International Journal of Clinical Pharmacy

Background Oral anticoagulant therapy is indicated for the prevention of stroke or other thromboembolic events. Premature discontinuation of oral anticoagulants may increase the risk of thromboembolism resulting in adverse sequelae. There are sparse data on the prevalence and the predictors of dabigatran discontinuation in Malaysian patients with atrial fibrillation. Objectives Determine the reasons and identify associated factors for abrupt discontinuation of dabigatran, assess the switching pattern and the occurrence of thromboembolic events after dabigatran discontinuation. Setting A university-affiliated tertiary hospital in Kuala Lumpur, Malaysia. Methods The clinical and demographic data of a cohort who were initiated with dabigatran between 2010 and 2012 at the University of Malaya Medical Centre were reviewed until the date of death or on 31st December 2013. Those patients who discontinued dabigatran were further followed up until 31st December 2015 to determine the occurrence of any thromboembolic event. Main outcome measure Permanent discontinuation of dabigatran for more than 8 weeks. Results 26 (14 %) of a cohort of 192 patients discontinued dabigatran therapy during a median follow-up period of 20 (range 3–45) months. About one-half of the discontinuation occurred within the first 6 months of dabigatran use. The three most cited reasons for discontinuation are bleeding events (19 %), high out-of-pocket drug payment (19 %) and cardioversion (19 %). Heart failure [adjusted odds ratio 3.699 (95 % confidence interval 1.393–9.574)] or chronic kidney disease [adjusted odds ratio 5.211 (95 % confidence interval 1.068–23.475)] were found to be independent risk factors for abrupt dabigatran discontinuation. Patients who discontinued dabigatran received warfarin (38 %), antiplatelet agents (16 %) or no alternative antithrombotic therapy (46 %). Five of the 26 patients who discontinued dabigatran developed an ischaemic stroke within 3–34 months after discontinuation. Conclusion Abrupt dabigatran discontinuation without an alternative oral anticoagulant increases the risk of thromboembolic events. As adverse drug events and renal impairment contribute substantially to the premature discontinuation of dabigatran, it is important to identify and monitor patients at risk to reduce dabigatran discontinuation rate especially during the first six months of dabigatran therapy.

Background Physiological and psychological changes during puberty and a low adherence to complex treatment regimens often result in poor glycemic control in adolescents with type 1 diabetes mellitus (T1DM). The benefit of pharmaceutical care in adults with diabetes mellitus type 2 has been explored; however, evidence in adolescents with T1DM is scarce. Objective To evaluate the impact of pharmaceutical care in adolescents with T1DM provided by pharmacists, in collaboration with physicians and diabetes educators on important clinical outcomes (e.g., HbA1c and severe hypoglycemia) Setting: At the outpatient Helios Paediatric Clinic and at the 12 regular community pharmacies of the study patients with 14 pharmacists in the Krefeld area, Germany, and at the University Pediatric Clinic with one clinical pharmacist on-site in Sarajevo, Bosnia-Herzegovina. Methods A randomized, controlled, prospective, multicenter study in 68 adolescents with T1DM. The intervention group received monthly structured pharmaceutical care visits delivered by pharmacists plus supplementary visits and phone calls on an as needed basis, for 6 months. The control group received usual diabetic care. Data were collected at baseline and after 3 and 6 months. Main outcome measures: The between-group difference in the change from baseline in glycosylated hemoglobin (HbA1c) and the number of severe hypoglycemic events in both groups. Results The improvement from baseline in HbA1c was significantly greater in the intervention group than in the control group after 6 months (change from baseline −0.54 vs. +0.32 %, p = 0.0075), even after adjustment for country-specific variables (p = 0.0078). However, the effect was more pronounced after only 3 months (−1.09 vs. +0.23 %, p = 0.00002). There was no significant between-group difference in the number of severe hypoglycemia events. (p = 0.1276). Conclusion This study suggests that multidisciplinary PhC may add value in the management of T1DM in adolescents with inadequate glycemic control. However, the optimal methods on how to achieve sustained, long-term improvements in this challenging population require further study.

Background Due to the drug-centred tradition of Chinese hospital pharmacy and the lack of corresponding laws and regulations, Chinese clinical pharmacists may experience the problems of role ambiguity and role conflict. These problems may affect whether clinical pharmacists undertake their responsibilities, thus affecting the level of clinical pharmacy care. Objective To evaluate the level of Chinese clinical pharmacists’ role ambiguity and role conflict and to analyse their influence on the undertaking of responsibilities. Setting Research was conducted in 31 provinces (autonomous regions) and municipality directly under the Central Government in mainland China. Main outcome measure Chinese version of a role ambiguity and role conflict scale was used to measure clinical pharmacists’ role ambiguity and role conflict. A scale for clinical pharmacists’ responsibilities was established to measure whether clinical pharmacists undertake their responsibilities. Methods Subgroup analysis and logistic regression were employed to analyse the phenomenon of Chinese clinical pharmacists’ role ambiguity and role conflict and their influence on their fulfilment of responsibilities. Results Clinical pharmacists in China experience role ambiguity and role conflict. Clinical pharmacists in the eastern region, tertiary hospitals, and hospitals where clinical pharmacists training programs are available were less likely to experience role ambiguity and role conflict than those in the central and western regions, secondary hospitals, and hospitals where clinical pharmacists training programs are not available. Role ambiguity and role conflict have significant impacts on whether clinical pharmacists undertake certain responsibilities. Conclusion This study shows that clinical pharmacists in China experience problems with role ambiguity and role conflict and it will affect their fulfilment of their responsibilities. We propose that corresponding policies and measures should be taken to alleviate role ambiguity and role conflict and improve clinical pharmacy service.

The growing evidence on psychotropic drug safety in pregnancy has been possible thanks to the increasing availability of real-world data, i.e. data not collected in conventional randomised controlled trials. Use of these data is a key to establish psychotropic drug effects on foetal, child, and maternal health. Despite the inherent limitations and pitfalls of observational data, these can still be informative after a critical appraisal of the collective body of evidence has been done. By valuing real-world safety data, and making these a larger part of the regulatory decision-making process, we move toward a modern pregnancy pharmacovigilance. The recent uptake of real-world safety data by health authorities has set the basis for an important paradigm shift, which is integrating such data into drug labelling. The recent safety assessment of sodium valproate in pregnant and childbearing women is probably one of the first examples of modern pregnancy pharmacovigilance.

Background The effects of mycophenolic acid exposure in the early period after transplantation on clinical outcomes have been reported; however, mycophenolic acid exposure in the early period after transplantation in Asian kidney transplant recipients who receive 1.5 g/d mycophenolate mofetil has never been investigated. Objective To determine mycophenolic acid exposure on day 3 post-transplantation in kidney transplant recipiens who receive 1.5 g/d mycophenolate mofetil. The effects of the reduced renal function on mycophenolic acid area under the concentration–time curve (AUC) and the achievement of the target AUC on the incidence of biopsy proven acute rejection during the first month post-transplantation were also evaluated. Setting A university hospital Method Blood samples and 24-h urine were collected on day 3 post-transplantation. Main outcome measures The mycophenolic acid AUC was calculated by linear trapezoidal rule and compared with the target of 45 mg*h/L. Results Of 42 Thai kidney transplant recipiens, the mean mycophenolic acid AUC of 45.1 mg*h/L (SD 14.7) was comparable to the AUC target (P = 0.962). Significant differences of the mycophenolic acid AUC were observed between patients with urine output of < 2400 mL and those with urine output ≥ 2400 mL (35.3 ± 6.6 and 47.4 ± 15.2, respectively; P = 0.002), and between patients with 24-h measured CrCl < 25 mL/min and those with CrCl ≥ 25 mL/min (38.0 (29.0, 42.2) and 49.2 ± 14.0, respectively; P = 0.017). Proportions of overall biopsy proven acute rejection among patients with mycophenolic acid AUC of < 45 and ≥ 45 mg*h/L were comparable (20.0% and 23.5%, respectively; P = 1.000). Conclusions After the starting dosage of 1.5 g/d mycophenolate mofetil, the mean mycophenolic acid AUC on day 3 post-kidney transplantation is comparable with the target of 45 mg*h/L. Severely reduced renal function significantly influences mycophenolic acid exposure.

Background It is not unusual to find obese and cachectic patients in the hematology oncology setting. However, information on dosage in these groups is scarce. Objective The objectives of our study were to explore the dosing strategies applied in the treatment of obese and cachectic cancer patients and to determine whether these strategies are applied in clinical trials. Setting Members of the Spanish Group for the Development of Hematology–Oncology Pharmacy (GEDEFO). Methods We invited all cancer hospital pharmacists to participate in a survey. Main outcome measure Descriptive statistics of the dosing strategies approaches. Results We invited 159 eligible hospitals to participate, and 38 responded to the survey. A total of 50 surveys were received: different strategies were applied by different physicians from the same hospital and by hematology and oncology departments. Body mass index was used to define obesity and cachexia in 40 and 30 % of the cases, respectively. Capping the body surface area (BSA) was the approach most commonly followed (64.1 %) in obese patients, whereas no specific approach was adopted in cachectic patients. In hematology patients, the BSA calculation was based on ideal body weight or adjusted body weight in 16.0 % of cases (n = 2) and 50.0 % of cases (n = 6), respectively; in oncology patients, use of adjusted or ideal body weight was negligible. Actual body weight was the main approach in obese patients (35 surveys) and cachectic patients (48 surveys). Creatinine clearance was assessed mainly using the Cockcroft and Gault equation (around 76.0 % of responses). As for clinical trials, 64.1 % of the respondents (n = 25 hospitals) considered the criteria from each clinical trial individually. Conclusions Dose adjustments are more frequent in obese patients than in cachectic patients. In cancer oncology patients, dose is adjusted mainly by hematology and hematopoietic cell transplant teams. Capping BSA is the most frequent strategy, followed by calculating actual body weight.

Worldwide, the treatment of tuberculosis is based on evidence-based guidelines developed by the World Health Organization (WHO) for national tuberculosis programs. However, the importance of health related quality of life, the adequate management of side effects associated with antituberculosis drugs and the elaboration of tuberculosis treatment outcome categories are a few issues that need to be addressed in forthcoming WHO guidelines for the treatment of tuberculosis.

Background Duloxetine is currently approved for chronic pain management; however, despite some evidence, its utility in acute, postoperative pain remains unclear Aim of the review This systematic review and meta-analysis is to determine if duloxetine 60 mg given perioperatively, is safe and effective at reducing postoperative opioid consumption and reported pain following elective orthopedic surgery. Method CINAHL, Medline, Cochrane Central Registry for Clinical Trials, Google Scholar, and Clinicaltrials.gov were searched using a predetermined search strategy from inception to January 15, 2019. Covidence.org was used to screen, select, and extract data by two independent reviewers. Individual study bias was assessed using the Cochrane Risk of Bias tool. Opioid consumption data were converted to oral morphine milligram equivalents (MME) and exported to RevMan where meta-analysis was conducted using a DerSimonian and Laird random effects model. Results Six randomized-controlled trials were included in the literature review of postoperative pain and adverse effects. Five studies were utilized for the meta-analysis of postoperative opioid consumption; totaling 314 patients. Postoperative pain analysis showed variable statistical significance with overall lower pain scores with duloxetine. Adverse effects included an increase in insomnia with duloxetine but lower rates of nausea and vomiting. Meta-analysis revealed statistically significant [mean difference (95% CI)] lower total opioid use with duloxetine postoperatively at 24 h [− 31.9 MME (− 54.22 to − 9.6), p = 0.005], 48 h [− 30.90 MME (− 59.66 to − 2.15), p = 0.04] and overall [− 31.68 MME (− 46.62 to − 16.74), p < 0.0001]. Conclusion These results suggest that adding perioperative administration duloxetine 60 mg to a multimodal analgesia regimen within the orthopedic surgery setting significantly lowers total postoperative opioid consumption and reduces pain without significant adverse effects.

Background Communication between hospital and community pharmacists when a patient is discharged from hospital can improve the accuracy of medication reconciliation, thus preventing unintentional changes and ensuring continuity of supply. It allows problems to be resolved before a patient requires a further supply of medication post-discharge. Despite evidence demonstrating the benefits of sharing information, community pharmacists’ willingness to receive information and advances in information technology (particularly electronic discharge medication summaries), there is little published evidence to indicate whether communication has improved over the last 15 years. This study aimed to explore community pharmacists’ experience of information sharing by and with their local hospital and GP practices. Objectives (1) To establish the extent to which community pharmacies currently receive discharge medication information, and for which patients.(2)To determine community pharmacy staff opinion on where and how current communication practice could be improved. Setting Community Pharmacies in one Primary Care Organisation (PCO) in England. Method Semi-structured interviews conducted during visits to community pharmacies. Main outcome measure Reported receipt of discharge medication information from hospitals and general practices. Results A total of 14 community pharmacies participated. Current provision of information to community pharmacies from hospitals regarding medication changes at discharge was reported to be inconsistent and lacking in quality. Where information was received it was predominantly for patients who receive their medicines in monitored dosage systems (MDS) rather than for the general population of patients. Some examples of “notable practice” were reported. Conclusion Community pharmacists received post-discharge information rarely and mainly for patients where the hospital perceived the patient’s medication issues as “complex”. Practice was inconsistent overall. These findings suggest that the potential of community pharmacists to improve patient safety after discharge from hospital is not being utilised.