Medicine Name Changes: The Practical Implications for Patient Safety and Clinical Practice Chris Giles, Pharmacy Practice Unit As covered in CIRCUIT last year, the Therapeutic Goods Administration (TGA) announced in April 2016 that it had updated over 200 active ingredient names used in Australia to align with those used internationally. Whilst some changes are minor, e.g. phonetic changes and/or changes to names of esters/salts of medicines (not the medicine name itself), others are much more significant changes to medicine names, resulting in substantial or complete name changes. ¬¬ Refer to Table 1 for some common examples ¬¬ Full details are on the TGA website: tga.gov.au/updating-medicineingredient-names TGA have allowed a 4 year transition period (ending April 2020), during which time the following changes are expected to occur: Different manufacturers of the same medicine are implementing the name change on packages, labels, product information (PI) and consumer medicines information (CMI) at different points in time. To date, very few products have been updated. Unfortunately, advance communication from manufacturers regarding name changes to affected products is inconsistent and there is no TGA mechanism available to monitor and advise health professionals when the manufacturers make the name changes on medicine packaging and PI/CMIs.2 So it is anticipated that a number of changes to the medicinal products themselves will not be known until those products reach health services and pharmacies. Updates to affected medicine names in pharmacy systems (dispensing and imprest), prescribing systems, electronic medicines management systems, and other clinical resources (e.g. AusDI, MIMS, Therapeutic Guidelines, PBS Online, etc.) will occur gradually as per software vendors’ own timeframes. For many such clinical information systems, it is not just a “simple matter” of updating to match the TGA list. Considerations of character limits in software database fields are important to ensure the safe on-screen displays and printed information (e.g. dispensing and storage labels, prescriptions), particularly for dual labelled medicines, e.g. “lidocaine
(lignocaine) with adrenaline (epinephrine)”. TGA acknowledge these challenges for the clinical software vendors and that the required name changes for medicines packaging and documents may not be able to be applied identically from the TGA list into such clinical applications.² However there is no standard list or business rules for how the name changes may be safely truncated to be accommodated in such clinical systems. During this transition period, manufacturers packaging, PI’s, CMI’s may therefore not match the drug names on dispensing labels, drug storage locations (dispensary and clinical areas) and/or prescriptions/medication orders. This poses a number of risks to patient safety. Confusion due to different medication names may result in: 1. Unnecessary delays or dose omissions: ¬¬ Handwritten medication order does not match the dispensing label and/or product packaging, leading to delays/ omissions in dosing. ¬¬ Pharmacy/nursing staff cannot locate medication as it is located in a different place on imprest or dispensary due to name change, e.g. thyroxine will be renamed as levothyroxine, eformoterol becomes formoterol. 2. Patients may be administered incorrect medication: ¬¬ Genuine product selection errors may not be detected prior to patient administration as an assumption is made that it is “just another TGA name change”. 3. Accidental overdose/duplicate dosing of the same drug with different names: ¬¬ Patients/carers confused about new medication names or mismatch in labelling and packaging information, and may consume medicines concurrently with old and new names. A number of mitigation strategies are recommended for implementation by health services during the transition period to minimise these risks: 1. Provide education and ongoing support for the clinical workforce regarding required changes in clinical practice (refer Table 2 on right for examples): ¬¬ Ensure ready access to the full list of medicine ingredient names that are changing in areas of clinical practice
(e.g. medication treatment rooms), and at the point of care (e.g. in folder with medication chart) ¬¬ Communicate information about the changes to all prescribers, including visiting medical officers, and table at Medical Advisory committees, and specialty medical practice committees/ craft groups. ¬¬ Include in medication related learning and development programs for nursing and pharmacy staff. 2. Include both the old and new name on shelf labels where medications are stored. Where a significant name change necessitates a change in the storage sequence, strategies should be to ensure that medicines can be easily located, e.g. implemented (e.g. “shelf talkers”, signs on/inside imprest cupboard doors. 3. Ensure universal application of new medicine names to embed throughout clinical practice: review all local policies, procedures, guidelines and resources, including documents provided to patients, containing medicine ingredient names that are changing and update them to include both the old and new name. 4. Ensure any applicable name changes are highlighted in medication counselling with patients and/or carers. Health services should conduct a local risk assessment of the impact of these name changes when deciding which are the most appropriate and effective risk mitigation strategies for their clinical environment and patient mix. Ongoing monitoring and evaluation of the effectiveness of these strategies by the appropriate clinical governance committee(s) should continue throughout the extended transition period. Any medication incidents/near misses arising from confusion due to these medicine name changes must be reported and investigated to determine if any further strategies are required to further improve patient safety. Over the next few years a sustained and consistent effort will not only be required by the health services in managing the risks outlined above, but also by health professionals in changing their practice to ensure the transition to the international medicine names is completed in the safest manner possible for patient care. References are available on request.