A systematic review of patient medication error on self-administering medication at home.

Review

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A systematic review of patient medication error on selfadministering medication at home 1.

Introduction

2.

Method

3.

Results

4.

Discussion

5.

Conclusion

6.

Expert opinion

Jose Joaquıń Mira†, Susana Lorenzo, Mercedes Guilabert, Isabel Navarro & Virtudes Perez-Jover †

Universidad Miguel Hernańdez, Elche, Spain

Introduction: Medication errors have been analyzed as a health professionals’ responsibility (due to mistakes in prescription, preparation or dispensing). However, sometimes, patients themselves (or their caregivers) make mistakes in the administration of the medication. The epidemiology of patient medication errors (PEs) has been scarcely reviewed in spite of its impact on people, on therapeutic effectiveness and on incremental cost for the health systems. Areas covered: This study reviews and describes the methodological approaches and results of published studies on the frequency, causes and consequences of medication errors committed by patients at home. A review of research articles published between 1990 and 2014 was carried out using MEDLINE, Web-of-Knowledge, Scopus, Tripdatabase and Index Medicus. Expert opinion: The frequency of PE was situated between 19 and 59%. The elderly and the preschooler population constituted a higher number of mistakes than others. The most common were: incorrect dosage, forgetting, mixing up medications, failing to recall indications and taking out-of-date or inappropriately stored drugs. The majority of these mistakes have no negative consequences. Health literacy, information and communication and complexity of use of dispensing devices were identified as causes of PEs. Apps and other new technologies offer several opportunities for improving drug safety. Keywords: medication errors, patient participation, patient safety, physician-patient relations, self-medication Expert Opin. Drug Saf. [Early Online]

1.

Introduction

Medication error (ME) has been defined as “the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim” [1]. Patient safety studies have stressed that preventable MEs constitute a relevant health problem [2-4], since they are the principal causes of adverse events (AEs) [5,6], especially among the elderly [2,7,8]. It is generally thought that those responsible for MEs are health professionals (due to mistakes in prescription, preparation or dispensing). However, in many cases, it is the patients themselves (or their caregivers) who make mistakes in the administration of the medication, which could result in AEs. From this point of view, any preventable event that may cause or lead to inappropriate medication use (including those that harm patients and those that do not) while the medication is in the control of the patient or the consumer could be considered a medical error [9]. Whilst research on patient safety has paid a great deal of attention to MEs committed by professionals, those made by patients have aroused far less interest [10,11].

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Article highlights. .

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Medication errors (MEs) are not the sole responsibility of the physicians and pharmacists. Patients make errors too. The frequency of patients making MEs is between 19 and 59%; it is higher when the patient is dependent on a caregiver. The majority of errors have no negative consequences for patients, but in 26% of cases patients suffer harm. Incorrect dosage, mixing up medications, failing to recall indications, taking out-of-date drugs and taking inappropriately stored medicines are the most frequent sources of error. Multiple comorbidities, polymedication, inadequate interaction with caregivers, inappropriate design of dispensing devices and low health literacy are common causes of patients’ MEs in their homes. The development of apps and other new-technology tools offer new opportunities for improving drug safety. However, many questions in this field remain unanswered.

This box summarizes key points contained in the article.

In practice, the following situations may occur [12-14]: i) self-medication when a medicine was taken by the patient but not prescribed by the doctor; ii) non-adherence, whereby a medication was prescribed by the doctor but not taken by the patient, or the patient failed to follow the dosage indications or the stipulated schedule; and iii) non-persistence (ceasing to take the medication before the stipulated period has elapsed). Self-medication, voluntary non-adherence and non-persistence involve intention on the part of the patient; on the other hand, a substantial portion of non-adherence occurs involuntarily [15], often due to forgetting to take medication but in other cases due to patient error. A patient medication error at the home (PE) occurs when a medication is prescribed by the doctor but taken in incorrect doses, at the wrong time, confused with other medication because of similar appearance/name/and so on, wrongly stored so that its therapeutic effectiveness is affected and so on. MEs also occur when patients use devices inappropriately; these devices could include [16,17] glucometers, inhalers, dosing cups, oral syringes and teaspoons or dosing-spoons. MEs lead to, or have the potential to lead to, patient harm and constitute a serious threat to patient safety [18]. The causes and consequences of non-adherence (voluntarily and involuntarily) have been widely studied [19]. However, the study of the epidemiology of patient MEs has been scarcely reviewed. PEs have an impact on people (from raising doubts to actually doing harm), reduce the therapeutic effectiveness and represent an incremental cost for the health systems. Some studies have drawn attention to this source of risk [11,17-19], but so far there have been no reviews of knowledge about this topic. The aim of the 2

present study is to review and describe the methodological approaches and results of published studies on the frequency, causes, consequences and avoidance of MEs committed involuntarily by patients on self-administering medicines at home.

2.

Method

A manual and computerized review of the literature from January 1990 to November 2014 was carried out using the following electronic databases: MEDLINE, Web-of-Knowledge, Scopus, Tripdatabase and Index Medicus. This review period was defined taking into account the publication date of studies that led to the modern era of patient safety. Thus, we expected that looking at articles going back to the 1990s would reduce the probability of leaving out relevant studies. The search was confined to peer-reviewed research articles in English or Spanish. References from retrieved articles were searched to locate further studies. The PRISMA guideline [20] was used to report items. Inclusion criteria were studies that focused on empirical, review or assessment work in relation to errors made by patients in their homes. We included studies on types of errors on taking medication prescribed by a doctor or as the result of self-medication, factors that brought them about and their consequences. Keywords used for the review included a combination of the term ‘patient error’ with the following Medical Subject Headings terms: patient safety; medication errors; wrong doses; misuses medication; misuses drugs; adverse events; non-voluntary non-adherence; selfmedication; and over-the-counter medication. Studies on the frequency and causes of voluntary non-adherence were excluded, although we did consider those studies on involuntary non-adherence that contributed data on AEs due to forgetting one’s medication or failing to follow correctly the therapeutic regimen (incorrect dosage, wrong timing). Studies on self-medication when not related to the occurrence of patient harm according to the classification of errors by Buetow et al. [21] were not included in this review. Studies on patients acting as vigilant partners in safety (second control) thereby helping professionals avoid AEs or on the use of medicines for suicide attempts (successful or otherwise) were also excluded. The studies were reviewed to decide whether they fulfilled the inclusion criteria by two independent reviewers (JJM, MG), using the titles, abstracts or full article. The final decision was made jointly by the two reviewers. Additional articles were retrieved from the reference lists of the articles found through the initial online search. From the articles selected, the following information was categorized: methodology employed, number and profiles of participating patients, frequency of PEs found, and typology, causes and consequences of those errors made by patients in their homes.

Expert Opin. Drug Saf. (2015) 14(5)

A systematic review of patient medication error on self-administering medication at home

Records identified through database searching (n = 4748)

Additional records identified through other sources (n = 22)


Records after duplicates removed (n = 2949)

Records screened (n = 1821)

Records excluded (n = 1571)

Full-text articles assessed for eligibility (n = 250)

Full-text articles excluded, with reasons (n = 182)

Studies included in qualitative synthesis (n = 68)

Studies included in quantitative synthesis (meta-analysis) (n = 0)

Figure 1. PRISMA flow chart.

3.

Results

The search identified 250 papers of potential relevance (Figure 1). After screening, 66 studies were considered eligible for inclusion in this review. Additionally, three studies [12,22,23] from outside the designated period were included because they represented the bases of subsequent studies. In total, 69 studies that explored the taxonomy, frequency, causes and consequences of PEs in the administration of medication and alternatives to avoid errors at home were considered [11,12,17,21-84]. Of these, 6 were published in Spanish. A total of 22 studies were identified as relevant for this review. The screening strategies permitted the identification of studies covering relevant issues for several patient profiles, types of medication, therapeutic regimens and interventions for reducing mistakes. The selected studies provided sufficient information for the categories of information defined to reflect the current state of this issue. The first study reviewed was published in 1962. In this pioneering study recovered from reading other articles, Schwartz et al. [12] defined a PE as a involving a medicine

that was: i) taken by the patient but not ordered by the doctor; ii) ordered by the doctor but not taken by the patient; and iii) ordered by the doctor but taken in incorrect doses, at the wrong time or with total lack of understanding of its purpose. Patients who erred at all were more likely to make multiple mistakes than single mistakes. On asking 178 patients, they found an average of 2.6 errors per error-making patient. Since 1990, 9 articles reviewing the PE research lines and results, and 23 describing the epidemiology of PE in specific samples of patients, usually diabetics, asthmatics and chronic obstructive pulmonary disease (COPD) or cardiovascular patients, have been published. The majority of published works were from 2005 onwards, from which time we find an increase in the number of studies carried out on this topic (narrative reviews 12/22 [54.5%] and studies for determining the frequency of PE 8/10 [80%]). Five studies [10,11,17,21,26] presented in overall fashion the problem of PE, and 3 reviewed the frequency with which a particular patient profile committed PEs (with inhalers [24,51] or on calculating their insulin dose [41]). One qualitative study presented a preliminary taxonomy of patients’ errors [21], while another set out to


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Table 1. Literature review. The problem of patients medication error at home or at work. Authors

Year Participants

Principal results

Conclusions

Schwartz et al.

1962 178 patients

269 PEs, 108 with more serious consequences were identified Forgetting (25%) and self-medication (16%) were the causes of the most severe complications Those who erred at all were more likely to make multiple mistakes than single mistakes. Average number 2.6 errors per error-making patient 36 articles were published. Samples sizes ranged from 41 to 11,891 patients The prevalence of reported admissions resulting from ADRs ranged from 0.2 to 21.7% 22.7% of ADR hospitalizations were induced by noncompliance in 11 reports A quarter of all insulin-dependent patients commit serious dosage errors

It is possible to identify the common and uncommon kinds of errors patients make Health professionals can cooperate by being alert to them and by instituting preventive measures Labeling of drugs, teaching and more imaginative use of visual aids are useful to avoid errors Drug-induced hospitalizations for all causes account for approximately 5% of all admissions


[12]

Einarson [26]

1993 Review (1966 -- 1989) of studies on hospitalization due to adverse drug reactions

Grissinger and Lease [41]

2003 Review of studies on errors with insulin that includes description of typical PEs

Fink and Rubin [24]

Buetow and Elwyn [50]

Rau [51]

Lau [17]

Buetow et al. [21]

The complexity of vial and syringe self-administration increases MEs The complexities associated with the use of conventional syringes increase MEs 2005 How patients are using 28 -- 68% of patients do not use metered- Patient education is a critical factor inhalers and caregivers are dose inhalers or powder inhalers well in the use and misuse of describing how they use enough to benefit from the prescribed medication inhalers medication 39 -- 67% of nurses, doctors and respiratory therapists are unable to adequately describe or perform critical steps for using inhalers In USA, 5 -- 7 billion dollars is wasted annually because of inhaler misuse 2006 Seeking a response to the Clinical providers can only be responsible Patients appear to be morally question “Are patients to, but not for, patients. In turn, patients responsible for the avoidable errors morally responsible for their have a responsibility to their clinical they make, contribute to or can errors?” providers to meet the requirements of influence their patient role Recognition that patients may be morally responsible for the errors they make contributes to managing clinical risks to patients in health care 2006 Review of studies on the 32 -- 96% of patients commit errors in the PEs associated with the appropriate use of aerosols by patients use of aerosols dosing device. High incidence of with COPD PEs on using aerosols 2008 Review of perspectives on Range of patients errors from 12 to 51%, The problem of MEs will require patients’ self-management mainly in association with incorrect dosing system-wide efforts to create and Consumer’s initiation of medications, sustain safety culture and change in particularly with respect to over-thepractice counter and complementary and alternative medicines, need more attention 2009 8 Nominal Groups with Taxonomy of 70 potential types of errors Almost all the taxonomies of patients (64) and 3 with classifying them in 8 categories and medical error fail to discuss caregivers (19) 2 main groups: action errors and mental patients’ contribution to error errors Research is needed to understand how patients, clinicians and systems interact to co-create and reduce errors

ADRs: Adverse drug reactions; COPD: Chronic obstructive pulmonary disease; ME: Medication errors; PE: Patient medication error.

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Table 1. Literature review. The problem of patients medication error at home or at work (continued). Authors

Year Participants

Principal results

Conclusions

Britten [10]

2009 Review of studies on causes of MEs that examines studies on errors made by patients 2011 Review of studies on patients for patient safety

Frequency of PEs of around 59%; 26% with more serious consequences

Patients frequently make MEs, and the risk is greater in elderly patients This risk increased linearly with the number of medications taken Patients also make mistakes in the course of treatment. This fact cannot be rejected The identification of all these sources of patients’ error contributes to patient safety


Mira [11]

There is scarcely any literature on MEs made by patients Most frequent PEs: forgetting, confusion or incorrect administration of medication, and mistakes on recalling the indications of doctors and/or nurses Diabetics’ mistakes: hypoglycemia by mistake of medication or food and misunderstandings when taking the medication. Communication failures are at the base of an important part of the patients’ errors These failures can be stopped easily by involving patients

ADRs: Adverse drug reactions; COPD: Chronic obstructive pulmonary disease; ME: Medication errors; PE: Patient medication error.

answer the question of whether patients are morally responsible for their errors [50], considering the role of health care providers in them (Table 1). MEs in the case of children depend of the accuracy of their parents’ or caregivers’ dispensation. In 1987, Gribetz and Crunley [22] published their work showing the frequency of dosage errors by children’s caregivers on calculating the milligram per kilogram per dose; in this case, 26% of cases resulted in significant underdosing of acetaminophen. Two years later, Delamater et al. [23] highlighted the most common errors in self-monitoring of blood glucose among adolescents (not cleaning fingers, not placing strips correctly or wiping the strip at the wrong time). Children’s caregivers’ errors were among the first types of PE to be studied. From 1990 onwards, 11 articles were published showing the inaccuracy of doses given, the potential injuries, and the frequency of over-the-counter medication and errors related to it. Neuspidel and Taylor [74], in 2013, reviewed the research on the most common children’s caregivers’ MEs, which included communication gaps between parents, inaccurate use of support tools for home medication and failure to comply with prescriptions (e.g., giving children their medication the wrong number of times per day). It also showed that 80% of pediatricians were unaware of such errors. Rickenbach and Julious [29] published the first study with the target of reducing the number of errors in the use inhalers in 1994. They described a method to identify the extent of inhaler fullness. However, the majority of studies screened were published from 2010 onwards (12/19, 63%). Methodological approaches of studies on PEs The methods employed in the empirical studies were classified into three categories: i) retrospective studies of point3.1

prevalence or period-prevalence of PEs carried out using the patient’s clinical records, databases on adverse reactions or data on medication intoxication, which, in some cases, included checking or complementing the information through patient interviews, studies involving semi-structured or structured interviews or surveys with samples of adult patients (Table 2) [25,28,35,37-40,42,45-49,52-55,60,65,69,71,77]; and with samples of parents’ or caregivers’ children (Table 3) [22,23,27,30,32,33,36,43,63,66,68,75]; ii) studies based on adverse reactions to drugs registered in the databases of Poison Centers (Table 4) [58,64,80]; and iii) studies on intervention for reducing the number of errors (Table 5) [29,31,34,44,57-59,61,62,67,70,72,75,78,79,81-84]. Pre-schoolers, diabetics, patients that use inhalers and the elderly are the most commonly studied groups. Not all studies include a denominator, so that it is not always possible to estimate the percentage of patients that make MEs. Also, there is substantial variability in the sample sizes, though many studies deal with large samples [27,39,40,45,48,54,55,69]. Among the intervention studies, only 5/18 (28%) used a control group to compare outcomes [34,59,70,75,79].

Frequency of PEs The number of adults patients who make at least one ME in their homes is situated, according to the research, between 12 and 59% [10,17,39,69] increasing to 75% among the elderly with a complex therapeutic regimen (suffering two or more illness and using daily more than five different medicines per day) [25,42,71]. However, Raehl et al. [37], in a crosssectional study with 57 elderly patients using 325 agents, found 94% of correct dosage, 97% correct coingestion with food or water and 89% correct regimen, although cognitive 3.2


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Table 2. Literature review. Retrospective studies of frequency of patients medication errors at home or at work. Authors

Year Participants

Al Mahdy and Seymour [25]

1990 261 patients aged 61 -- 97

Drug errors are particularly likely to occur when more than three drugs are prescribed Elderly need written material that gives details in lay language about drug actions and possible sideeffects

Kabadi et al.

1994

Clinically acceptable user proficiency in capillary blood glucose testing can be maintained in most subjects


[28]

Hesselink et al.

2001

[35]

Alto et al. [38]

2002

Raehl et al. [37]

2002

Molimard et al.

2003

[40]

Principal results

Only 10% of patients could name all their medications correctly 70% committed some type of ME 64% made some dosage error The older the patients, the poorer their cognitive state and the more the medicines they were taking, the more the errors made 40 patients 30 subjects consistently obtained clinically acceptable measures using capillary blood glucose readings or improved over time 9 subjects showed deterioration 1 subject failed 558 asthma and COPD patients 24.2% of the patients made at least one essential mistake in their inhalation technique Type of inhaler related to an incorrect inhalation technique Patients using the Rotahaler/ Spinhaler, Turbuhaler, MDI or Cyclohaler/Inhaler-Ingelheim were at significantly higher risk of making inhalation mistakes (OR 16.08, 13.17, 11.60 and 3.27, respectively) 111 patients with type 1 and 53% percent of patient glucose type 2 adult diabetes values were within 10% of the control value 84% were within 20% of the control value 16% varied 20% or more from the control value 1.8% had dangerously inaccurate glucose determinations 0.9% made no errors in testing 57 elderly patients using 94% (306) reported correct dosage 325 agents 95% (309) correct indication for 97% (314) correct coingestion with food or water 89% (288) correct regimen Most frequent problem was underdosing of cardiovascular drugs Mini-Mental State Examination was related to errors 3811 patients treated for at 76% of patients made at least one least 1 month with an error with MDI compared to inhalation device 49 -- 55% with breath-actuated inhalers Errors compromising treatment efficacy were made by 11 -- 12% of patients treated with Aerolizer, Autohaler or Diskus compared to 28% and 32% of patients treated with MDI and Turbuhaler, respectively Overestimation of good inhalation by general practitioners was maximal for Turbuhaler (24%), and lowest for Autohaler and MDI (6%)

Conclusions

An incorrect inhalation technique is common among pulmonary disease patients in primary care

Despite multiple technical errors when self-monitoring blood glucose, most patients obtained clinically useful values

Seniors’ ability to take oral prescription drugs safely was affected by cognitive function and socioeconomic status

There are differences in the handling of inhaler devices in real life in primary care that are not taken into account in controlled studies There is a need for continued education of prescribers and users in the proper use of these devices to improve treatment efficacy

AEs: Adverse events; COPD: Chronic obstructive pulmonary disease; MDI: Metered dose inhaler; ME: Medication error; OR: Odds ratio; PEs: Patient errors.

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Table 2. Literature review. Retrospective studies of frequency of patients medication errors at home or at work (continued). Authors

Year Participants

Principal results

Conclusions

Gurwitz et al.

2003 27,617 patients 12-month study period

1523 identified adverse drug events, of which 27.6% (421) were considered preventable (PEAs) Errors associated with PEAs occurred most often at the stages of prescribing (58.4%) and monitoring (60.8%) Errors involving patient adherence (21.1%) were also common Examples of identified PEs include taking the wrong dose, continuing to take medication despite instructions by the physician to discontinue drug therapy, refusal to take a needed medication, continuing to take a medication despite recognized adverse effects or drug interactions known to the patient and taking another person’s medication 24% of patients used pressurized MDIs poorly Failure to correctly perform essential steps for reliable lung delivery with the Aerolizer Inhaler, Turbuhaler and Diskus was found in 17, 23 and 24% of patients, respectively In the under-65s, just 10% of those who were prescribed 9 drugs said they took all of them correctly. 75% of those who took 2 drugs said they took them correctly In those aged over 65, 10% of those taking 9 drugs and 20% of those taking 8 said they took them all correctly. This figure rose to 75% when only one drug was taken Using the ’shaking method’, patients overestimated the amount remaining by around 40 doses

Adverse drug events are common and often preventable among older persons in the ambulatory clinical setting Interventions focused on improving patient adherence with prescribed regimens and monitoring of prescribed medications may also be beneficial


[39]

Melani et al. [45] 2004 1056 patients were using pressurized metered-dose inhalers, 230 Aerolizer Inhaler, 524 Turbuhaler, 475 Diskus

Leal et al. [42]

2004 212 patients aged under 65 and 228 over-65s

Holt et al. [47]

2005 117 patients

Sorensen et al.

2005 204 polymedicated patients (10 drug on average) aged 72

[46]

51 (25%) with AEs in the 3 months prior to the study 56 (27.5%) fail to administer the correct dosage 43 (21.1%) store medicines for subsequent use without indication from a doctor 32 (11%) take a dose higher than that prescribed by the doctor 40 (19.6%) take out-of-date medicines 17 (8.3%) fail to store medicines appropriately

The use of inhaler is associated with a similar percentage of inadequate inhalation technique

More PEs among polymedicated patients

Patients are unable to determine when an MDI should be discarded, resulting in insufficient drug delivery at the end of the life of an inhaler for the majority of patients, and wastage of the drug for others Polymedication is a risk for patient safety When AEs occur, the probability of the patient presenting poorer heath status increases 3.5 times When medicines are not stored correctly, the health risk of using medication increases 4.2 times



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Table 2. Literature review. Retrospective studies of frequency of patients medication errors at home or at work (continued).


Authors

Year Participants

Principal results

Conclusions

Metlay et al. [48] 2005 4955 patients

A substantial proportion of older adults on high-risk medications do not recall receiving instructions for the use of their medications and do not take advantage of existing systems for organizing medication regimens

Sander et al.

Patients do not have a reliable means of monitoring the contents of their metered-dose inhalers, which is causing serious problems that need to be addressed It is important to periodically instruct type 2 diabetic patients in the proper self-monitoring of blood glucose technique

2006

[52]

Mu¨ller et al. [53] 2006

Sestini et al. [54] 2006

Fernańdez et al.

2006

[49]

Field et al. [55]

2007

32% reported that they had not received any specific instructions about their medications Only a minority of patients reported that they were given instructions on what foods to avoid with medications, what drugs to avoid with medications and what to do if they missed a dose 54% indicated that they used a pillbox for organizing their medications 500 patients using metered87 (25%) of the 342 respondents dose inhalers who named a bronchodilator reported having found their MDIs empty during an asthma exacerbation 462 randomly selected patients During the pretest, 383 patients with type 2 diabetes (83%) made at least one mistake performing self-monitoring of blood glucose In the second observation, the average number of mistakes fell from 3.1 to 0.8 per patient 1305 patients suffering from Inhaler misuse was common and asthma or COPD using inhalers similar for both pressurized MDIs and dry powder inhalers For both types of inhalers, misuse was significantly and equally associated with increased age, less education and less instruction by health care personnel 73 patients with a mean age of Administration errors 16 (29%), 79 years forgetting 13 (24%), incorrect dose 7 (13%) PEs were more frequent in the case of inhalers 30,000 patients studied over 188 patient safety incidents were the course of a year identified In 59 cases there was no participation of the patient Patients were responsible for 99 AEs and 30 potential AEs Drug categories associated with > 10 events were hypoglycemic, cardiovascular drugs, anticoagulants, diuretics and nonopioid analgesics The majority of errors occurred in administering the medication (31.8%), following clinical advice (21.7%) or modifying the regimen when advised to do so (41.9%) OR for three -- four medications was 2.0, for five -- six medications was 3.1 and for seven or more medications was 3.3 The strongest association was with

Many doctors are not familiar with the relevant characteristics of currently available inhalers The prescription of dry powder inhalers may be subjected to gender, socio-economic and instruction bias

Polymedicated seniors with high numbers of MEs The most prevalent error was incorrect administration, especially in the case of inhaled drugs The PEs leading to AEs most often occurred in administering the drug, modifying the medication regimen and failing to follow clinical advice about medication use The most common underlying reasons for errors were related to the demands that complex medication regimens and changes in those regimens placed on patients and the presence of dementia, confusion and sensory problems Patients with MEs did not differ from other older adults in age or sex but were taking more regularly scheduled medications and had more chronic conditions


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Year Participants


Sarkar et al. [60] 2010

Lefkowitz [65]

2011

Mira et al. [69]

2012

Lenahan et al.

2013

[73]

Mira et al. [71]

2013

Principal results

the Charlson Comorbidity Index; OR for a score of 3 -- 4 was 8.6, and for a score of 5 or more was 15.0 111 diabetics 264 patient safety incidents and 9 months of observation 111 AEs 66 (59%) AEs were related to medication and 23 (21%) to diet errors Patients were responsible for 205 (77%) incidents 400 diabetics comparing their The majority of the participants ability to differentiate between correctly identified the insulin/pen to long- and short-acting insulinbe used in a specific scenario containing prefilled pens 97.3% of the responses for the differentiated SoloSTAR were correct, compared with 83.7% for FlexPen and 79.3% for undifferentiated SoloSTAR, which translates to error percentages of 2.7, 16.3 and 20.7%, respectively (p < 0.05 for differentiated SoloSTAR vs FlexPen and undifferentiated SoloSTAR) 1247 primary care patients 241 (19.4%) reported having made some ME 136 (11%) forgot to take the medication, and 73 (6%) confused the pills because of their appearance 151 patients (12.1%) three errors were detected, in 37 (3%) two were detected, and in 53 (4.3%) just one was detected 215 hypertensive patients (68% 25.4% missed doses in past week females) 60% of patients were able to identify all of their hypertension medications by name. These were less likely to have limited literacy (37.7%) than those who identified medications by appearance (67.3%) 21% of patients had medication changes that occurred in the past month. This, however, was not significantly associated with one’s ability to identify their medicine 382 patients aged over 65 MEs in the past year was reported by 287 patients (75%), and 16 patients (4%) reported four or more errors Most cases concerned the dosage, a similar appearance of the medication or a lack of understanding of the physician’s instructions Very severe consequences occurred in 19 cases (5%). Multiple comorbidities and a greater number of treatments were associated with making mistakes Frequent changes in prescription,

Conclusions

Lower health literacy predicted more AEs Patients showing poorer communication with doctor and difficulties with self-care presented more AEs This study suggests that the full pen body color used on SoloSTAR pens enhances the patients’ ability to differentiate between the long- and short-acting insulin compared with the standard approach of differing colors for label and injection button

Patients dissatisfied with the information provided by the doctor reported more errors Chronic patients need know how to avoid the forgetting, confusion and mistakes that frequently occur with the medication once at home

Patients had considerable difficulty recalling their medications by name, and we found that the ability to properly name medications was associated with health literacy Patients need understand their medications

Mistakes by polymedicated patients with multiple comorbidities represent a real risk that should be addressed by the professionals



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Mira et al. [77]

Year Participants

Principal results

2014 199 diabetic and renal patients and 60 caregivers

not considering the prescriptions of other physicians, inconsistency in the messages, being treated by various different physicians at the same time, a feeling of not being listened to or loss of trust in the physician were associated with making medication mistakes 59 (29.5%) and 42 (70%) of the 60 professionals considered that patients frequently made errors that affected the success of their treatment There were no differences in the frequency of the reported errors based on gender, educational level or marital status The most commonly reported errors were taking the wrong medication (n = 70; 35%) and mixing up medicines (n = 15; 7.5%) Diabetics who had not been adequately informed, compared to renal patients, reported a higher number of errors

Conclusions

PEs were frequent because of communication failures and confusion Diabetic patients had a higher chance of committing an error than renal patients


function (Mini-Mental State Examination) was related to errors. A total of 23% of adverse-drug-reactions have been attributed to patient error [26] (normally due to taking the wrong dose, continuing the medication when it is no longer indicated, taking the wrong drug by mistake, etc.). MEs tend to be concentrated in certain types of patient [12,53]. Of patients over 65, 4% committed four or more errors over the course of a year [71]. Patients who commit a dosage error, who confuse one pill with another and so on tend to accumulate various errors within a short space of time. Patients with asthma, COPD or diabetes tend to make more errors due to the use of devices (glucometers, inhalers or aerosols) for controlling the process or administering the medication. In the opinion of patients themselves and of health professionals, PEs were common among diabetic patients [77]. Between 16 and 84% of diabetics make errors using glucometers, leading to wrong insulin doses [38,53]. In Spain, 36% of patients with diabetes admitted to having committed four or more MEs in the previous year [77]. Between 24 and 32% [35,45] of asthmatics or COPD patients use inhalers incorrectly (and up to 75% in the case of some models [24,40]) or have problems knowing when their dose is finished or take the wrong dose. In some cases, this figure can be as high as 96% [51]. The most widely studied ME made by children’s parents or caregivers is over- or underdosing, with between 53 and 67% 10

of wrong doses according to the research [22,30,43,66,68,74,75]. It is estimated that among adolescent diabetics, 18% fail to use the glucometer correctly [23], although the figure may actually be higher [32].

Types of PEs PEs have been categorized as [21]: errors requiring some action on the part of the patient (e.g., taking the wrong dose, taking a drug intended for someone else or for a pet) and errors arising from lacking the correct information, misinterpreting the instructions or forgetting the doctor’s/pharmacist’s indications. The most common PEs are: incorrect dosage [17,25,27,30,33,39,41,43,46,49,63,66,68,71], taking the wrong medication [77], mixing up medications or foods [48,60], not wearing gloves when handling agents with risk of toxicity [75], failing to correctly recall the doctor’s indications [11,71,77], taking out-of-date drugs [39], misuse of inhalers [24,45,47,52,54] or taking medicines that have been inappropriately stored [46,71]. It is very common for parents to give medicines to their children without consulting a pediatrician [27,36]. It has been found that 70% of pre-schoolers are medicated by their parents or caregivers (anti-pyretics and non-opioid analgesics, anti-bacterials, and cough and cold preparations were the medicines most widely used in this manner) without a pediatrician’s advice [27,36,64,74,80]. 3.3



Table 3. Literature review. Retrospective studies of frequency of caregivers’ medication errors. Authors

Year Participants

Principal results

Conclusions

Gribetz and Crunley [22]

1987 Parents of 96 young children

Underdosing was most commonly noted in the younger, lighter patient population Health care professionals should specifically inquire about the details of acetaminophen administration when discussing antipyresis with parents

Delamater et al.

1989 58 adolescents

92% administered acetaminophen, and of these, 67% gave less than the usual recommended dose of 10 -- 15 mg/kg per dose In the case of an elixir preparation 26% resulting in significant underdosing of acetaminophen (2.3 ± 1.3 mg/kg per dose) 82% obtained an accuracy measure using self-monitoring of blood glucose Frequent errors were not cleaning fingers (45%), not placing blood on strips correctly (21%), and wiping strip at wrong time (14%) 53.7% of 3-year-old children were given a drug by their parents without prescription from a pediatrician in the 30 days prior to the study The most common were paracetamol (Tylenol) (66.7%) and other medicines for coughs or colds (66.7%) 34% of the parents did not remember their child’s weight 60% calculated the wrong doses 33% could not accuracy measure the amount Accurate performance of individual skills ranged between 14.6 and 99.6%


[23]

Kogan et al. [27] 1994 8145 mothers of pediatric patients

Simon and Weinkle [30]

1997 100 caregivers of children

Perwien et al.

2000 266 youth with diabetes

[32]

Madlon-Kay and 2000 130 patients volunteers Mosch [33]

Birchley et al. [36]

2002 25 parents of pediatric patients

Goldman and Scolnik [43]

2004 213 caregivers of children

Yin et al. [63]

2010 302 parents of pediatric patients

75% for measure liquid medication used teaspoon 92% parents measured the correct dose when using the oral dosing syringe Common errors included misinterpreting instructions, confusing teaspoons and tablespoons on a medicine cup and misreading a dosage chart when weight and age were discordant Participants commonly misinterpreted this instruction as meaning every 6 h while awake, and indicated three rather than four doses The majority of parents buy medicines for their children on their own initiative, without prescription from a pediatrician

Periodic evaluation and retraining are required for maintenance of selfmonitoring of blood glucose skills

Parents frequently give non-prescription medicines to their children, without being fully conscious of the risks

Caregivers need better education about giving their child over-the-counter medication

Younger children, children using a new blood glucose testing meter and children suspected of having hypoglycemia should be supervised and observed when testing Oral dosing devices such as oral dosing syringes, oral droppers, cylindrical spoons and medication cups are preferred over the traditional household teaspoon or measuring spoon, because they are more accurate

The non-prescription medication most commonly bought by parents is paracetamol The majority is unaware of the risks of the non-prescription medicines they buy A significant portion of our population gives an underdose of acetaminophen, reflecting lack of knowledge or misuse

47% gave acetaminophen in the recommended dose, 12% gave an overdose and 41% gave an underdose of acetaminophen 30.5% of parents dosing accurately Dosing errors by parents were highly (within 20% of the recommended dose) prevalent with cups compared with were using the cup with printed markings droppers, spoons or syringes and 50.2% using the cup with etched markings More than 85% dosed accurately with droppers or syringes Cups were associated with increase (OR

OR: Odds ratio. Expert Opin. Drug Saf. (2015) 14(5)

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Table 3. Literature review. Retrospective studies of frequency of caregivers’ medication errors (continued).


Authors

Year Participants

Walsh et al. [66]

2011

Ryu et al. [68]

2012

Neuspiel and Taylor [74]

2013

Walsh et al. [75]. 2013

Principal results

26.7) of making a dosing error (20% deviation) compared with the oral syringe Compared with the oral syringe, cups were also associated with increase (OR 7.3) of making large dosing errors Limited health literacy was associated with making a dosing error (OR 1.7) 52 homes 61 medication errors, including 31 with a Authors reviewed potential to injure the child and 9 that did 280 medications injure the child Injuries often occurred when parents failed to fill prescriptions or to change doses due to communication problems, leading to further testing or continued pain, inflammation, seizures, vitamin deficiencies or other injuries Errors not previously reported in the literature included communication failures between two parents at home leading to administration errors and difficulty preparing the medication for administration 300 patients of 34 subjects (11.3%) had dose errors caregivers using greater than 10% (5 ml target) liquid medications 6 (2.0%) had a variance of > 20% Dose errors greater than 10% of the target volume were more common for the etched dosing cup (47.1%, n = 8), the dosing spoon (50.0%, n = 5) and the printed dosing cup (30.8%, n = 4), but these three devices were used by only 13.3% of the study participants Review of studies Frequent error sources included parents medication errors in failing to fill prescriptions or to change children doses due to communication barriers Communication failures between two parents occurred in some cases, with subsequent administration errors and difficulty in medication preparation for administration When parents used support tools for home medication use (e.g., alarms or reminders), error rates were significantly less than among parents not using such tools (44 vs 95%, respectively) The patients’ physicians were unaware of 80% of the errors detected Observed 242 medica- 72 medication errors, including 4 that tion administrations resulted in injury and 40 with potential in the homes of for injury 92 patients 47 parents were observed administering chemotherapy, only 5 wore gloves when handling these agents to avoid toxicity 63.5% of errors during drug administration Parent administration errors were often caused by miscommunication between parents and clinicians or between in-home caregivers regarding changes in oral chemotherapy dose

OR: Odds ratio.

12


Conclusions

Caregivers’ errors were common among children with sickle cell disease and seizure disorders

Dose errors were more common with the etched dosing cup, the dosing spoon, and the printed dosing cup

Since home medication administration is of such great magnitude in pediatrics, involvement of parents and other child caregivers will be critical to reduce the harmful impact of medication errors to children

The rate of injuries due to error (3.6/ 100 patients) was high Nonchemotherapy medications were more often involved in an error than chemotherapy medications



Table 4. Literature review. Patient medication errors data from Poisons Information Centres. Authors

Year Participants

Principal results

Conclusions

Shah and Barker [58]

2008 A 6-year analysis of the National Poison Data System in USA

The majority of OHMEs reported did not result in any significant morbidity or mortality and were managed at home without need for health care referral

Cassidy et al.

2011 MEs reported to the National Poisons Information Centre of Ireland

1,166,116 outcomes of OHME occurring at home, school or work 353,664 (30.3%) occurred in children under 6 years of age 88,451 (7.5%) received medical evaluation by a health care provider 229 (0.01%) deaths were reported The five leading drug categories were analgesics, cough/cold medications, cardiovascular agents, antihistamines and antimicrobials Most common error reported in both children and adults was taking or giving medication twice, followed by other incorrect dose Enquiries about MEs were reported for 736 patients (31.3% over 3 years) In children, MEs with non-prescription pharmaceuticals predominated (n = 722) and anti-pyretics and non-opioid analgesics, anti-bacterials, and cough and cold preparations were the main pharmaceutical classes involved 2297 (97%) MEs were as a result of drug administration errors (comprising a double dose [n = 1040], wrong dose [n = 395], wrong medication [n = 597], wrong route [n = 133], and wrong time [n = 110]) 1381 consecutive errors reviewed, 97.8% involved a single incident and 88.3% one drug MEs were significantly more frequent at night (60.5%) Children younger than 6 years (58.9%), parents responsible for 55.6% of cases, wrong dose 34.5% and different medication 30.1% Analgesics (27.4%) and antimicrobials (12.2%) were the most common pharmaceuticals Reasons for the errors were look-alike packaging (31.4%) and misunderstood instructions (28%) Most followed-up patients (97.1%) were asymptomatic or mildly affected; there was one severe case and no mortality

[64]

Lavon et al. [80]

2014 MEs outside health care facilities attended in a National Poison Centre In Israel 5-month period

Collaboration among pharmaceutical manufacturers, consumers, medical and regulatory communities is needed to advance patient safety and reduce MEs

Errors occurring outside health care facilities as reported to a National Poison Centre include young children, parents’ responsibility, misunderstood instructions, night-time, single incident, one medication, oral route, liquid formulation, analgesics or antibiotics, wrong dose or medication, and an asymptomatic or mild clinical outcome. Improved packaging, labeling and patient education are recommended

ME: Medication errors; OHME: Out-of-hospital medication errors.

Consequences of PEs The majority of errors have no negative consequences for patients [37,58], but some can have severe consequences [26,55,58,60,71,75] -- indeed, in an estimated 26% of cases [10]. Prevalence of PEs causing harm has been calculated at around 4/1,000 [55]. The inappropriate use of analgesics, cough/cold medications, cardiovascular agents, insulin, antihistamines and antimicrobials lead to maximum AEs [58,64]. 3.4

Causes of PEs The intrinsic causal factors most widely studied are related to patients’ profile and level of health literacy. Extrinsic causal factors for PEs are related to quality of the information provided and communication with caregivers and complexity of use dispensing devices. Very often, parents are unaware of the risks, interactions or appropriate dosages. They wrongly calculate dosage, have 3.5


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Table 5. Literature review. Interventions to reduce MEs made by patients. Authors

Year Participants

Rickenbach and Julious [29]

1994 98 patients using inhalers

Health workers should ask if the patient has difficulty assessing aerosol inhaler fullness and, providing it is recommended by the aerosol inhaler manufacturers, offer to describe the floatation assessment method

Bergenstal et al.

2000

Further effort is needed to establish standards for evaluating self-monitoring of blood glucose

[31]

Epstein et al.

2001

[34]

Frush et al. [44]

2004

Basheti et al.

2007

[58]

Sobhani et al. [57]

2008

Principal results

33 participants (34%) stated they had difficulty assessing inhaler fullness 83% feeling the contents move while shaking the inhaler to assess fullness 28 underestimated fullness by > 15%; 8 participants (15%) underestimated fullness by > 50% The inhaler canisters floated in four positions indicating different levels of fullness The ranges of inhaler fullness for each position were statistically different. This was irrespective of inhaler type for the 12 proprietary brands studied 280 patients with type 1 and 19% had blood glucose test results type 2 diabetes greater than the 15% limit for meter accuracy After reeducation, 69% of those who had initially failed achieved acceptable results 105 patients using conventional Fewer than 50% of patients in pressurized aerosol inhalers divided both groups demonstrated optimal in trained (n = 43) and control breath-holding when using the (n = 62) device There was no significant difference between the formally trained groups and control groups in the percentage of handling steps performed correctly (79 vs 78%, respectively) 101 caregivers of children Introducing a simple method of dosing over-the-counter medication in a home setting using a color-coding concept was useful to reduce the deviation from recommended dosage 97 asthmatic patients who At entry, correct inhaler technique completed the study implementing was displayed by 7% of Inhaler technique education Turbuhaler users and 13% of Diskus users At 3 months, the correct technique was demonstrated by 85% of active Turbuhaler users and 96% of active Diskus users Improvements in Turbuhaler and Diskus inhaler technique were reflected in improved clinical outcomes 96 Individuals at least 18 years of An acceptable dose was defined as age 5.0 ± 0.5 ml Subject were asked to measure a 64 (67%) subjects measured an 5 ml (1 teaspoon) dose of Tylenol acceptable dose using the syringe; (acetaminophen) suspension, using 14 (14.6%) using the cup the EZY Dose oral syringe and the A majority of subjects believed that dosing cup provided by the the syringe (80%) and cup (71%) manufacturer would measure an accurate dose

Conclusions

Patient handling of Turbuhaler was generally good, with no evidence that a structured education intervention offered an advantage over the usual education incidental to the prescribing or dispensing process

A color-coded method compared with conventional methods improves the caregivers’ ability to correctly determine and measure an over-the-counter medication for their child A pharmacist patient interaction about inhaled medications is crucial Improved inhaler technique will have an effect on asthma control and health care use

Droppers and dosing cups were the most commonly used devices in the home for measuring liquid medications Subjects were more likely to measure an acceptable dose with an oral syringe when compared with a dosing cup

MDI: Metered dose inhaler; ME: Medication errors; PAS: Parental Analgesia Slide; PEs: Patient errors; QR: Quick response.

14



Table 5. Literature review. Interventions to reduce MEs made by patients (continued). Authors

Toumas et al.


[59]

Year Participants

2009 Pharmacy students randomly allocated to: small-group training (n = 123) or self-directed Internetbased training (n = 113)

Hixson et al. [62] 2010 160 parents accompanying children aged between 1 and 13 years

Kjome et al. [61] 2010 338 patients using glucometer

Mulvaney et al. [70]

Mira et al. [67]

2012 96 diabetics adolescents in a cell phone group and 50 in a traditional self-report group

2012 99 insulin-treated patients and 33 doctors and nurses

Principal results

Conclusions

Most (87%) participants perceived that the cup was easy to use; 63% believed that the syringe was easy to use There was a significant improvement in the number of participants demonstrating correct technique in both groups, with no significant difference between the groups in the percent of change 40% of students still continued to demonstrate incorrect technique following the intervention Increased student confidence following the intervention was a predictor for correct inhaler technique Authors compared the ability of parents to calculate the correct paracetamol (acetaminophen) dose, interval and frequency for their child when using either product information leaflets or the PAS PAS is a new device developed with the objective of improving parental dosing accuracy PAS resulted in a reduction in the absolute percentage dose error from a median of 33 to 0% and an increase in the number of correct dosage intervals and frequencies (59/80 to 70/80) Before intervention (instructed in the correct use of their glucometer) 5% of the patients had measurements that deviated from pharmacy blood glucose values by > 20% and user errors were observed for 50% of the patients After intervention the percentage of patients who made user errors had decreased to 29% 83% preferred to have the assessment done at the community pharmacy Morning time was associated with worse monitoring and insulin administration, accounting for 59 -- 74% of missed self-care tasks Cell phones were most frequently used to send parents’ blood glucose values in a text message, or to call a parent if they forgot diabetes supplies Precautions reported by patients: review of doubts before the visit and diet adherence were

A large proportion of study participants were unable to measure an accurate dose with either device Self-directed Internet-based training is as effective as smallgroup training in improving students’ inhaler technique Neither intervention may be considered sufficiently effective

PAS resulted in improved parental ability to calculate paracetamol dose, interval and frequency while preserving their ability to demonstrate an accurate drug volume

A community pharmacy-based quality assessment procedure of patients’ self monitoring of blood glucose significantly reduced the number of user errors Patients reported increased confidence in their blood glucose measurements after their measurements had been assessed at the pharmacy

Mobile phones provide a feasible method to measure glucose monitoring and insulin administration in adolescents

Information about the most common MEs may contribute to patient safety



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Table 5. Literature review. Interventions to reduce MEs made by patients (continued).


Authors

Year Participants

Principal results

Conner and Buck [72]

2013 Review study about dose counter and metered dose inhaler

Perula de Torres et al. [76]

2014 154 patients in the experimental group (physicians using motivational interview) and 84 in the control group

Tanner et al. [78] 2014 120 parents of pediatric patients

Mira et al. [80]

2014 23 patients participated in three nominal groups. 99 patients participated in a Clinical Trial to assess effectiveness of an app

related to a lower number of PEs Female patients better follow athome instructions for blood glucose monitoring and use pillboxes to avoid errors For health care professionals, safety may increase if patients: play a more active role in their treatment (91%) and inform their doctors about their different treatments (88%) Up to 40% of patients believe they are taking their asthma medication when they actually are activating an empty or nearly empty MDI Device design makes it impossible for an MDI to cease delivering drug doses at an exact point, and the number of actuations in an MDI may be twice the nominal number of recommended medication doses Number of errors fell from 110 to 20 in the experimental group (reduction of 48%) PEs decreased more in the experimental group than in the control group 83% were able to report their children’s weights correctly and measure a correct dose using a medicine cup 42% measured acceptable doses with the medicine cup with clear markings 60.0% measured acceptable doses with the medicine cup with printed markings Of the 45% who incorrectly read the medication dosing chart, most chose a lower dose range than what would be appropriate for their children’s weights There were differences in participants’ ability to measure accurate doses using the various measuring devices To avoid errors, patients associate medication with everyday activities (e.g., meals), use pillboxes and make notes on the packaging Experimental group reported fewer missed doses of medication An app only helped to significantly reduce MEs in patients with an initially higher rate of errors Patients with no experience with information and communication technologies reported fewer missed doses and fewer MEs

Conclusions

Dose counters may help to improve asthma management helping to ensure that patients receive accurate metered doses of asthma rescue medication to relieve bronchoconstriction

Motivational interview was effective for reducing MEs in polymedicated patients aged over 65

Medicine cups were the devices parents reported using most frequently Parents underdosed using cup Medicine cups brought about a higher occurrence of dosing errors when compared with the other devices Poor knowledge of children’s current weights and confusion between pounds and kilograms were sources of potential error for dosing

The pillbox app reduces rates of forgetting and of medication errors Elderly patients with no previous experience with information and communication technologies are capable of effectively using an app designed to help them take their medicine more safely


16




Table 5. Literature review. Interventions to reduce MEs made by patients (continued). Authors

Year Participants

Principal results

Conclusions

Mira et al. [81]

2014 265 patients aged over 65

Older complex chronic patients are unaware of the precautions they must adopt to use their medications safely Patient knowledge does contribute to reducing medication errors Nearly one-third of patients said their doctors were not telling them about the precautions they should take

Tseng and Wu [82]

2014 68 elderly with multiple chronic conditions

Mira et al. [83]

2014 61 patients aged over 60

Yin et al. [84]

2014 287 parents of children < 9 years. Cross-sectional analysis

46% used a pillbox 40% patients did not answer correctly 50% of the questions concerning their medication Better medication knowledge was related to a smaller number of MEs Mistakes was also related to the number of drugs patients remembered that they were taking, number of prescriptions and the actual number of diagnoses Developed an app based on QR codes including reminders for medication, assistance with pilldispensing, recording of medications, position of medications and notices of forgotten medications for elderly outpatients App was highly accepted by the elderly 13 (21%) reported having made at least one ME during the previous year (3 [5%] had made two MEs) 6 (10%) the error concerned confusion about the drug to be taken, 1 (1.6%) concerned drug interaction after mixing drugs that should not have been mixed, 8 (13%) patients took their medication at the wrong time and 1 (1.6%) took more than stipulated Patients were satisfied with an app based on Barr and QR codes to reduce PEs 41% parents made dosing errors (daily dose liquid medication) Advanced counseling (teachback, drawings/pictures, demonstration, showback) and dosing instrument were reported by 33% and 19%, respectively; 15% reported both Advanced counseling and instrument provision in were associated with decreased errors (30.5 vs 46.4%; 21.8 vs 45.7%)

M-health system could assist elderly outpatients’ homecare, preventing medication errors and improving their medication safety

App was particularly well valued by the patients who normally used pillboxes or who made notes on the packaging to help them recall the purpose of the medicine There is a patient profile that is particularly well predisposed to using this tool as an aid to avoiding errors

Counseling strategies and dosing instrument provision may be especially effective in reducing errors when used together


difficulty relating the dosage to their child’s weight [33,74] or fail to use correctly the cups or spoons for administering the medication [61,78]. Paracetamol (Tylenol and other medicines for cough or cold) is the most common wrongly administered medicine. Health literacy and errors have been associated [61], for example, with low-health-literacy parents’

difficulties in correctly interpreting dosages [78]. Between 30 and 56% of PEs reported to Poison Centers because of unexpected complications correspond to children aged 6 or under whose parents have given them a drug on their own initiative [58,64,80]. The majority of such errors occur at night (60%).


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In the study by Sarkar et al. [60], 111 diabetics were responsible for 205 incidents affecting their own safety. Patients with lower levels of health literacy committed more errors [24,30,53,60,73]. The complexity of syringe selfadministration is at the root of a large part of insulin dosage errors [41]. Incorrect technique using devices such as glucometers or inhalers caused a large proportion of MEs [24,33,35,38,40,45,52,63]. But diabetics also commit errors with their diet and with the care of their feet [60,67]. Women appear to be better than men at following instructions for home blood glucose monitoring [67]. The older the patients, the more the cognitive difficulties they have, and the more the medicines they take per day, the more the number of PEs they are likely to commit [10,24,42,46,49,55,71]. A total of 90% of the oldest patients acknowledge that PEs are common [24,42], but poor cognitive state has been identified as a frequent cause of MEs [25,37,46,55]. Errors have been found to be more frequent as a consequence of misunderstandings [11,12,77] (including miscommunication between in-home caregivers regarding changes in oral chemotherapy dose [75]) and self-medication [21]. Just 10% know the names of the medication they take [24], and almost 50% have difficulty responding to simple questions about indications and dosage for the drugs they are taking [81]. At the same time, 32% lack clear indications about how to take their medication and are unaware of which foods or drinks to avoid or possible harmful interactions [48]. Communication failures with health care professionals were also found to be at the root of MEs [11,69,74,75]. One study related dissatisfaction with higher numbers of MEs [69]. Frequent changes of doctor or of medication or inconsistencies between messages from various doctors about the same health problem have all been associated with greater numbers of errors. Avoiding PEs A pioneering study [85] outside the analyzed period addressed a method for reducing patient MEs in the elderly. They were given verbal instructions on the nature and amount of their medication and a tear-off calendar. The authors found that patients made fewer errors than before when using this method. A series of studies have focused on trying to eliminate the causes of the most common MEs and thereby reduce their incidence. On the one hand, by improving the information provided to patients, which appears to contribute to a reduction in MEs [67,81], especially in the case of over-the-counter medicines [44]; and, on the other, by helping patients to correctly calculate their dose of insulin [70] or other medicines, such as paracetamol in the case of children [62,67]. Nevertheless, the majority of studies have concentrated on helping patients to use inhalers correctly [34,58,59] (including teaching them how to calculate the remaining doses [29,72]) or to increase accuracy in the use of glucometers [31,61], teaspoons or syringes [57]. 3.6

18

With a view to reducing PEs, patients use certain homegrown strategies that help them on a daily basis. Recent years have seen patients beginning to use apps on smartphones and tablets to make their medication administration safer. The ‘tricks’ patients use for reducing errors are [48,79]: using pillboxes or making notes on the medication packaging. When patients play a more active role and ask questions to resolve their doubts, the number of errors goes down [67]; also, the better the communication with the patient, the more likely it is that the number of errors will be lower [71]. Interventions for helping to reduce errors or palliating their consequences have been based on the use of the motivational interview, with reductions of 48% of errors in an experimental group of 154 patients [76]. With older people, it was found that an app that fulfilled the function of a pillbox (ALICE) helped -- in addition to increasing adherence -- to reduce MEs in those patients who made most mistakes [79]. In recent years, with the rise in use of smartphones, apps have been developed for helping patients administer their medication more safely. Among these, those that read barcodes or use quick responses are the latest to arrive [82,83], although we only have data on acceptability from patients. 4.

Discussion

MEs are not the sole responsibility of the doctor. Patients make errors too. This is clear in all studies carried out between 1962 and the present. Patients believe that other patients make MEs and also report that they themselves commit them. PEs usually have minor consequences or none at all, but in some cases they have serious health consequences, including hospitalization and death. Factors that contribute to medical errors in prescription or dispensing are also at the root of the PEs made by patients themselves with medicines at home [3,48,86-88]: the pre-schooler or elderly population, dependence on a caregiver, comorbidity, complexity of therapeutic regimen, being chronically ill, low health literacy or barriers in communication with caregivers, certain beliefs, and socioeconomic and lifestyle related factors can also contribute to MEs [89]. Among pre-schoolers, PEs are due above all to difficulties in administering the correct dose and excessive use of anti-pyretic drugs. Among the elderly, we more frequently find PEs caused by caregiver error due to the fact that the risk increases linearly with the number of medications taken [39,90]. Multiple comorbidities and polymedication are also related to errors made by patients themselves [88]. Prominent among the causes of PEs are low health literacy, polymedication, confusions and gaps in information due to inadequate interaction with caregivers, frequent changes of medication or doctor, or difficulties for calculating dosage because of inappropriate design of dispensing devices or ignorance of the patient’s weight. Inhalers and glucometers have been a particular focus of interest given that since the very earliest studies researchers have detected




the inappropriate use of such devices in a large proportion of patients. Color or shape for distinguishing drugs, informative packaging, dose counters, motivational interviews and apps are among the many strategies applied for reducing MEs. In some cases, they have proved useful with regard to the incidence of PEs, including in the case of the elderly. However, more research is needed. The results on the usefulness of labeling, color or shape differentiation are controversial, and a recent study showed an advantage of color differentiation on search time and accuracy compared with shape differentiation [91]. Many of the interventions are based on common patient strategies used to differentiate between medicines that rely on their color [92]. However, the use of bioequivalent medications represents a relevant change, since continual changes in the drugs’ appearance potentially generates confusion in patients and can result in more MEs [93,94]. In this case, the development of apps could help solve the problem because they include the image and the posology. Such tools are easy to use, even without previous Internet or smartphone experience [79], but such technology is of course not yet familiar to all or even nearly all the general public. The studies carried out to date have focused above all on setting out or describing the problem, and many questions remain unanswered. It must be acknowledged that it is very difficult to know what really happens in the home when people take medication. The variability is wide, and administration of medicines often depends not on the patient him/ herself but on a relative or caregiver [24,48]. The risk of mistakes is higher when the patient is dependent on several different caregivers. Although we know which drugs are associated with more errors, we have not made changes to the leaflets [95], to the packaging [96] or to the information provided with the prescription, with a view to, all together, contributing to safer use of medication. The national agencies responsible for the drug safety in each country or region should consider more direct intervention in relation to these key points for the improvement of safety in home medication. There is a need to increase the number of studies about patients’ role in patient safety. Some of the questions that remain open are: Why do some patients present the majority of PEs? What can be done to avoid the most common errors and are memory rules truly useful for reducing such errors [97]? Which types of MEs can be avoided by e-prescription and which cannot? How can we get patients to involve themselves more actively in the reduction of medication-associated risks? What kinds of problems are associated with the use of herbs or other natural products without telling one’s doctor? [98] What kinds of dosage errors occur when the patient lacks sufficient financial resources to pay for medicines? What effects do the new health apps [99,100] have on medication errors? Although we may have an idea of the type of PEs patients make, there are scarcely any studies on how patients can contribute to their own safety. Patients’ intrinsic characteristics

should be studied. For example, what leads certain patients to use pillboxes or make notes on packaging, or what questions they should know the answers to for making their medication use safer. The studies reviewed here suggest that on considering PEs it is not enough to focus our attention on the quality of the prescription, preparation or dispensing of drugs. It is also necessary to take into account that the full cycle of use of most medications outside of the hospital (i.e., the majority) includes the correct administration of the drugs by patients or by their caregivers once they are at home. For this reason, it is recommended to improve the verbal and written information [101] so as to head off the most common errors, such as incorrect self-administration or storing of medication. Also improvable is the design of dispensing devices such as syringes, cups or spoons, and also of inhalers (which could make it easier for patients to count the doses remaining). Furthermore, instructions for calculating the right dosage according to the patient’s weight could be made clearer. Limitations: This study only includes research published in English or Spanish. Although patients can commit a range of different errors over the course of their treatment, the present study has focused exclusively on PEs. Neither the frequency of self-medication nor voluntary non-adherence were analyzed. 5.

Conclusion

Patients make errors, especially those taking more than five different types of medication per day or who are dependent on a caregiver. These types of MEs should not be underestimated because they cause harm and lead to low self-esteem, loss of therapeutic effectiveness and an avoidable increase in health care costs. On informing patients, physicians and pharmacists should take into account the potential for MEs at homes, considering patient profiles, for example, as particularly good indicators of such potential. There are some important and relatively unexplored issues requiring a response with a view to reducing PE. In the meantime, efforts should be made to improve the verbal and written information provided and the design of dispensing devices (syringes, cups, spoons, inhalers, etc.), which are a prime cause of such errors. Moreover, there is a need to explore the use of apps and other new-technology tools that offer opportunities for improving drug safety. 6.

Expert opinion

Patient MEs (in the form of wrong doses, mixing up medications or foods, taking out-of-date drugs, drug-related device misuse, inappropriate storage, etc.) constitute a particular type of involuntary non-adherence involving the way people use medication at home, at work or at school. The rise of research on patient safety since the publication of To Err Is Human [1], and particularly subsequent studies on errors of


19


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prescription and dispensing of drugs, has influenced the increased interest in patient drug safety in recent years. Buetow et al. [21] described up to 70 different types of PEs. Their common feature is that they could have been avoided. Up to now, research on PEs has been confined to certain pathologies (notably asthma, diabetes and COPD), to certain quite specific patient profiles (pre-schoolers, the elderly) and to specific devices (inhalers, aerosols, glucometers, teaspoons/syringes -- accuracy). Other aspects central to patient medication safety have not been the subject of research, despite their relevance. This would be the case, for example, of errors associated with beginning a new medication or what happens when drugs have to be taken at night, when the risks of error are higher. New medicines are always being introduced into the market, of weekly or monthly use, which have different patterns of administration from those to which patients were accustomed, and this can generate confusion if the instructions are unclear. In many countries, there have been notable increases in the use of bioequivalent medicines, which limits the systems of domestic control patients have been using based on shape and color. Measures that patients adopt themselves to counteract side-effects (insomnia, constipation, etc.), tablets that should not be chewed or broken, medicines that should not be mixed with food or liquid or those that must be taken with food are probably associated with a higher risk of making errors, so that greater care is necessary for their safe use at home. Other important aspects relate to patients in the care of other persons and/or whose caregivers frequently change, or to behaviors that are unsafe or restrict the effectiveness of drugs, performed by patients with scarce economic resources on using less expensive drugs. Future research should consider paying more attention to such aspects with a view to avoiding the risks involved and a potential loss of therapeutic effectiveness. The studies carried out to date have concentrated on those situations in which it is most likely that patients would encounter gaps in drug use safety, so that the number of MEs would be higher. Interventions for reducing such errors still lack sufficient levels of evidence for making recommendations, and greater efforts are required in this direction. Clinical trials and cohort studies are still scarce. The fact that PEs do not generally have serious consequences has contributed to a lack of motivation for paying more attention to this problem. However, it should be borne in mind that patients (or parents/caregivers of children or mentally incapacitated adults) are responsible for administering medication daily at home, and that in some cases misuse of drugs can result in hospitalization or worse. The situation is akin to what happens in the case of MEs in primary care in the prescription, transcription, dispensing and administration of medicines. Their consequences are in general less serious than those associated with MEs that occur in hospitals, so that they have

20

attracted less research interest. But we know that MEs affect above all certain types of patient, notably the elderly. Foreseeably, there will be a marked increase in the number of very old people living alone, so that work on helping them to reduce the risks of home medication could become a priority in the area of patient safety. As occurs in the professional context, aids and tools that could be incorporated for reducing the likelihood of MEs constitute one of the core aspects in efforts to increase patient safety, and in this area the new technologies (we can cite two examples: e-prescriptions and medication-related apps) can contribute to greater security in the use of medicines, as already seems to be the case [102]. The roles of doctors, pharmacists and all other professionals working in the area of health, as well as those of health care systems and national and international medical and drug organizations, is crucial for ensuring safer use of medication. The majority of doctors and pharmacists are capable of describing the most common types of MEs, but they do not always identify in time their patients’ information needs or the help they might need for avoiding MEs, so that they cannot prevent them with total effectiveness. The role of professionals working in this field for increasing levels of health literacy is key, and this would seem to be one of the routes to pursue in efforts to avoid MEs in the home. Standardization of labeling [103] that would counteract some of the problems commonly encountered by patients self-medicating at home, or the introduction of patient reporting systems (e.g., for alerting responsible agents to home medication problems) are other forms of contributing to better patient safety, especially in relation to the problems the elderly face due to frequent changes of color and shape in bioequivalent medicines. But patients themselves must get involved in the question of their own safety. It is not just a question of the health system, of national and international agencies or of health professionals: patients’ own commitment is essential. In sum, patients’ MEs deserve more attention than they have been given so far. We already have some clues as to the causes of these mistakes, but it is time to make a concerted effort to reduce their occurrence by using and improving the knowledge we have.

Declaration of interest This study was funded by the Spanish Ministry of Health, Equality, and Social Policy (Program of Independent Clinical Research; Reference: EC11-527). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.



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Affiliation

Jose Joaquıń Mira†1,2,3, Susana Lorenzo4, Mercedes Guilabert2, Isabel Navarro2 & Virtudes Perez-Jover2 † Author for correspondence 1 Departamento de Salud Alicante-Sant Joan d’Alacant, Alicante, Spain 2 Universidad Miguel Hernańdez, Edificio Altamira, Avenida Universidad s/n, 03202 Elche, Spain E-mail: [email protected] 3 REDISECC, Red de Servicios de Salud Orientados a Enfermedades Crońicas, Madrid, Spain 4 Hospital Universitario Fundacioń Alcorcoń, Madrid, Spain

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