Medicines Governance in Primary Care

Improving the safety record of healthcare has become an international priority.

The importance of patient safety with specific focus on the safe management of medicines has been raised in several major policy documents in the UK.  In 2001, The Audit Commission’s Report, ‘A spoonful of Sugar - Medicines Management in NHS Hospitals’ was published and it states that medication errors account for about one fifth of deaths due to all types of adverse events in hospitals and are also an increasingly common stimulus for litigation. The document illustrates that in the year 2000 nearly 1100 people died in England and Wales alone as a result of medication incidents or adverse reactions to medicines, and that this number had increased fivefold in just ten years. It also notes that medication errors alone cost the NHS £500 million a year in additional days spent in hospital.  ‘An Organisation With a Memory’ (OWAM), Department of Health (DoH) report 2000, addresses the need for NHS organisations to evolve from it’s traditionally punitive culture to one that shares and learns from it’s mistakes, encouraging an open fairer culture. It stresses the importance of reporting by staff of adverse events and near misses and notes Heinrich’s ratio which for every serious accident there have been 300 occasions when the accident could have happened but was averted.

This publication was followed by ‘Building a Safer NHS for patients’ in 2001 which set out an action plan for implementing OWAM through which the National Patient Safety Association (NPSA) was borne to improve patient safety by reducing the risk of harm through error. In 2004 the DOH document ‘Building a Safer NHS for patients: improving medication safety’, focuses on strategies that organisations should adopt to reduce the occurrence of prescribing, dispensing and administration errors.

The release of the ‘Best Practice, Best Care’ consultation document by the Department of Health, Social Services and Public Safety (DHSSPS) in Northern Ireland in April 2001 set out the framework to improve the quality of care. In Feb 2003 the Health and Personal Social Services (Quality, Improvement and Regulation) Order 2003 applied a ‘statutory duty of quality’ on HSS Boards and Trusts. This means that each organisation has a legal responsibility to ensure that the care it provides must meet a required standard. In April 2006 the Controls Assurance Standards were produced to support the embedding of organisation-wide risk management in HPSS bodies. Medicines Management is one of the 21 standards and criterion 10 stipulates that ‘the organisation reports adverse incidents involving medicinal products and devices to the relevant agency, and appropriately manages any subsequent required action’. It further adds that the organisation should have a local, multidisciplinary, medication incident (prescribing, dispensing and administration) reporting and monitoring system as part of the risk management system and that the organisation should contribute to the regional analysis of medication incidents undertaken by the Northern Ireland Medicines Governance Team.

The Northern Ireland Medicines Governance Team was established in August 2002 and comprises of 6 senior pharmacists and an administrator dedicated to medicines risk management in acute Trusts in Northern Ireland. The Team have made excellent progress in addressing the following medicines safety areas:

In November 2004, the Team was awarded the Health Service Journal Award for Patient Safety.

Although much has been achieved in the secondary care setting, little attention has been paid to medication incidents in primary care despite it being the area where the bulk of medicines are prescribed and dispensed. The DHSSPS document ‘Making it Better- A Strategy for Pharmacy in the Community’ 2003 states ‘there is an urgent need for the development of a formal medicines risk management system in the primary care setting, which is analogous to that established in secondary care.’

The ‘Safety First -  A framework for sustainable improvement in the HPSS’, March 2006, sets an action plan to improve quality of care which will be reviewed and updated in 2007 to take account of progress and local and national developments. One of the actions included in this document is the extension of the Medicines Governance Team into primary care.

The extension of Medicines Governance into primary care aims to build a safety culture, which promotes medication incident reporting, learns and shares safety lessons and implements and disseminates solutions to prevent harm. The primary care section of the Team will have the following key tasks;

Medication incidents can occur at every stage in the process of a prescription being generated, the medicine procured, dispensed, labelled, supplied and administrated. Actual, prevented and potential incidents are detected by pharmacists, doctors, nurses, staff, carers and patients. At present there are no formal regional reporting arrangements in place for medication incidents and near misses which occur in primary care.

The first wave of this extension project is to pilot medication incident reporting, within community pharmacies in the Southern Health and Social Services Board for a three month period. The pilot will focus on the methodology for recording anonymous reports of medication incidents which have occurred within the pharmacy. Community pharmacists will not be asked to report incidents which have resulted from errors made by others i.e. prescribing and administration incidents are excluded. Examination of this specific part of medicines management in a unidisciplinary setting, will aim to build confidence and develop trust throughout all primary care professionals and staff. It will demonstrate that a system for medicines incident reporting encourages self reporting and learning.  

A Medicines Governance Pharmacist for the area has been appointed to aid management and implementation of the project. It is planned that the pilot will commence in Feb 2007 and the analysis to be completed by June 2007.

Feedback will be provided to community pharmacists through the production of a Newsletter, safety focus meetings and walkabout sessions from the Medicines Governance Pharmacist.

‘Medicines Governance: Improving Patient Safety’ distance learning material is available from www.nicppet.org.