Allergen immunotherapy extract treatment set preparation: Making a safer and higher quality product for patients

Current Allergy and Asthma Reports

Volumn 13, Issue 4, 2013, Pages 399-405

  Nelson, Michael R ^a   Petersen, Maureen M ^a   Wolverton, Wayne O ^a   Mikita, Cecilia P ^a  

^a WALTER REED ARMY MEDICAL CENTER   (United States)

Author keywords

Allergen immunotherapy; Compounded sterile product; Diluent; Extract; Practice parameter; Preparation; Safety; USP 797

Indexed keywords

ALLERGEN;

ARTICLE; DRUG CROSS REACTIVITY; DRUG EFFICACY; DRUG LABELING; DRUG MIXTURE; DRUG POTENCY; DRUG QUALITY; DRUG SAFETY; DRUG SENSITIZATION; DRUG STABILITY; DRUG STORAGE; DRUG SYNTHESIS; GOOD CLINICAL PRACTICE; HUMAN; IMMUNOSTIMULATION; IMMUNOTHERAPY; PATIENT SAFETY; PRACTICE GUIDELINE; PRESCRIPTION; PROFESSIONAL COMPETENCE; PROTECTIVE EQUIPMENT; QUALITY CONTROL; TRAINING;

ALLERGENS; DESENSITIZATION, IMMUNOLOGIC; DRUG COMPOUNDING; HUMANS; QUALITY CONTROL;

EID: 84881175750     PISSN: 15297322     EISSN: 15346315     Source Type: Journal    
DOI: 10.1007/s11882-013-0362-z     Document Type: Article

References (23)

1. Cox L, Nelson H, Lockey R, Calabria C, Chacko T, Finegold I, et al. Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol. 2011;127(1 Suppl):S1-55. Erratum in: J Allergy Clin Immunol. 2011;127(3):840.
2. Nelson MR, Cox L. Allergen immunotherapy extract preparation guidelines, in Lee, T, editor. Practice Management Resource Guide (2012 edition). http://www.aaaai.org/practice-resources/tools-and-technology/ practice-management-resources/practice-management-resource-guide.aspx. Accessed 21 May 2013.
3. US Pharmacopeial Convention, Inc. United States Pharmacopeia 27, Supplement 1. Chapter <797> "Pharmaceutical Compounding-Sterile Preparations" Revision Bulletin. Rockville, MD: US Pharmacopeial Convention, Inc.; 2008:16.
4. Cox L, Esch RE, Corbett M, Hankin C, Nelson M, Plunkett G. Allergen immunotherapy practice in the United States: guidelines, measures, and outcomes. Ann Allergy Asthma Immunol. 2011;107(4):289-99.
5. Nelson HS. Preparing and mixing allergen vaccines for subcutaneous immunotherapy. Clin Allergy Immunol. 2008;21:303-20.
6. Nelson HS, Iklé D, Buchmeier A. Studies of allergen extract stability: the effects of dilution and mixing. J Allergy Clin Immunol. 1996;98(2):382-8.
7. Grier TJ, LeFevre DM, Duncan EA, Esch RE. Stability of standardized grass, dust mite, cat, and short ragweed allergens after mixing with mold or cockroach extracts. Ann Allergy Asthma Immunol. 2007;99(2):151-60.
8. Plunkett G. Stability of allergen extracts used in skin testing and immunotherapy. Curr Opin Otolaryngol Head Neck Surg. 2008;16(3):285-91. Abstract.
9. Gunawan H, Takai T, Kamijo S, Wang XL, Ikeda S, Okumura K, et al. Characterization of proteases, proteins, and eicosanoid-like substances in soluble extracts from allergenic pollen grains. Int Arch Allergy Immunol. 2008;147:276-88.
10. Grier TJ, LeFevre DM, Duncan EA, Esch RE, Coyne TC. Allergen stabilities and compatibilities in mixtures of high-protease fungal and insect extracts. Ann Allergy Asthma Immunol. 2012;108(6):439-47.
11. Niemeijer NR, Kauffman HF, van Hove W, Dubois AE, de Monchy JG. Effect of dilution, temperature, and preservatives on the long-term stability of standardized inhalant allergen extracts. Ann Allergy Asthma Immunol. 1996;76:535-40.
12. Plunkett G. Stability of major allergen proteins in extract mixes diluted in human serum albumin (HSA), normal saline (NSP), or glycerin (GLY). J Allergy Clin Immunol. 2007;119:S105.
13. Johansen N, Weber RW, Ipsen H, Barber D, Broge L, Hejl C. Extensive IgE cross-reactivity towards the Pooideae grasses substantiated for a large number of grass-pollen-sensitized subjects. Int Arch Allergy Immunol. 2009;150(4):325-34.
14. Weber RW. Guidelines for using pollen cross-reactivity in formulating allergen immunotherapy. J Allergy Clin Immunol. 2008;122(1):219-21.
15. Nelson HS, Oppenheimer J, Buchmeier A, Kordash TR, Freshwater LL. An assessment of the role of intradermal skin testing in the diagnosis of clinically relevant allergy to timothy grass. J Allergy Clin Immunol. 1996;97:1193-201.
16. Hejl C, Wurtzen PA, Kleine-Tebbe J, Johansen N, Broge L, Ipsen H. Phleum pratense alone is sufficient for allergen-specific immunotherapy against allergy to Pooideae grass pollens. Clin Exp Allergy. 2009;39(5):752-9.
17. Leavengood DC, Renard RL, Martin BG, Nelson HS. Cross allergenicity among grasses determined by tissue threshold changes. J Allergy Clin Immunol. 1985;76(6):789-94.
18. Van Metre Jr TE, Rosenberg GL, Vaswani SK, Ziegler SR, Adkinson NF. Pain and dermal reaction caused by injected glycerin in immunotherapy solutions. J Allergy Clin Immunol. 1996;97:1033-9.
19. Anderson MC, Baer H. Antigenic and allergenic changes during storage of a pollen extract. J Allergy Clin Immunol. 1982;69:3-10.
20. Letz AG, Tankersley MS, Dice JP, England RW. Monitoring bacteriostasis in allergen extract preparation: 10yrs of culture data. J Allerg Clin Immunol. 2009;123(5):1175-6.
21. Lay PC, Bass R, Lin SY. Allergen vial mixing and immunotherapy: risks of infections and vial contamination. Otolaryngol Head Neck Surg. 2007;137(2):243-5.
22. Lay PC, Bass R, Hughes LF, Lin SY. Risks of allergy vial contamination: comparison of mixing in-office versus under ventilation hood. Otolaryngol Head Neck Surg. 2008;139(3):364-6.
23. Lin SY, Lay PC, Hughes LF, Bass R. The safety of multi-dose vials in allergen immunotherapy. Otolaryngol Head Neck Surg. 2008;139(2):195-7.