Risks with medicines use

Risks with medicines use

In addition to the potential for harm from adverse drug reactions to medicines when used correctly, patients may be harmed as a result of incorrect medicines use.

Awareness of the risks associated with healthcare has risen over the past decade following the publication in 2000 of To Err is Human in the USA by the Institute of Medicine. This milestone document acknowledged that healthcare is not as safe as it should be and pointed to medical errors, includ-ing medication errors, being a leading cause of death and injury. One of the events which triggered this publication was the death of a Boston Globe health reporter from an accidental overdose of chemotherapy.

In England, in 2000 the Department of Health published its own account of patient safety in the NHS. An Organisation with a Memory was written by an expert panel, chaired by the chief medical officer.⁵ It recognised that serious adverse events had been allowed to recur within the NHS due to a lack of capacity to learn from infrequent but devastating events.

A specific example used to illustrate the problem was the fatal conse-quence of inadvertent spinal injection of vinca alkaloids intended for intra-venous administration in chemotherapy regimens for the treatment of some haematological cancers. Between 1985 and publication of the report, 12 cases of maladministration of intravenous vinca alkaloids were known to have occurred, of which 10 were known to have resulted in either death or paralysis of the patient. The outcomes in the other two were unknown. Despite the known toxicity of vinca alkaloids, and warning labels on products, these preventable errors were being repeated with devastating consequences for patients, their families and the staff involved in their care.

An Organisation with a Memory recommended the establishment of an independent scheme for mandatory reporting of adverse healthcare events and near-misses to which staff could report confidentially. It recommended a single system for analysing and disseminating lessons learnt from these adverse events, making recommendations to improve patient safety and encouraging further reporting. The implementation of these recommenda-tions was described in Building a Safer NHS for Patients. Published in 2001, Building a Safer NHS for Patients: Implementing an Organisation with a Memory further recognised the complexity of healthcare and the risks associated with it. Patient safety was identified as a worldwide problem, and the need to improve safety in healthcare by strengthening systems through capturing data on error and learning from the analysis of incidents was described.

More specifically, the document established the National Patient Safety Agency (NPSA) and listed four key areas that should be the focus for change, two of which specifically referred to the use of medicines. The two targets for medication safety were to:

·      reduce to zero the number of patients dying or being paralysed by maladministered spinal injections by the end of 2001

·      reduce by 40% the number of serious errors in the use of prescribed drugs by 2005.

The way in which the NHS should work towards achieving these two targets was described in two subsequent documents, The Prevention of Intrathecal Errors and Building a Safer NHS for Patients: Improving Medication Safety.

The report into the prevention of intrathecal errors described two main strategies for error prevention: (1) human factors, encompassing training and education, ward and pharmacy procedures and policies; and (2) design changes. The concept of design or engineering safety was a new concept in risk management in healthcare at the time. The report highlighted the inherent risk of misconnection due to the universal use of a Luer connector as a root cause of the error, compounded in some situations by human actions. The themes of root cause analysis (RCA) and design change have since become embedded into the processes for investigating serious adverse events in the NHS.

Building a Safer NHS for Patients: Improving Medication Safety addressed the target of reducing the number of serious errors in the use of prescribed medicines. It described the published literature on medication safety and highlighted the processes, medicines and situations known to be associated with harm. The document recommended actions to be taken by NHS organisations to recognise and reduce these risks, although at the time these had not been accurately quantified. The publication drew attention to drugs known to be harmful and patient groups who were known to be at risk of harm from medicines: Table 12.2 lists these.