Optimizing anticoagulation therapy for in-hospital patients on direct oral anticoagulants: a single-centre modified Delphi study.

AIMS: The management of patients treated with direct oral anticoagulants (DOACs) during hospitalization is a common challenge in clinical practice. Although bridging is generally not recommended, too often DOACs are switched to parenteral therapy with low molecular weight heparins. Our objectives were to update a local guideline for perioperative DOAC management and to develop a guideline for the anticoagulation management in non-surgical patients regarding temporary DOAC discontinuation. METHODS: We executed a two-step modified Delphi study in a 1000-bed university hospital in Belgium. The Delphi questionnaires were developed based on a literature review and a telephone survey of prescribers. Two expert panels were established: one dedicated to perioperative DOAC management and the other to DOAC management in non-surgical patients. Both panels completed two rounds, commencing with an individual and online round, followed by a face-to-face group session. RESULTS: After the two-round Delphi process, the updated perioperative guideline on DOAC management included reasons for delaying the resumption of DOACs following surgery, such as oral intake not possible, the probability of re-intervention within 3 days, and insufficient haemostasis (e.g. active clinically significant haematoma, haemorrhagic drains or wounds). Furthermore, a guideline for non-surgical hospitalized patients was developed, outlining possible reasons for interrupting DOAC therapy. Both guidelines offer clear anticoagulation therapy strategies corresponding to the identified scenarios. CONCLUSIONS: We have updated and developed guidelines for DOAC management in surgical and non-surgical patients during hospitalization, which aim to support prescribers and to enhance targeted prescription review by hospital pharmacists.

The Indispensable Nasal Decongestant: Patients' Views and Perspectives on Nasal Decongestant Overuse.

BACKGROUND: Rhinitis medicamentosa (RM) is a type of nonallergic rhinitis caused by prolonged use of nasal decongestants (NDs). Although it is a preventable phenotype of rhinitis, little is known about patients dealing with this condition. OBJECTIVE: To gain a better understanding of patients' views and experiences of ND overuse, and potential facilitators and barriers to discontinue the overuse. METHODS: We performed a qualitative study using in-depth semistructured interviews with 22 patients who have been using an ND on an almost daily basis for at least 6 months. The interviews were conducted face-to-face, audio-recorded, and transcribed verbatim. Data analysis followed the grounded theory approach. RESULTS: Interviewees described the large impact of nasal congestion on their daily lives. Despite efforts to try other treatment options, the ND was considered the only effective aid to resolve the troublesome symptom. Most participants were aware that the prolonged use was problematic, sometimes leading to hiding behavior in order to avoid criticism by others including their health professionals. Many participants expressed a strong will to discontinue. However, multiple barriers to withdrawal were identified including fear of surgery or the impact of withdrawal on sleep, lack of good alternatives, and negative experiences with past withdrawal attempts. Patients thus face a dilemma in which the barriers to withdrawal currently outweigh the possible benefits. CONCLUSION: The use of NDs is considered indispensable by many chronic users. The facilitators and barriers identified in this study provide opportunities to reduce the use of NDs and the prevalence of RM in the future.

Prevalence of alcohol-drug interactions in community-dwelling older patients with polypharmacy.

OBJECTIVES: Alcohol and medication use are increasingly prevalent in the older population. Concurrent use of alcohol and alcohol-interactive (AI) medication can lead to significant adverse consequences. METHODS: Three reference works were used to create an explicit list of drug substances for which information about the interaction with alcohol was available in at least one of them. Additional information was extracted from the Summary of Product Characteristics (SPC). The first aim was to generate a list of 256 substances with standardized advice regarding the concurrent use of each drug with alcohol. The second aim was to observe the prevalence of potential drug-alcohol-interactions. The list was applied to a database containing information about alcohol and medication use of 1,016 community-dwelling older patients (≥70 years) with polypharmacy. RESULTS: About half of the sample population reported to consume alcohol at least once a week. Around 22% were classified as frequent drinkers (5-7 days/week) and 11% as heavier drinkers (>7 units/week). Ninety-three percent alcohol consumers in our sample took at least one chronic drug that potentially interacts with alcohol and 42% used at least one chronic drug for which alcohol use is considered contraindicated. CONCLUSIONS: We developed an explicit list of potentially drug-alcohol-interactions in older adults, with standardized handling advice. We observed that prevalence of potential drug-alcohol-interactions is substantial in community-dwelling older patients with polypharmacy.

Prevalence of alcohol-drug interactions in community-dwelling older patients with polypharmacy.

OBJECTIVES: Alcohol and medication use are increasingly prevalent in the older population. Concurrent use of alcohol and alcohol-interactive (AI) medication can lead to significant adverse consequences. METHODS: Three reference works were used to create an explicit list of drug substances for which information about the interaction with alcohol was available in at least one of them. Additional information was extracted from the Summary of Product Characteristics (SPC). The first aim was to generate a list of 256 substances with standardized advice regarding the concurrent use of each drug with alcohol. The second aim was to observe the prevalence of potential drug-alcohol-interactions. The list was applied to a database containing information about alcohol and medication use of 1,016 community-dwelling older patients (≥70 years) with polypharmacy. RESULTS: About half of the sample population reported to consume alcohol at least once a week. Around 22% were classified as frequent drinkers (5-7 days/week) and 11% as heavier drinkers (>7 units/week). Ninety-three percent alcohol consumers in our sample took at least one chronic drug that potentially interacts with alcohol and 42% used at least one chronic drug for which alcohol use is considered contraindicated. CONCLUSIONS: We developed an explicit list of potentially drug-alcohol-interactions in older adults, with standardized handling advice. We observed that prevalence of potential drug-alcohol-interactions is substantial in community-dwelling older patients with polypharmacy.

Application of the GheOP3S-tool in nursing home residents: acceptance and implementation of pharmacist recommendations.

Background and objective: The prevalence of potentially inappropriate prescribing (PIP) among nursing home (NH) residents is high. This study aimed to investigate the acceptance and implementation of pharmacist recommendations based on a screening tool for PIP, the Ghent Older People's Prescriptions community Pharmacy Screening (GheOP3S)-tool. Setting and method: Prospective observational study in NH residents (≥ 70 years, using ≥ 5 medications) with a 3-month follow-up period. A pharmacist screened the medication lists using the GheOP3S-tool and formulated recommendations to reduce PIP. The acceptance of recommendations discussed during face-to-face pharmacist-general practitioner (GP) meetings was recorded. Implementation was examined by comparing baseline and follow-up medication lists. A pre-post comparison of the number of chronic medications and GheOP3S-criteria; the anticholinergic and sedative burden quantified by the Drug Burden Index (DBI); and medication costs was performed. Results: Screening with the GheOP3S-tool resulted in 168 pharmacist recommendations for 50 NH residents, mainly to stop (78.0%) and to substitute (14.3%) medications. Ninety-three % (156/168) of recommendations were considered relevant. GPs acceptance rate was 44.9%. Fifty-four % of all accepted recommendations were implemented. At follow-up, the number of chronic medications (p = 0.007), and DBI scores (p = 0.004) significantly differed from baseline. There was no significant decrease in the number of GheOP3S-criteria (p = 0.075) and medication costs (p > 0.05). Conclusion: The acceptance and implementation of pharmacist recommendations were relatively low. Future studies should increase the involvement of patients and all health-care providers. Interdisciplinary collaboration with sufficient education for all disciplines and patients is essential.

A shared medication scheme for community dwelling older patients with polypharmacy receiving home health care: role of the community pharmacist.

Background and objective: An accurate medication scheme may be a useful tool to improve medication safety in primary care. This study aimed to identify (1) pharmacists' alterations to nurse medication schemes and (2) potential improvements to the contribution of the community pharmacist to a shared medication scheme within a multidisciplinary collaboration. Dosing frequency, potentially incorrect moments of intake, drug-drug interactions and medication complexity (quantified by the Medication Regimen Complexity Index, MRCI) were investigated. Setting and method: Observational study in community dwelling older patients (≥70 years) with polypharmacy receiving home health care (i.e. medications being prepared and/or administered by home care nurses). Home care nurses provided the community pharmacist with the original medication scheme ('nurse medication scheme'), subsequently the community pharmacist generated a standardized 'pharmacist medication scheme' which was uploaded on an electronic health platform (Vitalink). The researcher recorded all pharmacists' alterations and looked for possible additional improvements ('researcher medication scheme'). Results: Pharmacists made 482 alterations to the nurse medication schemes of 31 patients. Most important alterations included adding indication (61%), generic or brand name (18%) and moment of intake (9%). Pharmacists did not reduce dosing frequency. MRCI scores (median [IQR]) significantly differed between pharmacist (38 [15]) and nurse medication schemes (32 [11]) (p < 0.001) and between nurse (32 [11]) and researcher medication schemes (40 [15]) (p < 0.001). Conclusion: Alterations made by the community pharmacists enable more complete and accurate medication schemes; however, there is room for improvement in optimizing the patient's medication scheme in a multidisciplinary collaboration.

Community pharmacists' evaluation of potentially inappropriate prescribing in older community-dwelling patients with polypharmacy: observational research based on the GheOP³S tool.

Background: In this study, we aimed to (i) determine the prevalence of potentially inappropriate prescribing (PIP) in community-dwelling older polypharmacy patients using the Ghent Older People's Prescriptions community-Pharmacy Screening (GheOP³S) tool, (ii) identify the items that account for the highest proportion of PIP and (iii) identify the patient variables that may influence the occurrence of PIP. Additionally, pharmacist-physician contacts emerging from PIP screening with the GheOP³S tool and feasibility of the GheOP³S tool in daily practice were evaluated. Methods: A prospective observational study was carried out between December 2013 and July 2014 in 204 community pharmacies in Belgium. Patients were eligible if they were (i) ≥70 years, (ii) community-dwelling, (iii) using ≥5 chronic drugs, (iv) a regular visitor of the pharmacy and (v) understanding Dutch or French. Community pharmacists used a structured interview to obtain demographic data and medication use and subsequently screened for PIP using the GheOP³S tool. A Poisson regression was used to investigate the association between different covariates and the number of PIP. Results: In 987 (97%) of 1016 included patients, 3721 PIP items were detected (median of 3 per patient; inter quartile range: 2-5). Most frequently involved with PIP are drugs for the central nervous system such as hypnosedatives, antipsychotics and antidepressants. Risk factors for a higher PIP prevalence appeared to be a higher number of drugs (30% extra PIPs per 5 extra drugs), female gender (20% extra PIPs), higher body mass index (BMI, 20% extra PIPs per 10-unit increase in BMI) and poorer functional status (30% extra PIPs with 6-point increase). The feasibility of the GheOP³S tool was acceptable although digitalization of the tool would improve implementation. Despite detecting at least one PIP in 987 patients, only 39 physicians were contacted by the community pharmacists to discuss the items. Conclusion: A high prevalence of PIP in community-dwelling older polypharmacy patients in Belgium was detected which urges for interventions to reduce PIP.

Potentially inappropriate prescribing in nursing home residents detected with the community pharmacist specific GheOP(3)S-tool.

Background The Ghent Older People's Prescriptions community Pharmacy Screening (GheOP³S-)tool was recently developed to screen for potentially inappropriate prescribing (PIP). Objective We aimed (1) to determine PIP prevalence in older nursing home (NH) residents with polypharmacy using the GheOP³S-tool and (2) to identify those PIPs that are most frequently detected. Method A cross-sectional study was carried out between February and June 2014 in 10 NHs in Belgium, supplied by a community pharmacy chain. For each NH, 40 residents (≥70 years, using ≥5 chronic drugs) were included. PIP prevalence was determined using the GheOP³S-tool. Results 400 NH residents were included [mean age (±SD) 86.2 (±6.3) years; median number of drugs (±IQR) 10 (7-12)]. A total of 1728 PIPs were detected in 387 (97 %) participants (Median 4; IQR 2-6). The most prevalent items can be assigned to three categories: long-term use of central nervous system drugs (i.e. benzodiazepines, antidepressants and antipsychotics), use of anticholinergic drugs (mutual combinations and with underlying constipation/dementia) and underuse of osteoporosis prophylaxis. Conclusion Screening for PIP by means of the GheOP³S-tool revealed a high prevalence of PIP among older NH residents with polypharmacy. This finding urges for initiatives on the patient-level, but also on a broader, institutional level.

Analysis of drug use in institutionalized individuals with intellectual disability and tube feeding.

OBJECTIVES: Little is known about the medication used by people with intellectual disabilities (ID) and enteral feeding tube (EFT). However, in light of the complexity associated with drug administration through EFT, data on medication use in this population may be helpful in the development of practical guidelines and staff training initiatives. METHODS: A cross-sectional, observational study was conducted in six Belgian residential care facilities (RCFs) for individuals with ID. Anonymized medication records of all residents receiving chronic medication through EFT were collected (n = 156). All chronic drugs were categorized according to the ATC classification, and medication records were checked for potential major drug-drug interactions (DDI). RESULTS: The 156 residents used a total of 1029 chronic drugs via EFT, with a median of six drugs per resident (range 1-14). A total of 148 different drug molecules were identified, belonging to 38 main ATC therapeutic groups (ATC level 2). Antiepileptics, drugs for constipation and drugs for acid-related disorders were the most frequently used groups. Seventy-four of the 156 screened medication records (47%) contained at least one potential DDI; in total, 116 potential interactions were identified, which represent 38 different interacting drug pairs. CONCLUSION: This study describes medication use through EFT among people with ID in Belgian RCFs, with antiepileptics being the most frequently used group. Our study also demonstrated that a high number of drugs is administered through EFT, and that the number of potential DDIs is high. These observations warrant an increased attention for drug administration through the EFT in individuals with ID.

Older patients' prescriptions screening in the community pharmacy: development of the Ghent Older People's Prescriptions community Pharmacy Screening (GheOP³S) tool.

BACKGROUND: Ageing of the population often leads to polypharmacy. Consequently, potentially inappropriate prescribing (PIP) becomes more frequent. Systematic screening for PIP in older patients in primary care could yield a large improvement in health outcomes, possibly an important task for community pharmacists. In this article, we develop an explicit screening tool to detect relevant PIP that can be used in the typical community pharmacy practice, adapted to the European market. METHODS: Eleven panellists participated in a two-round RAND/UCLA (Research and Development/University of California, Los Angeles) process, including a round zero meeting, a literature review, a first written evaluation round, a second face-to-face evaluation round and, finally, a selection of those items that are applicable in the contemporary community pharmacy. RESULTS: Eighteen published lists of PIP for older patients were retrieved from the literature, mentioning 398 different items. After the two-round RAND/UCLA process, 99 clinically relevant items were considered suitable to screen for in a community pharmacy practice. A panel of seven community pharmacists selected 83 items, feasible in the contemporary community pharmacy practice, defining the final GheOP³S tool. CONCLUSION: A novel explicit screening tool (GheOP³S) was developed to be used for PIP screening in the typical community pharmacy practice.

Potentially inappropriate prescribing in community-dwelling older people across Europe: a systematic literature review.

BACKGROUND: Potentially inappropriate prescribing (PIP) is one of the main risk factors for adverse drug events (ADEs) in older people. PURPOSE: This systematic literature review aims to determine prevalence and type of PIP in community-dwelling older people across Europe, as well as identifying risk factors for PIP. METHODS: The PubMed and Web of Science database were searched systematically for relevant manuscripts (January 1, 2000-December 31, 2014). Manuscripts were included if the study design was observational, the study participants were community-dwelling older patients in Europe, and if a published screening method for PIP was used. Studies that focused on specific pathologies or that focused on merely one inappropriate prescribing issue were excluded. Data analysis was performed using R statistics. RESULTS: Fifty-two manuscripts were included, describing 82 different sample screenings with an estimated overall PIP prevalence of 22.6 % (CI 19.2-26.7 %; range 0.0-98.0 %). Ten of the sample screenings were based on the Beers 1997 criteria, 19 on the Beers 2003 criteria, 14 on STOPP criteria (2008 version), 8 on START-criteria (2008 version), and 7 on the PRISCUS list. The 24 remaining sample screenings were carried out using compilations of screening methods or used country-specific lists such as the Laroche criteria. It appears that only PIP prevalence calculated from insurance data significantly differs from the other data collection method categories. Furthermore, risk factors most often positively associated with PIP prevalence were polypharmacy, poor functional status, and depression. Drug groups most often involved in PIP were anxiolytics (ATC-code: N05B), antidepressants (N06A), and nonsteroidal anti-inflammatory and anti-rheumatic products (M01A). CONCLUSION: PIP prevalence in European community-dwelling older adults is high and depends partially on the data collection method used. Polypharmacy, poor functional status, and depression were identified as the most common risk factors for PIP.

Understanding medication adherence among patients of Turkish descent with type 2 diabetes: a qualitative study.

OBJECTIVES: To explore perspectives of Turkish migrants with type 2 diabetes mellitus (T2DM) on adherence to oral hypoglycaemic agents (OHA). DESIGN: In-depth interviews with 21 T2DM patients of Turkish descent recruited from primary care and community sources in Ghent, Belgium, using a theoretical sampling procedure. Analysis was guided by a grounded theory approach, using Nvivo 8. RESULTS: Respondents reported a multitude of barriers and facilitators of adherence to OHA. Some of these barriers are distinctive for T2DM patients of Turkish descent. Respondents' causal beliefs about stress and the Belgian climate often led to non-adherence during less stressful periods, like summer holidays in Turkey. Some respondents adjusted their medication use to food intake or during Ramadan fasting. Concerns about OHA were the main reason for the widespread use of herbal medicine in this sample. The religious framework used to interpret diabetes led, in combination with feelings of depression, to non-adherence in some respondents while it facilitated medication adherence in others. A potential gender effect with respect to the self-management of OHA was observed. Non-distinctive factors include: beliefs about OHA, polypharmacy, beliefs about the course of diabetes, forgetfulness, the perception of the doctor's medical expertise, feelings of depression and social support. CONCLUSION: Health care providers should explore in detail and regularly patients' perspectives on illness beliefs, medication beliefs and their trust in doctors' medical expertise as this will provide useful starting points for promoting medication adherence. Whenever possible health care workers should engage with their patients in therapeutic alliances.

Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease (PHARMACOP): a randomized controlled trial.

AIMS: Few well-designed randomized controlled trials have been conducted regarding the impact of community pharmacist interventions on pharmacotherapeutic monitoring of patients with chronic obstructive pulmonary disease (COPD). We assessed the effectiveness of a pharmaceutical care programme for patients with COPD. METHODS: The pharmaceutical care for patients with COPD (PHARMACOP) trial is a single-blind 3 month randomized controlled trial, conducted in 170 community pharmacies in Belgium, enrolling patients prescribed daily COPD medication, aged ≥ 50 years and with a smoking history of ≥ 10 pack-years. A computer-generated randomization sequence allocated patients to an intervention group (n = 371), receiving protocol-defined pharmacist care, or a control group (n = 363), receiving usual pharmacist care (1:1 ratio, stratified by centre). Interventions focusing on inhalation technique and adherence to maintenance therapy were carried out at start of the trial and at 1 month follow-up. Primary outcomes were inhalation technique and medication adherence. Secondary outcomes were exacerbation rate, dyspnoea, COPD-specific and generic health status and smoking behaviour. RESULTS: From December 2010 to April 2011, 734 patients were enrolled. Forty-two patients (5.7%) were lost to follow-up. At the end of the trial, inhalation score [mean estimated difference (Δ),13.5%; 95% confidence interval (CI), 10.8-16.1; P < 0.0001] and medication adherence (Δ, 8.51%; 95% CI, 4.63-12.4; P < 0.0001) were significantly higher in the intervention group compared with the control group. In the intervention group, a significantly lower hospitalization rate was observed (9 vs. 35; rate ratio, 0.28; 95% CI, 0.12-0.64; P = 0.003). No other significant between-group differences were observed. CONCLUSIONS: Pragmatic pharmacist care programmes improve the pharmacotherapeutic regimen in patients with COPD and could reduce hospitalization rates.

Vaginal distribution and retention of tablets comprising starch-based multiparticulates: evaluation by colposcopy.

We have developed fast-disintegrating tablets comprising starch-based pellets and excipient granules for intravaginal drug delivery. The purpose of this study was to evaluate the intravaginal disintegration, distribution and retention behavior of these tablets in sheep and women using colposcopy as visualization technique. One tablet was administered to each study subject (n = 6) and repeated colposcopy examination was performed over a 48 h and 24 h period in sheep and women, respectively. Colposcopy in sheep indicated that in vivo tablet disintegration was initiated within 30 min of vaginal administration and that due to disintegration of the pellets themselves, the formulation was transformed into a gel-like mass which distributed throughout the entire vaginal cavity within 2-4 h. In vivo tablet disintegration after intravaginal administration to women was complete within 4 h, whereby the formulation gradually spread throughout the vaginal cavity as complete covering was observed after 12 and 24 h. The persistent retention (up to 24 and 48 h in women and sheep, respectively) confirmed the long retention time of this vaginal formulation.

COPD management in primary care: an observational, community pharmacy-based study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a prevalent disease that is frequently treated in primary care. However, data regarding the primary care management of COPD are scarce. Such observational data are necessary to detect problem areas and to develop targeted interventions for improvement of COPD management. OBJECTIVE: To provide a detailed description of (1) drug therapy, (2) drug adherence, (3) inhalation technique, and (4) health status of patients with COPD recruited via community pharmacies. METHODS: A cross-sectional, observational study was conducted in 93 pharmacies in Belgium. Participants (N = 555) completed a questionnaire collecting information on personal characteristics, smoking history, influenza vaccination, COPD medication, and adverse effects. Adherence to COPD maintenance medication was analyzed 1 year retrospectively through prescription refill rates. Inhalation technique was scored using a checklist. Health status was evaluated with the St. George's Respiratory Questionnaire, the Clinical COPD Questionnaire, and the Modified Medical Research Council dyspnea scale. RESULTS: The mean age of the patients was 68.6 years; 73.7% were men and 37.2% were current smokers. The influenza vaccination status was significantly lower in patients aged less than 65 years (65.7%) than in patients aged 65 years or more (86.2%) (p < 0.001). Fixed combinations of inhaled corticosteroids and long-acting beta(2)-agonists were the most frequently used COPD medications (75.4%). About 48% of patients were underadherent (<80% adherence), 47% were adherent (80-120% adherence) and 5% were overadherent (>120% adherence). Predictors for underadherence were age and number of drugs. Twenty-one percent of patients made major inhalation technique errors with rescue medication; these were all errors in handling pressurized metered-dose inhalers (pMDIs). CONCLUSIONS: This observational study on COPD management in primary care highlights 4 main aspects that could be improved: (1) drug adherence, (2) inhalation technique with pMDIs, (3) influenza vaccination in COPD patients younger than 65 years, and (4) smoking cessation.

Medication use and disease management of type 2 diabetes in Belgium.

OBJECTIVE: The aim of this study was (International Diabetes Federation. Diabetes Atlas Second Edition Executive Summary. Brussels: International Diabetes Federation; 2003) to describe the current status of medication use and disease management of type 2 diabetic patients in Flanders (Belgium), (World Health Organization. Prevention of diabetes mellitus. Technical report series no. 844. Geneva: World Health Organization; 1994) to identify the aspects of type 2 diabetes care a community pharmacist could provide additional educational services for, and (American Diabetes Association. Diabetes Care 2006;29:S4-42) to propose these services as a pharmacist intervention. METHOD: We recruited 338 patients in 77 community pharmacies in Flanders (Belgium). Each patient completed a questionnaire collecting personal data, information on duration of diabetes, medication, diabetes symptoms and self-management. At inclusion, patients measured their fasting plasma glucose (FPG) on three consecutive days. Prescription drugs (antidiabetic and other) purchased by each patient during the 12 months prior to inclusion in the study were reviewed from anonymized computerized pharmacy records. MAIN OUTCOME MEASURES: Degree of self-management, glycaemic control and medication use. RESULTS: The mean FPG of the sample was 150.7+/-43.0 mg/dl. Controlled glycaemia (FPG between 90 and 130 mg/dl (5.0-7.2 mmol/l)) was achieved in only 34.9% of the patients. Mainstay of hypoglycemic treatment consisted of metformin monotherapy (29.6%) and metformin combined with sulfonylurea (29.0%). Regarding co-medication, 76.9% of the patients used antihypertensive drugs whereas only 33.1% and 39.9% were on aspirin and statin therapy, respectively. ADA recommendations for annual eye and foot examination were not followed in 38.8% (eye) and 39.2% (feet) of the patients. CONCLUSION: The current management of type 2 diabetic Flemish patients falls short of recommended treatment goals. Community pharmacists may play a role in enhancing the awareness of glycaemic control and in stimulating self-management in diabetic patients by motivating patients towards correct medication use, better medication adherence, healthy lifestyle and smoking cessation.