International Journal of Clinical Pharmacy

Anti-inflammatory drugs have been suspected on several occasions to have promoted development of bacterial infection among varicella patients. Some countries have not implemented childhood varicella vaccination. Three cases in our hospital suggested the predisposing role of NSAIDs in varicella patient deterioration. Open access to these drugs widely increases their use and patient information should be continually provided in the medical offices and at dispensing pharmacy counters. Taking account of the benefit/risk balance and applying the simple precautionary principle, it would be appropriate to be cautious about the use of NSAIDs in the paediatric population.

Background Medication histories (MHs) obtained at the time of patients’ admission to hospital are often incomplete, and lack of information about patients’ actual medicine use can potentially lead to prescribing failures and serious adverse events. Uses of clinical pharmacists in obtaining MHs are beneficial, but due to limited economic resources clinical pharmacists cannot be present in every hospital ward, and therefore pharmacy technicians (PTs) could probably be trained in obtaining MHs. Objective To compare discrepancies in MHs obtained by physicians and PTs in an emergency department. Second to evaluate, whether PTs could assist and/or replace physicians in obtaining MHs. Methods The study was conducted in the emergency department at Svendborg Hospital, Denmark and patients treated with a minimum of three prescribed medicines were included. On patients’ admission to hospital, physicians recorded the primary MHs, and within 48 h the secondary MHs were made by PTs. All MHs were conducted using standard guidelines. A clinical pharmacist reviewed the MHs, and based on these reviews, a final medication list was defined, and the MHs were compared to this. The discrepancies were registered with respect to type and therapeutic group (medicines). Results A total of 113 patients were included in this study, and data for 106 patients were analysed. On average, three discrepancies were detected for each patient in the primary MHs, and less than one discrepancy per patient in the secondary MHs. A total of 1075 prescriptions were registered, and for the physicians, 287 discrepancies (27 % of total prescriptions) were found, and for PTs the number was 28 (2 % of total prescriptions). The commonly detected discrepancy was “drug missing in the electronic patient record”. The largest number of discrepancies was found for nervous system medications (ATC group N), medicines from ATC group A (alimentary tract and metabolism) and respiratory medicine (ATC group R). Conclusion Fewer discrepancies in the MHs obtained by PTs than physicians were detected compared to standard medicine lists made by an experienced clinical pharmacist.

Visual impairment is a disability that can have a significant impact on the ability to take medication safely. As a result, pharmacists must adjust their practice to provide targeted and adapted support for this type of patient. The aims of the present study were (1) to illustrate the usual clinical practice of community pharmacists to support the optimisation of medication use in visually impaired patients, and (2) to identify solutions to improve pharmaceutical care for visually impaired patients. Semi-structured interviews with 18 French-speaking community pharmacists were conducted via videoconference in Belgium. Participants were recruited on a voluntary basis and through a snowball method. An interview guide was developed based on literature review. Interviews were carried out until theoretical saturation of the data, recorded, transcribed verbatim and analysed using thematic analysis. Data were organised by NVivo Software. Four themes were identified: community pharmacists’ training, identification of visually impaired patients by the pharmacist, communication with visually impaired patients and their proxies, and provision of appropriate pharmaceutical care. Participants stated that they had not received any training regarding visual impairment. They described that they did not always know how to recognise visually impaired patients and that communication was often difficult. This qualitative study has highlighted a lack of knowledge and skills among community pharmacists regarding visual impairment. One possible solution could be to develop recommendations and tools to improve the care of these patients.

Gastrointestinal adverse drug reactions (GADRs) of direct-acting antiviral agents (DAAs) in patients with chronic hepatitis C are underestimated. This study aimed to comprehensively evaluate the gastrointestinal safety of DAAs in patients with chronic hepatitis C. The US FDA Adverse Event Reporting System database was searched for GADR cases reported from 01 to 2012 to 30 September 2021. Twelve DAA types used for hepatitis C virus were included. The top 30 GADRs were assessed based on the use of DAAs, number of cases, and clinical features. A case–non-case disproportionality approach was used to confirm pharmacovigilance signals, whereby reporting odds ratios (ROR) with 95% CI were calculated. Nausea (70.01/1000), diarrhoea (39.10/1000), and vomiting (31.68/1000) accounted for the highest number of cases. The pooled median time-to-onset of the top 30 GADRs was 13 days (Q1-Q3: 2–38) and the proportion of drug discontinuation was 19.17%. The highest number of DAA-related cases involved ledipasvir/sofosbuvir (21.86%), sofosbuvir/velpatasvir (21.77%), and sofosbuvir (13.41%). When DAAs were considered as a class drug, after adjusting for age, sex, concomitant diseases and drugs that potentially induced GADRs, significant RORs for specific GADRs were noted, including abdominal discomfort (1.62, 95% CI 1.32–1.99), constipation (1.54, 95% CI 1.26–1.89), dyspepsia (1.25, 95% CI 1.01–1.55), abdominal distension (1.36, 95% CI 1.05–1.75), faeces discoloured (1.77, 95% CI 1.15–2.73), and gastric ulcer (2.37, 95% CI 1.28–4.41). Clinicians should have a deeper understanding of GADRs to improve the gastrointestinal tolerance of patients with chronic hepatitis C.

Background Total serum drug levels are routinely determined for the therapeutic drug monitoring of selected, difficult-to-dose drugs. For some of these drugs, however, knowledge of the free fraction is necessary to adapt correct dosing. Phenytoin, with its non-linear pharmacokinetics, >90 % albumin binding and slow elimination rate, is such a drug requiring individualization in patients, especially if rapid intravenous loading and subsequent dose adaptation is needed. In a prior long-term investigation, we showed the excellent performance of pharmacy-assisted Bayesian forecasting support for optimal dosing in hospitalized patients treated with phenytoin. In a subgroup analysis, we evaluated the suitability of the Sheiner-Tozer algorithm to calculate the free phenytoin fraction in hypoalbuminemic patients. Objective To test the usefulness of the Sheiner-Tozer algorithm for the correct estimation of the free phenytoin concentrations in hospitalized patients. Setting A Swiss tertiary care hospital. Method Free phenytoin plasma concentration was calculated from total phenytoin concentration in hypoalbuminemic patients and compared with the measured free phenytoin. The patients were separated into a low (35 ≤ albumin ≥ 25 g/L) and a very low group (albumin <25 g/L) for comparing and statistically analyzing the calculated and the measured free phenytoin concentration. Main outcome measures Calculated and the measured free phenytoin concentration. Results The calculated (1.2 mg/L (SD = 0.7) and the measured (1.1 mg/L (SD = 0.5) free phenytoin concentration correlated. The mean difference in the low and the very low albumin group was: 0.10 mg/L (SD = 1.4) (n = 11) and 0.13 mg/L (SD = 0.24) (n = 12), respectively. Although the variability of the data could be a bias, no statistically significant difference between the groups was found: t test (p = 0.78), the Passing–Bablok regression, the Spearman’s rank correlation coefficient of r = 0.907 and p = 0.00. The Bland–Altman plot including the regression analysis revealed no systematic differences between the calculated and the measured value [M = 0.11 (SD = 0.28)]. Conclusion In absence of a free phenytoin plasma concentration measurement also in hypoalbuminemic patients, the Sheiner-Tozer algorithm represents a useful tool to assist therapeutic monitoring to calculate or control free phenytoin by using total phenytoin and the albumin concentration.

Background Adherence to type 2 diabetes management is defined as the extent to which the behaviour of a person matches the one recommended by health care professionals. Control of this disease depends on adherence to diabetes management, which includes monitoring blood glucose levels, adopting a healthy diet, exercising, taking medication, quitting smoking, and undergoing psychosocial care and periodic check-ups. This can also prevent health complications and reduce medical costs. Objective The objective of this study is to validate a culturally appropriate instrument directed towards the Mexican population that measures a patient’s level of adherence to their type 2 diabetes mellitus management. Method The study design was cross-sectional. The instrument was applied individually (face to face researcher-assisted survey) by a member of the team. The study sample included 200 participants, which were attended at an outpatient clinic. To evaluate the psychometric validity of the scale we calculated response frequencies, the discrimination of items for extreme groups, the validity, and the internal reliability. The scale of adherence for complete management in patients with type 2 diabetes includes disease monitoring, complication prevention, and social support using questions and answers based on the Likert scale, corresponding to the 5 stages of the transtheoretical model. Main outcome measure The validity and internal reliability of the instrument to measure adherence to type 2 diabetes management, which proved to be justifiable and reliable with a Cronbach’s alpha of 0.92 and a total explained variance of 65.03%. Results The instrument was composed of 29 items and 6 factors: adherence to medical Cronbach’s alpha = 0.92 and dietary treatment Cronbach’s alpha = 0.88, change in dietary habits Cronbach’s alpha = 0.89, adherence to physical activity and exercise Cronbach’s alpha = 0.84, social support Cronbach’s alpha = 0.79, and prevention of complications Cronbach’s alpha = 0.70. The instrument obtained a content validity index (I-CVI) of 0.9. Conclusion The proposed instrument, which includes factors that measure adherence in type 2 diabetes mellitus patient’s management, using the transtheoretical model of behaviour change to simultaneously identify patient motivation to change their lifestyle, is valid and reliable.

Background The Indian Health Service Anticoagulation Training Program serves to improve patient safety through advanced anticoagulation management training. Although post-program evaluations of program content were conducted at the time of program delivery, little is known about translation of these learned skills into clinical practice. Objective This research sought to describe levels of self-reported participant confidence in anticoagulation management; development, implementation, and performance management of both core and supplemental activities of anticoagulation clinics or services; and current anticoagulation clinical practices subsequent to participating in the Anticoagulation Training Program. Setting A federal Indian Health Service healthcare facility in Oklahoma, USA. Methods A cross-sectional, electronic mail survey was designed, pretested, and administered to 267 eligible Anticoagulation Training Program participants from 1999 to 2009. Data were analyzed using descriptive statistics and interpreted to identify areas of strength and opportunities for improvement. Main outcome measures Information about confidence in anticoagulation management skills; development, implementation and improvement of both core and supplemental activities of anticoagulation clinics or services; and current anticoagulation clinical practices was collected. Results After training, over 90 % of participants reported agreement/strong agreement with statements about confidence in performing patient-care related anticoagulation activities. A smaller proportion (83.3–85.4 %) reported agreement/strong agreement with confidence in measuring, analyzing and reporting anticoagulation outcomes. Improvement activities were more common than development or implementation activities (65.4, 31.9 and 35.1 %, respectively). Not having well established reimbursement procedures, lack of dedicated clinic space, and lack of dedicated personnel salaries (47.3, 38.3 and 32.6 %, respectively) were reported as the most common barriers to developing, implementing or improving an anticoagulation clinic. Participants indicated that anticoagulation outcomes tracking was the most common supplemental development, implementation and improvement activity (37.9, 37.0 and 43.8 % respectively). Benchmarking was the least commonly reported outcomes-related activity by participants (33.6 %). Although there was only a modest gain in the number of established anticoagulation clinics after attending the Anticoagulation Training Program, approximately 21 % of participants reported using skills learned to establish other disease state management clinics. Conclusion In general, a majority of participants reported high levels of confidence related to direct patient care activities after attending the Anticoagulation Training Program. However there is a need to raise confidence in performance improvement and outcomes management activities to align with current accreditation standards in anticoagulation management as the Anticoagulation Training Program evolves.

Objective The aim of this paper was to develop a guideline on the over-the-counter management of gastroesophageal reflux disease with proton pump inhibitors (i.e. omeprazole). Setting A meeting of internationally renowned gastroenterologists in January 2009, in Berlin, Germany. Methods An expert panel group of gastroenterologists convened to develop a consensus-based algorithm for pharmacists for over-the-counter (OTC) treatment with proton pump inhibitors (PPIs). Key considerations were the short-term safety and efficacy of PPIs, and the extent of the risk to the sufferer, owing to the treatment not being controlled by a physician. Main outcome measures A consensus-based treatment algorithm for the OTC management of gastroesophageal reflux disease and evidence-based guidance on the use of OTC PPIs. Results As defined by the treatment algorithm, the pharmacist should first confirm the diagnosis based on the presence of typical symptoms and secondly, as a result, rule out general practitioner referral. The third step focuses on the nature, severity and frequency of the symptoms—the patients who might have the highest benefit from a short course (14 days) of OTC PPIs are those with less than three episodes of heartburn and/or acid regurgitation per week. Patients who have three or more episodes per week can use the OTC PPIs but should also be encouraged to visit a physician, and those who already have a diagnostic work-up can use proton pump inhibitors as rescue treatment if they are known responders. Guidance for pharmacists, in the form of questions and answers, summarises the current published clinical experience with PPIs in terms of their efficacy and safety, and optimal treatment schedule. Conclusions Gastroesophageal reflux disease imposes a considerable burden on sufferers. Owing to their accepted efficacy and safety, PPIs are becoming popular as OTC options for the treatment of gastroesophageal reflux disease symptoms such as heartburn and acid regurgitation. Effective self-management of gastroesophageal reflux disease with OTC PPIs, e.g. omeprazole, could lead to lasting freedom from symptoms and improved quality of life for sufferers.

Background Medication reconciliation has been mandated by the Irish government at transfer of care. Research is needed to determine the contribution of clinical pharmacists to the process. Objective To describe the contribution of emergency department based clinical pharmacists to admission medication reconciliation in Ireland. Main Outcome Measure Frequency of clinical pharmacist’s activities. Setting Two public university teaching hospitals. Methodology Adults admitted via the accident and emergency department, from a non-acute setting, reporting the use of at least three regular prescription medications, were eligible for inclusion. Medication reconciliation was provided by clinical pharmacists to randomly-selected patients within 24-hours of admission. This process includes collecting a gold-standard pre-admission medication list, checking this against the admission prescription and communicating any changes. A discrepancy was defined as any difference between the gold-standard pre-admission medication list and the admission prescription. Discrepancies were communicated to the clinician in the patient’s healthcare record. Potentially harmful discrepancies were also communicated verbally. Pharmacist activities and unintentional discrepancies, both resolved and unresolved at 48-hours were measured. Unresolved discrepancies were confirmed verbally by the team as intentional or unintentional. A reliable and validated tool was used to assess clinical significance by medical consultants, clinical pharmacists, community pharmacists and general practitioners. Results In total, 134 patients, involving 1,556 medications, were included in the survey. Over 97 % of patients (involving 59 % of medications) experienced a medication change on admission. Over 90 % of patients (involving 29 % of medications) warranted clinical pharmacy input to determine whether such changes were intentional or unintentional. There were 447 interventions by the clinical pharmacist regarding apparently unintentional discrepancies, a mean of 3.3 per patient. In total, 227 (50 %) interventions were accepted and discrepancies resolved. At 48-hours under half (46 %) of patients remained affected by an unintentional unresolved discrepancy (60 % related to omissions). Verbally communicated discrepancies were more likely to be resolved than those not communicated verbally (Chi-square (1) = 30.029 p < 0.05). Under half of unintentional unresolved discrepancies (46 %) had the potential to cause minor harm compared to 70 % of the resolved unintentional discrepancies. None had the potential to result in severe harm. Conclusion Clinical pharmacists contribute positively to admission medication reconciliation and should be engaged to deliver this service in Ireland.

Objective The economic profile of acute myeloid leukaemia (AML) is badly known. The few studies published on this disease are now relatively old and include small numbers of patients. The purpose of this retrospective study was to evaluate the induction-related cost of 500 patients included in the AML 2001 trial, and to determine the explanatory factors of cost. Setting “Induction” patient’s hospital stay from admission for “induction” to discharge after induction. Method The study was performed from the French Public Health insurance perspective, restrictive to hospital institution costs. The average management of a hospital stay for “induction” was evaluated according to the analytical accounting of Besançon University Teaching Hospital and the French public Diagnosis-Related Group database. Multiple linear regression was used to search for explanatory factors. Main outcome measure Only direct medical costs were included: treatment and hospitalisation. Results Mean induction-related direct medical cost was estimated at €41,852 ± 6,037, with a mean length of hospital stay estimated at 36.2 ± 10.7 days. After adjustment for age, sex and performance status, only two explanatory factors were found: an additional induction course and salvage course increased induction-related cost by 38% (±4) and 15% (±1) respectively, in comparison to one induction. These explanatory factors were associated with a significant increase in the mean length of hospital stay: 45.8 ± 11.6 days for 2 inductions and 38.5 ± 15.5 if the patient had a salvage course, in comparison to 32.9 ± 7.7 for one induction (P < 10−4). This result is robust and was confirmed by sensitivity analysis. Conclusion Consideration of economic constraints in health care is now a reality. Only the control of length of hospital stay may lead to a decrease in induction-related cost for patients with AML.