Centre conducting review:
Name: Queen's Joanna Briggs Collaboration
Contact for the review and primary reviewer:
Name: Kim Sears
Telephone: 613-533-6000 ext 78763
Email: [email protected]
Names and designation: Kim Sears RN PhD1 and Amanda Ross-White MLIS2
1Queen's University. Contact: [email protected]
2Queen's University. Contact: [email protected]
December 20, 2010
Expected Completion date:
June 20, 2011
Medication safety is a key issue in the quality and patient safety movement in Canada and worldwide. Medication delivery is complex in all areas of health care; safe delivery of medications to children, however, presents additional challenges and opportunities for error. Paediatric medication errors have been identified as the most frequent type of medical error involving children. 1,2 In paediatrics, children, especially those under the age of twelve, are treated as therapeutic orphans since suitable formulations of many drugs are based solely on adult requirements.3,4,5 Carleton and Smith noted that, until recently, it was assumed that children were “small adults”; thus, adult dosages were adjusted to account for the smaller body mass, with the assumption that clinical results would mimic those of adults. 5 Another common concern for paediatric medication administration is off-label prescribing as many drug companies have not received the appropriate approval for paediatric formulations. 6 In fact, 75% of licensed pharmaceuticals in North America have never been tested on children, yet they are utilized in paediatric hospital settings without adequate guidelines for safety and efficacy. 7
Children present unique demands in regards to medication ordering, dispensing, administering and monitoring as they often require weight-based dosing calculations, a situation further complicated by a lack of standardized paediatric easy-to-use dosage formulations. 8,9Further, the process of dosing is complicated by the interchange of milligrams and micrograms.6 Delivering medications to children requires that an individual dose incorporate comprehension of the age, weight and surface area of the child.10 As well, children's medications are dispensed in multiple preparations, including drops, elixirs, chewable tablets, capsules and infusions. 11 Tenfold medication errors are more likely to occur among children as a result of non-suspicious small volumes 1 posing severe consequences in paediatrics. 6 Recently, it has been shown that a host of biological, developmental and behavioural factors in children affect the safety and effectiveness of pharmaceuticals being used. These internal factors present an enormous concern for children whose condition is critical as they may have a limited ability to buffer the harmful effects of medications. 12 Further, very young children may be placed at higher risk as they may not be able to verbalize their experiences, feelings and subjective reactions to the medications.2
Another group at high risk for serious complications in regards to medication errors is those individuals over the age of 60. The US Federal Drug Agency (FDA) noted that more than half of fatal medication errors occurred in people 60 or over. 13 Another risk factor for this group is the aspect of polypharmacy. The issue of polypharmacy has been identified as a contributing risk factor to increased morbidity and mortality. 14 Further, another study identified that the odds for potentially inappropriate medication prescribing were higher for patients that are taking multiple drugs. 15 In the United States, it is estimated that at least one medication error occurs per day per adult hospitalized patient. 16This high rate of error demonstrates the complexity of the delivery of a medication. The delivery of a single medication involves 30 - 40 steps, each of which increases the risk for error.17 Kaushal et al. examined the rates of paediatric medication errors as well as actual and potential adverse drug events (ADEs) and then compared the findings with those of adults. The researchers reviewed 10,778 medication orders and found 616 medication errors; equating to 5.7 per 100 orders or 55 per 100 admissions. The potential for ADEs was three times higher in the paediatric population than in the adult patient population. 2
A retrospective search of two large medication data bases in the United States showed the risk of harm from medication errors in adults to be 13%, compared to 31 % in children.18 The researchers concluded that the paediatric population appeared to be more vulnerable to adverse outcomes from medication errors than were adults. Fortescue et al. (2003) studied 1,020 paediatric patients at two academic centers during a six week period and found that 120 (19.5%) of the medication errors were classified as potentially harmful.19
Although research into medication errors in hospital has been conducted, the safe delivery and consumption of medications in communities remains largely unstudied, despite the high volume of healthcare encounters (over 422 million prescriptions dispensed per year in Canada). The lack of research into medication errors in the community not only places patients and the Canadian healthcare system at risk, but also represents a lost opportunity for learning from errors and taking steps as an organization (e.g., workflow/dispensing changes) to reduce the likelihood of them occurring again. Although efforts have been made to make medication safety a priority 20, and in spite of research attempts to determine underlying causes of medication incidents 21, 22, 23, and error reduction strategies 22, 24, little is known about the safety of medication practices in Canada.
Medication safety in the home environment poses unique issues that are unaddressed by research into the institutional care environment. In particular, home care workers have identified concerns about the use of medication by someone other than the patient (either inadvertently through medication diversion or intentionally through the illegal trafficking of medication), accidental access to medication by persons other than the patient or primary caregiver, and both intentional incorrect administration such as overmedicating to avoid care responsibilities as well as unintentional incorrect administration. 25 An honest assessment of medication safety is needed to identify processes and organizational infrastructures that may place Canadians at risk.
Although research on medication safety has increased in the last few years, research in the area of medication errors in the community remains limited. A study from the United Kingdom reported an incidence rate of 22 near misses and 4 medication errors for every 10,000 items dispensed. 21 An observational study from the United States had a comparable incidence rate. 22 Furthermore, research indicates that 28% of all emergency visits occur because of a drug related problem, defined as an inappropriate prescription, an adverse drug reaction and/or a drug to drug interaction, with 24% of these resulting in a hospital admission.26 An initial search was performed in Cochrane Library of Systematic Reviews, JBI Library of Systematic Reviews, DARE, and Medline. No systematic reviews on the topic were identified in the above mentioned databases.
What are the incidence, prevalence and contributing factors associated with the occurrence of medication errors for children and adults in the community setting?
For this systematic review we'll use the following definitions:
“A medication error is 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. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labelling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.” 27
Community setting is settings for which care is provided or individuals live in which a person is not considered an inpatient in a hospital, for example, geographic communities, day care centres, schools, retirement homes and long term care facilities.
Incidence of medication errors is the number of newly identified medication errors during a specific time period.
Prevalence of medication errors is the number of medication errors that are present in a particular population at a given time.
Contributing factors associated with the occurrence of medications errors are other factors associated with increased risk of medication errors.
Polypharmacy is the use of a number of different drugs, possibly prescribed by different prescribers and filled in different pharmacies, by a patient who may have one or several health problems. 28
Types of studies
The review will consider studies that evaluate the incidence, prevalence and contributing factors associated with the occurrence of medication errors in the community setting for both children and adults. Any randomized controlled trials, non-randomized controlled trials, controlled before and after studies, other designs such as cohort, case control studies, cross-sectional studies and descriptive studies will be considered.
Types of participants
This review will consider studies that include adults (18 + years old) and children (0 to 18) living in the community that have experienced a medication error. The term “living in the community” includes living at home/ residential homes.
Types of intervention(s)/phenomena of interest
The review will consider studies that evaluate the incidence, prevalence and contributing factors associated with the occurrence of medication errors in the community setting for both children and adults.
Types of outcomes
This review will consider studies that include the following outcome measures: incidence, prevalence of medication error occurrence; and contributing factors associated with the occurrence of medication errors in the community setting for both children and adults.
The search strategy aims to find both published and unpublished studies in English language from inception of databases to current date. A three-step search strategy will be utilized in each component of this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies.
The databases to be searched include, but are not limited to:
Medline, CINAHL, Embase, GlobalHealth, ASSIA, Sociological Abstracts, Ageline, Cochrane, AMED, Mednar and PsycInfo.
The search for unpublished studies will include, but are not exclusive to:
Institute for Safe Medication Practice, Canadian Institute for Health Information, Canadian Patient Safety Institute and the Canadian Health Services Research Foundation, Proquest.
Initial keywords to be used will be:
1. Medication Errors/
2. medication err$.ab,ti.
3. drug err$.ab,ti.
4. Medication Therapy Management/
5. medication manag$.ab,ti.
6. drug manag$.ab,ti.
7. adverse drug event$.ab,ti.
8. medication safe$.ab,ti.
9. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8
10. exp Home Care Services/
11. Community Health Services/
12. Accidents, Home/
13. Community Health Nursing/
14. Community Mental Health Services/
15. Community Networks/
16. Community Pharmacy Services/
17. exp Residence Characteristics/
18. Physicians, Family/
19. Community Medicine/
20. Family Practice/
21. Physicians' Offices/
22. exp Residential Facilities/
23. Hospitals, Community/
24. exp Emergency Service, Hospital/
25. community dwell$.ab,ti.
26. living in the community.ab,ti.
27. home dwell$.ab,ti.
28. living at home.ab,ti.
29. home base$.ab,ti.
32. 30 or 31
33. 24 and 32
34. 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 25 or 26 or 27 or 28 or 29 or 33
35. 9 and 34
Assessment of methodological quality
Quantitative papers selected for retrieval will be assessed by two independent reviewers for methodological quality prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics. The appraisal instrument (JBI-MAStARI), selected will depend on the design on the study and will include: Critical Appraisal for Experimental Studies (Appendix I); Critical Appraisal Checklist for Comparable Cohort/ Case Control (Appendix II); JBI Critical Appraisal Checklist for Descriptive/ Case Series (Appendix III). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.
Quantitative data will be extracted from papers included in the review using the standardized data extraction tool entitled JBI MAStARI Data Extraction Form for Experimental and Observational Studies (Appendix IV). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. In some cases revision of the data extraction tool will occur after the full search has been conducted. All results will be subject to double data entry.
Quantitative papers will, where possible be pooled in statistical meta-analysis using the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI). Odds ratio (for categorical data) and weighted mean differences (for continuous data), odds ratio and relative risk for measurement of association, proportions for measurement of prevalence, proportions for cumulative incidence and relative risk for incidence density will be used for example for analysis. As well 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed using the standard Chi-square. Where statistical pooling is not possible the findings will be presented in narrative form.
Conflicts of interest
The reviewers declare no conflict of interest.
Acknowledgments: The lead author (KS) would like to acknowledge Queen's University for their funding support. The authors would like to acknowledge the support received from the Queen's Joanna Briggs Collaboration (QJBC), and in particular, the methodological support from Dr Christina Godfrey, QJBC methodologist.
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