The prevention of medication errors related to similar medicines names requires both pre- and post-marketing strategies and involves drug regulatory agencies, pharmaceutical manufacturers, medication error reporting programmes, health care practitioners and patients.
Pre-marketing strategies should aim at designing new drug names, which do not pose a risk for confusion with existing names. The proprietary (trade/brand) names of new medicines should be subject to human factors assessment and user testing by manufacturers; and non-proprietary (generic/active ingredient) by the WHO INN Programme. Evidence that names have been tested and are considered acceptable for use should be an essential requirement prior to the medicine receiving marketing authorization and should be made publicly available as a proposed name safety assessment report. By this, medicines with a high risk of name confusion would not be placed on the market.
Post-marketing strategies should aim at minimising errors occurring with medicines that are already on the market and comprise the implementation of specific practices that prevent errors due to name confusion and reporting and dissemination of experiences the aim of changing practices and thus reducing the risks of recurrence.
The dangers of INNs for antibody-drug conjugates
During the clinical trials of trastuzumab emtansine, deaths resulting from confusion with trastuzumab drew attention to the risks associated with International nonproprietary names (INNs) of such cytotoxic substances with a common part.
On May 8, 2014, the IMSN issued an Alert about the risk of confusion between the names trastuzumab emtansine and trastuzumab, recommending the use of both the INN and the brand name as an immediate measure to strengthen the differentiation between these products and advocating for a substitution of this INN in order to prevent such a potentially fatal similarity. Read more...
On 23 March 2015, the IMSN called on the WHO INN Programme to identify nomenclature that will reduce their potentially fatal similarities and define clear rules to help recognize products that include different substances, in order to make them safer. Download PDF
During the 10th IMSN meeting, held on 30 September and 1st October 2015 in Cartagena, Colombia, the IMSN discussed about the decisions taken during the 59th and the 60th INN Consultations, respectively held on 14‐16 October 2014 and on 13-15 April 2015. In the lack of any risk reduction solutions envisaged by the WHO INN Programme, the IMSN goes further by proposing several approaches in an open letter to the WHO INN Programme on 12 October 2015:
1st make awareness on active moieties;
2nd change the way of expressing the conjugate compound (taking in account human factor principles, the names of active substances should include a specific prefix for conjugated compound, such as con-, and/or be concatenated by “+”,“plus” or “/” without space);
3rd avoid attribution of INN to corresponding naked antibodies when antibody-drug conjugates are considered. Download PDF
IMSN Position Paper on Making Medicines Naming, Labelling and Packaging Safer
A poorly designed medicine name can cause communication and selection errors in practice that in some cases may be fatal or lead to severe harm. (October, 2013) Download PDF
IMSN Position Statement On Improving The Safety Of International Non-proprietary Names of Medicines (INNs)
Since there have been medication errors caused by confusion among INNs, it is important to recognize them and to work on improving their safety, as well. Effective and active management of INN-related risks should include:
- a systematic evaluation of each INN using appropriate risk assessment methods;
- revision by the World Health Organization (WHO) of INNs following associated errors with serious consequences;
- participation in a critical analysis of proposed INNs during WHO public consultations;
- incorporating INNs and common stems into healthcare professional undergraduate curricula. (November 2011) Download PDF
IMSN Comments on EMEA Recommendations on the Expression of Strength in the Name of Centrally Authorised Human Medicinal Products
Current European legal requirements regarding the expression of strength are flexible and do not take into consideration concerning the use of medicines by healthcare professionals and by patients in the real world. Using the concentration as the expression of strength in the name instead of the total content per total volume along with the per mL designation creates a situation prone to medication errors. (May 2008) Download PDF
IMSN Comments on EMEA Guideline on the acceptability of names for human medicinal products processed through the centralised procedure
The International Network of Safe Medication Practice Centres considers that it is important to:
- update medicines regulations to require manufacturers to assess the risks of possible sound- or look-alike confusion between the new proposed proprietary names and existing medicines. This evaluation should be carried out by a standardised procedure, which should include user testing of prescription in oral and written communication, and an assessment by an expert panel using techniques based on “failure mode and effect analysis”;
- ensure that when medication errors are reported to the manufacturers and regulatory authorities, there is open disclosure, discussion and feedback regarding previous similar incidents and error analysis to identify contributory factors, root causes, and an action plan to prevent a recurrence;
- promote sharing of medication error data handled by the medication error reporting systems in Europe with post-marketing monitoring centers, and establish a way or mechanism through which to channel this information to the EMEA. (April 2007) Download PDF
Updated on 12 October 2015