ASSURING SAFETY OF T/CM PRODUCTS: THE MALAYSIAN EXPERIENCE
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ASSURING SAFETY OF T/CM PRODUCTS:
THE MALAYSIAN EXPERIENCE
Abida Syed HaqNational Pharmaceutical Control BureauMinistry of Health Malaysia
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TRADITIONAL MEDICINES In 1994, about 4000 dietary supplements and
herbal products available in the USA. Today, it is estimated that there are over
29000 herbal and other natural products are available in the USA
In Malaysia, >9000 traditional medicines registered by the Drug Control Authority for use
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Malaysian Drug Registry
Cosmetics1757
Prescription Drugs
8891 (33%)
OTC6576 (24%)
Traditional Medicines
9693 (36%)
Prescription Drugs OTC Traditional Medicines Cosmetics
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TRADITIONAL MEDICINES (TM)
Generally used as health supplements and for
the treatment of benign, self limiting
conditions
Occasionally used to self treat serious illnesses
Products are widely advertised over the
Internet and through the mass media
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“IT IS NATURAL, THEREFORE IT IS SAFE”
Common misnomer Impossible to ensure that all medical
interventions including traditional medicines are entirely risk-free
Numerous reports of adverse effects associated with the use of TM
Unlike pharmaceuticals, TM continue to be marketed unless, or until, proven to be unsafe
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SAFETY ISSUES - MALAYSIA Products marketed with unsubstantiated
claims Adverse drug reactions e.g. Noni juice Continued presence of unregistered
products Adulterated products Counterfeit
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SAFETY ISSUES - MALAYSIA Product registration withdrawn
Aristolochic Acid Kava-kava Magnolia officinalis Adulteration
Steroids Fenfluramine Sibutramine Sildenafil Phenylpropanolamine
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SAFETY ISSUES - US FDA
In the past, no evaluation of herbals done Now, taking a new approach – evaluation
on available information being done to facilitate regulatory decisions being made
Products under study Chapparal, chromium picolinate,
glucosamine, melatonin, saw palmetto and shark cartilage
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FACTORS AFFECTING SAFETY Intrinsic factors
Inherent toxicity, adverse effects due to overdosage, interactions, underlying risk factors
Extrinsic factors Quality defects, misidentification, contamination,
adulteration, mislabeling, improper storage
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PRODUCT SAFETY Systems have to be put in place to ensure
safety of all products Responsibility of the
Manufacturers Product owners Regulatory authority Practitioners Retailers Consumers
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Mission
To have only safe traditional medicines which comply with set standards of quality available in Malaysia.
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Vision
To be a world leader in the production of safe traditional medicines which are of quality
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POLICIES & STRATEGIES Legislation
In Malaysia, all medicinal products including traditional remedies must be registered before they can be manufactured, imported, sold
Governed by Sale of Drugs Act Control of Drugs and Cosmetics Regulations Poisons Act Medicines Advertisement Act
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POLICIES & STRATEGIES Regulatory
All products are evaluated for quality & safety Paper and laboratory evaluation
Adherence to Good Manufacturing Practices All products subjected to surveillance Monitoring of adverse drug reactions Monitoring of labels, information leaflets Control of advertisements
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POLICIES & STRATEGIES Education
Manufacturers Good knowledge of plant nomenclature
Labeling of ingredients using scientific names
Botanical verification and identification of starting materials
Quality control and quality assurance procedures Integrity and self-regulation
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POLICIES & STRATEGIES Education
Practitioners of conventional medicines Basic knowledge on traditional medicines Break away from situation of “don’t ask, don’t
tell” Monitoring and reporting of adverse reactions
Public Using products in accordance to intended use Be forthcoming with information
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NATIONAL SURVEILLANCE PROGRAM
Ideally, all marketed products should undergo surveillance
Criteria for surveillance Registered, marketed products which have never
been tested Products previously found to have failed lab
analysis Manufacturers identified by GMP inspectors to
have problems “Tip-offs”/suspicious products
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NATIONAL SURVEILLANCE PROGRAM
Quality standards Microbial/ fungal Limit Tests Testing of toxic heavy metal contamination
i.e. lead, mercury, arsenic Detection of adulterants/ undeclared drugs
Adverse drug reactions monitoring Local International
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Year No. of Traditional Medicines Tested
Failure Rate No. of Product
Recalls
2000 1014 173
(17.06%)
97
(9.56%)
2001 652 157
(24.07%)
85
(13.03%)
2002(Jan-Aug)
784 151
(19.26%)
56
(7.14%)
NATIONAL SURVEILLANCE PROGRAM
Ref: National Pharmaceutical Control Bureau
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NATIONAL SURVEILLANCE PROGRAM
Year No. of Traditional Medicines Tested
No. Failed MLT
No. Failed Heavy
Metal Limits
2000 1014 57
(5.62%)
30
(2.95%)
2001 652 35
(5.36%)
37
(5.67%)
2002
(Jan-Aug)
784 68
(8.67%)
19
(2.42%)
Ref: National Pharmaceutical Control Bureau
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Strengths Good regulatory system Compulsory testing as part of the
registration procedure Post-marketing Surveillance System for investigating product complaints Adequate laboratory testing facilities for
surveillance samples
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Strengths Implementation of Good
Manufacturing Practices for all manufacturers of traditional medicines
QUALITY SAFETY ISO 9002 certified quality system PIC/S Certification A good pharmacy enforcement unit
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EVALUATION & REGISTRATION
SURVEILLANCE
GMP & LICENSING
PHARMACY ENFORCEMENT
SAFETY ISSUES
PUBLIC
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Weaknesses Poor compliance to GMP by some
manufacturers Inadequate finished product
testing by manufacturers Lack of standardisation of “active”
ingredients Security/tamper-proof packaging
systems
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Weaknesses Underreporting of adverse reactions
by health professionals, consumers No reporting of adverse reactions by
traditional medicine practitioners Inadequate availability of
information adverse reactions of ingredients interactions with pharmaceuticals contraindications
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Opportunities Increasing knowledge on the use of
traditional medicines by health professionals
Regular dialogues with traditional medicine practitioners
More stringent regulatory requirements to ensure the quality of starting materials, formulations used
Global partnership with WHO, other regulatory and health authorities
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THREATS
Complacency Unscrupulous manufacturers and
traders “Supply and Demand” for
unregistered products
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THE PARADIGM SHIFT Evidence on efficacy – inefficacy is also a
safety issue Evidence on the safety of products and
therapies used – not sufficient to just believe that it safe
Need to have a system for assuring product safety
Better quality control of products – underdosing, overdosing, contamination, adulteration are all safety issues
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THE WAY FORWARD Increased surveillance - by regulators,
industry Improved safety monitoring System for identifying unregistered/ counterfeit products Good knowledge base – information
hub In-house laboratory testing by
manufacturers
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It is an uphill task, but….
…we have already got a head start!
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