Hospital Pharmacy Compounding hospp.pptx

compounding pharmacy

1. Hospital Pharmacy Compounding Ensuring safe, patient-specific medications.

2. Agenda • Compounding: Bulk vs. Sterile • Regulatory Frameworks & Controls • Personnel & Aseptic Technique • Quality Control & Testing • Benefits, Challenges, Safety

3. Hospital Pharmacy Compounding Hospital pharmacy compounding is essential for creating patient-specific medications, such as pediatric doses or allergy-free formulations, and for addressing critical drug shortages. This specialized practice ensures optimal patient care when commercially available products are unsuitable or unavailable. Young pharmacist in a professional pharmacy setting.

4. Bulk Compounding Defined Bulk compounding prepares non-sterile drug products in large quantities. This is often for internal hospital use, addressing unavailable commercial formulations. Examples include oral suspensions or topical creams.

5. Sterile Compounding Essentials Sterile compounding involves manipulating sterile products or bulk drug substances. It creates patient-specific preparations, like IV medications, while rigorously preventing microbial contamination. Aseptic technique is paramount. Healthcare professionals in protective gear handle viral threats in a sterile environment.

6. Key Distinctions: Bulk vs. Sterile Bulk Compounding (Non-Sterile) Prepares non-sterile medications in large quantities for internal use. Lower regulatory burden, but still requires quality control for patient safety. Sterile Manufacturing Produces sterile products (e.g., injectables, eye drops) for direct patient administration. Stringent regulations (e.g., USP <797>) and high-risk profile due to infection potential.

7. Bulk Compounding (Non-Sterile) Sterile Compounding Primarily governed by State Boards of Pharmacy. Adheres to Good Manufacturing Practices (GMP) principles. Ensures quality and consistency for non-sterile preparations. Strictly regulated by USP <797> and <800>. Mandates specific facility, personnel, and process controls. Critical for patient safety and preventing contamination.

8. Naval personnel conduct hygiene tests in a laboratory. Environmental Control Zones • Sterile compounding requires classified cleanroom environments. • ISO classifications define air cleanliness levels. • Lower ISO number = fewer airborne particles. • ISO 5 (Class 100) is critical for aseptic processing.

9. Primary Engineering Controls PECs protect sterile products and personnel from contamination. They create ISO Class 5 environments for compounding.

10. Secondary Engineering Controls SECs, like buffer areas and ante-rooms, support PECs by controlling air quality and personnel entry. They maintain positive pressure and specific ISO classifications, crucial for sterile compounding.

11. Airflow Dynamics & HEPA HEPA Filters HEPA filters capture 99.97% of particles ≥0.3 microns, crucial for sterile environments. Unidirectional Airflow Air moves in parallel streams, sweeping contaminants away from critical areas. Contamination Control This system prevents microbial and particulate contamination during compounding.

12. Personnel Gowning Protocol Strict gowning, including sterile gloves, gowns, masks, and covers, prevents human-borne contamination in sterile compounding.

13. Aseptic Technique Mastery Rigorous aseptic technique training is crucial for all compounding personnel. This includes proper hand hygiene, sterile manipulation of components, and meticulous environmental disinfection to prevent contamination. Vaccine preparation in a sterile laboratory setting.

14. Pharmacist assists customer, showcasing science in healthcare. Competency Assessment Programs • Mandatory for all sterile compounding personnel. • Ensures adherence to USP <797> standards. • Includes media fills, gloved fingertip tests. • Validates continuous skill maintenance.

15. Environmental Monitoring Particle Counting Monitors airborne particles, both viable (microorganisms) and non-viable (dust), in sterile environments. Ensures air quality meets ISO classifications for compounding. Surface Sampling Swabs or contact plates collect samples from critical surfaces like compounding benches and equipment. Detects microbial contamination to ensure sterility. Air Sampling Active (impaction) and passive (settle plates) methods collect airborne microorganisms. Verifies the effectiveness of HVAC and HEPA filtration systems.

16. Bulk Product Quality Checks • Potency: Assay verifies active ingredient concentration. • Purity: Detects impurities and degradation products. • Physical Characteristics: Appearance, pH, viscosity, specific gravity. • Stability: Shelf-life testing under various conditions.

17. Sterility Testing Methods Sterility testing, via direct inoculation or membrane filtration, detects microbial contamination. These critical tests ensure compounded sterile products are safe for patient use.

18. The Limulus Amebocyte Lysate (LAL) test detects bacterial endotoxins. It prevents dangerous febrile reactions from contaminated injectable products.

19. Particulate Matter Analysis Inspects sterile products for visible and sub-visible particles. Prevents patient harm from emboli or inflammation. Ensures product safety and quality.

20. Potency and Purity Assays • Verify drug concentration (potency) is accurate. • Ensure absence of harmful impurities. • High-Performance Liquid Chromatography (HPLC) is key. • Ensures patient safety and drug efficacy.

21. pH and Osmolarity Verification pH Control for Compatibility Maintain product pH near physiological levels (7.35-7.45) to prevent irritation or tissue damage. Deviations can cause pain, vein irritation, or drug degradation. Osmolarity for Isotonicity Match product osmolarity (280-310 mOsm/L) to body fluids. Hypo- or hypertonic solutions can cause cell lysis or crenation, and fluid shifts.

22. Beyond-Use Dating (BUD) BUDs are assigned to compounded preparations, not manufacturer expiration dates. They reflect stability and sterility risk, determined by USP guidelines for non-sterile and sterile compounds. Colchicine chemical sample ampoule, Fluka Biochemika, BP 100mg.

23. Documentation and Batch Records Master Formula Records These are approved blueprints for compounding. They detail ingredients, quantities, equipment, and procedures for a specific preparation. Compounding Records Batch-specific records track each step of production. They include ingredient lot numbers, expiration dates, and personnel involved. Quality Assurance & Traceability Meticulous documentation ensures product quality and patient safety. It allows for full traceability from raw materials to dispensed product.

24. MEDICIS equipment for medical research radioisotope production. Validation and Qualification • Validation: Proving processes consistently yield quality products. • Qualification: Ensuring equipment and systems perform correctly. • Personnel Qualification: Verifying staff competency for tasks. • Critical for patient safety and medication efficacy.

25. Addressing Critical Needs Customization & Innovation In-house compounding mitigates drug shortages for essential medications. It ensures patient access to critical therapies, especially during supply chain disruptions or for orphan drugs. Pharmacies can tailor dosages and formulations (e.g., pediatric liquids, allergen-free) not commercially available. This allows for personalized medicine and development of novel, patient-specific treatments.

26. Compounding Challenges? Given the strict regulatory landscape, resource constraints, and the need for specialized skills, what are the primary challenges hospital pharmacies face in maintaining safe, compliant, and efficient compounding operations?

27. Ensuring Patient Safety Ultimately, rigorous bulk and sterile compounding practices are paramount to safeguarding patient health, preventing infections, and guaranteeing medication efficacy. This commitment underpins every step in hospital pharmacy manufacturing, from preparation to administration. Vaccine production facility with workers and city skyline.

28. Resources https://www.scribd.com/presentation/489619060/Bulk-and-Sterile-manufacturing https://renaissance.stonybrookmedicine.edu/system/files/Immediate%20Use%20Compounding.pptx https://www.youtube.com/watch?v=6qfVa3mebHE https://www.ashpadvantagemedia.com/ivcompetency/files/handout-ivcompetency.pdf

29. Conclusion • Compounding addresses unique patient needs and drug shortages. • Strict regulatory compliance (e.g., USP <797>) is paramount. • Environmental controls and aseptic technique prevent contamination. • Rigorous quality control and testing ensure product safety. • Patient safety is the ultimate goal of all compounding efforts.