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          Abstract

          We thank Weersink and colleagues for their interest in our study and reference to available practical guidance to support medication safety in cirrhosis.1 Their recommendations are a valuable resource to assist prescribers and may reduce harm due to medication‐related problems (MRPs), including “wrong drug choice,” “suboptimal dose,” and “adverse drug reactions.”2 It will be important to explore the impact of “unsafe” medications on patient outcomes in a prospective study, including the effectiveness of Weersink’s recommendations to improve medication safety. In addition to prescription of potentially inappropriate pharmacotherapy, there are several elements of a patient’s prescribed regimen that may lead to MRPs in chronic liver disease (CLD). People with decompensated cirrhosis are often required to manage a regimen that includes a variety of therapeutic classes, time‐specific and medication‐specific dosing instructions, and self‐monitoring requirements. Additionally, changes to prescribed therapies are common due to the natural history and complications of advanced liver disease. Complex and frequently changing medication regimens can lead to confusion and affect patients’ ability to self‐manage. Consequently, “safe” medications, such as diuretics and lactulose, can still be associated with harmful MRPs and hospitalization. Among the intervention patients (n = 57) enrolled in our randomized‐controlled trial of pharmacist‐led medication education intervention,2 over 72% of patients had ≥1 change to their medication regimen and over 22% had ≥5 changes between each intervention time point. Of these changes, 66.8% were to non‐CLD therapies. The mean Medication Regimen Complexity Index (MRCI) score3 at recruitment was 25.6 ± 13.5, which is higher than a previously reported score of 20 in nonadherent pre‐liver transplant patients.4 Non‐CLD medications represented over three quarters of the total frequency and additional instruction complexity scores, consistent with the proportion of non‐CLD medicines consumed by patients.2 While mean MRCI score did not change significantly between time points among surviving patients, those that died (n = 8) had a higher mean MRCI score at baseline (35.9 ± 18.3 vs. 23.9 ± 12.0; P = 0.019). Medication management in cirrhosis is complex, and improving medication safety requires consideration of multiple elements of a patient’s regimen from the perspective of the prescriber and the patient. We agree with Weersink and colleagues that tailored pharmacotherapy is needed to reduce unnecessary complexity and minimize use of unsafe or overprescribed medications (i.e. proton pump inhibitors) that may contribute to MRPs. There is a need for greater clinician awareness of available resources to support safe prescribing, especially outside the specialist setting given the complexity and risk for MRPs associated with non‐CLD therapies.

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          Medication‐Related Problems in Outpatients With Decompensated Cirrhosis: Opportunities for Harm Prevention

          People with decompensated cirrhosis are often prescribed a complex regimen of therapeutic and prophylactic medications. In other chronic diseases, polypharmacy increases the risk of medication misadventure and medication‐related problems (MRPs), with associated increased morbidity, mortality, and health care costs. This study examined MRPs in a cohort of ambulatory patients with a history of decompensated cirrhosis who were enrolled in a randomized controlled trial of a pharmacist‐led, patient‐oriented medication education intervention and assessed the association between MRPs and patient outcomes. A total of 375 MRPs were identified among 57 intervention patients (median, 6.0; interquartile range, 3.5‐8.0 per patient; maximum 17). Nonadherence (31.5%) and indication issues (29.1%) were the most prevalent MRP types. The risk of potential harm associated with MRPs was low in 18.9% of instances, medium in 33.1%, and high in 48.0%, as categorized by a clinician panel using a risk matrix tool. Patients had a greater incidence rate of high‐risk MRPs if they had a higher Child‐Pugh score (incidence rate ratio [IRR], 1.31; 95% confidence interval [CI], 1.09‐1.56); greater comorbidity burden (IRR, 1.15; 95% CI, 1.02‐1.29); and were taking more medications (IRR, 1.12; 95% CI, 1.04‐1.22). A total of 221 MRPs (58.9%) were resolved following pharmacist intervention. A greater proportion of high‐risk MRPs were resolved compared to those of low and medium risk (68.9% versus 49.7%; P < 0.001). During the 12‐month follow‐up period, intervention patients had a lower incidence rate of unplanned admissions compared to usual care (IRR, 0.52; 95% CI, 0.30‐0.92). Conclusion: High‐risk MRPs are prevalent among adults with decompensated cirrhosis. Pharmacist intervention facilitated identification and resolution of high‐risk MRPs and was associated with reduced incidence rate of unplanned hospital admissions in this group.
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            Factors Associated with Medication Non-adherence in Patients with End-Stage Liver Disease.

            Low medication adherence is known to contribute to worse health outcomes in the general population.
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              Guidance for Safety and Dosing of Medicines in Patients With Cirrhosis Is Available

              To the Editor: We read with great interest the article by Hayward et al.1 describing medication‐related problems (MRPs) in patients with decompensated cirrhosis. They found 375 MRPs among 57 patients randomized to a pharmacist‐led intervention. Almost half of these MRPs possessed a high risk of potential harm to the patient and led to a higher rate of unplanned admissions. The patients included in their study used various medicines in complex regimens.1 The vast majority of these medicines were used for conditions other than the chronic liver disease and were not prescribed by gastroenterologists. We agree with the authors that management and monitoring of patients with cirrhosis is challenging and that physicians may benefit from prescription guidance. We disagree with their statement that a list of potentially inappropriate medicines for decompensated cirrhosis is lacking. While such guidance was absent at the start of their study, we published practical guidance for the safe use of over 200 medicines for patients with cirrhosis in 2018 in a paper that is freely available (https://www.drugsinlivercirrhosis.org).2 This guidance consists of advice on the use of a medicine in patients with cirrhosis (e.g. “can be used” or “avoid the use”) and, if necessary, joined by a dosing recommendation.2 It includes some well‐known potentially inappropriate medicines (e.g., nonsteroidal anti‐inflammatory drugs). It also includes medicines that have less known inappropriateness in cirrhosis, such as sertraline. Exposure to sertraline is 4 times higher in patients with compensated cirrhosis compared to healthy controls, and exposure is predicted to increase even more in decompensated cirrhosis.3 This endorses that guidance for prescribing is able to assist prescribers managing non‐liver‐related comorbidities in these patients. We also studied the potential impact of our guidance in a retrospective real‐world study of patients with cirrhosis. Potentially unsafe medications were prescribed in 60% of the 5,618 included patients during follow‐up.4 We have not studied the impact of our guidance in a prospective study or on actual patient outcomes. An interesting approach would be to combine application of our guidance with a medication review, as described by Hayward et al., and examine the effect on hospital admissions and mortality. In conclusion, tailored pharmacotherapy is needed in cirrhosis, especially in patients with decompensated cirrhosis as they are susceptible to MRPs. Prescribers can be supported by practical guidance on safe prescribing and a high‐quality medication review.
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                Author and article information

                Journal
                Hepatol Commun
                Hepatol Commun
                10.1002/(ISSN)2471-254X
                HEP4
                Hepatology Communications
                John Wiley and Sons Inc. (Hoboken )
                2471-254X
                10 July 2019
                September 2019
                : 3
                : 9 ( doiID: 10.1002/hep4.v3.9 )
                : 1283-1284
                Affiliations
                [ 1 ] Centre for Liver Disease Research The University of Queensland, Translational Research Institute Woolloongabba Australia
                [ 2 ] Pharmacy Department Princess Alexandra Hospital Woolloongabba Australia
                [ 3 ] QIMR Berghofer Medical Research Institute Herston Australia
                [ 4 ] School of Pharmacy University of Queensland Woolloongabba Australia
                [ 5 ] School of Medicine and Public Health University of Newcastle Callaghan Australia
                [ 6 ] Department of Gastroenterology and Hepatology Princess Alexandra Hospital Woolloongabba Australia
                Author information
                https://orcid.org/0000-0001-6115-3420
                https://orcid.org/0000-0002-8823-3006
                https://orcid.org/0000-0002-0149-444X
                https://orcid.org/0000-0002-6716-1605
                https://orcid.org/0000-0002-8614-0199
                https://orcid.org/0000-0001-5008-8061
                Article
                HEP41398
                10.1002/hep4.1398
                6719738
                42b16d01-065d-470e-82d1-8f9af9556076
                © 2019 The Authors. Hepatology Communications published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                Page count
                Figures: 0, Tables: 0, Pages: 2, Words: 1153
                Funding
                Funded by: Metro South Health Program Grant
                Funded by: National Health and Medical Research Council
                Award ID: 1083090
                Categories
                Correspondence
                Correspondence
                Custom metadata
                2.0
                hep41398
                September 2019
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.8 mode:remove_FC converted:03.09.2019

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