiple global sources is important. That is why
international collaboration and data sharing on Pharmacovigilance
activities is vital. Organizations like the Uppsala Monitoring Centre play a
key role in collecting, analyzing and communicating ADR reports from across the
world to regulatory authorities and companies. Similarly, projects like the
Observational Medical Outcomes Partnership help pool real-world healthcare data
from different countries to better monitor drug safety issues. Global
cooperation helps leverage larger datasets to more efficiently detect potential
signals of harm and take globally coordinated actions to manage risks, when
required.
Challenges in developing countries
While pharmacovigilance capacities have grown in most developed countries,
challenges remain in establishing robust PV systems in developing world.
Limited resources, lack of trained manpower and awareness are some issues
faced. Underreporting of ADRs continues to be a major barrier - according to
estimates only about 5-10% of all ADRs get reported in developing countries
versus over 30% reporting rates achieved in developed nations. Weak regulations
and lack of coordination between stakeholders further hamper effective monitoring.
However, initiatives by WHO and others are helping address gaps through
simplified guidelines, improved training, use of mobile technologies for
reporting etc. Strengthening PV in developing world is critical given growing
access to medications there.
Role of healthcare professionals
Healthcare professionals like doctors, nurses, pharmacists form the backbone of
any pharmacovigilance program globally. They play a direct role in detecting,
reporting and managing adverse drug reactions experienced by patients under
their care. Spontaneous ADR reporting by healthcare professionals to national
PV centres/authorities is the single most important method of signal
generation. But non-reporting continues to be a challenge due to constraints
like time, lack of motivation and complexity of reporting processes in some
countries. Efforts targeting improved education, training, simplified reporting
tools and incentivizing reporting have helped enhance the participation of
healthcare professionals. Their role in strengthening pharmacovigilance for
patient safety cannot be undermined.
Patient involvement and empowerment
With growing access to health information, patients are also getting more
involved in monitoring their drug safety and reporting side effects. Certain
countries like UK have established direct patient reporting portals to national
PV centers. Patient groups also actively report safety issues. Tools enabling
direct patient reporting are expanding globally. At the same time, greater
efforts are required to improve health literacy and raise awareness on rational
medication use and responsibilities towards self-reporting of suspected ADRs.
Empowered through knowledge, patients can complement healthcare
professional-driven reporting and contribute immensely to effective
pharmacovigilance. Their role especially helps detect ADRs in over-the-counter
medications which may otherwise remain unreported.
Harnessing big data, artificial intelligence
With the healthcare revolution driven by digitization, large amounts of
electronic health records, insurance claims data and other digitized
information sources present opportunities for PV. 'Big data' strategies are
being explored to harness these real-world datasets using advanced analytics
including machine learning and artificial intelligence to assist with signal
detection and risk surveillance. For example, AI algorithms applied to large
clinical databases have shown potential in areas like screening large volumes
of case reports and biomedical literature to identify potential new safety
signals for further manual review. Such digital tools promise to enhance
pharmacovigilance through efficiency gains though their optimal use also
involves addressing challenges around privacy, biases and interpretability of
results. Overall, an innovative digital future holds promise for transforming
and scaling up global drug safety monitoring.
Pharmacovigilance activities play a critical public health role globally in
mitigating risks through ongoing safety monitoring once drugs are introduced in
the market. From spontaneous reporting by healthcare professionals and patients
to regulatory oversight and risk management - strong collaboration across
stakeholders remains key to success. With advancements in digitization and data
science, the future remains bright for further strengthening systems, enhancing
participation, and ensuring medication benefits far outweigh potential harms
under all circumstances through robust drug safety practices worldwide.
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