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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.)
Drug Allergy: Diagnosis and Management of Drug Allergy in Adults, Children and Young People.
Show detailsAnalysis of patient safety incidents reported to the National Reporting and Learning System (NRLS) over 8 years (2005–2013) identified 18,079 incidents involving drug allergy. There were 6 deaths, 19 ‘severe harms’, 4980 ‘other harms’ and 13,071 ‘near misses’ reported.130 The majority of these incidents involved a drug that was prescribed, dispensed or administered for a patient with a previously known allergy to the drug or drug class. The drug allergy information was usually documented in the clinical notes, medication card or allergy (red band) bracelet. Despite this a drug was administered to a patient known to be allergic resulting in moderate to severe harm in more than 1000 cases. This shows that documentation is often ineffective or is ignored and avoidable incidents due to drug error are common.
Patients who have experienced drug allergy are not routinely provided with written information. Therefore, with the passage of time, details of the drug, possible cross-reacting agents and an indication of the severity of the reaction become increasingly difficult to recall. In some clinical situations, it may be necessary to re-expose the patient, for example where an alternative drug is less effective or the patient has multiple drug allergies. However, with incomplete clinical details of the original reaction it may not be possible to make a judgement on whether a reaction was immunologically mediated, and hence assess the risk of an allergic reaction on re-exposure.
Detailed clinical information is also needed for patients referred for specialist investigation of drug allergy and that process may be prolonged, requiring additional consultations, if documentation is incomplete.
9.1. Review question: What are the most clinically and cost effective documentation strategies for communicating drug allergy information across all NHS services to prevent patients from receiving drugs to which they are allergic?
For full details see review protocol in Appendix C.
Table 18
PICO characteristics of review question.
Following discussion with the GDG, it was recognised that documentation completion rate would be an informative surrogate outcome for medication errors. Absence of information on drug allergy from documentation could be erroneously interpreted as absence of drug allergy and this can potentially lead to prescriber errors. Therefore, we have included studies that did not necessarily report rates of medication errors but reported how complete or accurate the recorded data were in documentation.
Due to the large number of interventions (some further interventions are described in the full protocol in Appendix C) it was decided to prioritise higher quality evidence if necessary. Pharmacy reviews and reconciliation were not classified as documentation strategies and studies describing these interventions were excluded.
9.2. Clinical evidence
In this review we aimed to identify documentation strategies that ensure that drug allergy status is clearly indicated and effective in minimising medication errors. Documentation includes the way physicians record the drug allergy status as well as how the person with the allergy might indicate that he or she has a drug allergy (such as bracelets, for example). Thirty-three observational studies1,8,9,15,19,27,29,41-44,58,62,66,69,89,97,103,105,110,111,118,129,132,135,146,147,152,153,155,156,165,175 and 2 randomised trials60,159 were included in this review.
Studies can be broadly divided into 2 main categories:
- Twenty-one studies 1,8,9,15,19,27,42-44,66,69,89,97,103,111,129,132,155,156,159,165,173 investigated the effectiveness of computerised physician or prescriber order entry systems (CPOE) and other computer systems that aim to limit errors in medication prescriptions for people with drug allergies.
- The computerised order systems included medication lists which sometimes suggested dosage and route as well as various levels of checking systems to alert physicians to a variety of issues including drug allergies (usually also including drug–drug interactions, drug–laboratory problems and redundant medication checks).
- Nine studies29,41,60,62,105,110,132,152,175 assessed the design of pro formas and charts to indicate drug allergy status and their effectiveness in minimising drug errors.
- Examples of such charts were provided in 4 studies.29,62,105,152 Three of those included a box with an ‘allergy’ heading and 1 of them provided additional prompts for type of reactions (however this study used the form both for assessment and documentation). The other studies referred to design, structure or designated areas without additional detail.
Evidence from the 2 randomised controlled trials60,159 was combined with evidence from observational studies. This was due to major problems with study design and directness of outcomes in the trials. The trial by Tamblyn et al. (2008), investigating ‘on demand’ versus ‘automatic’ alerts, refers to error rates and overrides without a specific group of drug allergy errors. In the trial by Harris et al. (2002) the structured pro forma intervention was only used by a small minority of participants.
Evidence for the main 2 categories (computerised, structured charts) are summarised in the clinical evidence summary tables (Table 22 and Table 23). Other individual types of documentation are described in 5 studies.58,135,146,147,153 These are summarised in narrative form in section 9.2.4. See also the study selection flow chart in Appendix E, forest plots in Appendix J, study evidence tables in Appendix H and exclusion list in Appendix K.
9.2.1. Summary of included studies
Table 19 summarises the main study characteristics of studies investigating the effectiveness of computer systems. Table 20 summarises the main study characteristics of studies investigating the effectiveness of the design of pro-formas and charts. Studies investigating other communication strategies are summarised in Table 21.
Table 19
Summary of studies addressing computerised documentation systems.
Table 20
Summary of studies addressing design of pro formas and charts.
Table 21
Summary of studies reporting other documentation strategies.
9.2.2. Computerised prescribing systems
Table 22
Clinical evidence summary table: computerised prescribing systems.
Narrative summary of other findings relating to computerised prescribing systems
- In 1 study,132 a national survey, 42% of responding physicians reported that they relied on the computer system to alert them to the drug allergy.
- Another study155 reported overall low completion rates of drug allergy records (61.6 for internists and 50.4 for paediatricians).
- In the randomised controlled trial159 physicians using an on-demand system noticed fewer errors, but acted on the majority of those that they looked at (saw 1% and acted on 76% of those seen). Physicians using an automatic system saw more of the prescribing problems but only acted on a minority of those seen (saw 10% and acted on 12% of those seen).
- One study97 found that change in ADE rate depended on the level of Clinical Decision Support System (CDS). Computerised Prescriber Order Entry system (CPOEs) with the more advanced CDS features resulted in more significant reduction of Adverse Drug Events (ADE).
- Introduction of CPOE in 1 study111 led to increase in the overall number of medication errors but decrease in the number of serious errors.
- Incorporation of individual patient data in to an existing computable ADR knowledge base in 1 study129 led to decrease in sensitivity but increase in specificity of the ADR detection system.
- In general, CPOEs evaluated in more recent years tended to be adapted to suit the purpose of the study site.
9.2.3. Pro formas or structured charts
Table 23
Clinical evidence summary table: pro formas or structured charts.
9.2.4. Other documentation strategies
- One study146 integrated a ‘quicklist’ containing the 75 most commonly prescribed medications in a paediatric department to the computerised order system and compared this to a computerised system without this list (that is, before implementation). Errors per 100 orders decreased from 31 to 14. With respect to drug allergies, errors per 100 orders decreased from 2 to 0. (Very Low quality evidence)
- One study135 in an US paediatric emergency department reported that out of the 28 children with confirmed drug allergy, 16 (57%) were given a bracelet. 5/16 (31%) were incorrect or blank. (Very Low quality evidence)
- The addition of structured product labelling to a computer system was investigated in another study.147 Even though the authors concluded that the structured system detected 4 times as many drug intolerance issues in twice as many patients, closer inspection of the results do not show differences in the detection of allergens between the intervention system and the existing system. (Very Low quality evidence)
- Results from a study of a revised version of an over-the-counter ibuprofen allergy alert, which included more information on symptoms of drug allergies, indicated that 78% of consumers and 100% of people with previous drug allergies preferred the revised version. (Very Low quality evidence)
- In 1 study58, introduction of ADE scorecards, a tool aimed to increase team ADE awareness by allowing information on ADE available to the entire care team, did not lead to any significant change in the rate of ADE. (Very Low quality evidence)
9.3. Economic evidence
Published literature
No relevant economic evaluations were identified.
See also the economic article selection flow chart in Appendix F.
9.4. Evidence statements
Clinical
Computerised medical records and prescriptions
- Very low quality evidence from 20 observational studies and 1 RCT showed that error rates tended to decrease after computer systems were introduced. Some studies did not show an overall improvement when direct comparisons were made between paper-based and computer-based prescriptions. In the studies reporting on overrides the majority of computer alerts (69–97%) were ignored. One observational study demonstrated that the resulting changes in adverse drug event (ADE) rates depended on the complexity of clinical decision support (CDS) incorporated in the host CPOE: the more advanced the CDS was the lower the ADE rates following introduction of the CPOE.
Pro formas or structured charts
- Very low quality evidence from 6 observational studies and 1 RCT evaluated new or revised versions of structured forms which allow the clinicians to record patient history and other clinical factors, and to assess patients' allergy status. Some of the positive outcomes included: increase in compliance with documentation of allergy status, presence of allergy information in referral letters, accuracy of allergy identification, the number of times allergy components were included or completed, and reduction in prescribing errors. Some of the negative outcomes were: increase in adverse drug reactions (in 1 study), decrease in frequency of recording of allergy by anaesthetists and no overall difference in quality of information provided by clinicians following intervention.
Other strategies
- Very low quality evidence from 5 observational studies showed that i) the medication error rate decreased following an integration of a ‘quicklist’ to an existing computerised system; ii) drug allergy information on a significant proportion of children's bracelet were incorrect; iii) structured product labelling did not have a significant impact on allergen detection; iv) a revised, more comprehensive version of an over-the-counter ibuprofen allergy alert was preferred; and v) introduction of ADE scorecards did not lead to change in ADE rate.
Economic
- No relevant economic evaluations were identified.
9.5. Recommendations and link to evidence
| Recommendations |
Documenting and sharing information with other healthcare professionals
Documenting new suspected drug allergic reactions
Maintaining and sharing drug allergy information
Documenting information after specialist drug allergy investigationsFor recommendations on referral to specialist services see Chapter 12 After specialist drug allergy investigations, allergy specialists should document:
|
|---|---|
| Relative values of different outcomes | The following outcomes were identified by the GDG as important for decision-making: medication errors (inappropriate prescription or administration of drugs), number of repeat drug allergic reactions, inappropriate avoidance of drugs and quality of life. The first 2 were considered by the GDG to be the most important outcomes. Not all of the stated outcomes were found in the studies included. In general, most of the studies reported outcomes related to medication prescribing errors or adverse drug reactions, and not specifically to drug allergy. |
| Trade-off between clinical benefits and harms | The GDG noted a recent report by NHS England 130 which highlighted the high incidence of medication errors and agreed that errors in prescribing and administering drugs are a serious concern. The GDG observed that, at present, the labelling and coding used in electronic documentation systems do not enable such systems to differentiate between a side effect and an allergic reaction. It was agreed that if the information entered into such systems was of poor quality in the first instance then the output would also be of poor quality. The GDG considered that any system which allows accurate recording of information and prevention of erroneous prescription or administration of medications would be highly beneficial in improving patient safety. Studies related to computerised prescriber order entry (CPOE) systems showed very high rates of overriding of automated alerts (between 69% and 97%). The GDG indicated that once a patient has been diagnosed as having a drug allergy, this status would remain on the patient's record. Therefore, if a patient had previously been incorrectly diagnosed as having a drug allergy, the trigger alerts at subsequent visits to their physician would be overridden. Those studies that implemented a structured approach to documentation saw a reduction in medication prescribing errors and adverse drug reactions, and also an increase in healthcare professionals' compliance in completing patients' medical charts. The GDG therefore endorsed the application of structured documentation to record details of suspected drug allergies. |
| Economic considerations | No relevant economic evidence was identified. The GDG did not prioritise this question for original economic analysis. The GDG agreed that accurately documenting a person's current drug allergy status is vital in order to prevent inadvertent exposure to an allergen, and so to ensure patient safety. Whilst this may require an initial increase in healthcare professionals' time whilst current records are improved, in many cases this is likely only to bring forward a discussion that a GP will have with the person at some later point in time. The GDG were confident that any cost from increased numbers of GP consultations would be outweighed by increases in quality of life and costs saved due to future additional drug allergic reactions avoided. Similarly, accurate documentation of all new suspected allergic reactions to drugs will help identify appropriate future treatment, leading to better clinical outcomes and improved quality of life, at low cost. Documentation of reactions which are found not to be allergic reactions will reduce the unnecessary future avoidance of drugs and so reduce the usage of more expensive and potentially less effective alternatives. Accurate and sufficiently detailed recording of information regarding reactions at the time they are first reported will also reduce time spent later attempting to understand records relating to drug allergy which are unclear or unstructured. As noted above, there is a significant incidence of medication errors at the point of drug prescription and administration.130 Avoidable repeat reactions can have significant impact on the health and quality of life of people who experience them and will give rise to significant treatment costs; low cost methods of reducing these errors are therefore likely to be cost effective. Checking the drug allergy status of a person before prescribing them a drug would take a matter of seconds within the course of a normal GP consultation for a person whose status has already been systematically documented according to these recommendations and whose status is unchanged. In the same way, the GDG agreed it would take healthcare professionals who dispense and administer medication a few seconds more to read prescriptions including slightly more information and to confirm this with the patient. Although a short amount of additional time added to many thousands of GP consultations and occasions when drugs are administered could add up to a significant total, the GDG emphasised the importance of accurate documentation and information sharing between health services in reducing both avoidable repeat allergic reactions and the costs involved in treating those reactions. There is also a possibility that time would be saved in some cases where a patient is currently asked to explain their full allergy history on multiple occasions to those prescribing, dispensing or administering drugs who are currently not provided with sufficient allergy information, and so need to elicit the information afresh on each occasion. The GDG agreed that these strategies were therefore likely to be highly cost effective compared to current practice. |
| Quality of evidence | The studies included were predominantly observational studies from the USA and the electronic systems that they evaluated were designed and developed to suit the purpose of the study site. None of these systems can be directly compared with current or prospective systems in the UK. Importantly, most of the studies focused on rates of medication prescribing errors or adverse drug reactions in general, and data specific to drug allergy were minimal. The outcomes of the included studies varied considerably, with some documentation strategies leading to positive results whilst others led to less favourable effects. Positive findings from the implementation of computerised systems cannot necessarily be attributed to the system alone. It is possible that introduction of a new system itself raises awareness amongst the personnel working at the site, or that training that accompanies the system's introduction improves practice amongst healthcare professionals. The studies did not provide sufficient data on what training was provided with the computerised systems. Overall, although the studies observed a reduction in medication prescribing errors and adverse drug reactions, the evidence from these studies was varied and of very low quality. Therefore, the evidence did not enable the GDG to make recommendations on specific systems, and highlighted the need for further research. |
| Other considerations | The GDG noted that there is an increase in the use of computerised systems and a push towards paperless systems being introduced in the NHS . However, in the absence of evidence, it is not possible to make recommendations specifically for computerised systems. Nevertheless, the GDG recognised that the quality of the information recorded within any documentation system is paramount and concluded that having a well organised, structured system in any format would be very helpful in reducing the number of prescribing errors and preventing allergic reactions. Specifying the information that needs to be recorded and allocating specific locations for details of drug allergy to be recorded will serve to enhance the skills of healthcare professionals in taking medical histories and increase their compliance in completing patients' medication charts. Details on the type of information or the level of detail being documented in patient records were not described within the studies. The GDG drafted consensus recommendations on when drug allergy status should be recorded, the level of detail required and who this information should be shared with based on their own clinical experience, and recent publications that have highlighted areas of good practice.2 The GDG was aware that some hospitals already have prescription forms including drug allergy status, but that this was not currently part of GP or dentist standard prescription forms (FP10, HS21B). The group noted the current inequality this posed in the delivery of care between primary and secondary settings. Given the GDG's observation on the lack of communication between healthcare professionals in primary and secondary care and across different departments within hospitals, it is important to ensure that structured documentation is in place at all levels of patient care. The GDG agreed that most prescriptions are now generated electronically and therefore including information on a patient's drug allergy status is possible.. It was noted that community pharmacy has a role in minimising re-exposure to drugs where there is a known drug allergy, and having information on the prescription form would enable this and help improve patient safety. The GDG agreed that a review of systems, including prescription forms for recording drug allergy is required because current levels and methods of documentation are inadequate. To prevent the loss of information about a patient's drug allergy between contacts with healthcare providers, it is important that patients are given the necessary information and details of their own drug allergy status, and that such information is held by the patient and shared with their clinicians. Evidence and recommendations related to this issue can be found in Chapter 10 (Information and support). Guidance on medicines reconciliation on hospital admissions is available in NICE patient safety guidance 1 (PSG1). The guidance aims to lay out patient safety solutions to ensure that medicines prescribed on admission correspond to those that the patient was taking before admission. The GDG also noted the recent i-care report2 of the Academy of Medical Royal Colleges that highlighted the need for patient records to follow a standardised structure and content and to be available across organisational boundaries. The report's recommendation for a recognised nomenclature of clinical terms such as SNOMED to be used within the NHS was endorsed by the GDG. Computerised systems for patient records currently use a variety of different codes for drug allergy, and the GDG agreed implementation of a standard code and terminology would improve patient safety and management. |
- Review question: What are the most clinically and cost effective documentation strategies for communicating drug allergy information across all NHS services to prevent patients from receiving drugs to which they are allergic?
- Clinical evidence
- Economic evidence
- Evidence statements
- Recommendations and link to evidence
- Documenting and sharing information with other healthcare professionals - Drug A...Documenting and sharing information with other healthcare professionals - Drug Allergy
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