Prescribing Guidance Research Articles

Results of the CYP-GUIDES randomized controlled trial: Total cohort and primary endpoints

CYP-GUIDES (Cytochrome Psychotropic Genotyping Under Investigation for Decision Support) is a randomized controlled trial (RCT) comparing 2 outcomes in hospitalized patients with major depressive disorder (MDD) treated according to the patient's CYP2D6 genotype and functional status versus standard psychotropic therapy. The primary outcome was hospital Length of Stay (LOS) and the secondary outcome was the Re-Admission Rate (RAR) 30 days after discharge.The trial setting was the Institute of Living at Hartford Hospital. CYP2D6 genotyping was implemented to detect common polymorphisms resulting in an enzyme with sub-normal, normal or supra-normal function. The electronic medical record (EMR) was utilized to transmit clinically actionable drug prescribing guidance based on the patient's CYP2D6 genotype to the physician.The RCT recruited 1500 patients, genotyped CYP2D6 in 1459, and randomized 477 to standard therapy (Group S), for whom treatment-as-usual guidance was delivered without consideration of patient CYP2D6 genotype, and 982 to genetically-guided therapy (Group G) where CYP2D6-based treatment recommendations were provided via EMR to physicians. For inpatients in Group G whose CYP2D6 function was sub- or supra-normal, medications primarily metabolized by the CYP2D6 enzyme were proscribed.The RCT developed a database of potential benefit to the field. The genetic, pharmacologic and clinical information is being simultaneously published. Results did not reveal differences in LOS or RAR between Group G and Group S, but confounders may have obscured the effects of pharmacogenetic guidance. We present strategies to assess effects of pharmacogenetic guidance on the most vulnerable patients at either extreme of CYP2D6 function treated with multiple psychotropics.

Unveiling the guidance heterogeneity for genome-informed drug treatment interventions among regulatory bodies and research consortia

Pharmacogenomics and personalized medicine interventions hold promise to optimize drug treatment modalities and hence, improve the quality of life of the patients by minimizing the occurrence of adverse drug reactions and/or maximizing drug treatment efficacy. To this end, proper guidance for accurately prescribing the correct drug at the right dose is empowered by major regulatory bodies, namely the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA), and well-recognized research consortia, like the Clinical Pharmacogenetics Implementation Consortium (CPIC), that propose therapeutic recommendations after the thorough evaluation of the existing scientific evidence base. In this context, the consistency of these recommendations is crucial for smoothly integrating pharmacogenomics into the clinic. Here, we collected all of the important and clinically actionable pharmacogenomics information provided by the aforementioned renowned sources and documented it in order to assess potential similarities and, most importantly, differences. Our data show that the level of concordance regarding the guidance provided for the same drug-gene association pairs varies significantly, despite the fact that it all derives from a single evidence base. In particular, apart from the expected similarities in a number of association pairs, especially the ones related to cancer genomics, there are still major discrepancies that create confusion as to which guidance should be followed in order to properly inform drug prescribing. This regulatory deficiency calls for the fruitful engagement of the regulatory agencies involved with the contribution of other experts engaged in the field of pharmacogenomics in an effort to harmonize the existing arsenal of guidance for genome-informed drug prescription. The achievement of harmonization would in turn expedite bringing personalized medicine closer to clinical fruition.

Patterns of use and perceptions of an institution-specific antibiotic stewardship application among emergency department and urgent care clinicians.

We surveyed emergency department and urgent care clinicians to assess patterns of use and perceived usefulness of a local antibiotic stewardship application to deliver institution-specific prescribing guidance. Among 114 eligible respondents, the application was widely utilized, and it was perceived to be a useful clinical resource that improved prescribing.

Understanding non-compliance with surgical antibiotic prophylaxis prescribing guidance, in Nigeria

Abstract Background Antimicrobial Resistance is a prominent worldwide threat that is increasing in low-to-middle income countries. Good antibiotic stewardship (AMS) improves compliance with evidence-based antimicrobial prescribing guidelines but just 4% of LMICs have national AMS initiatives in place and only 15% have national policies. As high as 20-50% of surgical antibiotic prophylaxis prescription in Nigeria is thought to be non-compliant. Behaviour change theories can structure our understanding of why poor compliance occurs and can facilitate development of effective interventions to improve it. Methods The Theoretical Domains Framework (TDF; Michie et al. 2009) was used to develop an online survey and interview schedule for focus group discussions. Audio recordings were transcribed and analysed by two researchers using thematic analysis, TDF and the COM-B model of behaviour change (Michie et al. 2010). Results 60 surgeons (59% male; 43% surgical consultant; 5-10 yrs experience) from Lagos University Teaching Hospital, Lagos University College of Medicine and Niger Delta University Teaching Hospital completed the survey. A sub-group of 14 surgeons (79% male; 86% surgical consultant; 10-15 yrs experience) participated in three focus groups. Whilst compliance with guidance was generally considered desirable, surgeons reported translating guidance to Nigerian practice and context was often difficult, time-consuming and restricted by not having access to recommended antibiotics. Conclusions Behaviour change theory can be used to further our understanding of key barriers and facilitators to non-compliance with surgical antibiotic prophylaxis prescribing guidance, amongst surgeons in Nigeria. This presentation will conclude with discussion of how findings from this project are being used to develop a cost-effective, scalable, decision-support smartphone app for prescribing behaviour change. Key messages Behaviour change theory can be used effectively to further understanding of barriers and facilitators to Nigerian surgeons’ non-compliance with surgical antibiotic prophylaxis prescribing guidance. We must form a comprehensive understanding of factors (social & environmental) driving non-compliant attitudes and behaviours, before creating interventions to change prescribing behaviour.

A tailored e-learning gives long-term changes in determinants of GPs’ benzodiazepines prescribing: a pretest-posttest study with self-report assessments

Objective: Despite guidelines and campaigns, general practitioners (GPs) continue to overprescribe benzodiazepines (BZDs). New approaches to improve prescribing are needed. Using behavior change techniques and tailoring interventions to user characteristics are vital to promote behavior change. This study evaluated the impact of a tailored e-learning module on factors known to determine BZD prescribing within GPs.Design: A pretest-posttest study design with three self-report assessments concerning determinants of BZD prescribing: at baseline, immediately after the module (short term) and six months after completion (long term).Setting: Flanders (Belgium)Intervention: A tailored e-module that focuses on avoiding initial BZD prescriptions and using psychological interventions as an alternative.Subjects: 244 GPsMain outcome measures: Assessed determinants include GPs’ attitudes concerning treatment options, perceptions of the patient and self-efficacy beliefs. Readiness to adhere to prescribing guidelines was evaluated through assessing motivation, self-efficacy and implementability of non-pharmacological interventions.Results: A significant and durable impact on determinants of BZD prescribing was observed. GPs underwent desirable changes in attitudes, perceptions and self-efficacy beliefs and these changes remained significant six months later.Conclusion: Tailoring an e-intervention to target group characteristics appears to be successful in promoting behavioral change in experienced GPs. Significant and lasting changes were observed in determinants of prescribing BZDs.Key PointsA tailored e-intervention resulted in significant and long term changes in previously identified determinants of prescribing BZDs. The e-module resulted in a positive impact on GPs’ readiness to adhere to BZD prescribing guidance and the way they experience psychosocial consultations. Tailoring an e-intervention to target group characteristics appears to be successful in promoting behavioral change in experienced GPs.

Improving the quality of insulin prescribing for people with diabetes being discharged from hospital

Medication errors involving insulin in hospital are common, and may be particularly problematic at the point of transfer of care. Our aim was to improve the safety of insulin prescribing...

COPD update and new guidance on antibiotics for exacerbations

NICE recently updated its guideline on the diagnosis and management of chronic obstructive pulmonary disease (COPD) and at the same time published new antimicrobial prescribing guidance on managing acute exacerbations of COPD. This article provides a summary of these two documents.

Depression and the dermatologist: a critical analysis of contemporary isotretinoin prescribing practices.

Management of patients with current or previous depression who require isotretinoin treatment for acne is a challenging area. Current opinion favours the view that isotretinoin-induced mood disturbance is a rare, idiosyncratic reaction, not reliably related to the presence of pre-existing depression. Nonetheless, in the absence of a definitive high-quality study, there remains a degree of legitimate uncertainty. With input from a psychiatrist, we created and administered a detailed survey featuring a range of low-, medium- and higher-risk clinical scenarios, designed to capture a snapshot of current dermatological practice. Respondents indicated a wide variability in their approach, with a substantial proportion referring on to Psychiatry where this was not deemed necessary. Few dermatologists appreciated the importance of behaviours suggesting impaired impulse control. We hope this study helps to refine guidance for isotretinoin prescribing, both to maximize safety and to ensure that deserving patients with acne are not excluded from appropriate treatment.

Influenza in carehome residents: applying a conceptual framework to describe barriers to the implementation of guidance on treatment and prophylaxis.

The European Centre for Disease Prevention and Control, National Institute for Health and Care Excellence and Public Health England have all endorsed the use of antivirals for the treatment and prophylaxis of influenza for care home residents. However, implementing these guidelines in practice is often challenging. This article aims to explore what factors impact the management of care home flu outbreaks in England according to national guidelines and highlight opportunities for change. Qualitative data from notified outbreaks between September 2017 to April 2018 in the South East of England were analyzed, applying the Greenhalgh framework for barriers to guideline implementation. Summary statistics on outbreak characteristics were generated. Stakeholders were mapped out using Eden and Ackermann's grid of interest and influence. A process map was developed to describe operational pathways. There was often a delay in notifying potential outbreaks to Public Health England. Clinicians cited a lack of robust evidence for the use of antivirals and the available guidelines being too unwieldy as reasons for not implementing prescribing guidance. Many high interests and high influence stakeholders are involved in the sometimes complex care pathway, requiring coordinated work and agreement before antivirals can be prescribed. Our findings highlight points in the care pathway that stakeholders can target to improve quality of care and increase the likelihood of national guidance being implemented. The principles described in this article can also be applied to other challenges of translating evidence into practice and cross-organisational working.

Determining the most effective exercise for gluteal muscle activation in children with cerebral palsy using surface electromyography

BackgroundReduced lumbo-pelvic postural control is a common feature of gait in children with Cerebral Palsy (CP). These features are commonly attributed to insufficiency of the hip musculature as well as underlying bony geometry. Exercises aimed at strengthening the hip muscles are frequently prescribed in children with Cerebral Palsy (CP). There is a lack of evidence indicating the most effective exercises in targeting gluteal muscle activation in this population. Research questionTo determine the most effective exercise for gluteal muscle activation in children with CP. MethodsThis was a cross-sectional study of children with CP. Surface EMG data from the gluteus medius (GMed) and maximus (GMax) on the more involved limb were recorded as participants completed 6 commonly prescribed gluteal strengthening exercises. EMG was assessed for peak activation, normalised to functional reference values. ResultsData from ten children (5 males, 5 females; mean +- SD age, 13+-3 years) were included for final analysis. The single leg bridge and step up were the most effective exercises for gluteal muscle activation. Differences in activation were found to be statistically significant using Friedman’s rank test (GMax p = 0.0001, GMed p = 0.0023). SignificanceThis study is the first to show clear differences in activation across gluteal strengthening exercises in a CP population. Exercises which involve weight bearing through a single limb appear most effective in activating the target muscles i.e the single leg bridge and the step up. Exercises involving double limb support or open-chain movements were less effective. The results of this study indicate that careful exercise selection is required to achieve targeted muscle activation in a paediatric CP population. The results of this study will provide guidance for exercise prescription for gluteal strengthening in this population and will inform future research studies on the effectiveness hip muscle strengthening programmes in CP.

To prescribe or not to prescribe: enhancing safety in remote prescribing

From time to time, it may be appropriate to use a telephone, or other non-face-to-face medium to prescribe medicines and treatment for patients. Non face-to-face media include telephone, fax, email, video link, or websites. This concept is known as remote prescribing and refers to prescribing for patients who are physically ‘remote’ or not in the same vicinity as the clinician ( Broadhead, 2011 ). Secondly, the term can also refer to an area of the UK described as being geographically ‘remote’, where direct face-to-face access to healthcare can be poor ( General Medical Council, 2017 ). Remote prescribing has been described as an important facility in healthcare, providing patients with greater accessibility to their medications and treatment ( Griffiths, 2018 ). However, remote prescribing is only acceptable in exceptional circumstances. The aim of this article is to identify and discuss clinical situations in which remote prescribing is acceptable, with an onus on safety. Broadhead (2011) proposes that the medical guidance for remote prescribing is analogous for other health professionals, including nurses and midwives who prescribe remotely using different forms of technology. Therefore, these guidelines will be referred to throughout this article.

Managing hypertension in people of African origin with diabetes: Evaluation of adherence to NICE Guidelines

BackgroundThe pathophysiology of hypertension in people of African origin differs from other ethnicities. This effect may be exacerbated in people with type 2 diabetes mellitus (T2DM), hence control of hypertension is particularly important in this population. AimsThe primary aim was to evaluate the adherence to National Institute of Clinical Excellence (NICE) guidance (National Guidelines NG28) for hypertension management in African origin patients with T2DM. MethodsThis study was done using electronic health records at a large primary care centre based in Birmingham, UK. Strict exclusion criteria were applied to identify individuals with T2DM, African origin patients and a diagnosis of hypertension. Retrospectively participants were identified, and NICE guideline adherence was assessed using descriptive statistics. Results78 patients were included in the study of which 28 (36%) were on the NICE recommended combination of antihypertensives, suggesting poor adherence to the guidance in primary care prescribing. The blood pressure control of 35 (44.9%) patients was suboptimal, although this group received more frequent blood pressure monitoring. Microalbuminuria remains a problem in the suboptimal group. ConclusionThis study provides insight into adherence to NICE guidance for managing hypertension in African origin patients with diabetes. Further work should be done to explore the effects of hypertension in this ethnic group and if there is a need for a more refined management guideline.

GPhC launches consultation on safety guidance for pharmacist prescribers

GPhC launches consultation on safety guidance for pharmacist prescribers

,,,Definitions Matter: A Taxonomy of Inappropriate Prescribing to Shape Effective Opioid Policy and Reduce Patient Harm

To date, no existing law or policy defines inappropriate prescribing, with only one state acknowledging the need for such a definition. At the federal level, a single provision of the SUPPORT Act of 2018 directs the Secretary of HHS to define inappropriate prescribing in a narrow context. Despite the expanding number of opioid prescribing laws, policies, and guidance documents, words like overprescribing, misprescribing, and over-utilization are used in myriad contexts with implicitly different meanings. This paper argues that defining inappropriate prescribing is a necessary antecedent sanctioning it. It may also improve policy by correcting for bias and other decisional errors. Using legal and multidisciplinary research, a taxonomy of misprescribing is offered with the categories of inadvertent overprescribing, corrupt prescribing, qualitative overprescribing, quantitative overprescribing, multi-class misprescribing, and underprescribing. The later three categories are less commonly considered in policy decisions, despite long standing evidence of associated morbidity and mortality. Particular attention is devoted the underprescribing category, which includes the predictable response by some providers to discharge patients without referrals, blanket refusals to consider opioid therapy, and abrupt or too rapid discontinuation of opioid therapy after years of use. These decisions are increasingly associated with significant harms, including patient suicides and poisoning deaths after patients turn to illicit sources of opioids — harms that are usually ignored in policy and law. The modest goal of this paper to offer an initial framework to guide development and evaluation of prescribing policies in alignment with existing evidence of harm.

Medical Cannabis Clinicians' Society publishes guidance for prescribers

Medical Cannabis Clinicians' Society publishes guidance for prescribers

GPhC prescribing guidance may restrict some patients from accessing their medicines, consultation told

GPhC prescribing guidance may restrict some patients from accessing their medicines, consultation told

Why did some practices not implement new antibiotic prescribing guidelines on urinary tract infection? A cohort study and survey in NHS England primary care.

To describe trends and geographical variation in prescribing of trimethoprim and nitrofurantoin to treat urinary tract infections, to describe variation in implementing guideline change and to compare actions taken to reduce trimethoprim use in high- and low-using Clinical Commissioning Groups (CCGs). A retrospective cohort study and interrupted time series analysis of English NHS primary care prescribing data, complemented by information obtained through Freedom of Information Act requests to CCGs. The main outcome measures were variation in practice and CCG prescribing ratios geographically and over time, including an interrupted time series, and responses to Freedom of Information requests. The amount of trimethoprim prescribed, as a proportion of nitrofurantoin and trimethoprim combined, remained stable and high until 2014, then fell gradually to <50% in 2017; this reduction was more rapid following the introduction of the 'Quality Premium'. There was substantial variation in the speed of change between CCGs. As of April 2017, for the 10 CCGs with the lowest trimethoprim ratios, 9 had reported at least one of: formulary change, work plan or incentive scheme to change prescribing behaviour. None of the 10 highest-ratio CCGs did so. Many CCGs failed to implement an important change in antibiotic prescribing guidance, and there is strong evidence suggesting that CCGs with minimal prescribing change did little to implement the new guidance. We recommend: (i) a national programme of training and accreditation for medicines optimization pharmacists; and (ii) remedial action for CCGs that fail to implement guidance-with all materials and data shared publicly for both such activities.

198. Pharmacist-Led Antimicrobial Prompting During Interdisciplinary Team Rounds as a Novel Antimicrobial Stewardship Intervention

BackgroundThere is a need to develop successful antibiotic stewardship interventions that do not require ID physicians. Our hospital implemented a pharmacist-driven intervention to prompt critical assessment of antibiotic regimens during interdisciplinary team rounds. We evaluated the acceptance of this intervention and the effects on concordance with institutional prescribing guidance.MethodsThis quality improvement initiative took place between November 2016 and June 2017 on a medical ward in an urban, level 1 trauma, public teaching hospital. During interdisciplinary team rounds, if the medicine team’s antimicrobial choice was not concordant with institutional prescribing guidance, the clinical pharmacist made a recommendation. We assessed prescribing for urinary tract infection, skin and soft-tissue infection, and pneumonia pre- and post-intervention. Prescribing was classified as overall guideline-concordant if the antibiotic choices and duration of therapy were consistent with institutional guidance.ResultsThirty cases from each period were evaluated. Recommendations to the medical team were made on 63% (92/146) of days and on 31% (205/664) of patients on antibiotics. The most common recommendation was regarding days of therapy (Figure 1). The recommendations were accepted in 76% (156/205) of cases. (Figure 2). There were improvements in both the inpatient (70% to 83%, P = 0.22) and discharge (64% to 86%, P = 0.35) antibiotic choices and overall guideline concordance (53% to 63%, P = 0.43); however, these were not statistically significant. Concordance with duration of therapy was similar between the periods (76% vs. 77%, P = 0.94) (Figure 3).ConclusionDuring interdisciplinary rounds, prompting by pharmacists to critically assess antibiotic regimens is a feasible antibiotic stewardship intervention that does not require ID expertise, is generally accepted by physicians, and may increase guideline-concordant antibiotic selection.Figure 1:Figure 2:Figure 3:Baseline (N = 30)Intervention (N = 30) P-valueConcordance with guidelinesInpatient antibiotic choice21/30 (70%)25/30 (83%)0.22Discharge antibiotic choice7/11 (64%)12/14 (86%)0.35Duration of therapy22/29 (76%)23/30 (77%)0.94Overall concordance16/30 (53%)19/30 (63%)0.43Disclosures All authors: No reported disclosures.

Reading Acuity as a Predictor of Low-Vision Reading Performance.

PurposeMost people with low vision experience difficulty with reading. Reading assessment can provide guidance for prescription of reading aids and strategies for reading rehabilitation. Here we investigate the effectiveness of letter acuity (LA) and reading acuity (RA) as predictors of low-vision reading performance.MethodsLow-vision subjects (n = 58), young control subjects (n = 52), and older control subjects (n = 14) participated in this study. The low-vision subjects were separated into a Macular group (n = 30) and a Nonmacular group (n = 28) based on whether the diagnoses primarily affected the macular area. LA was measured with the Lighthouse Distance Visual Acuity Chart and RA with the MNREAD Acuity Chart. Reading speeds were obtained across a range of print sizes from the MNREAD test. The MNREAD data were used to estimate required print sizes for three functionally important types of reading for each subject: spot reading (40 words/min [wpm]), fluent reading (80 wpm), and critical print size (required to achieve maximum reading speed).ResultsFor equal values of LA, the Macular group had significantly worse RA than the Nonmacular group. The differences between vision groups, as well as individual variations within groups, were largely explained by the differences in RA. RA is a better predictor than LA for spot reading size, fluent reading size, and critical print size.ConclusionsRA may provide more accurate assessment of reading performance than LA for purposes of low-vision reading rehabilitation.

Managing Inpatient Constipation: A Docusate Initiative

Introduction: Constipation is a common occurrence in the inpatient setting that mandates initiation of medications as appropriate. Docusate is a commonly used stool softener that decreases surface tension in the intestine and allows increased water entry into stool. Several studies conducted in different patient settings, including geriatric, pain, and general hospital medicine wards, have found inpatient use of docusate to be ineffective. In addition to little therapeutic benefit, docusate requires significant nursing time (45 sec/pill administered) and adds to patient pill burden. The aim of this study was to determine physician understanding of the management of constipation in the inpatient setting and to implement system-wide education initiatives and tools on appropriate therapies in order to reduce unnecessary docusate prescribing. Methods: Baseline data from a large academic inner-city hospital was obtained to determine prescribing habits of docusate. Utilizing the Plan-Do-Study-Act (PDSA) (Figure 1) quality improvement workflow, high-volume prescribers were determined. Interventions including education sessions on alternative therapies, including polyethylene glycol as a preferred laxative, as well as bowel-regimen prescribing guidance in the electronic medical record (EMR) prescribing dashboard were put in place.1108_A Figure 1. PDSA Cycle - Docusate prescribing initiativeResults: Orthopedic, Ob-Gyn, Neurosurgical, Medicine, and Urology services made the majority of docusate prescriptions. Baseline physician survey results from 70 medicine residents, found that 43% of residents reflexively ordered a bowel regimen if patient was elderly (age >65), while 34% of residents reflexively ordered a bowel regimen for all patients. Only 37% would wait to order bowel regimen if the patient had reported constipation. The majority (61%) of bowel regimens ordered included docusate, with 89% of prescriber's belief that docusate was at least some what effective in treatment of inpatient constipation. Following the intervention period, the overall docusate prescribing was reduced from an average of 22.6 orders/day to 17.5 orders/day (22% reduction) (Figure 2), along with a 60% increase (8.4 orders/day to 13.4 orders/day) in polyethylene glycol prescribing over this study period.1108_B Figure 2. Docusate prescribing; Trend throughout intervention periodConclusion: Our data demonstrate that implementation of system-wide educational and EMR prescribing tools can reduce inappropriate docusate prescriptions in the inpatient setting. Further steps will include continued education initiatives and resources for all high volume prescribers.