Sterile compounding for nurses I International Congress on Patient Safety ISMP Brazil & V International Forum on Patient Safety: Medication Errors, to April 10-12, 2014, Ouro Preto, Minas Gerais state, Brazil. Eric S. Kastango, MBA, RPh, FASHP

February 20, 2014

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Learning and Performance Objective At the conclusion of this presentation , learners will be able to:

• Identify selected work practices which must be followed by nurses on patient units to reduce the potential for microbial contamination and other errors in sterile admixtures compounded outside of the controlled pharmacy cleanroom.

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Important note… • The information provided in this presentation is not meant as a work around to compliance with existing state or federal regulations.

• However, the speakers understand that nursing personnel may be required to prepare routine sterile doses in hospitals and other patient care areas without the benefit of certain engineering controls (LAFWs).

• We hope to provide you with a review of the rationale for as well as specific work practices that must be taken to reasonably safeguard patients from receiving contaminated sterile preparations.

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Synthesis of Best Practice Recommendations… • The recommendations made in this presentation are a synthesis of United States best practice recommendations from a variety of professional bodies and are based on current science.

• There's always a balance between risks due to delays or perceived/real inefficiencies caused by reducing the vigor of protective work practice controls and optimal work practice and environmental controls

• Each organization must develop its own policy which defines the types of situations in which sterile drugs may be prepared without the benefit of optimal environmental controls.

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Evidence-Based Practice References • Centers for Disease Control and Prevention. Guidelines for the

Prevention of Intravascular Catheter-Related Infections. MMWR 2011 retrieved from http://www.cdc.gov/hicpac/pdf/guidelines/bsiguidelines-2011.pdf on January 29, 2013. – Working group members include: IDSA, SHEA, SCCM, ATS, ASCCA, ONS, APIC, INS, SCVIR, AAP, CDC and HICPAC

• Infusion Nurses Society. Infusion Nursing Society Standards of Practice. Journal of Infusion Nursing. 34(1S) January/February 2011: S1-110.

• United States Pharmacopeial Convention, Inc. Pharmaceutical

Compounding—Sterile Preparations. United States Pharmacopeia 36– National Formulary 31. Rockville, MD: US Pharmacopeial Convention, Inc.; 2013.

• Winters BD et al. Pronovost PF corresponding author. Clinical review:

translating evidence into practice. Critical Care. 2009. 13:210 retrieved from http://ccforum.com/content/13/6/210 on January 29, 2014.

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Exclusions • There are situations where sterile drug preparation on patient units should not be undertaken include: – The preparation of hazardous drugs which should only occur inside of protective environmental controls (e.g., biological safety cabinet) located inside a negative pressure ISO Class 7 cleanroom

– Complex drug preparation (more than 3 sterile ingredients) should not be prepared on patient care units, practitioner offices, emergency departments or operating rooms – Preparation of multiple doses for a given patient on a routine basis (e.g., preparation of multiple doses of a q 8 hour dose)

• The best practices recommended in this lesson do not apply in urgent or emergent situations where a delay in therapy may be life-threatening, such as CPR.

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Rationale…

Reduction of particles is fundamental to reducing the risk of contamination to sterile solutions. Particles act as transport vehicles for microorganisms. Particles can be inadvertently introduced through a variety of mechanisms. They are shed from many of the components intended for manipulation in a sterile compounding area. People are another significant source of particles. Motionless we shed about 100,000 skin cells per hour and with movement that increases to 600,000 particles per hour. That’s why garbing is so important.

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Other quality controls… Regardless of whether the compounding environment is a controlled cleanroom or a designated drug preparation area in a prescriber's office or patient care unit, all quality control actions must focus on modifying the environment and staff work practices to:

• Reduce dust and other particles that act as transport vehicles for bacteria

• Reduce or eliminate air currents that are not HEPA filtered and therefore carry particles and microbial contamination

• Clean all surfaces that come in contact with sterile solutions, sterile drugs, their containers and supplies used to mix the drugs

• Refrain from all "do ahead" sterile mixing that has traditionally been performed the interest of efficiency…storage is not your friend!

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Microbial Risk What are the factors on which we rate for risk of microbial contamination? • Microbial contamination risk is assigned based on the potential for the introduction of contamination during the compounding process.

• Risk is based on multiple factors including the: – Type of components (sterile versus non sterile) – Environment in which compounding occurs – Complexity of the compounding process

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Storage of Compounded Doses • The longer a dose is stored, the greater the chance that any microorganisms accidentally introduced during compounding may have grown to sufficient numbers to cause patient harm.

• Even under best physical plant conditions and the best employee work practice, the rate of contamination will be 0.1% (1 contaminated dose in 1000)

• Contamination rates published in the literature range from 0.3% to 16%

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SDCs, MDVs, PBP and Point of Care Activated Container Type

Preservatives

BUD

No

N/A because not stored

Single Dose Ampule Single Dose Vial* (SDV)

No

6 hours if opened in ISO class 5 OR 1 hour if opened is air worse than ISO 5*

Multiple Dose Vial (MDV)

Yes

28 days from initial puncture or per manufacturer’s package insert

Pharmacy Bulk Package (PBP)

No

6 hours or shorter if opened in ISO class 5

Point-of-Care Activated Systems

• • • •

ADD-Vantage™, MINI-BAG PLUS, addEASE® Attaching/activating these not considered compounding Acceptable for nursing to attach and activate Use manufacturer’s instructions for storage and stability

The CDC advised on a more conservative approach to further safeguard patients. The CDC stipulates that the remaining contents must be discarded at the end of the procedure/case and must not be stored.

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Drug Preparations DOs Single Dose Containers (SDC)

Multiple Dose Vials (MDV)/ other

• Use of SDCs is strongly

• If a MDV is used, it should be

encouraged – Discard SDCs after use

•

• Ampules – must be discarded after opening – do not store – Must use filter needle/filter straw

•

•

•

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used for 1 patient. Each entry into a MDV must be with a new unused sterile needle and syringe. Keep MDVs away from patient care environments. Subsequent to emergency treatment, discard all opened medications, solutions and supplies. Dispose of needles at the point of use in an approved Sharps unit.

Drug Preparation DON’Ts • Never leave a needle, cannula or other spike device in a vial stopper as it increases the risk of contamination.

• This image was taken in an actual office practice setting. This was one inventive way the practitioner thought they were complying with proper sterile compounding practices. By leaving the needle in the vials and storing them in a non ISO Class 5 space, these vials are at significant risk for contamination.

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This is NEVER acceptable practice.

Drug Preparation DON’Ts (continued) • Never use an IV container to • •

• •

obtain diluent/flush solution for more than 1 patient. Never use any supply (needle, syringe, tubing, etc.) on more than 1 patient. Don’t remove sterile packaging until immediately before the item is used. Never combine leftover contents of vials for later use. Don’t prepare medication in one syringe and transfer it to another syringe.

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• Don’t store vials in pockets. • Food and beverages must be stored separately from drugs and supplies.

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Unit Based Compounding Checklist

• This presentation borrows from Dr. Peter Pronovost’s pioneering work using a checklist of evidence-based steps to reduce catheter-related infection.

• Checklists provide 2 main benefits – Facilitate memory recall, especially with more routine activities (such as compounding medication) that can be overlooked when healthcare professionals are worrying about patients and the rigors of everyday practice – Makes the minimum expected steps explicit

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Compounding Critical Steps Checklist 1 2 3 4 5 6

• Designate a contained room/area for sterile drug preparation • Gather drug/supplies needed to compound 1 patient dose • Clean the drug preparation counter • Perform hand hygiene immediately prior to compounding • Don mask, gloves (sterile preferred) and disinfect • Use friction to cleanse all critical sites with sterile 70% IPA wetting entire surface

7

• Once critical sites dry, compound patient dose using aseptic technique without interruption

8

• Unless administered by same person who compounded without intervening steps, label the patient dose

9

• Document sterile compounding

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Designate a drug preparation area • Identify and restrict a room or area in a room to be used only for sterile drug preparation.

• The doors and windows in the room must be able to be kept closed.

• The surface of the counter must be impervious, smooth and able to stand up to cleaning agents.

• No eating/drinking may occur in the room at any time. • Lighting must be adequate for reading small print. • Entry to the designated drug preparation area must be prohibited while sterile compounding is occurring.

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Designate a drug preparation area (continued)

The counter for drug preparation must not be located near heating vents, fans, air conditioners or other equipment that generates particles and air currents. The counter must not be immediately adjacent to a sink where water can be splashed onto the compounding surface. Potable tap water contains microorganisms and endotoxins (100 to as many as 500 CFU/mL and 100 EU/mL for endotoxins) * US EPA National Primary Drinking Water Regulations. Retrieved from http://www.epa.gov/safewater/consumer/pdf/mcl.pdf on November 13, 2013.

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Compounding Critical Steps Checklist 1

2 3 4

5 6

• Designate a contained room/area for sterile drug preparation • Gather drug/supplies needed to compound 1 patient dose

• Clean the drug preparation counter • Perform hand hygiene immediately prior to compounding • Don mask, gloves (sterile preferred) and disinfect

• Use friction to cleanse all critical sites with sterile 70% IPA wetting entire surface

7

• Once critical sites dry, compound patient dose using aseptic technique without interruption

8

• Unless administered by same person who compounded without intervening steps, label the patient dose

9

• Document sterile compounding

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Review orders and gather supplies… • Review the prescribers order • Pull drug from inventory • Have someone else perform an

independent double-check of the drug selected. • Gather needed supplies • Bring them to the drug prep area

…and remember, prepare sterile drugs for only 1 patient at a time! Copyright © 2008-2014 CriticalPoint® - All Rights Reserved

Review orders and gather supplies… (continued) • Remove the ordered drug and solution from the inventory according to organizational policy.

• It is recommended that the Lot

This drug could be used up to an through November 1, 2013 but not on November 2nd.

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# and manufacturer’s expiration date be documented in the patient record for every drug container used (includes drug, diluents and fluid delivery vehicles such as minibags).

Review orders and gather supplies…(continued) • Staging is completed with the items for the patient-specific batch are brought into the designated drug prep area preferably in a tray like this one.

• To prevent mix-ups, only the drugs, solutions and supplies for 1 dose for a single patient are placed in each staging container.

• Place the staging bin just outside of the actual counter for drug preparation.

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Review orders and gather supplies…(continued) Gather the supplies you will need which may include:

• Sterile, powder-free gloves • Facemask (and beard cover if appropriate)

• • • •

Vial/ampule of drug Vial of diluent Delivery container Syringes as appropriate

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• • • • • •

Needles/vial adapters Filter straw/needle if ampules Sterile IPA single-use prep pads Label for final container Sharps disposal unit

Plastic bin for solution discards in necessary

Review orders and gather supplies…(continued) Sterile versus nonsterile IPA • Sterile single-use 70% isopropyl alcohol (sIPA) and other approved antiseptic agents are used to clean container entries (vials, injection ports, ampule necks, etc.)

• Nonsterile 70% isopropyl alcohol (IPA) is acceptable as a disinfecting agent to use on the compounding counter. It is also acceptable to use to wipe off staged items prior to placing them on to the cleaned compounding counter. Copyright © 2008-2014 CriticalPoint® - All Rights Reserved

Compounding Critical Steps Checklist 1

2 3 4

5 6

• Designate a contained room/area for sterile drug preparation • Gather drug/supplies needed to compound 1 patient dose

• Clean the drug preparation counter • Perform hand hygiene immediately prior to compounding • Don mask, gloves (sterile preferred) and disinfect

• Use friction to cleanse all critical sites with sterile 70% IPA wetting entire surface

7

• Once critical sites dry, compound patient dose using aseptic technique without interruption

8

• Unless administered by same person who compounded without intervening steps, label the patient dose

9

• Document sterile compounding

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Clean the drug preparation counter • Clear away any items from the counter designated for sterile drug preparation.

• Clean the counter with a general disinfectant such as Lysol IC™ or other germicidal detergent diluted according the manufacturer’s recommendations.

• It is acceptable to clean with 70% isopropyl alcohol (IPA) alone but it is better to clean with germicidal detergent followed by disinfection with IPA.

• Always allow the counter to dry completely before beginning drug preparations. Do NOT dry it with a paper towel.

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Compounding Critical Steps Checklist 1

2 3 4

5 6

• Designate a contained room/area for sterile drug preparation • Gather drug/supplies needed to compound 1 patient dose

• Clean the drug preparation counter • Perform hand hygiene immediately prior to compounding • Don mask, gloves (sterile preferred) and disinfect

• Use friction to cleanse all critical sites with sterile 70% IPA wetting entire surface

7

• Once critical sites dry, compound patient dose using aseptic technique without interruption

8

• Unless administered by same person who compounded without intervening steps, label the patient dose

9

• Document sterile compounding

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Perform hand hygiene and garbing • Whenever possible, hand hygiene should be performed at a sink with running water, appropriate antiseptic agent and a single-use towel.

• In circumstances where that is not possible, the use of a waterless antiseptic agent with persistent activity is acceptable.

• Examples of acceptable alcohol based surgical rubs with persistent activity are: Avagard™D by 3M or Surgicept® by CareFusion.

• The use of antiseptic towelettes/wipes is discouraged because they are not as effective as alcohol-based hand rubs or washing hands with antimicrobial soap and water.

• Wipes may not be used as a substitute to rubs or washing with antimicrobial soap.

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4 - Perform hand hygiene and garbing (continued) • If hand hygiene was performed with antimicrobial soap and water, after drying hands thoroughly, follow with the application of an alcohol based hand sanitizer.

• The CDC recommends choosing products that contain at least 60% alcohol.

• Apply as recommended by the manufacturer to the palm of the hand and rub hands and fingers together covering all surfaces until they are dry.

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Compounding Critical Steps Checklist 1

2 3 4

5 6

• Designate a contained room/area for sterile drug preparation • Gather drug/supplies needed to compound 1 patient dose

• Clean the drug preparation counter • Perform hand hygiene immediately prior to compounding • Don mask, gloves (sterile preferred) and disinfect

• Use friction to cleanse all critical sites with sterile 70% IPA wetting entire surface

7

• Once critical sites dry, compound patient dose using aseptic technique without interruption

8

• Unless administered by same person who compounded without intervening steps, label the patient dose

9

• Document sterile compounding

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Don garb • To protect the drug preparation area and the sterile solutions from contamination, staff are strongly advised to don a surgical facemask and facial hair cover (if applicable and available) before beginning drug preparation.

• Donning the facemask is the first step in garbing.

• The facemask (and beard cover) are put on before hand hygiene is performed.

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Don garb (continued) • Use of gloves during drug preparation is mandatory! – Why? • Though the compounding area is not a sterile field, sterile gloves are preferred during compounding because they have a known starting point in terms of the degree of bioburden.

• Non sterile gloves have a higher degree of microbial contamination • Another study* has confirmed that as workers put their hands in the box to take gloves, the remaining gloves in the box become increasingly contaminated.

• It is also strongly recommended that gloved hands (regardless of glove type) be disinfected with sIPA before beginning compounding or if for any reason gloved hands leave the designated compounding area. – Spray gloved hands with sIPA and rub sIPA overall surfaces until gloves are dry and then proceed with compounding. *Hughes KA, Cornwall J and others. Bacterial contamination of unused, disposable non sterile gloves on a hospital orthopaedic ward. Australia’s Med J. 2013. June 30; 6(6): 331-8 can be retrieved at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3702138/ Copyright © 2008-2014 CriticalPoint® - All Rights Reserved

Other garbing considerations… • Other hygiene considerations… – Jewelry is best minimized or eliminated – Since there is increased bacterial colonization under rings, they must be removed during hand washing.

– The area underneath rings is at increased risk for dermatitis due to the increased irritant exposure through frequent hand hygiene. – Artificial nails and tips are discouraged due to increased risk for fungal cross contamination. – If artificial nails/tips are worn, they must be kept short, preferably less than ¼ inch past fingertip.

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Compounding Critical Steps Checklist 1

2 3 4

5 6

• Designate a contained room/area for sterile drug preparation • Gather drug/supplies needed to compound 1 patient dose

• Clean the drug preparation counter • Perform hand hygiene immediately prior to compounding • Don mask, gloves (sterile preferred) and disinfect

• Use friction to cleanse all critical sites with sterile 70% IPA wetting entire surface

7

• Once critical sites dry, compound patient dose using aseptic technique without interruption

8

• Unless administered by same person who compounded without intervening steps, label the patient dose

9

• Document sterile compounding

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Disinfect critical sites • Remove the protective covers from all of the vials and containers that will be accessed.

• Cleanse the top of all vials, injection ports, ampule necks and other entry points for this patientspecific batch with sterile IPA (sterile single-use alcohol prep pad) or other approved antiseptic agent, using friction so that the entire top of the surface is wetted thoroughly.

• To be effective, the alcohol or antiseptic agent must be allowed to dry completely before the container is punctured.

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Compounding Critical Steps Checklist 1

2 3 4

5 6

• Designate a contained room/area for sterile drug preparation • Gather drug/supplies needed to compound 1 patient dose

• Clean the drug preparation counter • Perform hand hygiene immediately prior to compounding • Don mask, gloves (sterile preferred) and disinfect

• Use friction to cleanse all critical sites with sterile 70% IPA wetting entire surface

7

• Once critical sites dry, compound patient dose using aseptic technique without interruption

8

• Unless administered by same person who compounded without intervening steps, label the patient dose

9

• Document sterile compounding

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Compound dose using aseptic technique • Only the supplies needed to prepare the single patient dose may be placed on the drug preparation surface.

• Whether needles or needleless systems are used, asepsis and infection prevention activities remain the same.

• Once drug preparation has begun, it may not be interrupted until it is finished.

• Drug preparation is not considered complete until labeling has occurred.

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Compound dose using aseptic technique (continued) • All containers (fluids, vials and ampules) must be examined prior to use for damage or unexpected appearance. Products that exhibit turbidity, cloudiness or particulate matter may not be used.

• The image below is a photo of particulate matter in a syringe containing a drug that was diluted then withdrawn into the syringe.

Image from: Singhal, SK. Particulate Contamination in Intravenous Drugs: Coring from Syringe Plunger. J Anaesthesiol Clin Pharmacol. 2010. OctDec; 26(4): 564-565 can be found at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3087278/

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Compounding Critical Steps Checklist 1

2 3 4

5 6

• Designate a contained room/area for sterile drug preparation • Gather drug/supplies needed to compound 1 patient dose

• Clean the drug preparation counter • Perform hand hygiene immediately prior to compounding • Don mask, gloves (sterile preferred) and disinfect

• Use friction to cleanse all critical sites with sterile 70% IPA wetting entire surface

7

• Once critical sites dry, compound patient dose using aseptic technique without interruption

8

• Unless administered by same person who compounded without intervening steps, label the patient dose

9

• Document sterile compounding

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Label patient dose • Unless the person compounding the drug is walking immediately to the patient bedside to administer the drug with no intervening steps, the patient-dose must be labeled before it leaves the drug preparation area.

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Label patient dose (continued)

Place labels on the side of the bag that is opposite the manufacturer's labeling to permit visualization of the type of base solution. Doing so also prevents the volume increment marks from being obscured. Copyright © 2008-2014 CriticalPoint® - All Rights Reserved

7 – After drug preparation (continued)

Storage of sterile parenteral doses prepared on patient units, prescriber’s offices, emergency and operating rooms is not permitted due to increased risk of bacterial growth. Only drugs and solutions that have been prepared under optimal environmental conditions like those in the pharmacy may be stored for longer periods of time. Copyright © 2008-2014 CriticalPoint® - All Rights Reserved

Transport to the patient

Transport the labeled drug container directly to the patient location for administration which must begin within 1 hour from the time that drug preparation began. Copyright © 2008-2014 CriticalPoint® - All Rights Reserved

Compounding Critical Steps Checklist 1

2 3 4

5 6

• Designate a contained room/area for sterile drug preparation • Gather drug/supplies needed to compound 1 patient dose

• Clean the drug preparation counter • Perform hand hygiene immediately prior to compounding • Don mask, gloves (sterile preferred) and disinfect

• Use friction to cleanse all critical sites with sterile 70% IPA wetting entire surface

7

• Once critical sites dry, compound patient dose using aseptic technique without interruption

8

• Unless administered by same person who compounded without intervening steps, label the patient dose

9

• Document sterile compounding

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Document sterile compounding • Before leaving the compounding area, document drug preparation on the paper or electronic forms used at your organization. • Dispose of sharps, trash, gloves and mask in appropriate waste receptacles • Wipe the designated drug preparation area with 70% IPA • Wash your hands

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General Considerations… • Training Agenda – Care of the drug preparation area – Hand hygiene and garbing – Cleaning and disinfecting – Infection prevention and aseptic technique – Labeling

• Include return demonstration components

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• Written Policies and

Procedures – describe sterile drug preparation at each organization is strongly recommended – define exactly what actions are expected to take place to effectively reduce the likelihood of contamination to sterile drugs prepared at that location – Include specific instructions on labeling and documentation of drug preparation

Questions

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