Drug Shortage Updates 2012

Ontario Branch CSHP Members

Ontario Branch has representation on the Ministry of Health and Long-Term Care’s stakeholder teleconference as well as their Technical Advisory Committee.  Stakeholder teleconferences are held Tuesday and Thursday, and the Committee teleconferences on Wednesday and Friday.  

If you have any questions or suggestions that you, as a member, would like Ontario Branch CSHP to bring forth to the Ministry of Health and long-Term Care, please send an email to skorporal@cshp.ca and include your question and/or suggestion.

Visit the Drug Shortages eForum at http://psn.cshp.ca/ or sign up today at MY.CSHP.ca!

From Hospital News  “Ask the Ethicist: Year in Review”

November 29, 2012

"Finally, amidst all the other stories of the year, I think the last word ought to go out to all of our colleagues in the world of pharmacy – many of whom have made it possible to manage the ongoing shortage of some intravenous drugs due to interruptions in manufacturing by Sandoz and more recently Hospira. Ethicists in Canada have created resource allocation frameworks for making tragic choices if supplies were insufficient to meet critical needs. To date, such choices have been largely avoided by the hard work and collaboration of pharmacists who have kept supplies moving to where they are needed and prescribers informed of what is and what is not available. Kudos to you all!"

Hospira Shortage Update (November 7th, 2012):

The United States Food and Drug Administration (FDA) has taken a number of steps to improve quality standards for drug products. As a result of inspections under the improved standards, the FDA has reportedly uncovered a large number of quality control issues at Hospira plants in North Carolina, Colorado and Texas. In particular, Hospira’s Rocky Mount plant, which manufactures injectable drugs including anesthesia products, irrigation and intravenous solutions and renal and cardiovascular care products, has been a target of significant FDA scrutiny for more than two years for issues relating to their manufacturing processes.

As Hospira is undergoing remediation improvements, new issues arise requiring further attention. There are currently multiple areas of Hospira’s manufacturing processes requiring remediation improvements, and Hospira is currently conducting a review of these processes and company standards. Upgrades to meet remediation have caused the current supply issues, and as Hospira has had to balance compliance and supply, they have erred on the side of compliance with safety standards to ensure patient safety. As a result, many Hospira medications now appear on the FDA and Canadian drug shortages list.

Hospira has assured the provinces and Health Canada that they will meet all their contractual obligations for products facing supply issues. This includes providing any compensation for differences in cost as stated in the contract incurred as a result of purchase of alternative supply of items for which Hospira is unable to meet supply obligations.

Update on the Potassium Chloride (KCl) shortage:

The status of the 10mL and 20mL formats has changed as follows:

Documents regarding the Sandoz Canada Inc. drug shortage situation:

1)   A memo that provides an update from the Ministry of Health and Long-Term Care on the health system response

2)   A document entitled Ethical Framework for Resource Allocation during the Drug Supply Shortage, which provides ethical guidelines for health care providers on decision-making regarding redistribution of drug supplies based on need.

3) Criteria for Allocating Injectable Opioids During a Period of Undersupply

Updates:

Federal Update:

Ongoing Drug Shortage Issues:

Drug Shortages Update from June 13th, 2012

Drug Shortages Update from May 23rd, 2012

Health Canada has issued an Interim Directive:

Drug Shortages Update from May 16th, 2012

Drug Shortages Updates from May 10th, 2012

Please consider making your MP (not the MPP) aware of the difficulties you are having. We need changes to the special access process, and specific patient issues would help MP’s lobby the Federal Health Minister.

Finally, from the Emergency Operations Centre:

Good afternoon,

I am writing to let you know that as of today (May 09, 2012), the day-to-day management of the ministry’s response to the Sandoz drug shortage issue will be shifting from the Ministry Emergency Operations Centre to the Ontario Public Drug Programs Division.  After May 09, 2012, to reach the ministry about any issue related to the Sandoz drug shortage please contact Blair Parsons at 416-325-6630 or Blair.Parsons@ontario.ca. Blair will also be the contact for all reporting templates.

This is a demanding situation and we anticipate it will continue to be so for some time. However, the solutions instituted thus far are working well, and with your ongoing support, we are confident that the system will continue to manage.  

I would also like to take this opportunity to express my thanks to you and your organization for your support to date in the response to the Sandoz Drug Shortage.

Since the beginning of this disruption, the ministry has been guided by our Ministry Action Plan, a five-pillar plan providing a framework for inventory and impact assessment, inventory management, facilitation of procurement, modification of services, and communication. In alignment with our stewardship role, our primary focus has been on providing planning and tools to guide the system in their response.  As part of this plan, the ministry has supported the development of a process to report on critical inventory status, the creation and distribution of the Ethical Framework for Resource Allocation during the Drug Supply Shortage, and a LHIN-driven inventory Redistribution Plan . Regular communication forums have been created, and the ministry has been consistently advocating Ontario’s needs to the federal government to guide their licensing of new suppliers. 

I want to acknowledge the work that you and your organization have done – and continue to do – to respond to this event. Key experts from across the health system have given their time and effort to guide planning. The LHINs have taken a leadership role in inventory redistribution in their own areas, and cross LHIN boundaries where possible. The Drug Information Services have worked hard to provide informed support to clinical decision making and Group Purchasing Organizations have worked hard to source alternative suppliers on behalf of their clients. Facilities, agencies, and individual providers have made difficult decisions and taken a variety of measures to reduce wastage and use existing supplies responsibly.   From all areas of the health system we have seen solidarity and a willingness to meet the challenges posed by this event with creativity, diligence and commitment.

In closing, I wish to reiterate my sincere appreciation for all your work.

Thank-you,

Gerilynne Carroll
Ministry of Health and Long-Term Care
Emergency Operations Centre

Updates from the MOH on April 19th, 2012

New Drug Submissions

Vitamin K

Sandoz

Drug Shortages Update from April 12th, 2012

Updates as of Thursday, April 5th 2012

Updates from Monday, March 26th

Updates from Thursday, March 15th

Updates from Tuesday, March 13th