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Este editorial está siendo co-publicado por todas las revistas de la International Collaboration of Pharmacy Journal Editors

Abstract Background Knowledge, attitudes and substitution laws of biosimilars are not consistent across countries. Biosimilar acceptance among patients and healthcare professionals may be suffering from gaps in knowledge and understanding about biosimilars and their regulatory approval process. Pharmacists' roles and responsibilities changed considerably during the COVID-19 pandemic. Thus, they might have gained new skills and self-confidence in counseling and substitution of biosimilars. Aims To examine and compare the knowledge, perceptions and information needs of German and Swiss pharmacists regarding original biologicals and biosimilars in 2020 and 2022. Methods We conducted an online survey among Swiss and German community pharmacies in February 2020 (before) and August 2022 (after the COVID-19 pandemic). Descriptive statistics were calculated and the Chi-Square test was used for comparisons among categorical variables. Results A total of 764 pharmacists took part in the survey (390 in 2020 and 374 in 2022) with comparable demographics. The frequency of dispensing biologicals remained similar between German and Swiss pharmacists in 2020 and 2022, but the Swiss dispensation of biosimilars increased significantly in 2022 compared to 2020. Concerning the understanding of the term biosimilars, knowledge remained moderate in both countries in both years. Participants were equally familiar with the term and most felt sufficiently informed. In both countries, substitution with a biosimilar showed the least confidence of all attitudes. A third of the participants indicated correct substitution rules in their country. In both years, around 85% of the participants were highly interested in additional training on this topic. Discussion/Conclusion The results indicate that similarities and differences between Germany and Switzerland regarding knowledge and attitudes towards biologicals and biosimilars remained unchanged before and after the COVID-19 pandemic. An influence of the pandemic is unlikely. There is still a clear lack of knowledge among community pharmacists on biosimilars, especially regarding the substitution rules. Due to a rising market with many benefits but also big challenges to overcome, the topic of biosimilars should receive more attention in the future. This requires additional training for pharmacists.

Background Non-adherence to antihypertensive agents is common, mainly because of the low perceived burden of high blood pressure. General practitioners (GPs) are unable to predict whether patients are adhering to a recommended treatment. Knowledge about adherence might be of clinical interest in patients non-responding to antihypertensive treatment.Aim To assess the usefulness of an Adherence Monitoring Package (AMoPac) to identify non-adherence in patients non-responding to antihypertensive treatment.Methods AMoPac consists of (1) 4 weeks of electronic adherence monitoring, (2) pharmacist’s feedback on patient’s intake behaviour and (3) adherence metrics including clinical-pharmaceutical recommendations to the GP. AMoPac-HYP (‘Adherence Monitoring Package to identify non-adherence in ambulatory HYPertensive patients’) is an observational study among GPs and ambulatory patients with hypertension in a real-world setting. The primary outcome was GPs’ perceived usefulness of AMoPac. Secondary outcomes were (1) frequency of medication problems and prescribing errors; (2) types of pharmacist’s’ recommendations; (3) acceptance of the recommendations by GPs; (4) medication adherence and (5) patients’ satisfaction. Outcomes are reported descriptively. Data were collected with questionnaires and electronic monitoring of medicine intake.Results Fifteen GPs and 15 patients with hypertension participated in the AMoPac-HYP Study. Patients were on average 62 years old, and mean blood pressure was 137/83 mmHg. All GPs rated AMoPac as useful. The most frequently mentioned use was excluding non-adherence in patients with hypertension (93%). Medication problems and prescribing errors were observed in 80% of the patients. The study pharmacist recommended adherence support (N=9 patients) and treatment optimisation (N=8 patients). The recommendations were accepted and implemented in 10 of 17 cases by the GP. Patients’ mean taking and timing adherence were 90% and 86%, respectively. Satisfaction with the study procedures among patients was high.Conclusion AMoPac was rated as useful for identifying and excluding non-adherence in patients with hypertension and was highly accepted among patients. Including adherence data in clinical decision-making could contribute to optimising patient care.

BackgroundPatients with atrial fibrillation (AF) have a high risk for recurrent clinical events after an ischemic stroke. Direct oral anticoagulants (DOAC) are prescribed for secondary prevention. Adherence to DOAC is crucial mainly because of their short elimination half-life. Non-adherence to DOAC can negatively impact patients' outcomes. The relationship between (non-)adherence and recurrent clinical events is unknown in AF patients after initial stroke. We investigated adherence to DOAC in stroke survivors with AF who were included in the MAAESTRO study at the University Hospital Basel, Switzerland, between 2008 and 2022.MethodsThis study is a secondary analysis of data from MAAESTRO with a matched nested case-control design and 1:2 ratio. DOAC intake was measured with a small electronic device (Time4MedTM). We defined two arbitrary intervals of 17 days and 95 days as the longest time spans with electronic monitoring data per patient to maximize the number of participants with adequate amount of observation time available for analysis. Taking and timing adherence were calculated retrospectively i.e., prior to the recurrent event for cases. Trendline analysis of adherence over 95 days was calculated. Linear regression analysis was performed after adjusting for the co-variables age and daily pill burden. Sensitivity analysis was performed with controls for intervals in the reverse direction (prospectively).ResultsWe analyzed 11 cases and 22 matched controls (mean age: 75.9 ± 9.2 years vs. 73.1 ± 8.4 years; n.s.) with similar stroke characteristics (NIHSS, mRS, MoCA) and 36.4% women in each group. Mean adherence values were high and similar between cases and controls (95 days taking: 87.0 ± 18.9% (cases) vs. 90.8 ± 9.8% (controls), n.s.; similar values for timing adherence). Six hemorrhagic and five ischemic events had occurred. Compared to controls, a significantly higher 95 days taking adherence was observed for hemorrhagic events (96.0 ± 5.0% (cases) vs. 88.1 ± 11.5% (controls); pConclusionBecause recurrent ischemic events after an AF-related stroke were associated with low adherence to DOAC 96%.Trial registrationClinicalTrials.gov NCT03344146.

Abstract Background and Aims The World Health Organization has set a goal to eradicate hepatitis C virus (HCV) by the year 2030. Nonadherence to HCV treatment has substantial economic implications due to high treatment costs, among others. Barriers to start HCV treatment may be critical. The aim of this study was to assess pertinent barriers to HCV treatment in ambulatory patients with a history of illicit substance use and to compare them to the literature. Methods Barriers to HCV treatment mentioned by the key risk group (i.e., people who inject drugs) were retrieved from literature through a pragmatic literature search. From 34 published articles, we identified 80 modifiable barriers that were bundled in 23 items within the four topics “Personal difficulties and barriers to treatment,” “Personal motivation to be treated,” “Knowledge about the disease,” and “Received information about the medicine.” In‐depth semistructured interviews were performed face‐to‐face with ambulatory patients from the University Psychiatric Clinics in Basel, Switzerland. Transcripts were coded inductively. Results Interviews were performed with seven individuals (mean age: 48.3 years; range: 38–63 years; one woman) treated with oral direct‐acting antivirals between 2014 and 2022. Thirteen barriers to start HCV treatment were mentioned that corresponded to the five categories: information, attitudes, swallowing difficulties, social environment, and unfavorable lifestyle. The barrier “swallowing difficulties” emerged exclusively from the statements provided by the interviewees. Conclusion Barriers to the initiation of HCV treatment indicated by our interviewees clearly differed from the literature. Notably, the challenge of swallowing medicines may be particularly relevant for physicians prescribing and pharmacists dispensing HCV medication.

Background Adherence to pharmacotherapy is crucial to prevent symptom deterioration in chronic diseases. However, non-adherence to chronic treatments is prevalent, especially in polypharmacy. Practical tools to assess adherence to polypharmacy in primary care are missing.Aims We aimed to develop an Adherence Monitoring Package (AMoPac) for general practitioners (GPs) to identify patient non-adherence. We tested the feasibility and acceptance of AMoPac in the primary healthcare setting.Methods AMoPac was developed based on peer-reviewed literature. It consists in (1) electronic monitoring of patients’ medication intakes for 4 weeks, (2) receiving feedback on intake behaviour by the pharmacist and (3) generating an adherence report to communicate to the GPs. A feasibility study was conducted with heart failure patients. GPs’ acceptance of AMoPac was explored with semistructured interviews. Electronic transmission of the reports into the GP’s electronic health record along with laboratory reports stating N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels was analysed.Results We developed AMoPac and tested its feasibility with six GPs and seven heart failure patients. GPs were satisfied with the adherence report including the pharmaceutical-clinical recommendations. Integrated transmission of adherence reports to GPs was not feasible due to technical incompatibilities. Mean taking adherence was 86.4%±12.8% and three patients had low correct dosing-days (69%, 38% and 36%, respectively). NT-proBNP ranged from 102 to 8561 pg/mL and four patients had elevated values (>1000 pg/mL).Conclusion AMoPac is feasible in the primary healthcare setting, excluding the integrated transmission of adherence reports to GPs. The procedure was highly accepted by GPs and patients. AMoPac fills a gap by combining clinical values with adherence data, and therefore, delivers a multifaceted picture of the patient’s behaviour. In case of unmet adherence, our tool might facilitate the selection of patient-centred approaches to optimise pharmacological therapies in chronic heart failure patients.Trial registration number NCT04326101.

Abstract Comparison of several regimens of oral vitamin D including an individually calculated loading regimen with the aim of achieving serum values > 75 nmol/l. Interventional, randomized, 3-arm study in vitamin D-deficient outpatients. Participants were allocated to supplementation of 24,000 IU vitamin D monthly over three months, using either a monthly drinking solution (Vi-De 3) or capsule (D3 VitaCaps), or an individualized loading regimen with the capsules taken weekly. For the loading regimen, the cumulative dose was calculated according to baseline 25-hydroxy-vitamin D (25(OH)D) serum value and body weight. Main inclusion criteria were age ≥ 18 years and 25(OH)D serum concentration 50 nmol/l. Serum 25(OH)D values > 75 nmol/l were observed more frequently in patients taking the loading regimen (47% vs 11% drinking solution vs 12% capsules). Vitamin D-related adverse effects did not occur in any treatment groups. Capsules were preferred by 88.5% of the patients. Compared to treatments with monthly intake of 24,000 IU vitamin D, the intake of an individually calculated weekly loading regimen was able to raise serum concentrations > 50 nmol/l in all cases within a safe range.

Abstract Background To assess adherence to and preference for vitamin D substitution with different pharmaceutical forms and frequencies of administration. Methods A focus group of stakeholders aimed at preparing the design of an interventional, randomized, cross-over study with 2 × 2 groups obtaining monthly or weekly vitamin D products in liquid or solid form for 3 months each. Dosage corresponds to cumulated amount of recommended 800 IU daily (5.600 IU weekly / 24.000 IU monthly). Main inclusion criteria were a vitamin D serum value 75 nmol/l was achieved by 32% after 3 months and by 50% after 6 months. Preferred formulation was solid form (tablets, capsules) for 71% of participants, and preferred dosage frequency was monthly for 39% of participants. Conclusions Monthly oral vitamin D in solid form lead to the highest adherence, and is preferred by the participants. However, only one third of study participants achieved values in the optimal range of > 75 nmol/l cholecalciferol using weekly or monthly administration providing an average daily cholecalciferol dose of 800 IU. Trial registration NCT03121593 | SNCTP000002251 . Registered 30. May 2017,. Prospectively registered.

Background: Counseling patients on medication adherence could be ameliorated in pharmacy practice. There is a lack of simple and practical strategies to address medication adherence with patients in daily practice. The goal was to develop and test a framework that allows pharmacy teams to define and apply a strategy to address medication adherence in community pharmacies. Methods: A framework based on the principles of social marketing was developed. It consisted of 3 items: the target patient (“Who”), the target plan (“How”), and the target goal (“How many”). To test the framework, each participating pharmacy team developed their strategy by defining the 3 items and applied them during one pilot day. A master student observed the encounters between patients and pharmacy team members and used a structured checklist to document the patient's characteristics, counseling content, and strategy use. Pharmacy teams answered a feedback questionnaire at the end of the pilot day. Results: Ten pharmacy teams were included. During a brainstorming session that lasted on average 31 ± 8 min, unique strategies comprised 18 different target patients and 20 different target plans. The planned target goal was a mean of 31 patients (range: 1 to “all”). A total of 325 encounters were observed, of which 208 patients (64%) corresponded to the predefined target patients. Medication adherence was addressed with 73 patients (22.5%), and adherence counseling was performed with 50 patients (15%). The pharmacy teams accepted the framework and judged it feasible and adaptable to their needs. Conclusion: The proposed framework represents a simple tool that enables pharmacy teams to develop a strategy for addressing medication adherence in community pharmacies. Its adoption by pharmacy teams occurred without additional training and its integration into daily practice without difficulties. A further study is now needed to investigate if pharmacy teams can successfully engage patients in discussion on medication adherence and ultimately propose targeted adherence interventions.

Interchangeability between biological medicines and biosimilars, and subsequent substitution by pharmacists represent an important opportunity for costs savings for health care systems. Because biological medicines are complex products, the expert role of the pharmacist to inform patients and support physicians is indispensable. However, regulations on substitution of biosimilars differ around the globe, such that a substitution that is allowed in one country may be forbidden in another. Overall, pharmacists' knowledge of biosimilar medicines is incomplete and hesitancy to engage in substitutions is perceptible. As counter-balancing remedy, continued education about biosimilars is needed among practicing community pharmacists.

Abstract Background Poor 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. Methods This 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. Results Seventy-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

Objectives Particularly at transitions of care points information concerning current medication tends to be incomplete. A medication chart that contains all essential information on current therapy is likely to be a helpful tool for patients and healthcare providers. We aimed to investigate any type of benefits associated with medication charts provided at transition points.Methods A systematic review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was performed. Two databases, two online journals and two association websites dedicated to biomedicine and pharmacy issues were consulted to identify studies for the review using the search term ‘medication chart’ and synonyms. We run our search from database inception up to March 2019. Studies of any study design, intervention and population which examined the effect of paper-based medication charts were included. We extracted study results narratively and coded and classified them by themes and categories inductively by using the ‘framework method’ with content analysis. The methodological quality of the studies was assessed using the Effective Public Health Practice Project (EPHPP) tool.Results From the 846 retrieved articles, 30 studies met the inclusion criteria, mostly from Germany (18 studies) and the USA (5 studies). Thirteen studies reported a statistically significant result. In the ‘patient theme’, the most obvious benefits were an increase in medication knowledge, a reduction of medication errors and higher medication adherence. In the ‘interdisciplinary theme’, a medication chart represented a helpful tool to increase communication and inter-sectoral cooperation between healthcare providers. In the ‘theme of terms and conditions’, accuracy and currency of data are prerequisites for any positive effect. The quality of the studies was classified predominantly weak mainly due to unmet good quality criteria (no randomised controlled trials study design, no reported dropouts).Conclusion Overall, the reviewed studies suggested some benefits when using medication charts. Healthcare providers could consider using medication charts in their counselling practice. However, it is unknown whether the reported benefits lead to measurable improvement in clinical outcomes.PROSPERO registration number

Objectives To translate the SWAMECO from German into English; to complete content and face validity with healthcare professionals (HCPs) and with patients from the target population that is, community-dwelling adult patients taking three or more medicines for three or more months.Design The process followed guidance from Sousa et al and included translation and cross-cultural adaptation, and cognitive testing among selected HCPs and patients. As the SWAMECO questionnaire is a screening instrument, pilot testing was performed in the target population.Setting Three community pharmacies in and around Cork (Ireland) recruited patients for interviews and pilot testing.Participants Community-dwelling patients with ≥3 oral medications for ≥3 months, aged ≥18 years.Outcome measures Answers to the SWAMECO questionnaire; clarity of each question, each instruction and each response format.Results Issues related to cultural and conceptual differences were resolved by rewording some items. Ten HCPs and 11 patients completed the questionnaire and gave their feedback and opinions on criteria according to Fitzpatrick et al. Revisions included rewording; deleting of two questions; using of colour to signpost that is, where to skip questions that were not applicable to the participants; and replacement of the A-14 medication adherence scale with three validated items. Of the 66 patients enrolled for pilot testing, eight (12.1%) indicated swallowing difficulties. Difficulties with ingesting foods or liquids correlated with swallowing difficulties (p=0.001). All patients perceived discomfort (mean 6.9 on a Visual Analogue Scale from 0 to 10). Patients with swallowing difficulties were significantly more likely to report modifying their medicines (p=0.004) and having poorer medication adherence (p=0.028) than those who had no swallowing difficulties.Conclusions The version of the SWAMECO questionnaire in English contains 28 items and is ready for use in adults with polypharmacy.

Abstract 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.

Introduction: Calculating patients’ medication availability from dispensing or refill data is a common method to estimate adherence. The most often used measures, such as the medication possession ratio (MPR), average medication supplies over an arbitrary period. Averaging masks the variability of refill behavior over time. Goal: To derive a new absolute adherence estimate from dispensing data. Method: Dispensing histories of patients with 19 refills of direct oral anticoagulants (DOAC) between 1 January 2008 and 31 December 2017 were extracted from 39 community pharmacies in Switzerland. The difference between the calculated and effective refill day (ΔT) was determined for each refill event. We graphed ΔT and its dichotomized version (dΔT) against the MPR, calculated mean ΔT and mean dΔT per refill, and applied cluster analysis. Results: We characterized 2204 refill events from 116 DOAC patients. MPR was high (0.975 ± 0.129) and showed a positive correlation with mean ΔT. Refills occurred on average 17.8 ± 27.9 days “too early”, with a mean of 75.8 ± 20.2 refills being “on time”. Four refill behavior patterns were identified including constant gaps within or at the end of the observation period, which were critical. Conclusion: We introduce a new absolute adherence estimate ΔT that characterizes every refill event and shows that the refill behavior of DOAC patients is dynamic.

Abstract 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: 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 “Polymedication-Check” (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’ 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 < 0.001). NOAC patients (n = 31) had more knowledge gaps than VKA patients (n = 50; p < 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.

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

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.

BACKGROUND Vitamin B12 (VB12) deficiency can be treated with oral high-dose substitution or intramuscular (IM) injection of VB12. Whenever alternative routes of administration exist, patient preferences 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 treatment, in a typical primary care population. METHODS Prospective randomised nonblinded parallel-group trial. Patients were recruited by their general practitioner and randomly assigned to oral or IM treatment. Group O-oral was given 28 tablets of 1000 µg cyanocobalamin in a monthly punch card fitted with an electronic 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 analysed 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 questionnaire about their preference for the therapy options and associated 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], respectively, 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

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‘s acceptability was assessed with the System Usability Scale (SUS). Eleven elderly outpatients (mean age 80.2 ± 8.1 years) taking >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.

IntroductionDespite 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).MethodsWe 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.ResultsSixteen 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).ConclusionIn 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.

Pharmaceutical Care (PC) is a new academic discipline with a direct link to patient care. Since 2003 it has been integrated into the Swiss five-year university pharmacy curriculum. This article aims to describe (1) the concept of PC as a systematic process through which a pharmacist cooperates with the patient and healthcare professionals in designing, implementing and monitoring a therapeutic plan that will produce specific therapeutic outcomes; (2) the didactic concept used for the new discipline; (3) an illustrative example of how to teach pharmacy students the issues of patient non-compliance.