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Background and Objective: Amoxicillin-clavulanic acid (AX-CL) is the most consumed ß-lactam antibiotic worldwide. We aimed to establish the different phenotypes of ß-lactam allergy in patients reporting a reaction to AX-CL and to investigate the differences between immediate and nonimmediate onset., Methods: We performed a cross-sectional retrospective study at Hospital Clínico San Carlos (HCSC), Madrid and Hospital Regional Universitario de Málaga (HRUM), Málaga, Spain. We included patients reporting reactions with AX-CL who underwent the allergy workup between 2017 and 2019. Data on the reported reaction and allergy work-up were collected. Reactions were classified as immediate and nonimmediate with a 1-hour cut-off., Results: The study population comprised 372 patients (HCSC 208, HRUM 164). There were 90 immediate reactions (24.2%), 252 nonimmediate reactions (67.7%), and 30 reactions with unknown latency (8.1%). Allergy to ß-lactams was ruled out in 266 patients (71.5%) and confirmed in 106 patients (28.5%). The final main diagnosis in the overall population was allergy to aminopenicillins (7.3%), to CL (7%), to penicillin (6.5%), and to ß-lactams (5.9%). Allergy was confirmed in 77.2% and 14.3% of immediate and nonimmediate reactions, respectively, with a relative risk of 5.06 (95%CI, 3.64-7.02) for an allergy diagnosis in those reporting immediate reactions. Only 2/54 patients with a late-positive intradermal test (IDT) result for CL were diagnosed with CL allergy., Conclusion: Allergy was diagnosed in a minority of the study population. However, given that it was diagnosed 5 times more frequently in patients reporting immediate reactions, this classification proved useful for risk stratification. Late-positive IDT results for CL have no diagnostic value. Therefore, the late IDT reading for CL could be removed from the diagnostic work-up.

The controlled drug provocation test (DPT) is currently considered the gold standard for the diagnosis of drug allergy. Adverse drug reactions (ADRs) are an increasingly common presenting complaint in both primary and specialized care. In Spain, ADRs are usually assessed via the allergology department, which rules out immunological mechanisms in up to 90% of cases. An adequate approach to ADRs clearly impacts the costs and efficacy of the treatments prescribed by other specialists. Consequently, if we did not use DPTs, patients would require more expensive, more toxic, and less effective treatments in many cases. In recent years, many new drugs have been developed. This document is intended to be a practical guideline for the management of DPTs according to the vision of the Spanish Allergology Society. The diagnostic work-up begins with a detailed clinical history. Skin tests are only useful for some medications, and in most cases the diagnosis can only be confirmed by DPT. Although cross-reactivity is common, DPTs can confirm the diagnosis and help to find an alternative drug. Programmed individualized patient management based on the type of drug to be studied and the patient´s comorbidities usually enables a solution to be found in most cases.

Desensitisation protocols allow the continuation of treatment in patients who have presented hypersensitivity reactions. Carboplatin desensitisation solutions are usually prepared in the chemotherapy centralised units of hospital pharmacies and they are diluted under the established concentration limit to guarantee the stability of the preparation. An online survey was sent to hospital pharmacies, inquiring about local desensitisation protocols: reasons for use of desensitisation protocols, the protocols used and the stability given to carboplatin solutions. An important variability among the hospitals in carboplatin desensitisation practice was detected. Six different carboplatin desensitisation protocols were described and discordance with the storage period of the carboplatin solutions was observed. The lack of consensus on which protocol must be followed and data supporting the stability of the diluted product, contribute to distrust of carboplatin desensitisation protocols. Although the efficacy and safety of carboplatin desensitisation protocols has been widely demonstrated, many professionals still have concerns., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Diagnosis of hypersensitivity (HS) reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) in children is complex. The real prevalence of NSAID HS remains unknown because a drug provocation test (DPT) is not always performed with the culprit NSAID., Objective: To describe and compare the diagnostic workup among different European centers and to find out the real proportion of NSAID HS by performing a DPT with the culprit drug., Methods: We retrospectively collected data from children (0-10 years) and adolescents (10-18 years) with a history of NSAID reactions and who underwent a complete allergy workup including DPTs with the culprit in 6 different pediatric centers: Belgrade, Florence, Geneva, Madrid, Porto, and Rome., Results: A total of 693 children with a history of NSAID reactions were enrolled, and a total of 526 DPTs were performed with the culprit NSAID. The diagnosis of NSAID HS was confirmed in 19.6% (103 of 526) of children by performing a DPT with the culprit drug. The major differences in the allergy workup among the 6 centers concerned the duration of the DPT and the practical use of skin tests for diagnosing NSAID HS. In addition, the use of acetyl salicylic acid to differentiate single reactor or cross-intolerance patients is not common, except in Spain., Conclusion: The value of this study is that although different approaches are used around Europe to diagnose NSAID HS, we found that the percentage of confirmed NSAID HS is less than 20%. This highlights the importance of the DPT in confirming or excluding NSAID HS in the pediatric population., (Copyright © 2019. Published by Elsevier Inc.)

Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used throughout the world. They are frequently involved in hypersensitivity reactions, which range from local or mild reactions to systemic and severe reactions. Consequently, it is necessary to perform an exhaustive study of patients in order to make an accurate diagnosis, search for safe procedures in the case of severe reactions, and identify alternative treatment options. Various guidelines and protocols address the management of hypersensitivity to NSAIDs, although these vary widely from country to country. The Committees of Asthma, Rhinoconjunctivitis, and Drug Allergy of the Spanish Society of Allergy and Clinical Immunology (SEAIC) propose the present position statement on available options for provocation testing with aspirin/NSAIDs. This document is the fruit of an exhaustive review of current evidence and is based on recent publications addressing the diagnosis of patients with hypersensitivity to NSAIDs and on a consensus-oriented discussion among a group of experts from the SEAIC. The main objective was to draft an easy-toread, practical guideline for health care professionals in specialist areas who assess and manage patients with suspected hypersensitivity to NSAIDs. Furthermore, indications, contraindications, and procedures for oral, bronchial, and nasal provocation tests with aspirin/NSAIDs have been updated.

Background: Suspicion of allergic drug reaction can cause important disturbances in the patient's life., Objective: We evaluated in a prospective multicenter study the quality of life of patients who suffered a possible allergic drug reaction, and analyzed the effect of a drug allergy evaluation., Methods: Patients (>18 years old) answered the specific questionnaire twice: before the drug allergy evaluation, and 1 month after it was completed. Statistics were performed using STATA., Results: A total of 360 patients (240, 66.6% female; mean age, 45.4 years; standard deviation [SD], 15.6 years) completed the first questionnaire. After the evaluation, 150 of 346 patients (43.4%) were diagnosed as allergic to the drug (115 of 150 immediate; 35 of 150 delayed) and 196 of 346 patients (56.6%) as nonallergic. The mean value of the first questionnaire was 32.14 (SD, 11.84); patients with anaphylaxis, nonanaphylactic immediate reaction, with more than 1 drug reaction, or a chronic osteoarticular disease, had a statistically significant higher score in Q0 (worse quality of life). After the allergy study, the mean of the second questionnaire was 27.27 (SD, 9.96), showing a global improvement (P < .001). No statistically significant difference was found between drug allergic and non-drug allergic patients (P = .340); however, being >40 years old (P = .030), having a chronic osteoarticular disease (P = .003) and having more than 1 reaction to drugs (P < .001) were associated with a statistically significant worse quality of life after the evaluation., Conclusions: Having suffered anaphylaxis, more than 1 reported drug allergy or presenting a musculoskeletal disease are factors that worsen the quality of life. Quality of life improved significantly after completing a drug allergy evaluation., (Copyright © 2019 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Perioperative hypersensitivity reactions constitute a first-line problem for anesthesiologists and allergists. Therefore, hospitals should have a consensus protocol for the diagnosis and management of these reactions. However, this kind of protocol is not present in many hospitals, leading to problems with treatment, reporting of incidents, and subsequent etiological diagnosis. In this document, we present a systematic review of the available scientific evidence and provide general guidelines for the management of acute episodes and for referral of patients with perioperative hypersensitivity reactions to allergy units. Members of the Drug Allergy Committee of the Spanish Society of Allergy and Clinical Immunology (SEAIC) have created this document in collaboration with members of the Spanish Anesthesia Society (SEDAR). A practical algorithm is proposed for the etiologic diagnosis, and recommendations are provided for the management of hypersensitive patients.

Background: The incidence of perioperative hypersensitivity reactions, which can be life-threatening, ranges from 1 in 20,000 to 1 in 1361. These reactions are usually classified as IgE or non-IgE mediated. The aim of this study was to determine the incidence of allergic reactions during general anesthesia in our hospital, to establish the incidence of the allergic reactions for each drug used, to assess the frequency of IgE-mediated reactions in even mild reactions, and to compare the degree of agreement between anesthesiologist suspicion and allergy diagnosis., Methods: We included patients diagnosed with a clinical hypersensitivity reaction during a procedure under general anesthesia over a 30-month period (February 2008 to August 2010). Plasma histamine and serum tryptase concentrations were determined in these patients. We performed skin tests to diagnose the causative agent. Data from the hospital electronic prescribing system were collected to determine the ratio of reactions for each drug., Results: During the study period, 16,946 anesthetic procedures were performed (53% involved males; mean age, 51.6 years). Forty-four perianesthetic reactions were recorded, and the ratio of reactions was 1 in 385 operations (95% confidence interval, 1/529-1/287). Twenty-five reactions (25/44; 57%) occurred during the induction of anesthesia. Twenty-one reactions (21/44; 48%) were mild, involving only skin, and 23 of 44 (52%) were anaphylactic reactions. Four of 10 patients who had only a rash experienced IgE-mediated reactions. Five surgeries (11%) were suspended because of the severity of the reactions. Fifteen reactions (15/30; 50%) were IgE mediated, and, in 2 of 30 (7%), a non-IgE agent was found (cold urticaria and nonsteroidal anti-inflammatory drug intolerance). The ratio of reactions for each drug was as follows: protamine, 1 in 468; cisatracurium, 1 in 1388; amoxicillin-clavulanate, 1 in 1968; atracurium, 1 in 2039; and dipyrone, 1 in 3159., Conclusions: Perioperative reactions are more common than previously reported. Mild hypersensitivity perioperative reactions-involving only skin-should be considered in evaluating patients because a substantial number of these reactions are IgE mediated.

Vaccinations are one of the main public health tools for the control of vaccine-preventable diseases. If a child is identified as having had an allergic reaction to a vaccine, subsequent immunisations will probably be suspended - with the risks such a decision implies. The incidence of severe allergic reactions is very low, ranging between 0.5 and 1 cases/100,000 doses. Rather than the vaccine antigens as such, the causes of allergic reactions to vaccines are often residual protein components of the manufacturing process such as gelatine or egg, and less commonly yeasts or latex. Most vaccine reactions are mild and circumscribed to the injection site; although in some cases severe anaphylactic reactions can be observed. If an immediate-type allergic reaction is suspected at vaccination, or if a child with allergy to some of the vaccine components is scheduled for vaccination, a correct diagnosis of the possible allergic process must be made. The usual vaccine components must be known in order to determine whether vaccination can be safely performed., (Copyright © 2015 SEICAP. Published by Elsevier Espana. All rights reserved.)

Background: There are no Spanish guidelines or consensus statement on bradykinin-induced angioedema., Aim: To review the pathophysiology, genetics, and clinical symptoms of the different types of bradykinin-induced angioedema and to draft a consensus statement in light of currently available scientific evidence and the experience of experts. This statement will serve as a guideline to health professionals., Methods: The consensus was led by the Spanish Study Group on Bradykinin-Induced Angioedema (SGBA), a working group of the Spanish Society of Allergology and Clinical Immunology. A review was conducted of scientific papers on different types of bradykinin-induced angioedema (hereditary and acquired angioedema due to C1 inhibitor deficiency, hereditary angioedema related to estrogens, angioedema induced by angiotensin-converting enzyme inhibitors). Several discussion meetings of the SGBA were held in Madrid to reach the consensus., Results: The pathophysiology, genetics, and clinical symptoms of the different types of angioedema are reviewed. Diagnostic approaches are discussed and the consensus reached is described., Conclusions: A review of bradykinin-induced angioedema and a consensus on diagnosis are presented.

Objective: The diagnostic work-up of a drug hypersensitivity reaction is indeed difficult. In general, medical documentation of allergic reactions in medical reports is usually highly deficient or non-existent. The aim of this study was to analyse the prevalence of self-reported drug allergies in the surgical population as well as the criteria used in the diagnosis of drug hypersensitivity reactions., Methods: A prospective study with the consecutive participation of 1439 patients, following surgical intervention, attended the Post-Operative Care Unit. Previously, as a routine process during the pre-anesthesia consultation, all patients were questioned about whether they had any drug allergies to report and diagnostic work-up., Results: The prevalence of self-reported drug allergies was 8.3% (119/1439): 3.6% considered themselves allergic to β-lactams and 2.4% to non-steroidal anti-inflammatory drugs. Approximately one-third of the subjects (40 out of the 119) had not been subjected to any allergy diagnostic procedure and with 79 (66.4%), the only diagnostic test used by the Allergy Unit had been the skin prick-test. None of those participating in the study had tryptase, methylhistamine, specific IgE or intradermal tests carried out to characterize the diagnosis of the allergic reaction., Conclusions: These results show that self-reported drug allergies are highly prevalent and as yet little explored. It is an important prevalence which should bring about modifications to the prescription of certain medicaments. The medical personnel must be made aware of the need to make an accurate diagnosis of allergies to medicaments., (© 2010 Blackwell Publishing Ltd.)

Evaluation of allergic reactions to drugs is difficult because of the poor sensitivity of in vivo tests, which makes controlled administration of the drug necessary to confirm the diagnosis. In vitro tests are important in order to avoid the risks of in vivo testing. In the present review, we describe the different methods for detecting immunoglobulin (Ig) E antibodies that are specific to drugs involved in the development of type I (immediate) reactions. The 2 main in vitro methods are immunoassays and the basophil activation test, both of which have sufficient sensitivity and specificity for the detection of specific IgE antibodies, although with a limited number of drugs, and they have proven complementary to in vivo methods. We show the importance of the allergological workup of the patient within less than 1 year from the occurrence of the allergic reaction in order to obtain positive results in both in vivo and in vitro tests.

Background: Atopy is an important risk factor for asthma, rhinitis, atopic eczema and urticaria. For this reason, several studies have been done to determine the prevalence of atopy in the paediatric population. The important differences among these studies do not allow the extrapolating of results. In this study, we calculate the prevalence of atopy and atopy-related diseases in a paediatric population using a different methodology., Methods: Retrospective study among children referred for drug allergy in which the latter was discarded. We evaluated the prevalence of atopy (measured by allergen sensitisation), asthma, rhinitis, urticaria, atopic eczema and their characteristics., Results: Three hundred and forty-two patients were studied for adverse drug reaction. This was discarded in 325/342 patients. 20 % of the children in the sample were atopic. Atopy prevalence increased with age. Some atopy related disease was observed in 83/325 (25.5 %) children. Among these children allergen sensitisation increased from 42.3 % in the 0-3 years age group to 93.3 % in the 7-14 age group (p < 0.0001). Prevalence of asthma was 11.5 %, 10.2 % and 7 % in the 0-3, 4-6 and 7-14 age groups, respectively. Prevalence of rhinoconjunctivitis increased through age groups with a prevalence of 20 % among the 7 to 14-year old children., Conclusion: The use of this type of methodology seems to be correct to estimate the prevalence of atopy. Prevalence of allergen sensitisation is very high among 7 to 14-year old children with asthma and/or rhinoconjunctivitis.

Background: Allergic reactions to drugs constitute one of the most frequent reasons for consultations in Allergology services with an increasing prevalence in recent years., Objectives: To describe the results of the Alergológica-2005 study on the clinical characteristics of patients consulting for suspected drug allergies., Methods: Alergológica-2005 was a descriptive, cross-sectional, prospective, observational study undertaken with 4991 patients treated for the first time in Allergology services in Spain., Results: Seven hundred thirty-two patients (mean age 41.4 +/- 19.4 years) presented for drug allergies (62% females, 38% males). Diagnosis was confirmed in 26.6% of cases and rejected in 37.2%. Seventy five percent reported only cutaneous symptoms and 10% anaphylaxis. Forty-seven percent of reactions were caused by beta-lactams (63% of which were due to amoxicillin), 29% by nonsteroidal anti-inflammatory drugs (NSAIDs) and 10% by pyrazolones. Sixty nine children were treated for this reason, 8 of whom were diagnosed as drug allergic (5 to beta-lactams, 2 to NSAIDs and 1 to pyrazolones)., Conclusions: Drug allergies are the third most important reason behind consultations in Allergology services, after bronchial asthma and rhinitis. Females are predominantly affected and the beta-lactams, NSAIDs and pyrazolones are the 3 drug families most responsible.

Background: Skin testing with major and minor determinants of benzylpenicillin is recommended standard practice for the evaluation of patients with immediate hypersensitivity reactions to beta-lactams. However, commercial reagents for this purpose were recently dropped from the European market., Objective: In the present study, we assessed a new brand of reagents for use in skin testing in patients with suspected penicillin allergy., Methods: Prick tests and intradermal tests were performed with benzylpenicilloyl polylysine (PPL) and minor determinant mixture (MDM). Penicillin G, amoxicillin, and the culprit beta-lactam were also tested. If skin tests were negative, a single-blind oral challenge test was performed with the culprit active principle or penicillin. If both skin tests and challenge tests were negative, the same procedure was repeated between 2 and 4 weeks later., Results: A total of 636 patients were assessed. The allergy study was positive in 69 patients. Skin tests with PPL were positive in 30 patients (46.8%) and with MDM in 28 (43.7%). Sixteen patients displayed a positive reaction to both PPL and MDM (25%), while 42 patients (65.6%) had a positive reaction to either PPL or MDM alone. Thirty-two patients had positive skin test reactions to penicillin G or another p-lactam antibiotic. Five patients in whom a negative result was obtained in skin tests had a positive reaction to oral challenge., Conclusions: Our results indicate that a new brand of determinants that is commercially available in Europe is a reliable and useful tool for the diagnosis of beta-lactam allergy. The new reagents are a safe alternative to the previously available brand.

Background: The diagnosis of IgE-mediated immediate reactions to penicillins can be supported by in vivo or in vitro tests using classical benzylpenicillin determinants. The wide variety of beta-lactams and the description of new specificities requires a re-evaluation of the different tests available. The objective was to evaluate the diagnostic capacity of Pharmacia CAP System RAST FEIA amoxicilloyl c6 (AXO) and benzylpenicilloyl c1 (BPO) in patients with a documented IgE-mediated penicillin allergy., Methods: We studied 129 patients in five groups. Groups 1, 2, and 3 had developed an immediate reaction after penicillin treatment. Group 1 (n=19) were skin test positive to amoxicillin (AX) and/or BPO and/or minor determinant mixture (MDM); group 2 (n=29) were skin test positive to AX but negative to BPO and MDM; and group 3 (n=26) were skin test negative to all determinants, the diagnosis being confirmed by a previous repetitive history or controlled administration. Two control groups, one with nonimmediate reactions -- group 4 (n=25) -- and one with good tolerance to penicillin -- group 5 (n=30) -- were included. All samples were analyzed in vitro for AXO and BPO, and the results compared to the in vivo diagnosis., Results: AX was the drug most often involved. In group 1, 53% were in vitro positive for AXO and 68% for BPO, but 74% had at least one positive test result. In group 2, only 10% had a positive in vitro test to BPO compared to 41% to AXO. In group 3, 42% had positive BPO and/or AXO in vitro tests. In the control groups 4 and 5, the negative in vitro results for AXO were 96% and 100%, and for BPO 100% and 97%, respectively. A positive correlation between specific IgE levels and the time interval from the reaction to the evaluation was found only for group 3., Conclusions: This in vitro assay is beneficial for evaluating subjects allergic to beta-lactams. It is necessary to test for specific IgE to AXO in addition to BPO in patients with immediate allergic reactions after AX. The combination of in vivo and in vitro tests for estimating IgE antibodies to penicillins is important because of the existence of patients with a positive history but negative skin test.

Objective: The objective of this study is to identify the dermatological disorders (DDs) responsible for the most common skin lesions in the ICU, their incidence and their impact on mortality, degree of severity and length of stay in the ICU., Design and Setting: We performed a 2-year prospective study in a general medical and surgical ICU including, exceptionally, paediatric cases., Patients: We included all patients who presented skin lesions upon admission or developed them during their ICU stay., Results: Forty-six patients (10% of all admissions) were enrolled, with 51 DDs. SAPS II score (43) and mean length of stay (19 days) were significantly higher than in the general group of ICU admissions. Differences in mortality rates (26% versus 29%) were not statistically significant., Conclusions: DDs are entities that should be borne in mind in the critically ill patient; their incidence is by no means negligible and makes careful examination of the skin mandatory both on admission and during a patient's ICU stay.

Background: Adverse Drug Reactions (ADR) and Drug-Related Problems (DRP's) are a frequency cause of hospital emergency room visits and require better assessment., Method: An analysis was made of 1097 consecutive admission to the emergency room at the Nuestra Senora de los Volcanes, Hospital (currently the General Hospital of Lanzarote) in Arrecife de Lanzarote (Canary Islands) over a three-month period in order to detect any possible DAR or any other drug-related problems., Results: Nineteen (19) of the 1097 admissions were due to Adverse Drug Reactions (ADR) (1.73%; 95% IC:0.96%-2.5%). Some of the most outstanding of the other "Drug-Related Problems" (DRP's) were medication overdose, which was diagnosed in 5 (0.45%) of the patients; the worsening of the symptoms due to ceasing to take the medication was involved in 8 (0.72%), and incorrect treatments which involved medical care at the emergency room totaled 11 (1.0%). The number of drug-related problems (DRP's) in the sample totaled 43 (3.9%). The drug-related problems (DRP's) led to hospitalization in 1.9% of the cases seen in the emergency room and led to hospitalization in 9.6% of all of hospital admission through the emergency room for the period of time under study. The ADR led to 4.1% of the hospital admissions., Conclusions: Drug-related problems are a frequent, major problem which has not been well-analyzed in the emergency rooms. Additionally, emergency rooms can function as the first point of detection of a ADR among an outpatient population.

Objective: The objective of this study was to know the incidence of adverse drug reactions in a group of children sent to our office by their pediatrician under the suspicion of having suffered a drug reaction., Patients and Methods: Ninety-eight children were retrospectively studied. Family background, clinical picture, drugs involved, time elapsing between the onset of symptoms and the date of the study, association to other allergic conditions and diagnostic methods used "in vivo" and "in vitro" were evaluated., Results: Mean age of the patients was 4 years with 53.5% being female and 46.5% male. Positive drug allergy in the family background was found in 22%. The clinical picture showed urticaria and angioedema in 36%, morbiliform eruption in 31%, urticaria in 20%, only angioedema in 9% and other symptoms in 4%. Drugs involved included betalactams (78%), macrolides (17.5%) and others (less than 9%). The mean time elapsed between the onset of symptoms and the date of study was 2 years. There was association to other allergic conditions in 18% (50% in the cases in which the drug allergy was confirmed). RAST to penicillin G and V, amoxicillin and ampicillin was done in 28 cases (betalactams), being negative in all of them. Skin tests were carried out in 21 cases (betalactams), being positive in 19% (66% among the confirmed cases). In all but two cases a controlled provocation test was carried out, being positive only in 8., Conclusions: 1) The presence of adverse drug reactions is confirmed in only 9% of the cases. 2) Confirmation of the clinical history and the provocation test as the most reliable diagnostic methods currently available. 3) Acceptable sensitivity of the skin tests in the case of betalactams. 4) Null sensitivity of the RAST in the case of betalactams.

We present 219 cases of adverse reactions to penicillin and related antibiotics during 1995 in the Child Allergy Department of Gregorio Marañón University Hospital. Amoxicillin was the most frequent cause of the reaction. The most common clinical symptom was urticaria followed by angio-edema and other characteristic exanthemas. A diagnosis of allergy to penicillin and related drugs was only made in 20 cases in which the predominant symptomatology was urticaria and the antibiotic most commonly involved was again amoxicillin. Diagnosis was confirmed by a skin test, specific IgE determination and controlled provocation. In 3 of the 20 cases diagnosis was made in the reassessment or second study, which was carried out in all cases in which more than one year had passed between the reaction and the initial allergological study.