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Immunization case raises questions about medical self-regulation

During the holidays, a veteran Halifax pediatrician had his licence suspended for improperly administering vaccines to as many as 500 children.

Dr. William Vitale had a habit of mixing vaccines for various childhood immunizations into a single syringe rather than administering them separately. This can render vaccines ineffective, so many of those kids will need to get new shots.

The irony of this is that he told investigators he mixed shots into a single syringe to reduce the number of needles children would have to get.

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However well-intentioned, the most troubling part of Vitale's behaviour is how long it went on. Pediatric patients from 1992 to 1994 and again from 2003 to the present may need to be re-vaccinated. (There is a gap because the childhood immunization schedule in Nova Scotia did not call for more than one shot per visit between 1994 to 2003.)

Moreover, we know that in 2006, a parent complained her child did not receive the recommend vaccinations, exposing the vaccine-mixing problems. At the time, Vitale was simply spoken to by administrators with the health authority and he apparently promised to discontinue his practice of mixing vaccines.

No formal complaint was made to the College of Physicians and Surgeons of Nova Scotia, so no investigation was conducted and no formal action was taken until another parent complained late in 2013.

Immunization is a core responsibility of a physician. The rules on how to give shots are crystal clear. Doctors are even provided with an annual reminder of where and how vaccines should be administered and it states specifically that vaccines should not be co-administered (mixed, in lay terms).

If someone can flout the rules for a decade what does that say about the adequacy of oversight?

Medicine is a self-regulating profession. To practice, graduates of medical schools must register with their provincial college and remain members in good standing. The role of the college is to maintain standards of practice, investigate complaints about doctors on behalf of the public, and conduct disciplinary hearings and mete out punishment when appropriate. (The exception is when there is criminal behaviour.)

It must be stated – and stressed – that the vast majority of physicians discharge their duties professionally. But what can be done about the few who don't? How do you protect the public from the bad apples?

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The college can't be looking over everyone's shoulder, making sure, for example, that all doctors are administering vaccines properly. Rather, it tries to ensure all practising physicians are properly trained and are enhancing their knowledge on an on-going basis.

The standard way of doing this is with continuing medical education. Doctors attend conferences and lectures, earning CME credits, and each specialty has standards that must be met. There is some criticism of this system because it can be easy to get CME credits, but, again, most doctors take on-going education seriously.

There are also other measures to prompt doctors to keep up-to-date, such as the granting of privileges in health-care institutions. But is it enough?

There is a school of thought that argues physicians should be re-certified, obliged to write exams periodically to ensure they are as current as new graduates. But an ability to write exams is not the same as the ability to be a good doctor.

Monitoring performance for independent practitioners is difficult, an issue the Federation of Medical Regulatory Authorities struggles with continually.

In this case, lack of training was not an issue; Vitale has a distinguished academic record. He is essentially a rogue – someone who decided to do things his way. Regardless of the reason, it was wrong, unacceptable and deserving of sanction.

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The public complaints process ultimately worked, but it took a long time. That is not surprising: Every parent cannot be expected to know the details of childhood vaccination schedules. There was also no immediate, visible harm from the mixing of vaccines, so the problem was particularly difficult to spot.

The fact that Vitale worked in a solo practice didn't help either. Research clearly shows rogue practitioners almost always work alone, not in teams. Peer pressure is one of the best tools to ensure professional behaviour.

The good news is that when the College did learn of the problem, it acted quickly, suspending Vitale immediately and working to ensure affected children got vaccinated properly. But there is something unsatisfying about the whole process, when the case is shrugged off as an isolated incident.

People put a lot of trust in physicians – in some cases, they literally put their lives in doctors' hands. They need reassurance that patient safety is paramount and that bad apples will be weeded out quickly and efficiently. Quiet self-regulation doesn't necessarily deliver that message.

Follow me on Twitter: @picardonhealth

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