Through the Plain Language Labelling Initiative, new Canadian regulations have been introduced with the intention of improving the safe use of drugs by making labels and packages easier to read and understand. The label and package are the first points of interaction between a health product and a potential user. It is important that product labels and packages are designed with the user in mind and with consideration of the environment in which the product will be used.

This workshop will teach participants about user issues and safety principles pertinent to manufacturer design of safe and clear labels and packages for prescription health products. Participants will learn how these principles can be applied, with a focus on avoiding or mitigating harm associated with product-use errors.

Participants will have the opportunity to integrate their learning through hands-on review and analysis of health product labels and packages.

Participants will be asked to bring 1 or 2 prescription product labels and packages to the workshop.

Learning Objectives:

1. Understand user-identified issues and related patient safety principles that support the design of safe labels and packages for prescription health products
2. Learn how to design safe prescription product labels and packages with consideration of the user and the environment of use
3. Recognize opportunities for improvement in the design of prescription product labels and packages in order to enhance safe use

Location:	ISMP Canada Medication Safety Learning Centre 4711 Yonge Street Toronto, ON M2N 6K8
Cost:	$795.00 (plus applicable taxes)
Time:	8:30 am to 4:30 pm
Course Level:	Intermediate (assumes basic knowledge of health product label and package design regulations and standards; previous experience with label and package design is preferred)
Audience:	Health product label and package designers, manufacturing quality assurance managers, regulatory officers, group purchasing managers, group purchasing buyers, pharmacy buyers or purchasing technicians

Kim Streitenberger, RN

Kim joined ISMP Canada first in 2007 as a patient safety consultant with a focus on medication reconciliation. She is a registered nurse with more than 35 years of clinical, quality improvement and patient safety experience. Kim's clinical background is in pediatrics at Laurentian Hospital in Sudbury, Ontario and pediatric critical care at the Hospital for Sick Children. Prior to joining ISMP Canada, she has held formal program and corporate level quality improvement, patient safety and risk management roles within several academic healthcare organizations. Kim has a certificate in Quality Improvement and Patient Safety from the University of Toronto. She was a recipient of the OHA Health Achieve Patient Safety Award in 2005 and the Baxter Guardian Scholarship for Excellence in Patient Safety in 2010 for work on improving communication during patient transitions. Kim has been a frequent speaker at local, national and international conferences and has coauthored a variety of clinical and patient safety related articles.

Kim returned to ISMP Canada in 2014 where she has led the development of the Good Label and Package Practices Guide(s), the Canadian TALLman lettering list and principles and other labelling and packaging initiatives.

Valentina Jelincic, RPh

Valentina has been a consultant with ISMP Canada for over 13 years and has been a manager in the pharmacy department at The Hospital for Sick Children in Toronto since 2013. She has worked in the public and private sectors as a consultant, including with professional and non-profit associations.

She has over 25 years of practice in teaching hospitals, ranging from clinical pharmacist to pharmacy administrator. Her experience includes pharmaceutical product selection, formulary review and approval; clinical pharmacy practice; interdisciplinary strategic and project planning; procedure development; drug utilization management; implementation of new hospital programs; and budget development, control, and analysis. Her work has also included writing and editing of educational and healthcare materials, such as symposium proceedings, hospital clinical manuals, and medication safety articles. She has also published in the research literature and has edited English translations of medical articles and dossiers.

Valentina's work with ISMP Canada has involved the development and support of various safety initiatives, including many of the Medication Safety Self-Assessment tools, teaching FMEA and RCA to hospital practitioners, participation in the neuromuscular blocking agent labelling and packaging initiatives, work on Health Canada’s Look-Alike/Sound-Alike guidance, and leading the oncology LASA project with TALLman recommendations. Val is pleased to have worked with Kim on the safe labelling and packaging of medications, a project that relates to the daily activities of almost every healthcare practitioner.

A.M.	8:30 - 8:45	Registration
	8:45 - 9:00	Welcome and Introductions Review of the day's agenda and handouts Why are you here? What issues have you seen or experienced with health product labels and packages? Introduction to ISMP Canada - who we are, what we do
	9:00 - 9:45	Medication safety concepts and principles Review of adverse event rates Review of the medication-use process
	9:45 - 10:15	Break
	10:15 - 10:45	Overview of results from the label and package aggregate analysis, i.e., themes, key concepts
	10:45 - 11:30	Users and their environments The healthcare environment How errors occur, e.g. Swiss cheese model Hierarchy of effctive error reduction strategies, etc. Importance of safe label and package design
P.M.	11:30 - 12:30	Lunch
	12:30 - 14:00	Review of key labelling and packaging practices Design and layout Label information Packaging
	14:00 - 16:15	Label analysis activity (break included) Group Activity: analysis of labels the participant have brought with them Participants report on their analysis and suggested improvements to their own labels Discussion
	16:15 - 16:30	Summary and Closing

Contact Us:

Mail:	ISMP Canada Medication Safety Learning Centre 4711 Yonge Street, Suite 501 Toronto, ON M2N 6K8
Email:	education@ismp-canada.org
Phone:	416–733–3131
Toll Free:	1–866–544–7672
Fax:	416–733–1146