Content: Pharmacovigilance of drugs of natural origin: WHO and AYUSH guidelines for safety monitoring of natural medicine, Spontaneous reporting schemes for bio drug adverse reactions, bio drug-drug and bio drug-food interactions with suitable examples.

1. Presented by-
Mrs. Poonam Nilesh Chougule
Associate Professor
HOD PG Pharmacognosy Dept. AMCP
ADVANCED PHARMACOGNOSY - I
Pharmacovigilance of
Natural Drugs.

2. Content:
Pharmacovigilance of drugs of natural
origin:
• WHO and AYUSH guidelines for safety
monitoring of natural medicine,
• Spontaneous reporting schemes for bio drug adverse
reactions,
• bio drug-drug and bio drug-food interactions with
suitable examples.

3. Pharmacovigilance of drugs of natural origin:
Pharmacovigilance of drugs of natural origin involves the systematic monitoring,
assessment, and prevention of adverse effects or any other drug-related problems
associated with medicinal products derived from natural sources, such as plants,
animals, or minerals. This field is essential to ensure the safety and efficacy of
herbal remedies, traditional medicines, and other natural products used in
healthcare.
Natural products have been used for centuries in various traditional medicine
systems around the world. While many of these substances have therapeutic
benefits, they also pose potential risks due to variability in composition, potency, and
interactions with other medications. Pharmacovigilance aims to detect, evaluate,
and understand these risks to enhance patient safety.
The process involves the collection of data on adverse drug reactions (ADRs)
through spontaneous reporting, clinical studies, literature reviews, and other
surveillance methods. The data collected is then analyzed to identify patterns,
trends, and potential safety signals. Pharmacovigilance also involves assessing the
benefit-risk profile of natural drugs, ensuring that the therapeutic benefits outweigh the
potential risks.

4. Regulatory agencies and healthcare professionals play a crucial role in
pharmacovigilance by establishing reporting systems, conducting risk assessments, and
implementing measures to mitigate identified risks. Education and
communication efforts are essential to inform healthcare providers, patients, and the
public about the potential risks associated with natural products, as well as the importance
of reporting any adverse events.
In summary, pharmacovigilance of drugs of natural origin is a comprehensive
approach to safeguarding public health by systematically monitoring and
evaluating the safety of natural products. It involves collaboration between
regulatory authorities, healthcare professionals, and the pharmaceutical industry to ensure
that these products are used safely and effectively in the ever-evolving landscape of
healthcare.
Pharmacovigilance of drugs of natural origin is a specialized area within drug safety
that focuses on monitoring and assessing the safety profile of medicinal products
derived from natural sources, such as plants, animals, fungi, and minerals. These natural
products are often used in traditional or alternative medicine, and their
pharmacovigilance is crucial to ensure patient safety.

5. Some aspects pharmacovigilance for drugs of natural origin include:
1.Data Collection:
 Spontaneous Reporting: Healthcare professionals, patients, and
consumers are encouraged to report any adverse reactions or side
effects associated with natural products. This helps in the early
detection of potential safety concerns.
 Literature Surveillance: Continuous review of scientific literature
helps identify new information and reports related to the safety of
natural drugs.
2.Risk Assessment:
 Evaluation of Adverse Drug Reactions (ADRs): Systematic
analysis of reported adverse events helps in understanding the
nature and frequency of side effects associated with natural drugs.
 Identification of Safety Signals: Analysis of data to identify
emerging safety concerns and potential risks that may not have been
previously recognized.

6. 3.Benefit-Risk Assessment:
 Balancing Act: Assessing the overall benefit-risk profile of drugs
of natural origin to ensure that their therapeutic benefits justify
any potential risks.
 Comparative Analysis: Comparing the safety profile of natural
drugs with conventional pharmaceuticals to provide context for
decision- making.
4.Regulatory Oversight:
 Regulatory Authorities: National regulatory bodies play a key role
in setting up frameworks for monitoring and ensuring the safety
of natural products. They may issue guidelines, regulations,
and warnings based on pharmacovigilance findings.
 Labeling and Packaging: Ensuring that product labels
accurately reflect known safety information, including
potential risks and contraindications.

7. 5.Communication and Education:
 Healthcare Provider Awareness: Disseminating information about
the safety of natural drugs to healthcare professionals to
enhance their awareness and ability to make informed prescribing
decisions.
 Public Awareness: Educating patients and the general public
about the safe use of natural products and the importance of
reporting any adverse events.
Pharmacovigilance of drugs of natural origin is essential due to the
diverse and complex nature of these products. By systematically
monitoring and assessing their safety, regulatory authorities and
healthcare professionals can contribute to the safe and effective use of
natural drugs in patient care.

8. WHO guidelines for safety monitoring of natural
medicine:
The World Health Organization (WHO) provides general guidelines for the safety
monitoring of herbal medicines and traditional remedies. These guidelines aim to
establish a framework for member states to enhance the safety and quality of
traditional medicine. However, please note that guidelines and recommendations may
have evolved since then. It's essential to check the most recent WHO
publications for the latest information.
The principles and components of WHO guidelines for safety monitoring of
natural medicine include:
1.Regulatory Framework:
 Encourage member states to establish regulatory frameworks for the
registration, quality control, and safety monitoring of herbal
medicines and traditional remedies.
2.Quality Control and Standardization:
 Emphasize the importance of quality control measures, including the
standardization of herbal products to ensure consistency in
composition and efficacy.

9. 3. Pharmacovigilance Systems:
 Promote the establishment or strengthening of pharmacovigilance systems
for monitoring adverse reactions and other safety concerns associated with
natural medicines.
4.Data Collection and Reporting:
 Encourage the collection of data on the safety and efficacy of herbal medicines
through systems for spontaneous reporting, observational studies, and other
relevant methods.
5. Risk-Benefit Assessment:
 Recommend the continuous assessment of the risk-benefit profile of herbal
medicines, considering both the therapeutic benefits and potential risks
associated with their use.
6.Communication and Education:
 Emphasize the importance of communication and education initiatives to inform
healthcare professionals, traditional healers, and the public about the safe and
rational use of herbal medicines.

10. 7.Collaboration:
 Advocate for collaboration between regulatory
authorities, healthcare providers, traditional medicine
practitioners, and other stakeholders to ensure a
comprehensive approach to safety monitoring.
8.Research and Development:
 Encourage research on the safety and efficacy of
herbal medicines, including studies on potential
herb-drug interactions, long-term effects, and the
impact on vulnerable populations.

11. AYUSH guidelines for safety monitoring of
natural medicine:
The AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and
Homoeopathy) Ministry in India provides guidelines for the safety
monitoring of natural medicines. However, please note that guidelines and
recommendations may have been updated since then. It's essential to refer
to the most recent publications from the AYUSH Ministry or relevant health
authorities for the latest information.
General principlesand components of AYUSHguidelines for
safety monitoring of natural medicines include:
1. Regulatory Framework:
Emphasize the need for a regulatory framework to ensure the quality, safety, and
efficacy of Ayurvedic, Yoga & Naturopathy, Unani, Siddha, and Homoeopathic
products.
2. Quality Control:
Promote quality control measures, including the standardization of herbal and
traditional medicines to ensure consistency and adherence to established standards.

12. 3.Pharmacovigilance:
Advocate for the implementation of pharmacovigilance systems
specific to AYUSH products to monitor and assess adverse
reactions and safety
concerns.
4.Data Collection and Reporting:
Encourage the collection of data on adverse events and other safety-
related
information through mechanisms such as spontaneous
reporting, observational studies, and research initiatives.
5.Risk-Benefit Assessment:
Stress the importance of continuously assessing the risk-benefit
profile of
natural medicines, taking into consideration both the therapeutic
benefits and potential risks associated with their use.
6.Communication and Education:
Promote communication and education initiatives to create
awareness among healthcare professionals, practitioners, and the
public regarding the safe use of AYUSH medicines.

13. 7.Collaboration:
Encourage collaboration between regulatory authorities
healthcare providers, AYUSH practitioners, and other stakeholders
to foster a
comprehensive approach to safety monitoring.
8.Research and Development:
Support research initiatives aimed at enhancing the understanding
of the safety and efficacy of AYUSH medicines, including studies
on herb-drug interactions, long-term effects, and safety in specific
populations.
It is recommended to refer directly to the AYUSH Ministry's official
publications or contact relevant health authorities in India. Additionally,
individual states within the country may have their own regulations and
guidelines related to the safety monitoring of natural medicines.

14. Spontaneous reporting schemes for bio drug Adverse
reactions:
Involve voluntary reporting by healthcare professionals, patients,
and pharmaceutical companies to regulatory authorities. Healthcare
professionals observe and report adverse reactions in patients receiving
bio drugs, while patients can directly contribute their experiences.
Pharmaceutical companies are obligated to submit safety data as part of
post-marketing surveillance. Regulatory agencies oversee these schemes,
providing guidelines and analyzing the reported data to detect potential
safety signals. Global collaboration ensures the sharing of safety
information, creating a comprehensive understanding of bio drug safety.
Education campaigns raise awareness among healthcare professionals
and the public, encouraging timely reporting. Regular data analysis
facilitates signal detection, helping identify emerging safety concerns.
Effective risk communication ensures transparent dissemination of safety
information to stakeholders, contributing to the ongoing evaluation and
enhancement of the safety profile of bio drugs in real- world scenarios.

15. Spontaneous reporting schemes play a crucial role in monitoring and
collecting information about adverse reactions associated with bio
drugs, which are pharmaceutical products manufactured using
biological sources, such as living cells or organisms. These reporting
systems help regulatory authorities, healthcare professionals, and
pharmaceutical companies to identify potential safety issues, assess
risks, and take appropriate measures to ensure the safety of patients using
bio drugs.
Key aspects of spontaneous reporting schemes for bio drug adverse
reactions include:
1.Healthcare Professional Reporting:
 Encouraging healthcare professionals, including physicians,
nurses, and pharmacists, to report any adverse reactions they
observe in patients receiving bio drugs. This can be done
voluntarily through dedicated reporting systems provided by
regulatory authorities.

16. 2.Patient Reporting:
 Facilitating direct reporting from patients who experience adverse
reactions. Some spontaneous reporting systems encourage patients to
report their experiences to provide valuable insights into the real-
world safety profile of bio drugs.
3.Pharmaceutical Company Reporting:
 Mandating pharmaceutical companies to report adverse reactions
associated with their bio drug products. Companies are often required
to submit safety data to regulatory agencies as part of post-marketing
surveillance obligations.
4.Regulatory Oversight:
 Regulatory authorities, such as the U.S. Food and Drug
Administration (FDA) or the European Medicines Agency (EMA),
oversee and manage spontaneous reporting systems. They provide
guidelines for reporting and collect, analyze, and assess the reported
adverse events.

17. 5.Global Collaboration:
 Promoting collaboration between regulatory agencies,
healthcare professionals, and pharmaceutical companies at
the global level. This allows for the sharing of safety
information and facilitates a comprehensive
understanding of the safety profile of bio drugs across
different regions.
6.Education and Awareness:
 Conducting educational campaigns to increase awareness
among healthcare professionals and the public about the
importance of reporting adverse reactions associated with
bio drugs. This helps in improving the quantity and quality
of reports submitted.

18. 7.Data Analysis and Signal Detection:
• Regularly analyzing the collected data to detect potential safety
signals. Signal detection involves identifying patterns or trends that may
indicate previously unrecognized adverse reactions or an increased
frequency of known reactions.
8.Risk Communication:
• Communicating relevant safety information professionals, patients, and
the public. Timely to healthcare and transparent communication ensures
that stakeholders are informed about any emerging safety concerns
related to bio drugs.
Spontaneous reporting schemes are integral to post-marketing surveillance
and contribute to ongoing pharmacovigilance efforts, allowing for the
continuous evaluation of the safety of bio drugs in real-world clinical
settings.

19. Bio Drug-Drug and Bio Drug-Food Interactions:
Bio drug-drug interactions occur when two or more bio drugs, which are
pharmaceutical products derived from living organisms, interact within the body,
affecting their efficacy or safety. These interactions may lead to altered drug levels,
modified therapeutic effects, or increased risk of adverse reactions. Understanding
and managing bio drug-drug interactions are crucial in optimizing treatment outcomes
and minimizing potential risks for patients.
Bio drug-food interactions involve the influence of dietary factors on the
absorption, distribution, metabolism, and excretion of bio drugs. Certain foods or
nutritional components may interact with bio drugs, affecting their bioavailability or
pharmacokinetics. For instance, food may enhance or reduce drug absorption,
potentially impacting therapeutic effectiveness. Awareness of bio drug-food
interactions is essential for healthcare professionals to provide guidance to patients on
proper drug administration and dietary habits to ensure optimal treatment outcomes.
Monitoring and managing both types of interactions are critical components of
personalized medicine, promoting safe and effective use of bio drugs in diverse patient
populations.

20. Examples:
Bio Drug-Drug Interactions:
1. Cyclosporine and Statins:
 Cyclosporine, an immunosuppressant used after organ transplants, can interact
with statins, commonly prescribed for cholesterol management. This
interaction may increase the risk of statin-induced myopathy or muscle damage.
2.Warfarin and Antibiotics:
 Warfarin, an anticoagulant, may interact with certain antibiotics, affecting
its anticoagulant effect. For example, antibiotics like ciprofloxacin or
sulfamethoxazole/trimethoprim may potentiate the anticoagulant effect,
increasing the risk of bleeding.
3.Amiodarone and Digoxin:
 Amiodarone, an antiarrhythmic medication, can interact with digoxin, a drug
used for heart conditions. This interaction may lead to increased levels of
digoxin in the blood, potentially causing toxicity.

21. Bio Drug-Food Interactions:
1. Tacrolimus and Grapefruit Juice:
 Tacrolimus, an immunosuppressant, can have its absorption affected by
grapefruit juice. Consuming grapefruit juice may increase the blood levels of
tacrolimus, leading to potential toxicity.
2. Levothyroxine and Calcium-Rich Foods:
 Levothyroxine, a thyroid hormone replacement, should be taken on an empty
stomach. Calcium-rich foods or supplements can interfere with its absorption,
reducing its effectiveness.
3.Warfarin and Vitamin K-Rich Foods:
 Warfarin's anticoagulant effect is influenced by vitamin K levels. Eating
foods high in vitamin K, like leafy greens, can interfere with warfarin's
effectiveness, requiring careful monitoring and dose adjustment.
Understanding and managing these interactions are crucial to ensure the safe and
effective use of bio drugs in patients, highlighting the importance of individualized
treatment plans and regular monitoring in clinical practice.