Author Archives: Étienne Schmitt

IMSN Introduces New Global Targeted Medication Safety Best Practices

An international medication safety call to action is 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) has published its first set of Global Targeted Medication Safety Best Practices to identify, inspire, and mobilize widespread international improvement in error prevention. The inaugural best practices address issues that are well known to cause fatal and harmful medication errors despite repeated warnings and are intended to help focus global safety efforts for the next two years on those specific sources of patient harm.

The best practices highlight strategies that can have a higher impact on preventing errors because they are “high leverage” and do not rely on attention and vigilance by individuals. They call for healthcare practitioners and organizations to:

Global Targeted Medication Safety Best Practice 1
Remove potassium concentrate injections from all inpatient drug storage on nursing units.

Potassium is an electrolyte replenisher required for the maintenance of several physiological processes in the body. Frequently used to treat hypokalemia and other electrolyte abnormalities, intravenous potassium chloride, acetate or phosphate is available in vials or ampules as a concentrate for dilution. Improper administration of concentrated electrolytes is dangerous—tragic errors have occurred, due to rapid direct intravenous push administration of concentrated potassium solutions or wrong product selection (potassium concentrate mistaken for another drug). Vials of potassium also have been accidentally used instead of sterile water or saline to dilute vials of powdered or lyophilized drugs. Outcomes have often been fatal in children and adults and still happen around the world. Read on...

Global Targeted Medication Safety Best Practice 2
Prepare and dispense vinca alkaloids in a minibag, never in a syringe.

Vinca alkaloids (vincristine, vinblastine, vinorelbine) are chemotherapy drugs that should be administered intravenously and never by any other route. Deaths have been reported throughout the world when the drug was dispensed in a syringe but given into spinal fluid instead of intravenously. For example, more than 130 cases have been reported worldwide with vincristine given to leukemic patients. This often happens when a syringe of vincristine is mistakenly used instead of a syringe of cytarabine, hydrocortisone, or methotrexate, which are supposed to be given into spinal fluid to the same leukemic patient. Intrathecal administration of vinca alkaloids leads to the destruction of the central nervous system radiating from the injection site and is almost always fatal. Safety groups such as The World Health Organization, The Institute for Safe Medication Practices, The National Comprehensive Cancer Network and The Joint Commission have called for dispensing only in a minibag, not a syringe. Read on...

Global Targeted Medication Safety Best Practice 3
Prevent inadvertent daily dosing of oral methotrexate for non-oncologic solutions.

Methotrexate is a folate antimetabolite used in the treatment of tumor-causing diseases and non-oncological conditions such as psoriasis and rheumatoid arthritis. When used to treat disorders such as rheumatoid arthritis, the drug is administered weekly, while for some types of cancer, a more frequent or higher dose is used. Prescribing, transcribing, and dispensing errors with methotrexate have led to some patients receiving a daily instead of weekly dose. Fatal errors with methotrexate have been reported for many years, occurring both during hospitalization and after discharge. Read on...

The best practices document offers specific consensus-based risk reduction strategies for each, that have already been successfully adopted by numerous organizations all over the world, along with references for additional sources of information. The best practices have been reviewed and endorsed by experts from IMSN as well as posted for public comment. IMSN hopes to work in partnership with hospitals, international professional organizations, and regulators to encourage that these best practices be undertaken as a priority everywhere in the world. 

For more details on the IMSN Global Targeted Medication Safety Best Practices, read here

Download the IMSN Press Release May 30, 2019

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 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 13thmeeting. 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.

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.