Changes In Drug Therapy Research Articles

Pharmacogenomics at the Point of Care: A Community Pharmacy Project in British Columbia

In this study 180 patients were consented and enrolled for pharmacogenomic testing based on current antidepressant/antipsychotic usage. Samples from patients were genotyped by PCR, MassArray, and targeted next generation sequencing. We also conducted a quantitative, frequency-based analysis of participants’ perceptions using simple surveys. Pharmacogenomic information, including medication changes and altered dosing recommendations were returned to the pharmacists and used to direct patient therapy. Overwhelmingly, patients perceived pharmacists/pharmacies as an appropriate healthcare provider to deliver pharmacogenomic services. In total, 81 medication changes in 33 unique patients, representing 22% of all genotyped participants were recorded. We performed a simple drug cost analysis and found that medication adjustments and dosing changes across the entire cohort added $24.15CAD per patient per year for those that required an adjustment. Comparing different platforms, we uncovered a small number, 1.7%, of genotype discrepancies. We conclude that: (1). Pharmacists are competent providers of pharmacogenomic services. (2). The potential reduction in adverse drug responses and optimization of drug selection and dosing comes at a minimal cost to the health care system. (3). Changes in drug therapy, based on PGx tests, result in inconsequential changes in annual drug therapy cost with small cost increases just as likely as costs savings. (4). Pharmacogenomic services offered by pharmacists are ready for wide commercial implementation.

Remote heart failure management using a multiparameter implantable cardioverter-defibrillator alert: the multicentric RE-HEART registry

Abstract Background The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator (ICD)-based sensors into an index for prediction of impending heart failure (HF) decompensation. In patients with ICD and cardiac resynchronization therapy ICD remotely monitored at 13 Spanish centers, we analyzed the association between clinical events and HeartLogic alerts and we described the use of the algorithm for the remote management of HF. Methods The association between clinical events and HeartLogic alerts was studied in the blinded phase (from ICD implantation to alert activation – no clinical actions taken in response to alerts) and in the following active phase (after alert activation – clinicians automatically notified in case of alert). Results We enrolled a total of 215 patients (67±13 years old, 77% male, 53% with ischemic cardiomyopathy) with ICD (19%) or CRT-D (81%). The median duration of the blinded phase was 8 [3–12] months. In this phase, the HeartLogic index crossed the threshold value (set by default to 16) 34 times in 20 patients. HeartLogic alerts were associated with 6 HF hospitalizations and 5 unplanned in-office visits for HF. Five additional HeartLogic threshold crossings were not associated with overt HF events, but occurred at the time of changes in drug therapy or of other clinical events. The rate of unexplained alerts was 0.25 alert-patient/year. The median time spent in alert was longer in the case of HF hospitalizations than of in-office visits (75 [min-max: 30–155] days versus 39 [min-max: 5–105] days). The maximum HeartLogic index value was 38±15 in the case of hospitalizations and 24±7 in that of minor HF events. The median duration of the following active phase was 5 [2–10] months. After HeartLogic activation, 40 alerts were reported in 26 patients. Twenty-seven (68%) alerts were associated with multiple HF- or non-HF related conditions or changes in prescribed HF therapy. Multiple actions were triggered by these alerts: HF hospitalization (4), unscheduled in-office visits (8), diuretics increase (8), change in other cardiovascular drugs (5), device reprogramming (2), atrial fibrillation ablation (1), patient education on therapy adherence (2). The rate of unexplained alerts not followed by any clinical action was 0.13 alert-patient/year. These alerts were managed remotely (device data review and phone contact), except for one alert that generated an unscheduled in-office visit. Conclusions HeartLogic index was frequently associated with HF-related clinical events. The activation of the associated alert allowed to remotely detect relevant clinical conditions and to implement clinical actions. The rate of unexplained alerts was low, and the work required in order to exclude any impending decompensation did not constitute a significant burden for the centers. Funding Acknowledgement Type of funding source: None

IMPACT OF TRIKAFTA ON LUNG FUNCTION IN A CYSTIC FIBROSIS TRANSPLANT PATIENT

SESSION TITLE: Fellows Transplantation Posters SESSION TYPE: Fellow Case Report Posters PRESENTED ON: October 18-21, 2020 INTRODUCTION: Cystic fibrosis (CF) patients with at least one copy of F508del are eligible for Tezacaftor/Ivacaftor/Elexacaftor (Trikafta), a novel CFTR corrector/potentiator drug associated with increased lung function1 and likely improved sinus clearance. Trikata effects in lung transplant patients are unknown. We report a CF transplant patient, who developed reversible profound leukopenia, severely decreased lung function, and CT findings of peribronchial thickening and gas trapping after starting Trikafta for recurrent severe sinus disease. CASE PRESENTATION: A 30 year old CF female (homozygous F508del), underwent bilateral orthoptic lung transplant for end-stage lung disease and was treated with tacrolimus, azathioprine, prednisone valganciclovir, and sulfamethoxazole/trimethoprim for immunosuppression and infection prophylaxis. FEV1/FVC 3 months post-op were 3.36L/3.58L. Complaints of severe chronic sinusitis persisted and Trikafta was initiated with symptomatic benefit. 4 weeks later, she developed profound neutropenia, despite no antecedent changes in myelosuppressive drug therapy. Despite G-CSF, she was admitted with worsening respiratory symptoms and declining PFTs. She was afebrile with normal vital signs. Initial testing for bacterial and viral infections was negative. Azathioprine, Bactrim and Valcyte were held. Eravacycline was started empirically based on prior cultures. FEV1/ FVC declined to 2.62L/2.80L. Initial CT chest was essentially normal. Leucocyte counts slowly recovered with G-CSF. During this time, she began expectorating copious greenish ’sea-foam’ liquid. Repeat expiratory CT chest showed diffuse bronchial wall thickening and extensive air trapping. Bronchoscopy showed diffuse frothy secretions. Bronchoalveolar lavage had >80% return. Cell counts showed 100 nucleated cells/ml with benign differential. Following a negative cardiac and other etiologic workup, antibiotics were stopped and Trikata was discontinued as causation was suspected. Respiratory symptoms resolved and FEV1/FVC improved to supra-normal baseline over 2 weeks. DISCUSSION: Trikafta’s effect on transplanted lungs (where CFTR function is intrinsically normal) is unknown. Inflammatory cell-derived mediators are known to augment native CFTR function and increase airway epithelial cell fluid secretion in vitro2. We hypothesize that our patient’s symptoms and findings were due to exaggerated airway fluid secretion associated with repopulation of inflammatory cells. We propose that this led to airway edema, and bronchial wall thickening + gas trapping observed on imaging. Improvement in symptoms/PFTs after drug discontinuation support this. Etiology of profound leukopenia is less clear, though a previously undescribed direct drug-effect or altered GI absorption of other myelosuppressive medications are possible. CONCLUSIONS: Trikafta may have unexpected detrimental effects on a lung transplant physiology in CF patients Reference #1: Heijerman HGM, McKone EF, Downey DG, et al. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019. Reference #2: Abdullah LH, Coakley R, Webster MJ, et al. Mucin Production and Hydration Responses to Mucopurulent Materials in Normal versus Cystic Fibrosis Airway Epithelia. Am J Respir Crit Care Med. 2018; 197(4):481–491. doi:10.1164/rccm.201706-1139OC DISCLOSURES: No relevant relationships by Raymond Coakley, source=Admin input No relevant relationships by Christina Doligalski, source=Web Response No relevant relationships by Kunal Jakharia, source=Web Response No relevant relationships by leonard lobo, source=Web Response

Characteristics and Treatment Patterns of Newly Diagnosed Open-Angle Glaucoma Patients in the United States: An Administrative Database Analysis

To characterize newly diagnosed primary open-angle glaucoma (OAG) patients and to describe their treatment journey in United States clinical practice according to the use of topical therapy, laser trabeculoplasty, and surgical procedures. Retrospective claims database study. Patients with at least 2 diagnoses of OAG 7 days or more apart and within 1 year, with the first (index) diagnosis in 2010, at least 30 months of continuous enrollment before index diagnosis with no OAG diagnosis or medication (exception for ocular hypertension diagnosis), and 48 months of continuous enrollment. Analysis of United States healthcare insurance claims database (July 2007-December 2014). Treatment patterns and ophthalmology visits were evaluated over 48 months in 4 cohorts based on initial therapy after the index diagnosis: (1) drug monotherapy, (2) combination drug therapy, (3) glaucoma procedure, or (4) no claims for treatment. Treatment modification was defined as an addition to or change in drug therapy or procedure. In total, 83.0% of patients (5120/6172) began a drug therapy (69.5%) or underwent a procedure initially (13.5%); topical prostaglandin analogs (n= 2887/5120 [56.4%]) and laser trabeculoplasty (n= 705/5120 [13.8%]) were the most common. During the 4-year follow-up, 58.3% of patients (2109/3620) who began drug monotherapy experienced no further treatment modification. Over this period, 43.8% of patients who began treatment (2242/5120) experienced a treatment modification to the first treatment. Two thirds (1505/2242 [67.1%]) of these patients subsequently underwent a third treatment modification. Ophthalmology visits declined over time regardless of initial therapy, with the greatest decrease among the untreated and first-treatment procedure cohorts. The high rates of 2 or 3 treatment modifications over the 4-year period suggest an unmet need for glaucoma therapies with durable and predictable actions.

Drug-Related Problems and Pharmacist Intervention at a General Hospital in the Jazan Region, Saudi Arabia.

ObjectiveThis study examined the incidence of drug-related problems (DRPs) in different inpatient departments along with the medical team response to pharmacist’s action in addressing DRPs at Jazan Hospital, Saudi Arabia.Patients and MethodsThis retrospective study was conducted among inpatients at Ministry of Health hospital in Jazan, a region in southwestern Saudi Arabia. We collected data for a 2-year period (from 2016 to 2017). For any detected DRP of the ordered medications for dispensing, the inpatient pharmacist is sending report for that particular DRP with recommendation to the medical team which in turn might accept or reject such recommendation. Serious drug–drug interactions, as part of DRP, were assessed by utilizing three different online DDI checkers, including Lexi-Comp, Medscape, and Drugs.com.ResultsThe most common type of DRP was serious drug–drug interactions (49%). Over the study period, most incidences of DRPs were decreased. Of the DRPs in 2016 and 2017, antibiotics were the most commonly involved (51% and 69.5%) of cases, respectively, followed by proton pump inhibitors (25.3% and 14.1%) and statins (12.9% and 9.4%). Interestingly, of the 241 interventions for DRPs in 2016, 199 (82.5%) were accepted, resulting in a change in drug therapy (p=0.006). In 2017, 90 (70.3%) interventions out of 128 were accepted by the physician and the drug therapy changed (p=0.029).ConclusionPharmacist interventions appear to decrease the incidence of DRPs, which emphasize the importance of an optimal pharmaceutical care plan for clinical care settings.

Impact of pharmaceutical care programme on health outcome of geriatric patients

Background/objectivesHealth related problems of geriatrics require special attention because these people face many problems, associated to health, social support and economic uncertainty. The study aims to evaluate effectiveness of pharmaceutical care programme on health outcome of geriatric patients by identifying the drug related problem, comparing the medication adherence, and quality of life and resolving it. MethodsThe present study was a prospective interventional study carried over a period of three year and the study was performed in 3 phases. MMAS-8 and SF-36 are used in the study to find out medication adherence and quality of life respectively. ResultDuring the study period 770 patients data was collected, out of which maximum patients were in the age group of 60–70 range (50.4%).A total of 813 drug related problems were identified from 770 study subjects. The most common drug related problems was found to be drug interactions (40.9%). Patient counselling and health care information leaflet are the most interventions in the study. The acceptance rate of suggestions and the changes in drug therapy was found to be high (40.1%). Descriptive analysis, chi-square test and t-test are used in this study for statistical analysis. ConclusionPharmacist involvement in inpatients care can significantly help to identify, resolve and prevent the drug related problems. Outcomes of interventions indicate that almost 80.26% of problems are totally solved by pharmacist's interventions in this study. Pharmacist in geriatric health care has a positive influence on their health outcomes.

An Observational Study of Stroke and its Outcomes in a Tertiary Care Hospital

Introduction: Incidence of stroke is higher in developing countries than in developed countries. India shows prevalence of Cerebrovascular Disease (CVD) in the range of 52 to 843/100,000 population. Stroke causes 9% deaths around the world. The basic principle of managing stroke includes making an accurate diagnosis, choosing the effective drugs and dose for the stroke type. Aim: To analyse the outcomes of pharmacotherapy of stroke based on characteristics and clinical presentation of patients admitted to hospital and to know the adverse effect of drugs used. Materials and Methods: This cohort study was conducted with Department of Medicine and Neurology at Karnataka Institute of Medical Sciences, Hubballi from January 2015 to December 2015. After clearance from Institutional Ethics Committee, 162 cases were selected based on the inclusion and exclusion criteria. The clinical history, in examination modified Rankin score (mRS) at admission, discharge and on follow-up were recorded. The criteria for selecting the drugs, frequency, dosing, duration and change in drug therapy were recorded. The efficacy of drug therapy was assessed by clinical improvement. The adverse events were assessed and recorded. The patients were followed-up at three and six months. The data were entered after defining the variables in SPSS (version 16) from case record form. Descriptive statistics were used to summarise baseline data. Results: Of the 162 patients, 155 completed the six months follow-up. The median age of patients was 60 years for ischaemic and 55 years for haemorrhagic stroke. More males were admitted with strokes {108 (69.67%)} compared to females {47 (30.32%)}; 130 (83.87%) patients had ischaemic strokes, 16 (10.30%) haemorrhagic stroke {15 (9.67%) were intracerebral haemorrhage + 1 (0.63 %) patient had a subarachnoid haemorrhage}, 9 (5.8%) had Transient Ischaemic Attack (TIA). The modified Rankin score calculated for the patients was statistically significant between admission and discharge (1.29, p-value 0.0035), and that between three months and six months (0.9, p-value 0.003) of follow-up.Total 93% of 121 patients with ischaemic stroke received antiplatelet therapy. Amlodipine was the most commonly prescribed antihypertensive. Conclusion: Pharmacotherapy of stroke in the study was evidence-based and satisfactory. However, patients showed reduced compliance to all medications. Clinical presentation and type of stroke were important predictors of morbidity and mortality at the end of six months.

Reducing Inappropriate Drug Use in Older Patients by Use of Clinical Decision Support in Community Pharmacy: A Mixed-Methods Evaluation.

Older people are prone to drug-related harm. Clinical decision support systems (CDSSs) in community pharmacies may improve appropriate prescribing in this population. This study investigated (persistent) drug therapy changes and its determinants to reduce potentially inappropriate medication (PIM) in older patients based on CDSS alerts and to investigate barriers and facilitators for implementation of drug therapy changes based on these CDSS alerts. Five clinical decision rules based on national guidelines for inappropriate drugs in older patients were incorporated in a web-based CDSS in 31 community pharmacies between February and April 2017. The CDSS generated alerts for patients aged > 70years who had prescriptions for one of the following drugs: alprazolam, amitriptyline, barnidipine, duloxetine, fluoxetine, trazodone, quetiapine and olanzapine. The registered alert management data and medication dispensing histories were analysed to find potential determinants of persistent drug therapy changes. Ten pharmacists were interviewed about the barriers and facilitators for implementing drug therapy changes based on CDSS alerts. An inductive thematic analysis of the transcripts was performed. The pharmacists recorded the management of 1810 of the 2589 generated alerts, and 158 (8.7%) alerts were associated with a persistent drug therapy change. A logistic regression analysis found that the drug triggering the alert and the type of prescription [first dispensing vs. repeat; odds ratio 2.1 (95% confidence interval 1.4-3.2)] were significantly associated with persistent drug therapy changes. No association was found between persistent changes and age, sex, number of medicines in use, or recent clinical medication review. Analysis of the interviews revealed nine barriers and facilitators associated with drug therapy change. When community pharmacists implemented CDSS alerts to reduce inappropriate drug use in older patients, they registered a persistent drug therapy change in 8.7% of the cases. Alerts triggered by a first prescription were two times more likely to be associated with a persistent drug therapy change than alerts triggered by repeat prescriptions. This study found that clinical rules can be used to detect inappropriate drug use in older patients and that drug therapy can change based on the alerts. This suggests that CDSS alerts are a useful tool for implementing guidelines on PIM in older patients in daily practice.

Staying in touch with your patients to improve their care

Lately, I’ve been hearing a lot about pharmacy “touches.” An ambulatory care pharmacist colleague described a shift in recent years in the way she documents her impact on patient care in her multidisciplinary clinic practice. She said that she previously tracked only the number of scheduled visits for chronic disease management, but she has realized that she affects patients’ care in so many other ways. Whether in a hallway consult with a physician about a drug therapy change, in an impromptu patient education session, or through efforts to help a patient afford a new medication, she improves care through many avenues, and she now keeps track of all these big and small patient “touches.” This issue of Pharmacy Today highlights innovations in specialty pharmacy—where pharmacists work with often costly, “high-touch” medications (page 28). Some specialty pharmacies are increasingly taking an integrated approach to care, with pharmacists focusing on patient education as part of a multidisciplinary team. Pharmacists practicing in this model cite the benefits of having a pharmacist “closer to patients and their providers” to manage medication access and monitor drug therapy. You’ll also find the latest information on vaping and vaping-related illness (page 27), learn about an increasing trend of antibiotic use without a prescription (page 26), and get new guidelines on treating migraines in children (page 14) in this issue of Today. Stay up to date with the latest Beers Criteria on medication use in older adults with this month’s CPE article (page 42). Whether counseling patients in the pharmacy, interacting with providers in clinic, or helping patients to access and safely use their specialty medications, we are touching patients’ lives to improve their care. Investing in these small but essential daily interactions with our patients helps us to connect with them, stay in touch with their needs, and bring value to their care. Have a great Today!

Comparison of Interventions Made in an Ambulatory Pharmacist-Managed Refill Model to Usual Physician Care.

Background: With the current practice model, there is less time for physicians to address refill authorization requests (RARs) while performing consistent quality care, which creates an opportunity for pharmacists to assist in refills. Currently, inadequate evidence is available to support this intervention. Objective: To compare the rate of medication management interventions (MMIs - drug therapy changes, laboratory monitoring ordered, or office visit scheduled) initiated by the pharmacist-managed authorization center (PMAC) to usual care. Methods: A retrospective, noninferiority study looked at 4000 RARs from 6 primary care centers from January 2016 through March 2017. The primary endpoint compared the rate of MMIs between PMAC and usual care. Noninferiority was concluded if the upper limit of the 95% CI of the difference in interventions was <2%. Secondary endpoints included total, type, and acceptance rate of PMAC recommendations. Results: A total of 3830 patients were included, with 4732 medications requested (2183 reviewed by PMAC and 2549 by usual care). MMIs occurred in 153 medications within PMAC (7.0%) versus 90 for usual care (3.5%). The difference in total MMIs between PMAC and usual care was -3.5% (95% confidence interval = -4.8% to -2.2%). Medications reviewed by PMAC had significantly higher number of laboratory monitoring (P = .036) and scheduled appointments (P < .001). There were 294 PMAC recommendations (13.5%) with a 52.0% acceptance rate. Conclusion and Relevance: This study showed that PMAC was superior to usual care for reviewing RARs. There was a statistically significant improvement in medication monitoring and patient follow-up, supporting the idea of including a pharmacist in the decision making.

P6370Epidemiology of arterial hypertension in one of the regions of Russia

Abstract Aim To study the dynamics of the prevalence, awareness, risk factors (RF) and treatment of arterial hypertension (AH) among men and women according to a survey of a representative sample of the population of the Ryazan region (RR) in 2007–2016. Materials and methods In 2002, as a part of the Russian epidemiological “EPOCH” study, a representative sample of the RR population (2098 people, average age 44.8±18.6 years) was formed and surveyed using step-by-step randomization of medical institutions, medical districts and apartments. A repeated survey of the sample was conducted in 2007 (1,760 people, response 83.9%) and in 2016 (1,497 people, response 85.1%). The AH group included persons with blood pressure ≥140/90 mmHg detected during the double measurement and with normal blood pressure while receiving antihypertensive therapy. In individuals with AH the risk factors were assessed: smoking, alcohol abuse, salt abuse, obesity, burdened family history, low physical activity. Results The prevalence of AH over the past 9 years has increased from 39.3% to 43.9%, p&lt;0.001. The age-standardized prevalence of AH among women is higher than among men as in 2007 (42.1% versus 34.8%, p&lt;0.001) and in 2016 (46.9% vs. 41.8%, p&lt;0.05). Women's awareness about having AH increased from 83.9% to 88.9%, p&lt;0.05, in men it decreased (84.0% against 77.4% in 2007, p&gt;0.05). In the group of persons with AH, the more common risk factors are older age (56.8%), hereditary predisposition (58.9%), low physical activity (96.0%) and obesity (34.3%) compared with persons without AH (12.9%, 48.2%, 84.5% and 9.2%, respectively), they smoke less often (10.7% versus 23.2%) and use extra salt less often (29.5% against 38.4%), p&lt;0.001. The number of patients taking antihypertensive drugs reached 91.2% against 84.0% in 2007, p&lt;0.001. There was a decrease in the number of AH patients who: are treated intermittently (from 12.3% to 3.6%, p&lt;0.001), who take drugs only when blood pressure is high (from 16.2% to 6.2%, p&lt;0.001). The most frequently used antihypertensive drugs are still ACE inhibitors (64.8%), beta-blockers (48.9%), diuretics (42.5%), ARBs (29.2%) and calcium channel blockers (21.3%). The ratio of effectively treated AH patients increased in men from 14.6% to 27.8%, p&lt;0.001, in women from 25.0% to 39.5%, p&lt;0.001. A negative influence on the effectiveness of therapy was caused by smoking (RR 1.23; CI 1.11–1.37, p=0.005), salt abuse (RR 1.11; CI 1.06–1.23, p=0.04) and obesity (RR 1.16; CI 1.06–1.27, p=0.003). Conclusion Over the past nine years, the prevalence of hypertension in both the men and women has significantly increased in the Ryazan region. Increased treatment coverage and positive changes in drug therapy led to an increase in the number of effectively treated patients (from 21.4% to 35.5%, p&lt;0.001). Obesity, smoking, salt abuse are associated with an increased risk of non-effectiveness of hypertension therapy.

P20 Biosimilar use in children and young people with juvenile idiopathic arthritis in a real-world setting in the United Kingdom

Abstract Background Most research concerning biosimilar use in musculoskeletal diseases has been conducted in adults. Little to no data regarding the use of biosimilars in children and young people with juvenile idiopathic arthritis (JIA) exist. Our aim was to describe the characteristics of children and young people with JIA starting biosimilars in the United Kingdom (UK) with musculoskeletal diseases. Methods The Biologics for Children with Rheumatic Diseases (BCRD) study is an ongoing prospective UK study recruiting children and young people with JIA starting biologic therapies other than etanercept originator (followed in a separate parallel study) from 2010 onwards. Baseline information is collected via questionnaires completed by the treating physician or affiliated clinical research nurse. Follow-up data including disease activity measures and changes in drug therapy are collected at six months, one year and annually thereafter. From May-2015, data has been captured on anti-TNF biosimilars in the UK. Results To 18 June 2019, 159 patients had started a biosimilar; 84 (53%) infliximab (2 products), 60 (38%) etanercept (2 products), and 15 (9%) adalimumab. Of these, 53 (33%) started the biosimilar as their first biologic therapy. Fifty (31%) patients switched from their originator, median (IQR) time on originator before switch was 2.2 (1.1-4.1) years, with most citing cost or hospital policy (n = 22) as the reason and these patients had low disease activity (median active joint count was zero) at point of switch. Fifty-six (35%) patients switched to a biosimilar from a non-originator biologic with 37 (66%) switching for efficacy reasons and 13 (23%) for safety reasons, with higher disease activity reported (median active joint count was three); most (n = 32) switching from adalimumab. Follow-up data was available in 143 patients; median follow-up time was 1.1 (0.7, 1.9) years. Sixty-seven patients switched to another biologic in this period. The majority (n = 38) switched to a non-originator biologic, predominantly adalimumab (n = 22) or tocilizumab (n = 14). Nineteen patients switched between infliximab biosimilars. Ten patients switched to the originator biologic (two due to inefficacy, four due to adverse events, four due to painful injections), although only four of these were on the originator prior to starting biosimilar; overall, in patients who switched from originator to biosimilar, 8% switched back to the originator. Conclusion Biosimilars in children and young people with JIA are being used as both first-line and subsequent-line biologic therapy. Patients starting a biosimilar from an originator product had lower disease activity and reported switching due to cost reasons, whilst patient starting a biosimilar from a non-originator were doing so due to inefficacy. Overall tolerance of biosimilar appears to be good so far, with few patients switching back to the originator. It is imperative that these patients continue to be followed within the registers so that effectiveness and safety of these treatments can be captured. Conflicts of Interest The authors declare no conflicts of interest.

Blood pressure phenotype reproducibility in CKD outpatients: a clinical practice report.

Out-of-office blood pressure (BP) measurement is encouraged by recent hypertension guidelines for assessing BP phenotypes. These showed acceptable reproducibility in the short term, but few data exist about long-term reproducibility, particularly for chronic kidney disease (CKD) patients. We evaluated changes of the BP phenotypes at 6 and 12months in 280 consecutive non-dialysis CKD outpatients (186 males, age 71 ± 12years, eGFR 38 ± 13ml/min/1.73), without any change in drug therapy. Elevated BP is defined as office BP > 140/90 and home BP > 135/85mmHg for defining the following BP phenotypes: sustained uncontrolled hypertension (SUCH); white-coat uncontrolled hypertension (WUCH); masked uncontrolled hypertension (MUCH); and controlled hypertension (CH). At baseline, the prevalence of the phenotypes was SUCH 36.6%, CH 30.1%, WUCH 25.4% and MUCH 7.9%, and it was similar at 6months and 12months. On the other hand, individual phenotype reproducibility at 12 months was poor both overall (38.0%) and across the different phenotypes (SUCH 53.9%, WUCH 32.4% and CH 32.1%, MUCH 9.1%). Patients who were not maintaining the same phenotype (non-concordant) were not distinguished by age, sex, BMI, eGFR, presence of diabetes or cardiovascular disease, or pharmacological therapy. When reproducibility of BP phenotypes both at 6months and at 12months was assessed, it was very low (19.6%), particularly for MUCH (0%), CH (14%) and WUCH (15.5%), while it was 31% for SUCH. In a CKD cohort, the overall prevalence of the different BP phenotypes defined by office and home BP remains constant over time. However, only 38% of patients maintained the same phenotype at 12months, suggesting a poor reproducibility over time for the BP phenotypes.

TP2 COMMUNITY RHEUMATOLOGISTS' EXPERIENCE AND VIEWS ON NON-MEDICAL SWITCHING TO BIOSIMILARS

Chronic disease management requires sequential drug treatments, as toxicities develop and responses wane. Non-medical switching (NMS) is described as a change in drug therapy for non-clinical reasons, such as payer formulary, economic, or patient preference. This study aimed to assess community rheumatologists’ experience with and perceptions of NMS between originator biologics and their biosimilars in routine clinical practice. We surveyed US-based rheumatologists from various geographic locations and practice types in October and November 2018 to understand NMS of originator to biosimilars for rheumatoid arthritis (RA). Physician characteristics and responses were summarized using descriptive statistics. Among 54 participating rheumatologists, 45% practiced in suburban areas and 7% rural; 24% were solo practitioners, and 38% were from a small, medium, or large private community practice. Mean years in practice were 19 years (range 3-40). Biosimilars were used among 33 (61%) participating rheumatologists to treat patients with RA. Over one-third of rheumatologists reported increased use of biosimilars. Most common concerns for prescribing biosimilars were efficacy (43%), safety (41%), and patient’s insurance policy constraint (31%). Of 25 rheumatologists who switched at least one RA patient from Remicade (originator) to Inflectra (biosimilar) in the past year, 56% reported that NMS comprised >75% of these switches. Approximately one-third (35%) reported that prescribing biosimilars provided cost-savings to their practice and/or patients, one-third reported that they were not cost-saving, and the remaining 31% were not aware of the cost. The use of biosimilars for RA patients is increasing among US rheumatologists. The majority of the switching appears to be for non-medical reasons, and a minority of rheumatologists report cost-savings related to biosimilars. Further research is needed to assess the cost-effectiveness and comparative effectiveness of biosimilars versus originator biologics in RA.

Cardiac pacing in cardioinhibitory syncope in children.

Reflex vasovagal-or cardioinhibitory syncope is known to be a major cause of recurrent syncope in children. The mechanism of vasovagal syncope (VVS) is an interaction between a vagally mediated bradycardia or asystole and a more or less manifest vasodilatory component. Although pacing is not advisable as a standard approach in patients with VVS, it remains a treatment option of last resort in exceptionally severe cases, or patients with contraindication or refractoriness to drug therapy and life style changes. To effectively avoid VVS in these patients, the pacemaker has to both prevent bradycardia and to compensate for the vasodilatory component. Therefore, this study aimed to evaluate a simple pacemaker setting (VVI pacing with hysteresis) with the potential to prevent VVS in affected children. Clinical data of patients, who were presented to the Department for Pediatric Cardiology, Heart Center Leipzig, in the period of 2001-2017 for cardiac pacemaker implantation for cardioinhibitory syncope or pallid breath-holding spells, were collected retrospectively. Eleven pediatric patients, median age 2.7 (0.8-17) years, were included. Pacemaker settings are depicted. In 10 out of 11 patients, an entire abolishment of syncope could be achieved (P=.002). The presented VVI pacing with hysteresis seems to be a promising pacemaker setting in pediatric patients with cardioinhibitory syncope who need a pacemaker. Unnecessary ventricular stimulation is effectively avoided, while cardiac output is preserved during cardioinhibition, by providing a sufficient paced heart rate, compensating for the often present vasodilatory component.

Assessment of drug related problems and clinical pharmacist interventions in paediatric department of a tertiary care teaching hospital

Background: Drug-related problems (DRPs) are frequent in hospitalization in pediatrics. The main aim of present investigation is to assess drug related problems and clinical pharmacist interventions in pediatric department of tertiary care hospital.Methods: It was a prospective, observational and interventional study carried over a period of 6 months.Results: A total of 66 patients were identified with drug related problems. Among them 31 (42%) were in between 1month–2 years followed by 25 (34%) were in between 2-11 years, 10(24%) were in between 11-18 years of age. 30(45.3%) patients were prescribed with 0-3 drugs followed by 21 (31.3%) were prescribed with 3-5 drugs, 15(23.3%) were prescribed with 6-10 drugs. Most of the DRP’s observed in the study were drug interactions 52(78.78%) [major-19 (36.53%), moderate-27 (5192%) and minor-6(11.53%)] followed by adverse drug reactions 12 (18.18%), and duplication errors were 2 (3.03%). Majority of the clinical pharmacist recommendations were duration change 52 (34.66%), drug change 10(6.66%), dose reduction 2 (1.35%) followed by drug termination 2 (1.33%). Major significance of DRPs were noted high 31(57.96%), whereas 25 (39.8%) were moderate and 8 (12.12%) were minor. The acceptance rate of intervening clinical pharmacist recommendation and change in drug therapy was found to be high in 57 (86.66%) cases while in 9 (13.33%) cases suggestions were accepted but therapy was not changed. There were no cases with neither suggestion were accepted nor therapy changed.Conclusions: Clinical pharmacist involvement in inpatient pediatric care can significantly help to identify, resolve and prevent the drug related problems. The study concluded that the clinical pharmacist has a significant role in patients care at hospital.

Real-world incidence of patient-reported dyspnoea with ticagrelor.

Dyspnoea, a common and multifactorial symptom in patients with acute coronary syndrome, has been associated with lower quality of life and hospital readmission. Prescriber preference for antiplatelet therapy, the standard of care in this patient group, is shifting to ticagrelor due to mortality benefits demonstrated in trials compared with clopidogrel. In these trials, dyspnoea was more commonly reported in patients prescribed ticagrelor but the aetiology is still debated. An observational cohort study was conducted to quantify the rates and severity of dyspnoea reported in patients with acute coronary syndrome and newly prescribed ticagrelor compared with those prescribed clopidogrel. Dyspnoea was more commonly reported in patients prescribed ticagrelor at each follow up post-discharge (p = 0.016). Rates were higher than previously reported in clinical trials. In some patients, dyspnoea necessitated drug therapy change and was associated with readmission to hospital (p = 0.046). As ticagrelor is widely prescribed as a first-line antiplatelet agent for a range of patients with acute coronary syndrome, the incidence of dyspnoea in a generalized patient cohort may result in higher rates of drug discontinuation. This in turn could lead to higher rates of rehospitalisation and potential treatment failure than that reported from the controlled setting of a clinical trial.

Medication Plans at Hospital Admission - a Multicentre Analysis Using Statutory Health Insurance Data

Changes in drug therapy at intersectoral interfaces can lead to clinically relevant drug-related problems. This study aimed, therefore, at comparing the drug prescription continuity of patients with and without a medication plan at hospital admission. After ethical approval, patients of a health insurance company in 6 hospitals in Saxony were consecutively assigned to this study from November 2011 to January 2012 after written informed consent. We assessed the following drug-related data for patients with and without medication plan at hospital admission: (i) the medication prescribed by the hospital physician on the day of hospital admission and (ii) the medication of the hospital discharge letter. Patient-individual claims data were assigned to the inpatient data for a period of 6 months before and after inpatient treatment (data linkage). Of the 279 study participants, 173 (62 %) used a medication plan at hospital admission. Patients with a medication plan had a statistically significantly older age, higher numbers of drugs and diagnoses and fewer emergency admissions. At admission 53 % of the drugs were continued in patients with medication plan and 40 % in patients without a medication plan (p < 0.001). At hospital discharge 66 % and 64 % were continued after discharge (n. s.). Medication plans were mostly written by their GP (38 %) and in 12 % by the patients themselves. Even before implementation of the national medication plan, nearly two third of the patients had a medication plan at hospital admission. However, in many cases it had been prepared by the patients themselves. The existence of amedication plan can have an impact on the continuity of the drug prescription during hospitalisation but not after discharge.

Subjective well-being, drug attitude, and changes in symptomatology in chronic schizophrenia patients starting treatment with new-generation antipsychotic medication

BackgroundNon-adherence to medication remains a major challenge in the long-term management of patients with schizophrenia. Next to lack of insight into the illness, adverse effects of antipsychotic drugs, cognitive deficits, poor therapeutic alliance, reduced quality of life, missing social support, and negative attitudes toward medication are predictors of non-adherence. This study examined potential correlations between attitudes toward antipsychotic drug therapy, subjective well-being, and symptom change in patients with chronic schizophrenia.Methods30 patients with schizophrenia starting monotherapy with a new-generation antipsychotic were included into the study. The Drug Attitude Inventory (DAI) and the Subjective Well-being under Neuroleptic Treatment Scale, short form (SWN-K), were administered after 2, 4, and 12 weeks of treatment. At the same points in time and at baseline, psychopathological symptoms were rated by means of the Positive and Negative Syndrome Scale (PANSS), and functioning was assessed by means of the Global Assessment of Functioning Scale (GAF). Antipsychotic induced side effects were evaluated by using the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale.ResultsStudy participants had a mean age of 37.5 ± 9.7 years, baseline symptoms were mild. The PANSS total score improved significantly from baseline to weeks 4 (p = .003) and 12 (p = .001), respectively. Neither the DAI total score nor the SWN-K total score changed significantly over the course of time. The severity of symptoms was not correlated with drug attitude at any time point but was negatively correlated with wellbeing at weeks 2 (r = −.419, p = .021) and 4 (r = −.441, p = .015). There was no significant correlation between DAI and SWN-K total scores at any time point.ConclusionsNext to showing that the DAI and the SWN-K measure different aspects of subjective experiences during antipsychotic treatment these findings emphasize the use of both instruments to optimize adherence to medication.

Older Peoples' Adherence and Awareness of Changes in Drug Therapy after Discharge from Hospital.

Non-adherence is important to address because it might affect the effectiveness of therapy and lead to adverse effects. The objectives of this interview study were to investigate old peoples’ general adherence to drugs and their awareness of and adherence to changes in drug therapy after their hospital stay. Following ethical approval, 42 patients admitted to the medical ward were invited to participate in this study. Of these, 36 persons, with a mean age of 82.5 years, who were discharged to their home, were interviewed by telephone using the Medical Adherence Report Scale (MARS) to assess their general adherence to prescribed drugs. Questions regarding awareness and adherence to drug changes during their hospital stay were asked. Different factors related to adherence and non-adherence were investigated using the Pearson chi-square test and the independent sample t-test. The average MARS score was 23.9 ± 1.4, with 31 persons (86%) assessed as adherent to their drug therapy and 5 persons (14%) as non-adherent. Of the 36 people, 30 had at least one change in their drug therapy during their hospital stay, and 23 (77%) of these people were aware of all changes and 23 (77%) were adherent to all of the changes. No significant differences between adherence and age, gender, living situation, or number of drugs were found. This small study found that some older people who were discharged from hospital were generally non-adherent, and some were not aware of or adherent to changes made in the drug therapy during their hospital stay. This is an important problem to address with further interventions.