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…

ISMP Brazil alerts on confusion between insulin and vaccines

April 30, 2016 - On this D Day of flu immunization in Brasil, awareness is needed on confusion between insulin and vaccines as stated by an ISMP Brasil Alert following a serial error that occurred last Thursday 28 April 2016 in the community hospital of Maringá (North Paraná) where fifty employees received a dose of insulin by error instead of the influenza vaccine.

The nurse in charge of the vaccination of the hospital staff took the wrong box in the refrigerator where insulin and vaccine against influenza were stored. She has been confused with the packaging and administered the wrong substance to her colleagues and to herself. The administration of vaccines began at 9 am, and the error was spotted around 10am. Given the error, staff members who have been "vaccinated" with insulin received a glucose injection. To avoid problems, all were hospitalized and remained under observation until 21h. So far, fortunately, no employee showed any adverse effects.

ISMP Brasil Alerta-vacina 2016 04 29

Although having already alerted healthcare professionals about the risks of errors involving vaccines in a bulletin on insulins and on neuromuscular blockers, ISMP Brasil takes advantage of a National Safety Alert on this confusion between insulin and influenza vaccines occurrence to highlight the need for learning front of the internally identified errors and other health institutions; and to present some recommendations to prevent medication errors involving vaccines.

It is unfortunate that these errors continue to occur while they are long known: similar mix-ups between vaccines and insulin have led to the deaths of 21 children in 1997, others have been reported and published:

World Health Organization "Global manual on surveillance of adverse events following immunization" 2014; page 21.
Institute for Safe Medication Practices (ISMP) "What else is stored in a refrigerator with influenza vaccine?" ISMP Medication Safety Alert! Acute Care 2014; 19 (24): 1.
Shanks L et coll. "Learning without Borders: A Review of the Implementation of Medical ErrorReporting in Medecins Sans Frontieres" PLoS One 2015; 10 (9): e0137158.

And fatal confusions involving muscle relaxants are more serious and more worrying. The International Medication Safety Network (IMSN) has made it the starting point of its International Position Statement on Safer Vaccine Packaging and Label Design, calling on 14 December 2015 for greater worldwide attention to the problem of unsafe design of vaccine packaging and labelling.

Although without serious consequences for the health professionals who were the subject of this vaccination campaign, the error that occurred in Brasil recalls the urgency to understand and implement the proposals of the IMSN. Again and again, the IMSN position statement calls on healthcare professionals, pharmaceutical companies, technology vendors, professional organizations, and regulatory/standard-setting organizations to help improve vaccine safety and efficacy. Read on...

The New Zealand safe use of opioids collaborative

The Health Quality & Safety Commission New Zealand is running an 18-month formative collaborative to reduce opioid-related harm in hospitals.

The collaborative aim is to reduce opioid-related harm by 25 percent in district health board* (DHB) hospital’s participating areas, and build capability in medication safety and quality improvement methodology.

The collaborative began in September 2014 and ends in April 2016.
Opioids were chosen for the collaborative because of the associated harm identified in incident reports and a global trigger tool study done in three DHBs (1). The Institute for Healthcare Improvement’s (IHI) collaborative methodology (2) is being used and the IHI is providing external advice.

Participation in the collaborative is voluntary. All 20 DHBs and one private hospital are taking part. Only 18 of the multidisciplinary teams are actively testing interventions using plan-do-study-act cycles. The other three teams are engaged and learning the methodology. Teams include a consumer whenever possible.
Team members in individual hospitals are not funded. The Commission’s national collaborative team provides leadership, guidance and support through visits, phone calls and webinars. The Commission hosted four regional learning events as part of the initial engagement approach. Three national learning sessions when teams come together to learn and share have been hosted and up to three team members from each DHB were funded to attend.

Teams have used local findings to choose the opioid-related harm and the target ward(s) to work on. Most are aiming to reduce harm from opioid-related constipation, but there are teams focusing on respiratory depression, uncontrolled pain and nausea and vomiting.

It is anticipated that a bundle of evidence-based interventions will be identified by the end of the collaborative for implementation in any hospital area.
The formative collaborative is being independently evaluated. This has been ongoing and learnings are considered throughout.
Further information and learning session materials are available on the Commission’s website.

* A district health board is responsible for providing or funding the provision of health services in their district. Disability support services and some health services are funded and purchased nationally by the Ministry of Health.


  1. Seddon ME, Jackson A, Cameron C et al. The Adverse Drug Event Collaborative: a joint venture to measure medication-related patient harm. NZMJ 2013; 126 (1368): 9-20.
    Read on...
  2. Institute for Healthcare Improvement. The Breakthrough Series: Institute for Healthcare Improvement’s (IHI) Collaborative Model for Achieving Breakthrough Improvement. IHI Innovation Series white paper. 2003. Read on...