Identifying and Reducing Avoidable Drug-associated Bleeds

Janet Thomas


Betsi Cadwaladr University Health Board


This Betsi Cadwaladr University Health Board (BCUHB) pharmacovigilance/quality improvement project is about finding out more about just one fraction of medication-related harm; that of drug-associated bleeds (DaBs). It seeks to improve local/national data capture of DaBs, in order to learn lessons and reduce future occurrences.


Project Scope

Stakeholders include the local Endoscopy Steering Group and the Welsh Medical Imaging Sub-Committee of the Welsh Scientific Advisory Committee, local / national Clinical Coding departments, external Gastro-intestinal (GI) Reporting tool commercial software companies, NHS Wales Informatics Service (NWIS), the Medicines and Healthcare Products Regulatory Agency (MHRA) and its associates, BCUHB’s Drug and Therapeutics Group, finance department and cross-sector healthcare professionals.


The project, in time, will be a Wales-wide project impacting on the wider UK and beyond.


Initially, the Bevan Exemplar is working with stakeholders to refine the processes involved in identification of and capturing clinical coding of DaBs.


Another aspect is the collection of pharmacovigilance data regarding DaBs in the form of yellow MHRA cards. All drugs, whether new or long established therapies, have an inherent risk of Adverse Drug Reactions (ADRs). Identifying and reporting ADRs to the MHRA is an important part of drug surveillance. With time, root cause analysis of individual DaB cases should highlight avoidable DaBs and reveal potentially rectifiable contributory factors.


With improved clinical coding and identification, more accurate DaBs data should reflect a truer picture of both patient harm and NHS resource consumption.


Ultimately, national standards for the software companies engaged in gastro-intestinal (GI) reporting tools are strived for with parallel development of Bronchoscopy reporting tools for collecting drug-associated harm to lungs.


This project seeks to make a positive difference to reducing DaB harm and costs.


Why this Project?

  • The NHS can’t fix what it doesn’t know is wrong.

  • All NHS Professionals have a duty of care to learn and feedback regarding avoidable harm.

  • Landmark research published in 2004 highlighted that 6.5% of all admissions are related to medicines, of which 72% are avoidable [1]. It involved 18,000 patients in two Merseyside hospitals.

  • Gastro-intestinal (GI) bleeding was cited as the cause for 54% of deaths in this landmark study [1].

  • GI bleeding caused by drugs needs preventing.

  • However, bleeding as a mode of drug harm takes various forms, whether intracranial haemorrhage, haematoma or GI bleeding or from other body sites, so harm capture needs to count bleeds wherever they happen.

  • Capturing information regarding drug-associated bleeds should be routine for healthcare professionals across the specialties.

  • Pirmohamed et al [1] reported drugs causing bleeding were aspirin, non steroidal anti-inflammatory drugs, warfarin, and antidepressants. However there are new drugs which weren’t available in 2004. These include a novel class of oral anticoagulants widely prescribed within the NHS called NOACs. There is a known risk of GI bleeding with these and this risk is greater for those over 75 years of age [2].

  • NWIS data is available for emergency admissions involving DaBs, as coded by NHS Wales’ clinical coding departments but clinical coders rely on clear documentation in medical notes/reports.

  • Analysing DaB harm adds a new focus to a suspected medication-related admissions Wrexham project led by the Bevan Exemplar since April 2006.

  • Here is the Bevan Commission’s opportunity to use Welsh intelligence to lead the rest of the UK.


Anticipated Benefits


Within BCUHB & ultimately across Wales

Make it safer:

  • Help NHS Wales provide a safer, more efficient service.

  • Drive pharmacovigilance forward.

Make it sound:

  • More accurately count and clinically code DaBs.

Make it happen:

  • Elucidate which, when, where, how and why DaBs occur & identify solutions.

Make it sustainable:

  • Ultimately reduce DaB patient harm (and associated measures of this: deaths, inpatient bed days, gastroenterology scoping DaB costs, litigation, primary/secondary care consultations).

  • Work to reduce NHS pressure and hospital escalation status frequency.

  • Count DaBs’ financial cost to enable wider engagement.

  • Continuing motivation of applicant and front-line colleagues.

  • Continuing Professional Development of all through learning and feedback.


Within the UK

  • Develop a national standard, endorsed by the MHRA for all GI reporting tool commercial software companies.

  • Incorporate into the GI reporting tool which drugs are known to be associated with bleeds but include a free-text option to enable new harm from existing/new drugs to be recorded.

  • Similarly trigger development of a national standard for a Bronchoscopy reporting tool.


This Project Supports Prudent Healthcare

  • Through co-production with Gastroenterology/MHRA/software company/healthcare professionals: Better capture DaB clinical coding data. Introduce national standards for GI reporting tools and explore similar for, e.g. Bronchoscopy. Ultimately achieve fewer DaBs.

  • Utilising skills: Benefiting from Pharmacists’ root cause analysis/drug safety skills.

  • Harm & resource usage limitation: Reduce patient harm in terms of deaths, haemorrhages, bed days consumed, DAB episodes, gastroenterology scoping resource usage.

  • Helping the needy: DaBs (which includes haemorrhagic strokes) affect quality of life and can be fatal. The elderly are frequently affected.

  • Reduce inappropriate variation: Drive pharmacovigilance forward across BCUHB/Wales/UK for new and existing drug therapies.


Part of Cohort Bevan Exemplars 2015-16