Stewardship is Structure

Certainly in the Canadian context, Antimicrobial Stewardship is a public service.

public service noun

  1. : the business of supplying a commodity (as electricity or gas) or service (as transportation) to any or all members of a community
  2. : a service rendered in the public interest

It fulfills both of these dictionary definitions perfectly. Stewardship programs provide a service to members of communities — The community of healthcare providers to aid in their provision of care and to the community at large to provide the ongoing benefits of the availability of effective antimicrobials. This is very much in the public interest.

More established public services such as the police, fire fighting and waste removal are easy to conceptualize and understand. Others such as fisheries and forest management are more difficult. Few would dispute that the management of common resources is important, however. Common to all are several elements.

Information
Could the Department of Fisheries perform its’ functions without information? Of course not. Just as information about fish stocks is necessary to define sustainable fish harvest quotas, information is necessary to manage antibiotics. Fortunately, much of the information needed to manage antibiotic use is readily available. Millions of susceptibility tests are performed and all antibiotics distributed for human use are under prescription and have records associated. We haven’t yet done a good job of collation, redistribution and display but it is only a small amount of idea and resource away.

Manpower
Nothing ever prospers as a “side of the desk” endeavour. Why would Antimicrobial Stewardship be any different? It needs dedicated thoughtful people with appropriate skill sets – just like anything else. The good news is that evaluations of established AS programs have shown cost savings even after taking account the increased expenditures on manpower. Antimicrobials have been so poorly managed that there is much wasted resource. There is a large potential to turn misused antimicrobials into excellent, well-paid, stable jobs for Canadians.

Policies and Procedures
Policies are informed by principles and guide procedures. Goal statements and metrics for evaluation are central. Nothing unusual about this. However, this is new in Canada and much trial and error is to be expected. The principles should be firmly established but procedures will necessarily be diverse as Canadian health delivery is diverse.

Education
The cornerstone of sustainability. All established conservation programs become easier to enact as the benefits are recognized by more and more people. They become the norm.

Canada is poised for a Antimicrobial Stewardship revolution. We have the enthusiasm, the people and the need. We just need some structure.

A new look

InfectionNet has a new look and hopefully some new followers.

After a reasonably long and patient courtship with Drupal, we have cast it aside in favour of WordPress. Terry (the web design master) and I think infectionNet scrubs up quite well with her new content management software. There is a bit of tweaking yet to do so don’t fret over a bit of messed up formatting.

The elements are all still there – articles, notes from medical school lectures and laboratory protocols and I have added some important new sections. Therapy guidelines are derived from the Vancouver Island Health Authority’s Antimicrobial Review Committee’s empiric guidelines that were produced during a recent collaborative antibiotic stewardship effort at Cowichan District Hospital.

The Discussions section has been revamped and, hopefully, is a more user-friendly way of finding answers to your questions and to interact with peers. It is now easy to sign up with your Facebook or Google IDs and have your say.

The Cases section is very lean on content at present but there are plenty of interesting cases and they need display. Keep checking back, or better yet tell me about yours.

Be sure to sign up for email updates, and follow us on twitter as infectionNet is going to be much more proactive and interactive. If you have any suggestions at all please let me know using the contact form.

National pharmacare for antimicrobials

Canada is a patchwork of private – public coverage for pharmaceuticals. All provinces have pharmacare plans but they vary widely in coverage. Saskatchewan and Manitoba have forms of universal coverage while other provinces cover specific groups such as those on social services and the elderly.

In 2005 the first ministers conference saw a plea for a national pharmacare plan endorsed by all premiers. It was widely discredited as a provincial grab for federal money as a response to pharmaceuticals being the most rapidly expanding sector of healthcare expenditure. It was scoffed at by the federal government and deemed to be “too expensive” for consideration. This despite overwhelming evidence that the buying power and reduced bureaucracy afforded by cooperation would result in significant savings.

How about just antimicrobials? The federal expense would not be prohibitive. Outpatient antimicrobials total less than a billion dollars annually. It could lay the groundwork for future expansion to other classes and most importantly it would distinguish antimicrobials as needing special regulatory attention.

A National Antimicrobial Pharmacare plan is a sensible approach to the ever-expanding problem of antimicrobial resistance.

Stewardship is the word

I have been involved in the effort to improve antibiotic policy and practice for many years and a recent development may be a large help. Rather than advocating for prudence we are now recommending stewardship. Prudence – classically considered a virtue, in particular one of the four Cardinal virtues, conjures up the notion of morality. One who prescribes antibiotics poorly is immoral.

Stewardship is entirely different. It is an ethic that embodies cooperative planning and management of resources and conjures the notion of help and guidance. One who prescribes antibiotics poorly needs guidance.

I think this subtle shift in the language of antibiotic policy may help us immensely. Rather than demanding prudent use regulations that imply the stamping out of immorality we can offer frameworks for regulatory bodies to cooperatively guide prescribers. That guidance may necessarily have to include restrictive policies but with the restrictions arrived at in a more consensual fashion.

If you are interested in Antimicrobial Stewardship check out the International Society of Chemotherapy’s new Inventory of Antimicrobial Stewardship projects.

Stewardship with effect – The 4 C’s

This graph depicts the change in percentage of antibiotics belonging to the 4C group – clindamycin, cephalosporins, co-amoxiclav, and ciprofloxacin (fluoroquinolones) in Grampian, Scotland NHS acute care hospitals. There is a strong association with reductions in C. difficile incidence.

This graph show the changes in the individual classes of 4 C’s. Very impressive reductions demonstrating the power of organized stewardship efforts.

Thanks to Dr. Ian Gould for sharing this. This project was specifically designed to reduce the incidence of C. difficile by reducing the use of antibiotics most associated with C. difficile disease. Read more about The 4 C’s Project here at the International Society for Chemotherapy’s World Inventory of Antimicrobial Stewardship site.

It appears that Scotland is making great strides in organized antimicrobial stewardship having established a country-wide multidisciplinary forum in 2008 referred to as the Scottish Antimicrobial Prescribing Group (SAPG). Read more about their efforts here at the SAPG website.

An example of good, well-displayed information being well received

Problem
Protocols for microbiology laboratory technologists were hard to access. Paper manuals were hard to locate. “Cheat sheets” were not uniform and had been edited in an ad hoc fashion. Senior technologists offered differing opinions to junior technologists.

Solution
InfectionNet/Lab. Modern, web-based, well-displayed information accessible to all. One version. Controlled creation and editing. Easily enhanced.

In two short months this means of creating and displaying microbiology laboratory protocol information has been not only accepted but very actively embraced by Eastern Health laboratory staff. They have discussed, suggested improvements, and taken steps to assuming ownership of the content.

Good design effecting positive change – excellent.

Antibiotic resistant gonorrhea – another reason for antibiotic regulation

An excellent paper and accompanying editorial in the Canadian Medical Association Journal describes huge increases in fluoroquinolone antibiotic resistance in Ontario from 2002 to 2006. Similar changes have been described in many other parts of the world.

Fluoroquinolones have only been in existence since the 1980s and first licensed for sale in Canada in 1988. They were the first new class of antibiotic introduced for many years and were received with extreme expectations. They were widely touted as the solution to antibiotic resistance to penicillins, tetracyclines, sulfa antibiotics and others. Ciprofloxacin, the most successful of the class was brilliantly marketed to community-based physicians as having “IV power in an oral formulation”.

In 20 short years one might say “the arse has well and truly fallen out of ‘er”. Fluoroquinolones are all but useless for many clinical indications. 20 years! All over the world!

Another good reason to increase attention to antibiotic misuse and develop the regulatory structures needed to tackle this urgent and relentless problem.

H1N1 vaccine

Health Care Workers

I believe all health care workers should be immunized against H1N1 and that includes clerks and residents. All health care workers should be immunized annually with seasonal vaccine as well. Healthcare workers have a societal obligation to be available during times of need. The potential large societal benefit outweighs the individual risks.

General Population

Should all of the general population be immunized against H1N1? I am not so categorical here. I understand the position of the Public Health Agency of Canada concerning universal immunization. However, the large majority of illness has not been severe during the first part of this pandemic and a decision to decline immunization is a defendable one. This is certainly true with respect to those above 65 in which there has been very few infections suggesting considerable immunity.

Any risk/benefit analysis is predicate on quantification of risk and this is where things are less clear. The risk associated with this vaccine is undeniably small or it would not have been licensed by multiple national licensing bodies including our own. However, there are legitimate concerns over the level of safety owing to the obvious need for rapid evaluation. The quantification of safety needed for approval was very necessarily less than the level required for vaccines and other drugs that are not needed in as time-sensitive a fashion.

Controversies

The primary safety concerns pertain to the non-viral components of the vaccine as the viral antigens are produced in identical fashion to seasonal influenza vaccines. The Canadian vaccine Arepanrix from GlaxoSmithKline contains the preservative thimerosol and the adjuvant AS03, both of which are somewhat controversial.

Thimerosol
Thimerosol is used in the current vaccine because of the need for multi-dose vials to which adjuvant must be added shortly before administration. It is not practical to add adjuvant one dose at a time. It is a mercury containing preservative that has long been vilified by anti-vaccination groups (especially as a putative cause of autism) and has also been the subject of much study that has vindicated its safety. Despite this large safety data the scepticism persists and the last decade has seen a large reduction in its use especially in childhood vaccines.

My take: Thimerosol is NOT a significant concern.

AS03 Adjuvant
Adjuvants are substances added to vaccines to enhance immunologic response and in the case of H1N1 vaccine are needed to increase the supply of vaccine as much less viral antigen is needed per dose. Arepanrix contains 3.75 micrograms of influenza antigen while Non-adjuvanted vaccine needs 15 micrograms of antigen.

AS03 is one of 2 commercial “new generation” adjuvants that are similar but not identical. The other is MF59 from Novartis for which there is much more experience as it is part of Fluad – a seasonal influenza vaccine that has been widely used in Europe since 1997. The observations of long-term safety pertain to this use of MF59 and are extrapolated to AS03. Both AS03 and MF59 are oil-in-water emulsions containing squalene – a naturally occurring precursor to cholesterol and steroids that is plentiful in shark liver oil, the primary source of commercial squalene (The shark liver origin is the source of fear of problems in people with fish allergy. This is a theoretic problem that has never been reported).

Squalene is particularly controversial in the United States. It was implicated as the cause of “Gulf War Syndrome” when a study of sufferers reported a high incidence of anti-squalene antibodies. Despite much evidence to the contrary and the World Health Organization publishing an extensive report on the safety of squalene containing adjuvants, the US FDA has never approved a squalene-containing adjuvant and the issue may come to a head as H1N1 vaccine shortages loom large in the US.

My take :Early experience with AS03 suggests that is safe and large long-term experience suggests MF59 is very safe. Squalene appears to be a safe component of adjuvants. AS03 has not been used widely and definitive safety information remains to be generated.

Question your doctor about your antibiotic prescription

I gave a talk at the Canadian Society for Laboratory Science annual general meeting today concerning antibiotic resistance. In it I suggested that everyone has a role in the solution to the problem. Afterward someone asked me if they should question their physician more thoroughly when they are given a prescription. It is something I have been asked before and have generally been reluctant to suggest that questioning their doctor’s prescription decision was appropriate. I have been very conscious of the need for a cooperative, blameless approach.

I have changed my mind.

Everyone should demand very specific information about all antibiotic prescriptions. You should be aware of the exact diagnosis, the expected course of illness and symptoms that would suggest need for further medical assessment. Discussions of alternatives are completely appropriate. If your doctor can’t or won’t give you the information you want consider another opinion.

Taking antibiotics is serious business and deserves serious personal consideration. The more questions asked the better.