HOSPITAL FOCUS:

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

ACPE UAN: 0107-9999-16-034-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 conflicts 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

 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
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. 2015.

2
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. 2015.

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

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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): 313-7.

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): 313-7.

4
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). 2013.

Importance to Patient Safety

Medication that is delivered by a method other than orally
bypasses many of the bodys 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. www.globalrph.com/aseptic.

5
Importance to Patient Safety

"Judge Approves $200 Million Settlement over Meningitis Outbreak."CBS News 20 May 2015.

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 2015.

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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)

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Contamination
Contamination of
a compounded
medication can
come from many
sources:

Environment Equipment Personnel

Texas Tech University. Sterile Compounding and Preparations. April 2009.

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 105 particles/m3 or 100,000 particles/m3
Average urban environment has 35,000,000 particles/m3
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; 71:14566.

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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; 71:14566.

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 Where is the best location to
compound?

http://www.ashp.org/DocLibrary/Bookstore/P1794/P1794-Chp21.aspx

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; 71:14566

10
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; 71:14566

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

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 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; 71:14566

12
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; 71:14566.

What item of PPE is this technician

missing?

www.nursingcenter.com

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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; 71:14566

Procedure for Garbing

Shoe Sanitize
Sanitize Sanitize
covers, Enter Put on gloves
Wash hands Put on hands
hair buffer sterile with
hands with gown with
covers, area gloves isopropyl
alcohol alcohol
mask alcohol

American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile

Preparations. Am J Health-Syst Pharm. 2014; 71:14566.

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Understand the Aseptic Process
Horizontal Flow Hood Vertical Flow Hood

Globalrph.com

Principles of a Laminar Flow Hood

Aseptic Technique. Global RPh. www.globalrph.com/aseptic.

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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. www.globalrph,com/aseptic.

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. www.globalrph.com/aseptic

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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?

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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

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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
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

www.tshp.org

Compounding Resources
ASHP Guidelines on Compounding Sterile Preparations
(http://www.ashp.org/DocLibrary/BestPractices/PrepGdlQualAssurSterile.aspx)

ASHP Compounding Resource Center

(http://www.ashp.org/sterilecompounding)

Global RPh Aseptic Technique

(www.globalrph.com/aseptic)

Training modules available at your work site

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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

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