Practical considerations for the use of pre-mixed intravenous solutions A statement by the Safer Medicines Group of NSW TAG March 2011 Distributed to: - Drug and Therapeutics Committees - Directors of Clinical Governance We recommend you also inform: - Directors of Pharmacy - Directors of Nursing - Nursing Unit Managers - Procurement and Distribution Introduction The Medication Safety Self Assessment (MSSA) [1] recommends “commercially prepared, premixed IV solutions are used whenever they are available on the market”. This is particularly relevant for high-risk solutions. For example the MSSA recommends: “Vials of concentrated forms of electrolytes (e.g. potassium chloride, potassium phosphate, magnesium sulfate, and stock sodium chloride greater than 0.9%) that require dilution before IV use are not available as ward or imprest and/or in automated dispensing cabinets on any patient care units (including in operating room/anaesthesia stock).” Recent research shows that the preparation of infusions is the most error prone step in the medication management pathway.[2] Premixed intravenous solutions have many safety benefits including removal of the need for drug-dose calculations when making up an infusion. Additionally, using pre-mixed bags that have been manufactured to ensure sterility, or prepared in an aseptically controlled environment [3], may reduce opportunity for infusion-related sepsis and particulate contamination. There is also removal of the need to fully mix solutions to which concentrated solutions have been added prior to administration. Specifically manufactured solutions may also offer the benefit of providing a concentration close to isotonicity whereas ward-based admixtures will usually result in a solution which is hypertonic. As more pre-mixed solutions become available on Australian market it is important to be mindful of other practical considerations that may arise. These practical considerations are described on the following page. They are accompanied by relevant supporting evidence from the MSSA. The full text of the MSSA is available at https://mssa.cec.health.nsw.gov.au/MSSA_introduction.html. 2 PRACTICAL CONSIDERATIONS SUPPORTING EVIDENCE FROM THE MSSA Selection errors - packaging and labelling issues Premixed solutions often look identical. Manufacturer’s labelling on pre-mixed solutions should be clear to ensure there is minimal risk of product selection errors - Products with look-alike drug names and packaging that are known by the hospital staff to be problematic are stored separately and/or are highlighted with appropriate alerts in the pharmacy and ward/imprest areas. [MSSA 4.3] - Auxiliary warnings or other label enhancements (e.g. TALL-MAN LETTERS to accentuate differences in look-alike drug name pairs) are used on packages and storage bins of drugs with problematic names, packages, and labels.[MSSA 4.7] Product standardisation The number of available concentrations should be standardised and minimised within an - Concentrations for infusions of HIGH-ALERT drugs such as morphine, heparin, insulin, and inotropes used for adult/paediatric patients are institution and/or patient clinical area to avoid inadvertent under- or over-dosing through standardised to a single concentration that is used in at least 90% of the selection of an incorrect concentration. cases. [MSSA 5.1/5.2] Where the medicine is administered as a continuous infusion that is both dose and rate dependent, each institution should support safe provision of pre-mixed solutions with a DTC approved nomogram for determining the appropriate infusion rate for accurate dose delivery in differing clinical situations. Storage - Drugs stocked in patient care units are carefully selected for each unit by Storage of pre-mixed solutions may become an issue as an increasing number of considering the needs of each patient care unit, staff expertise and products become available on the market. Dedicated medication storage areas may not familiarity with specific drugs, the risk of error with each drug, and the age be large enough to store a variety of premixed solutions. Thus storage needs to be and diagnoses of typical patients being treated on the units. [MSSA 5.17] taken into account when ordering pre-mixed solutions. Storage of all S4 medicines must Drugs stocked in patient care units are available in the least number of be in an area with restricted access, kept locked unless in direct use. [4] doses, concentrations, and forms that will meet essential patient needs As premixed solutions may look similar to other premixed solutions and infusion fluids, between replenishment. [MSSA 5.18] storage areas should be arranged in such a way to minimise mix-ups and wrong product - Drug products stored in clinical areas are clearly laid out in a systematic selection. sequence which is clearly labelled and uniformly applied throughout the The size and security of safes and temperature-controlled storage conditions should be hospital. [MSSA 5.28] examined when considering the use of pre-mixed S8 medicines. Safes are often already crowded, refrigerators often not temperature-controlled, and the addition of premix solutions may increase the risk of selection error and diversion. Pumps and devices Wherever possible, smart pumps should be used without bypassing checks to support accurate administration of pre-mixed solutions. Pumps should be programmed to support standard concentrations of pre-mixed solutions. - General infusion pumps with SMART PUMP TECHNOLOGY are in use with full functionality employed to intercept and prevent wrong dose/wrong infusion rate errors due to misprogramming the pump, miscalculation, or an inaccurately prescribed dose or infusion rate. [MSSA 6.13] When premixed infusions are not available - IV solutions (injections and infusions) that are unavailable commercially are Wherever possible, individually dispensed infusions of non-standard, complex and/or prepared in the pharmacy unless needed in urgent lifesaving situations. high-risk medicines should be prepared under controlled and standardised conditions in [MSSA 5.16] the pharmacy department All staff will need to maintain mathematical skills in drug-dose calculation for preparing infusions from standard concentrations. When solutions are made up on the ward it is preferable for specialist/senior nursing staff (who are familiar with local policies for concentrations & rates) to take responsibility for infusion preparation. References 1. Medication Safety Self Assessment for Australian hospitals. Institute for Safe Medication Practices (Adapted for Australian use by the NSW Therapeutic Advisory Group and the Clinical Excellence Commission), 2007. 2. Where errors occur in the preparation and administration of intravenous medicines: a systematic review and Bayesian analysis. Quality and Safety in Health Care 2010;19:341-345 3. Therapeutic Goods Act 1989. Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009. 4. NSW Health: Medication Handling in NSW Public Hospitals: PD2007_077 4
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