CHALLENGES IN REGULATING QUALITY AND RATIONAL USE OF ANTIBIOTICS

1. CHALLENGES IN REGULATING QUALITY AND RATIONAL USE OF ANTIBIOTICS ALLIANCE FOR THE PRUDENT USE OF ANTIBIOTICS: INAGURAL MEETING COURTYARD HOTEL 13th NOVEMBER 2007 M. Ndomondo-Sigonda Director General - TFDA

2. Scope • About TFDA • Its Mission and Vision • Its Functions as MRA • Challenges

3. TFDA • Statutory organization under the MoH responsible for regulating and ensuring quality, safety & efficacy of food, drugs (human, veterinary and herbal), medical devices & cosmetic products • Established by the Act of parliament - Tanzania Food, Drugs & Cosmetics Act, No.1, 2003 • Followed repeal of Pharmaceuticals & Poisons Act, 1978 and Food (Control of Quality) Act, 1988

4. Its Mission & Vision • Mission - To protect and promote public health by ensuring quality, safety and effectiveness of food, drugs, cosmetics and medical devices • Vision - To become the best authority in regulating food, drugs, cosmetics, and medical devices in Africa by 2015

5. Key Functions of TFDA as Medicines Regulatory Authority • Regulation of drugs including antibiotics encompasses a variety of functions. • Amongst them include: • Product evaluation & registration • Licensing & Inspection of manufacturing facilities & distribution channels • Inspection and surveillance • Quality Control (QC) • ADR monitoring • Control of drug promotion & advertising

6. 1. Product Evaluation & Registration • Also known as marketing authorization and product licensing • Carried out to ensure that a pharmaceutical product has been adequately evaluated for safety, efficacy & quality and that the product information provided by the manufacturer is accurate. • Involves evaluation of technical & administrative data submitted about a drug product, deciding whether to approve or reject the product and issuing a Registration Certificate

7. 1. Product Evaluation…… • The overall process requires a legal foundation, an adequate number of qualified staff, sustainable resources, a data retrieval system and a system to ensure freedom from conflicts of interest, accountability and transparency.

8. 2. Licensing of manufacturing, distribution & retail sale • Specifications regarding pharmaceutical premises, personnel and procedures must be followed by pharmaceutical manufacturers, distributors and retailers if they wish to obtain and retain their licence to operate. • By means of these licences, TFDA control the activities of pharmaceutical manufacturers, importers and distributors & companies engaged in drug promotion andadvertising.

9. 3. Inspection & Surveillance • Enables TFDA to monitor whether pharmaceutical operations are carried out in accordance with approved standards and guidelines. • In so doing, TFDA uncover weaknesses and actual errors in drug production, QC, storage & distribution of drugs. • Activities include physical inspection and quality-testing of product samples.

10. 4. Quality Control • Controlling the quality of drugs before and after registration has been issued, is critical for ensuring the quality and safety of drugs. • Access to a QC laboratory is of paramount importance • The capacity of a MRA to undertake quality surveillance is also directly related to the operational capability of the QC laboratory. • The results of a laboratory assessment of samples of marketed drugs permit the MRA to evaluate the actual quality of products used in the country and to identify problems pertaining to drug quality.

11. 4. QC……. • QC testing minimizes the amount of sub-standard drugs & raw materials in circulation. • Encourage improvements in the standard of local manufacturing - manufacturers may be encouraged to upgrade their production sites, for example, by the prospect of an independent assessment of the quality of their products. • TFDA has a laboratory which operates to ensure that all of the above are being undertaken

12. 5. ADR Monitoring (Pharmacovigilance) • Overseeing and monitoring adverse reactions to drugs are important mechanisms for assessing the safety and efficacy of pharmaceutical products. • ADR monitoring is an essential form of post-marketing surveillance for drugs already on the market. • The existence and operation of this system is important in drug regulation and reflect the Authority’s ability to regulate the entire process of pharmaceutical product assessment.

13. 6. Control of Drug Promotion & Advertising • Pharmaceutical manufacturers & suppliers promote and/or advertise their products to health professionals & the general public using a number of methods. • Advertising in journals or other media • Direct mailings • Personal selling through sales representatives • Provision of gifts and samples • Sponsored symposiums and sponsored publication of information materials

14. 6. Drug Promotion Control…. • Such promotion aims to influence people’s attitudes, beliefs & behaviour and encourage them to use a particular brand of product. • Drug information can significantly influence the way drugs are used by consumers and providers of medicines (prescribers and dispensers). • Regulation of drug information and promotion is therefore necessary to prevent the dissemination of inaccurate and misleading information.

15. Challenges • Evaluation & registration of drugs including antibiotics in terms of the number of qualified staff, available reference materials, data management and processing of drug applications • Licensing of premises taking into account again human resources available, size of the country • Inspection – availability of financial & human resources & follow-ups after inspection • Quality testing – equipment, reagents, analysts etc

16. Challenges….. • Post-marketing surveillance (PMS) – Collection of samples, screening, analysis & results dissemination. TFDA has recently prepared a PMS programme which defines implementation strategies for efficient & effective PMS. • ADR monitoring – detecting, understanding, and assessing ADRs and sharing of information with the public • Promotion control – follow-ups after approval or rejection, control of banners, control of misleading claims

17. Challenges….. • Control of antibiotic resistance: • Enforcement or control of antibiotic prescribing and dispensing practices including limiting as “prescription only medicines (POM) • Monitoring of antibiotic resistance including dosage compliance and usage in food producing animals • Educating the public on the use of antibiotics

18. Ahsante