ORIGINAL RESEARCH
A FORMAL MEDICATION RECONCILIATION PROGRAMME IN A HAEMODIALYSIS UNIT CAN IDENTIFY MEDICATION DISCREPANCIES AND POTENTIALLY PREVENT ADVERSE DRUG EVENTS Winnie WY Chan1, Geetha Mahalingam1, Robert MA Richardson2,3, Olavo A Fernandes1,4, Marisa Battistella1,4 Leslie Dan Faculty of Pharmacy - University of Toronto, Toronto Ontario, Canada 2 Division of Nephrology, University Health Network; Toronto, Ontario, Canada 3 Department of Medicine, University of Toronto, Toronto, ON, Canada 4 University Health Network, Toronto General Hospital, Toronto, Ontario, Canada
1
Chan W.W.Y., Mahalingam G., Richardson R.M.A., Fernandes O.A., Battistella M. (2015). A formal medication reconciliation programme in a haemodialysis unit can identify medication discrepancies and potentially prevent adverse drug events. Journal of Renal Care xx(xx), 1–6.
SUMMARY Background: Patients on haemodialysis have been identified as high-risk for medication discrepancies and adverse drug events. Medication reconciliation is an important patient safety initiative to prevent adverse drug events. The primary objective of our study was to determine the number and types of medication discrepancies and drug therapy problems (DTPs) identified in patients on heamodialyisis. Our second objective was to assess the potential clinical impact and severity of all unintentional medication discrepancies identified. Methods: Patients in an academic haemodialysis unit were interviewed to obtain a best possible medication history (BPMH) between May and August 2010. The BPMH was documented and discrepancies were identified, classified and resolved with the interprofessional team. An interprofessional panel conducted a discrepancy clinical impact assessment for potential adverse drug events. Results: Two hundred and twenty-eight patients on haemodialysis were interviewed and 512 discrepancies were identified for 151 patients (3.4 discrepancies per patient). Of these, 174 (34%) were undocumented intentional discrepancies and 338 (66%) were unintentional discrepancies. The unintentional discrepancies were classified as 21% omissions, 36% commissions and 43% incorrect dose/frequency. Most drug therapy problems were related to patient taking a medication that was not indicated (25%), medication required but patient not taking (25%), patient not willing to take the medication as prescribed (28%) or incorrect dosing of a drug (20%). Overall, 6% of discrepancies were classified as clinically significant potential adverse drug events. Conclusion: Medication discrepancies appear to be common in patients on haemodialysis. Formal interprofessional medication reconciliation practice models are essential to identify discrepancies and prevent patients from experiencing adverse drug events.
K E Y W O R D S Adverse events Haemodialysis Medication reconciliation BIODATA Marisa Battistella is a clinical pharmacist in the nephrology programme at the University Health Network and Assistant Professor at the University of Toronto, Leslie Dan Faculty of Pharmacy. As Pharmacy Clinician Scientist, Marisa’s primary research interests are in the areas of medication safety and efficacy including pharmacokinetics and pharmacogenomics in the dialysis population. CORRESPONDENCE
Dr. Marisa Battistella, 200 Elizabeth Street, Toronto, ON, Canada M5G 2C4 Tel.: þ1 416-340-4800 ext 3207 Fax: þ1 416-340-3685 Email: [email protected]
INTRODUCTION Medication reconciliation is a formal process in which healthcare professionals partner with patients to ensure accurate and complete medication information is properly documented. It involves a systematic process for obtaining a best possible medication history (BPMH) and then comparing that information to medication orders in order to identify and resolve medication discrepancies and prevent adverse events (Kwan et al. 2007; Fernandes, 2009; Barton et al. 2013; Barton Pai et al. 2013). Patients on haemodialysis have an average of five comorbidities and are often on at least ten to twelve medications (Manley et al. 2003). Due to the complexities of their disease states and complicated medication regimen, patients on haemodialysis
© 2015 European Dialysis and Transplant Nurses Association/European Renal Care Association
Journal of Renal Care 2015
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Chan et al.
have been identified as a population at high risk for medication discrepancies and adverse drug events (Manley et al. 2003; Manley et al. 2005). One study identified at least one medication discrepancy in the drug records of 60% of patients on haemodialysis. In total, 113 discrepancies were identified in 38 patients over five months, resulting in an average of 3 discrepancies per patient. The authors speculated that patients were at risk for adverse drug events (49.6%) or making dosing errors (34.5%) if patients were started on medications based on their drug records (Manley et al. 2003). As medication discrepancies can be translated into medication errors, it is important to differentiate whether these discrepancies are considered as undocumented intentional or unintentional. An undocumented intentional discrepancy refers to medication change made by another healthcare professional but not listed on the medication record, whereas an unintentional discrepancy refers to medication change made inadvertently or deliberately by the patient without the knowledge of the healthcare team (Kwan et al. 2007). A study identified 358 discrepancies in 93 patients on haemodialysis over four months, in which 210 (59%) were undocumented intentional discrepancies and 148 (41%) were unintentional. The clinical effect of the unintentional discrepancies was further categorised by pharmacists into 3 classes based on the definition by Cornish et al. (2005). Class 1 discrepancies were the ones unlikely to cause patient discomfort or clinical deterioration. Class 2 discrepancies were the ones having the potential to cause moderate discomfort or clinical deterioration. Class 3 discrepancies were the ones that were thought to have the potential to cause severe discomfort or clinical deterioration (Cornish et al. 2005). Fifteen percent of the unintentional discrepancies were considered to have the potential to cause clinical deterioration or harm to patients (Leung et al. 2009). Currently published literature mainly focuses on the numbers and types of discrepancies and drug therapy problems in patients on haemodialysis. Information regarding the clinical impact and severity of unintentional medication discrepancies in the dialysis population is limited. The primary objective of our study was to determine the number and types of medication discrepancies and drug therapy problems (DTPs) identified in patients on haemodialysis. Our second objective was to assess the potential clinical impact and severity of all unintentional medication discrepancies identified.
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METHODS This was a prospective observational study conducted at the haemodialysis unit of a tertiary care university affiliated teaching hospital in Toronto, Ontario, Canada. All patients receiving haemodialysis in the unit between May and August 2010, and not requiring an interpreter were included. STUDY DESIGN A pharmacy student (G.M.) and nurse (A.M.) were trained to obtain BPMH according to the hospital’s standardised pharmacy departmental protocol. To ensure consistency in the medication history gathering process between the two interviewers, they were required to go through a BPMH validation process upon completion of their training. BPMH involves a systematic patient interview as well as verification of information with more than one source. For example, the interviewers would contact community pharmacies and physicians, inspect medication vials and review government medication databases, patient’s medication list and previous patient health records. The information gathered included the drug name, dose, frequency and route of administration for each medication a patient was currently taking (Fernandes, 2009). BPMH obtained by the interviewer was then compared with the current medication profile in patient’s chart. All medication discrepancies identified were recorded on a discrepancy form (Appendix 1) and brought to attention of the clinical pharmacist for further investigation. These discrepancies were then classified and resolved with the interprofessional team. The pharmacist assessed each discrepancy and categorised them as undocumented intentional or unintentional. Unintentional discrepancies were subcategorised as omission, commission, wrong dose or wrong frequency. Omission is one in which medication taken by the patient is not listed on haemodialysis medication record. Commission happens when the patient is no longer taking the medication but it is still listed on haemodialysis medication record (Leung et al. 2009). The pharmacist was also responsible for classifying the types of drug therapy problems (DTPs) identified with the discrepancies. DTPs were classified according to the seven categories proposed by Cipolle and others: unnecessary drug therapy (no clinical indication at this time), additional drug therapy required for clinical indication, drug not effective in producing response (ineffective), dosage too low to produce the desired response, drug causing an adverse
© 2015 European Dialysis and Transplant Nurses Association/European Renal Care Association
MEDICATION RECONCILIATION IN HAEMODIALYSIS
reaction (not dose related), dose too high resulting in side effects and patient not able or willing to take drug therapy (Cipolle et al. 2004). To determine the potential clinical impact of these unintentional discrepancies, an interprofessional panel which consisted of two pharmacists (S.I. and J.V.) and one nephrologist (M.J.) conducted a discrepancy clinical impact assessment for the potential to cause patient harm based on the Institute for Safe Medication Practices Canada proposed process (Medication Reconciliation in Acute Care, 2011). To optimise the consistency of discrepancies assessments amongst the clinical evaluator team, 12 sample cases were used for training and practice. One hundred percent agreement was achieved during the training session. For each unintentional discrepancy identified, an independent facilitator read out a description to the three clinical evaluators. Each evaluator categorised medication discrepancies as “unlikely”, “possible”, or “probable” potential to cause patient harm which includes patient discomfort and/or clinical deterioration if the discrepancy is not identified and addressed (Safer Healthcare Now, 2011). Based on the suggested guideline proposed by the Institute for Safe Medication
Characteristics
Overall (N ¼ 228)
Age, median vs mean ( SD), y 60 ( 17) Total number of discrepancies 512 Gender Male 129 (57) Female 99 (43) Reason for end-stage renal disease (ESRD) Diabetes 67 (29) Hypertension 59 (26) Glomerulonephritis 46 (20) Other 56 (25) Race Caucasian 95 (42) African American 42 (18) Asian 42 (18) Asian Pacific 40 (18) Other 9 (4) Comorbidities Coronary artery disease 66 (29) Hypertension 198 (87) Peripheral vascular disease 12 (5) Cerebrovascular disease 17 (7)
Practices, the probability of causing patient harm in percentage was 0–10% for unlikely, 11–50% for possible and >50% for probable (Safer Healthcare Now, 2011). The panel, then, voted to decide the probability of causing patient harm as a group. If disagreements within the panel occurred, the panel discussed the discrepancy and potential outcome until they reached a consensus. After consensus was achieved, each evaluator was required to indicate the potential clinical severity of the discrepancy on the patient on scale between 0 (no impact on patient) and 10 (death) individually. Becasue this study was a continuous quality improvement initiative, research ethics board approval was not required as performing best possible medication histories and identifying drug therapy problems is standard of practice at our institution. Discrepancies were documented and communicated with the patient and h\health care team as per usual practice. STATISTICAL ANALYSIS All data were entered into an Excel spreadsheet for analysis. Descriptive statistics were used in this study. Categorical data were presented as proportions. Continuous data were presented as means with standard deviations.
Patients with discrepancies (N ¼ 151)
Patients without discrepancies (N ¼ 77)
60( 15.5) 512 (3.4 discrepancies/patient)
63.5 ( 13) N/A
89 (59) 62 (41)
40 (52) 37 (48)
45 41 30 35
(30) (27) (20) (23)
22 18 16 21
(29) (23) (21) (27)
59 33 27 26 6
(39) (22) (18) (17) (4)
36 9 15 14 3
(47) (12) (19) (18) (4)
45 128 10 15
(30) (85) (7) (10)
21 70 2 2
(27) (91) (3) (3)
Table 1: Baseline characteristics.
Data are given as number (percentage) unless otherwise indicated.
© 2015 European Dialysis and Transplant Nurses Association/European Renal Care Association
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RESULTS A total of 290 patients on haemodialysis were approached and 62 were excluded as they required an interpreter; 228 patients were interviewed over the four-month period. The mean age of the patients was 60 17 years, and 129 (56%) were men. Table 1 provides baseline patient characteristics. Five hundred and twelve medication discrepancies were identified for 151 patients with an average of 3.4 discrepancies per patient. Of these discrepancies, 174 (34%) were undocumented intentional discrepancies and 338 (66%) were unintentional discrepancies. Ninety percent of the patients with discrepancies had at least one unintentional discrepancy. The unintentional discrepancies were classified as 73 (21%) omissions, 129 (37%) commissions and 146 (42%) incorrect dose/frequency (Figure 1). Omissions were mainly related to over-the-counter products such as vitamins, while commissions were mainly sleeping aids, blood pressure medications or phosphate binders. Incorrect dose/frequency mostly involved medications for blood pressure control. Drug therapy problems identified with the discrepancies including undocumented and unintentional were classified (Figure 2). The most common types of DTPs included patient taking a medication that was not indicated 122 (24%), medication required but patient not taking 126 (25%), patient not willing to take the medication as prescribed 142 (28%) or incorrect dosing of a drug 109 (21%). The interprofessional panel evaluated the potential clinical impact of these unintentional discrepancies. Overall, most of these discrepancies were considered by the panel to have an unlikely probability to cause
harm. However, for the 6% of discrepancies that were classified as “possible” in causing harm, the severity of impact was rated at 5.6 on a scale of 0 (no impact on patient) to 10 (death), which was deemed clinically significant. Some examples of discrepancies that were considered “possible” in causing harm included patient taking narcotic medication not listed on medication profile, patients taking one-half dose of the ordered phosphate binders and patients being non-compliant to blood pressure medications and anticoagulant.
DISCUSSION Medication discrepancies may lead to medication errors and adverse drug events. Our results are consistent with previous studies; an average of 3.4 discrepancies were identified per patient (Manley et al. 2003; Leung et al. 2009). Of the 512 medication discrepancies found, 34% were undocumented intentional discrepancies and 66% were unintentional discrepancies. The percentage (34%) of undocumented intentional discrepancies was lower than 59% as reported by Leung and colleagues (Leung et al. 2009). Even though our medication record had less undocumented intentional discrepancies compared to other studies, there is significant amount of discrepancies and it is a signal for better documentation. At our dialysis centre, the medication profile is updated by nurses, pharmacists or pharmacy students approximately once every month. Despite the frequent medication list update, it often does not accurately reflect patient’s current medication regimen. As patients on haemodialysis have numerous comorbidities, these patients are prone to hospitalisations and are
Figure 1: Classification of unintentional discrepancy.
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© 2015 European Dialysis and Transplant Nurses Association/European Renal Care Association
MEDICATION RECONCILIATION IN HAEMODIALYSIS
Figure 2: Frequency of drug therapy problems.
followed by multiple specialists. Changes to patient’s medications are made during hospitalisations and specialist consultations; however, most of the time neither the patient nor the consultant communicates these changes to the dialysis team. This finding suggests a need for improvement in communication between the different consultation services. One of the strategies is to provide patients on haemodialysis with printed copy of his or her reconciled medication list at least quarterly or at the time of any change in medication (St. Peter, 2010). This process may help minimise the number of undocumented intentional discrepancies. The majority of discrepancies (66%) were unintentional, and 21% were classified as omissions. It is not surprising medications that were missed on the medication profile were mostly over-thecounter products such as vitamins. Another 36% of the unintentional discrepancies were commissions. Frequent changes to patients’ medications and multiple prescribers probably account for these discrepancies. Finally, 42% of the discrepancies were related to medications listed as an incorrect dose or the wrong frequency. Many medications such as phosphate binders, erythropoiesis stimulating agents and antihypertensives used
for dialysis patients require close monitoring and careful titration. It is imperative for the team to judiciously inform the patients of changes to medication regimens and that the patients completely understand these changes. The most common type of drug therapy problems identified was patient not willing to take the medication as prescribed. Patients on haemodialysis take approximately 10–12 medications, and thus are known to be non-adherent to their medications (Manley et al. 2003). Two classes of medications were identified as “targeted” medications: phosphate binders and blood pressure medications. This has identified opportunities for the dialysis team to provide a more focused patient education to improve adherence on those medications. In addition to identifying the number of medication discrepancies and categorising them into drug therapy problems, this study evaluated the potential clinical impact of the unintentional medication discrepancies by an interprofessional panel assessment. Most of the discrepancies identified were deemed unlikely to cause harm; however, in the 6% that had a possibility to cause harm, the severity of impact was considered clinically significant.
© 2015 European Dialysis and Transplant Nurses Association/European Renal Care Association
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The low percentage of discrepancies classified as causing possible harm may be explained by the presence of 10 years of pharmacy service with nursing education in our dialysis unit. Most of the important/clinically significant drug therapy problems were potentially solved by this interprofessional teamwork. Our study has several limitations. Although patients were assessed prospectively for discrepancies and DTPs, the evaluation of the discrepancy to cause harm was performed retrospectively as this component of the study was time-consuming and required a panel. Furthermore, only the unintentional discrepancies were evaluated for potential to cause harm and the undocumented intentional discrepancies were not and these should be evaluated in future studies. Finally, we did not evaluate specific outcome data with respect to morbidity and mortality and this should be performed as discrepancies can lead to significant harm and cost to the healthcare system.
of medication discrepancies which can potentially prevent adverse events in this vulnerable patient population.
CONCLUSION Medication discrepancies appear to be very common in patients on haemodialysis, leading to drug therapy problems and potentially adverse events. Medication reconciliation, a major component of patient safety, should be performed in all dialysis units as it can detect medication discrepancies and potentially prevent adverse drug events.
ACKNOWLEDGEMENTS None.
CONFLICT OF INTEREST No conflict of interest has been declared by the author(s).
AUTHOR CONTRIBUTIONS IMPLICATIONS FOR PRACTICE Formal interprofessional medication reconciliation practice models are essential in patients on haemodialysis as they can identify medication discrepancies and can prevent patients from experiencing adverse drug events. These models will enable healthcare practitioners to identify patients who are at high risk
MB: Principal Project Leader, conceived study, participated in design and coordination, read and approved the final manuscript. GM RR, OF: Participated in design and coordination, undertook interviews, helped to draft manuscript, read and approved the final manuscript. WC: Analysed the data, helped to draft manuscript and approved the final manuscript.
REFERENCES Barton Pai A., Cardone K.E., Manley H.J. et al. (2013). Commentary medication reconciliation and therapy management in dialysisdependent patients: need for a systematic approach. CJASN 8, 1988–1999. Cipolle R., Strand L. & Morley P. (2004). Drug therapy problems. In pharmaceutical care practice: the clinician’s guide Chapter 7, 2nd edn. United States of America: McGraw-Hill Companies. Cornish P., Knowles S., Marchesano R. et al. (2005). Unintended medication discrepancies at the time of hospital admission. Arch Intern Med 165, 424–429. Fernandes O.A. (2009). Medication reconciliation – practical tips, strategies and tools for pharmacists. Pharm Pract 25, 24–32. Kwan Y., Fernandes O.A., Nagge J.J. et al. (2007). Pharmacist medication assessments in a surgical preadmission clinic. Arch Intern Med 167, 1034–1040. Leung M., Jung J., Lau W. et al. (2009). Best possible medication history for patients on haemodialysis obtained by a pharmacy technician. Can J Hosp Pharm 62, 286–391. Manley H.J., Dryer D., McClaran M. et al. (2003). Drug record discrepancies in an outpatient electronic medical record: frequency,
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type and potential impact on patient care at a haemodialysis center. Pharmacotherapy 23, 231–239. Manley H.J., Cannella C.A., Bailie G.R. et al. (2005). Medication-related problems in ambulatoryhaemodialysis patients: a pooled analysis. Am J Kidney Dis 46, 669–680. Institute for Safe Medication Practices Canada (2011). Meication Reconciliation Kit. Getting Started Kit. Version 3. Safer Healthcare Now by the Institute for Safe Medication Practices Canada (ISMP Canada). St. Peter W. (2010). Improving medication safety in chronic kidney disease patients on dialysis through medication reconciliation. Adv Chronic Kidney Dis 17, 413–419.
Supporting Information Additional Supporting Information may be found in the online version of this article at the publisher’s web-site. Appendix I: BPMH Discrepancy Form
© 2015 European Dialysis and Transplant Nurses Association/European Renal Care Association
A FORMAL MEDICATION RECONCILIATION PROGRAMME IN A HAEMODIALYSIS UNIT CAN IDENTIFY MEDICATION DISCREPANCIES AND POTENTIALLY PREVENT ADVERSE DRUG EVENTS Winnie WY Chan1, Geetha Mahalingam1, Robert MA Richardson2,3, Olavo A Fernandes1,4, Marisa Battistella1,4 Leslie Dan Faculty of Pharmacy - University of Toronto, Toronto Ontario, Canada 2 Division of Nephrology, University Health Network; Toronto, Ontario, Canada 3 Department of Medicine, University of Toronto, Toronto, ON, Canada 4 University Health Network, Toronto General Hospital, Toronto, Ontario, Canada
1
Chan W.W.Y., Mahalingam G., Richardson R.M.A., Fernandes O.A., Battistella M. (2015). A formal medication reconciliation programme in a haemodialysis unit can identify medication discrepancies and potentially prevent adverse drug events. Journal of Renal Care xx(xx), 1–6.
SUMMARY Background: Patients on haemodialysis have been identified as high-risk for medication discrepancies and adverse drug events. Medication reconciliation is an important patient safety initiative to prevent adverse drug events. The primary objective of our study was to determine the number and types of medication discrepancies and drug therapy problems (DTPs) identified in patients on heamodialyisis. Our second objective was to assess the potential clinical impact and severity of all unintentional medication discrepancies identified. Methods: Patients in an academic haemodialysis unit were interviewed to obtain a best possible medication history (BPMH) between May and August 2010. The BPMH was documented and discrepancies were identified, classified and resolved with the interprofessional team. An interprofessional panel conducted a discrepancy clinical impact assessment for potential adverse drug events. Results: Two hundred and twenty-eight patients on haemodialysis were interviewed and 512 discrepancies were identified for 151 patients (3.4 discrepancies per patient). Of these, 174 (34%) were undocumented intentional discrepancies and 338 (66%) were unintentional discrepancies. The unintentional discrepancies were classified as 21% omissions, 36% commissions and 43% incorrect dose/frequency. Most drug therapy problems were related to patient taking a medication that was not indicated (25%), medication required but patient not taking (25%), patient not willing to take the medication as prescribed (28%) or incorrect dosing of a drug (20%). Overall, 6% of discrepancies were classified as clinically significant potential adverse drug events. Conclusion: Medication discrepancies appear to be common in patients on haemodialysis. Formal interprofessional medication reconciliation practice models are essential to identify discrepancies and prevent patients from experiencing adverse drug events.
K E Y W O R D S Adverse events Haemodialysis Medication reconciliation BIODATA Marisa Battistella is a clinical pharmacist in the nephrology programme at the University Health Network and Assistant Professor at the University of Toronto, Leslie Dan Faculty of Pharmacy. As Pharmacy Clinician Scientist, Marisa’s primary research interests are in the areas of medication safety and efficacy including pharmacokinetics and pharmacogenomics in the dialysis population. CORRESPONDENCE
Dr. Marisa Battistella, 200 Elizabeth Street, Toronto, ON, Canada M5G 2C4 Tel.: þ1 416-340-4800 ext 3207 Fax: þ1 416-340-3685 Email: [email protected]
INTRODUCTION Medication reconciliation is a formal process in which healthcare professionals partner with patients to ensure accurate and complete medication information is properly documented. It involves a systematic process for obtaining a best possible medication history (BPMH) and then comparing that information to medication orders in order to identify and resolve medication discrepancies and prevent adverse events (Kwan et al. 2007; Fernandes, 2009; Barton et al. 2013; Barton Pai et al. 2013). Patients on haemodialysis have an average of five comorbidities and are often on at least ten to twelve medications (Manley et al. 2003). Due to the complexities of their disease states and complicated medication regimen, patients on haemodialysis
© 2015 European Dialysis and Transplant Nurses Association/European Renal Care Association
Journal of Renal Care 2015
1
Chan et al.
have been identified as a population at high risk for medication discrepancies and adverse drug events (Manley et al. 2003; Manley et al. 2005). One study identified at least one medication discrepancy in the drug records of 60% of patients on haemodialysis. In total, 113 discrepancies were identified in 38 patients over five months, resulting in an average of 3 discrepancies per patient. The authors speculated that patients were at risk for adverse drug events (49.6%) or making dosing errors (34.5%) if patients were started on medications based on their drug records (Manley et al. 2003). As medication discrepancies can be translated into medication errors, it is important to differentiate whether these discrepancies are considered as undocumented intentional or unintentional. An undocumented intentional discrepancy refers to medication change made by another healthcare professional but not listed on the medication record, whereas an unintentional discrepancy refers to medication change made inadvertently or deliberately by the patient without the knowledge of the healthcare team (Kwan et al. 2007). A study identified 358 discrepancies in 93 patients on haemodialysis over four months, in which 210 (59%) were undocumented intentional discrepancies and 148 (41%) were unintentional. The clinical effect of the unintentional discrepancies was further categorised by pharmacists into 3 classes based on the definition by Cornish et al. (2005). Class 1 discrepancies were the ones unlikely to cause patient discomfort or clinical deterioration. Class 2 discrepancies were the ones having the potential to cause moderate discomfort or clinical deterioration. Class 3 discrepancies were the ones that were thought to have the potential to cause severe discomfort or clinical deterioration (Cornish et al. 2005). Fifteen percent of the unintentional discrepancies were considered to have the potential to cause clinical deterioration or harm to patients (Leung et al. 2009). Currently published literature mainly focuses on the numbers and types of discrepancies and drug therapy problems in patients on haemodialysis. Information regarding the clinical impact and severity of unintentional medication discrepancies in the dialysis population is limited. The primary objective of our study was to determine the number and types of medication discrepancies and drug therapy problems (DTPs) identified in patients on haemodialysis. Our second objective was to assess the potential clinical impact and severity of all unintentional medication discrepancies identified.
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METHODS This was a prospective observational study conducted at the haemodialysis unit of a tertiary care university affiliated teaching hospital in Toronto, Ontario, Canada. All patients receiving haemodialysis in the unit between May and August 2010, and not requiring an interpreter were included. STUDY DESIGN A pharmacy student (G.M.) and nurse (A.M.) were trained to obtain BPMH according to the hospital’s standardised pharmacy departmental protocol. To ensure consistency in the medication history gathering process between the two interviewers, they were required to go through a BPMH validation process upon completion of their training. BPMH involves a systematic patient interview as well as verification of information with more than one source. For example, the interviewers would contact community pharmacies and physicians, inspect medication vials and review government medication databases, patient’s medication list and previous patient health records. The information gathered included the drug name, dose, frequency and route of administration for each medication a patient was currently taking (Fernandes, 2009). BPMH obtained by the interviewer was then compared with the current medication profile in patient’s chart. All medication discrepancies identified were recorded on a discrepancy form (Appendix 1) and brought to attention of the clinical pharmacist for further investigation. These discrepancies were then classified and resolved with the interprofessional team. The pharmacist assessed each discrepancy and categorised them as undocumented intentional or unintentional. Unintentional discrepancies were subcategorised as omission, commission, wrong dose or wrong frequency. Omission is one in which medication taken by the patient is not listed on haemodialysis medication record. Commission happens when the patient is no longer taking the medication but it is still listed on haemodialysis medication record (Leung et al. 2009). The pharmacist was also responsible for classifying the types of drug therapy problems (DTPs) identified with the discrepancies. DTPs were classified according to the seven categories proposed by Cipolle and others: unnecessary drug therapy (no clinical indication at this time), additional drug therapy required for clinical indication, drug not effective in producing response (ineffective), dosage too low to produce the desired response, drug causing an adverse
© 2015 European Dialysis and Transplant Nurses Association/European Renal Care Association
MEDICATION RECONCILIATION IN HAEMODIALYSIS
reaction (not dose related), dose too high resulting in side effects and patient not able or willing to take drug therapy (Cipolle et al. 2004). To determine the potential clinical impact of these unintentional discrepancies, an interprofessional panel which consisted of two pharmacists (S.I. and J.V.) and one nephrologist (M.J.) conducted a discrepancy clinical impact assessment for the potential to cause patient harm based on the Institute for Safe Medication Practices Canada proposed process (Medication Reconciliation in Acute Care, 2011). To optimise the consistency of discrepancies assessments amongst the clinical evaluator team, 12 sample cases were used for training and practice. One hundred percent agreement was achieved during the training session. For each unintentional discrepancy identified, an independent facilitator read out a description to the three clinical evaluators. Each evaluator categorised medication discrepancies as “unlikely”, “possible”, or “probable” potential to cause patient harm which includes patient discomfort and/or clinical deterioration if the discrepancy is not identified and addressed (Safer Healthcare Now, 2011). Based on the suggested guideline proposed by the Institute for Safe Medication
Characteristics
Overall (N ¼ 228)
Age, median vs mean ( SD), y 60 ( 17) Total number of discrepancies 512 Gender Male 129 (57) Female 99 (43) Reason for end-stage renal disease (ESRD) Diabetes 67 (29) Hypertension 59 (26) Glomerulonephritis 46 (20) Other 56 (25) Race Caucasian 95 (42) African American 42 (18) Asian 42 (18) Asian Pacific 40 (18) Other 9 (4) Comorbidities Coronary artery disease 66 (29) Hypertension 198 (87) Peripheral vascular disease 12 (5) Cerebrovascular disease 17 (7)
Practices, the probability of causing patient harm in percentage was 0–10% for unlikely, 11–50% for possible and >50% for probable (Safer Healthcare Now, 2011). The panel, then, voted to decide the probability of causing patient harm as a group. If disagreements within the panel occurred, the panel discussed the discrepancy and potential outcome until they reached a consensus. After consensus was achieved, each evaluator was required to indicate the potential clinical severity of the discrepancy on the patient on scale between 0 (no impact on patient) and 10 (death) individually. Becasue this study was a continuous quality improvement initiative, research ethics board approval was not required as performing best possible medication histories and identifying drug therapy problems is standard of practice at our institution. Discrepancies were documented and communicated with the patient and h\health care team as per usual practice. STATISTICAL ANALYSIS All data were entered into an Excel spreadsheet for analysis. Descriptive statistics were used in this study. Categorical data were presented as proportions. Continuous data were presented as means with standard deviations.
Patients with discrepancies (N ¼ 151)
Patients without discrepancies (N ¼ 77)
60( 15.5) 512 (3.4 discrepancies/patient)
63.5 ( 13) N/A
89 (59) 62 (41)
40 (52) 37 (48)
45 41 30 35
(30) (27) (20) (23)
22 18 16 21
(29) (23) (21) (27)
59 33 27 26 6
(39) (22) (18) (17) (4)
36 9 15 14 3
(47) (12) (19) (18) (4)
45 128 10 15
(30) (85) (7) (10)
21 70 2 2
(27) (91) (3) (3)
Table 1: Baseline characteristics.
Data are given as number (percentage) unless otherwise indicated.
© 2015 European Dialysis and Transplant Nurses Association/European Renal Care Association
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Chan et al.
RESULTS A total of 290 patients on haemodialysis were approached and 62 were excluded as they required an interpreter; 228 patients were interviewed over the four-month period. The mean age of the patients was 60 17 years, and 129 (56%) were men. Table 1 provides baseline patient characteristics. Five hundred and twelve medication discrepancies were identified for 151 patients with an average of 3.4 discrepancies per patient. Of these discrepancies, 174 (34%) were undocumented intentional discrepancies and 338 (66%) were unintentional discrepancies. Ninety percent of the patients with discrepancies had at least one unintentional discrepancy. The unintentional discrepancies were classified as 73 (21%) omissions, 129 (37%) commissions and 146 (42%) incorrect dose/frequency (Figure 1). Omissions were mainly related to over-the-counter products such as vitamins, while commissions were mainly sleeping aids, blood pressure medications or phosphate binders. Incorrect dose/frequency mostly involved medications for blood pressure control. Drug therapy problems identified with the discrepancies including undocumented and unintentional were classified (Figure 2). The most common types of DTPs included patient taking a medication that was not indicated 122 (24%), medication required but patient not taking 126 (25%), patient not willing to take the medication as prescribed 142 (28%) or incorrect dosing of a drug 109 (21%). The interprofessional panel evaluated the potential clinical impact of these unintentional discrepancies. Overall, most of these discrepancies were considered by the panel to have an unlikely probability to cause
harm. However, for the 6% of discrepancies that were classified as “possible” in causing harm, the severity of impact was rated at 5.6 on a scale of 0 (no impact on patient) to 10 (death), which was deemed clinically significant. Some examples of discrepancies that were considered “possible” in causing harm included patient taking narcotic medication not listed on medication profile, patients taking one-half dose of the ordered phosphate binders and patients being non-compliant to blood pressure medications and anticoagulant.
DISCUSSION Medication discrepancies may lead to medication errors and adverse drug events. Our results are consistent with previous studies; an average of 3.4 discrepancies were identified per patient (Manley et al. 2003; Leung et al. 2009). Of the 512 medication discrepancies found, 34% were undocumented intentional discrepancies and 66% were unintentional discrepancies. The percentage (34%) of undocumented intentional discrepancies was lower than 59% as reported by Leung and colleagues (Leung et al. 2009). Even though our medication record had less undocumented intentional discrepancies compared to other studies, there is significant amount of discrepancies and it is a signal for better documentation. At our dialysis centre, the medication profile is updated by nurses, pharmacists or pharmacy students approximately once every month. Despite the frequent medication list update, it often does not accurately reflect patient’s current medication regimen. As patients on haemodialysis have numerous comorbidities, these patients are prone to hospitalisations and are
Figure 1: Classification of unintentional discrepancy.
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MEDICATION RECONCILIATION IN HAEMODIALYSIS
Figure 2: Frequency of drug therapy problems.
followed by multiple specialists. Changes to patient’s medications are made during hospitalisations and specialist consultations; however, most of the time neither the patient nor the consultant communicates these changes to the dialysis team. This finding suggests a need for improvement in communication between the different consultation services. One of the strategies is to provide patients on haemodialysis with printed copy of his or her reconciled medication list at least quarterly or at the time of any change in medication (St. Peter, 2010). This process may help minimise the number of undocumented intentional discrepancies. The majority of discrepancies (66%) were unintentional, and 21% were classified as omissions. It is not surprising medications that were missed on the medication profile were mostly over-thecounter products such as vitamins. Another 36% of the unintentional discrepancies were commissions. Frequent changes to patients’ medications and multiple prescribers probably account for these discrepancies. Finally, 42% of the discrepancies were related to medications listed as an incorrect dose or the wrong frequency. Many medications such as phosphate binders, erythropoiesis stimulating agents and antihypertensives used
for dialysis patients require close monitoring and careful titration. It is imperative for the team to judiciously inform the patients of changes to medication regimens and that the patients completely understand these changes. The most common type of drug therapy problems identified was patient not willing to take the medication as prescribed. Patients on haemodialysis take approximately 10–12 medications, and thus are known to be non-adherent to their medications (Manley et al. 2003). Two classes of medications were identified as “targeted” medications: phosphate binders and blood pressure medications. This has identified opportunities for the dialysis team to provide a more focused patient education to improve adherence on those medications. In addition to identifying the number of medication discrepancies and categorising them into drug therapy problems, this study evaluated the potential clinical impact of the unintentional medication discrepancies by an interprofessional panel assessment. Most of the discrepancies identified were deemed unlikely to cause harm; however, in the 6% that had a possibility to cause harm, the severity of impact was considered clinically significant.
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The low percentage of discrepancies classified as causing possible harm may be explained by the presence of 10 years of pharmacy service with nursing education in our dialysis unit. Most of the important/clinically significant drug therapy problems were potentially solved by this interprofessional teamwork. Our study has several limitations. Although patients were assessed prospectively for discrepancies and DTPs, the evaluation of the discrepancy to cause harm was performed retrospectively as this component of the study was time-consuming and required a panel. Furthermore, only the unintentional discrepancies were evaluated for potential to cause harm and the undocumented intentional discrepancies were not and these should be evaluated in future studies. Finally, we did not evaluate specific outcome data with respect to morbidity and mortality and this should be performed as discrepancies can lead to significant harm and cost to the healthcare system.
of medication discrepancies which can potentially prevent adverse events in this vulnerable patient population.
CONCLUSION Medication discrepancies appear to be very common in patients on haemodialysis, leading to drug therapy problems and potentially adverse events. Medication reconciliation, a major component of patient safety, should be performed in all dialysis units as it can detect medication discrepancies and potentially prevent adverse drug events.
ACKNOWLEDGEMENTS None.
CONFLICT OF INTEREST No conflict of interest has been declared by the author(s).
AUTHOR CONTRIBUTIONS IMPLICATIONS FOR PRACTICE Formal interprofessional medication reconciliation practice models are essential in patients on haemodialysis as they can identify medication discrepancies and can prevent patients from experiencing adverse drug events. These models will enable healthcare practitioners to identify patients who are at high risk
MB: Principal Project Leader, conceived study, participated in design and coordination, read and approved the final manuscript. GM RR, OF: Participated in design and coordination, undertook interviews, helped to draft manuscript, read and approved the final manuscript. WC: Analysed the data, helped to draft manuscript and approved the final manuscript.
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type and potential impact on patient care at a haemodialysis center. Pharmacotherapy 23, 231–239. Manley H.J., Cannella C.A., Bailie G.R. et al. (2005). Medication-related problems in ambulatoryhaemodialysis patients: a pooled analysis. Am J Kidney Dis 46, 669–680. Institute for Safe Medication Practices Canada (2011). Meication Reconciliation Kit. Getting Started Kit. Version 3. Safer Healthcare Now by the Institute for Safe Medication Practices Canada (ISMP Canada). St. Peter W. (2010). Improving medication safety in chronic kidney disease patients on dialysis through medication reconciliation. Adv Chronic Kidney Dis 17, 413–419.
Supporting Information Additional Supporting Information may be found in the online version of this article at the publisher’s web-site. Appendix I: BPMH Discrepancy Form
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