CHALLENGES IN REGULATING QUALITY AND RATIONAL USE OF ANTIBIOTICS

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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

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Scope

• About TFDA
• Its Mission and Vision
• Its Functions as MRA
• Challenges

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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

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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

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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

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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

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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.

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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 and advertising.

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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.

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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.

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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

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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
  Authoritys ability to regulate the entire
  process of pharmaceutical product assessment.

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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

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6. Drug Promotion Control.

• Such promotion aims to influence peoples
  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.

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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

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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

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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

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Ahsante