An International Consensus List of Potentially Clinically Significant Drug-Drug Interactions in Older People.

OBJECTIVES: We aimed to establish an explicit list of potentially clinically significant drug-drug interactions (DDIs) in people aged ≥65 years. DESIGN: A preliminary list of potentially clinically significant DDIs was compiled, based on 154 DDIs identified from literature review. Subsequently, a 2-round online Delphi survey was undertaken with a multidisciplinary expert panel. A consensus meeting and a final round were conducted to validate the final DDI list and the scope of information provided. SETTING AND PARTICIPANTS: Twenty nine experts, including geriatricians and clinical pharmacists from 8 European countries. MEASURES: For each DDI, in the first 2 rounds, experts were asked to score the severity of potential harm on a 5-point Likert-type scale. DDIs were directly included on the final list if the median score was 4 (major) or 5 (catastrophic). DDIs with a median score of 3 (moderate) were discussed at a consensus meeting and included if ≥75% of participants voted for inclusion in the final round. RESULTS: Consensus was achieved on 66 potentially clinically significant DDIs (28 had a median score of 4/5 and 48 of 3 in the Delphi survey). Most concerned cardiovascular, antithrombotic, and central nervous system drugs. The final list includes information on the mechanism of interaction, harm, and management. Treatment modification is recommended for three-quarters of DDIs. CONCLUSION AND IMPLICATIONS: We validated a list of potentially clinically significant DDIs in older people, which can be used in clinical practice and education to support identification and management of DDIs or to assess prevalence in epidemiologic and intervention studies.

Use and Deprescribing of Potentially Inappropriate Medications in Frail Nursing Home Residents.

BACKGROUND: The STOPPFrail criteria were developed to assist physicians in deprescribing medications among frail patients approaching end of life. We aimed to measure the prevalence of potentially inappropriate medications (PIMs) and to describe changes over time, using STOPPFrail, in frail nursing home residents (NHRs) with limited life expectancy included in a medication review trial. METHODS: We conducted a post-hoc analysis of the COME-ON study, a cluster-controlled trial that evaluated the effect of a complex intervention on appropriateness of prescribing in Belgian nursing homes. We identified NHRs eligible for the application of STOPPFrail based on functional status, comorbidities, level of care and survival. PIM use was measured at baseline and at 8 months. Changes over time were compared in the control group (CG) and intervention group (IG). RESULTS: At baseline, 308 NHRs met the STOPPFrail eligibility criteria, of whom 196 (64.1%) had one or more PIM. At 8 months, among the 218 NHRs who were alive, there was an absolute reduction in the prevalence of PIMs of 9.1% in the CG (p < 0.05) and 10.2% in the IG (p < 0.05). We found large reductions for some medications (e.g. proton pump inhibitors) but no reduction for others (e.g. calcium). The percentage of NHRs with one or more PIM discontinued without a new PIM initiated was higher in the IG than the CG but the difference was not significant (35.1% vs 23.6%, p = 0.127). CONCLUSION: Among frail NHRs with poor survival prognosis, a significant and encouraging decrease in PIM prevalence over time was observed, probably facilitated by medication reviews. The overall prevalence of PIMs remained high, however.

Development of a process-oriented quality improvement strategy for the medicines pathway in nursing homes using the SEIPS model.

BACKGROUND AND OBJECTIVE: Medication errors in nursing homes are highly prevalent and occur in different stages of the medicines pathway. The application of the SEIPS (System Engineering Initiative for Patient Safety) model facilitates the identification of work system factors that contribute to errors. Therefore, the aim of our research was to investigate in-depth the medicines pathway in nursing homes by using the SEIPS model and to develop a set of key activities and aggregated key interventions to be used as a basis for quality-improvement strategies. METHODS: A variety of qualitative methods, including observations, semi-structured interviews, the development of a flowchart, an expert meeting and a working symposium, were used to identify processes and work system components. Key interventions and activities were developed in three rounds (one development and two validation rounds) across the different research methods to fine-tune the defined key interventions and activities. RESULTS: Our analysis revealed a large variety of tasks as well as persons elements, aspects related to technology and tools, organisational factors and environmental elements that all interact and influence the medicines pathway. The large number of tasks could be linked to eight overarching processes: prescribing, purchase and ordering, delivery, storage, preparation, administration, monitoring and (re-)admission. After three rounds (one development and two validation rounds), a final set of 137 key activities and 27 aggregated key interventions, concretising the eight processes, was obtained. CONCLUSION: The in-depth analysis of processes within the medicines pathway in nursing homes resulted in a set of key activities and aggregated key interventions which may serve as a basis for the nursing home sector and policy makers to enhance a safe and efficient medicines pathway.

Process evaluation of a complex intervention to optimize quality of prescribing in nursing homes (COME-ON study).

BACKGROUND: The COME-ON study was a cluster-controlled trial of a complex intervention that consisted of a blended training program, local interdisciplinary meetings, and interdisciplinary case conferences in Belgian nursing homes. The intervention was associated with significant improvements in the appropriateness of prescribing. The aims of this study were to describe the implementation of the intervention and to explore the experiences of participants, for the purpose of identifying factors associated with implementation and perceived impact and to draw lessons for future implementation. METHODS: We performed a mixed-method process evaluation. Questionnaires and reports were used to collect quantitative data on implementation and experiences from the 24 NHs and participating healthcare professionals (coordinating physicians, general practitioners, pharmacists, and nurses) in the intervention group. Multidisciplinary focus groups focusing on factors associated with implementation and perceived impact were conducted in 11 NHs. RESULTS: Overall, the rate of implementation and the satisfaction of participants were good, despite some variability between NHs and HCPs. Although perceived impact on nursing home residents varied, most participants perceived a positive impact for themselves. Factors associated with implementation and perceived impact were identified at different levels: intervention, healthcare professionals, organization, and external context. The interdisciplinary and face-to-face approaches were recognized as key elements for the success of the intervention, despite organizational constraints. The attitude of general practitioners was identified both as a barrier to and a facilitator for implementation and its success. The professional role and competency of the pharmacist influenced perceived impact. The pre-existing relationships between HCPs and the presence of a leader facilitated implementation and perceived impact. Remuneration was deemed necessary for the study and for future implementation. CONCLUSIONS: Overall, the intervention, and more specifically its interdisciplinary aspect, was well implemented and appreciated by HCPs. This probably contributed to the positive effect on the appropriateness of prescribing. Future implementation must take into account the various factors found to affect implementation and perceived impact, in order to maximize effect and sustainability. Trial registration Current Controlled Trials ISRCTN66138978; registered 18 November 2015, retrospectively registered, https://www.isrctn.com/ISRCTN66138978.

Cluster-Controlled Trial of an Intervention to Improve Prescribing in Nursing Homes Study.

OBJECTIVES: To investigate the impact of a complex multifaceted intervention on the appropriateness of prescribing for Belgian nursing home (NH) residents. DESIGN: A multicenter, nonblinded, cluster-randomized controlled trial, with randomization at the NH level, was set up [Cluster-Controlled Trial of an Intervention to Improve Prescribing in Nursing Homes (COME-ON) Study]. The complex intervention consisted of repeated interdisciplinary case conferences (ICCs) involving the general practitioner, pharmacist, and nurse, aimed at performing a medication review for each NH resident included. The ICCs were supported by a blended training program and local interdisciplinary meetings (discussion of the appropriate use of specific medication classes at the NH level). Control NHs delivered usual care. (isrctn.com: ISRCTN66138978). SETTING AND PARTICIPANTS: Belgian NHs with at least 35 NH residents were eligible to participate. Eligible residents were those aged 65 years or over, not receiving palliative care, and being treated by a participating general practitioner. MEASURES: The primary outcome measure related to appropriateness of prescribing at resident level and was considered successful when at least 1 potentially inappropriate medication (PIM) or potential prescribing omission (PPO) present at baseline had been solved at the end of study and when there were no new PIMs or PPOs at the end of study compared with baseline. Secondary outcomes included clinical outcomes, medication use, criterion-specific prevalence of PIMs and PPOs, and ICC outcomes. RESULTS: In total, 54 NHs (24 intervention; 30 control) and 1804 NH residents (847 intervention; 957 control) participated. Using a 3-level mixed-effects model accounting for data clustering, a significant effect in favor of the intervention was observed (odds ratio 1.479 [95% confidence interval 1.062-2.059, P = .021]). There was no significant difference between groups for most clinical outcomes. The median number of medications did not change over time in either group. CONCLUSIONS AND IMPLICATIONS: The complex multifaceted intervention tested in the COME-ON study successfully improved appropriateness of prescribing in NHs.

Potentially Inappropriate Prescribing in Belgian Nursing Homes: Prevalence and Associated Factors.

BACKGROUND/OBJECTIVES: Our aim was to describe the prevalence of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) in Belgian nursing homes and to identify characteristics of residents, general practitioners (GPs), and nursing homes (NHs) that are associated with the number of PIMs and PPOs. DESIGN: A cross-sectional study. SETTING: and Participants: Nursing home residents (NHRs), aged ≥65 years, not in palliative care were included in 54 Belgian NHs participating in the COME-ON study. MEASURES: Instances of PIMs were detected using a combination of the STOPP v2 and AGS 2015 Beers criteria. Instances of PPOs were detected using START v2. To assess factors associated with the number of PIMs and PPOs, a multivariate binomial negative regression analysis was performed. RESULTS: A total of 1410 residents, with a median age of 87 years, was included. The median number of medications taken was 9. PIMs were detected in 88.3% of NHRs and PPOs in 85.0%. Use of benzodiazepines (46.7%) and omission of vitamin D (51.5%) were the most common PIM and PPO, respectively. The factor most strongly associated with increased PIMs was the use of 5 to 9 drugs or ≥10 drugs [relative risk (RR) (95% confidence interval [CI]: 2.27 (1.89, 2.76) and 4.04 (3.37, 4.89), respectively]. The resident's age was associated with both decreased PIMs and increased PPOs. PIMs and PPOs were also associated with some NH characteristics, but not with GP characteristics. CONCLUSION: Implications: The high prevalence of PIMs and PPOs remains a major challenge for the NH setting. Future interventions should target in priority residents taking at least 10 medications and/or those taking psychotropic drugs. Future studies should explore factors related to organizational and prescribing culture. Moreover, special attention must be paid to the criteria used to measure inappropriate prescribing, including criteria relative to underuse.

STOPP/START version 2-development of software applications: easier said than done?

Explicit criteria, such as the STOPP/START criteria, are increasingly used both in clinical practice and in research to identify potentially inappropriate prescribing in older people. In an article on the STOPP/START criteria version 2, O'Mahony et al have pointed out the advantages of developing computerised criteria. Both clinical decision support systems to support healthcare professionals and software applications to automatically detect inappropriate prescribing in research studies can be developed. In the process of developing such tools, difficulties may occur. In the context of a research study, we have developed an algorithm to automatically apply STOPP/START criteria version 2 to our research database. We comment in this paper on different kinds of difficulties encountered and make suggestions that could be taken into account when developing the next version of the criteria.

Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON): study protocol of a cluster controlled trial.

BACKGROUND: Ageing has become a worldwide reality and presents new challenges for the health-care system. Research has shown that potentially inappropriate prescribing, both potentially inappropriate medications and potentially prescribing omissions, is highly prevalent in older people, especially in the nursing home setting. The presence of potentially inappropriate medications/potentially prescribing omissions is associated with adverse drug events, hospitalisations, mortality and health-care costs. The Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON) study aims to evaluate the effect of a complex, multifaceted intervention, including interdisciplinary case conferences, on the appropriateness of prescribing of medicines for older people in Belgian nursing homes. METHODS/DESIGN: A multicentre cluster-controlled trial is set up in 63 Belgian nursing homes (30 intervention; 33 control). In each of these nursing homes, 35 residents (≥65 years) are selected for participation. The complex, multifaceted intervention comprises (i) health-care professional education and training, (ii) local concertation (discussion on the appropriate use of at least one medication class at the level of the nursing home) and (iii) repeated interdisciplinary case conferences between general practitioner, nurse and pharmacist to perform medication review for each included nursing home resident. The control group works as usual. The study period lasts 15 months. The primary outcome measures relate to the appropriateness of prescribing and are defined as (1) among residents who had at least one potentially inappropriate medication/potentially prescribing omission at baseline, the proportion of them for whom there is a decrease of at least one of these potentially inappropriate medications/potentially prescribing omissions at the end of study, and (2) among all residents, the proportion of them for whom at least one new potentially inappropriate medication/potentially prescribing omission is present at the end of the study, compared to baseline. The secondary outcome measures include individual components of appropriateness of prescribing, medication use, outcomes of the case conferences, clinical outcomes and costs. A process evaluation (focusing on implementation, causal mechanisms and contextual factors) will be conducted alongside the study. DISCUSSION: The COME-ON study will contribute to a growing body of knowledge concerning the effect of complex interventions on the use of medicines in the nursing home setting, and on factors influencing their effect. The results will inform policymakers on strategies to implement in the near future. TRIAL REGISTRATION: Current Controlled Trials ISRCTN66138978.