Drug Allergy Guideline Consultation Table NICE internal comments table

Transcription

1 1. 31 NICE Medicines and NICE Medicines and NICE Medicines and NICE Medicines and 1 NICE 2 NICE 3 NICE 4 NICE Natial Institute for Health and Care Excellence Secti General General General General Drug Allergy Guideline Csultati Table NICE iernal commes table Commes Please insert each new comme in a new row. Would have been helpful to have line numbers the NICE too. Terminology: Although drug allergy is a recognised term, throughout other NICE guidance the Medicines and prescribing cere have been advised to use the term medicine rather than drug. The guidance developme project has also discussed this and agreed that medicine should be used in preference to drug. Terminology: throughout the guideline pers, people and patie are used. Suggest try to use csiste terminology throughout. The guideline does not csider drug iolerances as any poi. It may be helpful to distinguish the differe between an iolerance and drug allergy, particularly when csidering the recording of allergies. Developer s Respse Please respd to each comme ted. Thank you for your comme. Thank you for your comme. The term drug allergy was in the title of the remit provided by the Departme of Health to NICE. Any preference for other terminology would have been better highlighted at an earlier stage of this guideline s developme. The GDG agree this is the recognised term and should remain. They also csider that this usage makes clear that the guideline focuses allergies caused by drug treatmes rather than other preparatis An explanati for the use of this term has been added to the iroducti of the full guideline. Thank you for your comme. We will review to ensure appropriate usage of each term. Thank you for your comme. Unfortunately, drug iolerance or adverse reactis to drugs are not within the remit of this guideline NICE Medicines and 5 NICE Iroduc 3, line 3 Please explain or define idiosyncratic and Thank you for your comme the PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 1 of 34

2 6. 36 NICE Medicines and NICE Medicines and NICE Medicines and NICE Medicines and NICE Medicines and 6 NICE 7 NICE 8 NICE 9 NICE 10 NICE Secti Commes Please insert each new comme in a new row. Developer s Respse Please respd to each comme ti pseudo-allergic or add to the glossary. following definitis have been added to the glossary: Idiosyncratic is a reacti to a drug that is not predictable from its pharmacological acti. pseudo-allergic refers to clinical features of a reacti to a drug that are csiste with allergy but are not caused by a defined immunological mechanism. Iroduc ti Iroduc ti Key priorities for impleme ati Key priorities for impleme ati Key priorities for impleme ati 3, 4 th paragra ph 4, 4 th paragra ph Hypersensitivity is meied. May be worth explaining how this is differe to a drug allergy or whether this would be csidered to be a drug allergy? It is not clear why.and in geographical access to treatme would impact the diagnosis of drug allergy. 10 Terminology: Under ing new suspected drug allergic reactis please note other NICE guidance uses the term recording rather than docing. 10 Under ing new suspected drug allergic reactis it is not clear which health professial should be undertaking this. Is it the prescriber, the health professial ideifying the issue or any health professial who is providing care to that patie? 10 Under ing new suspected drug allergic reactis suggest also recording the medicine dose, form and strength in additi to the number of doses. Thank you for your comme we have changed this to allergic reactis. Thank you for your comme. We have amended the iroducti to read: variati both in how drug allergy is managed and in access to specialist drug allergy services.. Thank you for your comme. The GDG prefer the term docing. Thank you for your comme, the recoms are aimed at any health professial providing care to a pers with a suspected or cfirmed drug allergy. Thank you, the GDG agree and this has been added to the recom NICE Medicines and 11 NICE Key 10 Under ing new suspected drug allergic Thank you for your comme. It is very PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 2 of 34

3 NICE Medicines and NICE Medicines and NICE Medicines and NICE Medicines and NICE Medicines and 12 NICE 13 NICE 14 NICE 15 NICE 16 NICE Secti priorities for impleme ati Secti 1.2 Secti Commes Please insert each new comme in a new row. reactis specifically which drug or drug classes to avoid in future it is likely that this would not always be known. Suggest rewording to reflect this. 15 Title suggest changing docing to recording. 15 Guideline may wish to make reference to data protecti and data sharing legislati. Secti 1.3 of the managing medicine in care homes guideline may be of use. 15 It is also importa to record the date when this informati was recorded to ensure this is amended if a new allergy preses since the last date of recording. 15 Suggest recording the medicine dose, strength and form as well as the medicine name states recording the generic name and proprietary name suggest amending wording in this recom to be csiste with terminology. Developer s Respse Please respd to each comme importa that the healthcare professial docing a suspected drug allergy and advising the patie their future actis must determine which drugs and drug classes should be avoided in future. If it is uncertain whether a drug is safe to take then it must be avoided unless and uil any further investigatis are carried out and updated guidance is doced and given to the patie. Thank you for your comme and suggesti, however the GDG preferred the term docing. Thank you for your suggesti. Reference to this guideline will be made in Secti 3.2 Related NICE guidance. Thank you for your comme. The GDG believes that the date of recording an allergy would be standard procedure, but that keeping a record up to date is importa and this is covered by (recom 1.2.5) Thank you for your comme. The recom states the minimum amou of informati that should be recorded when all details of the reacti may not be known. For all new drug allergies a more detailed record has been recommended. Thank you for your comme. The recom states the minimum amou of informati that should be recorded when all details of the PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 3 of 34

4 NICE Medicines and NICE Medicines and NICE Medicines and NICE Medicines and 17 NICE 18 NICE 19 NICE 20 NICE Secti Commes Please insert each new comme in a new row. 15 The date when the reacti occurred will not always be known (particularly if happened a lg time ago) suggest adding wherever possible at the end of this bullet. 16 As for record medicine dose, strength and form as well as the name. 16 Which drug or drug classes to avoid in future this will not always be known, perhaps amend wording to include which drugs or drug classes to avoid for poteial drug allergies or something similar. 16 This recom will be difficult to impleme particularly when dispensing as drug allergy status is not recorded prescriptis issued by GPs other prescribers for dispensing primary care prescriptis by community pharmacists (e.g. FP10 prescriptis). Currely the format of FP10 prescriptis does not allow for recording allergy status. To ensure this recom is implemeed in practice will require a whole Developer s Respse Please respd to each comme reacti may not be known. For all new drug allergies a more detailed record has been recommended. Thank you for your comme. The GDG does not think this amendme is necessary. Thank you for your comme; the recom states the minimum informati that should be recorded when all details of the reacti may not be known. The GDG has included a more comprehensive list of informati to gather in recom Thank you for your comme. It is very importa that the healthcare professial docing a suspected drug allergy and advising the patie their future actis must determine which drugs and drug classes should be avoided in future. If it is uncertain whether a drug is safe to take then it must be avoided unless and uil any further investigatis are carried out and updated guidance is doced and given to the patie. Thank you for your comme. The GDG felt that there was evidence to support a structured system of docati, and csidered this recom to be implemeable. Drug allergy status is currely recorded prescripti forms within secdary care, but not in primary care, therefore highlighting an PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 4 of 34

5 NICE Medicines and NICE Medicines and 21 NICE 22 NICE Secti Commes Please insert each new comme in a new row. system change in primary care with GP computer systems and redesign of the FP10 prescripti form. It is not practically possible for all community pharmacists to check the allergy status of all prescriptis dispensed, although many community pharmacies will record this their own patie medicati records for regular attending paties. If allergies are recorded an alert will flag up the system at the poi of dispensing a cora-indicated medicine. Therefore suggest a recom that community pharmacists should csider recording the allergy status of all new paties recorded their patie medicati records. Perhaps adding a supplemeary recom about reviewing existing records too? GDG may wish to discuss this. Alternatively, community pharmacists could check the allergy status with the patie for newly prescribed medicines (as the status is not recorded the prescriptis). In the hospital setting checking a doced allergy status is comm practice. 16 Who is this recom aimed at? Is it all health professials who are involved with the care of the patie? 16 This recom is not practical with respect to dispensing in the primary care setting. Developer s Respse Please respd to each comme inequality in delivery of care. Thank you we have agreed to delete this recom. Thank you for your comme. The GDG believes that, with the implemeati of routine docati ( ) and the inclusi of drug allergy informati prescriptis (1.2.8); this recom will be practical in a primary care setting. PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 5 of 34

6 NICE Medicines and NICE Medicines and NICE Medicines and 23 NICE 24 NICE 25 NICE Secti Commes Please insert each new comme in a new row. 17 For prescriptis issued in any healthcare setting this will not be possible in practice for all prescriptis. Approximately 1 billi prescripti items were dispensed in the community in 2013 (data from the Health and Social Care Informati ). 17 Suggest also recording what the allergy was to (medicine name, dose, form and strength) provide written info. Perhaps the GDG could csider what informati providers may wish to include in their informati to paties. This could then be included in the recom. Suggestis include drug dose, form, strength, related drug classes with the poteial for allergy, who to coact before taking medicines, who to inform about drug allergies before any treatme (e.g. GP, deist, nurse), who to coact if allergy is suspected. 17 Suggest including if they are unsure at the end of the recom. Medicines can be purchased from n-pharmacies. Developer s Respse Please respd to each comme Thank you for your comme. The GDG felt that there was evidence to support a structured system of docati, and csidered this recom to be implemeable. Drug allergy status is currely recorded prescripti forms within secdary care, but not primary care prescriptis, therefore highlighting an inequality in delivery of care. Thank you for your comme. We have added name of the drug, however the dose, form and strength do not belg in this secti but are included in recom Thank you for your comme the informati that should be provided to paties is listed in recom However, we have also indicated that structured informati should be provided in the recom you refer to in your comme NICE Medicines and 26 NICE Thank you for your comme. The GDG believes it is importa for people to check every time they purchase over-the-couer drugs, and the safest advice is to recommend that they always csult a pharmacist (and hence not purchase medicines from shops without pharmacists) NICE Medicines and 27 NICE 17 Suggest include drug form and strength too. Thank you for your comme. We think PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 6 of 34

7 NICE Medicines and NICE Medicines and NICE Medicines and NICE Medicines and 28 NICE 29 NICE 30 NICE 31 NICE Secti Commes Please insert each new comme in a new row. 18 any safe alternative drugs that may be used. it may not always be known if the drug is safe uil the patie has taken it, suggest amend wording to reflect this comme. 18 Suggest cross referencing to recom doc details of the suspected drug allergy in the pers s medical records does this apply to primary or secdary care or both. Also need to link to recoms about sharing informati. Suggest link to recom This secti should be csiste with terminology, sometimes n-selective n-steroidal aiinflammatories is used and other times just nsteroidal ai-inflammatories. Also, not sure a patie would understand what a n-selective NSAID is, perhaps include examples in the recom of the comm es. Developer s Respse Please respd to each comme the informati specified is adequate. The drug strength and form is not required after drug allergy has been cfirmed or excluded. Thank you for your comme. It is very importa that the healthcare professial docing a suspected drug allergy and advising the patie their future actis must determine which drugs and drug classes should be avoided in future and which are safe. If it is uncertain whether a drug is safe to take then it must be avoided unless and uil any further investigatis are carried out and updated guidance is doced and given to the patie. Thank you for your comme we have moved this recom as suggested. Thank you for your comme. This applies to all locatis of care. We have added a link to recom as you suggested. Thank you for your comme. Some recoms apply to all NSAIDs, and some ly to n-selective NSAIDs (that is, NSAIDs other than selective COX-2 inhibitors). This recom is written for clinicians. We recommend that clinicians explain carefully to paties which drugs they can and cannot take and provide a full list (1.3.1, 1.3.2). PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 7 of 34

8 NICE Medicines and NICE Medicines and 32 NICE 33 NICE Secti s and Commes Please insert each new comme in a new row. 19 Need to csider if the decisi to use a COX-2 is clinically appropriate with other co-morbidities and other medicines currely being taken by the patie (e.g. cardiovascular risk). Suggest adding wording to the recom to reflect this comme. 19 Suggest seeking microbiologist advice before referring to a specialist drug allergy service to ensure no other alternative aimicrobial can be used. Cross ref with guidance being developed aimicrobial stewardship. Developer s Respse Please respd to each comme Thank you for your comme. We csider that this is addressed through specifying that the benefits and risks should be discussed before prescribing COX-2 inhibitors. Thank you for your comme. The recoms are specifically for referral to a specialist allergy service for the small number of people who require treatme with a beta lactam rather than the larger group where an alternative treatme may be an opti NICE Medicines and NICE Medicines and NICE Medicines and 34 NICE 35 NICE 36 NICE s and Secti 2.2. Secti Suggest including examples of some beta lactam aibiotics. 22, 1 st paragra ph 22, 3 rd paragra ph However in curre practice informati is usually not provided unless drug allergy is cfirmed by specialists it is not clear what this means. From practice paties will volueer allergy status when asked in a secdary care settings and this is often not cfirmed with specialists. Agree with this, however see comme recom We have added the aimicrobial stewardship guideline to our list of related guidance. Thank you for your comme. We do not think providing examples would be helpful due to the large number available. Thank you for your comme. This means that paties are currely rarely provided with informati about their cditi by healthcare professials except when they are seen by specialists. ted, thank you for your comme NICE Medicines and 37 NICE Secti 23, line If clinically appropriate. Need to csider co- Thank you for your comme. We PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 8 of 34

9 NICE Medicines and NICE Medicines and 38 NICE 39 NICE Secti Commes Please insert each new comme in a new row morbidities and drug ieractis with other medicines being taken. Secti 24, line Need to explain what oral aibiotic challenge is, suggest explaining what this is and who would undertake it. Secti Published guidance suggest making links to guidance for NSAID usage and also aimicrobials. Guidance under developme suggest adding in guidance relating to aimicrobials: PH aimicrobial resistance: changing riskrelated behaviours MPG aimicrobial stewardship Developer s Respse Please respd to each comme have amended the questi to include if clinically appropriate Thank you for your comme. An oral aibiotic challenge would csist of a supervised, incremeal dose oral aibiotic administrati; to be followed by administrati over the subseque 2 days (if supervised challenge negative). Thank you for your comme. We will add the link as suggested in your comme. We have also amended our iroducti to both the Full and the NICE s of the guideline, to include the detail you suggest. PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 9 of 34

10 SH British Associati of Dermatologists SH British Society for Allergy and Clinical Immunology (BSACI) SH British Society for Allergy and Clinical Immunology (BSACI) SH British Society for Allergy and Clinical Immunology (BSACI) SH British Society for Allergy and Clinical Immunology (BSACI) SH British Society for Allergy and Natial Institute for Health and Care Excellence Secti Drug Allergy Guideline Csultati Table Stakeholder commes table 04/04/14-16/05/14 Commes Please insert each new comme in a new row. 1 Full General General The British Associati of Dermatologists agrees with and would like to support the feedbacks submitted by the British Society for Cutaneous Allergy 5 Full General General N immediate reactis also include urticaria and this is never meied 6 Full General General Be aware of maiaining either the acryms or the full names: DRESS/DHS are often spelt with both names and SJS/TEN, AGEP are not 7 Full General General Amg n immediate rare reactis :add Nephritis 10 Full General General Do people with a severe reacti to NSAID have to avoid necessarily paracetamol? t clear. 11 Full General General For allergy during Anaesthsia there is no hi of explanati of what the culprit could be in relati Developer s Respse Please respd to each comme Thank you for your comme. Thank you for your comme. The GDG csider that it is possible to have an urticated exahem that is delayed but this is not true urticaria, which is by definiti mast cell mediated and therefore not t cell mediated (delayed). Thank you for your comme, this has been amended. Thank you for your comme, this has been added. Thank you for your comme. We do not classify paracetamol as an NSAID and it does not need to be avoided by somee who has had a reacti to an NSAID. Thank you for your comme. The questi reviewed was regarding PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 10 of 34

11 Clinical Immunology (BSACI) Secti Commes Please insert each new comme in a new row. to the time of drug administrati.just a general stateme the various possibility would be helpful Developer s Respse Please respd to each comme referral to specialist drug allergy services. The poi you raise is a specialist area, and not addressed in the guideline SH British Infecti Associati 1 Full General General There is a significa problem with paties being incorrectly labelled as allergic to aibiotics, usually penicillin. Sometimes, further history taking reveals that the allergy is not an allergy but a comm side-effect. Sometimes paties are inappropriately prescribed an aibiotic that they are supposed to be allergic to. In these cases, it would be very useful to the future treatmes of many of these paties if they could have the allergy label removed. This is extraordinarily difficult because experience shows that successive admissis to hospital (for example) leads to a reasserti of the allergy label because of freque previous docati of the allergy. In other words, ce labelled allergic, always labelled allergic. Strategies need to be researched and developed to enable de-labelling to occur and to be maiained. These need to be electric and n-electric. The guidance also meis that allergy testing should be offered to paties who will require the aibiotic in the future or who are at high risk of requiring it. This does not take accou of those, many more, paties for whom a secd line age is used. Sometimes these are less efficacious, sometimes more toxic, frequely both. Therefore, we believe that paties at risk of serious, life-threatening infectis such as endocarditis, should be offered allergy testing Thank you for your comme. We agree that many people are incorrectly labelled as allergic to aibiotics. The purpose of our recoms is to ensure that people with a possible allergy are thoroughly assessed so that a healthcare professial can make an informed judgeme as to whether they should be suspected as having had a drug allergic reacti or not. s have been made for detailed records to be made, maiained and shared in order to preve incorrect labelling of paties. A research recom has also been made for designing systems to doc drug allergy including structured patie records and improvemes to coding within electric record keeping. Chapter 11 (Referral to specialist drug allergy services) carefully csiders the clinical and cost effectiveness of referral for paties who would otherwise require secd-line drugs, PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 11 of 34

12 Secti Commes Please insert each new comme in a new row. anyway. Developer s Respse Please respd to each comme and ccludes that this would ly be cost effective for certain paties, such as those who are likely to have freque future need of beta-lactam aibiotics SH British Society Cutaneous Allergy SH British Society Cutaneous Allergy SH Departme of Health SH Royal College of Nursing 2 Full General General Freque mei is made to a specialist drug allergy service but there is no comme how this is cstituted or defined to enable it to provide diagnosis in an effective and efficie manner of both immediate and delayed hypersensitivity reactis 4 Full General General The doc csiders both immediate and nimmediate (delayed) type allergy. The doc in csidering investigati appears to focus immediate hypersensitivity (IgE; prick & iradermal tests). Investigati of n-immediate reactis should include patch testing. An expert with knowledge of delayed type hypersensitivity reactis and how to investigate these should be a member of the team. A collaborative approach is likely to lead to better patie outcomes 1 FULL General General I wish to cfirm that the Departme of Health has no substaive commes to make, regarding this csultati. 1 Full General General The Royal College of Nursing is a registered stakeholder for this guidance. The Royal College of Nursing was invited to comme the draft drug allergy clinical guideline. The doc was circulated to RCN The GDG believes that people at risk of endocarditis in the future will be covered by recom for those people requiring treatme with a beta-lactam aibiotic. Thank you for your comme. Service provisi is determined at a local level. The organisati of specialist services was not within the scope of this guideline. Thank you for your comme. Membership if the GDG included a Csulta Dermatologist. The guideline focused diagnostic tests that could be undertaken in a nspecialist setting and specialist investigatis were outside of the scope of this guideline. Thank you for your comme. Thank you for your commes. PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 12 of 34

13 Secti Commes Please insert each new comme in a new row. staff and Drug Allergies, Critical Rehabilitati and Emergency Nursing coact list for their views. Developer s Respse Please respd to each comme SH Royal College of Nursing SH Royal College of Physicians (RCP) SH Royal College of Physicians (RCP) Find below commes received from the reviewers. 2 Full General General Our members were in agreeme with the guidelines; however e pers did comme that when a GP has ideified a patie as having an allergy they should refer that patie to an allergy specialist cere. 1 Full General General The RCP is grateful for the opportunity to comme the draft guideline. Our experts in allergy broadly welcome the doc and feel that it is well researched and comprehensive. However, our experts in clinical pharmacology have raised a number of importa ccerns which they feel could have been avoided if a clinical pharmacologist had been included the GDG. These issues have been highlighted below. 14 Full General General Evidence summaries We note that the evidence for many of the recoms is graded of low or very low quality. Only data what informati to give was graded moderate. Thank you for your comme. The GDG csidered which paties should be referred to specialist drug allergy services for assessme, with regard to the clinical and cost effectiveness of referral, in Chapter 11 of the guideline. The GDG ccluded that it is appropriate for certain groups of paties to be referred, but it would not be cost effective to refer all paties with a suspected allergy. Thank you for your commes. Thank you for your comme. Most data came from observatial studies. The system for rating evidence, GRADE, csiders such data to start as low. Patie informati was based qualitative data which is appraised differely and the evidence in this secti was of better quality (moderate). PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 13 of 34

14 SH Royal Pharmaceutical Society SH Digital Assessme Service, NHS Choices Secti Commes Please insert each new comme in a new row. 1 Full General General The Royal Pharmaceutical Society welcomes the update to the NICE guidelines drugs allergy: diagnosis and manageme of drug allergy in adults, children and young people. We are pleased that pharmacy and pharmacists have been highlighted in the care and manageme pathway of drug allergies. Pharmacists as the experts in medicines usage have a vital role in ensuring that medicines are used correctly and safely. 1 Full General General DAS welcome the guideline and have no commes its coe SH NHS England 1 Full General General Thank you for the opportunity to comme the engageme exercise for the above guidance. I wish to cfirm that NHS England has no substaive commes to make regarding this csultati SH British Society Cutaneous Allergy SH Royal College of Physicians (RCP) 3 Appe ndice s The investigati of patch testing is meied in the scope but appears not to have been csidered in the full doc. 2 Full 1 10 line 3 Other reactis are caused by drug iolerance, idiosyncratic reactis and pseudo allergic reactis Developer s Respse Please respd to each comme Thank you for your comme. Thank you for your comme. Thank you for your comme. Thank you for your comme. Patch testing is meied in the Curre practice secti of the scope, but it was not e of the key clinical issues prioritised in the scope. Thank you for your comme. We have edited the iroducti and clarified the text SH Royal College of Physicians 3 Full 1 10 line 4 These terms require definiti and do not likely cover all mechanisms of adverse drug reacti. See Ars & Ferner Clarificati of terminology in drug safety. Drug Safety 2005; 28: The British Society for Allergy and Clinical Immunology (BSACI) defines drug allergy as an ted, thank you for your comme. However, we hope these guidelines will PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 14 of 34

15 (RCP) Secti Commes Please insert each new comme in a new row. adverse drug reacti with an established immunological mechanism Developer s Respse Please respd to each comme highlight the many differe types of drug hypersensitivity and allergy. Agreed. However, many clinicians equate drug allergy with immediate (Type I) hypersensitivity reactis SH Royal College of Physicians (RCP) 4 Full 1 10 line 12 Agreed too that the rider clinical features compatible is reasable. There is also evidence that these reactis are increasing: between 1998 and 2005, serious adverse drug reactis rose 2.6-fold. Thank you for your commes. We have added further referencing SH Royal College of Physicians (RCP) SH Royal College of Physicians (RCP) 5 Full 1 10 line 19 6 Full 1 10 line 21 Our experts in clinical pharmacology are not aware of any good studies of incidence, ly cous of reports which is not the same. Therefore, penicillin allergy can poteially be excluded in 9% of the populati This stateme should be looked at as it appears to suggest that the proporti of people who do not believe they are allergic to penicillin, but in fact are, is greater than 10%. 1:1000 is not comm Frequency categories [for adverse drug reactis] are defined using the following cvei: very comm ( 1/10); comm ( 1/100 to <1/10); uncomm ( 1/1,000 to <1/100); rare ( 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Thank you for your comme, we have reviewed the iroducti and think this is clear. Thank you for your comme. 1:1000 its own is not comm, however, in cjuncti with 5 10% of people with asthma, becomes more comm. PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 15 of 34

16 SH Royal College of Physicians (RCP) SH British Society for Allergy and Clinical Immunology (BSACI) SH Royal College of Physicians (RCP) Secti 7 Full 1 10 line 22 2 Full 1 10 line 25 8 Full 1 10 line 29 Commes Please insert each new comme in a new row. Within each frequency grouping, adverse reactis are preseed in order of decreasing seriousness. In these people, fatal reactis can occur with small doses of NSAIDs This must be rarer than fatal anaphylaxis to penicillin (which accous for about 1: deaths) Add a ref Computerised primary care record systems are often unable to distinguish between iolerance and drug allergy and this can lead to a false label of drug allergy, particularly if the pers s reacti took place many years previously and details about their reacti have been lost. Developer s Respse Please respd to each comme ted, thank you for your comme. Thank you for your comme. Further references have been added to the iroducti. Thank you for your comme. The GDG csider that the implemeati of this guideline will lead to improvemes in level of detail and accuracy in the recording and docati of drug allergy SH Royal College of Physicians (RCP) 9 Full line 20 Agreed. It is true generally that neither paties nor clinical staff distinguish clearly between ADRs generally and allergic ADRs specifically. Table The table makes it clear that the focus is Type I hypersensitivity. Thank you for your comme. We would csider this to be an asthma manageme questi rather than a general drug allergy topic SH British Society for Allergy and Clinical A questi asking whether it is clinically necessary to avoid NSAIDs in all paties with asthma would be a good additi. 3 Full Under review questis add amoxicillin, correct cofactor with cefaclor and suxe with suxamethium Thank you for your comme. Amoxicillin is listed at the foot of the previous page. We have made the PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 16 of 34

17 Immunology (BSACI) Secti Commes Please insert each new comme in a new row. Developer s Respse Please respd to each comme other suggested correctis SH Associati of SH Associati of SH Associati of SH British Society for Allergy and Clinical Immunology (BSACI) SH Royal College of Physicians (RCP) 1 Full 3.1. table 1 2 Full 3.1. table 1 15 Spelling of suxamethium Thank you for your comme, we have edited this. 15 Is there any place for reviewing the role of pholcodine in anaphylaxis (European evidence not in English language anaphylaxis in neuromuscular blocking drugs) 3 Full ? Missed out significa stakeholders Europeans (France and Denmark) and Australians 4 Full Algorith m 10 Full Algorith m 34 Under algorithm oset usually 1hour add from the last dose administrati 34 Algorithm This deals with immediate and delayed hypersensitivity. However, the algorithm needs work as it would make more clinical sense to organise by time from (first) exposure to set. It is also unclear why the treatme is by drug, although NSAIDs appear twice. Thank you for your comme, however, this was not included in the scope of the guideline. Thank you for your comme. Stakeholders delivering NHS care are invited to register to participate in the public csultatis for the developme of NICE guidance. Thank you for your comme. The assessme secti has been revised, following commes received. Thank you for your comme. The GDG csider an algorithm organised by symptom to be more helpful for clinical practice. However, we have revised and re-ordered the algorithm for greater clarity, with regards to manageme and referral. We believe it is right to warn of asthma + nasal polyps, but what about asthma without nasal polyps, and why coinue treatme with an NSAID if the patie has had a (suspected) PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 17 of 34

18 Secti Commes Please insert each new comme in a new row. allergic reacti? This could poteially be life threatening. Developer s Respse Please respd to each comme SH Royal College of Physicians (RCP) 11 Full line 14 Our experts in clinical pharmacology feel that this is incsiste with the recom at line 13 page 41/165 that in future they need to avoid all other n-selective NSAIDs, including overthe-couer preparatis. This should also refer to angioedema with ACE-Is Thank you for your comme. The heading was incorrect and we have now amended this. Thank you for your comme, reactis with ACE inhibitors do not typically occur within e hour of drug iake SH British Society Cutaneous Allergy SH Associati of SH Associati of 1 Full The scope does not exclude allergic reactis to topical drugs but these appear to have been excluded in the full doc. It should be made explicit that allergy to topical drugs has not been csidered. 4 Full line 11 [rec 1.2.3] 5 Full line 12 This is an overstateme uil a diagnosis is made suggest a change in text which pois out that uil test results are available an informed decisi / advice can be taken / given Correct timing for this stateme to be made Topical drugs were not prioritised for inclusi in this guideline and not listed in the areas included in the scope. Thank you for your comme. When a healthcare professial first assesses a patie and determines whether the patie should be classified as having a suspected drug allergy, they should then advise which drugs or drug classes should be avoided from that poi wards. If further investigatis are cducted later (if referred to specialist services) then this advice may be recsidered and changed at a later poi, however the patie must in the meaime know, and their medical records must state, the drugs they should avoid. Thank you for your comme; however we are unclear about your query. PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 18 of 34

19 SH Associati of SH Royal College of Physicians (RCP) SH Associati of 80. SH Royal College of Physicians (RCP) Secti 6 Full line Full line 25 7 Full line Full line 17 Commes Please insert each new comme in a new row. Should include whether referral to allergy specialist has been made (and to whom) the generic and proprietary name of the drug taken This should include a reminder that the reacti is sometimes to excipies such as tartrazine Avoid uil evidence refutes or cfirms allergy, otherwise risk not getting first line treatme Are drug allergy bracelets/necklaces of any value? Should paties be encouraged to buy them? Developer s Respse Please respd to each comme Thank you for your comme, the majority of people are not referred to specialist services. However, the GDG believe it is standard procedure that when paties are referred to specialists that this would be doced within the patie s records. Thank you for your comme. The GDG did not csider this to be a comm cause for drug allergy. Thank you for your comme, Although the guideline states that all reactis due to general anaesthesia are to be referred for specialist assessme, the vast majority of other drug reactis are not referred and therefore it would be inappropriate to include this in a generic recom. The GDG did not find evidence to specifically recommend bracelets or necklaces, although written patie held informati has been recommended in this guideline SH Associati of SH British Society for Allergy and Clinical 8 Full line 15 8 Full line 17 Need to comme testing here may be negative Under n specialistic Manageme Algorithm: what is the meaning of giving the single dose the first day? How many days? Thank you for your comme, please refer to the recommended criteria for referral. Thank you for your comme. After the single dose has been administered without a reacti, it could be coinued PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 19 of 34

20 Immunology (BSACI) SH British Society for Allergy and Clinical Immunology (BSACI) SH Associati of Secti 9 Full line 40 9 Full line 23 Commes Please insert each new comme in a new row. Everybody need NSAIDs, even children!; so cross out who need NSAIDs Should test there are issues with the lger term use with COX 2 inhibitors Developer s Respse Please respd to each comme according to clinical need. Thank you for your comme. t all people need NSAIDs. Of those people who have a disease or cditi that is commly treated using an NSAID; many could take an alternative painkiller or an alternative aiinflammatory, or both. This recom refers to people who require an NSAID because there are no suitable (adequately effective) alternative painkillers or aiinflammatories for them. Thank you for your comme. This research recom proposes that research should be cducted to determine whether paties who have experienced a severe reacti to a nselective NSAID should be referred to specialist services for assessme or not. COX 2 inhibitors should be prescribed according to best practice. The recoms do not provide guidance the durati of treatme SH The Royal College of Anaesthetists Some trusts do not make Cox-2 inhibitors available to prescribe. If they are to be recommended then require a stateme about availability 5 Full Lay comme: Key Research s There was general agreeme with these recoms, particularly the last two Availability is determined at a local level and is not within the remit of NICE guidance. Thank you for your comme. PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 20 of 34

21 SH Associati of SH British Society Cutaneous Allergy SH Associati of SH Royal College of Pathologists SH Associati of Secti Commes Please insert each new comme in a new row. Developer s Respse Please respd to each comme ccerning COX2 inhibitors and oral aibiotic challenges. 10 Full Sensible cclusi re use of an algorithm Thank you for your comme. 5 Full N immediate reactis to local anaesthetic are often localised to the site of injecti and if the patie is highly sensitised may begin within a few hours of injecti. In our experience n immediate reactis to local anaesthetic are not uncomm in comparis to immediate hypersensitivity that is rarely seen. 11 Full Should text state that high clinical suspici with negative tryptase still requires testing? 4 Full Chlorhexidine is an emerging importa cause for drug reactis. Yet is ly meied briefly under specific IgE. Some may csider it not a drug, but warras mei somewhere to raise awareness. With regard to data this many drug allergy ceres test for this in cjuncti with skin and iradermal testing and should be able to provide useful data sensitivity and specificity in additi to cut off values. 12 Full Should IgE testing be made more explicit for Neuromuscular blocking drugs included in small pri More specifics about investigating for GA and LA Thank you for your comme. We have amended our recom and this is now covered by the timing of under three days for n-immediate reactis. Also, the referral guidance covers immediate and n-immediate reactis. Thank you for your comme, the GDG agreed that a normal serum tryptase, taken acutely does not exclude drug allergy and this is stated in Relative Values of Differe Outcomes, in the Linking evidence to recoms table. Thank you for your comme. Those sectis of this guideline covering assessme of drug allergies, docati and providing informati apply to all drugs that can cause allergic reactis. In the secti referral to specialist services, 4 groups of drugs were investigated particularly, in line with the scope for this guideline, because they are particularly comm or importa. Thank you for your comme. We looked at IgE for neuromuscular blocking ages and results were incclusive, We were therefore unable PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 21 of 34

22 SH Associati of SH The Royal College of Anaesthetists SH The Royal College of Anaesthetists SH Associati of Secti Commes Please insert each new comme in a new row. reactis would be useful anaesthetists may be very aware but other practitiers may not e.g. patie preseing in general practice (crossreferral to BSACI testing guidelines) 13 Full Other reass for drugs given when allergy label has been attached but not cfirmed by testing - people do not think the reacti was true allergy. Text has already stated how many people have the label with no good evidence 3 Full Lay comme: it is noted that emphasis is given to providing paties with informati about their allergic reacti; at the same time lay members advise that a record of the allergic reacti is also kept cerally for that patie by the healthcare provider. 6 Full Lay comme: The general feeling is that the patie should have the same informati as the clinician. As suggested in the guideline paties often have the most reliable source of informati their own cditis /restrictis and given this they can advise of these in future clinical situatis. 14 Full There are risk in taking Cox-2 inhibitors which do not relate to allergy but are still significa needs to be acknowledged Developer s Respse Please respd to each comme to make recoms the basis of insufficie evidence. The scope of the guideline was limited to the manageme of drug allergy by ndrug allergy specialists. Thank you for your comme. Thank you for your comme. We agree that it is importa that informati is both given to paties (Chapter 9) and recorded in medical records (please see Chapter 8). Thank you for your comme. The recom states that the pers should be provided with informati (recom 1.2.3), which is the same informati shared with health professials. Thank you for your comme, our recom states that the risks and benefits associated with using selective COX-2 inhibitors should be discussed when csidering use. The recom has been amended to include the phrase low risk for drug allergy in order to clarify that the risk does not specifically relate to cardiovascular eves. PLEASE NOTE: Commes received in the course of csultatis carried out by the Institute are published in the ierests of openness and transparency, and to promote understanding of how recoms are developed. The commes are published as a record of the submissis that the Institute has received, and are not endorsed by the 22 of 34