How to meet the NSQHS Standard 4 – medication safety Like most serious undertakings, Standard 4 (medication safety) raises as many questions as it answers. What we know: The ten National Safety and Quality Health Service (NSQHS) Standards have been developed by the Australian Commission on Safety and Quality in Health Care (ACSQHC) are designed to provide a quality assurance mechanism that tests whether relevant systems are in place to ensure minimum standards of safety and quality are met, and a quality improvement mechanism that allows health services to realised aspirational or developmental goals. The intention of the Medication Safety Standard is to ensure competent clinicians safely prescribe, dispense and administer appropriate medicines to informed patients and carers. The ACSQHC has produced a draft Guide:    to help hospitals meet the requirements of the National Safety and Quality Health Service (NSQHS) standards; which provides examples of evidence a hospital can use to demonstrate how it is meeting the NSQHS Standards; and which provides additional information and resources and to support the implementation of the NSQHS Standards. It is important to note that the standards were designed by the ACSQHC to be applicable across all health care settings and to all categories of patients within those settings. The ACHS will be reviewing compliance with these standards from 1 January 2013. The five major criteria to achieve the Standard for medication safety are:      governance and systems; documentation of patient information; medication management processes; continuity of medication management; and communicating with patients and carers. The Standard describes 15 ways for the criteria to be achieved, and 37 actions required to do this. These 37 actions can be categorised into one or more of the following types of checking or reviewing:  that certain things are in place (e.g. policies and procedures, a governance structure etc.)      that regular assessment or monitoring is occurring (e.g. medication incidents are regularly monitored); that action is being taken (e.g. to reduce the risk of medication incidents); that certain things are documented (e.g. a medication history) that certain things are reported (e.g. ADRs are reported to the hospital and to the Therapeutic Goods Administration; and that audits where appropriate are conducted to provide evidence that the criteria re being met and the required activity is taking place (e.g. that a medication management plan id available in each patient’s clinical record). Obvious questions which arise in relation to audits (for which to date no guidance has been provided by the Commission) are:   how is the sample to be created; and what is the number of individual clinical recorded which need to be audited in order to provide a statistically appropriate level of confidence (e.g. to a 90% or 95% level) that the sample does not vary by more than 10% from the whole of the hospital’s patient population. The sampling method and size of the sample are critical to providing this level of confidence and to allow the audit to be conducted again with the confidence that the results of longitudinal audits (i.e. over time) can be compared and changes accurately identified. To date the Commission has also not provided a tool which will facilitate accurate and fast data collection and tabulation. It is possible to create such a tool, using MS Excel®, which allows data from multiple sources within the individual clinical record to be noted in a way that make this onerous task much easier. The examples that the AQCHC uses in the (draft) Guide provides a good ideas as to what activities are deemed to provide evidence of meeting the various criteria. What we need to know: To compliant with Standard 4 by 1 January 2013, hospitals and health services will need to decide:       which of the medication-related processes, records, documentation, audits etc. best demonstrate the hospital’s compliance with the criterion listed in Standard 4; which aspects of medication management will need to be audited to demonstrate compliance; which sampling method should be employed (e.g. random sampling of the individual clinical record for every patient discharged over a one month period using a consecutively numbered discharge patient approach); what should the size of the sample be in order to provide confidence that the sample varies from the total population by less than 10%; which tool(s) will enable data is to be collected and collated accurately and quickly; when and who will collect, collate and report the audit work; and  when the audit will be repeated in order to demonstrate progress towards meeting the requirements if the Standards. Although there are many important decisions to be made and a lot of work to be completed to demonstrate compliance, the effort will be worth it for what it will reveal of a hospital’s systems and practices in ensuring medication safety. Michael Ryan Director, PharmConsult. PharmConsult is Australasia's leading hospital pharmacy consultancy advising hospitals on the operational, financial, professional, service, risk and legislative issues associated with hospital pharmacy services. Ph: 03 9813 0580; www.pharmconsult.com.au First published in ‘Private Hospital’ (the official magazine of the Australian Private Hospitals Association), August 2012 edition