Guidelines on optimizing the use of proton pump inhibitors: PPI stewardship.

Proton pump inhibitors (PPIs) have been available for over three decades and are among the most commonly prescribed medications. They are effective in treating a variety of gastric acid-related disorders. They are freely available and based on current evidence, use of PPIs for inappropriate indications and duration appears to be common. Over the years, concerns have been raised on the safety of PPIs as they have been associated with several adverse effects. Hence, there is a need for PPI stewardship to promote the use of PPIs for appropriate indication and duration. With this objective, the Indian Society of Gastroenterology has formulated guidelines on the rational use of PPIs. The guidelines were developed using a modified Delphi process. This paper presents these guidelines in detail, including the statements, review of literature, level of evidence and recommendations. This would help the clinicians in optimizing the use of PPIs in their practice and promote PPI stewardship.

Pharmacist review of high-risk haematology outpatients to improve appropriateness of antifungal prophylaxis.

Background Patients with haematological malignancies are at high risk of invasive fungal infections. However, there is a lack of information about the utilisation of the recommended Australian antifungal prophylaxis guidelines in haematology outpatients. Objective To assess the impact of a weekly pharmacist review of high-risk adult haematology outpatients on the utilisation of appropriate antifungal prophylaxis. Setting Outpatient cancer centre, tertiary referral hospital in Sydney, Australia. Method A 3-month pre-and post-interventional study was conducted. A retrospective audit was conducted to obtain baseline utilisation of antifungal guidelines in adult haematology outpatients with acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome receiving chemotherapy. This was followed by a weekly pharmacist review over a 3-month period of all eligible outpatients assessing the appropriateness of antifungal agent, dose, use of therapeutic drug monitoring and presence of drug-interactions/contraindications. Recommendations to physicians were conveyed weekly and outcomes recorded. Main outcome measure Appropriate utilisation of antifungal prophylaxis guidelines in outpatient haematology patients before and after implementation of a 3-month weekly pharmacist review service. Results Forty patients were included in the retrospective group, equating to 348 reviews, while 42 patients equating to 269 reviews were included in the prospective group. Appropriate utilisation of antifungal prophylaxis guidelines increased from 31 to 54% post implementation of a pharmacist review (Odds Ratio = 2.44, 95% Confidence Interval: 1.07-5.58, p = 0.0344). The most common reason for nonadherence to guidelines in both groups was lack of therapeutic drug monitoring and failure to prescribe antifungal prophylaxis where indicated. The percentage of appropriate use of antifungal prophylaxis in patients with acute myeloid leukemia increased from 13 to 46% (p value < 0.01) after pharmacist intervention. The pharmacist made 153 recommendations from 269 reviews, with a percentage uptake of 40%. Moderate to severe drug interactions were identified in 19 reviews from 10 patients. One major azole antifungal-chemotherapy interaction was avoided. Conclusions Appropriate utilisation of antifungal prophylaxis guidelines can be improved through a regular pharmacist review. Future studies should identify whether improving adherence to antifungal guidelines leads to improved patient outcomes.

Implementation of a chemotherapy stewardship process.

PURPOSE: To design and implement a chemotherapy stewardship process to optimize the location of chemotherapy administration in an effort to decrease the number of inappropriate inpatient anticancer regimen administrations and decrease institutional costs associated with inpatient administration. SUMMARY: As the costs of anticancer agents continue to rise, it is crucial that multidisciplinary efforts are aimed at managing anticancer medication utilization; this is especially important for high-cost medications, medications whose use requires increased monitoring due to safety concerns, and medications that do not exert effects quickly and, as such, can be more appropriately administered in the outpatient setting. It is imperative that pharmacists play a role in managing chemotherapy medication utilization, as pharmacists provide expertise in formulary management, a vast knowledge of financial impact and reimbursement processes, and clinical knowledge that can help predict the expected effectiveness and adverse effects of each anticancer regimen. Our institution sought to develop and implement a multidisciplinary chemotherapy stewardship program targeting the optimization of site of anticancer agent administration with a goal of decreasing both cost and inappropriate utilization of high-cost, high-risk anticancer agents. CONCLUSION: Implementation of a chemotherapy stewardship service may decrease the number of inappropriate inpatient anticancer regimen administrations and decrease inpatient resource use, thereby decreasing costs to institutions. The concept of a chemotherapy stewardship process was well received by multidisciplinary healthcare colleagues, and a collaborative approach should be used to design and implement such processes.

Current state of opioid stewardship.

PURPOSE: The opioid epidemic continues to result in significant morbidity and mortality even within hospitals where opioids are the second most common cause of adverse events. Opioid stewardship represents one model for hospitals to promote safe and rational prescribing of opioids to mitigate preventable adverse events in alliance with new Joint Commission standards. The purpose of this study was to identify the prevalence of current hospital practices to improve opioid use. METHODS: A cross-sectional survey of hospital best practices for opioid use was electronically distributed via electronic listservs in March 2018 to examine the presence of an opioid stewardship program and related practices, including formulary restrictions, specialist involvement for high-risk patients, types of risk factors screened, and educational activities. RESULTS: Among 133 included hospitals, 23% reported a stewardship program and 14% reported a prospective screening process to identify patients at high risk of opioid-related adverse events (ORAEs). Among those with a prospective screening process, there was variability in ORAE risk factor screening. Formulary restrictions were dependent on specific opioids and formulations. Patient-controlled analgesia was restricted at 45% of hospitals. Most hospitals reported having a pain management service (90%) and a palliative care service providing pain management (67%). CONCLUSION: The absence of opioid stewardship and prospectively screening ORAEs represents a gap in current practice at surveyed hospitals. Hospitals have an opportunity to implement and refine best practices such as access to pain management specialists, use of formulary restrictions, and retrospective and prospective monitoring of adverse events to improve opioid use.

Do we need to adopt antifungal stewardship programmes?

Background: Although antimicrobial stewardship programmes are one of the highest priorities in healthcare systems and many articles have been published, few refer to the implementation of antifungal stewardship and highlight specific points on which efforts should be focused. Objective: To assess the percentage of patients with confirmed candidaemia in whom de-escalation was conducted, and the economic impact of step-down or step-up antifungal therapy. Additionally, we attempted to estimate the potential increase in drug minimum inhibitory concentrations or to detect resistant strains of Candida species. Methods: We selected, retrospectively, patients who had received systemic antifungal therapy between 2011 and 2016 for documented candidaemia. Statistical analysis and diagrams were used to assess the results. Results: Of 157 patients with confirmed candidaemia, 58 received azoles, 74 echinocandinsand 18 liposomal amphotericin B for empirical therapy. 51 patients were eligible to step-down to fluconazole but only 23 patients did so. Furthermore, in nine patients unjustified step-up from fluconazole to echinocandins or liposomal amphotericin B was carried out. The additional cost incurred bythe healthcare system due to high prices of echinocandins and liposomal amphotericin B in comparison with fluconazole was€211 837. Interestingly, it was found that one strain of C. albicans and two strains of C. glabrata were resistant to echinocandins. Conclusion: The presence of a multidisciplinary team, including an infection control specialist and a clinical pharmacist, would limit the prescription of advanced antifungal agents as empirical therapy. Moreover, this team would control the de-escalation process-where applicable-leading to a reduction in costs and, probably, a decrease in the emergence of resistant Candida species. These facts contribute to the broader discussion on the adoption of antifungal stewardship programmes.

Community pharmacist led medication reviews in the UK: A scoping review of the medicines use review and the new medicine service literatures.

BACKGROUND: Medicines Use Reviews (MURs) and the New Medicine Service (NMS) are services delivered by UK community pharmacists to improve adherence, improve patient understanding of their medicines and reduce medicines wastage. AIM: In this scoping review we aim to identify, map and critically examine the nature of existing empirical evidence in peer reviewed journals relating to MUR and NMS consultations. METHOD: Systematic searches identified the available MUR and NMS empirical literature. We sought data on barriers and facilitators to conducting MUR or NMS consultations, the perceptions of pharmacists and patients, the conduct of consultations, and outcomes of consultations. Searches from 2005 (when MURs were introduced) to May 2018 were conducted in MEDLINE, PsycINFO, Embase and Scopus databases. Data were extracted into Excel for examination of study characteristics, participant characteristics, type of intervention/services delivered and key study quantitative and/or qualitative findings. RESULTS: Forty-one papers from 37 studies met the inclusion criteria: 28 papers were of MURs, 10 of NMS and 3 for both services. Studies focused on the introduction and implementation of these services, with little attention to outcomes for patients; effectiveness was not evaluated beyond in a single NMS RCT. Observational data indicated that pharmacists and patients view MURs and the NMS positively, despite challenges implementing these services and apparent lack of communication between pharmacists and GPs. Consultations were reported to be short, typically 10-12 min, characterised by limited engagement with patients and their health problems. The extent and nature of advice on health behaviours during consultations or other content was rarely examined. CONCLUSION: The research literature on MURs and the NMS has developed slowly. There is much scope for further research attention to developing more patient-centred care.

Physician and pharmacist satisfaction and clinical needs for the real-time medication surveillance program in South Korea.

BACKGROUND: Since December 2010, a nationwide real-time medication surveillance program has been implemented in Korea to prevent potential adverse drug reactions. Our goal was to evaluate physicians' and pharmacists' satisfaction and clinical needs for the medication surveillance program in Korea. METHODS: Both web- and paper-based surveys were conducted using a structured questionnaire among 1164 physicians and pharmacists from May 23, 2014 to August 11, 2014. The survey consisted of questions about the participant's satisfaction with the medication surveillance program, clinical usefulness, clinical need for the medication surveillance program, and sociodemographic characteristics. Multivariate ordinal logistic regression was performed to investigate the factors influencing satisfaction levels with the medication surveillance program. RESULTS: We analyzed data from 1120 respondents, including 503 physicians and 617 pharmacists. Overall, 63.1% of the respondents were satisfied with the medication surveillance program. Pharmacists were more satisfied with the program than were physicians (69.1% vs. 55.6%; adjusted odds ratio, 2.13; 95% confidence interval, 1.65-2.76). Among the respondents, 77.8% cited a decrease in therapeutic duplication to be a major improvement resulting from the medication surveillance program, 82.6% considered the drug-drug interaction information useful, and 48.7% suggested that the program should include information on liver or kidney disease-drug interaction. CONCLUSIONS: Overall, 63.0% of physicians and pharmacists were satisfied, and a decrease in therapeutic duplication was regarded as the most beneficial component. Further improvements by considering clinical needs of physicians and pharmacists will be needed to increase satisfaction.

Supporting the provision of pharmacy medication reviews to marginalised (medically underserved) groups: a before/after questionnaire study investigating the impact of a patient-professional co-produced digital educational intervention.

OBJECTIVES: People who are marginalised (medically underserved) experience significant health disparities and their voices are often 'seldom heard'. Interventions to improve professional awareness and engagement with these groups are urgently needed. This study uses a co-production approach to develop an online digital educational intervention in order to improve pharmacy staffs' intention to offer a community pharmacy medication review service to medically underserved groups. DESIGN: Before/after (3 months) self-completion online questionnaire. SETTING: Community pharmacies in the Nottinghamshire (England) geographical area. PARTICIPANTS: Community pharmacy staff. INTERVENTION: Online digital educational intervention. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was 'behaviour change intention' using a validated 12-item survey measure. The secondary outcome measure was pharmacist self-reported recruitment of underserved groups to the medication review service. RESULTS: All pharmacies in the Nottinghamshire area (n=237) were approached in June 2017 and responses were received from 149 staff (from 122 pharmacies). At 3 months (after completing the baseline questionnaire), 96 participants (from 80 pharmacies) completed a follow-up questionnaire, of which two-thirds (n=62) reported completing the e-learning. A before/after comparison analysis found an improving trend in all the five constructs of behaviour change intention (intention, social influence, beliefs about capabilities, moral norms and beliefs about consequences), with a significant increase in mean score of participants' 'beliefs about capabilities' (0.44; 95% CI 0.11 to 0.76, p=0.009). In the short-term, no significant change was detected in the number of patients being offered and the patient completing a medication review. CONCLUSIONS: Although increases in the numbers of patients being offered a medication review was not detected, the intervention has the potential to significantly improve pharmacy professionals' 'beliefs about capabilities' in the short-term. Wider organisational and policy barriers to engagement with marginasied groups may need to be addressed. Future research should focus on the interplay between digital learning and practice to better identify and understand effective practice change pathways.

Medication regimen complexity and its impact on medication adherence and glycemic control among patients with type 2 diabetes mellitus in an Ethiopian general hospital.

Background: Different studies reported that higher diabetes-specific Medication Regimen Complexity Index (MRCI) has a negative impact on glycemic control potentially by decreasing medication adherence. However, information about regimen complexity and its association with adherence and glycemic control in Ethiopian patients with diabetes is unknown. Aim: To evaluate medication regimen complexity and to assess its impact on medication adherence and glycemic control among patients with type 2 diabetes Mellitus (T2DM). Methods: A hospital-based cross-sectional design was conducted at Debre Tabor General Hospital from 1 May 2018 to 30 June 2018. Medication regimen complexity was evaluated using the 65-item validated tool called Medication Complexity Index (MRCI). Adherence was measured using Morisky Medication Adherence Scale while patients were classified as having poor or good glycemic control based on the recent record of their fasting blood glucose. Multivariable logistic regression analysis was applied to determine the association between predictive variables and outcome variables. Results: A total of 275 patients with T2DM who meet the inclusion criteria were included in the final analysis. About 22.2% of the participants were classified as having high diabetes-specific MRCI, whereas 35.6% of the participants were classified as having high patient-level MRCI. The majority (70.5%) of the respondents were adherent to their medications, and 42.9% of the total population were categorized as having good glycemic control. According to the result of the multivariate analysis, patients with low-level and moderate-level MRCI of both diabetes-specific and patient-level MRCI were more adherent to their medication compared with patients with high MRCI. High diabetes medication regimen complexity was associated with poor glycemic control in the adjusted analyses (adjusted OR = 0.276; 95% CI = 0.100 o 0.759). Conclusion: The prevalence of high MRCImedication regimen complexity index is high among patients with T2DM. Patients with low and moderate regimen complexity had improved adherence. High diabetes-specific medication regimen complexity was associated with poor glycemic control. Simplification of a complex medication regimen for patients with diabetes should be sought by physicians and pharmacists to improve medication adherence and subsequent improvement in glycemic control.

The effect of hospital-based antithrombotic stewardship on adherence to anticoagulant guidelines.

Background Anticoagulant therapy is associated with a high risk of complications. Adherence to anticoagulant therapy protocols may lower this risk but adherence is often suboptimal. The introduction of a multidisciplinary antithrombotic team may improve adherence to anticoagulant guidelines among physicians. Objective To determine the effect of hospital-based multidisciplinary antithrombotic stewardship on adherence to anticoagulant guidelines among prescribing physicians. Setting This prospective non-randomised before-and-after study was conducted in patients hospitalized between October 2015 and December 2017 and treated with anticoagulant therapy. Method A multidisciplinary antithrombotic team focusing on education, medication reviews, drafting of local anticoagulant therapy protocols, patient counseling and medication reconciliation at admission and discharge was implemented in two Dutch hospitals. Main outcome measure Primary outcome was the proportion of the admitted patients in which the prescribing physician did adhere to the anticoagulant guidelines. Results The study comprised 1886 patients, of which 941 patients were included in the usual care period and 945 patients in the intervention period. Multivariable logistic regression analysis indicated that adherence was observed significantly more often during the intervention period (adjusted odds ratio [ORadj] 1.58, 95% confidence interval [95% CI] 1.21-2.05). Detailed analysis identified that the significantly higher overall adherence in the intervention period was attributed to dosing of LMWHs (odds ratio [OR] 1.58, 95% CI 1.16-2.14). Conclusion This study shows that introduction of a multidisciplinary antithrombotic stewardship leads to a significantly higher overall adherence to anticoagulant guidelines among prescribing physicians, mainly based on the improvement of dosing of low-molecular-weight-heparins.

Pharmacist-led medicine use review in community pharmacy for patients on warfarin.

Background Medicine use review by pharmacists has the potential to improve anticoagulation therapy management in patients on warfarin. Objective To develop, implement and evaluate a pharmacist-led medication use review service for patients on warfarin. Setting Six community pharmacies in Malta. Method Patients (N = 100) aged 18 or older and on warfarin were recruited through pre-selected community-pharmacies. These patients were then invited to attend two sessions: a review session (t1) and a follow-up session after 2 months (t2). During the medication use review session, medication reconciliation was performed (a) to detect drug-related problems using the DOCUMENT classification system, (b) to develop an individualised care plan for each patient and (c) to recommend an action for each identified problem for physician, pharmacist or patient consideration. At t2, the degree of acceptance of the recommendations was determined by assessing the number of drug-related problems for which action was taken to address the problem. International normalisation ration (INR) control was evaluated by calculating the percentage Time in Therapeutic Range (TTR) at t1 and t2 using the Rosendaal linear interpolation method. Main outcome measures Frequency and type of drug-related problems detected; percentage of accepted recommendations; and INR control. Results A total of 481 drug-related problems were identified; 40% (n = 190) were related to warfarin treatment. Need for monitoring (30%; n = 145), lack of compliance (20%; n = 97) and need for patient education (19%; n = 90) were the top three problems identified. There was a significant correlation between frequency of the problems and number of chronic medications (Spearman Correlation 0.583, p < 0.001), number of comorbidities (Spearman Correlation 0.327, p = 0.001) and older age (Spearman Correlation 0.285, p = 0.04). A total of 475 recommendations were followed-up; 49% (n = 234) were referred for consideration by the physician. The percentage of recommendations accepted (84%; n = 397) was significantly higher than the percentage of recommendations not accepted (16%; n = 78) (p < 0.001). The time in therapeutic range improved significantly from 68.7% at t1 to 79.8% at t2 (p = 0.01). Conclusions The high percentage of accepted recommendations and the improvement in INR control indicate that a pharmacist-led medication use review service in community pharmacy contributes to improving anticoagulation therapy management in patients on warfarin.

The relation between falls and medication use among elderly in assisted living facilities.

PURPOSE: Many elderly are concerned about falling transfer to assisted living facilities (ALF). Previous literatures studied the medication use and falls in the community, hospitals, or nursing homes, with scanty data about ALF. Therefore, the aim of the current case-control study was to assess the relation between medication use and falls among elderly in ALF. METHODS: A matched case-control study was conducted. The study was conducted in ALF in Cairo, Egypt. The study participants were 188 individuals; they were subdivided into two groups: fallers and nonfallers; timed up and go test (TUGT) was performed by all subjects. Medication data were collected according to the fall risk-increasing drugs list and the list of drugs that cause or worsen orthostatism. Other fall risk factors, as suggested by American Geriatric Society, were assessed. RESULTS: The use of vasodilators, diuretics, alpha blockers, opioids, antipsychotics, and sedative hypnotics were more common in fallers than in nonfallers (P < 0.001, P = 0.03, P < 0.001, P = 0.013, P < 0.001, and P < 0.001, respectively). Vasodilators, alpha blockers, and antipsychotics were significant predictors of falls even after adjustment for the possible confounding factors. Vasodilators, alpha blockers, opioids, sedative hypnotics, and recent dose changes in oral hypoglycemics were significant predictors of higher TUGT after adjustment for the possible confounding factors. CONCLUSION: The current study supported the risk of psychotropic and cardiovascular medications, with especial emphasis on vasodilators, alpha blockers, and antipsychotics, with raising concern about opioids, sedative hypnotics, and recent dose change in oral hypoglycemics.

Quality indicators to measure the effect of opioid stewardship interventions in hospital and emergency department settings.

PURPOSE: The purpose of this project was to develop a set of valid and feasible quality indicators used to track opioid stewardship efforts in hospital and emergency department settings. METHODS: Candidate quality indicators were extracted from published literature. Feasibility screening excluded quality indicators that cannot be reliably extracted from the electronic health record or that are irrelevant to pain management in the hospital and emergency department settings. Validity screening used an electronic survey of key stakeholders including pharmacists, nurses, physicians, administrators, and researchers. Stakeholders used a 9-point Likert scale to rate the validity of each quality indicator based on predefined criteria. During expert panel discussions, stakeholders revised quality indicator wording, added new quality indicators, and voted to include or exclude each quality indicator. Priority ranking used a second electronic survey and a 9-point Likert scale to prioritize the included quality indicators. RESULTS: Literature search yielded 76 unique quality indicators. Feasibility screening excluded 9 quality indicators. The validity survey was completed by 46 (20%) of 228 stakeholders. Expert panel discussions yielded 19 valid and feasible quality indicators. The top 5 quality indicators by priority were: the proportion of patients with (1) naloxone administrations, (2) as needed opioids with duplicate indications, and (3) long acting or extended release opioids if opioid-naïve, (4) the average dose of morphine milligram equivalents administered per day, and (5) the proportion of opioid discharge prescriptions exceeding 7 days. CONCLUSION: Multi-professional stakeholders across a health system participated in this consensus process and developed a set of 19 valid and feasible quality indicators for opioid stewardship interventions in the hospital and emergency department settings.

Assessment of prior opioid tolerance among new users of fentanyl transdermal system in FDA's Sentinel System.

PURPOSE: Fentanyl transdermal system (FTS) is intended only for patients with prior opioid tolerance. The purpose of this study is to identify the proportion of new FTS users who had evidence of prior opioid tolerance, by dosage strength, in FDA's Sentinel System. METHODS: We identified new FTS episodes (183-day washout) from 2009 through 2013. Members were <65 years and enrolled in medical and pharmacy coverage for 183 days prior to initial FTS dispensing (index). We assessed the proportion of users with prior tolerance stratified by dosage strength of FTS using four definitions of opioid tolerance: ≥30-mg oxycodone equivalents/day in each of 7 consecutive days immediately prior to index; ≥30-mg oxycodone equivalents/day for any 7 days in the 30 days prior to index (secondary); any dose in each of 7 days in the 7 consecutive days immediately prior to index (tertiary); and any dose for any 7 days in the 30 days prior to index (quaternary). RESULTS: Of 44 450 episodes of 25 mcg/hr FTS, 37% met the primary definition, and 77% met the quaternary definition. Of 3507 episodes of 100 mcg/hr FTS, 57% and 74% met the primary and quaternary definitions, respectively. Those aged 25 to 34 years had the highest proportion of episodes with prior tolerance; those aged 55 to 64 accounted for more of the episodes overall. CONCLUSIONS: In Sentinel, many new users of FTS did not have evidence of prior opioid tolerance by the primary definition, ie, the product label definition, which is the minimum standard for the lowest FTS dose (12 mcg/hr), especially at the highest strength (100 mcg/hr). Validation of this metric is warranted, but our findings suggest the need for further prescriber education regarding appropriate prescribing of FTS.

Improving inappropriate medication and information transfer at hospital discharge: study protocol for a cluster RCT.

BACKGROUND: Inappropriate medication and polypharmacy increase morbidity, hospitalisation rate, costs and mortality in multimorbid patients. At hospital discharge of elderly patients, polypharmacy is often even more pronounced than at admission. However, the optimal discharge strategy in view of sustained medication appropriateness remains unclear. In particular, unreflectingly switching back to the pre-hospitalisation medication must be avoided. Therefore, both the patients and the follow-up physicians should be involved in the discharge process. In this study, we aim to test whether a brief medication review which takes the patients' priorities into account, combined with a standardised communication strategy at hospital discharge, leads to sustained medication appropriateness and extends readmission times among elderly multimorbid patients. METHODS: The study is designed as a two-armed, double-blinded, cluster-randomised trial, involving 42 senior hospital physicians (HPs) with their junior HPs and 2100 multimorbid patients aged 60 years or older. Using a randomised minimisation strategy, senior HPs will be assigned to either intervention or control group. Following instructions of the study team, the senior HPs in the intervention group will teach their junior HPs how to integrate a simple medication review tool combined with a defined communication strategy into their ward's discharge procedure. The untrained HPs in the control group will provide data on usual care, and their patients will be discharged following usual local routines. Primary outcome is the time until readmission within 6 months after discharge, and secondary outcomes cover readmission rates, number of emergency and GP visits, classes and numbers of drugs prescribed, proportions of potentially inappropriate medications, and the patients' quality of life after discharge. Additionally, the characteristics of both the HPs as well as the patients will be collected before the intervention. Process evaluation outcomes will be assessed parallel to the ongoing core study using qualitative research methods. DISCUSSION: So far, interventions to reduce polypharmacy are still scarce at the crucial interface between HPs and GPs. To our knowledge, this trial is the first to analyse the combination of a brief deprescribing intervention with a standardised communication strategy at hospital discharge and in the early post-discharge period. TRIAL REGISTRATION: ISRCTN, ISRCTN18427377 . Registered 11 January 2018.

DREAMeR: Drug use Reconsidered in the Elderly using goal Attainment scales during Medication Review; study protocol of a randomised controlled trial.

BACKGROUND: Clinical medication reviews (CMR) are increasingly performed in older patients with polypharmacy. Studies have shown positive effects of CMR on process- and intermediate outcomes, like drug-related problems (DRPs). Little effect has been shown on clinical outcomes, like hospital admissions or health-related quality of life (HR-QoL). In particular, HR-QoL is related to the individual health-related goals and complaints of patients. The aim of this study is to investigate the effects of a CMR focused on personal goals on HR-QoL and health-related complaints in older patients with polypharmacy. METHODS: A randomised controlled trial will be performed in 35 Dutch community pharmacies aiming to include 630 patients aged 70 years and older using seven or more chronic drugs. Patients will be randomly assigned to control or intervention group by block-randomisation per pharmacy. Patients in the intervention group receive a CMR focused on patients' preferences, personal goals and health-related complaints. With every goal a goal attainment scale (GAS) will be proposed. Primary outcome measures are HR-QoL, measured with the EQ-5D-5L and EQ-VAS and the number of health-related complaints per patient measured with a written questionnaire, during a follow-up period of six months. Secondary outcomes are healthcare utilisation, number and type of drug changes, number and type of health-related goals, scores on GAS and number and type of DRPs and interventions. DISCUSSION: This study is expected to add evidence on the effects of a CMR on HR-QoL and health-related complaints in older patients with polypharmacy. New in this study is the use of personal goals measured with GAS and health-related complaints as patient-related outcome measures. TRIAL REGISTRATION: Netherlands Trial Register; NTR5713 .

Community pharmacists' views of using a screening tool to structure medicines use reviews for older people: findings from qualitative interviews.

Background The Medicines use review (MUR) service, provided by community pharmacists, seeks to optimise patients' use of medicines. There is limited evidence on the clinical effectiveness of this service. Structuring MURs to include an assessment of prescribing appropriateness, facilitated by a validated prescribing screening tool, has the capacity to enhance this service. Objective To explore community pharmacists' views on the facilitators and barriers towards the utilisation of a screening tool as a guide to conducting structured MURs. Setting Community Pharmacy, Northern Ireland. Method Using the 14 domain Theoretical Domains Framework (TDF), semi-structured interviews were conducted with community pharmacists. Interviews were digitally recorded, transcribed verbatim and analysed using the Framework method. Main Outcome Measure Pharmacists' views towards utilisation of a screening tool as a guide to conducting structured MURs. Results Based on the analysis of 15 interviews, 11 TDF domains ('Knowledge', 'Skills', 'Social and professional role and identity', 'Beliefs about capabilities', 'Beliefs about consequences', 'Reinforcement', 'Goals', 'Memory, attention and decision process', 'Environmental context and resources', 'Social influences', 'Behavioural regulation') were deemed relevant. Facilitators included: knowledge of patients, clinical knowledge, perceived professional role, patients' clinical outcomes, influence of peers. Barriers included: prioritisation of other clinical activities, inability to access patients' clinical information, perceived alienation from the primary healthcare team and staffing issues. Conclusions Using the TDF, key facilitators and barriers were identified in the use of a screening tool as a guide to conducting MURs. These findings may assist in further development of MURs as a means to optimise patients' medicines use.

Quality Use of the Pathology Data in Home Medicines Reviews: A Retrospective Evaluation.

BACKGROUND: Laboratory tests can be important tools for the assessment of pharmacotherapy. Nonetheless, there are no previous studies that have explicitly focused on the role of pathology data in Home Medicines Reviews (HMR), an Australian medication review program. OBJECTIVE: Evaluate pharmacists' recommendations regarding laboratory testing in the medication review process. METHODS: This retrospective review of HMRs assessed the prevalence of the pathology data provided by general practitioners. Additionally, the pharmacists' recommendations based on these laboratory data were compared with national and international guidelines. RESULTS: In total, 580 reports were evaluated. Of these, 179 reports did not contain any pathology data. Pharmacists commented on provided laboratory values in 324 reports and recommended further testing in 473 reports. Not all suggestions were related to previous values or were in line with guidelines. Most recommendations were regarding vitamin D and lipids (69% and 62% of medication review reports, respectively). Particularly, regarding renal impairment, pharmacists used their knowledge on dose adjustments and contraindications. In relation to full blood count, vitamin B12, and thyroid function, unjustified screenings were often recommended. In 26% of all reports, the pharmacists requested an array of tests without explaining the necessity for these tests. Conclusion and Relevance: Pharmacists provided useful advice based on the pathology data, which was concordant with national and international guidelines; however, in some cases, there was no rationale for the test recommendations provided. The outcome of the HMR program might be further enhanced if pharmacists had direct access to the patients' pathology data.

Comparison of dispensed medications and forensic-toxicological findings to assess pharmacotherapy in the Swedish population 2006 to 2013.

PURPOSE: To investigate person-level agreement between medication exposure as predicted using the PRE2DUP (a prescription-based design to estimate continuous drug use) method and postmortem toxicological findings, in the Swedish population during the years 2006 to 2013. METHODS: Using the Swedish National Board of Forensic Medicine's toxicology database and the Swedish National Board of Health and Welfare's registries on causes of death, dispensed medications, and in-patient care, forensic-toxicological findings were compared with prescription-based estimates of drug use for 27 medications. We modeled expected drug-use periods with the PRE2DUP using an algorithm of demonstrated high validity that evaluates personal drug-purchasing patterns with consideration to possible stockpiling of drugs and package information. Excluding criteria included self-inflicted death and recent in-patient care. RESULTS: In data from 18 627 performed autopsies, as well as 10 160 instances of dispensed drug use, the agreement between PRE2DUP drug-use periods and forensic toxicology was, overall, moderate (Cohen's kappa: 0.56 [95% confidence interval {CI}: 0.55-0.57]) with a positive predictive value, or predicted adherence rate, of 46.0%. The group-level predicted adherence and agreement were highest for antidepressants, at 71.0% (Cohen's kappa: 0.74 [CI: 0.73-0.76]), and lowest for cardiovascular drugs, at 21.5% (Cohen's kappa: 0.33 [CI: 0.31-0.36]). Predicted recreational use (negative predictive value) was low for all investigated drugs (0.0%-1.4%). The biological half-life explained 29% (P = 0.003) of the variability of the false-positive rate. CONCLUSIONS: Measured agreement between PRE2DUP-based drug-use estimates and forensic-toxicological findings is dependent upon a number of factors, including true continuous drug use and postmortem detectability of the investigated drugs, as well as the occurrence of unconventional dosing and true non-adherence.