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Guidelines for Safe Management of Pharmaceutical Waste

Guidance for Safe Management of Pharmaceutical Waste

Guidance Overview

The Guideline for Safe Management of Pharmaceutical Waste provides a comprehensive framework for the proper handling, segregation, storage, transportation, treatment, and disposal of pharmaceutical waste in Kenya. Developed by the Pharmacy and Poisons Board (PPB) in collaboration with key stakeholders, the guideline seeks to ensure public health and environmental safety by providing clear processes for managing pharmaceutical waste across the healthcare supply chain.

Purpose and Scope

Purpose:

1. • To establish best practices for the safe management of pharmaceutical waste to protect public health and the environment.
   • To align pharmaceutical waste management in Kenya with international standards, including those set by the World Health Organization (WHO) and the National Environment Management Authority (NEMA).
   • To prevent environmental contamination and public health hazards arising from improper disposal of pharmaceutical waste.

Scope:

• The guideline applies to all pharmaceutical waste generated within Kenya's healthcare sector, including expired drugs, contaminated materials, substandard or falsified medical products, and unused investigational products.
• It does not apply to other types of healthcare waste, such as sharps, infectious waste, pathological waste, radioactive waste, chemical waste, or general healthcare waste.

Key Features of the Guidance

1. Pharmaceutical Waste Minimization:

1. • Emphasizes strategies to reduce waste, including first-expiry-first-out (FEFO) stock management, refusal of short-dated pharmaceuticals, and returns of expired products to suppliers.

1. Segregation and Packaging:

1. • Details procedures for separating pharmaceutical waste from other healthcare waste.
   • Requires the use of appropriately labeled, leak-proof, and tamper-proof containers for storage and transport.

1. Storage Requirements:

1. • Stipulates that pharmaceutical waste must be stored in clearly marked, secured quarantine areas to prevent accidental use or access by unauthorized persons.
   • Encourages disposal within one year of generation to avoid prolonged storage.

1. Transportation of Pharmaceutical Waste:

1. • Provides requirements for transporting pharmaceutical waste, including vehicle licensing, driver training, and preparation of consignment notes for traceability.

1. Disposal Methods:

1. • Outlines approved methods such as incineration, encapsulation, and inertization to ensure safe and environmentally friendly disposal.
   • Highlights specific handling of hazardous pharmaceuticals, such as cytotoxic drugs, which require high-temperature incineration.

1. Supervision of Disposal:

1. • Mandates that all disposal activities be supervised by the PPB and carried out at NEMA-approved disposal sites.
   • Requires facilities to apply for disposal using prescribed forms and pay applicable supervision fees.

Roles and Responsibilities

1. Pharmacy and Poisons Board (PPB):

• Provides oversight, sensitization, and enforcement of the guideline.
• Issues certificates for pharmaceutical waste disposal and supervises disposal activities.

2. Pharmaceutical Waste Generators:

• Includes manufacturers, healthcare facilities, pharmacies, and distributors.
• Responsible for collecting, recording, segregating, and safely storing waste.
• Must transfer pharmaceutical waste to licensed disposal handlers.

3. Waste Transporters:

• Must be licensed by NEMA and use vehicles equipped with safety and containment features.
• Drivers must be trained in handling pharmaceutical waste and responding to emergencies.

4. Disposal Facility Operators:

• Must comply with PPB and NEMA regulations for waste treatment and disposal.
• Provide proof of safe disposal by issuing certificates of destruction.

5. National Environmental Management Authorities (NEMA):

• Ensure that disposal sites meet environmental safety standards and monitor emissions from incinerators and other treatment facilities.

Attached Files