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:

10 mL format: Additional stock of the 10 mL format has been received earlier than anticipated and is now available for distribution without any restrictions. Inventory is currently being distributed to regional warehouses and wholesalers. Product orders can now be placed by contacting the Hospira Customer Service Department or the CPDN order desk.
20 mL format: the stock of the 20 mL format has now depleted at Hospira and the next product availability has been moved to the week ending November 9th, 2012.
The availability of the 250 mL format remains unchanged and the next resupply is expected by Fall 2013.
Health Canada is now allowing Special Access Programme (SAP) requests for 250 mL formats of KCl from manufacturer B. Braun in 12 unit cases. A three week delivery time is anticipated for any 250 mL requests through SAP. Please refer to Health Canada’s SAP Guidance Document for additional information: http://hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/sapg3_pasg3-eng.php
Baxter premixed KCl minibags are available in limited supply. Please contact Baxter’s customer service representatives for additional information

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:

Sandoz Canada released its long term forecast to the Federal/Provincial Territorial working group on May 15. According to this forecast, most Sandoz products will be off allocation and back to normal supply by early 2013
Following extended stability studies, Sandoz and Health Canada jointly announced in May 2012 that the shelf life of Sandoz products currently in circulation will not be extended. Liability issues appear to be the primary concern
Sandoz has secured an alternative product source of Ondansetron from Europe; product will likely be available in Canada in July 2012. Furosemide will likely be the next product Sandoz secured from an alternate source.
The Special Access Program list has still not been released by Health Canada, despite repeated requests from hospitals and industry stakeholders.
Sandoz Canada routinely shuts down its Boucherville plant each summer for two weeks. This August, the plant will be shut down for 4-5 weeks to address sterile remediation issues. Sandoz has indicated that the shut down will consider supply outlook planning.

Ongoing Drug Shortage Issues:

Vitamin K shortages have been noted for Long-Term Care homes and midwives

Additional product for midwives is to be secured through hospitals – additional allocation can be supplied for those hospitals providing Vitamin K to midwives
Baxter has indicated that there is an account set up for LTC homes to access Vitamin K supply

Looking into the availability of Pharmascience, Inc., and Novopharm Ltd. 10 MG/ML formulations of propofol as an alternative
We are currently tracking several shortages of Sanofi products, in particular disopyramide and a recall of Bacille Calmette-Guérin (BCG) vaccine. These shortages are not expected to be ongoing and should be resolved promptly.

Drug Shortages Update from June 13^th, 2012

Sandoz has a planned shut-down for the summer for a plant retrofit that includes maintenance and sterilization of their facilities.
The shut-down is scheduled to begin August 4^th and end on September 5^th.
It is not anticipated that this will result in additional supply interruptions as Sandoz has reportedly built up inventory in preparation for the closure.
Additional information will be provided by Health Canada closer to the shut-down date.

Drug Shortages Update from May 23^rd, 2012

Health Canada has issued an Interim Directive:

Future Use Requests are made in circumstances where non-marketed drugs are required in anticipation of patients faced with a medical emergency. In the light of the Sandoz drug shortage, Health Canada will not request the regular reporting on the use of products released through the SAP's Future Use process.
Accurate records still need to be maintained on the use of all quantities of the product sold in the event that Health Canada requests such records.

Drug Shortages Update from May 16^th, 2012

There was mixed news from the Ontario stakeholder’s teleconference.
Health Canada has advised they will not allow shelf life extension for drugs in the marketplace.
Sandoz expects to be back to historical allocations by November 2012.
Ongoing, Sandoz will build in redundancies to mitigate any further issues at their Boucherville plant.

Drug Shortages Updates from May 10th, 2012

Sandoz had previously identified some potential extra capacity at their manufacturing plant and had surveyed jurisdictions across Canada to identify priority products to come off of back-order and go back into production. A list of priority products compiled from the responses of the jurisdictions was circulated in an FPT prioritization list.
The following products were identified as a priority by Ontario, and have been included on the FPT prioritization list:

FENTANYL CIT 50MCG/ML 2ML 10LIAM CA
MORPHINE SO4 10MG/ML 1ML 10LIAM CA
MIDAZOLAM 1MG/ML 5ML 10LIVI CA
FUROSEMIDE 10MG/ML 4ML 10LIVI CA
NALOXONE HCL 0.4MG/ML 1ML 10LIAM CA

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

Health Canada continues to receive new drug submissions for approval. No approvals have been recently announced but there are a number under review.
As Notices of Compliance (NOC) are issued to manufacturers, they are posted to their online database: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/noc-acc/index-eng.php

Vitamin K

The ministry continues to engage with FPT partners regarding Vitamin K.
We have been advised that oral formations are available via the Special Access Program (SAP).
A reminder that the SAP is available health care providers to access non-marketed drugs, some of which can be alternatives to products affected by the shortage: http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/index-eng.php

Sandoz

Sandoz is working on an allocation “road map”, which will provide a clearer indication of when supply will return to its normal state.
Gradual reductions in ordering are still being seen across the country.
Sandoz has been able secure some alternate supply from its plants in Europe. As a result, they will be able to bring in twodrugs – Furosemide and Ondansetron. This product will be available in May and June respectively.
- As a result, Sandoz reported that will have the potential for extra capacity at their Boucherville plant and they will be surveying Provinces and Territories regarding how best to use this capacity as it becomes available.
- The ministry will utilize the Drug Shortage Technical Advisory Group (DSTAG) to inform its response.
Sandoz has determined a list of 36 drugs in which a short shelf-life extension may be possible from Health Canada.
- While there are currently NO shelf-life extensions approved at this time, the ministry will provide a list of products currently under consideration by Sandoz.
- Health care providers are encouraged not to dispose of these particular drugs as they expire in the event they may be granted a shelf-life extension.
- The ministry will communicate any further information on this as it is received

Drug Shortages Update from April 12^th, 2012

Morphine 15mg/mL 1mL amps will be released from the national stockpile for Sandoz to ship
The SAP has approved almost half the submissions made and are expediting approvals. There will be information forthcoming on their website.
Please report any excess stock on the MOH report, as this information goes back to the LHIN to coordinate sharing.
Some products are not anticipated to come online until 2013- check the Sandoz website. We should "view this as a marathon, not a sprint," according to the Emergency Operations Committee at Ministry of Health (MOH).
There were plans for the four (4) major drug information centres to gather information about alternative therapeutic strategies and share that information but Alan Mallek confirmed today that DIRC, MetroDIS, LonDIS and OVRDIS could not develop a template and this has not happened. The MOH is soliciting information from stakeholders but the dissemination of this information is presently limited to the hotline and direct inquiries to one's respective DIC.

Updates as of Thursday, April 5^th 2012

A redistribution framework at the LHIN level is in development. It will focus on communication of product that is in urgent need and potential overstock or short-dated inventory for sharing.
Discussion has included dealing with the logistics of moving product and billing.
The community sector now has similar reporting templates to that of the hospital sector.
To date, there has not been “modification of services” report to the Ministry of Health (meaning cancelled procedures).
The Ministry of Health is engaging translators earlier in the process so that there is no delay posting finalized documents.
Discussions are underway federally, with Sandoz, about which products to prioritize for production, and what studies are necessary for extension of expiry dates in drugs not being produced.
The group buyers are also involved on the federal teleconferences and looking at national procurement strategies.

Updates from Monday, March 26^th

Stakeholder teleconferences continue to be held three (3) times per week.
The Ministry of Health and Long-Term Care has published an ethical decision-marking framework – link was posted last week (see below). It includes minimizing waste; for hospitals this might include such repackaging of ampoules into unit of use syringes as time and facilities permit. Those who have done so are encouraged to share stability information on the eForum for Drug Shortages on National CSHP website.
Current questions arising include new concerns about availability of Vitamin K and B12. The Ministry of Health and Long-Term Care is investigating these and other queries from last week hoping to have answers for the Wednesday (March 28^th) teleconference.
At the national/provincial/territorial table, a short list of 10 drugs to focus on has been requested. The staff at the Ministry of Health are clear that the 10 is a moving target and there are many others that are also important. Release of national emergency supplies is under discussion at that level as well.
Please send questions, comments, and/or feedback for the Ministry of Health to Carolee Awde-Sadler at cawde_sa@yahoo.ca so that they can be addressed.

Updates from Thursday, March 15^th

Stakeholder teleconferences have been increased to be held three (3) times weekly.
There are concerns from the dental practitioners about potentially having to close down.
Community pharmacy is to adopt the hospital model for reporting.
Also concerns raised about pharmacy up-staffing and who will cover these costs – this is to be taken forward.
Drug information is to be provided by drug information centres; the Ministry of Health and Long-Term Care is just providing contact information.
There is strong feedback that the Ministry of Health has committed to act on:

That the communication for this group to disperse should be sent out formally so that there is no miscommunication.
That there be something available on the Ministry of Health and Long-Term Care’s website – on the homepage front and centre – to inform and reassure patients.

Updates from Tuesday, March 13^th

The Ministry of Health and Long-Term Care is creating a spreadsheet with alternatives to affected drugs, with input from other provinces and the Ontario Drug Information Centres. They committed to post the results. Where the results are to be posted will be confirmed on Thursday, March 15^th, 2012.
Bioethicists have been convened to plan service allocations should service suspension become necessary.
A sub-group of the Technical Advisory Committee (TAC) has convened to consider community services with a focus on maintaining in-home palliative care. OPA has a representative on this group.
Redistribution of product may happen at the LHIN level; Ministry of Health and Long-Term Care may become involved prn.