Medication-related Harm Research Articles

"Doctor, would it surprise you if there were prescribing errors in this patient's medication?" Identifying eligible patients for in-hospital pharmacotherapeutic stewardship: A matched case-control study.

Evaluating a patient's medication list is critical to reduce prescribing errors (PEs), but is a labour- and time-intensive process. Identification of patients at risk of PEs could improve the allocation of scarce time and resources, but currently available prediction tools are not effective. To investigate whether ward doctors can identify patients at risk of PEs. This prospective matched case-control study was conducted on three clinical wards in an academic hospital. Otolaryngology and oncology ward doctors used clinical intuition to select patients requiring a clinical medication review (CMR) (cases). These patients were then matched 1:1 on age (±10years) and number (±1) of prescriptions with patients not selected for CMRs on the internal medicine and upper gastrointestinal surgery ward (controls). A multidisciplinary in-hospital pharmacotherapeutic stewardship team assessed the prevalence of PEs. A total of 387 patients with 5191 prescriptions were included. Overall, 799 PEs affecting 279 patients (72.1%) were identified. Most PEs (58.8%) occurred during hospitalization. There were no significant differences in age, number of prescriptions, sex, renal function or documented allergies or intolerances between the cases and controls or between controls and other patients who did not receive a CMR. The incidence of PEs was higher in cases than in controls (97.5% vs 72.5%, odds ratio= 14.8, 95% confidence interval [CI] 1.8-121.1, P= .002)). The rate of PEs was three times higher in cases than in controls (incidence rate ratio=3.0, 95% CI 2.3-4.0, P< .001). Ward doctors can effectively identify patients with PEs, and thus at risk of medication-related harm, using clinical intuition.

Designing an Intervention to Improve Medication Safety for Nursing Home Residents Based on Experiential Knowledge Related to Patient Safety Culture at the Nursing Home Front Line: Cocreative Process Study.

Despite years of attention, avoiding medication-related harm remains a global challenge. Nursing homes provide essential health care for frail older individuals, who often experience multiple chronic diseases and polypharmacy, increasing their risk of medication errors. Evidence of effective interventions to improve medication safety in these settings is inconclusive. Focusing on patient safety culture is a potential key to intervention development as it forms the foundation for overall patient safety and is associated with medication errors. This study aims to develop an intervention to improve medication safety for nursing home residents through a cocreative process guided by integrated knowledge translation and experience-based codesign. This study used a cocreative process guided by integrated knowledge translation and experience-based co-design principles. Evidence on patient safety culture was used as an inspirational source for exploration of medication safety. Data collection involved semistructured focus groups to generate experiential knowledge (stage 1) to inform intervention design in a multidisciplinary workshop (stage 2). Research validation engaging different types of research expertise and municipal managerial representatives in finalizing the intervention design was essential. Acceptance of the final intervention for evaluation was aimed for through contextualization focused on partnership with a municipal advisory board. An abductive, rapid qualitative analytical approach to data analysis was chosen using elements from analyzing in the present, addressing the time-dependent, context-bound aspects of the cocreative process. Experiential knowledge was represented by three main themes: (1) closed systems and gaps between functions, (2) resource interpretation and untapped potential, and (3) community of medication safety and surveillance. The main themes informed the design of preliminary intervention components in a multidisciplinary workshop. An intervention design process focused on research validation in addition to contextualization resulted in the Safe Medication in Nursing Home Residents (SAME) intervention covering (1) campaign material visualizing key roles and responsibilities regarding medication for nursing home residents and (2) "Medication safety reflexive spaces" focused on social and health care assistants. The cocreative process successfully resulted in the multifaceted SAME intervention, grounded in lived experiences shared by some of the most important (but often underrepresented in research) stakeholders: frontline health care professionals and representatives of nursing home residents. This study brought attention toward closed systems related to functions in medication management and surveillance, not only informing the SAME intervention design but as opportunities for further exploration in future research. Evaluation of the intervention is an important next step. Overall, this study represents an important contribution to the complex field of medication safety. RR2-10.2196/43538.

Under-Prescription of Drugs in the Elderly Population of Western Romania: An Analysis Based on STOPP/START Version 2 Criteria.

Background/Objectives: Numerous European countries, including Romania, are facing the concern of rapid ageing of their populations. Moreover, Romania's life expectancy ranks among the lowest in the European Union. In light of this, it is imperative that the assessment of medication-related harm be given national priority in order to secure and enhance pharmacotherapy and the medical act. In this study, we sought to describe and evaluate the under-prescribing practices among the Romanian elderly population. Methods: We conducted a cross-sectional study in urban areas of two counties in Western Romania (Timis and Arad) from November 2017 to February 2019. We collected chronic electronic prescriptions issued for elderly patients (>65 years old) with chronic conditions. The medication was prescribed by generalist or specialist physicians for periods ranging between 30 and 90 days. To assess inappropriate prescribing behaviours, a multidisciplinary team of specialists applied the Screening Tool of Older Persons' Prescriptions/Screening Tool to Alert to Right Treatment (STOPP/START) v.2 criteria to the collected prescriptions. Results: Within the 1498 prescriptions included in the study, 57% were issued to females, the mean age was 74.1 ± 6.95, and the average number of medicines per prescription was 4.7 ± 1.51. The STOPP criteria most commonly identified were the (1) long treatment duration (23.6%) and (2) prescription of neuroleptics (14.6%) or zopiclone (14.0%) as medications that increase the risk of falls. According to START criteria, the following medicines were under-prescribed: (1) statins (47.4%), (2) beta-blockers (24.5%), (3) antiresorptive therapy (10.0%), and (4) β2-agonists and muscarinic antagonists for chronic obstructive pulmonary disease (COPD) (4.5%). Within our study group, the prevalence of potentially inappropriate medications was 18.58%, whereas the prevalence of potential prescribing omissions was 49.2%. Conclusions: To decrease medication-related harm and morbid-mortality, and to increase the quality of life for elderly people in Romania, immediate actions are needed from national authorities. These actions include reinforcing primary care services, providing periodic training for physicians, implementing medication review services by pharmacists, and utilising electronic health records at their full capacity.

Medication-related harm (MRH) in Egyptian older adults post-hospital discharge: a health-care challenge

Medication-related harm (MRH) in Egyptian older adults post-hospital discharge: a health-care challenge

Identification of risk factors for adverse drug events in a general hospital.

Adverse events (AEs), and particularly adverse drug events (ADEs), represent a health problem as they can cause permanent damage or death. Understanding the frequency, location, and causes of ADEs can prevent harm to patients. The Global Trigger Tool, produced by the Institute for Healthcare Improvement (GTT/IHI), is widely used to identify AEs. Recognizing the profile of patients who suffer ADEs can reveal clinical or individual characteristics that predispose to the occurrence of AEs. A cross-sectional study was carried out through a retrospective analysis of 120 medical charts of patients discharged from hospital between October 2020 and April 2021. Patients over 18 years old, with a length of stay of more than 24 h, were included. The list of triggers used was from the medication module of the GTT/IHI, which was adapted for use in the institution. Two primary reviewers and a medical reviewer applied this tool. The primary reviewers independently assessed the randomized charts. A meeting to achieve consensus among the reviewers was held every 2 weeks to validate the identified ADEs; classifications were based on harm severity. Multivariate logistic regression was utilized to assess the variables that predicted the occurrence of ADEs, using the backward stepwise method. A total of 43 ADEs were identified, with a frequency of 36 per 100 admissions (43/120). Of these, five ADEs (12%) were responsible for patients being admitted to hospital. In the case of in-hospital ADEs, there were 42.2 per 1000 patients/day. The clinical manifestation of altered kidney function (16%) and the anatomical drug group of the nervous system (33%) were the most frequent ADEs. The multivariate logistic regression model was significant (×2 = 44.960, P < .001), indicating that factors such as: known drug allergy [odds ratio 5.728; 95% confidence interval (CI): 1.249, 26.274, P = .025]; being clinically hospitalized (odds ratio 7.504; 95% CI: 1.654, 34.037; P = .009); number of medicines used (odds ratio 1.100; 95% CI: 1.054, 1.148; P < .001); and being under the care of internal medicine (odds ratio 3.633; 95% CI: 1.257, 10.511; P = .017) were predictor variables associated with the occurrence of ADEs. A significant percentage of hospitalized patients experienced at least one ADE, with rates surpassing those found in similar studies. The GTT/IHI effectively assessed medication-related harm, emphasizing the need for tailored triggers based on population characteristics. Predictor variables can inform preventive strategies. Overall, the tool facilitated a localized risk assessment of medication use.

Medication management issues perceived by pharmacists and disability caregivers while supporting people with disability

BackgroundAustralia has a notable gap in guidance for pharmacists, caregivers and disability service providers in: (i) supporting people with disabilities (PWD) within the medication management cycle, (ii) understanding their obligations for providing high quality care, and (iii) preventing medication-related harm. ObjectiveThe objective of this study was to identify medication management issues for PWD from the perspective of disability caregivers and pharmacists when supporting PWD with their medication. MethodsA qualitative study design using semi-structured interviews of pharmacists and disability caregivers was undertaken across six different states or territories in Australia. ResultsInterviews were conducted with registered pharmacist participants (n=10), and disability workers (n=10). Seven themes emerged for both pharmacists and caregivers, with most sub-themes and codes concordant between the two cohorts. Clinical issues, particularly related to polypharmacy and psychotropic use; confidence in providing medicines and medication information accurately to PWD; practical and behavioural issues caregivers experienced when administering medication; challenges in providing individualised and person-centred care to PWD; inadequate communication and transfer of information between healthcare professionals, caregivers, and PWD; insufficient disability awareness training for pharmacists and medication training for caregivers; and challenges working with provider organisations within the current practice environment were described. ConclusionsThis study highlighted seven areas where issues were perceived to arise in medication management for PWD. By understanding the issues perceived by those directly providing care, it may be possible to improve medication management. Further research is needed to understand the perceived role of pharmacists in supporting medication management for PWD and their caregivers, and how enabling pharmacists scope might reduce medication-related risks and support QUM in this sector.

Identifying interventions that improve medication safety & rational use of medicines in India.

Background & objectives Medication-related harm is known to be the cause for about 1/10th of hospitalizations. Some estimates from India show that about 90 per cent of medicines consumed are inessential or irrational and contribute towards high out-of-pocket expenditure on health. In this context, the Indian Council of Medical Research in 2022 constituted a National Task Force (NTF) to explore possible solutions that could improve safe and rational use of medicines (SRUMs). The objective of this study was to identify research ideas in the field of SRUM through a survey of relevant stakeholders, and further to prioritize the research ideas using a pre-identified set of criteria. Methods The responses from the identified stakeholders were assessed using the Child Health and Nutrition Research Initiative method, which is an established research priority-setting methodology. First, the NTF asked for two to six research ideas from relevant Indian and global stakeholders on solutions to improve SRUM. The ideas were checked for duplicates, re-phrased where necessary and classified into various sub-themes. Subsequently, the research ideas were scored by Indian experts with relevant technical expertise using a pre-defined set of five criteria: innovativeness, effectiveness, translational value, answerability and applicability. Each research idea received from a stakeholder was assigned a score under each of the five criteria. The overall research priority score was calculated as a mean of all five criteria-specific scores and converted into a percentage. Results The final output of the prioritization process was a list of research ideas or questions, ranked by their scores. Total 209 unique ideas were received from 190 respondents, which were scored by 27 experts. The top three research topics on medication safety focused on cost-effective strategies for improving antimicrobial stewardship, safe use of poly-pharmacy in geriatric patients and drug take-back policy interventions. Regarding the rational use of medicine, the top three topics included testing mobile application-based antimicrobial stewardship interventions, development of diagnostics for antimicrobial resistance, and behavioural interventions. Interpretation & conclusions Several priority ideas found in this study also align with those of global priority, e.g., safe disposal practices and enhanced pharmacovigilance, rational use of medicines. Patient engagement, which underlines many of the top scoring ideas found in this study, is also inclined with the top research priorities reported by the WHO priority exercise on research into the safe use of medicines. However, to the best of our knowledge, this is the first such work from a low- and middle- income country on medication safety and rational use of medicines. The findings of this research priority-setting exercise can help to guide research for the development of policy-relevant and novel interventions to improve SRUM in India.

Extracellular vesicles as the next-generation modulators of pharmacokinetics and pharmacodynamics of medications and their potential as adjuvant therapeutics.

Pharmacokinetics (PK) and pharmacodynamics (PD) are central concepts to guide the dosage and administration of drug therapies and are essential to consider for both healthcare professionals and researchers in therapeutic planning and drug discovery. PK/PD properties of a drug significantly influence variability in response to treatment, including therapeutic failure or excessive medication-related harm. Furthermore, suboptimal PK properties constitute a significant barrier to further development for some candidate treatments in drug discovery. This article describes how extracellular vesicles (EVs) affect different aspects of PK and PD of medications and their potential to modulate PK and PD properties to address problematic PK/PD profiles of drugs. We reviewed EVs' intrinsic effects on cell behaviours and medication responses. We also described how surface and cargo modifications can enhance EV functionalities and enable them as adjuvants to optimise the PK/PD profile of conventional medications. Furthermore, we demonstrated that various bioengineering strategies can be used to modify the properties of EVs, hence enhancing their potential to modulate PK and PD profile of medications. This review uncovers the critical role of EVs in PK and PD modulation and motivates further research and the development of assays to unfold EVs' full potential in solving PK and PD-related problems. However, while we have shown that EVs play a vital role in modulating PK and PD properties of medications, we postulated that it is essential to define the context of use when designing and utilising EVs in pharmaceutical and medical applications. Existing solutions for pharmacokinetics and pharmacodynamics modulation are limited. Extracellular vesicles can optimise pharmacokinetics as a drug delivery vehicle. Biogenesis and administration of extracellular vesicles can signal cell response. The pharmaceutical potential of extracellular vesicles can be enhanced by surface and cargo bioengineering. When using extracellular vesicles as modulators of pharmacokinetics and pharmacodynamics, the 'context of use' must be considered.

Pre-clinical Models for Geriatric Pharmacotherapy.

With ageing of the population worldwide and discovery of new medications for prevention and management of age-related conditions, there is increasing use of medications by older adults. There are international efforts to increase the representativeness of participants in clinical trials to match the intended real-world users of the medications across a range of characteristics including age, multimorbidity, polypharmacy and frailty. Currently, much of the data on medication-related harm in older adults are from pharmacovigilance studies. New methods in pre-clinical models have allowed for measurement of exposures (such as chronic exposure, polypharmacy and deprescribing) and outcomes (such as health span functional measures and frailty) that are highly relevant to geriatric pharmacotherapy. Here we describe opportunities for design and implementation of pre-clinical models that can better predict drug effects in geriatric patients. This could improve the translation of new drugs from bench to bedside and improve outcomes of pharmacotherapy in older adults.

Frequency and preventability of adverse drug events in the outpatient setting

BackgroundLimited data exist regarding adverse drug events (ADEs) in the outpatient setting. The objective of this study was to determine the incidence, severity, and preventability of ADEs in the outpatient...

Assessment of a Geriatric Evaluation and Management in the Home (GEMITH) Service at a Quaternary Hospital: A Retrospective Observational Study.

Background: The increasing aging population in Australia has created a higher demand for specialist geriatric services within hospitals. A Geriatric Evaluation and Management in the Home (GEMITH) service was implemented at a quaternary Queensland hospital. The GEMITH service was unique as it incorporated a specialist pharmacist into the multidisciplinary team. Objective: To determine the medication safety and quality impact of the GEMITH service by evaluating the type and clinical significance of specialist pharmacist interventions. Methods: This was retrospective observational study of clinical interventions made by the GEMITH pharmacist for patients admitted to the service between October 2020 to April 2021. All pharmacist interventions were rated for their clinical significance using the Society of Hospital Pharmacists of Australia (SHPA) risk classification system. The ratings were undertaken by a panel of three pharmacists that independently assessed the interventions, coming together for final discussion. A narrative analysis of the interventions were derived through group consensus. Results: There was a total of 119 admissions to the GEMITH service, with 132 clinical interventions made by the specialist geriatric pharmacist. The majority (47%) of interventions were considered as low risk interventions, although high- (21%) and extreme-risk (2%) interventions still occurred. The most common type of intervention (32%) involved medication reconciliation. Other intervention types included monitoring recommendations, dosing interventions, and deprescribing suggestions. Conclusion: Multiple clinical interventions were made by the GEMITH pharmacist, which prevented possible and significant medication-related harm. This demonstrated the quality impact of the specialist pharmacist in improving medication safety for geriatric patients.

#325 Prescribing patterns in older people with advanced chronic kidney disease approaching the end of life

Abstract Background and Aims Advancing age and chronic kidney disease (CKD) are risk factors for polypharmacy—the regular daily intake of &amp;gt;5 medications. Polypharmacy is a key action area for the World Health Organization in its effort to reduce global medication-related harm. Deprescribing, the systematic review and rationalisation of potentially inappropriate medications, is a proposed way of addressing polypharmacy. Deprescribing is particularly relevant near the end of life, when preventative treatments provide less benefit. Prescribing practices for elderly people with advanced CKD in the last years of life are currently unknown. The aim of this study was to describe prescribing and deprescribing patterns in such a cohort. Method The EQUAL study [1] is an international, prospective cohort study of people ≥65 years with an incident estimated glomerular filtration rate (eGFR) of ≤20 ml/min/1.73 m2. We analysed data from participants who died during follow up, including 3-6 monthly study-visit-collected prescribed oral medications (POMs). Generalized additive models were used to explore trends leading up to death in the total number of POMs, and the proportion of participants taking specific medications. Data are presented for medications: a) identified as targets for deprescribing in the elderly with CKD (statins, proton-pump inhibitors (PPIs) and antihypertensives—alpha-blockers, beta-blockers, calcium-channel blockers (CCBs), diuretics and renin-angiotensin-aldosterone inhibitors (RAASis)); b) used for symptom control in kidney failure (opioids and gabapentinoids); and c) prescribed to &amp;gt;30% of the cohort (allopurinol, aspirin, vitamin D). Results Data from 563 participants were analysed, comprising 2793 study visits (median follow-up time 2.2 years (interquartile range (IQR) 1.1-3.8) pre-death), and 22,200 POMs. At baseline, mean age was 77.8 years (standard deviation (SD) 6.7), median eGFR 18.1 mls/min/1.73 m2 (IQR 15.0-21.2), and 87.2% were experiencing polypharmacy. The number of POMs increased over the time approaching death (Fig. 1)—7.3 (95% confidence interval (CI) 6.9-7.7) at 5 years pre-death, 8.3 (95% CI 8.0-8.6) at 2.5 years pre-death, and 8.7 (95% CI 8.4-9.1) at death. At their final study visit 90.1% were experiencing polypharmacy. Trends in the proportion of individuals prescribed specific medications differed by POM class (Fig. 2). Opioids, diuretics and PPIs increased in the last years of life; statins, RAASis, alpha-blockers and CCBs decreased; and allopurinol, beta-blockers and gabapentinoids remained stable. Aspirin and vitamin D showed phasic patterns, increasing then decreasing. Conclusion Elderly people with advanced CKD experience increasing levels of polypharmacy as they approach the end of life. Although there is evidence that certain medication classes are being deprescribed, this is outweighed by increased prescribing of other agents. Previous analyses of EQUAL decedents have shown that blood pressure decreases pre-death—we show this is despite reductions in most classes of antihypertensives. Our work suggests a high reliance upon pharmacological interventions (both symptom-directed and preventative) for older people with CKD who are approaching death. We cannot ascertain whether this reflects personalised prescribing, aligned with individuals’ preferences and prognoses; however, high levels of polypharmacy potentiate risks of side effects, medication burden and drug-drug interactions, and indicate a role for enhanced medication review in this setting.

Community pharmacists’ awareness, identification, and management of prescribing cascades: A cross-sectional survey

BackgroundPrescribing cascades can lead to unnecessary medication use, healthcare costs, and patient harm. Pharmacists oversee prescriptions from multiple prescribers and are well positioned to identify such cascades, making pharmacists key stakeholders to address them. ObjectivesTo evaluate community pharmacists’ awareness, identification, and management of prescribing cascades and to assess behavioural determinants that may be targeted in future strategies to minimise inappropriate prescribing cascades. MethodsAn online survey was developed using the Theoretical Domains Framework (TDF) and emailed to all registered community pharmacists in Ireland (n = 3775) in November 2021. Quantitative data were analysed using descriptive and inferential statistics. Free-text sections were given to capture reasons for non-resolution of identified prescribing cascades and suggestions to aid prescribing cascade identification and management; this text underwent content analysis. ResultsOf the 220 respondents, 51% were aware of the term ‘prescribing cascade’ before the survey, whilst 69% had identified a potentially inappropriate prescribing cascade in practice. Over one third were either slightly confident (26.4%) or not confident at all (10%) in their ability to identify potentially inappropriate prescribing cascades in patients' prescriptions before the survey, whilst 55.2% were concerned that patients were receiving prescribing cascades they had not identified. Most respondents wanted further information/training to help prescribing cascade identification (88.3%) and management (86.1%). Four predominant TDF domains identified were common to both i) influencing non-resolution of identified prescribing cascades and ii) in the suggestions to help identify and manage prescribing cascades: ‘Environmental Context and Resources’, ‘Social/Professional Role and Identity’, ‘Social Influences’ and ‘Memory, Attention and Decision Processes’. ConclusionsThere is a clear need to provide additional resources to help community pharmacists identify and manage prescribing cascades. These findings will support the development of theory-informed behaviour change strategies to aid the minimisation of inappropriate prescribing cascades and decrease the risk of medication-related harm for patients.

Preliminary feasibility assessment of a targeted, pharmacist-led intervention for older adults with polypharmacy: a mixed-methods study

BackgroundPolypharmacy is associated with the prescription of inappropriate medications and avoidable medication-related harm. A novel pharmacist-led intervention aims to identify and resolve inappropriate medication prescriptions in older adults with polypharmacy.AimTo conduct a preliminary feasibility assessment of the intervention in primary care, testing whether specific components of the intervention procedures and processes can be executed as intended.MethodThe mixed-methods study was approved by the New Zealand Health and Disability Ethics Committees and public health agency. Patients from a New Zealand general practice clinic were recruited over 4 weeks to receive the intervention. The preliminary feasibility assessment included measures of intervention delivery, patient-reported outcome measures, and perspectives from ten patients and six clinicians. Data were analysed quantitatively and qualitatively to determine if a full-scale intervention trial is warranted. The study's progression criteria were based on established research and guided the decision-making process.ResultsThe intervention met the study's progression criteria, including patient recruitment, retention, and adherence to the intervention procedures. However, several modifications were identified, including: (1) enhancing patient recruitment, (2) conducting a preliminary meeting between the patient and pharmacist, (3) supporting pharmacists in maintaining a patient-centred approach, (4) reviewing the choice of patient-reported outcome measure, (5) extending the 8-week follow-up period, (6) allocating more time for pharmacists to conduct the intervention.ConclusionThe study found the intervention feasible; however, additional development is required before progressing to a full-scale trial. This intervention has the potential to effectively reduce medication-related harm and improve outcomes for older adults with polypharmacy.Trial registration number ACTRN12621000268842 Date registered: 11/03/2021

Innovations in pharmacovigilance studies of medicines in older people.

Pharmacovigilance is defined by the World Health Organization as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem". Pharmacovigilance studies are critical for detecting and assessing adverse events of medicines that may not have been observed in clinical trials. This activity is especially important in older people who are often excluded from clinical trials as they have multiple chronic conditions and use multiple medicines for longer durations than the clinical trials. In this narrative review we describe innovative methods in pharmacovigilance studies of medicines in older people that leverage the increasing availability of digital health technologies, electronic health records and real-world health data to identify and quantify medication related harms in older people.

Influence of lack of blinding on the estimation of medication-related harms: a retrospective cohort study of randomized controlled trials

BackgroundEmpirical evidence suggests that lack of blinding may be associated with biased estimates of treatment benefit in randomized controlled trials, but the influence on medication-related harms is not well-recognized. We aimed to investigate the association between blinding and clinical trial estimates of medication-related harms.MethodsWe searched PubMed from January 1, 2015, till January 1, 2020, for systematic reviews with meta-analyses of medication-related harms. Eligible meta-analyses must have contained trials both with and without blinding. Potential covariates that may confound effect estimates were addressed by restricting trials within the comparison or by hierarchical analysis of harmonized groups of meta-analyses (therefore harmonizing drug type, control, dosage, and registration status) across eligible meta-analyses. The weighted hierarchical linear regression was then used to estimate the differences in harm estimates (odds ratio, OR) between trials that lacked blinding and those that were blinded. The results were reported as the ratio of OR (ROR) with its 95% confidence interval (CI).ResultsWe identified 629 meta-analyses of harms with 10,069 trials. We estimated a weighted average ROR of 0.68 (95% CI: 0.53 to 0.88, P < 0.01) among 82 trials in 20 meta-analyses where blinding of participants was lacking. With regard to lack of blinding of healthcare providers or outcomes assessors, the RORs were 0.68 (95% CI: 0.53 to 0.87, P < 0.01 from 81 trials in 22 meta-analyses) and 1.00 (95% CI: 0.94 to 1.07, P = 0.94 from 858 trials among 155 meta-analyses) respectively. Sensitivity analyses indicate that these findings are applicable to both objective and subjective outcomes.ConclusionsLack of blinding of participants and health care providers in randomized controlled trials may underestimate medication-related harms. Adequate blinding in randomized trials, when feasible, may help safeguard against potential bias in estimating the effects of harms.

Co-design of an intervention to improve patient participation in discharge medication communication.

Patients can experience medication-related harm and hospital readmission because they do not understand or adhere to post-hospital medication instructions. Increasing patient medication literacy and, in turn, participation in medication conversations could be a solution. The purposes of this study were to co-design and test an intervention to enhance patient participation in hospital discharge medication communication. In terms of methods, co-design, a collaborative approach where stakeholders design solutions to problems, was used to develop a prototype medication communication intervention. First, our consumer and healthcare professional stakeholders generated intervention ideas. Next, inpatients, opinion leaders, and academic researchers collaborated to determine the most pertinent and feasible intervention ideas. Finally, the prototype intervention was shown to six intended end-users (i.e. hospital patients) who underwent usability interviews and completed the Theoretical Framework of Acceptability questionnaire. The final intervention comprised of a suite of three websites: (i) a medication search engine; (ii) resources to help patients manage their medications once home; and (iii) a question builder tool. The intervention has been tested with intended end-users and results of the Theoretical Framework of Acceptability questionnaire have shown that the intervention is acceptable. Identified usability issues have been addressed. In conclusion, this co-designed intervention provides patients with trustworthy resources that can help them to understand medication information and ask medication-related questions, thus promoting medication literacy and patient participation. In turn, this intervention could enhance patients' medication self-efficacy and healthcare utilization. Using a co-design approach ensured authentic consumer and other stakeholder engagement, while allowing opinion leaders and researchers to ensure that a feasible intervention was developed.

Medication Management Strategies by Community-Dwelling Older Adults: A Multisite Qualitative Analysis.

Community-dwelling older adults taking 5 or more medications are at risk for medication-related harm. Managing multiple medications is a challenging task for patients and caregivers. Community-dwelling older adults self-manage their medications with minimal healthcare professional supervision. Although organizations, such as the Food and Drug Administration, often issue guidelines to ensure medication safety, how older adults understand and mitigate the risk of harm from medication use in the home environment is poorly understood. We conducted semistructured interviews with community-dwelling older adults 65 years and older who took 5 or more prescription medications to explore medication safety strategies they use. We also compared 2 organizations' medication safety guidelines for areas of concordance and discordance. A total of 28 older adults were interviewed. Four overarching themes of medication management strategies emerged: collaborating with prescribers, collaborating with pharmacists, learning about medications, and safe practices at home. Study findings revealed that older adults followed some of the published guidelines by the 2 government organizations, although there were some areas of discord. Some of the strategies used were unintentionally against the recommended guidelines. For example, older adults tried weaning themselves off their medications without notifying their providers. Older adults and their caregivers in our study used strategies different from those recommended by government organizations in managing medications to enhance drug safety. Patient-provider collaboration and positive patient outcomes can be improved by understanding and respecting strategies older adults use at home. Future studies must effectively incorporate older adults' perspectives when developing medication safety guidelines.

Psychotropic medicines' prevalence, patterns and effects on cognitive and physical function in older adults with intellectual disability in Ireland: longitudinal cohort study, 2009-2020.

The frequent prescribing of psychotropics and high prevalence of polypharmacy among older adults with intellectual disabilities require close monitoring. To describe change in prevalence, predictors and health outcomes of psychotropic use during the four waves (2009/2010, 2013/2014, 2016/2017, 2019/2020) of the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA). Eligible participants were adults (≥40 years) with intellectual disabilities who participated in all four waves of IDS-TILDA and who reported medication use for the entire period. Differences between groups were tested using Cochran's Q test for binary variables and the McNemar-Bowker test for variables with more than two categories. Generalised estimating equation models were used to assess associations between psychotropic use, participants' characteristics and health outcomes. Across waves (433 participants) there were no significant differences in prevalence of psychotropic use (61.2-64.2%) and psychotropic polypharmacy (42.7-38.3%). Antipsychotics were the most used subgroup, without significant change in prevalence between waves (47.6-44.6%). A significant decrease was observed for anxiolytics (26.8-17.6%; P < 0.001) and hypnotics/sedatives (14.1-9.0%; P < 0.05). A significant increase was recorded for antidepressants (28.6-35.8%; P < 0.001) and mood-stabilising agents (11.5-14.6%; P < 0.05). Psychotropic polypharmacy (≥2 psychotropics) was significantly associated with moderate to total dependence in performing activities of daily living over the 10-year period (OR = 1.80, 95% CI 1.21-2.69; P < 0.05). The study indicates an increase in usage of some classes of psychotropic, a reduction in others and no change in the relatively high rate of antipsychotic use over 10 years in a cohort of older adults with intellectual disabilities and consequent risk of psychotropic polypharmacy and medication-related harm.

The Economics of Medication Safety: A Cost-Benefits Analysis Framework for Evaluating an Electronic Medication System.

Medication prescribing in paediatrics is complex and compounded by the need to provide age and weight related doses, and errors continue to be problematic. Electronic medication systems (EMS) can reduce errors through dosing calculators and computerised decision support. However, evidence on costs and benefits of these systems is limited, particularly in paediatric hospitals. This paper presents the development of a cost-benefit analysis (CBA) framework to assess the impact of an EMS implementation in a paediatric tertiary hospital. An innovative component of the framework is the incorporation of the impact of the effects of the EMS for both the health system as well as for patients and their wider family networks, allowing a net social benefit assessment. We describe the impact of non-clinical out-of-pocket costs of admission and use discrete choice experiments to measure both medication related harm and the importance of medication safety to families and members of the community.