457 - Pemusnahan & Penarikan Sediaan Farmasi, Alkes dan BMHP

Summary

In this video, Dr. Sufi discusses the procedures for handling and destroying pharmaceutical preparations, medical devices, and BMHP (biomedical products) in clinics. He explains the importance of managing expired, damaged, or substandard products according to regulations to ensure safety and compliance. The destruction process includes steps such as marking and storing expired items, creating documented procedures, and coordinating with relevant parties for proper disposal. He also touches on the recall process for products with revoked distribution permits. The video aims to promote safety and proper management of pharmaceutical and medical products in health services.

Takeaways

• 😀 Destruction and withdrawal of pharmaceutical preparations, medical devices, and BMHP are essential for ensuring quality and safety in healthcare settings.
• 😀 Pharmaceutical supplies that have expired, do not meet quality requirements, or have their distribution permits revoked must be appropriately handled and destroyed or returned to the distributor.
• 😀 A system for handling damaged or expired drugs must be in place at clinics to ensure compliance with laws and regulations.
• 😀 The purpose of drug destruction is to minimize the risk of using substandard or expired products and to reduce the storage burden.
• 😀 Drugs, medical devices, and BMHP that fail to meet the required standards must be managed according to the established destruction procedures.
• 😀 When performing stock opname, any pharmaceutical supplies nearing expiration should be specially marked and stored according to the FIFO method.
• 😀 Expired pharmaceutical supplies should be stored separately and clearly marked, and can either be returned to the distributor or destroyed.
• 😀 Destruction procedures involve creating a list of the supplies to be destroyed, providing a destruction report, and coordinating with relevant parties on the method and schedule.
• 😀 Destruction must be carried out based on the type and form of the supplies, adhering to applicable regulations.
• 😀 Withdrawal of medical devices and BMHP is conducted when distribution permits are revoked or when products do not meet regulatory standards, either voluntarily or through an order by BPOM.

Q & A

What is the purpose of destroying pharmaceutical preparations, medical devices, and BMHP?

The purpose of destruction is to ensure that pharmaceutical preparations, medical devices, and BMHP that no longer meet the quality requirements are managed according to applicable standards. This reduces storage burden and the risk of using substandard drugs.

What types of products need to be destroyed according to the script?

Products that need to be destroyed include those that do not meet quality requirements, have expired, do not meet the requirements for use in health services, or have had their distribution permits revoked.

How should damaged or expired pharmaceutical supplies be handled?

Damaged or expired pharmaceutical supplies should be given special markings and stored separately. For expired products, the first expired products should be used first, and those that are completely expired should be returned to the distributor or destroyed.

What is the significance of a 'stock opname' in managing pharmaceutical preparations?

Stock opname is used to collect data on supplies whose expiration date is within the next 6 months, allowing for proper marking, storage, and management of expired or soon-to-expire products.

What steps are involved in the destruction process of pharmaceutical supplies?

The destruction process involves: 1) making a list of the pharmaceutical supplies to be destroyed, 2) providing a destruction report, 3) coordinating the schedule, method, and place of destruction with relevant parties, and 4) carrying out the destruction according to the type of product and applicable regulations.

How should the destruction of narcotics, psychotropics, and counterfeit drugs be handled?

The destruction of narcotics, psychotropics, and counterfeit drugs must be carried out according to laws and regulations, specifically designed for these types of drugs to ensure proper disposal.

What role does the pharmacy installation play in handling damaged or expired pharmaceutical products?

The pharmacy installation must create documented procedures for detecting damage and expiration of pharmaceutical products, and ensure proper handling and destruction according to applicable standards.

How are medical devices and BMHP withdrawn from distribution?

Medical devices and BMHP are withdrawn when their distribution permits have been revoked by the Minister of Health, or through a recall order from BPOM, either voluntary or mandatory. The owner of the distribution permit must ensure a proper report to BPOM.

What is the 'first expired first out' rule in pharmaceutical supply management?

The 'first expired first out' rule means that the first products to expire should be used or removed first to prevent the use of expired supplies, ensuring that newer products are available for use.

What are the key reasons for the withdrawal of pharmaceutical preparations from circulation?

Pharmaceutical preparations are withdrawn due to reasons such as failing to meet legal and regulatory standards, expiration, damage, or revocation of their distribution permit.