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Drug Safety

The drug safety program seeks to ensure that that prescription drugs are safe and effective, properly labeled and are dispensed according to valid prescriptions from authorized practitioners. The program also ensures that generic drugs are safe and therapeutically equivalent to their brand name counterparts, and that drugs are dispensed with child-resistant caps.

Objectives:

  • Prevent public exposure to unsafe, ineffective or misbranded prescription drugs by identifying and resolving problems or potential problems before consumers are placed at risk.
  • Inspect pharmacies, prescription drug wholesalers and other prescription drug interests at frequencies in accordance with Branch priorities.
  • Protect the drug supply against acts of terrorism.

Stragegies:

  • Routinely inspect drug wholesalers, pharmacies, dispensing practitioners and other prescription drug retailers.
  • Take immediate action within 24 hours whenever a product is determined to pose an imminent threat of serious or irreversible injury, serious illness, or even death. Action may include embargo and condemnation of adulterated or misbranded products, recall of those products with public notification, and order for immediate closure of the responsible firms(s).
  • Respond to all drug complaints:

    1 - Serious complaints involving illness or injury shall be investigated within 2 working days.
    2 - Non-serious complaints, e.g., one involving an economic or maketing issue, shall be investigated within 2 weeks

  • Developing partnerships with industry emphasizing:

    1 - The development of clear, concise compliance standards.
    2 - Improvements to the updating and distribution fo the Hawaii Drug Formulary of Equivalent Drug Products.
    3 - The timely notification of pharmacies and other prescription drug interests of recalls and alerts.
    4 - The refinement of Hawaii's drug laws and rules.
    5 - The development of an educational component to be implemented during the inspection of pharmacies, prescription drug wholesalers, and medical oxygen distributors.
    6 - The provision of consultative services to industry, the public, community groups and other government agencies.
    7 - The develpment of meaningful measureable performance measures.

  • Ensure that prescription drugs ar dispensed in child-resistant containers unless otherwise requested by the consumer.
  • Respond immediately to suspected acts of terrorism and natural disasters; assess and coordinate response with related agencies, coordinate the distribution of medical supplies, intitiate public notification, and implement product recall and destruction. other government agencies.

Performance Measures:

  • Inspect pharmacies, prescription drug wholesalers and other prescription drug interests according to Branch priorities.
  • Investigate prescription drug-related complaints within 48 hours of receipt.
  • Reduce the overall annual rate of violations per inspection.



If you have any questions, please contact:

Food and Drug Branch
591 Ala Moana Blvd.
Honolulu, HI 96813
Phone: (808) 586-4725
Fax: (808) 586-4729



Last update: 7 June 2004


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