Author Archives: Étienne Schmitt

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

IMSN welcomes the WHO Global Patient Safety Challenge on Medication Safety

On 29 March 2017 WHO launched a global initiative to reduce severe, avoidable medication-associated harm in all countries by 50% over the next 5 years. This so-called “Medication Without Harm” is the 3rd WHO Global Patient Safety Challenge on Medication Safety and involves several IMSN members.

The Global Patient Safety Challenge on Medication Safety aims to address the weaknesses in health systems that lead to medication errors and the severe harm that result. It lays out ways to improve the way medicines are prescribed, distributed and consumed, and increase awareness among patients about the risks associated with the improper use of medication.
Medication errors cause at least one death every day and injure approximately 1.3 million people annually in the United States of America alone. While low- and middle-income countries are estimated to have similar rates of medication-related adverse events to high-income countries, the impact is about twice as much in terms of the number of years of healthy life lost. Many countries lack good data, which will be gathered as part of the initiative. Globally, the cost associated with medication errors has been estimated at US$ 42 billion annually or almost 1% of total global health expenditure.
"We all expect to be helped, not harmed, when we take medication," said Dr Margaret Chan, WHO Director-General. "Apart from the human cost, medication errors place an enormous and unnecessary strain on health budgets. Preventing errors saves money and saves lives."
Every person around the world will at some point in their life take medicines to prevent or treat illness. However, medicines do sometimes cause serious harm if taken incorrectly, monitored insufficiently or as the result of an error, accident or communication problems.

Both health workers and patients can make mistakes that result in severe harm, such as ordering, prescribing, dispensing, preparing, administering or consuming the wrong medication or the wrong dose at the wrong time. But all medication errors are potentially avoidable. Preventing errors and the harm that results requires putting systems and procedures in place to ensure the right patient receives the right medication at the right dose via the right route at the right time.
Medication errors can be caused by health worker fatigue, overcrowding, staff shortages, poor training and the wrong information being given to patients, among other reasons. Any one of these, or a combination, can affect the prescribing, dispensing, consumption, and monitoring of medications, which can result in severe harm, disability and even death. Most harm arises from systems failures in the way care is organized and coordinated, especially when multiple health providers are involved in a patient’s care. An organizational culture that routinely implements best practices and that avoids blame when mistakes are made is the best environment for safe care.

The Challenge calls on countries to take early priority action to address these key factors: including medicines with a high risk of harm if used improperly; patients who take multiple medications for different diseases and conditions; and patients going through transitions of care, in order to reduce medication errors and harm to patients.
The actions planned in the Challenge will be focused on four areas: patients and the public; health care professionals; medicines as products; and systems and practices of medication. The Challenge aims to make improvements in each stage of the medication use process including prescribing, dispensing, administering, monitoring and use. WHO aims to provide guidance and develop strategies, plans and tools to ensure that the medication process has the safety of patients at its core, in all health care facilities.
"Over the years, I have spoken to many people who have lost loved ones to medication-related errors," said Sir Liam Donaldson, WHO Envoy for Patient Safety. "Their stories, their quiet dignity and their acceptance of situations that should never have arisen have moved me deeply. It is to the memories of all those who have died due to incidents of unsafe care that this Challenge should be dedicated."

Find out more on the World Health Organization website.