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WHO Guidelines On Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems

The WHO guidelines focus on enhancing safety monitoring of herbal medicines within pharmacovigilance systems to promote their safe use. They provide technical steps for countries to track risks associated with herbal medicines and emphasize the importance of reporting adverse reactions from various sources. The guidelines aim to improve data management and communication to ensure effective monitoring and assessment of herbal medicine safety.

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71 views4 pages

WHO Guidelines On Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems

The WHO guidelines focus on enhancing safety monitoring of herbal medicines within pharmacovigilance systems to promote their safe use. They provide technical steps for countries to track risks associated with herbal medicines and emphasize the importance of reporting adverse reactions from various sources. The guidelines aim to improve data management and communication to ensure effective monitoring and assessment of herbal medicine safety.

Uploaded by

at1413146
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance

systems.
Introduction
Safety is a top priority in herbal medicine healthcare.

These guidelines offer technical steps to monitor herbal medicine safety within existing
pharmacovigilance systems.

Aim to improve current systems to better track herbal medicine risks.

objectives
Promote the safe and proper use of herbal medicines.

Clear definitions for herbal medicine safety monitoring.

Adjust guidelines to fit each country’s healthcare system.

Help countries build/improve systems to track herbal medicine safety.

Promote correct and responsible use of herbal medicines.

Pharmacovigilance

Pharmacovigilance is the science of monitoring and ensuring the safety of medicines. It involves
detecting, assessing, understanding, and preventing side effects or other problems related to
drugs.

Expanded Scope:

1) Herbal medicines
2) Traditional and alternative therapies
3) Blood products
4) Biological treatments
5) Medical devices
6) Vaccine
SAFETY MONITORING OF HERBAL MEDICINES
1. Sources of Report
Adverse event reports mainly come from clinical trials and spontaneous reports.

Some countries require physicians to report adverse reactions, classifying these as spontaneous
reports.

CIOMS recommends focusing on the quality of a medical report, not its source

The source of a report can be an important factor in evaluating the report as it may affect the
quality and value of the information.

The nature, degree and even feasibility of any follow-up will also be highly dependent on the
source.

Some sources are: -

• Report from healthcare professionals


• Report from consumers
• Report from manufacturers
• Report from other Sources

2. Herbal products targeted for safety monitoring

1. According to Regulatory Status:

➢ Prescription herbal medicines.


➢ Non-prescription (over-the-counter) herbal medicines.
➢ Other herbal products intended for use in health care (e.g., supplements).

2. According to Registration/Marketing Status:-


➢ In development Herbal medicines in clinical trials (pre-approval).
➢ In development Herbal medicines under post-marketing surveillance (after approval).
➢ Under re-evaluation Herbal medicines in clinical trials for re-assessment.
➢ Under re-evaluation Herbal medicines under post-marketing surveillance for re-
assessment.
➢ On the market Herbal medicines under routine safety monitoring.
➢ Other marketed herbal health products (e.g., dietary supplements).

3. Reporting for suspected Adverse reactions


➢ Anyone who notices a bad reaction (doctors, nurses, patients, or manufacturers).
➢ Send reports to the National Pharmacovigilance Centre or regional center, depending on
the country’s system.
➢ Who can be Reports ?
• Health professionals
• Patients/consumers
• Manufacturers

*Key Information Needed:

Patient details like Age, sex, medical history.


Herbal product details like name, brand, manufacturer, batch, etc.
How it was used like dose, duration, route of administration.
Reason for use and adverse reaction details (symptoms, severity, outcome).
Other medicines/risk factors (allergies, prior exposure).
Name and address of Reporter.
4. Assessment of case reports

1. Individual case reports


2. Detection of signals at national level.
3. Detection of signals at international level
4. Use of an advisory committee
5. Investigation and analysis of the cause of suspected
6. adverse reactions
7. Technical expertise and basic equipment
5. Data management

1. Data Quality: Ensure accuracy, completeness, and avoid duplicates.


2. Data Storage: Maintain high-standard databases and select suitable software.
3. Data Analysis: Develop programs for regular, locally relevant outputs.
4. WHO Database: Improve global herbal medicine data using mining techniques.
5. Technical Support: Available from WHO/UMC for data management.

6. Communication :_The successful safety monitoring of herbal medicines depends on good


communication.

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