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Multiple Drug Intolerance Syndrome: a Large-Scale Retrospective Study

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Multiple Drug Intolerance Syndrome: a Large-Scale Retrospective Study View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Springer - Publisher Connector Drug Saf (2014) 37:1037–1045 DOI 10.1007/s40264-014-0236-x ORIGINAL RESEARCH ARTICLE Multiple Drug Intolerance Syndrome: A Large-Scale Retrospective Study Hisham M. R. B. Omer • James Hodson • Sarah K. Thomas • Jamie J. Coleman Published online: 2 November 2014 Ó The Author(s) 2014. This article is published with open access at Springerlink.com Abstract Background The term multiple drug intolerance syn- Key Points drome (MDIS) has been used to describe patients who express adverse drug reactions to three or more drugs Multiple drug intolerance syndrome (MDIS) is without a known immunological mechanism. significantly more likely in female patients, patients Objective To identify patient factors that could increase with comorbidities, and patients with previous the risk of MDIS. hospital admissions Method Inpatient records over a 5-year period were cap- tured from an electronic prescribing system to identify Deprivation and ethnicity are not significant risk patients with at least one documented drug allergy. Univari- factors for MDIS able and multivariable analyses were used to compare the With the exception of penicillin, allergies to a broad rates of MDIS across age, sex, weight, ethnicity, history of spectrum of drugs including nonpenicillin antibiotics atopy or psychological disorders, and previous admissions. are identified as significant risk factors for MDIS Results A total of 25,695 patients had a documented drug intolerance, 4.9 % of whom had MDIS. MDIS was sig- nificantly more likely in women (p \ 0.001), patients with multiple comorbidities (p \ 0.001), and patients with pre- vious hospital admissions (p \ 0.001). With the exception of penicillin (p = 0.749), MDIS was more frequent in 1 Introduction those with allergies to other drugs (p \ 0.001). Conclusion MDIS was associated with female gender, Adverse drug reactions are not uncommon, and ascertain- multiple comorbidities, and previous hospital admissions. ing the allergy status of a patient is an important part of the A documented allergy to penicillin did not increase the history taking process. A missed or incorrect diagnosis can likelihood of MDIS. have serious or even fatal consequences. Drug allergy is defined by the British Society for Allergy and Clinical Immunology as an adverse drug reaction with an estab- lished immunological mechanism [1]. In contrast, other H. M. R. B. Omer Á S. K. Thomas (&) Á J. J. Coleman adverse drug reactions not caused by an immunological College of Medical and Dental Sciences, University of mechanism may be pseudo-allergic, idiosyncratic, or Birmingham, Edgbaston, Birmingham B15 2TT, UK e-mail: [email protected] defined as an intolerance [2]. The term multiple drug intolerance syndrome (MDIS) has been used to describe J. J. Coleman e-mail: [email protected] patients who express adverse drug reactions to three or more drugs without a known immunological mechanism J. Hodson Á S. K. Thomas Á J. J. Coleman [3]. The prevalence of MDIS in the UK is unknown, University Hospitals Birmingham NHS Foundation Trust, although a large study in the USA found that 2.1 % of Birmingham, UK 1038 H. M. R. B. Omer et al. patients enrolled in a health plan group had three or more 2 Methods drug intolerances [4]. In spite of the seemingly low prev- alence of MDIS, these cases pose a real problem for phy- 2.1 Setting sicians. Often the fear of exacerbating an illness or triggering an anaphylactic reaction means that physicians This work was carried out in a large acute NHS Foundation avoid the list of culprit drugs at all costs. This can com- Trust. The Trust has a locally developed electronic pre- plicate treatment plans through the inability to prescribe scribing and administration system known as PICS (pre- optimal first-line therapies and necessitates the use of scribing, information and communication system), which is alternative, possibly less-effective treatments [5]. This, as used for prescribing and documenting the administration of well as variations in care, management, and diagnosis of medicines throughout all (*1,200) inpatient beds, as well drug allergy in the UK, has led to the provision of guidance as capturing information required to aid this process, such from the National Institute for Health and Care Excellence as the allergy status of a patient. The system was first [2]. installed in the renal unit in 1998 [11], and now covers all The mechanisms underlining MDIS are not well general and specialist medical and surgical specialities. A understood, but some researchers have proposed the idea of key feature of the system, for the purposes of this study, is nonspecific histamine release by mast cells and basophils that on a weekly basis all information within the system is [6]. It has recently been shown that MDIS patients have a exported to a comprehensive audit database for subsequent strong wheal-and-flare response to autologous serum [7]. investigation and analyses. This suggests the presence of autoreactive antibodies in the serum of patients with MDIS. It is thought that these 2.2 Data Collection antibodies, when triggered by culprit drugs, may target the high affinity IgE receptor (FceRI) to induce histamine Inpatient episodes between 1 January 2009 and 31 July release. However, preliminary results have shown that sera 2013 that had a documented allergy were captured for from MDIS patients are unable to stimulate significant analysis. For each patient, the demographics and medical histamine release from donor basophils. Whether this and drug histories were captured from PICS for further mechanism truly underpins the pathogenesis of MDIS analysis (Box 1). requires further clarification. Psychological factors may also have a role to play in MDIS. Evidence suggests that MDIS patients have higher Box 1 Patient and medical information captured on PICS for each levels of anxiety, worse health-related quality-of-life inpatient episode with a documented allergy scores, and increased likelihood of somatisation [8, 9]. Patient demographics Age Such factors may have a link to the nocebo effect, which is Sex defined as the emergence of negative effects following Ethnicity exposure to a nonharmful substance [10]. Patients who Weight have experienced a reaction to a drug are likely to have Post-code negative thoughts associated with that drug. In addition, Allergies Drug name patients are prone to elevated anxiety levels prior to elec- Medical history Number of documented comorbidities tive procedures. These negative thoughts are likely to have an influence on the subjective symptoms reported by MDIS Number of previous admissions to the Trust: atopic history: asthma (ICD10; J45), patients to culprit drugs. As a result, physicians may conjunctivitis (H10), eczema (B00.0) and struggle to differentiate between symptoms attributed to atopic dermatitis (L20), dermatitis (L23– somatisation and those attributed to drug allergies [9]. L27), rhinitis (J30), psoriasis (L40 & L41) In the present study, we investigated the characteristics Psychological comorbidities: of patients with three or more documented drug intoler- schizophrenia and other psychoses (F20–F29); affective disorders (F30–F39); ances, and compared these to patients with one or two neuroses stress-related and somatoform intolerances in order to determine whether any patient disorders (F40–F48); behavioural and factors are associated with MDIS. For the purpose of this personality disorders (F90–F98); other study, we refer to all patient-reported adverse effects as organic disorders (F00–F09) ‘‘allergy’’. Quotes are used to signify that patient-reported Drug history Presence of a prescription for: ‘‘allergies’’ do not necessarily represent true type I Antihistamines hypersensitivity reactions. The proportion of patients Adrenaline 1:1,000 (or preparations of this such as EpipenÒ) whose reactions are strictly IgE mediated in nature is Corticosteroids: prednisolone, hydrocortisone unknown. Multiple Drug Intolerance Syndrome 1039 2.3 Data Analysis binary logistic regression model. This model also included all of the demographic factors analysed previously, in order Individual drug allergy entries were categorised as antibi- to account for known associations with MDIS. otics or nonantibiotics. The antibiotics were then further The final stage of the analysis used univariable Fisher’s divided according to frequency of occurrence into eight exact tests to determine the drug classes that were most categories: cephalosporins, glycopeptides, macrolides, influential in predicting the patients with MDIS. All anal- penicillins, quinolones, tetracyclines, trimethoprim/sulfo- yses were performed using IBM SPSS v22 (IBM SPSS namides, and other antibiotics. Inc., Armonk, NY, USA) with statistical significance The nonantibiotic group were also further divided assessed at the 5 % level. according to frequency of occurrence into 11 categories: angiotensin converting enzyme inhibitors (ACEi), antihis- tamines, aspirin, latex, lipid regulators, nonsteroidal anti- 3 Results inflammatory drugs (NSAIDs), opioids, paracetamol, pea- nuts, shellfish, and other nonantibiotics. The ‘‘other non- Between 1 January 2009 and 31 July 2013 there were antibiotics’’ class contained less commonly reported drug 25,695 patients admitted on PICS with at least one docu- allergies such as anticoagulants, antiemetics, antihyper- mented drug allergy. A total of 1,250 (4.9 %) had three or tensives, and antimuscarinics.
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