The International Medication Safety Network (IMSN) releases its fourth Global Targeted Medication Safety Best Practices aimed at preventing errors related to improper preparation of 2-component vaccines

Several vaccines require mixing two components that are supplied by the manufacturer in physically separate containers. For example, a lyophilized powder and a vaccine-specific liquid diluent. Other vaccines may include a powder vial plus a liquid antigen vial or adjuvant component. These powder and liquid containers may be packaged together by the manufacturer or, in some cases, may arrive separately. Preparation of the vaccine for injection must be completed prior to administering the dose.

Unfortunately, errors sometimes occur when proper mixing does not happen and only one component of the two-component vaccine is administered, thus the patient will not be fully immunized. In other cases, an incorrect diluent is used to prepare the lyophilized powder, which may affect stability. Such errors may go undetected thus revaccination does not occur, potentially allowing the development of disease. Among the many opportunities for error, the IMSN has identified different scenarios

In some very dangerous cases, a dangerous substance was accidentally used in place of the vaccine diluent. For example, there have been several incidents where a paralyzing agent (neuromuscular blocker) has been used instead of a liquid diluent: in 2014 fifteen children died in Syria, and more recently in 2018 two others infants died in Samoa.

In May 2019, the International Medication Safety Network (IMSN) published its first set of Global Targeted Medication Safety Best Practices to identify, inspire, and mobilize widespread international improvement in error prevention.
This international medication safety call to action was aimed at preventing fatalities due to medication errors with concentrated potassium injection, inadvertent intraspinal injection of vincristine, and accidental daily instead of weekly dosing of methotrexate in patients with psoriasis or rheumatoid arthritis.

The International Medication Safety Network (IMSN) hold its 13th Annual Meeting on October 29 and 30, 2018 in Cascais, Portugal, hosted by the Portuguese Association of Hospital Pharmacist (APFH). The meeting focused mainly on 2 topics: drug product labelling and packaging safety and medication error in pharmacovigilance programs.

Targeting International best practice for safe labelling and packaging of prescription medicines

The IMSN members discussed strategies for reducing medication errors related to labelling with representatives of pharmaceutical companies (Abbvie, USA; Baxter, Portugal; BMS, USA; Eli Lilly, UK; Hikma, USA; Janssen, J&J, Netherlands; Novartis, USA; Pfizer, USA; UCB, USA) and medicine agencies (FDA, USA; ANVISA, Brasil; MHRA, UK; Norway Medicine Agency) in the perspective of implementing the recommendations of the June 2018 IMSN / FDA Summit.

Participants agreed on the following best practices:
1. Include both the per mL and the per container quantity, not the per mL quantity alone, when presenting the concentration for injectable; with prominence given to total content per container
2. Use metric units for products and eliminate ratio expressions
3. Eliminate potentially error-prone abbreviations and dose designations on labels, such as U for units, IU for international units, and trailing zeros (e.g., 1.0) to express strength
4. Prominently display cautionary statements on the carton and immediate container labels of NMBs, KCL concentrate injection, methotrexate, and other selected error-prone medications
5. Use contrasting label backgrounds for printing on glass ampules and recommended font size and label orientation to improve readability
6. Physically link or integrate "special" diluents for "specific drugs" with their powder component
7. Increase the adoption of ready to use/ready to administer syringes, premixed IV solutions, unit-dose packaging and other more efficient, safer packaging, while considering the overall cost of implementation
8. Develop product-specific world safety standards; for example, standard packaging for non-oncologic methotrexate to prevent accidental daily use and overdose
9. Include barcodes on primary packages so they can be scanned at the bedside or other locations where medications are dispensed and administered by healthcare practitioners
10. Mention prominently international non-proprietary names (INN) on labels

Participants agreed that an IMSN White Paper targeting International best practice for safe labelling and packaging of prescription medicines should be drafted and about the global need to use barcode in the medication use process for patient safety purpose, that IMSN will undertake a barcode readiness assessment at international level and lobby for European Datamatrix code on unit doses. Read on…

The IMSN promotes integrating Medication Error in Pharmacovigilance Programs

Adverse drug reactions and medication errors are two sides of the same coin: medication safety. The IMSN published almost ten years ago a Position Paper on Pharmacovigilance and Medication Errors. Read on...

Aiming to strengthen the cooperation between pharmacovigilance and medication error or patient safety incident reporting systems, the IMSN invited a panel discussion on medication error in pharmacovigilance programs during its 13^thmeeting. The nine countries that presented were: New Zealand, Morocco, United Kingdom, Canada, USA, France, Portugal, Germany and Norway.

There was a consensus view that more attention should be focused on promoting and extending greater involvement of more pharmacovigilance centres in medication error reporting and analysis and that the IMSN should become more active in participating and facilitating in this harmonisation. Specific activities and projects aimed at strengthening the harmonisation, complementarity and integration of pharmacovigilance and medication error were identified and supported by consensus. The IMSN Position Statement on pharmacovigilance and medication errors will be updated accordingly.

To reduce overall harm related to medication errors, harmonization at the global level is necessary. Many product containers exhibit labelling and packaging issues that contribute to errors in various countries. Also, domestic drug manufacturing does not exist in many countries, so drugs are commonly imported, often with features that can result in safety issues. Some international regulators have undertaken successful packaging and labelling changes that have reduced the risk of errors. The meeting provided an opportunity to share these experiences.

One of the goals of the meeting held on June 19 and 20, 2018, at the <strong>US Food and Drug Administration</strong> (FDA) White Oak (Silver Spring) campus in MD, was to create a minimum set of best practices for labelling and packaging aimed at reducing medication errors. Another goal was to promote the use of technologies to reduce medication errors, which led to discussions regarding the need for an international barcode standard. Representatives from GS1, a global standards organization for barcodes, were among the invited speakers.

Participants agreed that guidelines are needed regarding the presentation of critical label information to deal with look-alike labels, noting that logos and highly stylized graphics detract from readability of the label. They also suggested review of existing guidelines and consideration of the following best practices related to drug labelling and packaging:

1. Include both the per mL and the per container quantity, not the per mL quantity alone, when presenting the concentration for injectables
2. Use metric units for products, and eliminate ratio expressions
3. Eliminate potentially error-prone abbreviations and dose designations on labels, such as U for units, IU for international units, or trailing zeros (e.g., 1.0) to express strength
4. Prominently display cautionary statements on carton and immediate container labels of neuromuscular blockers, potassium chloride concentrate injection, methotrexate, and other selected error-prone medications
5. Use contrasting label backgrounds for the printing on glass ampules, and recommend font size and label orientation, to improve readability
6. Physically link or integrate diluents with drugs that are powders
7. Increase the adoption of ready-to-use/ready-to-administer syringes, premixed IV solutions, unit-dose packaging, and other more efficient, safer packaging, while considering the overall cost of implementation
8. Develop product-specific world safety standards; for example, standard packaging for non-oncologic methotrexate to prevent accidental daily use and overdoses
9. Include barcodes on packages so they can be scanned at the bedside or other locations where medications are dispensed or administered by healthcare providers

A discussion was also held on the processing and sharing of medication error information by global pharmacovigilance (PV) centers. A recommendation was made for the PV centers to seek input from healthcare practitioners and medication/patient safety organizations such as those already established in many of the IMSN member countries. Finally, participants agreed to create a white paper to promulgate these best practices.