Cpding Guidelines and Standards

COMPOUNDING STANDARDS & GUIDELINES

Non-Sterile Compounding

LEARNING OBJECTIVES

  • Upon completion of this section, students should be able to:

    • List relevant standards and guidelines for non-sterile compounding and their purpose, including:

      • USP 795 and USP 800

      • WHMIS and SDS

      • NAPRA

      • NIOSH List of Antineoplastics and Other Hazardous Drugs in Healthcare Settings

    • Use appropriate standards and guidelines to determine proper procedures for non-sterile compounding.

    • Identify hazardous risk levels of a drug and how to handle and dispense safely.

RELEVANT STANDARDS & GUIDELINES

  • Key standards and guidelines include:

    • OCP Non-sterile or Sterile compounding standards

    • NAPRA Model Standards for Non-Sterile or Sterile Compounding

    • Health Canada Policy on Manufacturing & Compounding Drug Products in Canada - POL-0051

    • USP–NF General Chapters for Compounding (<795>, <800>)

    • NIOSH List of Antineoplastic & Other Hazardous Drugs in Healthcare Settings

      • Published by the National Institute for Occupational Health & Safety of CDC.

    • WHMIS (Workplace Hazardous Material Information System) = guidelines for safe handling and storage of hazardous materials in Canada.

    • USP-NF = United States Pharmacopeia – National Formulary.

  • Key differences between a standard and a guideline:

    • Standards are binding regulations that must be followed, while guidelines are recommendations that can be adapted according to circumstances.

ORGANIZATION AND IMPLEMENTATION

  • OCP Non-Sterile Compounding Standards

    • Approved December 2017.

    • Adopted NAPRA Model Standards for Non-Sterile Compounding.

      • Initial implementation: January 1, 2020

      • Final compliance: January 1, 2021

        • Assess risks & gaps in processes by July 2020.

        • Personnel training and Quality Assurance to be completed by January 2, 2021.

        • Necessary improvements in facilities and equipment.

  • NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations

    • Approved March 2017, published January 2022.

    • Provides guidance to evaluate practice, develop procedures, and implement quality controls for both patients and compounders.

    • Refers to USP, NIOSH, WHMIS.

  • USP – NF Chapter <795> & <800>

    • Chapter <795> provides guidance for good non-sterile compounding practices.

    • Chapter <800> focuses on handling hazardous drugs in healthcare settings.

    • Chapter <1075> summarizes good compounding practices.

    • Updates to NIOSH List of Antineoplastic & Other Hazardous Drugs in Healthcare Settings are ongoing, with the last update in September 2016.

DEFINITIONS AND CATEGORIES

  • USP CHAPTER <795> (NON-STERILE COMPOUNDING)

    • Defines various terms related to compounding:

      • Risk definitions similar to NIOSH.

      • Categories of compounding:

        • Simple: Straightforward preparations, minimal manipulation.

        • Moderate: Requires special calculations or procedures.

        • Complex: Requires specialized training or equipment.

    • Requirements address:

      • Compounding process

      • Documentation: master formulae, compounding records, policies, procedures, quality processes.

      • Personnel training

      • Facilities for compounding

      • Equipment used for compounding

      • Handling of ingredients/components used in compounding

      • Stability & beyond-use date (BUD) for compounded products.

      • Packaging of compounded products.

USP & HEALTHCARE PROFESSIONALS

  • Medication Safety & Labeling

    • Importance of adhering to compounding standards to ensure patient safety.

    • Comprehensive guidelines for compounding from the USP-NF General Chapters.

    • Five essential compounding General Chapters include:

      • <797> (Pharmaceutical Compounding-Sterile Preparations): Procedures to avoid harm due to contamination or incorrect composition in sterile preparations.

      • <795> (Pharmaceutical Compounding-Nonsterile Preparations): Guidelines for preparing nonsterile compounded formulations.

      • <1160> (Pharmaceutical Calculations in Prescription Compounding): Guidance for necessary calculations in drug preparation.

      • <1163> (Quality Assurance in Pharmaceutical Compounding): Steps to maintain standards in compounded preparations.

      • <1176> (Prescription Balances and Volumetric Apparatus): Information about weighing and measuring devices in compounding.

    • General Chapters in Development:

      • <800> will focus on hazardous drugs handling strategies.

      • Another chapter for compounding investigational drugs is forthcoming.

GUIDELINES & STANDARDS

  • WHMIS 2015 Assessment

    • Introduces guidelines for handling chemicals safely in workplaces, covering:

      • Consumer guidelines

      • Workplace guidelines

    • Emphasizes the use of pictograms and keywords on labels along with Safety Data Sheets (SDS).

SAFETY DATA SHEETS (SDS)

  • Structure of SDS:

    • Section 1: Identification

      • Product identifier, manufacturer/distributor information, emergency contact, recommended and restricted uses.

    • Section 2: Hazard Identification

      • All chemical hazards and required label elements.

    • Section 3: Composition/Information on Ingredients

      • Ingredients and trade secret claims.

    • Section 4: First-Aid Measures

      • Required treatment and important symptoms/effects.

    • Section 5: Fire-Fighting Measures

      • Suitable extinguishing techniques; specific hazards.

    • Section 6: Accidental Release Measures

      • Emergency procedures for containment and cleanup.

    • Section 7: Handling and Storage

      • Safety precautions and incompatibilities.

    • Section 8: Exposure Controls/Personal Protection

      • Permissible exposure limits, recommended PPE.

    • Section 9: Physical and Chemical Properties

      • Physical characteristics of the chemical.

    • Section 10: Stability and Reactivity

      • Stability information, potential reactions.

    • Section 11: Toxicological Information

      • Health effects, exposure routes, toxicity measures.

    • Sections 12-16 cover ecological, disposal, transport, regulatory and other relevant information.

HANDLING HAZARDOUS DRUGS

  • Recognition of health risks associated with certain drugs, including:

    • Routes of exposure:

      • Skin absorption, ingestion through contact.

      • Inhalation.

    • Consequences: May include immediate acute reactions or long-term health conditions.

    • History: First NIOSH List issued in 2004, highlighting changes in drug handling practices as new drugs are developed.

    • Emphasis on learning techniques for safe handling from the outset of one's pharmacy practice.

EXPOSURE RISKS IN HANDLING HAZARDOUS DRUGS

  • Potential Methods of Exposure include:

    • Receiving and unpacking materials

    • Cleaning and waste disposal

    • Managing spills

    • Storing drugs

    • During compounding, administering, and dispensing processes.

LOCATIONS OF POTENTIAL EXPOSURE

  • Exposure can occur in various healthcare settings:

    • Hospitals

    • Surgical centers

    • Veterinary hospitals and clinics

    • Pharmacies

    • Home health care

    • Skilled nursing facilities.

NIOSH GUIDELINES

  • Key Definitions and Risk Factors include:

    • Types of health hazards based on drug toxicity.

    • Risk factors:

      • Toxicity of the drug itself.

      • Routes through which drugs can enter the body.

      • Techniques used for manipulating drugs, such as cutting tablets.

      • Exposure controls in use while handling medications, like isolation and PPE.

      • Listing criteria for drugs categorized in Tables 1-5 regarding their handling requirements and safety protocols.

TABLES IN NIOSH DOCUMENT

  • NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016

    • Table 1: Antineoplastic drugs

    • Table 2: Non-antineoplastic drugs with hazardous effects

    • Table 3: Non-antineoplastic drugs with reproductive adverse effects

    • Table 5: Recommendations for PPE and engineering controls depending on the level of risk involved with specific activities in drug handling.