Detection and management of clinically relevant drug-drug interactions with direct oral anticoagulants: an intervention study in community pharmacies.

INTRODUCTION: Direct oral anticoagulants (DOACs) are increasingly used and can be involved in clinically relevant drug-drug interactions (DDIs) that increase the risk of major bleeding or thromboembolism. Skilled drug interaction management is essential to ensure safe and effective use of DOACs. In this study, we aimed to investigate the impact of the detection and management of DDIs with DOACs in a real-life community pharmacy setting on the pharmacotherapy of DOAC users. METHODS: We conducted an intervention study in 201 community pharmacies in Belgium. On random days, patients purchasing DOACs or drugs known to interact with them were screened. When a DDI with the DOAC was detected, the pharmacist contacted the prescribing physician to discuss the management of the interaction. A previously developed practice-oriented DDI list accompanied by management plans for ambulatory care was used for both screening and management of the DDIs. RESULTS: In total, 751 patients were included, among whom 875 DDIs were identified, primarily pharmacodynamic DDIs (95.7 %). Predominant interacting drug classes included selective serotonin or serotonin and norepinephrine reuptake inhibitors (32.9 %), antiplatelets (30.9 %), and non-steroidal anti-inflammatory drugs (28.9 %). In 43.0 % of DDIs, an intervention was decided upon. At three-month follow-up, proposed pharmacotherapy changes had been implemented in 79.1 % of these DDIs. CONCLUSIONS: This study demonstrates that active screening and management of DDIs with DOACs in community pharmacies, in close collaboration with prescribing physicians, resulted in changes in pharmacotherapy in a substantial number of patients. This may contribute significantly to the safer utilisation of DOACs in high-risk populations.

Rhinitis Control and Medication Use in a Real-World Sample of Patients With Persistent Rhinitis or Rhinosinusitis: A Community Pharmacy Study.

BACKGROUND: Little is known about rhinitis control in real-life, nor about the contribution of treatment-related and patient-related factors. OBJECTIVE: This study aimed to examine the level of rhinitis control and rhinitis medication utilization in patients with persistent rhinitis and to identify predictors of rhinitis control. METHODS: A cross-sectional observational study was conducted in patients with persistent rhinitis recruited in community pharmacies. Participants completed the Rhinitis Control Assessment Test, a questionnaire on patient/rhinitis characteristics, and rhinitis medication use. A visual analog scale for nasal symptoms was also completed. Pharmacy dispensing data were used to calculate adherence to intranasal glucocorticoids. Nasal spray technique was evaluated using a standardized checklist. Predictors of rhinitis control were explored using a linear regression model. RESULTS: A total of 1,514 patients, recruited in 215 pharmacies, participated in the study (mean age 48.7 y, 62% female). Almost 60% exhibited suboptimal rhinitis control (Rhinitis Control Assessment Test ≤ 21 of 30). A 50-mm cut-off on the visual analog scale yielded 78.1% sensitivity to identify suboptimal rhinitis control. Participants most frequently used intranasal glucocorticoids (55.6%) and intranasal decongestants (47.4%). Only 10.3% of current nasal spray users demonstrated perfect technique. More than half (54.8%) of glucocorticoid users were identified as underadherent. Female sex, self-reported nasal hyperreactivity, active asthma, and use of oral/intranasal decongestants or nasal saline were identified as predictors of worse rhinitis control. CONCLUSIONS: Suboptimal rhinitis control was common in this real-life sample of persistent rhinitis patients. Improving use of rhinitis medication may be key to increase disease control.

Investigating Levothyroxine Use and Its Association with Thyroid Health in Patients with Hypothyroidism: A Community Pharmacy Study.

Background: To gain maximum therapeutic effect while minimizing side effects, it is imperative for patients with hypothyroidism to use their levothyroxine (LT4) correctly, such as adhering to the prescribed regimen. Little is currently known about how patients actually use LT4 in real life. We investigated the use of LT4, as well as the thyroid health (thyrotropin [TSH] and health-related quality of life [HR-QoL]), and evaluated if proper LT4 use is associated with better thyroid health. Methods: A cross-sectional observational study was conducted in a Belgian community sample of adults using LT4 for hypothyroidism since ≥2 years. Participants completed a self-administered questionnaire on patient characteristics, self-reported adherence to LT4, timing of intake, and co-medication. They also completed the thyroid-specific patient-reported outcome (ThyPRO-39) questionnaire, measuring the HR-QoL. Pharmacy dispensing data were used to calculate the medication possession ratio (MPR). Results: We included 856 participants (mean age 61.4 ± 14.3 years, 86% [740/856] females). Approximately one in four participants (138/563) had out-of-range TSH levels. Generally, ThyPRO-39 scores were in the lower part of the range (indicating better HR-QoL), with the scales "emotional susceptibility" and "tiredness" showing the worst scores. Approximately 28% (178/632) of the participants were classified as non-adherent (MPR <80%), corresponding to at least 73 cumulative days per year without LT4 intake. Twenty-five percent (212/854) of participants self-reported non-adherence, with unintentional non-adherence (forgetfulness) most frequently reported (21.9%, 187/854). Only 39% (329/836) of participants complied with the recommendation of ingesting LT4 ≥ 30 minutes before eating. Additionally, 7% (58/856) of participants concurrently used molecules that bind to LT4, without applying the recommended dosing interval. There was no significant correlation between LT4 usage (adherence, timing of intake, and interaction with complex forming drugs) and TSH or HR-QoL. Conclusions: We found that many participants with hypothyroidism did not use their LT4 as effectively as possible, particularly with respect to timing of administration. However, the participants' HR-QoL seemed largely satisfactory, and there was no significant correlation between correctly using LT4 and thyroid health.

Drug-drug interactions with direct oral anticoagulants: development of a consensus list for ambulatory care.

BACKGROUND: Direct oral anticoagulants (DOACs) can be involved in clinical relevant drug-drug interactions (DDIs) which may compromise safe and effective use. However, assessing the clinical relevance of DDIs with DOACs and managing these interactions optimally, can be challenging in clinical practice. AIM: To develop a practice-oriented list of potentially clinically relevant DDIs with DOACs with corresponding management plans for which it is important to screen in ambulatory care. METHOD: The RAND/UCLA appropriateness method was used to develop the DOACs DDI list. In a first step a preliminary list was compiled of potentially clinically relevant DDIs per DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) using five reference sources. Subsequently, a two-step modified Delphi process involving a multidisciplinary panel (n = 10) including both pharmacists and physicians with expertise in all decision-making disciplines involved in care for patients using DOACs and with diversity of practice setting, was used to reach expert agreement on a final list of DDIs with corresponding management plans. RESULTS: After a two-step consensus round, 71 DDIs for 20 different interacting drugs were included: five pharmacodynamic, nine pharmacokinetic inhibitor and six pharmacokinetic inducer interacting drugs. Considerations raised and discussed by the panellists were related to (1) the necessity of the interacting drug, (2) the manageability of the DDI (whether there are any alternatives), (3) the (clinical) evidence-base for the DDI and (4) the (potential) consequences of the DDI. CONCLUSION: We developed a consensus list with specific and straightforward management plans on potentially clinically relevant DDIs with DOACs, for use in ambulatory care.

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 and management of drug interactions between nonsteroidal anti-inflammatory drugs and antithrombotics in ambulatory care.

Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) and antithrombotic agents is associated with increased risks of both bleeding and thromboembolism. In this prospective intervention study, community pharmacists screened for NSAID-antithrombotic interactions and contacted the prescribing physician to discuss interaction management. We included 782 interactions; these were found in an older, polymedicated patient population (mean age: 68 y, median of 5 other drugs). Ibuprofen (in 43.0% of cases) and low-dose aspirin (78.8%) were the most frequently involved NSAID and antithrombotic, respectively. Anticoagulants were involved in 16.1% of interaction cases. For 61% of cases, the interacting drugs were prescribed by the same physician. The pharmacist-physician discussion about how to manage the interaction mostly resulted in no change of pharmacotherapy (60.7%); the most frequent reason given by physicians was that the NSAID was for short-term use only. In 39.3% of cases the discussion resulted in a pharmacotherapy change; replacing the NSAID by paracetamol was the most common change.

Revisiting the Food- and Nutrition-Related Curriculum in Healthcare Education: An Example for Pharmacy Education.

Objective: This study aimed to obtain an objective overview of nutritional topics discussed in community pharmacies to adapt the nutrition-related course content in pharmacy education. Methods: We performed an observational study between July 2014 and April 2015 in 136 community pharmacies in Belgium. During four months, each pharmacy intern recorded the first two food- and nutrition-related cases with which they were confronted. Each case was classified into one of 18 categories. Results: 1004 cases were included by 135 pharmacy interns. The most often discussed subjects include "food supplements" (38%), "baby food" (19%), and "healthy food and nutritional recommendations" (11%). In 45% (447/1004) of all cases, pharmacy interns were able to immediately discuss the cases without searching for additional information. Eventually, after looking up extra information, 95% (958/1004) of cases could be answered. Conclusions: Food- and nutrition-related cases are discussed in primary healthcare. We recommend food- and nutrition-related courses in the curriculum of every healthcare profession.

Appropriateness of direct oral anticoagulant dosing in patients with atrial fibrillation according to the drug labelling and the EHRA Practical Guide.

BACKGROUND: This study aimed to evaluate the prevalence of potential drug-drug interactions (DDIs) and the appropriateness of direct oral anticoagulant (DOAC) dosing according to both the Summary of Product Characteristics (SmPC) and the European Heart Rhythm Association (EHRA) Practical Guide in a 'real-world' sample of non-valvular atrial fibrillation (NVAF) patients. METHODS AND RESULTS: Data of a cross-sectional observational study in a primary care sample of 654 long-term DOAC users were used for this sub-analysis. A total of 262 potential DDIs were identified in 220 patients (33.6%). Pharmacodynamic DDIs were present in 163 patients (24.9%) and pharmacokinetic DDIs in 82 patients (12.5%). One-third of patients (33.8%) received reduced DOAC dose. According to the dosing recommendations in the SmPC, 81.7% of DOACs were dosed appropriately. According to the EHRA recommendations, 76.6% of DOACs were dosed appropriately. Dosing recommendations were consistent for 90.7% of patients, with both the SmPC and EHRA Practical Guide considering DOACs dosed appropriately in 74.5% of patients, overdosed in 7.8%, underdosed in 7.6% and contraindicated in 0.8%. However, for the remaining 9.3% dosing recommendations differed between SmPC and EHRA. CONCLUSIONS: This 'real-world' analysis of DOAC dosing demonstrated that in about one-third of NVAF patients potential DDIs were present. In 18.3% and 23.4% of patients, DOACs were dosed inappropriately according to the SmPC and EHRA Practical Guide respectively. In almost 10% of the study population dosing advice was inconsistent between both references. More research is needed to ensure appropriate DOAC dosing in this 'grey zone' population.

Community pharmacy-based study of adherence to non-vitamin K antagonist oral anticoagulants.

OBJECTIVE: This study aimed to assess implementation adherence (how well the patient's actual intake matches the prescribed dosing regimen) to non-vitamin K antagonist oral anticoagulants (NOACs) and to explore experiences with and beliefs about NOACs in a real-world sample of long-term NOAC users. METHODS: A cross-sectional observational study was conducted in home-dwelling adults who started taking a NOAC at least 1 year prior to inclusion. Pharmacy dispensing data were used to calculate the Medication Possession Ratio (MPR). Patients were recruited in 158 community pharmacies in Flanders, Belgium. They completed a questionnaire collecting basic characteristics and exploring self-reported adherence to NOACs (using the Medication Adherence Report Scale, MARS) and experiences with and beliefs about NOACs (using the Beliefs about Medicines Questionnaire, BMQ). RESULTS: A total of 766 patients (mean age 76.2±8.8 years, median CHA2DS2-VASc score 4 (IQR=3-4)) were included. The majority (93.5%) used NOAC for stroke prevention in atrial fibrillation. The median MPR was 95.2% (IQR=87.8-99.7) which corresponds with half of the study population not taking their NOAC on at least 17 cumulative days per year. Almost 21% of participants reported non-adherence on the MARS (score <25), with unintentional non-adherence (forgetfulness) most frequently reported (15.4%). Although two-thirds of NOAC users indicated to experience adverse drug reactions, the BMQ demonstrated a positive attitude towards NOAC therapy, where necessity beliefs outweigh the concerns. CONCLUSIONS: Our data indicate that long-term NOAC users have high implementation adherence and a positive attitude towards NOAC therapy. However, taking into account patients' thromboembolic risk and NOACs' short half-lives, further optimisation of NOAC use seems warranted in this population.

Eye drop technique and patient-reported problems in a real-world population of eye drop users.

OBJECTIVE: To assess eye drop technique and patient-reported problems with eye drop instillation in a primary care sample of eye drop users. METHODS: Cross-sectional observational study in 136 community pharmacies in Belgium. Patient inclusion criteria were being age ≥ 18 years and using eye drops for ≥ 1 month (to ensure that patients were already familiar with eye drop instillation). Participants demonstrated their eye drop technique and completed a self-administered questionnaire. RESULTS: Participants (n = 678) had a mean age of 68.9 ± 12.4 years. During the demonstration, almost everyone (98.0%) successfully instilled at least one drop in the eye, although 14% required multiple attempts to achieve this. Only 3% of the sample exhibited perfect drop technique, meaning that they performed correctly all the steps. Most common deviations were touching the bottle to the eye or eyelid (40.7% of patients), and failing to close the eye (67.8%) and perform nasolacrimal occlusion for at least 1 min (94.7%) after drop instillation. Importantly, we found that 20% of ophthalmic suspensions were not shaken before use. Forty percent of patients reported ≥ 1 problem with eye drop instillation. Most common problems were difficulties with getting a drop in the eye (18.3% of patients), too many drops coming out of the bottle (14.6%), and difficulty squeezing the bottle (12.2%). About half of the sample recalled having had education in eye drop instillation technique. CONCLUSION: This study showed suboptimal eye drop technique in real-world clinical practice. A proactive role of community pharmacists in detecting and resolving these problems could be helpful.

Self-Medication With Over-the-Counter Analgesics: A Survey of Patient Characteristics and Concerns About Pain Medication.

Pain is a common reason for self-medication with over-the-counter (OTC) analgesics. However, this self-treating population has remained largely uncharacterized. This cross-sectional observational study investigated individuals who self-medicate their pain with OTC analgesics to elucidate their pain characteristics and medication use. In addition, presence of and risk factors for concerns about pain medication were examined. The clinical profile of the participants (n = 1,889) was worse than expected with long-standing pain complaints (median pain duration of 9 years), pain located at multiple body sites (median of 4, and 13% with ≥10 painful body areas), about one-third suffering from daily pain and about 40% experiencing substantial pain-related disability. Head (58.6% of sample), low back (43.6%), and neck (30.7%) were the most common pain locations. About 73% had a physician diagnosis, mainly migraine and osteoarthritis. Paracetamol (used by 68.6% of patients) and nonsteroidal anti-inflammatory drugs (46.8%) were the most frequently used pain medications. About 40% of our sample showed substantial concern about the perceived need for pain medication and the perceived potential for harmful effects (eg, fear for addiction). These findings highlight the importance for health professionals to systematically probe pain patients about their self-medication practices and explore attitudes about pain medication. Perspective: This study found that the clinical picture of people who self-medicate their pain with OTC analgesics looked worse than expected. We also identified substantial concerns about pain medication. Therefore, we recommend that health professionals systematically probe pain patients about their self-medication practices and explore concerns about pain medication.

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.

The heterogeneity of headache patients who self-medicate: a cluster analysis approach.

Patients with headache often self-treat their condition with over-the-counter analgesics. However, overuse of analgesics can cause medication-overuse headache. The present study aimed to identify subgroups of individuals with headache who self-medicate, as this could be helpful to tailor intervention strategies for prevention of medication-overuse headache. Patients (n = 1021) were recruited from 202 community pharmacies and completed a self-administered questionnaire. A hierarchical cluster analysis was used to group patients as a function of sociodemographics, pain, disability, and medication use for pain. Three patient clusters were identified. Cluster 1 (n = 498, 48.8%) consisted of relatively young individuals, and most of them suffered from migraine. They reported the least number of other pain complaints and the lowest prevalence of medication overuse (MO; 16%). Cluster 2 (n = 301, 29.5%) included older persons with mainly non-migraine headache, a low disability, and on average pain in 2 other locations. Prevalence of MO was 40%. Cluster 3 (n = 222, 21.7%) mostly consisted of patients with migraine who also report pain in many other locations. These patients reported a high disability and a severe limitation of activities. They also showed the highest rates of MO (73%).

Drug administration via enteral feeding tube in residential care facilities for individuals with intellectual disability: A focus group study on guideline implementation.

People with profound intellectual disabilities often receive medication through enteral feeding tube (EFT). In a previous study, we found that current guidelines concerning medication preparation and administration through EFT are often not followed in residential care facilities (RCFs) for individuals with intellectual disabilities. The present qualitative study aimed to identify barriers and facilitators experienced by RCF staff members to following guidelines on medication administration via EFT, by conducting focus group interviews. Time constraints, lack of knowledge, lack of clear administration instructions, lack of necessary materials, and limited gastric fluid tolerance in certain residents were identified as barriers to following guidelines. Other influencing factors were the number of staff members, residents, and medications; habits; and the residents' comfort and well-being. To optimize care for this vulnerable patient population with EFT, an intervention can be set up focusing on improving staff members' medication-related knowledge and providing clear administration instructions and the necessary materials.

Characterisation of patient encounters in community pharmacies (with special focus on self-medication).

OBJECTIVES: To characterise patient encounters during routine drug dispensing in community pharmacies. METHODS: Cross-sectional survey in community pharmacies (Belgium). KEY FINDINGS: Fifty-four per cent of all encounters (N = 1650) concerned patients carrying a prescription, of which 39% were prescriptions for new medication and 61% were repeat prescriptions. In 62% of all encounters, patients asked for non-prescribed medication. Almost one-third of self-medication requests related to special patient populations (mainly children and elderly). CONCLUSIONS : Many encounters related to self-medication, and a substantial number of these self-medication requests concerned vulnerable patient populations.

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.

Self-medication in persistent rhinitis: overuse of decongestants in half of the patients.

BACKGROUND: Patients with rhinitis often self-medicate with over-the-counter drugs, however this self-treating population has remained largely unstudied. OBJECTIVE: To characterize individuals self-medicating persistent rhinitis and to determine the prevalence of and risk factors for intranasal decongestant overuse within this population. METHODS: A cross-sectional observational study of individuals self-medicating persistent rhinitis (defined according to the Allergic Rhinitis and its Impact on Asthma guidelines). Participants (n = 895) completed a self-administered questionnaire to assess current symptoms, rhinitis medication, and previous physician diagnosis. Intranasal decongestant overuse was defined as daily use for at least 1 year. RESULTS: The vast majority of subjects (95%) had moderate-to-severe rhinitis. Nasal congestion was the predominant symptom (median visual analog scale, 6.6 cm; interquartile range, 3.4 cm). Sixty-five percent had had their current nasal problems for more than 5 years. Approximately 80% had a physician diagnosis (mainly allergic rhinitis or rhinosinusitis). The prevalence of intranasal decongestant overuse was high (49%), despite the fact that most of the patients (80%) were educated about the limit on duration of use. Use of intranasal glucocorticosteroids was inversely related to being an overuser (odds ratio 0.24 [95% CI, 0.17-0.35]). The risk of intranasal decongestant overuse also was reduced by use of other medications (oral H1 antihistamines and decongestants), use of nasal saline solution, and more symptoms of itchy and/or runny eyes or colored mucus. Risk was increased by a more severely blocked nose, longer duration of symptoms, the presence of sleep disturbance, higher body mass index, and previous advice to limit the duration of intranasal decongestant use. CONCLUSION: Half of the individuals self-medicating persistent rhinitis overused intranasal decongestants, despite the fact that they were educated about the limit on duration of use.

Accuracy of the Medication Adherence Report Scale (MARS-5) as a quantitative measure of adherence to inhalation medication in patients with COPD.

BACKGROUND: Self-report is considered most suitable to measure medication adherence in routine clinical practice. However, accuracy of self-report as a quantitative measure of adherence is not well documented. OBJECTIVE: To assess the accuracy of a self-report measure of adherence (Medication Adherence Report Scale [MARS-5]) for identifying nonadherent users of inhalation medication among patients with chronic obstructive pulmonary disease (COPD), compared with medication refill adherence (MRA) as reference. METHODS: We used baseline data from the Pharmaceutical Care for Patients with COPD (PHARMACOP)-trial (n = 734). Patients with incomplete MARS-5 and/or incomplete pharmacy refill records were excluded (n = 121). Internal consistency of MARS-5 (Crohnbach α) and Spearman rank correlation (ρ) with MRA were calculated. Different thresholds for nonadherence were used to calculate sensitivity, specificity, and positive predictive value (PPV), compared with dichotomized MRA (MRA ≥80% = adherent). A receiver operating characteristic (ROC) curve was plotted to determine the goodness of test. RESULTS: 613 patients were included in the analysis. The mean adherence score by MARS-5 (range = 5-25) was 23.5 (SD = 2.6); mean adherence by MRA was 83.4% (SD = 23.8%). Internal consistency of MARS-5 was high (α = 0.77). Continuous MARS-5 scores correlated poorly with continuous MRA scores (ρ = 0.10; P = 0.011). When lowering the nonadherence threshold stepwise from 25 to 20, MARS-5 did not reach sufficient sensitivity (53% to 13%), specificity (57% to 94%), and PPV (42% to 57%) to detect nonadherers compared with dichotomized MRA. ROC curve plotting resulted in an area under the curve value of 0.56 (95% CI = 0.521-0.616; P = 0.005). CONCLUSION: Self-reported adherence measured by MARS-5 is inaccurate in identifying nonadherence to inhalation medication in patients with COPD.

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.

Ramadan fasting and diabetes: an observational study among Turkish migrants in Belgium.

AIMS: To investigate (i) Ramadan participation, (ii) provision of Ramadan-related advice by healthcare providers, (iii) medication use during Ramadan fasting among Turkish migrants with diabetes in Belgium. METHODS: This pilot observational study was conducted among a convenience sample of 52 Turkish migrants with diabetes in Belgium. Two questionnaires collected information on socio-demographic characteristics, diabetes-related characteristics, current hypoglycaemic medication with dosing regimen, participation in the past Ramadan, reasons for (non-)participation, use of hypoglycaemic medication during the past Ramadan, advice from their healthcare providers about fasting during Ramadan and follow-up of this advice. RESULTS: Sixteen patients (31%) had fasted during the past Ramadan. Main reason for Ramadan participation was reinforcement of faith (12/15), while the main reason for non-participation was having diabetes (34/36). About 56% of the study population had received recommendations from their healthcare provider(s) about fasting and diabetes during Ramadan. The most commonly provided advice was not to participate in Ramadan, followed by modification of drug therapy. Only 3 patients ignored the advice of their health professionals. In addition, only 60% of those who actually fasted received recommendations about intake of diabetes medication during the Ramadan. Most fasters continued their medication dose unchanged (87% of OHA users and 80% of the insulin users). CONCLUSIONS: This pilot study found a low prevalence of Ramadan fasting among Turkish migrants with diabetes in Belgium. We also found that provision of advice by healthcare providers could be improved. Larger scale studies are warranted to confirm these findings.