USP 800 & Inventory Management and Medication Shortage

USP 800

USP 800 continued

USP 800 guidelines apply to

USP 800 characteristics

USP 800 three distinct categories

AREAS OF USP 800

RESPONSIBILITY OF PERSONNEL HANDLING HAZARDOUS DRUGS AND TRAINING

COMPOUNDING REQUIREMENTS

Compounding requirements continued

Primary Engineering Control, PEC, Laminar Flow Cabinet

Containment Primary Engineering, Control, C-PEC, Class II Biosafety Cabinet

Containment Primary Engineering Control, C-PEC, Glovebox Isolator

Supplemental Control Device

Supplemental Control Device

Routes of Exposure vs Potential Risks

PERSONAL PROTECTIVE EQUIPMENT

Gowning in ISO 7 cleanroom

PERSONAL PROTECTIVE EQUIPMENT

FACILITY, ENVIRONMENTAL AND ENGINEERING CONTROL

FACILITY, ENVIRONMENTAL AND ENGINEERING CONTROL

Goal & Note

Know the note

DEACTIVATING, DECONTAMINATING, CLEANING AND DISINFECTING

Read package insert, know quote

DEACTIVATING, DECONTAMINATING, CLEANING AND DISINFECTING

The work surface of the C-PEC must be decontaminated between compounding different hazardous drugs

Cleaning steps

STORAGE, RECEIVING OF HAZARDOUS MEDICATIONS

Wiping HD prior to storage

NIOSH

NIOSH continued

NIOSH 2016

NIOSH 2024 HD

2024 NIOSH Criteria for Tables 1 & 2

When did NIOSH initiate its' first HD list?

NIOSH began to compile a hazardous drug list in 2004.

Approximately how many healthcare workers are exposed to HD medication annually?

Approximately 8 Million U.S. healthcare workers.

What year did <USP 800> become enforceable?

It became compendial applicable on November 01, 2023.

Provide 3 routes that an individual can be exposed to HD?

1. Oral—through ingestion

2. Inhalation—breathing in vapors

3. Dermal—contact

What PEC is used to compound a HD?

A C-PEC (Containment Primary Engineering Control) that is externally vented, such as a Biological Safety Cabinet (BSC) or a Compounding Aseptic Containment Isolator (CACI).

Is a CSTD required in pharmacy compounding?

No. The slides define the Closed System Transfer Device (CSTD) as a supplemental engineering control or adjunct control to provide an added level of protection

Is a CSTD required in the Administration of a HD?

(Note: The provided text slides only define a CSTD as a supplemental/adjunct control used alongside C-PECs for making preparations and do not mention or provide rules for drug administration).

How often should the C-PEC be wiped?

The work surface of the C-PEC must be decontaminated:

• At least once daily (when being used)

• Every 30 minutes while compounding

• Between compounding different hazardous drugs

• Any time there is a spill

• Before and after certification

• Any time voluntary interruption occurs

• If the ventilation tool is moved

• When surface contamination is suspected

What is the ACH that is required in a negative pressure room?

12 ACH (Air Changes Per Hour) for the storage room of hazardous drug APIs.

What is Inventory Management

What is Inventory Management continued

What is Inventory Management → cabinet

What is DSCSA

Best Practices

WHAT IS FIFO?

Key Aspects of a Drug Shortage:

What does FIFO mean?

First In, First Out. It is an inventory management method where the oldest inventory items (first in) are sold or used first (first out). In a pharmacy, this method helps reduce the risk of expired and obsolete products, ensuring optimal stock turnover and safety.

Why was DSCSA enacted?

Enacted in 2013, the Drug Supply Chain Security Act (DSCSA) was established to create an electronic, interoperable system to trace prescription drugs from manufacturer to pharmacy. Its primary goal is to protect consumers from counterfeit, stolen, or contaminated medications by requiring unique serialization, product identification, and digital transaction documentation.

What are examples of Best Practices for Inventory Control?

Incorporating bar-code scanning across the following inventory workflows:

• Stocking inventory in the pharmacy and other automated dispensing devices

• Scanning source ingredients during compounding, repackaging, and labeling processes

• Manual packaging of oral solid and liquid medications

• Retrieving medications from automated dispensing devices

• Dispensing medications from the pharmacy to any location

Key Areas that are impacted by Medication Shortage:

• Pharmacy Informatics , Technology and Medication Errors

• Medication Errors

How to Mitigate Medication Shortages

Causes & Solutions

What strategies should organizations implement to mitigate the impact of medication shortages?

Form a drug shortage team and resource allocation committee with pharmacists.

• Establish processes to identify alternative therapies.

• Ensure effective communication and update medical order sets/electronic health records.

Medication shortages impacts pharmacy and patient care and can potentially cause what issues?

Medication errors due to process changes.

• Patient treatment disruptions (delays, forced drug substitutions, or adverse events).

• Forced urgent changes to protocols and automation/IT systems.

What are examples of why there are medication shortages?

Manufacturing problems (43%).

Delays in manufacturing or shipping (15%).

Lack of active pharmaceutical ingredients (API) (10%).

Lack of financial incentive for less profitable, older generic drugs.

Poor manufacturer quality management systems.

chart to know