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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
2
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)
3
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
4
Latex Reactions1
5
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
6
Parts of a Vial
7
1. Coring from septum during vial puncture2. Release of latex proteins from undersurface of
septum
Possible Methods of Latex Contamination1
8
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
12
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
19
- “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
22
23
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
29
Other Recommendations
1. Standardized questionnaire for identification of “true” latex allergy
2. Standardized approach to identify vials containing latex (i.e. annually, assistant?, how?)
30
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
33
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
34
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
35
FH Policy Discussion
36
Any Last Questions?
37
References
38
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
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