scholarly journals A 5-year Study of Systemic Reactions Using both Shared and Patient-Specific Vaccines

2013 ◽  
Vol 4 (2) ◽  
pp. ar.2013.4.0057 ◽  
Author(s):  
Julian Melamed ◽  
Ami Mehra ◽  
Angela Ahuja-Malik
Keyword(s):  
Specific Immunotherapy ◽  
Systemic Reaction ◽  
Reaction Rates ◽  
Patient Specific ◽  
Subcutaneous Immunotherapy ◽  
Allergic Reactions ◽  
World Allergy Organization ◽  
Patient Records ◽  
Systemic Reactions ◽  
Dosage Errors

The safety of shared specific vaccines (SSVs) has been questioned by some experts. The purpose of this study was to evaluate the safety of SSVs. Details of systemic allergic reactions after subcutaneous immunotherapy injections were captured on a standardized form from July 2005 to July 2010. Patient records were evaluated for factors that might be associated with increased rate of systemic reactions and, in addition, were examined for any errors. Systemic reaction rates (SRRs) using a combination of shared and patient-specific vaccines (PSVs) were similar to previously reported studies (0.23 reactions per 100 shots). There were no systemic reactions resulting from errors where the incorrect shared allergen was administered, but we did note one reaction after an erroneously administered PSV. There were two dosage errors associated with both shared and patient-specific immunotherapy. Most reactions were mild to moderate (World Allergy Organization grade, 1 or 2). Severe reactions with 911 activations were noted in six patients. Thirty percent of reactions occurred out of the office and the average time to reaction was 48 minutes. Epinephrine was administered in only 60% of patients. Epicutaneous reactivity to mites, cats, dogs, and pollen but not mold occurred significantly more in reactors. Differences in SRRs were encountered between satellite offices. Using a combination of SSV and PSV, SRRs were similar to previously reported studies; moreover, no systemic reactions occurred where a SSV was erroneously administered. SRR surveillance is a useful safety tool.

scholarly journals A single-centre retrospective study of systemic reactions to subcutaneous immunotherapy

2020 ◽  
Author(s):  
Kara Robertson ◽  
Nazanin Montazeri ◽  
Urvashi Shelke ◽  
Samira Jeimy ◽  
Harold Kim
Keyword(s):  
Incidence Rate ◽  
Best Practice ◽  
Systemic Reaction ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Subcutaneous Immunotherapy ◽  
Single Centre ◽  
Epinephrine Administration ◽  
Epinephrine Injection ◽  
Systemic Reactions

Abstract BackgroundSubcutaneous immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual. MethodsA single centre retrospective chart review was performed for all patients with systemic reactions to subcutaneous immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University.Results28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered extract. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance.ConclusionsThis is the first Canadian study to review patients with systemic reactions to subcutaneous immunotherapy. Several best practice methods were employed throughout the study to optimize subcutaneous delivery of immunotherapy extract, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.

scholarly journals A single centre retrospective study of systemic reactions to subcutaneous immunotherapy

2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Kara Robertson ◽  
Nazanin Montazeri ◽  
Urvashi Shelke ◽  
Samira Jeimy ◽  
Harold Kim
Keyword(s):  
Incidence Rate ◽  
Best Practice ◽  
Systemic Reaction ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Subcutaneous Immunotherapy ◽  
Single Centre ◽  
Epinephrine Administration ◽  
Epinephrine Injection ◽  
Systemic Reactions

Abstract Background Subcutaneous immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual. Methods A single centre retrospective chart review was performed for all patients with systemic reactions to subcutaneous immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University. Results 28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered extract. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance. Conclusions This is the first Canadian study to review patients with systemic reactions to subcutaneous immunotherapy. Several best practice methods were employed throughout the study to optimize subcutaneous delivery of immunotherapy extract, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.

The safety of carbamylated monomeric allergoids for sublingual immunotherapy. Data from a pharmacovigilance study

Immunotherapy ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 195-202 ◽  
Author(s):  
Enrico Compalati ◽  
Cristoforo Incorvaia ◽  
Sara Urbano ◽  
Paola Strada ◽  
Franco Frati
Keyword(s):  
Adverse Drug Reactions ◽  
Sublingual Immunotherapy ◽  
Systemic Reaction ◽  
Subcutaneous Immunotherapy ◽  
Drug Reactions ◽  
Safety Database ◽  
Systemic Reactions ◽  
Spontaneous Reports ◽  
Post Marketing

Aim: Sublingual immunotherapy (SLIT) is significantly less concerned by systemic reactions than subcutaneous immunotherapy. Allergoids were introduced to reduce systemic reaction to subcutaneous immunotherapy, but may also be used for SLIT. Methods: This pharmacovigilance study evaluated the post-marketing reports collected in a safety database, including the number and the type (serious or not serious) of adverse drug reactions (ADRs) in Italy by SLIT with the carbamylated monomeric allergoid (CMA). Results: More than 15,000,000 CMA tablets were administered, with 25 spontaneous reports of ADRs, only two being serious. Conclusion: The rate of ADRs to CMA we found in this pharmacovigilance survey, corresponding to 0.0004% of all administered doses, is far lower than the rates commonly reported for allergen SLIT products.

scholarly journals A single-centre retrospective study of systemic reactions to subcutaneous immunotherapy

2020 ◽  
Author(s):  
Kara Robertson ◽  
Nazanin Montazeri ◽  
Urvashi Shelke ◽  
Samira Jeimy ◽  
Harold Kim
Keyword(s):  
Incidence Rate ◽  
Best Practice ◽  
Systemic Reaction ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Subcutaneous Immunotherapy ◽  
Single Centre ◽  
Epinephrine Administration ◽  
Epinephrine Injection ◽  
Systemic Reactions

Abstract Background Subcutaneous immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual. Methods A single centre retrospective chart review was performed for all patients with systemic reactions to subcutaneous immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University. Results 28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered serum. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance. Conclusions This is the first Canadian study to review patients with systemic reactions to subcutaneous immunotherapy. Several best practice methods were employed throughout the study to optimize subcutaneous delivery of immunotherapy serum, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.

scholarly journals A Single-Centre Retrospective Study of Systemic Reactions to Subcutaneous Immunotherapy

2020 ◽  
Author(s):  
Kara Robertson ◽  
Nazanin Montazeri ◽  
Urvashi Shelke ◽  
Samira Jeimy ◽  
Harold Kim
Keyword(s):  
Incidence Rate ◽  
Best Practice ◽  
Systemic Reaction ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Subcutaneous Immunotherapy ◽  
Single Centre ◽  
Epinephrine Administration ◽  
Epinephrine Injection ◽  
Systemic Reactions

Abstract Background: Subcutaneous immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual.Methods: A single centre retrospective chart review was performed for all patients with systemic reactions to subcutaneous immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University.Results: 28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered serum. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance.Conclusions: This is the first Canadian study to review patients with systemic reactions to subcutaneous immunotherapy. Several best practice methods were employed throughout the study to optimize subcutaneous delivery of immunotherapy serum, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.

scholarly journals Systemic reactions to subcutaneous allergen immunotherapy: real-world cause and effect modelling

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Adam Aue ◽  
Joella Ho ◽  
Rongbo Zhu ◽  
Harold Kim ◽  
Samira Jeimy
Keyword(s):  
Risk Factors ◽  
Treatment Plan ◽  
Systemic Reaction ◽  
Health Care Practitioner ◽  
Subcutaneous Immunotherapy ◽  
Epinephrine Administration ◽  
Multiple Risk Factors ◽  
Systemic Reactions ◽  
Multiple Risk ◽  
Practitioner Education

Abstract Background Subcutaneous immunotherapy (SCIT) is an effective treatment for allergic rhinoconjunctivitis. However, adverse events, including life-threatening systemic reactions, may occur. The purpose of this project is to identify risk factors for systemic reactions to SCIT and to provide practice-based solutions using a quality improvement (QI) framework. Methods A QI initiative was performed in a hospital-based, Canadian Allergy clinic administering SCIT in a 12-month period. Results A total of 4242 injections of SCIT were performed over a period of 12 months. Of these, 10 injections resulted in a systemic reaction requiring epinephrine administration (i.e., an incidence of 1 in 424 injections, or 0.24%). Eight patients had at least one documented risk factor for a systemic reaction, and six had multiple risk factors. Major risk factors included seasonal exacerbation of allergic rhinitis, uncontrolled asthma, and an error in route of administration. All reactions occurred with the highest allergen extract concentration. Conclusion This QI initiative highlights the need for improved patient and health care practitioner education and pre-administration screening. We suggest several considerations for SCIT administration: provide patients with written information on safety; screen patients before injections, including a review of treatment plan adherence and asthma control; adjust dosing to slow down buildup of the most concentrated immunotherapy extract, particularly in high risk patients; and apply additional safety measures in patients with multiple risk factors.

scholarly journals A single-centre retrospective study of systemic reactions to subcutaneous immunotherapy

2020 ◽  
Author(s):  
Kara Robertson ◽  
Nazanin Montazeri ◽  
Urvashi Shelke ◽  
Samira Jeimy ◽  
Harold Kim
Keyword(s):  
Incidence Rate ◽  
Best Practice ◽  
Systemic Reaction ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Subcutaneous Immunotherapy ◽  
Single Centre ◽  
Epinephrine Administration ◽  
Epinephrine Injection ◽  
Systemic Reactions

Abstract Background Subcutaneous immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual. Methods A single centre retrospective chart review was performed for all patients with systemic reactions to subcutaneous immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University.Results 28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered extract. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance.Conclusions This is the first Canadian study to review patients with systemic reactions to subcutaneous immunotherapy. Several best practice methods were employed throughout the study to optimize subcutaneous delivery of immunotherapy extract, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.

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