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Omissions and delay in antimicrobial therapy are common in acute hospitals with an untowrds impact on patient outcomes resulting in harm and prolong stay. We carried out a Quality Improvement Project (QIP) assessing 2 interventions in PDSA cycles to improve situation. This QIP was done in 3 stages and involved about 80 patients over 7 months. We collected data regarding antibiotic omissions on 3 random separate days which gave baseline omission rate. This was 8.5% and quite higher than the national average (5.3%). The reason for the omissions was not documented on the drug kardexes on most occasions. Initial intervention included staff education, verbally and through posters. Post intervention data was collected again on 3 separate days. This showed improvement and the omission rate fell from 8.5% to 5.6%. The percentage of omissions with no code written reduced from 56.25% to 18.18%. The second intervention included participation in EPMA (Electronic prescribing and medicines administration) pilot on the ward. Post EPMA, the omission rate reduced to 4.59%. All omissions had now a code written. The phenomenon of Antibiotic Omissions is an open challenge and its consequences are serious. We can conclude from our study that educational measures though effective are likely to be short-lived.Therefore, it can be asserted that Electronic prescribing is appropriate solution for antibiotic omissions and it also opens up new horizons for patient safety.

Aim To examine (a) when medication incidents occur and which type is most frequent; (b) consequences for patients; (c) incident reporters’ perceptions of causes; and (d) professional categories reporting the incidents. Design A descriptive multicentre register study. Methods This study included 775 medication incident reports from 19 Swedish hospitals during 2016–2017. From the 775 reports, 128 were chosen to establish the third aim. Incidents were classified and analysed statistically. Perceived causes of incidents were analysed using content analysis. Results Incidents occurred as often in prescribing as in administering. Wrong dose was the most common error, followed by missed dose and lack of prescription. Most incidents did not harm the patients. Errors in administering reached the patients more often than errors in prescribing. The most frequently perceived causes were shortcomings in knowledge, skills and abilities, followed by workload. Most medication incidents were reported by nurses.

Gashaw Binega Mekonnen,1 Surafel Ashenafi Addis2 1Department of Clinical Pharmacy, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia; 2University of Gondar Compressive Specialized Teaching Hospital, Hospital Pharmacy, Gondar, EthiopiaCorrespondence: Gashaw Binega Mekonnen Tel +251 938735983Email gasbinega@yahoo.comPurpose: This study aimed to assess the factors that affect adherence to co-trimoxazole preventive therapy (CPT) among human immunodeficiency virus (HIV)-positive adults in an antiretroviral therapy (ART) clinic at the University of Gondar Compressive Specialized Teaching Hospital (UOGCSTH).Methods: A hospital-based cross-sectional study was conducted from March 1 to April 30, 2018, at the ART clinic at UOGCSTH. Data were collected using face-to-face interviews with pretested and standard questionnaires. Binary and multivariable logistic regression analyses were used to assess the association between different variables. P< 0.05 was used to declare the association.Results: The prevalence of adherence to CPT by self-reporting measurement was 205 (67.8%). Factors such as level of education, taking street drugs (alcohol and khat), spouse knowledge about clients on CPT, knowledge of the benefit of CPT, duration of CPT, missed dose, got proper information on how to take CPT, and counseling done on refill were found to be significantly associated with adherence to CPT.Conclusion and Recommendations: The overall adherence to CPT was fair in our study. To improve the adherence, continuous education and counseling, giving group service support for clients and having a separate counseling room are some of the possible solutions.Keywords: factors, adherence, co-trimoxazole preventive therapy, HIV/AIDS, Ethiopia, University of Gondar

To evaluate the relationship between medication adherence and visual field progression in participants randomized to the medication arm of the Collaborative Initial Glaucoma Treatment Study (CIGTS).The CIGTS was a randomized, multicenter clinical trial comparing initial treatment with topical medications to trabeculectomy for 607 participants with newly diagnosed glaucoma.Three hundred seven participants randomized to the medication arm of the CIGTS.Participants were followed up at 6-month intervals for up to 10 years. Self-reported medication adherence and visual fields were measured. Medication adherence was assessed by telephone from responses to the question, "Did you happen to miss any dose of your medication yesterday?" The impact of medication adherence on mean deviation (MD) over time was assessed with a linear mixed regression model adjusting for the effects of baseline MD and age, cataract extraction, interactions, and time (through year 8, excluding time after crossover to surgery). Medication adherence was modeled as a cumulative sum of the number of prior visits where a missed dose of medication was reported.Mean deviation over time.Three hundred seven subjects (306 with adherence data) were randomized to treatment with topical medications and followed up for an average of 7.3 years (standard deviation, 2.3 years). One hundred forty-two subjects (46%) reported never missing a dose of medication over all available follow-up, 112 patients (37%) reported missing medication at up to one third of visits, 31 patients (10%) reported missing medication at one third to two thirds of visits, and 21 patients (7%) reported missing medication at more than two thirds of visits. Worse medication adherence was associated with loss of MD over time (P = 0.005). For subjects who reported never missing a dose of medication, the average predicted MD loss over 8 years was 0.62 dB, consistent with age-related loss (95% confidence interval [CI], 0.17-1.06; P = 0.007); subjects who reported missing medication doses at one third of visits had a loss of 1.42 dB (95% CI, 0.86-1.98; P0.0001); and subjects who reported missing medication doses at two thirds of visits showed a loss of 2.23 dB (95% CI, 1.19-3.26; P0.0001).This longitudinal assessment demonstrated a statistically and clinically significant association between medication nonadherence and glaucomatous vision loss.

PURPOSE: Adjuvant ovarian function suppression (OFS) in premenopausal hormone receptor (HR) positive breast cancer (BC) improves survival. Adherence to adjuvant gonadotropin-releasing hormone analogs (GnRHa) remains a challenge and is associated with toxicities and inconvenient parenteral administration. The goal of this study was to describe real-world adherence patterns and patient preferences surrounding adjuvant GnRHa. METHODS: We analyzed the medical records of premenopausal women with non-metastatic HR positive BC from January 2000 to December 2017; participants received adjuvant monthly goserelin or leuprolide at The Ohio State University. Data collected included demographics, clinicopathologic characteristics, and OFS adherence/side effects. We defined non-adherence as discontinuation of GnRHa within 3 years for a reason other than switching to an alternate OFS, delay > 7 days from a dose, or a missed dose. Chi-square tests assessed associations between clinical characteristics and outcomes. RESULTS: A total of 325 patients met eligibility. Of these, 119 (37%) patients were non-adherent to GnRHa; 137 (42%) underwent elective bilateral salpingo-oophorectomy after initial GnRHa. Those opting for surgery reported significantly more hot flashes (74% vs 48%, p < 0.001), arthralgias (46% vs 30%, p = 0.003), and vaginal dryness (37% vs 21%, p = 0.001) compared with patients remaining on GnRHa. CONCLUSION: Non-adherence to adjuvant GnRHa occurred in over a third of patients and almost half the patients initiating GnRHa underwent subsequent surgical ablation. These high frequencies highlight real-world patterns of OFS. Additionally, treatment toxicities may impact personal preference of OFS modality. Personalized practices to target predictors of adjuvant GnRHa non-adherence are critical to optimize symptoms, adherence, and survivorship.

Background: Successful diabetes treatment requires commitment and understanding of disease management by the patients. Objective: This trial aimed to evaluate the programme effectiveness of home medication review by community pharmacists (HMR-CP) in optimising diabetes care and reducing medication wastage. Methods: A randomised controlled trial was conducted on 166 patients with Type 2 Diabetes Mellitus (T2DM) who were randomly assigned to the intervention or control groups. The intervention group received HMR-CP at 0-month, 3-month, and 6-month. The primary outcome was haemoglobin A1c (HbA1c) while clinical outcomes, anthropometric data, and humanistic outcomes were the secondary outcomes. For the intervention group, drug-related problems (DRP) were classified according to the Pharmaceutical Care Network Europe Foundation (PCNE). Medication adherence was determined based on the Pill Counting Adherence Ratio (PCAR). The cost of medication wastage was calculated based on the total missed dose by the T2DM patients multiplied by the cost of medication. General linear model and generalised estimating equations were used to compare data across the different time-points within and between the groups, respectively. Results: No significant difference was observed in the demographic and anthropometric data at baseline between the two groups except for fasting blood glucose (FBG). There was a significant reduction in the HbA1c (-0.91%) and FBG (-1.62mmol/L) over the study period (p

Objective: The objectives of this study were to investigate the frequency and reasons for missing doses and impact of a pharmacist-led intervention to reduce the missed doses in intensive care units. Methods: This study was completed in two phases. In the first phase, a retrospective quality assurance audit was conducted to quantify the problem of missed doses from the pharmacist/nurse communication slip record. The frequency and potential reasons for missing dose occurrences were identified and listed, and respective solutions were finalized by a joint health-care team. In the second phase of the study, post-intervention analysis was done for a period of 1 month to check the impact of intervention. The data were recorded from pharmacy/nursing communication forms for medication, dosage form, route of administration (ROA), frequency of missed doses, and underlying reasons for missing doses. Findings: There was a substantial reduction in the number of incidences of missed doses in post-intervention phase. The number of events decreased from 190 (pre-intervention; 2 months) to 11 (post-intervention; 1 month), 389 to 87, and 133 to 12 for automatic stop order, unknown reason, and late mix medication, respectively. No missed dose event was recorded secondary to order overseen and inactive patient status in post-intervention phase. Moreover, identified reasons, ROA, frequency, and the system status were the significant predictors of missing doses. Conclusion: The findings of this study emphasized the need to introduce better documentation procedures and continuous surveillance system to decrease the number of missing doses and further improve already established drug distribution service.

Smart inhalers, connected to smartphones, can provide real-life objective information about the patterns of a patient's adherence and their inhaler technique during routine use. The e-modules contain the battery and measuring sensors. Many of these are add-on modules attached externally whilst others are integrated inside the inhaler. Smart inhalers that identify a dose has either been actuated or prepared do not confirm the dose was inhaled but they can send missed dose reminders and clinical studies have highlighted their potential to improve adherence and outcomes. The e-modules that measure an inhalation profile confirm a dose has been inhaled together with providing useful information about the inhaler technique. Studies confirm that the sensors are accurate and confirm their usefulness to provide information about real-life inhaler use. Add-on e-modules are generic whereas integrated smart inhalers can be approved containing active agents and, therefore, prescribed and instructed under healthcare guidance. Real-life studies need to be carried out to demonstrate their potential to improve disease control and prevent exacerbations to justifying their increased cost.

Objective This follow-up survey report describes medication adherence and patient preferences, beliefs, and expectations of maintenance hemodialysis treatment in Japan. Methods This patient-reported questionnaire-based survey was conducted in six regions in Japan from September 2016 to November 2016. Patients The questionnaire was provided to 700 patients (50-79 years old) on maintenance hemodialysis for >3 years who were members of the Japan Association of Kidney Disease Patients. Patients were randomly selected by a stratified sampling method based on patient distribution observed from the Japanese Society for Dialysis Therapy Renal Data Registry. Results A total of 524 (74.9%) complete patient questionnaires were evaluated; the mean (SD) age was 66.6 (7.2) years (men, 63.4%) with a dialysis vintage of 16.9 (9.1) years. Adherence was high for all types of medications: between 76.7% for phosphate binders and 95.7% for antidiabetic medications. The most common reason for a missed dose was forgetting to take medication [52.5% (117/223)]. Patient preference for oral medication was as low as 0.9% (1/110), 9% (31/345), and 2.9% (2/69) for patients who felt mental burden, felt no mental burden, and neither, respectively, with their current treatment regimen. In addition, 37.8% (198/524) of patients responded that the elimination of 1 medication (1 tablet) would reduce their mental burden. Conclusion The results of this survey show that overall medication adherence is high in Japanese patients on maintenance hemodialysis. While many patients perceive an absence of mental burden, they still prefer to avoid oral medication when possible.

Treatment adherence has been described as the process whereby patients take medications, follow diet, and effect other lifestyle changes that relate to agreed recommendations from healthcare providers. The determinants of such treatment adherence include patient, the health condition, therapy type, socioeconomic conditions, and the healthcare system. The study examined adherence in malaria patients treated with dihydroartemisinin-piperaquine in routine clinical care in northern Ghana. The study was conducted in Navrongo Health Research Centre in the Kassena-Nankana district of northern Ghana. Patients confirmed with uncomplicated malaria were prescribed dihydroartemisinin-piperaquine in blister packs to be taken daily for three days. Follow-up visits were made on days 3 and 28 after diagnosis to collect data on adherence, drug safety and therapeutic effectiveness. During follow-up visits, in-depth interviews were conducted and the blister packs directly observed for the number of tablets remaining. The in-depth interviews documented day-by-day account of doses taken, number of tablets taken during each dose, time of each dose, reasons for any leftover or missed dose, and whether or not there was vomiting. Treatment adherence was classified as definitely nonadherent, incomplete adherence, and completely adherent. A total of 405 patients were screened; 299 were positive by rapid diagnostic testing and 216 by microscopy. The average age was 12 years and females represented 54.0%. All participants completed day 3 follow-up but 12.7% had leftover pills. Treatment adherence was 50.9% (95% CI 44.1, 57.8), 36.1% (95% CI 29.7, 42.9), and 13.0% (95% CI 8.8, 18.2) for completely adherent, incomplete adherence, and definitely nonadherent, respectively. All completely adherent patients were free of parasitemia on day 28 of follow-up. A total of 49 adverse events related to malaria symptoms were documented. Effort to improve adherence should be individualized as it is dependent on a number of factors such as the patients’ temperament, the disease, support at home, and complexity of treatment.

S-1 plus oxaliplatin (SOX) is an established treatment for advanced gastric cancer. S-1 adherence is the key to successful SOX treatment. This study focused on S-1 adherence by evaluating real-world adherence to S-1 and investigating factors related to decreased S-1 adherence. This study included cases treated between August 1, 2014 and October 12, 2016 at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research. The S-1 adherence rate per cycle was defined as the number of times a patient took S-1/28. In this study, adherence to S-1 was assessed through pill counts and by asking the patient about the reason for non-adherence at a pharmaceutical outpatient clinic. Univariate and multivariate analyses were performed to investigate factors influencing lower adherence. This analysis included 116 patients evaluated for adherence to S-1 on SOX treatment. The median rate of adherence to S-1 was 92.8% in the first cycle and 90.5% in the seventh cycle. The median relative dose intensity of S-1 was 84.6%. In terms of reasons for nonadherence, patients most commonly cited nausea/vomiting (43.7%), diarrhea (20.8%), missed dose (11.8%), and fever (8.1%). Logistic regression analysis was performed using the most appropriate regression equation, and a significant association was detected with 1 factor, number of combined drugs ≥5 (odds ratio (OR) = 2.50; 95% confidence interval (CI), 1.04-6.03, p = 0.04). Eliminating unnecessary concomitant medications helps maintain proper adherence to S-1 in SOX treatment.

Background South Africa has achieved drug-susceptible TB (DS-TB) treatment success of only 77% among people with new and previously treated TB. Alternative approaches are required to improve medication adherence and treatment completion to limit transmission, TB relapse and the development of resistance. This study aims to implement and evaluate the use of adherence medication monitors (Wisepill evriMED 1000) with a differentiated response to patient care, among DS-TB patients in three provinces of South Africa. Methods In total, 18 public health clinics across three provinces were selected. Clinics were randomised to intervention or standard of care clinics. In each clinic, approximately 145 DS-TB patients are being enrolled to reach a total of 2610. All patients have their daily adherence monitored using medication monitors. In the intervention arm, patients are receiving medication monitor reminders and differentiated care in response to adherence data. This weekly review of daily real-time monitoring will be undertaken from a central database. The differentiated care model includes automated SMS reminders with a missed dose, research staff-initiated phone call to the patient with a second or third missed dose, a home visit if four or more doses are missed, and motivational counselling if four or more doses are missed repeatedly. Fidelity of the intervention will be measured through process evaluation. Patients in control clinics will receive medication monitors for adherence tracking, standard of care TB education, and normal clinic follow-up procedures. The primary outcome is the proportion of patients by arm with >80% adherence, as measured by the medication monitor. The feasibility and acceptability of the intervention will be assessed by in-depth interviews with patients, stakeholders, and study staff. A cost effectiveness analysis of the intervention and standard of care clinics will be conducted. Significance This trial will provide evidence for the use of an intervention, including medication monitors and differentiated care package, to improve adherence to TB treatment. Improved adherence should also improve TB treatment completion rates, thus reducing loss to follow-up rates, and TB relapse among people with TB. The intervention is intended to ultimately improve overall TB control and reduce TB transmission in South Africa. Trial registration Pan African Trial Registry PACTR201902681157721. Registered on 11 February 2019.

Background and importance Multiple sclerosis (MS) is a chronic progressive disease, one of the main causes of invalidity among young adults. Adherence may be difficult because treatment benefits are not immediately apparent, and most disease modifying therapies (DMTs) have tolerability and safety issues. Aim and objectives In our hospital, where almost 800 MS patients are treated monthly, no study has assessed adherence, so the purpose of this study was to evaluate adherence and identify patient reported barriers regarding adherence. Material and methods An observational retrospective study was conducted (January 2017 to January 2019). We evaluated adherence using missed dose ratio (MDR), and identified and quantified barriers to adherence using the MS treatment adherence questionnaire (MSTAQ). This tool has 30 items in three subscales: DMT barriers to adherence, DMT side effects (SE) and DMT coping strategies. We also collected demographic (age, sex) and treatment information (current DMT, DMT history, reason for switch therapy and exposure to treatment). Results 60 patients (44 women), average age 40.47 years had a mean treatment exposure of 6.38 years. Adherence was high because only 11 had missed one or more doses in the last month (MDR >0). When asked about missed dose in general, 22 patients reported barriers to taking medication. DMT scores are described in table 1. Conclusion and relevance Overall, adherence was high even though there were some barriers to adherence. SE and long duration of treatment could affect adherence, which is why it is important to detect and overcome barriers using such questionaries, to identify in time non-adherent patients and counsel them appropriately on how to use more coping strategies. References and/or acknowledgements Conflict of interest No conflict of interest

Medication adherence is a major problem for patients with chronic diseases that require long term pharmacotherapy. Many unanswered questions surround adherence, including how adherence rates translate into treatment efficacy and how missed doses of medication should be handled. To address these questions, we formulate and analyze a mathematical model of the drug concentration in a patient with imperfect adherence. We find exact formulas for drug concentration statistics, including the mean, the coefficient of variation, and the deviation from perfect adherence. We determine how adherence rates translate into drug concentrations, and how this depends on the drug half-life, the dosing interval, and how missed doses are handled. While clinical recommendations require extensive validation and should depend on drug and patient specifics, as a general principle our theory suggests that nonadherence is best mitigated by taking double doses following missed doses if the drug has a long half-life. This conclusion contradicts some existing recommendations that cite long drug half-lives as the reason to avoid a double dose after a missed dose. Furthermore, we show that a patient who takes double doses after missed doses can have at most only slightly more drug in their body than a perfectly adherent patient if the drug half-life is long. We also investigate other ways of handling missed doses, including taking an extra fractional dose following a missed dose. We discuss our results in the context of hypothyroid patients taking levothyroxine., Comment: 38 pages, 7 figures

Background Women with HIV have higher risk of depressive symptoms in the perinatal period. Evidence on how perinatal depressive symptoms affect viral suppression (VS) and adherence to antiretroviral therapy (ART) remains limited. Methods Perinatal depressive symptoms were assessed using 6 items from the AIDS Clinical Trials Group (ACTG) Quality of Life questionnaire. VS (viral load, In this longitudinal analysis of pregnant and postpartum women with HIV, we found that perinatal depressive symptoms were associated with lower adherence and lower viral suppression.

Background: Rivaroxaban is an oral anticoagulant used widely for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). During long-term anticoagulant therapy, delayed or missed doses are common. However, a lack of practical instructions on remedial methods has created a barrier to maximise the benefit of the medications. This study aimed to explore appropriate remedial dosing regimens for non-adherent rivaroxaban-treated patients. Methods: Monte Carlo simulation based on a previously established rivaroxaban population pharmacokinetic/pharmacodynamic (PK/PD) model for patients with NVAF was employed to design remedial dosing regimens. The proposed regimens were compared with remedial strategies in the European Heart Rhythm Association (EHRA) guide by assessing deviation time in terms of drug concentration, factor Xa activity, and prothrombin time under various scenarios of non-adherence. Results: The proposed remedial dosing regimens were dependent on delay duration. The missed dose should be taken immediately when the delay does not exceed 6 h; a half dose is advisable when the delay is between 6-20 h. A missed dose should be skipped if less than 4 h remains before the next dose. Age or renal function does not significantly influence remedial dosing regimens. The proposed regimens resulted in shorter deviation time than that of the EHRA guide in most non-adherence scenarios. Conclusion: EHRA guide may not provide optimal remedial strategies for rivaroxaban-treated non-adherent patients based on simulation. PK/PD and simulation provide valid evidence on the remedial dosing regimen of rivaroxaban for patients with NVAF, which could help to minimise the risk of bleeding and thromboembolism.

BackgroundRivaroxaban is a non-vitamin K oral anticoagulant used widely for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). During long-term anticoagulant therapy, delayed or missed doses are common. However, a lack of practical instructions on remedial methods has created a barrier for patients to maximise the benefit of their medications. This study aimed to explore appropriate remedial dosing regimens for rivaroxaban-treated patients with NVAF.MethodsMonte Carlo simulation based on a previously established rivaroxaban population pharmacokinetic/pharmacodynamic model for patients with NVAF was employed to design remedial dosing regimens. Both the European Heart Rhythm Association (EHRA) recommendations and the model were used to establish remedial dosing regimens, which were assessed considering the on-therapy range of drug concentration, factor Xa activity, and prothrombin time under various scenarios of non-adherence.ResultsRecommendations of EHRA guide may not be optimal. Our findings suggested that a missed dose is taken immediately when the delay is less than or equal to 6 h; a half dose is advisable when the delay exceeds 6 h but is less than 4 h before the next dose. It is recommended to skip a dose when there are less than 4 h before the next dose. Age or renal function do not significantly influence the remedial dosing regimen.ConclusionA remedial dosing regimen based on model-based Monte Carlo simulation was systematically developed for rivaroxaban-treated patients with NVAF with poor adherence to quickly restore drug concentrations to the on-therapy range and to reduce the risk of bleeding and thromboembolism.What is known on this topic?Remedial recommendations for delayed or missed rivaroxaban dose have been mentioned in package inserts and guide, but lack of solid supporting evidence.Monte Carlo simulation based on population analysis have been proved as an appropriate method to explore the remedial dosing strategy.What does this paper add?Remedial recommendations for delayed or missed rivaroxaban in different population are established based on Monte Carlo simulation.The choice of optimal remedial strategy is related to delay duration.This paper provides a more time-specific and individualized recommendations compared with previous recommendations.

Nusinersen is an antisense oligonucleotide approved for the treatment of spinal muscular atrophy. The drug is given intrathecally at 12 mg, beginning with 3 loading doses at 2-week intervals, a fourth loading dose 30 days thereafter, and maintenance doses at 4-month intervals. This population pharmacokinetic model was developed to clarify how to maintain targeted nusinersen exposure after an unforeseen one-time delay or missed dose. Simulations demonstrated that the impact of a one-time delay in dosing or a missed dose on median cerebrospinal fluid exposures depended on duration of interruption and the regimen phase in which it occurred. Delays in loading doses delayed reaching the peak trough concentration by approximately the duration of the interruption. Resumption of the regimen as soon as possible resulted in achieving steady state trough concentration upon completion of the loading phase. A short delay (30–90 days) during the maintenance phase led to prolonged lower median cerebrospinal fluid concentration if all subsequent doses were shifted by the same 4-month interval. However, administration of the delayed dose, followed by the subsequent dose as originally scheduled, rapidly restored trough concentration. If a dose must be delayed, patients should return to the original dosing schedule as soon as possible.

Background Prior studies have explored the use of regular reminders to improve adherence among kidney transplant recipients (KTRs), but none have included real-time alarms about drug dosage, frequency, and interval. In the present study, we aimed to evaluate the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system for increasing medication adherence among Korean KTRs. Methods In this prospective, multicenter, randomized controlled study, enrolled KTRs were randomized to either the ICT-based centralized monitoring group or control group. The ICT-based centralized monitoring system alerted both patients and medical staff with texts and pill box alarms if there was a missed dose or a dosage/time error. We compared the two groups in terms of medication adherence and transplant outcomes over 6 months, and evaluated patient satisfaction with the ICT-based monitoring system. Results Among 114 enrolled KTRs, 57 were assigned to the ICT-based centralized monitoring group and 57 to the control group. The two groups did not significantly differ in mean adherence at each follow-up visit. The intrapatient variability of tacrolimus and mycophenolic acid levels, renal function, and adverse transplant outcomes did not differ between the intervention and control groups, or between the intervention group with feedback generation and the intervention group without feedback generation. Patients showed high overall satisfaction with the ICT-based centralized monitoring system, which significantly improved across the study period (p = 0.012). Conclusions Due to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs. However, patients were highly satisfied with the system. Our results suggest that the ICT-based centralized monitoring system could be successfully applied in clinical trials. Trial registration ClinicalTrials.gov, NCT03136588. Registered 20 April 2017 - Retrospectively registered.

Objective: This study evaluated immunization compliance, immunization completeness, and vaccination errors frequency among Iraqi pediatric. Study design this study was restricted the analysis to types of vaccines administered before 2 years of age. A cohort study of 528 pediatrics born between 1st January 2003 and 31st Jun 2008 was selected. Immunization history of pediatric was collected retrospectively from pediatric immunization card. Immunization doses were classified to five types: Normal dose, early dose, missed dose, late dose, and extra dose. Pediatric who received all the immunization doses without any immunization dose errors was considered as complete immunization with full compliance. If the pediatric missed at least one immunization dose, this pediatric was considered partial immunization with noncompliance, and if this pediatric received at least one immunization dose error, this pediatric was considered complete immunization with noncompliance. Results: Less than half of pediatric were considered as partial immunization with noncompliance. 3696 immunization doses must receive by 528 pediatric, 25.3% of doses were normal doses, 8.3% as an early doses, 13.6% as a missed doses, 47.5% of doses were late doses, and 5.3% as an extra doses. Conclusions: Immunization errors occur frequently and leading to improper immunization compliance. This study recommended increasing effort to optimize childhood immunization. Key words: immunization, compliance, errors, pediatrics, two years.

Background Direct acting antiviral (DAA) treatments for Hepatitis C (HCV) are now widely available with sustained virologic response (SVR) rates of >90%. A major predictor of response to DAAs is adherence, yet few real-world studies evaluating adherence among marginalized people who use drugs and/or alcohol exist. This study evaluates patterns and factors associated with non-adherence among marginalized people with a history of drug use who were receiving care through a primary care, community-based HCV treatment program where opiate substitution is not offered on-site. Methods Prospective evaluation of chronic HCV patients initiating DAA treatment. Self-report medication adherence questionnaires were completed weekly. Pre/post treatment questionnaires examined socio-demographics, program engagement and substance use. Missing adherence data was counted as a missed dose. Results Of the 74 participants, who initiated treatment, 76% were male, the average age was 54 years, 69% reported income from disability benefits, 30% did not have stable housing and only 24% received opiate substitution therapy. Substance use was common in the month prior to treatment initiation with, 11% reported injection drug use, 30% reported non-injection drug use and 18% moderate to heavy alcohol use. The majority (85%) were treatment naive, with 76% receiving sofosbuvir/ledipasvir (8–24 weeks) and 22% Sofosbuvir/Ribarvin (12–24 weeks). The intention to treat proportion with SVR12 was 87% (60/69). In a modified ITT analysis (excluding those with undetectable RNA at end of treatment), 91% (60/66) achieved SVR12. Overall, 89% of treatment weeks had no missed doses. 41% of participants had at least one missed dose. In multivariate analysis the only factor independently associated with weeks with missed doses was moderate to heavy alcohol use (p=0.05). Conclusion This study demonstrates that strong adherence and SVR with DAAs is achievable, with appropriate supports, even in the context of substance use, and complex health/social issues.

BackgroundAlcohol use is a risk factor for nonadherence to antiretroviral therapy (ART) among people living with HIV/AIDS (PLWHA); however, differences in ART adherence across levels of alcohol use are unclear. This study examined whether "at-risk" alcohol use, defined by National Institute of Alcohol Abuse and Alcoholism guidelines, was associated with ART nonadherence among PLWHA.MethodsParticipants were 535 HIV-infected adults enrolled in studies at the HIV Neurobehavioral Research Program. ART nonadherence was identified by either self-reported missed dose or plasma viral load detectability (≥50copies/ml). Potential covariates for multivariable logistic regression included demographics, depression, and substance use disorders.ResultsUsing a stepwise model selection procedure, we found that at-risk alcohol use (OR=0.64; p=0.032) and low education (OR=1.09 per 1year increase in education; p=0.009) significantly predict lower ART adherence.ConclusionsA greater focus on the treatment of at-risk alcohol use may improve ART adherence among HIV-infected persons.

Background and Objectives Aripiprazole lauroxil (AL), a long-acting injectable antipsychotic for the treatment of schizophrenia, requires 21 days of oral aripiprazole supplementation upon initiation (21-day initiation regimen). An alternative 1-day initiation regimen utilizing a nano-crystalline milled dispersion of AL (ALNCD) plus a single 30 mg oral aripiprazole dose achieved aripiprazole concentrations associated with therapeutic doses of aripiprazole in the same time frame as the 21-day initiation regimen when starting AL (441 or 882 mg). A population pharmacokinetic (PopPK) model was developed to describe aripiprazole pharmacokinetics following administration of ALNCD, AL and oral aripiprazole, and evaluate dosing scenarios likely to be encountered in clinical practice. Methods In total, 12,768 plasma aripiprazole concentrations from 343 patients (from 4 clinical studies) were included in the PopPK analysis and used to construct the model. Results Concomitant administration of the 1-day initiation regimen with all approved AL dosing regimens (441, 662, or 882 mg monthly, 882 mg every 6 weeks, or 1064 mg every 2 months) is predicted to achieve aripiprazole concentrations associated with therapeutic doses of AL using the 21-day initiation regimen within 4 days, maintaining these concentrations until the next AL dose. Administration of the first AL injection 10 days after the 1-day initiation regimen resulted in median aripiprazole concentrations just before the second dose of AL ≥ 77% of that when coadministered on the same day. Coadministration of AL with a single ALNCD injection was predicted to be effective in rapidly re-establishing concentrations associated with therapeutic doses of AL following dose delay. Conclusions Model-based simulations demonstrate that the 1-day initiation regimen is suitable for starting treatment with all AL doses, allowing a window of ≤ 10 days between initiation and AL administration. ALNCD may also be used to re-establish concentrations associated with therapeutic doses of AL in conjunction with a delayed AL dose. Electronic supplementary material The online version of this article (10.1007/s13318-018-0488-4) contains supplementary material, which is available to authorized users.

Background: Hormonal contraceptive pills have evolved as a common form of contraception worldwide. Pharmacists play a vital role in providing safe and effective access to these medicines. In many developing countries such as the United Arab Emirates (UAE), these medicines are available to the general public without the presentation of a prescription which requires the pharmacist to shoulder responsibility by assessing and educating patients to assure their appropriate use. Objectives: To evaluate community pharmacists’ current practice of dispensing and counseling on hormonal contraceptives Methods: Simulated patient methodology was used in this study. A single simulated patient visited community pharmacies requesting an oral contraceptive as per a preplanned scenario. Information from the visits were recorded on a data collection form including: pharmacist assessing patient eligibility to take hormonal contraceptives, selecting the appropriate oral contraceptive, providing complete counseling on how to use the pill, adherence, missed dose handlings and side effects of the medication. The Pharmacist was prompted by the simulated patient to provide the information if they did not provide spontaneous counseling. The quality of pharmacists’ counseling was rated and consequently coded as complete, incomplete or poor. Results: A total of 201 community pharmacies were visited. More than 92% of the pharmacists did not ask the simulated patient any question to assess their eligibility to use contraceptives. Twenty three pharmacists (11.4%) selected the proper product. One hundred seventeen (58.2%) of the pharmacists provided spontaneous counseling on how to use the pill, 17 of them had their counsel rated as complete, but none of the pharmacists provided spontaneous counseling regarding adherence or side effects of the medications. On prompting, 10 pharmacists (12%) provided complete counseling regarding how to use oral contraceptives, 14 pharmacists (7.0%) provided complete counseling on adherence and missing dose handling and five pharmacists (2.5%) provided complete counseling about expected side effects. Conclusions: Pharmacists’ practice regarding hormonal contraceptive dispensing and counseling was suboptimal in this study. Areas needing intervention were related to pharmacist assessment of eligibility for oral contraceptive use, choice of optimal oral contraceptive for patient-specific co-morbidities and provision of adequate counseling regarding proper use, adherence and missed dose handlings.

Introduction: Denosumab, an anti-resorptive medication approved for treatment of osteoporosis, increases bone mineral density and reduces fracture risk. Discontinuation of treatment is associated with bone turnover rebound and reduced bone mineral density. We report a case of a woman without prior history of fragility fractures who presented with multiple spontaneous vertebral fractures two months after a missed dose of Denosumab, which is earlier than current available literature. Clinical Case: A 54-year old female was diagnosed with osteoporosis at the age of 50 with a DXA revealing T-scores of LS -2.9 SD, LFN -0.6 SD, TH -0.5 SD. Ten-year probability of MOF evaluated by FRAX was 6%. Work-up for secondary causes of osteoporosis during the time was unremarkable. She was started on Denosumab 60 mg every 6 months from July 2016 to July 2019, receiving a total of 5 injections. She had missed her dose of Denosumab in January 2020. Two months after the missed dose, she presented to a local hospital with complaints of chest and epigastric pain. A CTA was performed as part of evaluation which was unremarkable aside from an incidental finding of thoracic compression fractures. An MRI of the spine was subsequently done which showed a recent-appearing moderate to severe wedge compression fracture and edema of the T7 and T6 vertebral bodies, and of the upper two-thirds of the T4. A biological and radiological work-up to exclude other causes of osteoporosis to explain the patient’s vertebral fractures was performed. The patient did not have renal failure, vitamin D deficiency, hyperthyroidism, primary hyperparathyroidism, Cushing’s disease, hypophosphatemia, multiple myeloma, Celiac disease, diabetes mellitus, or prior glucocorticoid treatment. During the time of treatment and discontinuation of Denosumab, the patient was on adequate supplementation of calcium and Vitamin D. The patient’s vertebral fractures were treated with kyphoplasty. To treat osteoporosis and prevent further risk of fractures, she was started on an anabolic agent Abaloparatide. Conclusion: This case demonstrates rebound vertebral fractures occurring very shortly after discontinuing Denosumab in a relatively young woman with low probability of major osteoporotic fracture. Further investigation must be done to determine pathophysiological process involved of vertebral fractures and treatment regimen after sudden discontinuation of Denosumab.

Tezeta Fekadu,1 Mebrahtu Teweldemedhin,2 Eyerusalem Esrael,1 Solomon Weldegebreal Asgedom1 1School of Pharmacy, Department of Clinical Pharmacy, College of Health Sciences, Mekelle University, Mekelle, 2Unit of Biomedical Science, School of Medicine, College of Health Sciences and Referral Hospital, Aksum University, Aksum, Ethiopia Background: Intravenous medication administration errors (MAEs) may be accompanied by avoidable undesirable effects, which might result in clinical complications.Objective: The aim of the study was to determine the prevalence of MAEs and to identify the factors associated with such errors.Methods: A hospital-based cross-sectional study was conducted from March to April 2015. Data were collected by direct observation using a pretested data collection tool. Simple random sampling was used, and bivariate logistic regression model was used to identify the factors associated with MAEs. P value

Questions remain regarding optimal timeframes for asking about adherence in clinical care. We compared 4-, 7-, 14-, 30-, and 60-day timeframe missed dose items with viral load levels among 1099 patients on antiretroviral therapy in routine care. We conducted logistic and linear regression analyses examining associations between different timeframes and viral load using Bayesian model averaging (BMA). We conducted sensitivity analyses with subgroups at increased risk for suboptimal adherence (e.g. patients with depression, substance use). The 14-day timeframe had the largest mean difference in adherence levels among those with detectable and undetectable viral loads. BMA estimates suggested the 14-day timeframe was strongest overall and for most subgroups although findings differed somewhat for hazardous alcohol users and those with current depression. Adherence measured by all missed dose timeframes correlated with viral load. Adherence calculated from intermediate timeframes (e.g. 14-day) appeared best able to capture adherence behavior as measured by viral load.

Background Central aortic blood pressure (CBP) and CBP-derived parameters are independent predictors of cardiovascular risk. Angiotensin II receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors plus calcium channel blockers are the recommended first-line treatments in hypertensive diabetic patients; however, the effect in reducing CBP when a dose is skipped has not been established yet. The aim was to determine whether the fixed-dose combination of olmesartan/amlodipine (OLM/AML) provides equal efficacy and safety as the perindopril/AML (PER/AML) combination in reducing CBP, augmentation index (AIx), and pulse wave velocity (PWV) when a drug dose is missed. Methods In this noninferiority, randomized, double-blind, double-dummy parallel group, controlled design trial, 88 patients received either OLM 20-40mg/AML 5-10mg (41 patients) or PER 4-8mg/AML 5-10mg (47 patients) for 24 weeks. The main endpoint was the aortic systolic BP (SBP) after 24 weeks of treatment at 48 hours from the last administration. Results The OLM/AML combination reached the noninferiority criteria in reducing central systolic BP after 24 weeks of treatment and after the missed dose, compared to the PER/AML combination (-17 and -8mm Hg, respectively). Peripheral BP, AIx, and PWV were significantly lower in both groups after 24 weeks of treatment and 48 hours after the missed dose, observing a trend to a greater reduction in CBP-derived parameters in the OLM/AML group. Conclusions The OLM/AML combination is safe, well tolerated, and not inferior to the combination of PER/AML in lowering CBP and CBP-derived parameters in diabetic patients. OLM/AML provides longer-lasting efficacy in terms of CBP reduction compared to PER/AML.

Objective To explore the effects of four types of short message service (SMS) plus real-time adherence monitoring on antiretroviral therapy (ART) adherence: daily reminders, weekly reminders, reminders triggered after a late or missed dose (delivered to patients), and notifications triggered by sustained adherence lapses (delivered to patient-nominated social supporters). Design Pilot randomized controlled trial. Methods Sixty-three individuals initiating ART received a real-time adherence monitor and were randomized (1 : 1 : 1): (1) Scheduled SMS reminders (daily for 1 month, weekly for 2 months), then SMS reminders triggered by a late or missed dose (no monitoring signal within 2 h of expected dosing); SMS notifications to social supporters for sustained adherence lapses (no monitoring signal for >48 h) added after 3 months. (2) Triggered SMS reminders starting at enrolment; SMS notifications to social supporters added after 3 months. (3) CONTROL: No SMS. HIV RNA was determined at 9 months. Percentage adherence and adherence lapses were compared by linear generalized estimating equations and Poisson regression, respectively. Results Median age was 31 years, 65% were women, and median enrolment CD4 cell count was 322 cells/μl 97% took once daily tenofovir/emtricitabine/efavirenz. Compared to control, adherence was 11.1% higher (P = 0.04) and more than 48-h lapses were less frequent (IRR 0.6, P = 0.02) in the scheduled SMS arm. Adherence and more than 48-h lapses were similar in the triggered SMS arm and control. No differences in HIV RNA were seen. Conclusion Scheduled SMS reminders improved ART in the context of real-time monitoring. Larger studies are needed to determine the impact of triggered reminders and role of social supporters in improving adherence.

Background:It has been demonstrated that bioavailability of oral (P.O.) MTX reaches plateau at doses ≥15 mg QW, and that subcutaneous (S.C.) form has a better efficacy. Alongside with less side-effects this might translate into improvement in quality of life (QoL) and better adherence.Objectives:An academic-induced observational longitudinal study of patients with RA and peripheral form of PsA on csDMARDs who were switched from oral (P.O.) to subcutaneous (S.C.) MTX was conducted. Previously we reported on the better efficacy of S.C. compared to P.O. MTX. The objective of this part of the study we are presenting was to evaluate the 6-month changes in quality of life (QoL), adverse events and adherence in these patients.Methods:Forty-eight consecutive patients (79.2% women) with established diagnosis of RA (77.1%) and peripheral PsA were enrolled from the outpatient clinics in six centres in Croatia. Median age was 61 (39-79) years, and the median of disease duration was 120 (3-528) months. Data were collected at baseline (T0) (on P.O. MTX), at day 90 (±10 days) (T1) and at day 180 (±10 days) (T2), during S.C. MTX treatment. Median dose of MTX remained stable during the study (15mg QW). At each visit QoL was measured using EuroQuol-5D (EQ-5D), adverse events related to MTX use were recorded, and adherence by the number of missed dose.Results:EQ-5D global health assessment showed significant improvement in quality of life of patients on S.C. MTX during the 6 month follow-up (change from T0 to T2 8.6; 95%CI 4.00, 13.3), and the same trend was observed in each of its five component. Number of patients who experienced adverse events related to MTX use has decrease after switching from P.O. to S.C.MTX – from 52.1% during the last 3 months on P.O. MTX to 33.3% during the first 3 months and 18.2% during the last 3 months of S.C. MTX use. During the follow-up adherence to MTX therapy improved, with 25% of patients who missed dose during the last 3 months on P.O. MTX use, to 6,3% and 2.3% with missed dose in the first and the last 3 months on S.C. MTX, respectively.Conclusion:In our group of patients with RA and peripheral PsA who switched from P.O. to S.C. MTX there was a consistent improvement in QoL, less adverse-events and better adherence.Disclosure of Interests:Simeon Grazio Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Fresenius Kabi, Stada, Berlin-Chemie, Dijana Perković Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Fresenius Kabi, Nadica Laktašić Žerjavić Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Fresenius Kabi, Frane Grubisic Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Marija Glasnović Speakers bureau: Abbvie, Roche, Pfizer, Ana Gudelj Gračanin Speakers bureau: Abbvie. Roche, MSD, Eli Lilly, Pfizer, Željka Kolak: None declared, Helena Kolar Mitrović: None declared, Jadranka Morovic-Vergles Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Fresenius Kabi, Porin Perić: None declared, Petra Šimac: None declared, Iva Žagar Speakers bureau: Abbvie. Roche, MSD, Eli Lilly, Pfizer, Ines Doko Speakers bureau: Abbvie. Roche, Vladimir Trkulja: None declared

HIV pre-exposure prophylaxis (PrEP) is currently being adopted by members of key populations, such as gay and bisexual men (GBM), to reduce their risk of HIV acquisition. Given that adherence to a daily PrEP regimen ensures a maximum protective effect, it is critical to understand GBM’s behavioral responses to having missed PrEP doses. We report on data from one-on-one semi-structured interviews with GBM taking PrEP (n = 97). Using thematic analysis, we identified three distinct yet sometimes overlapping behavioral responses after identifying that a dose had been missed: (1) 59% continued with their next scheduled dose; (2) 49% described ‘making up’ for a missed dose by taking medication as soon as possible, within 24 hours of its scheduled dosing time; and (3) 11% reported ‘doubling’ their next PrEP dose. Participants provided potentially contradictory narratives about their sexual behavior after a missed dose: (1) 54% described making no changes in their sexual behavior; (2) 49% described adjusting their sexual behavior; and (3) 10% said the decision to adjust their behavior would be contingent upon how many doses they missed. Many participants presented multiple behavioral responses. Participants’ beliefs often paralleled current guidelines and empirical data on PrEP effectiveness in the event of a missed dose. However, participants varied in their reports of how best to navigate behavioral HIV risk in the context of a missed dose and for specific sex acts (e.g., oral versus anal sex). For PrEP prescribers, our data provide a useful lens to understand patients’ lived experiences with this new and dynamic HIV prevention tool. With the rise of infrequent or ‘on-demand’ PrEP dosing strategies, further research is needed to inform evidence-based interventions.

Background: In the counseling process, a multi-cultural competence of dispenser is among the key factors affecting his/her successful communication with patients for achieving optimal use of medications. For patients to use dispensed drugs appropriately, it is a must for them to understand the medication related information provided by the dispenser. Hence, the objective of this study was to identify parameters that likely affect ambulatory patients' knowledge of medication(s) provided at the exit of outpatient pharmacy of Federal Harar Police Hospital, Eastern Ethiopia.Methods: Cross-sectional study design was employed to conduct this study. An interview of patients was made at the exit of hospital pharmacy using a semi-structured questionnaire. The interview tool primarily assessed the knowledge of the patients for a maximum of three medications provided. Statistical Package for Social Sciences (SPSS), Version 20.0, was employed for analysis of the data. Chi-squared test was done to retain parameters with potential to have association; and the retained parameters were adjusted by performing bivariate and multivariate logistic regression analyses.Results: The result showed that only 37.2, 33.4 and 28.7% of the patients were able to recall the name of the drug(s), common side effects, and actions to be taken for missed doses, respectively. The likelihood of patients' knowledge for dispensed medications was high among patients aged 19–39 years (adjusted odds ratio [AOR]: 5.0; 95% CI: 1.04–24.2) and who thought their communication with dispenser had been polite (AOR: 4.62; 95% CI: 1.48–14.4). However, the knowledge status was found low among patients who were Afan Oromo speakers (AOR: 0.58; 95% CI: 0.35–0.95) and who came from rural residence (AOR: 0.48; 95% CI: 0.25–0.90).Conclusion: A high proportion of patients were unable to recall the drug (s) name, associated common toxicities, and actions to be taken in case of missed dose. In addition, patients who were at early adulthood and who were positive for the politeness of dispenser had better exit-knowledge of their medication. Therefore, for the patients' clear understanding of medications provided, it is mandatory to optimize patient–dispenser communication possibly by adapting multi-cultural communication skills and by providing focused training for dispensers to address factors that likely affect patient-dispenser interactions.

Background Once-daily extended-release (XR) antiepileptic drugs (AEDs) offer potential adherence and tolerability advantages over their BID immediate-release (IR) counterparts. However, patients with epilepsy will inevitably be at least occasionally nonadherent with a prescribed dosing regimen, regardless of formulation. Although perturbations in plasma concentrations due to dosing irregularities may have clinical consequences for AEDs with concentration–response relationships, clinical studies that deliberately expose patients to specific dosing irregularities in order to assess the effect on plasma concentrations and determine appropriate corrective actions would be unethical. Methods Computer simulation was used to assess the impact of irregular dosing on topiramate (TPM) concentrations in noninduced (monotherapy/neutral cotherapy) and induced (adjunctive therapy with enzyme-inducing AEDs) states using a population pharmacokinetic (PK) model developed to predict steady-state plasma concentration–time profiles produced by once-daily Trokendi XR® (extended-release topiramate capsules, Supernus Pharmaceuticals) and BID TPM-IR. Results Computer simulations predicted that, relative to adherent dosing, delaying a dose 4 to 24 h in noninduced patients would decrease trough (C min ) levels 9% to 31% in the case of TPM-IR and 6% to 27% with Trokendi XR; a single omitted dose would reduce C min by 21% (TPM-IR) and 27% (Trokendi XR). After dose recovery to correct for a delayed or omitted dose, simulated peak concentration (C max ) was higher than steady-state C max , regardless of formulation, although the magnitude of “overshoot” was consistently lower with Trokendi XR vs. TPM-IR. Doubling of a dose would increase C max by 26% and 28%, respectively. Predicted changes for nonadherent vs. adherent dosing were greater in the induced vs. noninduced state but were generally comparable for the two TPM formulations. Because the long half-life of TPM has been cited as a justification for QD dosing of TPM-IR, simulations also compared steady-state PK profiles of once-daily Trokendi XR and QD TPM-IR. Predicted TPM plasma concentration–time profiles were markedly different, as demonstrated by peak–trough fluctuation (QD TPM-IR, 64%; QD Trokendi XR, 18%) and 34% lower C min with QD TPM-IR. Conclusions Based on these simulations, dosing irregularities with once-daily Trokendi XR should pose no greater risk than with BID TPM-IR. In the event of a delayed or omitted Trokendi XR dose, TPM concentrations can be restored in noninduced and induced states by administering the delayed/omitted dose at any time during the next dosing interval or by adding the missed dose to the next scheduled dose.

OBJECTIVE To determine the effect of nonadherence to antiretroviral therapy (ART) on virologic failure and mortality in naive individuals starting ART. DESIGN Prospective observational cohort study. METHODS Eligible individuals enrolled in the Swiss HIV Cohort Study, started ART between 2003 and 2012, and provided adherence data on at least one biannual clinical visit. Adherence was defined as missed doses (none, one, two, or more than two) and percentage adherence (>95, 90-95, and 500 copies/ml) and mortality. RESULTS Of 3150 individuals followed for a median 4.7 years, 480 (15.2%) experienced viral failure and 104 (3.3%) died, 1155 (36.6%) reported missing one dose, 414 (13.1%) two doses and, 333 (10.6%) more than two doses of ART. The risk of viral failure increased with each missed dose (one dose: hazard ratio [HR] 1.15, 95% confidence interval 0.79-1.67; two doses: 2.15, 1.31-3.53; more than two doses: 5.21, 2.96-9.18). The risk of death increased with more than two missed doses (HR 4.87, 2.21-10.73). Missing one to two doses of ART increased the risk of viral failure in those starting once-daily (HR 1.67, 1.11-2.50) compared with those starting twice-daily regimens (HR 0.99, 0.64-1.54, interaction P = 0.09). Consistent results were found for percentage adherence. CONCLUSION Self-report of two or more missed doses of ART is associated with an increased risk of both viral failure and death. A simple adherence question helps identify patients at risk for negative clinical outcomes and offers opportunities for intervention.

This study focuses on reduction of medication errors by application of lean Six Sigma approach in Medication administration by nurses in a corporate chain hospital of India. It helped the hospital to understand the impact of dedicated Medication Nurse on the Medication administration error rate. the purpose of the research is to redesign the policy on medication administration i.e. introducing the concept of Medication nurse for the management of medication administration errors and depletion of interruptions faced in medication delivery in order to improve the efficiency, effectiveness and safety of care delivered to patients. as per the study done on medication administration, the medication error rate found was very high in a ward (mostly contributing were 31% of missed dose, 21% of wrong dose and 17% at wrong time) due to many interruptions and challenges faced by nurses during drug administration which in turn affecting the safety of care delivered to the patients and total medication delivery time taken by a general nurse was 9 minutes. By using the lean Six sigma methodology, it was observed rate of medication errors was decreased, the complexity of the work flow became simple and systematic, the work load on all nurses was decreased, and the average time for drug administering was decreased by 55% i.e. to 4 minutes in three months. thus, it helped in reducing mess up and complexity in the ward with better utilization of other nurses to perform other activities which are needed to be done at the same time and delivering best quality of patient care with high efficiency.

Few studies have examined antiretroviral therapy adherence in Latin American children. Standardized behavioral measures were applied to a large cohort of human immunodeficiency virus-infected children in Brazil, Mexico, and Peru to assess adherence to prescribed antiretroviral therapy doses during the three days prior to study visits, assess timing of last missed dose, and evaluate the ability of the adherence measures to predict viral suppression. Time trends in adherence were modeled using a generalized estimating equations approach to account for possible correlations in outcomes measured repeatedly in the same participants. Associations of adherence with human immunodeficiency virus viral load were examined using linear regression. Mean enrollment age of the 380 participants was 5 years; 57.6% had undetectable’ viral load ( 0.3). Last time missed any antiretroviral therapy dose was reported as “never” for 52.0% at enrollment, increasing to 60.7% and 65.9% at the 6- and 12-month visits, respectively (p

Intraoperative seizures during awake craniotomy with cortical and subcortical mapping are a common occurrence. Patients are routinely treated preoperatively with anti-convulsive medications to reduce seizure occurrence. Historically these drugs have not been believed to significantly affect awake craniotomy procedures. We report a patient undergoing intraoperative mapping with differential response and seizure occurrence based upon antiepileptic drug usage. A 43 year old female presented with history of seizures, right sided hemiparesis, electrical sensations, and difficulty with language function. She was determined to have a mass lesion involving the left frontal and temporal lobes and subsequently elected to undergo resection by awake craniotomy with intraoperative mapping. A first attempt at lesion resection was performed after a missed dose of anti-convulsant medication (levetiracetam) and was subsequently aborted because of repeated seizure activity. The threshold for seizure generation (1.75 mA) was observed to be significantly lower than expected. Therapy was begun with both levetiracetam and phenytoin prior to a second attempted resection one week later. Thresholds for cortical motor response in the second operation were significantly higher than expected (> 9.0 mA), and no intraoperative seizure activity was observed. To our knowledge this is the first quantitative example of antiepileptic drugs affecting the current required for intraoperative mapping. This case highlights the potential for higher current requirements in patients preoperatively treated with high doses of antiepileptic drugs, as well as the importance of confirming adequate dosage of antiepileptic drugs in patients at an increased risk of seizure generation.

Introduction: A Rational Medication Use Review was conducted in health facilities in five high burden provinces (KwaZulu Natal, Western Cape, Eastern Cape, Gauteng and North West) that account for 77% of MDR-TB cases and 92% of XDR-TB in South Africa. Methodology: A purposive sampling of health facilities was done and stratified to represent different models of DR-TB service providers including centralized sites, decentralized sites, and satellite sites. Records for review were selected randomly among patients who initiated treatment between October 2011 and December 2012 and descriptive analysis conducted. Results: The review involved 139 patients (76.3% MDR-TB and 17.3% XDR-TB). 76.3% of them had a pretreatment DST and this was used for regimen selection. Renal function monitoring for dose adjustment was poor although baseline serum creatinine values were available on record for 69.1% of the patients. There was a high degree of missed doses with 66.7% of the patients having at least one missed dose. Co-morbid conditions were common with 66.2%, 13.0% and 5.8% of the patents with HIV, hypertension and seizure disorders respectively. Only 30.2% of the MDR-TB patents and 50% of the XDR-TB patients had been assessed for adverse drug reactions during the intensive phase although 125 episodes of ADRs were on record. Serum creatinine monitoring was not consistent (only 22.3% of patients had monthly values) although 16.1% of the patients had levels that would have required dose adjustments that were not done. Conclusion: There are many factors related to the patient, drug therapy, health care providers, and the health system that may adversely influence DR-TB treatment outcomes and patient safety. These can be detected early through regular rational medication use review and institutionalization of the process. This however requires a multidisciplinary approach with involvement of levels of the health system and various institutions involved TB in medication use.

Introduction The introduction of new vaccines highlights concerns about high vaccine wastage, knowledge of wastage policies and quality of stock management. However, an emphasis on minimizing wastage rates may cause confusion when recommendations are also being made to reduce missed opportunities to routinely vaccinate children. This concern is most relevant for lyophilized vaccines without preservatives [e.g. measles-containing vaccine (MCV)], which can be used for a limited time once reconstituted. Methods We sampled 54 health facilities within 11 local government areas (LGAs) in Nigeria and surveyed health sector personnel regarding routine vaccine usage and wastage-related knowledge and practices, conducted facility exit interviews with caregivers of children about missed opportunities for routine vaccination, and abstracted vaccine stock records and vaccination session data over a 6-month period to calculate wastage rates and vaccine vial usage patterns. Results Nearly half of facilities had incomplete vaccine stock data for calculating wastage rates. Among facilities with sufficient data, mean monthly facility-level wastage rates were between 18 and 35% across all reviewed vaccines, with little difference between lyophilized and liquid vaccines. Most (98%) vaccinators believed high wastage led to recent vaccine stockouts, yet only 55% were familiar with the multi-dose vial policy for minimizing wastage. On average, vaccinators reported that a minimum of six children must be present prior to opening a 10-dose MCV vial. Third dose of diphtheria-tetanus-pertussis vaccine (DTP3) was administered in 84% of sessions and MCV in 63%; however, the number of MCV and DTP3 doses administered were similar indicating the number of children vaccinated with DTP3 and MCV were similar despite less frequent MCV vaccination opportunities. Among caregivers, 30% reported being turned away for vaccination at least once; 53% of these children had not yet received the missed dose. Discussion Our findings show inadequate implementation of vaccine management guidelines, missed opportunities to vaccinate, and lyophilized vaccine wastage rates below expected rates. Missed opportunities for vaccination may occur due to how the health system’s contradicting policies may force health workers to prioritize reduced wastage rates over vaccine administration, particularly for multi-dose vials.

Introduction Adherence of 95% or more to antiretroviral therapy is generally considered necessary for optimal virologic suppression in patients living with HIV/AIDS (PLWHA). In the African context of access followed by low viral load, understand the determinants of poor adherence is essential to improve compliance, optimise virologic suppression and reduce morbidity and mortality. Method A transversal analytical study referred to was conducted on patients aged at least 18 years on antiretroviral treatment for at least three months. We randomly selected patients and 9 support structures for PLWHA from 63 following more than 100 patients in Kinshasa, from May 2015 to August 2015. The Case Adherence Index (subjective method) and renewal of order (method objective) were used as indicators of compliance. Khi-2 and Student tests were used for comparisons. The determinants of nonadherence were sought in multivariate logistic regression analysis. Results On a global active file of 5724 patients, 400 were included. The median age was 43 years and the sex ratio in favour of the three women. The overall incidence of non compliance was 25%. The prevalence of non-objective compliance was higher than that of non-subjective compliance (29% vs 21%, p=0.01). In multivariate analysis, the payment of the consultation [adjusted OR 1.70 95% CI (1.020 to 2.813), p=0.042], side effects [adjusted OR 2.23 95% CI (1.32 to 3.74), p=0.002] and lack of perception that the missed dose can aggravate the disease [adjusted OR 4.15, 95% CI (1.03 to 16.67), p=0.045] have emerged as determinants of the overall non-adherence. Conclusion The results are in accordance with what has already been shown. The discrepancy observed between the two methods highlights the importance of access to biological methods. The identified risk factors will through regular evaluation, better identify PLWHA at greater risk of non-compliance and to offer enhanced compliance support.

BACKGROUND To explore the significance of short message service (SMS) on the management of pulmonary tuberculosis (TB) patients in reinforcing the treatment adherence and health awareness, and provide scientific evidences for popularizing this model and formulating related polices and measures. MATERIAL AND METHODS Six counties (districts) were selected by stratified cluster sampling method, and randomly divided into control group and intervention group. Pulmonary TB patients eligible to the study criteria were included in the study. SMS management and regular education of core knowledge about pulmonary TB were carried out in SMS group patients. The conventional directly observed therapy (DOT) was carried out in control group. Data was collected by questionnaire method. RESULTS A total of 350 patients were included in the study, including 160 cases in the SMS group and 190 cases in the control group. There were 270 males (77.1%) and 80 females (22.9%). The treatment completion rate in SMS group (96.25%) was significantly higher than that in the control group (86.84%) (χ²=9.52, P=0.002). Both the interrupted treatment rate and the missed dose rate in the SMS group were significantly lower than those in the control group (χ²=10.41, P=0.001; χ²=28.54, P

Purpose: To assess the knowledge of community pharmacists and senior pharmacy students in United Arab Emirates (UAE) about the proper use of oral contraceptive pills (OCPs) and to investigate factors associated with their knowledge.Method: A cross-sectional study was conducted using a validated self-administered questionnaire to community pharmacists and senior pharmacy students in UAE. The survey contained 22 questions divided into 3 parts: a) demographic information, b) OCPs general knowledge, c) OCPs proper use and missed dose instructions.Results: Community pharmacists had significantly higher knowledge scores than senior pharmacy students (26 vs 16.6 %; p = 0.032). Pharmacists with 10 - 20 years of experience had significantly lower knowledge scores than pharmacists with < 10 years of experience (p < 0.05). Conversely, gender, marital status and previous education on OCPs were not associated with knowledge score (p > 0.05).Conclusion: Participants had poor knowledge of proper use and missed dose instructions along with several misconceptions of OCPs. This can be enhanced by encouraging pharmacists to enroll in continuous educations activities that provide updated information about OCPs. Additionally, inclusion of an intensive elective course on OCPs in undergraduate pharmacy curricula may be helpful.Keywords: Oral contraceptives, Pharmacists, Pharmacy students, Counselling skills, misconceptions

While antiepileptic drugs (AEDs) remain the primary treatment for epilepsy, many patients continue to have seizures. Uncontrolled seizures may be related to AED half-life, since short half-life (SHL) AEDs require more frequent dosing compared with the simplified regimens of long half-life (LHL) AEDs. Long half-life AEDs may also improve seizure control by extending missed dose forgiveness periods. The value of LHL AEDs may be assessed as reduced healthcare utilization. The study's objective was to examine the impact of adding an LHL versus SHL adjunctive AED on the risk of hospitalizations in patients with uncontrolled epilepsy.This was a retrospective, longitudinal cohort study using the Symphony Health Solution Patient Integrated Dataverse. Patients ≥12 years old with uncontrolled epilepsy (≥2 medical claims ≥30 days apart) were identified during a study period (8/1/2012-7/31/2017). Patients were selected if they were subsequently initiated an adjunctive AED (excluding modified release formulations), and the prescription date served as the index. Patients were stratified into two mutually exclusive cohorts based on the index AED half-life (≤20 versus20 h). Poisson regressions with robust error variances were performed for the relative risks (RRs) of all-cause, epilepsy-related, and injury-related hospitalizations.A total of 4984 patients were identified (2705 in the LHL and 2279 in the SHL cohort). Compared with those in the SHL cohort, patients in the LHL cohort were significantly younger [mean (SD, years): 43.9 (18.5) versus 49.2 (17.2), p 0.001] and were less comorbid [mean (SD) of Charlson comorbidity index: 1.2 (1.8) versus 1.8 (2.2), p 0.001]. In the one-year postindex date, adjusting for group differences, the risks of both all-cause and epilepsy-related hospitalizations were significantly lower in the LHL cohort than in the SHL cohort [all-cause: 0.84 (95% CI: 0.76-0.93), p = 0.0006; epilepsy-related: 0.83 (0.73-0.94), p = 0.0046].Injury-related hospitalizations did not differ between LHL and SHL cohorts.In patients with uncontrolled epilepsy who were initiated on an adjunctive AED, the choice of an LHL versus SHL was associated with significantly lower risks of all-cause and epilepsy-related hospitalizations.

“Forgiveness” – the difference between a drug's postdose duration of action and its prescribed dosing interval – estimates the margin of therapeutic effect following a missed dose. Because this margin presumably decreases as dosing becomes less frequent, QD dosing of an antiepileptic drug (AED) is expected to be less forgiving than more frequent (e.g., BID) dosing of that same AED. However, if the AED is reformulated as an extended-release (XR) preparation, drug input may be prolonged relative to its immediate-release (IR) counterpart. It therefore stands to reason that forgiveness could be increased by an XR AED that extends the period during which therapeutic plasma concentrations are maintained if a dose is missed. Computer simulation was used to estimate forgiveness for an IR formulation of a hypothetical AED and its XR counterparts reformulated for less frequent dosing. Simulations determined forgiveness when the hypothetical IR AED was dosed TID, BID, and QD and when suitably designed XR formulations were dosed BID and QD. Simulations showed that forgiveness for an XR formulation can equal or exceed that for an IR formulation dosed more frequently.

Dabigatran etexilate (DE), rivaroxaban, and apixaban are nonvitamin K antagonist oral anticoagulants (NOACs) that have been compared in clinical trials with existing anticoagulants (warfarin and enoxaparin) in several indications for the prevention and treatment of thrombotic events. All NOACs presented bleeding events despite a careful selection and control of patients. Compared with warfarin, NOACs had a decreased risk of intracranial hemorrhage, and apixaban and DE (110 mg BID) had a decreased risk of major bleeding from any site. Rivaroxaban and DE showed an increased risk of major gastrointestinal bleeding compared with warfarin. Developing strategies to minimize the risk of bleeding is essential, as major bleedings are reported in clinical practice and specific antidotes are currently not available. In this paper, the following preventive approaches are reviewed: improvement of appropriate prescription, identification of modifiable bleeding risk factors, tailoring NOAC's dose, dealing with a missed dose as well as adhesion to switching, bridging and anesthetic procedures. © 2014 Lessire Sarah et al.

Background Corticosteroids are highly effective drugs with anti-inflammatory and immunosuppressive properties. Due to this, they have become a mainstay of pharmacotherapy in dermatology. However, improper and long term uses are associated with a number of serious adverse effects.Objective To investigate the corticosteroids use pattern, adverse effects and various factors associated with adverse effects in dermatological practice.Method A cross-sectional study was conducted in a dermatology department of tertiary care hospital. All patients using at least one corticosteroids, either topically or systemically or the combination were included in this study. Informed consent was taken from the patients and interviewed using structured questionnaire. Statistical analysis was performed by using SPSS 20. p-value < 0.05 was considered as statistically significant.Result Among the 60 participants under this study, 81.67% of them were females. The mean (±SD) age of the patients was 31.03 years (±15.0). A majority (58.30%) of the patients was prescribed with topical corticosteroids with low potency (25%). Most of them had used corticosteroids for urticaria. Adverse effects were reported by 33.30% of the patients. The most common adverse effect reported was the shedding of skin. Adverse effects was significantly associated with gender; use of systemic corticosteroids; regular use of corticosteroids; discontinuation of dose abruptly; and missed dose. However, there was no significant association between adverse effects and the duration of use of corticosteroids.Conclusion In conclusion, the present study suggested that the proper counselling and clear instruction regarding the use of corticosteroid should be provided to the patients for avoiding the abrupt discontinuation of the prescribed medication leading to treatment failure.