Research Pharmacist Research Articles

Delivering Pharmacogenetic Testing in the Community Setting

Click to increase image sizeClick to decrease image size Additional informationNotes on contributorsMark WagnerMark Wagner, PharmD, completed his PGY2 oncology pharmacy practice residency at St. Luke's MSTI in 2016 and is practicing as a clinical oncology pharmacist at the Cowell Family Cancer Center. Jessie Modlin, PharmD, is research pharmacist; Jennifer Eichmeyer, MS, CGC, is lead genetic counselor; and Jessica Monitz, PharmD, completed her PGY1 pharmacy practice residency at St. Luke's Medical Center. Paul Montgomery, MD, is the medical director of MSTI Research and one of three principal investigators of the newly formed Pacific Cancer Research Consortium that includes Providence Portland Medical Center, Swedish Cancer Institute; and Mountain States Tumor Institute. Natalie Perry is research project coordinator at MSTI.Jennifer EichmeyerMark Wagner, PharmD, completed his PGY2 oncology pharmacy practice residency at St. Luke's MSTI in 2016 and is practicing as a clinical oncology pharmacist at the Cowell Family Cancer Center. Jessie Modlin, PharmD, is research pharmacist; Jennifer Eichmeyer, MS, CGC, is lead genetic counselor; and Jessica Monitz, PharmD, completed her PGY1 pharmacy practice residency at St. Luke's Medical Center. Paul Montgomery, MD, is the medical director of MSTI Research and one of three principal investigators of the newly formed Pacific Cancer Research Consortium that includes Providence Portland Medical Center, Swedish Cancer Institute; and Mountain States Tumor Institute. Natalie Perry is research project coordinator at MSTI.Paul G. MontgomeryMark Wagner, PharmD, completed his PGY2 oncology pharmacy practice residency at St. Luke's MSTI in 2016 and is practicing as a clinical oncology pharmacist at the Cowell Family Cancer Center. Jessie Modlin, PharmD, is research pharmacist; Jennifer Eichmeyer, MS, CGC, is lead genetic counselor; and Jessica Monitz, PharmD, completed her PGY1 pharmacy practice residency at St. Luke's Medical Center. Paul Montgomery, MD, is the medical director of MSTI Research and one of three principal investigators of the newly formed Pacific Cancer Research Consortium that includes Providence Portland Medical Center, Swedish Cancer Institute; and Mountain States Tumor Institute. Natalie Perry is research project coordinator at MSTI.Jessica MonitzMark Wagner, PharmD, completed his PGY2 oncology pharmacy practice residency at St. Luke's MSTI in 2016 and is practicing as a clinical oncology pharmacist at the Cowell Family Cancer Center. Jessie Modlin, PharmD, is research pharmacist; Jennifer Eichmeyer, MS, CGC, is lead genetic counselor; and Jessica Monitz, PharmD, completed her PGY1 pharmacy practice residency at St. Luke's Medical Center. Paul Montgomery, MD, is the medical director of MSTI Research and one of three principal investigators of the newly formed Pacific Cancer Research Consortium that includes Providence Portland Medical Center, Swedish Cancer Institute; and Mountain States Tumor Institute. Natalie Perry is research project coordinator at MSTI.Jessie ModlinMark Wagner, PharmD, completed his PGY2 oncology pharmacy practice residency at St. Luke's MSTI in 2016 and is practicing as a clinical oncology pharmacist at the Cowell Family Cancer Center. Jessie Modlin, PharmD, is research pharmacist; Jennifer Eichmeyer, MS, CGC, is lead genetic counselor; and Jessica Monitz, PharmD, completed her PGY1 pharmacy practice residency at St. Luke's Medical Center. Paul Montgomery, MD, is the medical director of MSTI Research and one of three principal investigators of the newly formed Pacific Cancer Research Consortium that includes Providence Portland Medical Center, Swedish Cancer Institute; and Mountain States Tumor Institute. Natalie Perry is research project coordinator at MSTI.Natalie PerryMark Wagner, PharmD, completed his PGY2 oncology pharmacy practice residency at St. Luke's MSTI in 2016 and is practicing as a clinical oncology pharmacist at the Cowell Family Cancer Center. Jessie Modlin, PharmD, is research pharmacist; Jennifer Eichmeyer, MS, CGC, is lead genetic counselor; and Jessica Monitz, PharmD, completed her PGY1 pharmacy practice residency at St. Luke's Medical Center. Paul Montgomery, MD, is the medical director of MSTI Research and one of three principal investigators of the newly formed Pacific Cancer Research Consortium that includes Providence Portland Medical Center, Swedish Cancer Institute; and Mountain States Tumor Institute. Natalie Perry is research project coordinator at MSTI.

Obtaining i.v. fosfomycin through an expanded-access protocol.

One hospital's experience with procuring i.v. fosfomycin via an expanded-access protocol to treat a panresistant infection is described. In mid-2014, a patient at a tertiary care institution had an infection caused by a gram-negative pathogen expressing notable drug resistance. Once it was determined by the infectious diseases (ID) attending physician that i.v. fosfomycin was a possible treatment for this patient, the ID pharmacist began the process of drug procurement. The research and ID pharmacists completed an investigational new drug (IND) application, which required patient-specific details and contributions from the ID physician. After obtaining approval of the IND, an Internet search identified a product vendor in the United Kingdom, who was then contacted to begin the drug purchasing and acquisition processes. Authorization of the transaction required signatures from key senior hospital administrators, including the chief financial officer and the chief operating officer. Approximately 6 days after beginning the acquisition process, the research pharmacist arranged for the wholesaler to expedite product delivery. The ID pharmacist contacted the wholesaler's shipping company at the U.S. Customs Office, providing relevant contact information to ensure that any unexpected circumstances could be quickly addressed. The product arrived at the U.S. Customs Office 8 days after beginning the acquisition process and was held in the U.S. Customs Office for 2 days. The patient received the first dose of i.v. fosfomycin 13 days after starting the expanded-access protocol process. I.V. fosfomycin was successfully procured through an FDA expanded-access protocol by coordinating efforts among ID physicians, pharmacists, and hospital executives.

LO051: Validation of a clinical decision rule to detect patients with adverse drug events in the emergency department

Introduction: Adverse drug events (ADE) are a leading cause of emergency department (ED) visits, yet are missed in up to 50% of presentations. In 2014, Accreditation Canada, a not-for-profit organization that evaluates healthcare institutions based on quality of care, introduced a requirement for EDs to identify patients at high-risk for drug-related morbidity, so that medication management interventions can be targeted to high-risk groups. We derived a clinical decision rule to identify patients at high-risk for ADEs using 4 variables. Our objective was to validate the rule by determining its sensitivity and specificity in a new sample. Methods: We conducted a prospective observational study in two tertiary care and one urban community hospital in British Columbia and Ontario. We used a systematic selection algorithm to generate a representative sample, and enrolled adults who reported taking at least one medication during the prior two weeks. Nurses completed the clinical decision rule and evaluated patients for standardized clinical findings. Each patient was assessed by a research pharmacist and a physician who were blinded to data collected by nurses. Any disagreement was subsequently adjudicated by an independent committee. The primary outcome was an ADE, defined as an unintended and harmful event related to medication use resulting a change in medical management, hospital admission or causing death. We calculated the rule’s sensitivity, specificity, and the proportion of patients screening positive with 95% confidence intervals (CI). Results: Among 1529 enrolled patients, 196 (12.8%, 95% CI 11.2-14.6%) were deemed to have experienced an ADE. The rule, consisting of the variables (i) having a pre-existing medical condition or having taken antibiotics within one week, and (ii) age ≥ 80 or having a medication change within 28 days, had a sensitivity of 92.9% (95%CI 88.3%-96.0%) and a specificity of 35.0% (95%CI 32.5%-37.7%) for ADEs. The proportion of patients screening positive was 41.7%. Conclusion: Among adults presenting to EDs, the rule was sensitive for ADEs while maintaining reasonable specificity. If implemented, the rule may help identify those patients at high-risk for ADEs who may benefit from evaluation by a clinical pharmacist in the ED, and will help institutions meet current Accreditation Canada standards.

Attitude, barriers and facilitators to practice-based research: cross-sectional survey of hospital pharmacists in Saudi Arabia.

BackgroundLittle is known about the perceived attitude, barriers and facilitators of Saudi Pharmacists about practice based research. We aimed to measure the attitude, barriers, and facilitators of Saudi hospital pharmacists towards pharmacy practice research.MethodA cross-sectional survey of hospital pharmacists (n = 216) working in King Abdulaziz Medical Cities in Central, Eastern and Western region hospitals was conducted during first week of September, 2013. The survey instrument comprised of six different sections that explored pharmacists previous participation in research, items regarding attitude, perception and willingness to participate, motivators, barriers, different areas of interest for doing research and patient demographics. Quantitative data collected was initially explored using frequency distribution, and descriptive analysis was carried out. Mann-Whitney U and independent samples t-test were used to explore the differences between the study variables.ResultsOne hundred and eighty two pharmacists completed the survey yielding a response rate of 84 %. Fifty-nine percent of pharmacists have prior research experience. Pharmacists with research experience were more confident in reading and evaluating research papers (p = 0.01), and designing a research study (p = 0.001). Pharmacists with previous research experience were also more likely to participate in future research opportunities (p = 0.004) and were confident in their research skills (p = 0.003). No differences were observed about the perceived value of research, facilitators and barriers to participate in research, between pharmacists with prior research experience and pharmacists who have no prior experience to do research.ConclusionPharmacists in this study were unanimous about the importance of research but showed considerable differences in their confidence to carry out research. There is a need to provide additional support to enable Saudi pharmacists in conducting practice based research.Electronic supplementary materialThe online version of this article (doi:10.1186/s40545-016-0052-z) contains supplementary material, which is available to authorized users.

The potential and prospects of proximal remote sensing of arthropod pests.

Bench-top or proximal remote sensing applications are widely used as part of quality control and machine vision systems in commercial operations. In addition, these technologies are becoming increasingly important in insect systematics and studies of insect physiology and pest management. This paper provides a review and discussion of how proximal remote sensing may contribute valuable quantitative information regarding identification of species, assessment of insect responses to insecticides, insect host responses to parasitoids and performance of biological control agents. The future role of proximal remote sensing is discussed as an exciting path for novel paths of multidisciplinary research among entomologists and scientists from a wide range of other disciplines, including image processing engineers, medical engineers, research pharmacists and computer scientists. © 2015 Society of Chemical Industry.

Protocol for a Prospective (P) study to develop a model to stratify the risk (RI) of medication (M) related harm in hospitalized elderly (E) patients in the UK (The PRIME study).

BackgroundMedication related harm (MRH) is a common cause of morbidity and hospital admission in the elderly, and has significant cost implications for both primary and secondary healthcare resources. The development of risk prediction models has become an increasingly common phenomenon in medicine and can be useful to guide objective clinical decision making, resource allocation and intervention. There are no risk prediction models that are widely used in clinical practice to identify elderly patients at high risk of MRH following hospital discharge. The aim of this study is to develop a risk prediction model (RPM) to identify elderly patients at high risk of MRH upon discharge from hospital, and to compare this with routine clinical judgment.Methods/DesignThis is a multi-centre, prospective observational study following a cohort of patients for 8 weeks after hospital discharge. Data collection including patient characteristics, medication use, social factors and frailty will take place prior to patient discharge and then the patient will be followed up in the community over the next 8 weeks to determine if they have experienced MRH. Research pharmacists will determine whether patients have experienced MRH by prospectively reviewing records for unplanned emergency department attendance, hospital readmission and GP consultation related to MRH. Research pharmacists will also telephone patients directly to determine self-reported MRH, which patients may not have sought further medical attention for. The data collected will inform the development of a RPM which will be externally validated in a follow-up study.DiscussionThere are no RPMs that are used in clinical practice to help stratify elderly patients at high risk of MRH in the community following hospital discharge, despite this being a significant public health problem. This study plans to develop a clinically useful RPM that is better than routine clinical judgment. As this is a multi-centre study involving clinical settings that serve elderly people of heterogeneous sociodemographic background, it is anticipated that this RPM will be generalizable.Electronic supplementary materialThe online version of this article (doi:10.1186/s12877-016-0191-8) contains supplementary material, which is available to authorized users.

Assessment of Drug Related Problems in Patients with Chronic Diseases through Health Status Survey in a South Indian Rural Community Setting

A prospective study has been carried out to assess the incidence, prevalence and cost implications of drugrelated problems in patients with chronic diseases dwelling in a south Indian rural community setting. Details of patients with chronic diseases were recorded in a suitably designed data collection form and assessed for the potential drug-related problems in the prescriptions with the patient’s consent. Hepler and Strand classification was used to categorize the identified drug related problems. Each drug-related problem was assessed for its significance level and graded either as minor, moderate or major based on expected clinical outcome. Cost implications due to drug-related problems were also evaluated. During the study period, the research pharmacist visited 550 houses and interviewed 2370 people. Among the interviewed individuals, 215 (8.36%) people were found with chronic diseases. A total of 90 drug-related problems were observed in the patients’ prescriptions who met the study criteria. Noncompliance (22), untreated indications (18) and drug interactions (14) were the most commonly found drug-related problems. Among all drug-related problem’s, 9 drug related problems were graded as major, 37 were moderate and 44 were minor in severity. It is estimated that, a sum of 84 64 950 rupees could have been saved through the pharmacist intervention.

Utilisation of Nicotine Replacement Therapy within a Hospital Pharmacist Initiated Smoking-Cessation Intervention – A Pragmatic Randomised Controlled Trial

Introduction:Hospital pharmacists currently play a limited role in the management of nicotine withdrawal and smoking-cessation. They have multiple tasks and limited time; a strong evidence base is required to determine importance of including smoking-cessation interventions into their routine practice.Aims:The aims of this study were to evaluate the effectiveness of a hospital pharmacist initiated smoking-cessation intervention (SCI) in increasing the utilisation of Nicotine Replacement Therapy (NRT) in hospitalised smokers, and in increasing quit rates post-discharge.Methods:This study was conducted in a tertiary referral hospital using a pragmatic randomised control design. After screening, 100 inpatient smokers were enrolled and randomised by the research pharmacist (RP) to either the intervention or usual care arm (n= 50 for both arms). Smoking-cessation advice was available to all smokers during their hospital stay under the smoking management policy, which represented usual care. However, this approach is often unstructured and provided on an ad-hoc basis. Those in the intervention arm received brief SCI from the RP, who also facilitated NRT prescribing if required. Prescribing rates of NRT in the hospital and on discharge in both the groups were compared. Participants were contacted by phone three-months after enrolment to assess their seven-day point prevalence of abstinence (PPA) from smoking and use of NRT post-discharge.Results:A significantly higher proportion of participants in the intervention arm used NRT in the hospital (82% vs. 24%,Χ2= 33.8,p< 0.001) and at discharge (68% vs. 12%,Χ2= 32.7,p< 0.0001) and significantly more participants who received SCI from the RP continued to use NRT after discharge (OR 3.1, CI 1.2 to 8.2). A similar number of participants in both the groups claimed seven-day PPA after three-months (18% usual-care vs. 15% intervention-arm, OR 0.8, CI 0.24 to 2.67).Conclusions:Hospital pharmacist led brief SCI can enhance the utilisation of NRT in hospital and after discharge; there was no clear effect on cessation rates at three months. There is a need to explore feasible options for a coordinated, multidisciplinary approach to smoking-cessation in hospital and across the continuum, which may have a greater impact on long term smoking-cessation rates.

Efficacy, safety, and tolerability of augmentation pharmacotherapy with aripiprazole for treatment-resistant depression in late life: a randomised, double-blind, placebo-controlled trial

Treatment-resistant major depression is common and potentially life-threatening in elderly people, in whom little is known about the benefits and risks of augmentation pharmacotherapy. We aimed to assess whether aripiprazole is associated with a higher probability of remission than is placebo. We did a randomised, double-blind, placebo-controlled trial at three centres in the USA and Canada to test the efficacy and safety of aripiprazole augmentation for adults aged older than 60 years with treatment-resistant depression (Montgomery Asberg Depression Rating Scale [MADRS] score of ≥15). Patients who did not achieve remission during a pre-trial with venlafaxine extended-release (150-300 mg/day) were randomly assigned (1:1) to the addition of aripiprazole (target dose 10 mg [maximum 15 mg] daily) daily or placebo for 12 weeks. The computer-generated randomisation was done in blocks and stratified by site. Only the database administrator and research pharmacists had knowledge of treatment assignment. The primary endpoint was remission, defined as an MADRS score of 10 or less (and at least 2 points below the score at the start of the randomised phase) at both of the final two consecutive visits, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00892047. From July 20, 2009, to Dec 30, 2013, we recruited 468 eligible participants, 181 (39%) of whom did not remit and were randomly assigned to aripiprazole (n=91) or placebo (n=90). A greater proportion of participants in the aripiprazole group achieved remission than did those in the placebo group (40 [44%] vs 26 [29%] participants; odds ratio [OR] 2·0 [95% CI 1·1-3·7], p=0·03; number needed to treat [NNT] 6·6 [95% CI 3·5-81·8]). Akathisia was the most common adverse effect of aripiprazole (reported in 24 [26%] of 91 participants on aripiprazole vs 11 [12%] of 90 on placebo). Compared with placebo, aripiprazole was also associated with more Parkinsonism (15 [17%] of 86 vs two [2%] of 81 participants), but not with treatment-emergent suicidal ideation (13 [21%] of 61 vs 19 [29%] of 65 participants) or other measured safety variables. In adults aged 60 years or older who do not achieve remission from depression with a first-line antidepressant, the addition of aripiprazole is effective in achieving and sustaining remission. Tolerability concerns include the potential for akathisia and Parkinsonism. National Institute of Mental Health, UPMC Endowment in Geriatric Psychiatry, Taylor Family Institute for Innovative Psychiatric Research, National Center for Advancing Translational Sciences, and the Campbell Family Mental Health Research Institute.

Polyphenon E, non-futile at neuroprotection in multiple sclerosis but unpredictably hepatotoxic: Phase I single group and phase II randomized placebo-controlled studies

ObjectivesPhase I (PhI): assess the safety of Polyphenon E in people with multiple sclerosis (MS) and determine the futility of Polyphenon E as a neuroprotective agent. Correlate plasma levels of EGCG with neuroprotective effects.Phase II (PhII): Further assess safety and confirm the neuroprotective effects of Polyphenon E. DesignPhI: single group futility study. PhII: parallel group randomized double-blind placebo-controlled study. ParticipantsRecruitment area (both studies): LSU MS Center, New Orleans, LA and general public from surrounding areas.Inclusion criteria (both studies): 1) MS per 2005 McDonald criteria; 2) relapsing remitting or secondary progressive MS; 3) stable for six months prior to enrollment on either no therapy or glatiramer acetate (GA) for the PhI study and on either on GA or Interferon β for the PhII study.Exclusion criteria (both studies): 1) complete bone marrow ablation or alentuzumab use at any time; 2) mitoxantrone, cyclophosphamide, natalizumab or fingolimod use in the prior nine months; 3) liver problems or significant medical problems. InterventionsPhI: Polyphenon E, a green tea extract containing 50% of the antioxidant Epigallocatechin-gallate (EGCG), two capsules twice daily (200mg of EGCG per capsule; total daily dose 800mg) for six months.PhII: Polyphenon E or matching placebo capsules, same dose for one year. Only the research pharmacist knew treatment assignment and she randomized participants (one-to-one, stratified by GA or Interferon β, blocks of 4 or 6). Outcome evaluators did not discuss side effects with participants. Outcome measuresPhI: 1) adverse events (AE); 2) futility: decrease in N-acetyl aspartate (NAA) from baseline to six months of 10% or more; 3) association between EGCG plasma levels and change in NAA.PhII: 1) AEs; 2) difference in the rate of change of NAA-levels over twelve months.We measured NAA using a point resolved magnetic resonance spectroscopic imaging sequence (TE30/TR2000) on a 10cm×10cm×1cm volume of interest (VOI) located just superior to the lateral ventricles. The field of view was 16×16 resulting in 1cm3 voxels. We quantified NAA and creatine/phosphocreatine (Cr) levels using LCModel for post-processing. ResultsPhI: Ten participants enrolled and completed all assessments with no serious AEs. One discontinued therapy due to grade (G) I abnormal liver function tests (LFTs). We included all participants in the analysis. NAA adjusted for creatine increased by 10% [95% CI(3.4%,16.2%), p<0.01] rejecting the futility endpoint.PhII: Thirteen participants enrolled and twelve started treatment. The DSMB stopped the study because 5/7 participants on Polyphenon E had abnormal LFTs (G I, and 1G III). Median time to onset of abnormal LFTs was 20weeks [Inter-Quartile Range (IQR) (10,23)]. Only two participants completed the six-month visit, so we could not analyze the NAA levels.PhI participants took capsules from lot 189I1107 while 6/7 PhII participants took capsules from a new lot (L0206306). Both lots had similar levels of EGCG but differed in the levels of minor catechins. There were no significant differences between the lots on participants' median free EGCG plasma levels at either 3h or 8h as well as conjugated EGCG levels at 3h (all p>0.4, Wilcoxon exact test).Free EGCG levels at 8h correlated with changes in NAA adjusted by water content. A 1ng/ml higher EGCG plasma concentration correlated with a 0.9% increase in NAA[95% CI(0.5%,1.4%), visit*level interaction F=14.4, p<0.001]. However, EGCG plasma concentrations did not correlate with NAA adjusted by creatine (1ng/ml higher EGCG was associated with 0.02%,[95% CI(−0.27%,0.3%) change in NAA, p>0.5]). There was a trend towards an increase in creatine levels (referenced to water content) from baseline to exit (1 5% increase, [95% CI(−6%,17%), p=0.4]). The free EGCG levels at 8hours correlated significantly with change in creatine levels (1ng/ml higher EGCG level at 8h was associated with a 1.1% increase in creatine [95% CI(0.6%,1.6%)]). Thus it is possible that the discrepancy between the correlation of the EGCG 8h levels with NAA changes referenced to water and the 8h EGCG levels with NAA changes referenced to creatine was due to a change in creatine among the subjects with higher EGCG levels.Conjugated 3h and 8h levels and free 3h levels did not correlate with NAA changes (all p >0.5). Conclusions/classification of evidenceClass III evidence: Polyphenon E at a dose of 400mg of EGCG twice a day is not futile at increasing brain NAA levels. Class I evidence: some lots of Polyphenon E have a high risk of hepatotoxicity. FundingNational Center for Complementary and Alternative Medicine K23AT004433, National Multiple Sclerosis Society RG4816-A-1 and National Institute of General Medical Sciences 1 U54 GM104940. Mitsui Norin provided Polyphenon E and placebo and their representative reviewed the manuscript prior to publication. Mitsui Norin was not involved in other aspects of the study. The decision to submit the manuscript remained with the investigators. RegistrationNCT00836719 and NCT01451723NCT00836719NCT01451723.

Impact of high dose n-3 polyunsaturated fatty acid treatment on measures of microvascular function and vibration perception in non-alcoholic fatty liver disease: results from the randomised WELCOME trial.

The effect of n-3 fatty acid treatment on vibration perception thresholds (VPTs) and cutaneous microvascular reactivity is not known. We tested whether: (1) a 15-18 month treatment with high dose (4 g/day) docosahexaenoic (DHA) plus eicosapentaenoic (EPA) acid improved VPT and microvascular reactivity in patients with non-alcoholic fatty liver disease; and (2) there are associations between VPT, microvascular reactivity and metabolic variables. In the completed single centre, randomised, parallel group, placebo controlled Wessex Evaluation of fatty Liver and Cardiovascular markers in non-alcoholic fatty liver disease with OMacor thErapy (WELCOME) trial, we tested the effect of DHA+EPA on VPT at 125 Hz (big toe) and the cutaneous hyperaemic response (forearm) to arterial occlusion (ratio of maximum to resting blood flux [MF/RF]). Allocation and dispensing was carried out by an independent research pharmacist; all participants and research team members were blinded to group assignment. In all, 51 and 49 patients were randomised to placebo and DHA+EPA, respectively (mean age 51.4 years). Of these, 32 had type 2 diabetes. Forty-six (placebo) and 47 (DHA+EPA) patients completed the study; there were no important adverse (or unexpected) effects or side effects. In multivariable-adjusted regression models (intention-to-treat analyses), DHA+EPA treatment was associated with an increase in VPT (β coefficient 1.49 [95% CI 0.04, 2.94], p = 0.04). For VPT, the adjusted mean differences (95% CIs) in the placebo and DHA+EPA treatment groups were -0.725 (-1.71, 0.25) and 0.767 (-0.21, 1.75) m/s(2), respectively. With DHA+EPA treatment, there was no change in MF/RF (β coefficient 0.07 [95% CI -0.56, 0.70], p = 0.84), the adjusted mean differences (95% CIs) in the placebo and DHA+EPA treatment groups were -0.549 (-1.03, -0.07) and -0.295 (-0.77, 0.18) respectively. VPT was independently associated with age (β coefficient 0.019 [95% CI 0.010, 0.029], p < 0.0001) and MF/RF (β coefficient -0.074 [95% CI -0.132, -0.016], p = 0.013), but not with diabetes (p = 0.38). High dose n-3 fatty acid treatment did not improve measures of microvascular function or vibration perception. Ageing and microvascular reactivity are associated with a measure of peripheral nerve function. ClinicalTrials.gov NCT00760513. The study was funded by the National Institute for Health Research UK and Diabetes UK.

An Introduction to the Fundamentals of Randomized Controlled Trials in Pharmacy Research

The randomized controlled trial (RCT) is regarded as one of the most valued research methodologies for examining the efficacy or effectiveness of interventions.1 Randomized trials are most often associated with studies of drug effectiveness; however, they have also been successfully applied to research questions related to provision of care by pharmacists.2-5 This article is not intended to be an exhaustive guide on performing an RCT, but rather an introduction to the major concepts and approaches involved in designing and conducting an RCT. Readers requiring additional information are referred to more comprehensive publications6-9 and are encouraged to consult with researchers experienced in this area before undertaking a study. Throughout this paper, individuals enrolled in a study are referred to as “patients”, the individuals delivering the study (e.g., pharmacists in practice research) are referred to as the “investigators”, and those responsible for study design and analysis are referred to as the “study team”. DESIGN OF A RANDOMIZED CONTROLLED TRIAL

Involving community pharmacists in pharmacy practice research: experiences of peer interviewing.

Translation of interest in research into active engagement of community pharmacists as research partners/co-researchers remains a challenge. Involving pharmacists in specific research techniques such as peer interviewing, however, may enhance validity of the results. To enhance community pharmacists' involvement in pharmacy practice research through peer interview training. A subgroup of participants in a multi-phase pharmacy practice research project trained to do peer interviews. These pharmacist interviewers attended a workshop and were mentored. Comments from their feedback forms and ongoing engagement with the Research Associate were thematically analysed. Positive themes from five interviewers included the importance of the topic and their wish to learn skills beyond their everyday role. The small group format of the training day helped to build confidence. Interviewers felt their shared professional background helped them to capture relevant comments and probe effectively. There were challenges, however, for interviewers to balance research activities with their daily work. Interviewers experienced difficulty in securing uninterrupted time with interviewees which sometimes affected data quality by 'rushing'. Community pharmacists can be engaged as peer interviewers to the benefit of the volunteers and research team, but must be well resourced and supported.

Pharmacists' involvement in and attitudes toward pharmacy practice research: A systematic review of the literature.

The role of pharmacists in health care has evolved toward patient-centered care. Pharmacy practice-based research is essential to the advancement of practice; however, literature addressing attitudes and involvement of pharmacists in practice research indicates reluctance among them. An account of studies undertaken thus far is warranted. This systematic review aims to summarize and evaluate the views and attitudes of pharmacists regarding their involvement in pharmacy practice research as well as the barriers and enablers to such research. A systematic review of original studies published mainly in MEDLINE, PubMed, EBSCO, ScienceDirect, ProQuest, and Google Scholar was conducted to identify published studies that report pharmacists' attitudes and involvement in research as well as perceived facilitators and barriers. Data were independently extracted by two reviewers using a standardized data abstraction tool. Fifteen studies utilizing questionnaire-based surveys, focus groups or interviews were identified and included in the review. The majority of studies (10 of 15) involved community pharmacists, while only 6 involved hospital pharmacists. Studies were mostly conducted in the UK (5 of 15), followed by Australia and Canada (3 of 15 each). Early studies focused on pharmacists' attitudes on practice-based research, but most recently there was attention on practice-based research networks (PBRNs). Pharmacists' awareness, interest and willingness to participate in practice research, their actual involvement in research projects, and positive attitude toward research have increased over time. Pharmacists generally believed that practice-based research was needed for professional development of pharmacy and agreed with the importance of research to support evidence-based practice and to improve the quality of patient care and outcomes. The most commonly reported barriers to participation in research across the reviewed studies were: lack of time and workload; insufficient or lack of funds; and lack of research knowledge, training, mentorship and support. Pharmacists recognize the value of research in advancing pharmacy practice and indicate their willingness to be involved in independent research and in PBRNs. Lack of time, training and support were identified as the greatest limitations to participation in practice research. These findings have important implications on promoting research capacity building through the development of PBRNs involving academic and pharmacy practitioners as well as informal research training programs.

Community pharmacist-administered influenza immunization improves patient access to vaccination.

To describe the demographic characteristics and risk factors of patients receiving influenza vaccination in community pharmacies and to understand patient experiences and perceptions surrounding being vaccinated by a pharmacist. Survey data were collected by research pharmacists at 4 different community pharmacy locations in Toronto throughout a period of 8 weeks during October and November 2013. Participation in the survey was voluntary, and all patients vaccinated by pharmacists were invited to complete a survey following immunization. During the course of the study, 2498 vaccine doses were administered among all study sites, and 1502 surveys were completed. Our data showed a high degree of patient satisfaction, with 92% of patients indicating they were very satisfied with the pharmacist's injection technique and the services they received. Furthermore, 86% of patients were very comfortable with being vaccinated by a pharmacist, and 99% of patients reported they would recommend that friends and family be vaccinated by a pharmacist. Convenience and accessibility were major determinants of patient satisfaction, as shown by 46% of all written comments specifically addressing these factors. Of the patients surveyed, 25% were not regular annual vaccine recipients, and 47% were classified as being at high risk for influenza complications according to Public Health Agency of Canada criteria. Notably, 28% of total patients and 21% of high-risk patients reported that they would not have been immunized this year if pharmacy-based vaccination were not available. Our findings suggest that pharmacists provide a highly convenient and accessible option for seasonal flu vaccination that is viewed favourably by patients. Administration of the flu vaccine by pharmacists has the potential to positively affect public health by improving vaccination rates among high-risk patients, first-time or occasional vaccine recipients, and patients who may not otherwise have an opportunity to be vaccinated. It is hoped that expanding pharmacist vaccination services to include administration of other common vaccines would receive similar positive reception by patients and improve overall access to vaccination.

PD2-2 - A Tough Road to Get Jcog1111 Ready to Start Under the Advanced Medical Service System(Senshin Iryou B)

Adult T-cell leukemia/lymphoma (ATL) is a malignancy of Th2/Treg cells associated with HTLV-1, and its prognosis is still very poor. ATL is endemic in Japan, but the number of newly-diagnosed patients is limited to approximately 1200/year, while it is much rare in the rest of the world. ATL had been paid little interest to develop novel agents by pharmaceutical industries, mainly due to its rarity. The standard of care in Japan for indolent ATL (iATL) is watch and wait strategy until transformation to aggressive ATL, while early intervention by interferon-alpha and zidovudine (IFN/AZT) is reported to be a standard of care based on its survival benefits shown in a retrospective survey.In December 2009, Japan Clinical Oncology Group-Lymphoma Study Group (JCOG-LSG) decided to perform a prospective randomized study (JCOG1111) investigating the benefit of IFN/AZT for iATL by using the Advanced Medical Service System (formerly the Advanced Medical Evaluation System) aiming the application the agents for ATL based on Public Knowledge Approval. The study is now open, however, it took nearly 4 years to get the study started.To facilitate investigator initiated trial, it is extremely important to construct the infra-structures supporting investigators. In our experience, there was no other choice to ask the officers of our own institutes for help in preparing a lot of documents which are unfamiliar to physicians until the works were taken over by the JCOG Data Center. It is now functioning as a well-organized coordinating office not only for JCOG1111 but for coming future trials. Second, it is essential to corporate the supporting personnel such as clinical research coordinators and pharmacists in participating institutes. Third, simplifying the approval process is mandatory without compromising the scientific quality and safety of the trials. Finally, in each study, we have to consider appropriateness for performing investigator initiated trial, but not industry-sponsored.

Ad hoc study of the role of hospital pharmacists in clinical trials in Bulgaria

PURPOSE: The aim of our research is to study the role and responsibilities of the hospital pharmacists in conducting clinical trials in Bulgaria. MATERIAL AND METHODS: A special questionnaire was developed in the Faculty of Pharmacy, MUSofia. A total number of 30 hospital pharmacies were contacted and included in the study. Three of them refused to take part in the survey. The interview was via phone and included 4 questions (3 closed and 1 open). Mainly the head hospital pharmacy manager of the participating health institutions was interviewed. RESULTS: Analysis of the results shows that current practice in Bulgaria allowed hospital pharmacists to be involved in clinical trials but this case is not prevalent. The majority of the trials, conducted in our country that includes hospital pharmacies were with narcotic investigational products, which according to the specific local legislation can only be located at the site of the hospital pharmacy in a special metal shelf box. However there are lots of trials conducted without participation of hospital pharmacist/research pharmacist. CONCLUSION: The participation of the hospital pharmacist can be extended – to help manage adverse events, monitor the effect of the drugs under the study and awareness for the drug-to-drug interactions. There are protocols where apart from the investigational product – there are non-drugs under the study, i.e. placed on the market which should be dispensed at the beginning of the trials during the washout period and again here is the place for the research pharmacist to control these non-investigational products.

AB1186-HPR Compiling and Evaluating Evidence-Based Algorithms for the Monitoring of Rheumatoid Arthritis Patients Receiving Disease Modifying Antirheumatic Drugs and Biological Agents

BackgroundPharmacological management of rheumatoid arthritis patients is based on the use of complex drugs such as disease modifying anti-rheumatic drugs (DMARDs) and innovative biological agents. Safe use of these drugs...

Effect of clinical pharmacist intervention on medication discrepancies following hospital discharge

Medication discrepancies may occur at transitions in care and negatively impact patient outcomes. To determine if involving clinical pharmacists in hospital care, medication reconciliation and discharge medication plan communication can reduce medication discrepancies with a prospective, randomized, blinded, controlled trial. A large, tertiary care, academic medical center. The intervention consisted of clinical pharmacist medication reconciliation, patient education and improved communication of the discharge medication plan, as devised by the hospital physician and care team, to primary care physicians and community pharmacists. Medication discrepancies were identified by blinded research pharmacists who reviewed primary care physician and pharmacy records at discharge through 90 days post-discharge to create 30- and 90-day medication lists. Rate of medication discrepancies compared across groups. A total of 592 subjects from internal medicine, family medicine, cardiology and orthopedic services were evaluated for this study. Clinically important medication discrepancies in the primary care physician record were different between groups 30 days after hospital discharge following a clinical pharmacist's intervention. The mean number of medication discrepancies per patient for the enhanced group being nearly half the number in the control group. However, this effect did not persist to 90 days post-discharge and did not extend to community pharmacy records. The present study demonstrates the involvement of pharmacists in hospital care, medication reconciliation and discharge medication plan communication may affect the quality of the outpatient medical record.

How well do pharmacists know their patients? A case report highlighting natural health product disclosure

Natural health products (NHPs), a broad category that includes vitamins, minerals, herbs, homeopathic remedies, traditional medicines, probiotics, amino acids and fatty acids, are used to maintain and promote health, as well as to prevent or treat illness.1 Many consumers report using NHPs because they are perceived to be healthier or safer than conventional drugs.2 A Health Canada survey found that 73% of Canadians have reported using at least 1 NHP, and 20% believe NHPs are without adverse effects.2 As NHPs are available without a prescription, patients often use them to treat their medical conditions, based on advice obtained from the Internet, media sources and/or friends/family.3 Patients also do not consistently disclose NHP use to health care providers, nor are they routinely asked about such use.4-6 This lack of communication may have serious implications; for example, some NHPs, such as kava, have been associated with hepatotoxicity,7 and St. John’s wort may interact with a number of prescription medicines that may lead to failed therapeutic outcomes or increased risk of toxicity.8 Use of these products without health professional input could be inappropriate or lead to delayed recognition of adverse reactions if they occur. Community Pharmacy SONAR (Study Of Natural health product Adverse Reactions) is a multicentre study investigating adverse events (AEs) associated with the use of prescription drugs, NHPs and their concurrent use through the implementation of active surveillance. Consenting patients who reported an AE while also taking an NHP (both alone or concurrently with prescription drugs) were contacted by a research pharmacist (CN) to collect a detailed medical history. Detailed methods are available elsewhere.9 This study was approved by the Human Research Ethics Board at the University of Alberta. Here, we present a detailed case history of a SONAR study participant. The patient’s medication history is presented in a stepwise fashion to illustrate what can be learned when a pharmacist further questions a patient about NHP use—the initial information available is typical of routine pharmacy practice; the subsequent additive information can be learned when additional details are sought by the pharmacist.