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Sterile Compounding and Latex Precautions

Tracy SouzaBSc (Pharm) 2017

LMPS Pharmacy Resident(Medication Safety & Quality)

Overview of Presentation

1. Background2. Methods of Contamination3. Best Practice?

a. Literatureb. Organizations’ Recommendations

4. My Recommendations5. Discussion on FH Policy

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Background

- May 2021: NAPRA standards to become bylaws as per College of Pharmacists

- Standards include requirements for sterile compounding

- 1-6% of population has latex allergy- vial septum may include latex

- No LMPS policy on sterile compounding in patients with latex allergy

- FH Latex Precautions Policy (2007)

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Objectives of Research

- Identify best practice for sterile compounding in patients with latex allergies

- What do other guidelines recommend for sterile compounding in patients with latex allergies?

- Make recommendations for updating latex precautions policy

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Latex Reactions1

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Sensitivity Allergy

Incidence 1-6%

Classification Type IV Type I

Reaction Skin reactions Anaphylaxis(swelling)

Compounding Procedure1,9

Standard Procedure

Latex Precautions

Latex Sensitivity vs. Allergy

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Parts of a Vial

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1. Coring from septum during vial puncture2. Release of latex proteins from undersurface of

septum

Possible Methods of Latex Contamination1

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Thomsen & Berke (2000)2

- Less latex proteins in unpunctured vials?

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Thomsen & Berke (2000)2

Methods:- Vials:

- 20 vials with latex septum- 20 vials with latex-free septum- NS + latex controls

- latex free-syringe + 18 gauge needle- Immunoassay = 250ng/ml

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Thomsen & Burke (2000)2

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Results 1) Both latex septum and latex-free septum tested at 250-540 ng/ml

2) microbacterial growth x 1 vial

Conclusion Similar latex exposure in vials with a single puncture vs. no puncture

Primeau et. al3

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Study Objectives

Are latex allergens released from vial septum?

Design - in vivo- N=23 (12 = latex allergy)

Methods - 4 vials w/ latex in septum, 1 latex free vial- Inverted- 21 gauge needle - 0 punctures vs. 40 punctures

Results - no reaction in all patients w/ no latex allergy- Latex allergy: 0P = 2/12, 40P = 5/12

Conclusion 1) more punctures = more risk of coring2) all vials with latex septum pose a risk

regardless of procedure

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Study Conclusions - do not access vial contents with a decapper - 1 puncture is similar to 0 punctures- Any latex containing vial contains a risk

Anaphylaxis from Latex Septum

How many patients have had anaphylactic reactions that were caused by latex proteins in a parenterally compounded product?a. 42b. 7c. 2d. none of the above

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Anaphylaxis from Latex Septum

How many patients have had anaphylactic reactions that were caused by latex proteins in a parenterally compounded product?a. 42b. 7c. 2d. none of the above

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Latex Anaphylaxis

- no studies have demonstrated causation between anaphylaxis and latex proteins from vial stopper1

- associations only:- Neonate + lipid4 - Diabetic patients5

- FDA = insufficient evidence to ban stoppers containing latex1

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Fraser Health Policy (2007)6

- “1 puncture only”- “smallest gauge possible”- “...identify products containing natural rubber

latex...call manufacturers as required”- “...medication stability charts shall

indicate...where latex is present [or] unknown”

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Guidelines/Policies

- The following organizations have been reviewed for latex and compounding

- NAPRA - USP (United States Pharmacopeia)- CSHP- ASHP- BCCA- Other

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NAPRA7

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- “The existing compounding process yields high-quality sterile preparations that are safe for patients”

- No documents explaining processes for latex compounding

- Sent email → referred to CSHP guidelines

USP

- No mention of latex allergies in compounding standards for sterile compounding (797) or handling of hazardous drugs (800)

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CSHP8

- Only refers to cleaning/decontamination and use of latex-free products

- “Where possible, latex-free products shall be used”

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CSHP

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ASHPLatex Status ask all patients about latex allergy vs.

sensitivity

Application of latex recommendations

Patients with latex allergies

Compounding Technique

1. standard aseptic technique as per USP 797

2. ampoules for highly sensitive individuals

Identifying latex-status of manufactured vials

- no recommendations

Other - latex allergy protocol- list of substitutes

BCCA

1. Procedures and Techniques for Safe Handling of Hazardous Drugs - Preparation of Parenteral Hazardous Drugs for Latex Allergy Patients (2014)

2. Guidelines for Preparation of Parenteral Hazardous Drugs for Latex Allergy Patients (2015)

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BCCA9,10

Latex Status Allergy vs. sensitivity

When to apply policy only in patients with latex allergies (sensitive = standard procedure)

Compounding Technique/Procedure

see next slides

Identifying latex-status of manufactured vials

- contact manufacturer - update list annually

Other - Multidose: new vial for each dose - Cleaning: 15 minutes of fan blowing - Labelling: specialized auxiliary label

BCCA - Sterile Technique

Latex Allergic Patients:1. Remove any latex containing products

from biological safety cabinet2. Clean/disinfect, 15 min fan 3. If vial stopper contains latex (or unknown)

a. new vial for each doseb. solution = 1 poke, reconstitution = 2c. use negative pressure technique if

non-hazardous

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Other Organizations

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Organization Name of Guideline/Standard Comments

Association of Surgical Technologists11

Guidelines for Best Practices for the Natural Rubber Latex Allergic Patients

- 1 puncture into vial

College of Physicians and Surgeons of BC12

Accreditation Standards - Latex Allergy

Assessment: all patients

Questionnaire to include reaction, gloves, food allergies (cross-reactive potential)

List maintenance : regularly updated w/ substitutions

My Recommendations?

1. Screening for latex allergies 2. Policy applies only to individual patients with

allergies (not medication batches)3. Active list of all vials of parenteral

medications and whether they contain latex a. contact manufacturer directly

4. Use latex auxiliary label (“Latex-free preparation - use latex precautions”)

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Compounding Recommendations?

5. Compounding technique:a. Clean/decontaminate hood + 15 min of

fan blowingb. smallest needlec. 1 or 2 pokes (2 = reconstitution)d. ampoules where possiblee. negative pressure technique for

non-hazardous sterile compounding

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Other Recommendations

1. Standardized questionnaire for identification of “true” latex allergy

2. Standardized approach to identify vials containing latex (i.e. annually, assistant?, how?)

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Example of Latex Questionnaire13

http://www.gfclinic.com/wp-content/uploads/Latex-Allergy-Questionnaire-June-2011_1.pdf

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Conclusion

- True latex allergy is rare; however, exercise caution

- If no alternatives exist, apply latex policy and procedures

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Flow Diagram

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Latex reaction on Patient Profile?

Does vial have latex septum?

True allergy?

No? Standard Compounding Procedure

No Alternatives?

Latex Procedure (cleaning, up to 2 puncture etc.)

Discussion Time and Questions

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Group Discussion Questions

1. Apply policy to individual patients or compounded batches? 2. Sterile compounding technique during sterile compounding?

a. needle gauge?b. vial septum removal? c. # of punctures (1 vs. 2, dispensing pin)?d. materials used during compounding?

3. Compounding worksheets?4. Questionnaires

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FH Policy Discussion

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Any Last Questions?

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References

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1. Buchanan E, Schneider P, Forrey R. Compounding sterile preparations. Bethesda, Md.: American Society of Health-System Pharmacists; 2018.

2. Thomsen D, Burke T. Lack of latex allergen contamination of solutions withdrawn from vials with natural rubber stoppers. American Journal of Health-System Pharmacy. 2000;57(1):44-47.

3. Primeau MN, Adkinson NF, Hamilton RG. Natural rubber pharmaceutical vial closures release latex allergens that produce skin reactions. J Allergy Clin Immunol. 2001; 107:958-62.

4. Wynn R, Boneberg A, Lakshminrusimha S. Unexpected source of latex sensitization in a neonatal intensive care unit. Journal of Perinatology. 2007;27(9):586-588.

5. Heitz J, Bader S. An evidence-based approach to medication preparation for the surgical patient at risk for latex allergy: is it time to stop being stopper poppers?. Journal of Clinical Anesthesia. 2010;22(6):477-483.

6. Fraser Health. Compounded Sterile Preparations – Latex Precautions. 2007. P1-27. NAPRA. Model Standards for PHARMACY COMPOUNDING OF HAZARDOUS STERILE PREPARATIONS. 2016. P8. CSHP. Compounding: Guidelines for Pharmacies. 2014 p.131, 2199. BCCA. Procedures and Techniques for Safe Handling of Hazardous Drugs - Preparation of Parenteral Hazardous Drugs

for Latex Allergy Patients. 2014 p. 2-4.10. BCCA. Guidelines for Preparation of Parenteral Hazardous Drugs for Latex Allergy Patients. 2015 p. 1-3.11. Association of Surgical Technologists. Guidelines for Best Practices for the Natural Rubber Latex Allergic Patients. 2018 p.

1-15.12. College of Physicians and Surgeons of BC. Accreditation Standards - Latex Allergy. 2018 p. 1-4.13. Great Falls Clinic Medical Center. Latex Allergy Questionnaire. 2011 p. 1