The impact of emergency medicine pharmacists on medication safety for critically ill patients in the resuscitation area of an emergency department: a pilot study

doi:10.21203/rs.3.rs-4853055/v1

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Research Article

The impact of emergency medicine pharmacists on medication safety for critically ill patients in the resuscitation area of an emergency department: a pilot study

https://doi.org/10.21203/rs.3.rs-4853055/v1

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Background

Few studies of pharmacists’ impact on emergency department resuscitation care have been powered for key outcomes such as medication error and time to administration.

Aim

To conduct a pilot study to inform the design of a large interventional cohort study to determine if the presence of a pharmacist in an ED resuscitation setting reduces medication errors.

Methods

A pilot prospective controlled interventional cohort study of patients treated in the emergency department resuscitation area. The incidence of medication errors that occurred when a pharmacist was present (intervention) or absent (control) was collected. The pharmacist’s clinical activities were recorded and a review of study design and methods conducted to determine the feasibility of the study design. A sample size calculation was performed to power a larger study.

Results

A total of 62 patients were included, of which the pharmacist was present during resuscitation events for 38 (61%). The pharmacist provided clinical activities such as medication advice and double check, pre-emptive medication supply, medication error detection and timely interception, medication history and review. There were one prospectively and six retrospectively identified medication errors (25%) in the control arm and none in the intervention arm. Six errors were intercepted by the pharmacist. The sample size for the larger study was calculated at 40 patients in each arm.

Conclusions

A pharmacist’s presence during resuscitation events provides expert medication advice and facilitates the safe administration of medications. A larger study of 80 patients is necessary to confirm a significant reduction in medication errors.

emergency critical care

pharmacist

resuscitation

trauma

medication safety

This study evaluated ED resuscitation pharmacist roles using prospective and retrospective design and will inform the design, target outcome measures and sample size of a larger interventional cohort study
A pharmacist working as part of an emergency department resuscitation team can provide expert medication advice and assist nursing and medical staff when prescribing or administering medication in a resuscitation environment

Medication errors (MEs) are common in a tertiary hospital emergency department (ED) resuscitation area (ME).(1–3) Emergency physicians and nurses prescribe and administer high-risk medications to critically ill patients. Time sensitive clinical decisions are made, medications are administered rapidly, and verbal orders are common. This increases the likelihood of miscommunication and suboptimal safety checking, which can contribute to ME.(4, 5) An error with a high-risk medication can lead to patient harm.(6, 7) In an Australian ED, a prospective point prevalence study of 172 patients found that 28% (48/172) had an error of omission.(8) In a United States (US) study of 192 ED patients, 59% of patients had one or more MEs and 37% had errors not intercepted before administration.(9)

EM pharmacists have been associated with reduction in MEs and adverse drug events.(10–14) A study in four US EDs observed pharmacists reviewing medications for 6,471 patients including trauma and critical care. The EM pharmacists identified 504 medication errors (7.8 errors per 100 patients).(13) The majority (90.3%) of errors were intercepted before administration.(13) A US cross-sectional cohort study of 694 patients requiring resuscitation or trauma management found a significantly lower incidence of MEs when patients were treated in the presence of a pharmacist: 6/242 (2.5%) versus 137/452 (30.3%), relative risk ratio = 17.1 (95% confidence interval 7.4–39.4).(15) Pharmacist recommendations including dose and therapy alternatives were frequently accepted by doctors.(15) Despite this, in many hospital EDs within Australia, resuscitation areas do not have dedicated pharmacists.(16)

A recent systematic review of studies evaluating the impact of a pharmacist working within resuscitation or medical emergency response teams found significant improvements in outcomes such as time to initiation of time-critical medications, medication appropriateness and guideline compliance.(17) However, studies were predominantly small with significant heterogeneity in outcomes and cohorts. The authors recommended evaluation of the impact of pharmacists in ED resuscitation settings in controlled, prospective studies with robust sampling methods.(17)

Locally, significant MEs, some resulting in harm, have occurred in the ED resuscitation area. Incident analyses recommend that pharmacists be present during the management of critically unwell patients, to prevent MEs and ensure timely administration of time critical medicines. However studies evaluating the role of EM pharmacists in trauma, resuscitation or emergency critical care are limited and most were conducted in the US.(17) The US healthcare setting differs to Australia in terms of funding models, healthcare professional roles and education, electronic medication management systems and medication availability.(18) To our knowledge, a comprehensive investigation of the benefits of a pharmacist as part of the ED resuscitation team has not been conducted in Australia. In addition, few studies have been conducted prospectively or adequately powered for key patient outcomes such as ME reduction and time to administration of critical medicines. A pilot study to test the feasibility of a prospective patient allocation design and data collection methods was undertaken.

Aim

To conduct a pilot study to inform the design of a large interventional cohort study to determine if the presence of a pharmacist in an ED resuscitation setting reduces medication errors

Objectives:

1) Confirm the inclusion criteria and investigate the feasibility of prospective patient allocation and prospective and retrospective data collection

2) Identify the potential roles of a pharmacist working within an Australian ED resuscitation team

3) Identify outcome measures to determine impact of the pharmacist intervention

4) Perform a sample size calculation for the primary outcome of the definitive study

Ethics approval

Ethical approval was granted by the Metro South Human Research Ethics Committee (HREC/2019/QMS/54845 as per the requirements of the National Statement on Ethical Conduct in Human Research (2007)) in October 2019. A waiver of consent was approved for patients whose data were collected during the study.

Design

This was a prospective controlled interventional cohort pilot study comparing patients treated within the resuscitation area of an ED when a pharmacist was present (intervention) or absent (control). We ensured adherence to the Consolidated Standards of Reporting Trials (CONSORT) statement extension for pilot and feasibility studies.(19) In each arm, an independent research nurse observed the resuscitation, documenting any MEs that occurred. A randomized controlled trial was not undertaken due to the practicalities of rostering and availability of the the intervention pharmacist and research nurse at particular times and days. A convenience sampling method was used to recruit patients.

Setting

This pilot study was conducted in the ED of a 900-bed metropolitan hospital from July 2020 to January 2021. The ED is a level 1 trauma centre with approximately 73,000 adult presentations per year and five resuscitation bays. On arrival, patients meeting pre-defined observational parameters according to Australian Triage Scale (ATS) criteria and department guidelines are allocated to the resuscitation area of the ED by a triage nurse. As pharmacists are not typically present during the initial management of critically ill patients in the resuscitation area, the addition of the study pharmacist was a novel service. The intervention pharmacist was a senior ED pharmacist.

Patient Identification and assignment

Patients presenting to the ED and assigned to the resuscitation area were eligible for inclusion, identified in real-time using data from the electronic medical record (EMR) during the defined study period. Initially, all patients triaged to the ED resuscitation area during research pharmacist and/or research nurse rostered hours were included. The study occurred on Mondays: 1400–1800 with a pharmacist for 10 weeks (Intervention) and Tuesdays: 1400–1800 without pharmacist for 10 weeks (Control).

Data Collection

Data was collected prospectively and retrospectively:

Prospective data collection

Direct observations were performed by a research nurse with extensive clinical and EM research experience. Data were recorded on paper-based collection forms and included patient demographics and the number of doctors and nurses present at the commencement of the resuscitation. Medication data included details of the prescription and administration, as well as any MEs that occurred during the observation period. Pharmacist interventions and activities were recorded under the following categories: medication information provision and advice, administration advice, supply of medication, double-check before administration, documentation of allergies, medication error interception, documentation of medication history and review.

Retrospective data collection

An unblinded retrospective medical record review identified additional prescribing or administration errors detected that were not prospectively observed or could not be immediately assessed as an error by the research nurse. For example, the assessment of the appropriate choice and dose of antibiotics. The EMRs of all patients were examined retrospectively to assess whether the medication followed local guidelines, such as antimicrobial prescribing and immunisation guidelines. The accuracy of documentation of medications prescribed and administered during the resuscitation events in the medication administration record was recorded. A ME was defined as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer”. (20)

Outcome measures

The primary outcome was a description of study feasibility. Feasibility metrics included defined eligibility criteria and a data collection strategy, a description of the roles and activities of the intervention pharmacist, feasibility of delivery of the intervention and identification of suitable outcome measures. An outcome measure in this pilot study was the number of MEs that occurred during ED resuscitation events. Actual and potential MEs (i.e. errors intercepted by a nurse observer) were recorded.

Data Analysis

Data were entered into an Excel™ spreadsheet. Descriptive statistics were used to describe patient and clinician demographics. Pharmacist activities were recorded, categorized and tabulated. MEs were classified into relevant descriptive categories (for example drug class) and error type according to the National Coordinating Council for Medication Error Reporting and Prevention Taxonomy of Medication Errors.(21) Formal hypothesis testing was not conducted because this is not recommended in the CONSORT extension for pilot and feasibility studies.(19) Feasibility outcomes were reported using narrative synthesis and descriptive statistics for relevant outcomes.

Sample size calculation

This pilot study was conducted to inform the sample size for an adequately powered cohort study to evaluate the preferred primary outcome; number of MEs. There are a number of other outcomes of interest that have been previously identified that could be used as targets for research. Therefore, we conducted a series of sample size calculations for outcomes of interest, to inform future studies, using the results reported in a recently published systematic review.(17) These included:

Number of MEs which led to patient harm
Medication administration within 30mins of rapid response team alert
Median door to needle thrombolysis time
Proportion of patients given antibiotics within 60mins of ED arrival
Median ED arrival to antibiotic administration
Median ED arrival to 4-factor prothrombin complex concentrate (4F-PCC) administration
Mean time to postintubation sedation

Patient demographics and resuscitation team composition are summarised in Table 1. There were 62 patients recruited over a total duration of 6 months, 38(61%) in the intervention group and 24 in the control group. There were no significant differences in any baseline variables between groups.

Table 1

A summary of patient characteristics and resuscitation team composition
Variable	Intervention (n = 38)	Control (n = 24)	p-value
Median age, years (IQR)	56 (33–68)	51 (38.5–66)	0.83
Male, n (%)	25 (65.7)	17 (70.8)	0.68
ATS category, median (IQR)	2 (1–2)	1.5 (1–2)	0.35
Medical presentation	27	14
Trauma presentation	11	10
ATS = Australian Triage Scale, IQR = interquartile range

1. Feasibility study population, data collection

During the initial data collection period, the research team agreed that study recruitment should shift to a prioritized, ‘on demand’ response service as some patients allocated to the resuscitation area received few medications and were less likely to benefit from pharmacist intervention. The research team reset the inclusion criteria to include the following patients:

assigned an ATS category 1 or category 2 for a medical condition
toxicological related condition or overdose
requiring an immediate response following an internal ED alarm

A data collection tool which defined accuracy and threshold for ME documentation was developed and will be used in the data collection for the larger study. Independent review and severity level assessment of ME documented was not performed during the pilot but will be included in the study methodology for the definitive study.

Insert Table 1 here:

2. Pharmacist roles and activities identified and described

Pharmacist roles and activities observed during the pilot study included: medication information provision and advice, administration advice such as dilution and rate of administration, preemptive and timely supply of medication, double-check of medications before administration, documentation of allergies, therapeutic recommendations (e.g. choice and dose), documentation of medication history and medication review to identify medication related problems and ensure medications are optimised. Table 2 outlines the activities and their frequency. The intervention pharmacist advised on medication doses (eg. antibiotics, antiepileptics) and medication preparation and administration for medicines such as adrenaline, lacosamide and levetiracetam. Pharmacist medication review identified medication related problems that may have contributed to the presentation such as an inadvertent antiepileptic dose decrease in the community for a patient presenting with seizures.

Table 2

Medication and patient related activities performed by the study pharmacist (intervention group n = 38)
Medication related activities	Occasions	Patient related activities	Occasions
Preparation double check	24	Medication history and review	17
Administration advice	3	Medication error intercepted	5
Preparation	7	Documented ADR	2
Medication information provision and advice	2	Documentation-charting	2
Documentation - charting	2
Retrieval	24
Supply	5
ADR = adverse drug reaction, Retrieval = medication obtained from a location within the ED, supply = medication sourced from pharmacy

Insert Table 2 here:

3. Proposed primary outcome for large cohort study - medication error (ME)

Table 3 provides a summary of intercepted, observed or potential MEs. There were one prospectively and six retrospectively identified MEs in the control arm and none in the intervention arm. A total of six MEs were intercepted. The presence of a pharmacist reduced the number of incomplete documentation of medications in the EMR; 9 (38%) in the control arm vs 6 (16%) in the intervention.

Table 3

Medication errors intercepted, observed and identified retrospectively
Variable	Intervention (n = 38)	Control (n = 24)
ME total, n (%)	0 (0)	7 (29.2)
ME observed, n (%)	0 (0)	1 (0.04)
ME from retrospective review, n (%)	0	6 (25)
MAR documentation incomplete, n (%)	6 (16)	9 (37.5)
ME prevented by nurse or pharmacist present
ME intercepted by resus nurse, n	1	0
ME intercepted by resus pharmacist, n	5	0
MAR = Medication Administration Record, ME = Medication error, n = number of patients

Insert Table 3 here:

A summary of ME categories and corresponding examples are detailed in Table 4. Prescribing errors including wrong drug, wrong dose, and duplicate orders were found on three occasions. Additionally, three administration errors due to a monitoring error (contraindication), timing and duplication were recorded. Instances of incomplete MAR documentation were recorded as EC MERP Category A events (no error - circumstances that have the capacity to cause error). These events occurred when medications were administered during resuscitation management, but the administration was not recorded on the patients’ medication administration record.

Table 4

Medication error categories and examples
	Count of Observed Errors		Count of Errors from Retrospective Review		Examples
Error type	Intervention (n = 38)	Control (n = 24)	Intervention (n = 38)	Control (n = 24)
Wrong drug	0	0	0	2	ADT™ given when not indicated Inadequate antibiotic cover for traumatic wound
Improper Dose (Overdose)	0	0	0	1	Supratherapeutic dose of ropivacaine
Improper dose (Extra dose)	0	1	0	1	Ondansetron administered but not documented (re-administration intercepted by research nurse) Duplicate PRN IV hydralazine orders
Monitoring error (Drug-drug interaction)	0	0	0	1	Patient on PCA administered additional IV and oral opiates
Wrong time	0	0	0	1	Delay between bolus and infusion for alteplase
Charting accuracy
MAR documentation incomplete	6	7	0	2	Medications administered during resuscitation event not recorded on the medication administration record
ADT = diptheria and tetanus vaccine, MAR = medication administration record, PRN = when required, IV = intravenous, PCA = patient controlled analgesia

Insert Table 4 here:

4. Sample size calculation

Primary outcome for definitive study

A summary of the results of the sample size calculations are shown in Table 5. An a-priori power analysis using 80% power and 95% confidence intervals estimated a total sample size required for the primary outcome (proportion of patients with a ME) of 79 participants (rounded to 40 in each arm) based on the results of this pilot study and a similar study which reported medication error as the primary outcome(15).

Other outcomes identified

There were insufficient patients captured in this study that could be grouped and analysed for outcomes such as time to time-critical medication, and adherence to guidelines. Using data from literature to evaluate other important outcomes, such as time to medication administration, would require a sample size of up to approximately 250 participants. This was calculated by considering the largest sample size (Roman = 256) and by adding a selection of sample sizes calculated from studies measuring other outcomes of interest (Ernst(15) = 79, Feih(22) = 87, Roman(23) = 33, Masic(24) = 32 and Amini(25) = 37). This larger sample size would ensure an adequately powered study where time to medication administration was used as a primary outcome measure.

Table 5

Sample size calculation for future interventional cohort study
Study and Diagnosis	Outcome measure	Proportion or mean (control)	Proportion or mean (intervention)	Sample Size
Ernst(15)	Proportion of patients with a ME	0.303	0.025	79
Ernst(15)	Proportion of patients with ME which led to patient harm (Category D and above)	0.022	0.004	1710
PAH pilot study	Number (%) of ME in each group	0.292	0.026	73
Feih(22)	Proportion of medications administered within 30mins of RRT	0.222	0.536	87
Roman 21(27)	Median door to needle time thrombolysis (mins)	73	61	256
Roman 23(23)	Proportion of patients given antibiotics within 60mins of ED arrival	0.263	0.817	33
Roman 23(23)	Median ED arrival to antibiotic administration (min)	91	38	33
Masic 2019(24)	Median ED arrival to 4F-PCC administration	206.5	66.5	32
Amini(25)	Mean time to postintubation sedation	28	9	37
ME = medication errors, RRT = rapid response team alert, 4F-PCC = 4-factor prothrombin complex concentrate. PAH = Princess Alexandra Hospita

Insert Table 5 here:

Statement of key findings and interpretation

This pilot study aimed to inform the design of a large interventional cohort study to determine if the presence of a pharmacist in an ED resuscitation setting reduces medication errors. To do this we investigated the feasibility of a patient selection and data collection strategy, identified the potential roles, activities and outcome measures to determine the impact of a pharmacist working within an Australian ED resuscitation team and performed a sample size calculation for key outcomes.

This pilot identified the need for changes to our recruitment strategy. Recruitment was altered to a prioritised and ‘on demand’ response service after an initial trial period to ensure that the intervention was targeted to the most appropriate patient population. The research team reset the inclusion criteria to include patients assigned an ATS category 1 or category 2 for a medical condition, toxicological related condition or overdose, and those requiring care following an internal ED alarm. Prospective and retrospective data collection methods were consistent throughout the study.

A range of pharmacist activities were reported in this study including medication information provision, administration advice and double check of medication orders and administration, preemptive and efficient medication supply, medication error interception, documentation of medication history and medication review. This study suggests that a pharmacist’s presence within the resuscitation team has a positive impact on the accuracy of documentation of medications administered and the occurrence of MEs. While we determined that ME should be the primary outcome of interest for the larger definitive cohort study and that a sample size of 40 patients per arm is needed, several other key outcomes were identified that could be included as secondary outcomes in future studies (for example, time to time-critical medication administration).

A recent systematic review assessed studies investigating the impact of the presence of a pharmacist during the emergency management of critically ill patients requiring resuscitation or acute critical care.(17) The most frequent outcome reported was time to medication administration. Obtaining and preparing medications were identified as important roles of a pharmacist during resuscitation events.(17, 23, 24, 26–29). In 22 studies, a pharmacist had a positive effect by reducing the time to time-critical medication administration. These included a reduced time to administration of thrombolysis(27, 30), prothrombin complex concentrate(24, 29), antibiotics(23, 31, 32) and analgesics.(26, 28)

There have been numerous studies demonstrating that the interventions made by a pharmacist in the ED decrease MEs and potential costs associated with these errors. Relevant examples in this study include preventing the duplication medications such as ondansetron and hydralazine that may have resulted in patient harm. Other MEs identified in the retrospective review, included the prescription of a supratherapeutic dose of ropivacaine and incorrect antibiotic regimen for traumatic wound prophylaxis. A retrospective analysis of reported MEs over a five year period in an Australian ED found that out of 405 errors, 63% occurred during administration, 29% during prescribing and 11% occurred in the resuscitation area.(7) Half of the errors involved high-risk medications and 21% of errors caused patient harm.(7)

Resuscitation areas and the transition to the acute care area of the ED are high-risk for ME. Verbal orders are common during acute resuscitation events, which may increase the risk of a ME(4, 5) and incomplete documentation of medications in the EMR. Incomplete documentation of medications has led to errors including duplicate administration. This occurs when a medication is given, but not signed on the medication chart immediately and therefore readministered. MEs with a potential for patient harm can occur, especially when high alert medications such as aminoglycoside antibiotics or parenteral benzodiazepines are involved.(7) Our study found that pharmacists had an important role in improving the accuracy of medication documentation during and after resuscitation events by reducing the rate of incomplete documentation of medications in the EMR (38% in the control arm vs 16% in the intervention). This pilot highlighted the need for the development of an approved local workflow allowing pharmacists to assist doctors and nurses to ensure that verbal orders are transcribed onto the medication chart. This workflow was demonstrated in an Australian study, that showed when a medication change occurred during the response to a medical emergency, it was enacted by the pharmacist using a pharmacist partnered medication charting process in over a third of cases.(33).

Strengths, weaknesses and further research

We have determined that a study that recruits 80 participants is required to confirm the positive impact on the decrease of MEs found in this pilot study. If other outcomes were sought, then a larger sample size would be necessary, for example an additional 33 participants to investigate for time to antibiotic administration in sepsis and 87 for time to time-critical medication administration across a range of patient populations. Of interest, is that the evaluation of medication harm would require a sample size of 1710 patients. While this would be a valuable outcome to measure, sufficient resources and time would be significant barriers.

We used a senior pharmacist in this study and no specific training occurred prior to the intervention. Given the specialist nature of working in a resuscitation setting, a training module and competency framework should be developed to ensure that pharmacists practice safely and effectively in this setting. An interventional cohort study is needed to determine the impact of the pharmacist MEs and other key outcomes such as time to administration of time critical medication administration, accuracy of medication documentation and adherence to guidelines.

This pilot study has confirmed the feasibility and methodology for an investigation of a pharmacist’s involvement during resuscitation events in the ED. This pilot study suggests a potential reduction in MEs, and a larger study of at least 40 participants per arm would confirm this finding.

Acknowledgements

The authors would like to express sincere thanks to the staff of the Princess Alexandra Hospital Emergency and Pharmacy departments for their support and participation. We would also like to acknowledge and sincerely thank Dr Rob Eley for his expert help and advice regarding the design and his support for the conduct of this study. We are grateful for the support of the Metro South Research Support Scheme.

Funding

This study was conducted through the support of the Metro South Health Research Support Scheme funds from a Novice Researcher Small Grant award.

Conflicts of interest

The authors declare that they have no conflict of interest.

Author contributions:

EC, NF, KI and MB conceived the study, designed the protocol, determined the data collection points and validation of the data. EC conducted the and managed the data. NF and MB screened and reviewed studies and reviewed data items and provided advice on study design and manuscript development. EC drafted the manuscript, and MB and NF contributed substantially to its revision. KI provided expert advice and feedback on the design and review of the manuscript draft. EC takes responsibility for the paper as a whole.

Declaration of Interest:

EC, NF, KI and MB report no conflicts of interest

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The impact of emergency medicine pharmacists on medication safety for critically ill patients in the resuscitation area of an emergency department: a pilot study

Status:

Version 1

Abstract

Background

Aim

Methods

Results

Conclusions

Impact Statements

Introduction

Aim

Ethics approval

Method

Design

Setting

Patient Identification and assignment

Data Collection

Prospective data collection

Retrospective data collection

Outcome measures

Data Analysis

Sample size calculation

Results

1. Feasibility study population, data collection

2. Pharmacist roles and activities identified and described

3. Proposed primary outcome for large cohort study - medication error (ME)

4. Sample size calculation

Discussion

Statement of key findings and interpretation

Strengths, weaknesses and further research

Conclusion

Declarations

References

Status:

Version 1