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.

IMSN Encourages Regulators and Companies to Improve Medication Safety at the Global Level

The International Medication Safety Network (IMSN) recognizes the unsafe naming, labeling and packaging of medicines as an ongoing, often unrecognized worldwide threat to patient safety that requires a collaborative approach. At a recent conference, IMSN called for greater action to standardize safe medication practices and improve medication safety internationally.

Medication errors affect millions of patients around the world, sometimes leading to death or serious harm. But in many instances, more attention needs to be paid to medication errors by regulatory authorities and industry, and the importance of human factors principles in the selection and design of medicine names, labels, and packaging is being overlooked. For example, not all regulators require companies to include bar codes on medication labels, which is essential for use of safety technologies at the bedside, in the operating room, or in the pharmacy. Too often, the issue of errors is being addressed in individual countries, but not on a global scale.

header-imsntoronto2016At the IMSN Global Regulatory Meeting: Designing Medication Safety at the Global Level held in Toronto, Canada on October 24, 2016, delegates from 17 member countries shared their views and concerns with invited regulators on factors that contribute to medication errors at a global level. The main regulators involved in this field, such as the US Food and Drug Administration (FDA), Health Canada, the European Medicine Agency (EMA), and the Medicines & Healthcare Products Regulatory Agency (MHRA), were joined by the World Health Organization (WHO) Patient Safety program. A separate session was held with major IV solution and technology companies on October 25, 2016, including Aguettant, Baxter Healthcare, B. Braun, BD/Carefusion, Hospira/Pfizer, Grifols, and Fresenius Kabi.

Participants agreed on the following actions to be addressed immediately to protect patients from medication errors at a global level:

  • Safer packaging of medicines in ready-to-use forms, such as premixed intravenous infusions, prefilled syringes for high-alert injectable medications (including vaccines), and oral cytotoxics packaged in patient packs to support their specific posology;
  • Safer labeling of medicines, including the presence of a bar code or other machine readable identification on each unit-of-use dosage form to facilitate use of available technologies now and in the future;
  • Safer medication labelling with unequivocal expression of doses;
  • Metric graduations on all dosing devices for oral liquids;
  • Safer nomenclature by banishing dangerous abbreviations and umbrella brands;
  • Safer practices in using medicines that easily expose patients to serious risks of error, such as opioids and acetaminophen/paracetamol;
  • Recognition of the expertise needed for analysis (including an assessment for contributing factors in preventable adverse drug reactions) and prevention of medication errors, whether by promoting the role of medication safety officers or by encouraging premarket assessment of medicines and associated devices by manufacturers.

Participants agreed that effective bidirectional cooperation between safe practice centers, patient safety organizations and the pharmacovigilance community is needed.

In order to achieve a reduction of harm related to medication errors, harmonization at the global level also is necessary. The IMSN is committed to this harmonization of safe medication practices as they impact packaging and package labeling. Therefore, the IMSN is calling for a follow-up summit with regulatory authorities in order to establish minimum requirements and an action plan for medication safety worldwide.

Beyond product improvement, the IMSN supports the World Health Organization’s Global Patient Safety Challenge on Medication Safety, through the participation of several IMSN members. IMSN members are contributing to the WHO initiative to tackle obstacles and propose solutions to improve the safety of medication practices.

21 November 2016 IMSN Press Release Download PDF

Regulatory improvements on both sides of the Atlantic

North_Atlantic_Ocean_laea_relief_location_mapRecent news report improvements in the regulatory framework of medication errors from both sides of the Atlantic: North America from Health Canada, and Europe by the Council of Europe. These initiatives are in addition to others already taken by medicines agencies on each of the continents.

On June 30, 2016 Health Canada released new guidance for industry that will make product labels and packages easier for consumers and health professionals to read and understand. The intent of increasing clarity of labels is to reduce the risk of confusion, harmful errors and adverse reactions. To support the implementation of Health Canada's Plain Language Labelling Initiative, two Good Label and Package Practices Guides have been developed to provide direction to industry on the design of safe and clear health product labels. Both guides were developed in collaboration with the Institute for Safe Medication Practices (ISMP) Canada and in consultation with stakeholders, including healthcare professionals, patient groups and industry.

Clear, easy-to-understand labels and packages are essential for using medications safely and avoiding harm. I'm pleased to have worked closely with Health Canada and the members of the expert panel to develop the guides, which I think will go a long way to improving health product labels and packages in Canada.” said David U, President and Chief Executive Officer, Institute for Safe Medication Practices Canada.

On this side of the Atlantic too, ucm349567the US Food and Drug Administration offered on April 2016 the final version of the Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names as a part of the FDA’s efforts to meet the goals of the 2007 Prescription Drug User Fee Act, which include establishing “measures to reduce medication errors related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, dose designations, and error-prone labeling and packaging designs.”
Within the Center for Drug Evaluation and Research (CDER), the Division of Medication Error Prevention and Analysis (DMEPA) reviews medication error reports on marketed human drugs including prescription drugs, generic drugs, and over-the-counter drugs. Read on…

On June 1st 2016 at its 1258th meeting the Committee of Ministers of the Council of Europe adopted two Resolutions:

The ultimate goals of these resolutions are to promote public health through the harmonisation of requirements for medicinal preparations, support health professionals with appropriate guidance to prevent risk of health damage caused by drug preparation errors, and ensure that patient needs are fully met.

On this side of the Atlantic too, an article published in June 2016 and written by the Medicines Pharmacovigilance Division of the European Medicines Agency (EMA), described the key concepts of the European Unit good practice guidance for defining, classifying, coding, reporting, evaluating and preventing medication errors.emea_strap_url_cmyk_rev_en_std_cent.eps MASTER

  • Goedecke T, Ord K, Newbould V, Brosch S, Arlett P. Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention. Drug Saf. 2016; 39 (6): 491-500.

This is a commentary on the European measures published on 27 November 2015 together with the launch of a webpage highlighting measures recommended by the Agency to prevent medication errors for specific medicines, aiming to make available clear and easy-to-understand information to patients and healthcare professionals to further promote the safe use of medicines. Read on…
The EMA instructed the Drug Information Association to arrange an Information Day on Medication Errors on 20th October 2016 aiming to provide an opportunity for regulators, patients, healthcare professionals and industry to discuss first European experience with the new Good Practice Guide (GPG) on Medication Errors released in November 2015.

These initiatives on both sides of the Atlantic and beyond should benefit from being made consistent at global level. header-imsntoronto2016This is what the International Medication Safety Network (IMSN) is actively considering to meet regulators during its next annual meeting in Toronto in October 2016 in a comprehensive and concerted approach to share their views and concerns on labelling, packaging and nomenclature issues prone to medication errors and to further establish a consensus on a shared action plan for improving medication safety at the global level in coordination with the WHO Global Challenge on Medication Safety. Read on…