Free of charge medicine schemes in the NHS. A local and regional Drug and Therapeutic Committees (DTC) experience.

Introduction: Free-of-charge (FoC) medicine schemes are increasingly available and allow access to investigational treatments outside clinical trials or in advance of licensing or NHS commissioning. Methods: We retrospectively reviewed FoC medicine schemes evaluated between 2013 and 2019 by a single NHS trust and a regional drug and therapeutics committee (DTC). The details of each locally reviewed FoC scheme, and any nationally available MHRA Early Access to Medicines Scheme (MHRA EAMS) in the same period, were recorded and categorised. Results: Most FoC schemes (95%) allowed access to medicines intended to address an unmet clinical need. Over 7 years, 90% were company-FoC schemes and 10% were MHRA EAMS that were locally reviewed. Phase 3 clinical trial data were available for 44% of FoC schemes; 37% had phase 2 data; and 19% were supported only by phase 1, retrospective observational studies, or pre-clinical data. Utilisation of company-FoC schemes increased on average by 50% per year, while MHRA EAMS showed little growth. Conclusion: Company-FoC medicine schemes are increasingly common. This may indicate a preference for pharmaceutical companies to independently co-ordinate schemes. Motivations for company-FoC schemes remain unclear and many provide access to treatments that are yet to be evaluated in appropriately conducted clinical trials, and whose efficacy and risk of harm remain uncertain. There is no standardisation of this practice and there is no regulatory oversight. Moreover, no standardised data collection framework is in place that could demonstrate the utility of such programmes in addressing unmet clinical need or allow generation of further evidence.

Drug and Therapeutics Committee (DTC) evolvement and expanded scope in Ethiopia

Background: As a key partner of Ministry of Health (MOH) Ethiopia, The Clinton Health Access Initiative (CHAI) had been implementing the Child Survival Project (CSP) since October 2015. Strengthening DTC was one of its focuses to improve overall supply chain management (SCM). The objectives of this study are to review the evolution of DTCs in Ethiopia from their early years to current practice and identify the major hindering factors for their functionality. Methods: A descriptive study design was employed with mainly qualitative data collection methods and analysis. The assessment made use of both qualitative and quantitative data, generated from primary sources through key informant interviews and from secondary sources through desk review methods. Results: DTCs were introduced in Ethiopia in the early 1980’s. The mandate of DTCs has been given to four different government organizations since this time. As a result, its implementation was lagging. Recently, the government and its partners have given attention to DTCs. More than 5847 professionals underwent DTC training from 2016 onwards. DTC establishment in health facilities (HFs) improved from 85% to 98% between 2015 and 2019 during baseline and endline assessments carried out by CHAI/CSP. Similarly, DTC functionality in HFs improved from 20% to 63%. The CHAI/CSP regular supervision data analysis revealed that DTC establishment improved from 83% to 100% of HFs, while its functionality improved from 5% to 72% between 2016 and 2019, respectively. A chi-square test of independence examining the relationship between facility and pharmacy head training on DTCs and functionality of DTC in the same facility revealed significant association between the two variables at p<0.0001. Conclusions: Providing consistent capacity building and availing strong monitoring and evaluation system improves functionality of DTCs. Moreover, national coordinating bodies for DTCs and similar structures at Regional Health Bureaus and woreda health offices should be established.

Management and Appropriate Use of Diazoxide in Infants and Children with Hyperinsulinism

Background The diagnosis of hypoglycemia and the use of diazoxide have risen in the last decade. Diazoxide is the only Food and Drug Agency-approved pharmacologic treatment for neonatal hypoglycemia caused by hyperinsulinism (HI). Recent publications have highlighted that diazoxide has serious adverse effects (AEs) such as pulmonary hypertension (2–3%) and neutropenia (15%). Despite its increasing use, there is little information regarding dosing of diazoxide and/or monitoring for AEs. Methods We convened a working group of pediatric endocrinologists who were members of the Drug and Therapeutics Committee of the Pediatric Endocrine Society (PES) to review the available literature. Our committee sent a survey to its PES members regarding the use of diazoxide in their endocrine practices. Our review of the results concluded that there was substantial heterogeneity in usage and monitoring for AEs for diazoxide among pediatric endocrinologists. Conclusions Based on our extensive literature review and on the lack of consensus regarding use of diazoxide noted in our PES survey, our group graded the evidence using the framework of the Grading of Recommendations, Assessment, Development and Evaluation Working Group, and has proposed expert consensus practice guidelines for the appropriate use of diazoxide in infants and children with HI. We summarized the information on AEs reported to date and have provided practical ideas for dosing and monitoring for AEs in infants treated with diazoxide.

P08 Does the neonatal continuous intravenous infusion prescription chart reflect the medication the baby is actually receiving?

AimThe aim of this audit was to examine whether the continuous intravenous infusion prescription chart is an accurate reflection of the infusions the baby is actually receiving. The neonatal continuous infusion prescription charts were redesigned six months ago to reduce the prescribing burden of rewriting all continuous infusions on the Neonatal Intensive Care Unit (NICU) on a daily basis. On the new charts the prescription remains valid until it is crossed off or for a maximum period of 7 days. The impression of the pharmacist however is that prescribers are not always crossing off the prescription when they stop an infusion.MethodData collection commenced in June 2017 by the Lead Neonatal Pharmacist. All babies on NICU on a Monday for a period of 4 weeks were included. The continuous infusion prescription chart was compared to the continuous infusions actually being administered to each baby and the corresponding numbers recorded. Any prescriptions identified that were no longer being administered but had not been crossed off were marked as ‘inactive’ by the pharmacist and the nurse/prescriber made aware. The results were fed back the same day to the nurses/prescribers on shift by the pharmacist and cascaded to the Lead Neonatal Consultant for Medication Safety and Chair of Drug and Therapeutics Committee for dissemination to the wider neonatal team via email.A poster was designed and displayed on the ward to highlight the results.ResultsWeek 1–107 infusions prescribed; 60 being administered (47(44%) inactive prescriptions)Week 2–27 infusions prescribed; 21 being administered (6 (22%) inactive prescriptions)Week 3–26 infusions prescribed, 24 being administered (2 (8%) inactive prescriptions)Week 4–23 infusions prescribed, 20 being administered (3 (13%) inactive prescriptions)ConclusionThe continuous intravenous infusion prescription chart was not an accurate reflection of the medications a baby was actually receiving at the start of the audit; 44% of infusions prescribed were no longer being administered. The number of prescriptions crossed off when the decision was taken to stop the infusion improved throughout the 4 week period. By week 3 the majority of continuous infusion prescription charts matched the medications the baby was actually receiving. Both the infusions identified as inactive in week 3 and 2 out of the 3 infusions in week 4 were inotropes that had been slowly weaned to stop following the decision to stop on the ward round. These prescriptions were unable to be crossed off at the time the decision was made to stop the infusion, as the intention was to wean to stop; however the nurses informed the pharmacist conducting the audit that the prescribers were aware the infusions had now stopped and were due to come back and cross off the prescriptions.This audit demonstrates that a regular pharmacist presence highlighting issues with prescribing practice can drive change quite quickly and promote compliance with good prescribing procedures. Training has been incorporated in to the doctor induction programme and neonatal nurse training. The plan is to repeat the audit monthly to ensure compliance is maintained.

HELPING PARENTS/CARERS TO GIVE MEDICINES TO CHILDREN IN HOSPITAL

BackgroundMedicines given to children in hospital are often prepared, checked and administered by two-registered nurses. Children are more likely to accept medicines given by a parent/carer1 but many hospital policies do not support such practice. Indeed the Trusts Medicines Management Policy allows single person medicines administration, except for children, but does not specify how medicine preparation and administration should take place or who should witness this. Our aim was to identify ways of increasing parent/carer involvement in giving medicines to children in hospital.Objectives▸ Measure time delays with the current administration process▸ Identify obstacles that may prevent parent/carer involvement in giving medicines▸ Identify how to overcome potential/perceived problems with parent involvement▸ Determine parent/carer opinions of their involvement in giving medicines▸ Assess single nurse checking and parent administration of medicinesMethodDrug rounds were observed to identify time delays in medicines administration. A list of nineteen low risk medicines was proposed for parent administration with single nurse preparation. Focus groups were conducted, using structured questions, to get healthcare professionals perspective on the proposed changes and to approve a list of low risk medicines. Parents/carers were invited to complete a questionnaire regarding their involvement. Following Drug and Therapeutics Committee approval, parents/carers administered medicines with single nurse preparation during a trial period.ResultsAdministration of twenty-one medicines was observed under current practice. Delays were observed in all cases: average delay 6.5 minutes. Delays of 10 minutes were observed due to children fighting against having medicines administered by a nurse. Delays in 28% of cases were due to getting another nurse to check the preparation and seventeen of the twenty-one medicines observed where not in the medicines locker. Such delays often lead to parents administering medicines, despite the current policy not allowing such practice. Three focus groups, involving 12 staff, identified several problems and potential solutions to single nurse checking of medicines. The main concern was the risk of errors with dose calculations. Questionnaires were completed by 30 parents/carers and 97% wanted to be involved in administering medicines. The only parent/carer who did not, quoted: “My child will not take any medicine from me, this is part of the reason she has been admitted”. Most parents/carers (80%) felt their child would be more at ease if they give the medicine. During the trial eight medicines were administered by parents and carers and no delays were observed.ConclusionChildren often receive late medicines in hospital. Parents/carers want to be involved in giving their child medicines. They suggest children would be more at ease. Parents/carer would also gain experience to help when administering medicines at home. Nurses support parent's being more involved in giving medicines. Focus groups suggest that medicines requiring dose calculations should be removed from a list of low risk medicines and parents be encouraged to administer medicines.

The medicine selection process in four large university hospitals in Brazil: Does the DTC have a role?

Knowledge about evidence-based medicine selection and the role of the Drug and Therapeutics Committee (DTC) is an important topic in the literature but is scarcely discussed in Brazil. Our objective, using a qualitative design, was to analyze the medicine selection process performed in four large university hospitals in the state of Rio de Janeiro. Information was collected from documents, interviews with key informants and direct observations. Two dimensions were analyzed: the structural and organizational aspects of the selection process and the criteria and methods used in medicine selection. The findings showed that the DTC was active in two hospitals. The structure for decision-making was weak. DTC members had little experience in evidence-based selection, and their everyday functions did not influence their participation in DTC activities. The methods used to evaluate evidence were inadequate. The uncritical adoption of new medicines in these complex hospital facilities may be hampering pharmaceutical services, with consequences for the entire health system. Although the qualitative approach considerably limits the extent to which the results can be extrapolated, we believe that our findings may be relevant to other university hospitals in the country.