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The International Medication Safety Network (IMSN) is an international network of established safe medication practice centres, operating medication error reporting programmes and producing guidance to minimise preventable harms from medicine use in practice.
IMSN promotes safer medication practice to improve patient safety internationally. About IMSN

The IMSN continues its work on labelling and packaging safety and deepens its relationship with pharmacovigilance

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 inpharmacovigilance programs.

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

The ISMN 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 toprevent accidental daily use and overdose
9. Include barcodes on primary packages so theycan be scanned at the bedside or other locations where medications aredispensed 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 atinternational 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 onPharmacovigilance and Medication Errors. Read on...

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

There was a consensus view that more attention should be focussed 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.

Global regulators and safety advocates meet about drug container labelling and packaging

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.

Global regulators to meet on safety of drug container labels

A global summit on drug container labeling and packaging safety is planned June 19 and 20, 2018 on the FDA campus in White Oak (Silver Spring) MD. The meeting is being cosponsored by the US Food and Drug Administration (FDA) and the International Medication Safety Network (IMSN).

The World Health Organization (WHO) will also attend. Reduction of medication errors is a main theme of the World Health Organization's (WHO) Global Patient Safety Challenge: Medication Without Harm. The meeting is open to regulators, FDA staff, IMSN members and invited speakers only. More information can be found here.

To achieve a reduction of overall harm related to medication errors, harmonization at the global level is desirable. Many of the product container labeling, and packaging issues are common across countries. Also, in many countries and regions throughout the world, domestic drug manufacturing does not exist and it is common for drugs to be imported, often with features that can result in safety issues. Dangerous situations are also experienced when drug shortages lead to temporary importation of products, some of which exhibit unfamiliar characteristics that may raise safety issues here.

To maximize safety, it would be beneficial to identify safety issues, and harmonize labeling requirements as much as possible with a focus on reducing medication errors. Some regulators have already undertaken such efforts, and have met with some success in reducing medication errors related to approved labeling. This meeting will provide an opportunity to share experiences and discuss ways to improve medication safety globally.

Participating regulators include:

Anvisa (Brasil)
COFEPRIS (Mexico)
European Medicines Agency (EMA – European Union)
Ghana Food and Drug Administration
Health Canada
INFARMED (Portugal)
INVIMA (Colombia)
Medicines Evaluation Board of Netherlands
MHRA Medicines & Healthcare products Regulatory Agency (United Kingdom)
Saudi Food and Drug Authority
United States Food and Drug Administration