COMPOUNDING PHARMACY IN THE HOSPITAL SETTING SATURDAY/11:30AM-12:30PM

Transcription

1 HOSPITAL FOCUS: COMPOUNDING PHARMACY IN THE HOSPITAL SETTING SATURDAY/11:30AM-12:30PM ACPE UAN: L04-T 0.1 CEU/1 hr Activity Type: Knowledge-Based Learning Objectives for Pharmacy Technicians: Upon completion of this CPE activity participants should be able to: 1. List products that may be compounded in the hospital pharmacy setting 2. Describe the role of aseptic technique as it relates to patient safety 3. Discuss guidelines that relate to sterile and non-sterile product preparation 4. Identify tips that may be useful to the pharmacy technician in product preparation 5. List resources that may be helpful when providing compounding services at your pharmacy Speaker: Stephanie Malenfant, PharmD, MPH, BCOP Stephanie Malenfant is an Assistant Professor at the University of Iowa College of Pharmacy where she teaches courses regarding chemotherapy and supportive care for patients with cancer. She also maintains a clinic practice at the University of Iowa Hospitals and Clinics in the Adult Bone Marrow Transplant program. Stephanie earned her PharmD and Masters in Public Health (MPH) from the University of Iowa. She also completed a PGY-1 Pharmacy Practice Residency at the University of Iowa and continued on to a PGY-2 Oncology Pharmacy Residency at the University of Texas M.D. Anderson Cancer Center in Houston, TX. Speaker Disclosure: Stephanie Malenfant reports no actual or potential confl icts of interest in relation to this CPE activity. Off-label use of medications will not be discussed during this presentation. FEBRUARY 13, 2016 IOWA EVENTS CENTER DES MOINES, IOWA

2 Compounding Pharmacy in the Hospital Setting Stephanie Malenfant, PharmD, MPH, BCOP Disclosure Stephanie Malenfant reports no actual or potential conflicts of interest associated with this presentation 1

3 Learning Objectives Upon successful completion of this activity, pharmacists should be able to: List products that may be compounded in the hospital pharmacy setting Describe the role of aseptic technique as it relates to patient safety Discuss guidelines that relate to sterile product preparation Identify tips that may be useful to the pharmacy technician in product preparation List resources that may be helpful when providing compounding services at your pharmacy The Basics What is compounding? The art and science of preparing personalized medications for patients Individual ingredients mixed together to accommodate exact strength and dosages for a specific patient "What Is Compounding? - PCCA. Professional Compounding Centers of America. PCCA. Web. 14 Dec

4 Compounding- Then and Now Historically, most medications needed to be compounded by pharmacy staff Commercial medication manufacturing increased dramatically in the 1950s and 1960s Decreased need for compounding in outpatient pharmacies Many intravenous medications still require compounding Need for continued compounding recognized by government Provision in Food and Drug Modernization Act of 1997 "What Is Compounding? - PCCA. Professional Compounding Centers of America. PCCA. Web. 6 Dec Need for Compounding in Hospital Fewer commercially manufactured products Drug shortages reduce availability of ready-to-use products Need for patient specific dosing Specific fluid or diluent requirements Short stability products 3

5 Variety of Routes for Administration Intravenous Intramuscular Subcutaneous Intradermal Intrathecal Epidural Allen Jr, Loyd V. "Basics of Compounding Sterile Preparations: Nomenclature and Considerations." International Journal of Pharmaceutical Compounding 18(4): Compounding in the Hospital Setting Hospitals see an increased need for compounding to provide a variety of pharmaceuticals: Injectable medications Ophthalmics Irrigation solutions Diagnostic agents (contrast) Biologics Nutrients Radiopharmaceuticals Allen Jr, Loyd V. "Basics of Compounding Sterile Preparations: Nomenclature and Considerations." International Journal of Pharmaceutical Compounding 18(4):

6 Cleveland Clinic Example Data from a 1,300 bed medical center in 2012 Approximately 870,000 doses prepared Prepared medications included: Anti-infectives Pain management Chemotherapy Replacement fluids Electrolyte replacements Ophthalmic preparations Pharmacy Sterile Compounding Summit. American Society of Hospital Pharmacy (ASHP) Importance to Patient Safety Medication that is delivered by a method other than orally bypasses many of the body s natural defenses Skin barrier Efflux pumps in the stomach First pass effect Therefore an improperly prepared solution can have very dangerous side effects Infections Emboli Occlusions Aseptic Technique. Global RPh. 5

7 Importance to Patient Safety "Judge Approves $200 Million Settlement over Meningitis Outbreak."CBS News 20 May Importance to Patient Safety New England Compounding Center (NECC) outbreak Inability to meet standards in compounding led to outbreak of rare fungal complications Fungal meningitis affected more than 750 people, killed 64 people People affected in 20 states Courts sentencing to create $200 million compensation fund NECC ultimately declared bankruptcy "Judge Approves $200 Million Settlement over Meningitis Outbreak."CBS News 20 May

8 Keeping Your Patients Safe Aseptic technique is vital Carrying out a procedure under controlled conditions in a manner that minimizes contamination Also known as sterile compounding Sterile: Freedom from bacteria and other microorganisms Cannot be visibly seen Available Guidelines Many guidelines are available to help encourage best practices in sterile compounding: USP 797 American Society of Hospital Pharmacy (ASHP) National Institute for Occupational Safety and Health (NIOSH) Environmental Protection Agency (EPA) Occupational Safety and Health Administration (OSHA) 7

9 Contamination Contamination of a compounded medication can come from many sources: Environment Equipment Personnel Texas Tech University. Sterile Compounding and Preparations. April Environment Requirements for air quality within the clean room Should be built into the clean room ISO Class 5 environment generally recommended Allows a maximum 10 5 particles/m 3 or 100,000 particles/m 3 Average urban environment has 35,000,000 particles/m 3 Rely on high-efficiency particle air (HEPA) filter >99.99% efficient in removing particles 0.3 microns in size American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71:

10 Environment Laminar Airflow Workbench Biological Safety Cabinet Compounding Aseptic Isolator Nuaire.com Other Recommendations Must maintain 12 fresh air exchanges/hour Medium risk preparation areas should maintain a slight positive air pressure High risk and chemotherapy preparation areas should maintain a slight negative air pressure Create a separate ante area Situated between staging area and clean room Allows room for handwashing, garbing, product decontamination Area for sinks or other water sources including floor drains American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71:

11 Where is the best location to compound? Equipment Equipment placed in a clean room should be minimized to only that which is vital to compounding Materials should be stainless steel when possible All equipment that can come into contact with the medication product should remain clean Bins Compounding cabinets Medication vials and IV fluid bags Personnel Clean room- floors, walls, vents American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71:

12 Equipment All surfaces should be disinfected regularly Ideally once per shift, consider between batches Clean visible solids with germicidal detergent and water Disinfect area with sterile 70% isopropyl alcohol Must be disinfected again if power to cabinet is lost Maintaining a clean work area is essential! American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71: Equipment Minimize the amount of materials brought into clean room for compounding Remove any plastic covers from IV bags Clear off any dust or residue Bring in items to compound one medication at a time Only 4-5 items in the hood at a time if possible Do not remove items that maintain sterility Needle and syringe wrappers should stay intact until place in a hood 11

13 How could the sterility of this hood be improved? Restech.com Personnel Must be trained in proper aseptic technique Initial training should be documented Maintenance of training should be documented annually Should complete media-fill test at least every 12 months Should consider their own health or infection concerns Avoid sterile compounding duties with personal illness Weeping sores or rashs Pink eye Respiratory infection Fever American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71:

14 Personal Protective Equipment (PPE) PPE are equipment designed to keep personnel safe while compounding medications: Gloves Gowns Shoe covers Hair covers Beard covers American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71: What item of PPE is this technician missing? 13

15 Procedure for Garbing Should be done prior to entering clean room Work from dirtiest to cleanest Remove any additional garments Sweaters or jackets Visible jewelry Personal devices (music players, cell phones) Gloves should be cleaned or removed when dirty Non-stained gowns can be reused within one shift All other garb must be replaced Hair covers, shoe covers American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71: Procedure for Garbing Shoe covers, hair covers, mask Wash hands Sanitize hands with alcohol Put on gown Sanitize hands with alcohol Enter buffer area Put on sterile gloves Sanitize gloves with isopropyl alcohol American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71:

16 Understand the Aseptic Process Horizontal Flow Hood Vertical Flow Hood Globalrph.com Principles of a Laminar Flow Hood Aseptic Technique. Global RPh. 15

17 Avoid Coring the Vial Needles will come with a beveled tip Should be inserted at an angle with bevel tip up Once inserted needle can be positioned to a more effective position Aseptic Technique. Global RPh. Working Inside the Hood Keep a clear path between the filter and your product Watch your fingers! Allows for product to contact the cleanest air Place critical items as close as possible to filter In horizontal flow hood, place items no closer to filter than 3 inches Avoid working in the 6 inches closest to open air Avoid spraying or touching the HEPA filter This is to keep the filter clean Be extra careful while cleaning the hood Aseptic Technique. Global RPh. 16

18 Tips for Pharmacy Personnel Use PPE any time you handle medications This can include inventory procedures Know how to properly garb in full PPE Understand how your ventilated cabinet works Minimize the items in your ventilated cabinet Inspect your product for any visual signs of contaminant Maintain your aseptic technique training Calculations for Compounding Frequently used to determine what volume of medication is required to reach a specific required concentration Example: You are asked to compound an IV that includes 1 mg tacrolimus IV in a 100mL bag of 0.9% sodium chloride. What volume of tacrolimus should be added to the base bag if the tacrolimus comes as 5 mg/ml? 17

19 Calculations for Compounding You are asked to compound an IV that includes 1 mg tacrolimus IV in a 250mL bag of 0.9% sodium chloride. What volume of tacrolimus should be added to the base bag if the tacrolimus comes as 5 mg/ml? Tacrolimus 1mg X 1 ml = 0.2 ml 5 mg Add 0.2 ml of tacrolimus IV Compounding Labels 18

20 Compounding TPN Complex item to compound due to large variety of additive Base requires addition of amino acids and dextrose May add 2-10 other items Electrolytes: potassium, magnesium, phosphorus, calcium Vitamins: multivitamin, thiamine, zinc Other medications: insulin, famotidine TPN Compounder drugtopics.modernmedicine.com 19

21 Manually Compounding TPN Allow for plenty of space Assemble all required additives before starting Follow order of additives given on label Keep all additives organized Maintains thought process Reduces likelihood of contamination Compounding Resources ASHP Guidelines on Compounding Sterile Preparations ( ASHP Compounding Resource Center ( Global RPh Aseptic Technique ( Training modules available at your work site 20

22 Conclusion Sterile compounding is an everyday event in hospital pharmacy Compounding allows for individualized medications Improperly compounded medications can lead to complications for the patient Risk of contamination in sterile compounds is minimal when guidelines are followed appropriately 21