Adverse drug reaction reporting by community pharmacists- The barriers and facilitators

Purpose: The United Kingdom's “Yellow Card Scheme” for reporting of adverse drug reactions (ADRs) has been operating for 50 years, but reporting rates by community pharmacists remain low. The aim of the study was therefore to investigate the views and experiences of ADR reporting by community pharmacists in Wales, with a particular focus on the potential barriers and facilitators to reporting. Methods: Following ethics approval and piloting, a self‐complete questionnaire was mailed to all registered community pharmacies in Wales, UK (n = 713). A follow‐up mailing was sent to nonresponders after 2 weeks. Results A response rate of 52% (n = 372) was achieved, of whom 57% had never submitted a yellow card. Key barriers to reporting were not seeing ADRs, difficulty identifying the causative drug, not being sure which ADRs to report, and lack of time. Key facilitators were being able to report through dispensary software and having clearer guidelines about what to report. Differences between those who had previously reported ADRs and those who had not suggested lack of confidence and uncertainty about what to report were more of a barrier for nonreporters. Conversely, reporters wanted feedback on reports, ability to keep reports on their dispensary records, and remuneration to aid them with reporting. Conclusions While the respondents generally expressed positive attitudes towards ADR reporting, a number of barriers and potential facilitators were nevertheless identified. Clearer support and guidance for reporting, such as through a “champions” scheme similar to that run in Welsh hospitals, may help current nonreporters to engage

Annual SHOT Report 2015

SHOT is affiliated to the Royal College of PathologistsBe WARM: Work Accurately and Reduce Mistakes 1. Use a TACO checklist 2. Use a bedside checklist TACO Checklist Red Cell Transfusion for Non-Bleeding Patients. Human factors in hospital practice. Be safe! Use the bedside checklist. • Review the need for transfusion (do the benefits outweigh the risks)? • Can the transfusion be safely deferred until the issue can be investigated, treated or resolved? • Consider body weight dosing for red cells (especially if low body weight) • Transfuse one unit (red cells) and review symptoms of anaemia • Measure the fluid balance • Consider giving a prophylactic diuretic • Monitor the vital signs closely, including oxygen saturatio

Annual SHOT Report 2018

SHOT is affiliated to the Royal College of PathologistsAll NHS organisations must move away from a blame culture towards a just and learning culture. All clinical and laboratory staff should be encouraged to become familiar with human factors and ergonomics concepts. All transfusion decisions must be made after carefully assessing the risks and benefits of transfusion therapy. Collaboration and co-ordination among staff is vital

Annual SHOT Report 2021

SHOT is affiliated to the Royal College of Pathologists. This report is produced by SHOT working with MHRAPartnering with patients to enhance safety: Staff must ensure that they involve, engage and listen to patients as ‘partners’ in their own care, including transfusion support. Engaging patients, their families, and carers as ‘safety partners’ helps co-create safer systems, identify, and rectify preventable adverse events. Investing in safety - well-resourced systems with safe staffing levels: Healthcare leaders must ensure that systems are designed to support safe transfusion practice and allocate adequate resources in clinical and laboratory areas to ensure safe staffing levels, staff training in technical and non-technical skills and appropriate equipment, including IT systems. Just and learning safety culture: All healthcare leaders must promote a just, learning safety culture with a collective, inclusive, and compassionate leadership. Effective leaders must ensure staff have: access to adequate training, mentorship, and support. All staff in clinical and laboratory areas have a responsibility to speak up in case of any concerns and help embed the safety culture in teams

Annual SHOT Report 2020

SHOT is affiliated to the Royal College of Pathologists. This report is produced by SHOT working with MHRAKey SHOT messages • Ensuring transfusion teams are well resourced: Clinical and laboratory teams can function optimally only if adequately staffed and well resourced. Healthcare leaders and management must ensure that staff have access to the correct information technology (IT) equipment and financial resources for safe and effective functioning • Addressing knowledge gaps, cognitive biases, and holistic training: Transfusion training with a thorough and relevant knowledge base in transfusion to all clinical and laboratory staff along with training in patient safety principles, understanding human factors and quality improvement approaches are essential. It is important that staff understand how cognitive biases contribute to poor decision making so that they can be mitigated appropriately • Patient safety culture: Fostering a strong and effective safety culture that is ‘just and learning’ is vital to ensure reduction in transfusion incidents and errors, thus directly improving patient safety • Standard operating procedures (SOP): SOP need to be simple, clear, easy to follow and explain the rationale for each step. This will then ensure staff are engaged and more likely to be compliant and follow the SOP • Learning from near misses: Reporting and investigating near misses helps identify and control risks before actual harm results, thus providing valuable opportunities to improve transfusion safety • Learning from the pandemic: The learning from the pandemic experiences should be captured in every organisation, by everyone in healthcare and used to improve patient safet

Annual SHOT Report 2019

SHOT is affiliated to the Royal College of Pathologists. This report is produced by SHOT working with MHRAAccurate patient identification is fundamental to patient safety. Organisations must review all patient identification errors and address the causes of patient misidentification with use of electronic systems, and empowerment of patients and staff. Clinical and laboratory staff should be trained in fundamentals of transfusion, human factors, cognitive biases, investigating incidents and patient safety principles. All healthcare organisations should incorporate the principles of both Safety-I and Safety-II approaches to improve patient care and safety. Healthcare leaders should proactively seek signals for improvement from unsafe, suboptimal as well as excellent care. Healthcare management must recognise that safety and outcomes are multifaceted, a linear view of safety does not fully acknowledge the interdependencies of resources including their leadership, adequate staffing and knowledge. Healthcare leaders should ensure these are all in place to improve patient safety

Annual SHOT Report 2017

SHOT is affiliated to the Royal College of PathologistsTraining in ABO and D blood group principles is essential for all laboratory nd clinical staff with any responsibility for the transfusion process. This should form part of the competency assessments. All available information technology (IT) systems to support transfusion practice should be considered and these systems implemented to their full functionality. Electronic blood management systems should be considered in all clinical settings where transfusion takes place. This is no longer an innovative approach to safe transfusion practice, it is the standard that all should aim for. A formal pre-transfusion risk assessment for transfusion-associated circulatory overload (TACO) should be undertaken whenever possible, as TACO is the most commonly reported cause of transfusionrelated mortality and major morbidity (repeat from last year

Annual SHOT Report 2016

SHOT is affiliated to the Royal College of PathologistsABO-incompatible transfusions are the tip of the iceberg; they most commonly result from failure to identify the patient at the time of blood sampling (wrong blood in tube) or administration to the wrong patient. Pulmonary complications, particularly transfusion-associated circulatory overload (TACO), cause the most deaths and major morbidity. Delayed transfusions are an important cause of death, 25/115 (21.7%) 2010 to 2016. Many errors in transfusion, some with serious clinical consequences, relate to poor communication between teams, shifts and interfaces. The infrastructure needs improvement to facilitate exchange of results within and between hospitals. IT errors contributed to 1 in 5 SAE reported. IT is not infallible, it makes transfusion practice safer by helping to control and support the task, but does not replace knowledge about the task

Annual SHOT Report 2014

SHOT is affiliated to the Royal College of PathologistsBlood and blood component transfusion in the UK is very safe with a small number of adverse incidents in relation to the number of components issued and transfused. In 2014 (January to December) the total number of reports made to SHOT was 3668 and 3017 were analysed for this Annual Report (others were incomplete or withdrawn). The total number of reports made to the Medicines and Healthcare products Regulatory Agency (MHRA) was 1110 of which 764 were serious adverse events (errors in 97.8%) and 346 were serious adverse reactions. The proportion of SHOT reports where errors were the underlying cause was similar to 2013, 77.8% (2346 reports). Acute transfusion reactions (allergic/febrile) were the most common pathological reactions. The cumulative data (18 years) can be viewed on the website www.shotuk.org

Quality control of a medicinal larval (Lucilia sericata) debridement device based on released gelatinase activity

Lucilia sericata Meigen (Diptera: Calliphoridae) larvae are manufactured worldwide for the treatment of chronic wounds. Published research has confirmed that the primary clinical effect of the product, debridement (the degradation of non-viable wound tissue), is accomplished by a range of enzymes released by the larvae during feeding. The quality assessment of larval activity is currently achieved during production using meat-based assays, which monitor insect growth and/or the reduction in substrate mass. To support this, we have developed a complementary radial-diffusion enzymatic assay (RDEA) to produce a visual and measureable indication of the activity of larval alimentary products (LAP) collected under standardised conditions, against a gelatin substrate. Using basic laboratory equipment and reagents, the assay is rapid and suited to high-throughput. Assay reproducibility is high (SD 0.06 - 0.27, CV 0.75 - 4.31%) and the LAP collection procedure does not adversely affect larval survival (mortality < 2%). As a cost- and time-effective method, it is suited to academic or industrial use, supporting good manufacturing (or laboratory) practice (GMP and GLP) as a quality control (QC) assay