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BackgroundPoor medication-adherence is common in chronic lung patients, resulting in reduced health-outcomes and increased healthcare-costs. This study aimed to investigate the impact of an acoustic reminder and support calls on adherence to inhaled therapy in asthma and COPD patients and to determine their effect on exacerbations.MethodsThis single-blinded randomized controlled trial investigated asthma and COPD patients during 6 months in an ambulatory setting. The intervention consisted of daily alarm clock and support phone calls, whenever use of rescue medication doubled or inhaled medication was not taken as prescribed. Primary outcome was time to next exacerbation. Frequency of exacerbations, adherence to inhaled medication and quality of life scores were secondary outcomes. Cox and Poisson regression were used to determine intervention effect on time to exacerbation and frequency of exacerbations, respectively.ResultsSeventy-five participants were assigned to the intervention group and 74 to usual follow-up care. During a median follow-up of 6.2 months, 22 and 28% in the intervention and control groups respectively, experienced at least one exacerbation. Intervention had no effect on time to first exacerbation (HR 0.65, 95% CI 0.21 to 2.07,P = .24), but showed a trend toward a 39% decreased frequency of exacerbations (RR = 0.61, 95% CI 0.35 to 1.03,P = .070) for the adjusted models, respectively. The intervention group had significantly more days with 80–100% taking adherence regarding puff inhalers (82 ± 14% vs. 60 ± 30%,P P = .01). Timing adherence in participants using puff inhalers was higher in the intervention group (69 ± 25% vs. 51 ± 33%,P ConclusionParticipants assigned to the intervention group had significantly better taking and timing adherence of inhaled medication resulting in a trend towards a decreased frequency of exacerbations. However, no effect on time to next exacerbation was observed.Trial registrationClinicalTrials.gov:NCT02386722, Registered 14 February 2014.

Background: Pharmacists are increasingly involved in strategies to fight antimicrobial resistance by ensuring optimised antibiotic (AB) use, including adherence support. Successful adherence interventions should be tailored to patients’ barriers and validated instruments are needed. This study aimed to identify adherence barriers to AB treatment, develop a self-report questionnaire, and validate it in outpatients. Method: Adherence barriers were identified through a systematic literature search and focus group discussion. Unmodifiable and irrelevant barriers were excluded from further processing. A validation study assessed the questionnaire’s internal reliability and construct validity by comparing the questionnaire’s score with electronically monitored adherence data. Results: A 15-item questionnaire was created. Overall, 68 patients were included in the construct validation analysis (60.3% female). The mean consecutive taking adherence was 88% and the most frequently reported barriers were “worries about side-effects” (37%) and “having swallowing difficulties” (19%). Three items were excluded from the questionnaire, which was supported by an increase of Cronbach’s alpha (0.69 to 0.70). The 12-item version’s score correlated significantly with medication adherence rate (r = −0.34, p &lt, 0.01). Conclusion: The self-report questionnaire is a reliable and valid tool to pre-emptively assess adherence barriers in outpatients prescribed ABs. In the future, appropriate adherence interventions can be matched to barriers and tested in a pilot intervention study.

Background: Therapy with oral anticoagulation (OAC) can be challenging, especially in high risk groups such as chronic patients. Gaps in patient knowledge about OAC are linked to reduced effectiveness and safety of treatment. The objectives of this study were i) to assess OAC knowledge gathered during an intermediate medication review (MR) in patients taking vitamin K antagonists (VKA) or non-vitamin K antagonist oral anticoagulants (NOAC), ii) to assess OAC knowledge two weeks after the MR, and iii) to evaluate patient satisfaction with the MR service in community pharmacies. Methods: Chronic OAC patients were invited for a regular MR service in Swiss community pharmacies, the so-called &ldquo, Polymedication-Check&rdquo, (PMC). OAC knowledge was assessed with seven newly generated items asked face-to-face during a PMC and by telephone two weeks later. Knowledge gaps, pharmacists&rsquo, spontaneous interventions, and patient satisfaction were documented by observing pharmacy students. Treatment groups were compared. Results: Of all patients (n = 81), the number of patients with one or more knowledge gaps decreased from 66% to 31.3% after PMC (p &lt, 0.001). NOAC patients (n = 31) had more knowledge gaps than VKA patients (n = 50, p &lt, 0.05). Most patients (98.6%) were satisfied with the counselling provided by the pharmacists. Conclusion: The majority of chronic OAC patients shows knowledge gaps. Although spontaneous, the provision of tailored education during a PMC increased patient OAC knowledge.

Due to the negative outcomes of medication nonadherence, interventions to improve adherence have been the focus of countless studies. The congruence between adherence-related patient characteristics and interventions may partly explain the variability of effectiveness in medication adherence studies. In their latest update of a Cochrane review reporting inconsistent effects of adherence interventions, the authors offered access to their database for subanalysis. We aimed to use this database to assess congruence between adherence-related patient characteristics and interventions and its association with intervention effects.We developed a congruence score consisting of six features related to inclusion criteria, patient characteristics at baseline, and intervention design. Two independent raters extracted and scored items from the 190 studies available in the Cochrane database. We correlated overall congruence score and individual features with intervention effects regarding adherence and clinical outcomes using Kruskal-Wallis rank sum test and Fisher's exact test.Interrater reliability for newly extracted data was almost perfect with a Cohen's Kappa of 0.92 [95% confidence interval (CI) = 0.89-0.94; P 0.001]. Although present in only six studies, the inclusion of nonadherent patients was the single feature significantly associated with effective adherence interventions (P = 0.003). Moreover, effective adherence interventions were significantly associated with improved clinical outcomes (odds ratio = 6.0; 95% CI = 3.1-12.0; P 0.0001). However, neither the overall congruence score nor any other individual feature (i.e., "determinants of nonadherence as inclusion criteria," "tailoring of interventions to the inclusion criteria," "reasons for nonadherence assessed at baseline," "adjustment of intervention to individual patient needs," and "theory-based interventions") was significantly associated with intervention effects.The presence of only six studies that included nonadherent patients and the interdependency of this feature with the remaining five might preclude a conclusive assessment of congruence between patient characteristics and adherence interventions. In order to obtain clinical benefits from effective adherence interventions, we encourage researchers to focus on the inclusion of nonadherent patients.

Markus Messerli,1,2 Rebecca Aschwanden,1 Michael Buslau,2 Kurt E Hersberger,1 Isabelle Arnet1 1Pharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland; 2European Centre for the Rehabilitation of Scleroderma, Reha Rheinfelden, Rheinfelden, Switzerland Objectives: To assess subjective swallowing difficulties (SD) with medication intake and their practical consequences in patients suffering from systemic sclerosis (SSc) with a novel self-report questionnaire.Design and setting: Based on a systematic literature review, we developed a self-report questionnaire and got it approved by an expert panel. Subsequently, we sent the questionnaire by post mail to SSc patients of the European Center for the Rehabilitation of Scleroderma Rheinfelden, Switzerland.Participants: Patients were eligible if they were diagnosed with SSc, treated at the center, and were of age ≥18 years at the study start.Main outcome measures: Prevalence and pattern of SD with oral medication intake, including localization and intensity of complaints.Results: The questionnaire consisted of 30 items divided into five sections Complaints, Intensity, Localization, Coping strategies, and Adherence. Of the 64 SSc patients eligible in 2014, 43 (67%) returned the questionnaire. Twenty patients reported SD with medication intake (prevalence 47%), either currently (11; 26%) or in the past that had been overcome (9; 21%). Self-reported SD were localized mostly in the larynx (43%) and esophagus (34%). They were of moderate (45%) or strong to unbearable intensity (25%). Modification of the dosage form was reported in 40% of cases with SD. Adherence was poor for 20 (47%) patients and was not associated with SD (p=0.148).Conclusion: Our novel self-report questionnaire is able to assess the pattern of complaints linked to medication intake, that is, localization and intensity. It may serve as a guide for health care professionals in selecting the most suitable therapy option, enabling tailored counseling to reduce inappropriate medication modifications. Keywords: swallowing difficulties, medication intake, systemic sclerosis, coping behavior, self-report questionnaire, deglutition disorders

Introduction Multicompartment compliance aids (MCA) are widely used by patients. They support the management of medication and reduce unintentional nonadherence. MCA are filled with medicines unpacked from their original packaging. Swiss pharmacists currently provide MCA for 1–2 weeks, although little and controversial information exists on the stability of repackaged medicines. Objective We aimed to validate the usefulness of a simple screening method capable of detecting visual stability problems with repackaged medicines. Methods We selected eight criteria for solid formulations from The International Pharmacopoeia: (1) rough surface, (2) chipping, (3) cracking, (4) capping, (5) mottling, (6) discoloration, (7) swelling, and (8) crushing. A selection of 24 critical medicines was repackaged in three different MCA (Pharmis®, SureMed™, and self-produced blister) and stored at room temperature for 4 weeks. Pharmis® was additionally stored at accelerated conditions. Appearance was scored weekly. Results Six alterations (rough surface, cracking, mottling, discoloration, swelling, and crushing) were observed at accelerated conditions. No alteration was observed at room temperature, except for the chipping of tablets that had been stuck to cold seal glue. Conclusion The eight criteria can detect alterations of the appearance of oral solid medicines repackaged in MCA. In the absence of specific guidelines, they can serve as a simple screening method in community pharmacies for identifying medicines unsuitable for repackaging.

We translated the ABC adherence taxonomy (i.e., seven terms and their corresponding definitions) published by Vrijens et al. (2012) into French (F) and German (G) without changing the original meaning with the aim to promote a standardised taxonomy for medication adherence to French- and German-speaking researchers and clinicians.; A Delphi survey was performed. To generate round one, we identified French and German synonyms for the seven adherence terms through a literature search in Pubmed. Investigators translated the original English definitions into French and German. Panellists were members of ESPACOMP - the International Society for Patient Medication Adherence; experts suggested by ESPACOMP members and first authors of medication adherence publications in French and German. Google forms were used to create online questionnaires. Delphi rounds were performed until consensus was reached. The consensus was defined according to the acceptance rate as moderate consensus (50-75%), consensus (>75-95%), and strong consensus (>95%).; The literature search resulted in four to six (F) and four to seven (G) items per English term. Delphi rounds were launched between November 2016 and April 2018. Three rounds sufficed to reach consensus on all terms and definitions from 26 French-speaking and 25 German-speaking panellists. Preferred terms for medication adherence are "adhesion medicamenteuse" (82%) in French and "Medikamentenadharenz" (88%) in German.; The use of a common terminology for medication adherence with translations in French and German will contribute to standardise the vocabulary, to harmonise research projects and ultimately ease comparison of study results among researchers and clinicians.

Several methods exist for measuring medication adherence. The Time4MedTM device (Adherence Innovations, Hong Kong) is a small, electronic card to affix on medication packaging that records date and time of intakes when a button is pushed. We aimed to validate the device with an emphasis on polypharmacy. Twenty volunteers used Time4MedTM devices with a virtual thrice daily intake over 14 days. Diary-recorded date and time were compared to electronically-stored events. Functionality, reliability and recovery for different stress conditions were calculated. User&lsquo, s acceptability was assessed with the System Usability Scale (SUS). Eleven elderly outpatients (mean age 80.2 &plusmn, 8.1 years) taking &gt, 3 medications daily used the device over 4 weeks. Volunteers logged 847 events. Functionality (100%), sensitivity (94.9%), specificity (99.4%) and recovery (100%) were high. Dropping the smart card and storing it in a refrigerator caused either the recording of false events or no recording at all. The mean SUS score was 82.6 (SD 14.8), demonstrating excellent acceptability. Satisfaction was very high for volunteers and patients, except for pushing the button. Time4MedTM devices are highly accurate in recording, retaining and delivering electronic data of multiple medication intake. They are well accepted by elderly patients. They can be recommended in clinical studies and for practitioners who desire to elucidate adherence patterns of ambulatory patients.

Adherence to cardioprotective medications following myocardial infarction (MI) is commonly assessed using a binary threshold of 80%. We investigated the relationship between medication adherence as a continuous measure and outcomes in MI survivors using restricted cubic splines (RCS). We identified all patients aged ≥65 years hospitalised for MI from 2003–2008 who survived one-year post-discharge (n = 5938). Adherence to statins, beta-blockers, renin angiotensin system inhibitors (RASI) and clopidogrel was calculated using proportion of days covered to one-year post-discharge (landmark date). Outcomes were 1-year all-cause death and major adverse cardiac events (MACE) after the landmark date. Adherence-outcome associations were estimated from RCS Cox regression models. RCS analyses indicated decreasing risk for both outcomes above 60% adherence for statins, RASI and clopidogrel, with each 10% increase in adherence associated with a 13.9%, 12.1% and 18.0% decrease respectively in adjusted risk of all-cause death (all p

Objectives: Since 2002, Swiss community pharmacists have dispensed emergency contraception (EC) as pharmacist-only medicine ideally using the official Swiss protocol. Our study aimed to determine pharmacists' resolution of an imaginary EC case, compliance with the protocol, and provision of information on the risk of sexually transmitted infections (STIs). Methods: We conducted a simulated patient study with 69 students who each visited a community pharmacy. The scenario started with the student requesting the 'morning after pill'. Current practice was assessed using an online evaluation form adapted from the Medication-Related Consultation Framework. Descriptive and statistical analyses were carried out. Results: All pharmacists correctly identified that the person needed EC. All pharmacists used an EC protocol and asked on average 10.9 (standard deviation 0.68) of 11 compulsory EC assessment questions. In total, 93% of pharmacists addressed EC counselling items and 56% addressed the risk of STIs, mainly by mentioning that condoms offered the best protection (76%). Conclusions: Community pharmacists correctly issued the EC, complied with the dispensing protocol and used their professional judgement to ensure optimal EC use. There is nevertheless room for improvement regarding pharmacists' STI counselling. Finally, the protocol's STI section could be enriched with specific information to guide counselling.

Objectives To describe how stroke survivors with atrial fibrillation implement direct oral anticoagulant treatment and propose appropriate metrics to describe adherence. Materials and Methods Stroke patients with atrial fibrillation electronically recorded their self-administered direct oral anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban) during a 6-month observation phase after hospitalisation for ischemic stroke. Taking and timing adherence, correct dosing days, drug holidays, time of the day and day of the week subsets, dose-to-dose intervals and longest intervals between two consecutive doses were calculated from electronic monitoring data to describe and discuss the implementation phase of adherence. Results Data from 41 patients were analysed. Median age was 77 (IQR = 69–84), 63.4% were male and the majority suffered a mild stroke (median NIHSS: 1). Mean taking and timing adherence exceeded 90%. Correct dosing occurred in 86.6% of the days. Seven patients (17.1%) had intake pauses of three or more consecutive days. Patients with twice-daily regimen (70.7%) had higher taking adherence in the morning than in the evening (94.4% versus 89.9%; p = 0.001). No therapy- or anamneses-related characteristic was associated with taking adherence. Conclusions Although adherence to direct oral anticoagulants of stroke patients with atrial fibrillation exceeded 90%, deviant intake patterns such as drug holidays and missed evening doses were common and raise concerns. Appropriate adherence metrics calculated from electronic monitoring data may guide healthcare professionals elucidating patient-tailored adherence-enhancing interventions. ClinicalTrials.gov registration number: NCT03344146

Background: Pharmacist-led cognitive services (PLCS) are increasingly necessary in primary care as a response to patient-centered care. However, the implementation rate and remuneration models of PLCS are either absent or superficially described in the literature. Objective: The aim of this study is to review the implementation of PLCS in primary care across Europe and explore the associated third-party paid remuneration models. Methods: A cross-sectional study was conducted using an online survey sent to representatives of 44 European countries. The survey listed 21 PLCS and asked respondents to report the availability of the service, the rate of implementation and the existence of remuneration. To ensure credible data, data triangulation was sought using three representatives per country, representing backgrounds of community pharmacy, pharmacy practice research and health policy. Subsequently, data was validated, and consensus sought. Results: Data were collected between November 2016 and October 2017 from 34 different countries across Europe (79%). Provision of medicines’ information (94.1%), generic substitution (85.3%), provision of emergency oral contraception (70.6%) and point-of-care testing (67.7%) were the services reported as the most widely disseminated in European primary care. Medication review was the most disseminated among advanced services (55.9%). Medication review, adherence support and monitoring, prescription renewal, opioid substitution and travel medicine had the highest implementation rates reported. Half of the participating countries mentioned models of remuneration, predominantly based on a fee-for-service, with less frequent reports of pay-for-performance or mixed models of remuneration. Conclusions: The availability of PLCS is increasing and varying in scope across Europe. There is wide variation in the implementation level of services across Europe and a lack of valid data. Remuneration of PLCS is also spreading but no clear pattern was found that relates service provision to payment. info:eu-repo/semantics/publishedVersion

Background Oral anticoagulation therapy has proven beneficial impact on the prevention of thromboembolic events. However, the use of antocoagulatns also increases the risk of bleeds. To maximize the benefits and minimize the risks of the treatment, guidance on appropriate use of oral anticoagulants is essential. An international guideline describing relevant components and requirements for pharmaceutical care for patients receiving a therapy woth oral antocoagulants would increase the quality of care. However, recommendations on pharmaceutical care for patients on anticoagulation is lacking. Objective This study aims to develop an interprofessional guideline to support patients in their use of oral anticoagulation therapy. Method Two systematic literature searches were performed on existing guidelines on the management and interventions to improve-oral anticoagulant use, to generate possible recommendations. Subsequently, an international expert panel with 26 pharmacists with extensive experience in clinical and/or scientific work on anticoagulation from a total of 22 European and 4 non-European countries was constituted. With this (geographically well distributed) expert panel, a four-round internet-based Delphi technique was conducted to reach consensus on their relevance. Items were ranked on a 1–10 scale of agreement. A median agreement score of ≥ 7.5 was considered the threshold for consensus. Levels of importance were rated on a 1–3 scale. Setting A global network of 26 pharmacists specialized in oral antocoagulation therapy. Main outcome measure Development of inter-professional guideline. Results After the four Delphi rounds 18 guideline recommendations were formulated. Consensus of opinion was achieved for all recommendations (median agreement: 8.5–10.0), whereas mean levels of importance were between 1.1 and 2.0 (SD: 0.2–0.7). The following domains were rated as most important targets for improving the care around oral anticoagulation: ‘INR-monitoring’, ‘Transfer of care between health care settings’, ‘Adherence to medication’, ‘Patient communication and engagement’, and ‘Medication reconciliation and medication review’. Conclusion The 18 recommendations included in this guideline provide the base for optimization of anticoagulation care across different countries/healthcare systems. Future work involves translating the guideline recommendations into clinical practice. Once implemented, the recommendations of the guideline will support health care providers with the pharmaceutical care for patients on, oral anticoagulation which will improve the effective and safe use of these medicines. Electronic supplementary material The online version of this article (10.1007/s11096-019-00844-0) contains supplementary material, which is available to authorized users.

Background: Non-adherence to direct oral anticoagulants (DOACs) remains a matter of concern, especially for patients with a recent stroke. However, data on electronically monitored adherence and adherence-improving interventions are scarce. Aims: We aim to use electronic monitoring in DOAC-treated stroke patients to (i) evaluate the effect of an educational, reminder-based adherence-improving intervention, (ii) investigate predictors of non-adherence, (iii) identify reliable self-report measures of adherence, and (iv) explore the association of non-adherence with clinical outcomes. Methods: Single-center, randomized, crossover, open-label study. Adherence to DOACs of polymedicated patients self-administering their medication will be monitored electronically throughout the 12-month-long study following hospitalization for ischemic stroke. After a 6-month observational phase, patients will receive pharmaceutical counseling with feedback on their intake history and be given a multi-compartment pillbox for the subsequent 6-month interventional phase. The pillbox will provide intake reminders either during the first or the last three interventional-phase months. Patients will be randomly allocated to reminders-first or reminders-last. Study outcomes: Primary: non-optimal timing adherence; Secondary: non-optimal taking adherence; timing adherence; taking adherence; self-reported adherence; clinical outcomes including ischemic and hemorrhagic events; patient-reported device usability and satisfaction. Sample size estimates: A sample of 130 patients provides 90% power to show a 20% improvement of the primary adherence outcome with intake reminders. Discussion: MAAESTRO will investigate various aspects of non-adherence and evaluate the effect of an adherence-improving intervention in DOAC-treated patients with a recent stroke using electronic monitoring. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03344146, Swiss National Clinical Trials Portal SNCTP000002410.

Isabelle Arnet,1 Melanie Greenland,2 Matthew W Knuiman,2 Jamie M Rankin,3 Joe Hung,4 Lee Nedkoff,2 Tom G Briffa,2 Frank M Sanfilippo2 1Department of Pharmaceutical Sciences, Pharmaceutical Care Research Group, University of Basel, Basel, Switzerland; 2School of Population and Global Health, Faculty of Health and Medical Sciences, The University of Western Australia, Perth, WA, Australia; 3Cardiology Department, Fiona Stanley Hospital Murdoch, WA, Australia; 4School of Medicine, Sir Charles Gairdner Hospital Unit, The University of Western Australia, Perth, WA, Australia Background: Electronic health care data contain rich information on medicine use from which adherence can be estimated. Various measures developed with medication claims data called for transparency of the equations used, predominantly because they may overestimate adherence, and even more when used with multiple medications. We aimed to operationalize a novel calculation of adherence with polypharmacy, the daily polypharmacy possession ratio (DPPR), and validate it against the common measure of adherence, the medication possession ratio (MPR) and a modified version (MPRm). Methods: We used linked health data from the Australian Pharmaceutical Benefits Scheme and Western Australian hospital morbidity dataset and mortality register. We identified a strict study cohort from 16,185 patients aged ≥65 years hospitalized for myocardial infarction in 2003–2008 in Western Australia as an illustrative example. We applied iterative exclusion criteria to standardize the dispensing histories according to previous literature. A SAS program was developed to calculate the adherence measures accounting for various drug parameters. Results: The study cohort was 348 incident patients (mean age 74.6±6.8 years; 69% male) with an admission for myocardial infarction who had cardiovascular medications over a median of 727 days (range 74 to 3,798 days) prior to readmission. There were statins (96.8%), angiotensin converting enzyme inhibitors (88.8%), beta-blockers (85.6%), and angiotensin receptor blockers (13.2%) dispensed. As expected, observed adherence values were higher with mean MPR (median 89.2%; Q1: 73.3%; Q3: 104.6%) than mean MPRm (median 82.8%; Q1: 68.5%; Q3: 95.9%). DPPR values were the most narrow (median 83.8%; Q1: 70.9%; Q3: 96.4%). Mean MPR and DPPR yielded very close possession values for 37.9% of the patients. Values were similar in patients with longer observation windows. When the traditional threshold of 80% was applied to mean MPR and DPPR values to signify the threshold for good adherence, 11.6% of patients were classified as good adherers with the mean MPR relative to the DPPR. Conclusion: In the absence of transparent and standardized equations to calculate adherence to polypharmacy from refill databases, the novel DPPR algorithm represents a valid and robust method to estimate medication possession for multi-medication regimens. Keywords: medication adherence, claims database, DPPR, medication possession ratio, ­algorithm, administrative data

Background The burden of asthma and COPD among patients is high and people affected are frequently hospitalized due to exacerbations. There are numerous reasons for the lack of disease control in asthma and COPD patients. It is associated with non-adherence to guidelines on the part of the health care provider and with poor inhalation technique and/or non-adherence to the prescribed treatment plan by the patient. This study aims to present data on inhaler technique and its impact on quality of life (QoL) and symptom control in a typical population of patients with chronic lung disease from a randomized controlled trial on medication adherence. Methods For this cross-sectional analysis, 165 asthma and COPD patients were analyzed. Correct application of inhaler devices was tested using pre-defined checklists for each inhaler type. QoL and symptom control were investigated using COPD Assessment Test (CAT) and Asthma Control Test (ACT). Spirometry was used to measure forced vital capacity (FVC) and forced expiratory volume in one second (FEV1). Results Overall, incorrect inhalation technique ranged from 0 to 53% depending on the type of inhaler. COPD patients with incorrect device application had a higher CAT sum score compared to those with a correct device application (P = .02). Moreover, COPD patients with incorrect device application were more likely to suffer from cough (P = .03) and were more breathless while walking uphill or a flight of stairs (P = .02). While there was no significance found in asthma patients, COPD patients who used their devices correctly had a significantly better mean FEV1% predicted at baseline compared to those who applied their devices incorrectly (P = .04). Conclusions Correct inhalation of prescribed medication is associated with improved health status and lung function. These findings should encourage health professionals to provide instructions on correct inhalation technique and to regularly re-evaluate the patients’ inhalation technique. Trial registration ClinicalTrials.gov: NCT0238672, Registered 14 February 2014.

Corina Metaxas,1 Valerie Albert,1 Matthias Stahl,2 Kurt E Hersberger,1 Isabelle Arnet1 1Department of Pharmaceutical Sciences, Pharmaceutical Care Research Group, University of Basel, Basel, Switzerland; 2Department of Internal Medicine, Kantonsspital Basel-Land, Bruderholz, Switzerland Objective: Few studies have examined associations between patient knowledge of direct oral anticoagulants (DOAC) and clinical outcomes, mostly because of the lack of validated questionnaires for assessing knowledge. The aim of this study was to develop and validate a questionnaire to self-assess knowledge of DOAC.Methods: Twelve anticoagulation experts participated in the questionnaire development process to ensure content validity. The Knowledge Of Direct Oral Anticoagulants (KODOA)-test was submitted to patients on DOAC and to pharmacists to assess construct validity. Responsiveness was evaluated after educational counseling. Test–retest reliability was assessed to ensure stability over time, and Cronbach’s α was calculated for internal reliability. Index of difficulty and item discrimination (D-value) were calculated to assess the performance of single items.Results: The KODOA-test contains 15 items with multiple-choice answers. Each correct answer scores 1 point (max. score of 15). The KODOA-test was administered to 32 patients on DOAC and 28 pharmacists. Pharmacists scored significantly higher than patients at baseline (median score 13.3 vs 10.0; p

Objectives: To evaluate a prompt card (i.e., a post-card sized tool that lists counselling prompt information) with 5 key elements and 3 open key questions to ask patients in community pharmacies. Methods: Community pharmacists practicing in England and accredited to perform consultations used the prompt card during a formal consultation with emphasis on patients receiving oral anticoagulation. Main outcome measure was the number of performed consultations with pharmacists’ thoughts and feedbacks in writing. Results: During 8 weeks, 19 pharmacists (mean age: 36.6 (SD=9) years; 7 women; accredited an average of 12.9 (SD=9.8) years) performed 1,034 consultations and used the prompt card 104 times during anticoagulation consultations. Overall the prompt card was judged practical and relevant by the 16 pharmacists who used it (100%), especially because it outlines what a good consultation should comprise. The key elements offered a logical framework to guide the overall approach when undertaking a consultation. The two questions, “Why do you want to use this medicine?” and “Why would you not want to use this medicine?” generated negative responses from the patient and pharmacists, respectively. Conclusions: Our prompt card with key questions summarizing all the points that should be addressed in a consultation supported effective communication during patient-pharmacist interaction. Two questions need rephrasing and a further question is needed to determine how patients are using their medicines.

Background: In pharmacotherapy, the achievement of a target clinical outcome requires a certain level of medication intake or adherence. Based on Haynes's early empirical definition of sufficient adherence to antihypertensive medications as taking ≥80% of medication, many researchers used this threshold to distinguish adherent from non-adherent patients. However, we propose that different diseases, medications and patient's characteristics influence the cut-off point of the adherence rate above which the clinical outcome is satisfactory (thereafter medication adherence threshold). Moreover, the assessment of adherence and clinical outcomes may differ greatly and should be taken into consideration. To our knowledge, very few studies have defined adherence rates linked to clinical outcomes. We aimed at investigating medication adherence thresholds in relation to clinical outcomes. Method: We searched for studies that determined the relationship between adherence rates and clinical outcomes in the databases PubMed, EmbaseⓇ and Web of Science™ until December 2017, limited to English-language. Our outcome measure was any threshold value of adherence. The inclusion criteria of the retrieved studies were (1) any measurement of medication adherence, (2) any assessment of clinical outcomes, and (3) any method to define medication adherence thresholds in relation to clinical outcomes. We excluded articles considered as a tutorial. Two authors (PB and IA) independently screened titles and abstracts for relevance, reviewed full-texts, and extracted items. The results of the included studies are presented qualitatively. Result: We analyzed 6 articles that assessed clinical outcomes linked to adherence rates in 7 chronic disease states. Medication adherence was measured with Medication Possession Ratio (MPR, n = 3), Proportion of Days Covered (PDC, n = 1), both (n = 1), or Medication Event Monitoring System (MEMS). Clinical outcomes were event free episodes, hospitalization, cortisone use, reported symptoms and reduction of lipid levels. To find the relationship between the targeted clinical outcome and adherence rates, three studies applied logistic regression and three used survival analysis. Five studies defined adherence thresholds between 46 and 92%. One study confirmed the 80% threshold as valid to distinguish adherent from non-adherent patients. Conclusion: The analyzed studies were highly heterogeneous, predominantly concerning methods of calculating adherence. We could not compare studies quantitatively, mostly because adherence rates could not be standardized. Therefore, we cannot reject or confirm the validity of the historical 80% threshold. Nevertheless, the 80% threshold was clearly questioned as a general standard.

Objective To assess chlamydia knowledge, willingness to undertake pharmacy-based chlamydia testing, and facilitators and barriers to such testing in consumers and community pharmacists, in Australia (AUS) and Switzerland (CH). Methods Statements of interest were retrieved from literature and assembled into a 12-item online survey (English and German versions). Survey was disseminated through Facebook, pharmacies’ publicly available emails and professional websites (March 2015). Results Consumers and pharmacists (AUS: ncons = 198, npharm = 162; CH: ncons = 209, npharm = 223) were predominantly female (>65%). Mean chlamydia knowledge scores (maximum of 8) were higher in Australia in consumers (AUS: 6.8 ± 1.5 vs CH: 4.2 ± 2.4; p Conclusion The majority of consumers and pharmacists support pharmacy-based chlamydia testing. There is now emerging evidence that the policy makers in Australia and Switzerland need to develop pharmacy-based chlamydia testing as core business.

Background Patients with substance use disorders grow older thanks to effective treatments. Together with a high prevalence of comorbidities, psychological problems, and low social support, these patients are at high risk for medication non-adherence. Established treatment facilities face challenges to accommodate these complex patients within their setting. Electronic medication management aids (e-MMAs) might be appropriate to simultaneously monitor and improve adherence for these patients. Case presentation We report the first long-term experiences with a novel remote electronic medication supply model for two opioid-dependent patients with HIV. John (beginning dementia, 52 years, 6 tablets daily at 12 am) and Mary (frequent drug holidays, 48 years, 5–6 tablets daily at 8 pm) suffered from disease progression due to non-adherence. We electronically monitored adherence and clinical outcomes during 659 (John) and 953 (Mary) days between July 2013 and April 2016. Both patients retrieved over 90% of the pouches within 75 min of the scheduled time. Technical problems occurred in 4% (John) and 7.2% (Mary) of retrievals, but on-site support was seldom required. Viral loads fell below detection limits during the entire observation period. Conclusions Continuous medication supply and persistence with treatment of over 1.7 years, timing adherence of more than 90%, and suppressed HIV viral load are first results supporting the feasibility of the novel supply model for patients on opioid-assisted treatment and polypharmacy.

BACKGROUND: Vitamin B12 (VB12) deficiency can be treated with oral high-dose substitution or intramuscular (i.m.) injection of VB12. Whenever alternative routes of administration exist, patient prefer-ences should be considered when choosing the treatment. We aimed to assess outpatient preferences towards oral or IM VB12 substitution and confirm noninferiority of early biomarker response with oral treat-ment, in a typical primary care population. METHODS: Prospective randomised nonblinded parallel-group trial. Patients were recruited by their general practitioner and randomly as-signed to oral or IM treatment. Group O-oral was given 28 tablets of 1000 μg cyanocobalamin in a monthly punch card fitted with an elec-tronic monitoring system. Group I-IM received four, weekly injections of 1000 μg hydroxocobalamin. Blood samples were drawn before the first administration and after 1, 2 and 4 weeks of treatment, and ana-lysed for VB12, holotranscobalamin (HoloTc), homocysteine (Hcy) and methylmalonic acid (MMA). For group O-oral, treatment adherence and percentage of days with 2 dosing events were calculated. Before and after 28 days of treatment, patients were asked to fill in a ques-tionnaire about their preference for the therapy options and associ-ated factors. RESULTS: Between November 2013 and December 2015, 37 patients (age: 49.5 ± 18.5 years; women: 60.5%) were recruited for oral (19) or IM (18) treatment. Baseline values with 95% confidence intervals for serum VB12, HoloTc, Hcy and MMA were 158 pmol/l [145-172], 49.0 pmol/l [40.4-57.5], 14.8 µmol/l [12.0-17.7] and 304 nmol/l [219-390], respective-ly, in group O-oral and 164 pmol/l [154-174], 50.1 pmol/l [38.7-61.6], 13.0 µmol/l [11.0-15.1] and 321 nmol/l [215-427], respectively, in group I-IM (not significant). After 1 month of treatment, levels of VB12 and HoloTc showed a significant increase compared with baseline (group O-oral: VB12 354 pmol/l [298-410] and HoloTc 156 pmol/l [116-196]; group I-IM: VB12 2796 pmol/l [1277-4314] and HoloTc 1269 pmol/l [103-2435]). Hcy and MMA levels showed a significant decrease compared with baseline (group O-oral: Hcy 13.8 µmol/l [10.7-16.8] and MMA 168 nmol/l [134-202]; group I-IM: Hcy 8.5 µmol/l [7.1-9.8] and MMA 156 nmol/l [121-190]). HoloTc and MMA levels were normalised in all patients after 4 weeks of treatment, whereas normalisation of VB12 and Hcy was reached by all patients in group I-IM only. Response of VB12, HoloTc and Hcy was more pronounced in group I-IM (p

Background: Dependence on high-dose benzodiazepines (BZDs) is well known and discontinuation attempts are generally unsuccessful. A well established protocol for high-dose BZD withdrawal management is lacking. We present the case of withdrawal from high-dose lorazepam (>20 mg daily) in an unemployed 35-year-old male outpatient through agonist substitution with long-acting clonazepam and electronic monitoring over 28 weeks. Methods: All medicines were repacked into weekly 7 × 4 cavity multidose punch cards with an electronic monitoring system. The prescribed daily dosages of BZDs were translated into an optimal number of daily tablets, divided into up to four units of use. Withdrawal was achieved by individual leftover of a small quantity of BZDs that was placed in a separate compartment. Feedback with visualization of intake over the past week was given during weekly psychosocial sessions. Results: Stepwise reduction was obtained by reducing the mg content of the cavities proportionally to the leftovers, keeping the number of cavities in order to maintain regular intake behavior, and to determine the dosage decrease. At week 28, the primary objectives were achieved, that is, lorazepam reduction to 5 mg daily and cannabis abstinence. Therapy was continued using multidrug punch cards without electronic monitoring to maintain the management system. At week 48, a smaller size weekly pill organizer with detachable daily containers was dispensed. At week 68, the patient’s therapy was constant with 1.5 mg clonazepam + 5 mg lorazepam daily for anxiety symptoms and the last steps of withdrawal were started. Conclusions: Several key factors led to successful withdrawal from high-dose BZD in this outpatient, such as the use of weekly punch cards coupled with electronic monitoring, the patient’s empowerment over the withdrawal process, and the collaboration of several healthcare professionals. The major implication for clinical care is reduction by following the leftovers, and not a diktat from the healthcare professionals.

Background: Life expectancy of older drug users has increased, primarily thanks to opioid agonist treatment (OAT). Nursing homes are often not adapted to accommodate patients with substance use disorders. Although care and adherence to polypharmacy in older opioid users need considerable resources e.g., daily visits to an outpatient clinic, outpatient treatment and surveillance are provided as long as possible. We developed a novel medication supply model with an electronic dispenser of pre-packed medications located at patient home, after allowing for law requirements concerning the dispensing of opioids, and present preliminary results from three illustrative outpatients. Methods: The community pharmacy provided unit-of-dose pouches with all solid oral medications directly to patient home. Opioids for substitution were obtained at the addiction clinic in at least weekly intervals, otherwise in the pouches. The pouches were loaded into a lockable, remote-controlled medication management aid that was programmed according to the patient’s medication schedule. The dispenser reminds patients with acoustic alerts to take their medication and records dates and times of medication retrievals. It automatically sends an alert if a patient misses to retrieve a dose. Results: Our three outpatients used the electronic dispenser during 659, 118 and 61 days, with a total of 5, 9, and 18 pills to take daily at 1, 3 and 5 intake times, respectively. The majority of the doses were taken on the preset time (94%, 68.2% and 73.7%) or deliberately in advance (pocket dose). Clinical benefits were initiation and maintenance of a therapy for dementia over 18 months and suppression of HIV viral load over 1.8 years (patient 1), prevention of further dose escalation of pain medication (patient 2) and release of prompts to initiate the existential task of cooking (patient 3). Conclusion: Our novel supply model allows adequate implementation and persistence of complex treatments with outpatients. Clinical outcomes improved, patients and caregivers were satisfied, and resources were saved.

Contains fulltext : 170937.pdf (Publisher’s version ) (Open Access) Introduction: Despite much research, interventions to improve medication adherence report disappointing and inconsistent results. Tailored approaches that match interventions and patient determinants of non-adherence were seldom used in clinical trials. The presence of a multitude of theoretical frameworks and models to categorize interventions and patient determinants complicated the development of common categories shared by interventions and determinants. We retrieved potential interventions and patient determinants from published literature on medication adherence, matched them like locks and keys, and categorized them according to the Theoretical Domains Framework (TDF). Methods: We identified the most relevant literature reviews on interventions and determinants in a pragmatic literature search, extracted all interventions and determinants, grouped similar concepts to umbrella terms and assigned them to TDF categories. All steps were finalized in consensus discussion between the authors. Results: Sixteen articles (5 with determinants, 11 with interventions) were included for analysis. We extracted 103 interventions and 42 determinants that we divided in 26 modifiable and 16 unmodifiable determinants. All interventions and modifiable determinants were matched within 11 categories (Knowledge; Skills; Social/professional role and identity; Beliefs about capabilities; Beliefs about consequences; Intentions; Memory, Attention and decision processes; Environmental context and resources; Social influences; Emotion; and Behavioral regulation). Conclusion: In published trials on medication adherence, the congruence between interventions and determinants can be assessed with matching interventions to determinants. To be successful, interventions in medication adherence should target current modifiable determinants and be tailored to the unmodifiable determinants. Modifiable and unmodifiable determinants need to be assessed at inclusion of intervention studies to identify the patients most in need of an adherence intervention. Our matched categories may be useful to develop interventions in trials that investigate the effectiveness of adherence interventions.

Aim: The aim of this study is to investigate the effects of an acoustic reminder on medication adherence in lung patients. Methods: In this on-going prospective single-blind randomized controlled trial, in- and outpatients from several hospitals around Basel diagnosed with asthma or COPD and with prescribed inhalative medication were recruited. They must have experienced at least one exacerbation in the previous 12 months. The intervention group is provided with an acoustic reminder for inhalation and receives support calls when the medication is not taken as prescribed.In both groups, adherence was measured with electronic devices, which record date and time of each actuation. We present preliminary data of the first 54 patients (154 patients are planned to enroll) recruited since 2014. Adherence was defined as percentage of days with correct dosing (correct number of prescribed inhalations). Results: Of the 54 (76% male, 67.9±9.1 yrs) patients, 42 (78%) had COPD, 8 (15%) asthma and 4 (7%) asthma-COPD overlap syndrome. Adherence to puff inhalers was higher in the intervention compared to control group (80±19% vs. 51±21%; p Conclusion: These results suggest a beneficial effect of regular reminder on the adherence of lung patients. Adherence to once-daily dosage and powder capsules regimens appears to be better.