Therapeutic Substitution: Does one size really fit all?

Therapeutic Substitution: Does one size really fit all?2016-11-30T11:44:17+00:00

Your Health Could Be At Risk Just Because You Are Different!

Medicine rationing has crept into the fabric of Canadian life. As various administrations take a nip at our rights here and trim our access there, we need to pay close attention. Some of the new policies limiting our coverage are shaping our health care systems into monsters. If you haven’t encountered a monster yet, you soon might. Your drug plan could be the next one to adopt restrictive access policies. Here’s an analogy of what’s happening…

Imagine a government-funded ‘shoe plan’ where everyone is guaranteed a pair of shoes. Advertised as ‘shoes for everyone’, the program’s aim is to be cost-effective. The only downside is that there is just one size and style of shoe available – specifically a ladies’ size six red stiletto! Sure, it’s cost-effective, because the bulk purchase means the per-unit cost is very low, and a pair of shoes is available for everyone. Now, imagine the limits of such a program. The shoes would be useless for anyone who doesn’t have size six feet and the stamina to wear a stiletto. This ‘one size fits all’ approach to providing shoes is clearly absurd. So, why then are the various governments establishing similar systems to address health care?

When we look into the sensitivities, allergies, and preferences within any given group of people, there can be more variances than the total number of shoes in the world! Human adverse reaction to medication is no different. While medicines are essential to maintain a healthy population – representing the best value in health care today – they are not without consequences. Aunt Mable’s reaction to high blood pressure medicine is so severe she can’t stay on it without serious complications and Uncle Robert can’t take a certain headache medication without a worsening of his pain. My friend, Debbie, has little effect from any medicine at the recommended dose and Jacob breaks out in a rash from almost any antibiotic. We’ve all heard stories like these about medications; they are no surprise.

In fact, Health Canada established the MedEffect website in 2005 for online reporting of side effects to health and nutrition products, medical devices, and medication. The website is also a place for reporting if these goods don’t work or live up to claims made about their efficacy. Behind the website is a verified, centrally managed database containing reports from Canadians – such as the people who take these products, or their doctors, nurses, or pharmacists. The information gathered clearly demonstrates products working well for some people, producing no side effects, yet causing severe side effects in others. The existence of such a database confirms what we intrinsically know – that while similar in many ways, we are still unique. Vive la différence!

In a ‘one size fits all’ approach to medicine, some Canadians with severe acid reflux, or GERD, may not have access to the crucial medication that controls their relentless symptoms. This is because ‘cost-saving measures’ by drug plans are interfering with doctor-patient relationships and, in the long run, are not fiscally responsible.

The administrators of the British Columbia PharmaCare program took the first giant step down this slippery slope in July 2003. Their medicine rationing policy, called therapeutic substitution (TS), was introduced with very little warning or forethought for patient health.

All patients taking a proton pump inhibitor (PPI) to treat severe GERD had to stop taking the medication that was working for them and start taking the cheapest brand name drug. BC made this change to the reimbursement policy without any evidence to support the benefits of such a mass switching of patients from one drug to another, and without having conducted a pilot project to see if there might be a risk to patient health.

By BC PharmaCare’s own admission, 25% of the people they forced to switch ‘failed’ on the cheapest product. This meant that thousands of people went from being stabilized on a medication, to experiencing severe heartburn and side effects including diarrhea, vomiting, nausea, chest pain, and fatigue. Some were even admitted to hospital vomiting blood. Those who failed were eventually switched back to the medication that worked for them – after an eight week failure period – but the whole switching process was extremely hard on the patients.

True, the BC government plan worked for 75% of the people but at what cost to the 25%? If you are part of the minority who has trouble with the cheapest medication, your health could be at risk! We have to ask some serious questions. Is affordable, quality health care only for the majority? And when you consider that someday you might not be in the majority – will the system let you down?

The BC PharmaCare program administrators assumed that all of the medications in the PPI class were interchangeable despite the fact that they are all brand name products, not generic versions. BC did not substitute one product for its generic ‘equivalent,’ but it substituted one brand name product for another, totally different chemical. It’s like the man with size twelve feet trying to wear a ladies’ size six stiletto!

The consequences of the TS medicine rationing policy were costly and much more uncomfortable than the twisted ankle and blisters the wrong size of shoe might cause. First, there were the tangible extra burdens to the health care system in the forms of extra visits to doctors, emergency rooms, and hospitals; extra diagnostic testing; and wasted medication – 25% of prescriptions were thrown out when patients had side effects or loss of efficacy. Next, there was the toll on the patients that ranged from lost productive time to emotional and economic stresses. The real-life stories of patient harm in BC are overwhelming. Obviously ‘one size fits all’ does not work with medicine any better than it does with shoes.

This mass switching of stabilized patients proved to us what we already knew, that what works well for one individual, causes trouble in another. Just as each patient is different, so are the medications. Choice is imperative for doctors in determining the right treatment for the patient. In failing to recognize this, ‘cheapest drug first’ policies actually result in higher costs to the health care system.

When patients failed on the cheapest drug, the BC health care system had to pay for these patients to see their doctors, have diagnostic testing, and stay in the hospital. The thing about severe GERD is that its symptoms are very similar to those experienced during a heart attack. So, if the cheapest medication failed to control a patient’s GERD symptoms, they could end up with symptoms mimicking a heart attack. This is costly for the health care system and very scary for the patient!

Among the six various brand names in the PPI class of medication, the greatest cost difference is less than a dollar per daily dose. A patient could be on a more expensive

medication for years before it would amount to the cost of one full cardiac work-up in hospital for someone with chest pain. Allowing patients to remain on the medication that works for them would cause no disruption to their lives and no extra costs to the health care system.

Why would any government choose to risk patients’ health for such small savings in a drug budget, and such expensive potential spending in the medical, hospital, and diagnostic budgets? This is silo mentality, where one area of government does not recognize its affect on other areas. Those administrating the medical and hospital budgets would be wise to look over the shoulder of those managing the drug budget to make sure they are spending enough on medications to keep people out of hospitals and physicians offices. This would be true fiscal responsibility.

Worldwide research shows that to achieve optimal care and positive patient outcomes, physicians need the ability to prescribe medications based on best clinical practice guidelines in relation to the patients’ unique medical history. Physicians don’t make decisions based on hard facts alone; they make intuitive assessments of each individual patient based on years of medical training and clinical practice. Caring for patients is not like solving mathematical problems. Peoples’ health cannot be managed so simplistically. While medicine is science, it is also an art.

Why don’t jurisdictions managing health care funding recognize that it’s not about the numbers; it’s about people? It does not make economic sense to limit access to a medication that controls a serious illness today, then to pay thousands tomorrow for the consequences of a disease run rampant.

So what are the alternatives? Let’s not criticize what exists without shining a light on a new path to walk, and on a shoe that fits. First and foremost, drug reimbursement plans (government, private, etc.) must commit to pursuing measures that do not put patients at risk. Next, they should engage patients, physicians, pharmacists, and other interested parties in developing sustainable reforms that are uniquely Canadian. These could include educational programs to assist patients in using their medications as prescribed; encouraging overall wellness as a means of disease prevention and the implementation of other fully integrated patient health management strategies.

The Canadian Society of Intestinal Research and many other patient groups, particularly those who are members of the Best Medicines Coalition and the Better Pharmacare Coalition are asking the administrators of drug formularies all across Canada to stop putting patients’ health at risk and are offering solutions that recognize the need for fiscal restraint while still providing optimal patient treatment options.

Your drug plan could be next! Since British Columbia made the dramatic leap in implementing therapeutic substitution for proton pump inhibitors, other jurisdictions have begun cutting back access to these medications too. The Non-Insured Health Benefits (NIHB) program that provides benefits to some aboriginal people has also made dramatic cuts and patients are suffering.

It is getting worse. Today they are rationing medications for people with GERD, tomorrow it could be for cholesterol-lowering treatments, or anti-depression prescriptions, or the very medication you need to stay well.

Canadians deserve access to all medications approved by Health Canada. When used appropriately, medications save lives, ward off disease, and improve quality of life. I would rather trust decisions about my care to a physician who knows my medical history than to a government employee whose narrow-focused goal is to cut costs in one health care silo. What about you?


Gail Attara, President & CEO, GI Society
First published in the Inside Tract® newsletter issue 158 – November/December 2006