Adoption of new medicines in primary care: A comparison between the uptake of new oral anticoagulants and diabetes medicines.

AIMS: To gain insight in the uptake and practice variation in the prescription of 2 new medicine groups for common conditions in primary care (direct-acting oral anticoagulants [DOACs] and incretin-based therapies) from introduction, around 2007, to 2019 and the correlation between the adoption of those medicines in primary care. METHODS: Prescription data from general practices in the Dutch Nivel Primary Care Database from 2007 to 2019 were used. The percentage of patients with prescriptions for DOACs of all patients with prescriptions for DOACs and vitamin K antagonists was calculated per practice per year, as was the percentage of patients prescribed incretin-based therapies as a proportion of all patients with diabetes medication. Multilevel models were used to estimate practice variation for DOACs and incretin-based therapies, expressed as intraclass correlation coefficients. Linear regression analysis was used to study the association between the prescription of DOACs and incretin-based therapies. RESULTS: Per year, 46-424 general practices and 179 933-1 654 376 patients were included. In 2019, the mean percentage of patients per practice using DOACs or incretin-based therapies was 54.9 and 9.7%, respectively. The intraclass correlation coefficient decreased from 0.75 to 0.024 for DOACs and from 0.33 to 0.074 for incretin-based medicines during the study period. No clear correlation was found between the prescription of DOACs and incretin-based therapies. CONCLUSION: DOACs and incretin-based therapies have different adoption profiles and practice variation is large, especially in the years before these medicines were introduced in guidelines. Early adopters of both medicine classes differ.

A practice guide on antimicrobial stewardship in nursing homes.

A practice guide to help nursing homes set up an antimicrobial stewardship (AMS) program was developed based on experiences gained during a project at one of the largest providers of elderly care in the South-east of the Netherlands. The guideline for the implementation of AMS in Dutch hospitals served as a starting point and were tailored to the unique characteristics of a nursing home setting. This practice guide offers recommendations and practical tools while emphasizing the importance of establishing a multidisciplinary approach to oversee AMS efforts. The recommendations and practical tools address various elements of AMS, including the basic conditions to initiate an AMS program and a comprehensive approach to embed an AMS program. This approach involves educating nurses and caregivers, informing volunteers and residents/their representatives, and the activities of an antibiotic team (A-team). The practice guide also highlights a feasible work process for the A-team. This process aims to achieve a culture of continuous learning and improvement that can enhance the overall quality of antibiotic prescribing rather than making individual adjustments to client prescriptions. Overall, this practice guide aims to help nursing homes establish an AMS program through collaborative efforts between involved physicians, pharmacists, clinical microbiologists, and infection control practitioners. The involved physician plays a crucial role in instilling a sense of urgency and developing a stepwise strategy.

General practitioners-community pharmacists pharmacotherapy discussion groups: Analysis of their implementation through a series of case studies.

Background: The evolution of primary care practice has led to the implementation of pharmacotherapy discussion groups between general practitioners and community pharmacists (PPPDGs) in some countries. The aim of these groups is to improve drug prescribing practices and strengthen interprofessional relationships. Objective: To gain more insight into factors involved in successful implementation of PPPDGs. Methods: PPPDG implementation in three countries (Belgium, the Netherlands, Switzerland), was analyzed in a series of case studies. A grid describing different evaluation criteria was completed by stakeholders in their respective country. The data collection was followed by a literature review. Results: Various models were used to implement PPPDGs within each country and different dynamics were encountered. PPPDGs lead to positive effects on the quality and cost-effectiveness of drug prescribing and on the collaboration between general practitioners (GPs) and community pharmacists (CPs). Factors involved in implementation were also identified, such as expectations of GPs and CPs, configuration of the implemented model, and the role of CPs in the healthcare organization. Conclusions: This study provides insight into the factors involved in successful implementation of PPPDGs in Belgium, the Netherlands and Switzerland. The findings can be used by healthcare professionals to improve the safety, cost-effectiveness of drug prescriptions and systems in primary care. This study offers a starting point for further research in the field.

Marketing of medicines in primary care: An analysis of direct marketing mailings and advertisements.

INTRODUCTION: Marketing materials from pharmaceutical companies attempt to create a positive image of marketed, often new, medicines. To gain more insight in strategies pharmaceutical companies use to influence primary care practitioners' attitudes towards marketed medicines, we investigated the use of persuasion strategies in direct marketing mailings and advertisements from pharmaceutical companies sent to general practitioners. METHODS: General practitioners in the Netherlands were recruited to collect all direct marketing mailings, meaning all leaflets, letters and other information sent by pharmaceutical industries to the practice during one month (June 2022). Direct marketing mailings and advertisements in collected medical journals concerning medicines or diseases (together called marketing materials) were analysed according to presence of one of the seven common persuasion strategies, i.e. reciprocity, consistency/commitment, social proof, liking, authority, scarcity and unity; as well as marketed medicine and year of introduction. RESULTS: Twenty general practices collected 68 unique marketing materials concerning 37 different medicines. Direct factor Xa inhibitors (n = 12), glucagon-like peptide-1 analogues (n = 5) and sodium-glucose co-transporter 2 inhibitors (n = 4) were the most frequently marketed medicines. The median year of introduction of all marketed medicines was 2012. All seven persuasion strategies were identified, with liking (64.7% of all materials) and authority (29.4%) as most prominent strategies, followed by social proof (17.6%), unity (14.7%), scarcity (13.2%), reciprocity (11.8%) and consistency/commitment (2.9%). In addition to those strategies, we identified emotional pressure (30.9%) as one commonly used new strategy. CONCLUSION: Marketing materials sent to general practices use a wide range of persuasion strategies in an attempt to influence prescription behaviour. Primary care practitioners should be aware of these mechanisms through which pharmaceutical companies try to influence their attitudes towards new medicines.

Newer long-acting insulin prescriptions for patients with type 2 diabetes: prevalence and practice variation in a retrospective cohort study.

BACKGROUND: Little is known about prescription patterns of expensive non-recommended newer long-acting insulins (glargine 300 U/mL and degludec) for patients with type 2 diabetes mellitus (T2DM). AIM: To identify practice variation in, and practice- and patient-related characteristics associated with, the prescription of newer long-acting insulins to patients with T2DM in primary care. DESIGN AND SETTING: A retrospective cohort study in Dutch general practices (Nivel Primary Care Database). METHOD: A first prescription for intermediate or long-acting insulins in 2018 was identified in patients aged ≥40 years using other T2DM drugs. Per practice, the median percentage and interquartile range (IQR) of patients with newer insulin prescriptions were calculated. Multilevel logistic regression models were constructed to calculate intraclass correlation coefficients (ICCs) and quantify the association of patient and practice characteristics with prescriptions for newer insulins (odds ratios [ORs] and 95% confidence intervals [CIs]). RESULTS: In total, 7757 patients with prescriptions for intermediate or long-acting insulins from 282 general practices were identified. A median percentage of 21.2% (IQR 12.5-36.4%) of all patients prescribed intermediate or long-acting insulins per practice received a prescription for newer insulins. After multilevel modelling, the ICC decreased from 20% to 19%. Female sex (OR 0.77, 95% CI = 0.69 to 0.87), age ≥86 years compared with 40-55 years (OR 0.22, 95% CI = 0.15 to 0.34), prescriptions for metformin (OR 0.66, 95% CI = 0.53 to 0.82), sulfonylurea (OR 0.58, 95% CI = 0.51 to 0.66), or other newer T2DM drugs (OR 3.10, 95% CI = 2.63 to 3.66), and dispensing practices (OR 1.78, 95% CI = 1.03 to 3.10) were associated with the prescription of newer insulins. CONCLUSION: The inter-practice variation in the prescription of newer insulins is large and could only be partially explained by patient- and practice-related differences. This indicates substantial opportunities for improvement.

Home Care Patients' Experiences with Home Care Nurses' Support in Medication Adherence.

PURPOSE: To describe nurses' support interventions for medication adherence, and patients' experiences and desired improvements with this care. PATIENTS AND METHODS: A two-phase study was performed, including an analysis of questionnaire data and conducted interviews with members of the care panel of the Netherlands Patients Federation. The questionnaire assessed 14 types of interventions, satisfaction (score 0-10) with received interventions, needs, experiences, and desired improvements in nurses' support. Interviews further explored experiences and improvements. Data were analyzed using descriptive statistics and a thematic analysis approach. RESULTS: Fifty-nine participants completed the questionnaire, and 14 of the 59 participants were interviewed. The satisfaction score for interventions was 7.9 (IQR 7-9). The most common interventions were: "noticing when I don't take medication as prescribed" (n = 35), "helping me to find solutions to overcome problems with using medications" (n = 32), "helping me with taking medication" (n = 32), and "explaining the importance of taking medication at the right moment" (n = 32). Fifteen participants missed ≥1 of the 14 interventions. Most mentioned the following: "regularly asking about potential problems with medication use" (33%), "regularly discussing whether using medication is going well" (29%), and "explaining the importance of taking medication at the right moment" (27%). Twenty-two participants experienced the following as positive: improved self-management of adequate medication taking, a professional patient-nurse relationship to discuss adherence problems, and nurses' proactive attitude to arrange practical support for medication use. Thirteen patients experienced the following as negative: insufficient timing of home visits, rushed appearance of nurses, and insufficient expertise about side effects and taking medication. Suggested improvements included performing home visits on time, more time for providing support in medication use, and more expertise about side effects and administering medication. CONCLUSION: Overall, participants were satisfied, and few participants wanted more interventions. Nurses' support improved participants' self-management of medication taking and enabled patients to discuss their adherence problems. Adequately timed home visits, more time for support, and accurate medication-related knowledge are desired.

Alignment between outcomes and minimal clinically important differences in the Dutch type 2 diabetes mellitus guideline and healthcare professionals' preferences.

To evaluate the clinical benefit of new medicines for type 2 diabetes mellitus (T2DM), the Dutch guideline committee T2DM in primary care established the importance of outcomes and minimal clinically important differences (MCIDs). The present study used an online questionnaire to investigate healthcare professionals' opinions about the importance of outcomes and preferences for MCIDs. A total of 211 physicians, pharmacists, practice nurses, diabetes nurses, nurse practitioners and physician assistants evaluated the importance of mortality, macro- and microvascular morbidity, HbA1c, body weight, quality of life, (overall) hospital admissions and severe and other hypoglycemia on a 9-point scale. All outcomes were considered critical (mean scores 7-9), except for body weight and other hypoglycemia (mean scores 4-6). Only HbA1c and hospital admissions were valued differently by the guideline committee (not critical). Other relevant outcomes according to the respondents were adverse events, ease of use and costs. Median MCIDs were 4 mmol/mol for HbA1c (guideline: 5 mmol/mol) and 3 kg for body weight (guideline: 5 kg weight gain and 2,5 kg weight loss). Healthcare professionals preferred relative risk reductions of 20% for mortality (guideline: 10%) and macrovascular morbidity (guideline: 25%) and 50% for other hypoglycaemia (guideline: 25%). The MCID of 25% for microvascular morbidity, hospital admissions and severe hypoglycaemia corresponded to the guideline-MCID. Healthcare professionals' preferences were thus comparable to the views of the guideline committee. However, healthcare professionals had a stricter view on the importance of HbA1c and hospital admissions and the MCIDs for mortality and other hypoglycemia.

Healthcare Professionals' Preferred Efficacy Endpoints and Minimal Clinically Important Differences in the Assessment of New Medicines for Chronic Obstructive Pulmonary Disease.

BACKGROUND: Registration authorities evaluate effects of new medicines for chronic obstructive pulmonary disease (COPD) on airway obstruction, dyspnea, health status and exacerbations. To establish clinical relevance, minimal clinically important differences (MCIDs) are used. The aim of this study was to investigate which efficacy endpoints and MCIDs healthcare professionals consider clinically relevant for new COPD medicines. MATERIALS AND METHODS: 7,731 Healthcare professionals received an electronic questionnaire. Participants were asked for: 1) preferred efficacy endpoints for new COPD medicines and 2) cut-off values defining clinical relevance for forced expiratory volume in 1 sec (FEV1), Transition Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ). Those cut-off values were compared to the MCIDs used by registration authorities, namely 100 ml for FEV1, 1 unit for TDI and 4 units for SGRQ. RESULTS: 227 Healthcare professionals responded to the questionnaire. Most preferred efficacy endpoints were exacerbations (51.0%), airway obstruction (46.9%) and health status (44.9%). Mean cut-off values for TDI and SGRQ were significantly higher than the corresponding MCIDs, mean differences 1.5 (95%CI = 1.3-1.8, p < 0.001) and 7.0 (95%CI = 5.1-8.8, p < 0.001), respectively. The mean cut-off value for FEV1 was comparable to the MCID (mean difference 2.2, 95%CI = -19.9-24.3, p = 0.84). CONCLUSIONS: Healthcare professionals largely agree with efficacy endpoints used for the evaluation of new COPD medicines. However, they seem to prefer higher cut-off values for clinical relevance for TDI and SGRQ than the registration authorities. Effects of new medicines on TDI and SGRQ that are considered clinically relevant by registration authorities do, therefore, not necessarily reflect healthcare professionals' perspectives on clinical relevance.

The effect of biannual medication reviews on the appropriateness of psychotropic drug use for neuropsychiatric symptoms in patients with dementia: a randomised controlled trial.

Objective: We studied the efficacy of biannual structured medication reviews to improve the appropriateness of psychotropic drug (PD) prescriptions for neuropsychiatric symptoms (NPS) in nursing home patients with dementia. Study Design and Setting: In this randomised controlled trial, the intervention encompassed a structured multidisciplinary medication review by physician, pharmacist and nurse. During this 18-month study, the patient's medical files were assessed every 6 months. The primary outcome was the appropriateness of PD prescriptions defined by the Appropriate Psychotropic drug use In Dementia (APID) index sum score, lower scores indicating more appropriate use. Results: At baseline, 380 patients were included, of which 222 were randomised to the intervention group. Compared to the control group, the APID index sum score in the intervention group improved significantly for all PD prescriptions (-5.28, P = 0.005). Conclusion: We advise the implementation of a structured, repeated medication review with the essential roles of pharmacist, physician and nurse, into daily practice. This work was supported and funded by the Netherlands Organisation for Health Research and Development (ZonMw). Netherlands Trial Register (NTR3569).

Factors associated with appropriate psychotropic drug prescription in nursing home patients with severe dementia.

ABSTRACTBackground:We studied the patient and non-patients factors of inappropriate psychotropic drug (PD) prescription for neuropsychiatric symptoms (NPS) in nursing home patients with severe dementia. METHODS: In a cross-sectional study, the appropriateness of prescriptions was explored using the Appropriate Psychotropic drug use In Dementia (APID) index sum score. This index assesses information from medical records on indication, evaluation, dosage, drug-drug interactions, drug-disease interactions, duplications, and therapy duration. Various measurements were carried out to identify the possible patient and non-patient factors. Linear multilevel regression analysis was used to identify factors that are associated with APID index sum scores. Analyses were performed for groups of PDs separately, i.e. antipsychotics, antidepressants, anxiolytics, and hypnotics. RESULTS: The sample consisted of 338 patients with a PD prescription that used 147 antipsychotics, 167 antidepressants, 85 anxiolytics, and 76 hypnotics. It was found that older patients and more severe aggression, agitation, apathy, and depression were associated with more appropriate prescriptions. Additionally, less appropriate prescriptions were found to be associated with more severe anxiety, dementia diagnoses other than Alzheimer dementia, more physician time available per patient, more patients per physician, more years of experience of the physician, and higher nurse's workload. CONCLUSIONS: The association of more pronounced NPS with more appropriate PD prescriptions implies that physicians should pay more attention to the appropriateness of PD prescriptions when NPS are less manifest. Non-patient-related factors are also associated with the appropriateness of PD prescriptions. However, especially considering that some of these findings are counter-intuitive, more research on the topic is recommended.

Only 10% of the psychotropic drug use for neuropsychiatric symptoms in patients with dementia is fully appropriate. The PROPER I-study.

BACKGROUND: This study explores the appropriateness of psychotropic drug (PD) use for neuropsychiatric symptoms (NPS) in nursing home patients with dementia. METHODS: A cross-sectional study on 559 patients with dementia residing on dementia special care units in Dutch nursing homes was conducted. Appropriateness of PD use was assessed using the Appropriate Psychotropic drug use In Dementia (APID) index. The APID index score is calculated using information about individual PDs from patients' medical records. The index encompasses seven (different) domains of appropriateness, i.e. indication, evaluation, dosage, drug-drug interactions, drug-disease interactions, duplications, and therapy duration. RESULTS: A total of 578 PDs were used for NPS by 60% of the nursing home patients. Indication, evaluation, and therapy duration contributed the most to inappropriate use. Ten per cent of the PDs scored fully appropriate according to the APID index sum score, 36% scored fully appropriate for indication, 46% scored fully appropriate for evaluation, and 58% scored fully appropriate for therapy duration. Antidepressants were used the most appropriately, and antiepileptics the most inappropriately. CONCLUSIONS: The minority of the PD use was fully appropriate. The results imply that PD use for NPS in dementia can be improved; the appropriateness should be optimized with a clinical focus on the appropriate indications, evaluations, and therapy duration.

Medication management of febrile children: a qualitative study on pharmacy employees' experiences.

Background While fever is mostly self-limiting, antibiotic prescription rates for febrile children are high. Although every parent who receives a prescription visits a pharmacy, we have limited insight into pharmacy employees' experiences with these parents. Pharmacy employees do however exert an important role in ensuring children receive correct dosages and in advising parents on administration of antibiotics. Objective To describe pharmacists' and pharmacy assistants' experiences with parents contacting a pharmacy for their febrile child, and to identify ways of improving medication management of these children. Setting Community pharmacies in the Netherlands. Method A qualitative study including 24 Dutch pharmacy employees was conducted, performing four focus group discussions among pharmacy employees. Analysis was based on constant comparative technique using open and axial coding. Main outcome measure Pharmacy employees' experiences with parents contacting a pharmacy for their febrile child. Results Three categories were identified: (1) workload and general experience, (2) inconsistent information on antibiotic prescriptions, (3) improving communication and collaboration. Pharmacy employees experienced that dosing errors in antibiotic prescriptions occur frequently and doctors provide inconsistent information on prescriptions. Consequently, they have to contact doctors, resulting in a higher workload for both stakeholders. They believe this can be improved by providing the indication for antibiotics on prescriptions, especially when deviating from standard dosages. Conclusion Pharmacy employees experience a high amount of dosing errors in paediatric antibiotic prescriptions. Providing the indication for antibiotics in febrile children on prescriptions, especially when deviating from standard dosages, can potentially reduce dosage errors and miscommunication between doctors and pharmacy employees.

A reliable and valid index was developed to measure appropriate psychotropic drug use in dementia.

OBJECTIVES: The aim of this study was to develop an index derived from the Medication Appropriateness Index (MAI) items that is suited for clinical studies evaluating appropriateness of psychotropic drug use (PDU) for neuropsychiatric symptoms (NPS) in patients with dementia in nursing homes and to test its reliability and validity. STUDY DESIGN AND SETTING: An expert panel reviewed the MAI items to develop items for appropriateness of PDU; a second, independent, expert panel determined content validity of the items. An interrater reliability study was conducted (N = 54), and a summated index score, based on weighted item scores, was developed to enhance the use in clinical studies. Construct validity was explored using a representative sample of 560 medical records. RESULTS: Five existing MAI items were used, the MAI item "indication" was adjusted, a new item "evaluation" was added, and scoring rules were based on guideline recommendations, to create the Appropriate Psychotropic drugs use In Dementia (APID) index. The second expert panel concluded that all items contributed to the construct "appropriateness." All items and the summated index score had moderate to almost perfect interrater reliability (intraclass correlation coefficient for agreement, 0.577-1). The summated index score showed promising construct validity, for example, no multicollinearity issues were found. CONCLUSION: The results of this study show that the APID index is reliable and valid for measuring appropriateness of PDU for NPS in dementia in nursing homes in clinical studies.

PROPER I: frequency and appropriateness of psychotropic drugs use in nursing home patients and its associations: a study protocol.

BACKGROUND: Nursing home patients with dementia use psychotropic drugs longer and more frequently than recommended by guidelines implying psychotropic drugs are not always prescribed appropriately. These drugs can have many side effects and effectiveness is limited. Psychotropic drug use between nursing home units varies and is not solely related to the severity of neuropsychiatric symptoms. There is growing evidence indicating that psychotropic drug use is associated with environmental factors, suggesting that the prescription of psychotropic drugs is not only related to (objective) patient factors. However, other factors related to the patient, elderly care physician, nurse and the physical environment are only partially identified. Using a mixed method of qualitative and quantitative research, this study aims to understand the nature of psychotropic drug use and its underlying factors by identifying: 1) frequency and appropriateness of psychotropic drug use for neuropsychiatric symptoms in nursing home patients with dementia, 2) factors associated with (appropriateness of) psychotropic drug use. METHODS: A cross-sectional mixed methods study. For the quantitative study, patients with dementia (n = 540), nursing staff and elderly care physicians of 36 Dementia Special Care Units of 12 nursing homes throughout the Netherlands will be recruited. Six nursing homes with high average rates and six with low average rates of psychotropic drug use, based on a national survey about frequency of psychotropic drug use on units, will be included. Psychotropic drugs include antipsychotics, anxiolytics, hypnotics, antidepressants, anticonvulsants and anti-dementia drugs. Appropriateness will be measured by an instrument based on the Medication Appropriateness Index and current guidelines for treatment of neuropsychiatric symptoms. Factors associated to psychotropic drug use, related to the patient, elderly care physician, nurse and physical environment, will be explored using multilevel regression analyses. For the qualitative study, in depth interviews with staff will be held and analyzed to identify and explore other unknown factors. DISCUSSION: This study will provide insight into factors that are associated with the frequency and appropriateness of psychotropic drug use for neuropsychiatric symptoms. Understanding psychotropic drug use and its associations may contribute to better dementia care.

Improving psychotropic drug prescription in nursing home patients with dementia: design of a cluster randomized controlled trial.

BACKGROUND: Neuropsychiatric symptoms are highly prevalent in nursing home patients with dementia. Despite modest effectiveness and considerable side effects, psychotropic drugs are frequently prescribed for these neuropsychiatric symptoms. This raises questions whether psychotropic drugs are appropriately prescribed. The aim of the PROPER (PRescription Optimization of Psychotropic drugs in Elderly nuRsing home patients with dementia) II study is to investigate the efficacy of an intervention for improving the appropriateness of psychotropic drug prescription in nursing home patients with dementia. METHODS/DESIGN: The PROPER II study is a multi-center cluster randomized controlled, pragmatic trial using parallel groups. It has a duration of eighteen months and four six-monthly assessments. Six nursing homes will participate in the intervention and six will continue care as usual. The nursing homes will be located throughout the Netherlands, each participating with two dementia special care units with an average of fifteen patients per unit, resulting in 360 patients. The intervention consists of a structured and repeated multidisciplinary medication review supported by education and continuous evaluation. It is conducted by pharmacists, physicians, and nurses and consists of three components: 1) preparation and education, 2) conduct, and 3) evaluation/guidance. The primary outcome is the proportion of patients with appropriate psychotropic drug use. Secondary outcomes are the overall frequency of psychotropic drug use, neuropsychiatric symptoms, quality of life, activities of daily living, psychotropic drug side effects and adverse events (including cognition, comorbidity, and mortality). Besides, a process analysis on the intervention will be carried out. DISCUSSION: This study is expected to improve the appropriateness of psychotropic drug prescription for neuropsychiatric symptoms in nursing home patients with dementia by introducing a structured and repeated multidisciplinary medication review supported by education and continuous evaluation. TRIAL REGISTRATION: Netherlands Trial Registry (NTR): NTR3569.