14 December 2015 - The International Medication Safety Network (IMSN) has issued a position statement that calls for greater worldwide attention to the problem of unsafe design of vaccine packaging and labelling. The statement calls on healthcare professionals, pharmaceutical companies, technology vendors, professional organizations, and regulatory/standard-setting organizations to help improve vaccine safety and efficacy.

The IMSN statement provides recommendations, including:

• Packaging that minimizes the need to prepare individual doses, provides unit dose according to the mode of administration, and redesigned vials (where vials are still used) to accommodate larger labels.
• Labelling that uses larger fonts for better readability; adoption of World Health Organization Vaccine Presentation and Packaging Advisory Group (WHO VPPAG) expiration dates standard; provision of peel-off labels to facilitate syringe labelling; and improved differentiation of pediatric and adult formulations.
• For vaccines provided with diluents or two component vaccines:
  -- Packaging that forces proper mixing of the diluent or of the two components of the vaccine; for example a two-chambered syringe or vial. If not feasible, vials of vaccine and diluent or second component should be packaged together without prejudice of storage requirements.
  -- Provide clear instructions in or on the label for mixing components of vaccines requiring
  reconstitution. Display directions and warning to administer contents of both vials together on the front label of each carton, vial, and vial cap. The label of diluents must primarily identify them as such and make it clear they are not the actual vaccine. For example, “DILUENT for preparing” followed by name of vaccine. Place warning on diluents that they are not the actual product.
• Healthcare authorities and regulators should promote safer labelling and packaging of vaccines and make available recommendations to healthcare providers for safer vaccination practices.

Vaccine manufacturers are strongly encouraged to revise packaging and labelling as specified, with particular attention on vaccines with diluents or two-component vaccines. For a complete copy of the position statement, click here.

The European Medicines Agency (EMA) has published a good practice guide on medication errors to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the European Union (EU). This EMA good practice guide on medication errors complements the guideline on good pharmacovigilance practices (GVP) and other existing guidelines published by the EMA. It consists of two parts:

• the first part details how suspected adverse reactions that are caused by medication errors should be recorded, coded, reported and assessed. EMA expects this will improve reporting and learning from medication errors for the benefit of public health.
• the second part of the guide clarifies key principles of risk management planning by the EMA in relation to medication errors.

In parallel, EMA has launched a webpage highlighting measures recommended by the Agency to prevent medication errors for specific medicines. Although this information is also available in the European public assessment reports (EPAR) of these medicines, the purpose of these documents is to increase awareness of the additional measures recommended by EMA in order to ensure that a specific medicine is used correctly and to reduce the risk of medication errors. On November 27, 2015, EMA made following documents available on this new webpage:

• Questions and answers on recommendations to prevent administration errors with Velcade (bortezomib) (20/01/2012)
• European Medicines Agency recommends measures to ensure safe and effective use of Strensiq (26/06/2015)
• Guidance on prevention of medication errors with high-strength insulins (27/11/2015)
• Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance (27/11/2015)
• Compliance card to be given to patients using Farydak - Compliance card will ensure correct use and avoid medication errors (27/11/2015)

EMA efforts to communicate on any additional measure decided upon at EU level to prevent medication errors are welcome. However, as stated since a long time by the International Medication Safety Network (IMSN) members, education and information do not significantly reduce errors on their own, because they rely on memory. In particular, IMSN recommends that regulations for medicines naming, labelling and packaging in all countries should be strengthened to: require safer design and field testing before release for use; incorporate human factors theory; promote safer use in practice.

In October 2013, the International Medication Safety Network issued recommendations to regulators, pharmaceutical industry and healthcare providers as part of a comprehensive, worldwide solution to the problem of unsafe medicines naming, labelling and packaging. Download PDF

During the 2013 Paris Conference on safer naming, labelling and packaging of medicines, Dr. Michael Cohen, chairperson of IMSN, proposed that regulators and other stakeholders join IMSN at a summit to address this global threat to patient safety. This summit is expected to be held during fall 2015.

The International Medication Safety Network (IMSN) is particularly concerned by the risks of error related to antibody-drug conjugates and quickly alerted to these risks.
Beyond the trastuzumab emtansine case, no longer on the WHO INN Programme agenda for a substitution, the IMSN recalls again that other INNs of antibody-drug conjugates fall into the same problem.

In March 2015, the IMSN called on the WHO INN Programme to change the names of antibody-drug conjugates to reduce their potentially fatal similarities and define clear rules helping to recognize products including different substances and to make them safer.

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.

If requested, the IMSN is ready to contribute to the assessment of this risk reduction and prevention strategy, essential but belonging to the sole authority of the WHO INN Programme.