ASSURING SAFETY OF T/CM PRODUCTS: THE MALAYSIAN EXPERIENCE

1. ASSURING SAFETY OF T/CM PRODUCTS: THE MALAYSIAN EXPERIENCE Abida Syed Haq National Pharmaceutical Control Bureau Ministry of Health Malaysia

2. 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

3. Malaysian Drug Registry

4. 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

5. “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

6. SAFETY ISSUES - MALAYSIA • Products marketed with unsubstantiated claims • Adverse drug reactions e.g. Noni juice • Continued presence of unregistered products • Adulterated products • Counterfeit

7. SAFETY ISSUES - MALAYSIA • Product registration withdrawn • Aristolochic Acid • Kava-kava • Magnolia officinalis • Adulteration • Steroids • Fenfluramine • Sibutramine • Sildenafil • Phenylpropanolamine

8. 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

9. 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

10. 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

11. Mission • To have only safe traditional medicines which comply with set standards of quality available in Malaysia.

12. Vision • To be a world leader in the production of safe traditional medicines which are of quality

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. NATIONAL SURVEILLANCE PROGRAM Ref: National Pharmaceutical Control Bureau

20. NATIONAL SURVEILLANCE PROGRAM Ref: National Pharmaceutical Control Bureau

21. 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

22. 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

23. PUBLIC EVALUATION & REGISTRATION SAFETY ISSUES PHARMACY ENFORCEMENT SURVEILLANCE GMP & LICENSING

24. 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

25. 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

26. 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

27. THREATS • Complacency • Unscrupulous manufacturers and traders • “Supply and Demand” for unregistered products

28. 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

29. 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

30. It is an uphill task, but…. …we have already got a head start!

31. THANK YOU TERIMA KASIH THANK YOU