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Quantitative Exploration of Medication Errors among Older People: A Systematic Review

Running Title: Medication Errors in Older People: A Systematic Review

Shahrzad Salmasi1, Barbara C. Wimmer2, Tahir Mehmood Khan3,4, Rahul P. Patel2, Long Chiau Ming2,5

1Faculty of Pharmaceutical Sciences, Collaboration for Outcomes Research and Evaluation (CORE), University of British Columbia, Vancouver, Canada

2Pharmacy, School of Medicine, University of Tasmania, Hobart, Tasmania, Australia

3School of Pharmacy, Monash University Malaysia, Sunway City, Selangor, Malaysia

4The Institute of Pharmaceutical Sciences (IPS), University of Veterinary & Animal Sciences (UVAS), Lahore, Pakistan

5School of Pharmacy, KPJ Healthcare University College, Nilai, Negeri Sembilan, Malaysia.

E-mail:

Shahrzad Salmasi: [email protected]

Barbara C Wimmer: [email protected]

Tahir M Khan: [email protected]

Rahul P Patel: [email protected]

Corresponding author:

Dr Long Chiau Ming

Email: [email protected]

1. School of Pharmacy, KPJ Healthcare University College, Lot PT 17010, Persiaran Seriemas Kota Seriemas,71800 Nilai,Negeri Sembilan, Malaysia. Tel: +606-7942653; Fax:+606-794 2669

2. Unit for Medication Outcomes Research and Education, Pharmacy, University of Tasmania, Private Bag 26, Hobart, 7001, Tasmania, Australia. Tel: +603 32584775. Fax: +603 32584602

Abstract

Background: Medication Errors (ME) in older people are of importance due to global ageing patterns. Following on from aging-related changes in pharmacokinetics, pharmacodynamics, and the potential presence of multiple co-morbidities treated with polypharmacy, older people are highly vulnerable to the effect and consequences of MEs.

Objective: The primary outcome was to systematically review studies on the incidence and categories of medication errors (ME) in older people. Secondary outcomes included economic and clinical consequences of ME in older people, risk factors for ME in older people, and medications involved.

Methods: A comprehensive, electronic search was conducted using PubMed, EBSCOhost, OvidMedline and Proquest central databases for studies evaluating ME in older people published in peer-reviewed journals before November 2017. A secondary manual search was also conducted by checking the bibliographies of included studies to identify other relevant studies. There was no limitation imposed on the language, time of publication or the setting in which the study was carried out. The quality of identified studies was assessed based on 17 criteria adopted from Alsulami et al and Metsälä et al. The results were categorized using the phases of medication use when the error was detected or occurred.

Results: Eighteen studies met the inclusion criteria with a total of 467,193 participants from 11 countries. Identified MEs were administration errors (n=7, 1.2%-59.0%), prescribing errors (n=7, 1.6%-49.7%), transcribing errors (n=5, 15.0%-70.2%), reconciliation errors (n=4, 5.0%-53.6%), and dispensing errors (n=2, 2.0%-14.0%). People with polypharmacy had the highest tendency of MEs. Three studies reported severe clinical consequences from MEs ranging from 2.9% to 13.0%. The main category of medications involved in MEs were cardiovascular medications (n=15); nervous system medications (n=11); and medications for the alimentary tract and metabolism (n=8).

Conclusions: Administration and prescribing errors were the most frequently reported MEs in older people. Medication classes that were most commonly reported in the context of MEs in older people were cardiovascular medications and nervous system medications. We identified polypharmacy as a risk factor for MEs, which was found to correlate with the number of MEs in many stages of medication use. A lack of studies from Asia, Latin America and Africa highlights the need of future research in these regions.

PROSPERO registration number: CRD42016042975.

Keywords: Patient safety; nursing homes; medication error; medical error, measurement/epidemiology; human error

Key points:

1. Prescribing and administration errors are the most extensively studied errors in older people.

2. The highest medication error rate reported among older people was 70.2% for transcribing error.

3. Cardiovascular and nervous system medications were the most commonly reported therapeutic classes associated with medication errors in older people. The main risk factor associated with medication errors was the number of medications taken.

INTRODUCTION

Medication errors (MEs) can be 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” [1]. MEs cause between 44,000 and 98,000 deaths each year in United States of America (USA) hospitals, leading to an economic cost of $6-29 billion for such errors [2, 3].

MEs in older people are of importance due to global ageing patterns [4]. Medication is often the easiest and most effective treatment modality, but older people are highly vulnerable to the effect and consequence of MEs due to aging-related organ functions decline, multiple co-morbidity and polypharmacy. Polypharmacy can be defined as unnecessary medication use, use of any inappropriate medication, or the use of more medications than medically indicated [5-7].

A number of systematic reviews focusing on MEs have been reported. Alsulami et al systematically reviewed ME studies in the Middle East [8], and Salmasi et al wrote a systematic review on MEs in Southeast Asia [9]. Population-specific reviews have also been done: Krzyzaniak et al [10] focused on MEs in neonates, while Ghaleb et al [11] and Miller et al [12] performed systematic reviews to study MEs in pediatrics. There has only been one systematic review that reported MEs exclusively in the older people, however that systematic review by Metsala et al was limited to MEs occurring in acute care settings [13]. The primary objective of this review was to systematically review studies on the incidence and categories of MEs in older people in any setting.

METHODS

The study protocol for this systematic review has been registered and published in the international prospective register of systematic reviews (PROSPERO) with the registration number CRD42016042975.

Search strategy

A comprehensive, electronic search was conducted for studies published before November 2017 using PubMed, EBSCOhost, OvidMedline and Proquest central databases. A secondary manual search was conducted by checking the bibliographies of included studies (refer to supporting information S1 PRISMA Checklist). Detailed steps performed during the literature search are presented using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart (Figure 1).

Search terms used:

Keywords related to “prescribing error”, “administration error”, “transcribing error”, “medication safety”, “reconciliation error”, “wrong time”, “wrong medication”, “wrong regimen”, “wrong dose”, “wrong patients”, “preparation error” as well as MeSH terms related to “patient safety”, “nursing homes”, “medication error” combined with “elderly” or “old” “older” or “geriatric” or “senior citizen” were used.

Study selection:

Original peer-reviewed research studies were eligible if they comprised MEs in people aged 55 years and older. The United Nations use 60 years as the cut-off point to define older people [14]. The World Health Organization (WHO) has however used the cutoff of 55 years to define older people in many of its projects [15]. We chose the more conservative cutoff point of 55 to ensure no relevant study was excluded. Studies focusing on MEs caused by patients themselves, such as self-medication, were excluded. Studies were only included if they were designed to assess MEs. There was no limitation imposed on the language, time of publication or the setting in which the study was carried out. Unpublished or grey literature were not included.

Studies that reported MEs as a secondary or additional outcome and those not specifically designed to assess and analyze MEs were excluded. Moreover, the prescribing of Beers medication was not considered a ME. Beers criteria classify medications with a high risk of adverse reactions that are potentially inappropriate for older people [16]. While prescribing potentially inappropriate medications is discouraged and may lead to adverse drug reactions, their prescribing is not considered a ME and their evaluation was, hence beyond the scope of our study. Two reviewers (SS and TMK) independently screened titles and abstracts, followed by full texts of relevant articles. Any disagreements were resolved through discussion.

Data extraction

Two authors (SS and LCM) independently extracted data from each included trial, using a specially designed pre-piloted data extraction form on Microsoft Excel. Any disagreement was resolved by seeking the opinion of the third author (TMK). Respective authors were contacted if any additional information (age, sample size, or number of cases reviewed) was missing.

Outcomes measured

Primary outcome: incidence and categories of MEs in older people.

Secondary outcomes: economic and clinical consequences of ME in older people, reasons behind ME in older people and medications involved in MEs.

Quality assessment

The quality of the identified studies was assessed based on 17 quality assessment criteria adopted from Alsulami et al [8] and Metsälä et al [13]. For full checklist and results of quality assessment see Table 1. Two authors (SS, LCM) critically appraised all included studies, any disagreement was discussed until consensus was reached. Two points were assigned to items that were fully satisfied, one point was given for each checklist item that was partly satisfied. No points were given for items that did not apply and one point was deducted for items that were applicable but not met. The total point received were calculated and presented in Table 1.

Studies that scored less than 12 points (satisfied at least one-third of the 17 assessment criteria; n=6 criteria) were considered poor quality, 12-23 marks were considered average quality (satisfied at least two-thirds of the 17 assessment criteria; n=12 criteria), and studies that scored more than 23 marks were considered as good quality (satisfied more than two-thirds of the 17 assessment criteria). Below are the assessment criteria:

1. Aims/objectives of the study clearly stated.

2. Study background and theoretical framework are clearly defined.

3. Definition of what constitutes an ME.

4. Error categories specified.

5. Error categories defined.

6. Presence of a clearly defined denominator.

7. The design is clearly stated.

8. Data collection method described clearly.

9. Setting in which study conducted described.

10. Sampling and calculation of sample size described.

11. Describes any efforts to address potential sources of bias.

12. Answers the research questions logically.

13. Reliability measures.

14. Measures in place to ensure that results are valid.

15. Limitations of study listed.

16. Mention of any assumptions made.

17. Ethical approval.

Data synthesis and analysis

The included studies used different methodologies, making it difficult to compare between the error outcomes. Therefore, MEs were categorized by the phases of healthcare provision in which they were reported: dispensing, prescribing, transcribing, and administration [17, 18]. A summary of the analysis of MEs is presented in supporting information S2. The following definitions were used in categorizing the MEs:

Medication administration errors: ‘‘any difference between what the patient received or was supposed to receive and what the prescriber intended in the original order” [19].

Prescribing error: error in the process of prescribing the medication that leads to (or has the potential to lead to) patient harm [9].

Transcribing error: error which is “due to data entry error that is commonly made by the human operators” [20, 21].

Reconciliation error: error occurring during an organized interview process to document a comprehensive medication history prior to a patient's admission [22].

Quantitative analysis was performed using Stats Direct software. In this report, the number of time each ME subcategory was reported is indicated using “n”. Please note that “n” does not represent the number of included articles reporting an error because certain articles reported more than one studies that assessed certain errors in different settings.

RESULTS

Study characteristics

In total, 18 studies met the inclusion criteria. The total number of participants across the 18 studies were 475,867. Included studies were published over a period of 12 years from 2004 [23] to 2016 [24]. Participants’ mean age was ≥80 years in nine studies [17, 24-31], 70-80 years in five studies [18, 32-35], and 65-70 years in three studies [19, 23, 36]. Countries of origin were the USA [25, 31, 34, 35], France [17, 18, 27], Belgium [28, 30], England [19, 37], Canada [32], Indonesia [33], Israel [36], Malaysia [23], the Netherlands [29], Spain [24], and Sweden [26]. All studies were in English except for one [17], which was in French, and translated by a professional translator. Detailed characteristics of included studies are summarized in supporting information S3.

Quality of the included studies

Table 1 summarizes the quality assessment of included studies for the 17 quality assessment criteria. For detailed explanation of the quality assessment, please refer to the methods section. Two studies [17, 26] (11.1%) were categorized as poor quality, nine [18, 19, 24, 28, 32, 34-37] (50.0%) as moderate quality and seven studies [23, 25, 27, 29-31, 33] (38.9%) as high quality. Van den Bemt et al [29] had the highest quality score (31 points), meeting 16 out of the 17 quality assessment criteria.

All studies met criteria 1 and 2 (clear objective stated and clearly defined background). However, criteria 3, 10, 11 and 16 (definition of what constitutes a ME, mention of any assumptions made, sampling and calculation of sample size described, and description of any efforts to address potential sources of bias) were poorly met. This is important for future research because without this information, comparison between studies will be not feasible.

Table 1: Quality assessment of the included studies.

Total score

van den Bemt et al, 2009 [29]

—

Verrue et al, 2010 [30]

—

Young et al, 2008 [31]

—

Beckett et al, 2012 [25]

—

Abdullah et al, 2004 [23]

—

Quelennec et al, 2013 [27]

—

Ernawati et al, 2014 [33]

—

Kelly et al, 2012 [19]

—

Moro et al, 2016 [24]

—

Cornish et al, 2005 [32]

—

Ben-Yehuda et al,2011 [36]

—

Szczepura et al, 2011 [37]

—

Raimbault et al, 2013 [18]

—

Steinman et al, 2014 [34]

—

Somers et al, 2013 [28]

—

Picone et al, 2008 [35]

—

Midlov et al, 2005 [26]

—

Cecile et al, 2009 [17]

—

**Satisfies assessment criteria

*Partly satisfies assessment criteria

- Does not satisfy assessment criteria

X Assessment criteria do not apply

Overall ME rates reported:

MEs were reported based on the phase of healthcare provision in which they were detected, which was specified in all but two studies [17, 18]. Seven studies [19, 29-31, 33, 35, 37] reported administration error rates (1.2% [37] to 59.0% [33]).

Seven studies [18, 23, 28, 33-36] evaluated prescribing error. The error frequency ranged between 1.6% [35] and 49.7% [34]. One study, however, did not report the overall prescription error rate [18].

Five studies evaluated transcribing errors. Overall, reported transcribing error rates ranged from 15.0% to 70.2% [23, 26, 33, 35, 36]. Meanwhile, four included studies reported reconciliation errors (rate ranged from 5.0% to 53.6%) [24, 25, 27, 32]. Only two studies [33, 35] evaluated dispensing errors. Dispensing errors comprise discrepancies between the medication dispensed or supplied with the medication ordered or written on the prescription [9]. The rate of this ME was reported between 2.0% and 14.0%.

Below, the reported ME rates for each ME category are summarized.

Reconciliation errors

Incorrect dose/route/frequency were the most frequently reported subcategories of reconciliation errors. “Omission” accounted for the bulk of reconciliation errors with 87.9% [27], 46.4% [32], 40.5% [25], and 35.0% [24]. The second highest rate of error incidence in this category was “incomplete prescription reconciliation” (40.0%) [24].

Administration errors

The most frequently reported subcategories of administration errors were: “wrong drug/dosage form” (n=8) [19, 30, 31, 33], “wrong time” (n=7) [19, 29-31, 33, 37], “wrong dose/route/frequency” (n=6) [19, 30, 31, 33], followed by “omission” (n=5) [19, 29-31, 33, 35]. The highest incidence of error during administration belonged to “wrong time” (72.1%) [19], “wrong technique” (73.0%) [29] and “wrong documentation” (64.0%) [33].

One documented reason for the high rate of “wrong time” errors could be that the timing on medication charts might not be practical or compatible with nursing staff shift schedules (10 pm dose to be administered, in a setting where caregivers finish working at 8pm). Therefore, a customized drug administration timing adjusted to shift rotation could facilitate administering medication at the correct time by the nursing staff [38]. Similarly, for older people residing in a care facility, omissions might happen at the time of shift rotation if staff communication is suboptimal [39]. This scenario is different among older people living with family because health literacy, intentional and non-intentional adherence to medication could influence their medication adherence [40].

Prescribing or Dispensing errors

The most frequently reported subcategories of prescribing error were: “improper administration instructions” (n=8) [18, 28, 36], “drug interaction/contraindication” (n=8) [18, 28, 33, 34, 36], “wrong dose” (n=6) [18, 28, 33, 34, 36], and “over/under prescribing” (n=5) [18, 28, 33]. The highest rate of error during prescribing was “wrong dose” reported by Ben Yehuda et al to be 49% [36] whereas the highest incidence of dispensing error was based on “labeling errors” (22.0%) [33].

Transcribing errors

“Wrong drug/dosage form” (n=3) [26, 33, 36], and “wrong patient particulars” (n=3) [26, 33, 36] were the most frequently reported transcribing error subcategories. One study did not provide a detailed list of transcribing errors except for miswriting of diagnosis which was reported to be the most frequent transcribing error, with 277 cases (73.8%) [23].

Midlov et al focused on transcribing errors that occur during a patient's transition between primary healthcare and hospital [26]. The authors found that medications were often erroneously added when patients left the hospital, because the changes decided upon by physicians in the hospital were not transcribed.

Economic consequences of MEs

One study estimated the cost of prescribing and transcribing errors among older people at an outpatient pharmacy in Malaysia[23]. The projected total drug and humanistic (labour) cost of MEs per year was estimated to be 28,022.50 USD[41]. However, because no other study estimated the associated ME costs, comparisons were not possible.

Clinical consequences of MEs

Eight studies rated the clinical consequences of MEs [19, 24, 25, 27, 29-32]. The classification systems and criteria used to categorize the clinical consequences of MEs differed substantially between studies. One study adopted the classification from the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) [24], which categorizes MEs into nine categories (A-I) according to their clinical importance [42]. Two studies [19, 32] categorized MEs as having minor, moderate and severe clinical consequences, while the remaining five studies [25, 27, 29-31] used a narrative approach to report the clinical consequences of the MEs without the use of any specific classification system.

Medications involved

Below is a summary of medications commonly involved in MEs, by therapeutic class. The percentage in the brackets represents the proportion of studies that reported the association of these therapeutic classes with MEs. A detailed list of the medications involved in MEs in older people is presented in supporting information S2.

· Cardiovascular medication [17-19, 23, 25-32, 34, 35] (83.3%).

· Nervous system medication [17-19, 24-28, 32, 34, 35] (73.3%).

· Medications for the alimentary tract and metabolism [18, 19, 24, 26-28, 33, 34](53.3%).

· Analgesics [17, 19, 29, 30, 35, 37] (33.3%).

· Anti-infectives [17, 19, 23, 28, 33, 35] (33.3%).

· Diabetic medications [17, 23, 31, 33, 35] (27.8%).

· Mineral and vitamin supplements (e.g., vitamin D, calcium and iron) [18, 24, 25, 28] (22.2%).

· Hormones [25, 29, 34] (16.7%).

Analgesics, minerals and vitamins were mainly associated with omission errors that means they were indicated but not prescribed/administered [18, 28-30]. Cardiovascular medications were mostly associated with “wrong-dose” errors [29-31, 34], specifically warfarin was reported in this context [30, 31].

Factors contributing to MEs

Medication errors are usually not a result of a failure of an individual but a symptom of system failure . In March 2017, the WHO launched its Third Global Patient Safety Challenge with the aim of reducing preventable MEs by 50% in the next five years through addressing weaknesses in healthcare systems [15]. It was therefore necessary to assess the health care system factors contributing to MEs. Healthcare system factors contributing to MEs in older people were: polypharmacy [17, 23, 24, 27, 34-36], , inappropriate administration scheduling [19, 31], understaffing [29, 35], similar packaging [30], stress and time constraints [37], lack of staff training [23], medications associated with complex tasks (crushing)[29], and interruptions during ward rounds [37].

Seven studies [17, 23, 24, 27, 34-36] found a correlation between the number of medications taken and MEs. The highest rate of MEs was found in older people who received more than nine medications (32.1%) [23, 36]. Furthermore, the odds of a ME increased by 5.0% for each additional medication the patient received [35]. When taking nine or more medications there was a significantly increased risk if a transcribing error (OR 2.58 [95% CI 1.02, 6.51]) [36].

The number of medications prescribed to an older person was the strongest and most consistent predictor of prescribing problems. The rate of each subcategory of prescribing problem was approximately 10 times higher in patients with eight or more medications than in patients with one to three medications [34]. Moreover, the number of reconciled medications was found to correlate with reconciliation errors rates (R = 0.276, p = 0.002) [24].

DISCUSSION

The Institute of Medicine, in its report on the quality of healthcare “To Err is Human”, called for a more systematic approach to preventable events such as MEs [43]. To our knowledge, this systematic review is the first to summarize studies on MEs in the older people in all settings (teaching hospital, general hospital, outpatient pharmacy, nursing home and residential care).

Overall, the range of the MEs rates reported was very wide. This is likely due to heterogeneity of the studies in terms of the setting, method of data collection and reporting.

Identified MEs were administration errors (n=7, 1.2%-59.0%), prescribing errors (n=7, 1.6%-49.7%), transcribing errors (n=5, 15.0%-70.2%), reconciliation errors (n=4, 5.0%-53.6%), dispensing errors (n=2, 2.0%-14.0%). People with polypharmacy had the highest tendency of MEs. Prescribing, and administration errors were the most extensively studied errors in older population (58.0% of the included studies). Transcribing, reconciliation, and dispensing errors were the least extensively studied errors (20.0%, 17.0% and 8.0% of the included studies, respectively).

Medication classes most frequently involved in MEs were cardiovascular medications and nervous system medications which were reported by 83.3% and 73.3% of the included studies, respectively. The high frequency of cardiovascular medications involved in MEs because these are the most commonly prescribed medications in older people since cardiovascular diseases occur at exponentially increasing rates with advancing age [44]. The second most frequently cited medication class involved in MEs was nervous system medications such as benzodiazepines. Most studies did not report the percentage of the errors each medication class was responsible for. However, five studies [26-28, 32, 35] reported that nervous system medications were associated with more MEs than any other medication class, making up 26.0% [28], 25.9% [32], 22.0% [27], and 20.2% [35] of the total errors reported, respectively. In the study by Moro et al, however, nervous system medications were responsible for 18.0% of the reported MEs, ranking second after alimentary tract medications [24]. The association of this medication class with MEs could be related to their complex dosing and administration schedules. Considering the importance of medications such as benzodiazepines in older people in the context of potentially inappropriate medications, this finding should be investigated further in the future [45].

The majority of MEs were rated to have minor or moderate clinical consequences, however, different tools were used by different studies to make this classification. None of the included studies reported any MEs with fatal consequences. With regards to monetary consequences, no conclusion could be drawn because only one study [23] calculated the costs associated with MEs.

The main risk factor for MEs was the number of medications taken [17, 23, 24, 27, 34-36]. This is important because it has been suggested that people older than 75 years will have polypharmacy (defined as five or more medications) for more than half of their remaining life [46]. In the context of our findings, this fact highlights potential benefits of medication reconciliation, especially for older people with multiple medications [38].

Strengths and Limitations

Strengths comprise the comprehensive search without limitations on language, setting or publication dates. One limitation the authors faced was that in most studies the denominator of the samples was not reported. Additionally, high data heterogeneity and different data reporting, interpretation and classification systems precluded a meta-analysis. The systematic review was further limited by differences in defining MEs and adverse drug reactions by different authors and in different countries. Furthermore, assessment of the error measurement and reporting methods were not performed in this study due to lack of standardized guidelines for error measurement.

There were no reported studies on MEs in older people in African countries, Latin America, Australia and Oceania. Medication error studies were only available in 6 European countries (the Netherlands, Sweden, Spain, Belgium, England and France), out of the 43. Similarly in Asia, MEs were only studied in three countries out of 47 countries [47].

Future research

While the variation in error measurement and reporting limited out ability to meta-analysize the data, this is an important issue that needs to be studied independently and in more depth in the future. Also, cardiovascular and nervous system medications were the most commonly associated medications with MEs in older people. Hence, these two therapeutic classes should be studied more extensively with regards to their association with MEs in older people.

Moreover, there is a lack of studies from Asia, Latin America and Africa. More studies need to be conducted in these regions due to differences in demographics, disease, medication-use patterns and healthcare systems, the results reported by developed countries may not be applicable to developing countries in Asia and Africa.

Conclusion

In conclusion, prescribing and administration errors were the most extensively studied errors in older people. Cardiovascular and nervous system medications were the most commonly reported therapeutic classes associated with MEs in older people. The review also identified ME risk factors that were characteristic to older people such as polypharmacy. This systematic review identified a lack of studies on MEs in older people, especially in the African and Asian regions. Older people are specifically susceptible to MEs, hence more attention needs to be paid to older people when evaluating MEs.

Conflict of Interest: The authors have declared that no competing interests exist.

Financial Disclosure: The authors received no specific funding for this work.

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LEGENDS

Figure 1. PRISMA diagram demonstrating the search strategy and results

S1. PRISMA Checklist. PRISMA 2009 Checklist.

S2. Summary of the main outcomes of included studies

S3. Characteristics of the included studies