CDOB ( Cara Distribusi Obat yang Baik )

Summary

This video emphasizes the importance of adhering to pharmaceutical distribution regulations to ensure the safety and quality of drugs. It covers key guidelines such as those in the Health Ministry regulations and the technical guidelines for Good Distribution Practices (GDP). The script details the responsibilities of pharmaceutical wholesalers, ensuring proper procurement, storage, and distribution processes to protect public health. It highlights the importance of competent personnel, regular training, and appropriate facilities to maintain drug quality throughout the supply chain, aiming to prevent illegal and substandard medicines from reaching consumers.

Takeaways

• 😀 The pharmaceutical distribution system plays a crucial role in ensuring the safety and quality of drugs in Indonesia, and any discrepancies can have fatal consequences.
• 😀 The regulatory framework governing pharmaceutical distribution includes several important laws, including regulations on pharmaceutical wholesalers and distribution methods.
• 😀 Pharmaceutical wholesalers (PBF) must meet strict legal requirements such as having a legal entity, proper licenses, adequate facilities, and compliance with Good Distribution Practices (GDP).
• 😀 The process of obtaining a pharmaceutical wholesaler license involves multiple steps, including administrative verifications, technical audits, and recommendations from various authorities.
• 😀 The operation of pharmaceutical wholesalers must adhere to Good Distribution Practices (GDP) to ensure the quality of drugs throughout the distribution chain, from procurement to delivery.
• 😀 All involved stakeholders, including pharmaceutical wholesalers, regulatory bodies, and the public, must work together to maintain the integrity of the distribution system and uphold regulations.
• 😀 Facilities for storing and distributing pharmaceutical products must be equipped with appropriate tools and controlled environments, such as calibrated temperature systems and separate storage areas for damaged or expired products.
• 😀 The transportation of pharmaceutical products requires careful handling to maintain quality, ensuring that vehicles are suitable for the job and that goods are kept in optimal conditions.
• 😀 Proper documentation, such as purchase orders and transport records, is essential for verifying the authenticity and quality of pharmaceutical products to prevent counterfeiting.
• 😀 The pharmaceutical supply chain, from manufacturing to distribution to final sale, must follow strict regulations to protect public health, and stakeholders should be aware of their responsibilities to maintain a safe, effective distribution system.

Q & A

What is the main issue addressed in the video script?

The main issue discussed is the problem of illegal drug distribution, including the sale of controlled substances not following regulations and the circulation of fake or substandard drugs, which pose a severe risk, including fatalities.

What is the importance of the pharmaceutical distribution system?

The pharmaceutical distribution system is crucial because it ensures that medicines are safely and effectively distributed to various healthcare institutions, maintaining their quality and compliance with legal standards. Failure to adhere to these regulations could result in health risks, including death.

What laws and regulations govern the pharmaceutical distribution system in Indonesia?

The pharmaceutical distribution system in Indonesia is governed by several regulations, including the Ministry of Health Regulation No. 1148 of 2011, changes made by Ministry of Health Regulation No. 34 of 2014, and No. 30 of 2017, as well as technical guidelines set by the Head of the National Agency of Drug and Food Control (Badan POM).

Who are the stakeholders in the pharmaceutical distribution chain?

The stakeholders in the pharmaceutical distribution chain include large pharmaceutical traders (PBF), central and local government authorities, regulatory bodies, and the public, all of whom must work together to ensure compliance with distribution laws and regulations.

What are the main requirements for a pharmaceutical trader (PBF) to operate legally?

To operate legally, a PBF must be a legal entity (such as a corporation or cooperative), have a valid NPWP (tax identification number), employ a responsible pharmacist, meet building and storage standards, and ensure that no violations have occurred within the last two years.

What is the process for obtaining a pharmaceutical distributor license?

The process includes submitting an application to the Director General with supporting documents to the Provincial Health Office, undergoing an administrative verification, and meeting the requirements for Good Distribution Practice (CDOB). After these steps, the Ministry of Health or the relevant authority issues the distributor license.

What is CDOB, and why is it important in pharmaceutical distribution?

CDOB stands for 'Good Distribution Practice', which ensures that medicines maintain their quality throughout the distribution process. It is vital for protecting the integrity of medicines from manufacturing to delivery, ensuring that they reach consumers safely and effectively.

What facilities and equipment must a PBF maintain to comply with CDOB?

A PBF must maintain adequate facilities, such as sufficient storage space, secure access for goods, pest control measures, proper lighting, and appropriate temperature and humidity conditions. Additionally, the PBF must ensure that transport equipment, such as vehicles and cooling systems, meet CDOB standards.

What role does administrative oversight play in the CDOB system?

Administrative oversight is essential in ensuring that all aspects of CDOB are adhered to. This includes maintaining records of all distribution activities and generating reports, which are monitored regularly to ensure that regulations are followed throughout the distribution chain.

How does the pharmaceutical distribution system contribute to public health in Indonesia?

The pharmaceutical distribution system plays a critical role in ensuring that safe, effective, and high-quality medicines are available to all parts of Indonesia. By following CDOB and other regulations, it supports the overall health system and helps protect public health by preventing the circulation of unsafe or counterfeit drugs.