VANCOUVER, Jan. 22 /CNW/ - A new study published in the journal,
Alimentary Pharmacology & Therapeutics, reveals that a BC Government
PharmaCare policy introduced in July 2003, which was intended to reduce costs
by $42 million with minimal impact on patient health, in fact, cost the
healthcare system and patients $43.5 million and had a significant impact on
patients' quality of life.
"This therapeutic substitution policy, which forces patients to switch
from one of four Proton Pump Inhibitor brand medications to another brand name
that is the cheapest or forego PharmaCare coverage, was made without any
clinical studies or supportive data," said Gail Attara, study co-author and
executive director of The Canadian Society of Intestinal Research (CSIR). "It
is not about generic substitution, but is about the government replacing one
chemical for another non-bio-equivalent one, simply because it's cheaper."
Dr. James Gray, study co-author, clinical gastroenterologist, and
Associate Professor at the University of BC explained, "Following this policy
change, many patients who were forced to make a non-medically-necessary
medication change experienced destabilization of their acid-related diseases
and consequent symptoms. In some cases, severe symptoms such as relentless
heartburn, and medication side effects including diarrhea, vomiting, nausea,
chest pain, fatigue and, less commonly, vomiting blood, required visits to
physicians and even hospitalization. We felt strongly that this increased use
of healthcare resources would cancel out any possible savings to the drug
budget, but we needed to examine the data to be sure."
This original scientific paper focused on the impact of the therapeutic
substitution policy of Proton Pump Inhibitor (PPI) drugs. During the
three-year study period, as many as 87,000 patients in BC with acid-related
diseases had to stop taking the medication that was working for them, and
switch to the cheapest available PPI (n= 2003: 45,374; 2004: 24,676; 2005:
17,412). Researchers performed the most in-depth analysis of its type using
the BC Ministry of Health Services linked health databases for the period
2003-2005, which they accessed by special permission. The study found that, as
a direct result of the therapeutic substitution policy, there were $24.65
million spent on additional physician services, $9.75 million for additional
hospital services, and $9.11 million in increased PPI utilization, for a total
of more than $43.5 million.
"While anecdotal information existed, we knew we needed hard data to
confirm that any potential short-term savings to a drug budget from policies
such as this can be cancelled out by significant costs to physician and
hospital budgets," said Brett J. Skinner, co-author and director of
bio-pharmaceutical and health policy research at the Fraser Institute, who
collaborated with CSIR by taking the lead in data analysis. "This study points
to the dangers of decision-making within healthcare budgetary silos."
Therapeutic substitution requires patients to switch from one brand
product to another brand product in the same therapeutic class. It is
different from generic substitution where the drugs are bio-equivalent. This
policy falsely assumes that all PPIs are the same but, by definition, patented
medicines are different, as they elicit variable therapeutic outcomes and side
effects. British Columbia was the first province to implement this kind of
therapeutic substitution policy.
"Diversity within any therapeutic class is critical to optimizing patient
care," said Gray, "A physician needs all the tools available to properly care
for patients using an individualized approach because one size doesn't fit all
when it comes to healthcare. Limiting or restricting coverage for specific
medications makes the physician's job more difficult and in the long run, is
not beneficial for the patient."
"On the August long-weekend in 2003, I went to pick up my PPI
prescription, only to find that it hadn't been filled due the new therapeutic
substitution policy. Six weeks went by before I could see my doctor about this
forced medication switch," said Lynn Macdonald from Kelowna, BC "After
PharmaCare repeatedly denied coverage for the medication that my doctor
prescribed, and that had already been effectively treating my reflux, I was
finally granted approval, four years later! Not only did I suffer from my acid
reflux symptoms needlessly, my other health concerns worsened as well."
A previous study associated with Harvard University, often cited by the
BC Government as one that demonstrates the success of this policy, was too
narrow to evaluate fully the impact of therapeutic substitution. For example,
the earlier study was restricted to patients over 65 years old and looked at
hospital utilization associated with only one extreme outcome,
"CSIR has discussed the study results with the Ministry of Health
Services," said Attara, "And we look forward to further discussion on
initiatives to improve the quality of life for persons with acid-related
diseases in British Columbia." CSIR is asking for a public commitment from the
BC Government to disallow any therapeutic substitution because it harms
patients. Clearly, these drugs are all different, as are the patients who they
are designed to help.
CSIR strongly urges other jurisdictions to review the study findings
before considering or implementing any therapeutic substitution policies.
For further information:
For further information: or to view the study contact: Meaghan Benmore,
(604) 692-4228; or Julie Holroyde, (416) 413-1218