Safety Reporting and Pharmacovigilance.pptx

Safety Reporting and
Pharmacovigilance
Dr Abhishek Tengli

Pharmacovigilance
• Definition:
Pharmacovigilance is the science and activities related to the detection,
assessment, understanding, and prevention of adverse effects or any
other drug-related problems. Safety reporting is an essential aspect of
pharmacovigilance, which involves collecting, processing, and
evaluating information on the safety of drugs, biologics, and medical
devices

Background
• It is a relatively new field, having emerged in the 1960s as a response to the
thalidomide tragedy, which led to the birth of thousands of children with severe
birth defects.
• Following the thalidomide disaster, there was a growing awareness of the need to
systematically monitor and evaluate the safety and efficacy of medicines, both
during the pre-marketing and post-marketing phases. The World Health
Organization (WHO) recognized the importance of pharmacovigilance in 1968
when it established the Programme for International Drug Monitoring, which is
now a global network of over 150 countries.

• Since then, pharmacovigilance has evolved to become an essential component of
drug development and regulation. It has become a critical tool for identifying and
monitoring adverse drug reactions, evaluating the safety and efficacy of
medicines, and promoting the rational use of medications.
• Today, pharmacovigilance is an interdisciplinary field that involves collaboration
between healthcare professionals, regulatory authorities, pharmaceutical
companies, and patients. The focus is on ensuring the safe and effective use of
medicines, reducing the risks associated with their use, and improving patient
outcomes.

• As such, pharmacovigilance heavily focuses on ADR, which are defined as any
response to a drug which is noxious and unintended, including lack of efficacy (the
condition that this definition only applies with the doses normally used for
the prophylaxis, diagnosis or therapy of disease, or for the modification of
physiological disorder function was excluded with the latest amendment of the
applicable legislation).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.
• Information received from patients and healthcare providers via pharmacovigilance
agreements, as well as other sources such as the medical literature, plays a critical
role in providing the data necessary for pharmacovigilance to take place. To market
or to test a pharmaceutical product in most countries, adverse event data received
by the license holder (usually a pharmaceutical company) must be submitted to the
local drug regulatory authority.

• Ultimately, pharmacovigilance is concerned with identifying the hazards associated with
pharmaceutical products and with minimizing the risk of any harm that may come to
patients. Companies must conduct a comprehensive drug safety and pharmacovigilance
audit to assess their compliance with worldwide laws, regulations, and guidance.
• Adverse event (AE) reporting involves the receipt, triage, data entry, assessment,
distribution, reporting (if appropriate), and archiving of AE data and documentation. The
source of AE reports may include spontaneous reports from healthcare professionals or
patients (or other intermediaries); solicited reports from patient support programs; reports
from clinical or post-marketing studies; reports from literature sources; reports from the
media (including social media and websites); and reports reported to drug regulatory
authorities themselves. For pharmaceutical companies, AE reporting is a regulatory
requirement in most countries. AE reporting also provides data to these companies and
drug regulatory authorities that play a key role in assessing the risk-benefit profile of a
given drug.

Objectives
1. Ensure the safety of medicines by identifying and monitoring
adverse drug reactions (ADR).
2. Assess and evaluate the risks associated with the use of medicines.
3. Improve the rational use of medicines by providing accurate and up-
to-date information on their safety and efficacy.
4. Enhance patient safety and public health by identifying and
minimizing the risks associated with the use of medicines.
5. Provide timely and accurate information to regulatory authorities,
healthcare professionals, patients, and the general public.

Ensure the safety of medicines by identifying
and monitoring adverse drug reactions (ADR)
• Spontaneous reporting: Healthcare professionals, patients or caregivers
voluntarily report any ADRs to regulatory authorities or the drug
manufacturer.
• Clinical trials: These studies are conducted before a medication is approved
for use and involve monitoring patients for any potential ADRs.
• Observational studies: These studies involve monitoring patients in real-
world settings after a medication has been approved for use.
• Post-marketing surveillance: This involves monitoring a medication's safety
after it has been approved and is being marketed to the public.

Assess and evaluate the risks associated
with the use of medicines
• Dose-response relationship: The relationship between the dose of a
medication and its effect on the patient.
• Patient characteristics: Factors such as age, gender, and underlying health
conditions can affect the way a patient responds to a medication.
• Concomitant medication use: The use of other medications can interact
with the medication being assessed, increasing the risk of adverse effects.
• Route of administration: The way a medication is administered can affect
its efficacy and potential for adverse effects.
• Duration of treatment: The length of time a patient is exposed to a
medication can impact its safety and efficacy

Improve the rational use of medicines by providing
accurate and up-to-date information on their safety
and efficacy.
• Monitoring the safety and efficacy of medicines: By collecting and analyzing
data on adverse drug reactions and other drug-related problems,
pharmacovigilance can identify potential safety concerns and inform
decisions related to the use of medicines.
• Providing information on the safe and effective use of medicines: This
includes providing healthcare professionals and patients with up-to-date
information on the appropriate use of medicines, including dosing,
administration, contraindications, and precautions.

• Communicating information on the risks and benefits of medicines: This includes
providing information to patients and healthcare professionals on the potential
risks and benefits associated with the use of a medication, helping to improve the
decision-making process related to the use of medicines.
• Promoting the rational use of medicines: This includes promoting the use of
evidence-based medicine and encouraging healthcare professionals and patients to
make informed decisions about the use of medicines.

Enhance patient safety and public health by
identifying and minimizing the risks associated
with the use of medicines
• Monitoring the safety of medicines: By collecting and analyzing data on
adverse drug reactions and other drug-related problems, pharmacovigilance can
identify potential safety concerns and inform decisions related to the use of
medicines.
• Assessing and evaluating the risks associated with the use of medicines: By
analyzing data related to the safety and efficacy of a medication,
pharmacovigilance can determine the potential risks and benefits associated
with its use.
• Providing information on the safe and effective use of medicines: This includes
providing healthcare professionals and patients with up-to-date information on
the appropriate use of medicines, including dosing, administration,
contraindications, and precautions.

Provide timely and accurate information to
regulatory authorities, healthcare professionals,
patients, and the general public
• It is a critical component of pharmacovigilance. The information collected
through pharmacovigilance activities is used to evaluate the safety and
efficacy of medicines, inform regulatory decisions, and promote the
rational use of medications.
• Regulatory authorities rely on the data collected through
pharmacovigilance to make decisions related to the approval, labeling, and
post-marketing surveillance of medicines. Healthcare professionals use
this information to make informed decisions about the use of medications
and to manage any adverse effects that may arise. Patients rely on
pharmacovigilance to ensure the safety of the medications they take and to
be aware of any potential risks associated with their use.

• To provide timely and accurate information, pharmacovigilance systems must be
designed to collect and analyze data efficiently. This includes having well-defined
processes for reporting adverse events, collecting and analyzing data, and
communicating the findings to relevant stakeholders.
• The information collected through pharmacovigilance must also be communicated
clearly and effectively. Regulatory authorities, healthcare professionals, patients,
and the general public must be provided with information that is understandable,
actionable, and relevant to their needs

PHARMACOVIGILANCE AND SAFETY
REPORTING TECHNIQUES
• Spontaneous Reporting: This is the most common method used to collect adverse drug
reaction (ADR) data. Healthcare professionals and consumers report suspected ADRs
to national regulatory agencies, pharmaceutical companies, or regional
pharmacovigilance centers.
• Active Surveillance: This involves actively monitoring patients taking specific
medications for ADRs. This is done through various methods, such as patient
interviews, medical records review, and laboratory tests.
• Cohort Studies: This involves comparing the incidence of ADRs in patients taking a
specific medication to the incidence of ADRs in a control group of patients not taking
the medication. This is done to identify any increased risk of ADRs associated with the
medication.

• Case-Control Studies: This involves comparing the frequency of exposure to a
medication in patients who have experienced an ADR to the frequency of exposure in
patients who have not experienced an ADR. This is done to identify any association
between the medication and the ADR.
• Prescription-Event Monitoring: This involves monitoring patients who have been
prescribed a new medication to detect any ADRs that occur in the first few months of
treatment.
• Electronic Health Record (EHR) Mining: This involves using data from electronic
health records to identify potential ADRs associated with medications.
• Signal Detection: This involves using statistical methods to detect any unexpected
patterns or trends in ADR data that may suggest a new safety concern.
• Risk Management: This involves implementing measures to manage the risks
associated with a medication, such as prescribing restrictions or additional monitoring
requirements

• Clinical Trial Reporting: Clinical trial reporting is the process of collecting,
analyzing, and reporting data from clinical trials to regulatory authorities,
scientific journals, and the public. Pharmacovigilance clinical trial reporting
involves the systematic collection, analysis, and reporting of adverse events and
other safety-related data from clinical trials

SPONTANEOUS REPORTING
• Data collection: Reports of ADRs are collected from healthcare professionals,
patients, and other individuals, using a standardized reporting form.
• Data processing: The collected data is processed and entered into a database,
where it can be analyzed for potential safety concerns.
• Data analysis: The data is analyzed to identify potential safety concerns, using
methods such as signal detection and statistical analysis.
• Follow-up: Follow-up information may be collected to obtain additional details on
the reported ADRs, such as the patient's medical history and medication use.
• Communication: The information on the reported ADRs is communicated to
healthcare professionals, regulatory authorities, and the public, to ensure that they
are aware of any potential safety concerns.

ACTIVE SURVEILLANCE
• Patient Interviews: Healthcare professionals can conduct regular interviews with
patients taking a medication to ask about any symptoms or side effects they may
be experiencing.
• Medical Records Review: Healthcare professionals can review the medical records
of patients taking a medication to identify any potential ADRs.
• Laboratory Tests: Healthcare professionals can order laboratory tests to monitor
patients taking a medication for any potential ADRs.
• Outcomes Research: Outcomes research involves studying the long-term effects of
a medication on patients, including any potential ADRs.

COHORT STUDIES
• Identification of the study population: The study population consists of patients
who have been exposed to the medication of interest.
• Data collection: Data is collected on the patients' demographic characteristics,
medical history, medication use, and outcomes (including ADRs).
• Follow-up: Patients are followed over time to determine the incidence of ADRs.
• Data analysis: The data is analyzed to determine the incidence of ADRs and any
factors that may be associated with an increased risk of ADRs.

CASE CONTROL STUDY
• Identification of cases: Patients who have experienced the ADR of interest are
identified and recruited into the study.
• Selection of controls: A control group of patients who have not experienced the
ADR is selected and matched to the cases based on factors such as age, sex, and
underlying medical conditions.
• Data collection: Data is collected on the medication exposure of both cases and
controls, as well as other potential risk factors for the ADR.
• Data analysis: The data is analyzed to determine the association between
medication exposure and the ADR.

PRESCRIPTION-EVENT MONITORING
• technique used in pharmacovigilance to monitor the safety of newly marketed
medications. In PEM, healthcare professionals actively monitor patients who have
been prescribed a specific medication to detect any adverse drug reactions (ADRs)
that may occur.
• PEM differs from other active surveillance techniques in that it focuses on newly
marketed medications, rather than medications that have been on the market for a
longer period of time. It is designed to detect ADRs that may not have been
identified in premarketing clinical trials, as these trials are typically conducted in a
relatively small number of patients over a relatively short period of time.
• PEM has several advantages in pharmacovigilance. It allows for the identification
of previously unknown ADRs associated with newly marketed medications. It can
also provide information on the incidence and severity of ADRs associated with
these medications.

• However, PEM also has limitations. It can be costly and time-consuming to
conduct, and may require large sample sizes to detect rare ADRs. In addition, it
may be subject to bias due to factors such as loss to follow-up and confounding
variables. Therefore, PEM is often used in conjunction with other
pharmacovigilance techniques, such as spontaneous reporting and cohort studies,
to provide a more comprehensive understanding of medication safety.

ELECTRONIC HEALTH RECORD (EHR)
MINING:
• Data extraction: Data is extracted from electronic health records using natural
language processing (NLP) and other computational techniques.
• Data cleaning: The extracted data is cleaned and standardized to ensure
consistency and accuracy.
• Data analysis: The data is analyzed to identify potential ADRs, using methods
such as association rule mining and machine learning algorithms.
• Validation: The potential ADRs identified through EHR mining are validated
through additional analysis and clinical review.
• EHR mining has several advantages in pharmacovigilance. It allows for the
identification of potential ADRs in real-world clinical settings, where patients
may have comorbidities or be taking multiple medications. It can also provide
information on the incidence and severity of ADRs associated with specific
medications.

• However, EHR mining also has limitations. It requires access to large amounts
of electronic health record data, which may not be available in all settings. It
also requires sophisticated computational techniques and expertise in data
analysis. Additionally, the validity of the potential ADRs identified through
EHR mining may be influenced by factors such as the quality of the data and
the accuracy of the NLP and other computational techniques used.

SIGNAL DETECTION
• The steps involved in signal detection include:
1. Data collection: Data on medication use and ADRs are collected from various sources,
including spontaneous reporting systems, electronic health records, and clinical trials.
2. Data analysis: The data is analyzed to identify potential signals, using statistical and
epidemiological methods.
3. Signal evaluation: The potential signals are evaluated using criteria such as the strength
of the association, the biological plausibility, and the consistency of the data.
4. Signal prioritization: The potential signals are prioritized based on their potential
clinical significance and the level of uncertainty associated with them.
5. Further investigation: Signals that are considered to be of high priority and uncertain
are further investigated through methods such as case-control studies, cohort studies, or
clinical trials.

• Signal detection has several advantages in pharmacovigilance. It allows for the
identification of potential ADRs that may not have been identified in premarketing
clinical trials or other pharmacovigilance techniques. It can also provide
information on the incidence and severity of ADRs associated with specific
medications.
• However, signal detection also has limitations. It may be subject to bias due to
factors such as underreporting or incomplete data. Additionally, the identification
of a signal does not necessarily mean that a causal relationship exists between the
medication and the ADR, and further investigation is needed to confirm any
potential association.
• Therefore, signal detection is often used in conjunction with other
pharmacovigilance techniques, such as spontaneous reporting and active
surveillance, to provide a more comprehensive understanding of medication
safety.

RISK MANAGEMENT
• Risk identification: The first step in risk management is to identify potential risks
associated with a medication, based on factors such as its pharmacology,
mechanism of action, and clinical use.
• Risk evaluation: The identified risks are evaluated in terms of their severity,
frequency, and potential impact on patient outcomes.
• Risk mitigation: Strategies are developed to minimize the identified risks, which
may include measures such as modifying the medication's labeling, restricting its
use to certain patient populations, or requiring additional monitoring or testing.

• Risk communication: Information on the identified risks and their
management strategies is communicated to healthcare professionals,
patients, and regulatory authorities, to ensure that they are aware of the
potential risks and how to manage them.
• Risk monitoring: The identified risks and their management strategies
are monitored over time, to ensure that they remain effective and to
identify any new or emerging risks.

POST MARKETING SURVEILLANCE
• the safety and effectiveness of drugs after they have been approved and marketed. The
goal of post-marketing surveillance is to identify any new or previously unknown
adverse drug reactions (ADRs) that were not detected during the clinical trial phase of
drug development.
• Post-marketing surveillance activities may include spontaneous reporting, active
surveillance, and other methods of data collection and analysis. Regulatory agencies
and drug manufacturers are responsible for conducting post-marketing surveillance to
ensure that drugs continue to be safe and effective for their approved uses.
• Post-marketing surveillance is important because clinical trials are typically conducted
in a controlled environment with a limited number of patients, which may not
accurately reflect the real-world use of the drug. Additionally, some ADRs may only
become apparent after a drug has been on the market for an extended period, or after it
has been used by a large number of patients.

• One example of post-marketing surveillance is the US Food and Drug
Administration's (FDA) Adverse Event Reporting System (AERS). This system
collects reports of ADRs from healthcare professionals, patients, and drug
manufacturers and is used to monitor the safety of drugs on the US market.
• Overall, post-marketing surveillance is a critical component of pharmacovigilance,
as it allows for the ongoing monitoring and evaluation of the safety and
effectiveness of drugs in real-world settings. By identifying new or previously
unknown ADRs, post-marketing surveillance helps to ensure that drugs remain
safe and effective for patients

Clinical Trial Reporting
• Clinical trial reporting is the process of collecting, analyzing, and reporting
data from clinical trials to regulatory authorities, scientific journals, and the
public. Pharmacovigilance clinical trial reporting involves the systematic
collection, analysis, and reporting of adverse events and other safety-related
data from clinical trials.
• Pharmacovigilance clinical trial reporting is an essential component of drug
development, as it helps to identify potential safety issues associated with a
drug candidate during the clinical development process. The information
collected during pharmacovigilance clinical trial reporting is used to inform
regulatory decisions, clinical practice, and patient safety.

• Also known as AE (adverse event) or SAE (serious AE) reporting from clinical
trials, safety information from clinical studies is used to establish a drug's safety
profile in humans and is a key component that drug regulatory authorities consider
in the decision-making as to whether to grant or deny market authorization
(market approval) for a drug. AE reporting occurs when study patients (subjects,
participants) experience any kind of "untoward" event during the conducting of
clinical trials. Non-serious adverse events are typically captured separately at a
level lower than pharmacovigilance. AE and SAE information, which may also
include relevant information from the patient's medical background, are reviewed
and assessed for both causality and degree of seriousness by the study investigator.
This information is forwarded to a sponsoring entity (typically a pharmaceutical
company or academic medical center) that is responsible for the reporting of this
information, as appropriate, to drug regulatory authorities.
• The International Society of Pharmacovigilance is an international non-profit
scientific organization, which aims to foster pharmacovigilance both scientifically
and educationally, and enhance all aspects of the safe and proper use of medicines,
in all countries. It was established in 1992 as the European Society of
Pharmacovigilance.

Some of the key aspects of pharmacovigilance clinical trial reporting include:
• Adverse Event Reporting: All clinical trials must have a system in place for the
collection and reporting of adverse events. This includes the collection of data on
any adverse events, the severity and frequency of the events, and the relationship
between the events and the study drug.
• Data Management and Analysis: Data collected during clinical trials must be
managed and analyzed to identify any safety signals. This includes the use of
statistical methods to determine whether adverse events are occurring more
frequently in the study group than in the control group.
• Reporting to Regulatory Authorities: Clinical trial safety data must be reported to
regulatory authorities in a timely manner. This includes the submission of periodic
safety reports, which provide updates on the safety of the study drug, as well as
expedited reporting of serious adverse events.

• Communication with Investigators and Ethics Committees: Clinical trial
investigators and ethics committees must be informed of any safety issues that
arise during the trial. This includes providing regular updates on adverse event
data and any changes to the study protocol.
• Overall, pharmacovigilance clinical trial reporting is an important part of drug
development and ensures that the safety of study participants and patients is
monitored throughout the clinical trial process.

Safety Reporting and Pharmacovigilance.pptx

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