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Q. What is Pharmacovigilance and why
do companies need Pharmacovigilance?
Pharmacovigilance (PV) is a regulated practice
that is required to both gain and maintain market authorisation for products in
all major markets. Regulations differ from region to region but all contain
similar elements. PV requirements include the assessment of patient
as part of an integrated benefit-risk assessment that is
conducted throughout the product lifecycle. A positive benefit-risk balance is
required for a product to achieve market authorisation and depending on the
benefit-risk balance, post authorisation actions may be required to minimise
public safety risks. Once products are authorised, then PV requirements include
the ongoing collection, analysis and reporting of adverse drug reactions,
the periodic reporting of cumulative safety events and also the detection and
analysis of safety signals
for as long as the product is available in
Q. Tell us how to devise an effective Pharmacovigilance strategy? A.
Pharmaceutical companies employ dedicated
Pharmacovigilance functions to develop and deploy PV strategy. The PV function
is usually part of the development or medical organisation and reports to a
Chief Medical Officer. With the wide diversity of PV requirements ranging from
high volume routine adverse drug reaction (ADR) processing to knowledge of rich
benefit-risk assessment, a considered sourcing strategy is a good start in
defining PV strategy. Consideration is given to which processes must be
performed internally and which processes may be sourced externally to enhance
either internal capability or capacity.
Once the sourcing operating model is
defined, then effective and integrated processes need to be designed to both
protect patients and meet regulatory requirements in a timely and efficient
manner. Aligned to the processes is the development of appropriately skilled
staff and the deployment of technology configured to simplify the flow of
information and to generate insight from the mass of data that is processed
within a PV system.
Underpinning this approach of
people, process and technology are two further elements: development of a
quality management system to assure quality and compliance of operations and an
integrated approach to medical governance that ensures decisions are taken in a
consistent and transparent manner.
the common problems faced by Pharma companies, when
The problems for companies implementing
Pharmacovigilance arise from the range and complexity of activities that need
to be performed. Large multi-national pharmaceutical companies can process in
excess of 150,000 individual case safety reports in a year. Concurrently,
individual products may carry regulatory requirements to conduct post
authorisation safety studies, and Physicians from Pharmacovigilance will be
working with internal medical partners in benefit-risk teams engaged from first
in human exposure through the product's entire life on the market.
While these are common activities, often
performed globally, the divergence of national and regional regulations mean
that companies need to tailor approach to each market in which products are
developed and authorised.
does Business Intelligence (BI) and analytics play a role in Pharmacovigilance?
Pharmacovigilance functions collect and process large amounts of data
and information. Some of this is submitted to regulatory authorities, who in
turn maintain large databases of adverse drug reactions, consolidating
information from many market authorisation holders. These databases, both
within and external to Pharmaceutical companies are used for detecting safety
signals. Safety signals are
generally observed as a disproportional occurrence of certain adverse reactions
associated with certain drugs.
Data mining approaches used to identify such signals are commonly referred to
as signal detection. Before any safety signal is confirmed, it is rigorously
reviewed by the market authorisation holder with in-depth knowledge of the
product and its safety profile. This may in turn require further integration
and analysis of various data sets.
Q. How important is the need for
Pharmacovigilance in India? (PV trends in India)
. Compliance with pharmacovigilance regulations
is compulsory. Any company, either domestic or foreign, seeking to gain
authorisation to market medicinal products in India needs to comply with the
requirements of the National Pharmacovigilance Programme of India.
programme is administered by the Central Drugs Standards Control Organisation,
which is part of the Government's Ministry of Health and Family Welfare.
As the domestic Indian pharmaceutical industry seeks to gain market
authorisations to export to other countries, then it is compulsory to comply
with the local regulations in which each individual market authorisation is
Q. Can you share with us some critical findings from a
Pharmacovigilance inspection with some specific examples? A.
The Medicines and Healthcare
Products Regulatory Agency (MHRA), the UK government agency responsible for
ensuring that medicines and medical devices work and are acceptably safe, has
reported that the area where they are currently seeing the most critical
findings is in reference to safety information. This can include confirmed
safety signals not being added to the product label or product labels not being
distributed internally or to prescribers and patients in a timely manner.
Market authorisation holders are required to address each finding by way of a
Corrective and Preventative Action (CAPA). The detail of inspection findings is
often a confidential matter shared between the inspecting authority and the
market authorisation holder being inspected. However, where there is deemed to
be a real or potential impact on public health, then findings will be made
public and, in severe cases, carry with them significant fines.