Children's views on unlicensed/off-label paediatric prescribing and paediatric clinical trials

Objectives - To explore the views and perspectives of children on the unlicensed/off-label use of medicines in children and on the participation of children in clinical trials. Methods - Focus-group discussions, involving school children, were carried out in a range of primary and secondary schools in Northern Ireland. A purposeful sample was chosen to facilitate representation of various socioeconomic groupings. Results - A total of 123 pupils, aged from 10 to 16 years, from six schools, participated in 16 focus groups. In general, pupils viewed the unlicensed/off-label use of medicines in children as unsafe and unethical and felt it is necessary to test medicines in children to improve the availability of licensed products. The majority felt that older children should be told, and that parents should be told, about the unlicensed/off-label use of medicines in children, yet they recognised some implications of this, such as potential medication non-adherence. Conclusions - This is the first study to explore the views of healthy children on unlicensed medicine use in children. Children were able to recognise potential risks associated with the unlicensed use of medicines and felt it is necessary to test and license more medicines in children. Practice implications - Health care professionals should consider the views of children in decisions that affect their health.

Perceptions and attitudes of Jordanian paediatricians towards off-label paediatric prescribing

Objective To assess current experiences and attitudes of hospital based paediatricians towards off-label medicine prescribing. Setting Paediatric hospital wards and out-patient clinics. Design A prospective, questionnaire based study. Results A 30 item questionnaire was sent to 300 hospital based paediatricians and 250 (83%) were returned completed. Over 69% of responders were familiar with the term off-label medicines. However, only 28% were knowingly prescribing off-label medicines to children. The majority of respondents (90%) expressed concerns about the safety and efficacy of off-label medicines. Only 15% had observed Adverse Drug Reactions, and 31% a treatment failure. The vast majority of respondents (83%) did not obtain informed consent or tell parents they were prescribing off label medicines to their children. Conclusions Off-label prescribing of medicines to children is a familiar concept to the majority of paediatricians in Jordan although only a smaller number are aware that it is common in their practice. Respondents showed concern about off label prescribing, although the majority do not consider it necessary to inform parents. More comprehensive research is needed in this area in Jordan and other Middle Eastern countries.

Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials

To investigate the knowledge and views of a range of healthcare professionals (consultant paediatricians, general practitioners (GPs), community pharmacists and paediatric nurses) regarding the use of unlicensed/off-label medicines in children and the participation of children in clinical trials.

The development of a method for targeted prescribing support in coronary heart disease

Poster

The influence of electronic prescribing on pharmacist clinical intervention reporting

Poster

Use of general practice prescribing data as a surrogate estimate of statin compliance

Background and Objective: To maximise the benefit from statin therapy, patients must maintain regular therapy indefinitely. Non-compliance is thought to be common in those taking medication at regular intervals over long periods of time, especially where they may perceive no immediate benefit (News editorial, 2002). This study extends previous work in which commonly held prescribing data is used as a surrogate marker of compliance and was designed to examine compliance in those stabilised on statins in a large General Practice. Design: Following ethical approval, details of all patients who had a single statin for 12 consecutive months with no changes in drug, frequency or dose, between December 1999 and March 2003, were obtained. Setting: An Eastern Birmingham Primary Care Trust GP surgery. Main Outcome Measures: A compliance ratio was calculated by dividing the number of days treatment by the number of doses prescribed. For a once daily regimen the ratio for full compliance_1. Results: 324 patients were identified. The average compliance ratio for the first six months of the study was 1.06 ± 0.01 (range 0.46 – 2.13) and for the full twelve months was 1.05 ± 0.01 (range 0.58 – 2.08). Conclusions: The data shown here indicates that as a group, long-term, stabilised statin users appear compliant. However, the range of values obtained show that there are identifiable subsets of patients who are not taking their therapy as prescribed. Although the apparent use of more doses than prescribed in some patients may result from medication hording, this cannot be the case in the patients who apparently take less. It has been demonstrated here that the compliance ratio can be used as an early indicator of problems allowing targeted compliance advice can be given where it will have the most benefit. References: News Editorial. Pharmacy records could be used to enhance statin compliance in elderly. Pharm. J. 2002; 269: 121.

A comparison of antibiotic prescribing indicators and medicines management scoring in secondary care

Poster: - Robust prescribing indicators analogous to those used in primary care are not available currently in NHS hospital trusts - The Department of Health has recently implemented a scheme for self-assessment scoring medicines management processes (maximum 23) in NHS hospitals - There is no clear relationship between average values for two antibiotic prescribing indicators obtained in ten NHS hospital trusts in the West Midlands - There is no clear relationship between either indicator value and the corresponding self-assessment medicines management score - This study highlights the difficulties involved in assessing the medicines management processes in NHS hospitals; better medicines management evaluation systems are needed

Proton pump inhibitor prescribing following Endoscopic diagnosis in a district general hospital

Focal points: A systematic review of the use of proton pump inhibitors was conducted among patients undergoing diagnostic fibreoptic endoscopic examination of the upper gastrointestinal tract during the period July 2001 to February 2002 inclusive A total of 2,557 patients received a PPI following endoscopy and healing doses were prescribed to 75.3 per cent of these patients An “unknown indication” was stated as a diagnosis in 958 patients (37.5 per cent) of patients studied Although endoscopic diagnosis does not appear possible in all cases, the present study demonstrates that NICE guidance to employ the lowest appropriate dose of PPI is followed

Paediatric prescribing practice and opinions of paediatric prescribers on ePrescribing

Objective The aim of this study was to provide an initial insight into current UK paediatric prescribing practice. Methods In 2012 focus groups were conducted at Birmingham Children's Hospital (UK specialist hospital) with both medical and non-medical prescribers and analysed using thematic analysis. Key findings Both sets of prescribers used a wide range of resources to support their prescribing decisions. Dosing information was most commonly checked, and a lack of specialist paediatric information was reported in existing resources. All groups had high expectations of the support functions that should be included in an electronic prescribing system and could see many potential benefits. Participants agreed that all staff should see the same drug alerts. The overwhelming concern was whether the current information technology infrastructure would support electronic prescribing. Conclusions Prescribers had high expectations of electronic prescribing, but lacked confidence in its delivery. Prescribers use a wide range of resources to support their decision making when prescribing in paediatrics.

How should initial fit inform soft contact lens prescribing

Purpose: To investigate how initial HEMA and silicone-hydrogel (SiHy) contact lens fit on insertion, which informs prescribing decisions, reflect end of day fit. Methods: Thirty participants (aged 22.9. ±. 4.9 years) were fitted contralaterally with HEMA and SiHy contact lenses. Corneal topography and tear break-up time were assessed pre-lens wear. Centration, lag, post-blink movement during up-gaze and push-up recovery speed were recorded after 5,10,20. min and 8. h of contact lens wear by a digital slit-lamp biomicroscope camera, along with reported comfort. Lens fit metrics were analysed using bespoke software. Results: Comfort and centration were similar with the HEMA and SiHy lenses (p > 0.05), but comfort decreased with time (p <. 0.01) whereas centration remained stable (F = 0.036, p = 0.991). Movement-on-blink and lag were greater with the HEMA than the SiHy lens (p <. 0.01), but movement-on-blink decreased with time after insertion (F = 22.423, p <. 0.001) whereas lag remained stable (F = 1.967, p = 0.129). Push-up recovery speed was similar with the HEMA and the SiHy lens 5-20. min after insertion (p > 0.05), but was slower with SiHy after 8. h wear (p = 0.016). Lens movement on blink and push-up recovery speed was predictive of the movement after 8. h of wear after 10-20. min SiHy wear, but after 5 to 20. min of HEMA lens wear. Conclusions: A HEMA or SiHy contact lens with poor movement on blink/push-up after at least 10. min after insertion should be rejected.

Improving the management of behaviour that challenges associated with dementia in care homes:protocol for pharmacy-health psychology intervention feasibility study

INTRODUCTION: The inappropriate use of antipsychotics in people with dementia for behaviour that challenges is associated with an estimated 1800 deaths annually. However, solely focusing on antipsychotics may transfer prescribing to other equally dangerous psychotropics. Little is known about the role of pharmacists in the management of psychotropics used to treat behaviours that challenge. This research aims to determine whether it is feasible to implement and measure the effectiveness of a combined pharmacy-health psychology intervention incorporating a medication review and staff training package to limit the prescription of psychotropics to manage behaviour that challenges in care home residents with dementia. METHODS/ANALYSIS: 6 care homes within the West Midlands will be recruited. People with dementia receiving medication for behaviour that challenges, or their personal consultee, will be approached regarding participation. Medication used to treat behaviour that challenges will be reviewed by the pharmacist, in collaboration with the general practitioner (GP), person with dementia and carer. The behavioural intervention consists of a training package for care home staff and GPs promoting person-centred care and treating behaviours that challenge as an expression of unmet need. The primary outcome measure is the Neuropsychiatric Inventory-Nursing Home version (NPI-NH). Other outcomes include quality of life (EQ-5D and DEMQoL), cognition (sMMSE), health economic (CSRI) and prescribed medication including whether recommendations were implemented. Outcome data will be collected at 6 weeks, and 3 and 6 months. Pretraining and post-training interviews will explore stakeholders' expectations and experiences of the intervention. Data will be used to estimate the sample size for a definitive study. ETHICS/DISSEMINATION: The project has received a favourable opinion from the East Midlands REC (15/EM/3014). If potential participants lack capacity, a personal consultee will be consulted regarding participation in line with the Mental Capacity Act. Results will be published in peer-reviewed journals and presented at conferences.

Pharmacology and the safe prescribing of drugs

Understanding the pharmacological principles and safe use of drugs is just as important in surgical practice as in any other medical specialty. With an ageing population with often multiple comorbidities and medications, as well as an expanding list of new pharmacological treatments, it is important that surgeons understand the implications of therapeutic drugs on their daily practice. The increasing emphasis on high quality and safe patient care demands that doctors are aware of preventable adverse drug reactions (ADRs) and interactions, try to minimize the potential for medication errors, and consider the benefits and harms of medicines in their patients. This chapter examines these aspects from the view of surgical practice and expands on the implications of some of the most common medical conditions and drug classes in the perioperative period. The therapeutic care of surgical patients is obvious in many circumstances – for example, antibacterial prophylaxis, thromboprophylaxis, and postoperative analgesia. However, the careful examination of other drug therapies is often critical not only to the sustained treatment of the associated medical conditions but to the perioperative outcomes of patients undergoing surgery. The benefit–harm balance of many therapies may be fundamentally altered by the stress of an operation in one direction or the other; this is not a decision that should wait until the anaesthetist arrives for a preoperative assessment or one that should be left to junior medical or nursing staff on the ward.

An analysis and comparison of commonly available United Kingdom prescribing resources

Background and objective: Safe prescribing requires accurate and practical information about drugs. Our objective was to measure the utility of current sources of prescribing guidance when used to inform practical prescribing decisions, and to compare current sources of prescribing guidance in the UK with idealized prescribing guidance. Methods: We developed 25 clinical scenarios. Two independent assessors rated and ranked the performance of five common sources of prescribing guidance in the UK when used to answer the clinical scenarios. A third adjudicator facilitated review of any disparities. An idealized list of contents for prescribing guidance was developed and sent for comments to academics and users of prescribing guidance. Following consultation an operational check was used to assess compliance with the idealized criteria. The main outcome measures were relative utility in answering the clinical scenarios and compliance with the idealized prescribing guidance. Results: Current sources of prescribing guidance used in the UK differ in their utility, when measured using clinical scenarios. The British National Formulary (BNF) and EMIS LV were the best performing sources in terms of both ranking [mean rank 1·24 and 2·20] and rating [%excellent or adequate 100% and 72%]. Current sources differed in the extent to which they fulfilled criteria for ideal prescribing guidance, but the BNF, and EMIS LV to a lesser extent, closely matched the criteria. Discussion: We have demonstrated how clinical scenarios can be used to assess prescribing guidance resources. Producers of prescribing guidance documents should consider our idealized template. Prescribers require high-quality information to support their practice. Conclusion: Our test was helpful in distinguishing between prescribing resources. Producers of prescribing guidance should consider the utility of their products to end-users, particularly in those more complex areas where prescribers may need most support. Existing UK prescribing guidance resources differ in their ability to provide assistance to prescribers. © 2010 Blackwell Publishing Ltd.