Reducing Inappropriate Drug Use in Older Patients by Use of Clinical Decision Support in Community Pharmacy: A Mixed-Methods Evaluation.

INTRODUCTION: Older people are prone to drug-related harm. Clinical decision support systems (CDSSs) in community pharmacies may improve appropriate prescribing in this population. OBJECTIVE: This study investigated (persistent) drug therapy changes and its determinants to reduce potentially inappropriate medication (PIM) in older patients based on CDSS alerts and to investigate barriers and facilitators for implementation of drug therapy changes based on these CDSS alerts. METHODS: Five clinical decision rules based on national guidelines for inappropriate drugs in older patients were incorporated in a web-based CDSS in 31 community pharmacies between February and April 2017. The CDSS generated alerts for patients aged > 70 years who had prescriptions for one of the following drugs: alprazolam, amitriptyline, barnidipine, duloxetine, fluoxetine, trazodone, quetiapine and olanzapine. The registered alert management data and medication dispensing histories were analysed to find potential determinants of persistent drug therapy changes. Ten pharmacists were interviewed about the barriers and facilitators for implementing drug therapy changes based on CDSS alerts. An inductive thematic analysis of the transcripts was performed. RESULTS: The pharmacists recorded the management of 1810 of the 2589 generated alerts, and 158 (8.7%) alerts were associated with a persistent drug therapy change. A logistic regression analysis found that the drug triggering the alert and the type of prescription [first dispensing vs. repeat; odds ratio 2.1 (95% confidence interval 1.4-3.2)] were significantly associated with persistent drug therapy changes. No association was found between persistent changes and age, sex, number of medicines in use, or recent clinical medication review. Analysis of the interviews revealed nine barriers and facilitators associated with drug therapy change. CONCLUSION: When community pharmacists implemented CDSS alerts to reduce inappropriate drug use in older patients, they registered a persistent drug therapy change in 8.7% of the cases. Alerts triggered by a first prescription were two times more likely to be associated with a persistent drug therapy change than alerts triggered by repeat prescriptions. This study found that clinical rules can be used to detect inappropriate drug use in older patients and that drug therapy can change based on the alerts. This suggests that CDSS alerts are a useful tool for implementing guidelines on PIM in older patients in daily practice.

Moral dilemmas reflect professional core values of pharmacists in community pharmacy.

OBJECTIVES: The aim was to recognise the professional core values in the moral dilemmas of pharmacists in community pharmacy and to customise the descriptions of these values for community pharmacy practice. METHODS: The narratives of 128 moral dilemmas, collected from Dutch PharmD students and early career pharmacists who experienced these dilemmas in practice, were qualitatively analysed. An expert panel deductively coded relevant portions of these narratives with the core values as formulated by the Royal Dutch Pharmacists Association. Other values that emerged were inductively coded and if possible used to further customise the respective core values. KEY FINDINGS: The expert panel identified all four professional core values, that is, commitment to the patient's well-being (117, 91.4%), reliable and caring (116, 90.6%), pharmaceutical expertise (72, 56.2%) and responsibility to society (30, 23.4%) in the 128 moral dilemma narratives. Thirteen other values that emerged in the analysis could all be used for the customisation of the professional core values in descriptions that better reflect community pharmacy practice. CONCLUSIONS: Professional core values were identified in moral dilemma narratives of pharmacists in community pharmacy and customised for their practice. These customised core values can enable pharmacists to better recognise moral dilemmas in practice. This can add to the advancement of the profession as a pharmaceutical care practice.

Better specification of triggers to reduce the number of drug interaction alerts in primary care.

OBJECTIVE: Drug interaction alerts (drug-drug and drug-disease interaction alerts) for chronic medications substantially contribute to alert fatigue in primary care. The aim of this study was to determine which events require (re)assessment of a drug interaction and whether using these events as triggers in clinical decision support systems (CDSSs) would affect the alert rate. METHODS: Two random 5% data samples from the CDSSs of 123 community pharmacies were used: dataset 1 and 2. The top 10 of most frequent drug interaction alerts not involving laboratory values were selected. To reach consensus on events that should trigger alerts (e.g. first time dispensing, dose modification) for these drug interactions, a two-step consensus process was used. An expert panel of community pharmacists participated in an online survey and a subsequent consensus meeting. A CDSS with alerts based on the consensus was simulated in both datasets. RESULTS: Dataset 1 and 2 together contained 1,672,169 prescriptions which led to 591,073 alerts. Consensus on events requiring alerts was reached for the ten selected drug interactions. The simulation showed a reduction of the alert rate of 93.0% for the ten selected drug interactions (comparable for dataset 1 and 2), corresponding with a 28.3% decrease of the overall drug interaction alert rate. CONCLUSION: By consensus-based better specification of the events that trigger drug interaction alerts in primary care, the alert rate for these drug interactions was reduced by over 90%. This promising approach deserves further investigation to assess its consequences and applicability in daily practice.

Moral dilemmas of community pharmacists: a narrative study.

Background Pharmacists are increasingly involved in patient care. This new role in a complex healthcare system with demanding patients may lead to moral dilemmas. There has been little research into pharmacy ethics, and existing data are limited by their retrospective nature and small sample sizes. A thematic overview of the moral dilemmas experienced by community pharmacists is still missing. Objective To make a thematic overview of moral dilemmas experienced in daily pharmacy practice. Setting Dutch community pharmacy. Methods Dutch community pharmacists wrote a narrative about a moral dilemma they had experienced in clinical practice. The narratives were analysed using qualitative content analysis to identify underlying themes. Main outcome measure Themes of moral dilemmas. Results Twenty-two themes were identified in 128 narratives. These moral dilemmas arose predominantly during pharmacists' contact with patients and other health professionals. The relationship between the pharmacist, patient and other health professionals was complicated by other parties, such as legal representatives, health insurance companies, and regulators. Conclusion The moral dilemmas experienced by community pharmacists are more diverse than previously reported. The main dilemmas arose in their professional contacts, frequently when their professional autonomy was challenged by the behaviour of patients and other health professionals.

Aspects influencing patients' preferences for the management of drug-drug interactions: A focus group study.

OBJECTIVE: The management of drug-drug interactions (DDIs) involves a complex risk-benefit assessment, in which patients' preferences should be taken into account. The aim of this study was to examine the aspects influencing patients' preferences with regard to DDI management options. METHODS: A qualitative study consisting of five focus groups with patients chronically using cardiovascular drugs was conducted. Key questions concerned preferences regarding DDI management options for a provided fictitious DDI. Thematic analysis of the verbatim transcripts was performed. RESULTS: Despite their limited knowledge with respect to DDIs, patients easily chose a management option for the presented DDI. When additional information was provided, preferences showed to be fluid. Ten interdependent aspects influencing preferences were derived from patients' argumentations: risk perception, fear, acceptance of uncertainty, openness to change, willingness to take risk, trust in health care professional, financial & practical burdens, health condition, experience, and knowledge & assumptions. CONCLUSION: Patients' preferences regarding DDI management options were often determined by provided information. Preferences were dependent on an interplay of diverse aspects. PRACTICE IMPLICATIONS: Tailored provision of information and individualized counseling is needed for active patient involvement in DDI decision making.

Preferences of Patients and Pharmacists with Regard to the Management of Drug-Drug Interactions: A Choice-Based Conjoint Analysis.

INTRODUCTION: The management of drug-drug interactions (DDIs) is a complex process in which risk-benefit assessments should be combined with the patient's perspective. OBJECTIVE: The aim of this study was to determine patients' and pharmacists' preferences regarding DDI management. METHODS: We conducted a choice-based conjoint survey about a fictitious DDI concerning the combination of a cardiovascular drug and an antibiotic for pneumonia. Patients and pharmacists had to choose 12 times between two management options. The options were described by five attributes, including risk, benefit and practical consequences. Each attribute could have two different levels, which were varied over the choice tasks. Latent class analysis was used to identify potential classes of respondents with distinct patterns of similar preferences. RESULTS: In total, 298 patients and 178 pharmacists completed the questionnaire. The latent class model for both patients and pharmacists resulted in three classes. For patients, in one class the most importance was attached to avoiding switch of medication (class probability 20%), in a second class to fewer adverse events (41%), and in a third class to blood sampling (39%). For pharmacists, again one class attached the highest importance to avoiding switch of medication (31%). The other classes gave priority to curing pneumonia (31%) and avoiding blood sampling (38%). CONCLUSION: The results showed diverging preferences regarding DDI management among both patients and pharmacists. Different groups attached different value to risk and benefit versus practical considerations. Awareness of existing variability in preferences among and between pharmacists and patients is a step towards shared decision making in DDI management.

Clinical Decision Support and Optional Point of Care Testing of Renal Function for Safe Use of Antibiotics in Elderly Patients: A Retrospective Study in Community Pharmacy Practice.

OBJECTIVE: The aim was to investigate the management of drug therapy alerts on safe use of antibiotics in elderly patients with (potential) renal impairment and the contribution of optional creatinine point of care testing (PoCT) in community pharmacy practice. METHODS: Community pharmacists used a clinical decision support system (CDSS) for seven antibiotics. Alerts were generated during prescription processing in the case of previously registered renal impairment and when no information on renal function was available for patients aged 70 and over. Pharmacists could perform PoCT when renal function could not be retrieved from other health care professionals. Actions were registered in the CDSS. A retrospective descriptive analysis of alert management, performed PoCT and medication dispensing histories was performed. RESULTS: A total of 351 pharmacists registered the management of 88,391 alerts for 64,763 patients. For 68,721 alerts (77.7%), the pharmacist retrieved a renal function above the threshold for intervention. 1.7% of the alerts (n = 1532) led to a prescription modification because of renal impairment; in 3.0% of the alerts (n = 2631), the patient had renal impairment, but the pharmacist judged that no intervention was needed. Pharmacists performed 1988 PoCTs (2.2% of the alerts), which led to 15 prescription modifications (0.8% of the PoCT). CONCLUSION: Community pharmacists performed CDSS-based interventions to prevent potentially inappropriate (dosing of) antibiotics in elderly patients with renal impairment. Pharmacists were well able to retrieve information on renal function, using PoCT in a limited number of cases. The intervention rate could be greatly increased by better registration of information on renal function. Performing PoCT seems especially worthwhile in the highest age groups.

Lower alert rates by clustering of related drug interaction alerts.

OBJECTIVE: We aimed to investigate to what extent clustering of related drug interaction alerts (drug-drug and drug-disease interaction alerts) would decrease the alert rate in clinical decision support systems (CDSSs). METHODS: We conducted a retrospective analysis of drug interaction alerts generated by CDSSs in community pharmacies. Frequently generated combinations of alerts were analyzed for associations in a 5% random data sample (dataset 1). Alert combinations with similar management recommendations were defined as clusters. The alert rate was assessed by simulating a CDSS generating 1 alert per cluster per patient instead of separate alerts. The simulation was performed in dataset 1 and replicated in another 5% data sample (dataset 2). RESULTS: Data were extracted from the CDSSs of 123 community pharmacies. Dataset 1 consisted of 841 572 dispensed prescriptions and 298 261 drug interaction alerts. Dataset 2 was comparable. Twenty-two frequently occurring alert combinations were identified. Analysis of these associated alert combinations for similar management recommendations resulted in 3 clusters (related to renal function, electrolytes, diabetes, and cardiovascular diseases). Using the clusters in alert generation reduced the alert rate within these clusters by 53-70%. The overall number of drug interaction alerts was reduced by 11% in dataset 1 and by 12% in dataset 2. This corresponds to a decrease of 21 alerts per pharmacy per day. DISCUSSION AND CONCLUSION: Using clusters of drug interaction alerts with similar management recommendations in CDSSs can substantially decrease the overall alert rate. Further research is needed to establish the applicability of this concept in daily practice.

Nature and frequency of drug therapy alerts generated by clinical decision support in community pharmacy.

PURPOSE: The purpose of this study is to investigate the nature, frequency, and determinants of drug therapy alerts generated by a clinical decision support system (CDSS) in community pharmacy in order to propose CDSS improvement strategies. METHODS: This is a retrospective analysis of dispensed drugs and drug therapy alerts generated by a CDSS in community pharmacies. RESULTS: Data were extracted from the CDSS of 123 community pharmacies. After taking a 10% random sample of patients with a prescription in the period August 2013-July 2014, 1,672,169 dispensed prescriptions from 81,742 patients were included in the analysis. Of all processed prescriptions, 43% led to one or more drug safety alerts, most frequently drug-drug interaction alerts (15% of all prescriptions), drug-disease interaction alerts (14%), duplicate medication alerts (13%), and dosing alerts (7%). The majority of prescriptions with alerts (80%) were clustered in a minority of patients (16%). The therapeutic drug group of the prescribed drug was the most important determinant of alert generation. Prescriptions for antithrombotic agents accounted for 9.4% of all prescriptions with an alert, beta-blocking agents for 7.5% and angiotensin-converting-enzyme inhibitors for 6.1%. DISCUSSION AND CONCLUSION: The investigated CDSS in Dutch community pharmacy generated one or more drug therapy alerts in nearly half of the processed prescriptions. The majority of alerts were concentrated in a minority of therapeutic drug groups and patients. To decrease the alert burden, CDSS improvements should be directed at the prioritization and integration of drug therapy alerts for these therapeutic groups within patients.

NSAID-antihypertensive drug interactions: which outpatients are at risk for a rise in systolic blood pressure?

BACKGROUND: Management guidelines for drug-drug interactions between non-steroidal anti-inflammatory drugs (NSAIDs) and antihypertensives recommend blood pressure monitoring in hypertensive patients. We measured the short-term effect of initiating NSAIDs on systolic blood pressure (SBP) in users of antihypertensives, aiming to investigate which outpatients are at risk for an increase in SBP in daily clinical practice. DESIGN: A cohort study with a nested case-control design in Dutch community pharmacies. METHODS: Patients with a drug-drug interaction alert for a newly initiated NSAID and antihypertensive were interviewed and their SBP was measured at T0, after one week (T1) and after two weeks (T2). We evaluated risk factors for exceeding a predefined limit of change (PLoC) in SBP (≥ 10 mmHg to ≥ 140 mmHg) at T1 and T2 versus T0. RESULTS: For 112 patients the SBP at T0 was measured. Two patients were excluded (T0 SBP ≥ 180 mmHg). PLoC was exceeded in 10 patients (10.4%) at T1 and in seven patients (8.0%) at T2. Patients using etoricoxib (odds ratio (OR), 21.0; 95% confidence interval (CI), 3.7-120.6) and patients using >1 defined daily dose of an NSAID (OR, 3.3; 95% CI, 1.1-10.0) were at increased risk of a rise in SBP. CONCLUSIONS: A newly initiated NSAID has an immediate clinically relevant effect on SBP in some users of antihypertensives. Management guidelines for NSAID-antihypertensive drug-drug interactions should advise SBP monitoring before and after initiation of an NSAID or intensification of NSAID therapy. Monitoring is especially relevant in patients prescribed high dosages of NSAIDs. Etoricoxib should not be used in hypertensive patients.

Checklist for standardized reporting of drug-drug interaction management guidelines.

PURPOSE: Inconsistencies and omissions in drug-drug interaction (DDI) management guidelines may lead to harm and suboptimal therapy. The purpose of this study was to define a checklist for DDI management guidelines to help developers produce high-quality guidelines that will support healthcare providers in clinical practice. METHODS: We carried out a two-round Delphi process with an international panel of healthcare providers, most of whom are pharmacists involved in providing DDI information, in order to select those items that should be addressed in DDI management guidelines (including grading systems that could be used). RESULTS: Twenty-three panellists reached consensus on 19 items in two main domains. These were consolidated into a checklist of 15 elements for standardized reporting in management guidelines. For each element a description is provided to specify what information should be documented in that specific element. CONCLUSIONS: It was possible to reach a broad consensus on which relevant items should be included in a checklist for the development of DDI management guidelines.

Missed drug therapy alerts as a consequence of incomplete electronic patient records in Dutch community pharmacies.

BACKGROUND: Complete and up-to-date medical and pharmaceutical information in the electronic patient record (EPR) is a prerequisite for risk management in community pharmacy. OBJECTIVES: To analyze which information is missing in the EPR and which drug therapy alerts, therefore, fail to appear. METHODS: Pharmacy students selected patients who were dispensed a prescription drug and enlisted for >3 months in the participating pharmacies. Patients received a questionnaire in which they were asked to verify their medication history, and to provide additional patient information. For each enrolled patient, the students collected all relevant information from the EPR. Self-reported data from the patient were compared with data retrieved from the EPR. Missed information in the EPR was evaluated based on national professional guidelines. RESULTS: Questionnaires were received from 67% of the selected patients (442/660). Prescription drugs were missing in the EPR of 14% of the 442 patients, nonprescription drugs in 44%, diseases in 83%, and intolerabilities in 16%. In 38% of the patients (166/442), drug therapy alerts failed to appear because of missing information: drug-disease interactions in 34% of the patients, duplicate medications in 4%, drug-drug interactions (DDIs) in 4%, and drug intolerabilities in 2%. Among the (non-)prescription drugs missing, NSAIDs were most frequently responsible for the missed alerts. Diseases most frequently associated with missed alerts were gastroesophageal reflux disease, renal insufficiency, asthma/chronic obstructive pulmonary disease, and heart failure. CONCLUSIONS: Relevant patient information was frequently missing in the EPRs. The nonappearance of drug therapy alerts may have had clinical consequences for patients.

Clarity and applicability of drug-drug interaction management guidelines: a systematic appraisal by general practitioners and community pharmacists in the Netherlands.

BACKGROUND: Despite the availability and daily use of computerized drug-drug interaction surveillance systems, exposure to potentially relevant drug-drug interactions (DDIs) continues. DDI management guidelines are often inadequate and clear management options are lacking, which attributes to overriding of DDI signals. Although general criteria for the development and reporting of high-quality clinical practice guidelines have been identified, it appears these have not yet been applied to DDI management guidelines. OBJECTIVES: The aim of the study was to assess the clarity and applicability of guidelines for the management of potentially harmful DDIs. METHODS: We selected 13 DDIs that are potentially harmful for patients and frequently occur in community pharmacy practice in the Netherlands. The clarity and applicability of the management guidelines of these DDIs were appraised using the appropriate two domains - 'Clarity and presentation' and 'Applicability', of the validated Appraisal of Guidelines for Research and Evaluation (AGREE) Instrument. The appraisal was performed by 12 community pharmacists and 12 general practitioners. The standardized domain scores and mean item scores for 'Clarity and presentation' and 'Applicability' were compared. RESULTS: All DDI management guidelines were generally found to score well on 'Clarity and presentation', but poorly with respect to 'Applicability' (standardized domain scores 68.0 vs 26.1%). Within the domain 'Clarity and presentation', the item 'tools for application' received the lowest scores. Within the domain 'Applicability', cost implications, organizational barriers and key review criteria were all poorly documented. All guidelines presented non-directive advice using words such as 'consider' and 'regularly'. CONCLUSIONS: Developers of DDI management guidelines should take the appropriate domains of the AGREE Instrument into consideration in their development processes. The applicability of DDI management guidelines should be pretested before publishing. To improve guideline quality, more attention should particularly be paid to the available tools for applications and cost implications.

Documentation quality in community pharmacy: completeness of electronic patient records after patients' first visits.

BACKGROUND: When patients visit a community pharmacy for the first time, the creation of an electronic patient record (EPR) with relevant and up-to-date data is a prerequisite for adequate medication surveillance and patient counseling. OBJECTIVE: To investigate the level of completeness of documentation in the EPR after a patient's first visit to a Dutch community pharmacy. METHODS: In each participating pharmacy, newly enlisted (<3 mo) patients to whom at least one medication had been dispensed were enrolled in this survey. For each patient who could be interviewed, pharmacy master students used a structured questionnaire to gather relevant, mandatory patient data (ie, basic characteristics, current drugs used, diseases, intolerabilities, specific conditions) and nonmandatory patient data (eg, diagnostic and monitoring data, personal experiences and habits, drug use problems) from the patient's EPR and from a structured telephone interview with the patient. Data retrieved from the patient's EPR were compared with data provided by the patient during the telephone interview. RESULTS: Of 403 selected patients, 154 (38.2%) could be interviewed by telephone. Poor documentation of telephone numbers in the EPR was the main reason for nonresponse (134/249). Interviewers found that 67.7% of prescription drugs, 0% of over-the-counter drugs, 19.6% of diseases, 3.7% of intolerabilities, and none of the specific conditions reported by patients had been documented in the EPR. Nonmandatory data (personal experiences and habits, drug use problems) reported during the patient interview had not been documented in the EPR. CONCLUSIONS: The EPR after a patient's first visit to the community pharmacy is often incomplete. For new patients, the pharmacist should more proactively and systematically gather patient information, and all relevant information should be recorded, preferably in coded form, in the pharmacy information system to allow more adequate clinical risk management.

Clinical risk management of interactions between natural products and drugs.

Clinical risk management offers a systematic approach to minimize healthcare-related risks by paying attention to: (1) risk identification and assessment; (2) development and execution of risk reduction strategies; (3) evaluation of risk reduction strategies. This paper reviews these key areas for the risk of interactions between natural products and drugs (NPDIs) to explore how the impact of these interactions on public health can be minimized. It argues that specific components of clinical risk management need to be evaluated, before adoption, and then actively implemented if proven valuable.

Perceived diabetes status is independently associated with glucose monitoring behaviour among type 2 diabetes mellitus patients.

AIMS: To investigate if patients' perceptions of their diabetes status is related to blood glucose self-monitoring (SMBG) behaviour, independent of self-reported disease severity. METHODS: The setting of this study was a cross-sectional study among 1561 patients, 18 years or older, who filled at least two prescriptions for any glucose lowering drug between March 2002 and 2003 in the Netherlands. Using a 30-item self-administered questionnaire, data on self-monitoring behaviour (frequency of test strip use and objective of self-monitoring), perceived diabetes status and disease severity were gathered. Type 1 diabetes mellitus patients were excluded. We used logistic regression to calculate odds ratios (OR) and their 95% confidence intervals (CI). RESULTS: About 54% of the patients (n=841) returned evaluable questionnaires. After exclusion of 97 type 1 diabetes mellitus patients, 744 type 2 diabetes mellitus patients were included. Practising SMBG was more common among patients who rated their diabetes status as poorly or moderately controlled compared to those who rated it (very) well-controlled (OR 1.93; 95% CI: 1.20-3.12). A better perceived diabetes status was more likely in those who performed SMBG infrequently compared to those who performed SMBG frequently (p-value for trend=0.001). Self-reported factors of disease severity and personalized objectives did not affect these associations considerably. CONCLUSIONS: Among type 2 diabetes mellitus patients, SMBG behaviour is associated with patients' perceptions of diabetes status, irrespective of the self-reported disease severity.