HERBAL MEDICINE
PHARMACOVIGILANCE WORKSHOP
INTRODUCTION TO
HERBAL MEDICINE
John Mponda
Lecturer in Pharmacy,
ACEPHEM, College of
Medicine
PRESENTATION OUTLINE
Definitions
Reasons
why people use herbal
medicines
Role of World Health
Organization in Herbal Medicine
DEFINITIONS
DEFINITIONS IN TCM
 Traditional
medicine (TM) is the sum total
of the knowledge, skill, and practices
 based on the theories, beliefs, and
experiences indigenous to different cultures,
 used in the maintenance of health as well
as in the prevention, diagnosis,
improvement or treatment of physical and
mental illness.
DEFINITIONS FOR TCM
 Traditional
medicine is defined as
diverse health practices, approaches,
knowledge and beliefs incorporating
plant, animal and/or mineral based
medicines, spiritual therapies, manual
techniques and exercises applied singularly
or in combination to maintain well-being,
as well as to treat, diagnose or prevent
illness.
DEFINITIONS IN TCM
“Complementary
medicine” or
“Alternative medicine” refer to a
broad set of health care practices
that are not part of that country’s
own tradition or conventional
medicine and are not fully
integrated into the dominant
health-care system.
DEFINITIONS FOR TCM
 Herbal
medicines are defined as plant
derived material or preparations with
therapeutic benefits, which contain
either raw or processed materials
DEFINITIONS FOR TCM
 Dietary
supplements: a substance which
contains,, a vitamin, a mineral, a herb
or other botanical or an amino acid
intended to increase the total daily
intake of a concentrate, metabolite,
constituent, extract or combination of
these ingredients
DEFINITIONS FOR TCM
 Health
food: products that are presented
with specific health claims and therefore
regulated differently from other foods
 Functional foods: products which are
offered with specific health claims and
therefore regulated differently from other
foods
DEFINITIONS FOR TCM
 Medical
claims: specified to treat,
cure or prevent a disease or restore,
correct or modify physiological
functions. Products with medical
claims have to be registered by the
PMPB before allowed into the market.
DEFINITIONS FOR TCM
 Health
claims: “any statement,
suggestion or implication in labelling or
advertising that a product carries a
specific health benefit, but not nutritional
claims nor medicinal claims. Includes
nutrient function and recommended
dietary practice
DEFINITIONS FOR TCM
Nutrient
content
claims:
indicates that a certain product is
particularly rich or low in a
nutritional component such as
fibre or fat
DEFINITIONS FOR TCM
Structure/functional
claims:
These claims link a substance to
an effect on a structure or function
of the body
REASONS WHY PEOPLE
USE TCM
MEDICINES DEVELOPED
FROM TRADITIONAL
MEDICINE
Artemisia annua

Cinchona peruviana
Artesunate/
artemether
Quinine
Ephedra
sinica
Ephedrine/
Pseudoephedri
ne
MEDICINES DEVELOPED
FROM TRADITIONAL
MEDICINE

Willow tree
Colchicum
autumnale
Aspirin
Curare
Colchicine
tubocurarine
MEDICINES DEVELOPED FROM
TRADITIONAL MEDICINE
Papaver somniferum: morphine and codeine
WHY PEOPLE USE TCM
1.
Accessibility
 Used
widely because they
are available and
affordable than
conventional therapies
 woven into everyday life
and TM healers are
trusted members of the
society, TM is often first
source of health
WHY PEOPLE USE TCM
2. Affordability
Most
poor people in developing countries buy their
medicines out of pocket
This is due to stock outs and long distances to
facilities
The poor cannot afford the transport costs to the
health facility
Herbal medicines are cheap and TM practitioner
may accept trade in kind or offer sliding payment
scale
WHY PEOPLE USE TCM
3. Perceived safety
TCM
therapies are popular because of lower rate of
adverse effects compared with some pharmaceutical
based therapies.
Example St. John wort used to treat mild depression
(less side effects) than fluoxetine will more side effects.
Evidence shows patients may choose an herbal
medication over a conventional medication to avoid side
effects.
On contrary, TM products are not without risk and not
safer than conventional pharmaceuticals.
WHY PEOPLE USE TCM
4. Potential for treating disease
use TCM because of its perceived efficacy in
general for treating chronic illnesses that defy
conventional therapies
More than two-thirds of all drugs discovered in previous
quarter century were derived from natural products
Aspirin (Willow tree), paclitaxel (Pacific yew tree),
artemisinin (Artemisia annua)
Many Africans use TM to treat AIDS symptoms
People
ROLE OF WORLD HEALTH
ORGANIZATION IN USE OF
TCM
WHO SUPPORT FOR TRADITIONAL
AND COMPLEMENTARY MEDICINE
 facilitating
integration of T&CM into national
health systems
 developing and providing standards,
technical guidelines and methods on T&CM
 stimulating research on T&CM safety and
effectiveness;
 advocating rational use of T&CM through
evidence based use;
 mediating and facilitating information
exchange on T&CM
THE GOALS FOR THE WHO TRADITIONAL
MEDICINE STRATEGY 2014–2023
1.
2.

Harnessing the potential contribution of
T&CM to health, wellness, people
centered-health care and UHC;
Promoting safe and effective use of
T&CM through regulation, research and
integration of products, practices and
practitioners into the health system
Develop POLICIES, REGULATIONS and
GUIDELINES that address those forms of
T&CM
EVOLUTION OF THE WHO TM
STRATEGY 2014–2023
 provides
information, context, guidance and
support
 to policymakers, health service planners, public
health specialists, traditional and
complementary medicine communities
 and other interested parties about T&CM,
including PRODUCTS, PRACTICES and
PRACTITIONERS.
 It addresses issues in evaluating, regulating and
integrating T&CM to benefit the health of
individuals.
Evolution of the WHO TM Strategy
2014–2023
 T&CM
merges the terms TM and CM,
encompassing products, practices and
practitioners
 This strategy is an effective and proactive
response to the World Health Assembly
Resolution on traditional medicine,
 which encourages Member States to consider
T&CM as part of the health system and
 builds on the Beijing Declaration, adopted by
the WHO Congress on Traditional Medicine in
2008..
Most Member States regulate herbal products, although they
continue to develop, update and implement new regulations as needed
T&CM PRACTICES
 To
ensure the safety and quality of
T&CM, national health authorities
 must develop policies and strategies
that reflect their specific needs in dealing
with the most popular forms of T&CM
practiced in their country.
 In recognition of the fact that T&CM is
truly global, they must be prepared to deal
with new forms of T&CM from other
countries.
T&CM PRACTITIONERS
The knowledge and qualification of practitioners
have a direct bearing on patient safety.
 some T&CM practices have become established and
practitioners are required to complete an official
education/training programme.
 In many European countries and North America,
chiropractic, naturopathic, herbal and osteopathy
practitioners must be educated in university-level
programme.
 In DEVELOPING COUNTRIES, TM knowledge and
skills have been transferred from generation to
generation orally, making it difficult to identify
qualified practitioners

TCM REGULATIONTAIWAN
REGULATION OF HERBAL
MEDICINES IN TAIWAN
Currently,
the
herbal
medicine
industry in Taiwan is structured as
follows:
1.Dietary supplements make up 70% of
the market,
2.Scientific herbal medicines 13%,
3.Functional foods 10% and
4.Traditional Chinese medicine 7%
REGULATION OF HERBAL MEDICINES
IN TAIWAN
According to law, health maintenance claims
have to be approved by the Department of
Health
1.Regulation of blood lipid,
2.Promotion of gastrointestinal functions,
3.Alleviation of osteoporosis,
4.Maintenance of dental health,
5.Regulation of the immune system,
6.Regulation of blood sugar level and
7.Protection of the liver.E
TCM REGULATIONAFRICAN REGION
TCM USE IN THE AFRICAN REGION
 80%
population living in the WHO African
Region rely on traditional forms of medicine.
 90% in Burundi and Ethiopia,
 80% in Burkina Faso, the Democratic
Republic of Congo and South Africa;
 70% in Benin, Cote d'Ivoire, Ghana, Mali,
Rwanda and Sudan;
 60% in Tanzania and Uganda
POST-MARKET SURVEILLANCE
 need
to establish national surveillance systems
at different levels of the health sector in order to
monitor and evaluate any reported adverse
effects of traditional medicine
 In order to enhance the safety of patients and
consumers using traditional medicines, existing
national safety monitoring and
pharmacovigilance systems should be expanded
in scope to include herbal medicines.