CAS Advocacy on Drug Shortages seen as a “Text Book Example” of effective ethical government relations.

On February 10th, 2015, in Vancouver, BC, after more than five years of consistent advocacy from the Canadian Anesthesiologists’ Society, Federal Minister of Health Rona Ambrose announced a new federal policy affecting Canada’s drug supply.  From now on, it will be mandatory for pharmaceutical manufacturers to immediately inform government and the public of any events that may jeopardize Canadian drug supplies.

The Canadian Anesthesiologists’ Society was invited to attend that announcement in recognition of the fact that, since 2011,CAS Advocacy has been one of the main drivers, first putting the risk of drug shortages on the political agenda in Canada and then, with the February 10th announcement, achieving a giant first step towards true drug security for the Canadian health care system.

Leonard Domino has been a government relations professional in Ontario for more than 20 years, and he argues that the CAS’ five-plus years of work on the drug shortage file ranks as a “text book example” of the way government relations should work.

“Start with the issue itself.  The risk of drug shortages affects everyone in Canada, and no one was better placed to identify the problem than the anesthesiologists.  It was never a pocket book issue for them – it was all in the public interest.

“They used their scientific authority to raise the issue and explain it to political decision makers.  They reached out to any potential partners they could find, including other members of the medical profession.  They were persistent, and they were consistent:  during the years the CAS was pursuing this goal, the Society’s executive changed, membership changed, but their message was consistent.

“And they reasoned with the people they were talking to.  There were no political games.  They put the case clearly and authoritatively – and respectfully.  Both the political and the bureaucratic parts of the governments they talked to saw the CASas sincere, expert potential partners in solving the problem.

“The CAS has every right to be proud of what they’ve already achieved with this piece of advocacy.”

Leonard Domino says that, if the CAS persists with the same kind of positive, persistent and ethical advocacy that’s marked the last five years, there’s every reason to believe they will continue to influence government.

 

“WE HAVE MADE GREAT PROGRESS”

By: Dr Douglas DuVal, FRCPC

 

CAS received a call from the office of the Minister of Health on February 5 that we (CAS) were invited to be present and to speak at an announcement on the mandatory reporting of drug shortages, scheduled for February 10 in Vancouver. CAS President, Dr. Susan O’Leary, asked whether I would be able to go, and I was honoured to do so.

At approximately 9:00 a.m., the Minister made her announcement, followed by the other speakers, including British Columbia Minister of Health, Terry Lake, myself, and Suzanne Nurse, PhD, Chair, Canadian Epilepsy Alliance Drug Shortages Committee. Also in attendance was Dr Sukh Brar, President, British Columbia Anesthesiologists’ Society, who is well acquainted and on very cordial terms with Minister Lake.

Looking back, I note that CAS’ involvement in initiatives leading toward this important legislation really started with former CAS President, Dr Richard Chisholm expressing in a January 2011 letter to the Federal Minister of Health concerns about CAS members’ reports of shortages of propofol and reductions in the supply of Sodium Thiopental. As a result, it then became evident that Health Canada was lacking in ability to monitor and manage drug availabilities.

Just over a year later, the Sandoz manufacturing disruptions affected dozens of critical medications and triggered a very real crisis in Canada’s drug supply. On March 29, 2012, Dr Chisholm appeared before the House of Commons Standing Committee on Health (via video conference from Buenos Aires, Argentina, where he was attending the World Congress of Anaesthesiologists!) and gave a powerful address which included the statement that “we need a requirement for industry to tell about events that might disrupt the drug supply and an acceptance by government of a requirement to ask, to monitor, and make sure.”

On February 7, 2014, then President, Dr Patricia Houston, made a presentation on the problem of drug shortages to the Specialist Forum of the Canadian Medical Association (CMA). This presentation had an impact, and led to the creation by the CMA Board of Directors of a Drug Shortages Working Group in June 2014. When Dr Houston became CAS Past President, I “inherited” the drug shortages “file” and was committed to doing what I could to maintain its momentum.

As it happens, I reside in Minister Ambrose’s Edmonton-Spruce Grove constituency. I was fortunate to be able to arrange a one-on-one meeting with her on August 20, 2014 through the CMA MD-MP contact program (https://www.cma.ca/En/Pages/md-mp-contact-program.aspx). As was reported about this meeting in the last issue of Anesthesia News (http://www.cas.ca/English/Page/Files/69_CAS_Dec_2014_Newsletter.pdf), Minister Ambrose mentioned at the time that consultations about a mandatory reporting requirement for drug shortages had already wrapped up, and she anticipated that the requirement would be forthcoming.

We have made great progress. Mandatory reporting of anticipated drug supply disruptions is an important step, but we intend to continue to advocate directly and also through the CMA for processes that will be helpful in minimizing the impact of such supply disruptions when they occur. Specifically, we would like to see a process established whereby Health Canada, in the face of anticipated shortages of essential drugs in the domestic marketplace, may “fast-track” the approval and importation of alternative equivalent drugs that are being safely used in other jurisdictions. This could perhaps be accomplished through a broadening of the parameters under which the existing Health Canada “Special Access Program”1; is permitted to be invoked, or through a new and distinct process.”

1The Special Access Programme (SAP) provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada. Drugs considered for release by the SAP include pharmaceutical, biologic, and radio-pharmaceutical products not approved for sale in Canada.

 

 

PRESIDENT’S MESSAGE

 

“Leadership” commonly has wide-ranging definitions. Broadly, the dictionary defines it as “to lead a group of people or organization” but really it doesn’t have a one-size-fits-all definition.

The fact is that the definition of “leadership” varies as it is a complex concept.

In the CAS context, I believe that our leadership means we are organizationally proactive and responsive in serving our members’ needs and supporting the important work they do every day in all aspects of their patient care.

Most recently, two important “successes” underscore CAS’ leadership on the national stage – Health Minister Rona Ambrose’s recent announcement about the federal government’s actions regarding drug shortages, and the Choosing Wisely Canada campaign to promote discussion between physicians and patients.

 

CAS Advocacy Efforts on Drug Shortages Yields Government Action

On February 10, 2015, Health Minister Rona Ambrose announced that the federal government is moving to make it mandatory for pharmaceutical manufacturers to notify government and the public of threats that could lead to shortages of essential drugs. Dr Douglas DuVal, Vice-President, represented CAS at this announcement, which is the culmination of CAS’ unwavering advocacy efforts over five years.

CAS’ leadership role in this initiative is particularly important because drug shortages significantly impact patient care and therefore have a broad public interest component. We were advocating on a national stage and we achieved results.

I would like to acknowledge the dedication and leadership shown by Drs Richard Chisholm, Patricia Houston and Douglas DuVal, and all of the other committed volunteers who – each in their own way – keenly demonstrated that their collaborative styles of leadership reaped significant benefits.

 

Choosing Wisely Canada

For several months, CAS members have been hearing about the Choosing Wisely Canada campaign and surveys have now been distributed to members.

In fact, this campaign is an excellent opportunity to take a leadership role. It is aimed at helping physicians and patients engage in conversations about unnecessary tests, treatments and procedures, and supporting physician efforts to help patients make smart and effective choices to improve the quality of their care. With the considerable media attention on patients’ rights and expectations, CAS’ involvement in this campaign is in the interests of both our members and our patients.

 

Looking Ahead

I am very proud of our efforts as a Society and look forward to embracing other initiatives that will require us to take action.

What’s also important now is to mark your calendar for June 19-22 in Ottawa for the CAS Annual Meeting!  On the scientific program is interesting and leading-edge thinking focused on the brain and anesthesia. On the social side, there will be plenty of “fun” activities. Many CAS volunteers are already working hard to deliver an outstanding 2015 Annual Meeting. Please register early!

 

Dr Susan O’Leary, FRCPC

President