Providing information and support to patients

National Clinical Guideline Centre (UK)

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National Clinical Guideline Centre (UK). Drug Allergy: Diagnosis and Management of Drug Allergy in Adults, Children and Young People. London: National Institute for Health and Care Excellence (NICE); 2014 Sep. (NICE Clinical Guidelines, No. 183.)

10Providing information and support to patients

Patients are often left bewildered following a suspected allergic reaction to a drug. Many questions are asked and too often few are answered: Was the reaction predictable? Should I have been prescribed the drug? Will I have a more severe reaction next time? Which drugs do I need to avoid? Am I at risk when taking a new drug in future? How will this impact on my future treatment?

Fear of experiencing a further reaction can be heightened by a lack of information and worsened if the original reaction was severe. If the patient's record of the details of the allergic reaction is incomplete or the patient is not provided with written information, then the patient may either remain at risk of inappropriately receiving the same or a cross-reacting drug again, sometimes with catastrophic consequences, or a different drug may be incorrectly and unnecessarily avoided in the future, compromising the quality of future medical treatment. A drug allergy may not have been responsible for the original reaction, and so if drug allergy is excluded it is equally important that this information is conveyed to the individual in order to provide reassurance and enable optimal treatment to be prescribed in future.

Written information given to the patient at the time of the reaction, with details of drug, number of doses and the nature and severity of the reaction will avoid uncertainty and in many cases allow prescription of an alternative drug not known to cross-react with the original compound. Details of the drug and reaction are invaluable if the same drug is needed again and will also increase the accuracy of diagnosis if the patient requires referral for specialist drug allergy investigation.

10.1. Review question 1: What information and support should individuals with suspected drug allergy or their parents and carers receive?

10.2. Review question 2: What information and support should individuals who have had specialist investigations or their parents and carers receive?

A single search was conducted for the 2 review questions relating to patient information. The studies identified are presented in a single review, as the information was applicable to both questions.

Qualitative studies were identified as the main source of evidence for this review. The analysis of qualitative studies involves a search for common themes in participants' discourse. The themes from each study were extracted and it was then investigated how many studies identified the same theme or different themes. This evidence is summarised in Table 26.

For full details see the review protocol in Appendix C and study selection flow chart in Appendix E.

10.3. Clinical evidence

Eight qualitative studies were identified.⁶^,²¹^,²²^,⁵⁰^,⁶⁸^,⁸⁸^,⁹⁰^,¹⁰¹ Studies which addressed adverse drug reactions were included if they discussed patients with drug allergies as a subgroup of the study population. Of the 8 studies, 1⁶ directly applies to children; all other studies refer to adults with drug allergies. Summaries of study characteristics are presented in Table 25. In Table 26 common and individual themes are identified and summarised. Study quality is assessed according to criteria specific to qualitative research methods. These include clearly specified aims, study design, data collection and rigour of analysis. The complete list of quality characteristics is provided in the footnote to Table 25.

10.3.1. Study summary and quality

In Table 25 the included studies are briefly described. See Appendix H for full details of the studies. The numbers in the quality characteristics column refer to those characteristics, from a list of 14 items, which were assessed to be adequate or good.

Table 25Summary of studies included in the review: study quality

Reference	Population and setting	Aims of study	Data collection	Quality characteristics^(a)	Confidence in study
Arnott et al. 2012⁶	Parents of 44 children with suspected adverse drug reactions; Edinburgh	To inform the management of communication about ADRs in children and to identify any unmet psychological, information and communication needs described by parents.	Semi-structured interviews	1, 2, 3, 4, 5, 8, 9, 11, 12, 13, 14	Moderate
Butt et al. 2011²¹	14 adult survivors of SJS and TEN; 2 hospitals in UK	To explore the experiences, beliefs and attitudes of survivors of serious ADRs, using drug-induced Stevens–Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) as a paradigm.	Retrospective qualitative study using detailed semi structured interviews	1, 2, 3, 4, 5, 9, 12, 13, 14	Moderate
Butt et al. 2012²²	Adult survivors of SJS and TEN; 208 internet descriptions	To interpret the reasons for individuals with serious ADRs posting information about their experiences on the internet to determine whether issues discussed by patients and their relatives in their internet descriptions differ from those found through interviewing survivors of the condition face-to-face.	First person written narratives by patients, relatives or friends. 139 descriptions were posted by patients, 69 by relatives and 1 was jointly submitted by patient and relative. Of those posted by relatives, 30 were posted by mothers.	1, 2, 3, 4, 5, 8, 9, 12, 13, 14	Moderate
Franic & Pathak 2000⁵⁰	Random sample of 400 female patients of child bearing age from the Women's Clinic at the Ohio State University Medical Center in Columbus, Ohio, USA. 74 of the returned surveys were useable.	There were 6 objectives over all, 1 of which was relevant to this review: Do study participants prefer numerical as opposed to verbal descriptors in the communication of ADRs as drug therapy? (that is, not only what information should be communicated but how should it be presented)	Cross-sectional field study using survey instruments	1, 2, 3, 4, 5, 7, 8, 10, 12, 13, 14	Moderate
Hughes et al. 2002⁶⁸	10 adult patients purchasing a selected medicine (antihistamine, decongestant or ibuprofen) at a community pharmacy were interviewed. 4 focus groups of 22 patients total recruited through 2 local schools.	To investigate the knowledge of patients with regard to the side effects of over-the-counter medicines and the source of this information.	Ethnographic interviews and focus groups in Welsh School of Pharmacy, Cardiff University, UK	1, 2, 3, 4, 5, 13, 14	Low
Krska et al. 2011⁸⁸	1362 questionnaires, 27 telephone interviews and data from 230 Yellow Card reports all collected in the UK.	The aim was to determine how reporters to the Yellow Card Scheme identify adverse drug reactions.	open questions in postal questionnaires sent to all reporters during March 2008–January 2009 were categorised by 2 researchers independently; telephone interviews with a purposive sample of these reporters and the free-text field from completed Yellow Card reporting forms submitted during October 2005–September 2007.	1, 2, 3, 4, 5, 8, 11, 13, 14	Moderate
Laaksonen et al. 2002⁹⁰	82 patients were recruited using convenience sampling at a London teaching hospital during autumn 2000. 15% were assessed as having ‘definite’ or ‘probable’ adverse drug effects based on the Naranjo algorithm. The extent of information the patients desired was assessed through the ‘extent of information desired’ (EID) scale, a subscale of a larger 12 item scale that assesses the ‘Intrinsic Desire for Information’ (IDI scale).	The aim was to explore the characteristics of medical patients, their information requirements, relationships with their perceptions about prescribed medicines and coexistent adverse drug effects.	Semi-structured questions explored patients' perceptions of the adverse effects of prescribed drugs.	1, 2, 3, 4, 5, 6, 8, 9, 11, 13, 14	Moderate
Lorimer et al. 2012¹⁰¹	Patients with severe ADR admitted to a hospital for severe drug reactions 7 out of 15 had allergic reactions, including angioedema (enalapril (1), enoxaparin (1), clarithromycin (1)), Stevens–Johnsons syndrome (sulfasalazine (1)), severe rash (penicillin (1)), severe urticaria (amoxicillin (1)), allergic reaction to contrast media (1). Other reactions were gastrointestinal bleeds (NSAIDS (3)), extrapyramidal effects (metoclopramide (1)), jaundice (cimetidine (1)) urinary retention (antipsychotics (1)) bruising due to interaction with warfarin (clarithromycin (1)), muscle weakness, headache and confusion (statins (1)).	To explore patients' experiences of severe ADR and their views on reporting their ADRs to the Yellow Card scheme.	Semi-structured interview template was used. Open questions were used to explore the patients' views of their suspected ADR, information they have received about their medication, the potential effect on their future medication use and their views and knowledge of the Yellow Card scheme.	1, 2, 3, 4, 5, 8, 9, 11, 12, 13, 14	Moderate

a

Quality characteristics assessed:

Clear aims
Adequate background
Appropriate methodology
Appropriate design
Appropriate recruitment strategy (sample and sampling) and appropriate data collection
Reliability of data collection tool
Validity of data collection tool
Data collection methods described adequately
Data analysis methods described adequately
Reflexivity
Ethical issues
Rigorous data analysis
Clear findings
Value of research

10.3.2. Summary of themes

All themes identified by the authors of the included studies were extracted. Adverse drug reactions were not always separated from the subset ‘drug allergy’ but were included if the theme could be extrapolated to allergy. Nine themes are summarised in Table 26 below.

Table 26Summary of themes and related studies

Qualitative theme	Points highlighted in the theme	Studies identifying this theme
Poor explanations of possible adverse events or side effects of medications	Clinicians focused on other issues Written information not given or difficult to understand	Arnott 2012; Butt 2012
Non-medical sources of information	Personal experience with medicines Media coverage Information from family and friends Seeking advice of others with similar experience about cause, symptoms and treatment Internet (possible source of anxiety) Books Patient information literature not universally read. Reasons for reading: if medicine was new or not a regular medicine; side effect was experienced; medicine was for a child	Arnott 2012; Butt 2012; Hughes 2002; Krska 2011
Management and communication with regards to ADR	Information poorly matched to parents' need at a time of fear and anxiety Contradictory information Concerns ignored or dismissed	Arnott 2012
Implications of poor communication for patients and carers	Lack of information limits parental involvement about decisions for their child Fear of repetition of ADR Withholding of medications; avoidance of medicine in general Fear of effect on reproduction (fertility, heredity) Fear that other medical conditions may be related Less trust in healthcare professionals	Arnott 2012; Butt 2011; Butt 2012;
Feelings about the experience of having an ADR	Disbelief Anger Fear of future reaction; fear of losing a useful therapeutic option Frustration Isolation	Lorimer 2012
Information needs	Discussion with clinician of what happened Implications for future health How to avoid future reaction Patients who have had an adverse drug reaction are more interested in receiving information than those who have not had a reaction	Arnott 2012; Laaksonen 2002
Communication skills	Dialogue with clinician; information seen as responsibility of medical staff Internet web sites and chat groups Accessible and reliable information from pharmacist (rather than the Internet) Support from the stories of others Support from patient groups Information about side effects or risks most helpful if provided numerically	Arnott 2012; Butt 2011; Butt 2012; Franic 2000
Linking signs and symptoms to possible ADR	Timing of reaction Reaction listed in the patient information literature received Symptom was unusual or never had it before Changes with dose and rechallenge	Hughes 2002; Krska 2011
Problems with patient information literature	Writing too small Information related to children's medication dosage confusing and should be related to height and weight Long lists of side effects would cause patients to wrongly attribute symptoms to their medication Underused: Hughes et al. 2002, only 3/32 patients had read the patient information literature; Lorimer et al. 2012 not patients' job to inform themselves but the doctor's job.	Hughes 2002; Lorimer 2012

Table 26 indicates that the most frequently reported themes were ‘non-medical sources of information’, ‘implications of poor communication’, and ‘how to communicate’.

10.4. Economic evidence

Published literature

No relevant economic evaluations were identified.

See also the economic article selection flow chart in Appendix F.

10.5. Evidence statements

Clinical

Moderate quality evidence from 8 qualitative studies (n=1927) using semi-structured interviews, web posts, surveys and focus groups, identified 9 themes relating to patients' concerns about their own information sourcing, what their information requirements are and the consequences of poor communication. The 9 themes were:
1. Poor explanations of possible adverse events or side effects of medications.
2. Non-medical sources of information.
3. Management and communication with regards to ADRs.
4. Implications of poor communication for patients and carers.
5. Feelings about the experience of having an ADR.
6. Information needs.
7. Communication skills.
8. Linking signs and symptoms to a possible ADR.
9. Problems with patient information literature.
The themes that were identified by 4 out of 8 studies were ‘non-medical sources of information’, ‘implications of poor communication’, and ‘communication skills’. All other themes were reported in only 1 or 2 studies.

Economic

No relevant economic evaluations were identified.

10.6. Recommendations and link to evidence

Recommendations	17. Discuss the person's suspected drug allergy with them (and their family members or carers as appropriate) and provide structured written information (see recommendation 10). Record who provided the information and when. 18. Provide information in line with the recommendations in Patient experience in adult NHS services (NICE clinical guideline 138). 19. Ensure that the person (and their family members or carers as appropriate) is aware of the drugs or drug classes that they need to avoid, and advise them to check with a pharmacist before taking any over-the-counter preparations. 20. Advise people (and their family members or carers as appropriate) to carry information they are given about their drug allergy at all times and to share this whenever they visit a healthcare professional or are prescribed, dispensed or are about to be administered a drug. Providing information and support to people who have had specialist drug allergy investigations For recommendations on referral to specialist services see Chapter 12. 21. Allergy specialists should give the following written information to people who have undergone specialist drug allergy investigation: the diagnosis - whether they had an allergic or non-allergic reaction the drug name and a description of their reaction (see recommendation 1) the investigations used to confirm or exclude the diagnosis drugs or drug classes to avoid in future any safe alternative drugs that may be used. 22. Explain to people in whom allergy to a drug or drug class has been excluded by specialist investigation that they can now take this drug or drug class safely and ensure that their medical records are updated.
Relative values of different outcomes	The outcomes identified by the GDG as most important for decision-making were examples of information or support that led to an improvement in care and the management of drug allergy. The studies included in the review examined many different types of interventions and describe a variety of resulting outcomes. However some common themes emerged around information needs and methods of communication which demonstrated both good and bad practice. The GDG considered both the positive and negative outcomes reported in the studies when drawing up recommendations on what information should be given to support patients and the method of communication.
Trade-off between clinical benefits and harms	The GDG agreed that information about drug allergy given to patients is often ad hoc, and written information is rarely given. Providing information that would result in prescribing errors prevented and inappropriate medication being avoided would enable patients to avoid future drug allergic reactions and reduce the number of visits to their GP and emergency admissions to hospital. Providing information on details of the drug taken and the reaction along with any subsequent specialist investigations undertaken would improve communication between healthcare professionals and both help to prevent people without a drug allergy being incorrectly labelled as having an allergy, and ensure that people with a drug allergy avoid drugs to which they may be allergic. The gathering of this information is necessary in order to complete the patient's medical record (see Documentation, Chapter 9), but once collected it should also be shared with the patient. The importance of communication with patients who have had a suspected or confirmed drug allergy was highlighted by studies which described the fear of having a repeat reaction and the anxiety experienced by parents of children with a suspected drug allergy. The group agreed that a dialogue between the healthcare professional and the patient who has had a suspected or confirmed allergic reaction, or their carer, is important to ensure that opportunities are given to ask questions and to provide reassurance as well as practical advice.
Economic considerations	No relevant economic evidence was identified. The GDG did not prioritise this question for original economic analysis. The GDG expected that the impact on time and resource use of providing information to patients would be very small, and would be likely to be offset by an improvement in quality of life. Specifically, provision of information will help people to avoid the suspected allergen in the future, thereby reducing future costs to the health service and future impacts on quality of life through inadvertent repeat exposure. Good provision of information and discussion with a patient at the first opportunity may also reduce time spent by healthcare professionals in providing additional information and explanation to people on future occasions.
Quality of evidence	All of the included studies were qualitative research studies. The quality of each study was assessed in terms of confidence in the study, measured against 14 quality criteria specific to qualitative studies. Seven of the 8 included studies were given a ‘moderate’ level of confidence and 1 was given ‘low’ confidence. The 3 most frequently reported themes were non-medical sources of information, the implications of poor communication and how to communicate. The GDG acknowledged the implications of poor communication with patients, especially the fear felt by patients, and stressed the importance of providing clear and comprehensive information at both non-specialist and specialist visits. The GDG also referred to the recommendations given in NICE clinical guideline138 ‘Patient experience in adult NHS services’¹²² to emphasise good patient experience. Recommendations on checking to ensure that patients have the necessary knowledge, and on giving patients the responsibility to carry and share their drug allergy information are intended to minimise patients' fear, enhance communication between patients, clinicians and pharmacists, and enable the patient to better manage their confirmed or suspected drug allergy.
Other considerations	This review is closely connected with the review on documentation strategies (see Chapter 9). The quality of patient information can be improved through better documentation strategies and vice versa. The recommendations given here therefore advocate completion and maintenance of drug allergy documentation by healthcare professionals, provision of information to patients with effective communication and retention of that information by the patients.

Tables

Table 24Summary of protocol characteristics of review question

Population	Patients (or their family and carers) with history or experience of suspected or diagnosed drug allergy
Intervention	Information about diagnosis and management of drug allergy
Comparison	Information strategies compared with each other
Evaluation themes	Patient experiences; preferences; perceptions, including factors which improve or act as a barrier to optimal care. Clinical and quality of life outcomes related to diagnosis and management of drug allergy.
Study design	Qualitative studies and surveys

Bookshelf ID: NBK274145

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